GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Artesunate Injection IP (60mg/vial) (Zentrom)
B. Artesunate Injection IP (120mg/vial) (Zentrom)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Artesunate Injection IP (60mg/vial)
Composition:
Each vial contains:
Artesunate (Sterile) IP ………………………………………………60mg
This pack also contains:
1ml Ampoule of Sodium Bicarbonate Injection IP………5%w/v
5ml Ampoule of Sodium Chloride Injection IP……………0.9%w/v


B. Artesunate Injection IP (120mg/vial)
Composition:
Each vial contains:
Artesunate (Sterile) IP ………………………………………………120mg
This pack also contains:
2ml Ampoule of Sodium Bicarbonate Injection IP………5%w/v
10ml Ampoule of Sodium Chloride Injection IP……………0.9%w/v

THERAPEUTIC INDICATIONS:

Artesunate for Injection is indicated for the initial treatment of severe malaria in adult and pediatric patients.

DIRECTION OF USE:

For I.V./I.M. use only.
For IV use:
Add 10ml 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 120mg/vial.
Add 5ml 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 60mg/vial.
Mix again.
Inject by slow IV route over 2-3 minutes.
Do not put the solution in an IV drip.

For IM use:
Add 4ml of 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 120mg/vial.
Add 2ml of 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 60mg/vial.
Mix again.
Inject by IM route.

CAUTION AND SCHEDULE:

CAUTION: If any foreign particle is visible in the vial after dissolving the content, please do not use the solution & return for replacement.
The drug should not be promoted or used as a first line treatment of malaria.
Prepared solution should be used immediately.
FOR HOSPITAL USE ONLY
SCHEDULE: SCHEDULE ‘H’ DRUG: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store in a cool & dry place. Protect from moisture & direct sunlight. Do not freeze it.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Artesunate Injection IP (60mg/vial) Technical Specification:

Product Name:Artesunate Injection IP 60mg
Brand Name:Zentrom
Strength:60mg/vial, 120mg/vial
Dosage Form:Lyophilized Powder for Injection (Sterile)
Packing:Combi-pack (Vial + Ampoule + FFS ampoule)
Route of Administration:For I.V./I.M. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Antimalarial
Indication: Artesunate for Injection is indicated for the initial treatment of severe malaria in adult and pediatric patients.
Storage:Store in a cool & dry place. Protect from moisture & direct sunlight. Do not freeze it.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Artesunate Injection IP (60mg/vial)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Artesunate Injection IP (60mg/vial)
    Composition:
    Each vial contains:
    Artesunate (Sterile) IP ………………………………………………60mg
    This pack also contains:
    1ml Ampoule of Sodium Bicarbonate Injection IP………5%w/v
    5ml Ampoule of Sodium Chloride Injection IP……………0.9%w/v

THERAPEUTIC INDICATIONS:

Artesunate for Injection is indicated for the initial treatment of severe malaria in adult and pediatric patients.

DIRECTION OF USE:

For I.V./I.M. use only.

  • For IV use:
    Add 5ml 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 60mg/vial.
    Mix again.
    Inject by slow IV route over 2-3 minutes.
    Do not put the solution in an IV drip.
  • For IM use:    
    Add 2ml of 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 60mg/vial.
    Mix again.
    Inject by IM route.

CAUTION & SCHEDULE:

CAUTION: If any foreign particle is visible in the vial after dissolving the content, please do not use the solution & return for replacement.

The drug should not be promoted or used as a first line treatment of malaria.

Prepared solution should be used immediately.

FOR HOSPITAL USE ONLY

SCHEDULE: SCHEDULE ‘H’ DRUG: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store in a cool & dry place. Protect from moisture & direct sunlight. Do not freeze it.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Keep all medicines out of reach of children.

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a trusted choice for Artesunate Injection due to its unwavering commitment to pharmaceutical quality, extensive industry expertise, and rigorous regulatory compliance. Their global presence and well-established distribution network ensure widespread availability of Artesunate Injection, enhancing patient access to critical medications. Taj Pharmaceuticals’ investment in research and development underscores their dedication to pharmaceutical innovation, potentially leading to more effective formulations. A dependable supply chain and competitive pricing options contribute to the accessibility and affordability of Artesunate. Their patient-focused approach and commitment to safety align perfectly with the significance of malaria treatment medications, reinforcing trust in their products among healthcare providers and patients. Taj Pharmaceuticals’ dedication to quality, compliance, research, affordability, and patient support positions it as a reliable supplier, benefiting healthcare providers and patients worldwide.

