Reamberin^® (Solution) Instructions for Use

Marketing Authorization Holder

Polisan NTFF, LLC (Russia)

Contact Information

POLISAN NTFF LLC (Russia)

ATC Code

B05BB (Solutions affecting water-electrolyte balance)

Active Substance

Meglumine sodium succinate (Grouping name)

Dosage Forms

	Reamberin®	Solution for infusion 1.5%: bottle 200 ml or 400 ml 1 pc.
		Solution for infusion 1.5%: polymeric containers 250 ml 5 or 32 pcs., 500 ml 5 or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless.

Excipients: sodium chloride, potassium chloride, magnesium chloride hexahydrate (calculated as anhydrous), sodium hydroxide, succinic acid (for pH adjustment), water for injections.

Ionic composition per 1 liter sodium – 147 mmol, potassium – 4.02 mmol, magnesium – 1.26 mmol, chlorides – 109 mmol, succinates – 46 mmol, meglumine – 44.7 mmol.

Theoretical osmolarity 353 mOsmol/l.

200 ml – glass bottles with a capacity of 250 ml (1) – cardboard packs^×.
400 ml – glass bottles with a capacity of 450 ml (1) – cardboard packs^×.
250 ml – containers made of multilayer polyolefin film (5) – group cardboard packaging.
500 ml – containers made of multilayer polyolefin film (5) – group cardboard packaging.
250 ml – containers made of multilayer polyolefin film (32) – group cardboard packaging (for hospitals).
500 ml – containers made of multilayer polyolefin film (20) – group cardboard packaging (for hospitals).

^× Application of a first-opening control label is allowed.

Clinical-Pharmacological Group

Drug with detoxifying action for parenteral use

Pharmacotherapeutic Group

Solutions affecting water-electrolyte balance

Pharmacological Action

It has antihypoxic and antioxidant action, exerting a positive effect on aerobic processes in the cell, reducing the production of free radicals and restoring the energy potential of cells.

The drug activates enzymatic processes of the Krebs cycle and promotes the utilization of fatty acids and glucose by cells, normalizes the acid-base balance and blood gas composition. It has a moderate diuretic effect.

Preclinical safety data

As a result of preclinical study of acute toxicity, it was shown that intravenous administration of the drug in the maximum possible doses (volumes) to rats of both sexes does not cause changes in the behavior and general condition of the animals, mass coefficients of organs relative to control animals, macroscopic changes in the brain, internal and endocrine organs of the experimental animals and is not accompanied by irritation or necrosis at the site of drug administration.

In the study of chronic toxicity, it was shown that daily administration of the drug for 30 days to rats and dogs of both sexes does not lead to the development of pathological shifts in the general condition and behavior of the animals, does not have a toxic effect on cardiovascular activity, biochemical parameters, morphological composition of peripheral blood and bone marrow, on the functional state of the liver and kidneys, protein, carbohydrate and fat types of metabolism, does not cause dystrophic, destructive, focal sclerotic changes in parenchymal cells and stroma of internal organs, and is not accompanied by a local irritant effect.

Experimental study showed that the drug does not possess carcinogenic, mutagenic, teratogenic or embryotoxic activity. Administration of the drug to experimental animals was not accompanied by a local irritant effect and did not cause allergic reactions.

The results of preclinical study allow classifying Reamberin^® as toxicity class 5 (practically non-toxic medicinal substance), and the condition of animals that underwent acute administration indicates good tolerability of the drug.

Pharmacokinetics

When administered intravenously, the drug is rapidly utilized and does not accumulate in the body.

Indications

Adults and children aged 1 year and older

• As an antihypoxic and detoxifying agent for acute endogenous and exogenous intoxications of various etiologies.

ICD codes

Dosage Regimen

Intravenous drip.

Adults

Administered intravenously drip at a rate of 1-4.5 ml/min (up to 90 drops/min). The average daily dose is 10 ml/kg. The course of therapy is up to 11 days.

Children aged 1 year and older

Administered intravenously drip at a rate of 6-10 ml/kg/day at a rate of 3-4 ml/min. The course of therapy is up to 11 days.

The drug is contraindicated for use in children under 1 year of age (no experience of use).

Special patient groups

Studies in elderly patients have not been conducted. In this regard, the use of the drug should be started at a slower rate of administration: 20-40 drops/min (1-2 ml/min).

