Menjugate: Uses, Side Effects and Dosage

What the vaccine is used for:

Menjugate is a vaccine that is used to prevent disease caused by the bacteria named Neisseria meningitidis serogroup C. Neisseria meningitidis serogroup C bacteria can cause serious and sometimes life-threatening infections such as meningitis and septicaemia (blood poisoning).

What it does:

The vaccine works by causing your body to make its own protection (antibodies) against these Neisseria meningiditis group C bacteria.

This vaccine can only protect against meningococcal serogroup C bacteria. It cannot protect against other groups (strains) of meningococcal bacteria or against other causes of meningitis and septicaemia (blood poisoning).

If at any time you or your child experiences neck pain, neck stiffness or a dislike of light (photophobia), drowsiness or 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.

This vaccine cannot cause meningitis C (meningococcal C disease).

This vaccine contains a protein (called CRM197) from the bacteria that cause diphtheria. Menjugate does not protect against Diphtheria disease. This means that you/your child should receive other vaccines to protect against diphtheria when these are due or when advised by your doctor.

When it should not be used:

Menjugate should not be used if the person receiving the vaccine has ever had an allergic reaction to:

• any ingredient in the vaccine or
• any component of the container.

What the medicinal ingredient is:

One dose (0.5 ml of the reconsituted vaccine) contains the following amount of active substance: 10 micrograms of Neisseria meningitidis group C (strain C11) oligosaccharide chemically joined to 12.5 to 25.0 micrograms of Corynebacterium diphtheriae CRM197 protein.

What the important nonmedicinal ingredients are:

Aluminum hydroxide adjuvant

For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.

What dosage forms it comes in:

Menjugate is formulated as a powder for suspension (10 micrograms).

Menjugate is available in two presentations:

• Vial of vaccine plus vial of diluent
• Vial of vaccine plus syringe of diluent

WARNINGS AND PRECAUTIONS

NG

BEFORE you use Menjugate talk to your doctor or pharmacist if you (or your child):

• have an infectious illness (for example, high temperature, sore throat, cough, cold or flu)
• have haemophilia or any problem that may stop your blood from clotting properly
• been told that you have a weak immune system for any reason. For example, you have been told that you do not produce antibodies very efficiently, or you are taking medicines that reduce your immunity to infections (such as anti-cancer drugs or high doses of corticosteroids)
• have had your spleen removed or been told that your spleen does not work as it should
• are over 65 years old
• suffer from a kidney disease in which large amounts of protein appear in the urine (called nephrotic syndrome)

Pregnancy and breast-feeding

If you are pregnant, likely to become pregnant or are breast-feeding, you must tell your doctor before Menjugate is given. Your doctor or nurse may still advise you to have Menjugate if you are at high risk of infection with meningococcal group C bacteria.

Driving and using machines

You may feel dizzy or experience some other side effects after the injection. These could interfere with your driving or operating machinery. Do not drive or operate machinery until you know how Menjugate affects you.

Important information about some of the ingredients of Menjugate

The tip cap of the syringe contains 10% Dry Natural Rubber. Please tell your doctor if you (or your child) ever had an allergic reaction to latex.

INTERACTIONS WITH THIS MEDICATION

Menjugate may be given at the same time as other vaccinations but any other injected vaccines should be given into a different arm or leg from the site of the Menjugate injection.

Usual dose:

Menjugate will be given to you/your child by a health professional. The vaccine is usually given into the muscle of the thigh in infants, and into the shoulder muscle for older children, adolescents and adults. Your healthcare professional will take care to ensure the vaccine is not given into a blood vessel and will make sure that it is injected into muscle and not into the skin.

For children over the age of 12 months, adolescents and adults: a single dose (0.5 ml) of the vaccine is recommended.

For infants 2 months up to 12 months of age: a complete vaccination schedule in infants consists of three doses of Menjugate. The first dose is given to infants from 2 months of age. A gap of at least one month should occur between each of doses.

In order to maintain protection, a booster dose must be given after the infant course has been completed. Your doctor will advise you when your child should receive this.

Overdose:

Since Menjugate will be given by either a doctor or nurse, and each injection is a single dose of 0.5 millilitres, it is very unlikely that you (or your child) will be given too much vaccine. If you have any concerns about the amount of vaccine you (or your child) have been given, speak to your doctor or nurse.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, Menjugate may cause side effects in some persons. If any side effects worry you, or if you/your child have unusual symptoms, please contact your health professional.

If a serious allergic reaction occurs (usually in less than 1 in 10,000 people) tell your doctor straight away or go immediately/ take your child to the nearest Accident and Emergency department because urgent medical help may be needed.

The possible symptoms of serious allergic reactions can include:

• Swelling of the lips, mouth, throat (which may cause difficulty in swallowing)
• Difficulty breathing with wheezing or coughing
• Rash and swelling of the hands, feet and ankles
• Loss of consciousness and

• Very low blood pressure.

  These very rare reactions can occur immediately or very soon after the injection and there is usually a rapid recovery after the right treatment has been given.

  Other allergic reactions may start some days after the vaccine is given.

  These include:

  • rashes, sometimes with itching, purple skin spots or blotches,
  • blistering rashes that may also cause ulcers in the mouth and around the genital organs.

The most common side effects reported during clinical trials usually lasted only one to two days and were not usually severe. The side effects were:

Very common (in more than 1 in 10 people)

• In all age groups: redness, swelling and tenderness/pain at the injection site but these did not usually require further medical attention. Redness or swelling of at least 3 cm and tenderness causing discomfort with movement were rarely observed for more than 48 hours.
• Infants: being sick (vomiting)
• Infants and toddlers: irritability, drowsiness, difficulty sleeping, loss of appetite and diarrhoea.
• Secondary school children: headache
• Older children and adults: feeling generally unwell, muscle and joint pains
• Adults: feeling sick (nauseous)

Common (between 1 in 10 and 1 in 100 people)

• In all age groups: Fever (but rarely severe).
• Infants and toddlers: crying
• Toddlers: being sick (vomiting).
• Primary school children: headache

Other side effects reported during routine vaccination programmes include:

Very rare (less than 1 in 10,000 people)

Different age groups:

• enlarged lymph glands
• extensive swelling of the vaccinated limb
• dizziness
• faints
• numbness
• tingling sensation or pins and needles
• temporarily reduced muscle tone
• visual disturbances and sensitivity to light. These have usually occurred together with headache and dizziness.

Although fits have been reported very rarely after vaccination with Menjugate, it is thought that some of these reports in teenagers and adults may have been faints. In infants and young children, fits were usually associated with high fever. The majority of people affected have recovered rapidly.

There have been very rare reports of relapse of a kidney disorder called nephrotic syndrome following vaccination with this type of vaccine.

This is not a complete list of side effects. For any unexpected effects while taking Menjugate, contact your doctor or pharmacist.

HOW TO STORE IT

Store Menjugate in a refrigerator (+2°C to +8°C). Do not freeze. Keep the product in the outer carton in order to protect from light. Following reconstitution, Menjugate should be used immediately.

Keep out of reach of children.

Alternative storage condition: Menjugate can be taken out of the refrigerator and stored at room temperature (up to +25°C) for a period of up to 6 months. Menjugate should be used or thrown away within 6 months of the date of removal from the refrigerator or on reaching the expiry date indicated on the carton (whichever comes first).

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

www.gsk.ca

or by contacting the sponsor,

GlaxoSmithKline Inc.

7333 Mississauga Road

Mississauga, Ontario

L5N 6L4

1-800-387-7374

Last revised: October 20, 2017

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