IFOSFAMIDE INJECTION Powder for concentrate for solution for infusion (2016)
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Περιεχόμενα
Name of the medicinal product
Ifosfamide Injection 1g.
Qualitative and quantitative composition
Each vial contains 1g of ifosfamide. When reconstituted as directed, each milliliter of concentrate contains 80 mg Ifosfamide.
Pharmaceutical form
Powder for concentrate for solution for infusion. White powder.
Therapeutic indications
Ifosfamide is a cytotoxic drug for the treatment of malignant disease. As a single agent it has successfully produced objective remissions in a wide range of malignant conditions. Ifosfamide is also frequently ...
Posology and method of administration
Ifosfamide should only be administered when there are facilities for regular monitoring of clinical, biochemical and haematological parameters before, during and after administration and under the direction ...
Contraindications
Ifosfamide is contra-indicated in patients with: known hypersensitivity to ifosfamide. See section 4.4. urinary outflow obstruction severely impaired bone-marrow function (especially in patients previously ...
Special warnings and precautions for use
In individual patients, risk factors for ifosfamide toxicities and their sequelae described here and in other sections may constitute contraindications. In such situations, individual assessment of risk ...
Interaction with other medicinal products and other forms of interaction
Planned co administration or sequential administration of other substances or treatments that could increase the likelihood or severity of toxic effects (by means of pharmacodynamic or pharmacokinetic ...
Fertility, pregnancy and lactation
Pregnancy The administration of ifosfamide during organogenesis has been shown to have a fetotoxic effect in mice, rats, and rabbits and therefore may cause fetal damage when administered to pregnant women. ...
Effects on ability to drive and use machines
Potential side-effects on the central nervous system may transiently impair the ability to operate machinery and motor vehicles.
Undesirable effects
The adverse reactions and frequencies below are based on publications describing clinical experience with fractionated administration of ifosfamide as monotherapy with a total dose of 4 to 12 g/m² per ...
Overdose
Serious consequences of overdosage include manifestations of dose-dependent toxicities such as CNS toxicity, nephrotoxicity, myelosuppression, and mucositis. See Section 4.4. Patients who received an overdose ...
Pharmacodynamic properties
Ifosfamide is an antineoplastic, a cytotoxic alkylating agent. It is a prodrug and shows no in vitro cytotoxic activity until activated by microsomal enzymes. The cytotoxic activity of Ifosfamide (alkylation ...
Pharmacokinetic properties
Ifosfamide is rapidly absorbed from the site of administration, activation of Ifosfamide is primarily in the liver by microsomal mixed function oxidases. Elimination of metabolised Ifosfamide is primarily ...
Preclinical safety data
Not relevant.
List of excipients
None.
Incompatibilities
Benzyl alcohol-containing solutions can reduce the stability of ifosfamide.
Shelf life
Shelf life: Five years. The reconstituted solution should be used immediately. The product does not contain a preservative, therefore microbial stability cannot be guaranteed. When prepared under strict ...
Special precautions for storage
Do not store above 25°C. Keep container in outer carton.
Nature and contents of container
Type I or Type III clear glass injection vial with bromobutyl rubber closure and beading cap. Vials are packed singly in a cardboard box. Vials are packed with or without a protective plastic overwrap. ...
Special precautions for disposal and other handling
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Before parenteral administration, the substance must be completely dissolved. The ...
Marketing authorization holder
Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
Marketing authorization number(s)
PL 00116/0392
Date of first authorization / renewal of the authorization
15 December 2003
Date of revision of the text
17<sup>th</sup> June 2016
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