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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)

Engerix B is a vaccine used to prevent hepatitis B infection. It can also help to prevent hepatitis D infection.
Hepatitis B is an infectious illness of the liver caused by a virus. Some people have the hepatitis B virus in their body but cannot get rid of it. They can still infect other people and are known as carriers. The disease is spread by the virus entering the body following contact with body fluids, most often blood, from an infected person.
If the mother is a carrier of the virus she can pass the virus to her baby at birth. It is also possible to catch the virus from a carrier through, for example, unprotected sex, shared injection needles or treatment with medical equipment which has not been properly sterilised.

The main signs of the illness include headache, fever, sickness and jaundice (yellowing of the skin and eyes) but in about three out of 10 patients there are no signs of illness.
In those infected with hepatitis B one out of 10 adults and up to nine out of 10 babies will become carriers of the virus and are likely to go on to develop serious liver damage and in some cases cancer of the liver.
How Engerix B works
Engerix B contains a small amount of the ‘outer coating’ of the hepatitis B virus. This ‘outer coating’ is not infectious and cannot make you ill.
• When you are given the vaccine it will trigger the body’s immune system to prepare itself to protect against these viruses in the future.
• Engerix B will not protect you if you have already caught the hepatitis B virus.
Engerix B can only help to protect you against infection with hepatitis B virus.


Engerix B should not be given:
• if you have previously had any allergic reaction to Engerix B, or any ingredient contained in this vaccine. The active substances and other ingredients in Engerix B are listed at the end of the leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Take special care with Engerix B:
Your doctor needs to know before you are injected with Engerix B if you:
• have a severe infection with a high temperature (over 38°C). In these cases, the vaccination will be postponed until you are feeling better. A minor infection such as a cold should not be a problem, your doctor will advise whether you can still be vaccinated with Engerix B.
• have a poor immune system due to illness or drug treatment.
• have a bleeding problem or bruise(s) easily
Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.
If your child has breathing difficulties, please contact your doctor. This may be more common in the first three days following vaccination if your child is born prematurely (before or at 28 weeks of pregnancy).
As with all vaccines, not everyone who is vaccinated will be protected from getting the infection. Also if you have unknowingly been infected with hepatitis B virus before being vaccinated with Engerix B, the vaccine may not be able to prevent you getting the disease.
A poor response to the vaccine, possibly without achieving protection against hepatitis B, is more common in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some type of drug treatments. Your doctor may advise you to have a
blood test after completing the course of vaccinations to check how effective the vaccination has been. It may be necessary to have extra doses of the vaccine. Your doctor will advise you.
Using other medicines or vaccines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Pregnancy and breast-feeding
Tell your doctor if you are or think you may be pregnant or if you intend to become pregnant. Your doctor will discuss with you the possible risks and benefits of having Engerix B during pregnancy.
It is not known if Engerix B passes into breast-milk, however the vaccine is not expected to cause problems in breast-fed babies.
Driving and using machines
Engerix B is unlikely to affect your ability to drive or use machines. However, do not drive or use machines if you are feeling unwell.


Engerix B 10 micrograms (10 μg) is used to vaccinate children from birth and up to 15 years of age. The dose is 0.5 mL.
Engerix B 20 micrograms (20 μg) is used to vaccinate people from 16 years of age and above. The dose is 1 mL.
Engerix B is usually injected into the upper arm muscle in adults and children or into the thigh muscle in babies and young children. The vaccine must never be injected into a vein.
Engerix B is usually given as a total of three separate injections over 6 months as follows:
• First dose: at chosen date
• Second dose: 1 month later
• Third dose: 6 months after the first dose
Engerix B can also be given as a total of three doses over 3 months as follows: (This schedule may be given to people needing rapid protection)
• First dose: at chosen date
• Second dose: 1 month later
• Third dose: 2 months after the first dose
A fourth dose is recommended 12 months after the first dose.
In infants this schedule will allow for simultaneous administration of hepatitis B with other childhood vaccines.
In adults only, Engerix B 20 μg can also be given as a total of three doses over 1 month as follows: (This schedule may be given only to adults needing a rapid protection (e.g. overseas travelers)).
• First dose: at chosen date
• Second dose: 7 days later
• Third dose: 21 days after the first dose
A fourth dose is recommended 12 months after the first dose.
In children aged 11 to 15 years, Engerix B 20 μg (1 mL) may be given as a total of 2 doses as follows:
• First dose: at chosen date
• Second dose: 6 months after the first dose
However, in this case, protection against hepatitis B may not be obtained until after the second dose. This schedule may be given to children aged 11 to 15 years only if there is a low risk of having hepatitis B during the vaccination and if it is sure that the two doses will be given. If not, then the three doses of Engerix B 10 μg must be given.
Depending on individual circumstances and particularly if you had kidney disease, other vaccination schedules are also possible. You should follow the instructions from your doctor.
For maximum protection from getting infected by Hepatitis B virus, make sure you complete the full vaccination course of injections. If you miss an injection arrange another appointment as soon as you can. Your doctor will advise on the possible need for extra doses, including future booster doses.


Like all vaccines, Engerix B can cause side effects, although not everybody gets them. This is a widely used vaccine. Side effects that have been reported are:
♦ Very common (these may occur with more than 1 in 10 doses of the vaccine):
• irritability
• pain and redness at the injection site
• tiredness
♦ Common (these may occur with up to 1 in 10 doses of the vaccine):
• loss of appetite
• headache, drowsiness
• nausea, vomiting, diarrhoea, abdominal pain
• hard lump and swelling at the injection site
• fever, generally feeling unwell
♦ Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
• dizziness
• aching muscles
• flu-like symptoms, such as high temperature, sore throat, runny
nose, cough and chills
♦ Rare (these may occur with up to 1 in 1,000 doses of the vaccine):
• swollen glands in the neck, armpit or groin
• abnormal sensation such as of burning, prickling, tickling or tingling
• rash, itching, hives
• joint pain
♦ Very Rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Side effects that occurred very rarely during routine use of Engerix B:
• inflammation of the membrane around the brain (meningitis). The symptoms are fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light

