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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Meningococcal serogroups A, C, W-135 and Y conjugate vaccine

Read the entire leaflet carefully before receiving this vaccine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you or your child only and must not be passed on to others.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

This leaflet has been written assuming that the person who will receive the vaccine is the one reading it. However, the vaccine may be administered to both adults and children, so you may be reading it on behalf of your child.

Contents of the leaflet

1. What Nimenrix is and what it is used for
2. What you need to know before receiving Nimenrix
3. How Nimenrix is administered
4. Possible side effects
5. How to store Nimenrix
6. 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 the bacterium (germ) called “Neisseria meningitidis” of types A, C, W-135 and Y.

“Neisseria meningitidis” types A, C, W-135 and Y can cause serious diseases such as:

• meningitis – an infection of the membranes covering the brain and spinal cord.
• septicemia – a blood infection.

These infections spread easily from person to person and, if left untreated, can lead to death.

Nimenrix can be given to adults, adolescents, children and infants from the age of 6 weeks.

How Nimenrix works

Nimenrix helps your body produce its own protection (antibodies) against the bacteria. These antibodies help protect you against disease.

Nimenrix will only protect you against infections caused by the bacterium “Neisseria meningitidis” of types A, C, W-135 and Y.

2. What you need to know before receiving Nimenrix

Do not administer Nimenrix 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 rash, difficulty breathing, and swelling of the face or tongue. Seek medical attention immediately if you experience any of these signs.

If you are unsure, speak with your doctor or nurse before receiving Nimenrix.

Warnings and precautions

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

• you have an infection with high fever (over 38°C). If this is the case, the vaccine should not be given until you recover. A minor infection, such as a cold, should not be a problem. However, consult your doctor or nurse first.
• you have a blood clotting disorder or bruise easily.

If you are in any of the above situations (or are unsure), consult 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 achieve maximum benefit from vaccination with Nimenrix.

Fainting (especially in adolescents) may occur before or after any injection. Inform your doctor or nurse if you or your child has previously fainted after receiving an 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 medicines obtained without a prescription.

Nimenrix may be less effective if you are taking medicines that affect your immune system.

In infants, Nimenrix can be administered simultaneously with combined diphtheria-tetanus-acellular pertussis (DTPa) vaccines, including acellular pertussis (DTPa) with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b (HBV, IPV or Hib), such as the DTPa-HBV-IPV/Hib vaccine and the 10-valent pneumococcal conjugate vaccine.

From 1 year of age and older, Nimenrix can be administered at the same time as one of the following vaccines: hepatitis A (HAV) and hepatitis B (HBV), measles-mumps-rubella (MMR) vaccine, measles-mumps-rubella-varicella (MMRV) vaccine, 10-valent pneumococcal conjugate vaccine, or non-adjuvanted seasonal influenza vaccine.

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

In individuals aged 9 to 25 years, Nimenrix can be administered at the same time as the human papillomavirus vaccine [types 16 and 18] and a combined diphtheria (reduced antigen content)-tetanus-acellular pertussis vaccine.

Whenever possible, administration of Nimenrix and a vaccine containing tetanus toxoid, such as the DTPa-HBV-IPV/Hib vaccine, should be given simultaneously or Nimenrix should be administered at least one month before the tetanus toxoid-containing vaccine.

Each vaccine should be administered at different injection sites.

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before receiving Nimenrix.

Driving and using machines

Nimenrix is unlikely to affect your ability to drive or operate machinery. However, do not drive or use machines if you do not feel well.

Nimenrix contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per dose: essentially "sodium-free".

3. How Nimenrix is administered

Your doctor or nurse will administer Nimenrix.

Nimenrix is always injected into a muscle, usually in the upper arm or thigh.

Primary vaccination

Infants from 6 weeks to less than 6 months of age

Two injections given 2 months apart, for example at 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

One injection.

Booster dose

Infants from 6 weeks to less than 12 months of age:

One booster dose at 12 months of age, at least 2 months after the last dose of Nimenrix.

