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NRA-DIENOGEST is a brand name for Dienogest, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .............................................................................. 3 CONTRAINDICATIONS .................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
and WARNINGS AND PRECAUTIONS, Hepatic). Dienogest has not been studied in patients with impaired liver function. Renal Insufficiency Dienogest has not been studied in patients with impaired renal function. However, no special risk for these patients is expected since dienogest is almost completely metabolized before excretion and the metabolites are pharmacologically inactive.
STORAGE AND STABILITY NRA-Dienogest should be stored in the original package, between 15°C and 30°C. SPECIAL HANDLING INSTRUCTIONS There are no special handling instructions. DOSAGE FORMS, COMPOSITION AND PACKAGING NRA-Dienogest (dienogest) is available as white to off-white, round, biconvex tablets, debossed as “SG” and “11” on one side and plain on other side.
Each tablet contains 2 mg dienogest and the following nonmedicinal ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, potato starch, povidone, and talc. NRA-Dienogest is available in blister packs of 28’s (2 x 14’s) tablets with amber coloured PVDC foil.
4 g/mol Structural formula: Physicochemical properties: White or almost white or slightly yellow, crystalline powder. Practically insoluble in water sparingly soluble in methylene chloride, slightly soluble in methanol. Melting range is 204°C to 214°C.
) and PrVISANNE® tablets was conducted in healthy human adult female subjects under fasting conditions. ). ) was purchased in Canada. 3 Expressed as the median (range) only. 4 Expressed as the arithmetic mean (CV%) only. Study Demographics and Trial Design Three pivotal trials (Studies 307041, 307059, and 97085) evaluated the efficacy of dienogest in the management of pelvic pain associated with endometriosis using a visual analog scale (VAS) (0- 100 mm).
Patients with a confirmed diagnosis of endometriosis assessed by laparoscopy or laparotomy prior to treatment were included. These studies included patients with all stages of disease severity based on the rAFS or rARSM (revised American Society for Reproductive Medicine) classification systems.
The placebo-controlled study (Study 307041) was a multicenter, double-blind, randomized trial designed to prove the superiority of dienogest compared to placebo. A total of 198 patients with endometriosis were treated over a period of 3 months.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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8% and 26% of placebo patients) had moderate (stage III) and severe (stage IV) endometriosis, respectively. (14) An open-label extension to this placebo-controlled study included a total of 168 women to assess the long-term efficacy of continued dienogest treatment (Study 307059).
Patients previously treated with either placebo or dienogest in Study 307041 received dienogest for an additional 52 weeks. NRA-Dienogest Product Monograph Page 20 of 39 (15) Pelvic pain associated with endometriosis was also assessed in a 6-month noninferiority trial comparing dienogest and leuprorelin acetate in 252 patients with endometriosis (Study 97085).
5% and 15% of dienogest patients at baseline, respectively. (16) Table 5 – Summary of Pivotal Studies for the Management of Pelvic Pain Associated with Endometriosis with Dienogest (2 mg) Report (Study) / Phase (Study Design) Primary Endpoint Treatment Regimen Treatment Duration No.
9 (18-46) Table 5 – Summary of Pivotal Studies for the Management of Pelvic Pain Associated with Endometriosis With Dienogest (2 mg) Report (Study) / Phase (Study Design) Primary Endpoint Treatment Regimen Treatment Duration No. 0 (18-45) Abbreviations: VAS = visual analog scale a Pain medication allowed ibuprofen tablets up to 1,200 mg/day Study Results Pelvic Pain Associated […]