·          transverse myelitis
• bleeding or bruising more easily than normal
• as with all injectable vaccines, there is an extremely small risk of severe allergic reactions. These can be recognised by:
- itchy rash of the hands and feet
- swelling of the eyes and face
- difficulty in breathing or swallowing
These reactions will usually occur before leaving the doctor’s surgery. However, if you get any of these symptoms you should contact a doctor urgently
• paralysis, convulsions, fits or seizures, loss of skin sensitivity to pain or touch,
swelling or infection of the brain, numbness or weakness of the arms and legs, inflammation of nerves
• low blood pressure, narrowing or blockage of blood vessels
• purple or reddish-purple bumps on the skin, serious rashes
• joint pain and swelling, muscle weakness
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
To report any side effect(s):
Kingdom of Saudi Arabia
-National Pharmacovigilance centre (NPC)
• Fax: +966-11-205-7662
• Reporting hotline: 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: https://ade.sfda.gov.sa
-GlaxoSmithKline - Head Office, Jeddah
• Tel: +966-12-6536666
• Mobile: +966-56-904-9882
• Email: saudi.safety@gsk.com
• Website: https://gskpro.com/en-sa/
• P.O. Box 55850, Jeddah 21544, Saudi Arabia


5. How to store Engerix B
• Keep this vaccine out of the reach and sight of children.
• Store at 2 °C – 8 °C (in a refrigerator)
• Do not freeze.
• Store in the original package in order to protect from light.
• Do not use after the expiry date stated on the pack. The date for last use corresponds to the last day of the month mentioned.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


What Engerix B contains
The active substances are:
Engerix B 10 μg
1 dose (0.5 mL) contains:
Hepatitis B surface antigen 1, 2 10 micrograms
1Adsorbed on aluminium hydroxide, hydrated Total: 0.25 milligrams Al3+
2Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
Engerix B 20 μg
1 dose (1 mL) contains:
Hepatitis B surface antigen1, 2 20 micrograms
1Adsorbed on aluminium hydroxide, hydrated Total: 0.50 milligrams Al3+
2Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
The other ingredients in Engerix B 10 μg and Engerix B 20 μg are:
sodium chloride, sodium phosphate dehydrate, sodium dihydrogen phosphate and water for injections


Engerix B is a white and milky liquid presented in a glass prefilled syringe or glass vial.

 

Engerix B is a registered trademark of the GlaxoSmithKline group of companies.
© 2022 GlaxoSmithKline group of companies. All rights reserved
Marketing Authorisation Holder:
Glaxo Saudi Arabia Ltd.* Jeddah, KSA.
Address: P.O. Box 22617 Jeddah 21416 – Kingdom of Saudi Arabia.
*member of GlaxoSmithKline group of companies.
Manufacturer:
GlaxoSmithKline Biologicals S.A.
Rue de l’Institut 89
B-1330 Rixensart
Belgium
For any information about this medicinal product, please contact:
-GlaxoSmithKline - Head Office, Jeddah
• Tel: +966-12-6536666
• Mobile: +966-56-904-9882
• Email: gcc.medinfo@gsk.com
• website: https://gskpro.com/en-sa/
• P.O. Box 55850, Jeddah 21544, Saudi Arabia


Version number: GDS17/ IPI13 Date of issue: 12 August 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)

إنجیركس ب ھو لقاح یستخدم للوقایة من عدوى الالتھاب الكبدي (ب). كما یمكنھ المساعدة في الوقایة من عدوى الالتھاب
الكبدي (د).
الالتھاب الكبدي (ب) ھو مرض معدٍ یصُیب الكبد ویسُببھ فیروس. وفي بعض الحالات، یوجد فیروس الالتھاب الكبدي
(ب) في الجسم، ولا یمكن للمرضى التخلص منھ. ولكن المصاب بھ قد یظل مصدرًا للعدوى ویعُرف في ھذه الحالة باسم
حامل الفیروس. تنتشر العدوى عن طریق انتقال الفیروس إلى الجسم نتیجة ملامسة سوائل جسم مریض بالفیروس، مثل
الدم غالباً.

إذا كانت الأم حاملة للفیروس، فمن الممكن أن تنقل الفیروس إلى الطفل عند الولادة. كما یمكن انتقال الفیروس من حامل
الفیروس عن طریق ممارسة الجنس غیر الآمن أو إبر الحقن المشتركة أو العلاج بالأجھزة الطبیة التي لم یتم تعقیمھا
تعقیمًا مناسباً.
تتضمن العلامات الرئیسیة للمرض الصداع والحمى والتعب والیرقان (اصفرار الجلد والعینین)، ولكن لا تظھر علامات
المرض على ثلاثة من بین كل عشرة مرضى تقریباً.
وفي حالة المرضى بالالتھاب الكبدي (ب)، یصبح واحد من كل عشرة بالغین وما یصل إلى تسعة من كل عشرة
أطفال حاملین للفیروس، ومن المحتمل أن یتفاقم المرض ویتطور لإصابة بتلف خطیر في الكبد، وفي بعض الحالات
سرطان الكبد.
آلیة عمل إنجیركس ب
یحتوي إنجیركس ب على قدر قلیل من "الغلاف الخارجي" لفیروس الالتھاب الكبدي (ب). وھذا "الغلاف الخارجي"
غیر مُعدٍ ولا یمكنھ إصابتك بالمرض.
• عند إعطائك اللقاح، فإنھ یحفز جھاز المناعة في الجسم للاستعداد للوقایة من ھذه الفیروسات
في المستقبل.
• لن یحمیك إنجیركس ب إذا كنت مصاباً بالفعل بفیروس الالتھاب الكبدي ب.
من الممكن أن یساعد إنجیركس ب فقط في وقایتك من الإصابة بعدوى بالالتھاب الكبدي ب.

یجب عدم إعطاء إنجیركس ب في الحالات التالیة:
• إذا كنت قد تعرضت في السابق لأي تفاعل حساسیة للقاح إنجیركس ب أو أي من مكوِّنات اللقاح. ویتم سرد المواد
الفعاّلة والمكونات الأخرى الموجودة في لقاح إنجیركس ب في نھایة النشرة. قد تشمل علامات حدوث حساسیة
ظھور الطفح الجلدي المثیر للحكة وضیق التنفس وتورم الوجھ أو اللسان.
ینبغي توخي الحذر عند استخدام إنجیركس ب في الحالات التالیة:
من الضروري أن یعرف طبیبك قبل حقنك بلقاح إنجیركس ب، ما إذا كنت:
• تعاني من عدوى شدیدة مع ارتفاع في درجة الحرارة (أكثر من 38 درجة مئویة). ففي ھذه الحالات، قد یتم تأجیل
التطعیم حتى تتحسن حالتك. لیس من المفترض أن یمثل وجود عدوى بسیطة مشكلة مثل البرد، وسوف یخبرك
طبیبك ما إذا كان ما زال بإمكانك الحصول على لقاح إنجیركس ب
أم لا.
• تعاني من ضعف جھاز المناعة نتیجة لمرض أو علاج بالأدویة.
• تعاني من مشكلة النزْف أو تتعرض لكدمات بسھولة.
یمكن أن یحدث إغماء بعد، أو حتى قبل، أي حقن بالإبرة، ولذلك ینبغي إخبار الطبیب أو الممرضة إذا كنت قد تعرضت
أنت للإغماء بسبب حَقن سابق.
إذا كان طفلك یعاني من صعوبات في التنفس، یرُجى الاتصال بالطبیب. قد یكون ھذا العرض أكثر شیوعاً في الأیام
الثلاثة الأولى التالیة للتطعیم إذا وُلد طفلك قبل الأوان (قبل الأسبوع 28 من الحمل أو في أثنائھ).
وكما ھو الحال مع جمیع اللقاحات، قد لا یقي اللقاح بعض الأشخاص الذین تم تطعیمھم بھ من الإصابة بالعدوى.
إضافة إلى ذلك، إذا كنت قد أصُبت دون أن تدرى بعدوى فیروس الالتھاب الكبدي (ب) قبل التطعیم بلقاح إنجیركس ب،
فقد لا یكون للقاح تأثیر في وقایتك من الإصابة بالعدوى.
تعُد الاستجابة الضعیفة للقاح، وربما عدم تحقیق وقایة من الالتھاب الكبدي (ب)، أكثر شیوعاً بین كبار السن من الرجال
دون النساء، وخاصة المدخنین، أو الذین یعُانون من البدانة أو الأمراض المزمنة أو من یتلقون أنواعاً معینة من العلاج
بالأدویة. قد یطلب الطبیب خضوعك لتحلیل دم بعد انتھاء التطعیمات للتحقق من مدى فعالیة اللقاح.
قد یكون من الضروري الحصول على جرعات إضافیة من اللقاح. وسیقدم لك طبیبك المشورة بشأن ذلك.
استخدام أدویة أو لقاحات أخرى
یرُجى إخبار الطبیب إذا كنت تتناول حالیاً، أو قد تناول مؤخرًا أي أدویة أخرى، بما في ذلك الأدویة التي یتم الحصول
علیھا دون وصفة طبیة، أو إذا كان قد أخذ مؤخرًا أي لقاح آخر.
الحمل والرضاعة الطبیعیة
أخبري طبیبك إذا كنتِ حاملا أو إذا كنتِ تعتقدین أنكِ حامل أو إذا كنتِ تنوین الحمل. سیناقش طبیبِك معكِ المخاطر
والفوائد المحتملة لاستعمال إنجیركس ب أثناء الحمل.
لا تتوفر معلومات حول انتقال إنجیركس ب إلى لبن الأم، ولكن لا یتُوقعَّ أن یسبب اللقاح مشكلات للأطفال الذین یتغذون
على الرضاعة الطبیعیة.
القیادة واستخدام الآلات
لا یرجح تأثیر إنجیركس ب على قدرتك على القیادة أو استخدام الآلات. على أي حال لا تقود السیارة أو تستخدم الآلات
إذا شعرت أنك لست بخیر.

https://localhost:44358/Dashboard

یُستخدم إنجیركس ب 10 میكروجرام لتطعیم الأطفال منذ عمر یوم واحد وحتى 15 سنة. مقدار الجرعة 0,5 مل.
یُستخدم إنجیركس ب 20 میكروجرام ( 20 میكروجرام) لتطعیم الكبار بدءاً من عمر 16 سنة. مقدار الجرعة 1 مل.
بالنسبة للبالغین والأطفال، یحقن إنجیركس ب عادة في عضلة الجزء العلوي من الذراع، ویحُقن بھ الرضع والأطفال
الصغار في عضلة الفخذ. یحظر حقن اللقاح في الورید مطلقاً.
یحُقن إنجیركس ب عادة في ثلاث حقن منفصلة إجمالا،ً موزعة على مدار 6 أشھر على النحو التالي:
• الجرعة الأولى: في التاریخ المحدد
• الجرعة الثانیة: بعد شھر واحد
• الجرعة الثالثة: بعد 6 أشھر من الجرعة الأولى
كما یمكن الحقن بإنجیركس ب في ثلاث جرعات إجمالا،ً موزعة على مدار 3 شھور على النحو التالي:
(من الممكن استخدام ھذا الجدول الزمني مع الأشخاص الذین یحتاجون إلى حمایة سریعة)
• الجرعة الأولى: في التاریخ المحدد
• الجرعة الثانیة: بعد شھر واحد
• الجرعة الثالثة: بعد 2 أشھر من الجرعة الأولى
یوصى بإعطاء جرعة رابعة بعد 12 شھرًا من الجرعة الأولى.
في حالة الرضع، سیسمح ھذا الجدول الزمني بالتعامل مع الالتھاب الكبدي (ب) بالتزامن مع الحصول على لقاحات
الأطفال الأخرى.
في حالة البالغین فقط، یمكن الحقن بإنجیركس ب 20 میكروجرام في ثلاث جرعات إجمالا،ً موزعة على مدار شھر واحد
على النحو التالي: (قد یكون ھذا الجدول الزمني مناسباً فقط للبالغین الذین یحتاجون إلى حمایة سریعة (عند السفر إلى
الخارج مثلا)ً).
• الجرعة الأولى: في التاریخ المحدد
• الجرعة الثانیة: بعد 7 أیام
• الجرعة الثالثة: بعد 21 یومًا من الجرعة الأولى
یوصى بإعطاء جرعة رابعة بعد 12 شھرًا من الجرعة الأولى.
في حالة الأطفال الذین تتراوح أعمارھم بین 11 و 15 عامًا، یمكن الحقن بإنجیركس ب 20 میكروجرام ( 1 مل)
في جرعتین إجمالا على النحو التالي:
• الجرعة الأولى: في التاریخ المحدد
• الجرعة الثانیة: بعد 6 أشھر من الجرعة الأولى
ولكن في ھذه الحالة، قد لا یمكن الحصول على الوقایة من الالتھاب الكبدي ب إلا بعد الجرعة الثانیة. قد یكون ھذا
الجدول مناسباً للأطفال الذین تتراوح أعمارھم بین 11 و 15 عامًا، إذا كان معدل خطورة الإصابة بالالتھاب الكبدي (ب)
أثناء التطعیم منخفضاً وإذا كنت متأكداً من الحصول على الجرعتین. إذا لم یكن الأمر كذلك، فیجب الحصول على
الجرعات الثلاثة من إنجیركس ب 10 میكروجرام.
وفقاً للظروف الفردیة وخاصة إذا كنت تعاني من أمراض الكلُى، فقد یتم تحدید جدول آخر لك.
ویجب علیك الالتزام بتعلیمات الطبیب.
للحصول على أقصى قدر من الوقایة من الإصابة بفیروس الالتھاب الكبدي (ب)، احرص على حصولك على الجرعات
كاملة. إذا كانت قد فاتتك حقنة، فرتب موعداً آخر للحصول علیھا في أقرب وقت ممكن.
وسوف یخبرك الطبیب ما إذا كنت بحاجة للحصول على جرعات إضافیة، بما في ذلك جرعات معززة في المستقبل أم لا.

یمكن أن یسبب لقاح إنجیركس ب، مثل كل اللقاحات، آثارًا جانبیة؛ إلا أن تلك الآثار لا تصیب الجمیع. ھذا لقاح شائع
الاستخدام. الأعراض الجانبیة التي تم الإبلاغ عنھا ھي:
شائعة جداً (قد تصیب أكثر من حالة واحدة بین كل 10 جرعات من اللقاح): ♦
• سرعة الانفعال
• الشعور بألم واحمرار في موضع الحقن
• إجھاد
شائعة (قد تصیب نسبة تصل إلى حالة واحدة من كل 10 جرعات لقاح): ♦
• فقدان الشھیة
• الصداع، أو النعاس
• الغثیان أو القيء أو الإسھال أو ألم في البطن
• كتلة صلبة أو متورمة في موضع الحقن
• الحمى والشعور العام بعدم الراحة
غیر شائعة (قد تصیب نسبة تصل إلى حالة واحدة من كل 100 جرعة لقاح): ♦
• دوار
• آلام العضلات
• أعراض تشبھ أعراض الإنفلونزا، مثل ارتفاع درجة الحرارة، والتھاب الحلق، والرشح
والسعال والرعشة
نادرة (قد تصیب نسبة تصل إلى حالة واحدة من كل 1000 جرعة لقاح): ♦
• تورم الغدد في الرقبة أو الإبط أو الفخذ
• شعور غیر طبیعي مثل الشعور بحرقة أو وخز أو دغدغة أو نخز
• طفح جلدي أو حكة أو شرى
• ألم في المفاصل
نادرة جداً (قد تصیب نسبة تصل إلى حالة واحدة من كل 10000 جرعة لقاح): ♦
الآثار الجانبیة التي حدثت في حالات نادرة للغایة خلال روتین لقاح إنجیركس ب:
• التھاب الغشاء المحیط بالدماغ (التھاب السحایا). الأعراض ھي الحمى والغثیان والقيء والصداع وتیبس العنق
والحساسیة المفرطة للضوء الساطع

·     التهاب النخاع المُستَعْرِض 
• النزیف أو الإصابة بالكدمات بسھولة
• كما ھو الحال مع جمیع اللقاحات التي تؤخذ بالحقن، ھناك خطورة ضعیفة للغایة أن یكوّن الجسم تفاعلات
حساسیة الشدیدة. وتتمثل ھذه التفاعلات في:
- طفح مثیر للحكة في الیدین والقدمین
- تورم العینین والوجھ
- صعوبة في التنفس أو البلع
وعادةً ما تحدث ھذه التفاعلات قبل مغادرة عیادة الطبیب. ولكن إذا أصیبت بأي من ھذه الأعراض،
یجب علیك الاتصال بطبیب على وجھ السرعة
• الشلل، أو الاختلاج، أو النوبات، أو فقدان حساسیة الجلد للألم أو اللمس، تورم أو عدوى الدماغ، أو تنمیل أو
ضعف الذراعین والساقین، أو التھاب الأعصاب
• انخفاض ضغط الدم، أو ضیق أو انسداد الأوعیة الدمویة
• بثور أرجوانیة أو أرجوانیة محمرة على البشرة، أو طفح شدید
• ألم المفاصل أو تورمھا، أو ضعف العضلات
في حالة تفاقم أي من الآثار الجانبیة أو إذا لاحظت ظھور أي آثار جانبیة غیر مذكورة في ھذه النشرة، یرُجى إبلاغ
طبیبك أو الصیدلي.
للإبلاغ عن أي آثار جانبیة:
المملكة العربیة السعودیة
(NPC) - المركز الوطني للتیقظ والسلامة الدوائیة
+966-11-205- • فاكس: 7662
• الاتصال بالرقم الموحد: 19999
npc.drug@sfda.gov.sa : • البرید الإلكتروني
https://ade.sfda.gov.sa : • الموقع الإلكتروني
- -جلاكسو سمیث كلاین - المكتب الرئیسي، جد ة
+966-12- • الھاتف: 6536666
+966-56-904- • الجو اّل: 9882
saudi.safety@gsk.com : • البرید الإلكتروني
• الموقع الإلكتروني: https://gskpro.com/en-sa 32T /32T
• ص. ب. رقم 55850 ، جدة 21544 ، المملكة العربیة السعودیة.

