INFLUVAC

Main information

  • Trade name:
  • INFLUVAC inactivated influenza 0.5 mL vaccine long syringe needle free
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • INFLUVAC inactivated influenza 0.5 mL vaccine long syringe needle free
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215557
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215557

INFLUVAC inactivated influenza 0.5 mL vaccine long syringe needle free

ARTG entry for

Medicine Registered

Sponsor

Mylan Health Pty Ltd

Postal Address

Level 1 30 The Bond,30-34 Hickson Road,Millers Point, NSW, 2000

Australia

ARTG Start Date

24/09/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. INFLUVAC inactivated influenza 0.5 mL vaccine long syringe needle free

Product Type

Single Medicine Product

Effective date

9/08/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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 Immunistaion Guidelines.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

syringe

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Injection, solution

Route of Administration

Intramuscular

Subcutaneous

Visual Identification

CLEAR, COLOURLESS LIQUID.

Active Ingredients

Influenza virus haemagglutinin

15 microgram

Influenza virus haemagglutinin

15 microgram

Influenza virus haemagglutinin

15 microgram

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 08:32:35 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Summary of Product characteristics

Influvac PI

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PRODUCT INFORMATION

INFLUVAC

NAME OF THE MEDICINE

Influvac inactivated influenza vaccine (surface antigen)

DESCRIPTION

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

haemagglutinin/dose

A/Hong Kong/4801/2014 (H3N2)-like strain (A/Hong Kong/4801/2014, X-263B)15 µg

haemagglutinin/dose

B/Brisbane/60/2008-like strain (B/Brisbane/60/2008, wild type)15 µg haemagglutinin/dose

Inactive:

Potassium chloride, monobasic potassium phosphate, dibasic sodium phosphate, sodium chloride,

calcium chloride dihydrate, magnesium chloride hexahydrate 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 obtained within 2-3 weeks. The duration of post-vaccination immunity varies between

6-12 months.

INDICATIONS

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.

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 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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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 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.

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 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

Category B2.

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

lactating women.

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.

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 vaccine 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

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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.

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

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:

0.5 mL

Children from 6 months up to 35 months of age:

Clinical data are limited. A 0.25 mL dose is

recommended.

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.

Administration

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.

Vaccination schedule

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.

OVERDOSAGE

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

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