Revision Year: 2015 Publisher: AS GRINDEKS, Krustpils iela 53, RÄ«ga, LV-1057, Latvia Tel.: +371 67083205 Fax: +371 67083505 E-mail: grindeks@grindeks.lv
Meldonium is used in combination therapy in the following cases:
The daily dose is 500-1000 mg (5-10 ml) intravenously, used as a single dose or divided into two single doses. The duration of treatment is usually 10-14 days, thereafter continuing treatment with oral dosage forms.
The duration of treatment course is 4-6 weeks. The course of treatment can be repeated 2-3 times a year.
Elderly patients with hepatic and/or renal impairment may require lower doses of meldonium (see section 5.2.).
As the medicine is eliminated through the kidneys, in patients with mild to moderate renal disorders, reduced meldonium dose should be used (see section 4.4 and 5.2).
In patients with mild to moderate hepatic disorders, reduced meldonium dose should be used (see section 4.4 and 5.2).
There are no data on meldonium safety and efficacy in children and adolescents (up to 18 years of age), therefore this medicine in children and adolescents is contraindicated (see section 4.3).
Intravenously. The use of the medicine does not provide special preparation prior to administration.
It is advised to take the medicine in the first half of the day because of possible stimulating effect.
No cases of overdose have been reported. The medicine is of low toxicity and causes no threatening side effects.
In case of hypotension, headache, dizziness, tachycardia and general weakness may occur.
The treatment is symptomatic.
In case of severe overdose, hepatic and renal functions should be monitored. Haemodialysis is of no value because the medicine is highly bound to plasma proteins.
4 years.
Do not store above 25°C. Do not freeze.
5 ml of solution in clear glass ampoule.
5 ampoules in a PVC liner.
2 liners (10 ampoules) in a cardboard box.
Unused medicines or waste material should be disposed of in accordance with local requirements.
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