MIACALCIC 50IU AMPOULES

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

CALCITONIN SALMON

Διαθέσιμο από:

ZUELLIG PHARMA SDN BHD

INN (Διεθνής Όνομα):

CALCITONIN SALMON

Μονάδες σε πακέτο:

5 Ampoules

Κατασκευάζεται από:

Solupharm Pharmazeutische Erzeugnisse GmbH

Αρχείο Π.Χ.Π.

NT Pharma
SmPC_Malaysia
_Reference: Malaysia Package Insert Sept-15 (Swiss-26-Mar-15) Author:
Rghuram A, Kappel J, Zhang S, Tracking No. 2014-_
_PSB/G>C-0696-s, Date of Release: 03-Jun 2014 _
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 strengths 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 acute 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.
Treatment of hypercalcaemia of malignancy.
DOSAGE AND ADMINISTRATION
Due to the association between long-term calcitonin use and the onset
of malignancies (see
"Warnings and Precautions"), 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:
NT Pharma
SmPC_Malaysia
_Reference: Malaysia Package Insert Sept-15 (Swiss-26-Mar-15) Author:
Rghuram A, Kappel J, Zhang S, Tracking No. 2014-_
_PSB/G>C-0696-s, Date of Release: 03-Jun 2014 _
The standard maintenance dose i