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Epaxal Suspension for injection in a prefilled syringe Hepatitis A vaccine

What Epaxal is and what it is used for

Epaxal is a suspension for injection presented in prefilled syringe

Epaxal is used to vaccinate against hepatitis A (infectious jaundice) for adults and children from 1 year of age. The immune system is activated by means of killed hepatitis A virus, bound to virosomes (vaccine particles) consisting of fats (lipids) and proteins. Protection against hepatitis A nfection is achieved in 80-97% of vaccinated individuals after 14 days, in 92-100% after 28 days and in 78-100% after 1 year.

Before you use Epaxal

Do not use Epaxal

  • If you are hypersensitive to any of the vaccine components
  • If you are hypersensitive to eggs, chicken protein, or formaldehyde
  • If you have an acute infection with a fever, your vaccination should be postponed. Please tell your doctor if you think you have a fever.

Take special care with Epaxal

Before vaccination with Epaxal, please tell your doctor if you have any problems with your immune system, as this may affect the way the vaccine works. If you have had your spleen removed (splenectomy) or your immune system does not work properly (immunodeficiency), you should be given a second dose of vaccine, not earlier than 1 month after the first dose

Your doctor will decide if this is necessary.

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

Epaxal may contain traces of polymyxin B.

Experience in vaccinating children under the age of 1 and people over 60 is limited

Using other medicines together with Epaxal

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Epaxal can be administered simultaneously with other vaccines (influenza, typhoid fever, yellow fever, polio, diphtheria, tetanus and meningococcal vaccine A + C) and malaria prophylaxis However, Epaxal must not be mixed with other injectable vaccines in the same syringe

Pregnancy and breast-feeding

There is little experience in vaccinating pregnant women with Epaxal. Therefore consult your doctor before being vaccinated with Epaxal if you are pregnant.

It is unknown whether the vaccine is secreted in breastmilk. You should therefore consult with your doctor before being vaccinated with Epaxal when breastfeeding

Driving and using machines

The vaccine does not usually affect your ability to drive a car or operate machinery. However, please be aware that some side effects such as dizziness and headache may temporarily affect your ability to drive and carry out precision work.

How to use Epaxal

Adults and children from 1 year of age: 1 dose of 0.5 ml is injected intramuscularly into the upper arm. In patients with blood clotting problems the vaccine may be administered subcutaneously (under the skin) in the upper arm.

Booster vaccination: To ensure long-term protection a second (booster) dose of 0.5 ml is administered. This dose should preferably be given 6-12 months after the first dose, but may be given up to 4 years later. This prolongs the protective effect for at least 30 years for almost all users. Shake before use

Epaxal can be interchanged with other inactivated hepatitis A-vaccines for the first or second (booster) dose.

If you receive more Epaxal than you should

An unintentional second dose should not cause any side effects

Possible side effects

Like any medicines, Epaxal can cause side effects, although not everybody gets them Serious allergic reactions are always a possibility after receiving a vaccine. These reactions may include difficulty in breathing, blue discolouration of the tongue or lips, low blood pressure (causing dizziness) and collapse. When these signs or symptoms occur they usually develop very quickly after the injection is given and while the person affected is still in the clinic or doctor’s surgery. If any of these symptoms occur after leaving the place where your njection was given, you must consult a doctor immediately.

Very common (more than 1 of 10 persons):

  • headache
  • fatigue
  • local pain

Common (more than 1 of 100, but less than 1 of 10 persons):

  • hardening of the skin
  • redness
  • swelling
  • feeling sick
  • fever
  • nausea
  • loss of appetite
  • mild and short-lived diarrhoea

Uncommon (more than 1 of 1000, but less than 1 of 100 persons):

  • dizziness
  • skin rash/itching
  • vomiting
  • arthralgia (joint pain).

Very rare (less than 1 of 10 000 persons):

  • serious allergic reaction (anaphylactic shock)

Occasionally:

  • A short-lived and mild rise in levels of liver enzymes was observed on single occasions at the time of vaccination.
  • As observed with other vaccines, occasional inflammatory diseases of the central and peripheral nervous system may occur, including a paralysis travelling upward up to breathing paralysis, e.g. Guillain-Barre-Syndrome.

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.

How to store Epaxal

Store in a refrigerator (2 °C-8 °C). Store in the original package in order to protect from light

Do not freeze.

Keep out of the reach and sight of children.

Do not use Epaxal after the expiry date which is stated on the label and on the carton after Exp

The expiry date refers to the last day of that month.

Do not use Epaxal if you notice a cloudy appearance or particles in the vaccine

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.

Further information

What Epaxal contains

The active substance is inactivated hepatitis A virus (strain RG-SB) >24 IU adsorbed to virosomes (the adjuvant system) which consist of hemaglutinin from the influenza virus (A/Singapore/6/86; H1N1) 10 micrograms, phospholipids 100 micrograms (lecithin 80 micro-grams + cephalin 20 micrograms). Adjuvants are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.

The other ingredients are sodium chloride 4.5 mg, water for injections to make 0.5 ml

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially «sodium-free».

What Epaxal looks like and content of the pack

Epaxal consists of a clear, colorless liquid (solution for injection, suspension), distributed in prefilled syringes.

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