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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

What is Strensiq

Strensiq is a medicine used to treat the inherited disease hypophosphatasia that started in childhood. It contains the active substance asfotase alfa.

 

What is hypophosphatasia

Patients with hypophosphatasia have low levels of an enzyme called alkaline phosphatase that is important for various body functions, including the proper hardening of bones and teeth. Patients have problems with bone growth and strength, which can lead to broken bones, bone pain, and difficulty walking, as well as difficulties with breathing and a risk of seizures (fits).

 

What is Strensiq used for

The active substance in Strensiq can replace the missing enzyme (alkaline phosphatase) in hypophosphatasia. It is used for long-term enzyme replacement treatment to manage symptoms.

 

What benefits of Strensiq have been shown in clinical studies

Strensiq has shown benefits for patients’ mineralization of the skeleton and growth.


Do not use Strensiq

If you are severely allergic to asfotase alfa (see section ‘Warnings and precautions’ below) or any of the other ingredients of this medicine (listed in section 6). 

 

Warnings and precautions  

Talk to your doctor before using Strensiq.

•              Patients receiving asfotase alfa have had allergic reactions including life threatening allergic reactions requiring medical treatment similar to anaphylaxis. Patients who experienced anaphylaxis-like symptoms had difficulty breathing, choking sensation, nausea, swelling around the eyes, and dizziness. The reactions occurred within minutes after taking asfotase alfa, and can occur in patients who were taking asfotase alfa for more than one year. If you experience any of these symptoms, discontinue Strensiq and seek medical help immediately.

Should you experience anaphylactic reaction, or an event with similar symptoms, your doctor will discuss with you the next steps and the possibility to restart Strensiq under medical supervision. Always follow the instructions provided by your doctor.    

•              The development of blood proteins against Strensiq, also called anti-drug antibodies, may occur during the treatment. Talk to your doctor if you experience decreased efficacy with Strensiq.

•              Fatty lumps or decreased fatty tissue on the surface of the skin (localized lipodystrophy) have been reported at injection sites after several months in patients using Strensiq. Read section 3 carefully to know the injection recommendations. This is important to rotate the injection from among the following sites to reduce the risk of lipodystrophy: abdominal area, thigh, or deltoid.

•              In studies, some eye-related side-effects (e.g. calcium build-up on the eye [conjunctival and corneal calcification]) have been reported both in patients using Strensiq and those who were not, probably associated with hypophosphatasia. Talk to your doctor in case of problems with your vision.

•              Early fusion of the bones of the head (craniosynostosis) in children below 5 years of age has been reported in clinical studies of infants with hypophosphatasia, with and without use of Strensiq. Talk to your doctor if you notice any change in the shape of your infant’s head.

•              If you are treated with Strensiq, you may experience a reaction at the injection site (pain, nodule, rash, discoloration) during the injection of the medicine or during the hours following the injection. If you experience any severe reaction at the injection site, tell your doctor immediately.

•              Increase of parathyroid hormone concentration and low calcium levels have been reported in studies. As a consequence, your doctor may ask you to take supplements of calcium and oral vitamin D if needed.  

•              Weight gain may occur during your treatment with Strensiq. Your doctor will provide dietary advice as necessary.

 

Other medicines and Strensiq

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

 

If you need to undergo laboratory tests (giving blood for testing), tell your doctor that you are treated with Strensiq. Strensiq may cause some tests to show wrongly higher or lower results. Therefore, another type of test may need to be used if you are treated with Strensiq.  

 

Pregnancy 

Strensiq should not be used during pregnancy. The use of effective birth control during treatment should be considered in women who are able to get pregnant. 

 

Breast-feeding 

It is not known whether Strensiq can pass into breast milk. Tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Strensiq, considering the benefit of breast-feeding to the baby and the benefit of Strensiq to the mother.

 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

 

Driving and using machines

This medicine is not expected to have any effect on the ability to drive or use machines.

 

Important information about some of the ingredients of Strensiq

This medicine contains less than 1 mmol sodium (23 mg) per vial, which means it is essentially

‘sodium-free’.


Always use this medicine exactly as described in this leaflet or as your doctor, or pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How to use Strensiq will be explained to you by a doctor who is experienced in the management of patients with metabolic or bone related diseases. After being trained by the doctor or specialized nurse, you can inject Strensiq yourself at home.

 

Dose

•              The dose you receive is based on your body weight.

•              The correct dose will be calculated by your doctor and consists of a total of 6 mg of asfotase alfa per kg of body weight every week, given either as an injection of 1 mg/kg asfotase alfa 6 times per week or as 2 mg/kg asfotase alfa 3 times per week depending on the recommendation of your doctor. Each dose will be administered by injection under the skin (subcutaneous), (see the dosing chart below for detailed information on the volume to be injected, and the type of vials to be used, based on your weight). 

•              Doses will need to be adjusted regularly by your doctor as the body weight changes.

•              The maximum volume per injection should not exceed 1 ml. If more than 1 ml is required, you need to do multiple injections immediately one after the other.

 

 

        If injecting 3 x per week                                      If injecting 6 x per week

       

 

Body

Weight

(kg)

Volume to be injected

Color code of the vial to be used

3

0.15 ml

Dark blue 

4

0.20 ml

Dark blue 

5

0.25 ml

Dark blue 

6

0.30 ml

Dark blue 

7

0.35 ml

Orange

8

0.40 ml

Orange

9

0.45 ml

Orange

10

0.50 ml

Light blue

11

0.55 ml

Light blue

12

0.60 ml

Light blue

13

0.65 ml

Light blue

14

0.70 ml

Light blue

15

0.75 ml

Pink

16

0.80 ml

Pink

17

0.85 ml

Pink

18

0.90 ml

Pink

19

0.95 ml

Pink

20

1 ml

Pink

25

0.50 ml

Green

30

0.60 ml

Green

35

0.70 ml

Green

40

0.80 ml

Green

 

 

Body

Weight

(kg)

Volume to be injected

Color code of the vial to be used

6

0.15 ml

Dark blue

7

0.18 ml

Dark blue 

8

0.20 ml

Dark blue 

9

0.23 ml

Dark blue 

10

0.25 ml

Dark blue 

11

0.28 ml

Dark blue 

12

0.30 ml

Dark blue 

13

0.33 ml

Orange

14

0.35 ml

Orange

15

0.38 ml

Orange

16

0.40 ml

Orange

17

0.43 ml

Orange

18

0.45 ml

Orange

19

0.48 ml

Light blue

20

0.50 ml

Light blue

25

0.63 ml

Light blue

30

0.75 ml

Pink

35

0.88 ml

Pink

40

1 ml

Pink

50

0.50 ml

Green

60

0.60 ml

Green

70

0.70 ml

Green

80

0.80 ml

Green

90

0.90 ml

Green (x2)

100

1 ml

Green (x2)

 

 

 

Injection recommendations

•              You may experience a reaction at the injection site. Read section 4 carefully to know what side effects can occur before using this medicine

•              When injecting regularly, the injection site should be changed between different areas of the body to help reduce potential pain and irritation

•              Areas with a good amount of fat below the skin (thighs, arms (deltoids), abdomen, and buttocks) are the most suitable areas to inject. Please discuss with you doctor or nurse the best sites for you. 

 

Before injecting Strensiq, please read the following instructions carefully

•              Each vial is for single use and should only be punctured once. Strensiq liquid should look clear, slightly opalescent or opalescent, colourless to slightly yellow and may have a few small translucent or white particles in it. Do not use it if the liquid is discoloured or contains any

lumps or large particles in it and get a new vial. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

•              If you are injecting this medicine yourself, you will be shown how to prepare and inject the medicine by your doctor, pharmacist or nurse. Do not inject this medicine yourself unless you have received training and you understand the procedure.

 

How to inject Strensiq

 

Step 1: Preparing the Strensiq dose

 

1.     Wash your hands thoroughly with soap and water.

2.     Take the unopened Strensiq vial(s) out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature. Do not warm Strensiq in any other way (for example, do not warm it in a microwave or in hot water). Upon Removal of the vial(s) from refrigeration, Strensiq should be used within 3 hours maximum (see section 5. How to store Strensiq).

3.     Remove the protective cap from the Strensiq vial(s). Remove the protective plastic from the syringe to be used. 

4.     Always use a new syringe contained in a protective plastic.

5.     Place a larger bore needle (e.g. 25G) on the empty syringe and with the protective cap on, push down and turn clockwise the needle onto the syringe until it is tight.

6.     Remove the plastic cap covering the syringe needle. Pay attention not to hurt yourself with the needle. 

7.     Pull the plunger back to draw air into the syringe equal to your dose.

 

Step 2: Withdrawing Strensiq solution from the vial

 

 

 

 

1.      Holding the syringe and vial, insert the needle through the sterile rubber seal and into the vial.

 

2.      Push the plunger in completely to inject air into the vial.

 

             

             

3.      Invert the vial and syringe. With the needle in the solution, pull the plunger to withdraw the correct dose into the syringe. 

 

 

4.      Before removing the needle from the vial, check that the appropriate volume

 

has been withdrawn and check the syringe for air bubbles. In the event that bubbles appear in the syringe, hold the syringe with the needle pointing upwards and gently tap the side of the syringe until the bubbles rise to the top.

