MENQUADFI 0.5 ML Roztwór do wstrzykiwań
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Jak stosować MENQUADFI
Treść ulotki
MenQuadfi injectable solution
Meningococcal conjugate vaccine groups A, C, W and Y
Read this leaflet carefully before you or your child are given this vaccine
because it contains important information for you and your child.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed only for you or your child. Do not give it to other people.
- If any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What MenQuadfi is and what it is used for
- 2. What you need to know before you receive MenQuadfi
- 3. How to use MenQuadfi
- 4. Possible side effects
- 5. How to store MenQuadfi
- 6. Contents of the pack and other information
1. What MenQuadfi is and what it is used for
MenQuadfi (MenACWY) is a vaccine that can be given to children from 1 year of age, to
adolescents and adults.
MenQuadfi helps to protect against infections caused by bacteria (germs) called “ Neisseria
meningitidis”, specifically against types A, C, W and Y.
The bacteria “ Neisseria meningitidis” (also called meningococci) can be transmitted from person to
person and cause serious and sometimes life-threatening infectious diseases, such as:
- meningitis - an inflammation of the tissues surrounding the brain and spinal cord
- septicemia - a blood infection. Both infections can cause serious conditions with long-term effects and can lead to death.
MenQuadfi must be used in accordance with official national guidelines.
How MenQuadfi works
MenQuadfi helps the body to produce its own protection (antibodies) against the bacteria.
Antibodies help to protect against the disease.
MenQuadfi helps to protect only against diseases caused by Neisseria meningitidisof type A, C, W and Y.
- It does not protect against infections caused by other types of Neisseria meningitidis.
- It does not protect against meningitis or septicemia caused by other bacteria or viruses.
2. What you need to know before you receive MenQuadfi
MenQuadfi must not be given if:
- you are allergic to the active ingredient or any of the other ingredients of this vaccine (listed in section 6), or if you have had an allergic reaction to this vaccine before.
If you are not sure, ask your doctor, pharmacist or nurse before you are given
MenQuadfi.
Warnings and precautions
Consult your doctor, pharmacist or nurse before receiving MenQuadfi if you or your child:
- have an infection with high fever (above 38°C). If this applies to you, the vaccination will not be given until you feel better. You do not need to postpone vaccination in the case of a minor infection such as a cold. In any case, consult your doctor, pharmacist or nurse first;
- have bleeding problems or are easily prone to bruising;
- have fainted in the past after an injection. Fainting, sometimes followed by a fall (especially in adolescents), can occur after or even before an injection;
- have a weakened immune system (HIV infection, other illnesses or taking medicines that affect the immune system), as you may not benefit fully from MenQuadfi. If any of the above conditions apply to you (or if you have any doubts), consult your doctor, pharmacist or nurse before you or your child receive MenQuadfi.
As with any vaccine, MenQuadfi may not protect all vaccinated people.
Other medicines and MenQuadfi
Tell your doctor, pharmacist or nurse if you or your child are taking, have recently taken
or might take any other medicines, including other vaccines and over-the-counter medicines.
In particular, tell your doctor, pharmacist or nurse if you or your child are taking medicines
that affect the immune system, such as:
- high-dose corticosteroids
- chemotherapeutic medicines.
MenQuadfi can be given at the same time as other vaccines, using a different injection site.
These vaccines include: measles, mumps, rubella, varicella, diphtheria, tetanus, pertussis,
poliomyelitis, Haemophilus influenzaetype b, hepatitis B, pneumococcus, human papillomavirus and Neisseria
meningitidistype b.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding,
ask your doctor, pharmacist or nurse for advice before receiving MenQuadfi.
Driving and using machines
It is unlikely that MenQuadfi will affect your ability to drive or use machines.
However, do not drive or use machines if you do not feel well.
MenQuadfi contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.
3. How to use MenQuadfi
MenQuadfi will be administered by a doctor or nurse as a 0.5 mL injection into the muscle.
MenQuadfi is injected into the upper arm or thigh depending on age and muscle mass.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Immediately consult a doctor or healthcare professional or go to the nearest hospital emergency room if you or your child experience any of the following symptoms after vaccination:
- itchy rash
- difficulty breathing, shortness of breath
- swelling of the face, lips, throat or tongue This could be a sign of an allergic reaction.
