ALENDRONATE PLUS D3 CAL alendronic acid (as sodium) 70 mg and colecalciferol 140 microgram tablet and calcium 500 mg tablet comp

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

calcium carbonate, Quantity: 1.25 g (Equivalent: calcium, Qty 500 mg)

Beszerezhető a:

Dr Reddys Laboratories Australia Pty Ltd

INN (nemzetközi neve):

alendronate sodium,colecalciferol,Calcium carbonate,microcrystalline cellulose

Gyógyszerészeti forma:

Tablet, film coated

Összetétel:

Excipient Ingredients: microcrystalline cellulose; crospovidone; croscarmellose sodium; povidone; magnesium stearate; hypromellose; macrogol 8000; chlorophyllin-copper complex; titanium dioxide; Carnauba Wax

Az alkalmazás módja:

Oral

db csomag:

4 week supply (4 x Alendronate Plus D3-DRLA 70 mg/ 140 ug alendronic acid (as sodium) 70 mg and colecalciferol 140 microgram tab

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

for the treatment of: ? Osteoporosis in select patients where vitamin D and calcium supplementation is recommended,Prior to treatment, osteoporosis must be confirmed by: ? the finding of low bone mass of at least 2 standard deviations below the gender specific mean for young adults or by ? the presence of osteoporotic fracture

Termék összefoglaló:

Visual Identification: Capsule shaped dark green film coated tablet with a break bar on one side; Container Type: Multiple containers; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Engedélyezési státusz:

Licence status A

Engedély dátuma:

2015-01-14

Betegtájékoztató

ALENDRONATE
PLUS
D3 CAL 70 MG/ 140 ΜG
_Contains the active ingredient alendronate sodium/colecalciferol and
calcium carbonate _
CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
of
the
common questions about Alendronate
Plus
D3
Cal
70
mg/
140
µg.
It
is
particularly
important
that
you
read
the
sections
“When
to
take
it”
and
“How to take it” before you take this
medicine. This leaflet does not contain
all the available information.
It does not take the place of talking to
your doctor and pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking Alendronate Plus D3 Cal
against the benefits they expect it will
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
ALENDRONATE
PLUS D3 CAL IS USED FOR
Alendronate
Plus
D3
Cal
is
a
combination medicine consisting of 4
once weekly tablets of Alendronate
Plus
D3
-
DRLA
70
mg/
140
µg
(5600
IU)
together
with
24
or
48
tablets of ReddyCal.
Alendronate Plus D3 Cal is used to
treat
osteoporosis
and
to
provide
additional
vitamin
D
and
additional
calcium.
Osteoporosis is caused by changes in
the way bone is normally maintained.
Vitamin
D
is
an
essential
nutrient
required for calcium
absorption and
healthy bones. Calcium is an essential
mineral,
necessary
to
maintain
the
bone structure in the body.
_UNDERSTANDING BONE _
Bone
is
a
living,
growing
tissue.
Throughout
life,
our
bodies
are
breaking
down
old
bone
and
rebuilding new bone in a continuous
cycle. Until our late 20s, while bones
are still developing, we gain bone by
building more than we lose. From then
until
about
age
35
the
process
is
usually in balance, so that the amount
of
bone
lost
is
about
equal
to
the
amount that is replaced. This balanced
process keeps your skeleton healthy
and strong. After about age 35 this
balance is disturbed, with bone loss
occurring at a slightly faster rate than
it can be replaced. In women, after
m

Termékjellemzők

Product Information Alendronate Plus D3 Cal PI 1 of 24
ALENDRONATE PLUS D3 CAL
COMPOSITE PACK
NAME OF THE MEDICINE
Alendronic sodium and colecalciferol, and, calcium carbonate composite
pack.
ALENDRONATE SODIUM
Chemical Name:
(4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt
trihydrate.
Structural Formula:
CAS Number:
121268-17-5
Molecular Formula:
C
4
H
12
NNaO
7
P
2
•3H
2
O
Molecular Weight:
325.12
COLECALCIFEROL
Chemical Name:
colecalciferol(5_Z_,7_E_)-9,10-secocholesta-5,7,10(19)-trien-3β-ol.
colecalciferol
Structural Formula:
CAS Number:
67-97-0
Molecular Formula:
C
27
H
44
O
Molecular Weight:
384.6
CALCIUM CARBONATE
Calcium carbonate is described chemically as carbonic acid calcium
salt (1:1). The empirical formula of
calcium carbonate is CaCO
3
and its molecular weight is 100.09. The CAS Registry Number is
471-34-1.
DESCRIPTION
Alendronate sodium is a bisphosphonate that acts as a potent, specific
inhibitor of osteoclast- mediated
bone
resorption.
Bisphosphonates
are
synthetic
analogs
of
pyrophosphate
that
bind
to
the
Product Information Alendronate Plus D3 Cal PI 2 of 24
hydroxyapatite found in bone.
Alendronate sodium is a white or almost white, crystalline powder. It
is soluble in water, very slightly
soluble in methanol, practically insoluble in methylene chloride.
Colecalciferol (vitamin D
3
) is a secosterol that is the natural precursor of the
calcium-regulating hormone
calcitriol (1,25-dihydroxyvitamin D
3
).
Colecalciferol is a white to almost white crystalline powder.
Colecalciferol is practically insoluble in
water, free soluble in alcohol, soluble in fatty oils.
Alendronate Plus D3 Cal is a composite pack containing Alendronate
Plus D3 - DRLA 70 mg/140
µg(Alendronic acid (as alendronate sodium) and colecalciferol
[vitamin D3]) in addition to ReddyCal
tablets (calcium carbonate).
Each tablet of Alendronate Plus D3 - DRLA 70 mg/140 µg contains 91.37
mg of alendronate sodium,
which is the molar equivalent to 70 mg of alendronic acid, and 140 µg
of colecalciferol equivalent to