RATIO-NYSTATIN TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

NYSTATIN

متاح من:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

ATC رمز:

G01AA01

INN (الاسم الدولي):

NYSTATIN

جرعة:

100000UNIT

الشكل الصيدلاني:

TABLET

تركيب:

NYSTATIN 100000UNIT

طريقة التعاطي:

VAGINAL

الوحدات في الحزمة:

15

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

POLYENES

ملخص المنتج:

Active ingredient group (AIG) number: 0105858002; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2008-08-01

خصائص المنتج

PRESCRIBING
INFORMAtiON
ratio-NYSTATIN
Nystatin
oral
suspension
USP
100000
units
I mL
I
Nystatin
oral suspension
U
k
P
100000
units
I mL
.,
Sucrose
free
;;
Nystatin
oral
tablets
US~
500
000
units
I tablet
I
Nystatin
Vaginal
cream
USP
25 000 units
I g
and
100 000 u~its
I g
Nystatin
vaginal
tablets
U~p
100 000 units
I tablet.,
Nystatin
cream
USP
100000
units
I 9
Nystatin
ointment
USP
100000
units
I 9
Nystatin
powder
USP
1 billion
units
I jar
Antifungal!
Antibiotic
DATE OF PREPARATION:
December
17, 2001
ratiopharm
inc.
Canada J7 J 1 P3
C-OO20-1
Control #: 0001275962
060
PRESCRIBING
INFORMATION
.
ratio-NYSTATIN
Nystatin
oral suspension
U
!SP
100
000
units
I
mL
Nystatin
oral
suspension
U
L
P
100 000
units
I mL
Sucrose
free
"to::
Nystatin
oral
tablets
USA
500
000
units
I tablet
I
Nystatin
Vaginal
cream
U$p
25 000 units!
g
and
100 000 urits
! g
Nystatin
vaginal
tablets
U~p
100 000
units
I tablet
i
Nystatin
cream
USP
100 000 units
I 9
Nystatin
ointment
USP
100000
units
I 9
Nystatin
powder
USP
1 billion
units
I jar
Antifungal!
Antibiotic
INDICATIONS
AND CLINICAL
USE
~~~il~a~~~f:~~~:~:Of
the mouth (thrush) and inteslina: ~:~iliaSiS in infants and children.
051
Page 3
8
Oral tablets:
Prevention
and
treatment
of intestinal
moniliasis.
Prevention
or
treatment
of lower
intestinal
and anal infections
caused
by Candida
albican~ (monilia).
VaQinal
cream
and tablets:
'li.'~
Local treatment
of vaginal mycotic infections
caused
by ~andida
albicans
Topical
cream
and ointment:
For
dermatological
use
only.
Treatment
of
cutaneo~s
or
mucocutaneous
mycotic
infections
caused
by Candida
(monilia) species.
Powder:
For the treatment
of infections
of the oral cavity caused
by C. albicans
(monilia)
PRECAUTI(~
Little
activity
against
~acteri~,
protoz.oa
and viruses.
Di~continue
medication
if irritation
should
occur
from
topical
or Intravaginal
use.
I c:J..;!;
:gnancy,
the
vaginal
applicators
should
b~ '
t
'sed
only
on
the
advice
of
a
physician.
r :f;~
,
".)
'"
Appropriate
measures
should be taken to avoid reinfectiqn
during sexual intercourse.
A