LARGINID

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LARGINID (LARGINID)

Composition:

Active substance: dalargin;

1 ml of solution contains 1 mg of dalargin;

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

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear colorless liquid.

Pharmacotherapeutic group.

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

Pharmacological properties.

Pharmacodynamics.

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

Pharmacokinetics.

After injection, the hexapeptide dalargin undergoes rapid degradation under the action of endogenous peptidases, resulting in a half-life of several minutes from systemic circulation following administration.

Clinical characteristics.

Indications.

As part of complex therapy:

• Exacerbations of gastric and duodenal ulcer with prolonged ulcer healing;
• Obliterative diseases of lower limbs;
• Mental state disorders in alcoholism;
• Pancreatitis;
• Pancreonecrosis.

Contraindications.

Hypersensitivity to the components of the drug.

Severe arterial hypotension.

Interaction with other medicinal products and other types of interactions.

In case of pronounced pain symptoms, antacid agents should be administered concomitantly with the medicinal product LARGINID.

Special precautions for use.

This medicinal product contains less than 1 mmol (23 mg)/dose of sodium, i.e. practically sodium-free.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy.

If treatment with LARGINID is necessary, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery.

Not studied.

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

Dosage and Administration

LARGINID is administered intramuscularly or intravenously.

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

Intramuscular injections are given twice daily; intravenous injections—once daily. The maximum daily dose (by intramuscular administration) is up to 5 mL (5 mg).

The treatment course lasts 3–4 weeks. The total dose of LARGINID for the entire treatment course is 30–50 mg.

For alcoholic-induced mental disorders: 1 mL (1 mg) of the drug is administered intravenously in 10 mL of 0.9% sodium chloride solution.

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

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

Children.

There is no information on the safety and efficacy of LARGINID in children; therefore, LARGINID is not recommended for use in this age group.

Overdose.

Not described.

Adverse reactions.

Cardiovascular system: decreased blood pressure.

Cardiac disorders: tachycardia, palpitations.

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

Respiratory, thoracic and mediastinal disorders: increased or difficult breathing, shortness of breath.

Immune system: allergic reactions.

Skin and subcutaneous tissue: itching, hyperemia, urticaria; facial flushing, burning sensation of facial skin; pallor of the skin, sweating.

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

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

Reporting of adverse reactions after marketing authorization is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua

Shelf life. 3 years.

Storage conditions.

Store in a light-protected place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

1 ml in a vial made of colorless transparent glass.

5 vials in a blister pack, 2 blisters with a scarifier in a carton. When packaging vials with a break ring or break point, inclusion of a scarifier is omitted.

Prescription status. Prescription only.

Manufacturer.

LLC "BIOLIK PHARMA".

Manufacturer's location and address of its business activity.

Legal entity address:

70 Pomirky Street, Kharkiv, Kharkiv Oblast, 61070, Ukraine.

Address of business activity:

Pomirky-70, building b/n, Kharkiv, Kharkiv Oblast, 61070, Ukraine.