Riik: Iisrael
keel: inglise
Allikas: Ministry of Health
CALCITONIN SALMON; CALCITONIN SALMON
GENMEDIX , ISRAEL
H05BA01
SOLUTION FOR INJECTION
CALCITONIN SALMON 100 IU/ML; CALCITONIN SALMON 100 IU/ML
I.M, I.V, S.C, I.M, I.V, S.C
Required
LABORATORIO ITALIANO BIOCHIMICO FARMACEUTICO LISAPHARMA S.P.A, ITALY
CALCITONIN (SALMON SYNTHETIC)
CALCITONIN (SALMON SYNTHETIC)
Calcitonin is indicated for:• Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures.• For the treatment of Paget's disease, only in patients who do not respond to alternative treatments or for whom such treatments are not suitable, for example those with severe renal impairment.• Treatment of hypercalcemia of malignancy. Calcitonin is indicated for:• Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures.• For the treatment of Paget's disease, only in patients who do not respond to alternative treatments or for whom such treatments are not suitable, for example those with severe renal impairment.• Treatment of hypercalcemia of malignancy.
2011-11-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SALCO 100 IU , solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SALCO 100 IU/ml solution for injection – 1 ampoule contains: _Active principle:_ Salmon calcitonin 100 IU/ML SALCO is essentially sodium-free, see section 4.4. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for intramuscular, intravenous and subcutaneous injection. Salco is a clear, colourless aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Calcitonin is indicated for: Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures. For the treatment of Paget's disease, only in patients who do not respond to alternative treatments or for whom such treatments are not suitable, for example those with severe renal impairment. Treatment of hypercalcemia of malignancy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Salmon calcitonin may be administered at bedtime to reduce the incidence of nausea or vomiting which may occur, especially at the initiation of therapy. Due to evidence of an increased risk of malignancies and long term calcitonin use (see section 4.4), the treatment duration in all indications should be limited to the shortest period of time possible and using the minimum effective dose. _Prevention of acute bone loss due to sudden immobilisation such as in patients _ _with recent osteoporotic fractures_ The recommended dosage is 100 IU daily or 50 IU twice daily, administered subcutaneously or intramuscularly. The dose may be reduced to 50 IU daily at the start of remobilisation. The recommended treatment duration is 2 weeks and should not exceed 4 weeks in any case due to the association of the increased risk of malignancies and long term calcitonin use. _Paget’s disease:_ The recommended dosage is 100 IU per day administered subcutaneously or intramuscularly, however, a minimum dosage regimen of 50 IU three times a week has achieved clinical and Lugege kogu dokumenti