MENJUGATE 10 MICROGRAMS Zawiesina do wstrzykiwań
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MENJUGATE 10 micrograms injectable suspension
Meningococcal group C conjugate vaccine
Read this leaflet carefully before using this medicine as it contains important
information for you or your child.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or nurse.
- This vaccine has been prescribed only for you or your child. Do not give it to other people.
- If you or your child experience any side effects, including those not listed in this leaflet, ask your doctor or nurse. See section 4.
Contents of this leaflet:
- 1. What Menjugate is and what it is used for
- 2. What you need to know before using Menjugate for you or your child
- 3. How to use Menjugate
- 4. Possible side effects
- 5. How to store Menjugate
- 6. Contents of the pack and other information
1. What is Menjugate and what is it used for
Menjugate is a vaccine used to prevent the disease caused by the bacterium Neisseria meningitidisof
group C (also called group C meningococcus). The vaccine works by stimulating the body to produce
its own protection (antibodies) against these group C meningococcal bacteria.
Neisseria meningitidisof group C can cause serious infections that can sometimes be life-threatening, such
as, for example, meningitis and septicemia (blood infection).
This vaccine is used for the active immunization of children from 2 months of age, adolescents and
adults and induces protection only against group C meningococcal bacteria. It does not protect against other groups
(strains) of meningococcal bacteria or against other agents that can cause meningitis or septicemia (blood
infection). If at any time you or your child experience neck pain or stiffness, or discomfort caused by light (photophobia), drowsiness or confusion, red or purplish spots similar to bruises on
the skin that do not disappear when pressed, you should immediately contact your doctor or the nearest
Emergency Room.
This vaccine cannot cause type C meningitis (disease caused by group C meningococcus).
This vaccine contains a protein (called CRM197) from the bacterium that causes diphtheria. Menjugate does not
protect against diphtheria.This means that you (or your child) must receive a different vaccine to be protected against diphtheria when it is scheduled on the vaccination schedule or when recommended by your doctor.
2. What you need to know before using Menjugate for you or your child
Do not use Menjugate if you or your child:
- have previously had an allergic reaction to the active ingredientsor to any of the other ingredients of Menjugate (listed in section 6)
- have previously had an allergic reactionto diphtheria toxoid(a substance also present in other vaccines).
Warnings and precautions
Fainting, dizziness or other reactions related to this type of stress can occur as a response to administration with a needle. Tell your doctor or nurse if you (or your child) have
had this type of reaction before.
Consult your doctor or nurse before Menjugate is given to you or your child if you or your
child:
- suffer from hemophiliaor any other condition that prevents blood from clotting properly (for example, a low platelet count called thrombocytopenia) or are taking medications that may affect blood clotting
- have a weakened immune systemfor any reason (for example, if you, or your child, do not produce antibodies effectively or if you, or your child, are taking medications that reduce the immune response to infections, such as anticancer drugs or high doses of corticosteroids)
- are receiving treatment that blocks the part of the immune system known as complement activation, such as eculizumab. Even if vaccinated with Menjugate, you remain at higher risk of illness caused by Neisseria meningitidisgroup C bacteria
- have had their spleen removedor have been told that their spleen is not functioning properly
- have a infectious disease or high fever.In this case, it may be necessary to postpone vaccination with Menjugate. However, a minor infection (for example, a cold) is not a reason to postpone vaccination
- are over 65 years of age
- suffer from a kidney diseasein which there is a large amount of protein in the urine (called nephrotic syndrome). Cases of reactivation of this syndrome have been reported after vaccination. This vaccine may only induce protection against group C meningococcal bacteria. It cannot protect against other types of meningococcal bacteria.
Latex-sensitive individuals for the syringe presentation:
Although latex rubber has not been detected in the syringe cap, the safety of using Menjugate in latex-sensitive individuals has not been established.
Other medicines and Menjugate
Tell your doctor or nurse if you (or your child) are taking, have recently taken or might take
any other medicine.
