Per 1 ml of the product:
active substance: levocarnitine 300 mg,
excipients: citric acid monohydrate, methylparahydroxybenzoate, propylparahydroxybenzoate, purified water

Alimentary tract and metabolism. Other alimentary tract and metabolism products. Amino acids and derivatives.

Elcar, Oral Solution, is indicated for use in adults and children from 0 to 18 years of age for the treatment of primary and secondary carnitine deficiency.

It is recommended to monitor therapy by measuring plasma and urine levels of free and acyl L-carnitine to determine adequate dosage.
In primary or secondary carnitine deficiency, the dosage depends on the individual congenital abnormalities in metabolism and their severity during the treatment. In most cases, the recommended oral dose is 100-200 mg/kg/day, divided into 2-4 doses. If clinical and biochemical parameters do not improve, the dose may be increased on a short-term basis. High doses should be administered with caution and only when clinical and biochemical data suggest that dose escalation would be beneficial. High doses up to 400 mg/kg/day are required in acute metabolic decompensation or intravenous administration may be required in this case.
The duration of therapy should be based on the nature and severity of the disease and the therapeutic effect achieved; the period should be determined by a physician.
Special Populations
Patients with Renal Failure:
In secondary carnitine deficiency in patients with chronic end-stage renal failure, supporting therapy with 1 g/day oral dose should be prescribed.
Children
Children < 12 Years of Age, Infants and Newborns
The dosage depends on the individual congenital abnormalities in metabolism and their severity during the treatment. The recommended dose is 50-100 mg/kg/day, divided into 2-4 doses. If clinical and biochemical parameters do not improve, the dose may be increased on a short-term basis. High doses should be administered with caution and only when clinical and biochemical data suggest that dose escalation would be beneficial.

Administration of L-carnitine to diabetic patients receiving insulin or hypoglycemic oral treatment may cause hypoglycemia. In these patients, plasma glucose should be continuously monitored to control the hypoglycemic treatment.
In patients with severe renal impairment, prolonged oral administration of high doses of L-carnitine may increase concentrations of the potentially toxic metabolites such as trimethylamine (TMA) and trimethylamine-N-oxide (TMAO), as these metabolites are usually excreted in the urine. In such a case, urine, breath, and sweat have an unpleasant odor.
Taking levocarnitine too quickly causes adverse reactions in the gastrointestinal tract. The dose should be divided and administered evenly during the course of the day to maximize tolerability.
Convulsive seizures have been reported in patients with and without previous seizure activity. The frequency and/or severity of convulsive seizures was increased in patients with previous seizure activity.
Drug Interactions
Prior to administration of the drug, you should inform your physician about taking other drugs.
Glucocorticoids increase carnitine levels in many tissues (except the liver). Excessive doses of choline inhibit carnitine synthesis and activity. Carnitine may be combined with various anabolic agents; with drugs with antioxidant or/and antihypoxant effects.
Special Warnings
The drug contains methylparahydroxybenzoate and propylparahydroxybenzoate which may cause delayed hypersensitivity.
Children
Children < 3 years of age should be treated under medical supervision.
Pregnancy and Lactation
Due to the lack of studies, as a precautionary measure, it is advisable to avoid using Elcar during pregnancy.

Oral solution, 300 mg/ml

Protect from light. Do not store above 25°C.
After the first opening, the vial should be stored at a temperature of 2 to 8°C.
Keep out of reach of children.

3 years.
Once opened, the product should be used within 2 months.
Do not use the product beyond the expiry date.

PIQ-PHARMA LEK LLC,
1/19 Berezovaya Street, Severnyi Urban-Type Settlement
Belgorod District, Belgorod Region, 308010, Russia