Apo-Desmopressin tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

desmopressin (desmopressin acetate)

Available from:

Apotex Inc.

ATC code:

H01BA02

INN (International Name):

desmopressin (desmopressin acetate)

Dosage:

0,1mg

Pharmaceutical form:

tablets

Units in package:

(100) in plastic container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-06-22

Patient Information leaflet

Thê
Piru
6lånd
U.inêry
System
PART
III:
CONSUMER
INFORMATION
P'APO-DDSMopRESSIN
Desmopressin
Acetâte
Tablets
This
leaflet
is
part
Iil
of
a
three-part
.,product
Monograph"
publ
ished
when
AÉO-DESMOÞRESSIN
was
approved
for
sale
in
Canada
and
is
designed
specifically
for
Consumers,
This
leaflet
is
irrrn*u.y
and
will
not
tell
you
everything
about
ApO_
DESMOPRESSIN.
Contact
your
doctor
or
pharmacisr
ifyou
have
any
questions
abãut
the
drug.
Pharmacist:
Please
dispense
this
inserl
with
product.
What
is
the
medication
used
for?
What
are
APO-DESMOpRESSIN
ra
bters?
APO-DESMOPRESSIN
tablets
are
used
to prevent
or
control
the
frequent
urination,
increased
thirsl,
and
loss
of
warer
associared
with
Diabetes
lns¡piOu*
(*aier
diabetes).
What
is
Diabetes
tnsipidus
(DIl?
Diabetes
lnsipidus
is
a
rnedical
condition
in
which
.your
kidneys
are
unable
to
retain
water.
This
results
in
the
ploduction
of
large
volumes
of
urine
*l
i.l,
in
turn
makes
you
feel
dry
and
very
thirsty.
It
is
inrportant
to
point
out
that
DI
is
not
related
to
L"
rtpr
of
diabetes
mosr people
¡aue
hear¿
oi,
Diabetes
Mellitus
(sugar
diabetes).
In
DI,
there
is
no problenr
with
the
sugar
in
the
blood
or
r¡rine.
The problenr
either
concerns
the
lack
of
water-retaining
hornrone
in
tlre
blood
(
vasopressin
or
Anti-Dit¡retic
Hormone
What
causes
DI?
Most
DI
is
caused
by
inadequate
secretion
of
vasopressin
by
the
pituitary
gland.
This
can
happen
in
varying
degrees.
Sometimes
it
occurs
on
it.
o*n,
but
in
many
cases
it
is
accompanied
by
loss
of
other'
-
hormo.nes
made
by
the
pituitary.
In
this
even¡,
it
is
most
likely
to
be caused
either
by
abnormalitíes
of
the
pituitary
gland
or
as a
result
òf
treatment
to
remove
an
enlarged
pituitary
gland.
If
you
experíence
DI
following
pituitary
surgery,
this
may.
be
remporary,
in
which
case
it
wili
onlila;;
week
or
two,
but
in
some
cases
it
rnay
be
permanent.
Dl
can.occur
aI
any
age,
but
is
mostly
found
in
adults,
as
pituitary
enlargement
is
most
common
between
the
ages
of
20
and
50.
It
is
a
rare
disorder,
aflecting
only
a

Summary of Product characteristics

APOTEX
INC.
150
Signet
Drive
Weston,
Ontario
MgL
1T9
PRODUCT
MONOGRAPH
P'APO-DESMOPRESSIN
(Desmopressin
Acetate)
0.1 mg
and
0.2 mg
Tablets
Antidiuretic
Ytï0
/ltryJ
rldd
I
Er
t&tirl
DATE
OF PREPARATION
July
31,
2006
ControlNumber:
101024
Øza
â/;ra-ç
0iii6$ddr
Page
I
of34
Table
of
Contents
PART
I:
HEALTH
PROFESSIONAL
INFORMATION
INDICATIONS
AND
CLINICAL
USE
...."..."..
CONTRAINDICATIONS
WARNINGS
AN
D PRECAUTIONS
ADVERSE
REACTIONS
DRUG
INTERACTIONS
DOSACE
AND
ADMINISTRATION
OVERDOSAGE.
ACTTON
AND
C
LINICAL
PHARMACOLOGY
""..".".'
"''"
STORACE
AND
STABILITY
DOSAGE
FORMS,
COMPOSIT
ION
AND
PACKAGINC
PART
II:
SCIBNTIFIC
PHARMACEUTICAL
CLINICAL
TRIALS...
INFORMATION
TOXICOLOGY
REFERENCES..
PART
TII:
CONSUMER
INFORMATION
3
3
4
6
6
7
8
9
18
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l9
l9
2l
23
25
28
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i
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Page
2
ol34
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