NUVARING etonogestrel 11.7mg and ethinylestradiol 2.7mg vaginal drug delivery system

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ethinylestradiol, Quantity: 2.7 mg; etonogestrel, Quantity: 11.7 mg

Available from:

ORGANON PHARMA PTY LTD

Pharmaceutical form:

Drug delivery system, vaginal

Composition:

Excipient Ingredients: magnesium stearate; octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate; isododecane; ethylene/vinyl acetate copolymer; ethylene distearamide

Administration route:

Vaginal

Units in package:

3 rings, 1 ring

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

NUVARING is for use for contraception.

Product summary:

Visual Identification: Smoothe, flexible, transperant colourless ring with a noticeable join: 54 mm in diameter and 4 mm in cross-sectional diameter.; Container Type: Sachet; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-06-27

Patient Information leaflet

NUVARING
®
_(120 mcg etonogestrel/15 mcg ethinylestradiol)_
CONSUMER MEDICINE INFORMATION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING NUVARING
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.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
•
Read the leaflet also regularly if you are already using NuvaRing.
This is important because the information in the leaflet
may change.
WHAT NUVARING
CONTAINS:
COMPOSITION IN FULL
NuvaRing contains:
•
active substances: etonogestrel
(11.7 mg) and ethinylestradiol
(2.7 mg);
•
other substances: ethylene
vinylacetate copolymer (a type of
plastic that will not dissolve in
the body), magnesium stearate.
Etonogestrel and ethinylestradiol are
released from the ring at a rate of
0.120 mg/day and 0.015 mg/day
respectively, each for 3 weeks.
1. WHAT NUVARING
IS AND WHAT IT IS
USED FOR
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 the low
amount of hormones that is released,
NuvaRing is considered a low-dose
hormonal contraceptive. Since
NuvaRing releases two different
types of hormones it is a so-called
combined hormonal contraceptive.
NuvaRing works just like a
combined contraceptive pill (the Pill)
but instead of taking a pill every day,
the ring is used for 3 weeks in a row.
NuvaRing releases two female sex
hormones that prevent the release of
an egg cell from the ovaries. If no
egg is released you cannot become
pregnant. An advantage of NuvaRing
is that you do not have to remember
to take a pill every day.
NUVARING IS VERY RELIABLE, BUT AS
FOR ALL CONTRACEPTIVE METHODS,
PROTEC

Summary of Product characteristics

Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
NUVARING
®
(ETHINYLESTRADIOL AND ETONOGESTREL)
VAGINAL RING
1
NAME OF THE MEDICINE
Etonogestrel and ethinylestradiol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Controlled-release contraceptive ring for vaginal use. NuvaRing
releases etonogestrel and
ethinylestradiol at an average amount of 120 µg and 15 µg,
respectively, per 24 hours, over a
period of 3 weeks. The ring contains 11.7 mg etonogestrel and 2.7 mg
ethinylestradiol.
For full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Vaginal drug delivery system.
NuvaRing is a flexible, transparent, 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
For use for contraception.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
To achieve contraceptive effectiveness, NuvaRing must be used as
directed (see ‘HOW TO
USE NUVARING’ and ‘HOW TO START NUVARING’).
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_). However, it must be inserted correctly to
minimize the chance of expulsion.
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). If NuvaRing is
accidentally expelled
(e.g., while removing a tampon), it can be rinsed with cool to
lukewarm (not hot) water and
should be reinserted immediately. In the unusual case of women whose
partners object to