MENJUGATE 10 micrograms injectable suspension pre-filled syringe

Introduction

Package Leaflet: Information for the User

MENJUGATE 10 micrograms suspension for injection pre-filled syringe

Meningococcal group C conjugate vaccine

Read all of this leaflet carefully before you or your child start using this medicine because it contains important information for you or your child.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This vaccine has been prescribed for you or your child only. Do not pass it on to others.
• If you or your child experience any side effects, talk to your doctor or nurse, even if you or your child think they are not serious or were not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Menjugate and what is it used for
2. What you need to know before you or your child start using Menjugate
3. How to use Menjugate
4. Possible side effects
5. Storage of Menjugate
6. Contents of the pack and other information

1. What is Menjugate and what is it used for

Menjugate is a vaccine that is used to prevent diseases caused by the bacterium Neisseria meningitidisgroup C (also known as meningococcal group C bacterium). The vaccine works by stimulating the production of protective antibodies against meningococcal group C.

The bacterium Neisseria meningitidisgroup C can cause serious, life-threatening infections, such as meningitis and septicemia (blood infection).

This vaccine is used for the active immunization of children from 2 months of age, adolescents, and adults, and only protects against meningococcal group C bacteria. It does not protect against other groups of meningococcal bacteria or against other causes of meningitis or septicemia (blood infection).

If you or your child experience neck pain/stiffness or have a dislike of light (photophobia), drowsiness or confusion, red or purple spots like bruising that do not fade under pressure, you should contact your doctor or go to the Emergency Department immediately.

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

This vaccine contains the diphtheria protein CRM197. Menjugate does not protect against diphtheria.

This means that you (or your child) will need to receive other vaccines to protect against diphtheria when necessary or when your doctor advises.

2. What you need to know before you or your child are given Menjugate

Do not useMenjugate if you or your childhave:

• ever had an allergic reactionto the active substances or to any of the other components of Menjugate (listed in section 6)
• ever had an allergic reaction todiphtheria toxoid(a substance used in many other vaccines)

Warnings and precautions

Fainting, feeling of fainting, and other stress-related reactions can occur as a response to a needle injection. Tell your doctor or nurse if you (or your child) have had this type of reaction in the past.

Talk to your doctor or nurse before you or your child are given Menjugate or if you or your child:

• have haemophiliaor any other problem that may affect blood clotting (e.g. a low platelet count called thrombocytopenia) or are taking any medicine that affects blood clotting
• have a weakened immune systemfor any reason (e.g. you (or your child) do not produce antibodies efficiently, or you (or your child) are taking medicines that reduce the immune system's ability to fight infections, such as cancer medicines or high doses of corticosteroids)
• are receiving treatment that blocks a part of the immune system known as complement activation, such as eculizumab. Even if you have been vaccinated with Menjugate, you are still at higher risk of invasive disease caused by the bacterium Neisseria meningitidisgroup C
• have had your spleen removedor have been told that your spleen does not work properly
• have a febrile or infectious illness. In this case, vaccination with Menjugate may need to be postponed. However, a mild infection (e.g. a cold) is not a reason to postpone vaccination
• are over 65 years of age
• have a kidney diseasein which large amounts of protein appear in the urine (called nephrotic syndrome). Relapses have been reported after vaccination

This vaccine only protects against meningococcal group C bacteria. It does not protect against other groups of meningococcal bacteria.

People sensitive to latex (for the pre-filled syringe presentation):

Although natural rubber latex is not detected in the syringe cap, it has not been established that the use of Menjugate is safe in people sensitive to latex.

Using Menjugate with other medicines

Tell your doctor or nurse if you (or your child) are using, have recently used, or might use any other medicines.

Menjugate can be given at the same time as other vaccines, but any other injectable vaccine should be given at a different injection site, preferably in a different arm or leg from the Menjugate injection.

This includes:

• Oral or injectable polio vaccines
• Diphtheria and tetanus vaccines alone or in combination with pertussis vaccine
• Haemophilus influenzaetype b vaccine (Hib disease)
• Hepatitis B vaccine given alone or as combined vaccines against diphtheria, tetanus, Hib, polio, and pertussis
• Combined measles, mumps, and rubella (MMR) vaccines
• Pneumococcal conjugate vaccine

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your doctor or nurse before you are given Menjugate. However, if you are at high risk of getting meningococcal group C infection, your doctor or nurse may advise you to have Menjugate.

Driving and using machines

You may feel dizzy or experience other side effects after the injection. This could affect your ability to drive or use machines. Do not drive or use machines until you know how Menjugate affects you.

Menjugate contains:

This medicine contains less than 23 mg of sodium (1 mmol) per dose; this is essentially "sodium-free".

3. How to use Menjugate

Menjugate will be given to you or your child by a doctor or nurse.

The vaccine is usually given into the muscle of the thigh in infants and into the muscle of the shoulder in older children, adolescents, and adults. Your doctor or nurse will make sure that the vaccine is not given into a blood vessel and will ensure that it is injected into the muscle and not into the skin.

