Fluenz

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT  CHARACTERISTICS 
 
 

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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 
 
FLUENZ nasal spray suspension 
Influenza vaccine (live attenuated, nasal) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
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 
 
* propagated in fertilised hens’ eggs from healthy chicken flocks. 
** produced in VERO cells by reverse genetic technology. This product contains genetically 

modified organisms (GMOs). 
*** fluorescent focus units 
 
This vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision 
for the 2013/2014 season. 
 
The vaccine may contain residues of the following substances: egg proteins (e.g. ovalbumin) 
and gentamicin. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Nasal spray, suspension 
 
The suspension is colourless to pale yellow, clear to opalescent. Small white particles may be present. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Prophylaxis of influenza in individuals 24 months to less than 18 years of age. 
 
The use of FLUENZ should be based on official recommendations. 
 

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4.2 Posology and method of administration 
 
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 should not be used in infants and toddlers below 24 months of age because of safety 
concerns (see section 4.4). 
 
Method of administration 
Immunisation must be carried out by nasal administration. 
 
DO NOT INJECT FLUENZ. 
 
See section 6.6 for administration instructions. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 (e.g. gelatin), 
or to gentamicin (a possible trace residue), eggs or egg proteins (e.g. ovalbumin). 
 
Children and adolescents who are clinically immunodeficient due to conditions or immunosuppressive 
therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular 
immune deficiencies; and high-dose corticosteroids. FLUENZ 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. 
 
4.4 Special warnings and precautions for use 
 
As with most vaccines, appropriate medical treatment and supervision should always be 
readily available in case of an anaphylactic event following the administration of FLUENZ. 
 
FLUENZ 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. 
 
Do not administer FLUENZ to infants and toddlers younger than 12 months. In a clinical study, 
an increase in hospitalisations was observed in infants and toddlers younger than 12 months 
after vaccination (see section 4.8). It is not recommended to administer FLUENZ to infants 
and toddlers 12-23 months of age. In a clinical study, an increased rate of wheezing was 
observed in infants and toddlers 12-23 months of age after vaccination (see section 4.8). 
 
Vaccine recipients should be informed that FLUENZ 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 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. 

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4 

 
FLUENZ should under no circumstances be injected. 
 
No data exist regarding the safety of intranasal administration of FLUENZ in children with unrepaired 
craniofacial malformations. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Do not administer FLUENZ to children and adolescents younger than 18 years of age receiving 
salicylate therapy (see section 4.3). Do not use salicylates in children and adolescents younger 
than 18 years of age 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 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. 
 
The co-administration of FLUENZ with inactivated vaccines has not been studied. 
 
The concurrent use of FLUENZ 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, 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 are administered concomitantly, revaccination should be 
considered when appropriate. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There 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. 
 
Breastfeeding 
It 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. 
 
Fertility 
No data exist regarding the possible effects of FLUENZ on male and female fertility. 
 
4.7 Effects on ability to drive and use machines 
 
The vaccine is unlikely to have an effect on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
Safety 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 

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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 reactions 
 
The 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 disorders 
Uncommon: Hypersensitivity reactions (including facial oedema, urticaria and very rare anaphylactic 
reactions) 
 
Metabolism and nutrition disorders 
Very common: Decreased appetite 
 
Nervous system disorders 
Very 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 
 
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). 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. 
 

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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 
listed in Appendix V. 
 
4.9 Overdose 
 
There have been occasional reports of administration of twice the recommended dose of FLUENZ 
in the post-marketing setting. The adverse reactions reported were similar to those seen with the 
recommended single dose of FLUENZ. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Influenza vaccines, influenza live attenuated; ATC Code: J07BB03 
 
The influenza virus strains in FLUENZ 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. 
 
Efficacy 
FLUENZ has been administered to over 30,000 individuals in controlled clinical studies over multiple 
years, in various regions and using different vaccine strains. 
 
Paediatric studies 
 
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 Range

a 
Number 
of Study 

Participants 

Influenza 
Season 

Efficacy 
(95% CI)b 
Matched 
strains 

Efficacy 
(95% CI)b 
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)c 
72.0% 

(61.9, 79.8)c 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 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) 

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http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc�


7 

Study 
Number Region Age Range

a 
Number 
of Study 

Participants 

Influenza 
Season 

Efficacy 
(95% CI)b 
Matched 
strains 

Efficacy 
(95% CI)b 
All strains 

regardless of match 

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)d 

64.2% 
(44.2, 77.3)d 

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)e 

a M = months 
b Reduction in culture-confirmed influenza illness relative to placebo. 
c 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. 
d 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. 
e 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). 
 