Menjugate can be given at the same time as other vaccinations, but in this case the other
injectable vaccines must be given at a different injection site, preferably in a
different arm or leg from the Menjugate injection site.
These vaccines include:
- oral or injectable polio vaccine
- diphtheria and tetanus vaccine alone or combined with vaccines for pertussis
- vaccine for Haemophilus influenzaetype b (Hib)
- hepatitis B vaccine given alone or in combination with vaccines against diphtheria, tetanus, Haemophilus influenzaetype b, polio and pertussis
- combined measles, mumps and rubella (MMR) vaccine
- conjugated pneumococcal vaccine These other vaccines should be given at the recommended age as usual.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or nurse for advice before you are given Menjugate. The
doctor or nurse may still advise you to receive Menjugate if you are at high risk
of contracting group C meningococcal infection.
Driving and using machines
You may experience dizziness or other side effects after the injection. This may
interfere with your ability to drive or use machines. Do not drive or use machines until you
know how Menjugate affects you.
Menjugate contains:
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.
3. How to use Menjugate
Menjugate will be administered by a doctor or nurse.
The vaccine is usually administered into the thigh muscle in infants and young children and into the shoulder muscle in older children, adolescents and adults.
The doctor or nurse will ensure that the vaccine is not administered into a blood vessel and will make sure to inject it into the muscle and not into the subcutaneous tissue.
For children aged 12 months or older, adolescents and adults: a single dose (0.5 ml) of the vaccine is recommended.
For infants and young children aged between 2 and 12 months: two doses of Menjugate must be administered with an interval of at least two months.
In order to maintain protection, children who have completed the primary vaccination schedule with two doses must subsequently receive a booster dose. Your doctor will inform you when this dose should be administered to your child.
For information on vaccine handling, see the section for doctors and healthcare professionals at the
If you use more Menjugate than you should
Since Menjugate will be administered by a doctor or nurse and each injection consists of a single dose of 0.5 ml, it is very unlikely that you (or your child) will receive an excessive dose of vaccine.
If you have any doubts about the amount of vaccine administered to you (or your child), talk to your doctor or nurse.
If you have any questions about the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, Menjugate can cause side effects, although not everybody gets them.
manifest.
If you experience a severe allergic reaction (usually in less than 1 in 10,000 people), report it
immediately to your doctor or take yourself/your child to the nearest Emergency Room immediately
because urgent medical attention may be needed.
The symptomsof a severe allergic reaction may include:
- swelling of lips, mouth, throat (which may cause difficulty swallowing)
- difficulty breathing with wheezing or coughing
- skin rash and swelling of hands, feet and ankles
- loss of consciousness
- very low blood pressure.
These very rare reactions can occur immediately or shortly after the injection and usually resolve
rapidly if appropriate treatment is given.
Other allergic-type reactionsmay begin several days after vaccination.
These include:
- skin rashes, sometimes with itching, purple spots or patches on the skin
- rashes with blisters that can also cause ulcers in the mouth and around the genitals. The most common side effects reported during clinical trials generally lasted one or two days and were generally not serious. The side effects were: Very common(may affect more than 1 in 10 people)
- In all age groups: redness, swelling and tenderness/pain at the injection site. This type of reaction generally did not require further medical care. Redness or swelling of at least 3 cm and tenderness that interferes with movement have been rarely observed for more than 48 hours
- Infants and young children: feeling unwell (vomiting).
- Infants, young children and children up to 2 years: irritability, drowsiness, sleep disturbances, loss of appetite and diarrhea
- School-age children: headache
- Older children and adults: muscle and joint pain, general malaise
- Adults: feeling unwell (nausea).
Common(may affect up to 1 in 10 people)
- In all age groups: fever (but rarely severe)
- Infants, young children and children up to 2 years: crying
- Children up to 2 years: feeling unwell (vomiting)
- Elementary school children: headache
Other side effectsreported during routine vaccination programs include:
Very rare(may affect up to 1 in 10,000)
Different age groups:
- Swollen lymph nodes
- Dizziness
- Fainting
- Numbness
- Tingling or prickling sensation
- Temporary reduction in muscle tone
- Visual disturbances and sensitivity to light. This type of events generally occurred together with headache and dizziness
- Widespread swelling of the vaccinated limb.
