nasal spray, suspension
Pandemic influenza vaccine (H5N1) (live attenuated, nasal)
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 on children and adolescents from 12 months up to 18 years.
Pandemic influenza is a type of flu that occurs from time to time, breaks can be less than 10 years or last for several decades. It is spreading rapidly throughout the world. The signs of pandemic flu are about the same as regular flu 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 containing four strains), except that Pandemic influenza vaccine H5N1 AstraZeneca protects against a single influenza strain in the event of an officially declared pandemic.
When a person is given the vaccine, the immune system (the body’s natural defense system) produces its protection against the flu virus. None of the ingredients in the vaccine can cause the flu.
The virus in the Pandemic influenza vaccine H5N1 AstraZeneca is grown in chicken eggs. The influenza strain used for the vaccine in the event of an officially declared pandemic is recommended by the World Health Organization.
What you need to know before you receive the Pandemic influenza vaccine H5N1 AstraZeneca
You should not take the Pandemic flu vaccine H5N1 AstraZeneca
- if you have previously had a severe allergic reaction (ie life-threatening) to eggs, egg proteins, gentamicin, gelatin, or any of the other ingredients of this vaccine (listed in section 6 “Package contents and other information”). See section 4 “Possible side effects” for signs of allergic reactions. However, in a situation of a pandemic, your doctor may recommend that you be given the vaccine provided that appropriate medical treatment can be given immediately if you have an allergic reaction.
If any of these apply to you, tell your doctor, nurse, or pharmacist.
Warnings and cautions
Talk to a doctor, nurse, or pharmacist before vaccination
- if the child is younger than 12 months. Children younger than 12 months should not receive this vaccine due to the risk of side effects.
- if you have had an allergic reaction other than an acute, life-threatening allergic reaction to eggs, egg proteins, gentamicin or gelatin, or any of the other ingredients of this vaccine (see section 6 “Package contents and other information”).
- you are already taking acetylsalicylic acid (a substance found in many painkillers and antipyretics). This is because there is a risk of a very rare but serious disease (Reyes syndrome).
- if you have a blood disease or cancer that affects the immune system.
- if your doctor has told you that you have a weakened immune system due to an illness, drug, or other treatment.
- if you have severe asthma or currently have to wheeze.
- if you are in close contact with someone who has a severely weakened immune system (for example, a patient who has had a bone marrow transplant and needs isolation).
If any of these apply, tell your doctor, nurse, or pharmacist before getting vaccinated. He or she will determine if the Pandemic influenza vaccine H5N1 AstraZeneca is right for you.
Other medicines, other vaccines, and Pandemic influenza vaccine H5N1 AstraZeneca
Tell your doctor, nurse, or pharmacist if the person to be vaccinated is taking, has recently taken, or might be taking other medicines, including over-the-counter medicines.
- Do not give acetylsalicylic acid (a substance found in many painkillers and antipyretics) to children for four 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.
- We recommend that Pandemic influenza vaccine H5N1 AstraZeneca not be given at the same time as influenza-specific antiviral drugs such as oseltamivir and zanamivir. This is because the effect of the vaccine may be reduced.
Your doctor, nurse, or pharmacist will decide if the Pandemic influenza vaccine H5N1 AstraZeneca can be given at the same time as other vaccines.
Pregnancy and breastfeeding
- If you are pregnant, think you may be pregnant, or are planning to have a baby soon, tell your doctor, nurse, or pharmacist before getting vaccinated. He or she will determine if the Pandemic influenza vaccine H5N1 AstraZeneca is right for you.
- Pandemic influenza vaccine H5N1 AstraZeneca is not recommended for breastfeeding women.
Driving and using machines
- Pandemic influenza vaccine H5N1 AstraZeneca has no or negligible effect on the ability to drive and use machines.
How To Get Pandemic Influenza Vaccine H5N1 AstraZeneca
Pandemic influenza vaccine H5N1 AstraZeneca is given under the supervision of a doctor, nurse, or pharmacist.
Pandemic influenza vaccine H5N1 AstraZeneca should only be used as a nasal spray.
Pandemic influenza vaccine H5N1 AstraZeneca must not be injected.
Pandemic influenza vaccine H5N1 AstraZeneca is given as a spray in each nostril. You can breathe normally while receiving the Pandemic influenza vaccine H5N1 AstraZeneca. You do not need to inhale or sniff.
Dose
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 receive a second dose as a follow-up after a break of at least four weeks.
If you have any further questions on the use of this vaccine, ask your doctor, nurse, or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. In clinical trials with the vaccine, most side effects were mild and resolved rapidly.