Side effects in children (aged 2 years and over), adolescents and adults
Very common(may affect more than 1 in 10 people)
- pain at the injection site
- muscle pain
- headache
- general feeling of unwellness
Common(may affect up to 1 in 10 people)
- redness or swelling at the injection site
- fever
Uncommon(may affect up to 1 in 100 people)
- itching, warmth, bruising or rash at the injection site
- vomiting
- feeling of dizziness
- nausea
- fatigue (feeling tired)
Rare(may affect up to 1 in 1,000 people)
- swollen lymph nodes
- diarrhea
- stomach pain
- urticaria (hives)
- feeling of itching
- rash
- pain in the arms or legs
- chills
- armpit pain
- stiffness at the injection site Very rare(may affect less than 1 in 10,000 people)
- sudden and severe allergic reactions with difficulty breathing, urticaria, swelling of the face and throat, rapid heartbeat, dizziness, weakness, sweating and loss of consciousness
Not known(frequency cannot be estimated based on available data)
- allergic reaction
- seizures (convulsions) with or without fever
Side effects in children aged 12 to 23 months
Very common(may affect more than 1 in 10 people)
- tenderness/pain, redness or swelling at the injection site
- feeling irritable
- crying
- loss of appetite
- feeling sleepy
Common(may affect up to 1 in 10 people)
- fever
- vomiting
- diarrhea
Uncommon(may affect up to 1 in 100 people)
- difficulty sleeping
- urticaria (hives)
- itching, bruising, stiffness or rash at the place where the injection was given Very rare(may affect less than 1 in 10,000 people)
- sudden and severe allergic reactions with difficulty breathing, urticaria, swelling of the face and throat, rapid heartbeat, dizziness, weakness, sweating and loss of consciousness
Not known(frequency cannot be estimated based on available data)
- allergic reaction
- seizures (convulsions) with or without fever
Reporting of side effects
If you or your child experience any side effects, including those not listed in this leaflet,
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 MenQuadfi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date
refers to the last day of the month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
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 MenQuadfi contains
One dose (0.5 mL) contains:
- active substances
- Neisseria meningitidisgroup A polysaccharide 10 micrograms
- Neisseria meningitidisgroup C polysaccharide 10 micrograms
- Neisseria meningitidisgroup Y polysaccharide 10 micrograms
- Neisseria meningitidisgroup W polysaccharide 10 micrograms
conjugated to tetanus toxoid carrier protein 55 micrograms
- other ingredients
- sodium chloride
- sodium acetate (E 262)
- water for injections
Description of MenQuadfi and contents of the pack
MenQuadfi is a clear and colourless solution for injection.
MenQuadfi is available in packs of 1, 5 or 10 single-dose vials (0.5 mL) and in a pack of 1
single-dose vial (0.5 mL) including 1 empty single-use syringe and 2 needles. Not all pack sizes may be
marketed.
Marketing authorisation holder and manufacturer
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France
Manufacturer
Sanofi Winthrop Industrie
Voie de l’Institut
Parc Industriel d’Incarville
BP 101
27100 Val de Reuil
France
Sanofi-Aventis Zrt.
Building. DC5
Campona utca 1.
Budapest, 1225
Hungary
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
Lietuva
Swixx Biopharma, UAB
Tel: +370 5 2369140
België/Belgique /Belgien
Sanofi Belgium
Tél/Tel: +32 2 710.54.00
България
Swixx Biopharma EOOD
Teл.: +359 (0)2 4942 480
Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 2 710.54.00
Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111
Magyarország
sanofi-aventis zrt
Tel: +36 1 505 0055
DanmarkMalta
Sanofi A/S
Tlf: +45 4516 7000
Sanofi S.r.l.
Tel: +39 02 39394275
Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 54 54 010
Tel aus dem Ausland: +49 69 305 21 130
Nederland
Sanofi B.V.
Tel: +31 20 245 4000
Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30
Norge
Sanofi-aventis Norge AS
Tl: + 47 67 10 71 00
Österreich
Sanofi-Aventis GmbH
Tel: +43 (1) 80185-0.
España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00
Ελλάδα
ΒΙΑΝΕΞ Α.Ε.
Τηλ: +30.210.8009111
Polska
Sanofi Sp. z o.o.
Tel: +48 22 280 00 00
France
Sanofi Winthrop Industrie
Tél: 0800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23
Portugal
Sanofi – Produtos Farmacêuticos, Lda.
Tel: + 351 21 35 89 400
Hrvatska
Swixx Biopharma d.o.o
Tel: +385 1 2078 500
Ireland
sanofi-aventis Ireland T/A SANOFI
Tel: + 353 (0) 1 4035 600
România
Sanofi Romania SRL
Tel: +40(21) 317 31 36
Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00
Ísland
Vistor
Sími: +354 535 7000
Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600
Italia
Sanofi S.r.l.
Tel: 800536389
Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300
Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741 741
Sverige
Sanofi AB
Tel: +46 8-634 50 00
Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50
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
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- Kraj rejestracji
- Postać farmaceutycznaInjectable solution, 0.5 ML
- Kod ATCJ07AH08
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki MENQUADFIProducent: GLAXOSMITHKLINE VACCINES S.R.L.Bez receptyPostać farmaceutyczna: Powder and solvent for injectable solution, 5 MCG/5 MCG/5 MCG/5 MCGProducent: PFIZER EUROPE MA EEIGWymaga receptyPostać farmaceutyczna: Injectable suspension in pre-filled syringe, 0.5MLSubstancja czynna: meningococcus B, multicomponent vaccineProducent: GLAXOSMITHKLINE VACCINES S.R.L.Bez recepty
Odpowiedniki MENQUADFI w innych krajach
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Często zadawane pytania
MENQUADFI wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w MENQUADFI jest meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen conjugated. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
MENQUADFI jest produkowany przez SANOFI WINTHROP INDUSTRIE. 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 MENQUADFI 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 MENQUADFI 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 (meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen conjugated) to m.in. MENVEO, NIMENRIX, BEXSERO. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
