Consumer medicine information

Influvac Tetra

Influenza virus vaccine, surface antigen, quadrivalent (inactivated)

BRAND INFORMATION

Brand name

Influvac Tetra

Active ingredient

Influenza virus vaccine, surface antigen, quadrivalent (inactivated)

Schedule

S4

 

Consumer medicine information (CMI) leaflet

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

What is in this leaflet

This leaflet answers some of the common questions about INFLUVAC TETRA vaccine. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. Please read it carefully and keep it for future reference.

All medicines and vaccines have risks and benefits. Your doctor, nurse or pharmacist has weighed the possible risks of you having INFLUVAC TETRA against the expected benefits.

Talk to your doctor, nurse or pharmacist if you have any concerns about receiving INFLUVAC TETRA.

What Influvac Tetra is used for

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

Each year new types of influenza virus can appear, so every year INFLUVAC TETRA is changed to contain fragments of the new types of virus. Therefore, influenza vaccination is recommended every year.

Please note that INFLUVAC 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).

Influenza is an infectious illness. Influenza is spread by small droplets from the nose, throat or mouth of an infected person. Symptoms of influenza begin 48 hours after coming into contact with the virus. These consist of chills, fever, generalised aches and pains, headache and respiratory symptoms (sore throat, runny nose, cough). The severity and type of symptoms can vary. 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.

INFLUVAC TETRA can be used in adults and children over the age of 3 years.

Talk to your doctor, nurse or pharmacist if you have any questions.

Before you receive Influvac Tetra

Do not have INFLUVAC TETRA if:

  • you have had an allergic reaction to INFLUVAC TETRA, or any ingredient listed at the end of this leaflet
    Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
  • you have had an allergic reaction or became unwell after any other influenza vaccine (e.g. Fluvax, Vaxigrip, Fluarix Tetra etc.)
  • you are allergic to chicken proteins such as in eggs or feathers.
  • you are allergic to gentamicin
  • you have a severe infection with a high temperature. Vaccination should be postponed until after you have recovered.
    A minor infection such as a cold should not be a problem, but talk to your doctor, nurse or pharmacist about this before being vaccinated.
  • the expiry date printed on the pack has passed.
  • the packaging is torn or shows signs of tampering.

Talk to your doctor, nurse or pharmacist if you are not sure whether you should have INFLUVAC TETRA.

Do not give this vaccine to anyone else. This vaccine is prescribed specifically for you.

Before having INFLUVAC TETRA

Tell your doctor, nurse or pharmacist if:

  • you have been allergic to any other medicines, foods, dyes or preservatives
  • you have had INFLUVAC TETRA before and became unwell, tell your doctor, nurse or pharmacist before the next dose is given
  • you are pregnant or intend to become pregnant. Your doctor will discuss with you the benefits and risks of taking INFLUVAC TETRA when pregnant
  • 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 have ever had an illness affecting the nervous system, especially Guillain-Barre Syndrome (GBS)
    If you have had GBS, you may be more likely to develop GBS following influenza vaccination than someone who has never had GBS.
  • you have any medical conditions, such as an immune deficiency condition or a bleeding disorder.

Interactions with other medicines

Tell your doctor, nurse or pharmacist if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop, or have received another vaccine.

How Influvac Tetra is given

The doctor, nurse or pharmacist will give INFLUVAC TETRA as an injection.

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

How much is given

Adults and children over 3 years of age: 0.5 mL

For children less than 9 years of age who have not previously been vaccinated, a second dose of 0.5 mL should be given after an interval of at least 4 weeks.

How it is given

The injection may be given in the upper arm muscle.

For some people with bleeding problems, the injection may need to be given under the skin (subcutaneously).

INFLUVAC TETRA should never be given intravenously.

When it is given

INFLUVAC TETRA is generally given as a single dose in autumn each year before the start of the influenza season.

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

If the dose is missed

Talk to your doctor, nurse or pharmacist and arrange another visit as soon as possible.

