SPC, UK: AmBisome
||Gilead Sciences Ltd
||Flowers Building, Granta Park, Abington, Cambridge, Cambridge, CB21 6GT, UK
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συνδρομή διάρκειας 30 ημερών.
Name of the medicinal product
AmBisome 50 mg Powder for solution for infusion.
Qualitative and quantitative composition
Each vial contains 50 mg of amphotericin (50,000 units) encapsulated in liposomes. After reconstitution, ...
AmBisome is a sterile, Powder for solution for infusion. AmBisome is a yellow lyophilised cake or powder. ...
AmBisome is indicated in: the treatment of severe systemic and/or deep mycoses the treatment of visceral ...
Posology and method of administration
AmBisome should be administered by intravenous infusion over a 30 60 minute period. For doses greater ...
AmBisome is contraindicated in those patients who have shown hypersensitivity to the active substance ...
Special warnings and precautions for use
Anaphylaxis and anaphylactoid reactions have been reported in association with AmBisome infusion. Allergic ...
Interaction with other medicinal products and other forms of interaction
No specific interaction studies have been performed with AmBisome. However, the following drugs are known ...
Pregnancy and lactation
Pregnancy Teratogenicity studies in both rats and rabbits have concluded that AmBisome had no teratogenic ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Some of the undesirable ...
Fever and chills/rigors are the most frequent infusion-related reactions expected to occur during AmBisome ...
The toxicity of AmBisome due to acute overdose has not been defined. If overdose should occur, cease ...
Pharmacotherapeutic group: Antimycotics for systemic use, antibiotics ATC code: J02AA01 Mode of action ...
The pharmacokinetic profile of AmBisome, based upon total plasma concentrations of amphotericin B, was ...
Preclinical safety data
In subchronic toxicity studies in dogs (1 month), rabbits (1 month) and rats (3 months) at doses equal ...
List of excipients
Hydrogenated soy phosphatidylcholine Cholesterol Distearoylphosphatidylglycerol Alpha tocopherol Sucrose ...
AmBisome is incompatible with saline solutions and may not be mixed with other drugs or electrolytes. ...
3 years Shelf–life of AmBisome after first opening As AmBisome does not contain any bacteriostatic agent, ...
Special precautions for storage
AmBisome: Unopened vials; Do not store above 25°C. Do not freeze. Keep container in the outer carton. ...
Nature and contents of container
AmBisome is presented in 15 ml, 20 ml or 30 ml sterile, Type I glass vials. The closure consists of a ...
Special precautions for disposal and other handling
READ THIS ENTIRE SECTION AND SECTION 4.4 CAREFULLY BEFORE BEGINNING RECONSTITUTION AmBisome is not interchangeable ...
Marketing authorization holder
Gilead Sciences International Limited Granta Park Abington Cambridge CB21 6GT
Marketing authorization number(s)
Date of first authorization / renewal of the authorization
11 September 1998/24 September 2004.
Date of revision of the text
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί
πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.