Consumer medicine information

Fluarix Tetra

Influenza virus vaccine, split virion, quadrivalent (inactivated)

BRAND INFORMATION

Brand name

Fluarix Tetra

Active ingredient

Influenza virus vaccine, split virion, quadrivalent (inactivated)

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Fluarix Tetra.

What is in this leaflet

This leaflet answers some of the common questions about FLUARIX TETRA vaccine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines and vaccines have risks and benefits. Your doctor has weighed the possible risks of you or your child having FLUARIX TETRA against the expected benefits.

If you have any concerns about receiving FLUARIX TETRA talk to your doctor, nurse or pharmacist.

Keep this leaflet with this vaccine. You may need to read it again.

What Fluarix Tetra is used for

FLUARIX TETRA is used to help prevent certain types of influenza. The vaccine works by causing the body to produce its own protection (antibodies) against four different types of influenza virus.

The types of influenza antigen contained in FLUARIX TETRA may change from one year to another. Each year, the Australian Influenza Vaccine Committee (AIVC) recommends which ones to include. This decision is based on the types of influenza virus thought most likely to occur during the next flu season. Therefore, influenza vaccination is recommended every year.

Please note that FLUARIX TETRA will only protect you against the four types of influenza virus used to make the vaccine. It will not protect you from influenza caused by other types of influenza virus or from infections with other agents causing flu-like symptoms (such as the common cold).

FLUARIX TETRA cannot give you or your child influenza because the viruses in the vaccine have been killed.

Influenza is an infectious illness and is spread by small droplets from the nose, throat or mouth of an infected person. The most common symptoms of influenza include fever, sore throat, runny nose, coughing, general aches and pains, headache, weakness and tiredness, Most people recover completely within a week.

The risk of serious complications (e.g. pneumonia and death) is greater in very young, very old and chronically ill persons. FLUARIX TETRA can be used in adults and children older than 6 months of age.

Before you are given FLUARIX TETRA

When you or your child must not be given FLUARIX TETRA

FLUARIX TETRA must not be given if you or your child:

  • have had an allergic reaction to FLUARIX TETRA or any of the ingredients listed at the end of this leaflet
  • have had an allergic reaction or became unwell after any other influenza vaccine (e.g. Fluvax, Vaxigrip etc)

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

FLUARIX TETRA should not be given after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If you are not sure whether you or your child should have FLUARIX TETRA, talk to your doctor or nurse.

Do not give this vaccine to anyone else; your doctor has prescribed it specifically for you or your child.

Your doctor will discuss with you the possible risks and benefits of receiving FLUARIX TETRA.

Before being given FLUARIX TETRA

Tell your doctor if:

  • you or your child have a severe infection with a high temperature. Your doctor may decide to delay vaccination until the illness has passed. A minor infection such as a cold is not usually a reason to delay vaccination, but talk to your doctor or nurse about this before being vaccinated.
  • you are or think you may be pregnant or if you intend to become pregnant. Your doctor will discuss with you the possible risks and benefits of receiving FLUARIX TETRA during pregnancy.
  • you are breast feeding. Your doctor will discuss the risks and benefits of vaccination, however the vaccine is not expected to cause problems for breast-fed babies.
  • you or your child have had or have Guillain-Barré Syndrome (an inflammatory illness affecting nerves resulting in weakness of muscles).
  • you or your child have any medical conditions, such as:
    - an immune deficiency condition, or
    - a bleeding disorder.
  • you or your child have allergies to any medicines or substances, such as latex, dyes, foods or preservatives.
  • you or your child have received another vaccine, or are taking any prescription (eg theophylline, phenytoin, phenobarbitone, carbamazepine or warfarin) or OTC (over-the-counter) medicines. In particular mention if you or your child are taking medicines which suppress the immune system, such as steroids or cyclosporin. Some vaccines may be affected by other vaccines or medicines. Your doctor or pharmacist will be able to tell you what to do if FLUARIX TETRA is to be given with another vaccine or medicine.

Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you or your child fainted with a previous injection.

How FLUARIX TETRA is given

The doctor or nurse will give FLUARIX TETRA as an injection.

If you have any concerns about how this vaccine is to be given, talk to your doctor, nurse or pharmacist.