After receiving Influvac Tetra

Things to be careful of

Be careful driving or operating machinery until you know how INFLUVAC TETRA affects you. INFLUVAC 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 INFLUVAC TETRA before you drive a car, operate machinery, or do anything that could be dangerous if you are dizzy or light-headed.

Side effects

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

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

MILD EVENTS

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

  • redness, swelling, a hard lump, soreness, bruising or itching around the injection site
  • fever, chills, headache, malaise (generally unwell)
  • muscle aches and pains

MORE SERIOUS EFFECTS THAT MAY OCCUR RARELY

As with all vaccines given by injection there is a very small risk of serious allergic reaction. Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital, if you notice any of the following:

  • 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.

As with all vaccines given by injection there is a very small risk of such reactions. Allergy to INFLUVAC TETRA is rare. Any such severe reactions will usually occur within the first few hours of vaccination.

Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may occur during or soon after a dose of vaccine.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Storage

INFLUVAC TETRA is usually stored at the pharmacy or at the doctor's clinic or surgery.

If you need to store the vaccine, always:

  • Keep INFLUVAC 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 INFLUVAC TETRA in the original pack until it is time for it to be given.

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

Product Description

What it looks like

INFLUVAC TETRA is a clear, colourless liquid.

Packs of 1 or 10 pre-filled (0.5 mL) glass syringes.

Ingredients

Each 0.5 mL dose of INFLUVAC TETRA contains 15 micrograms of each of the four types of influenza virus fragments in a phosphate buffered salt solution:

  • A/Victoria/2570/2019 (H1N1)pdm09-like strain
  • A/Hong Kong/2671/2019 (H3N2)-like strain
  • B/Washington/02/2019-like (B/ Victoria lineage) virus
  • B/Phuket/3073/2013-like (B/ Yamagata lineage) virus.

And:

  • potassium chloride, monobasic potassium phosphate, dibasic sodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections.

The vaccine also contains limited quantities of egg protein (ovalbumin or chicken proteins), formaldehyde, cetrimonium bromide, sodium citrate, sucrose, gentamicin sulfate, traces of tylosine tartrate, hydrocortisone and polysorbate 80.

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

Sponsor

INFLUVAC TETRA is manufactured in The Netherlands for:

Mylan Health Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point, NSW 2000
Australia
Telephone: 1800 314 527

Registration numbers:

AUST R 292237

AUST R 292238

AUST R 281035

This leaflet was prepared in November 2020.

INFLUVAC® TETRA is a Mylan company trade mark

InfluvacTetra_cmi\Nov20/00

Published by MIMS January 2021

BRAND INFORMATION

Brand name

Influvac Tetra

Active ingredient

Influenza virus vaccine, surface antigen, quadrivalent (inactivated)

Schedule

S4

 

1 Name of Medicine

Quadrivalent Influenza Vaccine, surface antigen, inactivated (influenza virus haemagglutinin).

2 Qualitative and Quantitative Composition

Influvac Tetra is a purified, inactivated influenza vaccine (surface antigen), containing the following four influenza strains recommended for the 2021 influenza season:
A/Victoria/2570/2019 (H1N1)pdm09-like strain (A/Victoria/2570/2019, IVR-215).
A/Hong Kong/2671/2019 (H3N2)-like strain (A/Hong Kong/2671/2019, IVR-208).
B/Washington/02/2019-like strain (B/Victoria lineage) (B/Washington/02/2019, wild type).
B/Phuket/3073/2013-like strain (B/Yamagata lineage) (B/Phuket/3073/2013, wild type).
Each 0.5 mL dose contains 15 microgram haemagglutinin per each of the above mentioned viral strains, for a combined total amount of 60 microgram. Each strain has been propagated in fertilised hens' eggs from healthy chickens.
The type and amount of viral antigens in Influvac Tetra conform to the requirements of the Australian Influenza Vaccine Committee (AIVC) and the New Zealand Ministry of Health for the 2021 southern hemisphere influenza season.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Influvac Tetra is a clear colourless liquid for injection in pre-filled syringes (glass, type I).