What is Artesunate Injection and its uses:

Artesunate Injection is a pharmaceutical product that contains the active ingredient artesunate. It is primarily used for the treatment of severe malaria, a life-threatening tropical disease caused by the Plasmodium parasite transmitted through the bite of infected mosquitoes. Here are the key aspects of Artesunate Injection and its uses:

  • Treatment of Severe Malaria: Artesunate Injection is an essential component of the recommended treatment for severe malaria. It is highly effective in rapidly reducing the parasite load in the bloodstream and alleviating severe symptoms associated with malaria.
  • Rapid Action: Artesunate is known for its rapid onset of action, making it a crucial medication for addressing severe malaria cases, where timely treatment is critical to prevent complications and fatalities.
  • Malaria Parasite Eradication: Artesunate works by destroying the malaria parasites in the red blood cells, helping to clear the infection from the patient’s body.
  • Intravenous Administration: Artesunate is typically administered via intravenous (IV) injection by trained healthcare professionals. This route of administration ensures quick and direct delivery of the medication into the bloodstream.
  • Part of Combination Therapy: In the treatment of severe malaria, Artesunate is often used in combination with other antimalarial medications, such as intravenous quinine or oral artemisinin-based combination therapies (ACTs). These combinations are recommended by healthcare authorities to enhance treatment efficacy.
  • Global Health Significance: Malaria remains a significant global health challenge, particularly in regions where the disease is endemic. Artesunate, along with other antimalarial interventions, plays a crucial role in reducing the burden of malaria-related morbidity and mortality.

It’s important to note that the use of Artesunate Injection should be strictly supervised and administered by qualified healthcare providers, as the management of severe malaria requires specialized care. Additionally, prompt diagnosis and treatment of malaria are essential to maximize the chances of recovery and reduce the risk of complications. Patients should follow their healthcare provider’s instructions and complete the full course of treatment as prescribed.

How does Artesunate Injection work?

Artesunate Injection works as an antimalarial medication by targeting the Plasmodium parasites that cause malaria. It has a specific mechanism of action that helps to rapidly eliminate the parasites from the bloodstream. Here’s how Artesunate Injection works:

  • Damage to Parasite’s Membrane: Artesunate is a type of artemisinin derivative, and when it enters the bloodstream, it is rapidly taken up by the malaria parasites (Plasmodium species) that infect red blood cells. Inside the parasite, artemisinin undergoes chemical reactions.
  • Production of Reactive Oxygen Species (ROS): These chemical reactions generate highly reactive molecules known as reactive oxygen species (ROS) within the parasite’s cells. ROS are toxic to the parasite and can cause severe damage to its cell structures.
  • Breakdown of Parasite Cell: The increased levels of ROS cause oxidative stress within the parasite. This stress leads to the breakdown of the parasite’s cell membranes, proteins, and other essential components.
  • Parasite Destruction: As a result of the oxidative damage, the malaria parasite is effectively killed and destroyed. This process occurs relatively quickly, making Artesunate a crucial medication for the treatment of severe malaria, where rapid parasite clearance is essential to prevent complications and fatalities.
  • Reduction in Parasite Load: Artesunate not only eliminates existing parasites but also reduces the overall parasite load in the bloodstream. This reduction in parasite numbers helps alleviate the severe symptoms of malaria, such as high fever, organ dysfunction, and anemia.
  • Complementing Other Antimalarials: In the treatment of severe malaria, Artesunate is often used in combination with other antimalarial medications, such as intravenous quinine or oral artemisinin-based combination therapies (ACTs). Combining medications with different mechanisms of action can enhance treatment efficacy and reduce the risk of parasite resistance.

Artesunate’s ability to rapidly clear parasites from the bloodstream and alleviate severe symptoms has made it a vital component of antimalarial treatment regimens recommended by healthcare authorities worldwide. However, it’s essential that Artesunate Injection is administered by trained healthcare professionals, as the management of severe malaria requires specialized care and monitoring. Patients should follow their healthcare provider’s instructions closely to ensure effective treatment and recovery.

Benefits of Artesunate Injection:

  • Highly Effective Against Severe Malaria: Artesunate Injection is known for its high efficacy in rapidly reducing the parasite load in the bloodstream and alleviating severe symptoms of malaria. This makes it a crucial medication for the treatment of severe and life-threatening cases of malaria.
  • Quick Onset of Action: Artesunate has a rapid onset of action, meaning it starts working quickly once administered. This rapid action is essential in severe malaria cases, where timely treatment can be a matter of life and death.
  • Reduction in Complications: By swiftly clearing the malaria parasites from the bloodstream, Artesunate helps reduce the risk of complications associated with severe malaria, such as organ failure, cerebral malaria, and severe anemia.
  • Part of Combination Therapy: Artesunate is often used in combination with other antimalarial medications, such as quinine or artemisinin-based combination therapies (ACTs). This combination approach enhances treatment efficacy and helps prevent the development of drug resistance.
  • Global Health Impact: Malaria remains a significant global health challenge, particularly in tropical and subtropical regions. Artesunate, when used appropriately, contributes to the reduction of malaria-related morbidity and mortality on a global scale.

Common Side Effects of Artesunate Injection:

  • Injection Site Reactions: Pain, redness, or swelling at the injection site may occur, but these side effects are usually mild and temporary.
  • Nausea and Vomiting: Gastrointestinal side effects like nausea and vomiting can occur after Artesunate Injection. These side effects are generally manageable and tend to improve with time.
  • Dizziness: Some individuals may experience dizziness or light-headedness, especially when standing up quickly. This side effect can be managed by avoiding sudden movements.
  • Transient Decrease in White Blood Cells: Artesunate can temporarily reduce the number of white blood cells in the bloodstream, which play a role in the body’s immune response. This effect is usually reversible and not typically associated with increased infection risk during the course of treatment.
  • Elevated Liver Enzymes: In some cases, Artesunate may lead to elevated levels of liver enzymes in blood tests. Regular monitoring is essential to ensure any liver-related side effects are promptly identified and managed.
  • Allergic Reactions: While rare, allergic reactions to Artesunate are possible. Symptoms of an allergic reaction may include rash, itching, swelling, severe dizziness, and difficulty breathing. Immediate medical attention is necessary if an allergic reaction occurs.

It’s important to note that Artesunate Injection should be administered under the supervision of qualified healthcare professionals, as the treatment of severe malaria requires specialized care and monitoring. Patients should report any unusual or severe side effects to their healthcare provider promptly. The benefits of Artesunate in treating severe malaria far outweigh the potential side effects, but its use should always be guided by healthcare experts to ensure safe and effective treatment.

Frequently Asked Questions About Artesunate Injection:

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

  1. What is Artesunate Injection used for?

Artesunate Injection is primarily used for the treatment of severe malaria, a life-threatening disease caused by Plasmodium parasites transmitted through mosquito bites.

  1. How does Artesunate Injection work to treat malaria?

Artesunate works by rapidly killing the malaria parasites (Plasmodium species) in the bloodstream. It does so by generating highly reactive molecules called reactive oxygen species (ROS) within the parasites, leading to their destruction.

  1. Is Artesunate Injection effective against all types of malaria?

Artesunate is particularly effective against severe forms of malaria caused by various Plasmodium species. It is typically used in combination with other antimalarial drugs to maximize its effectiveness.

  1. Is Artesunate Injection safe to use during pregnancy?

Artesunate can be used during pregnancy, especially in cases of severe malaria, where the benefits outweigh the potential risks. However, its use should be carefully monitored by healthcare professionals.

  1. Are there any drug interactions with Artesunate?

Artesunate may interact with certain medications, so it’s essential to inform your healthcare provider about all the medications, supplements, and herbal products you are taking. They will assess potential drug interactions and adjust your treatment plan accordingly.

  1. What are the common side effects of Artesunate Injection?

Common side effects may include injection site reactions, nausea, vomiting, dizziness, and transient decreases in white blood cell count. These side effects are generally manageable and temporary.

  1. Can Artesunate be used to prevent malaria?

Artesunate is primarily used for the treatment of existing malaria infections, particularly severe cases. It is not typically used for malaria prevention. Preventive measures, such as insecticide treated bed nets and antimalarial medications, are recommended for malaria prevention.

  1. How should Artesunate Injection be stored?

Artesunate Injection should be stored according to the manufacturer’s instructions, typically at a controlled room temperature. It should be kept out of reach of children.

  1. Is Artesunate Injection available over-the-counter (OTC)?

No, Artesunate Injection is not available over-the-counter. It is a prescription medication and should be administered by qualified healthcare professionals.

  1. What should I do if I suspect a malaria infection?

If you suspect a malaria infection or experience symptoms such as high fever, chills, sweats, and body aches, seek immediate medical attention. Early diagnosis and treatment are crucial for malaria management and prevention of complications.

Patients should always consult their healthcare provider or medical professionals for personalized information and guidance regarding the use of Artesunate Injection, potential side effects, and appropriate treatment protocols for malaria.

As Artesunate Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Artesunate 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

Artesunate 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 Artesunate 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
Fax No: +91 22 2634 1274