CARBOPLATIN Solution for infusion (2018)
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Περιεχόμενα
Name of the medicinal product
Carboplatin 10 mg/ml concentrate for solution for infusion.
Qualitative and quantitative composition
1 ml of concentrate for solution for infusion contains 10mg of Carboplatin. Each 5 ml vial contains 50 mg carboplatin. Each 15 ml vial contains 150 mg carboplatin. Each 45 ml vial contains 450 mg carboplatin. ...
Pharmaceutical form
Concentrate for solution for infusion. A clear, colourless to slightly pale yellow solution free from particles.
Therapeutic indications
Carboplatin is indicated for the treatment of: advanced ovarian carcinoma of epithelial origin in:first line therapy second line therapy, after other treatments have failed. small cell carcinoma of the ...
Posology and method of administration
Dosage and Administration Carboplatin should be used by the intravenous route only. The recommended dosage of Carboplatin in previously untreated adult patients with normal kidney function, i.e. creatinine ...
Contraindications
Carboplatin is contraindicated in: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 patients with severe myelosuppression patients with pre-existing severe ...
Special warnings and precautions for use
Warnings Myelosuppression Myelosuppression as a result of carboplatin treatment is closely related to the renal clearance of the drug. Therefore, in patients with abnormal renal function, or who are receiving ...
Interaction with other medicinal products and other forms of interaction
Carboplatin may interact with aluminium to form a black precipitate. Needles, syringes, catheters or IV administration sets that contain aluminium parts which may come into contact with carboplatin, should ...
Fertility, pregnancy and lactation
Pregnancy Carboplatin can cause foetal harm when administered to a pregnant woman. Carboplatin has been shown to be embryotoxic and teratogenic in rats receiving the drug during organogenesis. No controlled ...
Effects on ability to drive and use machines
No studies of the effects on the ability to drive and use machines have been performed. However, carboplatin may cause nausea, vomiting, vision abnormalities and ototoxicity; therefore, patients should ...
Undesirable effects
The frequency of adverse reactions reported is based on a cumulative database of 1,893 patients receiving single agent carboplatin injection and post-marketing experience. The list is presented by system ...
Overdose
No overdosage occurred during clinical trials. Symptoms Symptoms may include myelosuppression, renal, hepatic and auditory function impairment. Reports of doses up to 1600mg/m² indicate patients feeling ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, Platinum compounds ATC code: LO1XA02 Carboplatin, like Cisplatin, interferes with DNA intrastrand and interstrand crosslinks in cells exposed to the drug. ...
Pharmacokinetic properties
Following administration of Carboplatin in man, linear relationships exist between dose and plasma concentrations of total and free ultrafilterable platinum. The area under the plasma concentration versus ...
Preclinical safety data
Carboplatin has been shown to be embryotoxic and teratogenic in rats. It is mutagenic in vivo and in vitro and although the carcinogenic potential of Carboplatin has not been studied, compounds with similar ...
List of excipients
Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal product except those mentioned in section 6.6. Carboplatin may interact with aluminium to form a black precipitate. Needles, syringes, catheters ...
Shelf life
Shelf life Unopened: 2 years. After dilution: In use: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature and 30 hours at 2-8°C. From a microbiological point of ...
Special precautions for storage
Store below 25°C. Do not refrigerate or freeze. Keep vial in the outer carton in order to protect from light. For storage conditions of the diluted medicinal product, see section 6.3.
Nature and contents of container
Carboplatin infusion is supplied in 5 ml/15 ml/50 ml/100 ml type I amber glass vial containing 5 ml/15 ml/45 ml/60 ml concentrate for solution respectively. Vials are closed using grey chlorobutyl rubber ...
Special precautions for disposal and other handling
This product is for single dose use only. Contamination In the event of contact of carboplatin with eyes or skin, wash affected area with copious amounts of water or normal saline. A bland cream may be ...
Marketing authorization holder
Accord Healthcare Limited, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Marketing authorization number(s)
PL 20075/0028
Date of first authorization / renewal of the authorization
09/12/2008
Date of revision of the text
21/08/2018
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