MIACALCIC 100IU AMPOULES

Ülke: Malezya

Dil: İngilizce

Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktif bileşen:

SALCATONIN/CALCITONIN SALMON

Mevcut itibaren:

ZUELLIG PHARMA SDN BHD

INN (International Adı):

SALCATONIN/CALCITONIN SALMON

Paketteki üniteler:

5Units Units

Tarafından üretildi:

NOVARTIS PHARMA STEIN AG

Ürün özellikleri

Novartis Page 1
Malaysian Package Leaflet 01 Jul 2014 Miacalcic Ampoules
Miacalcic  Ampoules
Regulator of calcium homeostasis
DESCRIPTION AND COMPOSITION
Pharmaceutical forms
Miacalcic
® is available as a solution for injection or infusion in:
• ampoules (1 mL) containing 50 IU/mL or 100 IU/mL.
Active substance
The active substance is synthetic salmon calcitonin (INN name Calcitonin).
One millilitre contains 50 IU or 100 IU of synthetic salmon calcitonin.
One International Unit (= IU) corresponds to about 0.2 micrograms of synthetic salmon calcitonin.
Certain dosage strengt hs may not be available in all countries.
Active moiety
Salmon calcitonin.
Excipients
Acetic acid, sodium acetate trihydrate, sodium chloride, water for injections.
INDICATIONS
Miacalcic solution for injection or infusion is indicated for:
Prevention of ac ute bone loss due to sudden immobilization such as in patients with recent
osteoporotic fractures. The duration of treatment should not be more than 4 weeks.
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. The duration of treatment is limited to 3 months.
Treatement of hypercalcaemia of malignancy.
DOSAGE AND ADMINISTRATION
Due to the association between long- term calcitonin use and the onset of malignancies (see
"Warnings and P recautions"), treatment with calcitonin in all indications should be limited to
the shortest period of time possible and using the lowest effective dose.
Prevention of Osteoporosis
The lowest effective dose is not yet precisely known. The following dosage is currently
recommended: