Ulinastatin for Injection 1,00,000 IU (Ulinotaj)

Ulinastatin for Injection 1,00,000 IU Technical Specification:

GENERIC NAME OF MEDICINAL PRODUCT:

• Ulinastatin for Injection 100,000 Units

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Ulinastatin for Injection 1,00,000 Units
  Each vial contains:
  Ulinastatin J.P.………………………………1,00,000 unit
  Excipient………………………………………q.s.
  Water for Injection IP……………………q.s.

THERAPEUTIC INDICATION:

Ulinastatin is used in the treatment of severe sepsis and pancreatitis. Ulinastatin blocks the chemicals (digestive enzymes) which helps in digestion and also reduces the chemicals involved in inflammation of the pancreas.

Tested negative for HBsAg, HIV-1,2 and HCV antibodies.

DIRECTION OF USE:

Use I.V Only.

CAUTION AND SCHEDULE:

CAUTION: Not to be used if, after reconstituted solution contains visible solid particles.

Discard any unused portion of the contents.

Use only after reading the direction on the pack insert.

The safety for pregnant woman is NOT determined yet.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

WARNING: For Hospital use only.

SCHEDULE: SCHEDULE ‘H’ DRUG: CAUTION: To be sold by retail on the prescription of Registered Medical Practitioner only.

KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE AND DOSAGE:

STORAGE: Store between 2°C to 8°C. Protect from light. Do not freeze.

DOSAGE: As directed by Physician.

Note: Batch No., manufacturing details and price, printed on bottom panel.

Why Taj Pharmaceuticals?

Experience the exceptional quality and reliability of Taj Pharma when it comes to Ulinastatin for Injection. With a legacy of excellence and a dedication to your well-being, Taj Pharma stands as a trusted name in healthcare. Our commitment to quality begins with rigorous research and development processes. We employ cutting-edge technology and adhere to strict quality standards to ensure that every batch of Ulinastatin for Injection meets the highest efficacy and safety criteria. Taj Pharma’s global reputation speaks volumes about our dedication to providing life-saving medications. We are proud to serve patients and healthcare professionals worldwide, offering a comprehensive range of pharmaceutical solutions that make a difference in people’s lives.

Choose Taj Pharma for Ulinastatin for Injection, and you’re choosing a partner in health who values your safety and well-being above all else. Join the countless individuals and healthcare providers who trust Taj Pharma for their pharmaceutical needs.

What is Ulinastatin for Injection and its use?

Ulinastatin for Injection is a medication used in medical settings primarily for its anti-inflammatory and immunomodulatory properties. It contains ulinastatin as its active ingredient, which is a protease inhibitor naturally found in human urine. Here are some key uses and indications for Ulinastatin for Injection:

• Treatment of Acute Pancreatitis: Ulinastatin is often prescribed as a part of the treatment regimen for patients with acute pancreatitis. It can help reduce the inflammation and associated complications in the pancreas.
• Postoperative Inflammation: After certain surgical procedures, there can be significant inflammation and tissue damage. Ulinastatin may be used to mitigate the inflammatory response and speed up the recovery process.
• Sepsis: Ulinastatin has been studied for its potential role in the management of sepsis, a life-threatening condition characterized by a severe systemic infection and an overwhelming inflammatory response.
• Trauma and Burns: In cases of severe trauma or extensive burns, Ulinastatin may be used to control inflammation and prevent complications.
• Other Inflammatory Conditions: Ulinastatin’s anti-inflammatory properties may be beneficial in various conditions where excessive inflammation plays a role, such as acute lung injury or acute respiratory distress syndrome (ARDS).

Ulinastatin for Injection works primarily through its anti-inflammatory and immunomodulatory mechanisms. Here’s how it functions in the body:

• Anti-Inflammatory Effects: Ulinastatin inhibits the activity of various enzymes called proteases, particularly serine proteases, which play a key role in the inflammatory response. By inhibiting these enzymes, Ulinastatin reduces the breakdown of proteins and the release of inflammatory mediators. This action helps to dampen the overall inflammatory response in the body.
• Modulation of Immune Response: Ulinastatin can modulate the immune system’s response to injury or infection. It helps regulate the production and release of certain pro-inflammatory cytokines, such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6). By doing so, it helps prevent an excessive and harmful immune response, which can lead to tissue damage and organ dysfunction.
• Protection of Endothelial Cells: Ulinastatin has been shown to protect the endothelial cells lining blood vessels. This protection is important because endothelial dysfunction is a key feature of conditions like sepsis and acute pancreatitis. By preserving the function of these cells, Ulinastatin may help maintain proper blood flow and reduce tissue damage.
• Reduction of Oxidative Stress: Ulinastatin can also scavenge free radicals and reduce oxidative stress, which is often associated with inflammatory conditions. By reducing oxidative damage to cells and tissues, it contributes to the overall anti-inflammatory effect.

Ulinastatin’s precise mechanism of action may vary depending on the specific condition being treated. While it has demonstrated potential benefits in various inflammatory and critical care settings, its exact role and effectiveness may differ in each case. Healthcare professionals carefully consider the patient’s condition and the desired therapeutic outcome when determining the appropriate use of Ulinastatin for Injection.

Benefits of Ulinastatin for Injection:

• Anti-Inflammatory Effects: Ulinastatin is primarily used for its anti-inflammatory properties. It can help reduce inflammation in various medical conditions, including acute pancreatitis, sepsis, trauma, burns, and inflammatory lung diseases.
• Immunomodulatory Effects: Ulinastatin can modulate the immune response, helping to prevent excessive and harmful immune reactions. This is particularly valuable in conditions where an uncontrolled immune response can lead to tissue damage.
• Protection of Endothelial Cells: Ulinastatin can protect the endothelial cells lining blood vessels, which is important for maintaining proper blood flow and preventing complications associated with endothelial dysfunction.
• Oxidative Stress Reduction: By scavenging free radicals and reducing oxidative stress, Ulinastatin contributes to the overall well-being of cells and tissues.
• Potential for Enhanced Recovery: In surgical and postoperative settings, Ulinastatin may contribute to faster recovery by reducing inflammation and tissue damage.

Side Effects of Ulinastatin for Injection:

It’s important to note that while Ulinastatin is generally considered safe when used appropriately, it may still cause side effects in some individuals. Common side effects include:

• Injection Site Reactions: Pain, redness, or swelling at the injection site is possible.
• Gastrointestinal Distress: Some people may experience mild gastrointestinal symptoms such as nausea, vomiting, or diarrhea.
• Allergic Reactions: Although rare, allergic reactions can occur. Symptoms may include skin rash, itching, swelling, dizziness, or difficulty breathing. Seek immediate medical attention if you experience any signs of an allergic reaction.
• Liver Enzyme Elevation: In some cases, Ulinastatin may lead to elevated liver enzymes, which can be detected through blood tests. This usually resolves when the medication is discontinued.
• Other Rare Side Effects: Rarely, individuals may experience other side effects, such as fever, headache, or changes in blood pressure.

It’s crucial to use Ulinastatin under the guidance of a qualified healthcare professional who can assess the benefits and risks in your specific medical condition. If you experience any unusual or severe side effects while using Ulinastatin, you should contact your healthcare provider promptly. This list of side effects is not exhaustive, and individual responses to the medication can vary. Your healthcare provider can provide you with more information and guidance tailored to your situation.

Frequently asked questions (FAQs) about Ulinastatin for Injection:

1. What is Ulinastatin for Injection used for?

Ulinastatin for Injection is primarily used for its antiinflammatory and immunomodulatory properties in conditions such as acute pancreatitis, sepsis, trauma, burns, and inflammatory lung diseases.

2. How is Ulinastatin for Injection administered?

It is typically administered intravenously (IV) by healthcare professionals in a clinical or hospital setting.

3. What is the recommended dosage of Ulinastatin for Injection?

The dosage varies depending on the specific medical condition being treated and the patient’s individual health status. Your healthcare provider will determine the appropriate dosage for your case.

4. How often is Ulinastatin for Injection administered?

The frequency of administration also depends on the condition being treated. It may be given as a continuous infusion or in divided doses throughout the day.

5. What are the potential side effects of Ulinastatin for Injection?

Common side effects may include injection site reactions, gastrointestinal symptoms, and, rarely, allergic reactions. Your healthcare provider can provide more information on potential side effects.

6. Is Ulinastatin for Injection safe during pregnancy and breastfeeding?

The safety of Ulinastatin during pregnancy and breastfeeding is not well established. It should be used during pregnancy or breastfeeding only if the potential benefits outweigh the risks, and under the guidance of a healthcare provider.

7. Can I take Ulinastatin for Injection with other medications?

It’s important to inform your healthcare provider about all medications and supplements you are taking to avoid potential interactions. Ulinastatin may interact with certain drugs, so your healthcare provider will consider this when prescribing it.

8. How long will I need to take Ulinastatin for Injection?

The duration of treatment with Ulinastatin varies depending on the underlying condition. Your healthcare provider will determine the appropriate treatment duration for your case.

9. What should I do if I miss a dose of Ulinastatin for Injection?

Follow your healthcare provider’s instructions closely. If you miss a dose, inform your healthcare provider, and they will provide guidance on how to proceed.

10. Can I drive or operate heavy machinery while receiving Ulinastatin for Injection?

Ulinastatin is not known to impair the ability to drive or operate machinery. However, if you experience dizziness or any unusual side effects, it’s advisable to avoid such activities until you feel comfortable.

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

Ulinastatin 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 Ulinastatin 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