qanastek/EMEA-V3 huggingface dataset:
Influence of other medicinal products on EVRA
Influwenza ta ’ prodotti mediċinali oħra fuq EVRA
Medicinal product interactions, which result in an increased clearance of sex hormones can lead to breakthrough bleeding and hormonal contraceptive failure.
Prodotti mediċinali li ma jaqblux ma dan il- prodott, li jwasslu għall- tneħħija ta’ ormoni tas- sess mill - ġisem b’ rata aktar mgħaġġla jistgħu jwasslu għall- fsada li tinfed iċ- ċiklu u falliment tal- kontraċettiv ormonali.
This has been established with hydantoins, barbiturates, primidone, carbamazepine and rifampicin; bosentan, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, modafinil and phenyl butazone are also suspected.
Dan ġie stabbili bil- hydantoins, barbiturates, primidone, carbamazepine u rifampicin; bosentan, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, modafinil u phenyl butazone huma suspettati li jagħamlu dan ukoll.
The mechanism of these interactions appears to be based on the hepatic enzyme inducing properties of these medicinal products.
Il- mekkaniżmu ta ’ dawn l- azzjonijiet reċiproċi jidher li huwa bbażat fuq kwalitajiet li għandhom dawn il- prodotti mediċinali li jinduċu enzimi epatiċi.
Maximal enzyme induction is generally not seen for 2-3 weeks but may be sustained for at least 4 weeks after cessation of therapy.
Induzzjoni massima ta ’ l- enzimi ġeneralment ma tkunx tidher għal madwar ġimgħatejn sa 3 ġimgħat iżda tista ’ tibqa ’ sejra għal ta ’ l- anqas 4 ġimgħat wara l- waqfien tat- trattament.
The herbal preparation of St John’ s Wort (Hypericum perforatum) should not be taken concomitantly with this medicinal product as this could potentially lead to a loss of contraceptive effect.
John’ s Wort (Hypericum perforatum) m’ għandiex tittieħed flimkien ma ’ dan il- prodott mediċinali minħabba li din tista ’ potenzjalment twassal għat- telfa ta ’ l- effett kontraċettiv.
Breakthrough bleeding and unintended pregnancies have been reported.
Fsada li tinfed iċ- ċiklu u tqaliet mhux intenzjonati ġew irrappurtati.
This is due to induction of metabolising enzymes by St John’ s Wort.
John’ s Wort jagħmel induzzjoni ta ’ l- enzimi metabolizzaturi.
The inducing effect may persist for at least 2 weeks after cessation of treatment with St John’ s Wort.
John’ s Wort.
Contraceptive failures have also been reported with antibiotics, such as ampicillin and tetracyclines.
Fallimenti kontraċettivi ġew irrappurtat ukoll bl- antibijotiċi, bħal ma huma l- ampicillin u t - tetracyclines.
The mechanism of this effect has not been elucidated.
Il- mekkaniżmu ta ’ dan l- effett għadu mhux ċar.
In a pharmacokinetic interaction study, oral administration of tetracycline hydrochloride, 500 mg four times daily for 3 days prior to and 7 days during wear of EVRA, did not significantly affect the pharmacokinetics of norelgestromin or EE.
Fi studju ta ’ effett reċiproku farmakokinetiku, it- teħid mill- ħalq ta ’ tetracycline hydrochloride, 500 mg erba ’ darbiet kuljum għall - 3 ijiem qabel u 7 ijiem waqt l- użu ta ’ EVRA, m’ affetwax sinifikament il- farmakokinetika ta ’ norelgestromin jew EE.
Women on treatment with any of these medicinal products should temporarily use a barrier method in addition to EVRA or choose another method of contraception.
Nisa li qed jieħdu trattament bi kwalunkwe waħda minn dawn il- prodotti mediċinali għandhom jużaw kontraċezzjoni mekkanika flimkien ma ’ EVRA jew jgħażlu metodu ieħor ta ’ kontraċezzjoni.
With microsomal enzyme-inducing medicinal products, the barrier method should be used during the time of concomitant administration of these medicinal products and for 28 days after their discontinuation.
Flimkien ma ’ prodotti mediċinali li jinduċu l- ezimi mikrosomali l- kontraċezzjoni mekkanika għandha tintuża matul l- użu konkomitanti ta ’ dawn il- prodotti mediċinali u għal- 28 ġurnata wara li jitwaqqfu.
Women on treatment with antibiotics (except tetracycline) should use the barrier method until 7 days after discontinuation.
Nisa fuq trattament b’ antibijotiċi (minbarra t- tetracycline) għandhom jużaw kontraċezzjoni mekkanika sa 7 ijiem wara li dawn jitwaqqfu.
If concomitant medicinal product administration runs beyond the 3 weeks of patch treatment, a new treatment cycle should be started immediately without having the usual patch-free interval.
Jekk l- amministrazzjoni konkomitanti tal- prodott mediċinali tkun itwal mit- 3 ġimgħat tat- trattament bil- garża, ċiklu ġdid ta ’ trattament għandu jinbeda mingħajr ma jkun hemm l- intervall mingħajr garża li soltu jitħalla.
9 For women on long-term therapy with hepatic enzyme inducers, another method of contraception should be considered.
Għal nisa fuq terapija fit- tul b’ mediċini li jinduċu l- enzimi tal- fwied, għandu jiġi kkunsidrat metodu ieħor ta ’ kontraċezzjoni.
Influence of EVRA on other medications
L- influwenza ta ’ EVRA fuq mediċini oħra
Progestogens and estrogens inhibit a variety of P450 enzymes (e. g., CYP 3A4, CYP 2C19) in human liver microsomes.
CYP 3A4, CYP 2C19) fil - mikrosomi tal- fwied uman.
However, under the recommended dosing regimen, the in vivo concentrations of norelgestromin and its metabolites, even at the peak serum levels, are relatively low compared to the inhibitory constant (Ki), indicating a low potential for clinical interaction.
Madankollu, skond ir- regoli ta ’ dożi rakkomandati, il- konċentrazzjonijiet in vivo ta ’ norelgestromin u l- metaboliti tiegħu, anke fl- ogħla konċentrazzjonijiet fis- serum, huma relattivament baxxi meta mqabbla mal- konstant inibitorju (Ki), għaldaqstant dan juri potezjal baxx ta ’ interazzjoni klinika.
