BEKEMV

Warnings and precautions
Meningococcal and other Neisseria infections alert
BEKEMV treatment may reduce your natural resistance to infections, especially against certain organisms that cause meningococcal infection (severe infection of the linings of the brain and sepsis) and other Neisseria infections including disseminated gonorrhoea.
Consult your doctor before you take BEKEMV to be sure that you receive vaccination against
Neisseria meningitidis, an organism that causes meningococcal infection, at least 2 weeks before beginning therapy, or that you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Ensure that your current meningococcal vaccination is up to date. You should also be aware that vaccination may not prevent this type of infection. In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection.
If you are at risk of gonorrhoea, ask your doctor or pharmacist for advice before using this medicine.
Meningococcal infection symptoms
Because of the importance of rapidly identifying and treating certain types of infection in patients who receive BEKEMV, you will be provided a card to carry with you, listing specific trigger symptoms.
This card is named: “Patient Safety Card”.
If you experience any of the following symptoms, you should immediately inform your doctor:
– headache with nausea or vomiting
– headache with a stiff neck or back
– fever
– rash
– confusion
– severe muscle aches combined with flu-like symptoms
– sensitivity to light
Treatment for meningococcal infection while travelling
If you are travelling in a remote region where you are unable to contact your doctor or in which you find yourself temporarily unable to receive medical treatment, your doctor can make arrangements to issue, as a preventive measure, a prescription for an antibiotic to counter Neisseria meningitidis that you keep with you. If you experience any of the symptoms amongst those cited above, you should take the antibiotics as prescribed. You should bear in mind that you should see a doctor as soon as possible, even if you feel better after having taken the antibiotics.

Infections
Before starting BEKEMV, inform your doctor if you have any infections.

Allergic reactions
BEKEMV contains a protein and proteins can cause allergic reactions in some people.

Children and adolescents
Patients less than 18 years of age must be vaccinated against Haemophilus influenzae and
pneumococcal infections.

Older people
There are no special precautions needed for the treatment of patients aged from 65 years and over.

Other medicines and BEKEMV
Tell your doctor or pharmacist if you are using or have recently used or might use any other
medicines.

Pregnancy, breast-feeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before using this medicine.

Women of childbearing potential
The use of effective contraception during treatment and up to 5 months after treatment should be considered in women who are able to get pregnant.

Driving and using machines
BEKEMV has no or negligible influence on the ability to drive and use machines.

BEKEMV contains sorbitol
This medicine contains 50 mg sorbitol in each mL.
Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine. Patients with

HFI cannot break
down fructose, which may cause serious side effects.
You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.

BEKEMV contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially
“sodium free”.