Influvac Tetra

Inactivated influenza virus surface antigens (haemagglutinin & neuraminidase).

Influenza virus surface antigens (inactivated) (haemagglutinin and neuraminidase) of the following strains*: A/Brisbane/02/2018 (H1N1)pdm09-like strain (A/Brisbane/02/2018, IVR-190) 15 micrograms HA**, A/Kansas/14/2017 (H3N2)-like strain (A/Kansas/14/2017, NYMC X-327) 15 micrograms HA**, B/Colorado/06/2017-like strain (B/Maryland/15/2016, NYMC BX-69A) 15 micrograms HA**, B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type) 15 micrograms HA** per 0.5 mL dose.
*propagated in fertilised hens' eggs from healthy chicken flocks.
**haemagglutinin.
This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and competent authority decision for the 2019/2020 season.
Excipients/Inactive Ingredients: Potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections.
INFLUVAC Tetra may contain traces of eggs (such as ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin, which are used during the manufacturing process (see Contraindications).

Pharmacotherapeutic Group: Influenza vaccine. ATC Code: J07BB02.
Pharmacology: Pharmacodynamics: Mechanism of action: INFLUVAC Tetra provides active immunisation against four influenza virus strains: an A/(H1N1) strain, an A/(H3N2) strain, and two B strains (one from each lineage; B/(Victoria) and B/(Yamagata)). INFLUVAC Tetra manufactured according to the same process as the trivalent influenza vaccine Influvac, induces humoral antibodies against the haemagglutinins. These antibodies neutralise influenza viruses.
Specific levels of hemagglutination-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.
An immune response is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.
Pharmacodynamic effects: Immunogenicity of INFLUVAC Tetra compared to trivalent influenza vaccine Influvac: Clinical studies performed in adults of 18 years of age and older (INFQ3001) and children of 3 to 17 years of age (INFQ3002) assessed the safety and immunogenicity of INFLUVAC Tetra and its non-inferiority to trivalent influenza vaccine Influvac for the postvaccination HI Geometric mean antibody titer (GMT).
In both studies the immune response elicited by INFLUVAC Tetra against the three strains in common was non-inferior to trivalent influenza vaccine Influvac. INFLUVAC Tetra elicited a superior immune response against the additional B strain included in INFLUVAC Tetra compared to trivalent influenza vaccine Influvac.
18 years of age and older: In clinical study INFQ3001, 1,535 adults of 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 1.

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Paediatric population: Children 3-17 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 2.)

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Pharmacokinetics: Not applicable.
Toxicology: Preclinical Safety Data: Non-clinical data revealed no special hazard for humans based on conventional studies of repeat dose and local toxicity, reproductive and developmental toxicity and safety pharmacology studies

Prophylaxis of influenza; especially those who run an increased risk of associated complications.
INFLUVAC Tetra is indicated in adults and children from 3 years of age.
The use of INFLUVAC Tetra should be based on official recommendations.
Vaccination is particularly recommended for the following categories of patients, depending on national immunization policies: Persons aged ≥ 65 years, regardless their health condition.
Adults and children from 3 years of age with chronic disorders of the pulmonary or cardiovascular systems, including asthma.
Adults and children from 3 years of age with chronic metabolic diseases such as diabetes mellitus.
Adults and children from 3 years of age with chronic renal dysfunction.
Adults and children from 3 years of age with immunodeficiencies due to disease or immunosuppressant medication (e.g., cytostatics or corticosteroids) or radiotherapy.
Children from 3 years of age who receive long-term acetylsalicylic acid containing medication and might therefore be at risk for developing Reye's syndrome following an influenza infection.

Adults: 0.5 ml.
Paediatric population: Children from 3 to 17 years of age: 0.5 ml.
Children less than 9 years of age, who have not previously been vaccinated with a seasonal influenza vaccine: 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 in children have not been established.
Method of Administration: Immunisation should be carried out by intramuscular or deep subcutaneous injection.
Precautions to be taken before handling or administrating the medicinal product: For instructions for preparation of the medicinal product before administration, see Cautions for Usage.

Over dosage is unlikely to have any untoward effect.

Hypersensitivity to the active substances, to any of the excipients listed in Description or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin.
Immunisation shall be postponed in patients with febrile illness or acute infection.

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 Interactions.
This medicine contains less than 1 mmol sodium (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".
Fertility: No fertility data are available.
Effects on ability to drive and use machines: INFLUVAC Tetra has no or negligible influence on the ability to drive and use machines.

Pregnancy: 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 foetal and maternal outcomes attributable to the vaccine.
Breast-feeding: INFLUVAC Tetra may be used during breast-feeding.

Summary of the safety profile: The safety of INFLUVAC Tetra was assessed in two clinical trials in which healthy adults 18 years of age and older, and healthy children 3 to 17 years of age were administered INFLUVAC Tetra or trivalent influenza vaccine Influvac. Children from 3 to 8 years of age received one or two doses of INFLUVAC Tetra depending on their influenza vaccination history.
Most reactions usually occurred within the first 3 days following vaccination and resolved spontaneously within 1 to 3 days after onset. The intensity of these reactions was generally mild.
In all age groups, the most frequently reported local adverse reaction after vaccination observed in the clinical studies for INFLUVAC Tetra was vaccination site pain.
The most frequently reported general adverse reactions after vaccination observed in the clinical studies for INFLUVAC Tetra in adults and children from 6-17 years of age were fatigue and headache, for children from 3-5 years of age drowsiness, irritability and loss of appetite.
Similar rates of solicited adverse reactions were observed in recipients of INFLUVAC Tetra and trivalent influenza vaccine Influvac.
Tabulated summary of adverse reactions: The following undesirable effects are considered at least possibly related to INFLUVAC Tetra and have either been observed during the clinical trial with INFLUVAC Tetra or are resulting from post-marketing experience with the trivalent influenza vaccine Influvac.
The following frequencies apply: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); and not known (adverse reactions from post-marketing experience; cannot be estimated from the available data).
Adult and elderly: See Table 3.

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Paediatric population: See Table 4.

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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.
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.

Special Precautions for Disposal and Other Handling: The vaccine should be allowed to reach room temperature before use.
Shake before use. Inspect visually prior to administration.
Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Special Precautions for Storage: Store in a refrigerator (+2°C to +8°C).
Shelf-Life: 1 year.

Vaccines, Antisera & Immunologicals

J07BB02 - influenza, inactivated, split virus or surface antigen ; Belongs to the class of influenza viral vaccines.

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