Country: Malta
Language: English
Source: Medicines Authority
CISPLATIN
Fresenius Kabi Oncology PLC Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom
L01XA01
CISPLATIN 1 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
CISPLATIN 1 mg/ml
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2016-03-10
CISPLATIN - PACK INSERT - IRELAND+UK (Travesh Sharma) D:\Europe\Cisplatin\Ireland+UK\July 2014\Cisplatin - Pack Insert - Ireland+UK.indd SIZE: 455 X 315 MM 6 AUGUST 2014 11:38 AM VER. 05 TIMES NEW ROMAN 9 PTS. Black xxxxxx xxxxxxxxxx V002 THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY: PREPARATION AND HANDLING OF THE PRODUCT Refer to local cytotoxic guidelines. Like with all anti-neoplastic products caution is needed with the processing of cisplatin. Dilution should take place under aseptic conditions in a safety box, by trained personnel in an area specifically intended for this, and protective coats and gloves should be used. If no safety box is available, the equipment should be supplemented with a mask and protective glasses. Precautions should be taken to avoid contact with the skin and mucous membranes. If skin contact did occur anyway, the skin should be washed with soap and water immediately. With skin contact tingling, burns and redness have been observed. In case of contact with the mucous membranes they should be copiously rinsed with water. After inhalation dyspnoea, pain in the chest, throat irritation and nausea have been reported. In the event of spillage, operators should put on gloves and mop up the spilled material with a sponge kept in the area for that purpose. Rinse the area twice with water. Put all solutions and sponges into a plastic bag and seal it. Pregnant women must avoid contact with cytostatic drugs. Bodily waste matter and vomit should be disposed with care. If the solution is cloudy or a deposit that does not dissolve is noticed, the bottle should be discarded. A damaged bottle must be regarded and treated with the same precautions as contaminated waste. Contaminated waste must be stored in waste containers specifically marked for this. See section “Disposal”. PREPARATION OF THE INTRAVENOUS ADMINISTRATION Take the quantity of the solution that is needed from the bottle and dilute with at least 1 litre of the following solutions: • sodium chloride 9 mg Read the complete document
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cisplatin 1 mg/ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 1 mg of cisplatin. One vial of 10 ml concentrate for solution for infusion contains 10 mg of cisplatin. One vial of 20 ml concentrate for solution for infusion contains 20 mg of cisplatin. One vial of 50 ml concentrate for solution for infusion contains 50 mg of cisplatin. One vial of 100 ml concentrate for solution for infusion contains 100 mg of cisplatin. Excipient(s) with known effect: Each ml of solution contains 0.1 to 0.2 millimoles per ml of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless to pale yellow solution. The pH is between 3.5 to 6.5. The osmolarity is between 250 to 400 mOsmol/L. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cisplatin is intended for the treatment of: • advanced or metastatic testicular cancer • advanced or metastatic ovarian cancer • advanced or metastatic bladder carcinoma • advanced or metastatic squamous cell carcinoma of the head and neck • advanced or metastatic non-small cell lung carcinoma • advanced or metastatic small cell lung carcinoma. Page 2 of 18 Cisplatin is indicated in combination with radiotherapy in the treatment of cervical carcinoma. Cisplatin can be used as monotherapy and in combination therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS AND CHILDREN: The cisplatin dosage depends on the primary disease, the expected reaction, and on whether cisplatin is used for monotherapy or as a component of combination chemotherapy. The dosage directions are applicable for both adults and children. For monotherapy, the following two dosage regimens are recommended: • Single dose of 50 to 120 mg/m² body surface every 3 to 4 weeks; • 15 to 20 mg/m²/day for five days, every 3 to 4 weeks. If cisplatin is used in combin Read the complete document