MIACALCIC NASAL SPRAY 200 IU

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

SALCATONIN/CALCITONIN SALMON

MAH:

ZUELLIG PHARMA SDN BHD

INN:

SALCATONIN/CALCITONIN SALMON

units_in_package:

1Units Units; 1 Units Units

manufactured_by:

Delpharm Huningue S.A.S.

PIL

MIACALCIC
®
NASAL SPRAY
Synthetic salmon calcitonin (200IU/metered dose)
1
WHAT IS IN THIS LEAFLET
1.
What
_Miacalcic Nasal Spray_
is used
for
2.
How
_Miacalcic Nasal Spray_
works
3.
Before you use
_Miacalcic Nasal _
_Spray_
4.
How to use
_Miacalcic Nasal Spray_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Miacalcic _
_Nasal Spray_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _MIACALCIC NASAL SPRAY_ IS USED FOR
_PREVENTION OF OSTEOPOROSIS _
In
acute
bone
loss
due
to
sudden
immobilization such as in patients with
osteoporotic
fractures.
Miacalcic
should be supplemented with adequate
doses of calcium and vitamin D, as
needed
by
the
individual
patient,
to
prevent further loss of bone mass. The
maximum duration of treatment is 3
months.
_PAGET’S DISEASE (OSTEITIS DEFORMANS): _
Only in patients who do not respond to
alternative
treatments
or
for
whom
alternative treatments are not suitable:
The duration of treatment is normally 3
months
(also
refer
to
HOW
TO
USE
MIACALCIC NASAL SPRAY
).
_ALGODYSTROPHY _
_OR _
_SUDECK’S _
_DISEASE _
_(NEURODYSTROPHIC DISORDERS): _
Neurodystrophic
disorders
due
to
various causes and predisposing factors
such
as
post-
traumatic
painful
osteoporosis,
reflex
dystrophy,
shoulder-arm syndrome, causalgia and
drug- induced neurotrophic disorders.
The duration of treatment is up to 6
weeks.
HOW _MIACALCIC NASAL SPRAY_
WORKS
Calcitonin regulates the level of calcium
in the blood. It is used to reverse bone
loss and it is thought that it may also help
in bone formation.
If you have any questions about how
Miacalcic works or why this medicine
has been prescribed for you, ask your
doctor.
BEFORE YOU USE _MIACALCIC NASAL SPRAY _
•
_When you must not use it_
_ _
_Allergic reactions _
Since salmon calcitonin is a polypeptide,
allergic reactions are possible. Allergic-
type reactions, including isolated cases
of anaphylactic shock, have been
reported in patients receiving Miacalcic.
In patients with suspected
hypersensi

SPC

Page 1
Malaysian Package Leaflet Miacalcic Nasal Spray
Miacalcic  Nasal Spray
Regulator of calcium homeostasis .
DESCRIPTION AND COMPOSITION
Pharmaceutical form
Nasal spray solution in bottles fitted with a metering pump delivering at least 14 doses of 200
IU salmon calcitonin per actuation.
Active substance
T he active substance is synthetic salmon calcitonin (INN name c alcitonin).
One metered dose delivers 200 IU of synthetic salmon calcitonin.
One International Unit (= IU) corresponds to about 0.2 micrograms of synthetic salmon
calcitonin.
Active moiety
Salmo n calcitonin .
Excipients
Benzalkonium chloride, sodium chloride, hydrochloric acid (for pH adjust ment), water
(purified, Eur.P.) .
DESCRIPTION
Clear, colourless solution.
INDICATIONS
Miacalcic Nasal Spray is indicated for the treatment of:
Prevention of os teoporosis
In acute bone loss due to sudden immobilization such as in patients with osteoporotic
fractures (see PHARMACODYNAMICS ). Miacalcic should be supplemented with adequate
doses of calcium and vitamin D, as needed by the individual patient, to preve nt further loss of
bone mass. The maximum duration of treatment is 3 months.
Paget’s disease (osteitis deformans):
Only in patients who do not respond to alternative treatments or for whom alternative
treatments are not suitable: The duration of treatment is normally 3 months (also refer to
DOSAGE AND ADMINISTRATION).
Algodystrophy or Sudeck’s disease (neurodystrophic disorders):