English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Select site language

Pandemic influenza vaccine H5N1 AstraZeneca (Pandemic influenza vaccine H5N1 Medimmune) (reassortant influenza virus (live attenuated)...) – Package leaflet - J07BB03

Updated on site: 09-Oct-2017

Medication namePandemic influenza vaccine H5N1 AstraZeneca (Pandemic influenza vaccine H5N1 Medimmune)
ATC CodeJ07BB03
Substancereassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain
ManufacturerAstraZeneca AB

Package leaflet: Information for the user

Pandemic influenza vaccine H5N1 AstraZeneca, nasal spray suspension

Pandemic influenza vaccine (H5N1) (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 Pandemic influenza vaccine H5N1 AstraZeneca is and what it is used for

2.What you need to know before you are given Pandemic influenza vaccine H5N1 AstraZeneca

3.How Pandemic influenza vaccine H5N1 AstraZeneca is given

4.Possible side effects

5.How to store Pandemic influenza vaccine H5N1 AstraZeneca

6.Contents of the pack and other information

1.What Pandemic influenza vaccine H5N1 AstraZeneca is and what it is used for

Pandemic influenza vaccine H5N1 AstraZeneca is a vaccine to prevent influenza (flu) in an officially declared pandemic. It is used in children and adolescents 12 months to less than 18 years of age.

Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades. It spreads rapidly around the world. The signs of pandemic flu are similar to those of ordinary flu but may be more serious.

How Pandemic influenza vaccine H5N1 AstraZeneca works

Pandemic influenza vaccine H5N1 AstraZeneca is similar to Fluenz Tetra (a nasal influenza vaccine containing four strains), except Pandemic influenza vaccine H5N1 AstraZeneca provides protection against a single influenza strain in an officially declared pandemic.

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.

Pandemic influenza vaccine H5N1 AstraZeneca vaccine virus is grown in chicken eggs. The influenza strain used for the vaccine in an offically declared pandemic is recommended by the World Health Organisation.

2. What you need to know before you are given Pandemic influenza vaccine H5N1 AstraZeneca

You should not be given Pandemic influenza vaccine H5N1 AstraZeneca:

if you have previously had a serious allergic reaction (i.e. life-threatening) to eggs, egg proteins, gentamicin, or gelatin or any of the other ingredients of this vaccine (listed in section 6 “Contents of the pack and other information”). For signs of allergic reactions, see section 4 “Possible side effects”. However, in a pandemic situation, your doctor may

recommend to give you the vaccine provided that appropriate medical treatement is immediately available in case of an allergic reaction.

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 12 months of age. Children less than 12 months of age should not receive this vaccine because of the risk of side effects.

if you have had any allergic reaction other than a sudden life-threatening allergic reaction to eggs, egg proteins, gentamicin, or gelatin or any of the other ingredients of this vaccine (listed in section 6 “Contents of the pack and other information”).

if you are 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 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 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 Pandemic influenza vaccine H5N1 AstraZeneca is suitable for you.

Other medicines, other vaccines and Pandemic influenza vaccine H5N1 AstraZeneca

Tell your doctor, nurse or pharmacist if the person being vaccinated is taking, has recently taken or might take any other medicines, including medicines that do not require a prescription.

Do not give acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever) to children for 4 weeks after vaccination with Pandemic influenza vaccine H5N1 AstraZeneca 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 Pandemic influenza vaccine H5N1 AstraZeneca is not given at the same time as influenza-specific antiviral medicines such as oseltamivir and zanamivir. This is because the vaccine may work less effectively.

Your doctor, nurse or pharmacist will decide if Pandemic influenza vaccine H5N1 AstraZeneca can be given at the same time as other vaccines.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant, or plan to become pregnant soon, tell your doctor, nurse or pharmacist before vaccination. He or she will decide if Pandemic influenza vaccine H5N1 AstraZeneca is suitable for you.

Pandemic influenza vaccine H5N1 AstraZeneca is not recommended for breast-feeding women.

Driving and using machines

Pandemic influenza vaccine H5N1 AstraZeneca has no or negligible influence on the ability to drive and use machines.

3.How Pandemic influenza vaccine H5N1 AstraZeneca is given

Pandemic influenza vaccine H5N1 AstraZeneca will be administered under the supervision of a doctor, nurse or pharmacist.

Pandemic influenza vaccine H5N1 AstraZeneca must only be used as a nasal spray.

Pandemic influenza vaccine H5N1 AstraZeneca must not be injected.

Pandemic influenza vaccine H5N1 AstraZeneca will be given as a spray in each nostril. You can breathe normally while you are given Pandemic influenza vaccine H5N1 AstraZeneca. You do not need to actively inhale or sniff.

Dosage

The recommended dose for children and adolescents is 0.2 ml Pandemic influenza vaccine H5N1 AstraZeneca, administered as 0.1 ml in each nostril. All children will receive a second, follow-up dose after an interval of at least 4 weeks.

If you have any further questions on this vaccine, ask your doctor, nurse or pharmacist.

4.Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them. In clinical studies with the vaccine, most side effects were mild in nature and short-term.

Ask your doctor, nurse or pharmacist if you want more information about possible side effects from Pandemic influenza vaccine H5N1 AstraZeneca.

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 straightaway or seek urgent medical care if you experience any of the effects above.

