VAQTA Paediatric, suspension for injection

Read all of this leaflet carefully before you or your child is vaccinated because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed for you or your child only. Do not pass it on to others.
• If you or your child gets any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Do not use Vaqta Paediatric:

• if you or your child is allergic to the active substance or any of the other ingredients of Vaqta Paediatric (listed in section 6) or to neomycin or formaldehyde (see section 'Warnings and precautions').
• if you or your child is ill with a high temperature. The vaccination should be delayed until you or your child has recovered.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before Vaqta Paediatric is given:

• if you or your child has ever had an allergic reaction to a previous dose of Vaqta Paediatric. This vaccine may contain traces of an antibiotic called neomycin and a substance called formaldehyde, both of which are used during vaccine production and may be present in the vaccine in trace amounts.
• if you or your child has a poor or reduced immune system, due to:
  • corticosteroids, cytotoxic drugs or radiotherapy. Your doctor or nurse may wait until the treatment has finished.
  • HIV (human immunodeficiency virus infection) or any disease that affects the immune system. The vaccine may not protect as well as it protects people whose immune system is healthy.
• if you or your child has any problems with the blood that causes easy bruising or bleeding for a long time after minor cuts. Your doctor or nurse may still advise that you or your child should have Vaqta Paediatric but extra care is needed because of the risk of bleeding at the injection site. Your doctor or nurse may give Vaqta Paediatric as an injection under the skin instead of into muscle (see section 3) to try to reduce the risk of deep bleeding.

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.

• Measles, mumps, rubella and varicella (chickenpox) virus vaccines,
• Pneumococcal 7-valent conjugate vaccine,
• Polio vaccine (Inactivated),
• Diphtheria toxoid, tetanus toxoid, acellular pertussis, and Haemophilus influenzae b vaccines,
• Immunoglobulins (antibodies obtained from blood donors)

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’.

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.

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:

• injection-site swelling, injection-site warmth, injection-site bruising
• fever
• irritability
• diarrhoea

Uncommon: may affect up to 1 in 100 children:

• decreased or loss of appetite
• trouble sleeping, sleepiness, feeling of tiredness-drowsiness, or lack of energy, restlessness
• crying
• runny nose, cough, nasal congestion
• vomiting
• rash, diaper rash
• feeling unwell
• injection-site lump, injection-site rash

Rare: may affect up to 1 in 1,000 children:

• multiple allergies
• dehydration
• agitation, nervousness, fear, screaming
• dizziness, headache, loss of balance
• eyelid margin crusting
• asthma, blocked airways, sneezing, runny or itchy nose, mouth and throat pain
• nausea, stomach pain/discomfort, excessive gas in the stomach or bowel, frequent bowel movements, belching, infantile spitting up, constipation, discoloured faeces
• rash, itching and redness of the skin, blisters, clammy or warm skin, sweating
• inflamed joints
• at injection-site: bleeding, itching, discoloration, lump formation or an itchy rash; pain, discomfort
• fatigue, abnormality with manner of walking, feeling hot

Not known: frequency cannot be estimated from the available data

• Guillain-Barré syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs and upper body)
• thrombocytopenia (reduction in blood platelets which increases risks of bleeding and bruising

Side effects reported in children aged 2 years to 17 years

Very common: may affect more than 1 in 10 children:

• injection-site pain and tenderness

Common: may affect up to 1 in 10 children:

• headache
• injection-site warmth, redness and swelling, fever, bleeding under the skin at the injection site (ecchymosis)

Uncommon: may affect up to 1 in 100 children:

• irritability
• dizziness
• stomach ache, vomiting, diarrhoea, nausea
• rash, itching
• arm pain (in the injected limb), joint pain, muscle pain
• weakness/tiredness, injection-site itching and pain/soreness

Rare: may affect up to 1 in 1,000 children:

• loss of appetite
• nervousness
• sleepiness, abnormal skin sensations such as tingling
• ear ache
• flushing
• runny or blocked nose, cough
• hives, sweating
• stiffness
• hardness (induration) at the injection-site, flu-like illness, chest pain, pain, warmth, injection-site scab, stiffness/tightness and stinging

Not known: frequency cannot be estimated from the available data:

• Guillain-Barré syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs and upper body)
• thrombocytopenia (reduction in blood platelets which increases risks of bleeding and bruising)

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.

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:

• sodium borate
• sodium chloride
• water for injections

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: