Nimenrix polvo y disolvente para solucion inyectable en jeringa precargada

Prospectus:Information for the user

Nimenrix powder and solventfor injectable solution in pre-filled syringe

Conjugated vaccine against meningococcal groups A, C, W-135 and Y

Read this prospectus carefully before receiving this vaccine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribedonlyto you or your child and must not be given to others.
• Ifyou experienceadverse effects, consult your doctor or pharmacist, evenifthey do not appearin this prospectus.See section 4.

This prospectus has been written assuming that the person receiving the vaccine is the one reading it. However, the vaccine may be administered to adults and children, so it is possible that you are reading it for your child.

What is Nimenrix and what is it used for

Nimenrix is a vaccine that helps protect against infections caused by the bacteria (germ) called“Neisseria meningitidis”of types A, C, W-135 and Y.

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

• meningitis – an infection of the tissue that covers the brain and spinal cord.
• septicemia – an infection of the blood.

These infections are easily transmitted from one person to another and, if not treated, can cause death.

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

How Nimenrix works

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

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

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).

The signs of an allergic reaction may include a skin rash with itching, difficulty breathing, and swelling of the face or tongue.Seek medical attention immediately if you experience any of these symptoms.

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

Warnings and precautions

Consult your doctor or nurse before Nimenrix is administered if:

• you have a high fever (above 38°C). If this is the case, do not administer the vaccine until you are feeling better. A minor infection, such as a cold, should not be a problem. However, consult with your doctor or nurse first.
• you have a bleeding disorder or bruise easily.

If you are in any of the above circumstances (or are unsure), consult with your doctor or nurse before Nimenrix is administered.

Nimenrix may not provide complete protection for 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 benefit fully from Nimenrix vaccination.

Before or after any injection, dizziness may occur (especially in adolescents), so inform your doctor or nurse if you or your child have fainted after previous injections.

Other medicines and Nimenrix

Inform your doctor or nurse if you are using or have recently used any other medicine, including other vaccines and over-the-counter medications.

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

Nimenrix can be administered simultaneously with infant vaccines, including diphtheria-tetanus-acellular pertussis (DTPa) vaccines, including DTPa with hepatitis B, inactivated poliovirus, or Haemophilus influenzae type b (VHB, IPV, or Hib), such as the DTPa-VHB-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 some of the following vaccines: hepatitis A (VHA) and hepatitis B (VHB), measles-mumps-rubella (MMR) vaccine, measles-mumps-rubella-varicella (MMRV) vaccine, 10-valent pneumococcal conjugate vaccine, or seasonal influenza vaccine.

In the second year of life, Nimenrix can also be administered at the same time with diphtheria-tetanus-acellular pertussis (DTPa) vaccines, including DTPa with hepatitis B, inactivated poliovirus, or Haemophilus influenzae type b (VHB, IPV, or Hib), such as the DTPa-VHB-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 (types 16 and 18) vaccine and a combined diphtheria (reduced antigen content), tetanus, and acellular pertussis vaccine.

Whenever possible, the administration of Nimenrix and a vaccine that contains tetanus toxoid, such as the DTPa-VHB-IPV/Hib vaccine, should be done at the same time or Nimenrix should be administered at least one month before the vaccine that contains tetanus toxoid.

Each vaccine should be administered in different injection sites.

Pregnancy and breastfeeding

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

Driving and operating machinery

Nimenrix is unlikely to affect your ability to drive or operate machinery. However, do not drive or operate machinery if you are not feeling well.

Nimenrix contains sodium

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

Your doctor or nurse will administer Nimenrix.

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

First vaccination

Infants from 6 weeks to less than 6 months of age

Two injections administered with a 2-month interval, for example at 2 and 4 months of age (the first injection can be administered 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:

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

Previously vaccinated individuals 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 indicate if you need an additional Nimenrix injection and when you need it, 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 byNeisseria meningitidistypes W-135 or Y
• received the dose more than a year ago and may have a risk of infection caused byNeisseria meningitidistype A
• received the first dose at 12-23 months of age and may have an increased risk of infection caused byNeisseria meningitidistypes 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 do not receive one of the scheduled injections, it is essential to request another appointment.

Make sure you or your child completes the entire vaccination cycle.

If you have any other questions about the use of thismedication, ask your doctor orpharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. This medicine may cause the following side effects:

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

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

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

• bruising (hematomas) at the site where the injection was administered
• stomach and digestive problems, such as diarrhea, vomiting, and nausea.
• eruption (in infants)

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

• eruption
• hives
• itching
• unusual crying
• feeling of dizziness
• muscle pain
• pain in the arms or legs
• general feeling of being unwell
• difficulty sleeping
• reduced sensitivity, especially in the skin
• reactions at the site where the injection was administered, such as itching, feeling of heat or numbness, or appearance of a hard lump
• allergic reaction

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

• seizures (convulsions) related to high fever

Unknown frequency (cannot be estimated from available data):

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

Reporting of side effects

If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keepthis medicationout of sightand out of reachof children.
• Do not usethis medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.
• Store in the refrigerator (between 2°C and 8°C).
• Store in the original packaging to protect it from light.
• Do not freeze.
• Medicines should not be disposed of through drains or in the trash..Ask your pharmacist how to dispose ofthe packaging and the medicationsthat you no longer need.In this way, you will help protect the environment.

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 injection

Appearance of the product and contents of the pack

Nimenrix is a powder and solvent for injection.

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

Both must be mixed before use. The appearance of the vaccine mixed will be a transparent and colourless solution.

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

Only some pack sizes may be marketed.

Marketing authorisation holder and responsible person for manufacturing

For further information on this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of thissummary of product characteristics: 01/2025.

Other sources of information

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

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This information is intended for healthcare professionals only:

The vaccine should only be administered by intramuscular injection. Do not administer by intravascular, intradermal or subcutaneous route.

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

Nimenrix should not be mixed with other vaccines.

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

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

To know how to insert the needle in the syringe, see the explanatory drawing. However, the syringe provided with Nimenrix may be slightly different (without screw thread) from the syringe described in the drawing. In this 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;

in some cases it may be a bit difficult.

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

The reconstituted vaccine is a transparent and colourless solution.

The contents of the reconstituted vaccine should be visually inspected to observe any foreign particles and/or variation in physical appearance before administration. If any of these circumstances are observed, discard the vaccine.

After reconstitution, the vaccine should be administered promptly.

A new needle should be used to administer the vaccine.

The disposal of unused medicinal product and any waste materials should be in accordance with local requirements.