Brand name Nimenrix

Form solution for injection, powder and solvent

Active substance / Dosage

MENINGOCOCCAL GROUP A C W Y CONJUGATE VACCINE

Prescription type Prescription only

ATC code

J07AH08

Registration number 042040

Manufacturer PFIZER EUROPE MA EEIG

Nimenrix solution for injection, powder and solvent

Table of Contents

Package leaflet: Information for the user
Nimenrix powder and solvent for injectable solution in pre-filled syringe
1. What Nimenrix is and what it is used for
2. What you need to know before receiving Nimenrix
3. How to use Nimenrix
4. Possible side effects
5. How to store Nimenrix
6. Package contents and other information
Package leaflet: information for the user
Nimenrix powder and solvent for injectable solution in vials
1. What Nimenrix is and what it is used for
2. What you should know before receiving Nimenrix
3. How to use Nimenrix
4. Possible side effects
5. How to store Nimenrix
6. Package contents and other information
The following information is intended exclusively for healthcare professionals:

Package leaflet: Information for the user

Nimenrix powder and solvent for injectable solution in pre-filled syringe

Meningococcal serogroups A, C, W-135 and Y conjugate vaccine
Please read this leaflet carefully before receiving this vaccine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you or your child. Do not give it to others.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. This leaflet has been written assuming that the person to be vaccinated can read it, but since the vaccine may be administered to adults and children, you may need to read it on behalf of a child.

Contents of this leaflet:

What Nimenrix is and what it is used for
What you need to know before receiving Nimenrix
How to use Nimenrix
Possible side effects
How to store Nimenrix
Contents of the pack and other information

1. 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 known as
"Neisseria meningitidis" types A, C, W-135 and Y.
"Neisseria meningitidis" bacteria types A, C, W-135 and Y can cause serious diseases such as:

Meningitis – an infection of the lining covering the brain and spinal cord
Septicaemia – a blood infection. These infections spread easily from person to person and, if left untreated, can lead to death. Nimenrix can be administered to adults, adolescents, children, and infants from the age of 6 weeks onwards.

How Nimenrix works
Nimenrix helps the body produce protection (antibodies) against the bacteria. These antibodies help
protect against disease.
Nimenrix will only protect against infections caused by "Neisseria meningitidis" bacteria types A, C, W-135 and Y.

2. What you need to know before receiving Nimenrix

Nimenrix must not be given if:

you are allergic to the active substances or to any of the other components of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, difficulty breathing, or swelling of the face or tongue. Seek immediate medical advice if you notice any of these reactions. If you are unsure, ask your doctor or nurse before Nimenrix is administered.

Warnings and precautions
Talk to your doctor or nurse before receiving this vaccine if:

you have an infection with high fever (above 38 °C). If this applies to you, vaccination will be postponed until you feel better. A minor infection such as a cold is not a problem. However, please speak to your doctor or nurse first.
you have bleeding problems or bruise easily.

If any of the above applies to you (or you are unsure), talk to your doctor or nurse before receiving Nimenrix.
Nimenrix may not fully protect all vaccinated individuals. If you have a weakened immune system (for example due to HIV infection or medications affecting the immune system), you may not get the maximum benefit from Nimenrix.
Fainting (especially in adolescents) may occur during or even before any needle injection. Therefore, inform your doctor or nurse if you or the child has fainted after a previous injection.

Other medicines and Nimenrix
Tell your doctor or nurse if you are taking or have recently taken any other medicines, including other vaccines and over-the-counter medicines.
Nimenrix may be less effective if you are taking medicines that reduce the activity of the immune system.

In early infancy, Nimenrix can be given at the same time as vaccines against diphtheria, tetanus, and acellular pertussis (DTaP), including DTaP combination vaccines with hepatitis B, inactivated poliovirus, or Haemophilus influenzae type b (HBV, IPV or Hib), such as the DTaP-HBV-IPV/Hib vaccine, and with the 10-valent pneumococcal conjugate vaccine.