Table 2 FLUENZ Relative Efficacy in Active-controlled Paediatric Studies with Injectable 

Influenza Vaccine 
 

Study 
Number Region 

Age 
Rangea 

Number 
of Study 

Participants

Influenza 
Season 

Improved 
Efficacy 

(95% CI)b 
Matched 
strains 

Improved Efficacy 
(95% CI)b 

All 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)c 

fewer 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)d 

fewer 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 

a M = months. Y = years. Age range as described in the protocol for the study. 
b Reduction in culture-confirmed influenza illness relative to injectable influenza vaccine. 
c FLUENZ demonstrated 55.7% (39.9, 67.6) fewer cases than injectable influenza vaccine in 3,659 infants and 
toddlers 6-23 months of age and 54.4% (41.8, 64.5) fewer cases in 4,166 children 24-59 months of age. 
d FLUENZ demonstrated 64.4% (1.4, 88.8) fewer cases than injectable influenza vaccine in 476 infants and 
toddlers 6-23 months of age and 48.2% (12.7, 70.0) fewer cases in 1,579 children 24-71 months of age. 
 
Adult studies 
Several 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. 
 
5.2 Pharmacokinetic properties 
 
Not applicable. 
 

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5.3 Preclinical safety data 
 
Non-clinical data with FLUENZ reveal no special hazard for humans based on conventional 
non-clinical studies of repeated dose toxicity, reproduction and developmental toxicity, local 
tolerance, and neurovirulence. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sucrose 
Dibasic potassium phosphate 
Monobasic potassium phosphate 
Gelatin (porcine, Type A) 
Arginine hydrochloride 
Monosodium glutamate monohydrate 
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 
 
18 weeks. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C). 
 
Do not freeze. 
 
Protect from light. 
 
Before use, the vaccine may be taken out of the refrigerator, without being replaced, for a maximum 
period of 12 hours at a temperature not above 25°C. If the vaccine has not been used after this 12-hour 
period, it should be disposed of. 
 
6.5 Nature and contents of container 
 
FLUENZ 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 10. 
 
6.6 Special precautions for disposal and other handling 
 
Administration 
FLUENZ IS FOR NASAL USE ONLY. 
 DO NOT USE WITH A NEEDLE. Do not inject. 

 

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 FLUENZ 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 administration diagram (Figure 1) for step-by-step administration 

instructions. 
 
Figure 1 FLUENZ Administration 
 

 
 

     
Check expiry date 
Product must be used 
before 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 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. 
 
 

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7. MARKETING AUTHORISATION HOLDER 
 
MedImmune, LLC 
Lagelandseweg 78 
6545 CG Nijmegen 
Netherlands 
(Tel) +31 24 371 7310 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/10/661/002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 27 January 2011 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/. 
 

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http://www.ema.europa.eu/�


11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) 
AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 
SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 
 

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A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) 
AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturers of the biological active substance(s) 
 
MedImmune, LLC 
297 North Bernardo Avenue, 
Moutain View 
California, 94043 
USA 
 
MedImmune, LLC 
3055 Patrick Henry Drive 
Santa Clara 
California, 95054 
USA 
 
MedImmune, UK Limited 
Plot 6, Renaissance Way, Boulevard Industry Park, Speke 
Liverpool 
L24 9JW 
UK 
 
Name and address of the manufacturer responsible for batch release 
 
MedImmune, UK Limited 
Plot 6, Renaissance Way, Boulevard Industry Park, Speke 
Liverpool 
L24 9JW 
UK 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 Official batch release 
 
In accordance with Article 114 of Directive 2001/83/EC, the official batch release 
will be undertaken by a state laboratory or a laboratory designated for that purpose. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
 Periodic Safety Update Reports 
 
The marketing authorisation holder shall submit periodic safety update reports for this product 
in accordance with the requirements set out in the list of Union reference dates (EURD list) 
provided for under Article 107c(7) of Directive 2001/83/EC and published on the European 
medicines web-portal. 
 
