Engerix B
Italy
Table of Contents
Package leaflet: Information for the user
ENGERIX B 20 micrograms/1 ml, injectable suspension
Vaccine (adsorbed) (rDNA) against hepatitis B (HBV)
Please read this leaflet carefully before you are given this vaccine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This vaccine has been prescribed for you only. Do not give it to others.
- If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Engerix B is and what it is used for
- What you need to know before receiving Engerix B
- How Engerix B is administered
- Possible side effects
- How to store Engerix B
- Contents of the pack and other information
1. What Engerix B is and what it is used for
Engerix B is a vaccine used to prevent hepatitis B infection. It may also help prevent hepatitis D infection.
This vaccine can be given to both adults and adolescents from the age of 16 years. In exceptional circumstances, it may also be administered to children and adolescents from 11 to 15 years of age (see section 3).
Hepatitis B is an infectious liver disease caused by a virus. Some people carry the hepatitis B virus in their body and are unable to eliminate it. They can still infect others and are known as carriers. This disease spreads when the virus enters a person's body through contact with bodily fluids, often blood, from an infected person.
If a mother is a carrier of the virus, she can transmit it to her baby at birth. It is also possible to acquire the virus from a carrier through, for example, unprotected sex, sharing infected needles, or medical treatments using equipment that has not been properly sterilized.
The main signs of the disease include headache, fever, nausea, and jaundice (yellowing of the skin and eyes), although in three out of ten patients no symptoms appear.
Among people infected with the hepatitis B virus, one in ten adults and up to nine out of ten children will become carriers of the virus and may develop serious liver damage and, in some cases, liver cancer.
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 cause the disease.
- When the vaccine is administered, it stimulates the body's immune system to prepare for future protection against this virus.
- Engerix B does not protect if you have already been infected with the hepatitis B virus.
- Engerix B can only help protect against infection with the hepatitis B virus.
2. What you should know before receiving Engerix B
Engerix B must not be administered:
- if you are allergic (hypersensitive) to Engerix B or to any of the excipients of this vaccine (listed in section 6)
- if you have a fever (high temperature). Engerix B should not be administered if any of the conditions listed above apply to you. If you are unsure, speak with your doctor or pharmacist before receiving Engerix B. Inform your doctor or pharmacist if you have any allergies or if you have experienced health problems after receiving a vaccine.
Warnings and precautions
Talk to your doctor or pharmacist before receiving Engerix B if:
- you are on dialysis due to kidney problems or have a disease that may affect your immune system. People who are on dialysis, who have long-term liver problems, who are carriers of hepatitis C, or who are HIV positive can be vaccinated with Engerix B. This is because hepatitis B infections may be severe in these patients. Further information on kidney problems and dialysis is provided in section 3. If you are unsure whether any of the above conditions apply to you, speak with your doctor before receiving Engerix B.
Fainting (particularly in adolescents) may occur following, or even before, any injection with a needle. Therefore, inform the doctor or nurse if you or your child have previously fainted after an injection.
Like other vaccines, Engerix B may not fully protect you against hepatitis B. Certain factors such as advanced age, sex, overweight, smoking, and certain long-term medical conditions may reduce the immune response to the vaccine. If any of these conditions apply to you, your doctor may decide to perform a blood test or administer an additional dose of Engerix B to ensure you are protected.
Other medicines and Engerix B
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Engerix B can be administered simultaneously with most routine vaccines. Your doctor will ensure that the vaccines are injected separately and at different sites of the body.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before receiving this medicine.
Driving and using machines
It is unlikely that Engerix B will affect your ability to drive or operate machinery. However, do not drive or operate machinery if you do not feel well.
Engerix B contains sodium
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.
3. How Engerix B is administered
How the vaccine is administered
Your doctor will administer the recommended dose of Engerix B.
Engerix B will be given:
- by injection into the muscle of the upper arm, or
- by injection under the skin if you are prone to bruising easily or have bleeding disorders.
How much vaccine is administered
You will receive a series of Engerix B injections. Once you have completed the injection schedule, you can expect long-term protection against hepatitis B.
Adults and adolescents aged 16 years and older will receive a vaccine dose of 20 micrograms/1 ml.
