Special precautions for disposal and other handling: Cisplatin concentrate for solution for infusion is to be diluted before use. For preparation of solution for infusion, any device containing aluminium that may come in contact with cisplatin (sets for intravenous infusion, needles, catheters, syringes) must be avoided (see Incompatibilities as follows).
Preparation of solution for infusion must take place in aseptic conditions.
For dilution of the concentrate, one of the following solutions should be used: sodium chloride solution 0.9%; mixture of sodium chloride solution 0.9% and glucose solution 5% (1:1) (resulting final concentrations: sodium chloride 0.45%, glucose 2.5%).
Should hydration prior to the treatment with cisplatin be impossible, the concentrate may be diluted with: mixture of sodium chloride solution 0.9% and mannitol solution 5% (1:1) (resulting final concentrations: sodium chloride 0.45%, mannitol 2.5%).
Preparation of cisplatin solution for infusion: The required amount (dose) of the cisplatin concentrate 0.5 mg/ml calculated according to the instructions in Dosage & Administration should be diluted in 1-2 litres of one of the previously mentioned solutions.
The diluted solution should be administered only by intravenous infusion (see Dosage & Administration).
Only clear and colourless to yellowish solutions without visible particles should be used.
For single use only.
Cytotoxic agents should be prepared for administration only by personnel who have been trained in the safe handling of the preparation.
Refer to local cytotoxic handling guidelines.
As any other cytotoxic agent, cisplatin should be used with extreme caution: gloves, face masks and protective clothing are required and vital. Cisplatin should be processed under a protective hood, if possible. Contact with skin and/or mucous membranes must be avoided. Pregnant hospital employees should not work with cisplatin.
Skin contact: Rinse with large quantities of water. Apply an ointment if the patient has a temporary burning feeling. (Note: Some persons are sensitive to platinum and may experience a skin reaction).
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. In the case of spillage all items coming into contact with cisplatin should be handled and disposed in accordance to local cytotoxic guidelines.
Any unused product or waste material should be disposed of in accordance with local requirement.
Incompatibilities: Cisplatin reacts with aluminium which results in production of a black platinum precipitate. Therefore any device containing aluminium that may come in contact with cisplatin (sets for intravenous infusion, needles, catheters, syringes) must be avoided.
This medicinal product must not be mixed with other medicinal products except those previously mentioned in Special precautions for disposal and other handling.
The cisplatin concentrate for solution for infusion must not be diluted with glucose solution 5% alone or mannitol solution 5% alone, but only with the mixtures containing additionally sodium chloride as previously stated in Special precautions for disposal and other handling.
Antioxidants (such as sodium metabisulphite), bicarbonates (sodium bicarbonate), sulfates, fluorouracil and paclitaxel may inactivate cisplatin in infusion systems.