post-title portfolio-title Recombinant Streptokinase for Injection BP 5,00,000 IU (0.5MIU) 2023-01-10 12:06:29 no no

Recombinant Streptokinase for Injection BP 5,00,000 IU (0.5MIU)

GENERIC NAME OF MEDICINAL PRODUCT:

A. Recombinant Streptokinase for Injection BP (15,00,000IU)
B. Recombinant Streptokinase for Injection BP (7,50,000IU)
C. Recombinant Streptokinase for Injection BP (2,50,000IU)
D. Recombinant Streptokinase for Injection BP (5,00,000 IU)
E. Recombinant Streptokinase for Injection BP (1,00,000 IU)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Recombinant Streptokinase for Injection BP (15,00,000IU)
a) Each lyophilized vial (Upon adding 2ml of WFI) contains:
Streptokinase B.P………………………15,00,000IU
Excipients: Glycine, Sodium L Glutamate, Phosphate Buffer

B. Recombinant Streptokinase for Injection BP (7,50,000IU)
Each lyophilized vial (Upon adding 2ml of WFI) contains:
Streptokinase B.P………………………7,50,000IU
Excipients: Glycine, Sodium L Glutamate, Phosphate Buffer

C. Recombinant Streptokinase for Injection BP (2,50,000IU)
Each lyophilized vial (Upon adding 2ml of WFI) contains:
Streptokinase B.P………………………2,50,000IU
Excipients: Glycine, Sodium L Glutamate, Phosphate Buffer

D. Recombinant Streptokinase for Injection BP (5,00,000 IU)
Each lyophilized vial (Upon adding 2ml of WFI) contains:
Streptokinase B.P………………………5,00,000 IU
Excipients: Glycine, Sodium L Glutamate, Phosphate Buffer


E. Recombinant Streptokinase for Injection BP (1,00,000 IU)
Each lyophilized vial (Upon adding 2ml of WFI) contains:
Streptokinase B.P………………………1,00,000 IU
Excipients: Glycine, Sodium L Glutamate, Phosphate Buffer

THERAPEUTIC INDICATIONS:

Acute Evolving Myocardial Infarction
Acute Massive Pulmonary Embolism
Deep Vein Thrombosis
Arterial Thrombosis or Embolism
Arteriovenous Cannulae Occlusion. 

DIRECTION OF USE:

For Intravenous use only.
The solution should be used within 24 hours following reconstitution.
Roll and tilt the vial gently to reconstitute. Avoid shaking as it may cause foaming.
Do not add other medication to the container of Product.
Unused reconstituted drug should be discarded.
Reconstitute with Sterile Sodium Chloride Injection USP.
For more information refer pack insert.

CAUTION & WARNING:

CAUTION: The injection should not be used if it contains visible solid particles after reconstitution. Please do not use the solution and return the vial for free replacement.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
Kindly do not self-administer

STORAGE & DOSAGE:

Storage: Store at a temperature between 2°C to 8°C. Protect from light and moisture.
Do not freeze.
Keep all medicines out of reach of children.
Purified Lyophilized vial sealed in vacuum.
Discard any unused portion.
Dosage: As directed by the Physician.

Recombinant Streptokinase for Injection BP 5,00,000 IU (0.5MIU) Technical Specification:

Product Name:Recombinant Streptokinase for Injection BP
Brand Name:Generic
Strength:15,00,000IU (1.5MIU),
7,50,000IU (0.75MIU),
2,50,000IU(0.25MIU),
5,00,000 IU (0.5MIU),
1,00,000 IU (0.1MIU)
Dosage Form:Lyophilized
Dry Powder Injection (Sterile) *Preservative Free
*Albumin-free preparation
Packing:5ml Single Use Vial
Route of Administration:For IV Use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Thrombolytic Agent
Indication: Acute Evolving Myocardial Infarction,  Acute Massive Pulmonary Embolism, Deep Vein Thrombosis, Arterial Thrombosis or Embolism, Arteriovenous Cannulae Occlusion
Storage:Store at a temperature between 2°C to 8°C. Protect from light and moisture.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Recombinant Streptokinase for Injection BP (5,00,000 IU)

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Recombinant Streptokinase for Injection BP (5,00,000 IU)
    a) Each lyophilized vial (Upon adding 2ml of WFI) contains:
    Streptokinase B.P………………………5,00,000 IU
    Excipients: Glycine, Sodium L Glutamate, Phosphate Buffer

THERAPEUTIC INDICATIONS:

  • Acute Evolving Myocardial Infarction
  • Acute Massive Pulmonary Embolism
  • Deep Vein Thrombosis
  • Arterial Thrombosis or Embolism
  • Arteriovenous Cannulae Occlusion.

DIRECTION OF USE:

For Intravenous use only.
The solution should be used within 24 hours following reconstitution.
Roll and tilt the vial gently to reconstitute. Avoid shaking as it may cause foaming.
Do not add other medication to the container of the Product.
The unused reconstituted drug should be discarded.
Reconstitute with Sterile Sodium Chloride Injection USP.
For more information refer pack insert.

CAUTION & WARNING:

CAUTION: The injection should not be used if it contains visible solid particles after reconstitution. Please do not use the solution and return the vial for free replacement.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

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

Kindly do not self-administer

STORAGE & DOSAGE:

Storage: Store at a temperature between 2°C to 8°C. Protect from light and moisture.
Do not freeze.
Keep all medicines out of reach of children.
Purified Lyophilized vial sealed in a vacuum.
Discard any unused portion.

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals stands out as a trusted provider of Recombinant Streptokinase for Injection BP, offering compelling reasons for its preferred status in the pharmaceutical industry. With a proven track record spanning years, Taj Pharmaceuticals has earned a reputation for excellence in producing pharmaceuticals of the highest quality, ensuring stringent adherence to quality standards. Quality assurance is paramount at Taj Pharmaceuticals, with a steadfast commitment to maintaining the highest standards throughout the manufacturing process. This commitment ensures that Recombinant Streptokinase for Injection BP is meticulously crafted, a crucial factor when dealing with medications used in critical medical situations.

Recombinant Streptokinase is employed in thrombolytic therapy to dissolve blood clots, making safety and efficacy paramount. Taj Pharmaceuticals places a strong emphasis on these aspects, subjecting their products to rigorous testing to not only meet but often exceed regulatory requirements. This dedication guarantees the safety and effectiveness of the medication for patients in need. Taj Pharmaceuticals specializes in thrombolytic agents, particularly Recombinant Streptokinase. Their team comprises experienced professionals who possess a deep understanding of the complexities and specific demands associated with thrombolytic therapy. This expertise ensures the consistent production of dependable and effective medication.

With a global presence, Taj Pharmaceuticals ensures that healthcare providers and patients around the world have access to Recombinant Streptokinase for Injection BP. This extensive reach underscores their commitment to meeting the diverse needs of medical professionals and patients, regardless of geographical location. Customer satisfaction is at the core of Taj Pharmaceuticals’ philosophy. Their dedication to delivering top-quality products is complemented by outstanding customer service. This customer-centric approach ensures that healthcare providers and patients have a positive and reliable experience when selecting Recombinant Streptokinase for Injection BP from Taj Pharmaceuticals. Taj Pharmaceuticals is a trusted and reliable choice for Recombinant Streptokinase for Injection BP. Their long-standing experience, unwavering commitment to quality, specialized expertise in thrombolytic therapy, global reach, and dedication to customer satisfaction make them the preferred supplier for healthcare providers and patients seeking this crucial medication for thrombolytic therapy.

What is Recombinant Streptokinase for Injection and its uses?

Recombinant Streptokinase for Injection is a medication used in the field of medicine as a thrombolytic agent. It plays a crucial role in dissolving blood clots, a process known as thrombolysis. Here’s an overview of Recombinant Streptokinase and its primary uses:

  • Thrombolytic Medication: Recombinant Streptokinase is a thrombolytic medication used to break down and dissolve blood clots. It achieves this by activating a substance called plasminogen in the blood, which then converts into plasmin, an enzyme responsible for breaking down fibrin, a protein involved in blood clot formation.
  • Treatment of Acute Myocardial Infarction (Heart Attack): One of the most critical applications of Recombinant Streptokinase is in the management of acute myocardial infarction, commonly known as a heart attack. When administered promptly after the onset of a heart attack, it can help dissolve the blood clot blocking the coronary artery, restoring blood flow to the heart muscle. This rapid intervention can reduce the extent of heart muscle damage and improve the chances of survival.
  • Pulmonary Embolism: Recombinant Streptokinase is also used in the treatment of acute pulmonary embolism. In this condition, blood clots obstruct the pulmonary arteries, which carry blood to the lungs. By breaking down these clots, the medication helps improve blood flow to the lungs and relieve potentially life-threatening symptoms.
  • Deep Vein Thrombosis (DVT): DVT is a condition where blood clots form in the deep veins, typically in the legs. Recombinant Streptokinase may be used to dissolve these clots, reducing the risk of complications such as pulmonary embolism.
  • Arterial Thrombosis: In some cases, Recombinant Streptokinase can be employed to treat arterial thrombosis, where blood clots form in arteries. This may include conditions like acute limb ischemia, where blood flow to a limb is compromised due to a clot.

It’s important to note that Recombinant Streptokinase should be administered under the supervision of a healthcare professional, and the dosage and duration of treatment will depend on the specific medical condition being treated. The use of thrombolytic therapy carries risks, including bleeding, and its benefits must outweigh these potential risks. Additionally, not all patients are suitable candidates for thrombolytic therapy, and decisions regarding its use are based on careful evaluation of the individual’s medical history and the circumstances surrounding the condition. The timely administration of Recombinant Streptokinase can be life-saving in certain situations, particularly in the context of heart attacks and pulmonary embolisms, but it requires careful clinical assessment and management.

How Does Recombinant Streptokinase for Injection Work?

Recombinant Streptokinase for Injection works by utilizing a biochemical process called thrombolysis to break down blood clots within the bloodstream. Here’s how it works:

  • Activation of Plasminogen: When Recombinant Streptokinase is injected into the bloodstream, it does not directly attack the blood clot. Instead, it initiates a cascade of biochemical reactions. One of its primary actions is to bind to a substance called plasminogen, which is naturally present in the blood.
  • Conversion to Plasmin: Once bound to plasminogen, Recombinant Streptokinase triggers the conversion of plasminogen into its active form, plasmin. Plasmin is an enzyme that plays a crucial role in breaking down fibrin, a protein that forms the structural framework of blood clots.
  • Fibrinolysis: Plasmin, once activated, begins to break down the fibrin strands within the blood clot. Fibrinolysis is the process of enzymatically dissolving the fibrin meshwork that holds the blood clot together. As plasmin works on the clot, it gradually breaks it down into smaller fragments.
  • Clot Dissolution: Over time, as plasmin continues to degrade fibrin, the blood clot becomes progressively smaller and less stable. Eventually, the clot is completely dissolved into soluble products. This process restores blood flow in the affected blood vessel, alleviating the blockage.
  • Restoration of Blood Flow: By dissolving the blood clot, Recombinant Streptokinase helps to restore normal blood flow in the affected blood vessel. This can be lifesaving in conditions like acute myocardial infarction (heart attack) or pulmonary embolism, where prompt restoration of blood flow is essential to prevent tissue damage or organ failure.

It’s important to note that Recombinant Streptokinase does not distinguish between harmful clots and beneficial clots (such as those involved in wound healing). Therefore, its use must be carefully considered by healthcare professionals and administered only in situations where the benefits of clot dissolution outweigh the potential risks, which can include bleeding. Additionally, Recombinant Streptokinase is not the only thrombolytic agent available; there are others with different properties and mechanisms of action. The choice of thrombolytic therapy is based on the specific clinical condition, the patient’s medical history, and other factors, and should be determined by a healthcare provider.

Benefits and Side Effects of Recombinant Streptokinase for Injection:

Recombinant Streptokinase for Injection offers significant benefits in certain medical situations, particularly in the treatment of acute thrombotic conditions. However, like all medications, it can also be associated with potential side effects. Here’s an overview of the benefits and side effects of Recombinant Streptokinase:

Benefits:

  • Thrombolysis: The primary benefit of Recombinant Streptokinase is its ability to induce thrombolysis, which means it can dissolve blood clots. This is crucial in medical emergencies where rapid restoration of blood flow is necessary, such as in acute myocardial infarction (heart attack) or pulmonary embolism.
  • Reduced Tissue Damage: By dissolving blood clots, Recombinant Streptokinase helps prevent or minimize tissue damage that can occur when blood flow is blocked. This is particularly important in the heart and lungs, where inadequate blood supply can lead to severe organ damage.
  • Life-Saving: In cases of severe thrombotic events, such as massive pulmonary embolism or extensive coronary artery blockage during a heart attack, the use of Recombinant Streptokinase can be life-saving. It can rapidly restore blood flow, improving the chances of survival.

Side Effects:

  • Bleeding: The most significant side effect of Recombinant Streptokinase is an increased risk of bleeding. This can manifest as bleeding from the gastrointestinal tract, urinary tract, or, in severe cases, intracranial bleeding (hemorrhage). The risk of bleeding is a crucial consideration when deciding to use this medication.
  • Allergic Reactions: While rare, allergic reactions to Recombinant Streptokinase can occur. Symptoms may include skin rash, itching, swelling, or, in severe cases, anaphylactic shock, which is a life-threatening reaction requiring immediate medical attention.
  • Hypotension: The use of Recombinant Streptokinase can lead to a drop in blood pressure (hypotension), which can be problematic, especially in patients with pre-existing cardiovascular conditions.
  • Recurrent Clot Formation: After thrombolysis with Recombinant Streptokinase, there is a risk of recurrent clot formation, which may necessitate further treatment or interventions.
  • Hypersensitivity Reactions: Some individuals may experience hypersensitivity reactions, which can include fever, chills, and joint pain.
  • Nausea and Vomiting: Nausea and vomiting are less common side effects but can occur after Recombinant Streptokinase administration.

It’s important to note that the decision to use Recombinant Streptokinase is carefully considered by healthcare professionals, taking into account the specific clinical condition, the patient’s medical history, and the potential risks and benefits. The potential life-saving benefits of this medication in certain thrombotic emergencies must be weighed against the risk of bleeding and other adverse effects. Patients receiving Recombinant Streptokinase are typically closely monitored for any signs of bleeding or allergic reactions.

Frequently Asked Questions About Recombinant Streptokinase for Injection:

Recombinant streptokinase is a medication used to dissolve blood clots in certain medical conditions. Here are some frequently asked questions about recombinant streptokinase for injection:

  1. What is recombinant streptokinase?

Recombinant streptokinase is a genetically engineered form of streptokinase, an enzyme produced by bacteria. It is used as a thrombolytic agent to break down blood clots.

  1. What is recombinant streptokinase used for?

Recombinant streptokinase is used to treat conditions where blood clots can be lifethreatening, such as acute myocardial infarction (heart attack), deep vein thrombosis (DVT), and pulmonary embolism (PE).

  1. How does recombinant streptokinase work?

Recombinant streptokinase works by activating the body’s natural mechanism for dissolving blood clots. It converts plasminogen into plasmin, which is an enzyme that breaks down fibrin, the protein that forms blood clots.

  1. How is recombinant streptokinase administered?

Recombinant streptokinase is typically administered as an intravenous (IV) infusion in a hospital or clinical setting. The exact dosage and duration of treatment will depend on the specific condition being treated.

  1. What are the potential side effects of recombinant streptokinase?

Common side effects may include bleeding, allergic reactions, fever, and nausea. Serious side effects can include severe bleeding and allergic reactions. It is important to inform your healthcare provider of any side effects you experience.

  1. Who should not use recombinant streptokinase?

Recombinant streptokinase should not be used in patients with a history of bleeding disorders, recent surgery, severe uncontrolled high blood pressure, or a known allergy to streptokinase or any of its components.

  1. Is recombinant streptokinase safe during pregnancy and breastfeeding?

The safety of recombinant streptokinase during pregnancy and breastfeeding is not wellestablished. It should only be used if the potential benefits outweigh the risks and under the guidance of a healthcare professional.

  1. What precautions should be taken while using recombinant streptokinase?

Patients receiving recombinant streptokinase should be closely monitored for signs of bleeding, and healthcare providers should be alerted to any unusual symptoms or reactions. Avoid activities that could increase the risk of injury or bleeding.

  1. Can recombinant streptokinase be used in combination with other medications?

Your healthcare provider will determine the most appropriate treatment plan, which may include the use of other medications or procedures in conjunction with recombinant streptokinase.

  1. How effective is recombinant streptokinase?

The effectiveness of recombinant streptokinase depends on the specific condition being treated and how quickly treatment is initiated after the onset of symptoms. It is most effective when used as early as possible after a clotrelated event.

Always consult with a healthcare professional for detailed information and guidance on the use of recombinant streptokinase, as individual circumstances may vary. This information is meant to provide a general overview and should not substitute for medical advice.

As Recombinant Streptokinase for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Recombinant Streptokinase for Injection product to 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

Recombinant Streptokinase 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 Recombinant Streptokinase 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
Fax No: +91 22 2634 1274

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