MIACALCIC INJECTION 100 iuml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

SALMON-CALCITONIN SYNTHETIC

Available from:

ZUELLIG PHARMA PTE. LTD.

ATC code:

H05BA01

Dosage:

100 iu/ml

Pharmaceutical form:

INJECTION

Composition:

SALMON-CALCITONIN SYNTHETIC 100 iu/ml

Administration route:

INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Solupharm Pharmazeutische Erzeugnisse GmbH

Authorization status:

ACTIVE

Authorization date:

1990-06-26

Patient Information leaflet

MIACALCIC

 AMPOULES 50 IU/ML AND 100 IU/ML (1 ML) SOLUTION FOR 
INJECTION OR INFUSION 
MIACALCIC

  MULTIDOSE  VIALS  200  IU/ML  (2  ML)  SOLUTION  FOR  INJECTION  OR 
INFUSION 
Regulator of calcium homeostasis 
DESCRIPTION AND COMPOSITION 
ACTIVE SUBSTANCE 
The active substance is synthetic salmon calcitonin
(INN name Calcitonin). 
One millilitre contains 50 IU, 100 IU or 200 IU of synthetic salmon calcitonin. 
One  International  Unit  (=  IU)  corresponds  to  about  0.2  micrograms  of  synthetic  salmon 
calcitonin. 
ACTIVE MOIETY 
SALMON CALCITONIN PHARMACEUTICAL FORMS 
Miacalcic
®
 is available as a solution for injection or infusion in: 

  ampoules (1 mL) containing 50 IU/mL or 100 IU/mL 

  multidose vials* (2 mL) containing 200 IU/mL 

  The  amount  of  solution  contained  in  each  multidose  vial  is  sufficient  for  4  injections  of 
0.5 mL (four times 100 IU). 
Certain dosage strengths may not be available in all countries. 
INDICATIONS 
Miacalcic solution for injection or infusion is indicated for the
treatment of: 
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 
HYPERCALCEMIA AND HYPERCALCEMIC CRISIS DUE TO 

  tumoral  osteolysis  secondary  to  breast,  lung  or  kidney  carcinoma,  myeloma  and  other 
malignancies, 

  hyperparathyroidism, immobilization or vitamin D intoxication, 
Novartis 

Page 2 
International Package Leaflet 
01 July 2014 
Miacalcic Ampoules 

for  both  the  acute  treatment  of  emergencies  and  the  prolonged  treatment  of  chronic 
hypercalcemia, until specific therapy of the underlying condition
proves effective._

Summary of Product characteristics

MIACALCIC
® AMPOULES 50 IU/ML AND 100 IU/ML (1 ML) SOLUTION FOR
INJECTION OR INFUSION
MIACALCIC
® MULTIDOSE VIALS 200 IU/ML (2 ML) SOLUTION FOR INJECTION
OR INFUSION
Regulator of calcium homeostasis
DESCRIPTION AND COMPOSITION
ACTIVE SUBSTANCE
The
active
substance
is
synthetic
salmon
calcitonin
(INN
name
Calcitonin).
One millilitre contains 50 IU, 100 IU or 200 IU of synthetic salmon
calcitonin.
One International Unit (= IU) corresponds to about 0.2 micrograms of
synthetic salmon calcitonin.
ACTIVE MOIETY
SALMON CALCITONIN PHARMACEUTICAL FORMS
Miacalcic
®
is available as a solution for injection or infusion in:
• ampoules (1 mL) containing 50 IU/mL or 100 IU/mL
• multidose vials* (2 mL) containing 200 IU/mL
• The amount of solution contained in each multidose vial is
Certain dosage strengths may not be available in all countries.
INDICATIONS
Miacalcic
solution
for
injection
or
infusion
is
indicated
for
the
treatment of:
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
HYPERCALCEMIA AND HYPERCALCEMIC 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 hypercalcemia, until specific therapy of the
underlying condition proves effective.
NEURODYSTROPHIC DISORDERS (SYNONYMOUS WITH ALGODYSTROPHY OR
SUDECK’S DISEASE)
Caused by various etiological and predisposing factors such as
syndrome, causalgia, drug-induced neurotrophic disorders.
ADJUVANT THERAPY OF ACUTE PANCREATITIS
DOSAGE AND ADMINISTRATION
DOSAGE
ADULTS
ALL INDICATIONS
The solution in the multidose vials can be used for subcutaneous (s.c)
or intramuscular (i.m), injection or for continuous intravenous (i.v)
infusion, but is not suitable for i.v. bolus injection as it contains
phenol