Quốc gia: Indonesia
Ngôn ngữ: Tiếng Indonesia
Nguồn: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
MOLNUPIRAVIR
AMAROX PHARMA GLOBAL - Indonesia
MOLNUPIRAVIR
200 MG
KAPSUL
DUS, 4 BLISTER @ 10 KAPSUL
HETERO LABS LIMITED - India
2022-01-02
1 FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE AUTHORIZATION (EUA) OF MOLNUPIRAVIR CAPSULE MOVFOR MOLNUPIRAVIR CAPSULE Badan POM, the Indonesia Food and Drug Administration, has issued an Emergency Use Authorization (EUA) to permit the emergency use of Molnupiravir for the treatment of mild to moderate COVID-19 infection in adult patients 18 years and above who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19. THE EMERGENCY USE AUTHORIZATION OF MOLNUPIRAVIR IS FOR TREATMENT OF MILD TO MODERATE COVID-19 INFECTION IN ADULT PATIENTS 18 YEARS AND ABOVE WHO DO NOT REQUIRE SUPPLEMENTAL OXYGEN AND ARE AT INCREASED RISK OF PROGRESSING TO SEVERE COVID-19. ADMINISTRATION : MOLNUPIRAVIR MUST BE ADMINISTERED BY A HEALTHCARE PROFESSIONAL PURSUANT TO A VALID PRESCRIPTION OF A LICENSED PRACTITIONER. Molnupiravir Capsules can be taken with or without food. Patients should be advised to swallow the capsules whole and not to open, break, or crush the capsule. The dosage in adult patients is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days. Take molnupiravir as soon as possible after a diagnosis of COVID-19 has been made, and within 5 days of symptom onset. Completion of the full 5-day treatment course and continued isolation in accordance with public health recommendations are important to maximize viral clearance and minimize transmission of SARS-CoV-2. Health care providers must submit a report on all medication errors and ALL SERIOUS ADVERSE EVENTS related to molnupiravir, See specific reporting instructions below. WARNINGS 1. Prior to initiating treatment with molnupiravir, carefully consider the known and potential risks and benefits [see Warnings and Precautions, Use in Specific Populations, and Nonclinical Toxicology]. 2. Based on findings from animal reproduction studies, molnupiravir may cause fetal harm when administered to pregnant individuals. There are no available human data on the use of molnupiravir in pregnant individuals to evaluate the risk Đọc toàn bộ tài liệu