Urokinase for Injection 2,50,000IU Technical Specification:

Product Name:Urokinase for Injection
Brand Name:Generic
Strength:5,00,000IU(300mg), 5000IU(3mg), 50,000IU (30mg), 1,00,000UI(60mg), 2,50,000IU(150mg)
Dosage Form:Lyophilized Powder Injection (Sterile) *Pyrogen Free
Packing:1 Vial
Route of Administration:For I.V. 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:Anti-coagulant (thrombolytic)
Indication: UROKINASE breaks up blood clots. It is used to treat large blood clots formed in the lungs. This medicine may be used for other purposes. Urokinase is a physiologic thrombolytic agent that is produced in renal parenchymal cells. Unlike streptokinase, urokinase directly cleaves plasminogen to produce plasmin. When it is purified from human urine.
Storage:Store at 2°C to 8°C. Protect from light

GENERIC NAME OF MEDICINAL PRODUCT:

  • Urokinase for Injection 2,50,000IU 

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Urokinase for Injection 2,50,000IU 
    Each vial contains:
    Urokinase USP…………….……………2,50,000IU
    Excipients:
    Human Albumin B.P………………………….20mg
    Sodium Citrate B.P……………………………..24mg
    Disodium Hydrogen Phosphate Dihydrate B.P……….7.8mg
    Sodium Dihydrogen Phosphate Dihydrate B.P…………..20mg
  • Tested negative for HBsAg, HIV-1,2 and HCV antibodies

THERAPEUTIC INDICATION:

UROKINASE breaks up blood clots. It is used to treat large blood clots formed in the lungs. This medicine may be used for other purposes. Urokinase is a physiologic thrombolytic agent that is produced in renal parenchymal cells. Unlike streptokinase, urokinase directly cleaves plasminogen to produce plasmin. When it is purified from human urine.

CAUTION & WARNING:

CAUTION: The Injection should not be used if it contains visible particulate matter after reconstitution

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

STORAGE & DOSAGE:

Storage:  Store at 2°C to 8°C. Protect from light

KEEP MEDICINE OUT OF REACH OF CHILDREN.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharma stands as a beacon of excellence in thrombolytic therapy with its Urokinase for Injection. Backed by a rich legacy of precision and a steadfast commitment to patient well-being, Taj Pharma’s Urokinase is the trusted choice for dissolving blood clots effectively and safely. Our dedication to affordability ensures that life-saving therapy remains accessible to all, regardless of their financial circumstances. At Taj Pharma, we believe that healthcare should be inclusive, and we strive to make a difference in patients’ lives by offering cost-effective solutions. When you choose Taj Pharma for Urokinase for Injection, you choose a partner in your journey toward better health. We are at the forefront of innovation in thrombolytic therapy, continually advancing our products to deliver the best possible outcomes for patients. Experience the future of thrombolytic therapy with Taj Pharma, where quality, innovation, and patient care converge to offer a solution you can trust and depend on for your health and well-being.

What is Urokinase for Injection and its use?

Urokinase for Injection is a medication used in thrombolytic therapy, which is the process of dissolving blood clots. It contains the enzyme urokinase, which is naturally produced in the human body but is also manufactured as a pharmaceutical product. Here’s an overview of Urokinase for Injection and its common uses:

Uses of Urokinase for Injection:

  • Acute Pulmonary Embolism: Urokinase is often used to treat acute pulmonary embolism, a condition where blood clots block the pulmonary arteries in the lungs. Dissolving these clots can be life-saving and help restore normal lung function.
  • Deep Vein Thrombosis (DVT): It can also be used to treat deep vein thrombosis, a condition where blood clots form in the deep veins, typically in the legs. Urokinase helps dissolve these clots and reduce the risk of complications like pulmonary embolism.
  • Peripheral Arterial Occlusion: Urokinase may be used to treat peripheral arterial occlusion, where blood clots block blood flow in the arteries that supply the limbs. It helps restore blood flow and prevent tissue damage.
  • Central Venous Catheter Thrombosis: In some cases, urokinase is used to dissolve blood clots that form in central venous catheters, which are medical devices used to deliver medications or fluids directly into large veins.

It’s important to note that the use of Urokinase for Injection should be under the supervision of a healthcare professional, as the dosage and administration depend on the specific medical condition and the patient’s individual factors. The medication is typically administered as an intravenous infusion, and close monitoring is necessary to assess its effectiveness and any potential side effects or complications. As with any medication, there are risks and contraindications associated with Urokinase, and its use should be determined by a qualified medical practitioner based on the patient’s clinical situation.

How does Urokinase for Injection work?

