NEISVAC-C 0.5 ml INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the User

NeisVac-C 0.5 ml suspension for injection in a pre-filled syringe

Meningococcal group C conjugate vaccine (adsorbed)

Read all of this leaflet carefully before you or your child receive this vaccine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for you or your child. Do not pass it on to others.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is NeisVac-C and what is it used for
2. What you need to know before you receive NeisVac-C
3. How to use NeisVac-C
4. Possible side effects
5. Storage of NeisVac-C
6. Contents of the pack and other information

1. What is NeisVac-C and what is it used for

NeisVac-C is a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidisgroup C. This is a type of bacteria that can cause serious infections, which can sometimes produce potentially life-threatening symptoms such as meningitis and septicemia (blood infection).

NeisVac-C is given to children from 2 months of age, adolescents, and adults. The vaccine works by stimulating the body to produce its own protection (antibodies) against group C bacteria.

This vaccine will only protect against disease caused by Neisseria meningitidisgroup C bacteria. It will not protect against other groups of Neisseria meningitidisor other organisms that cause meningitis and blood infection. As with other vaccines, NeisVac-C may not completely prevent group C meningococcal infections in all vaccinated individuals.

2. What you need to know before you (or your child) receive NeisVac-C

Do not useNeisVac-C

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before receiving NeisVac-C if the person receiving the vaccine (for example, you or your child):

Neisseria meningitidis. For example:

This vaccine cannot cause group C meningococcal disease. If you or your child experience any of the following symptoms of a meningococcal infection, such as:

• neck pain
• neck stiffness
• intolerance to light (photophobia)
• drowsiness
• confusion
• purple spots that do not fade when pressed

you should contact your doctor, nurse, or go to the Emergency Department immediately.

This vaccine contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Other medicines and NeisVac-C

Tell your doctor, pharmacist, or nurse if you or your child are using or have recently used any other medicines, including those obtained without a prescription, or if you have recently received another vaccine.

Your doctor or nurse will inform you if it is necessary to administer NeisVac-C at the same time as other injectable vaccines.

NeisVac-C can be given at the same time, but as separate injections at different injection sites, as:

• polio
• measles, mumps, and rubella (MMR)
• diphtheria, tetanus, and pertussis (whooping cough)
• Haemophilus influenzaetype b (Hib)
• Streptococcus pneumoniae(pneumococcal)

NeisVac-C can be given to children at the same time as certain types of vaccines that protect against hepatitis B. Your doctor, pharmacist, or nurse will inform you if this is necessary and which vaccine is most suitable.

NeisVac-C can also be given at the same time as oral vaccines that protect against rotavirus infections.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before using this vaccine.

However, NeisVac-C may be given by your doctor, pharmacist, or nurse if the risk of infection is high.

Driving and using machines

No studies have been done on the effects of NeisVac-C on the ability to drive and use machines.

However, some of the effects listed in section 4 "Possible side effects" may affect you temporarily. If this happens, wait until the effects have gone before driving or using machines.

3. How to use NeisVac-C

A dose of NeisVac-C contains 0.5 ml (a very small amount of liquid).

NeisVac-C is injected into the muscle. It is usually injected into the thigh in children under one year of age and into the arm in older children, adolescents, and adults.

Children between 2 and 4 months of age

Your child will be given two doses of NeisVac-C, at least two months apart.

Children from 4 months of age onwards, adolescents, and adults

They will be given one dose.

Children between 2 and 12 months

A booster dose should be given at approximately 12-13 months of age, at least 6 months after the last NeisVac-C vaccination in the primary vaccination schedule.

If you (or your child) have been given more NeisVac-C than recommended

There is no experience with overdose of NeisVac-C. However, overdose is highly unlikely since it is administered via a single-dose syringe by a doctor or nurse.

If you miss a dose of NeisVac-C or the vaccination schedule is interrupted

Your doctor or nurse will inform you of the vaccination schedule to follow. If you or your child miss one of the recommended doses or interrupt the recommended vaccination schedule, you may not achieve complete protection.

If you have any other questions about the use of this vaccine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, NeisVac-C can cause side effects, although not everybody gets them.

As with all injectable vaccines, allergic reactions can occur. Although they are very rare, they can be serious. For this reason, medical treatment should always be available for a period of time after vaccination.

The signs and symptoms of serious allergic reactions include:

• swelling of the lips, mouth, and throat that can cause difficulty swallowing or breathing
• skin rash and swelling of the hands, feet, and ankles
• loss of consciousness due to a drop in blood pressure.

These signs or symptoms usually occur immediately after the injection, when the person is still in the clinic or doctor's office. Talk to your doctor or nurse IMMEDIATELY if any of these symptoms occur once you have left the office or clinic.

