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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Cisplatin 1 mg/ml Sterile Concentrate (2009)

Εκδότης

Εκδότης Hospira UK Ltd
Διεύθυνση Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW
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Περιεχόμενα

Name of the medicinal product

Cisplatin 1 mg/ml Sterile Concentrate.

Qualitative and quantitative composition

1 ml of concentrate for solution for infusion contains 1 mg of cisplatin. 1 vial of 10 ml concentrate ...

Pharmaceutical form

Concentrate for Solution for Infusion. Vials containing a clear, colourless to pale yellow solution. ...

Therapeutic indications

Cisplatin is indicated in metastatic, non-seminomatous germ cell carcinoma, advanced stage and refractory ...

Posology and method of administration

ADULTS AND CHILDREN Cisplatin should be administered by IV infusion over a 6-8 hour period. The recommended ...

Contraindications

Cisplatin may give allergic reactions in some patients. Use is contraindicated in those patients with ...

Special warnings and precautions for use

WARNINGS AND PRECAUTIONS This agent should only be administered under the direction of oncologists in ...

Interaction with other medicinal products and other forms of interaction

Cisplatin can be used in combination with other cytostatics with corresponding mechanisms of action. ...

Pregnancy and lactation

Use in Pregnancy There are no adequate data from the use of cisplatin in pregnant women. Cisplatin has ...

Effects on ability to drive and use machines

There are no known effects of cisplatin on the ability to drive or operate machinery. However the profile ...

Undesirable effects

Nephrotoxicity: Renal toxicity has been noted in about one third of patients given a single dose of ...

Overdose

Overdosage can be expected to cause the toxic effects described above, but to an exaggerated degree. ...

Pharmacodynamic properties

Cisplatin has biochemical properties similar to those of bifunctional alkylating agents. The drug inhibits ...

Pharmacokinetic properties

There is good uptake of cisplatin by the kidneys, liver and intestine. More than 90% of platinum containing ...

Preclinical safety data

Cisplatin has been shown to be mutagenic. It may also have an anti-fertility effect. Other anti-neoplastic ...

List of excipients

Mannitol Sodium Chloride Dilute Hydrochloric Acid Water for Injections

Incompatibilities

There is a total loss of cisplatin in 30 minutes at room temperature when mixed with metoclopramide and ...

Shelf life

Prior to first use: 24 months. In use: 24 hours.

Special precautions for storage

Prior to first use: Do not store above 25°C. Do not refrigerate or freeze. Keep container in the outer ...

Nature and contents of container

10 mg/10 ml, 50 mg/50 ml and 100 mg/100 ml presentations in Type I amber glass vials and Onco-Tain® vials ...

Special precautions for disposal and other handling

Single use only. Discard any unused contents. Refer to local cytotoxic handling guidelines. Dilution ...

Marketing authorization holder

Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UK

Marketing authorization number(s)

PL 04515/0026

Date of first authorization / renewal of the authorization

6th September 1996

Date of revision of the text

May 2009
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.