VEKLURY- remdesivir injection VEKLURY- remdesivir injection, powder, lyophilized, for solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

REMDESIVIR (UNII: 3QKI37EEHE) (REMDESIVIR - UNII:3QKI37EEHE)

Mevcut itibaren:

Gilead Sciences, Inc.

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of VEKLURY for the treatment of coronavirus disease 2019 (COVID-19) in pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg, with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, who are: - 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. Refer to CDC website1 for additional details. VEKLURY has been authorized by FDA for the emergency uses described above. VEKLURY is not FDA-approved for these uses. VEKLURY is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of VEKLURY under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or

Ürün özeti:

How Supplied VEKLURY for injection, 100 mg, is supplied as a single-dose vial containing a sterile, preservative-free white to off-white to yellow lyophilized powder. It requires reconstitution and further dilution prior to administration by intravenous infusion [see Dosage and Administration (2.5)]. Discard unused portion. The container closure is not made with natural rubber latex. Storage and Handling Do not reuse or save reconstituted or diluted VEKLURY for future use. This product contains no preservative; therefore, partially used vials should be discarded [see Dosage and Administration (2.6)]. Store VEKLURY for injection, 100 mg, vials below 30°C (below 86°F) until required for use. After reconstitution, use vials immediately to prepare diluted solution. Dilute the reconstituted solution in 0.9% sodium chloride injection, USP within the same day as administration. The diluted VEKLURY solution in syringe should be used immediately. The diluted VEKLURY solution in the infusion bags can be stored up to 24 hours at room temperature (20°C to 25°C [68°F to 77°F]) or 48 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]) prior to administration.

Yetkilendirme durumu:

unapproved drug other

Ürün özellikleri

VEKLURY- REMDESIVIR INJECTION
VEKLURY- REMDESIVIR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
GILEAD SCIENCES, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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FACT SHEET FOR HEALTHCARE PROVIDERS
EMERGENCY USE AUTHORIZATION (EUA) OF VEKLURY (REMDESIVIR) FOR THE
TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN PEDIATRIC
PATIENTS WEIGHING 3.5 KG TO LESS THAN 40 KG OR PEDIATRIC PATIENTS
LESS THAN 12 YEARS OF AGE WEIGHING AT LEAST 3.5 KG, WITH POSITIVE
RESULTS OF DIRECT SARS-COV-2 VIRAL TESTING WHO ARE:
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
IMPORTANT PRESCRIBING INFORMATION
SUBJECT:
UPDATED EMERGENCY USE AUTHORIZATION (EUA) FOR TREATMENT OF
CORONAVIRUS DISEASE 2019 (COVID-19) IN PEDIATRIC PATIENTS WEIGHING
3.5 KG TO LESS THAN 40 KG OR PEDIATRIC PATIENTS LESS THAN 12 YEARS OF
AGE WEIGHING AT LEAST 3.5 KG WITH POSITIVE RESULTS OF DIRECT SEVERE
ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV-2) VIRAL
TESTING, WHO ARE: 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, AND VARIATIONS IN CARTON
AND VIAL LABELING OF VEKLURY (REMDESIVIR)
Dear Healthcare Provider:
Gilead Sciences, Inc., would like to clarify the appropriate use and
the variable packaging
and labeling of the antiviral VEKLURY (REMDESIVIR).
Gilead's remdesivir (brand name VEKLURY) was approved by the US Food
and Drug
Administration (FDA) on January 21, 2022 for adults and pediatric
patients (12 years of
age and older and weighing at least 40 kg) for the treatment of
coronavirus disease
2019 (COVID-19) with positive results of direct severe acute
respiratory syndrome
coronavirus 2 (SARS-CoV-2) viral testing, who are:
Hospitalized, or
Not hospitalized and have mild-to-mo