Studies in patients with renal impairment have not been conducted. In this regard, it is recommended to exercise caution when using the drug in such patients.

Patients with alkalosis

If decompensated alkalosis is detected, the use of the drug should be discontinued until the acid-base state of the blood normalizes.

Adverse Reactions

According to WHO, adverse effects are classified according to the frequency of their development as follows: very common (≥1/10); common (from ≥1/100 to <1/10); uncommon (from ≥1/1000 to <1/100); rare (from ≥1/10000 to <1/1000); very rare (<1/10000); frequency unknown (frequency cannot be estimated from the available data).

Immune system disorders very rare – allergic reactions, angioedema, anaphylactic shock.

Skin and subcutaneous tissue disorders very rare – allergic rash, urticaria, itching.

Cardiac disorders very rare – tachycardia, palpitations, dyspnea, pain in the heart area, chest pain.

Vascular disorders very rare – arterial hypotension/hypertension, short-term reactions in the form of a burning sensation and redness of the upper body.

Gastrointestinal disorders very rare – nausea, vomiting, metallic taste in the mouth, abdominal pain, diarrhea.

Respiratory, thoracic and mediastinal disorders very rare – dyspnea, dry cough.

Nervous system disorders very rare – dizziness, headache, convulsions, tremor, paresthesia, agitation, anxiety.

General disorders and administration site conditions: very rare – hyperthermia, chills, sweating, weakness, pain at the injection site, swelling, hyperemia, phlebitis.

Adverse reactions are possible with rapid administration of the drug.

To avoid the occurrence of adverse reactions, it is recommended to follow the dosing regimen and the rate of drug administration.

If adverse reactions occur, it is recommended to reduce the rate of drug administration.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after registration of the medicinal product in order to ensure continuous monitoring of the benefit-risk ratio of the medicinal product. Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting systems of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to meglumine sodium succinate and/or to any of the excipients included in the drug;
• Condition after traumatic brain injury accompanied by cerebral edema;
• Acute renal failure;
• Chronic kidney disease (GFR less than 15 ml/min/1.73 m²);
• Pregnancy;
• Breastfeeding period.

With caution the drug should be used in patients with alkalosis, renal failure.

Use in Pregnancy and Lactation

Pregnancy

It is contraindicated to use the drug Reamberin^® during pregnancy due to the lack of clinical studies in these groups of patients.

Lactation

It is contraindicated to use the drug Reamberin^® during breastfeeding due to the lack of clinical studies in these groups of patients.

Use in Renal Impairment

Contraindicated in acute renal failure, chronic kidney disease (stage 5, GFR less than 15 ml/min).

It is recommended to exercise caution when using the drug in patients with renal impairment.

Pediatric Use

The drug is prescribed to children over 1 year of age.

Geriatric Use

In elderly patients, the use of the drug should be started at a slower rate of administration.

Special Precautions

Due to the activation of aerobic processes in the body by the drug, a decrease in blood glucose concentration and the appearance of an alkaline urine reaction are possible. In patients with diabetes mellitus or patients with reduced glucose tolerance, periodic monitoring of blood glucose concentration is required.

This drug contains 4.02 mmol of potassium per 1 liter. This should be taken into account by patients with reduced renal function and patients on a potassium-restricted diet.

This drug contains 147 mmol of sodium per 1 liter. This should be taken into account by patients on a sodium-restricted diet.

If the color of the solution changes or if a precipitate is present, the use of the drug is unacceptable.

Effect on ability to drive vehicles and mechanisms

It is not recommended to drive vehicles and work with mechanisms during the course of treatment with the drug Reamberin^®.

Overdose

There is no information on drug overdose.

Drug Interactions

The drug combines well with antibiotics, water-soluble vitamins, glucose solution. Combines with drugs containing phosphates, sulfates or tartrates.

Incompatibility

Due to the lack of compatibility studies, Reamberin^® in a bottle or container should not be mixed with other medicinal products.

It is unacceptable to administer the drug Reamberin^® intravenously simultaneously with calcium preparations due to the possible precipitation of calcium succinate.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C (77°F); freezing is allowed.

Shelf Life

The shelf life of the drug in glass bottles is 5 years, in polymeric containers – 3 years. Do not use after the expiration date printed on the packaging.

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.