How much is given

For adults and children over 6 months of age: 0.5 mL is given.

How it is given

FLUARIX TETRA is generally injected into the upper arm or upper thigh muscle.

When it is given

For adults and older children FLUARIX TETRA is generally given as a single dose each year before the start of the influenza season, which is usually in winter.

  • First dose: on an elected date
  • Second dose: 4 weeks after the first (ONLY for children aged 6 months to less than 9 years receiving influenza vaccination for the first time)

Vaccination should be repeated every year as new types of influenza virus can appear each year.

If you miss a dose

If a scheduled dose is missed, talk to your doctor or nurse and arrange another visit as soon as possible.

After being given FLUARIX TETRA

Things to be careful of:

Be careful driving or operating machinery until you know how FLUARIX TETRA affects you. FLUARIX TETRA should not normally interfere with your ability to drive a car or operate machinery, but in some people vaccination can cause dizziness or light headedness. Make sure you know how you react to FLUARIX TETRA before you drive a car or operate machinery, or do anything that could be dangerous if you are dizzy or lightheaded.

Side effects

Tell your doctor, nurse or pharmacist as soon as possible if you or your child do not feel well during or after having had a dose of FLUARIX TETRA.

FLUARIX TETRA helps protect most people from influenza, but it may have unwanted side effects in a few people. All medicines and vaccines can have side effects. Sometimes they are serious; most of the time they are not. Some side effects may need medical treatment.

Ask your doctor, nurse or pharmacist to answer any questions you may have.

Most unwanted effects with FLUARIX TETRA are mild and usually clear up within a few days. These effects, as with other vaccines, generally occur around the injection site.

Tell your doctor if you notice any of the following that are troublesome or ongoing:

  • redness, swelling, a hard lump, soreness, bruising or itching around the injection site
  • pain at the injection site
  • fever, chills, shivering, sweating, dizziness, headache, malaise (generally unwell)
  • muscle aches and pains
  • joint pain
  • loss of appetite, feeling sick, vomiting, diarrhoea, stomach pain
  • irritability
  • drowsiness
  • fatigue
  • rash

The above list includes mild side effects.

Tell your doctor as soon as possible if you notice any of the following:

  • transient swollen glands in the neck, armpit or groin
  • painful swelling in the arms or legs
  • vomiting
  • Flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills
  • weakness of muscles

In very young children high fevers may result in convulsions (fits). It is advisable to monitor young children for high fevers post (influenza) vaccination.

There have been rare reports of Guillain-Barré Syndrome (an inflammatory illness affecting nerves resulting in weakness of muscles), however these events have not been definitely linked to the use of influenza vaccines.

The above list includes serious side effects that may require medical attention.

As with all vaccines given by injection there is a very small risk of serious allergic reaction. Contact your doctor immediately or go to the casualty department of your nearest hospital if any of the following happens:

  • swelling of limbs, face, eyes, inside of nose, mouth or throat
  • shortness of breath, breathing or swallowing difficulties
  • hives, itching (especially of the hands or feet), reddening of skin (especially around the ears), or severe skin reactions
  • unusual tiredness or weakness that is sudden and severe

Allergy to FLUARIX TETRA is rare. Any such severe reactions will usually occur within the first few hours of vaccination. Tell your doctor or pharmacist if you notice anything that is making you feel unwell during or after a dose of vaccine.

Other side effects not listed above may also occur in some people.

After being given FLUARIX TETRA

Storage

FLUARIX TETRA is usually stored at the doctor’s clinic or surgery, or at the pharmacy.

If you need to store FLUARIX TETRA always:

  • Keep FLUARIX TETRA in the refrigerator stored between +2°C and +8°C.
    THE PACK SHOULD NEVER BE FROZEN. FREEZING DESTROYS THE VACCINE.
  • Keep the vaccine out of the reach of children.
  • Keep FLUARIX TETRA in the original pack until it is time for it to be given.

Ask your pharmacist what to do with any left over FLUARIX TETRA that has expired or has not been used.

Product description

What it looks like

FLUARIX TETRA comes in a pre-filled syringe in packs of 1 and 10. It is a colourless, slightly opalescent liquid.