 

5.      Once all the bubbles are at the top of the syringe, gently push on the plunger to force the bubbles out of the syringe and back into the vial.

 

 

 

6.      After removing the bubbles, recheck the dose of medication in the syringe to be sure you have drawn up the correct amount. You may need to use several vials to withdraw the complete amount needed to reach the correct dose.

 

Step 3: Placing the needle for injection on the syringe

 

1.     Remove the needle from the vial. Recap with one hand by placing the cap on a flat surface,  slide the needle into the cap, lift it up and snap it on securely using only one hand.

2.     Carefully remove the larger bore needle pushing down and turning counterclockwise. Dispose the needle with the protective cap in your sharps container.

3.     Place a smaller bore needle (e.g. 27 or 29G) on the filled syringe and with the protective cap on, push down and turn clockwise the needle onto the syringe until it is tight. Pull the cap straight off the needle.

4.     Hold the syringe with the needle pointing up and tap the barrel of the syringe with your finger to remove any air bubbles.

Control visually that the volume contained into the syringe is correct.

The volume per injection should not exceed 1 ml. If it is the case, multiple injections should be done at different sites.

You are now ready to inject the correct dose.

 

Step 4: Injecting Strensiq

 

 

1.     Choose an injection site (thighs, abdomen, arms (deltoids), buttocks). Most suitable areas for injection are marked grey in the picture. Your doctor will advise you on the possible injection sites

 

NOTE: do not use any areas in which you feel

 lumps, firm knots, or pain; talk to your doctor

about anything you find.

2.     Gently pinch the skin of the chosen injection area between your thumb and index finger.

 

 

3.     Holding the syringe like a pencil or a dart, insert the needle into the raised skin so it is at an angle of between 45º and 90º to the skin surface. 

 

For patients who have little fat under the skin or thin skin, a 45º angle may be preferable.

 

 

 

4.     While continuing to hold the skin, push the syringe plunger to inject the medicine slowly, and steadily all the way in.

 

5.     Remove the needle, release the skin fold and gently place a piece of cotton wool or gauze over the injection site for a few

                                                                           This will help seal the punctured tissue and

                                                                  prevent any leakage. Do not rub the injection site

after injection. 

If you need a second injection for your prescribed dose, get another Strensiq vial and repeat steps 1 through 4.

 

Step 5: Disposing of supplies

 

Please collect your syringes, vials and needle in a sharps container. Your doctor, pharmacist or nurse will advise you on how you can obtain a sharps container.

 

 

If you use more Strensiq than you should

If you suspect that you have been accidently administered a higher dose of Strensiq than prescribed, please contact your doctor for advice.

 

If you forget to use Strensiq

Do not inject a double dose to make up for a forgotten dose and contact your doctor for advice.

 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

 


Like all medicines, this medicine can cause side effects, although not everybody gets them.

 

If you are not sure what the side effects below are, ask your doctor to explain them to you.

 

The most serious side effects seen in patients receiving asfotase alfa have been allergic reactions including life threatening allergic reactions requiring medical treatment similar to anaphylaxis. This side effect is common [may affect up to 1 in 10 people]). Patients who experienced these serious allergic reactions had difficulty breathing, choking sensation, nausea, swelling around the eyes, and dizziness. The reactions occurred within minutes after using asfotase alfa and can occur in patients who were using asfotase alfa for more than one year. If you experience any of these symptoms, discontinue Strensiq and seek medical help immediately. 

 

Additionally, other allergic reactions (hypersensitivity) which may appear as redness (erythema), fever (pyrexia), rash, itchiness (pruritis), irritability, feeling sick (nausea), throwing up (vomiting), pain, chills (rigor), numbness of the mouth (hypoaesthesia oral), headache, blushing (flushing), fast beating of the heart (tachycardia), and cough may occur commonly. If you experience any of these symptoms, discontinue Strensiq and seek medical help immediately.

 

Very common: may affect more than 1 in 10 people

Reactions at the injection site during the injection of the medicine or during the hours following the injection (which can lead to redness, discolorations, itching, pain, fatty lumps or decreased fatty tissue on the surface of the skin, skin hypopigmentation, and/or swelling)

Fever (pyrexia)

Irritability

Skin redness (erythema)

Pain in hands and feet (pain in extremity)

Bruise (contusion)

Headache

 

Common: may affect up to 1 in 10 people

Stretched skin, skin discolouration 

Feeling sick (nausea)

Numbness of the mouth (hypoaesthesia oral)

Aching muscles (myalgia) Scar

Increased tendency to bruise 

Hot flush

Infection of skin at injection site (injection site cellulitis)

Reduced levels of calcium in the blood (hypocalcaemia)

Kidney stones (nephrolithiasis)

 

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in section 6. By reporting side effects you can help provide more information on the safety of this medicine.

 


Keep this medicine out of the sight and reach of children.

 

Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP. The expiry date refers to the last day of that month.

 

Store in a refrigerator (2°C-8°C). Do not freeze.

Store in the original package in order to protect from light. 

After opening the vial, the product should be used immediately (within 3 hours maximum at room temperature, between 23°C and 27°C).

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

 


The active substance is asfotase alfa. Each ml of solution contains 40 mg of asfotase alfa.

Each vial of 0.45 ml solution (40 mg/ml) contains 18 mg of asfotase alfa.

Each vial of 0.7 ml solution (40 mg/ml) contains 28 mg of asfotase alfa. Each vial of 1 ml solution (40 mg/ml) contains 40 mg of asfotase alfa.

 

The other ingredients are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate and water for injections.

 


Strensiq is presented as a clear, slightly opalescent or opalescent, colourless to slightly yellow aqueous solution for injection in vials containing 0.45 ml, 0.7 ml and 1 ml of solution. A few small translucent or white particles may be present. Pack size of 12 vials. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Alexion Europe SAS

103-105 rue Anatole France

92300 Levallois-Perret

France

 

Manufacturer

Alexion Pharma International Operations Unlimited Company

College Business and Technology Park, Blanchardstown

Dublin 15

Ireland


02/2022
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

ما هو سترينسك

سترينسيك هو دواء يٌستخدم في علاج مرض وراثي يُسمى نقص الفوسفاتاز الذي بدأ في الطفولة. وهو يحتوي على المادة الفعّالة أسفوتاس ألفا.

ما هو مرض نقص الفوسفاتاز

نقص الفوسفاتاز هو مرض وراثي يعاني المصابون به من انخفاض في مستويات إنزيم يسمى الفوسفاتاز القلوي  والذي يلعب دورًا مهمًّا في مختلف وظائف الجسم، بما في ذلك حصول العظام والأسنان على

الصلابة المطلوبة. ونتيجة لذلك يعاني المرضى المصابون من مشاكل في نمو العظام وقوتها، مما قد يؤدي إلى كسور في العظام، وألم في العظام، وصعوبة في المشي، بالإضافة إلى صعوبات في التنفس وخطر حدوث نوبات( تشنّجات).

ما هي دواعي استخدام سترينسك

يمكن للمادة الفعالة في سترين سك أن  تُعوض عن الإنزيم الناقص )الفوسفاتاز القلوي( لدى المصاب بنقص الفوسفاتاز. ولذلك يُستخدم هذا الدواء في العلاج التعويضي الطويل الأمد للأنزيم للسيطرة على أعراض المرض.

ما هي فوائد استخدام سترين سك التي ظهرت في الدراسات السريرية

أظهرت الدراسات السّريريّة فوائد استخدام سترين سك في تمَعدُن الهيكل العظمي ونموه لدى المرضى.

لا تستخدم سترينسك
إذا كان لديك حساسية شديدة نحو أسفوتاس ألفا (أنظر فقرة "الاحتياطات والتحذيرات" أدناه) أو نحو أيّ من
المكوّنات الأخرى لهذا الدواء (المُدرجة في الفقرة رقم 6 .)