Although seizures have been reported very rarely after vaccination with Menjugate, it is believed
that in some cases occurring in adolescents and adults, they may have been fainting. In infants, in
young children and in smaller children, seizures were generally associated with
high fever. The majority of patients recovered quickly.
Cases of recurrence of a kidney disease called nephrotic syndrome have been reported very rarely after administration of this type of vaccine.
In very premature babies (at the 28th week of gestation or earlier), longer-than-normal intervals between breaths may occur for two-three days after vaccination.
Reporting of side effects
If you or your child experience any side effects, including those not listed in this
leaflet, please tell your doctor or nurse. You can also report side effects directly to
adverse.
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Menjugate
Keep this vaccine out of the sight and reach of children.
Do not use Menjugate after the expiry date which is stated on the pack.
The vaccine consists of a vial or a syringe.
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial or syringe in the outer packaging
to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your doctor or
nurse how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Menjugate contains
Each 0.5 ml dose of vaccine contains the following amount of activesubstance:
10 micrograms of oligosaccharide of Neisseria meningitidisgroup C (strain C11) chemically
conjugated to 12.5 – 25 micrograms of CRM197 protein of Corynebacterium diphtheriae.
The active substance is adsorbed on aluminium hydroxide (0.3 – 0.4 mg Al) in 0.5 ml (1 dose) of vaccine.
The otheringredients are: sodium chloride, histidine and water for injections (see also the end of
paragraph 2).
Description of the appearance of Menjugate and contents of the pack
Menjugate is an injectable suspension.
Each dose of Menjugate is available as:
- Vial containing an opalescent white suspension or
- Syringe containing an opalescent white suspension
Pack sizes: 1, 5 and 10 doses. Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder: GSK Vaccines S.r.l., Via Fiorentina 1, 53100
Siena, Italy
Manufacturer :GSK Vaccines S.r.l., Bellaria-Rosia, 53018 Sovicille (SI), Italy
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The following information is intended for healthcare professionals only:
Syringe:
Gently shake the syringe containing the vaccine before administration. Remove the cap
from the syringe and insert a suitable needle. Before administration, visually inspect the vaccine for
the presence of particles and changes in colour. Before injecting the vaccine, ensure that there are no air
bubbles in the syringe. If foreign particles or changes in physical appearance are observed, discard the
vaccine.
Vial:
Gently shake the vial with the vaccine. Using a syringe and a suitable needle (21 G, 40 mm long)
draw up the entire contents of the vial. Before injection, replace the needle with one suitable for
administration. Before administration, visually inspect the vaccine for the presence of
particles and changes in colour. Before injecting the vaccine, ensure that there are no
air bubbles in the syringe. If foreign particles or changes in physical appearance are observed,
discard the vaccine.
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- Kraj rejestracji
- Postać farmaceutycznaInjectable suspension, 10 MICROGRAMS
- Kod ATCJ07AH07
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki MENJUGATEPostać farmaceutyczna: Injectable suspension in pre-filled syringe, 0.5MLSubstancja czynna: meningococcus B, multicomponent vaccineProducent: GLAXOSMITHKLINE VACCINES S.R.L.Bez receptyPostać farmaceutyczna: Injectable solution, 0.5 MLProducent: SANOFI WINTHROP INDUSTRIEWymaga receptyProducent: GLAXOSMITHKLINE VACCINES S.R.L.Bez recepty
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MENJUGATE nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w MENJUGATE jest meningococcus C, purified polysaccharides antigen conjugated. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
MENJUGATE jest produkowany przez GLAXOSMITHKLINE VACCINES S.R.L.. 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 MENJUGATE 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 MENJUGATE 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 C, purified polysaccharides antigen conjugated) to m.in. BEXSERO, MENQUADFI, MENVEO. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
