Data Sheet
Fluvax®
INACTIVATED INFLUENZA VACCINE (SPLIT VIRION)
For the prevention of influenza caused by Influenza Virus, Types A and B
Description
This is a purified, inactivated, split virion (split virus) vaccine each 0.5 mL of which contains antigens representative of the following types:
A/Brisbane/59/2007 (IVR-148) (A/Brisbane/59/2007 (H1N1) - like) 15 μg haemagglutinin per dose
A/Uruguay/716/2007 (NYMC X-175C) (A/Brisbane/10/2007 (H3N2) - like) 15 μg haemagglutinin per dose
B/Florida/4/2006 (B/Florida/4/2006 - like) 15 μg haemagglutinin per dose
Each 0.5 mL dose also contains: sodium chloride 4.1 mg, sodium phosphate - dibasic anhydrous 0.3 mg, sodium phosphate - monobasic 0.08 mg, potassium chloride 0.02 mg, potassium phosphate - monobasic 0.02 mg and calcium chloride 1.5 μg.
The following are present in each 0.5 mL dose: sodium taurodeoxycholate ≤ 5 μg, ovalbumin ≤ 1 μg, sucrose < 10 μg, neomycin ≤ 0.7 ng, polymyxin B sulfate ≤ 0.11 ng and β-propiolactone ≤ 1.4 ng
The type and amount of viral antigens in Fluvax® vaccine conform to the requirements of the Australian Influenza Vaccine Committee and the New Zealand Ministry of Health for the winter of 2009. The strains chosen for vaccine manufacture are endorsed by the Australian Influenza Vaccine Committee as being antigenically equivalent to the reference virus.
The vaccine is prepared from virus grown in the allantoic cavity of embryonated eggs, inactivated by β-propiolactone, purified by zonal centrifugation and disrupted by sodium taurodeoxycholate. Fluvax® vaccine conforms in safety and sterility to the requirements of the British Pharmacopoeia.
PHARMACOLOGY
Fluvax® vaccine has been shown to induce antibodies to the viral surface glycoproteins, haemagglutinin and neuraminidase. These antibodies are important in the prevention of natural infection.
INDICATIONS FOR USE
For the prevention of influenza caused by Influenza Virus, Types A and B. For further information regarding recommendations for influenza vaccination, please refer to the relevant immunisation guidelines.
The New Zealand Immunisation handbook 2006 recommends annual vaccination groups including the following; all people 65 years of age and older, and people under 65 years of age with cardiovascular disease, chronic respiratory disease, diabetes, chronic renal disease, cancer and others.
Special considerations apply to children and pregnant women; please refer to the appropriate immunisation guidelines.
CONTRAINDICATIONS
Individuals with anaphylactic hypersensitivity to eggs and/or chicken feathers, neomycin, polymyxin B sulfate, and any other component of the vaccine should not be given Fluvax® vaccine. This would include persons who, upon ingestion of eggs, develop swelling of the lips or tongue or experience acute respiratory distress or collapse.
Immunisation should not be performed during an acute feverish illness (fever > 38.5°C). However, minor illness with or without fever should not contraindicate the use of influenza vaccine.
PRECAUTIONS
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.
Patients with a history of Guillain-Barré Syndrome with an onset related in time to influenza vaccination may be at increased risk of again developing Guillain-Barré Syndrome if given influenza vaccine. The risk should be weighed against the benefits to the individual patient of influenza vaccination. Because patients with a history of Guillain-Barré Syndrome 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 Guillain-Barré Syndrome.
Influenza vaccination has been shown to produce substantial antibody titres against influenza in vaccinated Human Immunodeficiency Virus infected persons who have minimal acquired immunodeficiency syndrome-related symptoms and high CD4+ T-lymphocyte cell counts. In patients who have advanced Human Immunodeficiency Virus disease and low CD4+ cell counts, influenza vaccine might not induce protective antibody titres; a second dose of vaccine does not improve the immune response in these persons.
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. (See also Indications for Use).
DRUG 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 advised of the possibility of an interaction and told to look out for signs of elevated levels of medication.
ADVERSE REACTIONS
The adverse events reported are presented below according to System Organ Class and frequency.
Adverse event frequencies are defined as follows: Very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000) and very rare (< 1/10,000).
Blood and Lymphatic System Disorders
Rare: Transient thrombocytopenia.
Immune System Disorders
Rare: Allergic reactions including anaphylactic shock.
Nervous System Disorders
Rare: Neuralgia, paraesthesia and convulsions.