Ingredients

Each 0.5 mL dose of FLUARIX TETRA contains 15 micrograms of each of the four types of influenza virus fragments.

  • A/Brisbane/02/2018 (H1N1)pdm09-like virus
  • A/South Australia/34/2019 (H3N2)-like virus
  • B/Washington/02/2019-like (B/Victoria lineage) virus
  • B/Phuket/3073/2013-like (B/Yamagata lineage)virus

The vaccine also contains:

  • polysorbate 80
  • octoxinol 10
  • dl-alpha-tocopheryl acid succinate
  • sodium chloride
  • dibasic sodium phosphate dodecahydrate
  • monobasic potassium phosphate
  • potassium chloride
  • magnesium chloride hexahydrate
  • water for injections
  • ovalbumin (≤0.05 micrograms)
  • formaldehyde (≤5 micrograms)
  • hydrocortisone (trace)
  • gentamicin sulphate(trace)
  • sodium deoxycholate (trace)

FLUARIX TETRA is not made with any human blood or blood products, or any other substances of human origin.

The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

Supplier

FLUARIX TETRA is supplied in Australia by:

GlaxoSmithKline Australia Pty Ltd
Level 4,
436 Johnston Street,
Abbotsford, Victoria, 3067
AUSTRALIA

Registration Numbers:

AUST R 200674 - prefilled syringe without needle*

AUST R 210806 - prefilled syringe with needle*

AUST R 242512 – prefilled syringe with detached needle

*not currently supplied

Date of Preparation:
23 October 2019

Version 8.0

Trade marks are owned by or licensed to the GSK group of companies.

© 2019 GSK group of companies or its licensor.

Published by MIMS April 2020

BRAND INFORMATION

Brand name

Fluarix Tetra

Active ingredient

Influenza virus vaccine, split virion, quadrivalent (inactivated)

Schedule

S4

 

1 Name of Medicine

Quadrivalent influenza vaccine (split virion, inactivated).

6.7 Physicochemical Properties

Chemical structure.

Not applicable.

CAS number.

Not applicable.

2 Qualitative and Quantitative Composition

Fluarix Tetra is an inactivated and purified split influenza vaccine. The antigen composition and strains for the 2020 influenza season corresponds to the following types:
A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Brisbane/02/2018, IVR-190);
A/South Australia/34/2019 (H3N2) - like strain (A/South Australia/34/2019, IVR-197);
B/Washington/02/2019 - like strain (B/Washington/02/2019, wild type);
B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type).
Fluarix Tetra is prepared using whole virus cultivated in embryonated hens' eggs. The virus is concentrated and purified by clarification, adsorption and centrifugation. The purified whole virus is then treated with the detergent sodium deoxycholate and again centrifuged, and the resulting antigen suspension is inactivated with formaldehyde.
Each 0.5 mL vaccine dose contains 15 microgram haemagglutinin of each of four influenza strains in phosphate buffered saline.
The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.
Fluarix Tetra meets the WHO requirements for biological substances and influenza vaccines and the European Pharmacopoeia requirements for influenza vaccines.
The type and amount of viral antigens in Fluarix Tetra conform to the annual requirements of the Australian Influenza Vaccine Committee (AIVC) and the New Zealand Ministry of Health.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Suspension for injection.
Fluarix Tetra is a colourless to slightly opalescent suspension.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02.
Fluarix Tetra provides active immunisation against the four influenza virus strains (two A subtypes and two B strains) contained in the vaccine. Fluarix Tetra induces humoral antibodies against the haemagglutinins. These antibodies neutralise influenza viruses.
Specific levels of haemagglutination-inhibition (HI) antibody titer post-vaccination with inactivated influenza virus vaccines have not been correlated with protection from influenza illness but the HI antibody titers have been used as a measure of vaccine activity. In some human challenge studies, HI antibody titres of ≥ 1:40 have been associated with protection from influenza illness in up to 50% of individuals.
Annual revaccination with the current vaccine is recommended because immunity declines during the year after vaccination, and because circulating strains of influenza virus might change from year to year. Protection afforded as a result of vaccination with Fluarix Tetra is specific to the influenza strains contained in Fluarix Tetra or to closely related strains.

Clinical trials.

Efficacy in children 6-35 months of age.

The efficacy of Fluarix Tetra was evaluated in clinical study D-QIV-004, a randomised, observer-blind, non-influenza vaccine-controlled trial conducted during influenza seasons 2011 to 2014. Healthy subjects aged 6 through 35 months were randomized (1:1) to receive Fluarix Tetra (N = 6,006) or a non-influenza control vaccine (N = 6,012). They were administered 1 dose (in case of history of influenza vaccination) or 2 doses, approximately 28 days apart.
Efficacy of Fluarix Tetra was assessed for the prevention of reverse transcription polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B disease (moderate to severe and of any severity) due to any seasonal influenza strain. Starting 2 weeks post-vaccination until the end of the influenza season (approximately 6 months later), nasal swabs were collected following an influenza like event, and tested for influenza A and/or B by RT-PCR. All RT-PCR-positive specimens were further tested for viability in cell culture and to determine whether the viral strains matched those in the vaccine.
Fluarix Tetra met the predefined criteria for primary and secondary vaccine efficacy objectives presented in Table 5.
Exploratory analyses were conducted on the Total Vaccinated Cohort including 12,018 subjects (N = 6,006 for Fluarix Tetra, N = 6,012 for control). Fluarix Tetra was efficacious in the prevention of moderate to severe influenza caused by each of the 4 strains (Table 6), even when there was significant antigenic mismatch with 2 of the vaccine strains (A/H3N2 and B/Victoria).
Additionally, for RT-PCR confirmed cases of any severity, Fluarix Tetra reduced the risk of visits to the general practitioner by 47% (Relative Risk (RR): 0.53 [95% CI: 0.46; 0.61], i.e. 310 versus 583 visits) and to the emergency room by 79% (RR: 0.21 [95% CI: 0.09; 0.47], i.e. 7 versus 33 visits). The use of antibiotics was reduced by 50% (RR: 0.50 [95% CI: 0.42; 0.60], i.e. 172 versus 341 subjects).

Immunogenicity in children and adults.

Immunogenicity of Fluarix Tetra was evaluated in terms of HI Geometric mean antibody titer (GMT) at 28 days after the last dose (children) or Day 21 (adults) and HI seroconversion rate (4-fold rise in reciprocal titer or change from undetectable [< 10] to a reciprocal titer of ≥ 40).
In study D-QIV-004 (children 6-35 months), the evaluation was performed in a sub-cohort of 1,332 children (753 in the Fluarix Tetra group and 579 in the control group). The results are presented in Table 7.
The effect of a 2-dose priming schedule in D-QIV-004 was evaluated by assessing the immune response after revaccination one year later with 1 dose of Fluarix Tetra in study D-QIV-009. This study demonstrated that 7 days post-vaccination, immune memory in children 6 to 35 months of age had been elicited for all four vaccine strains.
Immunogenic non-inferiority of Fluarix Tetra was assessed versus Fluarix in children in study D-QIV-003 (approximately 900 children 3 to < 18 years of age in each treatment group who received one or two doses of either vaccine) and adults in study D-QIV-008 (approximately 1,800 subjects 18 years of age and older received 1 dose of Fluarix Tetra and approximately 600 subjects received 1 dose of Fluarix). In both studies, Fluarix Tetra elicited an immune response against the three strains in common that was non-inferior to Fluarix and a superior immune response against the additional B strain included in Fluarix Tetra. The results are presented in Table 7.

5.2 Pharmacokinetic Properties

Absorption.

Not applicable.

Distribution.

Not applicable.

Metabolism.

Not applicable.

Excretion.

Not applicable.

5.3 Preclinical Safety Data

Genotoxicity.

Fluarix Tetra has not been tested for genotoxic potential.

Carcinogenicity.

Fluarix Tetra has not been tested for carcinogenic potential.

4 Clinical Particulars

4.1 Therapeutic Indications

Fluarix Tetra is a quadrivalent vaccine indicated for active immunisation of adults and children from 6 months of age for the prevention of influenza disease caused by the influenza virus types A and B contained in the vaccine (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
The use of Fluarix Tetra should be based on official recommendations.

