NUVARING

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

ETHINYLESTRADIOL; ETONOGESTREL

Commercializzato da:

ORGANON PHARMA ISRAEL LTD., ISRAEL

Codice ATC:

G03CA01

Forma farmaceutica:

VAGINAL RING

Composizione:

ETHINYLESTRADIOL 2.7 MG; ETONOGESTREL 11.7 MG

Via di somministrazione:

VAGINAL

Tipo di ricetta:

Required

Prodotto da:

ORGANON LLC, USA

Gruppo terapeutico:

ETHINYLESTRADIOL

Area terapeutica:

ETHINYLESTRADIOL

Indicazioni terapeutiche:

Contraception. The safety and efficacy has been established in women aged 18 to 40 years.

Data dell'autorizzazione:

2014-11-30

Foglio illustrativo

[Organon] Proprietary
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine can be sold under doctor's prescription only
NUVARING
®
VAGINAL RING
COMPOSITION:
Active ingredients and quantity:
Etonogestrel 11.7 mg
Ethinylestradiol
2.7 mg
Etonogestrel and ethinylestradiol are released from the ring at a rate
of 0.120 mg/day and 0.015
mg/day, each for 3 weeks.
For a list of inactive ingredients see section 6.1 "WHAT NUVARING
CONTAINS".
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 NUVARING
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
This leaflet contains concise information about NUVARING. If you have
any further questions, ask
your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their medical condition seems similar to yours.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
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, “SIDE
EFFECTS”).
1.
WHAT NUVARING IS INTENDED FOR?
THERAPEUTIC GROUP: a contraceptive vaginal ring that contains estrogen
and a progestagen.
NUVARING 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 slowly releases
these hormones into the blood circulation. Because of

Scheda tecnica

1.
NAME OF THE MEDICINAL PRODUCT
NuvaRing
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NuvaRing contains 11.7 mg etonogestrel and 2.7 mg ethinylestradiol.
The ring releases etonogestrel and ethinylestradiol at an average
amount of 0.120 mg and 0.015
mg, respectively per 24 hours, over a period of 3 weeks.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal ring
NuvaRing 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.
The safety and efficacy have been established in women aged 18 to 40
years.
The decision to prescribe NuvaRing should take into consideration the
individual woman’s
current risk factors, particularly those for venous thromboembolism
(VTE), and how the risk of
VTE with NuvaRing 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, NuvaRing must be used as
directed (see ‘How to use
NuvaRing’ and 'How to start NuvaRing').
_ _
_Paediatric population _
The safety and efficacy of NuvaRing in adolescents under the age of 18
have not been studied.
Method of administration
HOW TO USE NUVARING
The woman herself can insert NuvaRing in the vagina. The physician
should advise the woman
how to insert and remove NuvaRing. For insertion the woman should
choose a position that is
most comfortable for her, e.g. standing with one leg up, squatting, or
lying down._ _NuvaRing
should be compressed and inserted into the vagina until it feels
comfortable. The exact position of
NuvaRing in the vagina is not critical for the contraceptive effect of
the ring (_see Figures 1-4_).
Once NuvaRing has been inserted (see ‘How to start NuvaRing’) it
is left in the vagina
continuously for 3 weeks. Advise women to regularly check for the
presence of NuvaRing in the
vagina (for example, before and after intercourse).