 

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D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 
SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 
 Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed 
in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 
subsequent updates of the RMP. 
 
An updated RMP shall be submitted annually until renewal. 
 
When the submission of a PSUR and the update of a RMP coincide, they should be submitted 
at the same time. 
 
In addition, an updated RMP should be submitted: 

 At the request of the European Medicines Agency; 
 Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk 
profile or as the result of an important (pharmacovigilance or risk minimisation) 
milestone being reached. 

 

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14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 

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A. LABELLING 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS (2 X 5 NASAL APPLICATORS) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
FLUENZ nasal spray suspension 
Influenza vaccine (live attenuated, nasal) 
2013/2014 season 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
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 
 
* propagated in fertilised hens’ eggs from healthy chicken flocks. 
** produced in VERO cells by reverse genetic technology. 
*** fluorescent focus units. 
 
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for 
the 2013/2014 season. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains also: sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin 
(porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Nasal spray, suspension 
10 single-use nasal applicators (0.2 ml each) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For nasal use only. Do not inject. 
Read the package leaflet before use. 
 
 

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6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
 
Do not freeze. 
 
Protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 
IF APPROPRIATE 

 
Please read the package leaflet for disposal of medicines no longer required. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
MedImmune, LLC 
Lagelandseweg 78 
6545 CG Nijmegen 
Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/10/661/002 < – 10 sprayers> 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

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15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
 

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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
PACK SIZE OF 5 SINGLE-USE NASAL APPLICATORS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
FLUENZ nasal spray suspension 
Influenza vaccine (live attenuated, nasal) 
2013/2014 season 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
MedImmune, LLC 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
For nasal use only. Do not inject. 
 
5 single-use nasal applicators (0.2 ml each) 
 
Store in a refrigerator. Do not freeze. 
 

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20 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SINGLE-USE NASAL APPLICATOR 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
FLUENZ 
Influenza vaccine 
2013/2014 season 
 
 
2. METHOD OF ADMINISTRATION 
 
For nasal use only. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.2 ml 
 
 
6. OTHER 
 

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21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 

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Package Leaflet: Information for the user 
 

Fluenz nasal spray suspension 
Influenza vaccine (live attenuated, nasal) 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before the vaccine is given because it contains important 
information for you or your child. 
 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, nurse or pharmacist. 
- This vaccine has been prescribed for you or your child only. Do not pass it on to others. 
- If any of the side effects gets serious, talk to your doctor, nurse or pharmacist. This includes 

any possible side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet: 
 
1. What Fluenz is and what it is used for 
2. What you need to know before you are given Fluenz 
3. How Fluenz is given 
4. Possible side effects 
5. How to store Fluenz 
6. Contents of the pack and other information 
 
 
1. What Fluenz is and what it is used for 
 
Fluenz is a vaccine to prevent influenza (flu). It is used in children and adolescents 24 months 
to less than 18 years of age. 
 
When a person is given the vaccine, the immune system (the body’s natural defence system) 
will produce its own protection against the influenza virus. None of the ingredients in the 
vaccine can cause the flu. 
 
Fluenz vaccine viruses are grown in chicken eggs. The vaccine targets three strains of influenza 
virus each year, following the annual recommendations by the World Health Organisation. 
 
 
2. What you need to know before you are given Fluenz 
 
You will not be given Fluenz 
 
 if you are allergic to eggs, egg proteins, gentamicin, or gelatin or any of the other ingredients 

of Fluenz (listed in section 6 “Contents of the pack and other information”). For signs of allergic 
reactions, see section 4 “Possible side effects”. 

 if you have a blood disorder or a cancer that affects the immune system. 
 if you have been told by your doctor that you have a weakened immune system as a result 

of a disease, medicine, or other treatment. 
 if you are under 18 years of age and already taking acetylsalicylic acid (a substance present 

in many medicines used to relieve pain and lower fever). This is because of the risk of a very 
rare but serious disease (Reye’s syndrome). 

 
If any of these apply, tell your doctor, nurse or pharmacist. 
 