Nevertheless, physicians are advised to refer to prescribing information for recommendations regarding management of concomitant therapy, especially for agents with a narrow therapeutic index metabolised by these enzymes (e. g. cyclosporin).
Madankollu, it- tobba għandhom ikunu avżati biex jirreferu għall- informazzjoni dwar kif tippreskrivi għal rakomandazzjonijiet dwar l- amministrazzjoni ta ’ terapija konkomitanti, speċjalment għal dawk l- aġenti b’ indiċi terapewtiċi stretti immentabolizzati b’ dawn l- enzimi (eż. cyclosporin).
Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered due to induction of lamotrigine glucuronidation.
Kontraċettivi ormonali kombinati wrew tnaqqis sinjifikanti fil- konċentrazzjonijiet fil- plażma ta ’ lamotrigine meta ko- amministrati minħabba induzzjoni ta ’ glukuronidazzjoni ta ’ lamotrigine.
This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Dan jista ’ jnaqqas il- kontroll tal- attakki pupletiċi: għalhekk, jista ’ jkun hemm bżonn ta ’ aġġustament fid - doża ta ’ lamotrigine.
Laboratory tests
10 Testijiet tal- laboratorju
Certain endocrine and liver function tests and blood components may be affected by hormonal contraceptives:
Ċerti testijiet tal- funzjoni ta ’ l- endokrina u tal- fwied u komponenti tad- demm jistgħu jiġu affettwati minn kontraċettivi ormonali:
− Increased prothrombin and factors VII, VIII, IX and X; decreased anti-thrombin III; decreased protein S; increased norepinephrine (noradrenaline)-induced platelet aggregability.
- Protrombin u fatturi VII, VIII, IX, u X jiżdiedu; l- anti- trombin III jonqos; il- proteina S tonqos, it -
− Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay.
tat- tiroide li qed jiċċirkola, kif imkejjel permezz tal- jodju li jeħel mal- proteini (PBI), T4 b ’ kolonna jew b’ analiżi radjoimmunoloġika.
Free T3 resin uptake is decreased, reflecting the elevated TBG, free T4 concentration is unaltered.
L- ammont ta ’ raża ta ’ T3 libera li tista ’ tintuża tonqos li jirrifletti il- livell ta ’ TBG għoli, il- konċentrazzjoni ta ’ T4 liberu tibqa ’ l- istess.
Other binding proteins may be elevated in serum.
Proteini oħra li jeħlu mal- proteini tad- demm li jista ’ jkollhom livell għoli fis- serum.
Sex hormone-binding globulins (SHBG) are increased and result in elevated levels of total circulating endogenous sex steroids.
Globulini li jeħlu ma ’ l- ormoni tas- sess (SHBG) jiżdiedu u jwasslu għal livelli ogħla ta ’ total ta ’ sterojdi tas- sess endoġeniċi li qed jiċċirkulaw.
However, the free or biologically active levels of sex steroids either decrease or remain the same.
Madankollu l- livelli ta ’ sterojdi tas- sess liberi jew bijoloġikament attivi jonqos jew jibqa ’ l- istess.
High-density lipoprotein (HDL-C), total cholesterol (Total-C), low-density lipoprotein (LDL-C) and triglycerides may all increase slightly with EVRA, while LDL-C/ HDL-C ratio may remain unchanged.
Il- lipoproteini b’ denistà għolja (HDL- C), il- kolesterol totali (Total- C), il- lipoproteini b’ denistà baxxa (LDL- C) u t- trigliċerajds kollha jistgħu jiżdiedu ftit b’ EVRA, filwaqt li l- proporzjon ta ’ LDL- C/ HDL - C jista ’ jibqgħa l- istess.
Glucose tolerance may be decreased.
It- tolleranza għall- glukożju tista ’ tonqos.
Serum folate levels may be depressed by hormonal contraceptive therapy.
Livelli tal- folate fis- serum jistgħu jitnaqqsu bit- terapija kontraċettiva ormonali.
This has potential to be of clinical significance if a woman becomes pregnant shortly after discontinuing hormonal contraceptives.
Dan jista ’ jkun klinikamnet sinifikanti jekk mara tinqabad tqila f’ qasir żmien wara li twaqqaf il- kontraċettivi ormonali.
All women are now advised to take supplemental folic acid peri-conceptionally.
In- nisa kollha issa huma mwissija biex jieħdu folic acid supplementari qabel il - konċepiment.
EVRA is not indicated during pregnancy.
EVRA m’ huwiex indikat waqt it- tqala.
Epidemiological studies indicate no increased risk of birth defects in children born to women who used hormonal contraceptives prior to pregnancy.
Studji epidemjololġiċi ma juru l- ebda żieda fir- riskju ta ’ difetti tat- twelid fi tfal li twieldu lil nisa li użaw kontraċettivi ormonali qabel it- tqala.
The majority of recent studies also do not indicate a teratogenic effect when hormonal contraceptives are used inadvertently during early pregnancy.
Il- maġġoranza ta ’ l- istudji riċenti wkoll ma jurux effett teratoġeniku meta kontraċettivi ormonali jintużaw involontarjament fil- bidu tat- tqala.
For EVRA there are no clinical data on exposed pregnancies, which allow conclusions about its safety during pregnancy.
Għall- EVRA m’ hemmx tagħrif kliniku dwar l- użu fi tqaliet esposti, li jwasslu għal konklużjonijiet dwar is- sigurtà tagħha waqt it- tqala.
10 Studies in animals have shown reproductive toxicity (see section 5.3).
Studji li saru fuq l- annimali wrew ħsara riproduttiva (ara sezzjoni 5. 3).
On the basis of available data, a potential risk of masculinisation as a consequence of an exaggerated hormonal action cannot be excluded.
Fuq il- bażi ta ’ tagħrif disponibbli, risku potenzjali ta ’ maskulinizzazzjoni bħala konsegwenza ta ’ azzjoni ormonali esaġerata ma jistax jiġi eskluż.
If pregnancy occurs during use of EVRA, EVRA should be stopped immediately.
Jekk isseħħ tqala waqt l- użu b’ EVRA, EVRA għandha titwaqqaf immedjatament.
Therefore, the use of EVRA is not to be recommended until the breast-feeding mother has completely weaned her child.
