solution for injection, suspension in pre-filled syringe
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccines ( adsorbed )
What Twinrix Pediatric is and what it is used for
Twinrix Pediatric is a vaccine used in infants, children, and adolescents from 1 year up to and including 15 years of age and which protects against two different diseases: hepatitis A and hepatitis B. The vaccine works by causing the body to produce its protection ( antibody ar) against these diseases.
- Hepatitis A: Hepatitis A is an infectious disease that can affect the liver. The disease is caused by the hepatitis A virus. Hepatitis A virus can be transmitted from one person to another through food and drink, or when swimming in water contaminated with sewage. Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus. Symptoms consist of nausea (general malaise), fever, and aches and pains. After a few days, the whites of the eyes and the skin may turn yellowish (jaundice). The severity and type of symptoms can vary. Young children do not always develop jaundice. Most recover completely, but the illness is often severe enough to require you to stay home from work for at least a month.
- Hepatitis B: Hepatitis B is caused by the hepatitis B virus. It causes swelling of the liver ( inflammation ). Virus et is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) from infected people.
Vaccination is the best way to protect yourself against these diseases. The vaccine does not contain any components that can cause infection.
What you need to know before you receive Twinrix Pediatric
Do not take Twinrix Pediatric if
- you are allergic to:
- the active substances or any other ingredient in this medicine (listed in section 6)
- neomycin.
Signs of an allergic reaction may include an itchy rash, shortness of breath, and swelling of the face or tongue.
- you have previously had an allergic reaction to any hepatitis A or hepatitis B vaccine.
- you have a severe infection with a high fever (over 38 °C). A minor infection such as a common cold is probably not a problem, but talk to the doctor first.
Warnings and precautions
Before receiving Twinrix Pediatric, talk to your doctor or pharmacist
- you have had any health problems after previous vaccinations
- you have a weak immune system due to illness or drug treatment
- you have a bleeding disorder or bruise easily.
Fainting may occur (mainly in young people) after, or even before, any needle injection. Therefore, tell the doctor or nurse if you have fainted during a previous injection.
Other medicines and Twinrix Pediatric
Twinrix Pediatric can be given at the same time as a human papillomavirus vaccine (HPV vaccine). When the vaccines are given at the same visit, however, different injection sites (different body part, e.g. opposite arm) must be used.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 receiving this vaccine.
It is not known whether Twinrix Pediatric passes into breast milk. However, the vaccine is not expected to cause any problems for children who are breastfed.
Twinrix Pediatric contains neomycin and sodium
Tell your doctor if you have previously suffered from an allergic reaction to neomycin ( an antibiotic ).
This medicine contains less than 1 mmol (23 mg) of sodium per dose , i.e. it is almost “sodium-free”.
How Twinrix Pediatric should be used
You will receive a total of three injections over a period of 6 months. Each injection is given at a separate visit. First dose one will be given as agreed. The other two doses will be given one month and six months after the first dose .
- First dose: as agreed
- Second dose: 1 month later
- Third dose: 6 months after first dose one
If an additional dose or a top-up dose is needed, the doctor will let you know.
If you miss an appointment for vaccination, you must talk to the doctor and get a new appointment.
Make sure you complete the vaccination program with three injections . Otherwise, you will not have complete protection against the diseases.
The doctor will give you Twinrix Pediatric as an injection into the upper arm muscle or thigh muscle of your child.
The vaccine must never be given into a vein.
If you have any further questions about this vaccine, ask your doctor or pharmacist.
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 that have occurred during clinical studies , during routine use of the vaccine, with individual hepatitis A and hepatitis B vaccines or with the formulation intended for adults
| Very common (1 in 10 vaccine doses or more often): | ||
| Pain and redness at the injection site. | ||
| Common (up to 1 in 10 vaccine doses): | ||
| Drowsiness, headacheNauseaLoss of appetiteSwelling or bruising at the injection siteFeeling sick, fatigueFever 37.5 °C or higherIrritability. | ||
| Uncommon (up to 1 in 100 vaccine doses): | ||
| Diarrhea, vomiting, stomach acheRashMuscle painUpper respiratory tract infection. | ||
| Rare (up to 1 in 1000 vaccine doses): | ||
| Swollen glands in the neck, armpits or groin ( lymphadenopathy )DizzinessDecreased sensitivity to pain or touch ( hypesthesia )Tingling and crawling ( paresthesia )Hives, itchingJoint painLow blood pressureFlu-like symptoms such as high fever, sore throat, runny nose, cough and chills. | ||
| Very rare (up to 1 in 10,000 vaccine doses): | ||
| Reduction in the number of blood platelets , which increases the tendency to bleed and the risk of bruising ( thrombocytopenia )Dark violet or brown-red spots visible through the skin (thrombocytopenic purpura)Swelling or inflammation of the brain ( encephalitis )Degenerative brain disease ( encephalopathy )Nerve inflammation ( neuritis )Numbness or weakness in arms and legs ( neuropathy ), paralysisCrampsSwelling of the face, mouth or throat ( angioneurotic oedema )Dark violet or red-violet skin nodules ( lichen planus), severe skin rash (erythema multiforme)Joint swelling, muscle weaknessInflammation of the membranes around the brain, which can cause severe headaches with neck stiffness and sensitivity to light ( meningitis )Inflammation in certain blood vessels ( vasculitis )Severe allergic reactions ( anaphylaxis , anaphylactoid reactions and symptoms similar to serum sickness). Signs of severe allergic reactions may include skin rash that may itch or blister, swelling around the eyes and face, difficulty breathing or swallowing, sudden drop in blood pressure and loss of consciousness. Such reactions can occur before you have time to leave the reception. If you experience any of these symptoms, contact your doctor immediately.Abnormal liver valuesMultiple sclerosis , swelling of the spinal cord ( myelitis )Drooping eyelids and paralysis of the muscles in one half of the face (facial paralysis)Transient nerve inflammation causing pain, weakness and paralysis of the arms and legs, often progressing to the chest and face ( Guillain-Barré syndrome )Disease of the optic nerve ( an optic neuritis )Immediate pain at the injection site, stinging and burning sensation. |
How to store Twinrix Pediatric
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton. The expiration date is the last day of the specified month.
Store in a refrigerator (2°C – 8°C).
Store in the original packaging. Light sensitive.
Do not freeze. Freezing destroys the vaccine.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
What Twinrix Pediatric contains
| – | The active substances are: | |
| Hepatitis A virus (inactivated) 1,2 | 360 ELISA Units | |
| Hepatitis B surface antigen 3,4 | 10 micrograms | |
| 1 Produced in human diploid cells (MRC-5) | ||
| 2 Adsorbed on aluminum hydroxide hydrate | 0.025 milligrams of Al 3+ | |
| 3 Produced in yeast cells (Saccharomyces cerevisiae) with recombinant DNA technology | ||
| 4 Adsorbed on aluminum phosphate | 0.2 milligrams of Al 3+ | |
| – | The other ingredients in Twinrix Pediatric are: sodium chloride and water for injections. |
Appearance and package sizes of the medicine
Solution for injection , suspension in prefilled syringe
Twinrix Pediatric is a white, slightly milky liquid packaged in a pre-filled glass syringe (0.5 ml).
Twinrix Pediatric is supplied in packs of 1, 10 and 50 with or without needles.
Not all pack sizes may be marketed.
GlaxoSmithKline Biologicals said
Rue de l’Institut 89
B-1330 Rixen species
Belgium
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