Mithraring 0.120 mg/0.015 mg per 24 hours, vaginal delivery system

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Etonogestrel; Ethinylestradiol

Sẵn có từ:

Mithra Pharmaceuticals S.A.

Mã ATC:

G02BB01

INN (Tên quốc tế):

Etonogestrel; Ethinylestradiol

Liều dùng:

0.120 mg/0.015 milligram(s)/24 hours

Dạng dược phẩm:

Vaginal delivery system

Khu trị liệu:

vaginal ring with progestogen and estrogen

Tình trạng ủy quyền:

Not marketed

Ngày ủy quyền:

2019-08-13

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE USER
[Invented name] 0.120 mg/0.015 mg per 24 hours, vaginal delivery
system
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 THIS
MEDICINE 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.
WHAT IS IN THIS LEAFLET:
1. WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE [INVENTED NAME]
2.1 Do not use [Invented name]
2.2 Warnings and precautions
Blood clots
Cancer
2.3 Children and adolescents
2.4 Other medicines and [Invented name]
Laboratory tests
2.5 Pregnancy and breast-feeding
2.6 Driving and using machines
3. HOW TO USE [INVENTED NAME]
3.1 How to insert and remove [Invented name]
3.2 Three weeks in, one week out
3.3 When to start with the first ring
3.4 What to do…
_If your ring is accidentally expelled from the vagina _
_If your ring has temporarily been out of the vagina _
_If your ring breaks _
_If you have inserted more than one ring _
_If you have forgotten to insert a new ring after the ring-free
interval _
_If you have forgotten to remove the ring _
_If you have missed a menstrual period _
_If you have unexpected bleeding _
_If you want to change the

Đặc tính sản phẩm

Health Products Regulatory Authority
24 January 2022
CRN00CPCY
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mithraring 0.120 mg/0.015 mg per 24 hours, vaginal delivery system
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mithraring 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 delivery system.
Mithraring 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.
Mithraring 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 Mithraring should take into consideration
the individual woman's current risk factors, particularly
those for venous thromboembolism (VTE), and how the risk of VTE with
Mithraring 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, Mithraring must be used as
directed (see
_'How to use Mithraring _
' and
_'How to start _
_Mithraring_').
_Paediatric population _
The safety and efficacy of Mithraring in adolescents under the age of
18 have not been established. No data are available.
Method of administration
HOW TO USE Mithraring
The woman herself can insert Mithraring in the vagina. The physician
should advise the woman how to insert and remove
Mithraring. 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. Mithraring should be compressed and inserted
into the vagina until it feels comfortable. The exact
position of Mithraring in the vagina is not critical for the
contraceptive effec