MIACALCIC INJECTION 50 iuml

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

SALMON-CALCITONIN SYNTHETIC

Dostopno od:

ZUELLIG PHARMA PTE. LTD.

Koda artikla:

H05BA01

Odmerek:

50 iu/ml

Farmacevtska oblika:

INJECTION

Sestava:

SALMON-CALCITONIN SYNTHETIC 50 IU/ml

Pot uporabe:

INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR

Tip zastaranja:

Prescription Only

Izdeluje:

Solupharm Pharmazeutische GMbH

Status dovoljenje:

ACTIVE

Datum dovoljenje:

1990-06-26

Navodilo za uporabo

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._

Lastnosti izdelka

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
calci-
tonin. 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 0.5mL (four times 100IU)
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 treat-
ments are not suitable.
Hypercalemia 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 post-
traumatic painful osteoporosis, reflex dystrophy, shoulder arm
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