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| - T Uchovávejte v původním obalu, aby byl přípravek chráněn před vlhkostí.
Tento léčivý přípravek nevyžaduje žádné zvláštní teplotní podmínky uchovávání.he storage conditions must be possible for the user to follow and it is therefore necessary to restrict the statements to those achievable in practice. Results from stability studies, presented at the time of submission, should serve as guidance. A direct correspondence should exist between the label statements and the demonstrated stability characteristics of the finished product. The use of terms such as “room temperature” or “ambient conditions” is not acceptable. If no storage warning is required, state “No special precautions for storage.”
Storage warnings should use 1 or more of the standard statements from the Note for Guidance on declaration of storage conditions in the product information of medicinal products.
For statements to be included regarding storage of sterile products that have been opened, diluted, or reconstituted, a cross-reference should be made to Section 6.3. In-use shelf life may need to be stated for other medicinal products if development studies have found it to be necessary.
In exceptional circumstances, information may be given on storage under conditions other than those stated in the label and leaflet and on the approved short-term shelf life applicable under these conditions.
Note that if a specific storage warning is required, the warning should be the same for the SPC, label, and PL..
A warning to keep the product out of the reach and sight of children should not be included.
The exact wording of the statements given in the table below will be applied throughout the European Community (EC) taking into consideration that, due to the national linguistic and cultural differences, two alternatives are presented for storage below 25°C and for storage below 30°C. The regulatory authorities in a particular country within the EC decide which of these will be acceptable. Any other statements are acceptable only if unavoidable and, in particular, where the core storage statements are documented to be inappropriate. The alternative proposal is to have any given unique storage requirements supported by relevant data and to be realistically achievable in practice.
For common storage conditions, use the example statements in the following table as applicable.
Other specific statements may be applicable to the product.
In principle, medicinal products should be packaged in containers that ensure stability and protect the finished product from deterioration. A storage statement should not be used to compensate for inadequate or inferior packaging. Nevertheless, the following statements may be used to emphasize the need for precautions to the patient.
If appropriate use one of the statements below. Modify or delete these statements as necessary.
For sensitivity to moisture:
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