ZINPLAVA 25 mg/mL concentrate for solution for infusion

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What ZINPLAVA is and what it is used for
2. What you need to know before you are given ZINPLAVA
3. How you are given ZINPLAVA
4. Possible side effects
5. How to store ZINPLAVA
6. Contents of the pack and other information

How ZINPLAVA works

• When people get CDI, they are usually given an antibiotic to get rid of the infection, but CDI can often come back within weeks or months.
• The bacteria responsible for CDI produce a toxin that can inflame and damage your colon, causing stomach pain and severe diarrhoea. ZINPLAVA acts by attaching to the toxin and blocking it, thereby preventing the symptoms of CDI from coming back.

You should not be given ZINPLAVA if:

• you are allergic to bezlotoxumab or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

ZINPLAVA is not a treatment for CDI. ZINPLAVA has no effect on the CDI you have now.

ZINPLAVA is given with the antibiotic therapy you are taking for CDI.

Children and adolescents

ZINPLAVA should not be used in children and adolescents below 18 years of age.

Other medicines and ZINPLAVA

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

• If you are pregnant or trying to get pregnant, tell your doctor.
• We don’t know if ZINPLAVA will harm your baby while you are pregnant.
• If you are breast-feeding or are planning to breast-feed, check with your doctor first.
• We don’t know if ZINPLAVA gets in your breast milk and is passed to your baby.
• You and your doctor should decide together if you will use ZINPLAVA.

Driving and using machines

ZINPLAVA has no or very little effect on the ability to drive and use machines.

ZINPLAVA contains sodium

This medicine contains 182.8 mg sodium (main component of cooking / table salt) in each vial. This is equivalent to 9.1 % of the recommended maximum daily dietary intake of sodium for an adult.

If you miss an appointment to get ZINPLAVA

• Call your doctor or healthcare professional right away to reschedule your appointment.
• It is very important that you do not miss the dose of this medicine.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

What ZINPLAVA contains

• The active substance is bezlotoxumab. Each mL of concentrate contains 25 mg of bezlotoxumab.
• The other ingredients are citric acid monohydrate (E330), diethylenetriaminepentaacetic acid, polysorbate 80 (E433), sodium chloride, sodium citrate dihydrate (E331), water for injections, and sodium hydroxide (E524) (for pH adjustment).

What ZINPLAVA looks like and contents of the pack

The concentrate for solution for infusion is a clear to moderately opalescent, colourless to pale yellow liquid.

It is available in cartons containing one glass vial.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder in Great Britain:

Marketing Authorisation Holder in UK (Northern Ireland):

Manufacturer