الاحتياطات والتحذيرات
تحدث إلى طبيبك قبل استخدام سترينسك.
• ظهرت لدى بعض المرضى ممن عولجوا بأسفوتاس ألفا ردود فعل تحسسية بما في ذلك ردود فعل تحسسية
مهددة للحياة تتطلب علاجاً طبياً شبيه بعلاج التأق. وقد عانى المرضى الذين ظهرت عليهم أعراض تشبه
أعراض التأق من صعوبة في التنفس، والإحساس بالاختناق، والغثيان، والتورم حول العينين، والدوخة.
وقعت ردود الفعل هذه في غضون دقائق بعد استخدام أسفوتاس ألفا، ويمكن أن تحدث لدى المرضى الذين
يستخدمون أسفوتاس ألفا لمدة تتجاوز العام الواحد. إذا عانيت من أيّ من هذه الأعراض، توقّف عن
استخدام سترين سك واطلب المساعدة الطبية على الفور.
• إذا واجهت رد فعل تأقي، أو حدث له أعراض مشابهة، فسوف يناقش معك الطبيب الخطوات التالية التي
ينبغي اتخاذها وإمكانية إعادة استخدام سترين سك تحت إشراف طبي. اتبع التعليمات المقدمة من قبل الطبيب
دائما.
• قد يحدث تطوير بروتينات الدم ضد سترين سك، والتي تسمى أيضًا الأجسام المضادة للأدوية ، أثناء العلاج.
تحدث إلى طبيبك إذا واجهت فعالية منخفضة مع سترينسك.
• تم الإبلاغ عن وجود كتل دهنية أو نقص في الأنسجة الدهنية على سطح الجلد (حثل شحمي موضعي) في
مواقع الحقن بعد عدة أشهر في المرضى الذين يستخدمون سترين سك. اقرأ القسم 3 بعناية لمعرفة توصيات
الحقن. من المهم تدوير الحقن من بين المواقع التالية لتقليل خطر الإصابة بالحثل الشحمي: منطقة البطن أو
الفخذ أو العضلة الدالية.
• تم الإبلاغ في بعض الدراسات عن حدوث بعض الأعراض الجانبية المُ تعلّقة بالعي ون )على سبيل المثال ،
تراكم الكالسيوم في العين ]تكلس الملتحمة والقرنية[( قد تكون مرتبطة

بمرض نقص الفوسفاتاز لدى المرضى سواء أولئك الذين استخدم وا سترينسك أو ممن لم يستخدموه. استشر
طبيبك في حال ظهور مشاكل في الرؤيا لديك.
• تم الإبلاغ عن حدوث التحام مُبكر لعظام الرأس عند الأطفال (تعظم الدروز الباكر) دون سن الخامسة في
الدراسات السريرية
التي أُجريت على ال رضع الذين يعانون من نقص الفوسفاتاز، مع وبدون استخدام سترين سك. استشر طبيبك
إذا لاحظت أي تغيير في شكل رأس رضيعك.
• قد تُصاب أثناء مُعالجتك بسترين سك برد فعل في م وضع الحقن (ألم، ظهور عقيدات، طفح جلدي، تغير في
اللون) أثناء حقن الدواء أو أثناء الساعات التي تلي الحقن. إذا واجهت أي رد فعل حاد في موضع الحقن،
أخبر طبيبك على الفور.
• تم الإبلاغ في بعض الدراسات عن حدوث ارتفاع في تركيز هرمون الغدة الجار درقية وانخفاض مستويات
الكالسيوم في الدم. ولذلك، قد يطلب منك الطبيب تناول مكملات غذائية تحتوي على الكالسيوم
وفيتامين د الفموي إذا لزم الأمر.
• قد تحدث زيادة في الوزن أثناء العلاج بسترين سك. سيقدم لك طبيبك نصائح غذائية عند الضرورة.
أدوية أخرى وسترين سك
أخبر طبيبك أو الصيدلي إذا كنت تستخدم، أو استخدمت مؤخرّا أو قد تستخدم أيّ أدوية أخرى.
إذا كنت ستخضع لإجراء فحوصات م خبرية (إعطاء الدم للفحص)، أخبر طبيبك بأنك تتعالج بسترين سك. قد
يؤدي استخدام سترينسك للحصول على نتائج أعلى أو أقل لبعض الفحوصات بشكل خاطئ. لذلك قد تخضع
لنوع آخر من الفحوصات إذا كنت تتعالج بسترين سك.
الحمل
ينبغي تجنّب استخدام سترين سك أثناء الحمل . يجب مراعاة استخدام وسيلة فعالة لتحديد النسل أثناء العلاج
لدى النساء القادرات على الحمل.

الرضاعة الطبيعية
من غير المعروف ما إذا كان سترين سك يمكن أن ينتقل إلى حليب الثدي. أخبر ي طبيبك إذا كنت تقومين
بالرضاعة الطبيعية أو تخططين للقيام بذلك. سيساعدك طبيبك بعد ذلك على تحديد ما إذا كنت ستتوقفين عن
الرضاعة الطبيعية ، أو ما إذا كنت ستتوقفين عن تناول سترين سك، مع الأخذ في الاعتبار فائدة الرضاعة
الطبيعية للطفل وفائدة سترين سك للأم.
إذا كن ت حاملاً أو تقومين بالرضاعة الطبيعية ، تعتقدين أ نّك قد تكونين حاملاً أو تخططين لإنجاب طفل،
استشيري طبيبك أو الصيدلي قبل تناول هذا الدواء.
القيادة واستخدام الآلات
لا يُتوقع أن يكون لهذا الدواء أي تأثير على القدرة على القيادة أو استخدام الآلات.
معلومات هامّة حول بعض مكونات سترين سك
يحتوي هذا الدواء على أقل من 1 مليمول من الصوديوم ) 23 مجم( في كل قارورة، مما يعني أنه خالٍ من
الصوديوم.

https://localhost:44358/Dashboard

استخدم هذا الدواء دائمًا كما هو موضح في هذه النشرة أو حسب ارشادات الطبيب أو الصيدلي أو الممرض .

استشر طبيبك أو الصيدلي أو الممرض إذا كنت غير متأكد.

سيقوم الطبيب الذي لديه خبرة في علاج المرضى الذين يعانون من أمراض التمثيل الغذائي أو الأمراض الأخرى المُتعلقة بالعظام بتوضيح كيفية استخدام سترين سك لك. وستتمكّن من حقن نفسك بسترين سك في المنزل بعد أن يتم تدريبك على ذلك من قبل الطبيب أو الممرض المتخصص. 

الجرعة

• تعتمد الجرعة التي تتلقاها على وزن جسمك.

• سيتم حساب الجرعة الصحيحة من قبل الطبيب وتتكون من 6 مجم من الأسفوتاس ألفا لكل كيل وجرام من    وزن الجسم كل أسبوع. تعطى إما كحقنة 1 مجم / كجم أسفوتاز ألفا 6 مرات في الأسبوع أو 2 مجم / كجم أسفوتاز ألفا 3 مرات في الأسبوع حسب توصية طبيبك. كل جرعة ستكو ن  تُعطى عن طريق الحقن تحت الجلد، )انظر إلى جدول الجرعات أدناه للحصول 

  على معلومات مفصلة عن حجم الدواء المراد حقنه، ونوع القارورة التي ينبغي استخدامها ،تبعًا لوزنك.( • سيحتاج الطبيب إلى تعديل الجرعات بانتظام مع تغير وزن الجسم.

• يجب ألا يتجاوز الحجم الأقصى للحقن 1 مل. إذا كان المطلوب أكثر من 1 مل، فيجب عليك إعطاء   عدة حقن على الفور واحدة تلو الأخرى.

 

 

 

 

 

 

 

الحقن 3 مرات/الأسبوع                                                       الحقن 6 مرات/الأسبوع                                                             

  

 

رمز اللون

للقارورة التي ينبغي استخدامها

حجم الدواء الذي سيتم حقنه

وزن الجسم

)كجم(

أزرق غامق

15,0 مل

 6

أزرق غامق

18,0 مل

 7

أزرق غامق

20,0 مل

 8

أزرق غامق

23,0 مل

 9

أزرق غامق

25,0 مل

 10

أزرق غامق

28,0 مل

 11

أزرق غامق

30,0 مل

 12

برتقالي

33,0 مل

 13

برتقالي

35,0 مل

 14

برتقالي

38,0 مل

 15

برتقالي

40,0 مل

 16

برتقالي

43,0 مل

 17

برتقالي

45,0 مل

 18

أزرق فاتح

48,0 مل

 19

أزرق فاتح

50,0 مل

 20

أزرق فاتح

63,0 مل

 25

زهري

75,0 مل

 30

زهري

88,0 مل

 35

زهري

1 مل

 40

أخضر

50,0 مل

 50

أخضر

60,0 مل

 60

أخضر

70,0 مل

 70

أخضر

80,0 مل

 80

أخضر )×2(

90,0 مل

 90

أخضر )×2(

1 مل

 100

 

 

رمز اللون

للقارورة التي ينبغي استخدامها

حجم الدواء الذي سيتم حقنه

وزن الجسم

)كجم(

أزرق غامق

15,0 مل

 3

أزرق غامق

20,0 مل

 4

أزرق غامق

25,0 مل

 5

أزرق غامق

30,0 مل

 6

برتقالي

35,0 مل

 7

برتقالي

40,0 مل

 8

برتقالي

45,0 مل

 9

أزرق فاتح

50,0 مل

 10

أزرق فاتح

55,0 مل

 11

أزرق فاتح

60,0 مل

 12

أزرق فاتح

65,0 مل

 13

أزرق فاتح

70,0 مل

 14

زهري

75,0 مل

 15

زهري

80,0 مل

 16

زهري

85,0 مل

 17

زهري

90,0 مل

 18

زهري

95,0 مل

 19

زهري

1 مل

 20

أخضر

50,0 مل

 25

أخضر

60,0 مل

 30

أخضر

70,0 مل

 35

أخضر

80,0 مل

 40

 

توصيات تتعّلق بالحقن

• قد تواجه رد فعل في م وضع الحقن .راجع الفقرة 4 بعناية لمعرفة الأعراض الجانبية التي يمكن أن تحدث    قبل استخدام هذا الدواء.

• عند الحقن بانتظام ،يجب تغيير م وضع الحقن بين مناطق مختلفة من الجسم للمساعدة في الحد من    الشعور بالألم والتھيج المحتملين.

