Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESMOPRESSIN ACETATE; DESMOPRESSIN ACETATE; DESMOPRESSIN ACETATE
Ferring Sdn. Bhd.
DESMOPRESSIN ACETATE; DESMOPRESSIN ACETATE; DESMOPRESSIN ACETATE
30tablet Tablets
CATALENT UK SWINDON ZYDIS LIMITED
MINIRIN ® Oral Lyophilisate for sublingual Desmopressin Acetate 60mcg and 120mcg Consumer Medication Information Leaflet (RiMUP) READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in the leaflet WHAT IS IN THIS LEAFLET : 1. What MINIRIN ® is used for 2. How MINIRIN ® works 3. Before you use MINIRIN ® 4. How to use MINIRIN ® 5. While you are using it 6. Side effects 7. Storage and Disposal of MINIRIN ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT MINIRIN ® IS USED FOR MINIRIN ® is provided as oral lyophilisate in sublingual tablet. It is used to treat: i. Central diabetes insipidus. ii. Primary nocturnal enuresis (from 5 years of age) when the enuresis alarm has not had the desired effect in patients with normal ability to concentrate urine. iii. Symptomatic treatment of nocturia in adults, associated with nocturnal polyuria, i.e. nocturnal urine production exceeding bladder capacity. HOW MINIRIN ® WORKS MINIRIN ® contains active ingredient desmopressin (free base), as desmopressin acetate. Desmopressin is a structural analogue of the natural hormone arginine vasopressin. It provides an antidiuretic effect, lasting in most patients for 8-12 hours. BEFORE YOU USE MINIRIN ® When you must not use it Do not use MINIRIN ® if you are: • Habitual or psychogenic polydipsia (urine production exceeding 40 ml/kg/24 hours); • Known or suspected cardiac insufficiency and other conditions that require treatment with diuretics; • Moderate and severe renal insufficiency (creatinine clearance below 50 ml/min); • Syndrome of inappr Прочетете целия документ
Proposed packaging material Code (44,45) -I-MY -04.06 Size Submission ☒NDA ☐Renewal ☐Variation change detail no.: Deficiency letter by NPRA dated 25 -09-2017 Code of p revious version (44,45) -I-MY -04.05 Change s Requested by NPRA to : change product n ame to: oral lyophilisate for sublingual xx mcg ☐CCDS version: ☐Core PIL version: ☐SPC country/version/date: ☐LAC no.: Name & Date JIWO, 2 5-Sept -2017 MINIRIN ® Oral Lyophilisates for sublingual 60 mcg and 120 mcg QUALITATIVE AND QUANTITATIVE COMP OSITION MINIRIN ® Oral Lyophilisate for sublingual 60 mcg: One oral lyophilisate contains 60 m cg desmopressin (free base), as desmopressin acetate . MINIRIN ® Oral Lyophilisate for sublingual 120 mcg: One oral lyophilisate contains 120 m cg desmopressin (fre e base), as desmopressin acetate . Excipients : Gelatin (from fish) , mannitol (E4 21) and citric acid , anhydrous (E330) . PHARMACEUTICAL FORM Oral lyophilisate MINIRIN ® Oral Lyophilisate for sublingual 60 mcg: White, round, oral lyophilisate marked with a d rop shaped figure on one side. MINIRIN ® Oral Lyophilisate for sublingual 120 mcg: White, round, oral lyophilisate marked with two drop shaped figures on one side. THERAPEUTIC INDICATIONS Central diabetes insipidus. Primary nocturnal enuresis (from 5 years of age) when the enuresis alarm has not had the desired effect in patients with normal ability to concentrate urine. Symptomatic treatment of nocturia in adults, associated with nocturnal polyuria, i.e. nocturnal urine production exceeding bladder c apacity. POSOLOGY AND METHOD OF ADMINISTRATION General The dose of M INIRIN ® Oral Lyophilisate is individually adapted. MINIRIN ® Oral Lyophilisate 60 mcg is calculated to correspond to M INIRIN ® tablet 0.1 mg, and 120 mc g corresponds to 0.2 mg (see also sec tion Pharmac okinetic properties ). Desmopressin should always be taken at the same time in relation to food intake, since food intake causes decreased absorption and by that also might influence the effect of desmopressin, see secti Прочетете целия документ