SIMDAX Injection Ref.[8654] Active ingredients: Levosimendan

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

Product name and form

SIMDAX 2.5mg/mL injection concentrate.

Pharmaceutical Form

The concentrate is a clear, yellow or orange solution for dilution prior to administration.

Qualitative and quantitative composition

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
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

Povidone
Citric acid
Anhydrous ethanol

Pack sizes and marketing

Levosimendan 2.5 mg/mL concentrate is available in 5 mL and 10 mL vials.

  • 8 or 10 mL Type I glass vials containing 2.5mg levosimendan/mL.
  • Chlorobutyl or Bromobutyl rubber closure with fluoropolymer coating

Pack sizes:

  • 1, 4, 10 vials of 5 mL
  • 1, 4, 10 vials of 10 mL

Marketing authorization holder

Pharmacy Retailing (NZ) Limited, trading as Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Auckland, New Zealand

Marketing authorization dates and numbers

29 March 2010

Drugs

Drug Countries
SIMDAX Austria, Brazil, Cyprus, Estonia, Spain, Finland, Hong Kong, Croatia, Israel, Lithuania, Mexico, New Zealand, Poland, Romania, Turkey

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