PANDEMIC INFLUENZA VACCINE H5N1 ASTRAZENECA NASAL SPRAY SUSPENSION
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Introduction
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, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on 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. Do not pass it on to others.
- If you think any of the side effects mentioned in this leaflet are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack:
- What Pandemic influenza vaccine H5N1 AstraZeneca is and what it is used for
- What you need to know before Pandemic influenza vaccine H5N1 AstraZeneca is given
- How Pandemic influenza vaccine H5N1 AstraZeneca is given
- Possible side effects
- Storing Pandemic influenza vaccine H5N1 AstraZeneca
- 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 in the event of an officially declared pandemic. It is used in children and adolescents from 12 months up to less than 18 years of age.
Pandemic influenza is a type of influenza that occurs at intervals of less than 10 years to several decades. It spreads rapidly around the world. The signs of pandemic influenza are similar to those of ordinary influenza but can be more severe.
How Pandemic influenza vaccine H5N1 AstraZeneca works
Pandemic influenza vaccine H5N1 AstraZeneca is similar to Fluenz Tetra (a nasal influenza vaccine that contains four strains), except that Pandemic influenza vaccine H5N1 AstraZeneca provides protection against a single strain in an officially declared pandemic situation.
When a person is given the vaccine, the immune system (the body's natural defense system) produces its own protection against the influenza virus. None of the components of the vaccine can cause influenza.
The vaccine virus in Pandemic influenza vaccine H5N1 AstraZeneca is grown in chicken eggs. The influenza strain used in the vaccine in an officially declared pandemic situation is the one recommended by the World Health Organization.
2. What you need to know before Pandemic influenza vaccine H5N1 AstraZeneca is given
Pandemic influenza vaccine H5N1 AstraZeneca must not be given to:
- If you have had a severe allergic reaction(i.e. potentially life-threatening) to eggs, egg proteins, gentamicin, gelatin or any of the other components 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 that you are given the vaccine, provided that medical treatment is available immediately in case of an allergic reaction.
If any of these conditions apply to you, tell your doctor, nurse or pharmacist.
Warnings and precautions
Tell your doctor, nurse or pharmacist before vaccination:
- If you have had any allergic reaction other than a sudden and potentially life-threatening allergic reactionto eggs, egg proteins, gentamicin, gelatin or any of the other components of this vaccine(listed in section 6 "Contents of the pack and other information").
If any of these conditions apply to you, tell your doctor, nurse or pharmacist before vaccination. He or she will decide if Pandemic influenza vaccine H5N1 AstraZeneca is suitable for you.
Using Pandemic influenza vaccine H5N1 AstraZeneca with other medicines and other vaccinesTell your doctor, nurse or pharmacist if the person to be vaccinated is using, has recently used or might use 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 childrenfor 4 weeks after vaccination with Pandemic influenza vaccine H5N1 AstraZeneca unless your doctor, nurse or pharmacist tells you otherwise. This is due to the risk of Reye's syndrome, a very rare but serious disease that can affect the brain and liver.
- Pandemic influenza vaccine H5N1 AstraZeneca should not be givenat the same time as antiviral medicines against influenzasuch as oseltamivirand zanamivir. This is because the vaccine may lose its effect.
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 or think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before vaccination. He or she will decide if Pandemic influenza vaccine H5N1 AstraZeneca is suitable for you.
- Pandemic influenza vaccine H5N1 AstraZeneca is not recommendedin breast-feeding women.
Driving and using machines
- The influence of Pandemic influenza vaccine H5N1 AstraZeneca on the ability to drive and use machines is negligible.
3. How Pandemic influenza vaccine H5N1 AstraZeneca is given
Pandemic influenza vaccine H5N1 AstraZeneca will be given under the supervision of a doctor, nurse or pharmacist.
Pandemic influenza vaccine H5N1 AstraZeneca should only be used for 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 Pandemic influenza vaccine H5N1 AstraZeneca is being given. You do not need to inhale or sniff.
Dose
The recommended dosefor children and adolescents is 0.2 ml of Pandemic influenza vaccine H5N1 AstraZeneca, given as 0.1 ml in each nostril. All childrenwill receive a second follow-up dose at least 4 weeks after the first dose.
If you have any further questions on the use of this medicine, 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 this vaccine, most side effects were short-lived and mild.
Ask your doctor, nurse or pharmacist for more information on the possible side effects of Pandemic influenza vaccine H5N1 AstraZeneca.
Some side effects may be serious:
Very rare
(may affect up to 1 in 10,000 people)
- severe allergic reactions: signs of allergic reaction can include difficulty breathing and swelling of the face or tongue.
Tell your doctor immediately or seek urgent medical attentionif you notice any of these symptoms.
In clinical studies with adults who received Pandemic influenza vaccine H5N1 AstraZeneca, the most common side effects were headache and infection of the upper respiratory tract (inflammation of the nose, throat and sinuses).
