Nuvaring vaginal delivery system (vaginal ring)

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

etonogestrel, ethinylestradiol

Disponível em:

N.V. Organon

Código ATC:

G02BB01

DCI (Denominação Comum Internacional):

etonogestrel, ethinylestradiol

Dosagem:

11,7mg+ 2,7mg

Forma farmacêutica:

vaginal delivery system (vaginal ring)

Unidades em pacote:

(1) sachet

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2019-12-03

Características técnicas

S
UMMARY OF
P
RODUCT
C
HARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
NuvaRing®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ring contains:
active ingredients: 11.7 mg etonogestrel and 2.7 mg ethinylestradiol;
excipients: ethylene vinylacetate copolymer [28% vinylacetate];
ethylene vinylacetate copolymer [9%
vinylacetate]; magnesium stearate.
The ring releases 0.120 mg of etonogestrel/ 0.015 mg of
ethinylestradiol per day.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal ring, 0.120 mg etonogestrel /0.015 mg ethinylestradiol for
day.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Contraception.
NuvaRing 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 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
(see
sections
“Contraindications” and “Precautions”).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
To achieve contraceptive effectiveness, NuvaRing must be used as
directed in subsections “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.
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 of the ring 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 ring in the vagina is not critical for the contraceptive
effect (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 c