4.3 Contraindications

Fluarix Tetra should not be administered to individuals with known hypersensitivity after previous administration of Fluarix Tetra or influenza vaccines or to any component of the vaccine.

4.4 Special Warnings and Precautions for Use

Fluarix Tetra should under no circumstances be administered intravascularly.
It is good clinical practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
As with other vaccines, vaccination with Fluarix Tetra should be postponed in individuals suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited.
Fluarix Tetra is not effective against all possible strains of influenza virus. Fluarix Tetra is intended to provide protection against those strains of virus from which the vaccine is prepared and to closely related strains.
Patients with a history of Guillain-Barré syndrome (GBS) with an onset within six weeks of an influenza vaccination may be at increased risk of again developing GBS if given influenza vaccine. Such risk should be weighed against the benefits to the individual patient of influenza vaccination.
As patients with a history of GBS have an increased likelihood of again developing the syndrome, the chance of them coincidently developing the syndrome following influenza vaccination may be higher than in individuals with no history of GBS.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
As with other vaccines administered intramuscularly, Fluarix Tetra should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these individuals.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.

Latex.

Prefilled syringe with attached needle.

This presentation of Fluarix Tetra cannot be considered latex-free. The removable needle shield contains natural rubber latex.

Prefilled syringe with separate needle.

The syringe cap, syringe plunger and needle protector of the prefilled syringes of Fluarix Tetra with separate needles are not made with natural rubber latex.

Use in the elderly.

Antibody responses were lower in older adults who received Fluarix Tetra than in younger subjects. In a randomized, double-blind (2 arms) and open-label (one arm), active-controlled study, immunogenicity and safety were evaluated in a cohort of subjects 65 years of age and older who received Fluarix Tetra (N = 1,517); 469 of these subjects were 75 years of age and older. In subjects 65 years of age and older, the geometric mean antibody titers post-vaccination and seroconversion rates were lower than in younger subjects (18 through 64 years of age) and the frequencies of solicited and unsolicited adverse events were generally lower than in younger subjects.

Paediatric use.

See Section 4.4 Special Warnings and Precautions for Use.

Effects on laboratory tests.

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).

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed. If Fluarix Tetra is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
Influenza vaccine can impair the metabolism of warfarin, theophylline, phenytoin, phenobarbitone and carbamazepine by the hepatic cytochrome 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 variable from individual to individual. 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 their medication.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

A reproductive and developmental toxicity study in which female rats were administered Fluarix Tetra (0.2 mL dose per rat, approximately 80x the human dose on the basis of bodyweight) twice prior to mating showed no adverse effects on female fertility.
(Category A)
A developmental and reproductive toxicity study has been performed in which female rats were administered Fluarix Tetra by IM injection (0.2 mL dose per rat, approximately 80x the human dose on the basis of bodyweight) twice prior to mating, four times during gestation, and once on lactation day 7. Exposure to Fluarix Tetra did not result in systemic maternal toxicity (no adverse clinical signs and no change in body weight or food consumption). In addition, no adverse effects on pregnancy, parturition, lactation, or embryo-foetal or pre-weaning development were observed. There were no vaccine-related foetal malformations or other evidence of teratogenesis noted in this study.
The Australian Department of Health has reviewed the considerable extent of immunisation of pregnant Australian women with inactivated influenza vaccines, the international published literature, the very limited reporting of possible adverse effects and the studies conducted by vaccine manufacturers and concluded that there is no increased risk of any adverse foetal or maternal outcomes attributable to the vaccine. Fluarix Tetra can be given to a pregnant woman following an assessment of the risks and benefits. Because of the known adverse consequences of influenza infection in pregnant women, Australian health authorities recommend vaccination of pregnant women.
The safety of Fluarix Tetra when administered to breastfeeding women has not been evaluated. It is unknown whether Fluarix Tetra is excreted in human breast milk.
Vaccine antigen specific antibodies were transferred to rat pups via milk from dams administered Fluarix Tetra during gestation and lactation, with no adverse effects.
Fluarix Tetra should only be used during breastfeeding when the possible advantages outweigh the potential risks.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial data.

