Techinical Specification of Remdesivir Injection 100mg:

Product Name:Remdesivir Injection 100mg
Brand Name:Remdetaj
Strength:100mg/vial
Dosage Form:Lyophilized Powder for Injection
(Sterile)
Packing:100mg Vial (30ml Tabular USP Type I)
Route of Administration:For I.V. Use only
Pack Insert/Leaflet:Covid Use Instert, PIL (Patient Use Leaflet)
Export countries:Cambodia, Kyrgyzstan, Malaysia, Philippines, Indonesia, Singapore, Thailand, Laos, Vietnam, Myanmar, Iraq, Lebanon, Turkmenistan, Uzbekistan, Georgia, Azerbaijan
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antiviral, Coronavirus (COVID-19)
Indication: Remdesivir Injection (Remdetaj) is associate with antiviral drugs used for treating COVID-19. COVID-19 is caused by an outbreak known as a coronavirus. Remdesivir Injection stops the virus multiplying in cells and this stops the virus multiplying at intervals the body. This could facilitate your body to beat the infection and will assist you retrieve quicker.
Storage:Store below 30°C (86°F). After reconstituted vials must be keep up to four hours at temperature (20°C to 25°C [68°F to 77°F]).

Store diluted remdesivir injection for infusion up to twenty four hours at below 25°C or forty eight hours storage in a fridge (2°C – 8°C).

Taj Pharmaceuticals is a pioneer company that is popular as an authentic manufacturer and exporter of Lyophilized Remdesivir Injection 100mg. The superior Lyophilized Injection manufacturing facilities, cutting-edge R & D capabilities, vast domestic network, and substantial international presence the company enjoys are the source of its competitive advantage.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Remdesivir For Injection 100mg/vial (Remdetaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

THERAPEUTIC INDICATIONS:

Remdesivir Injection (Remdetaj) is associate with antiviral drugs used for treating COVID-19. COVID-19 is caused by an outbreak known as a coronavirus. Remdesivir Injection stops the virus spreading in blood cells and this hence stops the virus multiplying within the lungs. This could facilitate your body to beat the infection and will assist you retrieve quicker.

DIRECTION OF USE:

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

CAUTION & WARNING:

CAUTION: it’s dangerous to require this preparation except underneath medical management. Keep out of reach and sight of under age child.

Use immediately after dissolving the contents.

If any foreign particle is visible when dissolving the contents, Please don’t use the Injection.

Note: Refer attached package insert for detailed dosage and administrations details, directions to be used and precautions.

STORAGE & DOSAGE:

Storage: Store below 30°C (86°F). After reconstituted vials can be keep up to four hours at temperature (20°C to 25°C [68°F to 77°F]).

Store diluted remdesivir vials for infusion up to twenty four hours at below 25°C or forty eight hours in a icebox or fridge (2°C – 8°C).

Keep all medicines out of reach of under age children.

Read enclosed leaflet before use

POM Schedule 2 PP

Dosage: As directed by Physician.

Remdesivir Injection 100mg Export Market:

Taj Pharma Lyophilized Plant export Remdesivir Injection 100mg/vial in following countries:

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

Russia and CIS Countries: Kirgiz, Armenia, Moldova, Belarus, Uzbekistan, Russia, Ukraine, Georgia, state, Kazakhstan, Azerbaijan, Tajikistan.

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

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

Remdesivir Injection 100mg Regulatory Documents:

  • Certificate of Analysis (COA)
  • Certificate of Pharmaceuticals Product (COPP)
  • Method of Analysis (MOA)
  • CTD record / ACTD Dossiers / eCTD Dossiers
  • Stability information (Accelerated stability / long run stability / Zone 4b)
  • Free Sale Certificate (FSC)