Fluenz - patient leaflet, side effects, dosage

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

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

• Official batch release

with Article 114 of Directive 2001/83/EC, the official batch release aken by a state laboratory or a laboratory designated for that purpose.

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.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE

• 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.

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

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.

• 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

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

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

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

5. CONTENTS BY WEIGHT, BY VOLU ME OR BY UNIT

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.

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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.

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 tak 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 und

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.

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.

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

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.

6. Contents of the pack and other information

What Fluenz looks like and contents of the pack

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien NV AstraZeneca SA Tel: +32 2 370 48 11	Lietuva UAB ,,AstraZeneca Lietuva“ Tel: +370 5 2660550
Efc^rapufl Tn AstraZeneca UK Limited Tea.: +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.	Magyarország AstraZeneca Kft
Tel: +420222807111 Danmark AstraZeneca A/S Tlf: +45 43 66 64 62	Tel.: +36 1 883 6500 Malta Associated Drug Co. Ltd Tel: +356 2277 8000
Deutschland AstraZeneca GmbH	Nederland AstraZeneca BV
Tel: +49 41 03 7080 Eesti AstraZeneca Eesti OÜ Tel: +372 6549 600	Tel: +31 79 363 2222 Norge AstraZeneca AS Tlf: +47 21 00 64 00
EXXáSa AstraZeneca A.E. Tql: +302 106871500	Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0
España AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00 France AstraZeneca Tél: +33 1 41 29 40 00 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 000	Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 874 35 00 Portugal AstraZeneca Produtos Farmacéuticos, Lda. Tel: +351 21 434 61 00 Romania 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

Khnpoç

AXéKTœp OappaKeuTiKrç At5

Tql: +357 22490305

Latvija

SIA AstraZeneca AB Latvija

Tel: +371 67321747

This leaflet was last revised in.

Detailed information on this medicine is available on the European Medicines Agency web site:

.

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.

With a single motion, depress plunger as rapidly as possible until the dose-divider clip prevents you from going further.

dose-divider clip

For administration in the other nostril, pinch and remove the dose-divider clip from plunger.

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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