Data Sheet
VAXIGRIP®
INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP
Composition
Inactivated Influenza Vaccine (Split Virion) BP
Description
A purified, inactivated, split vaccine, each 0.5 mL of which contains antigens representative of the following types:
A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006 IVR-145) 15 mcg haemagglutinin, A/Brisbane/10/2007 (H3N2)-like strain (A/ Brisbane/10/2007 IVR-147) 15 mcg haemagglutinin and B/Florida/4/2006 -like strain (B/Brisbane/3/2007) 15 mcg haemagglutinin, in an aqueous suspension. An aqueous suspension is a buffered saline solution composed of: 4 mg sodium chloride, 100 mcg potassium chloride, 575 mcg sodium phosphate – dibasic dihydrate, 100 mcg potassium phosphate – monobasic and water for injection to 0.5mL.
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. The vaccine may contain traces of formaldehyde, octoxinol-9 (Triton X-100) and neomycin due to the use of these substances during production.
The type and amount of viral antigens contained in VAXIGRIP® conform to the current requirements of the Influenza Vaccine Committee of the Commonwealth Department of Health and New Zealand Communicable Diseases Control Advisory Committee.
Actions
Influenza vaccines have been shown to give antibody responses and to provide protection against clinical illness in a proportion of vaccinees. Because the influenza virus is capricious antigenically and because significant changes in its antigenic behaviour may occur from time to time, protection afforded by VAXIGRIP® is limited to the strains from which the vaccine has been prepared or to closely related strains.
VAXIGRIP® conforms in safety and sterility to the requirements of the British Pharmacopoeia.
Indications
Vaxigrip is indicated for the prevention of influenza caused by Influenza Virus types A and B in adults, children and infants from 6 months of age.
The current New Zealand Immunisation Handbook recommends annual vaccination for the following persons:
- All people 65 years of age and over.
- People under 65 years of age with:
- Cardiovascular disease - ischaemic heart disease, congestive heart failure, rheumatic heart disease, congenital heart disease, cerebrovascular disease.
- Chronic respiratory disease - Asthma if on regular preventative therapy; other chronic respiratory disease with impaired lung function.
- Diabetes.
- Chronic renal disease.
- Any cancer, excluding basal or squamous skin cancers if not invasive.
- Other conditions - autoimmune disease, immune suppression, HIV, transplant recipients, neuromuscular and CNS diseases, haemoglobinopathies, children on long-term aspirin.
Pregnant women
Influenza vaccine should be offered, and is funded, for pregnant women with a medical condition (as above). The vaccine should be given before the influenza season. Although the inactivated influenza vaccine is considered by many experts to be safe at any stage of pregnancy, others prefer to administer the influenza vaccine in the second trimester to avoid a coincidental association with spontaneous abortion. Practitioners should assess the risks for individual women. Although the publicly funded vaccine is not yet available for pregnant women (without a risk condition) the Infectious Diseases Advisory Committee to the Ministry of Health makes the following recommendations for pregnant women:
- Women in the first trimester of pregnancy should not be vaccinated.
- Influenza vaccination is recommended for women who are beyond the first trimester of pregnancy (ie, greater than 14 weeks gestation) during the influenza season.
Other adults
Healthy individuals should also consider the use of the vaccine, especially if they are in close contact with individuals at high risk of complications. Employers should consider providing influenza vaccine to avoid illness in their employees, especially those engaged in health care and other essential community services. Immunizing healthy individuals has been shown to be cost effective.
Contraindications
VAXIGRIP® should not be given to persons known to be allergic to fowl proteins (eggs, feathers or chicken meat) or any other component 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 use. The syringes are for single use only and must not be used in more than one individual.
Do not administer by intravascular route. Ensure that the needle does not penetrate a blood vessel.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Since this vaccine contains traces of formaldehyde, octoxinol-9 (Triton X-100) and neomycin due to the use of these substances during production, it should be used with caution in subjects with a hypersensitivity to any of these substances.
Caution should be exercised 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 onset related in time to influenza vaccination may be at increased 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 seem prudent to avoid subsequent influenza vaccination in this group.
Because patients with a history of GBS have an increased 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 case of anaphylactic reactions. Adrenaline should always be ready for immediate use whenever any injection is given.
Use in Pregnancy (Category B2)
There is no convincing evidence of risk to the foetus from immunisation of pregnant women using inactivated virus vaccines, bacterial vaccines, or toxoids.
Safety of use during pregnancy has not been established; benefits of vaccination should be weighed against potential risks. However, as VAXIGRIP® is an inactivated vaccine, it does not share the theoretical risks associated with live vaccines.
Interactions
Increased drug levels due to an effect of influenza immunisation on drug metabolism have been reported with theophylline, phenytoin sodium and warfarin. These effects have not been observed consistently.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique can be used to disprove these results. The transient false positive reactions could be due to IgM response 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, malaise, shivering, tiredness, headache, sweating, myalgia, arthralgia, and lymphadenopathy.
These 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 observed 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 use 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 'series' was approximately 1 in 2,000,000. Such an excess incidence of GBS has not been demonstrated in subsequent years when recipients of the 1978 and 1979 vaccines were studied. An association between Guillain-Barré Syndrome and the Influenza vaccines used in the Northern Hemisphere USA in the 1992-93 and 1993-94 seasons has been reported. The excess cases of Guillain-Barré Syndrome attributed to Influenza vaccination was 1 to 2 cases for each million persons vaccinated.
Very rarely cases 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 seen commonly with VAXIGRIP®, 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.
One dose is usually sufficient for those persons previously exposed to viruses of similar antigenic content to the strains present in the vaccine. In children and young adults lacking such experience and in those with some impairment of immune mechanisms, two doses separated by an interval of at least one month are recommended.
The vaccine should be administered by intramuscular or deep subcutaneous injection.
| Adults and children 3 years of age and over: | 0.5 mL. |
|---|---|
| Infants and children 6 months to 35 months: | 0.25 mL. |
For the 0.25 mL dose, push the plunger to the edge of the black mark on the
glass syringe so that half of the volume is eliminated. Inject the remaining
volume.
Note: VAXIGRIP® should be administered to children under 5 years of age with care (see INDICATIONS; ADVERSE REACTIONS).
Presentation
Syringe containing 0.5 mL of vaccine.
Packs of 1 or 10 syringes
Storage
Store at 2°C to 8°C. Do not freeze. Protect from light.
Medicines Classification
PRESCRIPTION ONLY MEDICINE
Manufacturer
Sanofi Pasteur S.A.
Lyon, France
Distributor
New Zealand:
sanofi-aventis new zealand limited
Level 8, James and Wells Tower
56 Cawley Street
Ellerslie
Auckland
New Zealand
Tel: 0800 727 838
Date of Preparation
November 2007
® VAXIGRIP is a registered trademark of Sanofi Pasteur SA