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  • Doba použitelnosti (cs)
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  • 006.003
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  • T3 roky 33 roky3he shelf life should be given for the medicinal product as packaged for sale and after dilution or reconstitution or after first opening if appropriate. The following items should be addressed: Shelf life of the medicinal product as packaged for sale Shelf life after dilution or reconstitution according to directions Shelf life after first opening the container A clear statement of the shelf life should be given, in an appropriate unit of time (eg, 6 months, 1 year, 18 months, 2 years, 30 months, 3 years). For statements to be included regarding in-use shelf lives of sterile products, consult the Note for Guidance on maximum shelf life for sterile products for human use after first opening or following reconstitution. An in-use shelf life may need to be stated for other medicinal products if development studies have found it to be necessary. No reference should be made to the container unless there are different shelf lives for different containers. Storage conditions should not be included. No reference should be made to the container unless there are different shelf lives for different containers. Storage conditions should not be included except for the storage conditions after opening (see the corresponding guideline). Statements such as ‘Do not use after the expiry date’ should not be included. (cs)
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