Patient Leaflet Updated 20-Apr-2020 | Merck Sharp & Dohme Limited
Package Leaflet: Information for the User
VAQTA® Adult, Suspension for injection
Hepatitis A vaccine, inactivated, adsorbed.
Read all of this leaflet carefully before you are vaccinated because it contains important information for you.
What is in this leaflet:
1. What Vaqta Adult is and what it is used for
2. What you need to know before Vaqta Adult is given
3. How Vaqta Adult is given
4. Possible side effects
5. How to store Vaqta Adult
6. Contents of the pack and other information
1. What VAQTA Adult is and what it is used for.
Vaqta Adult 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 will be protected.
This vaccine will not protect you 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 hepatitis A infection.
The vaccination may not work properly if the person to be vaccinated is already infected with the hepatitis A virus.
Vaqta Adult is for adults aged 18 years and over. This vaccine is not suitable for anyone younger than 18 years of age.
2. What you need to know before VAQTA Adult is given
Do not use Vaqta Adult:
Warnings and precautions
Talk to your doctor, pharmacist or nurse before Vaqta Adult is given:
The container of this medicinal product contains latex rubber. May cause severe allergic reactions.
As with other vaccines, Vaqta Adult may not completely protect all persons who are vaccinated.
Please tell your doctor if you have a history of jaundice or have lived in an area where hepatitis A is common. Your doctor will determine whether you should be tested for hepatitis A antibodies prior to vaccination.
Other medicines and VAQTA Adult
Tell your doctor or pharmacist if you are taking, have 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) and are not mixed in the same syringe.
Studies with a paediatric formulation have shown that the vaccine may be given at the same time as measles, mumps, rubella, varicella, pneumococcal 7-valent conjugate, inactivated polio, diphtheria toxoid, tetanus toxoid, acellular pertussis or Haemophilus influenzae type b vaccines.
Pregnancy, breast-feeding and fertility
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 whether you should receive the vaccine.
Driving or using machines
There are no data to suggest that Vaqta Adult affects the ability to drive or operate machinery.
VAQTA Adult contains sodium
This medicine contains less than 1mmol (23mg) per dose, that is to say, essentially ‘sodium-free’.
3. How VAQTA Adult 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. This may take a little longer if the injection is given under the skin, rather than into the muscle.
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. This booster will protect you against hepatitis A for at least 6 years. It is predicted that hepatitis A antibodies will remain at least 25 years after vaccination.
If necessary, Vaqta Adult can be given as a booster injection 6 to 12 months after you received a first dose of another inactivated hepatitis A vaccine.
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. Your doctor or nurse will avoid giving you the injection either into the skin or into a blood vessel. People who are at risk of bleeding a lot after an injection (see section 2) may sometimes be given Vaqta Adult as an injection under the skin but not into muscle to try to reduce the risk of bleeding.
Use in children and adolescents
Vaqta Adult is not recommended for individuals less than 18 years of age.
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 are still in the clinic or doctor’s surgery. If any of these symptoms occurs after leaving the place where you received the injection, contact a doctor IMMEDIATELY.
Frequency of side effects
Very common: may affect more than 1 in 10 people:
injection-site tenderness, pain, warmth, swelling, redness
Common: may affect up to 1 in 10 people :
Uncommon: may affect up to 1 in 100 people:
Rare: may affect up to 1 in 1,000 people
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 Adult
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 Adult contains
The active ingredient is: Inactivated hepatitis A virus (produced on MRC-5 human diploid cells, adsorbed on amorphous aluminium hydroxyphosphate sulfate).
One dose (1 mL) contains 50U hepatitis A virus (inactivated) adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.45 milligram as aluminium).
The other ingredients are:
What Vaqta Adult looks like and contents of the pack
A pre-filled syringe or vial containing 1 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 Adult is an opaque white suspension.
Marketing Authorisation Holder
The Marketing Authorisation Holder in the UK is:
The manufacturer responsible for batch release at the following manufacturing sites is:
This leaflet was last revised in November 2018.
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