There are different schedules by which Engerix B may be administered. Your doctor will choose the most appropriate one for your case:
Schedule 1 – for adults or adolescents aged 16 years or older
First injection – now
Second injection – 1 month after the first injection
Third injection – 6 months after the first injection
Schedule 2 – for adults or adolescents aged 16 years or older
First injection – now
Second injection – 1 month after the first injection
Third injection – 2 months after the first injection
Fourth injection – 12 months after the first injection
- This schedule may also be used if you are being vaccinated following recent exposure to the hepatitis B virus, as it provides protection more rapidly.
Schedule 3 – for adults only (from 18 years of age onwards)
This schedule will only be used under exceptional circumstances, for example, if you are travelling to a high-risk area within one month of vaccination.
First injection – now
Second injection – 1 week after the first injection
Third injection – 3 weeks after the first injection
Fourth injection – 12 months after the first injection
Schedule 4 – for children and adolescents from 11 to 15 years of age only
This schedule is used only when it is uncertain whether the child will receive the third injection. Engerix B (20 micrograms/1 ml) is used in this case, providing a higher level of protection compared to two doses of Engerix B (10 micrograms/0.5 ml).
First injection – now
Second injection – 6 months after the first injection
- When this schedule is used, protection may not always be achieved until after the second dose. This two-dose schedule is used only when the risk of hepatitis B infection during the vaccination course is relatively low and when completion of the schedule can be ensured. It is very important that you attend for your injections at the recommended times. If you have any questions about the amount of vaccine you will receive, discuss them with your doctor.
Kidney problems and dialysis
- Subjects aged 16 years and older: If you have kidney problems or are on dialysis, your doctor may decide to vaccinate you with four double doses (2 x 20 micrograms/1 ml) of vaccine at months 0, 1, 2, and 6. Your doctor may also decide to perform a blood test to ensure that you are protected against hepatitis B.
4. Possible side effects
Like all vaccines, this vaccine can cause side effects, although not everyone experiences them. The following side effects may occur after this vaccination:
Allergic reactions (may occur in up to 1 case in every 10,000 doses of vaccine)
If you experience an allergic reaction, consult your doctor immediately. Symptoms may include:
- swelling of the face
- low blood pressure
- difficulty breathing
- bluish discoloration of the skin
- loss of consciousness
These symptoms usually appear very soon after the injection is administered. Seek immediate medical advice if they occur after you have left the clinic.
Other side effects include:
Very common (may occur in more than 1 case in every 10 doses of vaccine)
- pain and redness at the injection site
- fatigue
- irritability
Common (may occur in up to 1 case in every 10 doses of vaccine)
- headache
- drowsiness
- nausea or vomiting
- diarrhoea or abdominal pain
- loss of appetite
- fever
- general feeling of being unwell
- swelling at the injection site
- injection site reactions such as formation of a hard lump
Uncommon (may occur in up to 1 case in every 100 doses of vaccine)
- dizziness
- muscle pain
- influenza-like symptoms
Rare (may occur in up to 1 case in every 1,000 doses of vaccine)
- swollen glands
- hives, rash and itching
- joint pain
- tingling sensations
Very rare (may occur in up to 1 case in every 10,000 doses of vaccine)
- easy bruising and difficulty with blood clotting following injury
- low blood pressure
- inflammation of blood vessels
- sudden swelling of the face around the mouth and in the throat area (angioneurotic oedema)
- inability to move muscles (paralysis)
- nerve inflammation (neuritis), which may cause loss of sensation or numbness, including a temporary inflammation of nerves causing pain, weakness and paralysis of the limbs, often progressing to the chest and face (Guillain-Barré syndrome), eye nerve disease (optic neuritis), and multiple sclerosis
- difficulty moving arms and legs (neuropathy)
- brain inflammation (encephalitis)
- degenerative brain disease (encephalopathy)
- infection around the brain (meningitis)
- seizures
- loss of skin sensitivity to pain or touch (hypoesthesia)
- development of purple or reddish-purple skin swellings (lichen planus)
- appearance of red or purplish spots on the skin
- joint stiffness and pain (arthritis)
- muscle weakness
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Engerix B
- Keep this vaccine out of the sight and reach of children.
- Do not use this vaccine after the expiry date stated on the label and carton following EXP. The expiry date refers to the last day of that month.
- Store in a refrigerator at 2°C to 8°C.
- Do not freeze.
- Keep in the original packaging to protect from light.
- Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What Engerix B contains
- The active substance is the "outer coat" of the hepatitis B virus. Each dose contains 20 micrograms/1 ml of protein derived from this outer coat, adsorbed onto aluminium hydroxide hydrate.
- The excipients are sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate and water for injections.
Description of the appearance of Engerix B and contents of the pack
- Engerix B is a white, turbid injectable liquid.
- For vials: Injectable suspension (20 micrograms/ml). Packs containing 1, 10, 25 or 100 vials.
- For pre-filled syringes: Injectable suspension in pre-filled syringe (20 micrograms/ml). Packs containing 1 and 10 syringes. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Biologicals s.a. – Rixensart (Belgium)
Local representative: GlaxoSmithKline S.p.A. – Viale dell’Agricoltura, 7 - 37135 Verona - Italy
GlaxoSmithKline Biologicals s.a., Rue de l’Institut 89, B-1330 Rixensart, Belgium
This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria, Denmark, Finland, Iceland, Netherlands, Norway, Spain, Sweden: Engerix-B
Belgium, Luxembourg, Portugal, Italy: Engerix B
France, Ireland: Engerix B-20
Germany: Engerix-B Adult
Greece: Engerix
Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco).
The following information is intended for healthcare professionals only:
During storage, the content may show a fine white sediment with a clear, colorless supernatant.
Once mixed, the vaccine is slightly cloudy.
The vaccine should be inspected visually for the presence of foreign particulate matter and/or abnormal appearance prior to administration. If either condition is observed, do not administer the vaccine.
The entire content of a single-dose container must be withdrawn and injected immediately.
Instructions for the pre-filled syringe
Luer Lock adapter
Hold the syringe by the barrel, not by the plunger.
Unscrew the syringe cap by turning it counterclockwise.
Plunger
Cap
Needle hub
To attach the needle to the syringe, gently connect the needle hub to the Luer Lock adapter and rotate one-quarter turn clockwise until securely locked.
Do not pull the plunger out of the syringe barrel.
If this occurs, do not administer the vaccine.
Disposal
Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.
Package leaflet: Information for the user
ENGERIX B 10 micrograms/0.5 ml, injectable suspension
Hepatitis B vaccine (adsorbed) (rDNA) (HBV)
Please read this leaflet carefully before this vaccine is administered to you/your child, as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This vaccine has been prescribed only for you/your child. Do not give it to others.
- If you/your child experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. In this leaflet, any reference to "you" also applies to "your child".
Contents of this leaflet:
- What Engerix B (10 µg/0.5 ml) is and what it is used for
- What you need to know before receiving Engerix B (10 µg/0.5 ml)
- How Engerix B (10 µg/0.5 ml) is administered
- Possible side effects
- How to store Engerix B (10 µg/0.5 ml)
- Package contents and other information
1. What Engerix B (10 µg/0.5 ml) is and what it is used for
Engerix B (10 µg/0.5 ml) is a vaccine used to prevent hepatitis B infection. It may also help
prevent hepatitis D infection.
This vaccine can be administered to infants, children, and adolescents up to and including 15 years of age.
Hepatitis B is an infectious liver disease caused by a virus. Some people have the hepatitis B virus in their body and are unable to eliminate it. These individuals can still infect others and are known as carriers. The disease spreads when the virus enters a person's body through contact with bodily fluids, often blood, from an infected person.
If a mother is a carrier of the virus, she can transmit it to her baby at birth. In addition, it is possible to contract the virus from a carrier through, for example, unprotected sex, sharing infected needles, or treatments with medical equipment that has not been properly sterilized.
Main signs of the disease include headache, fever, nausea, and jaundice (yellowing of the skin and eyes), although the disease is asymptomatic in three out of ten patients.
Among people infected with the hepatitis B virus, one in ten adults and up to nine out of ten children will become carriers of the virus and may develop serious liver damage and, in some cases, liver cancer.
How Engerix B (10 µg/0.5 ml) works
Engerix B (10 µg/0.5 ml) contains a small amount of the "outer coat" of the hepatitis B virus. This "outer coat" is non-infectious and cannot cause the disease.
- When the vaccine is administered, it stimulates the body's immune system to prepare for future protection against this virus.
- Engerix B (10 µg/0.5 ml) does not protect if you are already infected with the hepatitis B virus.
- Engerix B (10 µg/0.5 ml) can only help protect against infection by the hepatitis B virus.
2. What you should know before being given Engerix B (10 µg/0.5 ml)
Engerix B (10 µg/0.5 ml) must not be given:
- if you are allergic (hypersensitive) to Engerix B (10 µg/0.5 ml) or to any of the other ingredients of this vaccine (listed in section 6)
- if you have a fever (high temperature). Engerix B (10 µg/0.5 ml) must not be given if any of the above conditions apply to you. If you are not sure, speak with your doctor or pharmacist before receiving Engerix B (10 µg/0.5 ml). Inform your doctor or pharmacist if you have any allergies or if you have experienced health problems after receiving a vaccine.