• المناطق الأكثر ملائمة للحقن هي المناطق التي تحتوي على كمية كبيرة من الدهون تحت الجلد )الفخذين والذراعين) العضلة الدالية( والبطن والأرداف(.. يرجى التأكد من طبيبك أو الممرض من أفضل المواقع بالنسبة لك.

يرجى قراءة التعليمات التالية بعناية قبل حقن سترين سك 

• كل قارورة مُعدّة للاستخدام الفردي فقط ويجب ثقبها مرة واحدة فقط .يجب أن يكون سائل سترين سك صافى

، براقًا قليلاً أو براقًا ، عديم اللون إلى الأصفر قليلا وقد يحتوي على عدد قليل من الجزيئات الصغيرة الشفافة أو البيضاء. لا تستخدمه إذا تغير لون السائل أو احتوى على كتل أو جزيئات كبيرة واحصل على  قارورة جديدة.  

  يجب التخلص من أي منتج أو نفايات طبية غير مستخدمة وفقًا للمتطلبات المحلية.

• إذا كنت تقوم بحقن هذا الدواء بنفسك، فسيتم توضيح كيفية تحضير وحقن الدواء من قبل الطبيب أو    الصيدلي أو الممرض لك. لا تقم بحقن نفسك بهذا الدواء إلا إذا تلقيت تدريباً وفهمت الإجراءت.

كيفية حقن سترين سك:

الخطوة 1: تحضير جرعة سترين سك

1.    إغسل يديك بعناية بالماء والصابون.

 

 

2.    أخرج قارورة سترين سك غير المفتوحة من الثلاجة لمدة 15 إلى 30 دقيقة قبل الحقن للسماح للسائل بالوصول إلى درجة حرارة الغرفة. لا تقم بتسخين سترين سك بأي طريقة أخرى )على سبيل المثال ، لا تقم

بتسخينه في الميكروويف أو في الماء الساخن(. عند إزالة القارورة من الثلاجة ، يجب استخدام سترين سك في غضون 3 ساعات كحد أقصى )انظر القسم 5. كيفية تخزين سترين سك(.

3.    قم بإزالة الغطاء الواقي من قارورة سترين سك. قم بإزالة البلاستيك الواقي عن المحقنة التي ستستخدمها .

4.    استخدم دائما محقنة جديدة محفوظة داخل غطاء بلاستيكي واقي.

5.    ضع إبرة تجويف أكبر )على سبيل المثال قياس 25 ( على المحقنة الفارغةمع الغطاء الواقي ، اضغط لأسفل و ادر الإبرة في اتجاه عقارب الساعة على المحقنة حتى يتم إحكامها.

6.    قم بإزالة الغطاء البلاستيكي الذي يغطي إبرة المحقنة.

احرص على تجنب إيذاء نفسك بالإبرة.

7.    اسحب المكبس للخلف لسحب الهواء إلى المحقنة بما يساوي جرعتك.

الخطوة 2: سحب محلول سترين سك من القارورة.

 

1.    أمسك المحقنة والقنينة ، أدخل الإب رة من خلال الختم المطاطي المعقم وفي القارورة.

 

2.    ادفع المكبس بالكامل لحقن الهواء في القارورة.

 

3.    اقلب القارورة والمحقنة. باستخدام الإبرة في المحلول، اسحب المكبس لسحب الجرعة الصحيحة إلى المحقنة.

 

 

4.    قبل إخراج الإبرة من القارورة ، تأكد من سحب الحجم المناسب وافحص المحقنة بحثا عن فقاعات هواء.

في حالة ظهور فقاعات في المحقنة ، أمسك المحقنة مع توجيه الإبرة لأعلى وانقر برفق على جانب المحقنة حتى ترتفع الفقاعات إلى الأعلى.

 

5.    بمجرد أن تكون جميع الفقاعات في الجزء العلوي من المحقنة ، اضغط برفق على المكبس لإخراج الفقاعات من المحقنة والعودة إلى القارورة.

6.    بعد إزالة الفقاعات ، أعد فحص جرعة الدواء في المحقنة للتأكد من أنك قمت بسحب الكمية الصحيحة .

قد تحتاج إلى استخدام عدة قوارير لسحب الكمية الكاملة اللازمة للوصول إلى الجرعة الصحيحة.

 

الخطوة 3: وضع الإبرة للحقن على المحقنة

 

1.    أخرج الإبرة من القارورة .قم باعادة وضع الغطاء البلاستيكى بيد واحدة عن طريق وضع الغطاء على سطح مستو ، وحرك الإبرة في الغطاء ، ورفعه لأعلى وثبته بإحكام باستخدام يد واحدة فقط.

2.    قم بإزالة إبرة التجويف الأكبر بحذر بدفعها لأسفل وتدويرها عكس اتجاه عقارب الساعة. تخلص من الإبرة ذات الغطاء الواقي في حاوية الأدوات الحادة.

3.    ضع إبرة ذات تجويف أصغر )على سبيل المثال قياس 27 أو 29( على المحقنة المملوءة مع الغطاء الواقي ، اضغط لأسفل و ادر الإبرة في اتجاه عقارب الساعة على المحقنة حتى يتم إحكامها. اسحب الغطاء مباشرة من الإبرة.

4.    امسك المحقنة مع توجيه الإبرة لأعلى واضغط على ماسورة المحقنة بإصبعك لإزالة أي فقاعات هواء.

 

تأكد بالنظر أن حجم الدواء داخل ال م حقنة صحيح.

يجب ألايتجاوز حجم الحقن 1 مل .أما إذا كان الأمر كذلك، يجب إجراء العديدمن الحقن في مواضع مختلفة.

أنت الآن جاهز لحقن الجرعة الصحيحة.

1.              قم باختيار م وضع الحقن )الفخذين والبطن والذراعين )العضلة الدالية(،  والأرداف(. المناطق الأكثر ملاءمة للحقن مُحدّدة باللون الرمادي في الصورة. سوف ينصحك طبيبك بمواضع الحقن المحتملة لك. 

ملاحظة: لا تستخدم أي مواضع تشعر فيها بوجود كتل أو عُ قد ثابتة أو ألم .

                                                         تحدث مع طبيبك عن أي شيء تجده.         

 

 

2.              قم بقرص الجلد في موضع الحقن الذي اخترته برفق بين إبهامك وإصبع السبابة.

 

3.              امسك ال م حقنة كما تمسك قلم الرصاص أو السهم، ثم قم بإدخال الإبرة في طيّة الجلد المرفوعة بزاوية تتراوح بين 45º و 90º  مع سطح الجلد.

قد يكون من الأفضل استخدام زاوية 45 درجة للمرضى الذين لديهم القليل من الدهون تحت الجلد أو ذوي الجلد ال رقيق.

 

4.              مع الاستمرار في الإمساك بالجلد، ادفع مكبس المحقنة لحقن الدواء ببطء وباستمرار حتى الانتهاء. 

5.              قم بإزالة الإبرة، وتحرير طية الجلد ووضع قطعة من القطن أو الشاش برفق فوق م وضع الحقن لبضع ثوان. سيساعد هذا على سد الأنسجة المثقوبة ومنع أي تسرب. لا تفرك م وضع الحقن بعد الحقن.

إذا كنت بحاجة إلى حقنة ثانية للجرعة الموصوفة لك ، احصل على قارورة  أخرى من سترين سك وكرر الخطوات من 1 إلى 4.

 

الخطوة 5: التخلص من الإمدادات

 يرجى جمع المحاقن،  والقوارير  والإبر المستخدمة في الحاوية الخاصة بذلك. سوف يُرشدك طبيبك أو الصيدلي أو الممرض إلى كيفية الحصول على حاوية الأدوات الحادة.

إذا استخدمت من سترين سك أكثر مما يجب 

إذا كنت تظن أنك قد استخدمت جرعات عالية من سترين سك بشكل عرَضي، فيرجى مراجعة الطبيب للحصول على المشورة.

إذا نسيت استخدام سترين سك 

لا تحقن جرعة مضاعفة للتعويض عن جرعة منسية  وراجع الطبيب للحصول على المشورة.

 

إذا كان لديك أي أسئلة أخرى حول استخدام هذا الدواء، اسأل طبيبك أو الصيدلي أو الممرض.

مثل جميع الأدوية ، يمكن أن يسبب هذا الدواء آثارًا جانبية ، على الرغم من عدم حدوثها لدى الجميع.

إذا لم تكن متأكدًا من الآثار الجانبية أدناه ، فاطلب من طبيبك أن يشرحها لك.

كانت أخطر الآثار الجانبية التي لوحظت في المرضى الذين يتلقون أسفوتاز ألفا هي ردود الفعل التحسسية بما في ذلك ردود الفعل التحسسية التي تهدد الحياة والتي تتطلب علاجًا طبيا مشابهًا للتأق. هذا التأثير الجانبي

شائع (قد يؤثر على ما يصل إلى 1 من كل 10 أشخاص). المرضى الذين عانوا من هذه الحساسية الخطيرة يعانون من صعوبة في التنفس ، والإحساس بالاختناق ، والغثيان ، والتورم حول العينين ، والدوخة. حدثت التفاعلات في غضون دقائق بعد استخدام أسفوتاز ألفا ويمكن أن تحدث في المرضى الذين كانوا يستخدمون أسفوتاز ألفا لأكثر من عام. إذا واجهت أيا من هذه الأعراض ، فتوقف عن تناول سترينسك واطلب المساعدة الطبية على الفور.

بالإضافة إلى ذلك ، تفاعلات حساسية أخرى (فرط الحساسية) والتي قد تظهر على شكل احمرار( إلتهاب إحمراري للجلد) ، حمى( زيادة حرارة الجسد) ، طفح جلدي ، حكة ، تهيج ، غثيان ، تقيؤ (قيء) ، ألم ، قشعريرة (رعشة) ، قد يحدث بشكل شائع خدر في الفم (نقص الحس الفموي) ، صداع ، احمرار ، خفقان سريع للقلب

(تسرع القلب) ، وسعال. إذا واجهت أيا من هذه الأعراض ، فتوقف عن تناول سترينسك واطلب المساعدة الطبية على الفور.

 

 

شائعة جدًا: قد تظهر لدى أكثر من 1 من كل 10 أشخاص

ردود الفعل في موقع الحقن أثناء حقن الدواء أو خلال الساعات التي تلي الحقن (والتي يمكن أن تؤدي إلى احمرار أو تغير في اللون أو حكة أو ألم أو كتل دهنية أو نقص الأنسجة الدهنية على سطح الجلد ونقص تصبغ الجلد و / أو تورم) حمى (بيركسيا) التهيج

احمرار الجلد (حمامي)

ألم في اليدين والقدمين (ألم في الأطراف) كدمة  صداع الراس

 

شائعة: قد تظهر لدى حتى 1 من كل 10 أشخاص شد الجلد ، تغير لون الجلد الشعور بالغثيان 

خدر في الفم (نقص الحس الفموي) آلام العضلات (ألم عضلي) ندب

زيادة الميل للكدمات مطاردة ساخنة

إصابة الجلد في موقع الحقن (التهاب النسيج الخلوي في موقع الحقن) انخفاض مستويات الكالسيوم في الدم (نقص كالسيوم الدم) حصوات الكلى (تحصي الكلية)

 

الإبلاغ عن الأعراض الجانبية

إذا أُصبت بأي أعراض جانبية، تحدث إلى طبيبك أو الصيدلي أو الممرض. يتضمن ذلك أي أعراض جانبية محتملة غير مدرجة في هذه النشرة. يمكنك أيضًا الإبلاغ عن الأعراض الجانبية مباشرةً عبر نظام الإبلاغ الوطني الوارد في الملحق السادس . يمكنك المساعدة في تقديم المزيد من المعلومات حول سلامة هذا الدواء من خلال الإبلاغ عن الأعراض الجانبية.    

احفظ هذا الدواء بعيدا عن مرأى  ومتناول الأطفال.

لا تستخدم هذا الدواء بعد تاريخ انتهاء الصلاحية المُدرج على الكرتون  ومُلصق القارورة بعد كلمة EXP. يشير تاريخ انتهاء الصلاحية إلى آخر يوم في ذلك الشهر.

احفظه في الثلاجة( 2 درجة مئوية - 8 درجة مئوية.) لا تجمده.

احفظ هذا الدواء داخل علبته الأصلية من أجل حمايته من الضوء.

يجب استخدام المنتج بعد فتح القارورة على الفور  (خلال 3 ساعات كحد أقصى عند درجة حرارة الغرفة ، بين 23 درجة مئوية و 27 درجة مئوية.)

لا تتخلص من أي أدوية عن طريق مياه الصرف الصحي أو النفايات المنزلية. اسأل الصيدلي عن كيفية التخلص من الأدوية التي لم تعد تستخدمها .سوف تساعد هذه التدابير في حماية البيئة.

المادة الفعالة هي أسفوتاس ألفا. يحتوي كل مل من المحلول على 40 مجم من أسفوتاس ألفا .

القارورة الواحدة بسعة 45,0 مل محلول )40 مجم/مل( تحتوي على 18 مجم من الأسفوتاس ألفا.

القارورة الواحدة بسعة 7,0 مل محلول )40 مجم/مل( تحتوي على 28 مجم من الأسفوتاس ألفا.

القارورة الواحدة بسعة 1 مل محلول )40 مجم/مل( تحتوي على 40 مجم من الأسفوتاس ألفا.

 

المكونات الأخرى هي كلوريد الصوديوم، فوسفات أحادي الصوديوم مونوهيدرات، فوسفات ثنائي الصوديوم هيبتاهيدرات والماء المُخصّص للحقن.

يتوفر سترين سك على شكل محلول مائي صافٍ ، براق قليلا أو براق، عديم اللون أو مائل إلى اللون الأصفر مُعدّ للحقن ومُعبأ في قوارير تحتوي على 45,0 مل ،7,0 مل و 1 مل من المحلول. قد يكون هناك عدد قليل من الجزيئات الصغيرة الشفافة أو البيضاء.

تحتوي العبوة على 12 قارورة. 

قد لا تُسوق جميع أحجام العبوات في بلدك.

مالك حق التسويق

أليكسيو ن الأوروبيّة SAS

 

103-105 شارع أناتول فرنسا

92300 ليفالوا بيريه فرنسا

المُصنّع

شركة أليكسيون فارما انترناشونال أوبريشنز اللامحدودة كوليج بزنس وتكنولوجي بارك، بلانتشارستاو ن

دبلن 15 إيرلندا

03/2022
 Read this leaflet carefully before you start using this product as it contains important information for you

Strensiq 40 mg/ml solution for injection Strensiq 100 mg/ml solution for injection

Strensiq 40 mg/ml solution for injection Each ml of solution contains 40 mg of asfotase alfa*. Each vial contains 0.3 ml solution and 12 mg of asfotase alfa (40 mg/ml). Each vial contains 0.45 ml solution and 18 mg of asfotase alfa (40 mg/ml). Each vial contains 0.7 ml solution and 28 mg of asfotase alfa (40 mg/ml). Each vial contains 1.0 ml solution and 40 mg of asfotase alfa (40 mg/ml). Strensiq 100 mg/ml solution for injection Each ml of solution contains 100 mg of asfotase alfa*. Each vial contains 0.8 ml solution and 80 mg of asfotase alfa (100 mg/ml). * produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture. For the full list of excipients, see section 6.1.

Solution for injection (injection). Clear, slightly opalescent or opalescent, colourless to slightly yellow, aqueous solution; pH 7.4. A few small translucent or white particles may be present.

Strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease (see section 5.1).


Treatment should be initiated by a physician experienced in the management of patients with metabolic or bone disorders.

 

Posology

 

Recommended dosage regimen of asfotase alfa is 2 mg/kg of body weight administered subcutaneously three times per week, or a dosage regimen of 1 mg/kg of body weight administered subcutaneously six times per week.

Maximum recommended dose of asfotase alfa is 6 mg/kg/week (see Section 5.1). 

 

Refer to the dosing chart below for more details.

 

Body

Weight

(kg)

If injecting 3x per week

If injecting 6 x per week

Dose to be injected

Volume to be injected

Vial type used for injection

Dose to be injected

Volume to be injected

Vial type used for injection

3

6 mg

0.15 ml

0.3 ml

 

4

8 mg

0.20 ml

0.3 ml

5

10 mg

0.25 ml

0.3 ml

6

12 mg

0.30 ml

0.3 ml

6 mg

0.15 ml

0.3 ml

7

14 mg

0.35 ml

0.45 ml

7 mg

0.18 ml

0.3 ml

8

16 mg

0.40 ml

0.45 ml

8 mg

0.20 ml

0.3 ml

9

18 mg

0.45 ml

0.45 ml

9 mg

0.23 ml

0.3 ml

10

20 mg

0.50 ml

0.7 ml

10 mg

0.25 ml

0.3 ml

11

22 mg

0.55 ml

0.7 ml

11 mg

0.28 ml

0.3 ml

12

24 mg

0.60 ml

0.7 ml

12 mg

0.30 ml

0.3 ml

13

26 mg

0.65 ml

0.7 ml

13 mg

0.33 ml

0.45 ml

14

28 mg

0.70 ml

0.7 ml

14 mg

0.35 ml

0.45 ml

15

30 mg

0.75 ml

1 ml

15 mg

0.38 ml

0.45 ml

16

32 mg

0.80 ml

1 ml

16 mg

0.40 ml

0.45 ml

17

34 mg

0.85 ml

1 ml

17 mg

0.43 ml

0.45 ml

18

36 mg

0.90 ml

1 ml

18 mg

0.45 ml

0.45 ml

19

38 mg

0.95 ml

1 ml

19 mg

0.48 ml

0.7 ml

20

40 mg

1.00 ml

1 ml

20 mg

0.50 ml

0.7 ml

25

50 mg

0.50 ml

0.8 ml

25 mg

0.63 ml

0.7 ml

30

60 mg

0.60 ml

0.8 ml

30 mg

0.75 ml

1 ml

35

70 mg

0.70 ml

0.8 ml

35 mg

0.88 ml

1 ml

40

80 mg

0.80 ml

0.8 ml

40 mg

1.00 ml

1 ml

50

 

50 mg

0.50 ml

0.8 ml

60

60 mg

0.60 ml

0.8 ml

70

70 mg

0.70 ml

0.8 ml

80

80 mg

0.80 ml

0.8 ml

90

90 mg

0.90 ml

0.8 ml (x2)

100

100 mg

1.00 ml

0.8 ml (x2)

 

 

Missed dose

If a dose of asfotase alfa is missed, a double dose should not be injected to make up for the missed dose. 

