Miacalcic 100IU/1mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

calcitonin salmon, Quantity: 100 IU/mL

Available from:

Chiesi Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium acetate; sodium chloride; glacial acetic acid; water for injections

Administration route:

Intramuscular, Subcutaneous, Intravenous

Units in package:

5 x 1mL

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

- Active Paget's diseasein patients who do not respond to alternative treatments or for whom such treatments are not suitable,- Hypercalcaemia.

Product summary:

Visual Identification: Clear, colourless solution, practically free of visible foreign particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-21

Patient Information leaflet

MIACALCIC
®
1
MIACALCIC
®
_salcatonin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Miacalcic.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page.
Some more recent information on the
medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Miacalcic
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MIACALCIC IS
USED FOR
Miacalcic contains salcatonin, which
is similar to calcitonin, a hormone
produced by the body.
•
Miacalcic is used to treat Paget's
disease when other therapies
cannot be used or have proven
unsuccessful
Paget's disease is a chronic disorder
of the bones of the skeleton. Bone is
a living tissue and, just like other
parts of the body, it is constantly
being renewed. This process is called
bone remodelling.
Remodelling involves two types of
bone cells - osteoclasts, which break
down old bone and osteoblasts,
which make new bone. In people
with Paget's disease the osteoclasts in
some bones are overactive, causing
the bone to break down more quickly
than usual. The osteoblasts then try
to work faster to replace the lost
bone. The new bone that is formed
may be thicker but weaker than
normal, which can cause pain and
may lead to fractures (broken bones).
Miacalcic works by slowing down
the breakdown of bone by the
osteoclasts. This allows bone
remodelling to go back to normal and
protects the bones from being
weakened. Miacalcic may also
relieve bone

Summary of Product characteristics

1
MIACALCIC®
(SALCATONIN)
NAME OF THE MEDICINE
Salcatonin is a synthesised polypeptide hormone structurally identical
with salmon calcitonin. It
contains 32 amino-acids in linear sequence with a disulphide bridge at
position 1 and 7 and a
molecular weight of 3431.9 (free peptide). Salcatonin is a white or
grey-tinged white
amorphous powder. It is very soluble in water and very slightly
soluble in alcohol.
Chemical structure:
CAS number: 47931-85-1
H-Cys-Ser-Asn-Leu-Ser-Thr-Cys-Val-Leu-Gly-Lys-Leu-Ser-Gln-Glu-Leu-His-Lys-Leu-Gln-Thr-Tyr-Pro-Arg-Thr-Asn-Thr-Gly-Ser-Gly-Thr-Pro-NH
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Naturally-occurring calcitonin is synthesised by parafollicular cells
in the thyroid gland of
mammals and the ultimobranchial gland of birds and fish. The potency
of salmon calcitonin is
standardised according to its ability to lower plasma calcium levels
of rats as compared to the
International Reference standard.
DESCRIPTION
Each mL MIACALCIC injection contains 50 or 100 I.U. salcatonin
(present as polyacetate
polyhydrate), sodium acetate 0.2%, glacial acetic acid 0.2% and sodium
chloride 0.75%.
PHARMACOLOGY
PHARMACOTHERAPEUTIC GROUP, ATC CODE
: Regulator of calcium homeostasis, H05BA01.
The secretion and biosynthesis of calcitonin in both animals and man
are regulated by the
concentration of calcium in plasma. When the calcium concentration is
high the amount of the
hormone increases.
The pharmacological activity of salmon calcitonin is the same as that
of mammalian calcitonin.
In man, data on relative potency are sparse, but salcatonin is thought
to be at least 10-40 times
as potent by weight as porcine or human calcitonin in producing
hypocalcaemia depending on
methodology. Presumably due to its greater affinity for receptor
binding sites in bone and
kidney, and slower rate of metabolism, salcatonin has a longer
duration of action.
Calcitonin inhibits osteoclastic bone resorption, altering both the
number and/or resorptive
activity of osteoclasts