Individuals previously vaccinated, 12 months of age and older:

Inform your doctor if you have previously received an injection of another meningococcal vaccine different from Nimenrix.

Your doctor will advise you whether you need an additional injection of Nimenrix and when it is needed, especially if you or your child:

• received the first dose at 6–14 months of age and may have an increased risk of infection caused by Neisseria meningitidis types W-135 or Y
• received the dose approximately more than one year ago and may be at risk of infection caused by Neisseria meningitidis type A
• received the first dose at 12–23 months of age and may have an increased risk of infection caused by Neisseria meningitidis types A, C, W-135, or Y

You will be informed when you or your child should return for the next injection. If you or your child misses one of the scheduled injections, it is important to arrange another appointment.

Make sure that you or your child completes the full vaccination course.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The following adverse effects may occur with this medicine:

Very common (may occur with more than 1 in every 10 doses of the vaccine):

• fever
• tiredness (fatigue)
• headache
• numbness sensation
• loss of appetite
• irritability
• swelling, pain, and redness at the injection site.

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

• bruising (haematomas) at the injection site
• stomach and digestive problems, such as diarrhoea, vomiting, and nausea
• rash (in infants)

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

• rash
• hives
• itching
• unusual crying
• dizziness
• sore muscles
• pain in arms or legs
• general malaise
• difficulty sleeping
• decreased sensation, especially in the skin
• reactions at the injection site, such as itching, warmth, or numbness, or development of a hard lump
• allergic reaction

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

• seizures associated with high fever

Frequency not known (cannot be estimated from available data):

• swelling and redness at the injection site; this may affect a large area of the limb where the vaccine was administered
• swollen lymph node
• severe allergic reaction

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nimenrix

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
• Store in a refrigerator (between 2 °C and 8 °C).
• Keep in the original packaging to protect from light.
• Do not freeze.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Nimenrix

• The other components are:

• In the powder: sucrose and trometamol

• In the solvent: sodium chloride (see section 2 “Nimenrix contains sodium”) and water for injections

Appearance of the medicinal product and contents of the container

Nimenrix is a powder and solvent for injectable solution.

Nimenrix is supplied as a white powder or paste in a single-dose glass vial and a clear, colourless solvent in a pre-filled syringe.

Both must be mixed before use. The reconstituted vaccine will appear as a clear, colourless solution.

Nimenrix is available in packs of 1 or 10, with or without needles.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

You can request further information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the most recent review of this leaflet: 01/2025.

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

This information is intended for healthcare professionals only:

The vaccine must only be administered by intramuscular route. Do not administer by intravenous, intradermal or subcutaneous route.

If Nimenrix is administered at the same time as other vaccines, different injection sites must be used.

Nimenrix must not be mixed with other vaccines.

Instructions for reconstitution of the vaccine with the solvent in the pre-filled syringe:

Nimenrix must be reconstituted by adding the entire contents of the pre-filled syringe to the vial containing the powder.

For instructions on how to insert the needle into the syringe, refer to the explanatory diagram. However, the syringe supplied with Nimenrix may be slightly different (without a screw thread) compared to the syringe shown in the diagram. In such a case, the needle should be inserted without screwing.

1. Insert the needle into the syringe

and then turn it clockwise until it locks

(see drawing).

1. Remove the needle protector;

this may sometimes

be a little difficult.

1. Add the solvent to the powder. After adding the solvent to the powder, shake the mixture well until the powder is completely dissolved in the solvent.

The reconstituted vaccine is a clear, colorless solution.

The reconstituted vaccine should be visually inspected for the presence of particulate matter and/or any changes in physical appearance prior to administration. If either of these conditions is observed, the vaccine should be discarded.

After reconstitution, the vaccine should be administered promptly.

A new needle must be used to administer the vaccine.

Any unused medicine and materials that have come into contact with it should be disposed of in accordance with local regulations.