ABRAXANE Powder for suspension for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Abraxane 5 mg/ml powder for suspension for infusion.
Qualitative and quantitative composition
Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles. Each vial contains 250 mg of paclitaxel formulated as albumin bound nanoparticles. After reconstitution, each ml of suspension ...
Pharmaceutical form
Powder for suspension for infusion. The reconstituted suspension has a pH of 6-7.5 and an osmolality of 300-360 mOsm/kg. The powder is white to yellow.
Therapeutic indications
Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing ...
Posology and method of administration
Abraxane should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents. It should not be substituted for or with other paclitaxel ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Lactation (see section 4.6). Patients who have baseline neutrophil counts <1500 cells/mm³.
Special warnings and precautions for use
Abraxane is an albumin-bound nanoparticle formulation of paclitaxel, which may have substantially different pharmacological properties compared to other formulations of paclitaxel (see sections 5.1 and ...
Interaction with other medicinal products and other forms of interaction
The metabolism of paclitaxel is catalysed, in part, by cytochrome P450 isoenzymes CYP2C8 and CYP3A4 (see section 5.2). Therefore, in the absence of a PK drug-drug interaction study, caution should be exercised ...
Fertility, pregnancy and lactation
Contraception in males and females Women of childbearing potential should use effective contraception during treatment and up to 1 month after receiving treatment with Abraxane. Male patients treated with ...
Effects on ability to drive and use machines
Abraxane has minor or moderate influence on the ability to drive and use machines. Abraxane may cause adverse reactions such as tiredness (very common) and dizziness (common) that may affect the ability ...
Undesirable effects
Summary of the safety profile The most common clinically significant adverse reactions associated with the use of Abraxane have been neutropenia, peripheral neuropathy, arthralgia/myalgia and gastrointestinal ...
Overdose
There is no known antidote for paclitaxel overdose. In the event of an overdose, the patient should be closely monitored. Treatment should be directed at the major anticipated toxicities, which are bone ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, plant alkaloids and other natural products, taxanes ATC Code: L01CD01 Mechanism of action Paclitaxel is an antimicrotubule agent that promotes the assembly ...
Pharmacokinetic properties
The pharmacokinetics of total paclitaxel following 30- and 180-minute infusions of Abraxane at dose levels of 80 to 375 mg/m² were determined in clinical studies. The paclitaxel exposure (AUC) increased ...
Preclinical safety data
The carcinogenic potential of paclitaxel has not been studied. However, based on the published literature, paclitaxel is a potentially carcinogenic and genotoxic agent at clinical doses, based upon its ...
List of excipients
Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate)
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Unopened vials: 3 years. Stability of reconstituted suspension in the vial: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C in the original carton, protected from light. ...
Special precautions for storage
Unopened vials Keep the vial in the outer carton in order to protect from light. Neither freezing nor refrigeration adversely affects the stability of the product. This medicinal product does not require ...
Nature and contents of container
50 ml vial (type 1 glass) with a stopper (butyl rubber), with an overseal (aluminium), containing 100 mg of paclitaxel formulated as albumin bound nanoparticles. 100 ml vial (type 1 glass) with a stopper ...
Special precautions for disposal and other handling
Preparation and administration precautions Paclitaxel is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Abraxane. The use ...
Marketing authorization holder
Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands
Marketing authorization number(s)
EU/1/07/428/001 EU/1/07/428/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 11 January 2008 Date of latest renewal: 14 January 2013
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