Other possible side effects of Pandemic influenza vaccine H5N1 AstraZeneca in children and adolescents:
Very common
(may affect more than 1 in 10 people):
- stuffy or runny nose
- loss of appetite
- weakness
Common
(may affect up to 1 in 10 people):
- fever
- muscle pain
- headache
Uncommon
(may affect up to 1 in 100 people):
- skin rash
- nosebleeds
- allergic reactions
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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. Storing 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 label of the applicator after EXP.
Store in a refrigerator (between 2°C and 8°C). Do not freeze.
Keep the nasal applicator in the outer packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Container contents and additional information
Composition of Pandemic influenza vaccine H5N1 AstraZeneca
The active substance is:
Reassorted influenza virus* (live attenuated) of the following strain**:
Strain A/Vietnam/1203/2004 (H5N1)
(A/Vietnam/1203/2004, MEDI 0141000136) 107.0±0.5 FFU***
………………………………………………………..………per 0.2 ml dose
- multiplied in fertilized chicken eggs from healthy chicken coops.
** 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 and the EU decision for the pandemic.
The other components are sucrose, potassium hydrogen phosphate, potassium dihydrogen phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, and water for injection.
Appearance of Pandemic influenza vaccine H5N1 AstraZeneca and container contents
This vaccine is presented as a suspension for nasal spray in a single-use nasal applicator (0.2 ml) in a pack size of 10 units.
The suspension is colorless to pale yellow, transparent to slightly turbid. It may present small white particles.
Marketing authorization holder
AstraZeneca AB,
SE-151 85
Södertälje,
Sweden
Manufacturer
AstraZeneca Nijmegen B.V.,
Lagelandseweg 78
Nijmegen, 6545CG
Netherlands
MedImmune, UK Limited,
Plot 6, Renaissance Way,
Boulevard Industry Park,
Speke,
Liverpool L24 9JW,
United Kingdom
For further information about this medicinal product, please contact the local representative of the marketing authorization holder:
België/Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 11 | Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550 |
| Luxembourg/Luxemburg AstraZeneca S.A./N.V. Tél/Tel: +32 2 370 48 11 |
Ceská republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 111 | 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 40 809034100 | Nederland AstraZeneca BV Tel: +31 85 808 9900 |
Eesti AstraZeneca Tel: +372 6549 600 | Norge AstraZeneca AS Tlf: +47 21 00 64 00 |
Ελλάδα AstraZeneca A.E. Τηλ: +30 2-10 6871500 | 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 22 245 7300 |
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 00704500 | Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010 |
Κύπρος Αλέκτωρ Φαρμακευτική Λτδ Τηλ: +357 22490305 | Sverige AstraZeneca AB Tel: +46 8 553 26 000 |
Latvija SIA AstraZeneca Latvija Tel: +371 67377100 |
Date of last revision of this leaflet: MM/YYYY
This medicinal product has been authorized with a «conditional approval». This approval mechanism means that further information on this medicinal product is awaited. The European Medicines Agency will review the new information on this medicinal product at least once a year and this leaflet will be updated as necessary.
Other sources of information
Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu.
Instructions for healthcare professionals
This information is intended solely for healthcare professionals:
Pandemic influenza vaccine H5N1 AstraZeneca must be used by the nasal route only.
- Do not use with a needle.Do not inject.
- Do not use Pandemic influenza vaccine H5N1 AstraZeneca if the expiration date has expired or if the sprayer is damaged, for example if the plunger is loose or displaced from the sprayer or if there is any sign of loss of content.
- Check the appearance of the vaccine before administration. The suspension should be colorless to pale yellow, transparent to opalescent. It may present small white particles.
- Pandemic influenza vaccine H5N1 AstraZeneca is administered as a divided dose in both nasal cavities as described below. (See also How to administer Pandemic influenza vaccine H5N1 AstraZenecain section 3).
- After administering half of the dose in one nasal cavity, administer the other half of the dose in the other nasal cavity immediately or shortly after.
- The patient can breathe normally while the vaccine is being administered; there is no need to inhale or aspirate actively through the nose.
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Check the expiration date The product must not be used after the date stated on the applicator label. | Prepare the applicator Remove the rubber cap from the end. Do not remove the dose divider clip from the other end of the applicator. | Place the applicator With the patient in an upright position, place the end inside the nasal cavity to ensure that Pandemic influenza vaccine H5N1 AstraZeneca is administered in the nose. |
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Press the plunger With a single movement, press the plunger as quickly as possibleuntil the dose divider clip prevents further movement. | Remove the dose divider clip To administer in the other nasal cavity, pinch and remove the dose divider clip from the plunger. | Spray in the other nasal cavity Place the end immediately inside the other nasal cavityand, with a single movement, press the plunger as quickly as possibleto administer the rest of the vaccine. |
See section 5for information on storage and disposal.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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