국가: 남아프리카
언어: 영어
출처: South African Health Products Regulatory Authority (SAHPRA)
Cipla Medpro Manufacturing (Pty) Ltd
See ingredients
PELLET
EACH CAPSULE CONTAINS LOPINAVIR 40,0 mg RITONAVIR 10,0 mg
Canceled
2021-02-06
Cipla Medpro (Pty) Ltd Lopinavir 40 and Ritonavir 10 mg 1.3.2 (Clean PIL) (Oral pellets) Version 4 Page 1 of 16 PATIENT INFORMATION LEAFLET FOR LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS SCHEDULING STATUS: S4 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM: LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS (Lopinavir 40 mg and Ritonavir 10 mg) ORAL PELLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS: • KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. • IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR PHARMACIST. • LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS HAS BEEN PRESCRIBED FOR YOU PERSONALLY AND YOU SHOULD NOT SHARE YOUR MEDICINE WITH OTHER PEOPLE. IT MAY HARM THEM, EVEN IF THEIR SYMPTOMS ARE THE SAME AS YOURS. WHAT LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS CONTAIN: Each capsule of oral pellets contains lopinavir 40 mg and ritonavir 10 mg as active ingredients. The other ingredients are colloidal silicon dioxide, copovidone, gelatin capsule, hydroxyl propyl methylcellulose, PEG-6000, sodium stearyl fumarate, sorbitan monolaurate and talc. Capsule ingredients: ammonia solution, black iron oxide, gelatin, iron oxide yellow, potassium hydroxide, propylene glycol, purified, shellac, sodium dodecyl sulfate and titanium dioxide. Cipla Medpro (Pty) Ltd Lopinavir 40 and Ritonavir 10 mg 1.3.2 (Clean PIL) (Oral pellets) Version 4 Page 2 of 16 Sugar free. WHAT LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS ARE USED FOR: LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS are indicated in combination with other antiretroviral agents for the treatment of HIV infection. BEFORE YOU TAKE LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS: DO NOT TAKE LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS IF: You are allergic to lopinavir, ritonavir or to any of the other ingredients of LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS. You have severe liver disease. You are currently taking any of the following medicines: • Sedatives s 전체 문서 읽기
Cipla Medpro (Pty) Ltd Lopinavir 40 mg and Ritonavir 10 mg 1.3.1.1 (Clean PI) (Oral pellets) Version 4 Page 1 of 41 PROPOSED PROFESSIONAL INFORMATION FOR LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS SCHEDULING STATUS: S4 PROPRIETARY NAME AND DOSAGE FORM: LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS (Lopinavir 40 mg and Ritonavir 10 mg) ORAL PELLETS COMPOSITION: Each capsule of oral pellets contains lopinavir 40 mg and ritonavir 10 mg as active ingredients. List of excipients: colloidal silicon dioxide, copovidone, gelatin capsule, hydroxyl propyl methylcellulose, PEG-6000, sodium stearyl fumarate, sorbitan monolaurate and talc. Capsule ingredients: ammonia solution, black iron oxide, gelatin, iron oxide yellow, potassium hydroxide, propylene glycol, Shellac, sodium dodecyl sulfate and titanium dioxide. Sugar free. PHARMACOLOGICAL CLASSIFICATION: A 20.2.8 Anti-viral agents PHARMACOLOGICAL ACTION: Cipla Medpro (Pty) Ltd Lopinavir 40 mg and Ritonavir 10 mg 1.3.1.1 (Clean PI) (Oral pellets) Version 4 Page 2 of 41 PHARMACODYNAMIC PROPERTIES: Lopinavir/ritonavir oral pellets is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases. As co-formulated in these oral pellets, ritonavir inhibits the CYP3A4-mediated metabolism of lopinavir, thereby resulting in increased plasma levels of lopinavir. Inhibition of HIV protease prevents cleavage of the _gag-pol_ polyprotein resulting in the production of immature, non-infectious virus. HIV-1 isolates with reduced susceptibility to lopinavir have been selected _in vitro. _The presence of ritonavir does not appear to influence the selection of lopinavir resistant viruses _in vitro. _Reduced viral susceptibility to lopinavir has been observed in clinical studies. _Cross-resistance: _ Data obtained from four patients previously treated with one or more protease inhibitors who developed increased lopinavir phenotypic resistance during therapy with lopinavir/ritonavir, indicated that patients either remained cross-resistant or 전체 문서 읽기