AMBISOME Powder for solution for infusion (2019)
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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, the concentrate contains 4 mg/mL amphotericin B. Excipient with known effect: For a full list of ...
Pharmaceutical form
Sterile, powder for solution for infusion. Yellow lyophilised cake or powder.
Therapeutic indications
AmBisome is indicated in adults and children aged 1 month to 18 years old for: the treatment of severe systemic and/or deep mycoses the treatment of visceral leishmaniasis in immunocompetent patients including ...
Posology and method of administration
Non-equivalence of amphotericin products Different amphotericin products (sodium deoxycholate, liposomal, lipid complex) are not equivalent in terms of pharmacodynamics, pharmacokinetics and dosing and ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 unless, in the opinion of the physician, the condition requiring treatment is life-threatening and amenable only ...
Special warnings and precautions for use
Anaphylaxis and anaphylactoid reactions Anaphylaxis and anaphylactoid reactions have been reported in association with AmBisome infusion. Allergic type reactions, including severe infusion-related reactions ...
Interaction with other medicinal products and other forms of interaction
No specific interaction studies have been performed with AmBisome. However, the following medicinal products are known to interact with amphotericin B and may interact with AmBisome: Nephrotoxic medications ...
Fertility, pregnancy and lactation
Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Pregnancy The safety of AmBisome in pregnant women has not been established. ...
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
Summary of adverse reactions The following adverse reactions have been attributed to AmBisome based on clinical trial data and post-marketing experience. The frequency is based on analysis from pooled ...
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 Mechanism of action and pharmacodynamic effects Amphotericin B is a macrocyclic, polyene antifungal antibiotic produced ...
Pharmacokinetic properties
The pharmacokinetic profile of AmBisome (liposomal amphotericin B (L-AmB), based upon total plasma concentrations of amphotericin B, was determined in cancer patients with febrile neutropenia and bone ...
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 medicinal products or electrolytes. This medicinal product must not be mixed with other medicinal products except those mentioned ...
Shelf life
Shelf life: 4 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 ...
Special precautions for storage
AmBisome unopened vials. Do not store above 25°C. Keep the container in the outer carton. For storage conditions after reconstitution and dilution of the 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 equivalent to other amphotericin products (see section 4.2). AmBisome must be reconstituted using Sterile ...
Marketing authorization holder
Gilead Sciences International Ltd, 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
March 2019
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