Fluenz nasal spray suspension Influenza vaccine (live attenuated, nasal)
- This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
- Company information
- More information about this medicine
|Reassortant influenza virus* (live attenuated) of the following strains**:|
|A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, MEDI 228029)||107.0±0.5 FFU***|
|A/Victoria/361/2011 (H3N2)-like strain (A/Texas/50/2012, MEDI 237514)||107.0±0.5 FFU***|
|B/Massachusetts/2/2012-like strain (B/Massachusetts/2/2012, MEDI 237751)||107.0±0.5 FFU***|
|..........................................................................................................................per 0.2 ml dose|
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 should not be used in infants and toddlers below 24 months of age because of safety concerns (see section 4.4).
Method of administrationImmunisation must be carried out by nasal administration.DO NOT INJECT FLUENZ.See section 6.6 for administration instructions.
PregnancyThere are limited data from the use of FLUENZ in pregnant women.While animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, FLUENZ is not recommended during pregnancy.
BreastfeedingIt is not known whether FLUENZ is excreted in human milk. Therefore, as some viruses are excreted in human milk, FLUENZ should not be used during breastfeeding.
FertilityNo data exist regarding the possible effects of FLUENZ on male and female fertility.
Summary of the safety profileSafety data regarding use of FLUENZ have been compiled from over 28,500 children and adolescents 2 to 17 years of age from clinical studies and over 52,500 children and adolescents from post-authorisation safety studies. Additional experience has occurred with marketed use of this vaccine.Although safety in children and adolescents with mild to moderate asthma has been established, data in children with other pulmonary diseases or with chronic cardiovascular, metabolic or renal diseases are limited. In studies of adults in which a high percentage of individuals had underlying chronic medical conditions, the safety profile of FLUENZ was comparable to the safety profile observed in individuals without these conditions.
Summary of adverse reactionsThe most common adverse reaction observed in clinical studies was nasal congestion/rhinorrhoea.Adverse reaction frequencies are reported as:Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100)Very rare (< 1/10,000)
Immune system disordersUncommon: Hypersensitivity reactions (including facial oedema, urticaria and very rare anaphylactic reactions)
Metabolism and nutrition disordersVery common: Decreased appetite
Nervous system disordersVery common: Headache
Respiratory, thoracic, and mediastinal disordersVery common: Nasal congestion/rhinorrhoeaUncommon: Epistaxis
Skin and subcutaneous tissue disordersUncommon: Rash
Musculoskeletal and connective tissue disordersCommon: Myalgia
General disorders and administration site conditionsVery common: MalaiseCommon: PyrexiaIn 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). 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 is not indicated for use in infants and toddlers younger than 24 months (see section 4.4).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.
Reporting of suspected adverse reactionsReporting 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:
United KingdomYellow Card Scheme Website: www.mhra.gov.uk/yellowcard
EfficacyFLUENZ has been administered to over 30,000 individuals in controlled clinical studies over multiple years, in various regions and using different vaccine strains.
Paediatric studiesFLUENZ'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 Participants||Influenza Season||Efficacy(95% CI)bMatched strains||Efficacy(95% CI)bAll strains regardless of match|
|D153-P502||Europe||6 to 35 M||1,616||2000-2001||85.4% (74.3, 92.2)||85.9% (76.3, 92.0)|
|2001-2002||88.7% (82.0, 93.2)||85.8% (78.6, 90.9)|
|D153-P504||Africa, Latin America||6 to 35 M||1,886||2001||73.5% (63.6, 81.0)c||72.0% (61.9, 79.8)c|
|2002||73.6% (33.3, 91.2)||46.6% (14.9, 67.2)|
|D153-P513||Asia/ Oceania||6 to 35 M||2,107||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)|
|D153-P501||Asia/ Oceania||12 to 35 M||2,764||2000-2001||72.9% (62.8, 80.5)||70.1% (60.9, 77.3)|
|2001-2002||84.3% (70.1, 92.4)d||64.2% (44.2, 77.3)d|
|AV006||USA||15 to 71 M||1,259||1996-1997||93.4% (87.5, 96.5)||93.4% (87.5, 96.5)|
|1997-1998||100% (63.1, 100)||87.1% (77.7, 92.6)e|
|Study Number||Region||Age Rangea||Number of Study Participants||Influenza Season||Improved Efficacy(95% CI)bMatched strains||Improved Efficacy(95% CI)bAll strains regardless of match|
|MI-CP111||USA, Europe, Asia/ Oceania||6 to 59 M||7,852||2004-2005||44.5% (22.4, 60.0) fewer cases than injectable||54.9% (45.4, 62.9)cfewer cases than injectable|
|D153-P514||Europe||6 to 71 M||2,085||2002-2003||52.7% (21.6, 72.2) fewer cases than injectable||52.4% (24.6, 70.5)dfewer cases than injectable|
|D153-P515||Europe||6 to 17 Y||2,211||2002-2003||34.7% (3.9, 56.0) fewer cases than injectable||31.9% (1.1, 53.5) fewer cases than injectable|
Adult studiesSeveral studies against placebo have shown that FLUENZ may have some efficacy in adults. However, a conclusion on clinical benefit of this vaccine in adults could not be made given that results observed in some studies versus injectable influenza vaccines were suggestive of a lower efficacy of FLUENZ.
Figure 1 FLUENZ Administration
|Check expiry dateProduct must be used before date on applicator label.||Prepare the applicatorRemove rubber tip protector. Do not remove dose-divider clip at the other end of the applicator.||Position the applicatorWith the patient in an upright position, place the tip just inside the nostril to ensure FLUENZ is delivered into the nose.|
|Depress the plungerWith a single motion, depress plunger as rapidly as possible until the dose-divider clip prevents you from going further.||Remove dose-divider clipFor administration in the other nostril, pinch and remove the dose-divider clip from plunger.||Spray in other nostrilPlace the tip just inside the other nostril and with a single motion, depress plunger as rapidly as possible to deliver remaining vaccine.|
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- influenza vaccine