Very rare: Encephalopathy, neuritis or neuropathy and Guillain-Barré syndrome.
Vascular Disorders
Very rare: Vasculitis with transient renal involvement.
Skin and Subcutaneous Tissue Disorders
Uncommon: Pruritus, urticaria and rash.
General Disorders and Administration Site Conditions
Very Common: Injection site inflammation.
Common: Influenza-like illness, Injection site ecchymosis and induration
Influenza-like illness may include pyrexia, chills, headache, malaise and myalgia.
These reactions usually resolve within 1-2 days without treatment.
Guillain-Barré Syndrome has been very rarely reported in temporal association with administration of influenza vaccines. In the 1976 swine influenza vaccination program, the United States Public Health Advisory Committee on Immunization Practices found that Guillain-Barré Syndrome 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 Guillain-Barré Syndrome was not demonstrated in subsequent years when recipients of the 1978 or 1979 vaccines were studied. However, in 1998, the United States Public Health Advisory Committee on Immunization Practices reported that a study of the 1992-93 and 1993-94 seasons found an elevation in the overall relative risk for Guillain-Barré Syndrome which represents an excess of an estimated one to two cases of Guillain-Barré Syndrome per million persons vaccinated.
Children usually react more to influenza vaccines than adults. However, split virion (split virus) influenza vaccines have been found to be less reactogenic than whole virus vaccines.
Clinical safety data in the paediatric population has been collected in an open-label, multi-centre study evaluating the safety, tolerability and immunogenicity of Fluvax® vaccine in a paediatric population (Group A: ≥ 6 months to < 3 years, given two 0.25 mL doses and Group B: ≥ 3 years to < 9 years, given two 0.5 mL doses) with 298 participants.
Fluvax® vaccine was found to be safe and well tolerated. There were no serious adverse events which were attributed to the vaccine. All adverse events have been included in the analysis, regardless of investigator's assessment of relatedness to the vaccine. Very common adverse events (≥ 1/10) reported included pain, erythema and swelling at the injection site; fever, headache, cough, sore throat, rhinitis, myalgia, vomiting/diarrhoea, loss of appetite, irritability and teething. Headache and myalgia occurred less frequently in Group A, while vomiting/diarrhoea and irritability occurred less frequently in the Group B population.
DOSAGE AND ADMINISTRATION
Immunisation is normally undertaken in the autumn, in anticipation of winter outbreaks of influenza.
Dosage:
Children 6 months to 35 months 0.25 mL
Adults and children from 36 months 0.5 mL
NOTE: Fluvax® vaccine should be administered to children under 5 years of age with care (see Indications for Use; Adverse Reactions).
One dose is sufficient for persons previously exposed to viruses of similar antigenic composition to the strain(s) present in the vaccine. In children under 9 years lacking such experience, and in those with some impairment of immune mechanisms, two doses separated by an interval of at least 4 weeks are recommended.
Administration:
It is important that the contents of the container be shaken thoroughly immediately before use.
Before administering the 0.25 mL paediatric dose, carefully discard half the volume from the syringe, which is prefilled with 0.5 mL. To do so, depress the plunger to the half dose marking on the glass syringe barrel. Inject the remaining 0.25 mL of vaccine.
The vaccine should be administered by intramuscular or deep subcutaneous injection.
Fluvax® vaccine is presented as a single-use syringe and any remaining contents should be discarded.
OVERDOSAGE
There is no specific information on overdose of CSL Influenza Vaccine.
For general advice on overdose management, call the New Zealand Poisons Centre on 0800 POISON or 0800 764 766.
MODE OF ISSUE
Each disposable syringe contains a single 0.5 mL dose of vaccine.
The Fluvax® vaccine syringe is supplied encased within a clear film wrapper. The presence of the film wrapper provides assurance that the product has not been opened. Do not use if the film wrap is damaged or missing.
STORAGE
Fluvax® vaccine should be stored, protected from light, at 2°C to 8°C. IT MUST NOT BE FROZEN.
NAME AND ADDRESS
Manufactured by:
CSL Limited ABN 99 051 588 348
45 Poplar Road Parkville
VICTORIA 3052 AUSTRALIA
Distributed by:
CSL Biotherapies (New Zealand) Limited
Level 9, Building 5
666 Great South Road
Central Park
Penrose
AUCKLAND
NEW ZEALAND
DATE OF PREPARATION
3 November 2008
®Registered Trademark of CSL Limited.