Transcription of JURNISTA (170706) ADS - Medsafe
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JURNISTA (170706) ADS - Medsafe
CCDS 161123 1 JURNISTA (170706) ADS JURNISTA PROLONGED-RELEASE TABLETS DATA SHEET 1. PRODUCT NAME JURNISTA 4 mg modified-release tablets JURNISTA 8 mg modified-release tablets JURNISTA 16 mg modified-release tablets JURNISTA 32 mg modified-release tablets JURNISTA 64 mg modified-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION JURNISTA is available as prolonged-release tablets containing 4, 8, 16, 32 and 64 mg hydromorphone hydrochloride. Excipient(s) with known effect: One tablet of 4 mg tablet contains mg lactose One tablet of 8 mg tablet contains mg lactose One tablet of 16 mg tablet contains mg lactose One tablet of 32 mg tablet contains mg lactose One tablet of 64 mg tablet contains mg lactose For a full list of excipients, see section List of excipients.
CCDS161123 2 JURNISTA (170706) ADS 4. CLINICAL PARTICULARS 4.1 Therapeutic indications JURNISTA is indicated in the treatment of moderate to severe chronic pain. 4.2 Dose and method of …
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