Etonogestrel/Ethinylestradiol Sandoz 0,120 mg/0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ETHINYLESTRADIOL 3,5 mg/stuk ; ETONOGESTREL 11 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

G02BB01

INN (Algemene Internationale Benaming):

ETHINYLESTRADIOL 3,5 mg/stuk ; ETONOGESTREL 11 mg/stuk

farmaceutische vorm:

Hulpmiddel voor vaginaal gebruik

Samenstelling:

COPOLYMEER VAN ETHYLEEN-VINYLACETAAT (28 pCt. vinylacetaat) ; POLYURETAAN,

Toedieningsweg:

Vaginaal gebruik

Therapeutisch gebied:

Vaginal Ring With Progestogen And Estrogen

Product samenvatting:

Hulpstoffen: COPOLYMEER VAN ETHYLEEN-VINYLACETAAT (28 pCt. vinylacetaat); POLYURETAAN;

Autorisatie datum:

2017-09-11

Bijsluiter

Sandoz B.V.
Page 1/19
Etonogestrel/Ethinylestradiol Sandoz 0,120 mg/0,015 mg per 24 uur,
hulpmiddel voor vaginaal gebruik
RVG 118995
1313-v8a
1.3.1.3 Bijsluiter
Mei 2023
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
ETONOGESTREL/ETHINYLESTRADIOL SANDOZ® 0,120 MG/0,015 MG PER 24 UUR,
HULPMIDDEL VOOR VAGINAAL GEBRUIK
etonogestrel/ethinylestradiol
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):

They are one of the most reliable reversible methods of contraception
if used correctly.

They slightly increase the risk of having a blood clot in the veins
and arteries, especially in the
first year or when restarting a combined hormonal contraceptive
following a break of 4 or
more weeks.

Please be alert and see your doctor if you think you may have symptoms
of a blood clot (see
section 2 “Blood clots”).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING [NATIONALLY
COMPLETED NAME] BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
Your medicine is available as the above name but will be referred to
as throughout
this leaflet
WHAT IS IN THIS LEAFLET
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IS IT USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE [NATIONALLY COMPLETED NAME]
3. HOW TO USE [NATIONALLY COMPLETED NAME]
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE [NATIONALLY COMPLETED NAME]
6. CONTENTS OF THE PACK AND OTHER INFORMATION
_ _
_ _
_ _
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] is a contraceptive vaginal ring used to
prevent pregnancy. Each ring
contains a small amount of two female sex hormones – etonogestrel
and ethinylestradiol. The ring
slo

Productkenmerken

Sandoz B.V.
Page 1/22
Etonogestrel / Ethinylestradiol Sandoz 0,120 mg /0,015 mg per 24 uur,
hulpmiddel voor vaginaal gebruik
RVG 118995
1311-v7b
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
1. NAME OF THE MEDICINAL PRODUCT
Etonogestrel/Ethinylestradiol Sandoz 0,120 mg/0,015 mg per 24 uur,
hulpmiddel voor vaginaal gebruik
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
[Nationally completed name] contains 11.0 mg etonogestrel and 3.474 mg
ethinylestradiol. The ring
releases etonogestrel and ethinylestradiol at an average amount of
0.120 mg and 0.015 mg 120
micrograms and 15 micrograms, respectively per 24 hours, over a period
of 3 weeks.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Vaginal delivery system.
[Nationally completed name] is flexible, transparent, and colourless
to almost colourless ring, with an
outer diameter of 54 mm and a cross-sectional diameter of 4 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Contraception
[Nationally completed name] is intended for women of fertile age. The
safety and efficacy have been
established in women aged 18 to 40 years.
The decision to prescribe [nationally completed name] should take into
consideration the individual
woman’s current risk factors, particularly those for venous
thromboembolism (VTE), and how the risk of
VTE with [nationally completed name] compares with other combined
hormonal contraceptives (CHCs)
(see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
To achieve contraceptive effectiveness, [nationally completed name]
must be used as directed (see ‘How
to use [nationally completed name]’ and ‘How to start [nationally
completed name]’).
_Paediatric population _
The safety and efficacy of [nationally completed name] in adolescents
under the age of 18 have not been
studied.
METHOD OF ADMINISTRATION
How to use [nationally completed name]
The woman herself can insert [nationally completed name] in the
vagina. The physician should advise the
woman how to insert and remove [nationall