FLUENZ 0.2 ml Spray do nosa, zawiesina
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Jak stosować FLUENTS
Treść ulotki
Fluenz nasal spray, suspension
Influenza vaccine (live, nasal)
Read this leaflet carefully before the vaccine is administered as it contains
important information for you or the child.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, nurse or pharmacist.
- This vaccine has been prescribed only for you or the child. Do not give it to other people.
- If any side effects occur, ask your doctor, nurse or pharmacist. They can understand any side effects not listed in this leaflet. See section 4.
Contents of this leaflet:
- 1. What Fluenz is and what it is used for
- 2. What you need to know before Fluenz is administered to you
- 3. How Fluenz is administered
- 4. Possible side effects
- 5. How to store Fluenz
- 6. Contents of the pack and other information
1. What is Fluenz and what is it used for
Fluenz is a vaccine that prevents influenza. It is used in children and adolescents aged
between 2 and 18 years. Fluenz helps to protect against the viral strains present in the vaccine and against
other strains closely related to them.
How Fluenz works
When a person receives the vaccine, the immune system (the body's natural defense system)
produces antibodies against the influenza virus. No component of the vaccine can cause
influenza.
The viruses contained in the Fluenz vaccine are grown on chicken eggs. Each year the vaccine is directed
against three strains of influenza viruses, based on the annual recommendations of the
World Health Organization.
2. What you need to know before you are given Fluenz
Fluenz will not be given if the person:
- is allergicto the active ingredients, to gentamicine (trace residues from the manufacturing process) or to any of the excipients of this vaccine listed in section 6.
- has ever had a severe allergic reaction to eggs or egg proteins. Regarding the symptoms of allergic reactions, see section 4.
- suffers from a blood diseaseor a tumorthat affects the immune system.
- has been informed by the doctorthat they have a weakened immune systemfollowing an illness, a medicine or another treatment (such as acute and chronic leukemias, lymphoma, symptomatic HIV infection, cellular immunodeficiencies and high-dose corticosteroids).
- is takingacetylsalicylic acid(a substance present in many medicines, used to relieve pain and reduce fever). This is due to the risk of contracting a very rare but serious disease (Reye's syndrome).
If any of these conditions apply to you, tell your doctor, nurse or pharmacist.
Warnings and precautions
The doctor or nurse will ensure that medical treatment and
adequate supervision are readily available in case of a rare anaphylactic reaction (a very serious
allergic reaction with symptoms such as difficulty breathing, dizziness, weak and rapid heartbeat and rash) to
following administration.
Consult your doctor, nurse or pharmacist before vaccination:
- if you suffer from severe asthmaor are currently wheezing.
- if you have a severe acute illness associated with fever or infection, or if you have nasal congestion. Your doctor may decide to delay vaccination until the fever or nasal congestion has subsided.
- if you are in close contact with someone whose immune system is severely weakened(e.g., a patient who has received a bone marrow transplant who must remain in isolation).
- if you have congenital defects affecting the bones and tissues of the skull and face that have not been surgically corrected.
If any of these conditions apply to you, tell your doctor, nurse or pharmacist before
getting vaccinated. They will decide if Fluenz is suitable for you.
Children under 2 years of age
Children under 2 years of age should not receive this vaccine due to the risk of side
effects.
Other medicines, other vaccines and Fluenz
Tell your doctor, nurse or pharmacist if the person to be vaccinated is taking, has
recently taken or may take any other medicine, including over-the-counter medicines.
- Do not administeracetylsalicylic acid(a substance present in many medicines used to relieve pain and reduce fever) to childrenfor 4 weeks after vaccination with Fluenz, unless your doctor, nurse or pharmacist decides otherwise. This is due to the risk of Reye's syndrome, a very rare but serious disease that affects the brain and liver.
- Fluenz should not be takenat the same time as other antiviral medicinesspecific for influenza, such as oseltamivirand zanamivir. The vaccine may be less effective.
The doctor, nurse or pharmacist will decide whether Fluenz can be taken with other
vaccines.
Pregnancy and breastfeeding
- If you are pregnant, suspect or are planning a pregnancy, or are breastfeeding, tell your doctor, nurse or pharmacist before receiving thisvaccine. Fluenz is not recommendedfor pregnant or breastfeeding women.
Driving and operating machinery
- Fluenz does not or negligibly alters the ability to drive vehicles or operate machinery.
3. How Fluenz is administered
Fluenz must be used exclusively as a nasal spray.
Fluenz must not be injected.
Fluenz will be administered with one spray in each nostril. You can breathe normally while Fluenz is
administered. It is not necessary to inhale or actively breathe in.
Dose
The recommended dosefor children and adolescents is 0.2 mL of Fluenz, administered in
doses of 0.1 mL per nostril. Children from 2 to 8years of age who have not previously received an
influenza vaccinewill receive a second follow-up dose 4 weeks
after the first. Follow the instructions of the doctor, nurse or pharmacist regarding whether and when
the child should return to receive the second dose.
If you have any doubts about this vaccine, consult your doctor, nurse or pharmacist.
4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Ask your doctor, nurse or pharmacist if you would like more information about the possible
side effects of Fluenz.
Some side effects can be serious
Very rare(may affect 1 in 10,000 people)
- severe allergic reaction: signs of a severe allergic reaction can include shortness of breath and swelling of the face or tongue.
If you experience any side effect like those described above, seek
immediate medical attention or urgent medical care.
Other possible side effects of Fluenz
Very common(may affect more than 1 in 10 people)
- runny or blocked nose
- loss of appetite
- general feeling of being unwell
Common(may affect up to 1 in 10 people)
- fever
- muscle aches
- 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, even those not listed in this leaflet, please
tell your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system listed in Annex 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 this vaccine after the expiry date which is stated on the applicator label and on the
pack after the letters EXP.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Store the nasal applicator in the outer packaging to protect it from light.
Before use, the vaccine can be kept out of the refrigerator for a maximum of 12 hours at a temperature
not exceeding 25 °C. After 12 hours, the vaccine must be disposed of.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Fluenz contains
The active substances are:
Recombinant live attenuated influenza virus* of the following three strains**:
A/Strain similar to Victoria/4897/2022 (H1N1)pdm09
(A/ Norway/31694/2022, MEDI 369815) 10 FU***
A/Strain similar to Croatia/10136RV/2023 (H3N2)
(A/ Perth/722/2024, MEDI 392611) 10 FU***
B/Strain similar to Austria/1359417/2021
(B/ Austria/1359417/2021, MEDI 355292) 10 FU***
......................................................................................................................per dose of 0.2 mL
* Propagated in fertilised hen eggs from healthy flocks.
** Produced in VERO cells by reverse genetics. The product contains genetically modified organisms (GMOs).
*** Fluorescent Units
The vaccine is in accordance with the recommendations (Northern Hemisphere) of the World Health
Organization (WHO) and the European Union decision for the 2025/2026 season.
The vaccine may contain traces of the following substances: egg proteins (e.g. ovalbumin) and
gentamicin. The excipients are sucrose, dipotassium phosphate, potassium dihydrogen phosphate,
gelatin, arginine hydrochloride, monosodium glutamate monohydrate and water for injections.
Description of the appearance of Fluenz and contents of the pack
The vaccine is presented as a nasal spray suspension (0.2 mL), contained in a single-dose nasal
applicator (Type 1 glass). Pack sizes of 1 or 10 nasal applicators. Not all pack sizes may be
marketed in your country.
The suspension is from colourless to pale yellow, clear or slightly opalescent. Small white particles
may be present.
Marketing Authorisation Holder
AstraZeneca AB,
SE-151 85 Södertälje
Sweden
Manufacturer
AstraZeneca Nijmegen B.V.,
Lagelandseweg 78
Nijmegen, 6545CG
Netherlands
For further information on this medicinal product, please contact the local representative of the
Marketing Authorisation Holder:
België/Belgique/Belgien
AstraZeneca S.A./N.V.
Tel: +32 2 370 48 11
Lietuva
UAB AstraZeneca Lietuva
Tel: +370 5 2660550
България
АстраЗенека България ЕООД
Тел.: +359 24455000
Luxembourg/Luxemburg
AstraZeneca S.A./N.V.
Tél/Tel: +32 2 370 48 11
Česká 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: +30 210 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 73 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) DAC
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
Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu.
------------------------------------------------------------------------------------------------------------------------
Instructions for healthcare professionals
The following information is intended for healthcare professionals only:
Fluenz is for single-dose nasal use only.
- Do not use with a needle.Do not inject.
- Do not use Fluenz after the expiry date or if the nebuliser appears damaged, for example if the plunger rod is loose or removed from the nasal applicator or if there are signs of leakage.
- Check the appearance of the vaccine before administration. The suspension should be from colourless to pale yellow, from clear to opalescent. Small white particles may be present.
- Fluenz is administered as a divided dose into both nostrils as described below (see section 3).
- After administering half of the dose into one nostril, administer the other half into the other nostril immediately or shortly thereafter.
- The patient may breathe normally during vaccine administration; active inspiration or inhalation is not necessary.
Clip for dose
division
Plunger stopper
Tip protector
of the dispenser
Plunger rod
Check the
expiry date
The product must not
be used after the
date stated
on the applicator
label.
Prepare the applicator
Remove the
protection
from the tip
of the dispenser. Do not
remove the clip for the
dose division
at the other end
of the applicator.
Position
the applicator
With the patient in
an upright position,
insert the tip just
inside the nostril
to ensure delivery of Fluenz
into the nose.
Press the plunger
With one movement,
press the plunger as
quickly as possible
until the clip for the
dose division prevents
further movement.
Spray into the other
nostril
Insert the tip just
inside the other
nostriland with
one movement
press the plunger
as quickly as
possibleto deliver
the remaining vaccine.
See section 5for advice on storage and disposal.
Remove the clip for
dose division
For administration
into the other nostril, squeeze
and remove the clip for the
dose division from the
plunger.
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- Kraj rejestracji
- Postać farmaceutycznaNasal spray, suspension, 0.2 ml
- Kod ATCJ07BB03
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki FLUENTSPostać farmaceutyczna: Nasal spray, solution, 0.2 MLSubstancja czynna: influenza, live attenuatedProducent: ASTRAZENECA ABBez receptyPostać farmaceutyczna: Injectable suspension, 0.5 mLSubstancja czynna: influenza, inactivated, split virus or surface antigenProducent: SEQIRUS NETHERLANDS B.V.Bez receptyPostać farmaceutyczna: Injectable suspension in pre-filled syringe, 60 Microgrammi/HaSubstancja czynna: influenza, inactivated, split virus or surface antigenProducent: SANOFI WINTHROP INDUSTRIEBez recepty
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Substancją czynną w FLUENTS jest influenza, live attenuated. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
FLUENTS jest produkowany przez ASTRAZENECA AB. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie FLUENTS jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić FLUENTS w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (influenza, live attenuated) to m.in. PANDEMIK INFLUENTSA VAKKINE 5N1 ASTRATSENEKA, KELLDEMIK, EFLUELDA TETRA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
