Valsts: Dienvidāfrikas Republika
Valoda: angļu
Klimata pārmaiņas: South African Health Products Regulatory Authority (SAHPRA)
Mylan Pharmaceuticals (Pty) Ltd
100,0 mg
POWDER
EACH VIAL CONTAINS REMDESIVIR 100,0 mg
Registered
Mylan (Pty Ltd Injection, 100 mg/vial DESREM Remdesivir 03 October 2023 Signature Page 1 of 8 1.3.2 PROPOSED CLEAN PIL PATIENT INFORMATION LEAFLET SCHEDULING STATUS S4 DESREM 100 MG/VIAL LYOPHILIZED POWDER FOR INJECTION FOR LV INFUSION REMDESIVIR SUGAR FREE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING DESREM • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse or other health care provider. _ _ WHAT IS IN THIS LEAFLET 1. What DESREM is and what it is used for 2. What you need to know before you use DESREM 3. How to receive DESREM 4. Possible side effects 5. How to store DESREM 6. Contents of the pack and other information 1. WHAT DESREM IS AND WHAT IT IS USED FOR DESREM contains the active substance remdesivir. It is an antiviral medicine used for treating COVID-19. Mylan (Pty Ltd Injection, 100 mg/vial DESREM Remdesivir 03 October 2023 Signature Page 2 of 8 COVID-19 is caused by a virus called a coronavirus. DESREM stops the virus multiplying in cells and this stops the virus multiplying in the body. DESREM will be given to people with COVID-19. DESREM It is suitable for adults. It will only be given to patients who have pneumonia, and need extra oxygen to help them breathe. _ _ 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DESREM DESREM SHOULD NOT BE ADMINISTERED TO YOU: • if you are hypersensitive (allergic) to remdesivir or any of the other ingredients of DESREM (listed in section 6). _ _ WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before starting treatment with DESREM: • if you have liver problems. Some people developed increased liver enzymes when given DESREM. Your doctor will do blood tests before starting treatment to check whether you can be given it safely. • if you have kidney problems. People with severe kidney problems will not be given this medicine. Your doctor will do blood tests to check whether you can be given it safely. _REACTIONS FOLLOWING THE INFUSION _ DESREM can cause allergic reactions or Izlasiet visu dokumentu
Mylan (Pty Ltd Injection, 100 mg/vial DESREM Remdesivir 03 October 2023 Signature…………….……. Page 1 of 19 1.3.1.1 PROPOSED PI PROFESSIONAL INFORMATION SCHEDULING STATUS S 4 1 NAME OF THE MEDICINE DESREM 100 mg/vial Lyophilized Powder for Injection for lV Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg of remdesivir. Each ml of concentrate contains 5 mg of remdesivir. DESREM 100 mg vial contains 3 g sulfobutylether-β-cyclodextrin sodium salt (SBECD). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilized powder for injection for lV infusion. White to off-white to yellow lyophilized powder or lumps or solid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DESREM is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia requiring supplemental oxygen (see section 5.1). _ _ Mylan (Pty Ltd Injection, 100 mg/vial DESREM Remdesivir 03 October 2023 Signature…………….……. Page 2 of 19 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Use of DESREM is confined to healthcare facilities in which patients can be monitored closely (see section 4.4). POSOLOGY The recommended dosage of DESREM is: • Day 1 – single loading dose of DESREM 200 mg given by intravenous infusion. • Day 2 onwards – 100 mg given once daily by intravenous infusion. The total duration of treatment should be at least 5 days and not more than 10 days. SPECIAL POPULATIONS _ELDERLY _ No dose adjustment of DESREM is required in patients over the age of 65 years (see sections 5.1 and 5.2). _RENAL IMPAIRMENT _ The pharmacokinetics of remdesivir have not been evaluated in patients with renal impairment. Patients with eGFR ≥ 30 ml/min have received remdesivir for treatment of COVID-19 with no dose adjustment. DESREM should not be used in patients with eGFR < 30 ml/min (see sections 4.4 and 5.2). _HEPATIC IMPAIRMENT _ The pharmacokinetics of remdesivir have not been evaluated in patients with hepatic impairment. It is not known if dosage Izlasiet visu dokumentu