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Country of origin : Ukraine

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levosimendan

Vials 2.5 mg/ml - 5 ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
Ukraine
GMP approvals
EU GMP
Unavailable markets
Iraq , Kazakhstan , Ukraine , Uzbekistan , Vietnam
Comments
DCP submitted
Manufacturer #15907
A world leader in the production and maintenance of medicines as well as a leading exporter with a proven track record of exporting to more than 40 countries. High quality and constant innovation have proven to be the biggest achiever here.

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LEVOSIMENDAN

Levosimendan belongs ta category of medicines called calcium sensitisers. It is used to manage acute decompensated congestive heart failure. It works by increasing the sensitivity of the heart to calcium thus increasing cardiac contractility without arising in intracellular action. It is one of a new class of heterogeneous agents, the calcium sensitisers. Its dual mechanism of action enhances cardiac contractility and vasodilatation without affecting intracellular free calcium, thereby reducing the proarrhythmic potential. It can be administered intravenously (IV) which makes it a therapeutic option for acute decompensated Congestive Heart failure and it is tolerated well in patients with acute heart failure. It has favorable effects on neuro-hormone levels in heart failure patients. These properties make it a good medication to treat heart failure (acute and chronic), sepsis, post-resuscitation myocardial dysfunction and peri-operative optimization of cardiac patients with cardiomyopathy.
Levosimendan is sold under the brand names SIMDAX , Dopamine, Digoxin amongst others.
The Orion Corporation originally developed Levosimendan. They applied for a new drug patent in 1998 in the U.S, which was later withdrawn due to FDA request to conduct further trials. Then in 2000, Sweden became the first country to allow the sale of Levosimendan. More than 60 countries worldwide have approved the drug; however, it is yet to receive its FDA approval in North America, where it is currently in Phase III of development.

Forms and Dosage:

Levosimendan is available in a vial containing 12.5mg in 5ml. Levosimendan infusion starting dose is 0.1 mg per kilo per minute and titrated to 0.2 mg/kg/min as long as systolic blood pressure remains stable after the first 2–3 hours. In the treatment of acute heart failure, the recommended interval is 24 hours. To prevent the risk of hypotension in patients who have systolic blood pressure Initial bolus of Levosimendan is usually not administered.

The price of Levosimendan

In India, consumers have to pay $8 for 12.5 mg for injection for 1 Box of Lyophilized vial.

How does it work?

Levosimendan improves myocytes’ calcium sensitivity as it binds to troponin C in a calcium-dependent manner. The resulting outcome is an increase in contractility without raising calcium levels. Its actions relax vascular smooth muscles by opening adenosine triphosphate sensitive potassium channels.

Finding Levosimendan Manufacturers and Suppliers:

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