What is a Patient Information Leaflet and why is it useful?

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.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: EU/1/16/1156/001.

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

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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

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

  • 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.

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:

  • 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.

3. How you are given ZINPLAVA

  • You will get ZINPLAVA as an infusion (drip) into a vein.
  • You will get ZINPLAVA in one dose and it will take about 1 hour. Your dose will be calculated using your body weight.
  • You should keep taking your antibiotic for CDI as directed by your doctor.

If you miss an appointment to get ZINPLAVA

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

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)

  • diarrhoea
  • dizziness
  • feeling sick (nausea)
  • fever
  • headache
  • high blood pressure
  • shortness of breath
  • tiredness

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland:

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie

Malta: ADR Reporting at: www.medicinesauthority.gov.mt/adrportal

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

  • 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

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

Manufacturer

SP Labo NV
Industriepark 30
B-2220 Heist-op-den-Berg
Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Merck Sharp & Dohme Limited
Tel: +44 (0) 1992 467272

This leaflet was last revised in June 2018

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

© Merck Sharp & Dohme Limited, 2018. All rights reserved.

PIL.ZIN.18.UK.6424.T-011