Injection 10% 5 ml N10

3-(2,2,2-trimethylhydrazinium)propionate dihydrate (Mildronate) is astructural analogue of a precursor of carnitine — gamma-butyrobetaine(GBB). Mildronate inhibits the activity ofgamma-butyrobetain-hydroxylase, causing a decrease of carnitinebiosynthesis and long-chain fatty acids transport through cellmembranes. It prevents the accumulation of Acyl-CoA and Acyl-carnitine,the metabolites of long-chain fatty acids in cells, thus diminishingtheir adverse effects.

Under the conditions of ischemia,Mildronate activates the anaerobic glycolysis and stimulates the ATPproduction, and transport, restores the balance between oxygen deliveryand consumption.Decrease of carnitine concentration results inactivation of synthesis of gamma-butyrobetaine, which possessvasodilatating activity.

Mildronate exerts cardio protectiveeffect. In the case of chronic congestive heart failure it augmentsmyocardial contractility, increases the tolerance of the organism tophysical overload. In patients with II—III stage stable angina pectorisMildronate increases the physical capacity and decreases the number ofangina pectoris attacks.

In the cases of acute and chronicischemic cerebrovascular disturbances Mildronate ameliorates cerebralblood flow in the ischemic region, promoting redistribution of bloodflow in favour of ischemic zone.

Mildronate is alsocharacterised by a tonic effect. It prevents functional disturbances ofsomatic and vegetative nervous system.

Indications.Cardiovascular diseases: chronic coronary heart disease, stable anginapectoris, chronic heart failure, functional cardiovasculardisturbances, cardiomyopathy. Acute and chronic ischemiccerebrovascular disturbances.

Mildronate is used also in thecases of decreased performance, physical and psycho emotional overload,and during recovery process.

Do not use Mildronate:

- if you are hypersensitive to Mildronate or any of the other ingredients of the medicine.
You must tell your doctor before using your medicine, if:
· you are pregnant or intend to become pregnant;
· are breast feeding.

Special care with Mildronate:Mildronate should be used with caution in patients with chronic liveror kidney diseases during long term therapy. Safety of Mildronateapplication in children less than 12 years age was not studied.

Pregnancy:No clinical data are available on the drug safety during pregnancy. Toavoid a possible undesirable action on the organism of mother andfetus, Mildronate is not given during pregnancy.

Breast-feeding:It is not known whether active substance is excreted in human milk. Ifmother needs to be treated with the drug, she has to stop breast-feeding.

Driving and using machines: The cases of Mildronate unfavorable effect on ability to drive or use machines are unknown.

Using other medicines:Please inform your doctor or pharmacist if you are taking or haverecently taken any other medicines, even those not prescribed.Mildronate could be combined with antianginal drugs, anticoagulants,antiagregants, antarrhythmic drugs, cardiac glycosides, diuretics etc.Mildronate may intensify the actions of several cardiovascular agentssuch as nitroglycerine, nifedipine, beta-adrenoblockers, hypotensiveagents and peripheral vasodilators.