Nimenrix – Vaccine uses, dose and side effects

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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
  • 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 BelgiumManufacturer 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 / Luxemburg
Pfizer 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 4333HungaryPfizer Kft
Tel: +36 1 488 3700
Czech RepublicPfizer, spol. s roTel: + 420-283-004-111MaltaVivian Corporation Ltd.Tel: +35621 344610
DenmarkPfizer ApSTel: +45 44 201 100The NetherlandsPfizer BVTel: +31 (0) 10 406 43 01
GermanyPfizer Pharma GmbHTel: +49 (0) 30 550055-51000NorwayPfizer ASTel: +47 67 526 100
EestiPfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500AustriaPfizer 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: +34914909900PortugalPfizer Laboratories, Lda.Tel: +351 21 423 5500
FrancePfizerTel: +33 (0) 1 58 07 34 40RomaniaPfizer Romania SRLTel: +40 (0) 21 207 28 00
CroatiaPfizer Croatia dooTel: + 385 1 3908 777SloveniaPfizer Luxembourg SARLPfizer, underwriting and dryingpharmacevtske dejavnosti, LjubljanaTel .: + 386 (0) 1 52 11 400
IrelandPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161Slovak RepublicPfizer Luxembourg SARL,organizing serviceTel: + 421 2 3355 5500
IcelandIcepharma hfPhone: +354 540 8000Finland / FinlandPfizer OyPuh / Tel: +358 (0) 9 430 040
ItalyPfizer SrlTel: +39 06 33 18 21SwedenPfizer ABTel: +46 (0) 8 550 520 00
ύπροςPfizer Aλλάς AE (Cyprus Branch):Ηλ: +357 22 817690United Kingdom (Northern Ireland)Pfizer LimitedTel: +44 (0) 1304 616161
LatviaPfizer Luxembourg SARL subsidiary LatvijāTel .: + 371 670 35 775

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