Urokinase for Injection works as a thrombolytic agent by activating the body’s natural clot-dissolving system. Here’s how Urokinase works:

  • Plasminogen Activation: Plasminogen is an inactive precursor enzyme found in the bloodstream. Urokinase acts on plasminogen, converting it into its active form, known as plasmin.
  • Plasmin’s Role: Plasmin is a powerful enzyme responsible for breaking down fibrin, a structural protein found in blood clots. Fibrin is the mesh-like substance that holds a blood clot together.
  • Fibrinolysis Initiation: Once plasmin is activated, it begins to work on the fibrin strands within the blood clot. Plasmin cleaves the fibrin strands at various points, breaking down the clot’s structural integrity.
  • Clot Dissolution: As plasmin continues to break down fibrin, the blood clot gradually dissolves into smaller fragments. These fragments are then removed from the bloodstream by the body’s natural mechanisms.
  • Restoration of Blood Flow: By dissolving the clot, Urokinase helps restore blood flow in the affected blood vessel. This is crucial in medical conditions where clots obstruct blood flow and can lead to severe complications or even be life-threatening.

Urokinase is particularly effective against blood clots because it directly targets the process of clot formation. This makes it a valuable treatment option for conditions like pulmonary embolism (where clots block arteries in the lungs), deep vein thrombosis (clots in deep leg veins), and other thromboembolic disorders.

Benefits of Urokinase for Injection:

  • Effective Clot Dissolution: Urokinase is highly effective in dissolving blood clots, making it a valuable tool in the treatment of conditions where clot removal is essential for patient recovery.
  • Life-Saving in Emergencies: Urokinase can be life-saving in situations such as acute pulmonary embolism and deep vein thrombosis, where rapid clot dissolution is crucial to restoring normal blood flow and preventing serious complications.
  • Minimizes Tissue Damage: By promptly dissolving blood clots, Urokinase helps reduce or prevent tissue damage that can occur when blood flow is obstructed.
  • Potential for Preserving Organ Function: In conditions like peripheral arterial occlusion, Urokinase can help preserve organ function by restoring blood flow to affected limbs.
  • Minimizes Risk of Pulmonary Embolism: In cases of deep vein thrombosis, timely treatment with Urokinase can reduce the risk of pulmonary embolism, a potentially life-threatening condition.

Side Effects of Urokinase for Injection:

  • Bleeding: The most common side effect of Urokinase is bleeding, which can range from mild to severe. This can include nosebleeds, gum bleeding, gastrointestinal bleeding, or even intracranial bleeding in rare cases.
  • Allergic Reactions: Some individuals may experience allergic reactions to Urokinase, which can include hives, rash, itching, swelling, or difficulty breathing. These reactions are rare but can be serious.
  • Low Blood Pressure: Urokinase may cause a drop in blood pressure, leading to dizziness or fainting in some cases.
  • Fever and Chills: Flu-like symptoms, including fever and chills, may occur during or after Urokinase treatment.
  • Re perfusion Injury: In some cases, the restoration of blood flow to an area that was previously ischemic (lacking blood supply) can lead to reperfusion injury, which may cause tissue damage.
  • Formation of Antibodies: In rare instances, the body may develop antibodies against Urokinase, rendering it less effective in subsequent treatments.
  • Other Potential Complications: Urokinase treatment can carry risks, and patients should be closely monitored for any potential side effects or complications, such as blood cell count changes or kidney issues.

The benefits of Urokinase treatment often outweigh the potential risks, especially in life-threatening situations where blood clots need to be rapidly dissolved. However, its use should be carefully considered and closely monitored by healthcare professionals to ensure patient safety and optimal outcomes. Patients should also be informed of potential risks and report any unusual symptoms to their healthcare team promptly.

Frequently Asked Questions about Urokinase for Injection:

Certainly! Here are some frequently asked questions (FAQs) about Urokinase for Injection:

  1. What is Urokinase for Injection?

Urokinase for Injection is a medication used in thrombolytic therapy to dissolve blood clots. It contains the enzyme urokinase, which activates the body’s natural clotdissolving system.

  1. What conditions can Urokinase for Injection treat?

Urokinase is used to treat conditions such as acute pulmonary embolism, deep vein thrombosis, peripheral arterial occlusion, and central venous catheter thrombosis.

  1. How is Urokinase for Injection administered?

Urokinase is typically administered as an intravenous (IV) infusion under the supervision of a healthcare professional.

  1. How quickly does Urokinase work to dissolve blood clots?

The effectiveness of Urokinase in dissolving blood clots can vary depending on factors like the size and location of the clot. In some cases, it can lead to rapid clot dissolution.

  1. Are there any contraindications for using Urokinase for Injection?

Urokinase should not be used in cases of active bleeding, recent surgery, bleeding disorders, or certain medical conditions. Your healthcare provider will assess whether it is safe and appropriate for your specific situation.

  1. What are the potential side effects of Urokinase for Injection?

Common side effects may include bleeding, allergic reactions, low blood pressure, fever, and chills. It’s important to report any unusual symptoms to your healthcare provider.

  1. Can Urokinase be used during pregnancy or breastfeeding?

The use of Urokinase during pregnancy or breastfeeding should be discussed with a healthcare provider to weigh potential risks and benefits.

  1. Is it safe to consume alcohol while receiving Urokinase treatment?

Alcohol consumption should be discussed with your healthcare provider, as it may interact with medications and affect treatment outcomes.

  1. Can Urokinase be used in children or the elderly?

Urokinase can be used in both children and the elderly, but dosages may vary based on individual factors and should be determined by a healthcare provider.

  1. Is it necessary to monitor blood clotting parameters during Urokinase treatment?

Yes, regular monitoring of blood clotting parameters is crucial to ensure the treatment is effective and to detect and manage any potential side effects or complications.

  1. How long does Urokinase treatment typically last?

The duration of Urokinase treatment will vary depending on the specific medical condition being treated and the patient’s individual response to the therapy. Your healthcare provider will determine the appropriate treatment plan.

We are exporting our Urokinase Injection product to Following Countries:

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

North and Central America: Belize, Costa Rica, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Suriname,

South America: Brazil, Argentina, Bolivia, Chile, Colombia, Ecuador, French Guiana, Guyana, Paraguay, Peru, Uruguay, Venezuela

Caribbean Countries: Jamaica, Cuba, Dominican Republic, Haiti, Guadeloupe, Martinique, Puerto Rico, Saint-Barthélemy, Saint-Martin, St Lucia, Trinidad & Tobago, Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine,

African Countries: Kenya, Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia, Mozambique, Malawi, Seychelles, Gambia, Somalia, Sierra Leone, Libya

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

Other Countries: Turkey, Cyprus, Cayman Island, Papua New Guinea (PNG), All West Indies Country

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

Urokinase Injection Regulatory Documents:

  1. Certificate of Analysis (COA)
  2. Method of Analysis (MOA)
  3. Stability Data (Accelerated stability / Long term stability / Zone 4b)
  4. CTD Dossier / ACTD Dossiers / eCTD Dossiers
  5. Certificate of Pharmaceuticals Product (COPP)
Contact the most reliable manufacturer of Urokinase 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

GENERIC NAME OF MEDICINAL PRODUCT:

A) Urokinase for Injection 5,00,000IU
B) Urokinase for Injection 5000IU
C) Urokinase for Injection 50,000IU
D) Urokinase for Injection 1,00,000IU
E) Urokinase for Injection 2,50,000IU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Urokinase for Injection 5,00,000IU Each vial contains:
Urokinase USP…………….……………5,00,000IU
Excipients:
Human Albumin B.P...............................20mg
Sodium Citrate B.P...................................24mg
Disodium Hydrogen Phosphate Dihydrate B.P..........7.8mg
Sodium Dihydrogen Phosphate Dihydrate B.P..............20mg

B) Urokinase for Injection 5000IU Each vial contains:
Urokinase USP…………….……………5000IU
Excipients:
Human Albumin B.P...............................20mg
Sodium Citrate B.P...................................24mg
Disodium Hydrogen Phosphate Dihydrate B.P..........7.8mg
Sodium Dihydrogen Phosphate Dihydrate B.P..............20mg

C) Urokinase for Injection 50,000IU Each vial contains:
Urokinase USP…………….……………50,000IU
Excipients:
Human Albumin B.P...............................20mg
Sodium Citrate B.P...................................24mg
Disodium Hydrogen Phosphate Dihydrate B.P..........7.8mg
Sodium Dihydrogen Phosphate Dihydrate B.P..............20mg

D) Urokinase for Injection 1,00,000IU Each vial contains:
Urokinase USP…………….……………1,00,000 I.U.
Excipients:
Human Albumin B.P...............................20mg
Sodium Citrate B.P...................................24mg
Disodium Hydrogen Phosphate Dihydrate B.P..........7.8mg
Sodium Dihydrogen Phosphate Dihydrate B.P..............20mg

E) Urokinase for Injection 2,50,000IU Each vial contains:
Urokinase USP…………….……………2,50,000IU
Excipients:
Human Albumin B.P...............................20mg
Sodium Citrate B.P...................................24mg
Disodium Hydrogen Phosphate Dihydrate B.P..........7.8mg
Sodium Dihydrogen Phosphate Dihydrate B.P..............20mg

THERAPEUTIC INDICATION:

UROKINASE is breaks up blood clots.
It is used to treat large blood clots formed in the lungs. This medicine may be used for other purposes.
Urokinase is a physiologic thrombolytic agent that is produced in renal parenchymal cells.
Unlike streptokinase, urokinase directly cleaves plasminogen to produce plasmin. When it is purified from human urine.

CAUTION & WARNING:

CAUTION: The Injection should not be used if it contains visible particulate matter after reconstitution
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 2°C to 8°C. Protect from light
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Dosage: As directed by Physician.