From the first year of life, Nimenrix can be administered simultaneously with any of the following vaccines: hepatitis A (HAV) and hepatitis B (HBV) vaccines, measles-mumps-rubella (MMR) vaccines, measles-mumps-rubella-varicella (MMRV) vaccines, 10-valent pneumococcal conjugate vaccine, or non-adjuvanted seasonal influenza vaccines.

In the second year of life, Nimenrix can also be administered at the same time as combination vaccines against diphtheria-tetanus-acellular pertussis (DTaP), including DTaP combination vaccines with hepatitis B, inactivated poliovirus, or Haemophilus influenzae type b (HBV, IPV or Hib), such as the DTaP-HBV-IPV/Hib vaccine, and with the 13-valent pneumococcal conjugate vaccine.

In individuals aged between 9 and 25 years, Nimenrix may be administered concurrently with the bivalent [types 16 and 18] Human Papillomavirus vaccine and a combination vaccine against diphtheria (reduced antigen content), tetanus and acellular pertussis (dTap).
Whenever possible, Nimenrix and a vaccine containing tetanus toxoid (TT), such as the DTaP-HBV-IPV/Hib vaccine, should either be co-administered or Nimenrix should be given at least one month before the TT-containing vaccine.
A different injection site will be used for each vaccine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before receiving Nimenrix.

Driving and using machines
It is unlikely that Nimenrix will affect your ability to drive or operate machinery. However, do not drive or operate machinery if you do not feel well.

Nimenrix contains Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to use Nimenrix

Nimenrix will be administered by a doctor or nurse.
Nimenrix is always injected into a muscle, usually in the upper arm or thigh.

Primary vaccination
Infants aged between 6 weeks and less than 6 months
Two injections given 2 months apart, for example at 2 and 4 months of age (the first injection
may be given from 6 weeks of age).

Infants aged 6 months and older, children, adolescents, and adults
One injection.

Booster doses
Infants aged between 6 weeks and less than 12 months:
One booster dose at 12 months of age, given at least 2 months after the last dose of Nimenrix.

Individuals aged 12 months and older who have been previously vaccinated:
Inform your doctor if you have previously received an injection with another meningococcal vaccine different from Nimenrix.
Your doctor will advise you whether and when you need another dose of Nimenrix, especially if you or the child:

received the first dose between 6 and 14 months of age and may be at particular risk of infection due to Neisseria meningitidis types W-135 and Y
received the dose approximately more than a year ago and may be at risk of infection caused by Neisseria meningitidis type A
received the first dose between 12 and 23 months of age and may be at particular risk of infection caused by Neisseria meningitidis types A, C, W-135 and Y

You will be informed when you or the child should receive the next injection. If you or the child miss an injection, it is important to schedule another appointment.
Make sure that you or the child complete the entire vaccination course.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everyone experiences them. The following side effects may occur with this medicine:
Very common (may occur in more than 1 in 10 doses of vaccine):

fever
fatigue (tiredness)
headache
drowsiness
loss of appetite
irritability
swelling, pain and redness at the injection site

Common (may occur in up to 1 in 10 doses of vaccine):

bruising (haematoma) at the injection site
stomach and digestive problems such as diarrhoea, vomiting and nausea
skin rash (in early childhood)

Uncommon (may occur in up to 1 in 100 doses of vaccine):

skin redness (erythema)
hives (urticaria)
itching (pruritus)
crying
dizziness
muscle pain
pain in arms or legs
general malaise
difficulty sleeping
decreased sensation or sensitivity, particularly in the skin
injection site reactions such as itching, a feeling of warmth or numbness, or a hard lump
allergic reaction

Rare (may occur in up to 1 in 1,000 doses of vaccine):

seizures (fits) associated with high temperature

Not known: frequency cannot be estimated from the available data

swelling and redness at the injection site; this may affect a large area of the limb where the vaccination was given
swollen lymph nodes
severe allergic reaction

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 Nimenrix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C).
Keep in the original packaging to protect the medicine from light.
Do not freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nimenrix contains