The following side effects have been reported in clinical studies:

Very common (affect more than 1 in 10 people)

• In all age groups:
• • redness, swelling, mild pain, and pain at the injection site
• In children under 2 years:
• • fever, irritability, fatigue, drowsiness, somnolence, crying, vomiting, loss of appetite, hardness at the injection site
  • • In children over 2 years and adults:

• headache

Common (affect up to 1 in 10 people)

• In children:
• • sore throat, runny nose, cough, diarrhea
• In children under 2 years:
• • • sleep disturbance, irritability, skin rash, increased sweating
  • In children over 2 years and adults:
  • fever, malaise, vomiting

• In childrenover 2 yearsold:

• fatigue, drowsiness, somnolence, dizziness, nausea, abdominal pain, pain in the arms or legs, itching, bruising, skin inflammation

• In adults:

• muscle pain

Uncommon (affect up to 1 in 100 people)

• In children:

• local swelling, redness, chills

• In children under 2 years:

• abdominal pain, indigestion, malaise, pain in the arms or legs, skin redness, skin inflammation

• In children over 2 years and adults:

• swollen lymph nodes

• In childrenover 2 yearsold:

• allergic reaction (including difficulty breathing), decreased appetite, agitation/restlessness, abnormal or reduced sensitivity, fainting, crying, convulsions, eyelid swelling, nasal congestion, increased sweating, skin rash, muscle stiffness and joint stiffness, neck pain, muscle pain, joint pain, back pain, irritability, weakness,

• In adults:

• flu-like illness

Rare (affect up to 1 in 1,000 people)

• In children under 2 years:

• allergic reaction (including difficulty breathing), eyelid swelling, bruising, muscle stiffness and joint stiffness

• In children under and over 2 years:

• collapse

• In childrenover 2 yearsold:

• flu-like illness

The following side effects have also been reported:

• low platelet count that can cause bleeding into the skin and mucous membranes
• febrile convulsions
• meningitis (inflammation of the membrane that surrounds the brain)
• loss of muscle tone or floppiness in arms and legs in young children
• abnormal breathing intervals
• skin rashes that can affect a large part of the body, causing blisters and peeling. They can also affect the inside of the mouth and eyes
• red or purple spots on the skin due to bleeding
• hives

If your doctor or nurse has told you that you have nephrotic syndrome, it is possible that this condition may recur a few months after vaccination. Nephrotic syndrome is a kidney disease that can cause swelling, particularly around the face or eyes, presence of protein in the urine with a foamy appearance, and/or weight gain. Tell your doctor or nurse if you notice similar symptoms after vaccination.

If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist, or nurse.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in the Spanish Medicines Agency's Pharmacovigilance System for Human Use: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this vaccine.

5. Storage of NeisVac-C

Keep this vaccine out of the sight and reach of children.

Do not use this vaccine after the expiry date stated on the carton. Unless the day is indicated, the expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Keep the syringe in the outer packaging to protect it from light.

Within the expiry date, the vaccine can be stored at room temperature (up to 25°C) for a single period of up to 9 months. During this period, the vaccine can be returned to the refrigerator (between 2°C and 8°C). Note the start date and revised expiry date on the vaccine packaging.

Under no circumstances should the revised expiry date of the vaccine stored at room temperature exceed the original expiry date stated on the vaccine packaging. The vaccine should be used or discarded at the end of this period.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicines to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of NeisVac-C

The active substance in a dose of the vaccine (0.5 milliliters) is 10 micrograms of polysaccharide (de-O-acetylated) of Neisseria meningitidisgroup C (strain 11). This is conjugated to 10-20 micrograms of a protein called tetanus toxoid, adsorbed on hydrated aluminum hydroxide (0.5 milligrams of Al3+).

The other ingredients are sodium chloride (common salt), water for injections, and hydrated aluminum hydroxide. Hydrated aluminum hydroxide is included in this vaccine as an adjuvant to improve and/or prolong the protective effect of the vaccine.

Appearance of the product and pack contents

NeisVac-C is a white or off-white semi-opaque injectable suspension that is supplied in a pre-filled syringe.

It is available in packs containing 1, 10 (clinic pack), or 20 pre-filled syringes. However, not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pfizer, S.L.

Avda. Europa 20B - Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

You can request more information about this vaccine from the local representative of the marketing authorization holder:

Manufacturer

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

Belgium

This vaccine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

This leaflet was approved in April 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

The vaccine is for intramuscular use only. Do not administer subcutaneously or intravascularly.

If more than one vaccine is to be administered, separate injection sites should be used.

NeisVac-C should not be mixed with other vaccines in the same syringe.

The need for booster doses in individuals primovaccinated at 12 months of age or older has not yet been established.

During storage, a white deposit and a clear supernatant may be observed. Therefore, the vaccine should be shaken before administration to ensure homogenization. If foreign particles or discoloration are observed in the syringe, the vaccine should be discarded by the healthcare professional.

Each pre-filled syringe is packaged in a blister. The opening in the blister seal is intentional and allows for moisture equilibrium during the recommended warming before vaccine administration. To remove the syringe, open the blister by separating the lid. Do not push the syringe through the blister.

The package of 1 may include up to two needles of different sizes. When two needles are provided, it is recommended to use the smaller needle for injection in children and the larger needle for vaccination in adults. This product does not contain latex.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.