Twinrix Paediatric - patient leaflet, side effects, dosage

1. What Twinrix Paediatric is and what it is used for

Twinrix Paediatric is a vaccine used in infants, children and adolescents from 1 year up to and including 15 years to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.

• Hepatitis A: Hepatitis A is an infectious disease, which can affect the liver. This disease is

caused by the hepatitis A virus. The hepatitis A virus can be passed from person to person in food and drink, or by swimming in water contaminated by sewage. Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus. These consist of nausea (feeling sick), fever and aches and pains. After a few days the whites of eyes and skin may become yellowish (jaundice). The severity and type of symptoms can vary. Young children may not develop jaundice. Most people recover completely but the illness is usually severe enough to keep people off work for about a month.

• Hepatitis B: Hepatitis B is caused by the hepatitis B virus. It causes the liver to become

swollen (inflamed). The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.

Vaccination is the best way to protect against these diseases. None of the components in the vaccine are infectious.

2. What you need to know before you receive Twinrix PaediatricTwinrix Paediatric should not be given if     you are allergic to:

• – the active substances, or any of the ingredients of this medicine (listed in section 6).

• – neomycin.

Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.

• you have previously had an allergic reaction to any vaccine against hepatitis A and hepatitis B

diseases.

• you have a severe infection with a high temperature (over 38°C). A minor infection such as a

cold should not be a problem, but talk to your doctor first.

Warnings and precautions

Talk to you doctor or pharmacist before you receive Twinrix Paediatric if:

• you have experienced any health problems after previous administration of a vaccine.
• you have a poor immune system due to illness or drug treatment.
• you have a bleeding problem or bruise/ bruises easily.

Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore tell the doctor or nurse if you fainted with a previous injection.

Other medicines and Twinrix Paediatric

Twinrix Paediatric can be given with a Human Papillomavirus (HPV) vaccine at a separate injection site (another part of your body, e.g. the other arm) during the same visit.

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

Pregnancy and breast-feeding

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

It is not known if Twinrix Paediatric passes into breast milk, however the vaccine is not expected to cause problems in breast-fed babies.

Twinrix Paediatric contains neomycin and sodium

Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic).

This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

• 3. How Twinrix Paediatric is given

You will receive a total of three injections over 6 months. Each injection is given on a separate visit. The first dose will be given on an elected date. The remaining two doses will be given one month, and six months after the first dose.

at an elected date 1 month later 6 months after the first dose

Your doctor will advise on the possible need for extra doses, and future booster dosing.

If you miss a scheduled injection, talk to your doctor and arrange another visit.

Make sure you finish the complete vaccination course of three injections. If not, you may not be fully protected against the diseases.

The doctor will give Twinrix Paediatric as an injection into your upper arm muscle or into the thigh muscle of your child.

The vaccine should never be given into a vein.

If you have any further questions on the use of this vaccine, ask your doctor or pharmacist.

4. Possible side effects

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

Side effects that may occur are the following:

Side effects occured during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines or with the adult formulation of Twinrix.

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

• Pain and redness at the injection site

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

• Drowsiness, headache
• Nausea
• Loss of appetite
• Swelling or bruising at the injection site
• Generally feeling unwell, tiredness
• Fever equal to or greater than 37.5°C
• Irritability

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

• Diarrhoea, vomiting, stomach pain
• Rash
• Aching muscles
• Upper respiratory tract infection

Rare (these may occur with up to 1 in 1,000 doses of the vaccine)

• Swollen glands in the neck armpit or groin (lymphadenopathy)
• Dizziness
• Loss of skin sensitivity to pain or touch (hypoaesthesia)
• Feeling of pins and needles (paraesthesia)
• Hives, itching
• Joint pain
• Low blood pressure
• Flu-like symptoms such as high temperature, sore throat, runny nose, cough and chills

Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)

• Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
• Purple or red brown spots visible through the skin (thrombocytopenic purpura)
• Swelling or infection of the brain (encephalitis)
• Degenerative disease of the brain (encephalopathy)
• Inflammation of nerves (neuritis)
• Numbness or weakness of the arms and legs (neuropathy), paralysis
• Fits or seizures
• Swelling of the face, mouth or throat (angioneurotic oedema)
• Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme)
• Joint swelling, muscular weakness
• Infection around the brain which may give severe headache with stiff neck and sensitivity to light (meningitis)
• Inflammation of some blood vessels (vasculitis)
• Serious allergic reactions (anaphylaxis, anaphylactoid reactions and mimicking serum sickness). Signs of serious allergic reactions may be rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness. Such reactions may occur before leaving the doctor’s surgery. However, if you get any of these symptoms you should contact a doctor urgently.
• Abnormal laboratory liver test results
• Multiple sclerosis, swelling of the spinal cord (myelitis)
• Drooping eyelid and sagging muscles on one side of the face (facial palsy)
• A temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barre syndrome)
• A disease of the nerves of the eye (optic neuritis)
• Immediate injection site pain, stinging and burning feeling

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Twinrix Paediatric

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Store in the original package in order to protect from light.

Do not freeze. Freezing destroys the vaccine.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other informationWhat Twinrix Paediatric containsThe active substances are:360 ELISA Units10 micrograms

Hepatitis A virus (inactivated)1,2

Hepatitis B surface antigen3,4

• 1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated

  0.025 milligrams Al3+

  
  

• 3Produced in yeast cells (Saccharomyces cerevisiae ) by recombinant DNA technology

• 4Adsorbed on aluminium phosphate 0.2 milligrams Al3+

The other ingredients in Twinrix Paediatric are: sodium chloride, water for injections.

What Twinrix Paediatric looks like and contents of the pack

Suspension for injection in pre-filled syringe.

Twinrix Paediatric is a white, slightly milky liquid presented in a glass pre-filled syringe (0.5 ml).

Twinrix Paediatric is available in packs of 1, 10 and 50 with or without needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Detailed information on this medicine is available on the European Medicines Agency web site:

The following information is intended for healthcare professionals only:

Upon storage, a fine white deposit with a clear colourless layer above may be observed.

The vaccine should be re-suspended before use. When re-suspended, the vaccine will have a uniform hazy white appearance.

Re-suspension of the vaccine to obtain a uniform hazy white suspension

The vaccine should be re-suspended following the steps below.

• 1. Hold the syringe upright in a closed hand.

• 2. Shake the syringe by tipping it upside down and back again.

• 3. Repeat this action vigorously for at least 15 seconds.

• 4. Inspect the vaccine again: