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

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Hospira UK Ltd
Διεύθυνση :
Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW
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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 for solution for infusion contains 10 mg of cisplatin. 1 vial of 50 ml concentrate for solution for ...

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 ovarian carcinoma, advanced stages and refractory bladder carcinoma and squamous cell carcinoma ...

Posology and method of administration

ADULTS AND CHILDREN Cisplatin should be administered by IV infusion over a 6-8 hour period. The recommended dose of cisplatin in adults and children is 50 to 100 mg/m<sup>2</sup> as a single IV dose every ...

Contraindications

Cisplatin may give allergic reactions in some patients. Use is contraindicated in those patients with a history of allergic reaction to cisplatin or other platinum containing compounds. Cisplatin induces ...

Special warnings and precautions for use

WARNINGS AND PRECAUTIONS This agent should only be administered under the direction of oncologists in specialist units under conditions permitting adequate monitoring and surveillance. Supportive equipment ...

Interaction with other medicinal products and other forms of interaction

Cisplatin can be used in combination with other cytostatics with corresponding mechanisms of action. The nephrotoxicity, ototoxicity and myelosuppression induced by cisplatin will be additive to existent ...

Pregnancy and lactation

Use in Pregnancy There are no adequate data from the use of cisplatin in pregnant women. Cisplatin has been shown to be mutagenic in bacteria. It produces chromosome aberrations in tissue-cultures of animal ...

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 of undesirable effects (central nervous system and special senses) may reduce the patients' driving ...

Undesirable effects

Nephrotoxicity: Renal toxicity has been noted in about one third of patients given a single dose of cisplatin when prior hydration has not been employed. It is first noted during the second week after ...

Overdose

Overdosage can be expected to cause the toxic effects described above, but to an exaggerated degree. Adequate hydration and osmotic diuresis may help reduce the toxicity of cisplatin if administered promptly ...

Pharmacodynamic properties

Cisplatin has biochemical properties similar to those of bifunctional alkylating agents. The drug inhibits DNA synthesis by producing intrastrand and interstrand cross links in DNA. Protein and RNA synthesis ...

Pharmacokinetic properties

There is good uptake of cisplatin by the kidneys, liver and intestine. More than 90% of platinum containing species remaining in the blood are bound (possibly irreversibly) to plasma proteins. Penetration ...

Preclinical safety data

Cisplatin has been shown to be mutagenic. It may also have an anti-fertility effect. Other anti-neoplastic substances have been shown to be carcinogenic and this possibility should be borne in mind in ...

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 sodium metabisulphite in concentrations equivalent to those that would be found on mixing with a ...

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 carton. In use: Following dilution in 0.9% sodium chloride injection, chemical and physical in-use ...

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 with rubber closures, packed as single vials or packs of 10.

Special precautions for disposal and other handling

Single use only. Discard any unused contents. Refer to local cytotoxic handling guidelines. Dilution Cisplatin 1 mg/ml Sterile Concentrate should be diluted in 2 litres of 0.9% sodium chloride injection. ...

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