What NeisVac C is used for and how to use it
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NeisVac C - Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Meningococcal Meningitis Prophylaxis
Class: Immunologic agents, Vaccine combinations
Form: Liquid solution, Intramuscular (IM)
Ingredients: Neisseria meningitidis group C polysaccharide conjugated with (joined to) 10 to 20 micrograms of tetanus toxoid protein, adsorbed on 0.5 mg aluminium hydroxide

Meningococcal Group C-TT Conjugate Vaccine, Adsorbed

About This Medication

What is NeisVac-C Vaccine and What Does It Do

The name of the vaccine is NeisVac-C vaccine (meningococcal group C-TT conjugate vaccine, adsorbed) and is a suspension for injection packaged in pre-filled syringes.

NeisVac-C vaccine is one of a general group of medicines called vaccines, which are used to protect against infectious diseases. NeisVac -C vaccine is used to prevent disease caused by bacteria called Neisseria meningitidis group C. The vaccine works by causing the body to produce its own protection (antibodies) against the group C bacteria.

The Neisseria meningitidis group C bacteria can cause serious and sometimes life-threatening infections such as meningitis and septicaemia (blood poisoning).

NeisVac-C 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 vaccine cannot completely prevent meningococcal group C infections in all people who are vaccinated.

What Is In Your Medication

One dose (0.5 mL) of the vaccine contains, as the active ingredient, 10 micrograms of Neisseria meningitidis group C polysaccharide conjugated with (joined to) 10 to
20 micrograms of tetanus toxoid protein, adsorbed on 0.5 mg aluminium hydroxide.

The other ingredients in NeisVac-C vaccine are sodium chloride and water for injection.

What Dosage Forms Does Your Medication Come In

NeisVac-C vaccine is supplied as a suspension for injection in pre-filled syringes.

Warnings and Precautions

NeisVac-C vaccine should not be given if the answer to the following question is “YES” for the person receiving the injection.

  • Have you ever had an allergic reaction (for example, symptoms such as itchy generalized skin rash, swelling of the face and throat, difficulty in breathing, blue discolouration of the tongue or lips, low blood pressure and collapse) to any ingredient of the vaccine including tetanus toxoid?

NeisVac-C vaccine may not be suitable for you if the answer to the following question is “YES”. Your doctor or nurse will decide if you may receive NeisVac-C vaccine.

  • Have you ever had an allergic reaction to any other vaccine intended to protect against meningococcal group C infections?

NeisVac-C vaccine may have to be delayed if the answer to the following question is “YES” for the person receiving the injection.

  • Do you have an infectious illness (for example, high temperature, sore throat, cough, cold or flu)?

Take special care with NeisVac-C vaccine.

If the answer to any of the following questions is “YES” for the person receiving the injection, talk with your doctor or nurse before having this vaccine as it may not be suitable. In some instances, you may still be given the vaccine but it may not provide very high protection against infections caused by the group C bacteria.

  • Do you have haemophilia or any other problem that may stop your blood from clotting properly?
  • Have you been told that you have a weak immune system for any reason? For example, have you been told that you do not produce antibodies very efficiently, or are you taking medicines that reduce your immunity to infections (such as anti-cancer drugs or high doses of corticosteroids)?
  • Have you had your spleen removed or been told that your spleen does not work as it should?
  • Are you over 65 years old?

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. Parents are advised to contact their physician, if any abnormal breathing is noticed.

Breastfeeding and pregnancy

  • Are you pregnant, planning to become pregnant or breastfeeding? NeisVac-C vaccine may still be given to you by a doctor or nurse if the risk of infection is considered to be high.

Driving and operating machinery

  • The vaccine is unlikely to affect your ability to drive or operate machinery.

Although this vaccine contains tetanus toxoid, it does not reliably protect you against tetanus (lockjaw). Therefore, routine vaccines against tetanus should still be given when they are due (your doctor or nurse will advise you when you need vaccination against tetanus).

Interactions With This Medication

Although there are no known interactions with other medicines, you should tell your doctor or nurse about any other medicines which you are taking, whether prescribed or bought without prescription.

Your doctor or nurse will advise you if you should need to have NeisVac-C vaccine at the same time as other injected vaccines.

NeisVac -C vaccine may be given at the same time as, but as separate injections at different injection sites from vaccines that protect against polio, measles, mumps, and rubella (MMR), diphtheria, tetanus and pertussis (whooping cough), infections caused by Haemophilus influenzae (Hib), pneumococcal infections, and rotavirus infections.

NeisVac-C vaccine 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.

Proper Use of This Medication

Usual Dose

One dose of NeisVac-C vaccine is 0.5 mL (half a millilitre a very small amount of liquid). It is usually injected into the muscle of the arm (in children from the age of 12 months and older persons) or thigh (in children from two months old up to the age of 12 months). In children 12 to 24 months of age, the vaccine may be administered in the muscle of the arm or the thigh. 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 so when administering the vaccine.

