Kraj: Holandia
Język: niderlandzki
Źródło: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DESMOPRESSINEACETAAT 267 µg/stuk SAMENSTELLING overeenkomend met ; DESMOPRESSINE 240 µg/stuk
DESMOPRESSINEACETAAT 267 µg/stuk SAMENSTELLING overeenkomend met ; DESMOPRESSINE 240 µg/stuk
Tablet voor sublinguaal gebruik
CITROENZUUR 0-WATER (E 330) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL
Sublinguaal gebruik
1900-01-01
1A Pharma GmbH Page 1/8 Desmopressine 1A Pharma ® 60, 120 en 240 microgram, tabletten voor sublinguaal gebruik RVG 129992; 129993; 129994 1.3.1.3 Bijsluiter Juni 2023 1 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER DESMOPRESSINE 1A PHARMA 60 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL GEBRUIK DESMOPRESSINE 1A PHARMA 120 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL GEBRUIK DESMOPRESSINE 1A PHARMA 240 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL GEBRUIK desmopressin _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 pharmacist. • 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [nationally completed name] is and what it is used for 2. What you need to know before you take [nationally completed name] 3. How to take [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR _ _ [Nationally completed name] contains the active substance desmopressin which lowers the amount of urine that is produced by the kidneys. [Nationally completed name] is used to treat: • a chronic disease called DIABETES INSIPIDUS, which causes extreme thirst and a constant production of large amounts of diluted urine. IMPORTANT: this should not be confused with diabetes mellitus • BEDWETTING (involuntary nightly urination) in patients from 6 years old • FREQUENT URINATION DURING THE NIGHT in adults 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] _ _ DO NOT TAKE [NATIONALLY COMPLETED NAME] IF YOU • are allergic to Przeczytaj cały dokument
1A Pharma Page 1/12 Desmopressine 1A Pharma ® 60, 120 en 240 microgram, tabletten voor sublinguaal gebruik RVG 129992; 129993; 129994 1311-v1 1.3.1.1 Samenvatting van de Productkenmerken June 2023 1 1. NAME OF THE MEDICINAL PRODUCT Desmopressine 1A Pharma 60 microgram, tabletten voor sublinguaal gebruik Desmopressine 1A Pharma 120 microgram, tabletten voor sublinguaal gebruik Desmopressine 1A Pharma 240 microgram, tabletten voor sublinguaal gebruik 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _[Nationally completed name] 60 micrograms>_ Each sublingual tablet contains 67 micrograms desmopressin acetate equivalent to 60 micrograms desmopressin. _[Nationally completed name] 120 micrograms> Przeczytaj cały dokument_ Each sublingual tablet contains 133 micrograms desmopressin acetate equivalent to 120 micrograms desmopressin. _[Nationally completed name] 240 micrograms> _ Each sublingual tablet contains 267 micrograms desmopressin acetate equivalent to 240 micrograms desmopressin. Excipient(s) with known effect _[Nationally completed name] 60 micrograms> _ Each sublingual tablet contains 65.23 mg lactose (as monohydrate). _ _ _[Nationally completed name] 120 micrograms> _ Each sublingual tablet contains 65.18 mg lactose (as monohydrate). _ _ _[Nationally completed name] 240 micrograms> _ Each sublingual tablet contains 65.08 mg lactose (as monohydrate)._ _ _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sublingual tablet _[Nationally completed name] <60 micrograms> _ White or almost white, round, tablet, rounded on the upper and lower side, debossed with ‘I’ on one side and plain on other side, with 6.5 mm of length and 2 mm of thickness. _ _ _[Nationally completed name] <120 micrograms> _ White or almost white, octagonal, tablet, rounded on the upper and lower side, debossed with ‘II’ on one side and plain on other side, with 6.5 mm of le