SIMDAX Injection (2019)
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Περιεχόμενα
Name of the medicinal product
SIMDAX 2.5mg/mL injection concentrate.
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 ...
Pharmaceutical form
The concentrate is a clear, yellow or orange solution for dilution prior to administration.
Therapeutic indications
Simdax is indicated for the short-term treatment of acutely decompensated chronic heart failure (ADHF) in situations where conventional therapy is not sufficient, and in cases where inotropic support is ...
Posology and method of administration
Method of Administration Simdax is for in-hospital use only. It should be administered in a hospital setting where adequate monitoring facilities and expertise with the use of inotropic agents are available. ...
Contraindications
Hypersensitivity to Simdax or to any of the excipients. Severe hypotension and tachycardia (see section 5.1, Pharmacodynamics; section 4.4, Special warnings and precautions for use). Significant mechanical ...
Special warnings and precautions for use
A haemodynamic effect of Simdax, which may be more pronounced in the beginning of therapy, may be a decrease in systolic and diastolic blood pressure, therefore, Simdax should be used with caution in patients ...
Interaction with other medicinal products and other forms of interaction
In vitro studies utilizing human liver microsomes have shown that levosimendan is unlikely to cause significant drug-drug interactions with agents metabolised by cytochrome P450 (CYP) enzymes due to its ...
Fertility, pregnancy and lactation
Fertility No data available. Pregnancy There is no experience of using Simdax in pregnant women. Animal studies have shown toxic effects on reproduction (see section 4.4, Special warnings and precautions ...
Effects on ability to drive and use machines
No data available.
Undesirable effects
In placebo-controlled clinical trials for ADHF (REVIVE programme), 53% of patients experienced adverse reactions, the most frequent of which were ventricular tachycardia, hypotension, and headache. In ...
Overdose
Overdose of Simdax may induce hypotension and tachycardia. In clinical trials with Simdax, hypotension has been successfully treated with vasopressors (e.g. dopamine in patients with congestive heart failure ...
Pharmacodynamic properties
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 ...
Pharmacokinetic properties
General The pharmacokinetics of levosimendan are linear in the therapeutic dose range 0.05-0.2 μg /kg/min. Distribution The volume of distribution of levosimendan (Vss) is approximately 0.2 L/kg. Levosimendan ...
Preclinical safety data
Simdax has been evaluated in clinical trials involving over 2800 heart failure patients. The efficacy and safety of Simdax for the treatment of ADHF were assessed in the following randomised, double-blind, ...
List of excipients
Povidone Citric acid Anhydrous ethanol
Incompatibilities
No data available.
Shelf life
24 months from the date of manufacture.
Special precautions for storage
Store at 2°-8°C. Refrigerate. Do not freeze. The colour of the concentrate may turn to orange during storage, but there is no loss of potency, and the product may be used until the indicated expiration ...
Nature and contents of container
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 ...
Special precautions for disposal and other handling
No data available.
Marketing authorization holder
Pharmacy Retailing (NZ) Limited, trading as Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Auckland, New Zealand
Date of first authorization / renewal of the authorization
29 March 2010
Date of revision of the text
May 2019
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