What Menveo is and what it is used for
Menveo is a vaccine that is used for active immunization of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitidis serogroups A, C, W135 and Y, to prevent invasive disease. The vaccine works by causing your body to make its own protection (antibodies) against these bacteria.
Neisseria meningitidis group A, C, W135 and Y bacteria can cause serious and sometimes life-threatening infections such as meningitis and sepsis (blood poisoning).
Menveo cannot cause bacterial meningitis or diphtheria.
Before you or your child are given Menveo
Do not use Menveo if you or your child has :
- ever had an allergic reaction to the active substances or any of the other ingredients of Menveo (see Section 6 Further Information)
- ever had an allergic reaction to diphtheria toxoid (a substance used in a number of other vaccines)
- an illness with high fever. However, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination.
Take special care with Menveo if you (or your child) have:
Haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants).
This vaccine can only protect against meningococcal group A, C, W135, and Y bacteria. It cannot protect against other types of meningococcal bacteria other than groups A, C, W135 and Y, or against other causes of meningitis and sepsis (blood poisoning).
Little is known about the effectiveness of Menveo when administered to individuals with weakened immunity due to use of immunosuppressive medications, or HIV infection, and other possible causes. It is possible that the effectiveness of Menveo could be reduced in such individuals.
As with any vaccine, Menveo may not fully protect 100% of those who get the vaccine.
The tip cap of the syringe contains 10% Dry Natural Rubber. Although the risk for developing allergic latex reactions is very small, healthcare professionals are encouraged to consider the benefit risk prior to administering this vaccine to patients with known history of hypersensitivity to latex.
- 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.
Menveo may be given at the same time as other vaccinations. These include: Tetanus, Reduced Diphtheria and Acellular Pertussis Vaccine (Tdap), and Human Papillomavirus Vaccine (HPV).
Menveo’s effect could be diminished when administered to individuals who are taking medicines that suppress the immune system.
Other injected vaccines must be given into a different arm from the site of the Menveo injection.
- Pregnancy and breast-feeding
If you are pregnant, likely to become pregnant or are breast-feeding, you must tell your doctor before Menveo is given. Your doctor or nurse may still recommend that you receive Menveo if you are at high risk of infection with meningococcal group A, C; W-135 and Y bacteria.
- Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. Dizziness has been very rarely reported following vaccination. This may temporarily affect the ability to drive or use machines.
Important information about some of the ingredients of Menveo
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
This medicinal products contains less than 1 mmol potassium (39 mg) per dose, i.e. essentially ‘potassium- free'”
How to use Menveo
Menveo will be given to you or your child by a doctor or nurse.
The vaccine is usually given into the upper arm muscle (deltoid) for 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 adolescents (from 11 years of age) and adults: a single dose (0.5 ml) of the vaccine is recommended.
There are limited data in individuals aged 56-65 and there are no data in subjects aged older than 65 years
For information on the reconstitution of the vaccine see the section for medical or healthcare professionals at the end of this leaflet.
Possible side effects
Like all medicines, Menveo can cause side effects, although not everybody gets them.
The most common side effects reported during clinical trials usually lasted only one to two days and were not usually severe. The most common side effects that were reported during clinical trials are listed below.
Very common (affects more than 1 user in 10): headache, nausea, injection site pain, injection site redness(< 50 mm), injection site firmness or swelling (< 50 mm), injection site itching, malaise
Common (affects 1 to 10 users in 100): rash, injection site redness (> 50 mm), injection site firmness or swelling (> 50 mm), fever > 38°C, chills
Uncommon (affects 1 to 10 users in 1,000): dizziness
How to store Menveo
Keep out of the reach and sight of children.
Do not use Menveo after the expiry date which is stated on the outer carton after EXP. The expiry date refers to the last day of that month
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the vial and the pre-filled syringe in the outer carton in order to protect from light.
After reconstitution, the product should be used immediately. However, chemical and physical stability after reconstitution was demonstrated for 8 hours below 25°C.
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 Menveo contains
One dose (0.5 ml of the reconstituted vaccine) contains:
| (Originally contained in the powder)Meningococcal group A oligosaccharide 10 micrograms
Conjugated to Corynebacterium diphtheriae CRM197 protein 33.3 micrograms |
16.7 to |
| (Originally contained in the solution)Meningococcal group C oligosaccharide 5 micrograms
Conjugated to Coryne bacterium diphtheriae CRM197 protein 12.5 micrograms |
7.1 to |
| Meningococcal group W135 oligosaccharide Conjugated to Coryne bacterium diphtheriae CRM197 protein 8.3 micrograms | 5 micrograms 3.3 to |
| Meningococcal group Y oligosaccharide Conjugated to Coryne bacterium diphtheriae CRM197 protein 10.0 micrograms | 5 micrograms 5.6 to |
The other ingredients are
In the powder: potassium dihydrogen phosphate and sucrose.
In the solution: sodium chloride, sodium dihydrogen phosphate monohydrate, sodium hydrogen phosphate dihydrate, and water for injection (See also end of Section 2).
What Menveo looks like and contents of the pack
Menveo is a powder and a solution for injection. Each dose of Menveo is supplied as a:
Vial containing the MenA Lyophilised Conjugate Component as a white to off-white powder
Pre-filled syringe containing the MenCWY Liquid Conjugate Component as clear solution
The contents of the two components (vial and pre-filled syringe) are to be mixed prior to vaccination providing 1 dose of 0.5 ml.