驾照记分周期VAXIGRIP® JUNIOR
INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP
PRODUCT INFORMATION
COMPOSITION
特鲁利Inactivated Influenza Vaccine (Split Virion) BP
DESCRIPTION
电石生产工艺A purified, inactivated, split vaccine, each 0.25 mL of which contains antigens reprentative of the following types:
A/New Caledonia/20/99 (H1N1)-like strain (A/New Caledonia /20/99 IVR-116) 7.5ug haemagglutinin, A/Wisconsin/67/2005 (H3N2)-like strain (A/Wisconsin/67/2005 NYMCX-161B) 7.5 µg haemagglutinin and B/Malaysia/2506/2004 - like strain 7.5 µg haemagglutinin, in an aqueous suspension. An aqueous suspension is a buffered saline solution compod of: 2 mg sodium chloride, 50 µg potassium chloride, 287.5 µg sodium phosphate – dibasic dihydrate, 50 µg potassium phosphate – monobasic and water for injection to 0.25 mL.
The vaccine is prepared from virus grown in the allantoic cavity of
embryonated eggs, inactivated by formaldehyde, purified by zonal centrifugation, and disrupted by a Triton X-100 process. This vaccine may contain < 10 picograms of neomycin.
The type and amount of viral antigens contained in VAXIGRIP® JUNIOR
conform to the current requirements of the Influenza Vaccine Committee of
the Commonwealth Department of Health and New Zealand Communicable Dias Control Advisory Committee.
ACTIONS
Influenza vaccines have been shown to give antibody respons and to
provide protection against clinical illness in a proportion of vaccinees.
Becau the influenza virus is capricious antigenically and becau significant changes in its antigenic behaviour may occur from time to time, protection afforded by VAXIGRIP®JUNIOR is limited to the strains from which the
vaccine has been prepared or to cloly related strains.
VAXIGRIP® JUNIOR conforms in safety and sterility to the requirements of
the British Pharmacopoeia.
INDICATIONS
VAXIGRIP® JUNIOR is indicated for the prevention of influenza caud by Influenza Virus types A and B especially in children from 6 months to 6 years普法内容
who run an incread risk of associated complications. The current Australian National Health and Medical Rearch Council recommendations (The Australian Immunisation Handbook, 8th Edition, 2003) relevant to this age
group are:
1. Individuals who are at incread risk of influenza-related complications Annual vaccination is recommended for the groups:
蒜蓉粉丝蒸带子
–Children (6 months to 6 years old) with chronic disorders of the pulmonary or circulatory systems. This includes children with congenital heart
dia and cystic fibrosis, and vere asthmatics such as tho requiring frequent hospitalisations.
–Children (6 months to 6 years) with other chronic illness requiring regular medical follow-up or hospitalisation in the preceding year. This includes diabetes mellitus (and other chronic metabolic dias), renal
dysfunction, haemoglobinopathies, or immunosuppression (including
immunosuppression caud by medication).
–Children (6 months to 6 years) on long-term aspirin therapy who therefore may be at risk of developing Reye’s syndrome after influenza.
2. Tho who can transmit influenza to persons at incread risk
Annual vaccination is recommended for, children 6 months to 6 years who are houhold members of persons in incread-risk groups.
3. U of influenza vaccine in other groups
Influenza vaccine is recommended for:
–Children 6 months to 6 years infected with HIV.
–Child travellers 6 months to 6 years including tho in one of the above risk groups and tho who wish to reduce their chance of becoming infected with influenza. In particular, tho child travellers in large tourist groups or travelling to the Northern Hemisphere from October to March, should consider influenza vaccination prior to departure, noting that, children who are vaccinated with the previous ason’s vaccine before travel should be revaccinated in the autumn with the current vaccine. CONTRAINDICATIONS
Influenza virus is propagated in eggs for the preparation of influenza virus vaccine. Therefore, VAXIGRIP® JUNIOR should not be given to children with a history of hypernsitivity (allergy), especially anaphylactic reactions, to eggs or egg products. VAXIGRIP® JUNIOR should not be given to children known to have hypernsitivity to any components of the vaccine. Immunisation should not be performed during an acute feverish illness. PRECAUTIONS
The contents of the syringe must be shaken thoroughly immediately before u. The syringes are for single u only and must not be ud in more than one individual.
Do not administer by intravascular route. Ensure that the needle does not penetrate a blood vesl.
Antibody respon in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Since this vaccine contains traces of formaldehyde, octoxynol-9 (Triton X-100) and neomycin due to the u of the substances during production, it should be ud with caution in subjects with a hypernsitivity to any of the substances.
Caution should be exercid when a patient with a history of an allergic condition such as asthma or dermatitis is to be given influenza vaccine.
Patients with a history of Guillain-Barré Syndrome (GBS) with an ont related in time to influenza vaccination may be at incread risk of again developing GBS if given influenza vaccine. While this risk should be weighed against the benefits to the individual patient of influenza vaccination, it would em prudent to avoid subquent influenza vaccination in this group.
Becau patients with a history of GBS have an incread likelihood of again developing the syndrome, the chance of them coincidentally developing the syndrome following influenza vaccination may be higher than in individuals with no history of GBS.
As with other injectable vaccines, appropriate medical treatment and supervision should always be available in ca of anaphylactic reactions. Adrenaline should always be ready for immediate u whenever any injection is given.
U in Pregnancy(Category B2)
Not applicable. This vaccine is for u in children aged 6 months to 6 years.
Interactions
Influenza vaccine can impair the metabolism of warfarin, theophylline, phenytoin, phenobarbitone and carbamazepine by the hepatic P450 system. Results from studies have been variable in degree of interaction and time after vaccination for the interaction to take effect. The interaction may be idiosyncratic. Patients taking warfarin, theophylline, phenytoin, phenobarbitone or carbamazepine should be advid of the possibility of an interaction and told to look out for signs of elevated levels of medication.
The immunological respon may be diminished if the patient is undergoing immunosuppressant treatment.
Following influenza vaccination, fal positive results in rology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been obrved. The Western Blot technique can be ud to disprove the results. The transient fal positive reactions could be due to IgM respon by the vaccine.
ADVERSE REACTIONS
Children usually react more strongly to influenza vaccines than adults. However, split virion (split virus) influenza vaccines have been found to be less reactive than whole virus vaccines.
The following reactions are most common:
•Local reactions, consisting of swelling, redness, ecchymosis, induration, pruritus, tenderness and/or pain.
•Systemic reactions, consisting of fever of short duration, malai, shivering, tiredness, headache, sweating, myalgia, arthralgia, and
齐步走教案
lymphadenopathy.
The reactions usually disappear within 1-2 days without treatment.
Allergic reactions: urticaria, pruritus, erythematous rash, dyspnoea, and angioedema, exceptionally leading to shock have been reported.
The following events are obrved rarely: neuralgia, paraesthesia, convulsion, and transient thrombocytopenia.
Neurological disorders, such as encephalomyelitis, neuritis, and Guillain Barré Syndrome have been reported.
Post vaccination neurological disorders have been reported following the u of almost all biological products. Guillain-Barré Syndrome (GBS) has been very rarely reported in temporal association with administration of influenza vaccines. In the 1976 swine influenza vaccination program the U.S. Public Health Advisory Committee on Immunisation Procedures (ACIP) found that GBS occurred at an incidence of approximately 1 in 100,000 after immunisation and that the death rate in this ‘ries’ was approximately 1 in 2,000,000. Such an excess incidence of GBS has not been demonstrated in
subquent years when recipients of the 1978 and 1979 vaccines were studied. An association between Guillain-Barré Syndrome and the Influenza vaccines ud in the Northern Hemisphere USA in the 1992-93 and 1993-94 asons has been reported. The excess cas of Guillain-Barré Syndrome attributed to Influenza vaccination was 1 to 2 cas for each million persons vaccinated.世界十大黑客
Very rarely cas of vasculitis with transient renal involvement, arthritis, LE rash and LE syndrome or polymyalgia rheumatica have been reported following vaccination with inactivated influenza vaccine, however the causality has not been established.
Although allergic reactions are not en commonly with VAXIGRIP ® Junior, they may occur rarely. Adrenaline should be readily available to treat such reactions.
DOSAGE AND ADMINISTRATION
Immunisation is normally undertaken in the autumn, in anticipation of winter outbreaks of influenza.晋安帝
One do is usually sufficient for tho persons previously expod to virus of similar antigenic content to the strains prent in the vaccine. In children lacking such experience and in tho with some impairment of immune mechanisms, two dos parated by an interval of at least one month are recommended.
The vaccine should be administered by intramuscular or deep subcutaneous injection.
Infants and Children 6 months to 35 months: 0.25 mL.
Note: VAXIGRIP ® JUNIOR should be administered to children under 5 years of age with care (e INDICATIONS; ADVERSE REACTIONS).
The Australian National Health and Medical Rearch Council recommends that influenza vaccine can be administered concurrently with other vaccines, including pneumococcal polysaccharide vaccine and all the scheduled childhood vaccines (e Australian Immunisation Handbook, 8th edition, 2003 page 171).
PRESENTATION
Syringe containing 0.25 mL of vaccine.
Packs of 1 or 10 syringes
STORAGE
Store at 2°C to 8°C. Do not freeze. Protect from light.
MANUFACTURER
SANOFI PASTEUR S.A
1541 Avenue Marcel Merieux
69280 Marcy l’Etoile
FRANCE.
Parc Industriel D’Incarville
27100 Val De Reuil
FRANCE
DISTRIBUTOR
Australia
SANOFI PASTEUR PTY LTD
ABN 79 085 258 797
Talavera Corporate Centre – Building D
12 – 24 Talavera Road
Macquarie Park NSW 2113
Australia