یجب حفظ الدواء بعیداً عن متناول ومرأى الأطفال.
یحُفظ بین 2 و 8 درجات مئویة (في الثلاجة)
یجب عدم تجمیده.
یحُفظ في العبوة الأصلیة لحمایتھ من الضوء.
لا یجوز الاستخدام بعد تاریخ انتھاء فترة الصلاحیة المذكور على العبوة. یوافق تاریخ آخر استخدام آخر یوم من
الشھر المذكور.
یجب عدم التخلصّ من الأدویة بإلقائھا في میاه الصرف أو المخلفات المنزلیة. ینبغي استشارة الصیدلي عن كیفیة
التخلص من الأدویة التي لم تعد بحاجة إلیھا. فھذه الإجراءات من شأنھا المساعدة على حمایة البیئة.

محتویات لقاح إنجیركس ب
المواد الفعاَّلة ھي:
إنجیركس ب 10 میكروجرام
تحتوي الجرعة الواحدة ( 0,5 مل) على:
10 میكروجرام 2 ، المستضد السطحي للالتھاب الكبدي (ب ) 1
1مُمْتزَ في ھیدروكسید الألومنیوم، مرطب الإجمالي: 0,25 ملیجرام 3+
P Al
عن طریق تكنولوجیا الحمض النووي مُعاد التركیب (Saccharomyces cerevisiae) 2تم إنتاجھا في خلایا خمیرة
 

إنجیركس ب 20 میكروجرام
تحتوي الجرعة الواحدة ( 1 مل) على:
20 میكروجرام 2 ، المستضد السطحي للالتھاب الكبدي (ب ) 1
1مُمْتزَ في ھیدروكسید الألومنیوم، مرطب الإجمالي: 0,50 ملیجرام 3+
P Al
عن طریق تكنولوجیا الحمض النووي مُعاد التركیب (Saccharomyces cerevisiae) 2تم إنتاجھا في خلایا خمیرة
تشمل المكونات الأخرى في إنجیركس ب 10 میكروجرام وإنجیركس ب 20 میكروجرام:
كلورید الصودیوم، وفوسفات الصودیوم ثنائي الھیدرات، فوسفات الصودیوم ثنائي الھیدروجین، وماء للحقن.
شكل لقاح إنجیركس ب ومحتویات العبو ة
إنجیركس ب سائل أبیض وحلیبي یأتي في محقن زجاجي معبأ أو قنینة من الزجاج.

 

إنجیركس ب ھو علامة تجاریة مسجلة لمجموعة شركات
كافة الحقوق محفوظة .GlaxoSmithKline لعام 2022 محفوظة لمجموعة شركات © حقوق الطبع
مالك التسویق المعتمد:
جدة، المملكة العربیة السعودیة *Glaxo Saudi Arabia Ltd.
العنوان: ص. ب. 22617 جدة 21416 – المملكة العربیة السعودیة.
.GlaxoSmithKline *إحدى شركات
الشركة المصنعة:
GlaxoSmithKline Biologicals S.A.
Rue de l’Institut 89
B-1330 Rixensart
Belgium
للإستفسار عن أي معلومات عن ھذا المستحضر الدوائي، یرجى الإتصال بالأرقام التالیة:
- جلاكسو سمیث كلاین المكتب الرئیسي - المقر الرئیسي، جدة
+966-12- • الھاتف: 6536666
+966-56-904- • الجوّال: 9882
gcc.medinfo@gsk.com : • البرید الإلكتروني
• الموقع الإلكتروني: /https://gskpro.com/en-sa
• ص. ب. رقم 55850 ، جدة 21544 ، المملكة العربیة السعودیة
للإبلاغ

للإبلاغ عن أي آثار جانبیة:
المملكة العربیة السعودیة
(NPC) - المركز الوطني للتیقظ والسلامة الدوائیة
+966-11-205- • فاكس: 7662
• الاتصال بالرقم الموحد: 19999
npc.drug@sfda.gov.sa : • البرید الإلكتروني
https://ade.sfda.gov.sa : • الموقع الإلكتروني
- -جلاكسو سمیث كلاین -المكتب الرئیسي ، جدة
+966-12- • الھاتف: 6536666
+966-56-904- • الجو اّل: 9882
audi.safety@gsk.com : • البرید الإلكتروني s
• الموقع الإلكتروني: /https://gskpro.com/en-sa /
• ص. ب. رقم 55850 ، جدة 21544 ، المملكة العربیة السعودیة

رقم الإصدار:GDS17/IPI13 12 August تاریخ الإصدار: 2022
 Read this leaflet carefully before you start using this product as it contains important information for you

Engerix-B (Adult/Paediatric)

10 µg dose vaccine 1 dose (0.5 ml) contains: Hepatitis B surface antigen 1, 2 10 micrograms 1Adsorbed on aluminium hydroxide, hydrated Total: 0.25 milligrams Al3+ 2Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 20 µg dose vaccine 1 dose (1 ml) contains: Hepatitis B surface antigen1, 2 20 micrograms 1Adsorbed on aluminium hydroxide, hydrated Total: 0.50 milligrams Al3+ 2Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology The vaccine is highly purified, and exceeds the WHO requirements for recombinant hepatitis B vaccines. No substances of human origin are used in its manufacture.

Suspension for injection. Turbid white suspension. Upon storage, a fine white deposit with a clear colourless supernatant may be observed.

Engerix-B is indicated for active immunisation against hepatitis B virus (HBV) infection caused by all known subtypes in subjects of all ages considered at risk of exposure to HBV. It can be expected that hepatitis D will also be prevented by immunisation with Engerix-B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Immunisation against hepatitis B is expected in the long term to reduce not only the incidence of this disease, but also its chronic complications such as chronic active hepatitis B and hepatitis B associated cirrhosis.
In areas of low prevalence of hepatitis B, immunisation is particularly recommended for those belonging to groups identified at increased risk of infection (see below), however, universal
2
immunisation of all infants and adolescents will contribute to the control of hepatitis B on a population basis.
In areas of intermediate and high prevalence of hepatitis B, with most of the population at risk of acquiring the HBV, the best strategy is to provide universal immunisation of neonates, infants, children and adolescents, as well as adults belonging to groups at increased risk of infection.
The WHO, the US Immunisation Practices Advisory Committee (ACIP) and the American Academy of Paediatrics advocate that the vaccination of new-borns and/or the vaccination of adolescents is the optimal strategy for the control of hepatitis B in all countries.
Groups identified at increased risk of infection: health care personnel, patients frequently receiving blood products, personnel and residents of institutions, persons at increased risk due to their sexual behaviour, illicit users of addictive injectable drugs, travellers to areas with a high endemicity of HBV, infants born of mothers who are HBV carriers, persons originating from areas with a high endemicity of HBV, patients with sickle-cell anaemia, patients who are candidates for organ transplantation, household contacts of any of the above groups and of patients with acute or chronic HBV infection, subjects with chronic liver disease (CLD) or at risk of developing CLD (e.g. Hepatitis C virus carriers, persons who abuse alcohol), others (police personnel, fire brigade personnel, armed forces personnel and anybody who through their work or personal lifestyle may be exposed to HBV).


Posology
20 μg dose vaccine. The 20 μg dose (in 1 ml suspension) is intended for use in subjects 16 years of age and older.
10 μg dose vaccine. The 10 μg dose (in 0.5 ml suspension) is intended for use in neonates, infants and children up to and including the age of 15 years.
However, the 20 μg vaccine can also be used in subjects from 11 years up to and including 15 years of age as a 2-dose schedule in situations when there is a low risk of hepatitis B infection during the vaccination course and when compliance with the complete vaccination course can be assured (see section "Pharmacodynamics").
Primary immunisation schedules
− All subjects:
A 0, 1 and 6 months schedule gives optimal protection at month 7 and produces high antibody titres. An accelerated schedule, with immunisation at 0, 1 and 2 months, will confer protection more quickly and is expected to provide better patient compliance. With this schedule, a fourth dose should be administered at 12 months to assure long term protection as titres after the third dose are lower than those obtained after the 0, 1, 6 months schedule. In infants this schedule will allow for simultaneous administration of hepatitis B with other childhood vaccines.
− Subjects 18 years of age and above:
In exceptional circumstances in adults, where an even more rapid induction of protection is required, e.g. persons travelling to areas of high endemicity and who commence a course of vaccination against hepatitis B within one month prior to departure, a schedule of three intramuscular injections given at 0, 7 and 21 days may be used. When this schedule is applied, a fourth dose is recommended 12 months after the first dose (see section "Pharmacodynamics" for seroconversion rates).
− Subjects from 11 years up to and including 15 years of age:
The 20 μg vaccine may be administered in subjects from 11 years up to and including 15 years of age according to a 0, 6 months schedule. However, in this case, protection against hepatitis B infections may not be obtained until after the second dose (see section "Pharmacodynamics"). Therefore, this schedule should be used only when there is a low risk of hepatitis B infection during the vaccination course and when completion of the two-dose vaccination course can be assured. If both conditions cannot be assured (for instance patients undergoing haemodialysis, travellers to endemic regions and close contacts of infected subjects), the three-dose or the accelerated schedule of the 10 μg vaccine should be used.
3
− Patients with renal insufficiency including patients undergoing haemodialysis 16 years of age and above:
The primary immunisation schedule for patients with renal insufficiency including patients undergoing haemodialysis is four double doses (2 x 20 μg) at elected date, 1 month, 2 months and 6 months from the date of the first dose. The immunisation schedule should be adapted in order to ensure that the anti-HBs antibody titre remains equal to or higher than the accepted protective level of 10 mIU/ml.
− Patients with renal insufficiency including patients undergoing haemodialysis up to and including 15 years of age, including neonates:
Patients with renal insufficiency, including patients undergoing haemodialysis, have a reduced immune response to hepatitis B vaccines. Either the 0, 1, 2 and 12 months or the 0, 1, 6 months schedule of Engerix-B 10 μg can be used. Based on adult experience, vaccination with a higher dosage of antigen may improve the immune response. Consideration should be given to serological testing following vaccination. Additional doses of vaccine may be needed to ensure a protective anti-HBs level ≥ 10 mIU/ml.
− Known or presumed exposure to HBV:
In circumstances where exposure to HBV has recently occurred (eg needlestick with contaminated needle) the first dose of Engerix-B can be administered simultaneously with hepatitis B immune globulins (HBIg) which however must be given at a separate injection site (see section "Interactions"). The 0, 1, 2-12 months immunisation schedule should be advised.
− Neonates born of mothers who are HBV carriers:
The immunisation with Engerix-B (10 μg) of these neonates should start at birth, and one of the two immunisation schedules have to be followed. Either the 0, 1, 2 and 12 months or the 0, 1 and 6 months schedule can be used; however, the former schedule provides a more rapid immune response. When available, HBIg should be given simultaneously with Engerix-B at a separate injection site as this may increase the protective efficacy.
These immunisation schedules may be adjusted to accommodate local immunisation practices with regard to the recommended age of administration of other childhood vaccines.
Booster dose
The need for a booster dose in healthy individuals who have received a full primary vaccination course has not been established; however, some official vaccination programmes currently include a recommendation for a booster and these should be respected.
For haemodialysis and other immunocompromised patients, booster doses are recommended in order to ensure an antibody level of ≥ 10 mIU/ml.
Booster data are available. The booster dose is as well tolerated as the primary vaccination course.
• Method of administration
Engerix-B should be injected intramuscularly in the deltoid region in adults and children or in the anterolateral thigh in neonates, infants and young children. Exceptionally the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
Engerix-B should not be administered in the buttock or intradermally since this may result in a lower immune response.


Engerix-B should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous Engerix-B administration. HIV infection is not considered as a contraindication for hepatitis B vaccination.

As with other vaccines, the administration of Engerix-B should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication for immunisation.

Because of the long incubation period of hepatitis B it is possible for unrecognised infection to be present at the time of immunisation. The vaccine may not prevent hepatitis B infection in such cases.

