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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)

Pharmacotherapeutic group: influenza vaccine - ATC code: J07BB02.
Vaxigrip Tetra is a vaccine. This vaccine administered to you or your child from 6 months of age helps to protect you or your child against influenza (flu).
When a person is given Vaxigrip Tetra, the immune system (the body’s natural defence system) will produce its own protection (antibodies) against the disease. When given during pregnancy the vaccine helps to protect the pregnant women but also helps to protect her baby from birth to less than 6 months of age through the transmission of protection from mother to baby during pregnancy (see also Sections 2 and 3).
None of the ingredients in the vaccine can cause flu.
The use of Vaxigrip Tetra should be based on official recommendations.
Flu is a disease that can spread rapidly and is caused by different types of strains that can change every year. Due to this potential change in circulating strains on a yearly basis, as well as the duration of protection intended by the vaccine, vaccination is recommended every year. The greatest risk of catching flu is during the cold months between October and March. If you or your child were not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring since you run the risk of catching flu until then. Your doctor will be able to recommend the best time to be vaccinated.
Vaxigrip Tetra is intended to protect you or your child against the four strains of virus contained in the vaccine about 2 to 3 weeks after the injection. In addition, if you or your child are exposed to flu immediately before or after your vaccination, you or your child could still develop the illness as the incubation period for flu is a few days.
The vaccine will not protect you or your child against the common cold, even though some of the symptoms are similar to flu.


To make sure that Vaxigrip Tetra is suitable for you or your child, it is important to tell your doctor or pharmacist if any of the points below apply to you or your child. If there is anything you do not understand, ask your doctor or pharmacist to explain.
Do not use Vaxigrip Tetra:
- If you or your child are allergic to:
• The active substances, or
• Any of the other ingredients of this vaccine (listed in Section 6), or
• Any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol-9,
- If you or your child have an illness with a high or moderate temperature or an acute illness, the vaccination should be postponed until after you or your child have recovered.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Vaxigrip Tetra.
You should tell your doctor before vaccination if you or your child have:
- A poor immune response (immunodeficiency or taking medicines affecting the immune system),
- Bleeding problem or bruising easily.
Your doctor will decide if you or your child should receive the vaccine.
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore tell your doctor or nurse if you or your child fainted with a previous injection.
As with all vaccines, Vaxigrip Tetra may not fully protect all persons who are vaccinated.
Not all babies less than 6 months of age born to pregnant women vaccinated during pregnancy will be protected.
If, for any reason, you or your child have a blood test within a few days following a flu vaccination, please tell your doctor. This is because false positive blood test results have been observed in a few patients who had recently been vaccinated.
Children
Vaxigrip Tetra is not recommended for use in children below 6 months of age.
Other medicines and Vaxigrip Tetra
Tell your doctor or pharmacist if you or your child are receiving, have recently received or might receive any other vaccines or any other medicines.
- Vaxigrip Tetra can be given at the same time as other vaccines by using separate limbs.
- The immunological response may decrease in case of immunosuppressant treatment, such as corticosteroids, cytotoxic drugs or radiotherapy.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant, ask your doctor or pharmacist for advice before using this vaccine.
Vaxigrip Tetra can be used in all stages of pregnancy.
Vaxigrip Tetra may be used during breast-feeding.
Your doctor/pharmacist will be able to decide if you should receive Vaxigrip Tetra.
Driving and using machines
Vaxigrip Tetra has no or negligible influence on the ability to drive or use machines.

Vaxigrip Tetra contains potassium and sodium
This medicine contains less than 1 mmol potassium (39 mg) and sodium (23 mg) per dose, i.e. essentially ‘potassium- free’ and ‘sodium- free’.


Dosage
Adults receive one 0.5 ml dose.
Use in children
Children from 6 months to 17 years of age receive one 0.5 ml dose.
If your child is less than 9 years old and has not been previously vaccinated against flu, a second dose of 0.5 ml should be given after at least 4 weeks.
If you are pregnant, one 0.5 ml dose given to you during pregnancy may protect your baby from birth to less than 6 months of age. Ask your doctor or pharmacist for more information.
How Vaxigrip Tetra is given
Your doctor or nurse will administer the recommended dose of the vaccine as an injection into the muscle or under the skin.
If you or your child use more Vaxigrip Tetra than you should
In some cases, more than the recommended dose was used.
In these cases, when side effects were reported, the information was in line with what is described in Section 4.
If you have any further questions on the use of this product, ask your doctor or pharmacist.


Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Allergic reactions
Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you or your child experience allergic reactions that can be life threatening.
Symptoms may include rash, itching, hives, redness, difficulty breathing, shortness of breath, swelling of the face, lips, throat, or tongue, cold, clammy skin, palpitations, dizziness, weakness or fainting.
Other side effects reported in adults and elderly
Very common (may affect more than 1 in 10 people):
- Headache, muscular pain (myalgia), generally feeling unwell (malaise) (1), pain at the injection site.
(1) Common in elderly
Common (may affect up to 1 in 10 people):
- Fever (2), shivering, reactions at the injection site: redness (erythema), swelling, hardness (induration).
(2) Uncommon in elderly
Uncommon (may affect up to 1 in 100 people):
- Dizziness (3), diarrhoea, feeling sick (nausea) (4), fatigue, reactions at the injection site: bruising (ecchymosis), itching (pruritus), and warmth.
(3) Rare in adults (4) Rare in elderly
- Hot flush: only seen in the elderly.
- Swelling of the glands in the neck, armpit or groin (lymphadenopathy): only seen in adults.

Rare (may affect up to 1 in 1,000 people):
- Anomalies in the perception of touch, pain, heat and cold (paraesthesia), sleepiness, increased sweating (hyperhidrosis), unusual tiredness and weakness (asthenia), flu-like illness.
- Joint pain (arthralgia), discomfort at the injection site: only seen in adults.
Other side effects reported in children from 3 to 17 years of age
Very common (may affect more than 1 in 10 people):
- Headache, muscular pain (myalgia), generally feeling unwell (malaise), shivering (5), reactions at the injection site: pain, swelling, redness (erythema) (5), hardness (induration) (5).
(5) Common in children from 9 to 17 years of age
Common (may affect up to 1 in 10 people):
- Fever, bruising (ecchymosis) at the injection site.
Uncommon (may affect up to 1 in 100 people) in children from 3 to 8 years of age:
- Temporary reduction in the number of certain types of particles in the blood called platelets; a low number of these can result in excessive bruising or bleeding (transient thrombocytopaenia): only seen in one child of 3 years of age.
- Moaning, restlessness.
- Dizziness, diarrhoea, vomiting, upper abdominal pain, joint pain (arthralgia), fatigue, warmth at the injection site.
Uncommon (may affect up to 1 in 100 people) in children from 9 to 17 years of age:
- Diarrhoea, itching (pruritus) at the injection site.
Other side effects reported in children from 6 to 35 months of age
Very common (may affect more than 1 in 10 people):
- Vomiting (1), muscular pain (myalgia) (2), irritability (3), appetite lost (3), generally feeling unwell (malaise) (2), fever.
(1) Uncommon in children from 24 to 35 months of age (2) Rare in children less than 24 months of age
(3) Rare in children from 24 to 35 months of age
- Reactions at the injection site: pain/tenderness, redness (erythema).
- Headache: only seen in children from 24 months of age.
- Drowsiness, unusual crying: only seen in children less than 24 months of age.
Common (may affect up to 1 in 10 people):
- Shivering: only seen in children 24 months and older.
- Reactions at the injection site: hardness (induration), swelling, bruising (ecchymosis).
Uncommon (may affect up to 1 in 100 people):
- Diarrhoea, hypersensitivity.
Rare (may affect up to 1 in 1,000 people):
- Flu-like illness, reactions at the injection site: rash, pruritus (itching).
In children from 6 months to 8 years of age who receive 2 doses, side effects are similar after the first and after the second dose. Fewer side effects may happen after the second dose in children from 6 to 35 months of age.
When seen, side effects generally happen in the first 3 days after the vaccination and go away by themselves in 1 to 3 days after they start. The intensity of observed side effects was mild.
Overall, side effects were generally less frequent in elderly than in adults and children.
The following side effects have been reported after administration of Vaxigrip. These side effects may occur with Vaxigrip Tetra:
- Pain situated on the nerve route (neuralgia), fits (convulsions), neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss

of reflexes, paralysis of part or all the body (encephalomyelitis, neuritis, Guillain-Barré syndrome).
- Blood vessel inflammation (vasculitis) which may result in skin rashes and in very rare cases in temporary kidney problems.
- Transient thrombocytopenia, lymphadenopathy, paraesthesia in other age groups than those described above for these side effects.
Reporting of side effects
If you or your child 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.
By reporting side effects you can help provide more information on the safety of this medicine.

To report any side effect(s):
• Saudi Arabia:
The National Pharmacovigilance and Drug Safety Center (NPC)
• Fax: +966-11-205-7662
• Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340
Toll free phone: 8002490000
• Email: npc.drug@sfda.gov.sa
• Website: www.sfda.gov.sa/npc
Sanofi Pharmacovigilance: KSA_Pharmacovigilance@sanofi.com


Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light.
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 substances are: Influenza virus (inactivated, split) of the following strains*:
A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09 - like strain (A/Guangdong-Maonan/SWL1536/2019, CNIC-1909)……………………………………..15 micrograms HA**
A/Hong Kong/2671/2019 (H3N2) - like strain (A/Hong Kong/2671/2019, IVR-208) ... 15 micrograms HA**
B/Washington/02/2019 - like strain (B/Washington/02/2019, wild type) ............ 15 micrograms HA**
B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type) .................... 15 micrograms HA**
Per 0.5 ml dose
* propagated in fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin
This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2020/2021 season.
- The other ingredients are: a buffer solution containing sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, and water for injections.
Some components such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol-9 may be present in very small amounts (see Section 2).


The vaccine, after shaking gently, is a colourless opalescent liquid. Vaxigrip Tetra is a suspension for injection presented in a pre-filled syringe of 0.5 ml, with attached needle or without needle, in box of 1. Not all pack sizes may be marketed.

The Marketing Authorisation Holder is:
SANOFI PASTEUR
14 ESPACE HENRY VALLÉE
69007 LYON
FRANCE

The Manufacturer is:
SANOFI PASTEUR
VAL DE REUIL (VDR),
Parc Industriel d’Incarville,
27100 VAL DE REUIL, France


May 2020
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

المجموعة الدوائيّة العلاجيّة: لقاح الأنفلون ا ز رمز – إيه تي سي " ATC :" J07BB02 .
فاكسيغريب تيت ا ر هو لقاح. يساعد هذا اللقاح الذي يتم إعطاؤه لك أو لطفلك من عمر 6 أشهر على حمايتك أو
حماية طفلك من الأنفلون ا ز )الأنفلون ا ز(.
عندما يتم إعطاء الشخ ص فاكسيغريب تيت ا ر، فإن الجهاز المناعي )نظام الدفاع الطبيعي للجسم( سينتج حمايته
الخاصة )الأجسام المضادة( ضد المرض. عندما يُعطى اللقاح أثناء الحمل، فإنه يساعد على حماية النساء
الحوامل ولكنه يساعد أيضًا في حماية طفلها من الولادة إلى أقل من 6 أشهر من العمر من خلال انتقال
الحماية من الأم إلى الطفل أثناء الحمل )انظر أيضًا القسمين 2 و 3 . )
لا يُمكن لأيّ من مك ونات اللقاح أن يسبب الإنفلون ا ز .
ينبغي أن يستند استخدام فاكسيغريب تيت ا ر على التوصيات الرسمية.
الأنفلون ا ز مرض يمكن أن ينتشر بسرعة وينتج عن أنواع مختلفة من السلالات التي يمكن أن تتغير كل عام.
بسبب هذا التغيير المحتمل في السلالات المنتشرة على أساس س نوي، وكذلك مدة الحماية التي يوفرها ا للقاح،
يوصى بتلقّي التطعيم كل عام. يكون أ على خطر للاصابة بالانفلون ا ز خلال الأشهر الباردة، بين أكتوبر ومارس
"تشرين الأول وآذار". إذا لم يتم تطعيمك أنت أو طفلك في فصل الخريف، يظل خيار تطعيمك منطقيا حتى
موعد الربيع بما أنك تواجه خطر الاصابة بالأنفلون ا ز حتى ذلك الحين. سينصحك طبيبك بأفضل وقت للتطعيم .
لقد تم إعداد فاكسيغريب تيت ا ر ليوفر لك أو لطفلك الحماية من السلالات الأربعة من الفيروس الموجودة في
اللقاح بعد حوالي 2 إلى 3 أسابيع من حقنه. بالإضافة إلى ذلك، إذا تع رضت أنت أو طفلك لفيروس الأنفلون ا ز
قبل التطعيم أو بعده فو اً ر ، فلا ي ا زل بإمكانك أنت أو طفلك الإصابة بهذا المرض لأن فترة حضانة الأنفلون ا ز
بضعة أيام .
لن يحميك اللقاح أن ت أو طفلك من نزلات البرد، على الرغم من أن بعض أع ا رضها تشبه الأنفلون ا ز.

من المهم إخبار طبيبك أو الصيدلي إذا كانت أيّ من النقاط التالية تنطبق عليك أو على طفلك وذلك للتأكد من
أن فاكسيغريب تيت ا ر مناسب لك أو لطفلك. إذا استعصى عليك فهم أي شيء، اطلب من طبيبك أو الصيدلي
توضيحه لك.
لا تستخدم فاكسيغريب إذا :
• كنت أنت أو طفلك مصابان بالحساسية تجاه :
o المواد الفعالة، أو
o أي من المك ونات الأخرى لهذا اللقاح )المُ درجة في الفقرة رقم 6(، أ و
o أي مكون آخر قد يتواجد بكميات صغيرة جدًا مثل البيض )بروتين البي ض، بروتينات الدجاج(،
النيومايسين، الفورمالديهايد أو الأوكتوكسينول - 9 ،
• إذا كنت أنت أو طفلك مصابًا بمر ض مصحو ب بحمّى شديدة أو متوسطة أو مرض حاد، فيجب تأجيل
التطعيم حتى تتعافى أنت أو طفلك.
التحذي ا رت والإحتياطات
تحدث إلى طبيبك أو الصيدلي أو الممرض قبل استخدا م فاكسيغريب تيت ا ر .
يجب عليك إخبار طبيبك قبل التطعيم إذا كان لديك أو لدى طفلك:
• استجابة مناعية ضعيفة )نقص المناعة أو تتناول الأدوية التي تؤثر على جهاز المناعة(،
• مُشكلة نزيف أو حدوث كدمات بسهولة.
سيقرر طبيبك إذا كان ينبغي أن تتلقى أنت أو طفلك اللقاح.
يمكن أن يحدث الإغماء )في الغالب لدى الم ا رهقين( بع د، أو حتى قبل تلقي أيّ حقنه. لذلك أخبر طبيبك أو
ممرضتك إذا تعرّضت أنت أو طفلك للإغماء مع تلقي أي حقنة في السابق .

كما هو الحال مع جميع اللقاحات، قد لا يؤمن فاكسيغريب تيت ا ر الحماية ا لتامة لجميع الأشخاص الذين تم
تطعيمهم .
لن يتم حماية جميع الأطفال الذين تقل أعمارهم عن 6 أشهر والمولودين من نساء حوامل تم تطعيمهن أثناء
الحمل.
يُرجى إخبار طبيبك إذا كنت ستخضع أنت أو طفلك لإج ا رء فحص للدم لأي سب ب من الأسبا ب في غضون أيام
قليلة بعد التطعيم بلقاح الأنف لونزا. وذلك لأنه لوحظ ظهور نتائج فحو ص للدم إيجابية خاطئة لدى عدد قليل من
المرضى الذين تم تطعيمهم مؤخ ا رً.
الأطفال
لا يُنصح باستخدام فاكسيغريب تيت ا ر لدى الأطفال ممن تقل أعمارهم عن 6 أشهر .
استخدام أدوية أخرى مع فاكسيغريب تيت ا ر
أخبر طبيبك أو الصيدلي إذا كنت أنت أو طفلك تستخدم، استخدمت أو ستستخدم أي لقاحات أخرى أو أي
أدوية أخرى .
• يمكن إعطاء فاكسيغريب تيت ا ر في نفس الوقت مع اللقاحات الأخرى باستخدام مواضع حقن منفصلة على
أط ا رف مختلفة .
• قد تنخفض الاستجابة المناعية في حالة العلاج المناعي، مثل الكورتيكوستيرويدات أو الأدوية الكيميائية أو
العلاج الإشعاعي.
الحمل والرضاعة الطبيعي ة
إذا كن ت حاملاً أو مُرضعة، تعتقدين أ نك قد تكونين حاملاً أو تخططين لإنجاب طفل، استشيري طبيبك أو
الصيدلي قبل استخدام هذا اللقاح .
يمكن استخدام فاكيغريب تيت ا ر في جميع م ا رحل الحمل.
يمكن استخدام فاكيغريب تيت ا ر أثناء الرضاعة الطبيعية .
سيتمكن طبيبك/الصيدلي من تحديد ما إذا كان يجب عليك تلقي فاكسيغريب تيت ا ر .

القيادة واستخدام الآلات
فاكسيغريب تيت ا ر ليس له تأثير يُذكر على القدرة على القيادة واستخدام الآلات .
معلومات هامة حول بعض مكوّنات فاكسيغريب تيت ا ر
يحتوي فاكسيغريب تيت ا ر على البوتاسيوم والصوديو م

يحتوي هذا الدواء على أقل من 1 م ليمول من البوتاسيوم ) 39 مجم( والصوديوم ) 23 مجم( في الجرعة الواحدة،
أي أنّه خا ل من البوتاسيوم والصوديوم أساسًا .

https://localhost:44358/Dashboard

الجرعة
الكبار

جرعة واحدة مقدارها 0.5 مل.
الأطفال
الجرعة للأطفال من سن 6 أشهر إلى 17 سنة هي حقنة واحدة مق دارها 0.5 مل.
إذا كان عمر طفلك أقل من 9 سنوات ولم يتم تطعيمه سابقاً ضد الأنفلون ا ز، فيجب إعطاؤه جرعة ثانية مقدارها
0.5 مل بعد فترة لا تقل عن 4 أسابيع من الجرعة الأولى.
إذا كنت حاملاً ، فإن جرعة واحدة مقدارها 0.5 مل تعطى لك أثناء الحمل قد تحمي طفلك من الولادة إلى أقل
من 6 أشهر من العمر. إسأل طبيبك أو الصيدلي للحصول على مزيد من المعلومات.
كيف يتم إعطاء فاكسيغريب تيت ا ر
سيقوم الطبيب أو الممرض بإعطاء الجرعة الموصى بها من اللقاح كحقنة في العضل أو تحت الجلد.
إذا تلقيت أنت أو طفلك من فاكسيغريب تيت ا ر أكثر مما ينبغ ي
في بعض الحالات ، تم استخدام أكثر من الجرعة الموصى بها .
في هذه الحالات ، عندما تم الإبلاغ عن الآثار الجانبية ، كانت المعلومات متوافقة مع ما تم وصفه في القسم
4 .

إذا كانت لديك أي أسئلة أخرى حول استخدام هذا المنتج ، اسأل طبيبك أو الصيدلي.

كما هو الحال مع سائر الأدوية، يمكن أن يُسبب هذا اللقاح أع ا رضًا جانبية، على الرغم من أنها لا تحدث لدى
جميع من يتلقاه.
ردود الفعل التحسسي ة
اتصل بطبيبك أو أخصائي الرعاية الصحية على الفور أو انتقل إلى أقرب غرفة طوارئ في المستشفى على
الفور إذا كنت أنت أو طفلك تعاني من الحساسية التي قد تهدد الحياة.
قد تشمل الأع ا رض طفح جلدي أو حكة أو الشرى أو احم ا رر أو صعوبة في التنفس أو ضيق في التنفس أو تورم
في الوجه أو الشفتين أو الحلق أو اللسان أو البرد أو جلد رط ب أو خفقان أو دوخة أو ضعف أو إغماء .
الأع ا رض الجانبية الأخرى المُ ب لغ عنها لدى البالغين وكبار السن
شائعة جدًا )قد تُؤثر على أكثر من 1 من كل 10 أشخاص(:
• الصداع ، ألم عضلي، الشعور بالتوعك) 1 (، ألم في م وضع الحقن.
( 1 ( شائع لدى كبار الس ن
شائعة )قد تُؤثر على ما يصل إلى شخص واحد من كل 10 أشخاص(:
• الحمى) 2 (، القشعريرة، ردود الفعل في م وضع الحقن: احم ا رر )حمامي(، وتورم، وصلابة ) تيبس( .
( 2 ( غير شائع في كبار الس ن
غير شائعة )قد تُؤثر على ما يصل إلى شخص واحد من كل 100 شخص(:
• الدوخة) 3 (، والإسهال، والغثيان) 4 (، والتعب، وردود الفعل في م وضع الحقن: كدمات، وحكّ ة، ودفء.
( 3 ( نادرة لدى البالغين، ) 4 ( نادرة لدى كبار الس ن
• الهبات الساخنة: لوحظت لدى كبار السن فقط .
• تورم الغدد في الرقبة أو الإبط أو الفخذ )اعتلال العقد اللمفية(: لوحظت لدى البالغين فقط .
ناد رة )قد تُؤثر على ما يصل إلى 1 من كل 1000 شخص(:

• اضط ا رب في حاسة ال لمس والألم والح ا ررة والبرودة )ال م ذل(، والنعاس، وزيادة التعرق )فرط التعرق(، والتعب
غير العادي والضعف )الوهن(، مرض شبيه بالإنفلون ا ز.
• آلام المفاصل )ألم مفصلي(، والاحساس بعدم الارتياح في م وضع الحقن: لدى البالغين فقط .
الأع ا رض الجانبية الأخرى المُ ب لغ عنها لدى الأطفال م ن عمر 3 إلى 17 سنة
شائعة جدًا )قد تُؤثر على أكثر من 1 من كل 10 أشخاص(:
• الصداع، ألم عضلي، توعك، قُشعريرة) 5 (، تفاعلات في م وضع الحقن: ألم، تورم، احم ا رر) 5 (، صلابة
)تيبس() 5 .)
( 5 ( شائع لدى الأطفال من عمر 9 إلى 17 سن ة
شائعة )قد تُؤثر على ما يصل إلى شخص واحد من كل 10 أشخاص(:
• حمى وكدما ت في م وضع الحقن .
غير شائعة )قد تؤثر على ما يصل إلى شخص واحد من بين كل 100 شخص( لدى الأطفال من 3 إلى 8
سنوات من العمر:
• انخفاض مؤقت في عدد أحد عناصر الدم المسمى بالصفائح الدموية؛ يمكن أن يؤدي انخفاض عدد الصفائح
إلى تكدُّم أو نزيف مفرط )قلة الصفيحات العابرة(: حدثت لدى طفل واحد يبلغ 3 سنوات من العمر.
• الشكوى والتململ.
• الدوخة والإسهال والقيء وآلام البطن العلوية وآلام المف اصل والتعب والدفء في م وضع الحقن.
غير شائعة )قد تحدث لدى ما يصل إلى شخ ص واح د من بين كل 100 شخص( عند الأطفال من سن 9 إلى
17 عامًا :
• الإسهال والحكة في م و ضع الحقن .
الأع ا رض الجانبية الأخرى المُ ب لغ عنها لدى الأطفال من سن 6 إلى 35 شه ا ر من العم ر
شائعة جدًا )قد تُؤثر على أكثر من 1 من كل 10 أشخاص(:
• القيء) 1 (، ألم عضلي) 2 (، والتهيج) 3 (، وفقدان الشهي ة) 3 (، الشعور العام بالتوعك) 2 (، حمى.
( 1 ( غير شائعة لدى الأطفال من عمر 24 إلى 35 شه اً ر، ) 2 ( ناد رة لدى الأطفال أقل من 24 شه اً ر من العمر
( 3 ( نادرة لدى الأطفال من سن 24 إلى 35 شه اً ر

• ردود الفعل في م وضع الحقن: ألم/إيلام، احم ا رر )حمامي(.
• الصداع: يظهر لدى الأطفال من عمر 24 شه اً ر فقط .
• النعاس، البكاء الغير عادي: لوحظ لدى الأطفال ا لأصغر من 24 شه اً ر من العمر.
شائعة )قد تُؤثر على ما يصل إلى شخص واحد من كل 10 أشخاص(:
• قُشعريرة: لوحظت لدى الأطفال بدءاً من عمر 24 شه ا ر وما فوق.
• ردود الفعل في م وضع الحقن: الصلابة )ال تيبّس(، التو رم، الكدمات.
غير شائعة )قد تُؤثر على ما يصل إلى شخص واحد من كل 100 شخص(:
• الإسهال، فرط الحساسية .
ناد رة )قد تؤثر على ما يصل إلى 1 من كل 1000 شخص(:
• مرض يشبه الإنفلون ا ز، وردود الفعل في م وضع الحقن: طفح جلدي، حكة .
كانت الأع ا رض الجانبيّة التي حدثت لدى الأطفال من عمر 6 أشهر إلى 8 سنوات ممن تلقّوا جرعتين متماثلة
بعد الجرعتين. قد تحدث أع ا ر ض جانبية أقل بعد الجرعة الثانية عند الأطفال من سن 6 إلى 35 شه اً ر .
تحدث الأع ا رض الجانبية المُلاحظة عادة خلال الأيام الثلاثة الأولى بعد التطعيم وتختفي من تلقاء نفسها في
غضون يوم إلى ثلاثة أيام بعد بدئها. كانت شدة الأع ا ر ض الجانبية الملا ح ظة خفيفة.
كانت الأع ا ر ض الجانبية أقل حدوثًا بشكل عام لدى كبار السن مقارنة بالبالغين والأطفال.
تم الإبلاغ عن الأع ا ر ض الجانبية التالية بعد إعطاء لقاح فاكسيغريب، وقد تحدث مع فاكسيغريب تيت ا ر :
• ألم عصبي، وتشنجات، واضط ا ربات عصبية قد تؤدي إلى تيبس الرقبة، والارتباك، والخدر، والألم
وضعف الأط ا رف، وفقدان التوازن، وفقدان الانعكاسات اللاإ ا ردية، وشلل جزء من الجسم أو بأكمله )التهاب
الدماغ والنخاع، التهاب العصب، متلازمة غي لان باريه(
• التهاب الأوعية الدموية الذي قد يؤدي إلى حدوث طفح جلدي وفي حالات نادرة للغاية إلى مشاكل الكلى
المؤقتة.

