Prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age. The use of Fluenz Tetra should be based on official recommendations.

Posology Children and adolescents from 24 months: 0.2 ml (administered as 0.1 ml per nostril). For children who have not previously been vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks. Fluenz Tetra should not be used in infants and toddlers below 24 months of age because of safety concerns regarding increased rates of hospitalisation and wheezing in this population (see section 4.8). Method of administration Immunisation must be carried out by nasal administration. Do not inject Fluenz Tetra. Fluenz Tetra is administered as a divided dose in both nostrils. After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter. The patient can breathe normally while the vaccine is being administered – there is no need to actively inhale or sniff. See section 6.6 for administration instructions.

- Hypersensitivity to the active substances, to any of the excipients listed in section 6.1 (e.g. gelatin), or to gentamicin (a possible trace residue). - Severe allergic reaction (e.g. anaphylaxis) to eggs or to egg proteins (e.g. ovalbumin). - Children and adolescents with clinical immunodeficiency due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids. Fluenz Tetra is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency. - Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye’s syndrome with salicylates and wild-type influenza infection.

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 most vaccines, appropriate medical treatment and supervision should always be readily available to manage an anaphylactic event or serious hypersensitivity event following the administration of Fluenz Tetra. Fluenz Tetra should not be administered to children and adolescents with severe asthma or active wheezing because these individuals have not been adequately studied in clinical studies. Vaccine recipients should be informed that Fluenz Tetra is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts. Vaccine recipients should attempt to avoid, whenever possible, close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination. Peak incidence of vaccine virus recovery occurred 2-3 days post-vaccination in Fluenz clinical studies. In circumstances where contact with severely immunocompromised individuals is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus. Fluenz Tetra should under no circumstances be injected. No data exist regarding the safety of intranasal administration of Fluenz Tetra in children with unrepaired craniofacial malformations.

Do not administer Fluenz Tetra to children and adolescents receiving salicylate therapy (see section 4.3). Do not use salicylates in children and adolescents for 4 weeks after vaccination unless medically indicated as Reye’s syndrome has been reported following the use of salicylates during wild-type influenza infection. The co-administration of trivalent Fluenz with the live attenuated vaccines: measles, mumps, rubella, varicella and orally-administered poliovirus has been studied. No clinically meaningful changes in immune responses to measles, mumps, varicella, orally-administered poliovirus or Fluenz have been observed. The immune response to rubella vaccine was significantly altered. However, this alteration might not be of clinical relevance with the two dose immunisation schedule of the rubella vaccine. This observation with trivalent Fluenz is relevant to the use of Fluenz Tetra because Fluenz Tetra (influenza vaccine-live attenuated, nasal) is identical to Fluenz with the only difference being the addition of a fourth strain (a second B strain) to Fluenz Tetra. The co-administration of Fluenz Tetra with inactivated vaccines has not been studied. The concurrent use of Fluenz Tetra with antiviral agents that are active against influenza A and/or B viruses has not been evaluated. However, based upon the potential for influenza antiviral agents to reduce the effectiveness of Fluenz Tetra, it is recommended not to administer the vaccine until 48 hours after the cessation of influenza antiviral therapy. Administration of influenza antiviral agents within two weeks of vaccination may affect the response of the vaccine. If influenza antiviral agents and Fluenz Tetra are administered concomitantly, revaccination should be considered based on clinical judgement.

Pregnancy There is a moderate amount of data from the use of Fluenz Tetra in pregnant women. There was no evidence of significant maternal adverse outcomes in 138 pregnant women who had a record of receiving trivalent Fluenz in a US-based health insurance claims database. In more than 300 case reports in the AstraZeneca safety database of vaccine administration to pregnant women, no unusual patterns of pregnancy complications or foetal outcomes were observed. While animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, and post-marketing data offer some reassurance in the event of inadvertent administration of the vaccine, Fluenz Tetra is not recommended during pregnancy. Breast-feeding It is not known whether Fluenz Tetra is excreted in human milk. Therefore, as some viruses are excreted in human milk, Fluenz Tetra should not be used during breast- feeding. Limited available evidence suggests that the trivalent Fluenz is not excreted in breastmilk. Fertility No data exist regarding the possible effects of Fluenz Tetra on male and female fertility.

