দেশ: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
BEZLOTOXUMAB
MERCK SHARP & DOHME ISRAEL LTD
J06BB21
CONCENTRATE FOR SOLUTION FOR INFUSION
BEZLOTOXUMAB 25 MG / 1 ML
I.V
Required
MERCK SHARP & DOHME CORP., USA
BEZLOTOXUMAB
ZINPLAVA is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults who are receiving antibacterial drug treatment of CDI and are at high risk for recurrence of CDI
2018-12-10
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine is to be supplied upon physician’s prescription only ZINPLAVA ® 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Each mL of concentrate contains: 25 mg of bezlotoxumab For a list of inactive ingredients see section 6. “FURTHER INFORMATION”. See also section 2.7 “Important information about some of the ingredients of the medicine”. READ ALL OF THIS LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. 1. WHAT ZINPLAVA IS INTENDED FOR? 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. THERAPEUTIC GROUP: Antiinfectives for systemic use, specific immunoglobulins. HOW ZINPLAVA WORKS When people get CDI, they are usually given an antibiotic to get rid of the infection, but CDI can 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. BEFORE USING ZINPLAVA Talk to your doctor before you are given ZINPLAVA. 2.1 DO NOT USE ZINPLAVA IF: you are hypersensitive (allergic) to bezlotoxumab or any of the other ingredients of this medicine (For a list of inactive ingredients, see section 6). 2.2 SPECIAL WARNINGS REGARDING USE OF ZINPLAVA 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. 2.3 CHILDREN AND ADOLESCENTS ZINPLAVA should not be used in c সম্পূর্ণ নথি পড়ুন
1 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 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. 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. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZINPLAVA is indicated for the prevention of recurrence of _ Clostridium difficile _ infection (CDI) in adults who are receiving antibacterial drug treatment of CDI and are 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). 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). _Renal impairment _ No dose adjustment is necessary for patients with renal impairment (see section 5.2). 2 _Hepatic impairment_ No dose adjustment is necessary for patients with hepatic impairment (see section 5.2). _ _ _Paediatric population _ The safety and efficacy of ZINPLAVA in patients below 18 years of age have not been established. No data are available. Method of administration Administer the diluted solution for infusion intravenously over 60 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter. ZINPLAVA sh সম্পূর্ণ নথি পড়ুন