ATELVIA ONCE-A-MONTH risedronate sodium 150 mg tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

risedronate sodium

제공처:

Theramex Australia Pty Ltd

INN (International Name):

Risedronate sodium

승인 상태:

Registered

환자 정보 전단

ATELVIA
®
- CMI Version 1.0
1
ATELVIA
®
_risedronate sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Atelvia.
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 taking Atelvia
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ATELVIA IS USED
FOR
Atelvia is used to treat bone disease
and belongs to a group of medicines
called bisphosphonates.
Atelvia works directly on your bones
to make them stronger and therefore
less likely to break or fracture.
Atelvia 5mg daily, 35mg Once-a-
Week and 150mg Once-a-Month
tablets are used to treat:
•
osteoporosis (brittle or fragile
bones that may fracture easily)
•
osteoporosis caused by taking
steroids
Atelvia 30mg tablets are used to
treat:
•
Paget's disease of the bone.
These conditions are caused by
changes in the way bone is normally
maintained.
_UNDERSTANDING BONE _
Bone is a living tissue consisting of
calcium and other minerals.
Throughout life, old bone is
constantly broken down and replaced
with new bone. After the age of 35,
bone loss may occur faster than your
body can replace it. If you lose too
much bone then they become weaker
and are more likely to break.
_OSTEOPOROSIS _
Osteoporosis (brittle bone disease) is
a disease that causes bones to
become weaker. Weak bones break
(fracture) easily.
Many patients with osteoporosis have
no symptoms and may not even
know that they have osteoporosis.
However osteoporosis makes you
more likely to break bones when you
have a fall or bump. The spine, hip
and wrist are the most likely bones to
break, although this can happen to
any bone in your body. Osteoporosis
can also cause back pain, height loss
and a curved back.
Osteoporosis is common in w

제품 특성 요약

Theramex Australia Pty Ltd Version 1.0 1
PRODUCT INFORMATION
ATELVIA
®
, ATELVIA
® COMBI & ATELVIA
® COMBI D
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Risedronate, Calcium carbonate, Cholecalciferol
NON-PROPRIETARY NAME
Risedronate
Each ATELVIA
®
tablet contains the equivalent of 5, 30, 35, 75 or 150 mg of
risedronate sodium.
The empirical formula for risedronate sodium is C
7
H
10
NO
7
P
2
Na. The chemical name of risedronate
sodium is [1-hydroxy-2-(3- pyridinyl)ethylidene]bis(phosphonic acid)
monosodium salt.
Calcium Carbonate Tablet
Also contains 1250 mg calcium carbonate tablets. Each calcium tablet
contains 1250 mg calcium
carbonate, which is equivalent to 500 mg elemental calcium.
Calcium Carbonate/Cholecalciferol Sachet
Each sachet contains 2500 mg calcium carbonate and 22
µ
g (880 IU) cholecalciferol, which is
equivalent to 1000 mg elemental calcium and 22
µ
g (880 IU) vitamin D3. The terms cholecalciferol
and vitamin D3 are equivalent. The chemical name of cholecalciferol is
(5Z,7E)-9,10-secocholesta-
5,7,10(19)-trien-3β-ol. Molecular formula: C
27
H
44
O.
CHEMICAL STRUCTURE
The chemical structure of risedronate sodium is the following:
Molecular Weight: 305.10
The CAS registry number is 115436-72-1
The chemical structure of cholecalciferol:
Molecular Weight: 384.6
The CAS registry number is 67-97-0
Theramex Australia Pty Ltd Version 1.0 2
DESCRIPTION
Risedronate sodium is a fine, white to off-white, odourless,
crystalline powder. It is soluble in water
and in aqueous solutions and essentially insoluble in common organic
solvents.
Calcium carbonate is a white powder, practically insoluble in water,
with a relative molecular
weight of 100.1.
Cholecalciferol is a secosterol that is a natural precursor of the
calcium-regulating hormone
calcitriol (1,25-dihydroxyvitamin).
Risedronate
Each ATELVIA
®
tablet contains risedronate sodium (5, 30, 35, 75 or 150 mg), lactose
(5, 30 or 35
mg tablets only), crospovidone, magnesium stearate, microcrystalline
cellulose, hydroxypropyl
cellulose, hypromellose,