Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2019 Publisher: Pharmacy Retailing (NZ) Limited, trading as Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Auckland, New Zealand
SIMDAX 2.5mg/mL injection concentrate.
Pharmaceutical Form |
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The concentrate is a clear, yellow or orange solution for dilution prior to administration. |
Each mL contains 2.5 mg of levosimendan.
Levosimendan is an inotrope agent with a unique mode of action. It is a calcium sensitizer, which increase cardiac contractility by enhancing the sensitivity of the myocardium to calcium. As a result, levosimendan produces positive inotropic effects that are independent of beta-receptors or cyclic AMP.
It also has a vasodilator effect, by opening ATP-sensitive potassium channels in vascular smooth muscles, which results in smooth muscle relaxation. The combination of inotropic and vasodilator actions results in an increased force of contraction with decreased preload and afterload in the myocardium.
Levosimendan is chemically named as (-) - (R) - [[4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)-phenyl]hydrazono]-ropanedinitrile. It is a yellow to brownish-yellow powder with a molecular weight of 280.3, an empirical formula of C14H12N6O and the following structure:
Levosimendan is a moderately lipophilic compound. Its solubility in distilled water is 0.04mg/mL, in ethanol 7.8 mg/mL, and at a pH of 8 in phosphate buffer (67 mM) 0.9mg/Ml.
For a full list of excipients, see section 6.1.
Active Ingredient | Description | |
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Levosimendan |
Levosimendan enhances the calcium sensitivity of contractile proteins by binding to cardiac troponin C in a calcium-dependent manner. Levosimendan increases the contraction force but does not impair ventricular relaxation. |
List of Excipients |
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Povidone |
Levosimendan 2.5 mg/mL concentrate is available in 5 mL and 10 mL vials.
Pack sizes:
Pharmacy Retailing (NZ) Limited, trading as Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Auckland, New Zealand
29 March 2010
Drug | Countries | |
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SIMDAX | Austria, Brazil, Cyprus, Estonia, Spain, Finland, Hong Kong, Croatia, Israel, Lithuania, Mexico, New Zealand, Poland, Romania, Turkey |
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