Neisvac-c

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 the package leaflet carefully before you or your child are vaccinated, as it contains important information for you.

Keep this package 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 a specific person. Do not pass it on to others.
If you experience any side effects, including any not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What NeisVac-C is and what it is used for
• 2. Important information before receiving NeisVac-C
• 3. How NeisVac-C is given
• 4. Possible side effects
• 5. How to store NeisVac-C
• 6. Contents of the pack and other information

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

NeisVac-C is a vaccine that is intended to prevent invasive meningococcal disease caused by Neisseria meningitidis group C bacteria. This type of bacteria can cause severe and life-threatening infections, such as meningitis and septicemia (blood infection).
NeisVac-C is given to children from 2 months of age, adolescents, and adults. The vaccine stimulates the body to produce its own defense mechanisms (antibodies) against group C bacteria.
NeisVac-C only protects against diseases caused by Neisseria meningitidis group C bacteria. It does not provide protection against infections caused by other groups of Neisseria meningitidis bacteria or other microorganisms that cause meningitis and septicemia.
As with other vaccines, NeisVac-C may not provide complete protection against group C meningococcal infection in all vaccinated individuals.

2. Important information before receiving NeisVac-C

When not to use NeisVac-C

If you have ever had an allergic reaction to a previous dose of this vaccine or to any of its components, including tetanus toxoid (listed in section 6). Symptoms of an allergic reaction include skin rash, facial and throat swelling, difficulty breathing, blue discoloration of the tongue or lips, low blood pressure, and collapse.
If you have ever had an allergic reaction to another meningococcal group C vaccine.

Warnings and precautions

Before receiving NeisVac-C, discuss with your doctor, pharmacist, or nurse if you have:
hemophilia, are taking blood-thinning medications, or have any other condition that affects blood clotting
a severe infection with fever. In this case, you should discuss with your doctor or nurse to postpone vaccination
an autoimmune disease or have a weakened immune system. In this case, the vaccine may provide lower protection against Neisseria meningitidis group C bacteria. For example:
if you have antibody production disorders
if you are taking medications that reduce your immune response (e.g., anticancer medications or high doses of corticosteroids)
if you have had your spleen removed or have spleen function disorders, were born prematurely (before 28 weeks of gestation). Within 2 or 3 days after vaccination, longer-than-normal pauses in breathing may occur, which may require monitoring, and you are over 65 years old.

• if you have antibody production disorders
• if you are taking medications that reduce your immune response (e.g., anticancer medications or high doses of corticosteroids)
• if you have had your spleen removed or have spleen function disorders, were born prematurely (before 28 weeks of gestation). Within 2 or 3 days after vaccination, longer-than-normal pauses in breathing may occur, which may require monitoring, and you are over 65 years old.

This vaccine cannot cause meningococcal disease. If you experience any of the following symptoms of meningococcal infection, such as neck pain, neck stiffness, photophobia, sleepiness, altered consciousness, red or purple spots that do not fade under pressure, you should contact your doctor, nurse, or nearest emergency department immediately.
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, which means the vaccine is considered "sodium-free".

NeisVac-C and other medicines

Tell your doctor, pharmacist, or nurse about all the medicines you are taking, including those available without a prescription, and any other vaccines you have recently received.
Your doctor or nurse will decide whether you can receive NeisVac-C at the same time as other vaccines given by injection.
NeisVac-C can be given at the same time as other vaccines, but in separate injections and at different sites, such as vaccines against:
polio (Heine-Medina disease);
measles, mumps, and rubella (MMR);
diphtheria, tetanus, and pertussis (whooping cough);
Haemophilus influenzae type b (Hib);
Streptococcus pneumoniae (pneumococcal disease).
NeisVac-C can also be given to infants at the same time as certain types of hepatitis B vaccine. Your doctor, pharmacist, or nurse will decide whether this is necessary and which vaccines are suitable.
NeisVac-C can also be given at the same time as oral rotavirus vaccines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor, pharmacist, or nurse for advice before receiving this vaccine.
Your doctor, pharmacist, or nurse may still give you NeisVac-C if there is a high risk of infection.

