Remdesivir For Injection Technical Specifications:

Product Name:Remdesivir For Injection
Brand Name:Remdetaj
Strength:100mg/vial
Dosage Form:Lyophilized Powder for Injection (Sterile)
Packing:100mg Vial
Route of Administration:For I.V. use only
Pack Insert/Leaflet:Covid Use Leaflet, PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antiviral & used to treat coronavirus (COVID-19)
Indication: Remdesivir for Injection (Remdetaj) is an antiviral medicine used for treating COVID-19. COVID-19 is caused by a virus called a coronavirus. Remdesivir Injection stops the virus multiplying in cells and this stops the virus multiplying in the body. This can help your body to overcome the virus infection, and may help you get better faster.
Storage:Store below 30°C (86°F). After reconstituted vial can be stored up to 4 hours at room temperature (20°C to 25°C [68°F to 77°F]). Store diluted remdesivir solution for infusion up to 24 hours at below 25°C or 48 hours in a refrigerator (2°C – 8°C).

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  1. Remdesivir For Injection 100mg/vial
    Composition:
    Each Vial Contains:
    Remdesivir ………………………….100mg
    Excipients …………………………. Q.S.

THERAPEUTIC INDICATIONS:

Remdesivir for Injection (Remdetaj) is an antiviral medicine used for treating COVID-19. COVID-19 is caused by a virus called a coronavirus. Remdesivir Injection stops the virus multiplying in cells and this stops the virus multiplying in the body. This can help your body to overcome the virus infection, and may help you get better faster.

DIRECTION OF USE:

Remdesivir must be reconstituted with 19 mL sterile water for injections and diluted in sodium chloride 9 mg/mL (0.9%) solution for injection before being administered via intravenous infusion over 30 to 120 minutes.

CAUTION & Warning:

CAUTION: It is dangerous to take this preparation except under medical supervision. Keep out of reach and sight of children.

Use immediately after dissolving the contents.

If any foreign particle is visible after dissolving the contents, Please do not use the solution.

Note: Refer accompanying package insert for detailed dosage, directions for use and precautions.

STORAGE & DOSAGE:

Storage: Store below 30°C (86°F). After reconstituted vial can be stored up to 4 hours at room temperature (20°C to 25°C [68°F to 77°F]).

Store diluted remdesivir solution for infusion up to 24 hours at below 25°C or 48 hours in a refrigerator (2°C – 8°C).

Keep all medicines out of reach of children.

Read enclosed leaflet before use

POM Schedule 2 PP

Dosage: As directed by Physician.

Remdesivir For Injection I.V Export Market

We export Remdesivir For Injection 100mg/vial in following countries:

Southeast Asia: Malaysia, Cambodia, Philippines, Indonesia, Singapore, Thailand, Laos, Vietnam, Brunei Darussalam, Myanmar

GCC/ Middle East Countries: Oman, Lebanon, Saudi Arabia, Iraq, Bahrain, Yemen, Jordan, UAE

Russia and CIS Countries: Kyrgyzstan, Armenia, Moldova, Belarus, Uzbekistan, Russia, Ukraine, Georgia, Turkmenistan, Kazakhstan, Azerbaijan, Tajikistan

African Countries: Sudan, Zambia, Nigeria, Liberia, Benin, Tanzania, Angola,

Other Asian Countries: Bhutan, Mauritius, Malaysia, Myanmar, Sri Lanka, Nepal, Cambodia

Remdesivir For Injection I.V. Regulatory Documents:

  • Certificate of Analysis (COA)
  • Certificate of Pharmaceuticals Product (COPP)
  • Method of Analysis (MOA)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Stability Data (Accelerated stability / Long term stability / Zone 4b)
  • Free Sale Certificate (FSC)

REMDETAJ™ (remdesivir) is an antiviral medication that directly inhibits viral replication of SARS-CoV-2.REMDETAJ™ (remdesivir) is an antiviral medication that
directly inhibits viral replication of SARS-CoV-2.

REMDETAJ™ acts to inhibit the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which is essential for viral replication—and thus creation of virions that circulate in the body2,5REMDETAJ™ (remdesivir) improved clinical outcomes in hospitalized patients across a spectrum of COVID-19 disease severity.

5 DAYS SHORTER
RECOVERY TIME
WITH REMDETAJ™