Influenza Vaccine (Surface Antigen Inactivated)
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SOLID 1000575802
v1.0
PACKAGE LEAFLET: INFORMATION FOR THE USER Imuvac Junior, suspension for injection
Influenza vaccine (surface antigen, inactivated) 2014/2015 season
Read all of this leaflet carefully before your child is vaccinated.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist
- This vaccine has been prescribed for your child. Do not pass it on to others.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet
1 WHAT IMUVAC JUNIOR IS AND WHAT IT IS USED FOR
2 BEFORE YOUR CHILD USES IMUVAC JUNIOR
3 HOW TO USE IMUVAC JUNIOR
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE IMUVAC JUNIOR
6 FURTHER INFORMATION
1. WHAT IMUVAC JUNIOR IS AND WHAT IT IS USED FOR
Imuvac Junior is a vaccine. This vaccine helps to protect children from 6 to 35 months against influenza (flu), particularly in children who run a high risk of associated complications. The use of Imuvac Junior should be based on official recommendations.
When your child is given the vaccine Imuvac Junior, the immune system (the body’s natural defence system) will produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu.
Flu is a disease that can spread rapidly and is caused by different types of strains that can change every year. Therefore, this is why your child might need to be vaccinated every year. The greatest risk of catching flu is during the cold months between October and March. If your child was not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring since your child runs the risk of catching flu until then. Your doctor will be able to recommend the best time to be vaccinated.
Imuvac Junior will protect your child against the three strains of virus contained in the vaccine from about 2 to 3 weeks after the injection.
The incubation period for flu is a few days, so if your child is exposed to flu immediately before or after vaccination, it could still develop the illness.
The vaccine will not protect your child against the common cold, even though some of the symptoms are similar to flu.
2. BEFORE YOUR CHILD USES IMUVAC JUNIOR
To make sure that Imuvac Junior is suitable for your child, it is important to tell your doctor or pharmacist if any of the points below apply to your child. If there is anything you do not understand, ask your doctor or pharmacist to explain.
Do not use Imuvac Junior
If your child is allergic (hypersensitive) to:
• the active substances, or
• any of the other ingredients of Imuvac Junior (see section 6 "Further information"), or
• any component that may be present in very small amounts such as eggs (ovalbumin or chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin (an antibiotic that is used to treat bacterial infections), .
If your child has an illness with a high temperature or acute infection, the vaccination shall be postponed until after your child has recovered.
Take special care with Imuvac Junior
You should tell your doctor before vaccination if your child has a poor immune response (immunodeficiency or taking medicines affecting the immune system).
Your doctor will decide if your child should receive the vaccine.
If, for any reason, your child has a blood test within a few days following a flu vaccination, please tell your doctor. This is because false positive blood test results have been observed in a few patients who had recently been vaccinated.
As with all vaccines, Imuvac Junior may not fully protect all persons who are vaccinated.
Using other medicines
- Please tell your doctor or pharmacist if your child is taking or has recently taken other vaccines or any other medicines, including medicines obtained without a prescription.
- Imuvac Junior can be given at the same time as other vaccines by using separate limbs. It should be noted that the side effects may be stronger.
- The immunological response may decrease in case of immunosuppressant treatment, such as corticosteroids, cytotoxic drugs or radiotherapy.
Pregnancy and breast-feeding
Not applicable
Driving and using machines
Not applicable
3. HOW TO USE IMUVAC JUNIOR Dosage
Children from 6 months to 35 months may receive either one 0.25 ml dose or one 0.5 ml dose in accordance with existing national recommendations.
If your child has not been previously vaccinated against flu, a second dose should be given after at least 4 weeks.
Method and/or route(s) of administration
Your doctor will administer the recommended dose of the vaccine as an injection into the muscle or deep under the skin.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Imuvac Junior can cause side effects, although not everybody gets them.
During clinical trials, the following side effects have been observed. Their frequencies have been estimated as Common: affects 1 to 10 users in 100:
• headache
• sweating
• muscular pain (myalgia), joint pain (arthralgia)
• fever, generally feeling unwell (malaise), shivering, fatigue
• local reactions: redness, swelling, pain, bruising (ecchymosis), hardness (induration) around the area where the vaccine is injected.
These reactions usually disappear within 1-2 days without treatment.
Next to the above common side effects, the following side effects occurred after the vaccine came on the market:
• allergic reactions:
- leading to medical emergency with a failure of the circulatory system to maintain adequate blood flow to the different organs (shock) in rare cases,
- swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other part of the body (angioedema) in very rare cases.
• skin reactions that may spread throughout the body including itchiness of the skin (pruritus, urticaria), rash
• blood vessel inflammation which may result in skin rashes (vasculitis) and in very rare cases in temporary kidney problems.
• pain situated on the nerve route (neuralgia), anomalies in the perception of touch, pain, heat and cold (paraesthesia), fits (convulsions) associated with fever, neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all the body (encephalomyelitis, neuritis, Guillain-Barre Syndrom)
• temporary reduction in the number of certain types of particles in the blood called platelets; a low number of these can result in excessive bruising or bleeding (transient thrombocytopenia); temporary swelling of the glands in the neck, armpit or groin (transient lymphadenopathy)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
5. HOW TO STORE IMUVAC JUNIOR
Keep out of the sight and reach of children.
Do not use Imuvac Junior after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store Imuvac Junior in a refrigerator (+ 2 °C to + 8 °C). Do not freeze.
Store in the original package in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Imuvac Junior contains
The active substances are:
Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains*:
|
- A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, |
7.5 |
micrograms |
HA |
|
X-181) |
** | ||
|
- A/Texas/50/2012 (H3N2)-like strain (A/Texas/50/2012, X-223A) |
7.5 ** |
micrograms |
HA |
|
-B/Massachusetts/2/2012-like strain (B/Massachusetts/2/2012, BX-51B) |
7.5 ** |
micrograms |
HA |
|
per |
0.25 ml dose |
* propagated in fertilised hens’eggs from healthy chicken flocks ** haemagglutinin
This vaccine complies with the World Health Organisation (WHO) recommendation (Northern hemisphere) and EU recommendation for the 2014/2015 season.
The other ingredients are: potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections.
What Imuvac Junior looks like and contents of the pack
Imuvac Junior is a suspension for injection presented in prefilled glass syringe (with / without needle) containing 0.25 ml of a colourless clear injection fluid. Each syringe can only be used once.
Pack size of 1 or 10.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
BGP Products Ltd.
Abbott House, Vanwall Business Park Vanwall Road, Maidenhead, SL6 4XE, UK.
Manufacturer:
Abbott Biologicals B.V.
Veerweg 12 NL -8121 AA Olst
Registration number:
PL 43900/0041
This medicinal product is authorised in the Member States of the EEA under the following names:
Influvac Enfant France
Influvac Junior Finland, Germany, Netherlands, Portugal
Influvac S Junior Belgium, Luxembourg
Imuvac Junior United Kingdom
This leaflet was last revised in January 2015.
The following information is intended for medical or healthcare professionals only:
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
The vaccine should be allowed to reach room temperature.
Shake before use. Inspect visually prior to administration.
Do not use the vaccine if foreign particles are present in the suspension.
Remove the needle guard / cap
Hold the syringe upright and expel the remaining air.
Do not mix with other medicinal products in the same syringe.
The vaccine is not to be injected directly into any blood vessel.
See also section 3: HOW TO USE IMUVAC JUNIOR
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This information is confidential