Influvac Prescribing Information
PRESCRIBING INFORMATION
Influenza vaccine Tetra MYL, suspension for injection in pre-filled syringe
(Influenza vaccine, surface antigen, inactivated)
Please refer to Summary of Product Characteristics (SmPC) before prescribing.
Indication: Prophylaxis of influenza in adults and children from 6 months of age especially those who run an
increased risk of associated complications. The use of Influenza vaccine Tetra MYL should be based on official
recommendations.
Presentation: Influenza vaccine (surface antigen, inactivated) containing the purified haemagglutinin and neuraminidase antigens prepared from the A and B influenza virus strains recommended by WHO. Suspension for injection in pre-filled syringe. A colourless clear liquid.
Dosage and administration: Adults and 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, should be given after an interval of at least 4 weeks. Children less than 6 months of age: The safety and efficacy of Influenza vaccine Tetra MYL has not been established. Immunisation should be carried out by intramuscular or deep subcutaneous injection. The preferred sites for intramuscular injection are the anterolateral aspect of the thigh in children 6 months – 35 months of age, or the deltoid muscle in children from 36 months of age and adults.
Contraindications: Hypersensitivity to active ingredients or excipients (Please refer to SmPC) and to any components that may be present as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin. Postpone immunisation in patients with febrile illness or acute infection.
Warnings and precautions: Appropriate medical treatment and supervision should be available in case of an anaphylactic event. Influenza vaccine Tetra MYL should not be administered intravascularly. Caution to be taken for individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to such individuals. 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 disturbances, paraesthesia and tonicclonic
limb movements during recovery. It is important that procedures are in place to avoid injury from faints. Influenza vaccine Tetra MYL is not effective against all possible strains of influenza virus. This vaccine is intended to provide protection against those strains of virus from which vaccine is prepared and to closely related strains. Antibody response may be insufficient in immunosuppressed patients or those receiving immunosuppressive treatment. Interference with serological testing (Please refer to SmPC).
Interactions with other medicinal products: Influenza vaccine Tetra MYL may be given at the same time as other vaccines, but separate limbs should be used. It should be noted that the adverse reactions may be intensified. Following influenza vaccination, false positive results in serology tests using the ELISA method to detect HIV1, Hepatitis C and HTLV1 have been seen.
Fertility, pregnancy and lactation:
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: May be given during breastfeeding. Fertility: No fertility data are available.
Effects on ability to drive and use machines: The vaccines have no or negligible influence on the ability to drive or use machines.
Undesirable effects:
In all age groups, the most frequently reported local adverse reaction after vaccination observed in the clinical studies was vaccination site pain. Adults and Elderly: Very common: Headache, fatigue, local reaction: pain. Common: Sweating, myalgia, arthralgia, malaise, shivering, local reactions: redness, swelling, ecchymosis, induration. Uncommon: Fever. Side effects for which frequency cannot be estimated, please refer to SmPC. Children (6 months to 17 years): Very common: Headache, drowsiness, sweating, appetite loss, nausea, abdominal pain, diarrhoea, vomiting, irritability, fussiness, myalgia, fatigue, fever, malaise, local reactions: pain, redness, swelling, induration. Common: Arthralgia, shivering, local reaction: ecchymosis.
Side effects for which frequency cannot be estimated, please refer to SmPC.
Marketing Authorisation Number and Basic NHS Price: Influenza vaccine Tetra MYL suspension for injection in pre-filled syringe: PL 46302/0056; 10 x 0.5 ml pack for £99.40.
MAH: Mylan Products Ltd. Further information is available on request from: Mylan Products Ltd., Station Close, Potters Bar, Herts, EN6 1LT. Tel. 01707 853000
Date of Revision of Prescribing Information: Feb 2025
Veeva Reference: UK-INF-2024-00003
Adverse events should be reported
Please report suspected adverse drug reactions (ADRs) to the MHRA through the Yellow Card scheme. You can report via the Yellow Card website http://www.mhra.gov.uk/yellowcard, the free Yellow Card app available from the Apple App Store or Google Play Store or some clinical IT systems (EMIS/SystmOne/Vision/MiDatabank) for healthcare professionals. Alternatively, you can report suspected adverse drug reactions to the Yellow Card scheme by calling 0800 731 6789 for free, Monday to Friday between 9am and 5pm. You can leave a message outside of these hours. When reporting please provide as much information as possible. By reporting adverse drug reactions you can help provide more information on the safety of this medicine. You can also report directly to the distributor at pv.uk@viatris.com