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Dalargin (Solution, Lyophilisate) Instructions for Use

ATC Code

A02BX (Other drugs for the treatment of gastric and duodenal ulcers and GERD)

Active Substance

Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine diacetate (Grouping Name)

Clinical-Pharmacological Group

Antiulcer drug with antisecretory activity

Pharmacotherapeutic Group

Drugs for the treatment of diseases associated with acidity disorders; drugs for the treatment of gastric and duodenal ulcer disease and gastroesophageal reflux disease (GERD)

Pharmacological Action

A synthetic hexapeptide, an analog of leucine-enkephalin. It suppresses proteolysis and promotes the healing of gastric and duodenal ulcers.

It has moderate antisecretory activity, reducing the acidity of gastric juice.

It suppresses the external secretion of the pancreas in response to various stimuli (including food, secretin). In pancreatic lesions, the drug reduces hyperfermentemia, limits necrotic foci and promotes their replacement with full-fledged tissue, and weakens the synthesis of proteolytic enzymes by the pancreas.

It has a slight hypotensive effect.

Indications

As part of combination therapy for gastric and duodenal ulcers in the acute phase; acute pancreatitis; pancreatic necrosis.

ICD codes

ICD-10 code Indication
K25 Gastric ulcer
K26 Duodenal ulcer
K27 Peptic ulcer
K85 Acute pancreatitis
K86.8 Other specified diseases of pancreas (atrophy, calculi, cirrhosis, fibrosis of pancreas)
ICD-11 code Indication
DA60.Z Gastric ulcer, unspecified
DA61 Peptic ulcer of unspecified site
DA63.Z Duodenal ulcer, unspecified
DC31.Z Acute pancreatitis, unspecified
DC34 Obstructive pancreatitis
DC35.Z Other specified diseases of pancreas, unspecified
DC3Z Diseases of pancreas, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Lyophilisate

Administered intramuscularly or intravenously.

Depending on the indications and clinical situation, a single dose is 1-5 mg, frequency of application is 1-4 times/day. The course of treatment is established individually.

Solution

Immediately before use, the contents of the ampoule with the lyophilisate are dissolved in 1 ml of isotonic sodium chloride solution.

The drug is administered intramuscularly or intravenously.

For gastric ulcer and duodenal ulcer in the acute phase, a single dose is 1-2 mg, the maximum daily dose is 5 mg. The course of treatment is 3-4 weeks. The total dose per course of treatment is 30-50 mg.

For acute pancreatitis, the drug is administered intravenously at a dose of 2 mg, then 5 mg 1-2 times/day. The course of treatment is 4-6 days.

For acute necrotizing pancreatitis, it is administered intravenously at 5 mg 3-4 times/day (with an interval of 6-8 hours). The course of treatment is from 2 to 6 days.

Adverse Reactions

Possible decrease in blood pressure, allergic reactions.

Contraindications

Hypersensitivity to the active substance; arterial hypotension, acute infectious processes; pregnancy, breastfeeding period; age under 18 years, .

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

During treatment, due to possible side effects (decrease in blood pressure, which may lead to dizziness and visual impairment), it is recommended to exercise caution when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Enhances the effect of opioid analgesics.

Naloxone blocks the antiulcer effect of this drug.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

B-PHARM, LLC (Russia)

Manufactured By

Academician E.I. Chazov NMRC Of Cardiology Of The Ministry Of Health Of The Russian Federation, FSBI (Russia)

Dosage Form

Bottle Rx Icon Dalargin Lyophilizate for the preparation of solution for intravenous and intramuscular administration 1 mg: ampoules 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of solution for intravenous and intramuscular administration in the form of a white amorphous powder or porous mass, an odor of acetic acid is allowed.

1 amp.
Dalargin 1 mg

1 mg – ampoules (5) – cardboard packs.
1 mg – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Academician E.I. Chazov NMRC Of Cardiology Of The Ministry Of Health Of The Russian Federation, FSBI (Russia)

Dosage Form

Bottle Rx Icon Dalargin Lyophilizate for the preparation of solution for intravenous and intramuscular administration 1 mg: amp. 5 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of solution for intravenous and intramuscular administration 1 amp.
Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine diacetate 1 mg

Ampoules (5) – contour plastic packaging (1) – cardboard packs.
Ampoules (5) – contour plastic packaging (2) – cardboard packs.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Dalargin Solution for intravenous and intramuscular administration 1 mg/1 ml: amp. 1 ml, 2 ml, 5 ml 3, 5, 6 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent, colorless liquid; an odor of acetic acid is allowed.

1 ml
Dalargin (Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine diacetate [calculated as tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine]) 1 mg

Excipients : sodium chloride, 1M acetic acid solution (for pH adjustment), water for injection.

1 ml – ampoules (3) – contour cell packaging (1) – cardboard packs.
1 ml – ampoules (3) – contour cell packaging (2) – cardboard packs.
1 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
1 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.
1 ml – ampoules (10) – cardboard boxes.
2 ml – ampoules (3) – contour cell packaging (1) – cardboard packs.
2 ml – ampoules (3) – contour cell packaging (2) – cardboard packs.
2 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.
2 ml – ampoules (10) – cardboard boxes.
5 ml – ampoules (3) – contour cell packaging (1) – cardboard packs.
5 ml – ampoules (3) – contour cell packaging (2) – cardboard packs.
5 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
5 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.
5 ml – ampoules (10) – cardboard boxes.

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Dosage Form

Bottle Rx Icon Dalargin Solution for intravenous and intramuscular administration 1 mg/ml: 1 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent, colorless liquid; an odor of acetic acid is allowed.

1 ml
Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine 1 mg

Excipients : sodium chloride – 9 mg, 1 M acetic acid – to pH 5.0-7.0, water for injection – up to 1 ml.

Ampoules (5) – contour cell packaging (2) – cardboard packs.
Ampoules (10) – cardboard packs.

Marketing Authorization Holder

BioVetTechnology SPC, LLC (Russia)

Manufactured By

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Form

Bottle Rx Icon Dalargin Lyophilizate for the preparation of solution for intravenous and intramuscular administration 1 mg: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of solution for intravenous and intramuscular administration in the form of a white or white with a yellowish tint amorphous powder or porous mass; an odor of acetic acid is allowed.

1 amp.
Dalargin (tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine)* 1 mg

* calculated as the anhydrous, acetic acid-free substance.

1 mg – glass ampoules (5) – contour plastic packaging (1) – cardboard packs.
1 mg – glass ampoules (5) – contour plastic packaging (2) – cardboard packs.
1 mg – glass ampoules (5) – contour cell packaging (1) – cardboard packs.
1 mg – glass ampoules (5) – contour cell packaging (2) – cardboard packs.
1 mg – glass ampoules (5) – cardboard packs with an insert.
1 mg – glass ampoules (10) – cardboard packs with an insert.

Marketing Authorization Holder

Ellara, LLC (Russia)

Dosage Form

Bottle Rx Icon Dalargin Solution for intravenous and intramuscular administration 1 mg/1 ml: amp. 1 ml 5, 10, 20 or 25 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration colorless, transparent; an odor of acetic acid is allowed.

1 ml
Dalargin (as diacetate) 1 mg

Excipients : anhydrous disodium hydrogen phosphate, citric acid (for pH adjustment), water for injection.

1 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
1 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.
1 ml – ampoules (5) – contour cell packaging (4) – cardboard packs.
1 ml – ampoules (5) – contour cell packaging (5) – cardboard packs.
1 ml – ampoules (5) – cardboard packs with a corrugated insert.
1 ml – ampoules (10) – cardboard packs with a corrugated insert.

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