Posology : מינונים

4.2     Posology and method of administration

Posology
To achieve contraceptive effectiveness, NuvaRing must be used as directed (see ‘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.
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).
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, the woman should follow the instructions given in section 4.2 ‘What to do if the ring is temporarily outside the vagina’ (for more information, see also section 4.4 ‘Expulsion’).

NuvaRing must be removed after 3 weeks of use on the same day of the week as the ring was inserted. After a ring-free interval of one week a new ring is inserted (e.g. when NuvaRing is inserted on a Wednesday at about 22.00 h the ring should be removed again on the Wednesday 3 weeks later at about 22.00 h. The following Wednesday a new ring should be inserted).
NuvaRing can be removed by hooking the index finger under the ring or by grasping the ring between the index and middle finger and pulling it out (Figure 5). The used ring should be placed in the sachet (keep out of the reach of children and pets) and discarded as described in section 6.6. The withdrawal bleed usually starts 2-3 days after removal of NuvaRing and may not have finished completely before the next ring insertion is due.

Use with other female vaginal barrier methods

NuvaRing may interfere with the correct placement and position of certain female barrier methods, such as a diaphragm, cervical cap, or female condom. These contraceptive methods should not be used as back-up methods with NuvaRing.

How to insert NuvaRing with fingers only



Figure 1
Take NuvaRing out of the sachet


Figure 2
Compress the ring

Figure 3
Choose a comfortable position to insert the ring
Figure 4A                     Figure 4B                      Figure 4C 
Insert the ring into the vagina with one hand (Figure 4A), if necessary the labia may be spread with the other. Push the ring into the vagina until the ring feels comfortable (Figure 4B). Leave the ring in place for 3 weeks (Figure 4C).

Figure 5:
NuvaRing can be removed by hooking the index finger under the ring or by grasping the ring between the index and middle finger and pulling it out.



How to start NuvaRing
No hormonal contraceptive use in the preceding cycle
NuvaRing has to be inserted on the first day of the woman's natural cycle (i.e. the first day of her menstrual bleeding). Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended in addition for the first 7 days of NuvaRing use.

Changing from a combined hormonal contraceptive
The woman should insert NuvaRing at the latest on the day following the usual tablet-free, patch- free or placebo tablet interval of her previous combined hormonal contraceptive.
If the woman has been using her previous method consistently and correctly and if it is reasonably certain that she is not pregnant she may also switch from her previous combined hormonal contraceptive on any day of the cycle.

The hormone-free interval of the previous method should never be extended beyond its recommended length.

Changing from a progestagen-only method (minipill, implant or injection) or from a progestagen- releasing intrauterine system [IUS].
The woman may switch on any day from the minipill (from an implant, or the IUS on the day of its removal, from an injectable when the next injection would be due) but should in all of these cases use an additional barrier method for the first 7 days of NuvaRing use.

Following first-trimester abortion
The woman may start immediately. When doing so, she needs not to take additional contraceptive measures. If an immediate application is considered undesirable, the woman should follow the advice given for ‘No hormonal contraceptive use in the preceding cycle’. In the meantime, she should be advised to use an alternative contraceptive method.
Following delivery or second-trimester abortion
For breast-feeding women, see section 4.6.

Women should be advised to start during the fourth week after delivery or second-trimester abortion. When starting later, the woman should be advised to additionally use a barrier method for the first 7 days of NuvaRing use. However, if intercourse has already occurred, pregnancy should be excluded or the woman has to wait for her first menstrual period, before starting NuvaRing use.

Deviations from the recommended regimen

Contraceptive efficacy and cycle control may be compromised if the woman deviates from the recommended regimen. To avoid loss of contraceptive efficacy in case of a deviation, the following advice can be given:

•   What to do in case of a lengthened ring-free interval
The woman should insert a new ring as soon as she remembers. A barrier method such as a male condom should be used in addition for the next 7 days. If intercourse took place during the ring-free interval, the possibility of a pregnancy should be considered. The longer the ring-free interval, the higher the risk of a pregnancy.

•   What to do if the ring was temporarily outside the vagina
NuvaRing should be left in the vagina for a continuous period of 3 weeks. If the ring is accidentally expelled, it can be rinsed with cool to lukewarm (not hot) water and should be reinserted immediately.

If NuvaRing has been out of the vagina for less than 3 hours contraceptive efficacy is not reduced. The woman should reinsert the ring as soon as possible, but at the latest within 3 hours.

If NuvaRing has been out of the vagina, or is suspected to have been out of the vagina for more than 3 hours during the 1st or 2nd week of use, contraceptive efficacy may be reduced. The woman should reinsert the ring as soon as she remembers. A barrier method such as a male condom should be used until NuvaRing has been in the vagina continuously for 7 days. The longer the time NuvaRing has been out of the vagina and the closer this is to the ring-free interval, the higher the risk of a pregnancy.

If NuvaRing has been out of the vagina, or is suspected to have been out of the vagina for more than 3 hours during the 3rd week of the three-week use period, contraceptive efficacy may be reduced. The woman should discard that ring, and one of the following two options should be chosen:

1. Insert a new ring immediately
Note: Inserting a new ring will start the next three-week use period. The woman may not experience a withdrawal bleed from her previous cycle. However breakthrough spotting or bleeding may occur.
2. Have a withdrawal bleeding and insert a new ring no later than 7 days (7x24 hours) from the time the previous ring was removed or expelled.
Note: This option should only be chosen if the ring was used continuously for the preceding 7 days.

If NuvaRing was out of the vagina for an unknown amount of time, the possibility of pregnancy should be considered. A pregnancy test should be performed prior to inserting a new ring.
•     What to do in case of lengthened ring-use

Although this is not the recommended regimen, as long as NuvaRing has been used for maximally 4 weeks, contraceptive efficacy is still adequate. The woman may maintain her one-week ring-free interval and subsequently insert a new ring. If NuvaRing has been left in place for more than 4 weeks, contraceptive efficacy may be reduced and pregnancy should be ruled out before inserting a new NuvaRing.

If the woman has not adhered to the recommended regimen and subsequently has no withdrawal bleed in the following ring-free interval, pregnancy should be ruled out before inserting a new NuvaRing.

How to shift periods or how to delay a period

If in exceptional cases a period needs to be delayed, the woman may insert a new ring without having a ring-free interval. The next ring can be used for up to 3 weeks again. The woman may experience bleeding or spotting. Regular use of NuvaRing is then resumed after the usual one- week ring-free interval.

To shift her period to another day of the week than the woman is used to with her current scheme, she can be advised to shorten her forthcoming ring-free interval by as many days as she likes. The shorter the ring-free interval, the higher the risk that she does not have a withdrawal bleed and will experience breakthrough bleeding and spotting during the use of the next ring.