Adverse reactions reported for Fluarix Tetra in the different age groups are listed according to the following frequency categories: Very common ≥ 1/10, Common ≥ 1/100 to < 1/10, Uncommon ≥ 1/1,000 to < 1/100, Rare ≥ 1/10,000 to < 1/1,000 and Very rare < 1/10,000.

Adults.

A clinical study with Fluarix Tetra in adults has evaluated the incidence of adverse reactions in subjects ≥ 18 years who received one dose of Fluarix Tetra (N = 3,036) or Fluarix (N = 1,010).
The following adverse reactions per dose have been reported (see Table 1):

Children aged 6 months to < 18 years.

Two clinical studies evaluated the reactogenicity and safety of Fluarix Tetra in children who received at least one dose of Fluarix Tetra or a control vaccine.
One study enrolled children 3 to < 18 years of age who received Fluarix Tetra (N = 915) or Fluarix (N = 912). The second study enrolled children 6 to < 36 months of age who received Fluarix Tetra (N = 6,006) or a non-influenza vaccine control (N = 6,012) (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
The following adverse reactions per dose have been reported (see Table 2):
Table 3 shows the incidence of solicited local and systemic adverse reactions overall/dose within 7 daysa after vaccination in children aged 6 through 35 monthsb (Total Vaccinated Cohort):

Post-marketing data.

Post-marketing experience with Fluarix and Fluarix Tetra, which are both manufactured according to the same antigen production and formulation process and are essentially similar other than Fluarix lacking a second B-strain, identified the following adverse reactions1 (see Table 4).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Fluarix Tetra should under no circumstances be administered intravascularly.

Children aged < 6 months.

The safety and efficacy of Fluarix Tetra in children aged less than 6 months have not been established.

Dosage.

Fluarix Tetra should be administered as a single 0.5 mL injection.
Children 6 months to less than 9 years of age who have not previously been vaccinated against influenza should receive a second dose of 0.5 mL after an interval of at least 4 weeks.

Administration.

Vaccination should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

Insufficient data are available.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

The vaccine preparation also contains polysorbate 80, octoxinol 10, dl-alpha-tocopheryl acid succinate, sodium chloride, dibasic sodium phosphate dodecahydrate, monobasic potassium phosphate, potassium chloride, magnesium chloride hexahydrate, water for injections.
Residual amounts of ovalbumin ≤ 0.05 microgram and formaldehyde ≤ 5 microgram, but also traces of gentamicin sulphate, hydrocortisone, and sodium deoxycholate from the manufacturing process may be present.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

The shelf life of Fluarix Tetra is a maximum of 15 months from the date of manufacture if stored between temperatures of +2°C and +8°C.
The expiry date of the vaccine is indicated on the label and packaging.

6.4 Special Precautions for Storage

Fluarix Tetra must be stored between +2°C and +8°C and be protected from light.
Do not freeze. Discard if vaccine has been frozen.

6.5 Nature and Contents of Container

Fluarix Tetra is presented in pre-filled syringes as pack sizes of 1 or 10.
The pre-filled syringes are made of neutral glass type I, which conforms to European Pharmacopoeia requirements.
Not all pack sizes may be distributed in Australia.
Fluarix Tetra inactivated split influenza vaccine suspension for injection 0.5 mL pre-filled PRTC syringe without needle [AUST R 242512].
Fluarix Tetra inactivated split influenza vaccine suspension for injection 0.5 mL pre-filled syringe with needle [AUST R 210806]*.
Fluarix Tetra inactivated split influenza vaccine suspension for injection 0.5 mL pre-filled syringe without needle [AUST R 200674]*.
* Not currently supplied.

6.6 Special Precautions for Disposal

Instructions for use and handling.

The vaccine presents as a colourless to slightly opalescent suspension.
The syringe should be shaken and inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.

Instructions for use and handling of the vaccine presented in prefilled syringe with separate needle.

To attach the needle to the syringe, refer to the pictures provided in the patient information insert.
1. Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap by twisting it anticlockwise.
2. To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock. (See picture.)
3. Remove the needle protector, which on occasion can be a little stiff.
4. Administer the vaccine.
Any unused product of waste material should be disposed of in accordance with local requirements.
Fluarix Tetra is for single use in one patient only.

Summary Table of Changes