Driving and using machines

No studies have been conducted on the effects of NeisVac-C on the ability to drive and use machines. However, some side effects mentioned in section 4 "Possible side effects" may temporarily affect you. In this case, you should wait until the side effects have resolved before driving or operating machinery.

3. How NeisVac-C is given

A single dose of NeisVac-C is 0.5 ml (a very small amount of liquid).
NeisVac-C is given by injection into a muscle. The injection is usually given in the thigh in infants and in the arm in older children, adolescents, and adults.
Infants from 2 months to 4 months of age should receive two doses of NeisVac-C, with an interval of at least two months.
Infants over 4 months of age, older children, adolescents, and adults should receive one dose.
Infants from 2 months to 12 months of age should receive a booster dose at around 12-13 months, at least 6 months after the last dose of NeisVac-C in the primary vaccination series.

Overdose of NeisVac-C

There is no experience with overdose of NeisVac-C. Overdose of the vaccine is very unlikely, as it is given in a single-dose pre-filled syringe and is administered by a doctor or nurse.

Missed dose of NeisVac-C or interruption of the vaccination series

Your doctor or nurse will inform you about the vaccination schedule. Missing a scheduled dose or interrupting the vaccination series may result in incomplete protection.
If you have any further 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 vaccines given by injection, allergic reactions can occur. Although they are very rare, they can be serious. For this reason, people who have been vaccinated should be kept under observation for a sufficient amount of time after vaccination and should have access to and the possibility of immediate use of appropriate medical equipment and personnel.
Symptoms of serious allergic reactions include:
swelling of the lips, mouth, and throat, which may cause difficulty in swallowing or breathing;
hives and swelling of the hands, feet, and ankles;
loss of consciousness due to low blood pressure.
These symptoms usually develop shortly after injection, while the person is still in the hospital or clinic. If these symptoms occur after leaving the place where the vaccine was given, you should contact your doctor or nurse immediately.
In clinical trials, the following side effects have been reported:

• At any age:
• redness, swelling, tenderness, and pain at the injection site
• In infants and toddlers:
• fever, irritability, fatigue, sleepiness, drowsiness, crying, vomiting, decreased appetite, hardness at the injection site
• In children and adults:
• headache

Common (may affect up to 1 in 10 people)

• In infants and toddlers and children:
• sore throat, runny nose, cough, diarrhea
• In infants and toddlers:
• sleep disturbances, irritability, rash, excessive sweating
• In children and adults:
• fever, malaise, vomiting
• In children:
• fatigue, sleepiness, drowsiness, dizziness, nausea, abdominal pain, pain in the arms or legs, itching, bruising, skin rash
• In adults:
• muscle pain

Uncommon (may affect up to 1 in 100 people)

• In infants and toddlers and children:
• local swelling, sudden redness, chills
• In infants and toddlers:
• abdominal pain, nausea, malaise, pain in the arms or legs, redness of the skin, skin rash
• In children and adults:
• enlarged lymph nodes
• In children:
• allergic reactions (including difficulty breathing), decreased appetite, restlessness and/or agitation, abnormal or decreased sensation, fainting, crying, convulsions, eyelid swelling, stuffy nose, excessive sweating, rash, stiffness of the muscles and joints, neck pain, muscle pain, joint pain, back pain, irritability, weakness
• In adults:
• flu-like symptoms

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

• In infants and toddlers:
• allergic reactions (including difficulty breathing), eyelid swelling, bruising, stiffness of the muscles and joints
• In infants and toddlers and children:
• fainting
• In children:
• flu-like symptoms

The following side effects have also been reported:

• decreased platelet count, which can lead to bruising on the skin and mucous membranes
• febrile seizures
• meningitis
• loss of muscle tone or muscle weakness in infants
• abnormal breathing pauses
• widespread skin rash that can lead to blistering and peeling of the skin. The rash can also affect the mouth and eyes
• red or purple spots on the skin due to bleeding
• hives

