Prospecto: information for the user

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

Conjugate polysaccharide meningococcal group C vaccine (adsorbed)

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

2.What you need to know before starting NeisVac-C

3.How to use NeisVac-C

4.Possible adverse effects

5.Storage of NeisVac-C

6.Contents of the pack and additional information

NeisVac-C is a vaccine to prevent invasive meningococcal disease caused byNeisseria meningitidisgroup C. This is a type of bacteria that can cause severe infections, which sometimes produce potentially fatal symptoms/reactions such as meningitis and septicemia (blood infection).

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

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

No useNeisVac-C

• If you have ever had an allergic reaction to any previous dose of this vaccine or to any of its components, including tetanus toxoid (listed in section 6). The symptoms of an allergic reaction include skin rash, facial and throat inflammation, difficulty breathing, blue discoloration of the tongue or lips, decreased blood pressure, and collapse

• If you have ever had an allergic reaction to any other vaccine indicated for preventing meningococcal infections of group C.

Warnings and precautions

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

• has hemophilia, is taking an anticoagulant, or has any other condition that prevents proper blood clotting;
• has an acute illness with fever. In this case, your doctor or nurse may advise delaying vaccination until you are feeling better.
• has an autoimmune disease or a weakened immune system for any reason. The vaccine can still be administered, but it may provide a lower level of protection against Neisseria meningitidis group C.For example:
• • if you do not produce antibodies very efficiently;
  • if you are taking medications that reduce your immunity to infections (such as anticancer medications or high doses of corticosteroids);
  • if you do not have a spleen or have been told that your spleen does not function correctly;
• was born very prematurely (at 28 weeks of gestation or earlier). There may be longer than usual intervals between breaths for 2-3 days after vaccination and this may require follow-up;
• is over 65 years old.

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

• neck pain
• stiff neck
• intolerance to light (photophobia)
• drowsiness
• confusion
• spots similar to red or purple rash that do not disappear when pressed

you must contact your doctor, nurse, or go to the Emergency Service immediately.

This vaccine contains less than 1mmol of sodium (23mg) per dose; this is, essentially “sodium-free”.

Other medicines and NeisVac-C

Inform your doctor, pharmacist, or nurse if you or your child isusing orhas recentlyusedany other medicine, 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 administered at the same time, but as separate injections in different injection sites, as the vaccines for:

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

NeisVac-C can be administered 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 the most suitable vaccine.

NeisVac-C can be administered at the same time as oral vaccines that protect against infections caused by rotavirus.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor, pharmacist, or nurse before using this vaccine.

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

Driving and operating machinery

No studies have been conducted on the effects of NeisVac-C on the ability to drive and operate machinery.

However, some of the effects listed in section4 “Possible adverse effects” may temporarily affect you. If this occurs, wait until the effects have disappeared before driving or operating machinery.

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

NeisVac-C is injected into the muscle. It is normally injected in the thigh in children under one year and in the arm in children over one year, 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 administered approximately at 12 – 13 months of age, at least six months after the last vaccination with NeisVac-C in the primary vaccination schedule.

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

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

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

Your doctor or nurse will inform you of the vaccination schedule to follow. If you or your child forgets one of the recommended doses or interrupts the recommended vaccination schedule, incomplete protection may be achieved.

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

Like all vaccines, NeisVac-C can cause side effects, although not everyone will experience them.

As with all injectable vaccines, allergic reactions may occur. Although they are very rare, they can be severe. For this reason, it is always necessary to monitor and have appropriate medical treatment available for a certain period of time after vaccination.

The signs and symptoms of severe 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 injection, when the person is still in the clinic or doctor's office. Consult your doctor or nurse immediately if any of these symptoms occur once you have left the consultation or clinic.

The following side effects have been reported in clinical studies:

Very common (affects 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 (affects up to 1 in 10 people)

• In children:
• • Sore throat, runny nose, cough, diarrhea
• In children under 2 years:
• • • Sleep disturbances, irritability, skin rash, increased sweating
  • In children over 2 years and adults:
  • Fever, discomfort, vomiting

• In childrenover 2 years:

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

• In adults:

• Muscle pain

Uncommon (affects up to 1 in 100 people)

• In children

• Local swelling, redness, chills

• In children under 2 years

• Abdominal pain, indigestion, discomfort, pain in the arms or legs, skin redness, skin inflammation

• In childrenover 2 yearsand adults:

• Lymph node inflammation

• In childrenover 2 years:

• Severe allergic reaction (including difficulty breathing), decreased appetite, agitation/irritability, 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 (affects up to 1 in 1,000 people)

• In children under 2 years:

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

• In children under and over 2 years:

• Coma

• In childrenover 2 years:

• Flu-like illness

Also, the following side effects have been reported:

• Low platelet count that causes skin and mucous membrane bleeding
• Febrile convulsions
• Meningeal irritation (covering the brain)
• Loss of muscle tone or weakness in arms and legs in young children
• Abnormal respiratory intervals
• Skin rashes that can affect most 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
• Urticaria

If your doctor or nurse has informed 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. Inform your doctor or nurse if you notice similar symptoms after vaccination.

If any of these side effects become severe or if you notice any side effect not mentioned in this prospectus, inform your doctor, pharmacist, or nurse.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse even if it is a possible side effect not mentioned in this prospectus. You can also report them directly through the national notification system included in the Spanish System of 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 vaccine.

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiration date shown on the packaging. Unless the day is specified, the expiration date is the last day of the month indicated.

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

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

Under no circumstances should the revised expiration date of the vaccine stored at room temperature exceed the expiration date marked according to the vaccine's shelf life. The vaccine must be used or discarded at the end of this period.

Medicines should not be disposed of through the drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of NeisVac-C

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

The other components are sodium chloride (cooking salt), water for injection preparations, and hydrated aluminum hydroxide. Hydrated aluminum hydroxide is included in this vaccine as an adsorbent to improve and/or prolong the protective effect of the vaccine.

Appearance of the product and contents of the package

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

It is presented in containers containing 10 or 20 pre-filled syringes (clinical package). However, only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Pfizer, S.L.

Avda. Europa 20B - Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Further information about this vaccine can be requested from the local representative of the holder of the marketing authorization:

Responsible for manufacturing

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) with the following names:

This leaflet was approved in April 2024

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

The vaccine is only for intramuscular use. Do not administer by subcutaneous or intravascular route.

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

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

No established yet the need for booster doses in individuals primovacunated at 12 months of age or older.

During storage, a white deposit and transparent supernatant may be observed. Therefore, the vaccine must be shaken before administration for homogenization. If foreign particles or coloration are observed in the syringe, the vaccine must be discarded by the healthcare professional.

Each pre-filled syringe is packaged in a blister. The opening in the seal of the blister is made intentionally and allows for the balance of humidity during the recommended heating before administration of the vaccine. To remove the syringe, open the blister by separating the cap. 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 vaccination 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.