Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
PARICALCITOL
ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL
H05BX02
CAPSULES
PARICALCITOL 1 MCG
PER OS
Required
ABBVIE LTD., UK
PARICALCITOL
PARICALCITOL
Zemplar is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal insufficiency (chronic kidney disease stage 3 and 4 ) patients and chronic renal failure (chronic kidney disease stage 5) patients on haemodialysis or peritoneal dialysis.
2014-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 THE MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY ZEMPLAR 1 MICROGRAM Soft capsules THE ACTIVE INGREDIENT AND ITS QUANTITY: Each capsule of Zemplar 1 microgram )mcg( contains: paricalcitol 1 microgram )mcg( Inactive and allergenic ingredients – see section 6 “Further information” in this leaflet. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment/for you. Do not pass it on to others. It may harm them, even if it seems to you that their ailment/medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is indicated for the prevention and treatment of secondary hyperparathyroidism in patients who suffer from chronic renal insufficiency )chronic kidney disease at stage 3 or 4( or in patients suffering from renal failure )chronic kidney disease stage 5( and undergoing hemodialysis or peritoneal dialysis. THERAPEUTIC GROUP: An anti-parathyroid agent. This medicine is a synthetic form of active vitamin D. Active vitamin D is required for the normal function of many tissues in the body, including the parathyroid gland and bones. In people who have normal kidney function, this form of active vitamin D is produced naturally by the kidneys, but in people with kidney failure, the production of active vitamin D is markedly reduced. Zemplar therefore provides a source of active vitamin D when the body cannot produce enough active vitamin D, and helps to prevent the consequences of low levels of active vitamin D, namely, high levels of parathyroid hormone, which may cause bone problems. Zemplar is used in adult patients with chronic kidney disease )stages 3, 4 and 5(. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • you are sensitive )allergic( to the active ingredient Soma hati kamili
Zem Cap_API_Mar_2020_CL 1 Zemplar 1 microgram Soft Capsules Prescribing Information 1. NAME OF THE MEDICINAL PRODUCT Zemplar 1 microgram capsules, soft 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule of Zemplar 1 microgram contains 1 microgram of paricalcitol. Excipient with known effect: Each capsule of Zemplar 1 microgram contains 0.71 mg of ethanol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, soft 1 microgram capsule: oval, grey soft capsule imprinted with ZA 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Zemplar is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal insufficiency (chronic kidney disease Stages 3 and 4) patients and chronic renal failure (chronic kidney disease Stage 5) patients on haemodialysis or peritoneal dialysis. 4.2 Posology and method of administration Posology Chronic Kidney Disease (CKD) Stages 3 and 4 Zemplar should be administered once a day, either daily or three times a week taken every other day. Initial dose Zem Cap_API_Mar_2020_CL 2 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 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 4 Week Intervals Daily Dose Three Times a Week Dose 1 The same or increased Increase 1 microgram Increase 2 micrograms Decreased by < 30% Decreased by ≥30%, ≤60% Maintain Maintain Decreased > 60% Decrease 2 1 microgram Decrease 2 2 micrograms iPTH < 60 pg/ml (7 pmol/l) 1 To be administered no more frequently than every other day. 2 If a patient is taking Soma hati kamili