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NAME OF THE MEDICINE
Influvac inactivated influenza vaccine (surface antigen)
Influvac 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 conform to the requirements of the Australian
Influenza Vaccine Committee (AIVC) and the New Zealand Ministry of Health for the winter of 2017.
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 0.5 mL of which contains
antigens representative of the following type:
A/Michigan/45/2015 (H1N1)pdm09-like strain (A/Singapore/GP1908/2015, IVR-180) 15 µg
A/Hong Kong/4801/2014 (H3N2)-like strain (A/Hong Kong/4801/2014, X-263B)15 µg
B/Brisbane/60/2008-like strain (B/Brisbane/60/2008, wild type)15 µg haemagglutinin/dose
Potassium chloride, monobasic potassium phosphate, dibasic sodium phosphate, sodium chloride,
calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections.
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 obtained within 2-3 weeks. The duration of post-vaccination immunity varies between
For the prevention of influenza caused by influenza virus, types A and B.
For full details regarding recommendations for influenza vaccination, please refer to the relevant
National Immunisation Guidelines.
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 patients with an acute febrile illness.
The presence of a minor illness with or without fever should not contraindicate the use of Influvac.
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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 should not be administered intravascularly.
Influvac 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.
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress related
reactions can occur following, or even before, any vaccination as a psychogenic response to the needle
injection. This can be accompanied by several neurological signs such as transient visual disturbance,
paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in
place to avoid injury from faints.
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
Influvac 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.
No fertility data are available.
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Use in pregnancy
No relevant animal data is available. There is no convincing evidence of risk to the foetus from
immunisation of pregnant women using inactivated virus vaccines, bacterial vaccines, or toxoids. In
pregnant high risk patients the possible risks of clinical influenza infection should be weighed against
the possible risks of vaccination.
There is evidence from a number of studies that pregnant women, particularly during the second and
third trimester, are at increased risk of influenza associated complications. It is therefore recommended
that all women who will be in the second or third trimester of pregnancy during the influenza season be
vaccinated in advance, so they are protected during that season.
Use in lactation
No relevant animal data is available. There are no known contraindications to the use of Influvac by
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.
Effects on ability to drive and use machines
Influvac has no or negligible influence on the ability to drive and use machines.
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 vaccine were recorded.
The events are categorised by frequency according to the following definitions:
Very common: (frequency
0.1% and < 1 %)
0.01% and < 0.1 %)
Very rare (frequency < 0.01 %)
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
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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.
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.
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
One dose is sufficient for persons previously exposed to viruses of similar antigenic composition to the
strain(s) present in the vaccine. In those with some impairment of immune mechanisms, two doses
separated by an interval of at least four weeks are recommended.
Adults and children 3 years of age and older:
Children from 6 months up to 35 months of age:
Clinical data are limited. A 0.25 mL dose is
For children from 6 months up to 9 years of age who have not previously been vaccinated, a second
dose may be given after an interval of at least four weeks.
Influvac should be administered by intramuscular or deep subcutaneous injection. Influvac should not
be administered intravenously.
Influvac should not be mixed with other injection fluids.
Data on the administration of Influvac with other vaccines is not available.
For administration of a 0.25 mL dose from a syringe, push the front side of the plunger exactly to the
edge of the mark so that half of the volume is eliminated; a reproducible volume of vaccine remains in
the syringe suitable for administration.
The syringe is for use in a single patient on one occasion only. Remaining contents should be discarded.
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Instructions for use/handling
Influvac should be allowed to reach room temperature, shaken well and inspected visually before use.
Influvac 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.
Given the nature of the product and mode of administration the probability of over dosage is negligible.
For general advice on overdose management:
In Australia, contact the Poisons information Centre on 131 126.
PRESENTATION AND STORAGE CONDITIONS
Single-dose 0.5 mL pre-filled glass syringe, 1’s and 10’s:
with needle: AUST R 81465*;
needle-free: AUST R 210453*;
with 16 mm needle AUST R 215555;
with 25 mm needle AUST R 215556*;
needle-free: AUST R 215557*
* Presentations not currently marketed
Keep out of the sight and reach 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
BGP Products Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000 Australia
POISON SCHEDULE OF THE MEDICINE
Schedule 4 – Prescription Only Medicine
Date of first inclusion in the Australian Register of Therapeutic Goods (the ARTG):
16 January 2002
Date of most recent amendment:
02 December 2016