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23 

Warnings and precautions 
 
Talk to your doctor, nurse or pharmacist before vaccination: 
 if the child is less than 24 months of age. Children less than 24 months of age should not 

receive this vaccine because of the risk of side effects. 
 if you have severe asthma or are currently wheezing. 
 if you are in close contact with someone with a severely weakened immune system 

(for example, a bone marrow transplant patient needing isolation). 
 
If any of these apply, tell your doctor, nurse or pharmacist before vaccination. He or she will 
decide if Fluenz is suitable for you. 
 
Other medicines, other vaccines and Fluenz 
 
Tell your doctor, nurse or pharmacist if the person being vaccinated is taking, has recently taken 
or might take any other medicines. 
 Do not give acetylsalicylic acid to children aged less than 18 years for 4 weeks after 

vaccination with Fluenz unless your doctor, nurse or pharmacist tells you otherwise. 
This is because of the risk of Reye’s syndrome, a very rare but serious disease that 
can affect the brain and liver. 

 It is recommended that Fluenz is not given at the same time as influenza-specific antiviral 
medicines. This is because the vaccine may work less effectively. 

 
Your doctor, nurse or pharmacist will decide if Fluenz can be given at the same time as other vaccines. 
 
Pregnancy and breast-feeding 
 If you are pregnant, think you may be pregnant, plan to become pregnant soon or are breast 

feeding, tell your doctor, nurse or pharmacist before receiving this vaccine. Fluenz is not 
recommended for women who are pregnant or are breast-feeding. 

 
 
3. How Fluenz is given 
 
Fluenz will be administered under the supervision of a doctor, nurse or pharmacist. 
 
Fluenz must only be used as a nasal spray. 
 
Fluenz must not be injected. 
 
Fluenz will be given as a spray in each nostril. You can breathe normally while you are given Fluenz. 
You do not need to actively inhale or sniff. 
 
Dosage 
 The recommended dose for children and adolescents is 0.2 ml Fluenz, administered as 0.1 ml 

in each nostril. 
 Children who have not previously had an influenza vaccine will receive a second, follow-up 

dose after an interval of at least 4 weeks. Follow your doctor, nurse or pharmacist’s instructions 
about when your child should return for the second dose. 

 
 
4. Possible side effects 
 
Like all medicines, Fluenz can cause side effects, although not everybody gets them. 
 
Ask your doctor, nurse or pharmacist if you want more information about possible side effects 
from Fluenz. 
 

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24 

Some side effects may be serious 
 
Very rare 
(may affect up to 1 in 1,000,000 people): 
 severe allergic reaction: signs of a severe allergic reaction may include shortness of breath and 

swelling of the face or tongue. 
 
Tell your doctor straight away or seek urgent medical care if you experience any of the effects 
above. 
 
Other possible side effects of Fluenz 
 
Very common 
(may affect more than 1 in 10 people): 
 runny or stuffy nose 
 reduced appetite 
 weakness 
 headache 
 
Common 
(may affect up to 1 in 10 people): 
 fever 
 muscle aches 
 
Uncommon 
(may affect up to 1 in 100 people): 
 rash 
 nose bleed 
 allergic reactions 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Fluenz 
 
Keep this vaccine out of the sight and reach of children. 
 
Do not use Fluenz after the expiry date which is stated on the applicator label after the letters EXP. 
 
Store in a refrigerator (2°C to 8°C). Do not freeze. 
 
Protect from light. 
 
Before use, the vaccine may be taken out of the refrigerator, without being replaced, for a maximum 
period of 12 hours at a temperature not above 25°C. If the vaccine has not been used after this 12-hour 
period, it should be disposed of. 
 
Any unused product or waste material should be disposed of in accordance with local requirements 
for medical waste. Do not throw away any medicines via wastewater or household waste. Ask your 
pharmacist how to throw away medicines you no longer use. These measures will help protect the 
environment. 
 

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http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc�


25 

 
6. Contents of the pack and other information 
 
What Fluenz contains 
 
The active substances are: 
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 
 
* propagated in fertilised hens' eggs from healthy chicken flocks. 
** produced in VERO cells by reverse genetic technology. This product contains genetically 

modified organisms (GMOs). 
*** fluorescent focus units 
 
This vaccine complies with the WHO (World Health Organisation) recommendations 
(Northern Hemisphere) and EU decision for the 2013/2014 season. 
 
