Menjugate Liquid: 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).

This vaccine is used for immunisation of children from 2 months of age, adolescents and adults and it can only protect against meningococcal group C bacteria.

What it does:

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

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 MENJUGATE:

• any ingredient in the vaccine (including diphteria toxoid); or,
• any component of the container.

What the medicinal ingredient is:

Each 0.5 ml dose of 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 nonmedicinal ingredients are:

Aluminium hydroxide, histidine, sodium chloride, water for injection.

What dosage forms it comes in:

MENJUGATE Liquid is formulated as a suspension for injection

MENJUGATE Liquid is available in two presentations:

• Vial*of vaccine
• Syringe of vaccine

*Format not available in Canada.

WARNINGS AND PRECAUTIONS

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)
• if you receive treatment that blocks the part of the immune system known as complement activation, such as eculizumab. Even if you have been vaccinated with MENJUGATE you remain at increased risk of disease caused by the Neisseria meningitidis group C bacteria.
• 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)

• was born prematurely (before or at 28 weeks of pregnancy), particularly with breathing difficulties. Stopping breathing or irregular breathing for a short time may be more common in the first three days following vaccination in these babies and they may need special monitoring.

Fainting, feeling faint or other stress-related reactions can occur as a response to any needle injection. Tell your doctor or nurse if you have experienced this kind of reaction previously.

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).

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.

Important information about some of the ingredients of MENJUGATE

Latex-sensitive individuals – for syringe presentation:

Although no natural rubber latex is detected in the syringe tip cap, the safe use of MENJUGATE in latex-sensitive individuals has not been established.

Please tell your doctor if you (or your child) ever had an allergic reaction to latex.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or have recently received any other vaccine.

MENJUGATE can be given at the same time as any of the following vaccines:

• Polio vaccines given by mouth or by injection,
• Diphtheria and Tetanus vaccines alone or in combination with Whooping cough vaccine,
• Haemophilus influenzae type B (Hib disease) vaccine,
• Hepatitis B vaccine given alone or at the same time as combined vaccines against Diphtheria, Tetanus, Hib disease, Polio and Whooping cough,
• Measles, Mumps and Rubella (MMR) combined vaccines,
• Pneumococcal conjugate vaccine.

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.

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.

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
• 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 children (aged 12 through 23 months): irritability, drowsiness, difficulty sleeping, loss of appetite and diarrhoea.
• Older children and adults: feeling generally unwell, feeling sick (nauseous), muscle and joint pains, headache

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

• In all age groups: Fever.
• Infants and children aged 12 through 23 months: crying
• Children aged 12 through 23 months: 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.

In babies born very prematurely (at or before 28 weeks of gestation), longer gaps than normal between breaths may occur.

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

REPORTING SUSPECTED SIDE EFFECTS

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. Keep out of reach of children.

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: June 11, 2019

^©2019 GSK group of companies or its licensor

Trademarks are owned by or licensed to the GSK group of companies.