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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

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Βιβλιογραφική αναφορά

Προτάσεις

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

Εκδότης

Εκδότης Accord Healthcare Limited
Διεύθυνση Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, UK
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

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 ...

Pharmaceutical form

Concentrate for solution for infusion. A clear, colourless to slightly pale yellow solution free from ...

Therapeutic indications

Carboplatin is indicated for the treatment of: 1. Advanced ovarian carcinoma of epithelial origin in: ...

Posology and method of administration

Dosage and Administration Carboplatin should be used by the intravenous route only. The recommended dosage ...

Contraindications

Carboplatin is contraindicated in patients with: Hypersensitivity to the active substance or to other ...

Special warnings and precautions for use

Warnings Carboplatin should be administered by individuals under the supervision of a qualified physician ...

Interaction with other medicinal products and other forms of interaction

Concurrent therapy with nephrotoxic drugs or ototoxic drugs such as amino glycoside, vancomycin, capreomycin ...

Pregnancy and lactation

Pregnancy The safe use of Carboplatin during pregnancy has not been established: Studies in animals have ...

Effects on ability to drive and use machines

Carboplatin has no or negligible influence on the ability to drive and use machines. However Carboplatin ...

Undesirable effects

Incidences of adverse reactions reported here under are based on cumulative data obtain in a large group ...

Overdose

Symptoms of overdose Carboplatin was administered in Phase I studies at a dosage of up to 1600 mg/m2 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, Platinum compounds ATC code: L01XA02 Carboplatin is ...

Pharmacokinetic properties

Following administration of Carboplatin in man, linear relationships exist between dose and plasma concentrations ...

Preclinical safety data

Carboplatin has been shown to be embryotoxic and teratogenic in rats. It is mutagenic in vivo and in ...

List of excipients

Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal product except those mentioned in section ...

Ημερομηνία λήξης

Unopened: 2 years. After dilution In use: Chemical and physical in-use stability has been demonstrated ...

Special precautions for storage

Store below 25°C. Do not refrigerate or freeze. Keep vial in the outer carton in order to protect from ...

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/ ...

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 ...

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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.