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Influvac Tetra

Vaccine

Influvac Tetra

Suspension for injection in pre-filled syringe; A colourless clear liquid, filled in single-dose syringes.

INFLUVAC ® TETRA 2021-2022 SEASON

 

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Influenza virus surface antigens (inactivated) (haemagglutinin and neuraminidase) of the following strains*:

- A/Victoria/2570/2019 (H1N1)pdm09-like strain (A/Victoria/2570/2019, IVR-215)

 (15 μg haemagglutinin/dose)

- A/Cambodia/e0826360/2020 (H3N2)-like strain (A/Cambodia/e0826360/2020, IVR-224)

(15 μg haemagglutinin/dose)

- B/Washington/02/2019-like strain (B/Washington/02/2019, wild type)

(15 μg haemagglutinin/dose)

 - B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type)

(15 μg haemagglutinin/dose)

* propagated in fertilised hens’ eggs from healthy chicken flocks.

This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and competent authority decision for the 2021/2022 season.

For a full list of excipients see section 5.1.

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 section 3.3).

  1. PHARMACEUTICAL FORM

Suspension for injection in pre-filled syringe; A colourless clear liquid, filled in single-dose syringes.  3. CLINICAL PARTICULARS 3.1 Therapeutic indications Prophylaxis of influenza; especially those who run an increased risk of associated complications. Influvac Tetra is indicated in adults and children from 6 months of age. The use of Influvac Tetra should be based on official recommendations.

      3.    CLINICAL PARTICULARS

3.1 Therapeutic indications

Prophylaxis of influenza; especially those who run an increased risk of associated complications. Influvac Tetra is indicated in adults and children from 6 months of age. The use of Influvac Tetra should be based on official recommendations.

3.2 Posology and method of administration

Posology

Adults: 0.5 ml.

Paediatric population:

Children from 6 months 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.

Infants less than 6 months of age: the safety and efficacy of Influvac Tetra have not been established. Method of Administration

Immunisation should be carried out by intramuscular or deep subcutaneous injection. The preferred sites for intramuscular injection are the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 6 months through 35 months of age, or the deltoid muscle in children from 36 months of age and adults. Precautions to be taken before handling or administrating the medicinal product: For instructions for preparation of the medicinal product before administration, see section 5.6.

3.3 Contraindications

Hypersensitivity to the active substances, to any of the excipients listed in section 5.1 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.

3.4 Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 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. As with other vaccines administered intramuscularly, Influvac Tetra should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects. 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. Influvac Tetra is not effective against all possible strains of influenza virus. Influvac Tetra is intended to provide protection against those strains of virus from which the vaccine is prepared and to closely related strains. As with any vaccine, a protective immune response may not be elicited in all vaccinees. Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. Interference with serological testing: see section 3.5. 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”.

3.5 Interaction with other medicinal products and other forms of interaction

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.

3.6 Fertility, pregnancy and lactation 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.

Breastfeeding

Influvac Tetra may be used during breastfeeding.

Fertility

No fertility data are available.

3.7 Effects on ability to drive and use machines

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

3.8 Undesirable effects

 a. Summary of the safety profile

The safety of Influvac Tetra was assessed in three clinical trials. 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 or trivalent influenza vaccine Influvac. In a third study, the safety of Influvac Tetra was assessed in healthy children from 6 months to 35 months of age administered Influvac Tetra or a noninfluenza vaccine control. In both children studies, children from 6 months 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 to 17 years of age were fatigue and headache, and for children from 3 to 5 years of age drowsiness, irritability and loss of appetite. The most frequently reported general adverse reactions after vaccination observed in the clinical studies for Influvac Tetra in children from 6 months to 35 months of age were irritability/fussiness. Similar rates of solicited adverse reactions were observed in recipients of Influvac Tetra and trivalent influenza vaccine Influvac.  The rates of solicited systemic adverse reactions were similar in recipients of Influvac Tetra and the non-influenza vaccine, whereby the rates of solicited local adverse reactions were lower in recipients of Influvac Tetra.

b. 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 Influvac Tetra and/or 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).