If you have previously been diagnosed with nephrotic syndrome, there may be an increased risk that this condition will recur within a few months after vaccination. Nephrotic syndrome is a kidney disease that can cause swelling, especially of the face or around the eyes, protein in the urine, which makes it foamy, and/or weight gain. If you experience similar symptoms after vaccination, you should inform your doctor or nurse.
If any of these side effects get worse, or if you experience any side effects not listed in this package leaflet, you should inform your doctor, pharmacist, or nurse.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this vaccine.
Side effects can also be reported to the marketing authorization holder or its representative.

5. How to store NeisVac-C

Store the vaccine out of sight and reach of children.
Do not use this vaccine after the expiry date stated on the carton after EXP. Unless otherwise stated, the expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze. Store the pre-filled syringe in the outer carton to protect from light.
This vaccine can be stored at room temperature (up to 25°C) for a single period of up to 9 months within the shelf-life of the vaccine. During this period, the vaccine can be returned to the refrigerator (2°C - 8°C). The start date of storage at room temperature and the new expiry date should be written on the vaccine packaging. In no case should the new expiry date for storage at room temperature exceed the original shelf-life of the vaccine. At the end of this period, the vaccine should be used or discarded.
Medicines should not be disposed of via wastewater or household waste. 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

What NeisVac-C contains

The active substance of the vaccine in one dose (0.5 ml) is 10 micrograms of polysaccharide (O-deacetylated) Neisseria meningitidis group C (strain 11). It is conjugated to 10-20 micrograms of a protein called tetanus toxoid and is adsorbed onto hydrated aluminum hydroxide (0.5 mg Al).
The other ingredients are: sodium chloride (common salt), water for injections, and hydrated aluminum hydroxide. The hydrated aluminum hydroxide in this vaccine serves as an adsorbent to enhance and/or prolong the protective effect of the vaccine.

What NeisVac-C looks like and contents of the pack

NeisVac-C is a white or almost white, semi-transparent suspension for injection, supplied in a pre-filled syringe.
Packs of 1, 10, or 20 pre-filled syringes are available. However, not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer

Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium
For further information on this vaccine, please contact your local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
Phone: +48 22 335 61 00

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
NeisVac-C
Cyprus
NeisVac-C
Denmark
NeisVac-C
France
NeisVac
Germany
NeisVac-C
Greece
NeisVac-C
Hungary
NeisVac-C
Iceland
NeisVac-C
Ireland
NeisVac-C
Italy
NeisVac-C
Luxembourg
NeisVac-C
Malta
NeisVac-C
Netherlands
NeisVac-C
Poland
NeisVac-C
Portugal
NeisVac-C
Spain
NeisVac-C
United Kingdom (Northern Ireland)
NeisVac-C

Date of last revision of the package leaflet: 04/2024

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Information intended for healthcare professionals only:
The vaccine is for intramuscular injection only. It must not be given subcutaneously or intravascularly.
When administering more than one vaccine, injections should be given at different sites.
NeisVac-C should not be mixed with other vaccines in the same syringe.
It has not been established whether there is a need for booster doses in individuals aged 12 months and older at the time of the first dose.
During storage, a white deposit and a clear supernatant may form. Before administration, the vaccine should be shaken to obtain a homogeneous suspension.
If the vaccine contains foreign particles or discoloration, it should be discarded by a healthcare professional.
Each pre-filled syringe is packaged in a blister. The break in the blister seal is intentional and allows for humidity equalization during recommended warming before vaccine administration.
To remove the pre-filled syringe from the blister, the covering foil should be removed. The pre-filled syringe should not be pressed out of the blister.
Packages containing 1 pre-filled syringe may include two needles of different sizes. When two needles are included, the smaller needle is recommended for injections in children and the larger needle for injections in adults. The immediate packaging does not contain latex.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.