U-trip

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT U-TRYP (U-TRYP)

Composition:

Active substance: ulinastatin;

4 ml of solution contain ulinastatin 100,000 IU;

Excipients: m-cresol, sucrose, disodium hydrogen phosphate dihydrate, Tween 80, phosphoric acid.

Pharmaceutical form. Injection solution.

Main physicochemical properties: clear, colorless solution.

Pharmacotherapeutic group. Protease inhibitors.

ATC code B02A B.

Pharmacological properties.

Pharmacodynamics. Ulinastatin is a protease inhibitor isolated from human urine. Ulinastatin inhibits inflammatory markers: trypsin, pancreatic elastase, polymorphonuclear leukocyte elastase, as well as endotoxin-stimulated production of TNF-alpha and interleukins 1 and 8; it inhibits coagulation and fibrinolysis and enhances microperfusion. Therefore, ulinastatin is an effective immunomodulating agent for the prevention of organ dysfunction and supports homeostasis.

Pharmacokinetics. After intravenous administration of doses of 300,000 IU/10 ml to healthy male subjects, the concentration of ulinastatin in blood decreased linearly. The elimination half-life of ulinastatin is approximately 40 minutes. Within one hour after administration, 24% of ulinastatin is excreted in urine.

Clinical characteristics.

Indications.

Treatment of acute pancreatitis (pancreatitis) of mild and severe course.

Contraindications.

Hypersensitivity to the active substance or to any of the components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Not studied.

Special precautions for use.

Ulinastatin should be administered with caution to patients with a history of allergies.

Ulinastatin cannot replace conventional therapeutic methods (transfusion, oxygen therapy, and antibiotics) in the treatment of septic shock.

Use during pregnancy or breastfeeding.

The safety of use in pregnant women has not been established to date. The physician must decide whether to administer ulinastatin to pregnant women or potentially pregnant women, weighing the clinical condition of these patients.

Breastfeeding .

Generally, ulinastatin is not administered to women during breastfeeding. If the drug is prescribed, breastfeeding should be discontinued.

Ability to influence the reaction rate when driving or operating machinery.

The medicine Y-Trip may affect the ability to drive vehicles or operate other automated systems due to the development of visual disturbances and dizziness.

Administration and Dosage

The contents of 1–2 vials of ulinastatin at 100,000 IU (reconstituted using 100 mL of 5% dextrose solution or 100 mL of 0.9% physiological saline) should be administered by intravenous infusion over 1 hour, 1–3 times daily for 3–5 days. The dosage may be adjusted depending on the patient's age and severity of symptoms.

Children. Ulinastatin is not approved for use in children. Dosage for use in children has not yet been established.

Overdose.

Cases of overdose have not been reported.

There is no specific antidote.

Adverse reactions.

Gastrointestinal disorders: nausea, vomiting, diarrhea.

Laboratory findings: changes in aspartate aminotransferase and alanine aminotransferase levels; decreased leukocyte count.

General disorders and administration site reactions: increased body temperature; redness, itching, pain at the injection site, allergic reactions.

Shelf life. 2 years.

Storage conditions.

Store at 2 to 8 °C in a place protected from light. Do not freeze.

Keep out of reach of children.

Incompatibility.

The medicinal product must not be mixed with other medicinal products.

Use only the solvents specified in the section "Instructions for use and dosage".

Packaging.

Injection solution 100,000 IU in 4 ml in a vial. One vial in a cardboard box.

Prescription category. By prescription only.

Manufacturer.

Bharat Serums and Vaccines Limited.

Manufacturer's address and location of its business operations.

PLOT NO: K-27, PARTS K-27 AND K-27/1, ANAND NAGAR, VILLAGE JAMBIVILI, EDISHINAL MIDS,, AMBERNA (I) – 421506

Taluka: AMBERNATH CITY, District: THANE - ZONE 6, India