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The package leaflet pl shall be drawn up in accordance with the smpc. The guideline on excipients in the label and package leaflet of medicinal products for human use is also applicable to the smpc.
Pravastatin sodium should be given either one hour before or at least four hours after the resin see section 4. For patients taking ciclosporin with or without other immunosuppressive medicinal products, treatment should begin with 20 mg of pravastatin sodium once daily and titration to 40 mg should be performed with caution see section 4.
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In the european union, the european medicines agency has jurisdiction smpc s1 pdf files and the relevant documents are called the " summary of product characteristics" spc or smpc smpc s1 pdf files and the document for end- users is called the " patient information leaflet" or " package leaflet". Facebook is showing information to help you better understand the purpose of a page.
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