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

In infants from 2 months to 12 months:two doses of Menjugate should be given at least two months apart.

To maintain protection, a booster dose should be given after the two-dose vaccination schedule has been completed in children. Your doctor will tell you when this booster dose should be given to your child.

See the section for healthcare professionals at the end of this leaflet for information on handling the vaccine.

If you use more Menjugate than you should

Since Menjugate is given by a doctor or nurse, and each injection is a single dose of 0.5 ml, 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 given to you or your child, talk to your doctor or nurse.

If you have any further questions on the use of Menjugate, ask your doctor or nurse.

4. Possible side effects

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

If a severe allergic reaction occurs (which happens in less than 1 in 10,000 people), tell your doctor immediately / take your child to the Emergency Department because urgent medical attention may be needed.

Symptomsof severe allergic reactions can be:

• Swelling of the lips, mouth, throat (which may cause difficulty 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 side effects may occur immediately or soon after the injection and usually resolve quickly after appropriate treatment.

Other allergic reactionsmay start several days after the vaccine is given.

They may be:

• Rash, sometimes with itching, purple spots, or redness
• Rash with blisters that may also cause ulcers in the mouth and around the genital area

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

Very common(may affect more than 1 in 10 people)

• In all age groups: redness, swelling, and sensitivity/pain at the injection site, which usually did not require medical attention. Rarely, redness or swelling of at least 3 cm and sensitivity that causes discomfort when moving for more than 48 hours have been reported
• Infants: vomiting
• Infants and young children (between 12 and 36 months): irritability, drowsiness, difficulty sleeping, loss of appetite, and diarrhea
• Older children: headache
• Older children and adults: muscle and joint pain, general feeling of being unwell
• Adults: general feeling of being unwell (with nausea)

Common(may affect up to 1 in 10 people)

• In all age groups: fever (but rarely severe)
• Infants and young children (between 12 and 36 months): crying
• Young children (between 12 and 36 months): vomiting
• Older children: headache

Other side effectsreported during routine vaccination programs:

Very rare(may affect up to 1 in 10,000 people)

Various age groups:

• swollen lymph nodes
• dizziness
• fainting
• numbness
• tingling or cramps
• temporary reduction in muscle tone
• visual disturbances and sensitivity to light, usually occurring with headache and dizziness
• extensive swelling of the vaccinated limb

Although very rarely reported after vaccination with Menjugate, some of these reports in adolescents and adults may be fainting spells. In infants and young children, seizures were usually associated with high fever. Most people affected recovered quickly.

Very rarely, after vaccination with this type of vaccine, there have been reports of relapse of a kidney disorder called nephrotic syndrome.

After vaccination, in very premature babies (born before 28 weeks of gestation), longer pauses between breaths than normal may occur for 2-3 days.

Reporting of side effects

If you or your child experience any side effects, talk to your doctor or nurse, even if you or your child think they are not serious or were not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Menjugate

Keep this vaccine out of the sight and reach of children.

Do not use Menjugate after the expiry date which is stated on the carton. This vaccine is a vial or a pre-filled syringe.

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

Medicines should not be disposed of via wastewater or household waste. Ask your doctor or nurse how to dispose of the packaging and any unused medicine. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Menjugate

Each 0.5 ml dose of the vaccine contains the following amount of active substance: 10 micrograms of Neisseria meningitidisgroup C (strain C11) oligosaccharide conjugated to 12.5-25.0 micrograms of Corynebacterium diphtheriaeCRM197 protein.

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

The otheringredients are: sodium chloride, histidine, and water for injections (see also the end of section 2).

Appearance and pack of Menjugate

Menjugate is a suspension for injection.

Each dose of Menjugate is presented as:

• a vial with a white opalescent suspension

or

• a pre-filled syringe with a white opalescent suspension

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

GSK Vaccines S.R.L.

Via Fiorentina 1

53100 Siena, Italy

Local representative:

GlaxoSmithKline, S.A.

P.T.M C/Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

GSK Vaccines S.R.L.

Bellaria-Rosia

53018 Sovicille (Siena), Italy

Date of last revision of this leaflet:

January 2020

This information is intended only for healthcare professionals:

Syringe:

Gently shake the syringe with the vaccine before administration. Remove the syringe cap and attach a suitable needle. The vaccine should be inspected visually for particulate matter and changes in appearance before administration. Check that the syringe does not contain air bubbles before injecting the vaccine. If any foreign particles and/or changes in physical appearance are observed, the vaccine should be discarded.

Vial:

Gently shake the vial with the vaccine. Using a syringe and a suitable needle (21G, 1½ inches [40 mm] in length), withdraw the entire contents of the vial. Before injection, replace the needle with a suitable one for administration. The vaccine should be inspected visually for particulate matter and changes in appearance before administration. Check that the syringe does not contain air bubbles before injecting the vaccine. If any foreign particles and/or changes in physical appearance are observed, the vaccine should be discarded.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es/