Ország: Dél-afrikai Köztársaság
Nyelv: angol
Forrás: South African Health Products Regulatory Authority (SAHPRA)
LITHA PHARMA (PTY) LTD
Not Indicated
Coated tablet
Each tablet contains PROPIVERINE HYDROCHLORIDE EQUIVALENT TO PROPIVERINE 5,0 mg
Registered
2023-07-07
RESPONSE TO CLINICAL COMMITTEE RECOMMENDATION DATED 21 SEPTEMBER 2017 APPLICANT: PHARMAFRICA (PTY) LIMITED PROPRIETARY NAME: DETRUNORM® REGISTRATION NUMBER: 36/5.4/0019 STRENGTH AND DOSAGE FORM EACH TABLET CONTAINS 15 MG PROPIVERINE HYDROCHLORIDE PROPOSED PATIENT INFORMATION LEAFLET _Submitted to MCC: _ _30 July 2018 _ _Module 1.3.2 Proposed Patient Information Leaflet _ _ZA CTD July 12_v5 _ _Version: Clean Copy _ _Page 1 of 8 _ _ _ PROPOSED PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S3 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM: DETRUNORM® (Tablets). Each tablet contains 15 mg propiverine hydrochloride. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING DETRUNORM ®. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor, professional healthcare provider, or your pharmacist. DETRUNORM has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT DETRUNORM CONTAINS The active substance is propiverine hydrochloride. The other ingredients are: Lactose monohydrate, powdered cellulose, magnesium stearate, sucrose, talc, heavy kaolin, calcium carbonate, titanium dioxide (E 171), acacia gum, colloidal anhydrous silica, Macrogol 6000, glucose monohydrate, montan wax. Contains sugar – lactose monohydrate; glucose and sucrose. RESPONSE TO CLINICAL COMMITTEE RECOMMENDATION DATED 21 SEPTEMBER 2017 APPLICANT: PHARMAFRICA (PTY) LIMITED PROPRIETARY NAME: DETRUNORM® REGISTRATION NUMBER: 36/5.4/0019 STRENGTH AND DOSAGE FORM EACH TABLET CONTAINS 15 MG PROPIVERINE HYDROCHLORIDE PROPOSED PATIENT INFORMATION LEAFLET _Submitted to MCC: _ _30 July 2018 _ _Module 1.3.2 Proposed Patient Information Leaflet _ _ZA CTD July 12_v5 _ _Version: Clean Copy _ _Page 2 of 8 _ _ _ WHAT DETRUNORM IS USED FOR Detrunorm is used to treat people who have difficulty controlling their bladder (incontinence) _ _ due to bladder overactivity or, in some cases, problems w Olvassa el a teljes dokumentumot
PACKAGE INSERT FOR DETRUNORM ® SCHEDULING STATUS: S3 PROPRIETARY NAME (AND DOSAGE FORM): DETRUNORM ® Tablets COMPOSITION: Each tablet contains 15 mg propiverine hydrochloride. INACTIVE INGREDIENTS: Lactose monohydrate, powdered cellulose, magnesium stearate, sucrose, talc, heavy kaolin, calcium carbonate, titanium dioxide (E 171), acacia gum, colloidal anhydrous silica, Macrogol 6000, glucose monohydrate, Cochineal red A (E124, lake), moutan wax. Contains sugar – lactose monohydrate; glucose and sucrose. PHARMACOLOGICAL CLASSIFICATION: A.5.4 Medicines affecting autonomic functions Cholinolytics (Anticholinergics) PHARMACOLOGICAL ACTION: DETRUNORM ® Tablets are spasmolytic and anticholinergic: Inhibition of calcium influx causing musculotropic spasmolysis. PHARMACODYNAMIC PROPERTIES In animal models propiverine hydrochloride causes a dosage dependent decrease of the intravesical pressure and an increase in bladder capacity. The effect is based on the sum of the pharmacological properties of propiverine and its three active metabolites which are directly musculotropic and anticholinergic. PHARMACOKINETIC PROPERTIES _ABSORPTION _ After oral administration of DETRUNORM ® propiverine hydrochloride is rapidly absorbed from the gastrointestinal tract. Maximal plasma concentrations are reached after 2.3 hours as an average after a single dose of one coated tablet. The average absolute bioavailability of DETRUNORM ® is 40.5 % (arithm. Mean value for AUC o- (p.o.) /AUC 0- (i.v.) ). _DISTRIBUTION _ Propiverine is already intensively metabolized pre-systemically. After repeated application (15 mg two to three times a day) steady state is reached after four to five days at a higher concentration level than after single dose application (C average = 61 ng/ml). The calculated volume of distribution (after 10 mg, 20 mg respectively) of approximately 253 l (125 – 473 l) indicates, that a large amount of available propiverine is distributed to peripheral compartments. The protein binding is around 90% for the pare Olvassa el a teljes dokumentumot