 

Special population

 

Adult patients

The pharmacokinetics, pharmacodynamics, and safety of asfotase alfa have been studied in patients with hypophosphatasia > 18 years old. Dose adjustment is not needed in adult patients with paediatriconset hypophosphatasia (HPP) (see Sections 5.1 and 5.2).

 

Elderly

The safety and efficacy of asfotase alfa in elderly patients have not been established and no specific dose regimen can be recommended for these patients.

 

Renal impairment

The safety and efficacy of asfotase alfa in patients with renal impairment have not been evaluated and no specific dose regimen can be recommended for these patients.

 

Hepatic impairment

The safety and efficacy of asfotase alfa in patients with hepatic impairment have not been evaluated and no specific dose regimen can be recommended for these patients.

 

Method of administration

 

Strensiq is for subcutaneous use only. It is not intended for intravenous or intramuscular injection. The maximum volume of medicinal product per injection should not exceed 1 ml. If more than 1 ml is required, multiple injections may be administered at the same time.

Strensiq should be administered using sterile disposable syringes and injection needles. The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy.

 

Injections sites should be rotated and carefully monitored for signs of potential reactions (see section 4.4).

 

Patients can self-inject only if they have properly been trained on administration procedures. For handling of the medicinal product before administration, see section 6.6.

 


Severe or life-threatening hypersensitivity to the active substance or to any of the excipients if hypersensitivity is not controllable (see section 4.4).

Traceability

 

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

 

Hypersensitivity

 

Hypersensitivity reactions including signs and symptoms consistent with anaphylaxis have been reported in patients treated with asfotase alfa (see section 4.8). These symptoms included difficulty breathing, choking sensation, periorbital edema, and dizziness. The reactions have occurred within minutes after subcutaneous administration of asfotase alfa and can occur in patients on treatment for more than 1 year. Other hypersensitivity reactions included vomiting, nausea, fever, headache, flushing, irritability, chills, skin erythema, rash, pruritus, and oral hypoaesthesia. If these reactions occur, immediate discontinuation of treatment is recommended and appropriate medical treatment should be initiated. The current medical standards for emergency treatment should be observed.

 

Consider the risks and benefits of re-administering asfotase alfa to individual patients following a severe reaction, taking other factors into account that may contribute to the risk of a hypersensitivity reaction, such as concurrent infection and/ or use of antibiotics. If the decision is made to readminister the product, the re-challenge should be made under medical supervision and consideration may be given to use of appropriate pre-medication. Patients should be monitored for recurrence of signs and symptoms of a severe hypersensitivity reaction.   

 

The need for supervision for subsequent administrations and need for emergency treatment for home care should be at the discretion of the treating physician.

 

Severe or potentially life-threatening hypersensitivity is a contraindication to re-challenge, if hypersensitivity is not controllable (see section 4.3).

 

Injection reaction

 

Administration of asfotase alfa may result in local injection site reactions (including, but not limited to, erythema, rash, discoloration, pruritus, pain, papule, nodule, atrophy) defined as any related adverse event occurring during the injection or until the end of the injection day (see section 4.8).

Rotation of injection sites may help to minimize these reactions.  

Strensiq administration should be interrupted in any patient experiencing severe injection reactions and appropriate medical therapy administered.

 

Lipodystrophy 

 

Localized lipodystrophy, including lipoatrophy and lipohypertrophy, has been reported at injection sites after several months in patients treated with asfotase alfa in clinical trials (see section 4.8). Patients are advised to follow proper injection technique and to rotate injection sites (see section 4.2).

 

Craniosynostosis

 

In asfotase alfa clinical studies adverse events of craniosynostosis (associated with increased intracranial pressure), including worsening of pre-existing craniosynostosis and occurrence of ArnoldChiari malformation, have been reported in hypophosphatasia patients < 5 years of age. There are insufficient data to establish a causal relationship between exposure to Strensiq and progression of craniosynostosis. Craniosynostosis as a manifestation of hypophosphatasia is documented in published literature and occurred in 61.3% of patients between birth and 5 years of age in a natural history study of untreated infantile-onset hypophosphatasia patients. Craniosynostosis can lead to increased intracranial pressure. Periodic monitoring (including fundoscopy for signs of papilloedema) and prompt intervention for increased intracranial pressure is recommended in hypophosphatasia patients below 5 years of age.

 

Ectopic calcification

 

In asfotase alfa clinical studies ophthalmic (conjunctival and corneal) calcification and nephrocalcinosis have been reported in patients with hypophosphatasia. There are insufficient data to establish a causal relationship between exposure to asfotase alfa and ectopic calcification. Ophthalmic (conjunctival and corneal) calcification and nephrocalcinosis as manifestations of hypophosphatasia are documented in published literature. Nephrocalcinosis occurred in 51.6% of patients between birth and 5 years of age in a natural history study of untreated infantile-onset hypophosphatasia patients. Ophthalmology examination and renal ultrasounds are recommended at baseline and periodically in hypophosphatasia patients.

 

Serum Parathyroid Hormone and Calcium

 

Serum parathyroid hormone concentration may increase in hypophosphatasia patients administered asfotase alfa, most notably during the first 12 weeks of treatment. It is recommended that serum parathyroid hormone and calcium be monitored in patients treated with asfotase alfa. Supplements of calcium and oral vitamin D may be required. See section 5.1.

 

Disproportionate weight gain

 

Patients may display disproportionate weight increase. Dietary supervision is recommended.

 

Excipients

 

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. the product is essentially ‘sodium-free’.

 


No interaction studies have been performed with asfotase alfa. Based on its structure and pharmacokinetics, asfotase alfa is unlikely to affect Cytochrome P-450 related metabolism.

 

Asfotase alfa contains a catalytic domain of tissue non-specific alkaline phosphatase. Administration of asfotase alfa will interfere with routine measurement of serum alkaline phosphatase by hospital laboratories resulting in serum alkaline phosphatase activity measurements of several thousand units per litre. Asfotase alfa activity results must not be interpreted as the same measure as serum alkaline phosphatase activity owing to differences in enzyme characteristics.

 

Alkaline Phosphatase (ALP) is used as the detection reagent in many routine laboratory assays. If asfotase alfa is present in clinical laboratory samples, aberrant values could be reported.

 

The treating physician should inform the testing lab that the patient is treated with medication affecting the ALP levels. Alternative assays (i.e. not utilizing an ALP-conjugated reporter system) may be considered in patients treated with Strensiq.

 


Pregnancy

 

There are insufficient data from the use of asfotase alfa in pregnant women.

Following repeated subcutaneous administration to pregnant mice in the therapeutic dose range (>0.5 mg/kg), asfotase alfa levels were quantifiable in fetuses at all doses tested, suggesting cross-placental transport of asfotase alfa. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Asfotase alfa is not recommended during pregnancy and in women of childbearing potential not using contraception.

 

Breast-feeding

 

There is insufficient information on the excretion of asfotase alfa in human milk. A risk to the newborns/infants cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from asfotase alfa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

Fertility

 

Preclinical fertility studies were conducted and showed no evidence of effect on fertility and embryo-fetal development (see section 5.3).

 


Strensiq has no or negligible influence on the ability to drive and use machines.


Summary of the safety profile

 

Supportive safety data reflect exposure in 112 patients with perinatal/infantile (n=89), juvenile-onset

(n = 22), adult onset (n = 1) HPP (age at enrollment from 1 day to 66.5 years) treated with asfotase alfa, with a treatment duration range from 1 day to 391.9 weeks [7.5 years]). The most common adverse reactions observed were injection site reactions (74%). A few case reports of anaphylactoid/hypersensitivity reaction have been received

 

Tabulated list of adverse reactions 

 

Adverse reactions with asfotase alfa are listed by system organ class and preferred term using

MedDRA frequency convention very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

 

Table 1: Adverse Reactions Reported in clinical trials in hypophosphatasia patients

System Organ Class

Frequency category

Adverse reaction

Infections and infestations

Common

Injection site cellulitis

Blood and lymphatic system disorders

Common

Increased tendency to bruise

Immune system disorders

Common

 

Anaphylactoid reactions  Hypersensitivity2  

Metabolism and nutrition disorders

Common

Hypocalcaemia

Nervous system disorders

Very common

Headache

Vascular disorders

Common

Hot flush

Gastrointestinal disorders

Common

Hypoaesthesia oral Nausea

Skin and subcutaneous tissue disorders

Very common

Erythema

Common

Skin discolouration 

Skin disorder (stretched skin)

Musculoskeletal and connective tissue disorders

Very common

Pain in extremity

 

Common

Myalgia

Renal and urinary disorders

Common

Nephrolithiasis

General disorders and administration site conditions

Very common

Injection site reactions[1]

Pyrexia

Irritability

Common

Chills

Injury, poisoning and procedural complications

Very common

Contusion

Common

Scar

Description of selected adverse reactions

 

Injection site reactions

 

Injection site reactions (including injection site atrophy, abscess, erythema, discolouration, pain, pruritus, macule, swelling, contusion, bruising, lipodystrophy (lipoatrophy or lipohypertrophy), induration, reaction, nodule, rash, papule, haematoma, inflammation, urticarial, calcification, warmth, haemorrhage, cellulitis, scar, mass, extravasation, exfoliation and vesicles) are the most common adverse reactions observed in about 74% of the patients in clinical studies. Most injection site reactions were mild and self-limiting, and the majority (> 99%) were reported as non-serious. In the clinical trial setting, the majority of patients who experienced an injection site reaction had the first occurrence within the first 12 weeks of treatment with asfotase alfa, and some patients continued to experience injection site reactions until 1 or more years after initiating asfotase alfa dosing.  One patient withdrew from the trial due to injection site hypersensitivity.

