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SPC, UK: Carboplatin 10 mg/ml concentrate for solution for infusion (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Accord Healthcare Limited
Διεύθυνση :
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, UK
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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: 1. Advanced ovarian carcinoma of epithelial origin in: first line therapy second line therapy, after other treatments have failed. 2. Small cell carcinoma ...

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 patients with: Hypersensitivity to the active substance or to other platinum containing compounds Breast feeding Severe myelosuppression Bleeding tumors Pre-existing severe ...

Special warnings and precautions for use

Warnings Carboplatin should be administered by individuals under the supervision of a qualified physician who is experienced in the use of anti-neoplastic therapy. Diagnostic and treatment facilities should ...

Interaction with other medicinal products and other forms of interaction

Concurrent therapy with nephrotoxic drugs or ototoxic drugs such as amino glycoside, vancomycin, capreomycin and diuretics is not recommended, since this may lead to increased or exacerbated toxicity due ...

Pregnancy and lactation

Pregnancy The safe use of Carboplatin during pregnancy has not been established: Studies in animals have shown reproductive toxicity (see 5.3.). Carboplatin has been shown to be an embryo toxin and teratogen ...

Effects on ability to drive and use machines

Carboplatin has no or negligible influence on the ability to drive and use machines. However Carboplatin may cause nausea and vomiting, indirectly impairing the ability to drive and use machines.

Undesirable effects

Incidences of adverse reactions reported here under are based on cumulative data obtain in a large group of patients with various pretreatment prognostic features. The following frequencies have been used: ...

Overdose

Symptoms of overdose Carboplatin was administered in Phase I studies at a dosage of up to 1600 mg/m² i.v. per course. At this dosage, life-threatening haematological side effects with granulocytopenia, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, Platinum compounds ATC code: L01XA02 Carboplatin is an antineoplastic agent. Its activity has been demonstrated against several murine and human cell lines. ...

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 ...

Ημερομηνία λήξης

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 view, the ...

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 ...

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-Dec-2008

Date of revision of the text

28-Feb-2012