The vaccine will not prevent infection caused by other pathogens known to infect the liver such as hepatitis A, hepatitis C and hepatitis E virus.

The immune response to hepatitis B vaccines is related to a number of factors, including older age, male gender, obesity, smoking habits and route of administration. In subjects who may respond less well to the administration of the hepatitis B vaccines (e.g. more than 40 years of age etc.), additional doses may be considered.

In patients with renal insufficiency including patients undergoing haemodialysis, HIV infected patients and persons with an impaired immune system, adequate anti-HBs antibody titres may not be obtained after the primary immunisation course and such patients may therefore require administration of additional doses of vaccine (see section "Dosage" - Patients with renal insufficiency including patients undergoing haemodialysis).

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.

Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.

Engerix-B should not be administered in the buttock or intradermally since this may result in a lower immune response.

Engerix-B should under no circumstances be administered intravascularly.

As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section "Pharmacodynamics").

The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunization series to very premature infants (born £ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.


The simultaneous administration of Engerix-B and a standard dose of HBIg does not result in lower anti-HBs antibody titres provided that they are administered at separate injection sites.
Engerix-B can be given concomitantly with DTP, DT and/or polio vaccines, if this fits conveniently in an immunisation scheme recommended by the country Health Authority.
Engerix-B can be administered together with measles-mumps-rubella vaccines, Haemophilus influenzae b vaccine, hepatitis A vaccine and BCG.
Engerix-B can be given concomitantly with Human Papillomavirus (HPV) vaccine (Cervarix).
Administration of Engerix-B at the same time as Cervarix has shown no clinically relevant interference in the antibody response to the HPV antigens. Anti-HBs geometric mean antibody concentrations were lower on co-administration, but the clinical significance of this observation is not known since the seroprotection rates remain unaffected. The proportion of subjects reaching anti-HBs ≥ 10mIU/ml was 97.9% for concomitant vaccination and 100% for Engerix-B alone.
Different injectable vaccines should always be administered at different injection sites.
Interchangeability of hepatitis B vaccines
Engerix-B may be used to complete a primary immunisation course started either with plasma-derived or with other genetically-engineered hepatitis B vaccines, or as a booster dose in subjects
5
who have previously received a primary immunisation course with plasma-derived or with other genetically-engineered hepatitis B vaccines.


Pregnancy

Adequate human data on use during pregnancy and adequate animal reproduction studies are not available.

However, as with all inactivated viral vaccines one does not expect harm for the foetus. Engerix-B should be used during pregnancy only when clearly needed, and the possible advantages outweigh the possible risks for the foetus.

Lactation

Adequate human data on use during lactation and adequate animal reproduction studies are not available.

No contraindication has been established.


The vaccine is unlikely to produce an effect on the ability to drive and use machines.


 

The safety profile presented below is based on data from more than 5,300 subjects.
Frequencies are reported as:
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)
Frequency
Adverse reactions
Clinical trials
Very common
Irritability, pain and redness at injection site, fatigue
Common
Appetite lost, headache (very common with 10 μg formulation), drowsiness, gastrointestinal symptoms (such as nausea, vomiting, diarrhoea, abdominal pain), swelling at injection site, malaise, injection site reaction (such as induration), fever (≥37.5 °C)
Uncommon
Dizziness, myalgia, influenza-like illness
Rare
Lymphadenopathy, paresthesia, rash, pruritus, urticaria, arthralgia
Post-marketing data
Meningitis, thrombocytopenia, anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness, paralysis, convulsions, hypoaesthesia, encephalitis, encephalopathy, neuropathy, neuritis, hypotension, vasculitis, angioneurotic oedema, lichen planus, erythema multiforme, arthritis, muscular weakness,transverse myelitis.
In a comparative trial in subjects from 11 years up to and including 15 years of age, the incidence of local and general solicited symptoms reported after a two-dose regimen of Engerix-B 20 μg was similar overall to that reported after the standard three-dose regimen of Engerix-B 10 μg.
6
To report any side effect(s):
Kingdom of Saudi Arabia
-National Pharmacovigilance centre (NPC)
• Fax: +966-11-205-7662
• Reporting Hotline: 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: https://ade.sfda.gov.sa
-GlaxoSmithKline - Head Office, Jeddah
• Tel: +966-12-6536666
• Mobile: +966-56-904-9882
• Email: saudi.safety@gsk.com
• Website: https://gskpro.com/en-sa/
• P.O. Box 55850, Jeddah 21544, Saudi Arabia


Cases of overdose have been reported during post-marketing surveillance. Adverse events reported following overdosage were similar to those reported with normal vaccine administration.


Pharmaco-therapeutic group: Hepatitis B vaccine, ATC code J07BC01
Engerix-B induces specific humoral antibodies against HBsAg (anti-HBs antibodies). Anti-HBs antibody concentrations ≥ 10 mIU/ml correlate with protection to HBV infection.
• Protective efficacy and long-term immune response
At risk groups:
In field studies, a protective efficacy between 95% and 100% was demonstrated in neonates, children and adults at risk.
A 95% protective efficacy was demonstrated in neonates of HBeAg positive mothers, immunised according to the 0, 1, 2 and 12 or 0, 1 and 6 schedules without the concomitant administration of HBIg at birth. However, simultaneous administration of HBIg and vaccine at birth increased the protective efficacy to 98%.
Twenty years after primary vaccination during infancy, subjects born to mothers who were HBV carriers, received a challenge dose of Engerix-B. One month later, at least 93% of subjects (N=75) mounted an anamnestic response demonstrating immune memory.
Healthy subjects:
The table below summarizes seroprotection rates (i.e. percentages of subjects with anti-HBs antibody concentrations ≥ 10 mIU/ml) obtained in clinical studies with the different schedules mentioned in “Dosage”:

 

Population

 

 

Schedule

 

Seroprotection rate

Healthy subjects

0, 1, 6 months

at month 7: ³ 96 %

 

0, 1, 2 – 12 months

at month 1: 15 %
at month 3: 89 %
at month 13: 95.8 %

 

Healthy subjects 18 years of age and above

0, 7, 21 days – 12 months

at day 28: 65.2 %
at month 2: 76 %
at month 13: 98.6 %

The long-term immune response was assessed in a clinical trial in subjects from 11 years up to and including 15 years of age at the time of primary vaccination. The seroprotection rates obtained with the two different dosages and schedules were evaluated up to 66 months after the first dose of the primary vaccination and are presented in the table below:

Vaccine groups

Seroprotection rate

Month 2

Month 6

Month 7

Month 30

Month 42

Month 54

Month 66

Engerix-B 10 µg

(0, 1, 6 months schedule)

55.8 %

87.6 %

98.2 %

96.9 %

92.5 %

94.7 %

91.4 %

Engerix-B 20 µg

(0, 6 months schedule)

11.3 %

26.4 %

96.7 %

87.1%

83.7 %

84.4 %

79.5 %

These data show that a primary vaccination with Engerix-B vaccine induces circulating anti-HBs antibodies that persist for at least 66 months. After having completed the primary course, at each time point there is no clinically significant difference in the seroprotection rates when comparing the 2 vaccine groups. All subjects in both vaccine groups (including subjects with anti-HBs antibody concentrations < 10 mIU/ml) received a challenge dose 72 to 78 months after primary vaccination. One month after the challenge dose, all subjects mounted an anamnestic response to the challenge dose and were shown to be seroprotected (i.e. anti-HBs antibody concentrations ≥ 10 mIU/ml). These data suggest that protection against hepatitis B may still be conferred through immune memory in all subjects who responded to primary vaccination but lost seroprotection level of anti-HBs antibodies.
Long-term persistence was assessed in a clinical study in subjects (N=292) aged 15 to 16 years, vaccinated in the first 2 years of life with 3 doses of Engerix B. The anti-HBs seroprotection was 65.4% at 14 years [range 13.5-15.5 years] after primary vaccination. At this time point, all subjects (including subjects with anti-HBs antibody concentrations < 10 mIU/ml) received a challenge dose. One month after the challenge dose, 97.9% of subjects were shown to be seroprotected. An anamnestic response was observed in 92.9% of subjects seronegative before the challenge dose (N=84) and in 98.6% of subjects seropositive before the challenge dose (N=207).
8
Patients with renal insufficiency including patients undergoing haemodialysis:

Age (years)

Schedule

Seroprotection rate

16 and above

0, 1, 2, 6 months
(2 x 20 µg)

at month 3: 55.4 %
at month 7: 87.1 %

Patients with type II diabetes:

 

Age (years)

Schedule

Seroprotection rate

at Month 7

20-39

0, 1, 6 months
(20 µg)

88.5 %

40-49

81.2 %

50-59

83.2 %

³ 60

58.2 %

 

·         Reduction in the incidence of hepatocellular carcinoma in children:

A significant reduction in the incidence of hepatocellular carcinoma has been observed in children aged 6-14 years following a nationwide hepatitis B vaccination in Taiwan. There was a significant decline in the prevalence of hepatitis B antigen, the persistence of which is an essential factor in the development of hepatocellular carcinoma.

 


Evaluation of pharmacokinetic properties is not required for vaccines.


Appropriate safety tests have been performed.


Aluminium (as aluminium hydroxide)
Sodium chloride, sodium phosphate dihydrate, sodium dihydrogen phosphate, water for injections.
Polysorbate 20 is present as residual from the manufacturing process.


Engerix-B should not be mixed with other vaccines.


3 years

Store in a refrigerator (2°C - 8°C).
Do not freeze. Store in the original package in order to protect from light.
9
Stability data indicate that Engerix-B is stable at temperatures up to 37°C for 3 days or up to 25°C for 7 days. These data are intended to guide healthcare professionals in case of temporary temperature excursion only. The storage conditions are detailed on the packaging.


Engerix-B is presented in a glass vial or glass prefilled syringes.
The vials and prefilled syringes are made of neutral glass type I, which conforms to European Pharmacopoeia Requirements.
Not all presentations are available in every country.


vaccine should be well shaken before use to obtain a slightly opaque, white suspension.
The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration. In the event of either being observed, do not administer the vaccine.
When using a vial, use different needles to pierce the rubber stopper and to inject the vaccine.
Instructions for the pre-filled syringe
Hold the syringe by the barrel, not by the plunger.
Unscrew the syringe cap by twisting it anticlockwise.
To attach the needle, connect the hub to the Luer Lock Adaptor and rotate a quarter turn clockwise until you feel it lock.
Do not pull the syringe plunger out of the barrel. If it happens, do not administer the vaccine.
Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.

 

Engerix-B is a trademark owned or licensed to by GSK group of companies

To report any side effect(s):

Kingdom of Saudi Arabia

-National Pharmacovigilance centre (NPC)

  • Fax: +966-11-205-7662
  • Call NPC at +966-11-2038222, Ext: 2317-2356-2340
  • Reporting Hotline: 19999
  • E-mail: npc.drug@sfda.gov.sa
  • Website: www.sfda.gov.sa/npc

-GlaxoSmithKline - Head Office, Jeddah

  • Tel:  +966-12-6536666
  • Mobile: +966-56-904-9882
  • Email: saudi.safety@gsk.com 
  • Website: https://gskpro.com/en-sa/
  • P.O. Box 55850, Jeddah 21544, Saudi Arabia

 

THIS IS A MEDICAMENT

- Medicament is a product which affects your health, and its consumption contrary to instructions are dangerous for you.

- Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.

- The doctor and the pharmacist are experts in medicine, its benefits and risks.

- Do not by yourself interrupt the period of treatment prescribed for you.

- Do not repeat the same prescription without consulting your doctor.

- Keep all medicine out of reach of children

Council of Arab Health Ministers

Union of Arab Pharmacists

 

 

 


Manufacturer: GlaxoSmithKline Biologicals s.a. 89, rue de l’Institut – 1330 Rixensart Belgium Tel: (32) 2 656 81 11 Fax: (32) 2 656 80 00

Version number: GDS017/ IPI13 Date of issue: 12 August 2022 © 2022 GSK group of companies, all rights reserved.
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