GYNERA

देश: इसराइल

भाषा: अंग्रेज़ी

स्रोत: Ministry of Health

सक्रिय संघटक:

ETHINYLESTRADIOL; GESTODENE

थमां उपलब्ध:

BAYER ISRAEL LTD

ए.टी.सी कोड:

G03CA01

फार्मास्यूटिकल फॉर्म:

COATED TABLETS

रचना:

ETHINYLESTRADIOL 0.03 MG; GESTODENE 0.075 MG

प्रशासन का मार्ग:

PER OS

प्रिस्क्रिप्शन प्रकार:

Required

द्वारा बनाया गया:

BAYER WEIMAR GMBH UND CO.KG, GERMANY

चिकित्सीय क्षेत्र:

ETHINYLESTRADIOL

चिकित्सीय संकेत:

Hormonal contraception.

प्राधिकरण की तारीख:

2020-09-30

सूचना पत्रक

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור
ןכדועמ(
ןכדועמ(
ןכדועמ(
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)
)
)
__ ךיראת
5.10011.03
__ __ םושירה רפסמו תילגנאב רישכת םש
00
-
25622
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51
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050
GYNERA
םושירה לעב םש
_
מ"עב לארשי רייאב
_
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
נ טסקט
יחכו
שדח טסקט
4.5
INTERACTION
WITH OTHER MEDICINAL
PRODUCTS AND OTHER
FORMS OF INTERACTION

Interactions
Hepatic enzyme inducers
Drugs which induce hepatic
enzymes (especially
cytochrome P450 3A4)
increase the
metabolism of contraceptive
steroids and hence may result
in breakthrough bleeding and
pregnancy. The following
have been shown to have
clinically important
interactions with
COCs:
_Antiretroviral agents _

ritonavir;

nelfinavir;

nevirapine.
_ _
_Anticonvulsants _

barbiturates (including
phenobarbitone);

primidone;

phenytoin;-

carbamazepine;

oxcarbazepine;

topiramate.
_ _
_Antibiotics/antifungals _

griseofulvin;

rifampacin.
_ _
_Herbal remedies _

St John’s wort
(Hypericum
perforatum)
Managing interactions with
hepatic enzyme inducers
Interactions can occur with
drugs that induce microsomal
enzymes which can result in
increased clearance of sex
hormones and which may
lead to breakthrough bleeding
and/or contraceptive failure.
Women on short term

Interactions
Enzyme inducers
Interactions can occur with
drugs that induce microsomal
enzymes (especially
cytochrome P450 3A4) which
can result in increased
clearance of sex hormones and
which may lead to
breakthrough bleeding and/or
contraceptive failure.
treatment with any of these
drugs should temporarily use
a barrier method in addition
to the COC or choose another
method of contraception. The
barrier method shou

उत्पाद विशेषताएं

רשואו קדבנ ונכותו תואירבה דרשמ י"ע
עבקנ הז ןולע טמרופ
THE CONTENT OF THIS LEAFLET WAS APPROVED BY THE MINISTRY OF HEALTH IN
JANUARY 2016 AND
UPDATED ACCORDING TO THE GUIDELINES OF THE MINISTRY OF HEALTH IN JULY
2019
1.
NAME OF THE MEDICINAL PRODUCT
Gynera
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Actives:
Gestodene
75 micrograms
Ethinylestradiol
30 micrograms
Excipients:
Lactose monohydrate
37.43 mg
Sucrose
19.66 mg
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Sugar-coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormonal contraception.
The decision to prescribe Gynera should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with
Gynera compares with other combined hormonal contraceptives (CHCs)
(see sections 4.3 and 4.4)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_First treatment cycle: _1 tablet daily for 21 days, starting on the
first day of the menstrual cycle.
Contraceptive protection begins immediately.
_Subsequent cycles: _Tablet taking from the next pack of Gynera is
continued after a 7-day interval,
beginning on the same day of the week as the first pack.
_Changing from 21-day combined oral contraceptives: _The first tablet
of Gynera should be taken on
the first day immediately after the end of the previous oral
contraceptive course. Additional
contraceptive precautions are not required.
_ _
_Changing from a combined Every Day pill (28 day tablets): _
Gynera should be started after taking the last active tablet from the
Every Day Pill pack. The first
Gynera tablet is taken the next day. Additional contraceptive
precautions are not then required.
_Changing from a progestogen-only pill (POP): _
The first tablet of Gynera should be taken on the first day of
bleeding, even if a POP has already
been taken on that day. Additional contraceptive precautions are not
then required. The remaining
progestogen-only