Երկիր: Նիդերլանդեր
Լեզու: հոլանդերեն
Աղբյուրը: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PARICALCITOL 2 µg/stuk
Regiomedica GmbH Teichstrasse 66 D-79539 LÖRRACH (DUITSLAND)
H05BX02
PARICALCITOL 2 µg/stuk
Capsule, zacht
BUTYLHYDROXYTOLUEEN (E 321) ; ETHANOL 96 % 1,4 mg/stuk ; GELATINE (E 441) ; GLYCEROL (E 422) ; IJZEROXIDE ROOD (E 172) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD,
Oraal gebruik
Paricalcitol
Hulpstoffen: BUTYLHYDROXYTOLUEEN (E 321); ETHANOL 96 % 1,4 mg/stuk; GELATINE (E 441); GLYCEROL (E 422); IJZEROXIDE ROOD (E 172); TITAANDIOXIDE (E 171); TRIGLYCERIDEN MIDDELLANGE KETEN; WATER, GEZUIVERD;
2014-04-10
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PORONTAZIN 1 MICROGRAM, ZACHTE CAPSULES PORONTAZIN 2 MICROGRAM, ZACHTE CAPSULES paricalcitol 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 Porontazin is and what it is used for 2. What you need to know before you take Porontazin 3. How to take Porontazin 4. Possible side effects 5. How to store Porontazin 6. Contents of the pack and other information 1. WHAT PORONTAZIN IS AND WHAT IT IS USED FOR Porontazin contains the active substance paricalcitol, which is a synthetic form of active vitamin D. Active vitamin D is required for the normal functioning of many tissues in the body, including the parathyroid gland and bones. In people who have normal kidney function, this active form of vitamin D is naturally produced by the kidneys, but in kidney failure the production of active vitamin D is markedly reduced. Porontazin therefore provides a source of active vitamin D, when the body cannot produce enough and helps to prevent the consequences of low levels of active vitamin D, namely high levels of parathyroid hormone which can cause bone problems. Porontazin is used in adult patients with kidney disease Stages 3, 4 and 5 and children aged 10 to 16 years with kidney disease Stages 3 and 4. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PORONTAZIN DO NOT TAKE PORONTAZIN: - if you are ALLERGIC to paricalcitol or to any of the other ingredients of this medicine (listed in section 6). - if you have very high levels of CALCIUM or VITAMIN D in your blood. Your doc Կարդացեք ամբողջական փաստաթուղթը
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Porontazin 1 microgram, zachte capsules Porontazin 2 microgram, zachte capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule Porontazin 1 microgram contains 1 microgram paricalcitol Each capsule Porontazin 2 microgram contains 2 micrograms paricalcitol Excipients with know effect: Each capsule Porontazin 1 microgram contains 0.7 mg ethanol Each capsule Porontazin 2 microgram contains 1.4 mg ethanol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, soft. Porontazin 1 microgram are white to off-white, oval, soft-gelatin capsules containing a clear oily liquid. Porontazin 2 microgram are red, oval, soft-gelatin capsules containing a clear oily liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Porontazin is indicated in adult and paediatric patients 10 to 16 years of age for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease Stages 3 and 4. Porontazin is indicated in adult patients for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease Stage 5 in patients who are on haemodialysis or peritoneal dialysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology CHRONIC KIDNEY DISEASE (CKD) STAGES 3 AND 4 Porontazin should be administered once a day, either daily or three times a week taken every other day. INITIAL DOSE The initial dose is based on baseline intact parathyroid hormone (iPTH) levels. TABLE 1. INITIAL DOSE BASELINE IPTH LEVEL DAILY DOSE THREE TIMES A WEEK DOSE* ≤ 500 pg/ml (56 pmol/l) 1 microgram 2 micrograms > 500 pg/ml (56 pmol/l) 2 micrograms 4 micrograms * To be administered no more frequently than every other day 2 DOSE TITRATION Dosing must be individualised based on serum or plasma iPTH levels, with monitoring of serum calcium and serum phosphorus. Table 2 presents a suggested approach for dose titration. TABLE 2. DOSE TITRATION IPTH LEVEL RELATIVE TO BASELINE DOSE ADJUSTMENT AT 2 TO Կարդացեք ամբողջական փաստաթուղթը