Active ingredient
- hepatitis a vaccine, purified inactivated, for paediatrics and adolescents
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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VAQTA paediatric
PACKAGE LEAFLET: INFORMATION FOR THE USER
VAQTA® Paediatric, Suspension for injection
Hepatitis A vaccine, inactivated, adsorbed
For children and adolescents
Read all of this leaflet carefully before you or your child is vaccinated because it contains important information for you.
What is in this leaflet:
1. What Vaqta Paediatric is and what it is used for
2. What you need to know before Vaqta Paediatric is given
3. How Vaqta Paediatric is given
4. Possible side effects
5. How to store Vaqta Paediatric
6. Contents of the pack and other information
1. What VAQTA Paediatric is and what it is used for
Vaqta Paediatric is one of a general group of medicines called vaccines. Vaccines are used to protect against infectious diseases. They work by causing the body to produce its own protection against the targeted disease.
This vaccine helps to protect against hepatitis A infection.
Hepatitis A is a virus that attacks the liver, which can be caught from food or drink that contains the virus. Symptoms of hepatitis A include a yellowing of the skin and eyes (jaundice) and feeling generally unwell.
When an injection of this vaccine is given, the body’s natural defences will produce protection (antibodies) against the hepatitis A infection. However, it usually takes 2 to 4 weeks after receiving the injection before you or your child will be protected.
This vaccine will not protect against other viruses that infect the liver (such as hepatitis B, hepatitis C or hepatitis E). This vaccine protects against hepatitis A but cannot cause a hepatitis A infection.
The vaccination may not work properly if the person to be vaccinated is already infected with the hepatitis A virus.
Vaqta Paediatric is for children from 12 months old up to 17 years old. This vaccine is not suitable for children under 12 months of age or adults aged 18 years and over.
2. What you need to know before VAQTA Paediatric is given
Do not use Vaqta Paediatric:
Warnings and precautions
Talk to your doctor, pharmacist or nurse before Vaqta Paediatric is given:
The container of this medicinal product contains latex rubber. May cause severe allergic reactions.
As with other vaccines, Vaqta Paediatric may not completely protect all persons who are vaccinated.
Please tell your doctor if you or your child have had a history of jaundice or have lived in an area where hepatitis A is common. Your doctor will determine whether you or your child should be tested for hepatitis A antibodies prior to vaccination.
Other medicines and VAQTA Paediatric
Tell your doctor or pharmacist if you or your child is taking, has recently taken or might take any other medicines (or other vaccines).
This vaccine can be given at the same time as any of the following provided that they are given in different parts of the body (for example another arm or leg) and are not mixed in the same syringe.
In adults, Vaqta may be given at the same time as yellow fever and polysaccharide typhoid vaccines.
Pregnancy, breast-feeding and fertility
If you or your child is pregnant or breast-feeding, think you or your child may be pregnant or is planning to have a baby, ask your doctor or pharmacist for advice whether you or your child should receive the vaccine.
Driving and using machines
There are no data to suggest that Vaqta Paediatric affects the ability to drive or operate machinery.
VAQTA Paediatric contains sodium
This medicine contains less than 1mmol sodium (23mg) per dose, that is to say essentially ‘sodium-free’.
3. How VAQTA Paediatric is given
The vaccine will be injected by a doctor or nurse who has been trained in the use of vaccines and who is equipped to deal with any rare severe allergic reaction to the injection.
Short term protection against hepatitis A is achieved within 2 to 4 weeks after receiving this vaccination.
Long term protection against hepatitis A requires a second dose (booster) injection of an inactivated hepatitis A vaccine. This is usually given between 6 and 18 months after the first dose. Healthy children who have had two doses have been found to have antibody levels for at least 10 years. It is predicted that hepatitis A antibodies will remain at least 25 years after vaccination.
Safety and effectiveness in infants < 12 months of age have not been established.
Method of administration
The doctor or nurse will shake the syringe immediately before use and check that the liquid is white and cloudy and that there are no large particles.
The vaccine is given as an injection into a muscle in the upper outer part of the arm (deltoid muscle). The muscle in the outer thigh region may be used in children if the deltoid muscle is not sufficiently developed. Your doctor or nurse will avoid giving you or your child the injection either into the skin or into a blood vessel. Children who are at risk of bleeding a lot after an injection (see section 2) may sometimes be given Vaqta Paediatric as an injection under the skin but not into muscle to try to reduce the risk of bleeding.
4. Possible side effects
Like all medicines and vaccines, this vaccine can cause side effects, although not everybody gets them.
As with all vaccines, allergic reactions, in rare cases leading to shock, may occur. These reactions may include:
When these signs or symptoms occur they usually develop very quickly after the injection is given and while you or your child is still in the clinic or doctor’s surgery. If any of these symptoms occur after leaving the place where you or your child’s injection was given, contact a doctor IMMEDIATELY.
Side effects reported in children aged 12 months to 23 months
Very common: may affect more than 1 in 10 children:
injection-site pain/tenderness and injection-site redness
Common: may affect up to 1 in 10 children:
Uncommon: may affect up to 1 in 100 children:
Rare: may affect up to 1 in 1,000 children:
Not known: frequency cannot be estimated from the available data
Side effects reported in children aged 2 years to 17 years
Very common: may affect more than 1 in 10 children:
Common: may affect up to 1 in 10 children:
Uncommon: may affect up to 1 in 100 children:
Rare: may affect up to 1 in 1,000 children:
Not known: frequency cannot be estimated from the available data:
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store VAQTA Paediatric
Keep this vaccine out of the sight and reach of children.
The vaccine should not be used after the expiry date (Exp) which is stated on the carton and syringe or vial label.
The vaccine must be stored in a refrigerator between 2°C and 8°C (making sure that it does not freeze) so that the vaccine keeps its effectiveness.
Do not use this vaccine if you notice that it has an unusual appearance (see section 6) or contains particulate matter.
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 information
What Vaqta Paediatric contains
The active ingredient is: Inactivated hepatitis A virus (produced on MRC-5 human diploid cells, adsorbed on amorphous aluminium hydroxyphosphate sulfate).
One dose (0.5 mL) contains 25U hepatitis A virus (inactivated) adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.225 milligram as aluminium).
The other ingredients are:
What Vaqta Paediatric looks like and contents of the pack
A pre-filled syringe or vial containing 0.5 millilitre (one dose) of the vaccine. The vaccine is available in single packs of the vial or pre-filled syringe with or without a needle.
Not all presentations may be marketed.
After thorough agitation, Vaqta Paediatric is an opaque white suspension.
Marketing Authorisation Holder
The Marketing Authorisation Holder in the UK is:
Manufacturer
The manufacturer responsible for batch release at the following manufacturing sites is:
This leaflet was last revised in November 2018.
© Merck Sharp & Dohme Limited, 2018. All rights reserved.
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