Remdesivir for Injection 100mg Technical Specification:

Product Name:Remdesivir For Injection
Brand Name:Remdetaj
Strength:100mg/vial
Dosage Form:Lyophilized Powder for Injection (Sterile)
Packing:1 Single Dose Vial + WFI Tray
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:

  • Remdesivir For Injection 100mg

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Remdesivir For Injection 100mg
    Composition:
    Each Lyophilized 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 injection USP to get 5mg/ml of remdesivir solution.

The reconstituted solution should be further diluted in sodium chloride 9 mg/mL (0.9%) saline solution for injection preferred total volume 100ml before being administered via intravenous infusion over 30 to 120 minutes.

After reconstitution, vials can be stored up to 4 hours at room temperature prior to administration or 24 hours at refrigerated temperature.

Dilute within same day as administration or Use immediately after dissolving the contents.

REFER ACCOMPANYING PACKAGE INSERT FOR DETAILED DOSAGE, DIRECTIONS FOR USE AND PRECAUTIONS.

 CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.
Keep out of reach and sight of children.
Do not reuse or save unused Remdesivir lyophilized powder or diluted solution for infusion for future use.
If any foreign particle is visible after dissolving the contents, Please do not use the solution. 

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

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).

REFER ACCOMPANYING PACKAGE INSERT FOR DETAIL STORAGE CONDITION.

Dosage: As directed by the Physician.

NOTE:

  • Before administration of the injection to the patient, it is the responsibility of the treating physician/ institution to administer informed consent form (ICF) as prescribed, CDSCO approved format included inside the carton.
  • POM Schedule 2 PP

Why Taj Pharmaceuticals?

Taj Pharmaceuticals, the beacon of pharmaceutical excellence, is your trusted source for Remdesivir for Injection, a vital therapy for severe viral infections like COVID-19. Our unwavering commitment to pharmaceutical innovation, quality, and global health makes us the preferred partner in ensuring the availability of this life-saving medication during critical times. In the face of healthcare challenges, Taj Pharmaceuticals continues to lead with unwavering dedication. Our world-class manufacturing facilities adhere to rigorous quality standards, guaranteeing the purity and potency of each Remdesivir dose. As a pharmaceutical ally, Taj Pharmaceuticals collaborates with healthcare professionals and institutions worldwide, ensuring patients receive timely access to Remdesivir for Injection. Choose Taj Pharmaceuticals as your dependable source, where pharmaceutical excellence meets a profound commitment to global health and well-being. Trust Taj Pharmaceuticals for Remdesivir for Injection and experience pharmaceutical innovation and reliability that sets us apart in the journey to combat severe viral infections.

What is Remdesivir for Injection and its uses?

Remdesivir for Injection is a medication used for the treatment of severe viral infections, particularly those caused by RNA viruses. It gained significant attention during the COVID-19 pandemic as a potential treatment for severe cases of the disease.

Uses:

  • COVID-19 Treatment: Remdesivir was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19 in certain hospitalized patients. It is intended for individuals with severe cases of COVID-19 who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
  • Treatment of Other Viral Infections: Beyond its use in COVID-19, Remdesivir has shown promise in the treatment of other viral infections, including Ebola virus disease and respiratory syncytial virus (RSV) infection. Research is ongoing to explore its efficacy against various viral pathogens.
    Remdesivir is an antiviral medication that works by inhibiting the replication of the virus within the host’s cells. It interferes with the virus’s ability to copy its genetic material, thereby slowing down the viral replication process. This can help reduce the severity and duration of the illness caused by certain viruses.

It’s important to note that Remdesivir is typically administered in a hospital or clinical setting under the supervision of healthcare professionals, and its use is determined based on the specific viral infection and the patient’s clinical condition.

How does Remdesivir for Injection Work?

Remdesivir for Injection is an antiviral medication that works by inhibiting the replication of certain RNA viruses within the host’s cells. Here’s how it works:

  • Intracellular Activation: After being administered as an injection, Remdesivir is converted into its active form inside the host’s cells. This conversion is essential for the medication to effectively inhibit viral replication.
  • Inhibition of Viral RNA Replication: Once activated, Remdesivir becomes a nucleotide analog. Nucleotides are the building blocks of RNA and DNA, the genetic material of viruses. Remdesivir is similar in structure to adenosine, one of the natural nucleotides required for RNA synthesis.
  • Incorporation into Viral RNA: During viral replication, the virus’s RNA polymerase enzyme incorporates Remdesivir into the growing viral RNA chain. This incorporation initially appears to be a natural nucleotide addition.
  • Termination of RNA Synthesis: However, once Remdesivir is incorporated into the viral RNA chain, it acts as a “chain terminator.” This means that it prevents further addition of nucleotides to the RNA chain. As a result, viral RNA synthesis is prematurely terminated.
  • Inhibition of Viral Replication: The premature termination of viral RNA synthesis disrupts the replication process, preventing the virus from producing new copies of itself effectively.

By interfering with viral RNA synthesis, Remdesivir effectively inhibits the replication of RNA viruses like the coronavirus (SARS-CoV-2), which is responsible for COVID-19. This inhibition can reduce the viral load in the body, potentially leading to a decrease in the severity and duration of the illness. It’s important to note that Remdesivir is not a cure for viral infections but rather a treatment that can help manage the symptoms and limit the spread of the virus within the body. Its use is typically reserved for severe cases of viral infections, and it is administered under the supervision of healthcare professionals.