Your child may receive one or two injections before they are 12 months old, and another injection at approximately 12 to 13 months of age, with an interval of at least 6 months after last NeisVac-C vaccination.

Older children (12 months and older), adolescents and adults will receive one injection only.

Overdose

For management of a suspected drug overdose, please contact your regional Poison Control Centre.

An overdose is highly unlikely to happen because it is administered from a single-dose syringe by a doctor or nurse.

Side Effects and What to Do About Them

As with all medicines, NeisVac -C vaccine may cause side effects in some persons. If any side effects worry you, or you have any unusual symptoms, please contact your doctor, nurse or pharmacist. Side effects occurring in more than 1 in 10 people are considered to be very common. Those that occur in more than 1 in 100 people but less than 1 in 10 are considered to be common, and side effects occurring in fewer than 1 in 10,000 people are considered to be very rare.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in cases of very rare but serious allergic reactions.

Symptoms of serious allergic reactions include: swelling of the lips, mouth, throat (which may cause difficulty in swallowing or breathing), sometimes accompanied by a rash and swelling of the hands, feet and ankles. Symptoms of allergic reactions may also include drops in blood pressure and unconsciousness. When these signs or symptoms occur they usually develop very quickly after the injection is given and while the person affected is still in the clinic or doctor’s office. If any of these symptoms occur after leaving the place where your injection was given, you must consult a doctor IMMEDIATELY.

Very rarely, severe skin rashes can occur 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. Less severe allergic reactions include itching, hives and other rashes.

Fits (seizures) have been reported very rarely after vaccination including some fits in people who already had fits at times. In teenagers and adults, some of the reports of fits may actually have been fainting attacks. In infants and young children seizures were usually associated with fever and were likely to be febrile convulsions. Most people recovered rapidly after the fit.

Injection site reactions are very common side effects in all age groups and include redness, swelling, hardening at the site of injection, and tenderness/pain at the injection site. Headaches and fever are also very common.

Other very common side effects in infants and/or toddlers are loss of appetite, feeling or being sick and diarrhea, crying, irritability, drowsiness and sleepiness, or impaired sleeping.

Muscle pain and pains in the arms or legs are common or very common in older children and adults.

Common side effects in older children are loss of appetite, feeling or being sick or diarrhea

Very rare side effects include swollen lymph glands, dizziness, faints, abnormal or reduced sensation, loss of muscle tone or floppiness in infants, and purple spots or blotches under the skin which may be caused by a drop in special blood cells responsible for clotting and may look like bruises.

If you have previously been told by your doctor that you suffer from nephrotic syndrome (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) there may be an increased chance that this condition will reoccur within a few months after vaccination. You should tell your doctor if you notice similar symptoms after vaccination.

This vaccine cannot cause meningococcal group C disease. If you or your child experiences neck pain, neck stiffness or a dislike of light (photophobia), drowsiness or confusion, or red or purple bruise-like spots that do not fade under pressure you should contact your doctor or local Hospital Emergency Department immediately to rule out other causes.

If you notice any other side effects not mentioned in this leaflet, please inform your doctor, nurse or pharmacist.

How to Store It

This medicine should be stored in the refrigerator at +2°C to +8°C (Do Not Freeze) . The product may be taken out of the refrigerator and stored at room temperature for a single period of not more than 9 months, as long as this time period ends before the expiry date written on the label. The date that the product is taken out of the refrigerator should be written on the box in the space provided. If the product has not been used within 9 months of the date it was taken out of the refrigerator (or by the expiry date, whichever is sooner), the product should be discarded.

The vaccine should be used before the expiry date printed on the label.

Keep out of the sight and reach of children.

Reporting Suspected Side Effects

To monitor vaccine safety, the Public Health Agency of Canada collects case reports on adverse events following immunization.

For Health Care Professionals

If a patient experiences an adverse event following immunization, please complete the appropriate Adverse Events following Immunization (AEFI) Form and send it to your local Health Unit in your province/territory.

For the General Public

Should you experience an adverse event following immunization, please ask your doctor, nurse, or pharmacist to complete the Adverse Events following Immunization (AEFI) Form.

If you have any questions or have difficulties contacting your local health unit, please contact Vaccine Safety Section at Public Health Agency of Canada:

By toll-free telephone: 1-866-844-0018
By toll-free fax: 1-866-844-5931
E-mail: caefi@phac-aspc.gc.ca
At the following website:
http://www.phac-aspc.gc.ca/im/vs-sv/index-eng.php

By regular mail:
The Public Health Agency of Canada
Vaccine Safety Section
130 Colonnade Road
Ottawa, Ontario
K1A 0K9 Address Locator 6502A

NOTE: Should you require information related to the management of side effects, contact your health care provider before notifying the Public Health Agency of Canada. The Public Health Agency of Canada does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals, can be found at www.pfizer.ca or can be obtained by contacting the sponsor, Pfizer Canada Inc.,
at: 1-800-463-6001 (Medical Information).