In clinical studies with adults who received Pandemic influenza vaccine H5N1 AstraZeneca, the most common side effects were headache and upper respiratory tract infection (inflammation of the nose, throat, and sinuses).

Other possible side effects of Pandemic influenza vaccine H5N1 AstraZeneca:

Very common

(may affect more than 1 in 10 people):

runny or stuffy nose

reduced appetite

weakness

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 Pandemic influenza vaccine H5N1 AstraZeneca

Keep this vaccine out of the sight and reach of children.

Do not use this vaccine 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.

Keep the nasal applicator in the outer carton in order to protect from light.

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 Pandemic influenza vaccine H5N1 AstraZeneca contains

The active substance is:

Reassortant influenza virus* (live attenuated) of the following strain**:

A/Vietnam/1203/2004 (H5N1) strain

107.0±0.5 FFU***

(A/Vietnam/1203/2004, MEDI 0141000136)

.......................................................................................................

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 a genetically modified organism (GMO).

***fluorescent focus units

This vaccine complies with the WHO recommendation and EU decision for the pandemic.

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 Pandemic influenza vaccine H5N1 AstraZeneca 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 colourless to pale yellow, clear to slightly cloudy. Small white particles may be present.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden

Manufacturer: MedImmune, UK Limited, Plot 6, Renaissance Way, Boulevard Industry Park, Speke, Liverpool, L24 9JW, UK

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

België/Belgique/Belgien

Lietuva

AstraZeneca S.A./N.V.

UAB ,AstraZeneca Lietuva

Tel: +32 2 370 48 11

Tel: +370 5 2660550

България

Luxembourg/Luxemburg

АстраЗенека България ЕООД

AstraZeneca S.A./N.V.

Тел: +359 24455000

Tél/Tel: +32 2 370 48 11

Česká republika

Magyarország

AstraZeneca Czech Republic s.r.o.

AstraZeneca Kft.

Tel: +420 222 807 111

Tel.: +36 1 883 6500

Danmark

Malta

AstraZeneca A/S

Associated Drug Co. Ltd

Tlf: +45 43 66 64 62

Tel: +356 2277 8000

Deutschland

Nederland

AstraZeneca GmbH

AstraZeneca BV

Tel: +49 41 03 7080

Tel: +31 79 363 2222

Eesti

Norge

AstraZeneca

AstraZeneca AS

Tel: +372 6549 600

Tlf: +47 21 00 64 00

Ελλάδα

Österreich

AstraZeneca A.E.

AstraZeneca Österreich GmbH

Τηλ: +30 2-10 6871500

Tel: +43 1 711 31 0

España

Polska

AstraZeneca Farmacéutica Spain, S.A.

AstraZeneca Pharma Poland Sp. z o.o.

Tel: +34 91 301 91 00

Tel.: +48 22 245 73 00

France

Portugal

AstraZeneca

AstraZeneca Produtos Farmacêuticos, Lda.

Tél: +33 1 41 29 40 00

Tel: +351 21 434 61 00

Hrvatska

România

AstraZeneca d.o.o.

AstraZeneca Pharma SRL

Tel: +385 1 4628 000

Tel: +40 21 317 60 41

Ireland

Slovenija

AstraZeneca Pharmaceuticals (Ireland) Ltd

AstraZeneca UK Limited

Tel: +353 1609 7100

Tel: +386 1 51 35 600

Ísland

Slovenská republika

Vistor hf.

AstraZeneca AB, o.z.

Sími: +354 535 7000

Tel: +421 2 5737 7777

Italia

Suomi/Finland

AstraZeneca S.p.A.

AstraZeneca Oy

Tel: +39 02 98011

Puh/Tel: +358 10 23 010

Κύπρος

Sverige

Αλέκτωρ Φαρμακευτική Λτδ

AstraZeneca AB

Τηλ: +357 22490305

Tel: +46 8 553 26 000

Latvija

United Kingdom

SIA AstraZeneca Latvija

AstraZeneca UK Ltd

Tel: +371 67377100

Tel: +44 1582 836 836

This medicine has been given “conditional approval”. This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicines at least every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

------------------------------------------------------------------------------------------------------------------------

Instructions for healthcare professionals

The following information is intended for healthcare professionals only:

Pandemic influenza vaccine H5N1 AstraZeneca is for nasal use only.

Do not use with a needle. Do not inject.

Do not use Pandemic influenza vaccine H5N1 AstraZeneca 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.

Pandemic influenza vaccine H5N1 AstraZeneca is administered as a divided dose in both nostrils as described below. (See also How Pandemic influenza vaccine H5N1 AstraZeneca 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.

Check expiry date

Prepare the applicator

Position the applicator

Product must be used

Remove rubber tip

With the patient in an

before date on applicator

protector. Do not remove

upright position, place

label.

dose-divider clip at the

the tip just inside the

 

other end of the

nostril to ensure

 

applicator.

Pandemic influenza

 

 

vaccine H5N1

 

 

AstraZeneca is delivered

 

 

into the nose.

Depress the plunger

Remove dose-divider

Spray in other nostril

With a single motion,

clip

Place the tip just inside

depress plunger as

For administration in the

the other nostril and

rapidly as possible until

other nostril, pinch and

with a single motion,

the dose-divider clip

remove the dose-divider

depress plunger as

prevents you from going

clip from plunger.

rapidly as possible to

further.

 

deliver remaining

 

 

vaccine.

See section 5 for advice on storage and disposal.

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed