qanastek/EMEA-V3 huggingface dataset:
Each 20 cm2 transdermal patch contains 6 mg norelgestromin (NGMN) and 600 micrograms ethinyl estradiol (EE).
Kull 20 ċm2 garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda fiha 6mg norelgestromin (NGMN) u 600 mikrogramma ethinyl estradiol (EE).
Each transdermal patch releases an average of 203 micrograms of NGMN and 33.9 micrograms of EE per 24 hours.
Kull garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda terħi medja ta ’ 203 mikrogramma ta ’ NGMN u 33. 9 mikrogramma ta ’ EE kull 24 siegħa.
Medicinal product exposure is more appropriately characterized by the pharmacokinetic profile (see section 5.2).
L- esponiment tal- prodott mediċinali huwa ikkaratterizzat b’ mod xieraq iktar fil- profil farmakokinetiku (ara sezzjoni 5. 2).
Transdermal patch.
Garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda.
EVRA is a thin, matrix-type transdermal patch consisting of three layers.
EVRA hija garża rqiqa, tat- tip matrċi, li tikkonsisti fi tliet saffi u li tipprovdi mediċina li tgħaddi minn ġol- ġilda.
The outside of the backing layer is beige and heat-stamped “ EVRA”.
Il- parti esterna tas- saff ta ’ rinforz huwa kaféllatte u stampat “ EVRA ” permezz tas- sħana.
Female contraception
Kontraċezzjoni tan- nisa
EVRA is intended for women of fertile age.
EVRA hija intenzjonata għan- nisa ta ’ età fertili.
The safety and efficacy has been established in women aged 18 to 45 years.
Is- sigurtà u l- effikaċja tagħha ġiet stabbilita fin- nisa ta ’ bejn it- 18 u l- 45 sena.
To achieve maximum contraceptive effectiveness, patients must be advised to use EVRA exactly as directed.
Biex tikseb l- effett massimu ta ’ kontraċezzjoni, il- pazjenti għandhom jingħataw parir li jużaw EVRA eżattament skond l- istruzzjonijiet.
For initiation instructions see ‘ How to start EVRA’ below.
Għall- istruzzjonijiet tal- bidu ara ‘ Kif tibda EVRA ’ hawn taħt.
Only one patch is to be worn at a time.
Garża waħda biss għandha titwaħħal kull darba.
Each used patch is removed and immediately replaced with a new one on the same day of the week (Change Day) on Day 8 and Day 15 of the cycle.
Kull garża għandha titneħħa u tinbidel b’ oħra ġdida immedjatament fl- istess ġurnata tal- ġimgħa (Ġurnata tal- Bdil) fit- 8 u l- 15- il Ġurnata taċ- ċiklu.
Patch changes may occur at any time on the scheduled Change Day.
Bdil tal- garża jista ’ jsir fi kwalunkwe ħin tal - Ġurnata tal- Bdil skedata.
The fourth week is patch-free starting on Day 22.
Ir- raba ’ ġimgħa hija il- ġimgħa mingħajr garża li tibda fit- 22 Ġurnata.
A new contraceptive cycle begins on the next day following patch-free week; the next EVRA patch should be applied even if there has been no bleeding or if bleeding has not yet stopped.
Ċiklu ġdid ta ’ kontraċezzjoni jibda l- għada tal- ġimgħa mingħajr garża; il- garża EVRA li jkun imiss għandha tiġi applikata anke jekk ma kienx hemm fsada jew jekk il- fsada tkun għada ma waqfitx.
Under no circumstances should there be more than a 7-day patch-free interval between dosing cycles.
M’ għandu, għall- ebda ċirkustanza jkun hemm intervall ta ’ aktar minn sebat ijiem mingħajr garża bejn iċ- ċikli fejn tingħata d- doża.
If there are more than 7 patch-free days, the user may not be protected against pregnancy.
Jekk ikun hemm aktar minn sebat ijiem mingħajr garża, il- persuna tista ’ ma tkunx protetta mit- tqala.
A non- hormonal contraceptive must then be used concurrently for 7 days.
Kontraċettiv mhux ormonali għandu għalhekk jiġi użat flimkien magħha għall- sebat ijiem.
As with combined oral contraceptives, the risk of ovulation increases with each day beyond the recommended contraceptive- free period.
Jekk tkun saret kopulazzjoni
If intercourse has occurred during such an extended patch-free interval, the possibility of fertilisation should be considered.
2 f’ tali perjodu ta ’ waqfa fit- tul mingħajr kontraċezzjoni, il- possibbiltà ta ’ fertilizzazzjoni għandha tiġi kkunsidrata.
2 Method of administration
Metodu ta ’ kif għandu jingħata
EVRA should be applied to clean, dry, hairless, intact healthy skin on the buttock, abdomen, upper outer arm or upper torso, in a place where it will not be rubbed by tight clothing.
EVRA għandha tiġi applikata fuq ġilda nadifa, xotta, mingħajr pil, u intatta fuq il- warrani, fuq iż- żaqq, fin- naħa ta ’ barra tal- parti ta ’ fuq tad- driegħ, jew fin- naħa ta ’ fuq tat- torso, f’ post fejn ma tħokkx ma ħwejjeġ issikkati.
EVRA should not be placed on the breasts or on skin that is red, irritated or cut.
EVRA m’ għandiex titpoġġa fuq is- sider jew fuq ġilda li hija ħamra, irritata jew maqsuma.
Each consecutive patch should be applied to a different place on the skin to help avoid potential irritation, although they may be kept within the same anatomic site.
Kull garża ġdida għandha tiġi applikata fuq il- ġilda f’ parti differenti minn ta ’ qabilha biex tevita l- possibbiltà ta ’ irritazzjoni, għalkemm tista ’ tinżamm fl- istess sit anatomiku.
The patch should be pressed down firmly until the edges stick well.
Il- garża għandha tingħafas sewwa l- isfel sakemm it- truf jeħlu sewwa.
To prevent interference with the adhesive properties of the patch, no make-up, creams, lotions, powders or other topical products should be applied to the skin area where the patch is placed or where it will be applied shortly.
Sabiex ma jkunx hemm interferenza mal- kolla tal- garża m’ għandux ikun hemm mejkapp, kremi, lozjonijiet, terer jew prodotti topikali oħra fuq il- ġilda fejn titpoġġa l- garża jew fejn se tiġi applikata dalwaqt.
It is recommended that users visually check their patch daily to ensure continued proper adhesion.
Huwa rrakkomandat li min qed juża l- garża jiċċekkjaha viżwalment kuljum biex jiżgura li tkun imwaħħla tajjeb.
Used patches should be discarded carefully in accordance with the instructions given in section 6.6.
Gareż użati għandhom jintremew b’ attenzjoni skond l- istruzzjonijiet mogħtija f’ sezzjoni 6. 6.
How to start EVRA
Kif tibda EVRA
When there has been no hormonal contraceptive use in the preceding cycle
Meta ma kien hemm l- ebda użu ta ’ kontraċettiv ormonali fiċ- ċiklu ta ’ qabel
Contraception with EVRA begins on the first day of menses.
Kontraċezzjoni b’ EVRA tibda fl- ewwel ġurnata tal- mestrwu.
A single patch is applied and worn for one full week (7 days).
Garża waħda tiġi applikata u tintlibes għall- ġimgħa sħiħa (sebat ijiem).
The day the first patch is applied (Day 1/ Start Day) determines the subsequent Change Days.
Il- ġurnata meta tiġi applikata l- ewwel garża (l- Ewwel Ġurnata / Ġurnata tal- Bidu) tiddetermina l- Ġranet ta ’ Bdil li jkun imiss.
The patch Change Day will be on this day every week (cycle Days 8, 15, 22 and Day 1 of the next cycle) The fourth week is patch-free starting on Day 22.
Il- Ġurnata tal- Bdil tal- garża tkun f’ din il- ġurnata kull ġimgħa (it- 8, il- 15, it- 22 Ġurnata u l- 1 Ġurnata taċ- ċiklu li jmiss).
If Cycle 1 therapy starts after first day of the menstrual cycle, a non-hormonal contraceptive should be used concurrently for the first 7 consecutive days of the first treatment cycle only.
Jekk it- trattament fl- ewwel ċiklu jibda ’ wara l- ewwel ġurnata taċ- ċiklu tal- menstrwazzjoni, flimkien miegħu għandu jintuża kontraċettiv mhux ormonali għall- ewwel sebat ijiem konsekuttivi ta ’ l- ewwel ċiklu ta ’ trattament biss.
When switching from an oral combined contraceptive
Meta taqleb minn kontraċettiv orali kkombinat
Treatment with EVRA should begin on the first day of withdrawal bleeding.
Trattament b’ EVRA għandu jibda fl- ewwel ġurnata tal- fsada wara l- waqfien mill- pilloli.
If there is no withdrawal bleeding within 5 days of the last active (hormone containing) tablet, pregnancy must be ruled out prior to the start of treatment with EVRA.
Jekk ma jkunx hemm fsada wara l- ħames ġurnata li tkun ittieħdet l- aħħar pillola attiva (li fiha l- ormoni), għandha tiġi eskluża t- tqala qabel ma jinbeda t- trattament b’ EVRA.
If therapy starts after the first day of withdrawal bleeding, a non-hormonal contraceptive must be used concurrently for 7 days.
Jekk it- trattament jibda wara l - ewwel ġurnata tal- fsada wara l- waqfien mill- pilloli, flimkien miegħu għandu jintuża kontraċettiv mhux ormonali għall- sebat ijiem.
If more than 7 days elapse after taking the last active oral contraceptive tablet, the woman may have ovulated and should, therefore, be advised to consult a physician before initiating treatment with EVRA.
Jekk jgħaddu aktar minn sebat ijiem minn meta l- mara tkun ħadet l- aħħar pillola orali kontraċettiva attiva, jista ’ jkun li hija tkun ovulat u għaldaqstant għandha tingħata parir biex tara tabib qabel tibda trattament b’ EVRA.
If intercourse has occurred during such an extended pill-free interval, the possibility of pregnancy should be considered.
Jekk tkun saret kopulazzjoni f’ tali perjodu ta ’ waqfa fit- tul mingħajr pilloli, l - possibbiltà ta ’ tqala għandha tiġi kkunsidrata.
When changing from a progestogen-only-method
Meta taqleb minn metodu ta ’ proġestoġen waħdu
The woman may switch any day from the minipill (from an implant on the day of its removal, from an injectable when the next injection would be due), but a back-up barrier method of birth control must be used during the first 7 days.
Mill- pillola tal- proġestoġen, il- mara tista ’ taqleb f’ liema ġurnata trid (mill- impjant tista ’ taqleb fil - ġurnata meta jitneħħa u mill- injezzjoni tista ’ taqleb meta jkun imissha injezzjoni oħra), iżda bħala rinforz għandu jintuża metodu ta ’ kontraċezzjoni mekkanika tal- kontroll tat- twelid matul l- ewwel sebat ijiem.
Following abortion or miscarriage
3 Wara abort jew korriment
After an abortion or miscarriage that occurs before 20 weeks gestation, EVRA may be started immediately.
Wara abort jew korriment li jseħħ qabel l- 20 ġimgħa tqala, EVRA tista ’ tinbeda immedjatament.
An additional method of contraception is not needed if EVRA is started immediately.
M’ hemmx bżonn metodu addizzjonali ta ’ kontraċezzjoni jekk EVRA tinbeda mill- ewwel.
Be advised that ovulation may occur within 10 days of an abortion or miscarriage.
Kun avżata li ovulazzjoni tista ’ sseħħ fi żmien għaxart ijiem minn abort jew korriment.
3 After an abortion or miscarriage that occurs at or after 20 weeks gestation, EVRA may be started either on Day 21 post-abortion or on the first day of the first spontaneous menstruation, whichever comes first.
Wara abort jew korriment li jseħħ fl- 20 ġimgħa tqala jew wara, EVRA tista ’ tinbeda jew fl- 21 ġurnata wara l- abort jew fl- ewwel ġurnata ta ’ l- ewwel menstrwazzjoni spontanja, skond liema minnhom tiġi l - ewwel.
The incidence of ovulation on Day 21 post abortion (at 20 weeks gestation) is not known.
L- inċidenza ta ’ ovulazzjoni fil- 21 ġurnata wara abort (fl- 20 ġimgħa tqala), m’ hijiex magħrufa.
Following delivery
Wara t- twelid
Users who choose not to breast-feed should start contraceptive therapy with EVRA no sooner than 4 weeks after child-birth.
Nisa li jgħażlu li ma jreddgħux għandhom jibdew it- trattament kontraċettiv b’ EVRA mhux aktar kmieni minn 4 ġimgħat wara t- twelid tat- tarbija.
When starting later, the woman should be advised to additionally use a barrier method for the first 7 days.
Meta t- trattament jinbeda aktar tard, il- mara għandha tingħata parir biex tuża wkoll kontraċezzjoni mekkanika tal- kontroll tat- twelid matul l- ewwel sebat ijiem.
However, if intercourse has already occurred, pregnancy should be excluded before the actual start of EVRA or the woman has to wait for her first menstrual period.
Madanakollu, jekk diġà kien hemm kopulazzjoni, għanda tiġi eskluża tqala qabel tinbeda EVRA jew inkella il- mara għandha tistenna l- ewwel menstrwazzjoni.
For breast-feeding women, see section 4.6.
Għal nisa li qed ireddgħu, ara sezzjoni 4. 6.
What to do if the patch comes off or partly detaches
X’ tagħmel jekk il- garża tinqala ’ kompletament jew parzjalment
If the EVRA patch partly or completely detaches and remains detached, insufficient medicinal product delivery occurs.
Jekk il- garża EVRA tinqala ’ kompletament jew parzjalment u tibqa ’ maqlugħa, ma jkunx hemm amministrazzjoni suffiċjenti tal- prodott mediċinali.
If EVRA remains even partly detached:
Jekk EVRA tibqa ’ anke parzjalment maqlugħa:
- for less than one day (up to 24 hours): it should be re-applied to the same place or replaced with
- għal inqas minn ġurnata waħda (sa 24 siegħa): għandha tiġi applikata mill- ġdid fl- istess post
a new EVRA patch immediately.
jew mibdula b’ garża EVRA ġdida immedjatament.
No additional contraceptive is needed.
M’ hemm bżonn ta ’ l- ebda kontraċezzjoni oħra.
The next EVRA patch should be applied on the usual “ Change Day”.
Il- garża EVRA li jkun imiss għandha tiġi applikata fil - “ Ġurnata tal- Bdil ” tas- soltu.
- for more than one day (24 hours or more) or if the user is not aware when the patch has lifted or
- għal aktar minn ġurnata waħda (24 siegħa jew aktar) jew jekk il- persuna ma ndunatx meta l -
The user should stop the current contraceptive cycle and start a new cycle immediately by applying a new EVRA patch.
garża nqalgħet kompletament jew parzjalment: il- persuna tista ’ ma tkunx protetta mit- tqala: il - persuna għandha twaqqaf iċ- ċiklu kurrenti ta ’ kontraċezzjoni u tibda ċiklu ġdid immedjatament billi taplika garża EVRA ġdida.
There is now a new “ Day 1” and a new “ Change Day”.
Minn issa l- quddiem hemm “ l- Ewwel Ġurnata ” ġdida u “ l - Ġurnata tal- Bdil ” ġdida.
A non-hormonal contraceptive must be used concurrently for the first 7 days of the new cycle only.
Kontraċettiv mhux ormonali għandu jintuża flimkien mat- trattament għall- ewwel sebat ijiem taċ- ċiklu l- ġdid biss.
A patch should not be reapplied if it is no longer sticky; a new patch should be applied immediately.
Il- garża m’ għandiex terġa ’ tiġi applikata jekk m’ għadiex twaħħal; garża ġdida għandha tiġi applikata immedjatament.
Supplemental adhesives or bandages should not be used to hold the EVRA patch in place.
Adeżivi supplimentari jew faxex m’ għandhomx jintużaw biex iżommu il- garża EVRA fil- post.
If subsequent EVRA patch change days are delayed
Jekk ikun hemm dewmien fil- ġranet ta ’ bdil tal- garża EVRA li jmiss
At the start of any patch cycle (Week One/ Day 1):
Fil- bidu ta ’ kwalunkwe ċiklu ta ’ użu tal- garża (L- Ewwel Ġimgħa / L- Ewwel Ġurnata):
The user may not be protected from pregnancy.
Il- persuna tista ’ ma tkunx protetta mit- tqala.
The user should apply the first patch of the new cycle as soon as remembered.
Il- persuna għandha tapplika l- ewwel garża taċ- ċiklu l - ġdid malli tiftakar.
There is now a new patch “ Change Day” and a new “ Day 1”.
Min issa l- quddiem hemm “ Ġurnata tal- Bdil ” tal- garża ġdida u “ l- Ewwel Ġurnata ” tal- garża ġdida.
A non-hormonal contraceptive must be used concurrently for the first 7 days of the new cycle.
Kontraċettiv mhux ormonali jrid jintuża flimkien mat- trattament għall- ewwel sebat ijiem taċ- ċiklu l- ġdid.
If intercourse has occurred during such an extended patch-free interval, the possibility of fertilisation should be considered.
Jekk tkun saret kopulazzjoni f’ tali perjodu ta ’ waqfa fit- tul mingħajr garża, il - possibbiltà ta ’ fertilizzazzjoni għandha tiġi kkunsidrata.
In the middle of the cycle (Week Two/ Day 8 or Week Three/ Day 15):
Fin- nofs taċ- ċiklu (It- Tieni Ġimgħa / It- Tmien Ġurnata jew it- Tielet Ġimgħa / Il- 15- il Ġurnata):
- for one or two days (up to 48 hours):
- għal jum jew jumejn (sa 48 siegħa): il- persuna għandha tapplika garża EVRA ġdida
The user should apply a new EVRA patch immediately.
immedjatament.
The next EVRA patch should be applied on the usual “ Change Day”.
Il- garża EVRA li jmiss għandha tiġi applikata fil - “ Ġurnata tal- Bidla ” tas- soltu.
If during the 7 days preceding the first skipped day of patch application, the patch was worn correctly, no additional contraceptive use is required.
4 Jekk fis- sebat ijiem ta ’ qabel dik il- ġurnata fejn ma twaħħlitx il- garża, il- garża kienet imwaħħla sewwa, ma hemmx bżonn l- użu ta ’ kontraċettiv addizzjonali.
- for more than two days (48 hours or more):
- għal aktar minn jumejn (48 siegħa jew aktar):
The
Il -
user should stop the current contraceptive cycle and start a new four-week cycle immediately by putting on a new EVRA patch.
persuna għandha twaqqaf iċ- ċiklu ta ’ kontraċezzjoni kurrenti u tibda ċiklu ġdid ta ’ erba ’ ġimgħat immedjatament billi tapplika garża EVRA ġdida.
There is now a new “ Day 1” and a new “ Change Day”.
Minn issa l- quddiem hemm “ l- Ewwel Ġurnata ” ġdida u “ l- Ġurnata tal- Bdil ” ġdida.
A non- hormonal contraceptive must be used concurrently for the first 7 consecutive days of the new cycle.
Kontraċettiv mhux ormonali għandu jintuża flimkien mat- trattament għall- ewwel sebat ijiem konsekuttivi taċ- ċiklu l- ġdid.
- at the end of the cycle (Week Four/ Day 22):
- fl- aħħar taċ- ċiklu (Ir- Raba ’ Ġimgħa / It- 22 Ġurnata):
If the EVRA patch is not removed at the beginning
Jekk il- garża EVRA ma titneħħiex fil- bidu
of Week 4 (Day 22), it should be removed as soon as possible.
tar- Raba ’ Ġimgħa (it- 22 Ġurnata) għandha titneħħa mill- aktar fis possibbli.
The next cycle should begin on the usual “ Change Day”, which is the day after Day 28.
Iċ- ċiklu li jmiss għandu jibda fil - “ Ġurnata tal- Bdil ” tas- soltu, li hija l- jum ta’ wara it- 28 Ġurnata.
No additional contraceptive use is required.
M’ hemm bżonn l- ebda użu ta ’ kontraċettiv addizzjonali.
Change Day adjustment
Aġġustament tal- Ġurnata tal- Bdil
In order to postpone a menstrual period for one cycle, the woman must apply another patch at the beginning of Week 4 (Day 22) thus not observing the patch free interval.
Sabiex tipposponi l- menstrwazzjoni għal ċiklu wieħed, il- mara għandha tapplika garża oħra fil- bidu tar- Raba ’ Ġimgħa (it- 22 Ġurnata) u b’ hekk ma tkunx qed tosserva l- perjodu mingħajr garża.
Breakthrough bleeding or spotting may occur.
Jista ’ jkun hemm fsada li tippenetra ċ- ċiklu jew fsada ħafifa ħafna.
After 6 consecutive weeks of patch wear, there should be a patch free interval of 7 days.
Wara sitt ġimgħat konsekuttivi li tintlibes il- garża, għandu jkun hemm perjodu ta ’ sebat ijiem mingħajr garża.
Following this, the regular application of EVRA is resumed.
Wara dan, l- applikazzjoni regolari ta ’ EVRA tista ’ titkompla.
If the user wishes to move the Change Day the current cycle should be completed, removing the third EVRA patch on the correct day.
Jekk il- persuna tkun tixtieq tmexxi l- Ġurnata tal- Bdil, iċ- ċiklu kurrenti għandu jitkompla billi titneħħa t- tielet garża fil- ġurnata li suppost.
During the patch-free week a new Change Day may be selected by applying the first EVRA patch of the next cycle on the first occurrence of the desired day.
Matul il- ġimgha mingħajr garża tista ’ tingħażel Ġurnata tal- Bdil ġdida billi l- ewwel garża EVRA taċ- ċiklu li jmiss tiġi applikata meta tasal il- ġurnata magħżula.
In no case should there be more than 7 consecutive patch-free days.
Għall - ebda raġuni m’ għandu jkun hemm perjodu ta ’ aktar minn sebghat ijiem mingħajr garża.
The shorter the patch-free interval, the higher the risk that the user does not have a withdrawal bleed and may experience breakthrough bleeding and spotting during the subsequent treatment cycle.
Aktar ma jkun qasir il- perjodu mingħajr garża aktar hemm ċans li l- persuna ma jkolliex fsada tal- waqfien mit - trattament u iżda jkun hemm fsada li tippenetra ċ- ċiklu jew fsada ħafifa ħafna fiċ- ċiklu sussegwenti ta ’ trattament.
In case of minor skin irritation
F’ każ ta ’ irritazzjoni ħafifa fil- ġilda
If patch use results in uncomfortable irritation, a new patch may be applied to a new location until the next Change Day.
Jekk l- użu tal- garża jwassal għal irritazzjoni skomda, għandha tiġi applikata garża ġdida f’ sit ġdid sakemm tasal il- Ġurnata tal- Bdil li jmiss.
Only one patch should be worn at a time.
Garża waħda biss għandha tintlibes kull darba.
Body weight equal or greater than 90 kg: contraceptive efficacy may be decreased in women weighing equal or greater than 90 kg.
Piż ta ’ 90 kg jew aktar: l- effikaċja tal- kontraċettiv tista ’ tonqos fin- nisa li jiżnu 90 kg jew aktar.
EVRA has not been studied in women with renal impairment.
EVRA ma ġietx studjata fin- nisa b’ indeboliment renali.
No dose adjustment is necessary but as there is a suggestion in the literature that the unbound fraction of ethinyl estradiol is higher, EVRA should be used with supervision in this population.
M’ hemm bżonn ta ’ l - ebda aġġustament tad- doża iżda f’ dokumenti kien ssuġġerit li l- porzjon ta ’ ethinyl estradiol li huwa liberu huwa ogħla, EVRA għanda tintuża b’ sorveljanza f’ din il- popolazzjoni.
EVRA has not been studied in women with hepatic impairment.
EVRA ma ġietx studjata fin- nisa b’ indeboliment epatiku.
EVRA is contraindicated in women with hepatic impairment (see section 4.3).
EVRA hija kontra - indikata f’ nisa b’ indeboliment epatiku (ara sezzjoni 4. 3).
Post-menopausal women:
Nisa wara l- menopawsa:
EVRA is not intended for use as hormonal replacement therapy.
EVRA m’ huwiex maħsub biex jintuża bħala terapija tas- sostituzzjoni ta ’ l - ormoni.
EVRA is not recommended for use in children and adolescents under age 18 due to insufficient data on safety and efficacy.
EVRA m’ huwiex rakkommandat għall- użu fit- tfal u fl- adoloxxenti f’ età taħt it- 18 - il sena minħabba dejta insuffiċjenti dwar is- sigurtà u l- effikaċja.
EVRA should not be used in the presence of one of the following disorders.
EVRA m’ għandiex tintuża f’ każ ta ’ xi wieħed minn dawn id- disturbi.
If one of these disorders occurs during the use of EVRA, EVRA must be discontinued immediately.
Jekk xi wieħed minn dawn id - disturbi jiġri waqt l- użu ta ’ EVRA, EVRA għandha titwaqqaf immedjatament.
- Presence or history of venous thrombosis, with or without the involvement of pulmonary
- Il- preżenza jew storja ta ’ trombożi fil- vini b’ involviment ta ’ emboliżmu pulmonari jew
embolism
mingħajru
- Presence or history of arterial thrombosis (e. g., cerebrovascular accident, myocardial infarction,
- Preżenza jew storja ta ’ trombożi fl- arterji (eż. inċident ċerebrovaskulari, infart miokardiaku,
retinal thrombosis) or prodrome of a thrombosis (e. g., angina pectoris or transient ischaemic attack)
trombożi fir- retina) jew prodromu ta ’ trombożi (eż. anġina pectoris jew attakk iskemiku għaddieni)
- Migraine with focal aura
- Migranja b’ awra fokali
- The presence of serious or multiple risk factor(s) for the occurrence of arterial thrombosis:
- Il- preżenza ta ’ fatturi serji jew aktar minn fattur wieħed ta ’ riskju li jwasslu għal trombożi fl -
- Severe hypertension (Persistent blood pressure values of ≥ 160 mm Hg systolic or ≥ 100 mm Hg
Pressjoni għolja ħafna (valuri ta ’ pressjoni għolja persistenti ta ’ ≥ 160 mm Hg sistolika jew
diastolic)
≥ 100 mm Hg dijastolika)
- Diabetes Mellitus with vascular involvement
- Dijabete Mellitus b’ involviment vaskulari
- Hereditary dyslipoproteinemia
- Dislipoprotinimja ereditarja
- Possible hereditary predisposition for venous or arterial thrombosis, such as activated protein C
- Possibiltà ta ’ pridispożizzjoni għal trombożi fil- vini jew fl- arterji; bħal ma huma reżistenza
(APC-) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant)
għall- proteina Ċ attivata (APC), defiċjenza ta ’ l- antithrombin III, defiċjenza tal- proteina Ċ, defiċjenza tal- proteina S, iperomoċistenimja, u antikorpi antifosfolipidi (antikorpi antikardjolipin, lupus kontra l- koagulazzjoni)
- Known or suspected carcinoma of the breast
- Karċinoma tas- sider magħrufa jew suspettata
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Karċinoma ta ’ l- endometriju jew xi neoplażmu ieħor magħruf jew suspettat li huwa dipendenti
- Abnormal liver function related to acute or chronic hepatocellular disease
- Funzjoni abnormali tal- fwied relatata ma ’ mard epatoċellulari akut jew kroniku
- Hepatic adenomas or carcinomas
- Adenomi jew karċinomi tal- fwied
- Undiagnosed abnormal genital bleeding
- Fsada ġenitali abnormali mingħajr dijanjosi
There is no clinical evidence indicating that a transdermal patch is, in any aspect, safer than combined oral contraceptives.
M’ hemmx evidenza klinika li tindika li l- garża transdermali hija, fi kwalunkwe aspett, aktar sigura mill- kontraċettivi orali kkombinati.
EVRA is not indicated during pregnancy (see section 4.6).
EVRA m’ hijiex indikata waqt it- tqala (ara sezzjoni 4. 6).
If any of the conditions/ risk factors mentioned below is present, the benefits of the use of EVRA should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using EVRA.
Jekk xi waħda minn dawn il- kundizzjonijiet/ fatturi ta ’ riskju msemmija hawn taħt, huma preżenti, il - benefiċċji li tintuża EVRA għandhom jiġu meqjusa fid- dawl tar- riskji li jista ’ jkun hemm għal kull mara individwali u dawn għandhom jiġu diskussi mal- mara qabel hija tiddeċiedi li tibda tuża EVRA.
In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should be emphatically told to contact her physician who will decide on whether its use should be discontinued.
F’ każ li kwalunkwe waħda minn dawn il- kundizzjonijiet jew fatturi ta ’ riskju jaggravaw, jiħraxu jew jidhru għall- ewwel darba, il- mara għandha tiġi mwissija b’ mod sod biex tikkuntatja lit- tabib tagħha li jiddeċiedi jekk l- użu tagħha għandux jitwaqqaf.
Thromboembolic and other vascular disorders
Mard tromboemboliku u mard vaskuari ieħor
Epidemiological studies have shown that the incidence of venous thromboembolism (VTE) in women with no other risk factors for VTE who use low dose oestrogen (< 50 micrograms ethinyl estradiol) combined contraceptives ranges from about 20 to 40 cases per 100,000 women-years, but this risk estimate varies according to the type of progestagen.
L- użu ta ’ kull kontraċettiv ormonali kkombinat, inkluż EVRA, izied ir- riskju ta ’ tromboemboliżmu venuż VTE (trombożi tal- vini fil- fond, emboliżmu pulmonari) meta mqabbel ma ’ min ma jagħmilx użu minnu.. Studji epidemjoloġiċi wrew li l- inċidenza ta ’ tromboemboliżmu venuż (VTE) f’ nisa li m’ għandhom l- ebda fatturi oħra ta ’ riskju għal VTE, li jużaw kontraċettivi kkombinati b’ doża baxxa ta ’ etroġenu (< 50 mikrogramma ethinyl estradiol) għandha medda ta ’ bejn 20 u 40 każ kull 100, 000 sena ħajja tan- nisa, iżda din l- istima tar- riskju tvarja skond it- tip ta ’ proġestaġen.
VTE is fatal in 1%-2% of cases.
Dan jikkumpara ma ’ 5 sa 10 każijiet kull 100, 000 sena ħajja tan- nisa għal min ma jużahomx u 60 każ kull 100, 000 tqala. VTE huwa fatali f’ 1% - 2% tal- każi.
Data from a retrospective cohort study in women aged 15 to 44 years have suggested that the incidence of VTE in women who used EVRA is increased in comparison with users of a levonorgestrel-containing OC (so-called “ second generation” OC).
Dejta minn studju cohort retrospettiv f’ nisa ta ’ età bejn il- 15 u l- 44 sena issuġġeriet li l- inċidenza ta ’ VTE f’ nisa li wżaw EVRA tiżdied meta mqabbla ma ’ min juża OC li fih levonorgestrel (hekk imsejjaħ OC “ tat- tieni ġenerazzjoni ”).
The incidence was 1.4 fold (95% CI 0.9-2.3) increased in women with or without other risk factors for VTE and 1.5 fold (95% CI 0.8-2.7) increased in women with no other risk factors for VTE.
L- inċidenza żdiedet b’ 1. 4 drabi aktar (95% CI 0. 9- 2. 3) f’ nisa b’ fatturi ta ’ riskju oħra għal VTE jew mingħajrhom u żdiedet b’ 1. 5 drabi aktar (95% CI 0. 8- 2. 7) f’ nisa mingħajr l- ebda fatturi ta ’ riskju oħra għal VTE.
Epidemiological studies have also associated the use of combined oral contraceptives (COCs) with an increased risk for arterial (myocardial infarction, transient ischaemic attack, stroke) thromboembolism.
6 Studji epidemjoloġiċi assoċjaw ukoll l- użu ta ’ kontraċettivi orali kkombinati (COCs) ma ’ riskju ogħla ta ’ tromboemboliżmu arterjali (infart mijokardijaku, attakk iskemiku għaddieni, puplesija).
Extremely rarely, thrombosis has been reported to occur in other blood vessels e. g., hepatic, mesenteric, renal, cerebral or retinal veins and arteries, in COC users.
Rari ħafna ġie rrappurtat li seħħet trombożi f’ vini jew arterji oħra eż. vini epatiċi, tal- mindil, renali, ċerebrali, jew retinali u arterji f’ min juża l- kontraċettivi orali kkombinati.
There is no consensus as to whether the occurrence of these events is associated with the use of COCs.
M’ hemm l- ebda qbil dwar jekk l- okkorrenza ta ’ dawn inċidenti hijiex assoċjata ma ’ l- użu ta ’ kontraċettivi orali kkombinati.
Symptoms of venous or arterial thrombosis can include:
Sintomi ta ’ trombożi tal- vini jew ta ’ l- arterji jistgħu jinkludu:
- Unilateral leg pain, and/ or swelling
- Uġigħ f’ riġel wieħed u/ jew nefħa
- Sudden severe pain in the chest with possible radiation to the left arm
- Uġigħ qawwi f’ daqqa fis- sider li jista ’ jinfirex għall- id ix- xellugija
- Sudden breathlessness, sudden onset of coughing without a clear cause
- Qtugħ ta ’ nifs f’ daqqa, sogħla li tiġi f’ daqqa u mingħajr kawża ċara
- Any unusual, severe, prolonged headache
- Kwalunkwe uġigħ ta ’ ras m’ hux tas- soltu, qawwija u li tieħu fit- tul
- Sudden partial or complete loss of vision
- Nuqqas totali jew parzjali f’ daqqa tal- vista
- Diplopia
- Diplopja
- Slurred speech or aphasia
- Kliem ma ’ jifthiemx jew afasja
- Vertigo; collapse with or without focal seizure
- Vertiġini; kollass b’ aċċessjoni fokali jew mingħajra
- Weakness or very marked numbness suddenly affecting one side or one part of the body
- Parti jew naħa waħda tal- ġisem li f’ daqqa waħda ssir dgħajfa jew imtarrxa
- Motor disturbances
- Disturbi taċ- ċaqlieq
- ‘ Acute’ abdominal pain
- Uġigħ addominali ‘ akut ’
The risk of venous thromboembolism in combined contraceptives users increases with:
Ir- riskju ta ’ tromboemboliżmu tal- vini f’ dawk li jużaw kontraċettivi kkombinati jiżdied jekk ikun hemm:
- Increasing age
- Kobor fl- età
- A positive family history (i. e. venous thromboembolism ever in a sibling or parent at relatively
- Storja pożittiva fil- familja (jiġifieri tromboemboliżmu fil- vini f’ aħwa jew f’ ġenitur f’ età
early age).
relattivament żgħira).
If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any hormonal contraceptive use
Jekk predisożizzjoni ereditarja hija ssuspettata, il- mara għandha tiġi rreferuta għand speċjalista għall- parir qabel issir deċiżjoni dwar kwalunkwe użu ta ’ kontraċettiv ormonali
- Prolonged immobilisation, major surgery to the legs, or major trauma.
- Immobilizzazzjoni fit- tul, kirurġija maġġuri fir- riġlejn, jew trawma maġġuri.
In these situations it is
F’ dawn is -
advisable to discontinue use (in the case of elective surgery at least 4 weeks in advance) and not to resume until two weeks after complete remobilisation
sitwazzjonijiet ta ’ min jirrakkmanda l- waqfien ta ’ l- użu (f’ każ ta ’ kirurġija elettiva għal mill - anqas 4 ġimgħat qabel) u li ma jerġax jinbeda t- trattament sa ġimgħatejn wara rimobilizzazzjoni kompleta
- Obesity (body mass index over 30 kg/ m²)
- Ħxuna żejda (indiċi tal- massa tal- ġisem aktar minn 30 kg/ m²)
- Possibly also with superficial thrombophlebitis and varicose veins.
- Possibiltà anke jekk ikun hemm tromboflebite superfiċjali u vini varikużi.
There is no consensus about
M’ hemmx qbil dwar
the possible role of these conditions in the aetiology of venous thrombosis.
ir- rwol li dawn il- kundizzjonijiet jista ’ jkollhom fl- etjoloġija tat- trombożi tal- vini.
The risk of arterial thromboembolic complications in combined contraceptives users increases with:
Ir- riskju ta ’ kumplikazzjonijiet tromboemboliċi ta ’ l- arterji f’ dawk li jużaw il- kontraċettivi kkombinati jiżdied jekk ikun hemm:
- Increasing age;
- Kobor fl- età;
- Smoking (with heavier smoking and increasing age the risk further increases, especially in
- Tipjip (aktar ma jiżdied l- ammont ta ’ tipjip u aktar ma jkun hemm kobor fl- età aktar jiżdied ir -
women over 35 years of age);
riskju, speċjalment fin- nisa li għandhom aktar minn 35 sena);
- Dyslipoproteiniaemia;
- Dislipoproteinimja;
- Obesity (body mass index over 30 kg/ m²);
- Ħxuna żejda (indiċi tal- massa tal- ġisem aktar minn 30 kg/ m²);
- Hypertension;
- Pressjoni għolja;
- Valvular heart disease;
- Mard tal- valvoli tal- qalb;
- Atrial fibrillation;
- Fibrillazzjoni ta ’ l- atriju;
- A positive family history (arterial thrombosis ever in a sibling or parent at a relatively early
- Storja pożittiva fil- familja (jiġifieri jekk qatt kien hemm tromboemboliżmu fil- vini f’ aħwa jew
age).
f’ ġenitur f’ età relattivament żgħira).
If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any hormonal contraceptive use.
Jekk predispożizzjoni ereditarja hija ssuspettata, il- mara għandha tiġi rreferuta għand speċjalista għall- parir qabel tiddeċiedi dwar kwalunkwe użu ta ’ kontraċettiv ormonali.
Biochemical factors that may be indicative of hereditary or acquired predisposition for venous or arterial thrombosis include Activated Protein C (APC) resistance, hyper homocysteinaemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
Fatturi biokimiċi li jistgħu jkunu indikattivi ta ’ predispożizzjoini ereditarja jew akkwiżita għal trombożi fil- vini jew fl- arterji jinkludu reżistenza għall- proteina Ċ attivata (APC), iperomoċistenimja, defiċjenza ta ’ l- antithrombin III, defiċjenza tal- proteina Ċ, defiċjenza tal- proteina S u antikorpi antifosfolipidi (antikorpi antikardjolipin, lupus kontra l- koagulazzjoni).
Other medical conditions, which have been associated with adverse circulatory events, included diabetes mellitus, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (e. g., Crohn’ s disease or ulcerative colitis).
7 Kundizzjonijiet mediċi oħrajn, li kienu assoċjati ma attakki avversi taċ- ċirkulazzjoni kienu jinkludu id- dijabete mellitus, il- lupus erythematosus sistemiku, is- sidrome uremiku emolitiku, l- infjammazzjoni kronika tal- musrana (eż. il- marda ta ’ Crohn, u l- kolite bl- ulċeri).
The increased risk for thromboembolism in the puerperium must be considered (see section 4.6).
Żjieda fir- riskju għal tromboemboliżmu fil- puerperu għandu jiġi kkunsidrat (ara sezzjoni 4. 6).
An increase in frequency or severity of headache (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of combination contraceptives.
Żjieda fil- frekwenza jew fil- qawwa ta ’ uġigħ ta ’ ras (li jista ’ jkun prodromiku ta ’ attakk ċerebrovaskulari) tista ’ tkun raġuni għalfejn kontraċettivi kkombinati jitwaqqfu immedjatament.
Women using combined contraceptives should be emphatically advised to contact their physician in case of possible symptoms of thrombosis.
Nisa li jużaw kontracettivi kkombinati għandhom jiġu mwissija b’ mod sod biex jikkuntattjaw lit- tabib f’ każ ta ’ sintomi possibbli ta ’ trombożi.
In case of suspected or confirmed thrombosis, hormonal contraceptive use should be discontinued.
F’ każ ta ’ trombożi ssuspettata jew ikkonfermata, l- użu ta ’ kontraċettiv ormonali għandu jitwaqqaf.
Adequate contraception should be initiated because of the teratogenicity of anti-coagulant therapy (coumarins).
Kontracezzjoni xierqa għandha tinbeda minħabba it - teratoġeniċità tat- terapija kontra l- koagulazzjoni (coumarins).
Tumours
Tumuri
An increased risk of cervical cancer in long-term users of COCs has been reported in some epidemiological studies, but there continues to be controversy about the extent to which this finding is attributable to the compounding effects of sexual behaviour and other factors such as human papilloma virus (HPV).
Żjieda fir- riskju ta ’ kanċer ċervikali f’ min uża l- kontraċettivi orali kkombinati għal- tul ta ’ żmien ġew irrappurtati f’ xi studji epidemjoloġiċi, iżda għadu jkun hemm kontroversji dwar sa fejn din is- sejba tista ’ tkun attribwita għall- effetti mħallta ta ’ mġiba sesswali u fatturi oħra bħall- virus papilloma uman (HPV).
The excess risk gradually disappears during the course of the 10 years after cessation of COC use.
Meta- analiżi ta ’ 54 studju epidemjoloġiku rrappurtaw li hemm żjieda żgħira fir- riskju (RR=1. 24) li ssir dijanjosi ta ’ kanċer tas- sider f’ nisa li f’ dak il- waqt ikunu qed jużaw kontraċettivi orali kkombinati. Ir - risku żejjed jitlaq bil- mod il- mod fuq medda ta’ 10 snin wara li jitwaqqaf l- użu tal- kontraċettivi orali kkombinati.
Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer.
Minħabba li l- kanċer tas- sider huwa rari f’ nisa taħt l- 40 sena, in- numru ta ’ dijanjożi ta ’ kanċer tas- sider li ssir f’ min qed juża l- kontraċettivi orali kkombinati bħalissa jew użahom dan laħħar, huwa żgħir meta mqabbel mar- riskju totali ta ’ kanċer tas- sider.
The breast cancers diagnosed in ever-users tend to be less advanced clinically than the cancers diagnosed in never-users.
Kankri tas- sider li saret dijanjosi tagħhom f’ min qatt uża t- trattament għandhom tendenza li ma jkunux klinikament avvanzati daqs dawk li tkun saret id- dijanjosi tagħhom f’ min qatt ma ’ uża t- trattament.
The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in COC users, the biological effects of COCs or a combination of both.
Il- mudell ta ’ żjieda fir- riskju li ġie osservat jista ’ jkun minħabba dijanjosi bikrija ta ’ kanċer tas- sider f’ min juża l- kontraċettivi orali kkombinati, l- effetti bijoloġiċi tal- kontraċettivi orali kkombinati jew taħlita tat- tnejn flimkien.
In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of COCs.
F’ każi rari, tumuri tal- fwied beninni, jew aktar rari, tumuri tal- fwied malinni ġew irrappurtati f’ min juża l- kontraċettivi orali kkombinati.
In isolated cases, these tumours have led to life-threatening intra-abdominal haemorrhages.
F’ każi iżolati, dawn it- tumuri wasslu għal emorraġiji fiż- żaqq li kienu ta ’ periklu għall- ħajja.
Therefore a hepatic tumour should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage occur in women using EVRA.
Għalhekk tumur epatiku għandu jiġi kkunsidrat fid- dijanjożi divrenzjali meta jkun hemm uġigħ qawwi fin- naħa ta ’ fuq taż- żaqq, fwied kbir jew sinjali ta ’ emorraġija fiż- żaqq f’ nisa li qed jużaw EVRA.
Other conditions
Kundizzjonijiet oħra
- Contraceptive efficacy may be reduced in women weighing equal or greater than 90 kg (see
- L- effikaċija tal- kontraċettiv tista ’ tkun anqas f’ nisa li jiżnu 90 kg jew aktar (ara sezzjonijiet 4. 2
sections 4.2 and 5.1).
u 5. 1).
- Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of
- Nisa li għandhom ipertrigliċeridemija jew storja tal- kundizzjoni fil- familja, jista ’ jkollhom żieda
pancreatitis when using combination hormonal contraceptives.
fir - riskju ta ’ pankreatite meta jużaw kontraċettivi ormonali ikkombinati.
- Although small increases of blood pressure have been reported in many women using hormonal
- Għalkemm ġew irrappurtati żidiet żgħar fil- pressjoni ta ’ ħafna nisa li jużaw kontraċettivi
contraceptives, clinically relevant increases are rare.
ormonali, żidiet li huma klinikamnet rilevanti huma rari.
A definitive relationship between hormonal contraceptive use and clinical hypertension has not been established.
Għadha ma ġietx stabbilita relazzjoni definittiva bejn l- użu tal- kontraċettivi ormonali u l- ipertensjoni klinika.
If, during the use of a combination hormonal contraceptive in pre-existing hypertension, constantly elevated blood pressure values or a significant increase in blood pressure do not respond adequately to antihypertensive treatment, the combination hormonal contraceptive must be withdrawn.
Jekk, waqt l- użu tal - kontraċettiv ormonali kkombinat f’ ipertensjoni diġà eżistenti, il- valuri tal- pressjoni kontinwament għoljin jew żieda sinifikanti fil- pressjoni ma jirrispondux suffiċjentement għat - trattament ipertensiv, il- kontraċettiv ormonali kkombinat għandu jitwaqqaf.
Combination hormonal contraceptive use may be resumed if normotensive values can be achieved with antihypertensive therapy.
L- użu ta ’ kontraċettiv ormonali kkombinat jista ’ jerġa ’ jitkompla jekk valuri ta ’ pressjoni normali jinkisbu b’ kura kontra l- pressjoni għolja.
- The following conditions have been reported to occur or deteriorate with both pregnancy and
- Il- kundizzjonijiet li ġejjin ġew irrappurtati li jiġru jew jiddeterjoraw kemm fit- tqala kif ukoll bl -
COC use, but the evidence of an association with COC use is inconclusive:
użu tal- kontraċettivi orali kkombinati, iżda l- evidenza ta ’ assoċjazzjoni ma ’ l- użu tal - kontraċettivi orali kkombinati huwa inkonklużiv:
Jaundice and/ or pruritus related to cholestasis; gallstones; porphyria; systemic erythematosus; haemolytic ureamic syndrome; Sydenham’ s chorea; herpes gestationis; otosclerosis-related hearing loss.
8 ġebla fil- marrara; porfirja; lupus erythematosus sistemiku; sindrome uremiku emolitiku; korea ta ’ Sydenham; erpete gestationis; nuqqas ta ’ smigħ relatat ma ’ l- otosklerożi.
- Acute or chronic disturbances of liver function may necessitate the discontinuation of
- Disturbi akuti jew kroniċi tal- funzjoni tal- fwied joħolqu l- bżonn tal- waqfien mill- użu tal -
combination hormonal contraceptives until markers of liver function return to normal.
kontraċettivi ormonali kkombinati sakemm il- markaturi li juru l- funzjoni tal- fwied jiġu lura għan- normal.
Recurrence of cholestatic-related pruritus, which occurred during a previous pregnancy or previous use of sex steroids necessitates the discontinuation of combination hormonal contraceptives.
Ir- rikurrenza ta ’ ħakk relatat mal- kolestasi li tkun diġà ġrat waqt tqala jew l- użu ta ’ sterojdi tas- sess toħloq il- bżonn li jitwaqqfu l- kontraċettivi ormonali ikkombinati.
