Immeran (Solution) Instructions for Use

Marketing Authorization Holder

Gemma-B SPCF, LLC (Russia)

Manufactured By

Technopark-Center LLC (Russia)

Contact Information

GEMMA-B NPK LLC (Russia)

ATC Code

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

Active Substance

Solanum tuberosum cormus extract (Grouping name)

Dosage Form

Immeran

Solution for intravenous administration 0.5 mg/1 ml: ampoules 3 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration transparent, colorless or slightly colored, odorless.

Excipients : sodium chloride – 9 mg, water for injection – up to 1 ml.

1 ml – ampoules made of colorless glass (3) – contour cell packaging (1) – cardboard packs.

Clinical-Pharmacological Group

A drug that exerts a protective effect on the gastric and duodenal mucosa. Antiulcer drug

Pharmacotherapeutic Group

Peptic ulcer herbal treatment agent

Pharmacological Action

The drug is a fraction from an aqueous extract of potato sprouts (Solanum tuberosum), consisting mainly of polysaccharides (including, among others, sucrose, arabinose, galactose, uronic acids) and a small amount of protein.

The drug normalizes the physiological processes of ulcer healing by activating regenerative and reparative processes in the gastric and duodenal mucosa, improving the spatial structure of collagen fibers in the submucosal layer, and also improving the trophism of the damaged area of the stomach or duodenum as a result of the formation of additional blood vessels.

Pharmacokinetics

The drug contains a complex of biologically active substances, therefore, conducting pharmacokinetic studies is not possible.

Indications

• In the complex therapy of gastric and duodenal ulcer in the acute phase, regardless of the presence or absence of Helicobacter pylori infection, as well as the level of acidity of gastric contents.

ICD codes

Dosage Regimen

Administer the drug intravenously as a slow bolus injection.

The single dose is 0.5 mg, which corresponds to the entire contents of one 1 ml ampoule.

Administer a total of three injections over a full 14-day treatment course.

Perform the injections strictly on the 1st, 7th, and 14th days of therapy.

Use the solution immediately after opening the ampoule; do not store the opened ampoule.

Inspect the solution visually for particulate matter or discoloration prior to administration; use only if the solution is clear and essentially colorless.

Ensure the injection is performed by a healthcare professional using aseptic technique.

Do not mix Immeran with other medicinal products in the same syringe or infusion container.

Discontinue treatment and initiate appropriate therapy if signs of a hypersensitivity reaction occur.

Adverse Reactions

Possible allergic reactions, the appearance of a short-term sensation of burning and pain at the injection site.

If any of the specified side effects worsen or any other side effects not listed in the instructions are noted, the patient must inform the doctor.

Contraindications

• Hypersensitivity to the components of the drug (including sucrose, arabinose, galactose, uronic acids, potato protein);
• Pregnancy;
• Breastfeeding period;
• Children under 18 years of age (due to the lack of results from clinical studies of the drug in pediatrics).

Use in Pregnancy and Lactation

The use of the drug during pregnancy and breastfeeding is contraindicated (due to the lack of data on the safety of the drug use in these categories of patients). If it is necessary to use the drug in women during lactation, breastfeeding should be discontinued.

Pediatric Use

Contraindicated for use in children under 18 years of age.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

The use of the drug does not affect the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, work of a dispatcher and operator).

Overdose

Cases of overdose have not been described to date.

Drug Interactions

Interaction with other drugs has not been described.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature from 2°C (35.6°F) to 10°C (50°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

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.