4 Clinical Particulars

4.1 Therapeutic 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.
Influvac Tetra is indicated in adults and children from 3 years of age and older.

4.2 Dose and Method of Administration

Adults and children 3 years of age and older.

0.5 mL dose.
For children less than 9 years of age who have not previously been vaccinated, a second dose of 0.5 mL should be given after an interval of at least 4 weeks.

Children less than 3 years of age.

The safety and efficacy of Influvac Tetra have not been established.
Influvac Tetra 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.

Administration.

Influvac Tetra should be administered by intramuscular or deep subcutaneous injection, whereas the intramuscular route is preferred.
Influvac Tetra should not be administered intravenously.
Influvac Tetra should not be mixed with other injection fluids.
The syringe is for single use in one patient only, any remaining residue should be discarded.

Instructions for use/handling.

Influvac Tetra should be shaken well and inspected visually before use.
Please refer to the relevant National Immunisation Guidelines for full details on preparations and vaccine administration.

4.3 Contraindications

Hypersensitivity to the active substances, to any of the excipients and to residues of eggs (ovalbumin, chicken proteins), formaldehyde, cetrimonium bromide, polysorbate 80, or gentamicin.
Anaphylaxis following a previous dose of any influenza vaccine.
Immunisation should be postponed in patients with febrile illness or acute infection.
Refer to the relevant National Immunisation Guidelines for full details on contraindications and precautions.

4.4 Special Warnings and Precautions for Use

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.
Influvac Tetra should under no circumstances be administered intravascularly.
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.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Interference with serological testing: see subheading Effects on laboratory tests below.
This medicine contains sodium, less than 1 mmol (23 mg) per dose, i.e. essentially 'sodium free'.
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially 'potassium free'.

Use in the elderly.

The safety and immunogenicity of Influvac Tetra was evaluated in adults ≥ 65 years in INFQ3001 (see Section 4.8 Adverse Effects (Undesirable Effects)). Overall serological responses in elderly subjects were lower than those in younger adult subjects.

Paediatric use.

The safety and efficacy of Influvac Tetra in children under 3 years of age have not been established.

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

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed. If Influvac Tetra is given at the same time as other vaccines, immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No animal or human fertility data are available.
(Category B2)
Inactivated influenza vaccines can be used in all stages of pregnancy. Larger datasets on safety are available for the second and third trimester, compared with the first trimester; however, data from worldwide use of influenza vaccine do not indicate any adverse fetal or maternal outcomes attributable to the vaccine.
Health authorities recommend vaccination for all pregnant women at any stage of pregnancy, particularly those who will be in the second or third trimester during the influenza season.
Influvac Tetra may be used during lactation.

4.7 Effects on Ability to Drive and Use Machines

Influvac Tetra has no or negligible influence on the ability to drive and use of machines.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial experience.

a) Summary of the safety profile.

In two clinical studies, healthy adults 18 years of age and older and healthy children 3 to 17 years of age were administered Influvac Tetra (1535 adults and 402 children) or trivalent influenza vaccine, Influvac (442 adults and 798 children). Similar rates of solicited adverse reactions were observed in recipients of Influvac Tetra and trivalent influenza vaccine Influvac.
The most frequently reported local adverse reaction after vaccination with Influvac Tetra in all age groups was pain at injection site in all age groups (16.3% in adults 18 years of age and older, and 59.0% in children).
In adults 18 years of age and above, the most frequently reported general adverse reactions after vaccination were fatigue (11.2%) and headache (10.3%).
In children aged 6 to 17 years, the most frequently reported general adverse reactions after vaccination were headache (24.0%) and fatigue (23.6%).
In children aged 3 to 5 years, the most frequently reported general adverse reaction after vaccination was irritability (21.0%).

b) Tabulated list of adverse reactions.