The active substances are:
After reconstitution, 1 dose (0.5 mL) contains:
Neisseria meningitidis group A polysaccharide 5 micrograms
Neisseria meningitidis group C polysaccharide 5 micrograms
Neisseria meningitidis group W-135 polysaccharide 5 micrograms
Neisseria meningitidis group Y polysaccharide 5 micrograms

conjugated to tetanus toxoid carrier protein 44 micrograms

The other components are:
In the powder: sucrose and tromethamine
In the solvent: sodium chloride (see section 2 “Nimenrix contains sodium”) and water for injections

Description of the appearance of Nimenrix and contents of the pack
Nimenrix is a powder and solvent for injectable solution.
Nimenrix is supplied as a white powder, possibly compacted, in a single-dose glass vial, and a clear, colourless solvent in a pre-filled syringe.
These must be mixed together before use. The mixed vaccine will appear as a clear, colourless solution.
Nimenrix is available in packs of 1 or 10 units with or without needles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Responsible manufacturer for batch release:
Pfizer Manufacturing Belgium N.V.
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Pfizer S.A./N.V.
Tél/Tel: +32 (0)2 554 62 11

България
Пфайзер Люксембург САРЛ, Клон България
Teл: +359 2 970 4333

Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111

Danmark
Pfizer ApS
Tlf.: +45 44 201 100

Deutschland
Pfizer Pharma GmbH
Tel: +49 (0)30 550055-51000

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ.: +30 210 6785 800

España
Pfizer, S.L.
Télf: +34 914909900

France
Pfizer
Tél: +33 1 58 07 34 40

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: 1800 633 363 (toll free)
+44 (0)1304 616161

Ísland
Icepharma hf
Simi: +354 540 8000

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ: +357 22 817690

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel.: +371 670 35 775

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 52 51 4000

Luxembourg/Luxemburg
Pfizer Luxembourg SARL
Tel: +352 271 5551

Magyarország
Pfizer Kft
Tel: +36 1 488 3700

Malta
Vivian Corporation Ltd.
Tel: +356 2134 4610

Nederland
Pfizer BV
Tel: +31 (0)800 633 4636

Norge
Pfizer AS
Tlf: +47 67 526 100

Österreich
Pfizer Corporation Austria Ges.m.b.H
Tel: +43 (0)1 521 15-0

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

România
Pfizer Romania S.R.L
Tel: +40 (0) 21 207 28 00

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel.: +386 (0)1 52 11 400

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

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.

The following information is intended exclusively for healthcare professionals:
The vaccine is for intramuscular use only. Do not administer intravascularly, intradermally or subcutaneously.
If Nimenrix is co-administered with other vaccines, different injection sites must be used.
Nimenrix must not be mixed with other vaccines.

Instructions for reconstituting the vaccine with the solvent supplied in the pre-filled syringe:
Nimenrix must be reconstituted by adding the entire contents of the pre-filled solvent syringe to the vial containing the powder.
To insert the needle into the syringe, refer to the figures. However, the syringe supplied with Nimenrix may be slightly different (without threaded tip) compared to the syringe shown in the figure. In this case, the needle should be inserted without screwing.

Holding the barrel of the syringe in one hand

(avoid holding the syringe plunger),
unscrew the syringe cap by rotating it counterclockwise.
Two hands rotating and attaching a protective cap to the tip of a syringe following the direction indicated by the arrows

To attach the needle to the syringe, rotate the needle clockwise into the syringe until it locks (see figure).
Remove the needle protective cap, which may in some cases be slightly difficult to remove.
Add the solvent to the powder. After adding the solvent to the powder, the mixture must be thoroughly agitated to ensure the powder is completely dissolved in the solvent.

The reconstituted vaccine is a clear, colourless solution.
Before administration, the reconstituted vaccine must be inspected visually for the presence of foreign particles and/or any change in physical appearance. If either is observed, discard the vaccine.
After reconstitution, the vaccine should be used immediately.
A new needle must be used to administer the vaccine.
Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.

Package leaflet: information for the user

Nimenrix powder and solvent for injectable solution in vials

Meningococcal conjugate vaccine groups A, C, W-135 and Y
Please read this leaflet carefully before receiving this vaccine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you or your child. Do not give it to others.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. This leaflet has been written assuming that the person for whom the vaccine is intended will read it, but the vaccine may be administered to adults and children, so you may be reading it on behalf of your child.

Contents of this leaflet

What Nimenrix is and what it is used for
What you need to know before receiving Nimenrix
How to use Nimenrix
Possible side effects
How to store Nimenrix
Contents of the pack and other information

1. 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 known as
"Neisseria meningitidis" types A, C, W-135 and Y.
"Neisseria meningitidis" bacteria types A, C, W-135 and Y can cause serious diseases such as:

Meningitis – an infection of the lining covering the brain and spinal cord
Septicaemia – a blood infection. These infections are easily spread from person to person and, if left untreated, can lead to death. Nimenrix can be administered to adults, adolescents, children and infants from the age of 6 weeks onwards.

How Nimenrix works
Nimenrix helps the body produce protection (antibodies) against the bacteria. These antibodies help
protect you against the disease.
Nimenrix will protect only against infections caused by "Neisseria meningitidis" bacteria types A, C, W-135 and Y.

2. What you should know before receiving Nimenrix

Nimenrix must not be given if:

you are allergic to the active substances or to any of the other components of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy red rash, difficulty breathing, or swelling of the face or tongue. Contact your doctor immediately if you notice any of these reactions. If you are unsure, ask your doctor or nurse before Nimenrix is administered.

Warnings and precautions
Consult your doctor or nurse before receiving this vaccine if:

you have an infection with a high fever (above 38 °C). If this applies to you, vaccination will be postponed until you feel better. A minor infection such as a cold should not be a problem. However, speak to your doctor or nurse first.
you have bleeding problems or bruise easily.

If any of the above apply to you (or you are unsure), talk to your doctor or nurse before receiving
Nimenrix.
Nimenrix may not fully protect all vaccinated individuals. If you have a weakened immune system
(for example due to HIV infection or medications that affect the immune system), you may not
achieve maximum benefit from Nimenrix.
Fainting (particularly in adolescents) may occur during or even before any injection with a needle. Therefore, inform your doctor or nurse if you or your child has fainted following a previous injection.
Other medicines and Nimenrix
Tell your doctor or nurse if you are taking or have recently taken any other
medicines, including other vaccines and over-the-counter medicines.
Nimenrix may not work as well if you are taking medicines that reduce the effectiveness of the immune system.
In early infancy, Nimenrix can be administered simultaneously with vaccines against diphtheria,
tetanus, and acellular pertussis (DTaP), including DTaP combination vaccines with hepatitis B, inactivated poliovirus, or Haemophilus influenzae type b (HBV, IPV or Hib), such as the DTaP-HBV-IPV/Hib vaccine, and with the 10-valent pneumococcal conjugate vaccine.

From the first year of life, Nimenrix can be administered simultaneously with any
of the following vaccines: hepatitis A (HAV) and hepatitis B (HBV) vaccines, measles–mumps–rubella (MMR) vaccines, measles–mumps–rubella–varicella (MMRV) vaccines, 10-valent pneumococcal conjugate vaccine, or non-adjuvanted seasonal influenza vaccines.
In the second year of life, Nimenrix may also be administered simultaneously with combination
vaccines against diphtheria–tetanus–acellular pertussis (DTaP), including DTaP combination vaccines with hepatitis B, inactivated poliovirus, or Haemophilus influenzae type b (HBV, IPV or Hib), such as the DTaP-HBV-IPV/Hib vaccine, and with the 13-valent pneumococcal conjugate vaccine.
In individuals aged between 9 and 25 years, Nimenrix may be administered concurrently with the Human Papillomavirus [Types 16 and 18] vaccine and a combined vaccine against diphtheria (reduced antigen content), tetanus and acellular pertussis (dTap).
Whenever possible, Nimenrix and a vaccine containing TT, such as DTaP-HBV-IPV/Hib,
should be co-administered or Nimenrix should be administered at least one month before the TT-containing vaccine.
A separate injection site will be used for each vaccine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, please consult your doctor before receiving Nimenrix.
Driving and using machines
It is unlikely that Nimenrix will affect your ability to drive or use machines.
However, do not drive or operate machinery if you do not feel well.
Nimenrix contains Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.