NuvaRing

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Ethinylestradiol 2.7mg (15µg/24h elution rate in-vivo);  ; Etonogestrel 11.7mg (120µg/24h elution rate in-vivo);  

Beschikbaar vanaf:

Merck Sharp & Dohme (New Zealand) Limited

INN (Algemene Internationale Benaming):

Ethinylestradiol 2.7 mg (15µg/24h elution rate in-vivo)

Dosering:

120mcg etonogestrel, 15mcg ethinylestradiol / 24h

farmaceutische vorm:

Vaginal ring

Samenstelling:

Active: Ethinylestradiol 2.7mg (15µg/24h elution rate in-vivo)   Etonogestrel 11.7mg (120µg/24h elution rate in-vivo)   Excipient: Evatane 1020 VN3 ethylene/vinyl acetate co-polymer Evatane 28-25 ethylene/vinyl acetate co-polymer Magnesium stearate

Eenheden in pakket:

Sachet, Al foil with LDPE inner and polyester outer, 1 dose unit

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Aspen Oss B.V

therapeutische indicaties:

Contraception.

Product samenvatting:

Package - Contents - Shelf Life: Sachet, Al foil with LDPE inner and polyester outer - 1 dose units - 36 months unopened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 months not refrigerated stored at or below 30°C. after dispensing - Sachet, Al foil with LDPE inner and polyester outer - 3 dose units - 36 months unopened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 months not refrigerated stored at or below 30°C. after dispensing

Autorisatie datum:

2009-07-20

Bijsluiter

NUVARING
®
1
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

Productkenmerken

NEW ZEALAND DATA SHEET
S-CCDS-MK8342A-RNG-112018
Page 1 of 25
1 PRODUCT NAME
NUVARING®
Ethinylestradiol 2.7 mg and Etonogestrel 11.7 mg
Vaginal Ring
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 120

g and 15

g, respectively for 24 hours, over a period of 3 weeks.
_Ethinylestradiol _
_Molecular Formula C_
_20_
_H_
_24_
_O_
_2_
_ _
_Molecular mass 296.4 _
_Cas. No. 57-63-6 _
_Chemical Name _
_19-nor-17_

_-pregna-1,3,5,(10)-trien-20-yne-3,17-diol _
_Etonogestrel_
_ _
_Molecular formula C_
_22_
_H_
_28_
_O_
_2 _
_ _
_Molecular mass 324.44 _
_ _
_Cas No. 54048-10-1 _
_Chemical name _
NEW ZEALAND DATA SHEET
S-CCDS-MK8342A-RNG-112018
Page 2 of 25
_(17_

_)-13-ethyl-17-hydroxy-11-methylene-18,19 dinorpregn-4-en-20-yn-3-one
_
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Controlled-release contraceptive ring for vaginal use.
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
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