Influvac Junior: Indications, Dosage, Precautions, Adverse Effects
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Influvac Junior - Product Information

Manufacture: Abbott Laboratories
Country: Australia
Condition: Influenza Prophylaxis
Class: Viral vaccines
Form: Intramuscular (IM)
Ingredients: H1N1 strain 7.5 micrograms, H3N2 strain 7.5 micrograms, B strain 7.5 micrograms, Potassium chloride, Potassium dihydrogen phosphate, Sodium phosphate-dibasic dihydrate, Sodium chloride, Calcium chloride, Magnesium chloride, Egg protein, Formaldehyde, Cetrimonium bromide, Polysorbate 80, Gentamicin

Name of the Medicine

Influvac Junior Inactivated influenza vaccine (surface antigen)

Description

Influvac Junior is a clear colourless suspension for injection. It is an egg-grown, inactivated influenza virus vaccine based on isolated surface antigens of A and B strains of myxovirus influenza.

The type and amount of viral antigens in Influvac Junior conform to the requirements of the Australian Influenza Vaccine Committee (AIVC) and the New Zealand Ministry of Health for the winter of 2012. The strains chosen for vaccine manufacture are endorsed by the AIVC as being antigenically equivalent to the reference virus.

This is a purified, inactivated influenza vaccine (surface antigen), each 0.25 mL of which contains antigens representative of the following type:

A/California/7/2009 NYMC X-181 (A/California/7/2009 (H1N1)-like)(7.5 µg haemagglutinin/dose)

A/Victoria/210/2009 NYMC X-187 (A/Perth/16/2009 (H3N2)-like)(7.5 µg haemagglutinin/dose)

B/Brisbane/60/2008 (B/Brisbane/60/2008-like) (7.5 µg haemagglutinin/dose)

Inactive

Each 0.25 mL dose also contains potassium chloride, potassium dihydrogen phosphate, sodium phosphate-dibasic dihydrate, sodium chloride, calcium chloride, magnesium chloride and water for injections.

Pharmacology

The vaccine stimulates production of antibodies with a specific capacity against influenza. Protection is only against those strains of the virus from which the vaccine is prepared or closely related strains.

Seroprotection is generally obtained within 2 to 3 weeks. The duration of post-vaccination immunity to homologous strains or to strains closely related to the vaccine strains varies, but is usually 6 to 12 months.

Indications

For the prevention of influenza caused by influenza virus, types A and B in children aged 6 months to 35 months.

For full details regarding recommendations for influenza vaccination, please refer to the relevant National Immunisation Guidelines.

Contraindications

Hypersensitivity to the active substances, to any of the excipients and to residues of eggs, chicken protein, formaldehyde, cetrimonium bromide, polysorbate 80, or gentamicin.

Immunisation should be postponed in subjects who have febrile illness or acute infection.

Precautions

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

Influvac Junior should not be administered intravascularly.

Influvac Junior should be administered subcutaneously to subjects with thrombocytopenia or a bleeding disorder, since bleeding may occur following an intramuscular injection.

Patients with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have a reduced antibody response in active immunisation procedures.

Patients with a history of Guillain-Barre 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.

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.

Influvac Junior should not be mixed with other vaccines in the same syringe.

Effects on Laboratory Tests

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 disproves the results. The transient false positive reactions could be due to the IgM response by the vaccine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies have not been conducted and therefore the effects of vaccination are unknown.

Use in Pregnancy

Category B2.

Not applicable.

Use in Lactation

Not applicable.

Use in Children Younger Than 6 Months

The safety and efficacy of Influvac in children younger than 6 months have not been established. No data are available.

Adverse Effects

In clinical studies Influvac was administered to 1101 subjects. No serious adverse reactions attributable to vaccine administration were reported. Local and general symptoms were recorded for a period of 3 days following vaccination and reactions usually disappeared within 1-2 days without treatment.

During clinical studies, local and general signs and symptoms reported by the vaccinee were recorded.

The events are categorised by frequency according to the following definitions:

Very common: (frequency 10 %)

Common (frequency 1 and <10 %)

Uncommon (frequency 0.1% and < 1 %)

Rare (frequency 0.01% and < 0.1 %)

Very rare (frequency < 0.01 %)

Local reactions Very common: redness, swelling, pain.
Common: ecchymosis, induration.
Body as a whole Very common: headache. Common: fever, malaise.
Uncommon: shivering, fatigue, sweating, myalgia, arthralgia.
Very rare: neuralgia, paraesthesia, convulsions, transient thrombocytopenia, allergic reactions (such as angioedema) leading to shock.

As with most biological products very rare post-vaccination neurological disorders such as encephalomyelitis, neuritis and Guillain-Barre syndrome (GBS) have been reported. Guillain- Barre syndrome (GBS) has been very rarely reported in temporal association with administration of influenza vaccines. In the 1976 swine influenza vaccination program, the US Public Health Advisory Committee on Immunization 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 was not demonstrated in subsequent years when recipients of the 1978 or 1979 vaccines were studied. However, in 1998, ACIP reported that a study of the 1992-93 and 1993-94 seasons found an elevation in the overall relative risk for GBS which represents an excess of an estimated one to two cases of GBS per million persons vaccinated.

Post-marketing Experience

Adverse reactions reported from post marketing surveillance are, next to the reactions which have also been observed during the clinical trials, the following:

Blood and Lymphatic System Disorders

Transient thrombocytopenia, transient lymphadenopathy

Immune System Disorders

Allergic reactions, in rare cases leading to shock, angioedema

Nervous System Disorders

Neuralgia, paraesthesia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barre syndrome.

Vascular Disorders

Vasculitis associated in very rare cases with transient renal involvement.

Skin and Subcutaneous Tissue Disorders

Generalised skin reactions including pruritus, urticaria or non-specific rash.

Dosage and Administration

Children from 6 months up to 35 months of age: 0.25 mL

For children who have not previously been vaccinated, a second dose may be given after an interval of at least four weeks.

Administration

Influvac Junior should be administered by intramuscular or deep subcutaneous injection. Influvac Junior should not be administered intravenously.

Influvac Junior should not be mixed with other injection fluids.

Data on the administration of Influvac Junior with other vaccines is not available.

Instructions for Use/Handling

Influvac Junior should be allowed to reach room temperature, shaken well and inspected visually before use.

Vaccination Schedule

Influvac Junior should be administered in autumn before the beginning of the influenza season or as required by the epidemiological situation. Vaccination should be repeated every year with an age appropriate dose of vaccine of updated antigen composition.

Overdosage

Given the nature of the product and mode of administration the probability of overdosage is negligible.

For general advice on overdose management:

In Australia, contact the Poisons information Centre on 131 126.

Presentation and Storage Conditions

Influvac Junior vaccine is presented as a single-use pre-filled glass syringe containing a 0.25 mL dose of vaccine.

Keep out of the reach and sight of children

Store between 2 and 8 degrees Celsius. Refrigerate, Do not freeze. Store in the original package in order to protect from light.

Name and Address of the Sponsor

Abbott Australasia Pty Ltd

32-34 Lord Street

Botany NSW 2019

TGA approval date: 24 November 2010

Annual strain update: 24 November 2011

Date of most recent amendment: 5 October 2012