Warnings and precautions
Talk to your doctor or pharmacist before you are given Engerix B (10 µg/0.5 ml) if:
- you are on dialysis due to kidney problems or have a disease that may affect your immune system. People who are on dialysis, who have long-term liver problems, who are carriers of hepatitis C, or who are HIV positive may still receive Engerix B (10 µg/0.5 ml) from their doctor. This is because hepatitis B infections can be very serious in these patients. Further information on kidney problems and dialysis can be found in section 3. If you are not certain whether any of the above conditions apply to you, speak with your doctor before receiving Engerix B (10 µg/0.5 ml).
Fainting (especially in adolescents) may occur following, or even before, any injection with a needle. Therefore, inform your doctor or nurse if you have previously fainted after an injection.
Like other vaccines, Engerix B (10 µg/0.5 ml) may not fully protect you against hepatitis B.
Various factors such as advanced age, sex, overweight, smoking, and other long-term medical conditions may reduce the immune response to the vaccine. If any of these conditions apply to you, your doctor may decide to perform a blood test or administer an additional dose of Engerix B (10 µg/0.5 ml) to ensure you are protected.
Other medicines and Engerix B (10 µg/0.5 ml)
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Engerix B (10 µg/0.5 ml) can be given at the same time as most routine vaccines. Your doctor will ensure that the vaccines are injected separately and at different sites of the body.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before receiving this medicine.
Driving and using machines
It is unlikely that Engerix B will affect your ability to drive or operate machinery.
However, do not drive or operate machinery if you do not feel well.
Engerix B (10 µg/0.5 ml) contains sodium
This vaccine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.
3. How Engerix B (10 µg/0.5 ml) is administered
How the vaccine is administered
Your doctor will administer the recommended dose of Engerix B (10 µg/0.5 ml).
Engerix B (10 µg/0.5 ml) will be administered:
- by injection into the muscle of the upper arm in children and adolescents,
- by injection into the muscle of the thigh in infants and young children,
- by subcutaneous injection if you are prone to bruising easily or have bleeding disorders.
How much vaccine is administered
You will receive a series of injections of Engerix B (10 µg/0.5 ml). Once you have
completed the injection schedule, long-term protection against hepatitis B can be expected.
- Infants, children, and adolescents up to and including 15 years of age usually receive a vaccine dose of 10 micrograms/0.5 ml. There are different schedules according to which Engerix B (10 µg/0.5 ml) may be administered. Your doctor will choose the most appropriate one for your case:
Schedule 1 – for infants, children, and adolescents up to and including 15 years of age
First injection – now
Second injection – 1 month after the first injection
Third injection – 6 months after the first injection
Schedule 2 – for infants, children, and adolescents up to and including 15 years of age
First injection – now
Second injection – 1 month after the first injection
Third injection – 2 months after the first injection
Fourth injection – 12 months after the first injection
- Schedule 2 allows Engerix B (10 µg/0.5 ml) to be administered simultaneously with other routine childhood vaccines in infants.
- This schedule may also be used if vaccination follows recent exposure to the hepatitis B virus, as it provides more rapid protection.
It is very important that you attend your appointments for injections at the recommended times. If you have any questions regarding the amount of vaccine to be administered, discuss them with your doctor.
Vaccination and childbirth
If you have hepatitis B and have just given birth, either Schedule 1 or 2 may be used to vaccinate your
baby.
- Your doctor may also decide to administer hepatitis B immunoglobulins (human antibodies) to the baby at the time of the first injection. This will help protect the baby against hepatitis B. These will be administered at a separate injection site.
Kidney problems and dialysis
If the child has kidney problems or is undergoing dialysis, the doctor may decide to perform a
blood test or administer additional vaccine doses to ensure the child is protected.
4. Possible side effects
Like all vaccines, this vaccine may cause side effects, although not everybody gets them. The following side effects may occur after this vaccination:
Allergic reactions (may occur in up to 1 case in 10,000 vaccine doses)
If you experience an allergic reaction, consult your doctor immediately. Symptoms may include:
- swelling of the face
- low blood pressure
- breathing difficulties
- bluish skin colouration
- loss of consciousness
These symptoms usually appear very soon after the injection is given. Consult your doctor immediately if they occur after you have left the clinic.
Other side effects include:
Very common (may occur in more than 1 case in 10 doses of vaccine)
- headache
- pain and redness at the injection site
- tiredness
- irritability
Common (may occur in up to 1 case in 10 doses of vaccine)
- drowsiness
- nausea or vomiting
- diarrhoea or abdominal pain
- loss of appetite
- fever
- general feeling of being unwell
- swelling at the injection site
- injection site reactions such as formation of a hard lump
Uncommon (may occur in up to 1 case in 100 doses of vaccine)
- dizziness
- muscle pain
- influenza-like symptoms
Rare (may occur in up to 1 case in 1,000 doses of vaccine)
- swollen glands
- hives, rash and itching
- joint pain
- tingling sensations
Side effects reported during the post-marketing use of Engerix B (10 µg/0.5 ml) include:
- easy bruising and difficulty in blood clotting when injured
- low blood pressure
- inflammation of blood vessels
- sudden swelling of the face around the mouth and in the throat area (angioneurotic oedema)
- inability to move muscles (paralysis)
- inflammation of nerves (neuritis), which may cause loss of sensation or numbness, including temporary nerve inflammation causing pain, weakness and paralysis of the limbs, often progressing to the chest and face (Guillain-Barré syndrome), eye nerve disease (optic neuritis), and multiple sclerosis
- difficulty in moving arms and legs (neuropathy)
- inflammation of the brain (encephalitis)
- degenerative brain disease (encephalopathy)
- infection around the brain (meningitis)
- seizures
- loss of skin sensitivity to pain or touch (hypoesthesia)
- development of purple or reddish-purple swellings (lichen planus)
- appearance of red or purplish spots on the skin
- joint stiffness and pain (arthritis)
- muscle weakness
In children born very prematurely (at 28 weeks of gestation or earlier), longer intervals between breaths may occur within 2–3 days after vaccination.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Engerix B (10 µg/0.5 ml)
- Keep this vaccine out of the sight and reach of children.
- Do not use this vaccine after the expiry date 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 to 8°C).
- Do not freeze.
- Keep in the original packaging to protect from light.
- Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Engerix B (10 µg/0.5 ml) contains
- The active substance is the "outer coat" of the hepatitis B virus. Each dose contains 10 micrograms/0.5 ml of protein derived from this outer coat, adsorbed onto aluminium hydroxide, hydrate.
- The excipients are sodium chloride, disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate, and water for injections.
Description of the appearance of Engerix B (10 µg/0.5 ml) and contents of the pack
- Engerix B (10 µg/0.5 ml) is a white, opaque injectable liquid.
- For vials: Injectable suspension (10 micrograms/0.5 ml). Packs of 1, 10 or 100.
- For pre-filled syringes: Injectable suspension (10 micrograms/0.5 ml). Packs of 1 or 10 with or without needles.
- Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline Biologicals s.a. – Rixensart (Belgium)
Local representative: GlaxoSmithKline S.p.A. – Viale dell’Agricoltura, 7 - 37135 Verona - Italy
Manufacturer
GlaxoSmithKline Biologicals s.a., Rue de l’Institut 89, B-1330 Rixensart, Belgium
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Denmark, Finland, Iceland, Norway, Sweden: Engerix-B
Belgium, Luxembourg, Spain: Engerix B Junior
France, Ireland, Italy: Engerix B-10
Germany: Engerix B Children
Greece: Engerix
Netherlands: Engerix-B Junior
Portugal: Engerix B
Further information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco).
_________________________________________________________________________________
The following information is intended exclusively for healthcare professionals:
During storage, a fine white sediment with a clear, colourless supernatant may be observed.
Once mixed, the vaccine is slightly opaque.
The vaccine should be inspected visually for the presence of foreign particulate matter and/or abnormal physical appearance before administration. If either condition is observed, do not administer the vaccine.
The entire contents of a single-dose container must be withdrawn and injected immediately.
Instructions for the pre-filled syringe
Luer Lock adapter
Hold the syringe by the barrel, not by the plunger.
Unscrew the syringe cap by turning it counterclockwise.
Plunger
Cap
Barrel
Needle hub
To attach the needle to the syringe, gently connect the needle hub to the Luer Lock adapter and rotate one-quarter turn clockwise until a secure lock is felt.
Do not remove the syringe plunger from the barrel.
If this occurs, do not administer the vaccine.
Disposal
Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.