Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Bezlotoxumab
Merck Sharp & Dohme B.V.
J06BB21
bezlotoxumab
Immune sera and immunoglobulins,
Enterocolitis, Pseudomembranous
Zinplava is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI.
Revision: 10
Authorised
2017-01-18
26 B. PACKAGE LEAFLET 27 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. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If you get any sid e effects, talk to your docto r. 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 Clostridioides difficile infection (CDI) from coming back in adults and children 1 year 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 colo n, 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 ZINPLAVA should not be used in children below 1 year of age. O THER MEDICINES AND ZINPLAVA T ell your doctor if you are Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ZINPLAVA 25 mg/mL concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 25 mg bezlotoxumab. One 40 mL vial contains 1 000 mg of bezl otoxumab. One 25 mL vial contains 625 mg of bezlotoxumab. Bezlotoxumab is a human monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology. It binds to C. difficile toxin B. Excipient with known effect Each mL of concentrate contains 0.2 mmol sodium, which is 4.57 mg sodium. This corresponds to 182.8 mg of sodium per vial (for the 40 mL vial presentation ) or 114.3 mg of sodium per vial (for the 25 mL vial presentation) . For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear to moderately opalescent, colourless to pale yellow liquid . 4. C LINICAL PARTICUL ARS 4.1 THERAPEUTIC INDICATIONS ZINPLAVA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in adult and paediatric patients 1 year of age and older at high risk for recurrence of CDI (see sections 4.2, 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ZINPLAVA should be administered during the course of antibacterial therapy for CDI (see sections 4.4 and 5.1). Adult and paediatric patients 1 year of age and older ZINPLAVA should be administered as a single intravenous infusion of 10 mg/kg (see below and section 6.6). The experience with ZINPLAVA in patients is limited to a single CDI episode and single administration (see section 4.4). Special populations Elderly No dose adjustment is necessary in patients ≥ 65 years of age (see section 5.2). 3 Renal impairment No dose adjustment is necessary for patients with renal impairment (see section 5.2). Hepatic impairment No dose adjustment is necessary for patients with hepatic impairment (see section 5.2). Pa ediatric population There is no relevant use of bezlotoxumab in children under 1 year of a Przeczytaj cały dokument