Instruction for use: Reamberin

Trade name of the drug – Reamberin

Name of grouping: Meglumine sodium succinate

Active substance: Meglumine sodium succinate

Dosage Form: Solution for infusion

Compositionactive substance:

Meglumine sodium succinate 15.00 g: N-methylglucamin (meglumine), 8.725 g;

Excipients:

Sodium chloride 6.00 g

Potassium chloride 0.30 g

Magnesium chloride (in terms of anhydrous) 0.12 g

Sodium hydroxide 1,788 g

Water for injection to 1.0 L

Description of Reamberin Clear, colorless liquid.

Pharmacotherapeutic group: Solutions affecting the water-electrolyte balance.
ATX Code Â05ÂÂ

Pharmacological Properties of ReamberinPharmacodynamics

Reamberin have anti-inflammatory and antioxidant effects, providing a positive effect on aerobic processes in the cell, reducing the production of free radicals and restores the energy potential of the cells. The drug activates enzymatic processes the Krebs cycle and promotes utilization of fatty acids and glucose by cells, normalizes the acid-base balance and blood gases. It has a mild diuretic effect.

Pharmacokinetics

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

Indications for Reamberin

Reamberin used in adults and children 1 year as antihypoxic and detoxifying agent in acute endogenous and exogenous intoxications of different etiologies.

Contraindications for Reamberin

Individual intolerance,

post-traumatic brain injury,

accompanied by swelling of the brain,

acute renal failure,

chronic kidney disease (stage 5, the glomerular filtration rate less than 15 mL / min),

pregnancy,

lactation.

Precautions

alkalosis,

renal failure.

Pregnancy and breast-feeding

Contraindicated use reamberin drug during pregnancy and breastfeeding because of lack of of clinical studies in these groups of patients.

Reamberin Dosage and Administration

Adults: administered intravenously at a rate 1-4.5 ml / min (up to 90 drops per minute). The average daily dose - 10 ml / kg. The course of treatment - up to 11 days.

Children: administered intravenously at the rate of 6-10 ml / kg per day at a rate of 3-4 ml / min. The course of treatment - up to 11 days.

Elderly patients: Studies in elderly patients have not been conducted. In connection with this use of the drug should be started with a slow injection speed: 30-40 drops (1.2 ml) per minute.

patients with renal insufficiency: Studies have not been conducted in patients with renal insufficiency. In this connection, it is recommended to be careful when using the drug in these patients.

Application of alkalosis: In identifying decompensated alkalosis use of the drug should be discontinued until normalization of blood acid-base status.

Side effect of Reamberin

With the rapid introduction of the drug, undesirable effects are classified according to their rate of development as follows:

- Very common (≥1 / 10);

- Often (from ≥1 / 100 to <1/10);

- Uncommon (from ≥1 / 1,000 to <1/100);

- Rare (from ≥1 / 10,000 to <1/1000);

- Very rare (<1/10000);

- Frequency not known (frequency can not be estimated from available data).

General disorders and injection site: very rare - pyrexia, chills, sweating, weakness, tenderness at the injection site, swelling, redness, phlebitis.

Violations of the immune system: very rarely - allergic reactions, angioedema, anaphylactic shock.

Disorders of the skin and subcutaneous tissue disorders: very rarely - allergic rash, urticaria, pruritus.

Disorders of the respiratory system, organs, thoracic and mediastinal disorders: very rarely - shortness of breath, dry cough.

Violations of the heart: rarely - tachycardia, palpitations, shortness of breath, chest pain, pain in the chest.

Violations of the vessels: rarely - hypotension / hypertension, transient response in the form of a burning sensation and redness of the upper body. Disorders of the gastrointestinal tract: rarely - nausea, vomiting, a metallic taste in the mouth, abdominal pain, diarrhea.

Disorders of the nervous system: very rarely - dizziness, headache, seizures, tremor, paresthesia, agitation, anxiety.

In the event of adverse reactions it is recommended to reduce the rate of drug administration.

If any of the undesirable effects mentioned in the instructions are compounded or you notice any other unwanted effects not mentioned in the instructions, inform your doctor.

Interaction

It goes well with antibiotics, water-soluble vitamins, glucose solution. It is not recommended to mix the drug in the bottle or container with other drugs.

It is unacceptable Reamberin intravenous drug simultaneously with calcium preparations due to the possible precipitation of calcium succinate.

special instructions for Reamberin

Because aerobic activation process the drug in the body may decrease in blood glucose concentrations, occurrence alkaline urine. In patients with diabetes or patients with impaired glucose tolerance requires periodic monitoring of blood glucose levels.

Effects on ability to drive vehicles, machinery is not recommended to drive and use machines during the course of treatment Reamberin

Release form of Reamberin

Solution for infusion 1.5%.

100 or 200 ml glass bottles with 125 and 250 ml, respectively, or in a 400 ml glass bottle with capacity of 450 or 500 ml, sealed with rubber stoppers, caps crimped aluminum caps or combination of aluminum and plastic. Each bottle with instruction on the medical application are placed in a pile of cardboard.

250 or 500 ml containers from a multilayer polyolefin film. 32 containers of 250 ml or 20 containers of 500 ml together with instructions for medical use are placed in a group container (for hospitals) of corrugated cardboard.

Number of instructions for medical use is equal to the number of primary packages in the group container.

Storage conditions of Reamberin

In the dark place at a temperature from 0 to 25 ° C. Avoid freezing of the drug.

When the color change of the solution or the presence of sediment drug application inadmissible. Keep out of the reach of children.

Shelf life of Reamberin

5 years in glass bottles, 3 years in containers of polymeric multilayer polyolefin film.

Do not use beyond the expiration date printed on the package.

Conditions of supply of Reamberin from pharmacies

On prescription.