Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
DESMOPRESSIN AS ACETATE
FERRING PHARMACEUTICALS LTD
H01BA02
TABLETS SOLUBLE
DESMOPRESSIN AS ACETATE 60 MCG
SUBLINGUAL
Required
FERRING GmbH ,GERMANY
DESMOPRESSIN
DESMOPRESSIN
Nocturnal enuresis.
2022-10-31
- PHARMACISTS' REGULATIONS (PREPARATIONS) PATIENT LEAFLET IN ACCORDANCE WITH THE 1986 This medicine is dispensed with a doctor’s prescription only MINIRIN MELT 60 MCG MINIRIN MELT 120 MCG TABLETS FOR SUBLINGUAL ADMINISTRATION ACTIVE INGREDIENTS Minirin Melt 60 mcg - Each tablet contains 60 mcg desmopressin free base (added as desmopressin acetate) Minirin Melt 120 mcg - Each tablet contains 120 mcg desmopressin free base (added as desmopressin acetate) Inactive ingredients and allergens - see section 6 "Additional information" READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? The medicine is intended for treatment of bedwetting (nocturnal enuresis). THERAPEUTIC GROUP: synthetic vasopressin analog. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: - you are sensitive (allergic) to desmopressin or to any of the other ingredients in this medicine (see section 6) - you have a severe heart or kidney disease - you are taking diuretics - you drink very large quantities of liquids, including alcohol - you are below the age of 5 or above the age of 65 - you have low blood sodium levels (hyponatremia) - you have a medical condition associated with increased ADH secretion (abnormal ADH secretion syndrome) AVOID DRINKING LARGE QUANTITY OF FLUIDS DURING TREATMENT WITH THE MEDICINE. DRINKING LARGE QUANTITY OF FLUIDS MAY LEAD TO WATER ACCUMULATION AND DILUTION OF THE CONCENTRATION OF SALTS IN THE BODY. THIS MAY CAUSE HEADACHE, NAUSEA/VOMITING, WEIGHT GAIN AND IN SEVERE CASES CONVULSIONS. SPECIAL WARNINGS ABOUT USING THIS MEDICINE _Before treatment with the medicine_ _, tell your doctor if you have:_ ● A disease causing impaired fluid and/or electrolyte balance. Izlasiet visu dokumentu
1. _NAME OF MEDICINAL PRODUCT _ MINIRIN MELT 60 MICROGRAMS MINIRIN MELT 120 MICROGRAMS 2. _QUALITATIVE AND QUANTITATIVE COMPOSITION_ MINIRIN MELT 60 MCG : each unit contains 60 micrograms desmopressin (free base), present as desmopressin acetate. MINIRIN MELT 120 MCG : each unit contains 120 micrograms desmopressin (free base) present as desmopressin acetate. 3. _PHARMACEUTICAL FORM _ Oral lyophilizate White, round, oral lyophilisate marked with one (60mcg) or two drop (120mcg) shaped figures on one side. 4. _CLINICAL PARTICULARS_ 4.1 THERAPEUTIC INDICATIONS Minirin Melt is indicated Nocturnal Enuresis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _NOCTURNAL ENURESIS: _ Oral lyophilisate administration Children over 5 years: The recommended initial dose is 120 microg at bedtime, administered sublingually. If this dose is not sufficient effective, the dose may be increased up to 240 microg sublingually. If treatment continues over the long-term, a treatment-free week should be introduced every three months, in order to ascertain whether the condition has resolved spontaneously. If the desired clinical effect has not been achieved after 4 weeks of dose titration, treatment should be discontinued. 4.3 CONTRA-INDICATIONS • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • A history of known or suspected cardiac insufficiency and other conditions requiring treatment with diuretic agents. Habitual or psychogenic polydipsia (resulting in a urine production exceeding 40 ml/kg/24 hours) • Patients over the age of 65 • Moderate and severe renal insufficiency (creatinine clearance below 50ml/min) • Known hyponatremia • Syndrome of inappropriate ADH secretion (SIADH) Before prescribing Minirin Melt the diagnosis of psychogenic polydipsia and alcohol abuse should be excluded. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE _Special warnings: _ When Minirin Melt is used for the treatment of enuresis, the fluid intake must be limited to a minimum from 1 hour before until Izlasiet visu dokumentu