Active ingredient
- bezlotoxumab
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 53095/0084.
ZINPLAVA 25 mg/mL concentrate for solution for infusion
Package leaflet: Information for the patient
ZINPLAVA® 25 mg/mL concentrate for solution for infusion
bezlotoxumab
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
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
1. What ZINPLAVA is and what it is used for
ZINPLAVA contains the active substance bezlotoxumab.
ZINPLAVA is a medicine that is given together with an antibiotic to prevent Clostridium difficile infection (CDI) from coming back in patients 18 years of age or older who have a high risk of CDI coming back.
How ZINPLAVA works
2. What you need to know before you are given ZINPLAVA
Talk to your doctor before you are given ZINPLAVA.
You should not be given ZINPLAVA if:
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
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.
3. How you are given ZINPLAVA
If you miss an appointment to get ZINPLAVA
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported in clinical trials:
Common (may affect up to 1 in 10 people)
Tell your doctor or health care professional if you notice any of the side effects above.
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.
5. How to store ZINPLAVA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator 2 °C to 8 °C. Do not freeze. Keep vial in the outer carton in order to protect from light.
The diluted solution of ZINPLAVA may be stored either at room temperature for up to 16 hours or under refrigeration at 2 °C to 8 °C for up to 24 hours. If refrigerated, allow the IV bag to come to room temperature prior to use.
Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements.
6. Contents of the pack and other information
What ZINPLAVA contains
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
For any information about this medicine, please contact:
This leaflet was last revised in September 2021.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
© Merck Sharp & Dohme (UK) Limited, 2021. All rights reserved.
PIL.ZIN.21.GB-NI.7760.R-001.RCN020458
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