Yaz tablets film-coated

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

제품 특성 요약 제품 특성 요약 (SPC)
25-05-2016

유효 성분:

light pink tablet-drospirenone, ethinylestradiol, white tablet- inactive

제공처:

Bayer Weimar GmbH & Co. KG

ATC 코드:

G03AA12

INN (International Name):

light pink tablet-drospirenone, ethinylestradiol, white tablet- inactive

복용량:

3mg+ 0,02mg

약제 형태:

tablets film-coated

패키지 단위:

(28/24 light pink tablet+4white tablet/) in blister

처방전 유형:

Prescription

승인 상태:

Registered

승인 날짜:

2016-05-24

제품 특성 요약

                                SUMMARY
OF
PROI}UCT
CHARACTERISTICS
NAME
OF'THE
MEDICINAL
PRODUCT
Yaz
0,02
mg/ 3 mg
film
coated
tablets
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
24 ligfi
pink
fi lm-coated
tablets:
Each
film-coated
tablet
contains
0.020
mg
ethinylestadiol
(as
betadex
clathrate)
and
3 mg
drospirenone.
Excipient
with known
effect:
lactose
46
mg
4 white placebo
(inactive)
fiim-coated
tablets:
The
tablet
does
not
contain
active
substances.
Excipient
with
known
effeet:
lactose
22 mg
For
the
fulI list
of excipients,
see
section
6.1.
" i g
PHARMACEUTICAL
FORM
'G
i
Film-coated
tablets
The
active
tablets
are
light
pink,
round
with
convex
faces;
one
side
embossed
with
the
letters
"DS"
in a regular
hexagon.
The
placebo
tablets
are
white,
round
with
convex
faces,
one
side
embosssd
with
the letters
"DP"
in a regular
hexagon.
CLINICAL
PARTICULARS
Therapeutic
indications
Oral contraception.
The
decision
to
prescribeYaz
should
take
into
consideration
the individual
woman's
gurrent
risk faetors,
particularly
those
for venous
thromboembolism
(VTE),
and
how
the
risk
of VTE with
Yaz
compares
with
other
Combined
Hormonal
Contraceptives
(CHCs)
(see
sections
4.3
and
4.4).
Posology
and
method
of administration
Method
of administraJlaa:
oral
use
Posalogt
How to take
Yaz
The tablets
must
be taken
every
day
at
about
the same
time,
if necessary
with
a
linle
liquid,
in the
order
shown
on the
blister
pack.
Tablet
taking
is
continuous.
one
tablet
is
to
be
kken daily
for
28
consecutive
days.
Each
subsequent
pack
{6'
4
4.1
4.2
l/,
r
V
is- started
the
day
after
the
last
tablet
of
the
previous
pack.
withdrawal
bleeding
usually
starts
on
day
2-3
after
starting
the
placebo
tablets
11a51
;;i
and
may
not
have
finished
before
the
next pack
is
started.
How
to
start
Yaz
!
No preceding
hormonal
contraceptive
use
(in
the
past
month)
Tablet-taking
has
to
s-tgt
on
day
I
of
the
woman's
natural
cycle
(i.e.
the
first
day
of her
menshual
bleeding).
n
changing
from
a
combined
hormonal
contraceptive,
(combined
oral
contraceptive
COC),
vaginal
ring
or tansdermat
pafch)
The
woman
sh
                                
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