See Tables 1 and 2.
These reactions usually disappear within 1-2 days without treatment.

Adverse reactions reported from post-marketing surveillance.

There has been no post-marketing exposure to Influvac Tetra. However, as all three of the influenza strains of trivalent influenza vaccine Influvac are included in Influvac Tetra, the following adverse reactions reported from post-marketing surveillance of trivalent influenza vaccine Influvac may occur also in vaccines receiving Influvac Tetra, next to the reactions which have also been observed during the clinical trials.

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 Barré 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.

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 or New Zealand at https://nzphvc.otago.ac.nz/reporting.

4.9 Overdose

Given the nature of the product and mode of administration the probability of overdosage is negligible.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia) or 0800 POISON or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Influvac Tetra provides active immunisation against four influenza virus strains: An A/(H1N1) strain, an A/(H3N2) strain, a B/Victoria strain and a B/Yamagata strain. Influvac Tetra, manufactured according to the same process as trivalent influenza vaccine Influvac, induces humoral antibodies against the haemagglutinins. These antibodies neutralise influenza viruses with matching antigens which has entered the body during infection.
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.
Seroprotection is obtained within 2-3 weeks. The duration of post-vaccination immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually between 6-12 months.

Clinical trials.

Immunogenicity of quadrivalent Influvac Tetra compared to trivalent Influvac.

Clinical studies performed in adults 18 years of age and older (INFQ3001) and children 3 to 17 years of age (INFQ3002) assessed the safety and immunogenicity of quadrivalent Influvac Tetra and its non-inferiority to trivalent influenza vaccine Influvac. The post-vaccination immunogenicity was assessed using HI Geometric mean antibody titer (GMT).
The studies found the immune response elicited by Influvac Tetra against the three viral strains in common was non-inferior to trivalent Influvac. Additionally, Influvac Tetra elicited a superior immune response against the additional B strain included in Influvac Tetra compared to trivalent Influvac.

Adults 18 years of age and older.

In clinical study INFQ3001, 1535 adults 18 years of age and older received a single dose of Influvac Tetra and 442 subjects received a single dose of trivalent Influvac. See Table 3.

Children 3 to 17 years of age.

In clinical study INFQ3002, 402 children of 3 to 17 years of age received one or two doses of Influvac Tetra and 798 children received one or two doses of trivalent Influvac based on their influenza vaccination history. See Table 4.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Genotoxicity.

No genotoxicity studies have been conducted with Influvac Tetra.

Carcinogenicity.

No carcinogenicity studies have been conducted with Influvac Tetra.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each 0.5 mL dose contains 0.10 mg potassium chloride, 0.10 mg monobasic potassium phosphate, 0.67 mg dibasic sodium phosphate dihydrate, 4.0 mg sodium chloride, 0.067 mg calcium chloride dihydrate, 0.05 mg magnesium chloride hexahydrate and q.s. to 0.5 mL water for injections.
Influvac Tetra antigens have been produced from eggs and are inactivated by formaldehyde treatment. Each 0.5 mL may also contain not more than 100 nanogram ovalbumin, 0.01 mg formaldehyde, 0.02 mg cetrimonium bromide, 1 mg sodium citrate, 0.2 mg sucrose, 1 nanogram gentamicin sulfate, traces of tylosine tartrate, hydrocortisone and polysorbate 80, which are used during the manufacturing process.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG).
The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

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.

6.5 Nature and Contents of Container

Single-dose 0.5 mL pre-filled glass syringe, available in packs of 1 or 10:
with 16 mm needle AUST R 292237.
with 25 mm needle AUST R 292238*.
without needle AUST R 281035*.
* Presentation not currently marketed.

6.6 Special Precautions for Disposal

Any unused medicine or waste material should be disposed of immediately.

6.7 Physicochemical Properties

Not applicable.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes