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 15,00,000IU (1.5MIU) 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 (15,00,000IU)

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • 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

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?

Meta Description: Taj Pharma, your preferred source for Recombinant Streptokinase for Injection, stands out for its unwavering commitment to excellence in thrombolytic therapy. Our product is the epitome of quality, meticulously crafted to meet the highest industry standards. With Taj Pharma, you can trust that every vial of Recombinant Streptokinase is manufactured with precision and rigorously tested for efficacy and safety. What sets us apart is our dedication to affordability without compromising on quality. We believe that life-saving treatments should be accessible to all, and we work tirelessly to ensure our Recombinant Streptokinase remains cost-effective for healthcare providers and patients alike.

At Taj Pharma, innovation is at the heart of what we do. We continually invest in research and development to advance thrombolytic therapy, seeking new ways to improve patient outcomes and reduce the burden of cardiovascular diseases. Choose Taj Pharma for Recombinant Streptokinase for Injection, and experience the assurance of quality, affordability, and cutting-edge solutions in thrombolytic treatment. Your health is our priority.

What is Recombinant Streptokinase for Injection and its use?

Recombinant Streptokinase for Injection is a medication used in thrombolytic therapy to treat various medical conditions related to blood clotting. It is a biotechnologically engineered form of streptokinase, an enzyme produced by certain bacteria, primarily Streptococcus species.

The primary use of Recombinant Streptokinase for Injection is to dissolve blood clots, a process known as thrombolysis or fibrinolysis. It accomplishes this by activating the body’s natural clot-dissolving system. This medication is particularly beneficial in the following medical scenarios:

  • Acute Myocardial Infarction (Heart Attack): Recombinant Streptokinase can be administered during a heart attack to help dissolve the clot causing the blockage in one of the coronary arteries. This action restores blood flow to the heart muscle, limiting damage and improving the patient’s chances of recovery.
  • Deep Vein Thrombosis (DVT): It can be used to treat deep vein thrombosis, which is the formation of blood clots in deep veins, typically in the legs. By dissolving these clots, the medication helps reduce the risk of complications like pulmonary embolism.
  • Pulmonary Embolism: Pulmonary embolism occurs when a blood clot travels to the lungs and blocks blood flow. Recombinant Streptokinase can be used to dissolve these clots and alleviate life-threatening situations.
  • Arterial Thrombosis: In cases where arterial blood clots occur, such as in peripheral arterial occlusion or stroke, Recombinant Streptokinase can be administered to restore blood flow and prevent tissue damage.

How does Recombinant Streptokinase for Injection work?

Recombinant Streptokinase for Injection works by utilizing a natural enzymatic process to dissolve blood clots. It’s important to understand the basic mechanism of blood clot formation to appreciate how this medication operates:

  • Blood Clot Formation: Blood clots, also known as thrombi, form as a protective response to bleeding or injury. They consist of a meshwork of a protein called fibrin, which traps blood cells and platelets, creating a clot. While this process is crucial for preventing excessive bleeding, it can become problematic when clots form inside blood vessels where they are not needed.
  • Role of Plasmin: The body has a natural mechanism to dissolve blood clots and prevent them from becoming too large. Plasmin is an enzyme responsible for breaking down fibrin, which is the structural component of the clot. Plasminogen is an inactive precursor of plasmin present in the blood.
  • Activation of Plasminogen: To initiate fibrinolysis (the process of dissolving clots), plasminogen needs to be converted into its active form, plasmin. This conversion is catalyzed by substances known as “plasminogen activators.” Recombinant Streptokinase for Injection serves as one such activator.

Here’s how Recombinant Streptokinase works:

  • When administered intravenously, Recombinant Streptokinase enters the bloodstream.
  • It binds to and activates plasminogen, converting it into active plasmin.
  • Plasmin then goes to work, breaking down the fibrin network that holds the blood clot together.
  • As plasmin degrades fibrin, the clot begins to dissolve, restoring blood flow in the affected blood vessel.

This process of fibrinolysis is essential in various medical conditions where blood clots pose a threat, such as in heart attacks, deep vein thrombosis, pulmonary embolism, and arterial thrombosis. By promoting clot dissolution, Recombinant Streptokinase helps to alleviate the obstruction caused by blood clots and reduce the risk of serious complications associated with these conditions.

Benefits of Recombinant Streptokinase for Injection:

  • Clot Dissolution: The primary benefit of Recombinant Streptokinase is its ability to dissolve blood clots effectively. This property is especially crucial in medical emergencies like heart attacks, strokes, and pulmonary embolisms, where prompt clot removal can save lives and reduce tissue damage.
  • Restoration of Blood Flow: By dissolving clots, this medication helps restore blood flow to blocked or narrowed blood vessels. This is vital for preventing organ damage and improving overall patient outcomes.
  • Reduced Risk of Complications: Recombinant Streptokinase can reduce the risk of complications associated with conditions like deep vein thrombosis (DVT) and pulmonary embolism. In DVT cases, it prevents clot extension or embolization to the lungs.
  • Minimized Tissue Damage: During heart attacks, Recombinant Streptokinase can limit the extent of heart muscle damage by reopening blocked coronary arteries, reducing the risk of heart failure.

Side Effects of Recombinant Streptokinase for Injection:

It’s important to note that while Recombinant Streptokinase can be life-saving, it may also have potential side effects and risks, including:

  • Bleeding: The most common side effect is bleeding, which can range from mild (e.g., nosebleeds, gum bleeding) to severe (e.g., gastrointestinal bleeding or intracranial bleeding). The risk of bleeding is increased in patients with a history of bleeding disorders or recent surgery.
  • Allergic Reactions: Some individuals may experience allergic reactions to Recombinant Streptokinase, which can include hives, rash, itching, swelling, or difficulty breathing. These reactions are rare but can be serious.
  • Low Blood Pressure: In some cases, Recombinant Streptokinase may cause a drop in blood pressure, leading to dizziness or fainting.
  • Nausea and Vomiting: These gastrointestinal symptoms may occur as a side effect of the medication.
  • Fever and Chills: Some patients may experience flu-like symptoms, including fever and chills, during or after treatment.
  • Formation of Antibodies: In rare cases, the body may develop antibodies against Recombinant Streptokinase, rendering it less effective in subsequent treatments.

It’s essential for healthcare providers to carefully evaluate the risks and benefits of Recombinant Streptokinase for each patient, taking into consideration their medical history, current condition, and any contraindications. Close monitoring during treatment is crucial to detect and manage potential side effects promptly. Patients should also be informed of these potential risks and side effects before starting treatment and encouraged to report any unusual symptoms to their healthcare team.

Frequently asked questions about Recombinant Streptokinase for Injection:

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

  • What is Recombinant Streptokinase for Injection?

Recombinant Streptokinase for Injection is a medication used to dissolve blood clots in conditions like heart attacks, strokes, deep vein thrombosis, and pulmonary embolism.

  • How does Recombinant Streptokinase work?

It activates plasminogen, an enzyme that breaks down fibrin, the protein in blood clots, thereby dissolving the clot and restoring blood flow.

  • When is Recombinant Streptokinase used?

It is used in medical emergencies, such as heart attacks, strokes, and pulmonary embolisms, to rapidly remove blood clots and restore blood circulation.

  • Is Recombinant Streptokinase safe?

While generally safe, it carries a risk of bleeding, allergic reactions, and other side effects. Its use should be carefully monitored by healthcare professionals.

  • How is Recombinant Streptokinase administered?

It is typically administered intravenously (IV) under the supervision of a healthcare provider.

  • What are the contraindications for Recombinant Streptokinase?

It should not be used in cases of active bleeding, recent surgery, bleeding disorders, or certain medical conditions.

  • Are there any drug interactions with Recombinant Streptokinase?

Some medications, like anticoagulants, may interact with Recombinant Streptokinase and increase the risk of bleeding.

  • What are the potential side effects of Recombinant Streptokinase?

Common side effects include bleeding, allergic reactions, low blood pressure, nausea, vomiting, and fever.

  • Can Recombinant Streptokinase be used during pregnancy or breastfeeding?

Its use during pregnancy or breastfeeding should be carefully considered, and the potential risks and benefits discussed with a healthcare provider.

  • How quickly should Recombinant Streptokinase be administered in emergencies like heart attacks?

In cases of heart attacks, it is most effective when administered as soon as possible after symptoms begin, ideally within a few hours.

  • Is Recombinant Streptokinase the only thrombolytic medication available?

No, there are other thrombolytic agents available, and the choice of medication depends on the specific clinical situation and patient factors.

  • What should I do if I experience side effects or have concerns about Recombinant Streptokinase treatment?

Contact your healthcare provider immediately to discuss any side effects or concerns. They can provide guidance and adjust the treatment plan if necessary.

Always consult with a healthcare professional for personalized information and guidance regarding the use of Recombinant Streptokinase for your specific medical condition or situation

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 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

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