GENERIC NAME OF THE MEDICINAL PRODUCT:

Remdesivir For Injection 100mg/vial (Remdetaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. 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.
WARNING 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 Technical Specification

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).

Remdesivir For Injection Manufacturers & Exporters in India

Remdesivir is an antiviral drug that combats coronavirus 2 that causes severe acute respiratory syndrome (SARS-CoV-2). The coronavirus disease (COVID-19) is treated in hospitalised patients with Remdesivir injection. Additionally, it is applied to non-hospitalized individuals with mild to moderate COVID-19 who are at a high risk of developing severe COVID-19. Only your doctor or someone working under his or her direct supervision should provide this medication. Taj Pharmaceuticals Limited is Mumbai, India based leading manufacturers and exporters of Remdesivir For Injection in India and International market.

How Remdesivir for Injection Works?

An antiviral drug called Remdesivir for Injection is used to treat COVID-19. A virus known as a coronavirus is what causes COVID-19. Remdesivir Injection prevents the virus from replicating in cells, which prevents the virus from replicating in the body. This may speed up your recovery by assisting your body in fighting off the virus infection.

How Should Remdesivir For Injection Be Used?

A medical expert administers this drug by injecting it directly into a vein. It is administered as prescribed by your doctor, typically once per day. Patients who are hospitalised receive it for 5 to 10 days, whereas those who are not are given it for 3 days. It is infused during a time frame of between 30 min and 2 hours.

Your medical condition and how you respond to treatment will determine how long the treatment will last.

Side Effects

  • Back pain
  • Fast heartbeat
  • Nausea
  • Chest tightness
  • Vomiting
  • Chills
  • Stomach pain
  • Difficulty swallowing
  • Cough
  • Trouble breathing
  • Hives, itching
  • Dark-colored urine
  • Unusual tiredness or weakness
  • Fever
  • Headache
  • Flushing
  • Yellow eyes or skin
  • Light-colored stools
  • Puffiness or swelling of the eyelids or around the eyes, lips, face, or tongue

Precautions

  • While you are receiving this medication, it is crucial that your doctor regularly monitor your progress to ensure that it is functioning as intended.
  • Tests on the blood and urine may be required to look for side effects.
  • The benefits of a medicine must be evaluated against the hazards when determining whether to use it. You will decide this along with your doctor.
  • If you have ever experienced an unusual or adverse reaction to this medication or any other medication, let your doctor know right away.
  • If you have any other allergies, such as those to foods, preservatives, colours, or animals, be sure to let your healthcare provider know.
  • You must read about all the ingredients carefully before using it.

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 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.

  • Warning: 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 (Lyophilized) 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)

Manufacturing Standard Operating Procedure:

Other Large Volume Parenterals (LVPs):

Other Dry Powder Injections:

Other Liquid Injections: