| 6.6 Special precautions for disposal and other handling
Deletion of text from 'Instructions for dilution' header
Handling
The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution. Handling of the concentrate should be done in a safety box 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.
If the preparation comes into contact with the eyes, this may cause serious irritation. The eyes should be rinsed immediately and thoroughly with water. If there is lasting irritation, a doctor should be consulted. If the solution is spilled on the skin, rinse thoroughly with water.
Instructions for dilution
An approved diluent for gemcitabine solution is sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative).
1. Use the aseptic technique during any dilution of gemcitabine for intravenous infusion administration.
2. Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.
3. Any unused product or waste material should be disposed of in accordance with local requirements.
10. DATE OF REVISION OF THE TEXT
DATE CHANGE
7th November 2011 (IB/004)
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