- Although combined hormonal contraceptives may have an effect on peripheral insulin resistance
- Għalkemm il- kontraċettivi ormonali kkombinati jista ’ jkollhom effett fuq ir- reżistenza periferali
and glucose tolerance there is no evidence for a need to alter the therapeutic regimen in diabetes during use of combined hormonal contraception.
ta ’ l- insulina u t- tolleranza tal- glukożju m’ hemm l- ebda evidenza ta ’ bżonn ta ’ bdil fil- mod ta ’ kif jittieħed it- trattment tad- dijabete waqt l- użu ta ’ kontraċezzjoni ormonali ikkombinata.
However, diabetic women should be carefully observed, particularly in the early stage of EVRA use.
Madankollu nisa dijabetiċi għandhom jiġu osservati b’ attenzjoni b’ mod partikolari fl- ewwel stadji ta ’ użu ta ’ EVRA.
- Worsening of endogenous depression, of epilepsy, of Crohn’ s disease and of ulcerative colitis
- Id- depressjoni endogenika, l- epilessija, il- marda ta ’ Crohn u l- kolite bl- ulċeri ġew irrppurtati li
has been reported during COC use.
marru għall- agħar waqt l- użu tal- kontraċettivi orali kkombinati.
- Chloasma may occasionally occur with the use of hormonal contraception, especially in users
- Kloasma tista ’ xi kultant tiġri bl- użu ta ’ kontraċezzjoni ormonali, speċjalment jekk dawk li qed
with a history of chloasma gravidarum.
jużawha jkollhom storja ta ’ kloasma gravidarum.
Users with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while using EVRA.
Persuni li qed jużaw it- trattament u li għandhom tendenza għall- kloasma għandhom jevitaw esponiment għax- xemx jew radjazzjoni ultravjola waqt l- użu t’ EVRA.
Chloasma is often not fully reversible.
Kloasma kemm- il darba ma tkunx kompletament riversibbli.
Medical examination/ consultation
Eżami mediku/ konsultazzjoni
Prior to the initiation or reinstitution of EVRA a complete medical history (including family history) should be taken and pregnancy should be ruled out.
Qabel il- bidu jew il- bidu mill- ġdid ta ’ l- użu t’ EVRA, għandha tittieħed storja medika kompluta (inkluż storja tal- familja) u għandha tiġi eskluża t- tqala.
Blood pressure should be measured and a physical examination should be performed guided by the contraindications (see section 4.3) and warnings (see section 4.4).
Il- pressjoni għandha titkejjel u għandu jsir eżami fiżiku ggwidat mill- kontra- indikazzjonijiet (ara sezzjoni 4. 3) u t- twissijiet (ara sezzjoni 4. 4).
The woman should also be instructed to carefully read the package leaflet and to adhere to the advice given.
Il - mara għandha tiġi wkoll infurmata biex taqra l- fuljett ta ’ tagħrif b’ attenzjoni u li żżomm mal- pariri mogħtija.
8 The frequency and nature of subsequent examinations should be based on established guidelines and be adapted to the individual woman on the basis of clinical impression.
Il- frekwenza u n- natura ta ’ eżamijiet sussegwenti għandhom ikunu bbażati fuq linji gwida stabbiliti u jiġu addattati għal- mara individwali fuq il- bażi ta ’ l- impressjoni klinika.
Women should be advised that hormonal contraceptives do not protect against HIV infections (AIDS) and other sexually transmissible diseases.
In- nisa għandhom jiġu nfurmati li kontraċettivi ormonali ma jipproteġux kontra infezzjonijiet ta ’ l - HIV (AIDS) u mard ieħor li jittieħed mis- sess.
Bleeding irregularities
Irregolaritajiet tal- fsada
With all combination hormonal contraceptives, irregular blood loss (spotting or breakthrough bleeding) can occur, especially during the initial months of usage.
B’ kull kontraċettiv ormonali kkombinat jista ’ jkun hemm telf ta ’ demm irregolari (fsada ħafifa ħafna jew fsada li tippenetra ċ- ċiklu), speċjalment waqt l- ewwel xhur ta ’ użu.
For this reason, a medical opinion on irregular blood loss will only be useful after an adjustment period of approximately three cycles.
Għal din ir- raġuni, opinjoni medika dwar telf ta ’ demm irregolari tkun ta ’ użu biss wara perjodu ta ’ aġġustament ta ’ madwar tliet ċikli.
If breakthrough bleeding persists, or breakthrough bleeding occurs after previously regular cycles, while EVRA has been used according the recommended regimen, a cause other than EVRA should be considered.
Jekk il- fsada li tinfed iċ- ċiklu tippersisti, jew jekk il- fsada li tinfed iċ- ċiklu tiġri wara li jkun diġà hemm ċikli regolari, waqt li EVRA tkun qed tintuża kif rakkomandat, għandha tiġi kkunsidrata kawża oħra li m’ hix EVRA.
Non-hormonal causes should be considered and, if necessary, adequate diagnostic measures taken to rule out organic disease or pregnancy.
Kawżi mhux ormonali għandhom jiġu kkunsidrati u, jekk ikun hemm bżonn, għandhom jittieħdu miżuri dijanjostiċi xierqa li jeskludu mard organiku jew tqala.
This may include curettage.
Dan jista ’ jinkludi curettage.
In some women withdrawal bleeding may not occur during this patch free period.
F’ xi nisa, fsada wara l- waqfa miċ- ċiklu ta ’ trattament tista ’ ma sseħħx f’ dan il- perjodu mingħajr garża.
If EVRA has been taken according to the directions described in section 4.2, it is unlikely that the woman is pregnant.
Jekk EVRA tpoġġiet skond id- direzzjonijiet deskritti f’ sezzjoni 4. 2, x’ aktarx li l- mara m’ hijiex tqila.
However, if EVRA has not been taken according to these directions prior to the first missed withdrawal bleed or if two withdrawal bleeds are missed, pregnancy must be ruled out before EVRA use is continued.
Madankollu, jekk EVRA ma tpoġġietx skond dawn id- direzzjonijiet qabel l- ewwel fsada li ma seħħitx wara l- waqfa ċiklika mit- trattament jew jekk il- fsada ma seħħitx għal- darbtejn wara żewġ waqfiet ċikliċi mit- trattament, t- tqala għandha tiġi eskluża qabel EVRA tista ’ titkompla.
Some users may experience amenorrhoea or oligomenorrhoea after discontinuing hormonal contraception, especially when such a condition was pre-existent.
Xi wħud mill- persuni li jużaw it- trattament jistgħu jesperjenzaw amenorreja jew oligomenorreja wara li titwaqqaf għal kollox il- kontraċezzjoni ormonali, speċjalment meta t- tali kundizzjonijiet kienu diġà jeżistu.
Herbal preparations containing St John’ s Wort (Hypericum perforatum) should not be used while taking EVRA (see section 4.5)
John’ s Wort (Hypericum perforatum) m’ għandhomx jintużaw waqt trattament b’ EVRA (ara sezzjoni 4. 5).
4.5 Interaction with other medicinal products and other forms of interaction
9 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott