Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESMOPRESSIN ACETATE
Ferring Sdn. Bhd.
DESMOPRESSIN ACETATE
1Units Units; 5.0 ml mL; 2.5 ml mL
FERRING GMBH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ MINIRIN ® NASAL SPRAY Desmopressin Acetate (0.1mg/ml) 1 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. Product Registration Holder and Manufacturer 10. Date of revision WHAT MINIRIN ® IS USED FOR MINIRIN ® is used to treat: i. Central diabetes insipidus (disorder which leads to extreme thirst and large urine volumes). ii. Renal concentrating capacity test (a diagnostic aid in the examination of the kidney function) HOW MINIRIN ® WORKS Desmopressin is a synthetic version of a naturally occurring substance produced in the brain called vasopressin and it regulates the kidneys ability to concentrate urine. BEFORE YOU USE MINIRIN ® _-When you must not use it _ Do not use MINIRIN ® if you have: • Urine production exceeding 40 ml/kg/24 hours; • Heart problems and other conditions that require treatment with diuretics (water pills); • Moderate and severe kidney problems; • Syndrome of inappropriate secretion of antidiuretics hormone (SIADH) causing fluid retention, resulting in weakness, tiredness or • confusion; • Low blood sodium level; • Hypersensitivity to Desmopressin or to any of the ingredients. _-Before you start to use it _ Before starting treatment with MINIRIN ® , you should check with your doctor, if you: - are 65 years or older, - have risk for increased pressure in the skull - fluid and/or electrolyte imbalance - suffer from bladder problems e.g. inability to hold in urine, frequent urination and/or urgent urination. - have enlarged prostate. - have urinary tract infection. - have bladder stone/growth. - have excessive thirst. - have poorly controlled diabetes. When used for central diabetes insipidus, experience from clinical use indicates a risk of severe low blood sodium levels in association with the nasal formulation of MINIRIN ® . When use Read the complete document
PROPOSED PACKAGING MATERIAL Code MINSPR-I-MY-01.01 Size 180x250, 180x300, 180x370, 180x420 Submission ☐ NDA ☐ Renewal ☒ Variation change detail no.: PI update with children CDI dose regimen _ _ Code of previous version 05,36-I-MY-02.02 Changes Change dosing regimen for CDI in children changed to ‘10 mcg 1-2 times a day’, align with RiMUP ☐ CCDS version: ☐ Core PIL version: ☐ SPC country/version/date: ☐ LAC no.: Name & Date JIWO, 04-Mar-2020 MINIRIN ® Nasal Spray 10mcrog/dose (0.1 mg/ml) QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 0.1 mg desmopressin acetate equivalent to 89 µg desmopressin, and 0.1 mg benzalkonium chloride. Excipients: Benzalkonium chloride (solution), sodium chloride, citric acid monohydrate (E 330), disodium phosphate dihydrate, and purified water. PHARMACEUTICAL FORM Nasal spray, solution. THERAPEUTIC INDICATIONS _Central diabetes insipidus _ The use of MINIRIN ® in patients with an established diagnosis will result in a reduction in urinary output with concomitant increase in urine osmolality and decrease in plasma osmolality. This will result in decreased urinary frequency and decreased nocturia. _Renal concentrating capacity test _ MINIRIN ® can be used to test the capacity of the kidneys to concentrate urine; as a diagnostic aid in the examination of the kidney function. This is especially useful in the differential diagnosis between level of urinary tract infections. Cystitis will opposite to pyelonephritis not cause a subnormal ability to concentrate urine. POSOLOGY AND METHOD OF ADMINISTRATION General 1 dose of the spray provides 0.1 ml, which corresponds to 10 µg desmopressin acetate. MINIRIN ® nasal formulations should be used only when treatment with oral formulations is inappropriate and always start at the lowest dose (see section Special warnings and precautions for use). Fluid restriction should be observed (see indication specific instructions in section Special warnings and precautions for use). If signs of water retention and/or hyponatraemia Read the complete document