SANDIMMUN Concentrate for solution for infusion (2015)
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Περιεχόμενα
Name of the medicinal product
SANDIMMUN Concentrate for Solution for Infusion 50mg/ml.
Qualitative and quantitative composition
The concentrate for solution for infusion contains 50 mg/ml. Each ampoule of 1 ml contains 50 mg of ciclosporin. Each ampoule of 5 ml contains 250 mg of ciclosporin. Excipients with known effect: Ethanol: ...
Pharmaceutical form
Concentrate for solution for infusion Clear, brown-yellow oleaginous concentrate.
Therapeutic indications
Transplantation indications Solid organ transplantation Prevention of graft rejection following solid organ transplantation. Treatment of transplant cellular rejection in patients previously receiving ...
Posology and method of administration
Posology The dose ranges given for oral administration are intended to serve as guidelines only. Sandimmun should only be prescribed by, or in close collaboration with, a physician with experience of immunosuppressive ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Combination with products containing Hypericum perforatum (St Johns Wort) (see section 4.5). Combination with ...
Special warnings and precautions for use
Medical supervision Sandimmun should be prescribed only by physicians who are experienced in immunosuppressive therapy and can provide adequate follow-up, including regular full physical examination, measurement ...
Interaction with other medicinal products and other forms of interaction
Drug interactions Of the many drugs reported to interact with ciclosporin, those for which the interactions are adequately substantiated and considered to have clinical implications are listed below. ...
Fertility, pregnancy and lactation
Pregnancy Animal studies have shown reproductive toxicity in rats and rabbits. Experience with Sandimmun in pregnant women is limited. Pregnant women receiving immunosuppressive therapies after transplantation, ...
Effects on ability to drive and use machines
No data exist on the effects of Sandimmun on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The principal adverse reactions observed in clinical trials and associated with the administration of ciclosporin include renal dysfunction, tremor, hirsutism, hypertension, ...
Overdose
The oral LD<sub>50</sub> of ciclosporin is 2,329 mg/kg in mice, 1,480 mg/kg in rats and >1,000 mg/kg in rabbits. The intravenous LD<sub>50</sub> is 148 mg/kg in mice, 104 mg/kg in rats, and 46 mg/kg in ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressive agents, calcineurin inhibitors ATC code: L04AD01 Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide consisting of 11 amino acids. It is a potent ...
Pharmacokinetic properties
Distribution Ciclosporin is distributed largely outside the blood volume, with an average apparent distribution volume of 3.5 l/kg. In the blood, 33 to 47% is present in plasma, 4 to 9% in lymphocytes, ...
Preclinical safety data
Ciclosporin gave no evidence of mutagenic or teratogenic effects in the standard test systems with oral application (rats up to 17 mg/kg/day and rabbits up to 30 mg/kg/day orally). At toxic doses (rats ...
List of excipients
Ethanol anhydrous Macrogolglycerol ricinoleate/polyoxyl 35 castor oil
Incompatibilities
Sandimmun concentrate for solution for infusion contains macrogolglycerol ricinoleate/polyoxyl 35 castor oil, which can cause phathalate stripping from polyvinyl chloride. If available, glass containers ...
Shelf life
Shelf life: 4 years.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package. Once an ampoule has been opened, the contents should be used immediately. Following dilution, ...
Nature and contents of container
Sandimmun Concentrate for Solution for Infusion is available in 1ml and 5ml uncoloured glass (type I) ampoules.
Special precautions for disposal and other handling
The concentrate should be diluted 1:20 to 1:100 with normal saline or 5% glucose, and given as a slow intravenous infusion over approximately 2 to 6 hours. Diluted infusion solutions must be discarded ...
Marketing authorization holder
Novartis Pharmaceuticals UK Limited Trading as: SANDOZ PHARMACEUTICALS, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Marketing authorization number(s)
00101/0153
Date of first authorization / renewal of the authorization
17 February 1983 / 17 February 1998
Date of revision of the text
24 July 2015
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