Benefits of Remdesivir for Injection:

  • Treatment of Severe Viral Infections: Remdesivir has shown effectiveness in the treatment of severe viral infections, particularly in cases where viral replication is a major factor contributing to the illness. It gained prominence during the COVID-19 pandemic as a treatment option for severe cases of the disease.
  • Reduction in Viral Load: By inhibiting viral replication, Remdesivir can reduce the viral load in the body. This may lead to a decrease in the severity and duration of symptoms associated with viral infections.
  • Hospitalization Shortening: In some cases, Remdesivir treatment has been associated with a shorter hospital stay, allowing patients to recover more quickly and potentially freeing up hospital resources.

Side Effects of Remdesivir for Injection:

  • Nausea and Vomiting: Nausea and vomiting are common side effects of Remdesivir treatment. These symptoms may be manageable with supportive care.
  • Elevated Liver Enzymes: Some patients may experience an increase in liver enzyme levels during Remdesivir treatment. Healthcare providers typically monitor liver function during therapy.
  • Infusion-Related Reactions: Infusion-related reactions, such as allergic reactions or hypersensitivity, can occur during or after the administration of Remdesivir. These reactions may include rash, itching, and low blood pressure. Healthcare providers are vigilant for such reactions during treatment.
  • Increased Risk of Bleeding: Remdesivir may lead to an increased risk of bleeding, particularly if a patient has pre-existing bleeding disorders or takes medications that affect blood clotting.
  • Kidney Dysfunction: There have been reports of kidney dysfunction in some individuals receiving Remdesivir. Healthcare providers may monitor kidney function during treatment.

It’s crucial to note that Remdesivir is typically administered in a hospital or clinical setting under the supervision of healthcare professionals. The decision to use Remdesivir is based on a careful assessment of the potential benefits and risks for each patient, taking into account the severity of the viral infection and the patient’s overall health. Patients should discuss any concerns or potential side effects with their healthcare provider during treatment.

Frequently Asked Questions about Remdesivir for Injection:

Certainly, here are some frequently asked questions (FAQs) about Remdesivir for Injection:

  1. What is Remdesivir for Injection used for?

Remdesivir for Injection is used for the treatment of severe viral infections, particularly those caused by RNA viruses. It gained prominence as a treatment option for severe cases of COVID19.

  1. How does Remdesivir work in treating viral infections?

Remdesivir inhibits viral replication by interfering with the synthesis of viral RNA. It acts as a chain terminator, preventing the virus from producing new copies of itself effectively.

  1. Is Remdesivir an effective treatment for COVID19?

Remdesivir has shown effectiveness in reducing the severity and duration of symptoms in some severe cases of COVID19. Its use is typically reserved for hospitalized patients with severe disease.

  1. Is Remdesivir a cure for COVID19?

Remdesivir is not a cure for COVID19 but a treatment that can help manage the symptoms and reduce the viral load in the body, potentially leading to improved clinical outcomes.

  1. Can Remdesivir be administered outside of a hospital setting?

Remdesivir is typically administered in a hospital or clinical setting, often through intravenous infusion. Its use is guided by healthcare professionals based on the patient’s clinical condition.

  1. Are there any specific side effects associated with Remdesivir for Injection?

Common side effects can include nausea, vomiting, infusion related reactions, elevated liver enzymes, and an increased risk of bleeding. However, the incidence and severity of side effects can vary among individuals.

  1. Is Remdesivir safe for pregnant or breastfeeding individuals?

The use of Remdesivir during pregnancy and breastfeeding should be carefully considered by healthcare providers, weighing the potential benefits against any risks.

  1. Can Remdesivir be used in pediatric patients?

Remdesivir has been authorized for use in pediatric patients under certain conditions. The dosage and administration may vary based on the child’s age and weight.

  1. Is Remdesivir effective against all viral infections?

Remdesivir has demonstrated efficacy against a range of RNA viruses but may not be effective against all viral pathogens. Its use is typically determined by the specific viral infection and clinical considerations.

  1. Is Remdesivir readily available for treatment?

Availability may vary by region and demand. Healthcare providers make decisions on its use based on local guidelines and the severity of the viral infection.

Patients and healthcare professionals should communicate closely when considering the use of Remdesivir for Injection, as its administration is guided by the patient’s clinical condition and the specific viral infection being treated.

As Remdesivir for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Remdesivir for Injection product in the Following Countries-

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

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

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

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

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

Remdesivir for Injection Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Remdesivir for Injection, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593

GENERIC NAME OF THE MEDICINAL PRODUCT:

Remdesivir For Injection 100mg (REMDETAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Remdesivir For Injection 100mg
Composition:
Each Lyophilized 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 injection USP to get 5mg/ml of remdesivir solution. The reconstituted solution should be further diluted in sodium chloride 9 mg/mL (0.9%) saline solution for injection preferred total volume 100ml before being administered via intravenous infusion over 30 to 120 minutes.

After reconstitution, vials can be stored up to 4 hours at room temperature prior to administration or 24 hours at refrigerated temperature.

Dilute within same day as administration or Use immediately after dissolving the contents.

REFER ACCOMPANYING PACKAGE INSERT FOR DETAILED DOSAGE, DIRECTIONS FOR USE AND PRECAUTIONS.

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.
Keep out of reach and sight of children.
Do not reuse or save unused Remdesivir lyophilized powder or diluted solution for infusion for future use.
If any foreign particle is visible after dissolving the contents, Please do not use the solution.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

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).
REFER ACCOMPANYING PACKAGE INSERT FOR DETAIL STORAGE CONDITION.
Dosage: As directed by the Physician.