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NEISVAC-C 0.5 ML SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): NEISSERIA MENINGITIDIS GROUP C POLYSACCHARIDE / TETANUS TOXOID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

NeisVac-C

0.5 ml

0727737

Suspension for injection in pre-filled syringe
Meningococcal Group C Polysaccharide Conjugate Vaccine
Adsorbed
Read all of this leaflet carefully before you start receiving this vaccine.
• Keep this leaflet until you have finished the complete vaccination course.
You may need to read it again.
• If you have further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child. Do not pass it
on to others.
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4
In this leaflet:
1. What NeisVac-C is and what it is used for
2. What you need to know before you take NeisVac-C
3. How to use NeisVac-C
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 one of a general group of medicines called vaccines, which
are used to protect against infectious diseases. NeisVac-C is used to
prevent disease caused by bacteria called Neisseria meningitidis group C.
The vaccine works by causing your body to produce its own protection
(antibodies) against the group C bacteria.
The Neisseria meningitidis group C bacteria can cause serious infections
such as meningitis and septicaemia (blood poisoning). These infections are
sometimes life-threatening.
This vaccine will only protect against disease caused by the meningococci
group C bacteria. It will not protect against infections caused by other
groups of meningococci or other organisms that cause meningitis and blood
poisoning. As with other vaccines, NeisVac-C cannot completely prevent
meningococcal group C infections in all people who are vaccinated.
2. What you need to know before you use NeisVac-C
Do not use NeisVac-C
• if you have ever had an allergic reaction to a previous dose of this
vaccine or to any ingredient of the vaccine including tetanus toxoid (listed
in section 6). The symptoms of an allergic reaction include skin rash,
swelling of the face and throat, difficulty in breathing, blue discolouration
of the tongue or lips, low blood pressure, and collapse.
• if you have ever had an allergic reaction to any other vaccine intended to
protect against meningococcal group C infections.
Vaccination with NeisVac-C may have to be delayed if you have an acute
illness with or without fever. In this case, your doctor may advise you to
postpone your vaccination until you are better.
Warnings and precautions
Talk to your doctor or pharmacist before using NeisVac-C
Take special care with NeisVac-C
• if you have haemophilia, are taking a blood thinner or have any other
problem that may stop your blood from clotting properly
• if you have been told that you have an autoimmune disease or that you
have a weak immune system for any reason. For example:
– Have you been told that you do not produce antibodies very efficiently?
– Are you taking medicines that reduce your immunity to infections (such
as anti-cancer drugs or high doses of corticosteroids)?
• if you have had your spleen removed or have been told that your spleen
does not work as it should
• if you suffer from a kidney disease in which large amounts of protein
appear in the urine (called nephrotic syndrome)
There have been reports that this condition may reappear after
vaccination. Your doctor will advise you if you can still have NeisVac-C.
What he says will depend on the exact type of kidney problem you have.
• if you are over 65 years old.
In these cases, talk to your doctor before receiving this vaccine, as it may
not be suitable for you. You may still be given the vaccine but it may not
provide very high protection against infections caused by the group  C
bacteria.
This medicinal product contains less than 1  mmol sodium (23 milligrams)
per dose, i.e. essentially “sodium-free”.
Other medicines and NeisVac-C
Tell your doctor or pharmacist if you are taking/using, have recently taken/
used or might take/use any other medicines.
Your doctor will advise you if you need to have NeisVac-C at the same time
as other injected vaccines.
NeisVac-C may be given at the same time as, but as separate injections at
different injection sites, to vaccines that protect against
• polio
• measles, mumps, and German measles (MMR)
• diphtheria, tetanus and pertussis (whooping cough)
• infections caused by Haemophilus influenzae (Hib)
• pneumococcal infections.
NeisVac-C can be given to infants at the same time as certain types of
vaccines that protect against hepatitis B infection. Your doctor will advise
you if this is necessary and which vaccine might be suitable.
NeisVac-C can also be given at the same time as oral vaccines that protect
against rotavirus infections.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
NeisVac-C may still be given to you by a doctor if the risk of infection is
considered to be high.
Driving and using machines
The vaccine is unlikely to affect a person’s ability to drive or operate
machinery.
3. How to use NeisVac-C
One dose of NeisVac-C is 0.5 ml (half a millilitre – a very small amount of liquid).
NeisVac-C will be injected into a muscle. It is usually injected into the thigh
for infants and into the arm for older children, adolescents, and adults.
The vaccine must not be injected under the skin or into a blood vessel and
your doctor or nurse will take care to avoid doing this when administering
the vaccine.
For infants from 2 to 4 months of age, two doses of NeisVac-C should be
given at least two months apart. For infants from 4 months of age, older
children, adolescents and adults one dose should be given.
After completion of the primary immunisation course in infants aged from
2  months up to 12  months of age a booster dose should be given at the
age of approximately 12 – 13 months with at least an interval of 6 months
after the last NeisVac-C vaccination. The need for booster doses in subjects
aged 12 months or more when first immunised has not yet been established.
NeisVac-C must not be mixed with other vaccines in the same syringe.
Separate injection sites should be used if more than one vaccine is being
administered.
If you are given more NeisVac-C than you should be given
There is no experience with overdose of NeisVac-C vaccine. However, an
overdose is highly unlikely to happen because the injection is given from a
single-dose syringe by a doctor.
If you miss a dose of NeisVac-C or stop the vaccination course
Your doctor will inform you about the vaccination schedule to follow. If you
miss a recommended dose or stop the recommended vaccination course,
this may result in incomplete protection.
If you have any further questions on the use of this vaccine, ask your doctor
or pharmacist.
4. Possible side effects
Like all medicines, NeisVac-C can cause side effects although not
everybody gets them.
As with all injectable vaccines, allergic reactions can happen. Although
they are very rare, they can be serious. To cover this possibility, effective
medical treatment and supervision should always be readily available for
the appropriate length of time after vaccination.
Signs and symptoms of serious allergic reactions include:
• swelling of the lips, mouth, and throat, which may cause difficulty in
swallowing or breathing
• a rash and swelling of the hands, feet, and ankles
• loss of consciousness due to a drop in blood pressure.
These signs or symptoms usually develop quickly after the injection is
given, while the person affected is still in the clinic or doctor’s surgery. If
any of these symptoms occur after leaving the place where the injection was
given, you must consult a doctor IMMEDIATELY.
The following side effects have been reported:
Very common side effects (affect more than 1 in 10 people)
• In all age groups:
– Redness, swelling, tenderness, and pain at the site of injection
• In infants / toddlers:
– Fever, irritability, drowsiness, sleepiness, crying, vomiting, decreased
appetite, hardening at the site of injection
• In children and adults:
– Headache
Common side effects (affect less than 1 in 10 people)
• In infants / toddlers and children:
– Sore throat, runny nose, cough, diarrhea, rash
• In infants / toddlers:
– Poor sleep, irritability, sweating
• In children and adults:
– Fever, feeling or being sick, vomiting
• In children:
– Fatigue, drowsiness, sleepiness, dizziness, nausea, belly pain, pain in
the arms or legs, itching, purple spots under the skin, rash
Uncommon side effects (affect less than 1 in 100 people)
• In infants / toddlers and children:
– Local swelling, flushing, chills
• In infants / toddlers:
– Belly pain, indigestion, feeling or being sick, pain in the arms or legs,
skin redness
• In children and adults:
– Swollen lymph glands
• In children:
– Irritability, weakness, stiffness of muscles and joints, neck pain,
muscle and joint pain, back pain, allergic reaction (including difficulty
in breathing), abnormal or reduced sensation, fainting, crying, fits
(seizures), decreased appetite, swelling of the eye lids, blocked nose,
rash, sweating
• In adults:
– Influenza-like illness

