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Microsoft word - vaxigrip english 2010 complete.docเอกสารกํากับยาภาษาอังกฤษ
Suspension for injection
INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Read all of this leaflet carefully before you or 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 medicine has been prescribed for you or 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 VAXIGRIP is and what it is used for
1. WHAT VAXIGRIP IS AND WHAT IT IS USED FOR
VAXIGRIP is a vaccine.
This vaccine helps to protect you or your child against influenza (flu), particularly if you or
your child runs a high risk of associated complications.
• Persons aged ≥ 65 years.
• Residents of nursing homes and other chronic-care, facilities that house persons of any
age who have chronic medical conditions. • Adults and children who have chronic disorders of the pulmonary or cardiovascular systems, including children with asthma. • Adults and children who have required regular follow-up or hospitalization during the preceding year because of chronic metabolic diseases including diabetes mellitus, renal dysfunction, hemoglobinopathies, or immunosuppression (including immunosuppression caused by medications). • Children and teenagers (aged 6 months - 18 years) who are receiving long-term aspirin therapy and therefore might be at risk for developing Reye syndrome after influenza. • Subjects who work in public services.
• Medical staff or family members of high-risk subjects.
VAXIGRIP should be used according to official recommendations.
When a person is given the vaccine VAXIGRIP, the immune system (the body’s natural
defences 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 virus strains that
can change every year. This is why you may need to be vaccinated every year. The greatest
risk of catching flu is during the coldest months. If you or your child was not vaccinated in the
autumn, it is still possible to do it until spring since you or your child runs the risk of catching
flu until then.
Your doctor will be able to recommend the best time to be vaccinated.
VAXIGRIP will protect you or your child against the three strains of virus contained in the
vaccine after about 2 to 3 weeks following the injection.
The incubation period for flu is a few days, so if you are exposed to flu immediately before or
after your vaccination, you could still develop the illness.
The vaccine will not protect you or your child against the common cold, even though
some of the symptoms are similar to flu.
In Thailand, peak influenza season occurs in between May and November, vaccination
should be carried out before or during the influenza peak season.
For tourists, travelling abroad, the vaccine should be received before travelling from
September to March for the Northern hemisphere and from June to September for Southern
2. BEFORE YOU USE VAXIGRIP
To make sure that VAXIGRIP is suitable for you or your child, it is important to tell your
doctor or pharmacist if any of the points below apply to you or your child.
If there is anything you do not understand, ask your doctor or pharmacist to explain.
Do not use VAXIGRIP
- If you or your child is allergic (hypersensitive) to the active substances, to any of the
ingredients of VAXIGRIP, to eggs, to chicken proteins, to neomycin, to formaldehyde or to octoxinol 9 (For other ingredients of VAXIGRIP, see section 6. "Further information"). If you or your child has an illness with a high temperature or an acute infection, the vaccination should be postponed until after you or your child has recovered.
Take special care with VAXIGRIP
You should tell your doctor before vaccination if you or your child has a poor immune response (immunodeficiency or taking medicines affecting the immune system), Your doctor will decide if you or your child should receive the vaccine. If, for any reason, you or your child has to have a blood test within the days following the 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, VAXIGRIP may not fully protect all persons who are vaccinated.
Using others medicines
Please tell your doctor or pharmacist if you or your child is taking or has recently taken any other vaccines or any other medicines, including medicines obtained without a prescription. VAXIGRIP can be given at the same time as other vaccines by using separate limbs. In this case the side effects may be intensified. The immunological response may decrease in case of immunosuppressant treatment such as corticosteroids, cytotoxic drugs or radiotherapy.
Pregnancy and breast-feeding:
Tell your doctor or pharmacist if you are pregnant or think you may be pregnant.
Limited data about flu vaccination in pregnant women do not indicate that the vaccine would
have harmful effects on the pregnancy or the baby. The use of this vaccine may be
considered from the second trimester of pregnancy. For pregnant women with a risk of
complications from the flu, administration of the vaccine is recommended, irrespective of
their stage of pregnancy.
VAXIGRIP may be used during breast-feeding.
Your doctor or pharmacist will be able to decide if you should receive VAXIGRIP.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
The vaccine is unlikely to affect your ability to drive or use machines.
3. HOW TO USE VAXIGRIP
Adults and children aged from 36 months receive one 0.5 ml dose
Children from 6 months to 35 months receive one 0.25 ml dose
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 VAXIGRIP 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 :
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.
In addition to the common side effects listed above, the following side effects occurred after
the vaccine came on the market:
- 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-Barré Syndrome), 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), For multidose presentation: This vaccine contains thiomersal (an organomercuric
compound) as a preservative, therefore allergic reactions (hypersensitivity) may occur.
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.
5. HOW TO STORE VAXIGRIP
Keep out of the reach and sight of children.
Do not use VAXIGRIP after the expiry date which is stated on the carton after EXP. The
expiry date refers to the last day of that month.
Store in a refrigerator (2oC - 8oC). Do not freeze. Keep the syringe or vial in the outer carton
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 VAXIGRIP contains
The active substance is:
Split influenza virus*, inactivated containing antigens equivalent to the following strains:
• A/California/7/2009 (H1N1) - like strain
(A/California/7/2009 (NYMC X-179A))………………….……………… 15 micrograms HA**
• A/Perth/16/2009 (H3N2) – like strain
(A/Wisconsin/15/2009 (NYMC X-183)) ………………………………. 15 micrograms HA**
• B/Brisbane/60/2008-lilke strain (B/Brisbane/60/2008)………………….15 micrograms HA**
* propagated in fertilised hens’ eggs from healthy chicken flocks The vaccine complies with the WHO (World Health Organisation) recommendations
(Southern Hemisphere) for the 2010 season.
The other ingredients are: thiomersal (in multidose vials only) and a buffer solution
containing sodium chloride, disodium phosphate dihydrate, potassium dihydrogen
phosphate, potassium chloride and water for injections.
What VAXIGRIP looks like and contents of the pack
VAXIGRIP is a suspension for injection in a prefilled syringe of 0.25, 0.5 ml in box of 1,10, or
20, vial of 10 doses of 0.5 ml in box of 1 or 10. Not all pack sizes may be marketed.
The vaccine, after shaking gently, is a slightly whitish and opalescent liquid.
Marketing Authorisation Holder
SANOFI PASTEUR S.A.
2 Avenue Pont Pasteur, F-69007 Lyon, France
This leaflet was last approved in 07/2009.
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 reaction following the administration of the
The vaccine should be brought to room temperature before use.
Shake before use.
The vaccine should not be used if foreign particles are present in the suspension.
It should not be mixed with other medicinal products in the same syringe.
For children, when one dose of 0.25 ml is indicated and if VAXIGRIP 0.5 ml presentation is
used, push the plunger stopper exactly to the edge of the mark of the syringe to eliminate
half of the volume. The remaining volume should be injected.
For multidose vial:
After removal of the first dose, the vaccine contained in the vial must be imperatively used
within 7 days.
For each dose taken and for each patient, a new sterile syringe fitted with a new sterile
needle is used.
Between different removals and in any case within 5 minutes maximum after removal of the
last dose, the vial should be placed back in the refrigerator to keep the product at the
required temperature, i.e. between 2oC and 8oC (never in the freezer).
A partially used vial must be destroyed immediately if:
Sterile removal has not been strictly carried out, There is any suspicion that a partially used vial has been contaminated, There is any visible sign of contamination, such as a change in the appearance or the presence of particles in suspension. In any case, when in storage period, the vial should be stored according to the conditions described in the manufacturer’s instructions for use. This vaccine is not to be injected directly into a blood vessel. See also section 3. HOW TO USE VAXIGRIP
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