powder and solvent for solution for injection in pre-filled syringe
Vaccine for group A, C, W135, and Y meningococcal infection, conjugated
What Nimenrix is and what it is used for
What Nimenrix is and what it is used for
Nimenrix is a vaccine that helps protect against infections caused by bacteria called ” Neisseria meningitidis ” type A, C, W-135, and Y.
” Neisseria meningitidis ” bacteria type A, C, W-135, and Y can cause serious diseases such as:
- meningitis – an infection of the membranes surrounding the brain and spinal cord
- sepsis – an infection of the blood
These infections are easily transmitted between people and can cause death if left untreated.
Numeric can be given to adults, adolescents, children, and infants over 6 weeks of age.
How Nimenrix works
Nimenrix helps the body produce its protection ( antibodies ) against the bacteria. These antibodies help protect you from disease.
Numeric only protects against infections caused by ” Neisseria meningitidis ” bacteria type A, C, W-135, and Y.
What you need to know before you get Nimenrix
Nimenrix should not be given:
- if you are allergic to the active substance or any of the other ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. Seek medical attention immediately if you notice any of these signs.
Talk to your doctor or nurse before receiving Nimenrix if you feel unsure.
Warnings and cautions
Talk to your doctor or nurse before receiving this vaccine if:
- you have a high fever infection (above 38 ° C). If this applies to you, the vaccination is postponed until you feel better. A mild infection such as a cold should not be a problem. However, talk to your doctor or nurse first.
- you have bleeding disorders or easily get bruises.
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before receiving Nimenrix.
Nimenrix may not provide full protection for everyone who is vaccinated. If you have a weakened immune system (eg due to HIV infection or medicines that affect the immune system) you may not get the full benefit of Nimenrix.
Fainting can occur (mainly in adolescents) after, or even before, any needle injection. Therefore, tell your doctor or nurse if you or your child fainted from a previous injection.
Other medicines and Nimenrix
Tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and other over-the-counter medicines.
Nimenrix may not work as well if you are taking medicines that affect your immune system.
Nimenrix may not work as well if you are taking medicines that affect your immune system.
In infants, Nimenrix can be given concomitantly with combined vaccines against diphtheria – tetanus – acellular pertussis (DTaP), including combination DTaP vaccines with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b (HBV, IPV or Hib) such as DTaP-HBV-IPV / HBV Hib vaccine, and with 10-valent conjugated pneumococcal vaccine.
From 1 year of age onwards, Nimenrix can be given concomitantly with any of the following vaccines: hepatitis A (HAV) and hepatitis B (HBV) vaccine, measles-mumps-rubella vaccine (MPR), measles-mumps-rubella-chickenpox vaccine (MPRV), 10-valent conjugated pneumococcal vaccine or seasonal flu vaccine without adjuvant.
During the second year of life, Nimenrix can also be given concomitantly with combined vaccines against diphtheria – tetanus – acellular pertussis (DTaP), including combination DTaP vaccines with hepatitis B, inactivated poliovirus, or Haemophilus influenzae type b (HBV, IPV, or Hib) such as DTaP- HBV-IPV / Hib vaccine, and 13-valent conjugated pneumococcal vaccine.
In subjects aged 9 to 25 years, Nimenrix can be given concomitantly with human papillomavirus vaccine [types 16 and 18] and combined vaccine against diphtheria (reduced antigen content), tetanus, and acellular pertussis.
If possible, Nimenrix and a TT-containing vaccine, such as DTaP-HBV-IPV / Hib vaccine, should be administered concomitantly or Nimenrix should be administered at least one month before the TT-containing vaccine.
Different injection sites are used for each vaccine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you must tell your doctor before taking Nimenrix.
Driving and using machines
Nimenrix is unlikely to affect your ability to drive or use machines. However, do not drive or use machines unless you are feeling well.
Nimenrix contains sodium
This vaccine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
How Nimenrix is given
Nimenrix is given by a doctor or nurse.
Nimenrix is always injected into a muscle, usually in the upper arm or thigh.
Primary vaccination
Infants from 6 weeks to 6 months of age
Two injections are given at 2-month intervals e.g. 2 and 4 months of age (the first injection can be given from 6 weeks of age).
Infants from 6 months of age, children, adolescents, and adults
An injection.
Refill doses
Infants from 6 weeks to 12 months of age
A booster dose at 12 months of age, at least 2 months after the last dose of Nimenrix.
Previously vaccinated people from 12 months of age
Tell your doctor if you have previously received an injection of a meningococcal vaccine other than Nimenrix.
Your doctor will tell you if and when you need another dose of Nimenrix, especially if you or your child:
- received the first dose one at 6-14 months of age and may be at particular risk of getting an infection caused by Neisseria meningitidis type W ‑ 135 or Y
- received dose one more than a year ago and may be at risk of getting an infection caused by Neisseria meningitidis type A
- received the first dose one at the age of 12–23 months and may be at particular risk of getting an infection caused by Neisseria meningitidis type A, C, W-135 or Y.
You will be informed when it is time for you or your child to come back for the next injection. If you or your child misses a booked injection, you must book a new appointment.
Make sure you or your child gets the entire vaccination series.
If you have any further questions on the use of this vaccine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Very common (these may occur with more than 1 in 10 doses of the vaccine):
- fever
- fatigue
- headache
- drowsiness
- loss of appetite
- irritation
- swelling, pain and redness where injection is given.
Common (these may occur with up to 1 in 10 doses of the vaccine):
- bruise (hematoma) where injection is given
- digestive and digestive problems such as diarrhea, vomiting and nausea
- skin rash (infant).
Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
- rash
- crying
- itching
- dizziness
- muscle aches
- pain in arms or legs
- general malaise
- difficulty sleeping
- decreased sensation or sensitivity, especially in the skin
- reactions where injection is given, e.g. itching , feeling of heat or numbness or a local hardening.
No known frequency: can not be calculated from the available data
- swelling and redness at the injection site; this can affect a large part of the vaccinated body part
- enlarged lymph nodes .
How to store Nimenrix
- 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 carton. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 ° C – 8 ° C).
- Store in the original package. Sensitive to light.
- Do not freeze.
- 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 substances are:
- After reconstitution contains 1 dose (0.5 ml):
Neisseria meningitidis group A polysaccharide 1 5 micrograms
Neisseria meningitidis group C polysaccharide 1 5 micrograms
Neisseria meningitidis group W-135 polysaccharide 1 5 micrograms
Neisseria meningitidis group Y polysaccharide 1 5 micrograms
1 conjugated to carrier protein of tetanus toxoid 44 micrograms
- After reconstitution contains 1 dose (0.5 ml):
- Other ingredients are:
- In the powder: sucrose and trometamol
- In the diluent: sodium chloride (see section 2 “Nimenrix contains sodium”) and water for injections
What the medicine looks like and contents of the pack
Nimenrix powder and solvent for solution for injection.
Nimenrix is supplied in the form of a white powder or cake in a disposable glass vial and a clear and colorless diluent in a pre-filled syringe.
These must be mixed before use. The reconstituted vaccine is a clear, colorless solution.
Nimenrix is available in packs of 1 and 10, with or without needles.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
| Marketing Authorisation Holder: Pfizer Europe MA EEIGBoulevard de la Plaine 171050 Brussels Belgium | Manufacturer responsible for batch release: Pfizer Manufacturing Belgium NVRijksweg 12 B-2870 Puurs Belgium |
Contact the representative of the marketing authorization holder to find out more about this vaccine:
| België / Belgique / Belgien Luxembourg / LuxemburgPfizer SA / NVTel: +32 (0) 2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. + 370 52 51 4000 |
| BulgariaPfizer Emperor Hamburg, Clone of BulgariaTel: +359 2 970 4333 | HungaryPfizer Kft Tel: +36 1 488 3700 |
| Czech RepublicPfizer, spol. s roTel: + 420-283-004-111 | MaltaVivian Corporation Ltd.Tel: +35621 344610 |
| DenmarkPfizer ApSTel: +45 44 201 100 | The NetherlandsPfizer BVTel: +31 (0) 10 406 43 01 |
| GermanyPfizer Pharma GmbHTel: +49 (0) 30 550055-51000 | NorwayPfizer ASTel: +47 67 526 100 |
| EestiPfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500 | AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0 |
| GreecePfizer Aλλάς AE Τηλ .: +30 210 6785 800 | PolandPfizer Polska Sp. z ooTel: +48 22 335 61 00 |
| SpainPfizer, SLTel: +34914909900 | PortugalPfizer Laboratories, Lda.Tel: +351 21 423 5500 |
| FrancePfizerTel: +33 (0) 1 58 07 34 40 | RomaniaPfizer Romania SRLTel: +40 (0) 21 207 28 00 |
| CroatiaPfizer Croatia dooTel: + 385 1 3908 777 | SloveniaPfizer Luxembourg SARLPfizer, underwriting and dryingpharmacevtske dejavnosti, LjubljanaTel .: + 386 (0) 1 52 11 400 |
| IrelandPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 | Slovak RepublicPfizer Luxembourg SARL,organizing serviceTel: + 421 2 3355 5500 |
| IcelandIcepharma hfPhone: +354 540 8000 | Finland / FinlandPfizer OyPuh / Tel: +358 (0) 9 430 040 |
| ItalyPfizer SrlTel: +39 06 33 18 21 | SwedenPfizer ABTel: +46 (0) 8 550 520 00 |
| K ύπροςPfizer Aλλάς AE (Cyprus Branch):Ηλ: +357 22 817690 | United Kingdom (Northern Ireland)Pfizer LimitedTel: +44 (0) 1304 616161 |
| LatviaPfizer Luxembourg SARL subsidiary LatvijāTel .: + 371 670 35 775 |