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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: AmBisome (2012)

Εκδότης

Εκδότης Gilead Sciences Ltd
Διεύθυνση Flowers Building, Granta Park, Abington, Cambridge, Cambridge, CB21 6GT, UK
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

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, ...

Pharmaceutical form

AmBisome is a sterile, Powder for solution for infusion. AmBisome is a yellow lyophilised cake or powder. ...

Therapeutic indications

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 ...

Contraindications

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 ...

Undesirable effects

Fever and chills/rigors are the most frequent infusion-related reactions expected to occur during AmBisome ...

Overdose

The toxicity of AmBisome due to acute overdose has not been defined. If overdose should occur, cease ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antimycotics for systemic use, antibiotics ATC code: J02AA01 Mode of action ...

Pharmacokinetic properties

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 ...

Incompatibilities

AmBisome is incompatible with saline solutions and may not be mixed with other drugs or electrolytes. ...

Shelf life

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)

PL: 16807/0001

Date of first authorization / renewal of the authorization

11 September 1998/24 September 2004.

Date of revision of the text

12/2011
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.