If you have any further questions on the use of Pandemic influenza vaccine H5N1 AstraZeneca, ask your doctor, nurse, or pharmacist.
Some side effects can be serious:
Very rare
(may affect up to 1 in 10,000 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 immediately or seek emergency medical attention if you get any of the above side effects.
In clinical trials in adults receiving Pandemic influenza vaccine H5N1 AstraZeneca, the most common adverse reactions were headache and upper respiratory tract infection ( 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):
- runny nose or stuffy nose
- reduced appetite
- weakness
Usual
(may affect up to 1 in 10 people):
- fever
- muscle aches
- headache
Less common
(may affect up to 1 in 100 people):
- rash
- nosebleeds
- allergic reactions
How to store Pandemic influenza vaccine H5N1 AstraZeneca
Keep this vaccine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the nasal pipette label after EXP.
Store in a refrigerator (2‑8 ° C). Do not freeze.
Store the nasal pipette in the outer carton 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 to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is:
Reassortant influenza virus * (live attenuated) of the following strain **:
Strain A / Vietnam / 1203/2004 (H5N1)
(A / Vietnam / 1203/2004, MEDI 0141000136) 10 7.0 ± 0.5 FFU ***
………………………………………….. ………………………………………….. … per 0.2 ml dose
* propagated in fertilized chicken eggs from healthy chicken herds.
** produced in VERO cells by reverse gene technology. This product contains a genetically modified organism (GMO).
*** fluorescent focus units
This vaccine complies with the World Health Organization’s recommendation and the EU decision on the pandemic.
The other ingredients are sucrose, dipotassium phosphate, potassium dihydrogen phosphate, gelatin (from pig, type A), arginine hydrochloride, monosodium glutamate monohydrate, and water for injections.
What the medicine looks like and the contents of the pack
This vaccine is supplied as a nasal spray, suspension in a disposable nasal pipette (0.2 ml) in a pack size of 10 pcs.
Suspension one is colorless to yellowish, clear to slightly cloudy. Small, white particles may be present.
Marketing Authorization Holder and Manufacturer
Manufacturer:
MedImmune Pharma BV,
Lagelandseweg 78
Nijmegen, 6545CG
Netherlands
MedImmune, UK Limited,
Plot 6, Renaissance Way,
Boulevard Industry Park,
Speke,
Liverpool L24 9JW,
UK
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11 | LithuaniaUAB, AstraZeneca LietuvaTel: +370 5 2660550 |
| BulgariaAustralia Bulgaria ЕООДTel: +359 24455000 | Luxembourg / LuxemburgAstraZeneca SA / NVTel: +32 2 370 48 11 |
| Czech RepublicAstraZeneca Czech Republic sroTel: +420 222 807 111 | HungaryAstraZeneca Kft.Tel .: +36 1 883 6500 |
| DenmarkAstraZeneca A / STel: +45 43 66 64 62 | MaltaAssociated Drug Co. Ltd.Tel: +356 2277 8000 |
| GermanyAstraZeneca GmbHTel: +49 41 03 7080 | The NetherlandsAstraZeneca BVTel: +31 79 363 2222 |
| EestiAstraZenecaTel: +372 6549 600 | NorwayAstraZeneca ASTel: +47 21 00 64 00 |
| GreeceAstraZeneca AE:Ηλ: +30 2‑10 6871500 | AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0 |
| SpainAstraZeneca Pharmacéutica Spain, SATel: +34 91 301 91 00 | PolandAstraZeneca Pharma Poland Sp. z ooTel .: +48 22 4 245 5 73 00 |
| FranceAstraZenecaTel: +33 1 41 29 40 00 | PortugalAstraZeneca Pharmaceutical Products, Lda.Tel: +351 21 434 61 00 |
| CroatiaAstraZeneca dooTel: +385 1 4628 000 | RomaniaAstraZeneca Pharma SRLTel: +40 21 317 60 41 |
| IrelandAstraZeneca Pharmaceuticals (Ireland) LtdTel: +353 1609 7100 | SloveniaAstraZeneca UK LimitedTel: +386 1 51 35 600 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicAstraZeneca AB, ozTel: +421 2 5737 7777 |
| ItalyAstraZeneca SpATel: +39 02 98011 | Finland / FinlandAstraZeneca OyPuh / Tel: +358 10 23 010 |
| .ΠροςAlexander the Great:Ηλ: +357 22490305 | SwedenAstraZeneca ABTel: +46 8 553 26 000 |
| LatviaSIA AstraZeneca LatvijaTel: +371 67377100 | United KingdomAstraZeneca UK LtdTel: +44 1582 836 836 |