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

Summary of the safety profile The safety experience with trivalent Fluenz is relevant to the use of Fluenz Tetra because Fluenz Tetra (influenza vaccine-live attenuated, nasal) is identical to Fluenz with the only difference being the addition of a fourth strain (a second B strain) to Fluenz Tetra. Safety data regarding use of Fluenz Tetra are based on data from Fluenz Tetra clinical studies in 2,231 children and adolescents 2 to 17 years of age, Fluenz clinical studies in over 29,000 children and adolescents 2 to 17 years of age and Fluenz post-authorisation safety studies in over 84,000 children and adolescents 2 to 17 years of age. Additional experience has occurred with marketed use of Fluenz. In clinical studies, the safety profile of Fluenz Tetra was similar to the safety profile of Fluenz. The most common adverse reaction observed in clinical studies was nasal congestion/rhinorrhoea. List of adverse reactions Adverse reaction frequencies are reported as: Very common (=1/10) Common (=1/100 to <1/10) Uncommon (=1/1,000 to <1/100) Rare (=1/10,000 to <1/1,000) Very rare (<1/10,000) Immune system disorders Uncommon: Hypersensitivity reactions (including facial oedema, urticaria and very rare anaphylactic reactions) Metabolism and nutrition disorders Very common: Decreased appetite Nervous system disorders Common: Headache Respiratory, thoracic and mediastinal disorders Very common: Nasal congestion/rhinorrhoea Uncommon: Epistaxis Skin and subcutaneous tissue disorders Uncommon: Rash Musculoskeletal and connective tissue disorders Common: Myalgia General disorders and administration site conditions Very common: Malaise Common: Pyrexia Paediatric population In an active-controlled clinical study (MI-CP111), an increased rate of hospitalisations (for any cause) through 180 days after final vaccination dose was observed in infants and toddlers 6-11 months of age (6.1% Fluenz versus 2.6% injectable influenza vaccine). Most hospitalisations were due to gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination. The rate of hospitalisations was not increased in Fluenz recipients 12 months and older. In the same study, an increased rate of wheezing through 42 days was observed in infants and toddlers 6-23 months of age (5.9% Fluenz versus 3.8% injectable influenza vaccine). The rate of wheezing was not increased in Fluenz recipients 24 months and older. Fluenz Tetra is not indicated for use in infants and toddlers younger than 24 months (see section 4.2). Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) have also been observed in the post-marketing setting with Fluenz. 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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

with Fluenz Tetra is unlikely due to its presentation as a pre-filled sprayer. Administration of a higher than recommended dose of Fluenz Tetra was reported rarely and the adverse reaction profile was comparable to that observed with the recommended dose of Fluenz Tetra.

Pharmacotherapeutic group: Influenza vaccines, influenza live attenuated; ATC Code: J07BB03 Since 1985, two distinct lineages of influenza B viruses (Victoria and Yamagata) have circulated worldwide. Fluenz Tetra is a tetravalent vaccine that contains antigens for four influenza virus strains, an A/(H1N1) strain, an A/(H3N2) strain, and two B strains (one from each lineage). Fluenz Tetra is manufactured according to the same process as Fluenz. The influenza virus strains in Fluenz Tetra are (a) cold-adapted (ca); (b) temperature-sensitive (ts); and (c) attenuated (att). As a result, they replicate in the nasopharynx and induce protective immunity. Clinical studies Clinical experience with Fluenz is relevant to Fluenz Tetra because both vaccines are manufactured using the same process and have overlapping compositions. Paediatric studies Fluenz efficacy Fluenz’s efficacy data in the paediatric population consist of 9 controlled studies comprising over 20,000 infants and toddlers, children and adolescents, conducted during 7 influenza seasons. Four placebo-controlled studies included second season revaccination. Fluenz has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine. See Table 1 and 2 for a summary of efficacy results in the paediatric population. Table 1 Fluenz Efficacy in Placebo Controlled Paediatric Studies Study Number Region Age Rangea Number of Study Participantsb Influenza Season Efficacy (95% CI)c Matched strains Efficacy (95% CI)c All strains regardless of match 2000-2001 85.4% (74.3, 92.2) 85.9% (76.3, 92.0) D153-P502 Europe 6 to 35 M 1,616 2001-2002 88.7% (82.0, 93.2) 85.8% (78.6, 90.9) 2001 73.5% (63.6, 81.0)d 72.0% (61.9, 79.8)d D153-P504 Africa, Latin America 6 to 35 M 1,886 2002 73.6% (33.3, 91.2) 46.6% (14.9, 67.2) D153-P513 Asia/ Oceania 6 to 35 M 1,041 2002 62.2% (43.6, 75.2) 48.6% (28.8, 63.3) D153-P522 Europe, Asia/ Oceania, Latin America 11 to 24 M 1,150 2002-2003 78.4% (50.9, 91.3) 63.8% (36.2, 79.8) 2000-2001 72.9% (62.8, 80.5) 70.1% (60.9, 77.3) D153-P501 Asia/ Oceania 12 to 35 M 2,764 2001-2002 84.3% (70.1, 92.4)e 64.2% (44.2, 77.3)e 1996-1997 93.4% (87.5, 96.5) 93.4% (87.5, 96.5) AV006 USA 15 to 71 M 1,259 1997-1998 100% (63.1, 100) 87.1% (77.7, 92.6)f a M=months b Number of study participants for year 1 efficacy analysis. c Reduction in culture-confirmed influenza illness relative to placebo. d Data presented for clinical trial D153-P504 are for study participants who received two doses of study vaccine. In previously unvaccinated study participants who received one dose in year 1, efficacy was 57.7% (95% CI: 44.7, 67.9) and 56.3% (95% CI: 43.1, 66.7), respectively, thus supporting the need for two doses of vaccine in previously unvaccinated children. e In study participants who received 2 doses in year 1 and placebo in year 2, efficacy in year 2 was 56.2% (95% CI: 30.5, 72.7) and 44.8% (95% CI: 18.2, 62.9), respectively, in D153-P501, thus supporting the need for second-season revaccination. f The primary circulating strain was antigenically dissimilar from the H3N2 strain represented in the vaccine; efficacy against the mismatched A/H3N2 strain was 85.9% (95% CI: 75.3, 91.9).