The other ingredients are sucrose, dibasic potassium phosphate, monobasic potassium phosphate, 
gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate and water 
for injections. 
 
What Fluenz looks like and contents of the pack 
 
This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) 
in a pack size of 10. 
 
The suspension is a colourless to pale yellow liquid that is clear to slightly cloudy. Small white 
particles may be present. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder: MedImmune, LLC, Lagelandseweg 78, 6545 CG Nijmegen, 
Netherlands, (Tel) +31 24 371 7310 
 
Manufacturer: MedImmune, UK Limited, Plot 6, Renaissance Way, Boulevard Industry Park, Speke, 
Liverpool, L24 9JW, UK 
 

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26 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
NV AstraZeneca SA 
Tel: +32 2 370 48 11 
 

Lietuva 
UAB ,,AstraZeneca Lietuva“ 
Tel: +370 5 2660550 
 

България 
ТП AstraZeneca UK Limited 
Тел.: +359 2 971 25 33 
 

Luxembourg/Luxemburg 
NV AstraZeneca SA 
Belgique/Belgien 
Tél/Tel: +32 2 370 48 11 
 

Česká republika 
AstraZeneca Czech Republic s.r.o. 
Tel: +420222807111 
 

Magyarország 
AstraZeneca Kft 
Tel.: +36 1 883 6500 
 

Danmark 
AstraZeneca A/S 
Tlf: +45 43 66 64 62 
 

Malta 
Associated Drug Co. Ltd 
Tel: +356 2277 8000 
 

Deutschland 
AstraZeneca GmbH 
Tel: +49 41 03 7080 
 

Nederland 
AstraZeneca BV 
Tel: +31 79 363 2222 
 

Eesti 
AstraZeneca Eesti OÜ 
Tel: +372 6549 600 
 

Norge 
AstraZeneca AS 
Tlf: +47 21 00 64 00 
 

Ελλάδα 
AstraZeneca A.E. 
Τηλ: +30 2 106871500 
 

Österreich 
AstraZeneca Österreich GmbH 
Tel: +43 1 711 31 0 
 

España 
AstraZeneca Farmacéutica Spain, S.A. 
Tel: +34 91 301 91 00 
 

Polska 
AstraZeneca Pharma Poland Sp. z o.o. 
Tel.: +48 22 874 35 00 
 

France 
AstraZeneca 
Tél: +33 1 41 29 40 00 
 

Portugal 
AstraZeneca Produtos Farmacêuticos, Lda. 
Tel: +351 21 434 61 00 
 

Hrvatska 
AstraZeneca d.o.o. 
Tel: +385 1 4628 000 
 

România 
AstraZeneca Pharma SRL 
Tel: +40 21 317 60 41 
 

Ireland 
AstraZeneca Pharmaceuticals (Ireland) Ltd 
Tel: +353 1609 7100 
 

Slovenija 
AstraZeneca UK Limited 
Tel: +386 1 51 35 600 
 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
AstraZeneca AB o.z. 
Tel: +421 2 5737 7777 
 

Italia 
AstraZeneca S.p.A. 
Tel: +39 02 98011 
 

Suomi/Finland 
AstraZeneca Oy 
Puh/Tel: +358 10 23 010 
 

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27 

Κύπρος 
Αλέκτωρ Φαρμακευτική Λτδ 
Τηλ: +357 22490305 
 

Sverige 
AstraZeneca AB 
Tel: +46 8 553 26 000 
 

Latvija 
SIA AstraZeneca AB Latvija 
Tel: +371 67321747 
 

United Kingdom 
AstraZeneca UK Ltd 
Tel: +44 1582 836 836 
 

 
This leaflet was last revised in. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
Fluenz is a trademark of MedImmune, LLC. 
 
------------------------------------------------------------------------------------------------------------------------ 
 
Instructions for health professionals 
 
The following information is intended for medical or healthcare professionals only: 
 
Fluenz is for nasal use only. 
 Do not use with a needle. Do not inject. 

 
 Fluenz is administered as a divided dose in both nostrils as described below. 

(See also, How Fluenz is given, in section 3). 
 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. 
 

 
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28 

   
Check expiry date 
Product must be used 
before 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 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. 

 
See section 5 for advice on storage and disposal. 

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	SUMMARY OF PRODUCT  CHARACTERISTICS
	A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET