MIACALCIC NASAL 200 200 iudose

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

SALMON CALCITONIN SYNTHETIC

Disponible des:

ZUELLIG PHARMA PTE. LTD.

Codi ATC:

H05BA01

Dosis:

200 iu/dose

formulario farmacéutico:

SPRAY

Composición:

SALMON CALCITONIN SYNTHETIC 200 iu/dose

Vía de administración:

NASAL

tipo de receta:

Prescription Only

Fabricat per:

Delpharm Huningue S.A.S

Estat d'Autorització:

ACTIVE

Data d'autorització:

1998-10-08

Informació per a l'usuari

MIACALCIC


NASAL SPRAY 
Regulator of calcium homeostasis 
DESCRIPTION AND COMPOSITION 
ACTIVE SUBSTANCE  
The active substance is synthetic salmon calcitonin
(INN name calcitonin). 
One metered dose delivers 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 FORM  
Nasal Spray solution in bottles fitted with a metering pump delivering at least 14 doses of 50 
IU, 100 IU or 200 IU salmon calcitonin per actuation. 
Certain dosage strengths may not be available in all countries. 
INDICATIONS 
Miacalcic Nasal Spray 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  
Neurodystrophic disorders (synonymous with algodystrophy or Sudeck's
disease) 
Neurodystrophic  disorders  caused  by  various  etiological  and  predisposing  factors  such  as 
post-traumatic  painful  osteoporosis,  reflex  dystrophy,  shoulder-arm  syndrome,  causalgia, 
drug-induced neurotrophic disorders. 
DOSAGE AND ADMINISTRATION 
DOSAGE 
ADULTS
_ _
ALL INDICATIONS 
It is recommended to administer Miacalcic Nasal Spray per
actuation to alternating nostrils. 
Novartis 

Page 2 
International Package Leaflet 
01 Jul 2014 
Miacalcic Nasal Spray 

Due to the association between occurrence of malignancies and long term calcitonin use (see 
section WARNINGS AND PRECAUTIONS), the treatment duration in all indications should 
be limited to the shortest period of time possible and using the
lowest effective dose. 
BONE PAIN ASSOCIATED WITH OSTEOLYSIS AND/OR OSTEOPEN

Fitxa tècnica

MIACALCIC
® NASAL SPRAY
Regulator of calcium homeostasis
DESCRIPTION AND COMPOSITION
ACTIVE SUBSTANCE
The
active
substance
is
synthetic
salmon
calcitonin
(INN
name
calcitonin).
One metered dose delivers 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 FORM
Nasal Spray solution in bottles fitted with a metering pump delivering
at least 14 doses of 50 IU, 100 IU or 200 IU salmon calcitonin per
actuation.
Certain dosage strengths may not be available in all countries.
INDICATIONS
Miacalcic Nasal Spray 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
Neurodystrophic
disorders
(synonymous
with
algodystrophy
or
Sudeck’s disease)
Neurodystrophic
disorders
caused
by
various
etiological
and
predisposing factors such as post-traumatic painful osteoporosis,
reflex dystrophy, shoulder-arm syndrome, causalgia, drug-induced
neurotrophic disorders.
DOSAGE AND ADMINISTRATION
DOSAGE
ADULTS
ALL INDICATIONS
It is recommended to administer Miacalcic Nasal Spray per actuation
to alternating nostrils.
Due to the association between occurrence of malignancies and long
term calcitonin use (see section WARNINGS AND PRECAUTIONS), the
treatment duration in all indications should be limited to the
shortest
period of time possible and using the lowest effective dose.
BONE PAIN ASSOCIATED WITH OSTEOLYSIS AND/OR OSTEOPENIA
In
bone
pain
associated
with
osteolysis
and/or
osteopenia
the
recommended dose is 200-400 IU daily. Up to 200 IU may be
administered as a single dose; in cases where a higher dosage is
required, it should be given in divided doses.
Dosage should be adjusted to the individual patient’s needs.
It may take several days of treatment until the analgesic effect is
fully
developed. For