Not applicable

Non-clinical data reveal no special hazard for humans based on conventional non-clinical studies of repeated dose toxicity, reproduction and developmental toxicity, local tolerance and neurovirulence

Sucrose Dipotassium phosphate Potassium dihydrogen phosphate Gelatin (porcine, Type A) Arginine hydrochloride Monosodium glutamate monohydrate Water for injections

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

18 weeks

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the nasal applicator in the outer carton in order to protect from light. Before use, the vaccine may be taken out of the refrigerator once for a maximum period of 12 hours at a temperature not above 25°C. Stability data indicate that the vaccine components are stable for 12 hours when stored at temperatures from 8°C to 25°C. At the end of this period, Fluenz Tetra should be used immediately or discarded.

Fluenz Tetra is supplied as a 0.2 ml suspension in a single-use nasal applicator (Type 1 glass), with nozzle (polypropylene with polyethylene transfer valve), nozzle tip-protector cap (synthetic rubber), plunger rod, plunger-stopper (butyl rubber) and a dose-divider clip. Pack size of 1 or 10. Not all pack sizes may be marketed.

Administration Fluenz Tetra IS FOR NASAL USE ONLY. • DO NOT USE WITH A NEEDLE. Do not inject. • Do not use Fluenz Tetra if the expiry date has passed or the sprayer appears damaged, for example, if the plunger is loose or displaced from the sprayer or if there are any signs of leakage. • Check the appearance of the vaccine before administration. The suspension should be colourless to pale yellow, clear to opalescent. Small white particles may be present. • Fluenz Tetra is administered as a divided dose in both nostrils. • After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter. • The patient can breathe normally while the vaccine is being administered – there is no need to actively inhale or sniff. • Refer to the Fluenz Tetra administration diagram (Figure 1) for step-by-step administration instructions. Figure 1 Fluenz Tetra Administration Check expiry date Product must not be used after date on applicator label. Prepare the applicator Remove rubber tip protector. Do not remove dose-divider clip at the other end of the applicator. Position the applicator With the patient in an upright position, place the tip just inside the nostril to ensure Fluenz Tetra is delivered into the nose. Depress the plunger With a single motion, depress plunger as rapidly as possible until the dose-divider clip prevents you from going further. Remove dose-divider clip For administration in the other nostril, pinch and remove the dose-divider clip from plunger. Spray in other nostril Place the tip just inside the other nostril and with a single motion, depress plunger as rapidly as possible to deliver remaining vaccine. Any unused medicinal product or waste material should be disposed of in accordance with local requirements for medical waste.

Feb. 5, 2026

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