البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
CINACALCET AS HYDROCHLORIDE
TEVA ISRAEL LTD
H05BX01
TABLETS
CINACALCET AS HYDROCHLORIDE 30 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
CINACALCET
Treatment of secondary hyperparathyrodism (HPT) in patients with end-dtage renal disease (ESRD) on maintenance dialysis therapy. cinacalcet teva may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate. Reduction of hypercalcaemia in patients with parathyroid carcinoma.Reduction of hypercalcaemia in patients with:• parathyroid carcinoma.• primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
2020-08-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986 The medicine is dispensed with a doctor’s prescription only CINACALCET TEVA 30 MG TABLETS COMPOSITION: Each tablet contains: Cinacalcet )as hydrochloride ( 30 mg CINACALCET TEVA 60 MG TABLETS COMPOSITION: Each tablet contains: Cinacalcet )as hydrochloride ( 60 mg CINACALCET TEVA 90 MG TABLETS COMPOSITION: Each tablet contains: Cinacalcet )as hydrochloride ( 90 mg For information about inactive ingredients, please see section 6 - “Further information”. 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 your treatment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. THIS MEDICINE IS NOT INTENDED FOR CHILDREN UNDER 18 YEARS OF AGE. 1. WHAT IS THE MEDICINE INTENDED FOR? • This medicine is intended to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products. • To reduce hypercalcemia )high levels of calcium in the blood( in patients with parathyroid cancer. • To reduce high levels of calcium in the blood )hypercalcemia( in patients with primary hyperparathyroidism when removal of the gland is not possible. THERAPEUTIC GROUP: The medicine controls the levels of calcium and has anti-parathyroid activity. It is used to treat ailments caused by impaired function of organs called the parathyroid glands. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: you are sensitive )allergic( to the active ingredient – cinacalcet or to any of the additional ingredients contained in the medicine )listed in section 6(. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE: Consult your doctor or pharmacist or nurse before taking Cinacalcet Teva. BEFORE TREATMENT WITH CINACALCET TEVA, TELL THE DOCTOR IF: You hav اقرأ الوثيقة كاملة
Cinacalcet Teva 30/60/90 mg Tab New SPC Notification 08-2020 RC 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cinacalcet Teva 30 mg film-coated tablets Cinacalcet Teva 60 mg film-coated tablets Cinacalcet Teva 90 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg cinacalcet (as hydrochloride). Each tablet contains 60 mg cinacalcet (as hydrochloride). Each tablet contains 90 mg cinacalcet (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. 30 mg tablets: Light green to green, oval shaped tablet, debossed with "C30" on one side of the tablet and plain on the other side. 60 mg tablets: Light green to green, oval shaped tablet, debossed with "C60" on one side of the tablet and plain on the other side. 90 mg tablets: Light green to green,, oval shaped tablet, debossed with "C90" on one side of the tablet and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Cinacalcet Teva may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1). Reduction of hypercalcaemia in patients with: • parathyroid carcinoma. • primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Secondary hyperparathyroidism _ _ Cinacalcet Teva 30/60/90 mg Tab New SPC Notification 08-2020 RC 2 _Adults and elderly (> 65 years) _ The recommended starting dose for adults is 30 mg once per day. Cinacalcet Teva should be titrated every 2 to 4 weeks to a maximum dose of 180 mg once daily to achieve a target parathyroid hormone (PTH) in dialysis patients of between 150-300 pg/ml (15.9-31.8 pmol/l) in t اقرأ الوثيقة كاملة