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SPC, UK: AmBisome Powder for solution for infusion (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Gilead Sciences Ltd
Διεύθυνση :
Flowers Building, Granta Park, Abington, Cambridge, Cambridge, CB21 6GT, UK
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Δωρεάν εγγραφή

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, the concentrate contains 4 mg/mL amphotericin B. For a full list of excipients, see section 6.1. ...

Pharmaceutical form

AmBisome is a sterile, Powder for solution for infusion. AmBisome is a yellow lyophilised cake or powder. After reconstitution, the product is an injectable intended to be administered by intravenous infusion. ...

Therapeutic indications

AmBisome is indicated in: the treatment of severe systemic and/or deep mycoses the treatment of visceral leishmaniasis in immunocompetent patients including both adults and children. the empirical treatment ...

Posology and method of administration

AmBisome should be administered by intravenous infusion over a 30 60 minute period. For doses greater than 5mg/kg/day, intravenous infusion over a 2 hour period is recommended (see section 4.4). The recommended ...

Contraindications

AmBisome is contraindicated in those patients who have shown hypersensitivity to the active substance or to any of the excipients unless, in the opinion of the physician, the condition requiring treatment ...

Special warnings and precautions for use

Anaphylaxis and anaphylactoid reactions have been reported in association with AmBisome infusion. Allergic type reactions, including severe infusion-related reactions can occur during administration of ...

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 to interact with amphotericin B and may interact with AmBisome: Nephrotoxic medications: Concurrent ...

Pregnancy and lactation

Pregnancy Teratogenicity studies in both rats and rabbits have concluded that AmBisome had no teratogenic potential in these species (See also section 5.3). The safety of AmBisome in pregnant women has ...

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 effects of AmBisome presented below may impact the ability to drive and use machines.

Undesirable effects

Fever and chills/rigors are the most frequent infusion-related reactions expected to occur during AmBisome administration. Less frequent infusion-related reactions may consist of one or more of the following ...

Overdose

The toxicity of AmBisome due to acute overdose has not been defined. If overdose should occur, cease administration immediately. Carefully monitor clinical status including renal and hepatic function, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antimycotics for systemic use, antibiotics ATC code: J02AA01 Mode of action Amphotericin B is a macrocyclic, polyene antifungal antibiotic produced by Streptomyces nodosus. Amphotericin ...

Pharmacokinetic properties

The pharmacokinetic profile of AmBisome, based upon total plasma concentrations of amphotericin B, was determined in cancer patients with febrile neutropenia and bone marrow transplant patients who received ...

Preclinical safety data

In subchronic toxicity studies in dogs (1 month), rabbits (1 month) and rats (3 months) at doses equal to or, in some species, less than the clinical therapeutic doses of 1 to 3 mg/kg/day, the target organs ...

List of excipients

Hydrogenated soy phosphatidylcholine Cholesterol Distearoylphosphatidylglycerol Alpha tocopherol Sucrose Disodium succinate hexahydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) ...

Incompatibilities

AmBisome is incompatible with saline solutions and may not be mixed with other drugs or electrolytes. This medicinal product must not be mixed with other medicinal products except those mentioned in section ...

Shelf life

3 years Shelf–life of AmBisome after first opening As AmBisome does not contain any bacteriostatic agent, from a microbiological point of view, the reconstituted or diluted product should be used immediately. ...

Special precautions for storage

AmBisome: Unopened vials; Do not store above 25°C. Do not freeze. Keep container in the outer carton. For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.

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 grey butyl rubber stopper and aluminium ring seal fitted with a removable plastic cap. Single-dose ...

Special precautions for disposal and other handling

READ THIS ENTIRE SECTION AND SECTION 4.4 CAREFULLY BEFORE BEGINNING RECONSTITUTION AmBisome is not interchangeable with other amphotericin products. AmBisome must be reconstituted using Sterile Water for ...

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