AURO-RISEDRONATE 30 risedronate sodium 30mg tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

risedronate sodium hemipentahydrate, Quantity: 34.43 mg (Equivalent: risedronate sodium, Qty 30 mg)

Dostopno od:

Arrotex Pharmaceuticals Pty Ltd

INN (mednarodno ime):

Risedronate sodium hemipentahydrate

Farmacevtska oblika:

Tablet, film coated

Sestava:

Excipient Ingredients: lactose monohydrate; hyprolose; crospovidone; microcrystalline cellulose; magnesium stearate; hypromellose; macrogol 400; titanium dioxide

Pot uporabe:

Oral

Enote v paketu:

28, 14

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Treatment of Paget?s disease of bone

Povzetek izdelek:

Visual Identification: White to off-white coloured, circular shaped film coated biconvex tablets debossed with 'L' on one side and '30' on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2012-10-03

Navodilo za uporabo

AURO-RISEDRONATE
CONSUMER MEDICINE INFORMATION
Ver 1.1
Page 1 of 4
AURO-RISEDRONATE 5, 30 & 35
Risedronate Sodium (as hemipentahydrate)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers some
common
questions
about
AURO-
RISEDRONATE.
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
AURO-RISEDRONATE
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
AURO-RISEDRONATE IS
USED FOR
AURO-RISEDRONATE
is
used
to
treat bone disease and belongs to a
group
of
medicines
called
bisphosphonates.
AURO-RISEDRONATE
works
directly on your bones to make them
stronger and therefore less likely to
break or fracture.
AURO-RISEDRONATE 5mg daily &
35mg Once-a- Week tablets are used
to treat:
•
osteoporosis (brittle or fragile
bones that may fracture easily)
•
osteoporosis caused by taking
steroids
AURO-RISEDRONATE
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

Lastnosti izdelka

Product Information:
AURO-RISEDRONATE (Risedronate Sodium Tablets 5 mg, 30 mg & 35 mg)
Ver 1.1
Page 1 of 22
PRODUCT INFORMATION
AURO-RISEDRONATE 5 (5 MG RISEDRONATE SODIUM TABLETS)
AURO-RISEDRONATE 30 (30 MG RISEDRONATE SODIUM TABLETS)
AURO-RISEDRONATE 35 (35 MG RISEDRONATE SODIUM TABLETS)
NAME OF THE MEDICINE
Risedronate Sodium Hemipentahydrate
CHEMICAL
NAME:
[1-hydroxy-2-(3-pyridinyl)-ethylidene]Bisphosphonic
acid
monosodium
salt,
hemipentahydrate
MOLECULAR FORMULA:
C
7
H
10
NO
7
P
2
Na.2.5 H
2
O
MOLECULAR WEIGHT:
350.13
CAS REGISTRY NUMBER:
_[329003-65-8]_
DESCRIPTION
Risedronate sodium hemipentahydrate is a white to off-white powder. It
is soluble in water and
insoluble in common organic solvents.
AURO-RISEDRONATE 5, 30 & 35 is available as tablets containing 5 mg,
30 mg & 35 mg
risedronate sosium as hemipentahydrate.
AURO-RISEDRONATE tablets contain following inactive ingredients:
Lactose, microcrystalline
cellulose (PH 101 & PH 102), hydroxypropylcellulose, crospovidone,
magnesium stearate.
Each
AURO-RISEDRONATE
5
tablet
also
contains
Opadry
Yellow
20C82695
(PI
ARTG-
106484).
Each AURO-RISEDRONATE 30 tablet also contains hypromellose, macrogol
400 & titanium
dioxide.
Each AURO-RISEDRONATE 35 tablet also contains Opadry Brown 20C86893
(PI ARTG-
106485).
PHARMACOLOGY
Risedronate is a potent pyridinyl bisphosphonate that binds to bone
hydroxyapatite and inhibits
osteoclast-mediated
bone
resorption.
Risedronate
is
a
third
generation
bisphosphonate.
In
Product Information:
AURO-RISEDRONATE (Risedronate Sodium Tablets 5 mg, 30 mg & 35 mg)
Ver 1.1
Page 2 of 22
preclinical studies risedronate demonstrated potent anti-osteoclast
and anti-resorptive activity,
increasing bone mass and biomechanical strength dose-dependently. The
activity of risedronate was
confirmed by bone marker measurements during pharmacodynamic and
clinical studies. With
risedronate 5 mg daily, decreases in biochemical markers of bone
turnover were observed within 1
month of treatment and reached a maximum decrease in 3-6 months,
remaining stable