Data Sheet
FLUARIX
Inactivated split influenza vaccine
Presentation
FLUARIX is an inactivated and purified split influenza vaccine, prepared in embryonated eggs.
The antigen composition and strains for the approaching influenza season are determined by the World Health Organisation (WHO) and the Commission of the European Community. This corresponds to the following types and subtypes:
A/Brisbane/59/2007: (IVR-148) (A/Brisbane/59/2007 (H1N1) - like strain)
A/Uruguay/716/2007 (NYMC X-175C) (A/Brisbane/10/2007 (H3N2) - like strain)
B/Brisbane/3/2007 (B/Florida/4/2006 - like strain)
Each 0.5 mL vaccine dose contains 15 μg haemagglutinin of each of the recommended strains, in phosphate buffered saline. The vaccine preparation also contains other excipients including saccharose, d-alpha-tocopheryl acid succinate and traces of formaldehyde and gentamicin sulphate.
Fluarix meets the WHO requirements for biological substances and influenza vaccines and the European Pharmacopoeia requirements for influenza vaccines.
Clinical Particulars
Therapeutic indications
Fluarix is indicated for prophylaxis against influenza in adults and children older than six months of age. Because of the possibility of increased morbidity and mortality from complications of influenza, vaccination is especially recommended for the following:
- Persons over 60 years of age,
- Persons who suffer from diseases of the cardiovascular system, metabolic diseases (diabetes), cystic fibrosis, chronic respiratory diseases, and chronic renal insufficiency,
- Persons with congenital or acquired immune deficiency.
Vaccination can be recommended for individuals exposed to increased risk of infection because of their occupation, such as medical personnel. In addition, prevention of disease in the workforce could lead to substantial economic benefits.
Fluarix should be administered before the beginning of the influenza season or as required by the epidemiological situations. Vaccination should be repeated every year with an age-appropriate dose of vaccine of updated antigen composition.
Posology and method of administration
Posology
The following dosage schedule is recommended.
| Age | Dose | Number of doses |
|---|---|---|
| 6-35 months | 0.25mL | 1 or 2* |
| 3-8 years | 0.5mL | 1 or 2* |
| >9 years | 0.5mL | 1 |
*Two doses separated by at least four weeks if the vaccine is being administered for the first time.
Method of administration
FLUARIX can be administered intramuscularly or subcutaneously.
FLUARIX should be administered subcutaneously to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
FLUARIX should under no circumstances be administered intravenously.
Contraindications
FLUARIX should not be administered to subjects with known hypersensitivity to egg proteins, to gentamicin or to any other constituent of the vaccine.
Special warnings and special precautions for use
As with other vaccines, the administration of FLUARIX should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor illness with or without fever should not contraindicate the use of FLUARIX.
FLUARIX will only prevent disease caused by influenza viruses.
Infections with other agents causing flu-like symptoms are not prevented by the vaccine.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Interaction with other medicaments and other forms of interaction
Immunisation can be affected by concomitant immunosuppressive therapy or an existing immunodeficiency.
FLUARIX can be administered simultaneously with other vaccines. However, different injection sites must be selected.
False positive ELISA serologic tests for HIV-1, Hepatitis C, and especially HTLV-1 may occur following influenza vaccination. These transient false-positive results may be due to cross-reactive IgM elicited by the vaccine. For this reason, a definitive diagnosis of HIV-1, Hepatitis C, or HTLV-1 infection requires a positive result from a virus-specific confirmatory test (e.g,Western Blot or immunoblot)
Pregnancy and lactation
Adequate human data on use during pregnancy and adequate animal reproduction studies are not available. However, as with all inactivated viral vaccines, the risks to the fetus are considered to be negligible. FLUARIX should be used during pregnancy only when clearly needed.
Adequate human data on use during lactation and adequate animal reproduction studies are not available. There is no known contraindication in the use of FLUARIX during lactation.
Effects on ability to drive and use machines
The vaccine is unlikely to produce an effect on the ability to drive and use machines.
Undesirable effects
In controlled clinical studies, signs and symptoms were solicited in all subjects for seven days following the administration of the vaccine. A checklist was used for this purpose. The vaccinees were also requested to report any clinical events occurring during the 30 days study period.
Local adverse events (pain, redness and swelling) and systemic adverse events such as low grade fever and malaise have been reported in a minority of vaccinees. These symptoms resolve spontaneously.
Allergic reactions in persons with a history of allergy against one of the components of the vaccine have been rarely reported. Serious hypersensitivity reactions (such as anaphylactoid shock) are extremely rare.
In comparative clinical trials conducted in children from 6 to 71 months of age and adults, the incidence of local and general solicited symptoms reported after the thiomersal free formulation was similar overall to that reported with the thiomersal reduced formulation.
Overdose
Not applicable.
Pharmacological Properties
Pharmacodynamic properties
FLUARIX induces humoral antibodies against the haemagglutinins. These antibodies neutralise influenza viruses.
A haemagglutinin inhibition titre equal to or greater than 1 : 40 in the serum is considered to be protective.
FLUARIX provides protection for the ongoing influenza season.
The seroconversion rates for the thiomersal free formulation of FLUARIX have been assessed in studies performed in children 6 to 71 months of age and in adults. The seroprotection rates following vaccination were in excess of the requirements by the European Pharmacopoeia for influenza vaccines (> 70% for adults 18-60y and > 60% for adults 60y and above).
Significant increases in serum titres of antibodies cross-reacting with Influenza A and B drift variants have been observed after vaccine with FLUARIX.
Pharmacokinetic properties
Evaluation of pharmacokinetic properties is not required for vaccines.
Preclinical safety data
Appropriate safety tests have been performed.
Pharmaceutical Particulars
Incompatibilities
FLUARIX should not be mixed with other vaccines in the same syringe.
Special precautions for storage
Fluarix must be stored between +2°C and +8°C.
DO NOT FREEZE. Discard if vaccine has been frozen.
Instructions for use/handling
Vaccines should be inspected visually for any foreign particulate matter and/or variation of physical aspects prior to administration. Before use, the vaccine should be well shaken to obtain a colourless to slight opalescent liquid. Discard if the content appears otherwise.
Shelf life
The expiry date of the vaccine is indicated on the label and packaging.
When stored under the prescribed conditions, the shelf life is 12 months.
Medicine Classification
Prescription Only Medicine.
Package Quantities
Prefilled syringes: 0.5mL in packs of 1 and 10.
Name and Address
GlaxoSmithKline NZ Ltd
AMP Centre
Cnr Albert & Customs Streets
Private Bag 106600
Downtown Auckland
NEW ZEALAND
Telephone: (09) 367 2900
Fax: (09) 367 2506
Date of Preparation
19 November 2008