Veklury lyophilized powder for injection (remdesivir 100 mgvial)

Land: Malasía

Tungumál: enska

Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Virkt innihaldsefni:

Remdesivir

Fáanlegur frá:

Gilead Sciences Malaysia Sdn. Bhd.

INN (Alþjóðlegt nafn):

Remdesivir

Einingar í pakka:

1 Vials

Framleitt af:

Hikma Farmaceutica (Portugal) S.A.

Vara einkenni

1
VEKLURY
® LYOPHILIZED POWDER FOR INJECTION
REMDESIVIR, 100 MG/VIAL
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
VEKLURY is indicated for the treatment of coronavirus disease 2019
(COVID-19) in adults and
pediatric patients (12 years of age and older and weighing at least 40
kg) with positive results of
direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
viral testing, who are_[see _
_Clinical Studies (14)]_:
•
Hospitalized, or
•
Not hospitalized and have mild-to-moderate COVID-19, and are at high
risk for progression to
severe COVID-19, including hospitalization or death.
2
DOSAGE AND ADMINISTRATION
2.1
DOSAGE AND ADMINISTRATION OVERVIEW
•
VEKLURY may only be administered in settings in which healthcare
providers have immediate
access to medications to treat a severe infusion or hypersensitivity
reaction, such as anaphylaxis,
and the ability to activate the emergency medical system (EMS), as
necessary _[see Warnings and _
_Precautions (5.1)]_.
•
Administer VEKLURY for the treatment of COVID-19 in adults and
pediatric patients (12 years of
age and older and weighing at least 40 kg) by intravenous infusion
only. Do not administer by any
other route.
•
VEKLURY for injection (supplied as 100 mg lyophilized powder in vial)
must be reconstituted with
Sterile Water for Injection prior to diluting in a 100 mL or 250 mL
0.9% sodium chloride infusion
bag.
•
Carefully follow the product-specific preparation instructions below
_[see Dosage and _
_Administration (2.5)]. _
2.2
TESTING BEFORE STARTING AND DURING TREATMENT WITH VEKLURY
Determine eGFR in all patients before starting VEKLURY and monitor
while receiving VEKLURY as
clinically appropriate _[see Dosage and Administration (2.4) and Use
in Specific Populations (8.4, _
_8.6)]._
Perform hepatic laboratory testing in all patients before starting
VEKLURY and while receiving
VEKLURY as clinically appropriate _[see Warnings and Precautions (5.2)
and Use in Specific _
_Populations (8.7)]._
2
Determine prothrombin time in all patients befo