MIACALCIC

Ülke: Endonezya

Dil: Endonezce

Kaynak: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktif bileşen:

CALCITONIN, SALMON

Mevcut itibaren:

PYRIDAM FARMA TBK - Indonesia

INN (International Adı):

CALCITONIN, SALMON

Doz:

100 IU

Farmasötik formu:

INJEKSI

Paketteki üniteler:

DUS, 5 AMPUL @ 1 ML

Tarafından üretildi:

SOLUPHARM PHARMAZEUTISCHE ERZEUGNISSE GMBH - Federal Republic of Germany

Yetkilendirme tarihi:

2022-01-28

Ürün özellikleri

MIACALCIC®
Ampoules
Description and composition
Pharmaceutical form
Ampoules (1 mL) contains 50 and 100 IU of synthetic salmon calcitonin.
Active substance
Active ingredients: Synthetic salmon calcitonin
One International Unit (=IU) corresponds to about 0.2 micrograms of
the drug
substance.
Active moiety
Salmon calcitonin.
Excipients
Glacial acetic acid, sodium acetate trihydrate, sodium chloride, water
for Injection.
Indications
Miacalcic solution for injection is indicated for the treatment of:
Osteoporosis in patients for whom alternative treatments are not
suitable
Primary osteoporosis, e.g. early and advanced stages of postmenopausal
osteoporosis
and senile osteoporosis in women and men.
Bone pain associated with osteolysis and/or osteopenia
PAGET’s disease of bone (osteitis deformans) only in patients who do
not
respond to alternative treatments or for whom such treatments are not
suitable
Hypercalcaemia and hypercalcaemic crisis due to
•
Tumoral osteolysis secondary to breast, lung or kidney carcinoma,
myeloma and other
malignancies.
•
Hyperparathyroidism, immobilization or vitamin D intoxication
For both the acute treatment of emergencies and the prolonged
treatment of chronic states, until
specific therapy of the underlying condition proves effective.
Neurodystropic disorders (synonymus with algodystrophy or SUDECK’S
DISEASE)
Due to various aetiological factors such as post-traumatic painful
osteoporosis, reflex
dystrophy, shoulder-arm syndrome, causalgia, drug-induced neurotrophic
disorders.
Dosage and administration
Dosage
All indications
Patients should receive precise instruction in the self-administration
of subcutaneous
injections from the physician or the nurse.
DISETUJUI OLEH BPOM : 21/01/2022
EREG100193VR12100050 - 51
Due to the association between occurrence of malignancies and long
term calcitonin
use (see section Special warnings and precautions for use), the
treatment duration in
all indications should be limited to the shortest period of time
possible and using the
lowest effective