 

Hypersensitivity

 

Hypersensitivity reactions include erythema/redness, pyrexia/fever, rash, pruritis, irritability, nausea, vomiting, pain, rigor/chills, hypoaesthesia oral, headache, flushing, tachycardia, cough, and signs and symptoms consistent with anaphylaxis (see section 4.4). A few case reports of anaphylactoid/hypersensitivity reaction have also been received and were associated with signs and symptoms of difficulty breathing, choking sensation, periorbital edema and dizziness.

 

Immunogenicity

 

There is potential for immunogenicity. Among 109 hypophosphatasia patients enrolled in the clinical studies and who have post baseline antibody data available, 97/109 (89.0%) tested positive for antidrug antibodies at some time point after starting Strensiq treatment. Among those 97 patients, 55 (56.7%) also showed the presence of neutralizing antibodies at some time point post-baseline. The antibody response (with or without presence of neutralizing antibodies) was time variant in nature. In clinical trials, the development of antibodies has not been shown to affect clinical efficacy or safety (see section 5.2). Data from post-marketing cases suggests that the development of antibodies may affect clinical efficacy.

 

No trends in adverse events based on antibody status were observed in clinical trials. Some patients confirmed positive for antidrug antibodies experienced injection site reactions (ISRs) and/or hypersensitivity, however there was no consistent trend in the frequency of these reactions over time noted between ADA ever positive and ADA always negative patients.

 

 

To report any side effect(s):

 

Saudi Arabia:

 

 The National Pharmacovigilance Centre (NPC):

 

 Fax: +966-11-205-7662

- SFDA Call Center: 19999

- E-mail: npc.drug@sfda.gov.sa

- Website: https://ade.sfda.gov.sa/

 

Other GCC States:

 Please contact the relevant competent authority.

 

[1] - Preferred terms considered as injection site reactions are presented in section below 2- Preferred terms considered as hypersensitivity are presented in the section below

 


There is limited experience with overdose of asfotase alfa. The maximum dose of asfotase alfa used in clinical studies is 28 mg/kg/week. No dose-related toxicity or change in the safety profile has been observed in clinical studies. Therefore, no overdose level has been determined. For management of adverse reactions, see sections 4.4 and 4.8.


Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes, ATC code: A16AB13

 

Asfotase alfa is a human recombinant tissue-nonspecific alkaline phosphatase-Fc-deca-aspartate fusion protein that is expressed in an engineered Chinese hamster ovary cell line. Asfotase alfa is a soluble glycoprotein comprised of two identical polypeptide chains, each with a length of 726 amino acids made from (i) the catalytic domain of human tissue-nonspecific alkaline phosphatase, (ii) the human immunoglobulin G1 Fc domain and (iii) a deca-aspartate peptide domain.

 

Hypophosphatasia 

 

Hypophosphatasia is a rare, severe, and potentially fatal, genetic disorder caused by loss-of-function mutation(s) in the gene encoding tissue non-specific alkaline phosphatase. Hypophosphatasia is associated with multiple bone manifestations including rickets / osteomalacia, altered calcium and phosphate metabolism, impaired growth and mobility, respiratory compromise that may require ventilation, and vitamin B6-responsive seizures.

 

Mechanism of action 

 

Asfotase alfa, a human recombinant tissue-nonspecific alkaline phosphatase-Fc-deca-aspartate fusion protein with enzymatic activity, promotes mineralisation of the skeleton in patients with hypophosphatasia.

 

Clinical efficacy and safety

 

Study ENB-006-09/ENB-008-10

 

Study ENB-006-09/ENB-008-10 was an open-label, randomised study. Thirteen patients were enrolled, 12 completed, and 1 discontinued (discontinuation early in the study due to a previously planned elective scoliosis surgery).  At study completion patients had received a median of over 76 months (6.3 years) of treatment (1 to 79 months). Five patients presented with symptoms of hypophosphatasia before 6 months age and 8 patients presented after 6 months age. Age at inclusion in the study was between 6 and 12 years old and was between 10 and 18 years old at completion, with 9 patients who became between 13 and 17 years old during the study.

The study employed historical controls from the same centres as patients who received asfotase alfa and who had been subject to a similar protocol of clinical management.

 

The effects of asfotase alfa on x-ray appearance

Trained radiologists evaluated pre- and post-baseline x-rays of wrists and knees of patients for the following signs: apparent physeal widening, metaphyseal flaring, irregularity of provisional zone of calcification, metaphyseal radiolucencies, metadiaphyseal sclerosis, osteopenia, ‘popcorn’ calcification in metadiaphysis, demineralization of distal metaphysis, transverse subphyseal band of lucency and tongues of radiolucency. X-ray changes from baseline were then rated using the

Radiographic Global Impression of Change rating scale as follows: -3=severe worsening, -2=moderate worsening, -1=minimal worsening, 0=no change, +1=minimal healing, +2=substantial healing, +3= near-complete or complete healing. The majority of the patients who received asfotase alfa moved to scores of +2 and +3 over the first 6 months of exposure and this was sustained with on-going treatment. Historical controls did not show change over time.

 

Bone biopsy

Tetracycline for bone-labelling was administered in two 3-day courses (separated by a 14-day interval) prior to acquisition of the bone biopsy. Trans-iliac crest bone biopsies were obtained by standard procedure. Histological analysis of biopsies used Osteomeasure software (Osteometrics, USA). Nomenclature, symbols and units followed recommendations of the American Society for Bone and Mineral Research. For 10 patients in the per-protocol set (excludes those patients who received oral vitamin D between baseline and week 24) who underwent biopsy of the trans-iliac bone crest before and after receiving asfotase alfa:

-              Mean (SD) osteoid thickness was 12.8 (3.5) µm at baseline and 9.5 (5.1) µm at week 24

-              Mean (SD) osteoid volume / bone volume was 11.8 (5.9)% at baseline and 8.6 (7.2)% at week

24

-              Mean (SD) mineralisation lag-time was 93 (70) days at baseline and 119 (225) days at week 24

 

Growth

Height, weight and head circumference were plotted on growth charts (series of percentile curves that illustrate distribution) available from the Centers for Disease Control and Prevention, USA. These reference data were drawn from a representative sample of healthy children and are not specific for children with special health care needs: they have been used in the absence of growth charts for children with hypophosphatasia.

For those patients who received asfotase alfa: 11/13 patients displayed persistent apparent catch-up height-gain as shown by movement over time to a higher percentile on CDC growth charts. 1/13 patients did not display apparent catch-up height-gain and 1 patient did not have enough data to permit judgement. Progress through Tanner stages appeared appropriate.

For the time period of observation of historical controls: 1/16 patients displayed apparent catch-up height-gain, 12/16 patients did not display apparent catch-up height-gain and data were inconclusive in 3/16 patients.

Some patients required oral vitamin D supplements during the study (see sections 4.4 and 4.8).

 

Study ENB-002-08/ENB-003-08  

 

Study ENB-002-08/ENB-003-08 was an open-label, non-randomised, non-controlled study.

11 patients were enrolled in the initial study and 10 patients entered the extension study, with

9 patients completing the extension study. At study completion, patients had received a median of over 79 months (6.6 years) of treatment (1 to >84 months). Onset of hypophosphatasia was under 6 months in all patients. Age at treatment initiation in the study was between 0.5 to 35 months.

7/11 patients in the full analysis set achieved Radiographic Global Impression of Change scores of +2 at Week 24 compared to baseline radiographs. The improvement in rickets severity was maintained for at least 72 months of follow-up treatment (including at least 84 months in 4 patients), as measured by the RGI C.

5/11 subjects displayed apparent catch-up height-gain. At last assessment (n = 10, 9 of whom had at least 72 months of treatment), median Z-score improvements from baseline were 1.93 for length/height and 2.43 for weight. Fluctuation in height-gain was apparent and may reflect the more severe disease and higher rate of morbidity in these younger patients.

 

Study ENB-010-10

 

Study ENB-010-10 was a controlled open-label study in 69 patients, aged 1 day to 72 months, with perinatal/infantile-onset HPP. The mean age at sign/symptom onset was 1.49 months. Patients received STRENSIQ at 6 mg/kg per week for the first 4 weeks. All patients began the study on a dose of asfotase alfa 6 mg/kg per week. The dose of asfotase alfa was increased for 11 patients during the study. Of these 11 patients, 9 patients had their doses increased specifically to improve clinical response. Thirty-eight patients were treated for at least 2 years (24 months) and 6 patients have been treated for at least 5 years (60 months). 

