VEKLURY 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

REMDESIVIR

可用日期:

GILEAD SCIENCES ISRAEL LTD

药物剂型:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

组成:

REMDESIVIR 100 MG/VIAL

给药途径:

I.V

处方类型:

Required

厂商:

GILEAD SCIENCES IRELAND UC, IRELAND

疗效迹象:

Veklury is indicated for the treatment of coronavirus disease 2019 (COVID-19) -in adults and pediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).-adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19

授权日期:

2020-07-29

产品特点

1
1.
NAME OF THE MEDICINAL PRODUCT
Veklury
®
100 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of remdesivir. After reconstitution, each
vial contains 5 mg/mL of
remdesivir solution.
Excipients with known effect
Each vial contains 3 g betadex sulfobutyl ether sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
White to off-white to yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Veklury is indicated for the treatment of coronavirus disease 2019
(COVID-19) in:
•
adults and paediatric patients (at least 4 weeks of age and weighing
at least 3 kg) with
pneumonia requiring supplemental oxygen (low- or high-flow oxygen or
other non-
invasive ventilation at start of treatment)
•
adults who do not require supplemental oxygen and who are at increased
risk of
progressing to severe COVID-19
(see section 5.1)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Patients should be monitored when receiving remdesivir (see section
4.4).
Patients receiving remdesivir in an outpatient setting should be
monitored according to local medical
practice. Use under conditions where treatment of severe
hypersensitivity reactions, including
anaphylaxis, is possible.
Posology
TABLE 1:
RECOMMENDED DOSE IN ADULTS AND PAEDIATRIC PATIENTS
GIVEN BY INTRAVENOUS INFUSION
ADULTS
PAEDIATRIC PATIENTS
(WEIGHING AT LEAST
40 KG)
PAEDIATRIC PATIENTS AT LEAST
4 WEEKS OLD (WEIGHING AT
LEAST 3 KG BUT LESS THAN
40 KG)
DAY 1
(SINGLE LOADING DOSE)
200 mg
200 mg
5 mg/kg
DAY 2 AND ONWARDS
(ONCE DAILY)
100 mg
100 mg
2.5 mg/kg
TABLE 2:
TREATMENT DURATION
2
_ _
ADULTS
_ _
PAEDIATRIC PATIENTS
(WEIGHING AT LEAST
40 KG)_ _
PAEDIATRIC PATIENTS AT LEAST
4 WEEKS OLD (WEIGHING AT
LEAST 3 KG BUT LESS THAN
40 KG)
Patients with PNEUMONIA
AND REQUIRING
SUPPLEMENTAL OXYGEN
The
recommended
duration of
treatment is 5
DAYS_ _
The recommended
duration of treatment is
5 DAYS_ _
DAILY FOR UP