10 micrograms / 0.5 ml, injection , suspension in prefilled syringe 
Vaccine Hepatitis B (rDNA) ( adsorbed ) (HBV)

Read this leaflet carefully before you / your child receives this vaccine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This vaccine has been prescribed for you / your child only. Do not give it to others.
  • If you / your child experiences side effects, talk to a doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet, “you” may also mean “your child”.

In this leaflet: 
1. What Engerix-B is and what it is used for 
2. What you need to know before you are given Engerix-B 
3. How Engerix-B is given 
4. Possible side effects 
5. How Engerix-B should be Store 
6. Contents of the packaging and other information 

1. What Engerix-B is and what it is used for

Engerix-B is a vaccine used against infection by hepatitis B. It can also help protect against infection by hepatitis D.

This vaccine can be given to newborns, children, and adolescents up to 15 years of age.

Hepatitis B is an infectious disease of the liver caused by a virus. Some people have the hepatitis B virus in their bodies but cannot get rid of it. They carry the virus and can still infect other people. The disease is spread by the virus entering the body through contact with body fluids, usually blood, from an infected person.

If the mother is a carrier of the virus, she can transmit it to her newborn baby at birth. The virus can also be transmitted from a carrier by e.g. unprotected sex if you share injection needles with other people or with medical equipment that has not been properly sterilized.

The most common signs of the disease are headache, fever, nausea, and jaundice (yellow skin and yellow eyes), but about 3 out of 10 patients get no symptoms. Among those infected with hepatitis B, 1 in 10 adults and up to 9 in 10 newborns will become carriers of the virus and probably later develop serious liver disease and in some cases liver cancer.

How Engerix-B works

Engerix-B contains small amounts of the “outer shell” of the hepatitis B virus. These outer parts are not contagious and can not make you sick.

  • When you receive the vaccine, the body’s immune system is activated and prepares to protect you against these types of viruses in the future.
  • Engerix-B does not protect if you have already been infected with the hepatitis B virus.
  • Engerix-B only protects you against being infected with the hepatitis B virus.

2. What you need to know before you get Engerix-B

Engerix-B should not be given:

  • if you are allergic (hypersensitive) to Engerix-B or any of the other ingredients of this vaccine (listed in section 6)
  • if you have a high body temperature (fever).

Engerix-B should not be given if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Engerix-B. Tell your doctor or pharmacist if you have any allergies or if you have ever experienced any health problems after vaccination.

Warnings and cautions

Talk to your doctor or pharmacist before taking Engerix-B if you:

  • is on dialysis due to kidney problems or if you have a disease that can affect the immune system.

People on dialysis, who have had liver problems for a long time or who are carriers of hepatitis C or are HIV- positive can still be vaccinated with Engerix-B by a doctor, as a hepatitis B infection can be serious in these people. For more information on kidney problems and dialysis, see section 3.

If you are not sure if any of the above applies to you, talk to your doctor before being vaccinated with Engerix-B.

Fainting can occur (mainly in adolescents) after, or even before, any needle injection. Therefore, tell your doctor or nurse if you have fainted from a previous injection.

Like other vaccines, Engerix-B may not give you full protection against hepatitis B. Several factors such as old age, gender, obesity, smoking, and some long-term problems reduce your immune response to the vaccine. If any of these apply to you, your doctor may decide to take a blood sample or give you another dose of Engerix-B, to ensure that you have received protection.

Other medicines and Engerix-B

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Engerix-B can be given at the same time as most other vaccines that are usually given routinely. The doctor ensures that the vaccines are given separately and at different injection sites.

Pregnancy and breastfeeding

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

Driving and using machines

Engerix-B is unlikely to affect your ability to drive or use machines. However, do not drive or use machines if you feel unwell.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Engerix-B contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.

3. How Engerix-B is given

How the vaccine is given

Your doctor will give you the recommended dose of one of Engerix-B.

Engerix-B said:

  • by injection into the upper arm muscle in children and adolescents
  • by injection into the upper part of the outer thigh muscle in infants and young children.
  • by injection under the skin if you get bruises easily or if you have any bleeding disorders.

How much vaccine is given

You will receive several injections with Engerix-B. Once you have received all the doses in the series, you can expect protection against hepatitis B for a long time.

  • Newborns, children, and adolescents up to the age of 15 usually receive the vaccine 10 micrograms / 0.5 ml.

There are several different schemes for how Engerix-B can be given. The doctor chooses what is most suitable for you.

Schedule 1 – for newborns, children, and adolescents up to 15 years
First injection one – as agreed
Second injection one – 1 month after the first injection a
Third injection one – 6 months after the first injection a
Schedule 2 – newborns, children, and adolescents up to 15 years
First injection one – as agreed
Second injection one – 1 month after the first injection a
Third injection one – 2 months following the first injection a
Fourth injection one – 12 months after the first injection, a
  • With Schedule 2, Engerix-B can be given to newborns at the same time as other childhood vaccines that are usually given routinely.
  • This schedule can also be used if you are vaccinated because you have recently been exposed to hepatitis B, as it provides faster protection.

You must follow the instructions from the doctor/nurse regarding return visits for future doses. Talk to your doctor if you have any questions about how many vaccinations you should receive.

Vaccination and childbirth

If you have hepatitis B and have recently given birth, Schedule 1 or 2 can be used to vaccinate your child.

  • Your doctor may also decide to give your child immunoglobulins against hepatitis B (human antibodies ) at the same time as the first injection. This provides additional protection against hepatitis B for your child. They are given in another place on the body.

Kidney problems and dialysis

If your child has kidney problems or is on dialysis, the doctor may decide to take a blood sample or give you an extra dose of the vaccine, to ensure that your child has received protection.

4. Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everybody gets them.

The following side effects may occur with this vaccine:

Allergic reactions

If you get an allergic reaction, contact a doctor immediately. The characters can be:

  • facial swelling
  • low blood pressure
  • breathing difficulties
  • blue skin
  • unconsciousness.

These signs generally begin very soon after you have received an injection. Contact your doctor immediately if this occurs after you leave the clinic.

Other side effects can be:

Very common (these may occur with more than 1 in 10 vaccine doses)

  • headache
  • pain and redness at the injection site
  • feeling tired
  • irritability.

Common (these may occur in up to 1 in 10 vaccine doses)

  • drowsiness
  • nausea (feeling sick) or vomiting (getting sick)
  • diarrhea or abdominal pain
  • loss of appetite
  • high body temperature (fever)
  • general malaise
  • swelling at the injection site
  • injection site reactions, e.g. induration.

Uncommon (these may occur with up to 1 in 100 vaccine doses)

  • dizziness
  • muscle aches
  • flu-like symptoms.

Rare (may occur in up to 1 in 1,000 vaccine doses)

  • swollen glands
  • hives, rash, and itching
  • joint pain
  • tingling and crawling.

Side effects that have been reported since the launch of Engerix-B include:

  • easy to get bruises and not being able to stop a bleed if you were to cut yourself
  • low blood pressure
  • inflammation of the blood vessels
  • sudden swelling of the face around the mouth and throat ( angioneurotic edema )
  • paralysis of the muscles (paralysis)
  • neuritis ( neuritis ) that can cause loss of sensation or numbness, including transient neuritis causing pain, weakness, and paralysis of the arms and legs, often progressing to the chest and face ( Guillain-Barré syndrome ), optic nerve disease( optic neuritis ), and multiple sclerosis (MS)
  • problems with moving arms and legs ( neuropathy )
  • brain inflammation ( encephalitis )
  • degenerative brain disease ( encephalopathy )
  • meningitis ( meningitis )
  • cramps
  • decreased sensitivity to pain or touch ( hypesthesia )
  • dark violet or red-violet skin lumps ( lichen planus)
  • red or dark violet spots on the skin
  • joint pain and stiff joints ( arthritis )
  • muscle weakness.

In very premature babies (born week 28 or earlier in pregnancy) there may be longer breaks between breaths than normal for 2-3 days after vaccination.

5. How to store Engerix-B

  • Keep this vaccine out of the reach and sight of children.
  • Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
  • Store in a refrigerator (2 ° C – 8 ° C).
  • Do not freeze.
  • Store in the original package.
  • 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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is the “outer shell” of the hepatitis B virus. Each dose contains 10 micrograms / 0.5 ml of the protein produced by the outer shell adsorbed on hydrated aluminum hydroxide.
  • The other ingredients are sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate, and water for injections.

What the medicine looks like and the contents of the pack

  • Engerix-B is a cloudy, white solution for injection.
  • The vaccine 10 micrograms / 0.5 ml is supplied in pre-filled syringes in pack sizes of 1 or 10 pieces, with or without needles.
  • Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

GlaxoSmithKline AB, Box 516, 169 29 Solna

Tel: 08-638 93 00

Email: info.produkt@gsk.com

Manufacturer:

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

B-1330 Rixensart

Belgium

This medicinal product has been authorized in the EEA Member States under the following names:

Austria, Denmark, Finland, Iceland, Norway,

Belgium, Luxembourg, Spain: Engerix B Junior

France, Ireland, Italy: Engerix-B-10

Germany: Engerix-B Children

Greece: Engerix

Netherlands: Engerix-B Junior

Portugal, United Kingdom: Engerix B

Muhammad Nadeem

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