MOVFOR

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

MOLNUPIRAVIR

제공처:

AMAROX PHARMA GLOBAL - Indonesia

INN (International Name):

MOLNUPIRAVIR

복용량:

200 MG

약제 형태:

KAPSUL

패키지 단위:

DUS, 4 BLISTER @ 10 KAPSUL

Manufactured by:

HETERO LABS LIMITED - India

승인 날짜:

2022-01-02

제품 특성 요약

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