1440 ELISA U / mL injection , suspension
inactivated hepatitis A vaccine

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

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

In this leaflet you will find information about:
1. What Havrix is ​​and what it is used for
2. Before you / your child receive Havrix
3. How to use Havrix
4. Possible side effects
5. How to store Havrix
6. Contents of the pack and other information

1. What Havrix is ​​and what it is used for

Havrix is ​​a vaccine against infection caused by the hepatitis A virus. The vaccine stimulates the body to make antibodies that protect against hepatitis A infection.

Hepatitis A is an infectious disease that can affect the liver. The disease is caused by the hepatitis A virus. Hepatitis A virus is found in the feces of people with hepatitis A and can be transmitted from one person to another via contaminated food, or when, for example, you swim in water that is contaminated with wastewater. Symptoms of hepatitis A begin 3 to 6 weeks after contact with the viruset. The symptoms consist of nausea (general malaise), fever, aches, and pains. After a few days, the whites of the eyes and the skin may turn yellow (jaundice). The severity and type of symptoms may vary. Young children do not always develop jaundice. Most recover completely, but the disease is often severe enough to make you feel unwell for about a month.

Vaccination is the best way to protect against this disease. The vaccine does not contain any ingredients that could cause infection.

2. Before you / your child receive Havrix

Do not use Havrix if you / your child

  • previously had an allergic reaction to Havrix or any of the other ingredients of the vaccine (listed in section 6).
  • is hypersensitive to neomycin or formaldehyde. Havrix may contain traces of these substances.
  • previously had an allergic reaction to another hepatitis A vaccine.

Contact a doctor immediately if you get any of the following symptoms ( angioedema ):

  • swelling of the face, tongue or throat
  • difficulty swallowing
  • hives and difficulty breathing.

Take special care with Havrix

Tell your doctor/nurse:

  • if you / your child have had any health problems after previous vaccinations
  • if you / your child has a severe infection with a high fever (above 38 ° C). A mild infection such as a common cold is probably not a problem, but talk to your doctor first.
  • if you / your child has a poor immune system due to illness or drug treatment
  • if you / your child has a bleeding disorder or easily gets bruises
  • if you / your child has any allergies .

In the cases mentioned above, the doctor can decide the right time for your / your child’s vaccination.

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

Use of other medicines or vaccines

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Also, tell us if you have recently received any other vaccine.

Pregnancy and breastfeeding

Talk to your doctor if you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby. Your doctor will discuss with you the possible risks and benefits of taking Havrix during pregnancy and breastfeeding.

Driving and using machines

Havrix is ​​unlikely to affect your ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

Havrix contains phenylalanine, potassium and sodium

This vaccine contains 166 micrograms of phenylalanine per dose (1 dose = 1 ml for adults) or 83 micrograms of phenylalanine per dose (1 dose = 0.5 ml for children). Phenylalanine can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.

This vaccine contains less than 1 mmol (39 mg) per dose of potassium, it is essential ‘potassium free.

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

3. How to use Havrix

A doctor or nurse injects the recommended dose of vaccine intramuscularly into the upper arm muscle. In young children, a dose is given in the upper part of the outer thigh muscle. The vaccine must never be given into a blood vessel (intravascularly).

The vaccine is given to adults (1 ml) and children over 1 year of age (0.5 ml). You / your child will receive 2 vaccine doses. The second dose one should be given 6-12 months after the first dose one, but can also be given up to 5 years after the first dose one.

It is important that you follow the instructions from the doctor/nurse regarding return visits for the next dose. If you / your child misses an appointment for vaccination, talk to your doctor/nurse and get a new appointment.

Make sure you / your child completes the vaccination schedule. Otherwise you / your child can not be sure of getting adequate protection against infection.

4. Possible side effects

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

The most common local side effects in both children and adults are pain, redness, and swelling at the injection site. The most common side effects in children are irritability and in adults fatigue and headache.

Very common (affects more than 1 in 10 people vaccinated):
  Irritability*HeadachePain and redness at the injection site, fatigue **.
Common (affects more than 1 in 100 people vaccinated):
  Loss of appetiteDrowsiness *Diarrhea, nauseaReactions such as swelling or hardening at the injection site feeling sick, fever.
Uncommon (affects more than 1 user in 1,000 but less than 1 in 100 people vaccinated):
  Upper respiratory tract infection, runny or stuffy nose dizziness**VomitingRashMuscle pain **, muscle stiffness not caused by muscle work **Flu-like symptoms such as fever, sore throat, runny nose, cough, and chills **
Rare (affects less than 1 in 1,000 people vaccinated):
  Reduced sensitivity to touchAbnormal sensations in the skin such as tingling, numbness, ant crawling, burning sensation, etc. **Itching**Overindulge.
The following side effects have also been reported:
  Allergic reaction in the form of swelling, redness, itching, runny nose and difficulty breathing sometimes severeCrampsVascular inflammationHivesSkin changes (sometimes severe)Swelling of the face, lips, tongue or throat, sometimes with shortness of breath or difficulty swallowing, so-called angioedema, see section 2Joint pain.

* refers to side effects reported with the formulation intended for children.

** refers to side effects reported with the formulation intended for adults.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Havrix

Keep out of sight and reach of children.

Store in a refrigerator (2 ° C – 8 ° C).

Do not freeze. Discard the vaccine if it has been frozen.

Store in the original package. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the label and carton.

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

1 dose of 1 ml (adult dose) contains: Inactivated hepatitis A virus 1, 2 1440 ELISA units
   
1 produced in human diploid cells
(MRC-5)adsorbed on aluminum hydroxide, hydrated
0.5 mg Al 3+
   
1 dose of 0.5 ml (child dose) contains: Inactivated hepatitis A virus 1, 2 720 ELISA units
   
1 produced in human diploid cells
(MRC-5)adsorbed on aluminum hydroxide, hydrated
0.25 mg Al 3+
  • The other ingredients are: amino acids for injection (contains phenylalanine), anhydrous disodium phosphate, potassium dihydrogen phosphate, polysorbate 20, potassium chloride, sodium chloride and water for injections.

What the medicine looks like and contents of the pack

Injection, suspension in the prefilled syringe.

Pre-filled syringe (type I glass) with flask (butyl) – packs of 1×0.5 ml (with or without needle), 10×0.5 ml (with or without needles), 1×1 ml (with or without needle), 10×1 ml (with or without needles).

Not all pack sizes may be marketed.

Marketing Authorization Holder / Information provided by:

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

Muhammad Nadeem

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