FLUAD TETRA Suspension for injection in pre-filled syringe (2023)
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Περιεχόμενα
1. Name of the medicinal product
Fluad Tetra, suspension for injection in pre-filled syringe. Influenza vaccine (surface antigen, inactivated, adjuvanted).
2. Qualitative and quantitative composition
Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*: Per 0.5 ml dose A/Victoria/4897/2022 (H1N1)pdm09-like strain<br>(A/Victoria/4897/2022 ...
3. Pharmaceutical form
Suspension for injection in pre-filled syringe (injection). Milky-white suspension.
4.1. Therapeutic indications
Prophylaxis of influenza in the elderly (65 years of age and older). Fluad Tetra should be used in accordance with official recommendations.
4.2. Posology and method of administration
Posology One 0.5 ml dose. Paediatric population The safety and efficacy of Fluad Tetra in children from birth to less than 18 years has not been established. Currently available safety and immunogenicity ...
4.3. Contraindications
Hypersensitivity to the active substances, to any of the components of the adjuvant, to any of the excipients listed in section 6.1, or to possible trace residues such as ovalbumin, kanamycin and neomycin ...
4.4. 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. Appropriate medical treatment and ...
4.5. Interaction with other medicinal products and other forms of interaction
No clinical data on concomitant administration of Fluad Tetra with other vaccines are available. If Fluad Tetra is to be used at the same time as another vaccine, it should be administered at separate ...
4.6. Pregnancy and lactation
Women of childbearing potential This medicine is not indicated in women of childbearing potential (see section 4.1). It is not to be used in women who are, or may be, pregnant or breast-feeding. Pregnancy ...
4.7. Effects on ability to drive and use machines
Fluad Tetra has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile Elderly population The safety of Fluad Tetra in elderly subjects 65 years of age and older was evaluated in two clinical studies (V118_20 and V118_18), in which 4269 received ...
4.9. Overdose
Overdosage is unlikely to have any untoward effect.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Influenza vaccine <b>ATC code:</b> J07BB02 Mechanism of action Fluad Tetra provides active immunisation against four influenza virus strains (two A subtypes and two B ...
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated-dose toxicity, reproductive and developmental toxicity, local tolerance and sensitisation.
6.1. List of excipients
For adjuvant: see also section 2. Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Water for injections ...
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
1 year.
6.4. Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Discard if the vaccine has been frozen. Keep the pre filled syringe in the outer carton in order to protect from light.
6.5. Nature and contents of container
0.5 ml of suspension for injection in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), presented with or without needle. Pack of 1 pre-filled syringe with needle Pack of 1 ...
6.6. Special precautions for disposal and other handling
Gently shake before use. After shaking, the normal appearance of the vaccine is a milky-white suspension. Visually inspect the contents of each pre-filled syringe for particulate matter and/or variation ...
7. Marketing authorization holder
Seqirus Netherlands B.V., Paasheuvelweg 28, 1105 BJ Amsterdam, The Netherlands
8. Marketing authorization number(s)
EU/1/20/1433/001 EU/1/20/1433/002 EU/1/20/1433/003 EU/1/20/1433/004
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 20 May 2020
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