DALARGIN-PHARMSYNTEZ

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DALARGIN-PHARMSYNTHESIS

Composition:

Active substance: dalargin;

1 ml of solution contains dalargin 1 mg;

Excipients: sodium chloride, acetic acid, water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Agents affecting the gastrointestinal tract and metabolic processes. ATC code A16AX.

Pharmacological properties.

Pharmacodynamics. Dalargin is a peptide compound (tyrosine-2-alanyl-glycyl-phenylalanyl-leucyl-arginine diacetate) containing residues of 6 amino acids. Dalargin belongs to agents that regulate metabolic processes. The drug accelerates healing of gastric and duodenal ulcers and reduces gastric juice acidity due to antisecretory activity. Dalargin also has a hypotensive effect. A positive effect of dalargin on mental functions in patients with alcoholism has been observed.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

As part of complex therapy: exacerbation of gastric and duodenal ulcer disease with prolonged ulcer healing; occlusive diseases of the lower limbs; mental disorders associated with alcoholism; pancreatitis, pancreatic necrosis.

Contraindications.

Hypersensitivity to the components of the drug, pronounced arterial hypotension.

Interaction with other medicinal products and other types of interactions.

If there is a pronounced pain symptom, antacid agents should be prescribed concurrently with Dalargin-Farmsintez.

Special precautions.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy.

If treatment with this medicinal product is necessary, breastfeeding should be discontinued.

Ability to affect reaction rate when driving or operating machinery.

Not studied.

If dizziness occurs during treatment with this medicinal product, patients should refrain from driving or operating machinery.

Dosage and Administration

Dalarzin-Farmsyntez should be administered intramuscularly and intravenously.

For peptic ulcer of the stomach and duodenum or occlusive diseases of the lower limbs, the single dose of Dalarzin-Farmsyntez is 1–2 mL (1–2 mg).

Intramuscular injections are given twice daily; intravenous injections—once daily. The maximum daily dose (with intramuscular administration) is up to 5 mL (5 mg). The treatment course lasts 3–4 weeks. The total dose of Dalarzin-Farmsyntez for the entire course of treatment amounts to 30–50 mg.

For psychiatric disorders of alcoholic origin, administer 1 mg of dalarzin intravenously in 10 mL of 0.9% sodium chloride injection solution.

For acute pancreatitis, administer the drug intravenously: on the first day—2 mL (2 mg), then 5 mL (5 mg) 1–2 times daily. The treatment course lasts 4 to 6 days.

For pancreatic necrosis, administer 5 mL (5 mg) intravenously 3–4 times daily (every 6–8 hours). The treatment course lasts from 2 to 6 days.

Children. There is no information regarding the safety and efficacy of Dalarzin-Farmsyntez in pediatric patients; therefore, the drug is not recommended for use in this age group.

Overdose. Not described.

Adverse reactions.

Cardiovascular system: decrease in blood pressure, tachycardia, palpitations.

Nervous system: headache, dizziness, numbness of upper extremities and face.

Respiratory system, thoracic organs and mediastinum: increased or difficult breathing, shortness of breath.

Immune system: allergic reactions.

Skin and subcutaneous tissues: itching, hyperemia, urticaria, redness or burning of facial skin, pallor of the skin, sweating.

Gastrointestinal tract: nausea, abdominal pain, including epigastric pain.

General disorders and administration site reactions: general weakness, chills, increased body temperature, chest pain, facial swelling; hyperemia, rash, itching at the injection site.

Shelf life. 3 years.

Storage conditions. Store in original packaging, in a place inaccessible to children, at a temperature not exceeding 25 °C.

Incompatibility. Do not use solvents not specified in the section "Instructions for use and dosage".

Packaging. 1 ml in vials; 10 vials per box or 5 vials in 1 blister, 2 blisters per box.

Prescription category. Prescription only.

Manufacturer.

JSC "LEKHEM–KHARKIV".

Address.

36 Severina Pototskoho Street, Kharkiv, Kharkiv region, 61115, Ukraine.

Marketing Authorization Holder.

LLC "FARMSYNTEZ".

Address.

34 Chobotarska St., bld. 34, off. 10, Kharkiv, 61052, Ukraine.