Nuvaring

Quốc gia: Armenia

Ngôn ngữ: Tiếng Anh

Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Thành phần hoạt chất:

etonogestrel, ethinylestradiol

Sẵn có từ:

N.V. Organon

INN (Tên quốc tế):

etonogestrel, ethinylestradiol

Liều dùng:

11,7mg+2,7mg

Dạng dược phẩm:

vaginal delivery system (vaginal ring)

Loại thuốc theo toa:

Prescription

Đặc tính sản phẩm

2
SUMMARY OF PRODUCT CHARACTERISTICS
21
1.
NAME OF THE MEDICINAL PRODUCT
NuvaRing, vaginal ring, 0.120 mg etonogestrel /0.015 mg
ethinylestradiol for day.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ring contains:
_active ingredients_: 11.7 mg etonogestrel and 2.7 mg
ethinylestradiol.
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.
A smooth, transparent, and colorless to almost colorless ring, without
major visible damages,
with transparent or almost transparent area at the junction.
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 “Special warnings and precautions for
use”).
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 i