NEISVAC-C 0.5 ml INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE
How to use NEISVAC-C 0.5 ml INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE
Translated with AI
This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
Show originalContents of the leaflet
- Introduction
- What is NeisVac-C and what is it used for
- What you need to know before you (or your child) receive NeisVac-C
- NeisVac-C can be given at the same time, but as separate injections at different injection sites, as:
- How to use NeisVac-C
- Possible side effects
- Storage of NeisVac-C
- Contents of the pack and other information
- Manufacturer
- 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.
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
- What is NeisVac-C and what is it used for
- What you need to know before you receive NeisVac-C
- How to use NeisVac-C
- Possible side effects
- Storage of NeisVac-C
- 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):
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:
Austria | NeisVac-C |
Belgium Cyprus | NeisVac-C NeisVac-C |
Denmark Estonia | NeisVac-C NeisVac-C |
France | NeisVac |
Germany | NeisVac-C |
Greece Hungary | NeisVac-C NeisVac-C |
Iceland | NeisVac-C |
Ireland | NeisVac-C |
Italy Latvia | NeisVac-C NeisVac-C |
Luxembourg Malta | NeisVac-C NeisVac-C |
Netherlands | NeisVac-C |
Poland | NeisVac-C |
Portugal Romania | NeisVac-C NeisVac-C |
Spain | NeisVac-C |
United Kingdom (Northern Ireland) | NeisVac-C |
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/
--------------------------------------------------------------------------------------------------------------------------
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.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to NEISVAC-C 0.5 ml INJECTABLE SUSPENSION IN PRE-FILLED SYRINGEDosage form: Suspension for injection in pre‑filled syringe, 10 µg/15 µgActive substance: meningococcus C, purified polysaccharides antigen conjugatedManufacturer: Nuron Biotech B.V.Prescription requiredDosage form: INJECTABLE, 0.5 ml single doseActive substance: meningococcus B, multicomponent vaccineManufacturer: Glaxosmithkline Vaccines S.R.L.Prescription requiredDosage form: INJECTABLE, 0.5 ml single doseActive substance: meningococcus B, multicomponent vaccineManufacturer: Glaxosmithkline Vaccines S.R.L.Prescription required
Online doctors for NEISVAC-C 0.5 ml INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE
Discuss questions about NEISVAC-C 0.5 ml INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE, including use, safety considerations and prescription review, subject to medical assessment and local regulations.
Frequently Asked Questions
