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MenJugate Kit

What Menjugate Kit is and what it is used for

Menjugate Kit is a vaccine that is used to prevent disease caused by a bacterium named Neisseria meningitidis group C (also referred to as meningococcal group C bacteria). The vaccine works by causing your body to make its own protection (antibodies) against these meningococcal group C bacteria.

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

This vaccine can only protect against meningococcal group 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 must contact your doctor or local Accident and Emergency Department immediately.

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

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

Before you are given Menjugate Kit

You will not be given Menjugate Kit if you (or your child):

  • ever had an allergic reaction to the active substance or any of the other ingredients of Menjugate Kit (see Section 6)
  • ever had an allergic reaction to diphtheria toxoid (a substance used in a number of other vaccines)
  • ever shown any signs of allergy following vaccination with Menjugate Kit
  • have a very high fever. In this case vaccination with Menjugate Kit may have to be delayed

Take special care with Menjugate Kit if you (or your child):

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

Before receiving any dose of Menjugate Kit you should be asked about your (or your child) personal and family health history. Your (or your child) immunization status and any previous side effects following vaccination must be reported to your doctor or nurse.

Talk with your doctor or nurse about these details before being given this vaccine as it may not be suitable for you (or your child). In some instances, you (or your child) may still be given the vaccine but it may not provide very high protection against infections caused by the group C bacteria.

Using other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Giving other vaccines

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

  • 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

These other vaccines should be given at the recommended ages as normal.

Pregnancy and breast-feeding

If you are pregnant, likely to become pregnant or are breastfeeding, you must tell your doctor before Menjugate Kit is given. Your doctor or nurse may still advise you to have Menjugate Kit 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 Kit affects you.

Important information about some of the ingredients of Menjugate Kit

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.

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.

How you are given Menjugate Kit

Menjugate Kit will be given by your doctor or nurse.

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 doctor or nurse 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 12 months and older, adolescents and adults: a single dose (0.5 ml) of the vaccine is recommended.

For infants 2 months up to 12 months of age: two doses of Menjugate Kit should be given at least two months apart. In order to maintain protection, a booster dose must be given after the infant course of two doses has been completed. Your doctor will advise you when your child should receive this.

For information on the reconstitution of the vaccine see the section for medical or healthcare professionals at the end of this leaflet.

If you use more Menjugate Kit than you should

Since Menjugate Kit 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.

Possible side effects

Like all medicines, Menjugate Kit can cause side effects, although not everybody gets them.

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 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 toddlers: irritability, drowsiness, difficulty sleeping, loss of appetite and diarrhoea.

Secondary school children: headache

Older children and adults: feeling generally unwell

Adults: muscle and joint pains, feeling sick (nauseous) Common (less than 1 in 10 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
  • 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 Kit, 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 for 2-3 days 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, nurse or pharmacist.

How to store Menjugate Kit

Keep out of the reach and sight of children.

Do not use Menjugate Kit after the expiry date which is stated on the carton.

The vaccine consists of a vial and a syringe and they may carry a different expiry date. The carton and ALL its contents must be discarded on reaching this outer carton expiry date.

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the vial and the syringe in the outer carton in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of this medicine. These measures will help to protect the environment.

Further information

What Menjugate Kit contains

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

The active substance is adsorbed on aluminium hydroxide (0.3 to 0.4 mg Al3+) in 0.5 ml (1 dose) of reconstituted vaccine.

The other ingredients in the vial of powder are: mannitol, sodium dihydrogen phosphate monohydrateand disodium phosphate heptahydrate.

The other ingredients in the syringe of aluminium hydroxide solvent are: sodium chloride and water for injections.

What Menjugate Kit looks like and contents of the pack

Menjugate Kit is a powder and solvent for suspension for injection. Each dose of Menjugate Kit is supplied as a:

Vial containing the active substance as a white to off-white powder

Syringe contains a white opalescent aluminium hydroxide solvent

The contents of the two components (vial and syringe) are to be mixed prior to vaccination.

Pack sizes: 1,5 or 10 doses. Not all pack sizes may be marketed.

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