Adults and elderly

 

Adverse Reactions Reported with Influvac Tetra

MedDRA System Organ Class

Very common ≥ 1/10

Common ≥ 1/100  to < 1/10

Uncommon ≥ 1/1,000  to < 1/100

Not Known a (cannot be estimated from the available data)

Blood and lymphatic system

 

 

 

lymphatic system

    Transient thrombocytopenia, transient lymphadenopathy

Immune system disorders

 

 

 

Allergic reactions, in rare cases leading to shock, angioedema

Nervous system disorders

Headache b

 

 

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

 

Sweating

 

 

Musculoskeletal and connective tissue disorders

 

 

 

 

General disorders and administration site conditions

Fatigue Local reaction: pain

Malaise, shivering Local reactions: redness, swelling, ecchymosis, induration

fever

 

 

a Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

b In elderly adults (≥ 61 years) reported as common

 

Paediatric population

Children (6 months to 17 years of age) Adverse Reactions Reported with Influvac Tetra

MedDRA System Organ Class

Very common ≥ 1/10

Common ≥ 1/100  to < 1/10

Uncommon ≥ 1/1,000  to < 1/100

Not Known a (cannot be estimated from the available data)

Blood and lymphatic system

 

 

 

 Transient thrombocytopenia, transient lymphadenopathy

Immune system disorders

 

 

 

Allergic reactions, in rare cases leading to shock, angioedema

Nervous system disorders

Headache c,

Drowsiness b

 

 

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

Sweating f

 

 

Generalized skiin reactions including pruritus, urticaria or non-specific rash

Metabolism and nutrition disorders

Loss of appetite b

 

 

 

 

Children (6 months to 17 years of age) Adverse Reactions Reported with Influvac Tetra

MedDRA System Organ Class

Very common ≥ 1/10

Common ≥ 1/100  to < 1/10

Uncommon ≥ 1/1,000  to < 1/100

Not Knowna (cannot be estimated from the available data)

Gastrointestinal disorder

Nausea c, abdominal pain c, diarrhea e, vomiting e

 

 

 

Psychiatric disorders

Irritability/ Fussinessn b

 

 

 

Musculoskeletal and connective tissue disorders

Myalgia c

Arthralgia c

 

 

General disorders and administration site conditions

Fatigue c , fever f , malaise c

Local reactions: pain, redness, swelling d, induration d

Shivering,

Local reaction: ecchymosis

 

 

a Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure

b Reported in children 6 months to 5 years of age

c Reported in children 6 to 17 years of age

d Reported as common in children 6 to 35 months of age

e Reported as common in children 3 to 5 years of age

f Reported as common in children 3 to 17 years of age

 

Reporting of suspected adverse reactions

 Reporting suspected adverse reactions after authorisation 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 via the national reporting system.

3.9 Overdose

Overdosage is unlikely to have any untoward effect.

5. PHARMACEUTICAL PARTICULARS

5.1 List of excipients

Potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections.

5.2 Incompatibilities

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

5.3 Shelf-life

1 year

5.4 Special precautions for storage

Store in a refrigerator (+2°C to +8°C). Do not freeze. Store in the original package in order to protect from light.

5.5 Nature and contents of container

0.5 ml suspension for injection in pre-filled syringe with / without needle (glass, type I), pack of 1 or 10. Not all pack sizes may be marketed.

5.6 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.

6. NAME AND PERMANENT ADDRESS OF OFFICIAL PLACE OF ESTABLISHMENT OF THE HOLDER OF THE MARKETING LICENSE

Abbott Biologicals B.V. C.J. van Houtenlaan 36 NL-1381 CP Weesp

The Netherlands

Manufacturer:

Abbott Biologicals B.V. Veerweg 12 NL-8121 AA Olst

The Netherlands

 7. DATE OF REVISION OF THIS TEXT

May 2021