• نقص الصفيحات العابرة ، اعتلال عقد لمفية ، مذل في الفئات العمرية الأخرى غير المذكورة أعلاه لهذه
الآثار الجانبية .
الإبلاغ عن الأع ا رض الجانبي ة
إذا واجهت أنت أو طفلك أيّ أع ا ر ض جانبية، تحدث مع طبيبك أو الصيدلي أو الممرض. يتضمن ذلك أي
أع ا رض جانبية مُ حتملة غير مدرجة في هذه النشرة. يمكنك أيضًا الإبلاغ عن الأع ا ر ض الجانبية مباشرةً عبر
نظام الإبلاغ الوطني. يمكنك المساعدة في تقديم مزيد من المعلومات حول سلامة هذا الدواء من خلال الإبلاغ
عن الأع ا ر ض الجانبية .

 

الابلاغ عن الأعراض الجانبية:
• المملكة العربية السعودية :
 المركز الوطنى للتيقظ والسلامة الدوائية
o فاكس: 7662 - 205 - 11 966 +
o للإتصال بالإدارة التنفيذية للتيقظ وإدارة الازمات هاتف: 2038222 - 11 966 + تحويلة :- 2340 -
2353 - 2356 - 2317 - 2354 - 2334
o الهاتف المجانى: 8002490000
o البريد الالكترونى: npc.drug@sfda.gov.sa
o الموقع الالكترونى: www.sfda.gov.sa/npc
o التيقظ الدوائي لشركة سانوفي: KSA_Pharmacovigilance@sanofi.com

احفظ هذا اللقاح بعيدًا عن م أ رى ومتناول الأطفال.
لا تستخدم هذا اللقاح بعد تاريخ انتهاء الصلاحية المذكور على المُ لصق والكرتون بع د كلمة " EXP ". يشير
تاريخ انتهاء الصلاحية إلى آخر يوم في ذلك الشهر.
احفظه في الثلاجة ) 2 درجة مئوية - 8 درجة مئوية(. لا تُجمّ ده. احفظ المحقنة داخل الكرتون الخارجي من
أجل حمايتها من الضوء .
لا تتخلص من أي أدوية عن طريق مياه الصرف الصحي أو النفايات المنزلية. اسأل الصيدلي عن كيفية
التخلص من الأدوية التي لم تعد تستخدمها. هذه التدابير سوف تساعد في حماية البيئة .

محتويات فاكسيغري ب
• المواد الفعالة: فيروس الأنفلون ا ز )المُعطّل( من السلالات التالية* :
A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09 - like strain (A/Guangdong-Maonan/SWL1536/2019, CNIC-1909)
15 ميكروج ا رم HA**
A/Hong Kong/2671/2019 (H3N2) - like strain (A/Hong Kong/2671/2019, IVR-208)
15 ميكروج ا رم HA

B/Washington/02/2019 - like strain (B/Washington/02/2019, wild type)
15 ميكروج ا رم HA**
B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type)
15 ميكروج ا رم HA**
في كل جرعة مقدارها 0.5 مل
*تكاثرت في بيض الدجاج المُخصّب المأخوذ من أس ا رب الدجاج السليمة
**هيم أغلوتيني ن ) ا رصّة دمويّة (
يتوافق هذا اللقاح مع توصيات منظمة الصحة العالمية )نصف الكرة الشمالي( وق ا رر الاتحاد الأوروبي لموسم
2020 / 2021 .
• المكونات الأخرى : محلول مُنظّم يحتوي على كلوريد الصوديوم، كلوريد البوتاسيوم، فوسفات ثنائي
الصوديوم ثنائي الهيد ا رت، فوسفات ثنائي هيدروجين البوتاسيوم، وماء للحقن .
قد تتواجد بعض العناصر الأخرى بكميّات قليلة جدًا مثل البيض )ألبومين البي ض، بروتينات الدجاج(،
نيومايسين، الفورمالديهايد أ و الأوكتوكسينول - 9 )انظر الفقرة 2

اللقاح، بعد رجّه بلطف، هو سائل مُعتم عديم اللون .
فاكسيغريب تيت ا ر عبارة عن مع لق للحقن يتوفّر في م حقنة مملوءة مسبقًا بحجم 0.5 مل، مُرفق بها إبرة، في
العلبة الواحدة.
قد لا يتم تسويق جميع أحجام العبوات.

مالك رخصة التسويق
سانوفي باستو ر
14 هنري فالي سباس
69007 ليو ن
فرنسا

الشركة المُصنعة
سانوفي باستو ر
فال دي رويل
المجمع الصناعي انكارفيل
27100 فال دي روي ل
فرنسا

مايو 2020 م .
 Read this leaflet carefully before you start using this product as it contains important information for you

Vaxigrip Tetra, suspension for injection in pre-filled syringe Quadrivalent influenza vaccine (split virion, inactivated)

Influenza virus (inactivated, split) of the following strains*: A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09 - like strain (A/Guangdong-Maonan/SWL1536/2019, CNIC-1909) ................................................................... 15 micrograms HA** A/Hong Kong/2671/2019 (H3N2) - like strain (A/Hong Kong/2671/2019, IVR-208)15 micrograms HA** B/Washington/02/2019 - like strain (B/Washington/02/2019, wild type) ............... 15 micrograms HA** B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type) ....................... 15 micrograms HA** Per 0.5 ml dose * propagated in fertilised hens’ eggs from healthy chicken flocks ** haemagglutinin This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2020/2021 season. For the full list of excipients, see Section 6.1. Vaxigrip Tetra may contain traces of eggs, such as ovalbumin, and of neomycin, formaldehyde and octoxinol-9, which are used during the manufacturing process (see Section 4.3).

Suspension for injection in pre-filled syringe. The vaccine, after shaking gently, is a colourless opalescent liquid.

Vaxigrip Tetra is indicated for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine for:
- active immunisation of adults, including pregnant women, and children from 6 months of age and older,
- passive protection of infant(s) from birth to less than 6 months of age following vaccination of pregnant women (see Sections 4.4, 4.6 and 5.1).
The use of Vaxigrip Tetra should be based on official recommendations.


Posology
Based on clinical experience with the trivalent vaccine, annual revaccination with influenza vaccine is recommended given the duration of immunity provided by the vaccine and because circulating strains of influenza virus might change from year to year.
Adults: one dose of 0.5 ml.
Paediatric population
- Children from 6 months to 17 years of age: one dose of 0.5 ml.
For children less than 9 years of age who have not previously been vaccinated, a second dose of 0.5 ml should be given after an interval of at least 4 weeks.
- Infants less than 6 months of age: the safety and efficacy of Vaxigrip Tetra administration (active immunisation) have not been established. No data are available.
Regarding passive protection: one 0.5 ml dose given to pregnant women may protect infants from birth to less than 6 months of age; however, not all these infants will be protected (see section 5.1).
Method of administration
The vaccine should be given by intramuscular or subcutaneous injection.
The preferred sites for intramuscular injection are the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 6 months through 35 months of age, or the deltoid muscle in children from 36 months of age and adults.
Precautions to be taken before handling or administering the medicinal product
For instructions on preparation of the medicinal product before administration, see Section 6.6.


Hypersensitivity to the active substances, to any of the excipients listed in Section 6.1 or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol-9. Vaccination should be postponed in case of moderate or severe febrile disease or acute disease.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
Vaxigrip Tetra should under no circumstances be administered intravascularly.
As with other vaccines administered intramuscularly, the vaccine should be administered with caution to subjects with thrombocytopaenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent injury from fainting and manage syncopal reactions.
Vaxigrip Tetra is intended to provide protection against those strains of influenza virus from which the vaccine is prepared.

As with any vaccine, vaccination with Vaxigrip Tetra may not protect all vaccinees.
Regarding passive protection, not all infants less than 6 months of age born to women vaccinated during pregnancy will be protected (see section 5.1).
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Interference with serological testing
See Section 4.5.


No interaction studies have been performed with Vaxigrip Tetra.
Vaxigrip Tetra can be given at the same time as other vaccines, based on clinical experience with Vaxigrip. Separate injection sites and separate syringes should be used in case of concomitant administration.
The immunological response may be reduced if the patient is undergoing immunosuppressant treatment.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false positive reactions could be due to the IgM response by the vaccine.


Pregnancy
Pregnant women are at high risk of influenza complications, including premature labour and delivery, hospitalization, and death: pregnant women should receive an influenza vaccine.
Vaxigrip Tetra can be used in all stages of pregnancy.
Larger datasets on safety of inactivated influenza vaccines are available for the second and third trimesters, compared with the first trimester; however, data from worldwide use of inactivated influenza vaccines, including Vaxigrip Tetra and Vaxigrip (trivalent inactivated influenza vaccine), do not indicate any adverse foetal and maternal outcomes attributable to the vaccine. Similar outcomes were observed in one clinical study conducted with Vaxigrip Tetra administered in pregnant women during the second or third trimester (230 exposed pregnancies and 231 live births).
Data from four clinical studies with the trivalent inactivated influenza vaccine (Vaxigrip thiomersal-free formulation) administered in pregnant women during the second or third trimester (more than 5,000 exposed pregnancies and more than 5,000 live births followed up to approximately 6 months post-partum) did not indicate any adverse foetal, newborn, infant and maternal outcomes attributable to the vaccine.
In clinical studies conducted in South Africa and Nepal, there were no significant differences between the Vaxigrip and placebo groups with regards to foetal, newborn, infant and maternal outcomes (including miscarriage, stillbirth, premature birth, low birth weight).
In a study conducted in Mali, there were no significant differences between the Vaxigrip and control vaccine (quadrivalent meningococcal conjugate vaccine) groups with regards to prematurity rate, stillbirth rate and low birth weight/small for gestational age rate.
For additional information, see Sections 4.8 and 5.1.
One animal study with Vaxigrip Tetra did not indicate direct or indirect harmful effects with respect to pregnancy, embryo-foetal development or early post-natal development.

Breastfeeding
Vaxigrip Tetra may be used during breastfeeding.
Fertility
There are no fertility data available in Humans. One animal study with Vaxigrip Tetra did not indicate harmful effects on female fertility.


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


a. Summary of the safety profile
The safety of Vaxigrip Tetra was assessed in six clinical trials in which 3,040 adults from 18 to 60 years of age, 1,392 elderly over 60 years of age and 429 children from 9 to 17 years of age received one dose of Vaxigrip Tetra and 884 children from 3 to 8 years of age received one or two doses of Vaxigrip Tetra depending on their influenza vaccination history and 1,614 children from 6 to 35 months of age received two doses (0.5 ml) of Vaxigrip Tetra.
Most reactions usually occurred within the first 3 days following vaccination, resolved spontaneously within 1 to 3 days after onset. The intensity of these reactions was mild.
The most frequently reported adverse reaction after vaccination, in all populations including the whole group of children from 6 to 35 months of age, was injection site pain (between 52.8% and 56.5% in children from 3 to 17 years of age and in adults, 26.8% in children from 6 to 35 months of age and 25.8% in elderly). In subpopulation of children less than 24 months of age, irritability (32.3%) was the most frequently reported adverse reaction.
In subpopulation children from 24 to 35 months of age, malaise (26.8%) is the most frequently reported adverse reaction.
The other most frequently reported adverse reactions after vaccination were:
- In adults: headache (27.8%), myalgia (23%) and malaise (19.2%),
- In elderly: headache (15.6%) and myalgia (13.9%),
- In children from 9 to 17 years of age: myalgia (29.1%), headache (24.7%), malaise (20.3%) and injection site swelling (10.7%),
- In children from 3 to 8 years of age: malaise (30.7%), myalgia (28.5%), headache (25.7%), injection site swelling (20.5%), injection site erythema (20.4%), injection site induration (16.4%), shivering (11.2%),
- In all children from 6 to 35 months of age: fever (20.4%) and injection site erythema (17.2%),
- In children less than 24 months of age: appetite lost (28.9%), crying abnormal (27.1%), vomiting (16.1%) and drowsiness (13.9%),
- In children from 24 to 35 months of age: headache (11.9%) and myalgia (11.6%).
Overall, adverse reactions were generally less frequent in the elderly than in adults and children.
b. Tabulated summary of adverse reactions
The data below summarize the frequencies of the adverse reactions that were recorded following vaccination with Vaxigrip Tetra during clinical trials and worldwide post-marketing surveillance.
Adverse events are ranked under headings of frequency using the following 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);
Not known (cannot be estimated from available data).
Adult and elderly
The safety profile presented below is based on:
- data from 3,040 adults from 18 to 60 years of age and 1,392 elderly over 60 years of age
- data from worldwide post-marketing surveillance (*).

Paediatric population
The safety profile presented below is based on:
- data from 429 children from 9 to 17 years of age who received one dose of Vaxigrip Tetra and from 884 children from 3 to 8 years of age who received one or two doses of Vaxigrip Tetra depending on their influenza vaccination history
- data from worldwide post-marketing surveillance (*).

The safety profile presented below is based on:
- data from 1,614 children from 6 to 35 months of age who received two doses of Vaxigrip Tetra
- data from worldwide post-marketing surveillance (*).

In children from 6 months to 8 years of age, the safety profile of Vaxigrip Tetra was similar after the first and the second injections with a trend of lower incidence of adverse reactions after the second injection compared to the first one in children from 6 to 35 months.
c. Adverse events
The following adverse events were reported following commercial use of Vaxigrip. A causal relationship with Vaxigrip Tetra has not been established.
• Blood and lymphatic system disorders
Transient thrombocytopenia (1), lymphadenopathy (1)
• Nervous system disorders
Paraesthesia (1), Guillain-Barré Syndrome (GBS), neuritis, neuralgia, convulsions, encephalomyelitis
• Vascular disorders
Vasculitis, such as Henoch-Schönlein purpura, with transient renal involvement in certain cases
(1) These adverse events were reported during clinical trials only in some age groups (see subsection b).
d. Other special populations
The safety profile of Vaxigrip Tetra observed in a limited number of subjects with co-morbidities enrolled in the clinical studies does not differ from the one observed in the overall population. In addition, studies conducted with Vaxigrip in renal transplant patients, and asthmatic patients showed no major differences in terms of safety profile of Vaxigrip in these populations.

- Pregnant women
In clinical studies conducted in pregnant women in South Africa and Mali with Vaxigrip (see Sections 4.6 and 5.1), frequencies of local and systemic solicited reactions reported within 7 days following administration of the vaccine, were consistent with those reported for the adult population during clinical studies conducted with Vaxigrip. In the South Africa study, local reactions were more frequent in the Vaxigrip group than in the placebo group in both HIV-negative and HIV-positive cohorts. There were no other significant differences in solicited reactions between Vaxigrip and placebo groups in both cohorts.
In one clinical study conducted in pregnant women in Finland with Vaxigrip Tetra (see sections 4.6 and 5.1), frequencies of local and systemic solicited reactions reported within 7 days following administration of Vaxigrip Tetra were consistent with those reported for the non-pregnant adult population during clinical studies conducted with Vaxigrip Tetra even though higher for some adverse reactions (injection site pain, malaise, shivering, headache, myalgia). When higher frequencies were observed, this increase was also seen with Vaxigrip used as comparator, suggesting a clinical study effect in this pregnant women population.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:
- To reports any side effect(s):
• Saudi Arabia:

 The National Pharmacovigilance and Drug Safety Centre (NPC)
• Fax: +966-11-205-7662
• Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
• Toll free phone: 8002490000
• E-mail: npc.drug@sfda.gov.sa
• Website: www.sfda.gov.sa/npc


Cases of administration of more than the recommended dose (overdose) have been reported with Vaxigrip Tetra. When adverse reactions were reported, the information was consistent with the known safety profile of Vaxigrip Tetra described in Section 4.8.


Pharmacotherapeutic group: Influenza vaccine, ATC code: J07BB02.
Mechanism of action
Vaxigrip Tetra provides active immunisation against four influenza virus strains (two A subtypes and two B types) contained in the vaccine.

Vaxigrip Tetra induces humoral antibodies against the haemagglutinins within 2 to 3 weeks. These antibodies neutralise influenza viruses.
Specific levels of haemagglutination-inhibition (HAI) antibody titer post-vaccination with inactivated influenza virus vaccines have not been correlated with protection from influenza illness but the HAI antibody titers have been used as a measure of vaccine activity. In some human challenge studies, HAI antibody titers of ≥1:40 have been associated with protection from influenza illness in up to 50% of subjects.
Since influenza viruses constantly evolve, the virus strains selected in the vaccine are reviewed annually by the WHO.
Annual revaccination with Vaxigrip Tetra has not been studied. However, based on clinical experience with the trivalent vaccine, annual influenza vaccination is recommended given the duration of immunity provided by the vaccine and because circulating strains of influenza virus change from year to year.
Efficacy of Vaxigrip Tetra
Paediatric population
- Children from 6 to 35 months of age (active immunisation):
A randomized placebo controlled study was conducted in 4 regions (Africa, Asia, Latina America and Europe) over 4 influenza seasons, in more than 5,400 children from 6 to 35 months of age who received two doses (0.5 ml) of Vaxigrip Tetra (N=2,722), or placebo (N=2,717) 28 days apart to assess Vaxigrip Tetra efficacy for the prevention of laboratory-confirmed influenza illness caused by any strain A and/or B and caused by vaccine similar strains (as determined by sequencing).
Laboratory-confirmed influenza illness was defined as influenza like-illness (ILI) [occurrence of fever ≥ 38°C (that lasts at least 24 hours) concurrently with at least one of the following symptoms: cough, nasal congestion, rhinorrhoea, pharyngitis, otitis, vomiting, or diarrhoea], laboratory-confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) and/or viral culture.

Table 1: Influenza Attack Rates and Vaxigrip Tetra Efficacy against laboratory-confirmed influenza illness in children from 6 to 35 months of age

In addition, a predefined complementary analysis showed Vaxigrip Tetra prevented 56.6% (95% CI: 37.0; 70.5) of severe laboratory-confirmed influenza illnesses due to any strain, and 71.7% (95% CI: 43.7; 86.9) of severe laboratory-confirmed influenza illnesses due to vaccine-similar strains. Furthermore, subjects receiving Vaxigrip Tetra were 59.2% (95% CI: 44.4; 70.4) less likely to experience a medically attended influenza illness than subjects receiving placebo.
Severe laboratory-confirmed influenza illnesses were defined as ILI laboratory-confirmed by RT-PCR and/or viral culture with at least one of the following items:
- fever > 39.5°C for subjects aged < 24 months or ≥ 39.0°C for subjects aged ≥ 24 months,
- and/or at least one significant ILI symptom which prevents daily activity (cough, nasal congestion, rhinorrhoea, pharyngitis, otitis, vomiting, diarrhoea),
- and/or one of the following events: acute otitis media, acute lower respiratory infection (pneumonia, bronchiolitis, bronchitis, croup), inpatient hospitalization.
- Children from 3 to 8 years of age (active immunisation):
Based on immune responses observed in children 3 to 8 years of age, the efficacy of Vaxigrip Tetra in this population is expected to be at least similar to the efficacy observed in children from 6 to 35 months (see “Children from 6 to 35 months of age ” above and “Immunogenicity of Vaxigrip Tetra“ below).
- Infants less than 6 months of age born to vaccinated pregnant women (passive protection):
Infants less than 6 months of age are at high risk of influenza, resulting in high rates of hospitalisation; however influenza vaccines are not indicated for active immunisation in this age group.
Efficacy in infants of women who received a single 0.5 ml dose of Vaxigrip Tetra during the second or third trimester of pregnancy has not been studied; however, efficacy in infants of women who received a single 0.5 ml dose of the trivalent inactivated influenza vaccine (Vaxigrip) during the second or third trimester has been demonstrated in clinical trials and can be extrapolated to Vaxigrip Tetra. Efficacy of the trivalent inactivated influenza vaccine (Vaxigrip) in infants following vaccination of pregnant women during the first trimester has not been studied in these trials. Necessary influenza vaccination during the first trimester should not be postponed (see section 4.6).
In randomized, controlled phase IV clinical studies conducted in Mali, Nepal and South Africa, approximately 5,000 pregnant women received Vaxigrip (trivalent influenza thiomersal-free vaccine) and approximately 5,000 pregnant women received placebo or control vaccine (quadrivalent meningococcal conjugate vaccine) during the second or third trimester of pregnancy. Vaccine efficacy against laboratory confirmed influenza in pregnant women was evaluated as a secondary endpoint in all three studies.
The studies conducted in Mali and South Africa demonstrated the efficacy of Vaxigrip for the prevention of influenza in pregnant women following vaccination during these trimesters of pregnancy (see table 2). In the study conducted in Nepal, the efficacy of Vaxigrip for the prevention of influenza in pregnant women following vaccination during these trimesters of pregnancy was not demonstrated.

Table 2: Influenza Attack Rates and Vaxigrip Efficacy against Laboratory-confirmed influenza in pregnant women

In the same randomized, controlled phase IV clinical studies conducted in Mali, Nepal and South Africa, 4530 of 4898 (92%) infants born to pregnant women who received Vaxigrip (trivalent influenza thiomersal free vaccine) and 4532 of 4868 (93%) infants born to pregnant women who
received a placebo or control vaccine
(quadrivalent meningococcal conjugate vaccine) (see table 3) during the second or third trimester of pregnancy, were followed up until approximately 6 months of age.
The studies confirmed the efficacy of Vaxigrip for prevention of influenza in infants from birth until approximately 6 months of age following vaccination of women during these trimesters of pregnancy. Women in their first trimester of pregnancy were not included in these studies; Vaxigrip efficacy in infants born to mothers vaccinated during the first trimester could therefore not be evaluated.

Table 3: Influenza Attack Rates and Vaxigrip Efficacy against Laboratory-confirmed influenza in infants following vaccination in pregnant women

The efficacy data indicate a waning protection of the infants born to vaccinated mothers by time after birth.
In the trial conducted in South Africa, vaccine efficacy was highest among infants 8 weeks of age or younger (85.8% [95% CI, 38.3 to 98.4]) and decreased over time; vaccine efficacy was 25.5% (95% CI, -67.9 to 67.8) for infants >8 to 16 weeks of age and 30.4% (95% CI, -154.9 to 82.6) for infants >16 to 24 weeks of age.
In the trial conducted in Mali, there is also a trend of higher efficacy of the trivalent inactivated influenza vaccine in infants during the first 4 months after birth, with lower efficacy within the 5th month of surveillance and a marked fall within the 6th month where protection is no longer evident.
The prevention of influenza disease can only be expected if the infant(s) are exposed to strains included in the vaccine administered to the mother.
Immunogenicity of Vaxigrip Tetra
Clinical studies performed in adults from 18 to 60 years of age, in elderly over 60 years of age, in children from 3 to 8 years of age and from 6 to 35 months of age assessed Vaxigrip Tetra immune response for HAI Geometric mean antibody titer (GMT) at Day 21 (for adults) and at Day 28 (for children), HAI seroconversion rate (4-fold rise in reciprocal titer or change from undetectable [< 10] to a reciprocal titer of ≥ 40), and HAI GMTR (post-/pre-vaccination titers).
One clinical study performed in adults from 18 to 60 years of age and in children from 9 to 17 years of age described the immune response of Vaxigrip Tetra for HAI GMT at Day 21. Another clinical study performed in children from 9 to 17 years of age described the immune response of Vaxigrip Tetra.
One clinical study performed in pregnant women described the immune response of Vaxigrip Tetra for HAI GMT at Day 21, HAI seroconversion rate, and HAI GMTR after one dose administered during the second or third trimester of pregnancy. In this study, the transplacental transfer was evaluated using HAI GMTs of mother blood, of cord blood and of ratio cord blood/mother blood, at delivery.

Vaxigrip Tetra induced a significant immune response to the 4 influenza strains contained in the vaccine.
Adults and elderly
A total of 832 adults from 18 to 60 years of age and 831 elderly over 60 years of age were assessed in terms of immune response after one dose of Vaxigrip Tetra.
Immunogenicity results are presented in the table below:
Table 4: Immunogenicity results in adults aged from 18 to 60 years and in elderly over 60 years

Pregnant women and transplacental transfer
A total of 230 pregnant women received Vaxigrip Tetra during the second or third trimester of pregnancy (from 20 to 32 weeks of pregnancy).
Immunogenicity results by HAI method, in pregnant women 21 days after vaccination with Vaxigrip Tetra are presented in table 5.
Table 5: Immunogenicity results by HAI method in pregnant women, 21 days post-vaccination with Vaxigrip Tetra

Immunogenicity descriptive assessment by HAI method, at delivery, in blood sample of mother (BL03M) and in cord blood sample (BL03B) and of the transplacental transfer (BL03B/ BL03M) are presented in table 6.
Table 6: Immunogenicity descriptive assessment by HAI method of Vaxigrip Tetra, at delivery

At delivery, the level of antibodies in the cord sample compared to the mother sample was almost doubled for the A/H1N1 strain and increased between 1.5 and 1.7 times for the A/H3N2, B/Brisbane, and B/Phuket strains, supporting that there is transplacental antibody transfer from mother to the newborn following vaccination of women with Vaxigrip Tetra during the second or third trimester of pregnancy.
These data are consistent with the passive protection demonstrated in infants from birth to approximately 6 months of age following vaccination of women during the second or third trimester of pregnancy with Vaxigrip in studies conducted in Mali, Nepal, and South Africa (see subsection Efficacy of Vaxigrip tetra).
Paediatric population
- Children from 9 to 17 years of age:
In a total of 429 children from 9 to 17 years of age who received one dose of Vaxigrip Tetra, the immune response against the 4 strains contained in the vaccine was similar to the immune response induced in adults from 18 to 60 years of age.
- Children from 6 months to 8 years of age:
A total of 863 children from 3 to 8 years of age received either one or two doses of Vaxigrip Tetra depending on their previous influenza vaccination history.
Children who received a one- or two-dose schedule of Vaxigrip Tetra presented a similar immune response following the last dose of the respective schedule.
In addition to the Vaxigrip Tetra efficacy, the immunogenicity of two 0.5 ml-dose of Vaxigrip Tetra was assessed 28 days after receipt of the last injection of Vaxigrip Tetra by HAI method in 341 children 6 to 35 months of age.
Immunogenicity results are presented in the table below:
Table 5: Immunogenicity results in children aged from 6 months to 8 years

These immunogenicity data provide supportive information in addition to vaccine efficacy data available in this population (see Efficacy of Vaxigrip Tetra).


Not applicable.


Non-clinical data revealed no special hazard for humans based on conventional studies of repeat dose and local toxicity, reproductive and developmental toxicity and safety pharmacology studies.


Buffer Solution – For 1000 mL:
- Sodium chloride …………………………. 8.00 g
- Potassium chloride…………………………0.20 g
- Disodium phosphate dihydrate……………. 1.15 g
- Potassium dihydrogen phosphate…………….0.20 g
- Water for injections………………………….qs


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


1 year

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light.


0.5 ml of suspension in pre-filled syringe (type I glass) with attached needle, equipped with a plunger stopper (elastomer chlorobutyl or bromobutyl) – pack size of 1.


The vaccine should be allowed to reach room temperature before use.
Shake before use. Inspect visually prior to administration.
The vaccine should not be used if foreign particles are present in the suspension.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


SANOFI PASTEUR 14 ESPACE HENRY VALLÉE 69007 LYON FRANCE

04 May 2020
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