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EU GMP Requirements for Investigational Medicinal Products (Annex 13)
Mechanism of action Provides bicarbonate (HCO) buffers excess hydrogen ions (H) Increases blood pH corrects metabolic acidosis In the kidneys: Increases urinary pH promotes excretion of acids and certain drugs (e.g., salicylates) Indications 1
Greater proportions of patients treated with WEGOVY injection achieved 5%, 10% and 15% weight loss than those treated with placebo as shown in Table 8
Guerrero, A
Switching may be considered for several reasons, including: Inadequate weight loss results Side effect intolerance Changes in insurance coverage Plateauing on current medication Seeking stronger appetite suppression or satiety Most transitions involve cross-titration, gradually adjusting doses to minimize gastrointestinal side effects and support a smooth switch
Adherence to treatment: Oral semaglutide should be taken daily in the morning with up to 4 ounces of water, at least 30 minutes before foods, liquids, or other medications
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