Date: 02 Mar 2015 Time: 13:36
Supplier Nº 0727737
Perigord Nº 248697
Supplier Baxter
Barcode Nº N/A
Smallest

BODY TEXT Size 8.4 pt

Dimensions 195 x 342 mm
Notes N/A
PAR Number PAR‑2015‑0021120

Market

Ireland, Malta
United Kingdom

Proof Nº 02
Component Leaflet
Code 2/5 727737
Drawing Nº TSBP20

Colours
Printing

Non-Printing

PMS 287

Profile

Rare side effects (affect less than 1 in 1000 people)
• In infants / toddlers:
– Allergic reaction (including difficulty in breathing), swelling of the eye
lids, collapse, skin inflammation, purple spots under the skin, stiffness
of muscles and joints
• In children:
– Influenza-like illness
The following side effects have also been reported:
– Loss of muscle tone or floppiness in infants
– Meningeal irritation
– Fits (seizures)
– Red or purple bruise-like spots or blotches under the skin
– Skin rashes that can cover much of the body and lead to blistering and
peeling. The inside of the mouth and the eyes can also be affected.
– Severe allergic reaction
– Swelling of the lips, mouth and throat, which may cause difficulty in
breathing
If you have previously been told by your doctor that you suffer from
nephrotic syndrome there may be an increased chance that this condition
will reoccur within a few months after vaccination. Nephrotic syndrome is a
kidney disease which may result in swelling, particularly around the face or
eyes, protein in the urine, making it appear frothy, and/or weight gain. You
should tell your doctor if you notice similar symptoms after vaccination.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In babies born very prematurely (at or before 28 weeks of gestation)
longer gaps than normal between breaths may occur for 2  –  3 days after
vaccination.
This vaccine cannot cause meningococcal group C disease. If you or your child
experiences any of the following symptoms of meningococcal infection, i.e.
• neck pain
• neck stiffness
• a dislike of light (photophobia)
• drowsiness
• confusion
• red or purple bruise-like spots that do not fade under pressure
you should contact your doctor or local Accident and Emergency
Department immediately.
Reporting of side effects
If you get 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 via the national reporting system
listed below.
United Kingdom
The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What NeisVac-C contains
The active substance in one dose (0.5  milli­litres) of the vaccine is of
10 micrograms of Neisseria meningitidis group C (strain 11) polysaccharide
(de-O-acetylated). This is linked to 10  –  20  micrograms of a protein
called tetanus toxoid, and is adsorbed on hydrated aluminium hydroxide
(0.5 milligrams Al3+).
The other ingredients are sodium chloride (cooking salt), water for injections
and hydrated aluminium hydroxide. Hydrated aluminium hydroxide is
included in this vaccine as an adsorbent to improve and/or prolong the
protective effects of the vaccine.
What NeisVac-C looks like and contents of the pack
The NeisVac-C suspension for injection is semi-opaque white to off-white.
Upon storage, a white deposit and clear supernatant can be observed.
Therefore the vaccine must be shaken to homogeneity before use. If foreign
particles or discolouration are detected in the syringe, the vaccine should
be discarded by the Health Care Professional.
NeisVac-C is supplied as a 0.5 millilitre (one dose) suspension for injection
in a pre-filled syringe. Pack sizes of 1, 10 or 20 pre-filled syringes are
available. However, not all pack sizes may be marketed.
Each pre-filled syringe is packed in a blister. The opening in the blister
seal is intended and allows for the equilibration of moisture during the
recommended warm-up prior to the administration of the vaccine. Open the
blister by removing the lid to take out the syringe. Do not press the syringe
through the blister.
The pack of 1 may include up to two needles of different sizes. Where
two needles are provided it is recommended to use the smaller needle for
injection in children and the larger needle for vaccination in adults. The
primary packaging is latex-free.
Marketing Authorisation Holder
United Kingdom:
Pfizer Limited
Ramsgate Road
Sandwich,
Kent,
CT13 9NJ
United Kingdom
Ireland:
Pfizer Healthcare Ireland
9 Riverwalk,
National Digital Park,
Citywest Business Campus,
Dublin 24
Ireland
Manufacturer
Pfizer Manufacturing Austria GmbH
Uferstrasse 15
2304 Orth an der Donau
Austria

Ireland
IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie
Malta
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store NeisVac-C
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton.
Unless the day is indicated, the expiry date refers to the last day of that
month.
This medicine should be stored in the refrigerator at +2°C to +8°C. Do not
freeze. Keep the syringe in the outer carton in order to protect from light.
The product may be stored at room temperature (up to +25°C) for a
maximum single period of nine months within the total shelf life. During this
period the product may be put back into the refrigerator at 2  –  8°C. The
starting date for storage at room temperature and the revised expiry date
should be stated on the product package. Under no circumstances must the
revised expiry date for storage at room temperature exceed the expiry date
set in accordance with the total shelf life of the product. At the end of this
period, the product should be used or discarded.

This medicinal product is authorised in the Member States of the EEA
under the following names:
Austria
Belgium
Bulgaria
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Íceland
Ireland
Italy

Perigord Nº 248697
Supplier Baxter
Barcode Nº N/A
Smallest

BODY TEXT Size 8.4 pt

Dimensions 195 x 342 mm
Notes N/A
PAR Number PAR‑2015‑0021120

NeisVac-C
NeisVac-C
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NeisVac-C
NeisVac-C
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NeisVac-C
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NeisVac-C
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NeisVac-C

This leaflet was last revised in 05/2015
For more detailed information on this medicine, please contact the local
representative of the Marketing Authorisation Holder.

Date: 02 Mar 2015 Time: 13:36
Supplier Nº 0727737

Latvia
Lithuania
Luxembourg
Malta
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Sweden
United Kingdom

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NeisVac
NeisVac-C
NeisVac-C
NeisVac-C
NeisVac-C
NeisVac-C
NeisVac-C

Market

Ireland, Malta
United Kingdom

Proof Nº 02
Component Leaflet
Code 2/5 727737
Drawing Nº TSBP20

Colours
Printing

Non-Printing

PMS 287

Profile

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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