Registered Tanzania · TMDA

U-TRYP 100000 I.U

Ulinastatin 100,000 I.U/5ml

TZ 19 H 0115 Lyophilized Injection 100,000 I.U

What it does

Ulinastatin is a medication that helps to reduce inflammation and protect organs during certain medical conditions.

Commonly used for: acute pancreatitis, severe burns, organ transplant procedures

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
TZ 19 H 0115
Registration date
2024-05-14
Expiry date
2029-05-13
Status
Registered/Compliant
Active ingredient
Ulinastatin 100,000 I.U/5ml
Dosage form
Lyophilized Injection
Strength
100,000 I.U
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Bharat Serums And Vaccines
Country of origin
INDIA
Manufacturer location
3RD Floor, Liberty Tower, Plot No. K-10, behind Reliable Plaza, Kalwa Industrial Estate, Gavate Wadi, MIDC, Airoli, Navi Mumbai, Maharashtra 400708, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:45:20 · updated 2026-09-24 03:00:47

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About this medicine

Ulinastatin is a medication that helps to reduce inflammation and protect organs during certain medical conditions.

What it treats

  • acute pancreatitis
  • severe burns
  • organ transplant procedures

How it works

It works by inhibiting enzymes that cause inflammation and tissue damage, helping the body to heal.

Who it's for

This medication is for patients experiencing severe inflammation or undergoing surgeries that may lead to organ stress.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: ulinastatin

Ulinastatin is a glycoprotein derived from human urine that exhibits protease inhibitor properties. It is primarily used for its anti-inflammatory and organ protective effects, particularly in conditions associated with acute inflammatory responses. Ulinastatin is often utilized in the management of acute pancreatitis, septic shock, and other critical illnesses where inflammation plays a significant role.

Indications

  • Acute pancreatitis
  • Septic shock
  • Acute respiratory distress syndrome
  • Acute kidney injury
  • Multiple organ dysfunction syndrome

Dosage

Children: Paediatric dosing should be determined based on clinical guidelines and is not specified here. Refer to paediatric dosing references for appropriate recommendations.

Adults: Dosing in adults typically involves intravenous administration, with specific doses depending on the clinical scenario and guidelines. Refer to local protocols for exact dosing recommendations.

Mechanism of action

Ulinastatin functions by inhibiting various serine proteases, including trypsin and chymotrypsin, which are involved in inflammatory processes. By modulating the activity of these enzymes, ulinastatin reduces the production of pro-inflammatory cytokines and mitigates tissue damage associated with excessive inflammation. Additionally, it can influence the balance of the immune response, promoting a more regulated inflammatory process.

Pharmacodynamics

The pharmacodynamic effects of ulinastatin include anti-inflammatory, anti-apoptotic, and organ-protective properties. It has been shown to reduce the levels of inflammatory mediators and protect against organ dysfunction in settings of systemic inflammation. The drug may help stabilize endothelial function and improve microcirculation, contributing to its therapeutic effects in critically ill patients.

Pharmacokinetics

Ulinastatin is administered intravenously and has a rapid onset of action. The drug has a relatively short half-life, necessitating careful consideration of dosing intervals in clinical settings. It is primarily cleared from the body through renal excretion, emphasizing the importance of renal function in determining appropriate dosing in patients with compromised kidney function.

Adverse effects

  • Allergic reactions
  • Nausea
  • Vomiting
  • Diarrhea
  • Rash
  • Fever

Precautions

  • Use with caution in patients with a history of allergic reactions to similar drugs.
  • Monitor renal function during treatment.

Pregnancy

Ulinastatin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is limited data on its safety in pregnancy.

Breast-feeding

It is not known whether ulinastatin is excreted in human milk. Caution should be exercised when administering to nursing mothers.

Storage

Store at 2-8 degrees Celsius. Protect from light and freeze.

Formulations

  • Injection solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.