At Week 48, 50/69 patients (72.5%) in the full analysis set achieved Radiographic Global Impression of Change scores ≥ 2, and were considered responders. Improvements in median RGI-C were maintained over the course of treatment, which ranged from 0.9 to 302.3 weeks, even if fewer patients were followed after Week 96 (a total of 29 patients were followed after Week 96 and ≤8 patients after Week 192).

Height, weight and head circumference were plotted on growth charts (series of percentile curves that illustrate distribution) available from the Centers for Disease Control and Prevention (CDC), USA. A total of 24/69 (35%) patients displayed apparent catch-up height-gain and 32/69 (46%) patients displayed apparent catch-up weight-gain, as shown by movement over time to a higher percentile on CDC growth charts. 40/69 patients and 32/69 patients did not show apparent catch-up gain in height and in weight, respectively. 4 patients did not have enough data to permit judgement and 1 patient could not be determined with certainty.

 

Study ENB-009-10

 

Study ENB-009-10 was an open-label, randomised study. The patients were randomly assigned to treatment group for the primary treatment period. Nineteen patients were enrolled, 14 completed, and

5 discontinued.  At study completion patients had received a median of over 60 months of treatment

(24 to 68 months). The onset of hypophosphatasia was under 6 months in 4 patients, between 6 months and 17 years in 14 patients, and over 18 years in one patient.  Age at inclusion was from 13 to 66 years and was between 17 and 72 years at study completion.

 

The adolescent (and adult) patients in this study did not display apparent height-gain.

Patients underwent biopsy of the trans-iliac bone crest either as part of a control group or before and after exposure to asfotase alfa:

-              Control group, standard of care (5 evaluable patients): mean (SD) mineralisation lag-time was

226 (248) days at baseline and 304 (211) days at week 24

-              0.3 mg/kg/day asfotase alfa group (4 evaluable patients): mean (SD) mineralisation lag-time was 1236 (1468) days at baseline and 328 (200) days at week 48

-              0.5 mg/kg/day asfotase alfa group (5 evaluable patients): mean (SD) mineralisation lag-time was 257 (146) days at baseline and 130 (142) days at week 48

After approximately 48 weeks all patients were adjusted to the recommended dose 1.0 mg/kg/day.

 

Ventilation support

In studies ENB-002-08/ENB-003-08 (11 patients) and ENB-010-10 (69 patients), both openlabel, non-randomised, non-controlled studies of patients aged 0.1 to 312 weeks at baseline.

69 patients completed the studies, and 11 discontinued. Patients received a median duration of treatment of 27.6 month (range from 1 day to 90 months). 29 of 80 patients required ventilation support at baseline:

∙ 16 patients required invasive ventilation support (intubation or tracheostomy) at baseline (one had a brief period of non-invasive ventilation at baseline before transfer).

-  7 patients were weaned off invasive ventilation (time on ventilation from 12 to 168 weeks), 4 patients were off any ventilation support, and 3 patients were on noninvasive ventilation support. Five out of 7 patients achieved an RGI-C score ≥2 - 5 patients continued with invasive ventilation support, 4 of them with RGI-C score <2

-  3 patients died whilst on ventilation support

-  1 patient withdrew consent

∙ 13 patients required non-invasive ventilation support at baseline.

-  10 patients were weaned off any ventilation support (time on ventilation from 3 to

216 weeks). 9 out of 10 patients achieved a RGI-C score ≥2, only 1 with RGI-C <2.  - 2 patients required invasive ventilation support and 1 patient continued with noninvasive ventilation support, all 3 patients died and with RGI-C score <2 

The natural history of untreated infantile-onset hypophosphatasia patients suggests high mortality if ventilation is required.

 

This medicinal product has been authorised under ‘exceptional circumstances’. This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.

The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary.


Pharmacokinetics of asfotase alfa were evaluated in a 1-month, multicenter, open-label, doseescalating, study in adults with hypophosphatasia. Cohort 1 (n=3) of the study received asfotase alfa 3 mg/kg intravenously the first week followed by 3 doses at 1 mg/kg subcutaneous at weekly intervals from weeks 2 to 4. Cohort 2 (n=3) received asfotase alfa 3 mg/kg intravenously the first week followed by 3 doses at 2 mg/kg subcutaneous at weekly intervals from weeks 2 to 4. After the 3 mg/kg for 1.08 hours intravenous infusion, the median time (Tmax) ranged between 1.25 to 1.50 hours, and the mean (SD) Cmax ranged between 42694 (8443) and 46890 (6635) U/L over the studied cohorts. The absolute bioavailability after the first and third subcutaneous administration ranged from 45.8 to 98.4%, with median Tmax ranging between 24.2 to 48.1 hours. After the 1 mg/kg weekly subcutaneous administration in Cohort 1 the mean (SD) AUC over the dosing interval (AUC) was 66034 (19241) and 40444 (N=1) U*h/L following the first and the third dose, respectively. After the 2 mg/kg weekly subcutaneous administration in Cohort 2 the mean (SD) AUC was 138595 (6958) and 136109 (41875) following the first and the third dose, respectively.

 

Pharmacokinetic data from all asfotase alfa clinical trials were analysed using population pharmacokinetic methods. The pharmacokinetic variables characterized by population pharmacokinetic analysis represent the overall hypophosphatasia patient population with age range from 1 day to 66 years, subcutaneous doses of up to 28 mg/kg/week and a range of disease onset cohorts. Twenty five percent (15 out of 60) of the overall patient population was adult (>18 years) at baseline. The absolute bioavailability and absorption rate following subcutaneous administration were estimated to be 0.602 (95% CI: 0.567, 0.638) or 60.2% and 0.572 (95%CI: 0.338, 0.967)/day or 57.2%, respectively. The central and peripheral volumes of distribution estimates for a patient with body weight of 70 kg (and 95% CI) were 5.66 (2.76, 11.6) L and 44.8 (33.2, 60.5) L, respectively. The central and peripheral clearance estimates for a patient with body weight of 70 kg (and 95% CI) were 15.8 (13.2, 18.9) L/day and 51.9 (44.0, 61.2) L/day, respectively. The extrinsic factors affecting asfotase alfa pharmacokinetic exposures were formulation specific activity and total sialic acid content. The average ± SD elimination half-life following subcutaneous administration was 2.28 ± 0.58 days.

In adult patients with pediatric-onset HPP, the pharmacokinetics of asfotase alfa at doses of 0.5, 2 and 3 mg/kg administered three times per week was consistent with those observed in pediatric patients with pediatric-onset HPP, and thus supported the approved dose of 6 mg/kg per week in treating adult patients with pediatric-onset HPP.

 

Linearity/non-linearity

 

Based on the results of population pharmacokinetic analysis it was concluded that asfotase alfa exhibits linear pharmacokinetic up to subcutaneous doses of 28 mg/kg/week. The model identified body weight to affect asfotase alfa clearance and volume of distribution parameters. It is expected that pharmacokinetic exposures will increase with body weight. The impact of immunogenicity on asfotase alfa pharmacokinetic varied over time due to the time varying nature of immunogenicity and overall was estimated to decrease pharmacokinetic exposures by less than 20%.

 


In nonclinical safety testing in rats, no body system-specific adverse effects were noted at any dose or route of administration.

 

Dose - and time-dependent acute injection reactions that were transient and self-limiting were noted in rats at intravenous use doses of 1 to 180 mg/kg.

 

Ectopic calcifications and injection site reactions were observed in monkeys when asfotase alfa was administered subcutaneously at daily doses up to 10 mg/kg through 26 weeks. These effects were restricted to injection sites and were partially or completely reversible.

There was no evidence of ectopic calcification observed in any other tissues examined.

 

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or toxicity to reproduction and development. However, in pregnant rabbits administered intravenous doses of up to 50 mg/kg/day asfotase alfa, anti-drug antibodies were detected in up to 75% of animals which could affect the detection of reproductive toxicity.

 

No animal studies have been conducted to evaluate the genotoxic and carcinogenic potential of asfotase alfa.

 


Sodium chloride

Sodium phosphate dibasic heptahydrate

Sodium phosphate monobasic monohydrate

Water for injections


In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.


30 months Chemical and physical in-use stability has been demonstrated for up to 3 hours at a temperature between 23°C to 27°C.

Store in a refrigerator (2°C – 8°C).

Do not freeze.

Store in the original package in order to protect from light.

For storage conditions after first opening of the medicinal product, see section 6.3.

 


Type I glass vial with a stopper (butyl rubber) and a seal (aluminium) with a flip-off cap (polypropylene).

 

Strensiq 40 mg/ml solution for injection

 

Filled volumes of the vials are: 0.3 ml, 0.45 ml, 0.7 ml and 1.0 ml

 

Strensiq 100 mg/ml solution for injection

 

Filled volumes of the vials are: 0.8 ml

 

Pack sizes of 1 or 12 vials

Not all pack sizes may be marketed.


Each vial is intended for single use only and should only be punctured once. Any unused solution in the vial should be discarded.

 

Strensiq should be administered using sterile disposable syringes and injection needles. The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy. An aseptic technique should be used.

 

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


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02/2022
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