Miacalcic

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Salcatonin 100 IU/mL;  ;  

Available from:

Chiesi New Zealand Limited t/a Emerge Health

INN (International Name):

Salcatonin 100 IU/mL

Dosage:

100 IU/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Salcatonin 100 IU/mL     Excipient: Glacial acetic acid Nitrogen Sodium acetate trihydrate Sodium chloride Water for injection

Units in package:

Ampoule, glass, 5x1ml, 5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Novartis Pharma AG

Therapeutic indications:

Acute bone pain associated with hip arthroplasty osteolysis and osteoporotic vertebral compression fracture.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 5x1ml - 5 mL - 60 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze). The product manufactured at Solupharm Pharmaceutical Products GmbH & Co. KG.

Authorization date:

1976-09-23

Patient Information leaflet

New Zealand Consumer Medicine Information
MIACALCIC CMI V 2.0
1
MIACALCIC
Calcitonin salmon (salcatonin)
100 IU/1mL solution for injection
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using MIACALCIC.
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.
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 calcitonin salmon (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 acute bone pain when bone deteriorates
after hip repair or surgery, or
spinal compression fractures.

MIACALCIC is also used to treat hypercalcaemia (high calcium levels in
the blood). It helps to reduce
the level of calcium

Summary of Product characteristics

NEW ZEALAND DATA SHEET
MIACALCIC Data Sheet v 2.0
1
MIACALCIC AMPOULES
1
PRODUCT NAME
MIACALCIC 100 IU synthetic calcitonin salmon (salcatonin) solution for
injection or infusion.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is synthetic calcitonin salmon (salcatonin).
One millilitre contains 100 IU of synthetic calcitonin salmon
(salcatonin). One International Unit (=
IU) corresponds to about 0.2 micrograms of synthetic calcitonin salmon
(salcatonin).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
MIACALCIC is available as a solution for injection or infusion in
ampoules (1 mL) containing 100
IU/mL.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MIACALCIC solution for injection or infusion is indicated for the
treatment of:-
ACUTE BONE PAIN ASSOCIATED WITH HIP ARTHROPLASTY OSTEOLYSIS AND
OSTEOPOROTIC VERTEBRAL
COMPRESSION FRACTURE.
PAGET'S DISEASE OF BONE (OSTEITIS DEFORMANS), ONLY IN PATIENTS WITH
THE FOLLOWING CONDITIONS
AND WHO DO NOT RESPOND TO ALTERNATIVE TREATMENTS OR FOR WHOM SUCH
TREATMENTS ARE NOT
SUITABLE:

Bone pain

Neurological complications

Increased bone turnover reflected in elevated serum alkaline
phophastase and urinary
hydroxyproline excretion

Progressive extension of bone lesions

Incomplete or repeated fractures
HYPERCALCAEMIA AND HYPERCALCAEMIC CRISIS DUE TO:

tumoural osteolysis secondary to breast, lung or kidney carcinoma,
myeloma and other
malignancies,

hyperparathyroidism, immobilisation or vitamin D intoxication,

for both the acute treatment of emergencies and the prolonged
treatment of chronic
hypercalcaemia, until specific therapy of the underlying condition
proves effective.
NEURODYSTROPHIC DISORDERS (SYNONYMOUS WITH ALGODYSTROPHY, SUDECK'S
DISEASE OR COMPLEX
REGIONAL PAIN SYNDROME), IN CONJUNCTION WITH PHYSIOTHERAPHY:
NEW ZEALAND DATA SHEET
MIACALCIC Data Sheet v 2.0
2

Caused by various aetiological and predisposing factors such as
post-traumatic painful
osteoporosis, reflex dystrophy, shoulder-arm syn