It- treddigħ jista ’ jiġi affettwat minn kontraċettivi ormonali kkombinati minħabba li dawn jistgħu inaqqsu l- kwantità u jibdlu l- kompożizzjoni tal- ħalib tas- sider. Għalhekk l- użu ta ’ EVRA m’ huwiex rakkomandat sakemm il- mara li qed tredda ’ tkun fatmet kompletament lit- tarbija tagħha.
EVRA has no or negligible influence on the ability to drive and use machines.
EVRA m’ għandha l- ebda effett jew ftit li xejn għandha effett fuq il- ħila biex issuq u tħaddem magni.
Undesirable effects
11 4. 8 Effetti mhux mixtieqa
4.8.1 Clinical Trial Data
4. 8. 1 Tagħrif minn Provi Kliniċi
The most commonly reported adverse drug reactions (ADRs) in clinical trials were headache, nausea, and breast tenderness, occurring in approximately 21.0%, 16.6%, and 15.9% of patients, respectively.
L- aktar reazzjonijiet avversi għall- mediċina rrappurtati (ADRs) fi provi kliniċi kienu uġigħ ta ’ ras, dardir u sensibilità fis- sider, li seħħew f’ bejn wieħed u ieħor 21. 0%, 16. 6%, u 15. 9% tal- pazjenti, rispettivament.
Frequency estimate: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000); not known (cannot be estimated from the available data).
Stima tal- frekwenza: komuni ħafna (≥ 1/ 10); komuni (≥ 1/ 100 sa < 1/ 10); mhux komuni (≥ 1/ 1, 000 sa < 1/ 100); rari (≥ 1/ 10, 000 sa < 1/ 1, 000); rari ħafna (< 1/ 10, 000); mhux magħruf (ma tistax tittieħed stima mid- dejta disponibbli).
System Organ Class
Provi Kliniċi
Adverse Drug Reactions in Clinical Trials Frequency
Infezzjonijiet u infestazzjonijiet Disturbi fil - metaboliżmu u n - nutrizzjoni
Very
Rari
Common
Rari ħafna
Uncommon
Disturbi
Rare
Aggre
Very rare
psikjatriċi
common Infections and infestations
Bidla fil - stabbiltà ta ’ l -
Fungal infection (vaginal only), Vaginal candidiasis, Vulvovaginal mycotic infection
burdata, emozzjoni, Burdata li Ansjetà, Nuqqas tinbidel minn ta ’ rqad, Tnaqqis ferħ għal fil- libido dwejjaq f’ daqqa waħda
Metabolism and nutrition disorders
tad- dmugħ
Fluid retention, Hypercholesterolemia
Disturbi fis -
Psychiatric disorders
Uġigħ ta ’
Depression, Mood altered, Mood swings
Sturdament,
Affect lability, Anxiety, Insomnia, Libido decreased
sistema nervuża Disturbi respiratorji, toraċiċi u medjastinali
Crying, Libido increased, Tearfulness
ras
Aggression
Migranja
Nervous system disorders
Emboliżmu pulmonari
Headache
Dardir
Dizziness, Migraine
Koleċistite
Respiratory, thoracic and mediastinal disorders
12 Disturbi fil- ġilda
Pulmonary embolism
Akne, Ħakk,
Gastrointestinal disorders
Dermatite tal -
Nausea
Kloasma
Abdominal distension, Abdominal pain, Abdominal pain lower, Abdominal pain upper, Vomiting, Diarrhoea
u fit- tessuti ta ’ taħt il- ġilda Disturbi muskolu - skelettrali u tal - connective tissue
Hepatobiliary disorders
kuntatt, Ħmura
Cholecystitis
Disturbi fis -
Skin and subcutaneous tissue disorders
Sensibbilità
Acne, Pruritus, Skin irritation
Skomfort fis -
Dermatitis contact, Erythema
Disturbi fis- sider,
Chloasma
Tnixxija
Musculoskeletal and connective
sider, Tkabbir
Muscle spasms
Konġestjonament
tissue disorders
ġenitali, Disturb
11
en -
Reproductive system and breast disorders
tas- sider, Uġigħ
Breast tenderness
fis- sider, Nefħa
Breast discomfort, Breast enlargement, Breast pain, Dysmen- orrhoea, Menorrhagia, Metrorrhagia, Uterine spasm, Vaginal discharge
tal -
Breast disorder, Breast engorgement, Breast swelling, Fibrocystic breast disease, Galactorrhoea, Premenstrual syndrome, Vaginal haemorrhage, Vulvovaginal dryness
orreja
Genital discharge, Menstrual disorder, Menstruation irregular
sider
Polymen- orrhoea
fis- sider,
General disorders and administration site conditions
fis- sider, Mard
Application site erythema, Application site irritation, Application site pruritus, Application site rash, Application site reaction, Fatigue, Malaise
menstrwazzjoni,
Application site dermatitis, Application site discolouration, Application site hypersensitivity, Application site pain, Application site papules, Application site vesicles, Generalized oedema
Menstrwazzjoni bl- uġigħ, Menstrwazzjoni esaġerata, Fsada mhux assoċjata mal - menstrwazzjoni, Spażmu ta ’ l - utru, Tnixxija mill- vaġina
Application site urticaria, Swelling
fibroċistiku tas - sider, Galactorreja, Sindrome ta ’ qabel il - menstrwazzjoni, Emorraġija vaġinali, Vulva u vaġina xotti
Applica- tion site oedema
Menstrwazzjoni irregolari
Investigations
Disturbi ġenerali
Weight increased
Ħmura fis- sit
Blood pressure increased, Blood triglycerides increased
Dermatite fis- sit
Blood cholesterol increased
Urtikarja fis- sit
4.8.2 Postmarketing Data Additional adverse drug reactions first identified during postmarketing experience with EVRA are listed below:
Nefħa
12 Infections and infestations
u kundizzjonijiet
Application site pustules, Rash pustular
ta ’ l -
Neoplasms benign, malignant and unspecified (Incl cysts and polyps)
ta ’ l -
Breast cancer, Breast cancer stage IV, Cervix carcinoma, Fibroadenoma of breast, Hepatic adenoma, Hepatic neoplasm, Uterine leiomyoma
ta ’ l -
Immune system disorders
fis- sit
Hypersensitivity
ta ’ mnejn
Metabolism and nutrition disorders
applikazzjoni,
Hyperglycaemia, Insulin resistance
applikazzjoni,
Psychiatric disorders Nervous system disorders
applikazzjoni,
Anger, Emotional disorder, Frustration Basilar artery thrombosis, Brain stem infarction, Carotid artery occlusion, Cerebral artery embolism, Cerebral artery occlusion, Cerebral artery thrombosis, Cerebral haemorrhage, Cerebral infarction, Cerebral thrombosis, Cerebral venous thrombosis, Cerebrovascular accident, Embolic stroke, Haemorrhage intracranial, Haemorrhagic stroke, Intracranial venous sinus thrombosis, Ischaemic cerebral infarction, Ischaemic stroke, Lacunar infarction, Migraine with aura, Subarachnoid haemorrhage, Superior sagittal sinus thrombosis, Thromboembolic stroke, Thrombotic stroke, Transient ischaemic attack, Transverse sinus thrombosis
ta ’ l -
Eye disorders
jingħata
Contact lens intolerance
Irritazzjoni fis -
Cardiac disorders
Telf ta ’ kulur tal -
Acute myocardial infarction, Myocardial infarction
Nefħa
Vascular disorders
applik
Arterial thrombosis, Arterial thrombosis limb, Axillary vein thrombosis, Budd-Chiari syndrome, Coronary artery thrombosis, Deep vein thrombosis, Embolism, Hepatic vein thrombosis, Hypertension, Hypertensive crisis,, Iliac artery thrombosis, Intracardiac thrombus, Jugular vein thrombosis, Mesenteric vein thrombosis, Pelvic venous thrombosis, Peripheral embolism, Portal vein thrombosis, Renal embolism, Renal vein thrombosis, Retinal artery occlusion, Retinal vascular thrombosis, Retinal vein occlusion, Splenic vein thrombosis, Superficial thrombophlebitis, Thrombophlebitis, Thrombosis, Vena cava thrombosis, Venous thrombosis, Venous thrombosis limb
sit ta ’ l - applikazzjoni, Ħakk fis- sit ta ’ l- applikazzjoni, Raxx fis- sit ta ’ l- applikazzjoni, Reazzjoni fis- sit ta ’ l - applikazzjoni, Għeja kbira, Telqa tal- ġisem mingħajr sinjali ta ’ mard
Respiratory, thoracic and mediastinal disorders
ġilda fis- sit ta ’ l - applikazzjoni, Sensittività eċċessiva fis- sit ta ’ l - applikazzjoni, Uġigħ fis- sit ta ’ l - applikazzjoni, Ponot żgħar fis - sit ta ’ l - applikazzjoni, Nfafet żgħar fis - sit ta ’ l - applikazzjoni, Edima mifruxa
Pulmonary artery thrombosis, Pulmonary thrombosis
Investigazzjonijiet
Gastrointestinal disorders
Żieda fil- piż
Colitis
Żieda fil -
Hepatobiliary disorders
Żieda tal -
Cholelithiasis, Cholestasis, Hepatic lesion, Jaundice cholestatic
pressjoni, Żieda tat- trigliċeridi fid - demm
Skin and subcutaneous tissues
kolesterol fid - demm
Alopecia, Angioedema, Dermatitis allergic, Eczema, Erythema multiforme, Erythema nodosum, Exfoliative rash,
4. 8. 2 Tagħrif ta ’ wara t- Tqegħid fis- Suq Reazzjonijiet avversi addizzjonali għall- mediċina li ġew identifikati għall- ewwel darba waqt esperjenza b’ EVRA wara t- tqegħid fis- suq huma elenkati hawn taħt:
13
13 Ponot żgħar fis- sit ta ’ l- applikazzjoni, Raxx bil- ponot Infezzjonijiet u infestazzjonijiet
disorders
Kanċer tas- sider, Kanċer tas- sider ta ’ l- istadju IV, Karċimoma taċ- ċerviċi, Neoplażmi beninni, Fibroadenoma tas- sider, Adenoma epatika, Neoplażmu epatiku, malinni, u dawk mhux Lejomajoma ta ’ l- utru speċifikati (inkluż ċesti u polipi)
Photosensitivity reaction, Pruritus generalised, Rash, Rash erythematous, Rash pruritic, Seborrhoeic dermatitis, Skin reaction, Urticaria
Sensittività eċċessiva Distubi fis- sistema immuni
Reproductive system and breast disorders
Ipergliċemija, Reżistenza għall- insulina Disturbi fil - metaboliżmu u n - nutrizzjoni
Amenorrhoea, Breast mass, Cervical dysplasia, Hypomenorrhoea, Menometrorrhagia, Oligomenorrhoea, Suppressed lactation
Intolleranza għal- lentijiet tal- kuntatt Disturbi fl- għajnejn
General disorders and administration site conditions
Infart mijokardjali akut, Infart mijokardjali Disturbi fil- qalb
Application site abscess, Application site anaesthesia, Application site atrophy, Application site bleeding, Application site bruising, Application site burn, Application site discharge, Application site discomfort, Application site dryness, Application site eczema, Application site erosion, Application site excoriation, Application site exfoliation, Application site induration, Application site infection, Application site inflammation, Application site mass, Application site nodule, Application site odour, Application site paraesthesia, Application site photosensitivity reaction, Application site scab, Application site scar, Application site swelling, Application site ulcer, Application site warmth, Face oedema, Irritability, Localised oedema, Oedema peripheral, Pitting oedema
Trombożi ta ’ arterja, Trombożi ta ’ arterja fid- dirgħajn jew ir- riġlejn, Disturbi vaskulari Trombożi ta ’ vina ta ’ l- abt, Sindrome ta ’ Budd- Chiari, Trombożi ta ’ l - arterja koronarja, Trombożi ta ’ vini fil- fond, Emboliżmu, Trombożi ta ’ vina epatika, Pressjoni għolja, Kriżi ta ’ pressjoni għolja, Trombożi ta ’ l - arterja ta ’ l- ilju, Trombożi fil- qalb, Trombożi fil- vina ġugulari, Trombożi fil- vina tal- mindil, Trombożi venuża tal- pelvi, Emboliżmu periferali, Trombożi fil- vina portali, Emboliżmu renali, Trombożi tal- vini renali, Sadda ta ’ l- arterja tar- retina, Trombożi vaskulari tar- retina, Sadda tal- vina tar- retina, Trombożi fil- vina tal- milsa, Tromboflebite superfiċjali, Tromboflebite, Trombożi, Trombożi fil- vena cava, Trombożi venuża, Trombożi venuża fi driegħ jew riġel
Investigations
Kolite Disturbi gastrointestinali
Blood cholesterol abnormal, Blood glucose abnormal, Blood glucose decreased, Low density lipoprotein increased
Kolelitjażi, Kolestażi, Leżjoni epatika, Suffejra kolestatika Disturbi fil- fwied u fil - marrara
Injury, poisoning and procedural complications
Kolesterol fid- demm mhux normali, Zokkor fid- demm mhux normali, Investigazzjonijiet Tnaqqis taz- zokkor fid- demm, Żieda fil- lipoproteina ta ’ densità baxxa
Contact lens complication
Kumplikazzjoni tal- lentijiet tal- kuntatt Korriment, avvalenament u kumplikazzjonijiet ta ’ xi proċedura
Serious ill effects have not been reported following accidental ingestion of large doses of oral contraceptives.
Ma kienux irrappurtati effetti serji ħżiena wara inġestjoni aċċidentali ta ’ dożi kbar ta ’ kontraċettivi orali.
Overdosage may cause nausea or vomiting.
Doża eċċesiva tista ’ tikkawża dardir jew rimettar.
Vaginal bleeding may occur in some females.
Fsada vaġinali tista ’ tiġri f’ xi nisa.
In cases of suspected overdose, all transdermal contraceptive systems should be removed and symptomatic treatment given.
F’ każi fejn tkun issuspettata li ttieħdet doża eċċessiva, is- sistemi kollha ta ’ kontraċezzjoni transdermali għandhom jitneħħew u għandu jingħata trattament sintomatiku.
Norelgestromin and estrogen; ATC-code:
Norelgestromin u estrogen; Kodiċi ATC:
EVRA acts through the mechanism of gonadotropin suppression by the estrogenic and progestational actions of ethinyl estradiol and norelgestromin.
EVRA taħdem permezz tal- mekkaniżmu tat- trażżin tal- gonadotropin bl- azzjonijiet estroġeniċi u proġestazzjonali ta ’ ethinyl estradiol u norelgestromin.
The primary mechanism of action is inhibition of the ovulation, but the alterations of the cervical mucus, and to the endometrium may also contribute to the efficacy of the product.
Il- mekkaniżmu t’ azzjoni primarju huwa l - inibizzjoni tal- ovulazzjoni, iżda bdil fil- mukus ċervikali u fl- endometriju jista ’ wkoll iwassal għall - effikaċja tal- prodott.
Pearl Indices (see table):
15 Indiċi Pearl (ara t- tabella):
Study Group
Grupp ta ’ l - Istudju
CONT-002 EVRA
KONT- 002 EVRA
CONT-003 EVRA
KONT- 003 EVRA
CONT-003 COC*
KONT- 003 COC *
CONT-004 EVRA
KONT- 004 KONT- 004 EVRA COC **
CONT-004 COC**
Suġġetti kollha li ħadu EVRA
All EVRA Subjects
# ta ’ ċikli
Method
21, 669
0.61
Indiċi Pearl 0. 73
0.67
0. 89
0.28
0. 57
1.02
1. 28
1.30
2. 27
0.72
0. 90
Failure Pearl Index (95% CI)
Totali (95% CI)
(0.0,1.14)
(0. 44, 1. 35)
(0,1.42)
(0, 1. 42)
(0,0.84)
(0, 0. 84)
(0.02,2.02) (0.03,2.57) (0.31,1.13)
(0. 02, 2. 02) (0. 03, 2. 57) (0. 31, 1. 13)
DSG 150 µg + 20 µg EE **:
DSG 150 µg + 20 µg EE *: **:
50 µg LNG + 30 µg for days 1 – 6, 75 µg LNG + 40 µg EE for days 7 – 11, 125 µg LNG + 30 µg EE for 12 – 21 days
50 µg LNG + 30 µg għall- ġranet 1 – 6, 75 µg LNG + 40 µg EE għall- ġranet 7 – 11, 125 µg LNG + 30 µg EE għall- ġranet 12 – 21
Exploratory analyses were performed to determine whether in the Phase III studies (n=3319) the population characteristics of age, race and weight were associated with pregnancy.
Analiżi esploratorji saru biex jiddeterminaw jekk fl- istudji tal- Fażi III (n=3319) il- karatteristiċi tal - popolazzjoni ta’ età, razza u piż kienux assoċjati ma ’ tqala.
The analyses indicated no association of age and race with pregnancy.
L- analiżi ma indikat l- ebda assoċjazzjoni ta’ età u razza mat- tqala.
With respect to weight, 5 of the 15 pregnancies reported with EVRA were among women with baseline body weight equal or greater than 90 kg, which constituted < 3% of the study population.
Iżda dwar piż, 5 sa 15- il tqala li kienu rrappurtati b’ EVRA ġraw fost nisa li kellhom il- linja bażi tal- piż ta ’ ġisimhom daqs jew aktar minn 90 kg, li kienu jagħmlu < 3% tal - popolazzjoni studjata.
Below 90 kg there was no association between body weight and pregnancy.
Għal piż anqas minn 90 kg ma kien hemm l- ebda assoċjazzjoni bejn il- piż tal - ġisem u t- tqala.
Although only 10-20% of the variability in pharmacokinetic data can be explained by weight (see Pharmacokinetic Properties, Special Populations), the greater proportions of pregnancies among women at or above 90 kg was statistically significant and indicates the EVRA is less effective in these women.
Għalkemm bejn 10- 20% biss tal- varjabilità fit- tagħrif farmakokinetiku tista ’ tiġi spjegata permezz tal- piż, il- propozjonijiet akbar ta ’ tqaliet fost nisa ta ’ 90 kg jew aktar, kienu statistikament sinifikanti u jindikaw li EVRA hija anqas effettiva f’ dawn in- nisa.
With the use of higher dosed COCs (50 microgram ethinyl estradiol) the risk of endometrial and ovarian cancer is reduced.
Bl- użu ta ’ kontraċettivi orali kkombinati li għandhom dożi ogħla (50 mikrogramma ethinyl estradiol) ir- riskju ta ’ kanċer ta ’ l- endometriju u ta ’ l- ovarji jitnaqqas.
Whether this is also applies to the lower dosed combined hormonal contraceptives remains to be confirmed.
Jekk dan japplikax ukoll għal kontraċettivi ormonali kkombinati b’ doża anqas għad irid jiġi kkonfermat.
Following application of EVRA, norelgestromin and ethinyl estradiol levels in serum reach a plateau by approximately 48 hours.
Wara l- applikazzjoni t’ EVRA, il- livelli ta ’ norelgestromin u ethinyl estradiol fis- serum jieqfu milli jkomplu jiżdiedu bejn wieħed u ieħor mat- 48 siegħa.
Steady state concentrations of norelgestromin and EE during one week of patch wear are approximately 0.8 ng/ ml and 50 pg/ ml, respectively.
Il- konċentrazzjonijiet fl- istat stabbli ta ’ norelgestromin u EE matul ġimgħa ta ’ lbies tal- garża EVRA huma bejn wieħed u ieħor ta ’ 0. 8ng/ ml u 50 pg/ ml rispettivament.
In multiple-dose studies, serum concentrations and AUC for norelgestromin and EE were found to increase only slightly over time when compared to week 1 cycle 1.
Fi studji b’ aktar minn doża waħda, konċentrazzjonijiet tas- serum u l- AUC għal norelgestromin u EE instabu li jiżdiedu ftit biss maż- żmien meta mqabbla ma ’ l- ewwel ċiklu ta ’ l - ewwel ġimgħa.
The absorption of norelgestromin and ethinyl estradiol following application of EVRA was studied under conditions encountered in a health club (sauna, whirlpool, treadmill and other aerobic exercise) and in a cold water bath.
L- assorbiment ta ’ norelgestromin u ethinyl estradiol wara l- applikazzjoni ta ’ EVRA ġie studjat fil - kundizzjonijiet li tiltaqa ’ magħhom fi klabb tas- saħħa (sawna, belliegħa ta ’ l- ilma tonda, tredmill, u eżerċizzji aerobiċi oħrajn) u f’ banju b’ ilma kiesaħ.
The results indicated that for norelgestromin there were no significant treatment effects on Css or AUC when compared to normal wear.
Ir- riżultati indikaw li għal norelgestromin ma kien hemm l- ebda effetti sinifikanti tat- trattament fuq is- Css jew l- AUC meta mqabbla ma ’ l- użu normali.
For EE, slight increases were observed due to treadmill and other aerobic exercise; however, the Css values following these treatments were within the reference range.
Għal EE, kienu osservati żidiet żgħar minħabba t- tredmill u eżerċizzju aerobiku ieħor; madankollu, il- valuri tas- Css wara dawn it- trattamenti kienu fil- marġini tar- riferenza.
There was no significant effect of cool water on these parameters.
Ma kien hemm l- ebda effett sinifikanti bl- ilma kiesaħ f’ dawn il- parametri.
Results from an EVRA study of extended wear of single contraceptive patch for 7 days and 10 days indicated that target Css of norelgestromin and ethinyl estradiol were maintained during a 3-day period of extended wear of EVRA (10 days).
Riżultati minn studju ta ’ EVRA fejn garża waħda ntlibset għal- 7 ijiem u 10 ijiem urew li l- livelli mixtieqa tas- Css ta ’ norelgestromin u ethinyl estradiol inżammu waqt il- perjodu tat- 3 ijiem żejda li EVRA intlibset (10 ijiem).
These findings suggest that clinical efficacy would be maintained even if a scheduled change is missed for as long as 2 full days.
Dawn is- sejbiet juru li l- effikaċja klinika tinżamm anke jekk bidla skedata tal- garża tinqabeż b’ jumejn sħaħ.
Norelgestromin and norgestrel (a serum metabolite of norelgestromin) are highly bound (> 97%) to serum proteins.
Norelgestromin u norgestrel (is- sustanza fis- serum iffurmata minn norelgestromin) jeħlu ħafna
Norelgestromin is bound to albumin and not to SHBG, while norgestrel is bound primarily to SHBG, which limits its biological activity.
Norelgestromin jeħel ma l- albumina u mhux mas- SHBG filwaqt li norgestrel jeħel primarjament mas- SHBG, li jillimita l- attività bioloġika tiegħu.
Ethinyl estradiol is extensively bound to serum albumin.
Ethinyl estradiol jeħel b’ mod estensiv ma ’ l- albumina tas- serum.
Biotransformation
Biotrasformazzjoni
Hepatic metabolism of norelgestromin occurs and metabolites include norgestrel, which is largely bound to SHBG, and various hydroxylated and conjugated metabolites.
Isir metaboliżmu epatiku ta ’ norelgestromin u l- metaboliti tiegħu jinkludu norgestrel, li huwa fil- biċċa l- kbira imwaħħal mas- SHBG u metaboliti varji idroksilati u konjugati oħrajn.
Ethinyl estradiol is also metabolised to various hydroxylated products and their glucuronide and sulfate conjugates.
Ethinyl estradiol jiġi wkoll immetabolizzat fi prodotti varji idrokslati u l- konjugi glukuronide u sulfati tagħhom.
15 Elimination
Eliminazzjoni
Following removal of a patch, the mean elimination half-lives of norelgestromin and ethinyl estradiol were approximately 28 hours and 17 hours, respectively.
Wara li titneħħa l- garża il- half- life medja ta ’ eliminazzjoni ta ’ norelgestromin u ethinyl estradiol kienu bejn wieħed u ieħor ta ’ 28 u 17- il siegħa rispettivament.
The metabolites of norelgestromin and ethinyl estradiol are eliminated by renal and fecal pathways.
Is- sustanzi mill- metaboliżmu ta ’ norelgestromin u ethinyl estradiol huma eliminati permezz ta ’ sistemi tal- kliewi u l- ippurgar.
Transdermal versus Oral Contraceptives
Kontraċettivi li jgħaddu minn ġol- ġilda versu kontraċettivi orali
The pharmacokinetic profiles of transdermal and oral combined hormonal contraceptives are different and caution should be exercised when making a direct comparison of these PK parameters.
Il- profili farmakokinetiċi ta ’ kontraċettivi ormonali kkombinati li jgħaddu minn ġol- ġilda u dawk orali huma differenti u għandu jkun hemm attenzjoni meta jsir paragun dirett ta ’ dawn il - parametri farmakokinetiċi.
In a study comparing EVRA to an oral contraceptive containing norgestimate (parent drug of norelgestromin) 250 µg/ ethinyl estradiol 35 µg, Cmax values were 2-fold higher for NGMN and EE in subjects administered the oral contraceptive compared to EVRA, while overall exposure (AUC and Css) was comparable in subjects treated with EVRA.
Fi studju li jqabbel EVRA ma ’ kontraċettiv orali li fih norgestimate (il- mediċina oriġinali ta ’ norelgestromin) 250 µg/ ethinyl estradiol 35µg, valuri ta ’ Cmax kienu darbtejn aktar għoljin għan - NGMN u EE fis- suġġetti li ngħatalhom il- kontraċettiv orali meta mqabbel ma ’ EVRA, filwaqt li l - esponiment totali (l- AUC u s- Css) kien paragunabbli fis- suġġetti li ħadu trattament b’ EVRA.
Inter-subject variability (%CV) for the PK parameters following delivery from EVRA was higher relative to the variability determined from the oral contraceptive.
Il - varjbbilità bejn is- suġġetti (% CV) għall- parametri farmakokinetiċi, kienet ogħla wara li dawn ingħataw minn EVRA, meta mqabbla mal- varjbbilità kkalkulata mill- kontraċettiv orali.
Effects of age, body weight, and body surface area
Effetti ta ’ l- età, il- piż tal- ġisem u l- erja tas- superfiċje tal- ġisem
The effects of age, body weight, and body surface area on the pharmacokinetics of norelgestromin and ethinyl estradiol were evaluated in 230 healthy women from nine pharmacokinetic studies of single 7- day applications of EVRA.
L- effetti ta ’ l- età, il- piż tal- ġisem u l- erja tas- superfiċje tal- ġisem fuq il- farmakokinetika ta ’ norelgestromin u ethinyl estradiol kienu evalwati f’ 230 mara b’ saħħitha minn disa ’ studji farmakokinetiċi ta ’ applikazzjonijiet waħdiet ta ’ 7 ijiem ta ’ EVRA.
For both norelgestromin and EE, increasing age, body weight and body surface area each were associated with slight decreases in Css and AUC values.
Kemm għal norelgestromin kif ukoll għal ethinyl estradiol, kobor fl- età, u żieda fil- piż tal- ġisem u fl- erja tas- superfiċje tal- ġisem kienu assoċjati ma ’ tnaqqis żgħir fil- valuri tas- Css u l- AUC.
However, only a small fraction (10 – 20%) of the overall variability in the pharmacokinetics of the norelgestromin and EE following application of EVRA may be associated with any or all of the above demographic parameters.
Madankollu, porzjon żgħir ħafna (10 - 20%) tal- varjbbilità fil- farmakokinetika ta ’ norelgestromin u EE wara l- applikazzjoni t’ EVRA, jistgħu jiġu assoċjati ma ’ xi waħda jew ma ’ kull waħda minn dawn il- parametri demografiċi msemmija hawn fuq.
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Tagħrif ta ’ qabel l- użu kliniku, magħmul fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni u riskju ta ’ kanċer, ma ’ juri l- ebda periklu speċjali għall- bnedmin.
With respect to the reproductive toxicity norelgestromin showed foetal toxicity in rabbits, but the safety margin for this effect was sufficiently high.
Dwar ħsara fuq is- sistema riproduttiva norelgestromin wera tossiċità fuq il- fetu fil - fniek, iżda l- marġini ta ’ sigurtà għal dan l- effett kienu suffiċjentement għoljin.
Data on reproductive toxicity of the combination of norelgestromin with ethinyl estradiol are not available.
Tagħrif dwar ħsara riproduttiva għal norelgestromin flimkien ma ethinyl estradiol m’ humiex disponibbli.
Data for combination of norgestimate (precursor of norelgestromin) with ethinyl estradiol indicate for female animals a decrease in fertility and implantation efficiency (rat), an increase in foetal resorption (rat, rabbit) and, with high dosages, a decrease in viability and fertility of female offspring (rat).
Tagħrif dwar norgestimate (is- sustanza qabel issir norelgestromin) flimkien ma ’ ethinyl estradiol fl- annimali nisa indika nuqqas fil- fertilità u fl- effiċjenza ta ’ l- implantazzjoni (far), żieda fir- risorbiment tal- fetu (far, fenek) u b’ dożi qawwija, nuqqas fil- vijabbiltà u fertilità tal- frieħ nisa (far).
The relevance of these data for human exposure is unknown as these effects have been seen as related to well-known pharmacodynamic or species-specific actions.
Ir- rilevanza ta ’ dan it - tagħrif għall- esponiment uman m’ hijiex magħrufa minħabba li dawn l- effetti intwerew bħala relatati ma ’ azzjonijiet magħrufa sewwa farmakodinamiċi jew speċifiċi għall- ispeċi.
Studies conducted to examine the dermal effect of EVRA indicate this system has no potential to produce sensitisation and results in only mild irritation when applied to rabbits skin.
Studji li saru biex jeżaminaw l- effett ta ’ EVRA fuq il- ġilda wera li din is- sistema m’ għandha l- ebda potenzjal li tagħmel sensibilizzazzjoni u tirriżulta biss f’ irritazzjoni ħafifa meta tiġi applikata lill- ġilda tal- fniek.
Backing layer: low-density pigmented polyethylene outer layer, polyester inner layer.
Is- saff ta ’ rinforz: polyethylene pigmentat ta ’ densità baxxa fil- parti esterna, polyester fil- parti interna.
Middle layer: polyisobutylene/ polybutene adhesive, crospovidone, non-woven polyester fabric, lauryl lactate.
Is- saff tan- nofs: adeżiv polyisobutylene/ polybutene, crospovidone, materjal polyester mhux minsuġ, lauryl lactate.
16 Third layer: polyethylene terephthalate (PET) film, polydimethylsiloxane coating.
It- tielet saff: rita ta’ polyethylene tetraphthalate (PET), kisja ta ’ polydimethylsiloxane.
To prevent interference with the adhesive properties of EVRA, no creams, lotions or powders should be applied to the skin area where the EVRA transdermal patch is to be applied.
Sabiex ma jkunx hemm interferenza mal- kolla ta ’ EVRA m’ għandhomx jiġu applikati kremi, lozjonijiet jew terer fuq il- ġilda fejn se titpoġġa l- garża EVRA li tipprovdi mediċina li tgħaddi minn ġol- ġilda.
Store in the original package in order to protect from light and moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u mill- umdità.
Do not refrigerate or freeze.
Tagħmlux fil- friġġ jew fil- friża
Primary packaging material
Materjal tal- pakkett primarju
A sachet is composed of four layers: a low-density polyethylene film (innermost layer), an aluminium foil, a low-density polyethylene film, and an outer layer of bleached paper.
Il- qartas huwa magħmul minn erba ’ saffi: rita polyethylene ta ’ densità baxxa (saff ta’ ġewwa nett), fojl ta ’ aluminju, rita polyethylene ta ’ densità baxxa, u saff fuq barra ta ’ karta ibbliċjata.
Secondary packaging material
Materjal tal- pakkett sekondarju
Sachets are packaged in a cardboard carton.
Il- qratas huma ppakkjati f’ kaxxa tal- kartun.
Every carton has 3, 9 or 18 EVRA transdermal patches in individual foil-lined sachets.
Kull kaxxa fiha 3, 9 jew 18- il garża EVRA li tipprovdi mediċina li tgħaddi minn ġol- ġilda fi qratas individwali infurrati bl- aluminju.
Sachets are wrapped per three in a transparent perforated plastic film and packed in a cardboard carton.
Il- qratas huma imgeżwrin tlieta tlieta f’ rita tal- plastik trasparenti imtaqqba u ppakkjati f’ kaxxa tal - kartun.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittiehdu meta jintrema u għal immaniġġar ieħor
Apply immediately upon removal from the protective sachet.
Applika immedjatament malli titneħha mill- qartas protettiv.
After use the patch still contains substantial quantities of active ingredients.
Wara l- użu il- garża jkun għad- fadlilha ammont sostanzjali ta ’ sustanzi attivi.
Remaining hormonal active ingredients of the patch may have harmful effects if reaching the aquatic environment.
L- ingredjenti ormonali attivi li jibqa ’ fil- garża jista ’ jkollhom effetti ħżiena jekk jaslu fl- ambjent akwatiku.
Therefore, the used patch should be discarded carefully.
Għalhekk il- garża użata għandha tintrema b’ attenzjoni.
The disposal label from the outside of the sachet should be peeled open.
It- tikketta tar- rimi fuq in- naħa ta ’ barra tal- qartas għandha titqaxxar biex tinfetaħ.
The used patch should be placed within the open disposal label so that the sticky surface covers the shaded area on the sachet.
Il- garża użata għandha titpoġġa ġewwa t- tikketta miftuħa tar- rimi sabiex in- naħa li twaħħal tgħatti l- erja oskura fuq il- qartas.
The disposal label should then be closed sealing the used patch within.
It- tikketta tar- rimi għandha imbagħad tingħalaq filwaqt li tisiġilla il- garża użata fuq ġewwa.
Any used or unused patches should be discarded according to local requirements or returned to the pharmacy.
18 Kwalunkwe gareż użati jew mhux użati għandhom jintremew kif jitolbu l- liġijiet lokali jew jiġu rritornati l- ispiżerija.
Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems.
Gareż użati m’ għandhomx jiġu fflaxxjati fit- tojlit jew jintremew ma ’ l- ilma fis - sistema tad- drenaġġ.
Turnhoutseweg, 30 B-2340 Beerse Belgium
Turnhoutseweg, 30 B- 2340 Beerse Il- Belġju
22 August 2002.
22 t’ Awwissu 2002.
22 August 2007.
22 ta ’ Awissu 2007.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
19 A.
19 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Janssen Pharmaceutica N. V., Turnhoutseweg 30, B-2340 Beerse, Belgium
Janssen Pharmaceutica N. V., Turnhoutseweg 30, B- 2340 Beerse, Il- Belġju
The MAH will continue to submit yearly PSURs unless otherwise specified by the CHMP
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq se jkompli jissottometti PSURs ta ’ kull sena sakemm is- CHMP ma jispeċifikax mod ieħor.
21 A.
21 ANNESS III
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
BOX OF 3 PATCHES BOX OF 9 PATCHES BOX OF 18 PATCHES
KAXXA TA ’ 3 GAREŻ KAXXA TA ’ 9 GAREŻ KAXXA TA ’ 18- IL GARŻA
EVRA transdermal patch
EVRA garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda
1 patch of 20 cm2 contains:
Garża waħda ta ’ 20ċm2 fiha:
6 mg norelgestromin and 600 micrograms ethinyl estradiol
6mg norelgestromin u 600 mikrogramma ethinyl estradiol
1 patch releases:
Garża waħda terħi:
203 micrograms norelgestromin and 33.9 micrograms ethinyl estradiol per 24 hours
203 mikrogramma norelgestromin u 33. 9 mikrogramma ethinylestradiol kull 24 siegħa
Other ingredients: polyisobutylene, polybutene, lauryl lactate, crospovidone, non-woven-polyester fabric
Ingredjenti oħra: polyisobutylene, polybutene, lauryl lactate, crospovidone, materjal polyester mhux minsuġ
3 transdermal patches 9 transdermal patches 18 transdermal patches
3 gareż li jipprovdu mediċina li tgħaddi minn ġol- ġilda 9 gareż li jipprovdu mediċina li tgħaddi minn ġol- ġilda 18 il- garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda
Transdermal use
Użu transdermali
23 Store in the original sachet and carton Do not refrigerate or freeze
Aħżen fil- qartas u l- kartuna oriġinali Tagħmlux fil- friġġ jew friża
Do not flush used or unused patches down the toilet.
Tifflaxxjax gareż użati jew mhux użati fit- tojlit.
See enclosed leaflet for disposal instructions.
Ara l- fuljett li ssib fil- pakkett għal- istruzzjonijiet dwar rimi.
Marketing Authorisation holder:
Sid l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Turnhoutseweg, 30 B-2340 Beerse, Belgium
Turnhoutseweg, 30 B- 2340 Beerse, Il- Belġju
3 transdermal patches EU/ 1/ 02/ 223/ 002:
3 gareż li jipprovdu mediċina li tgħaddi minn ġol- ġilda EU/ 1/ 02/ 223/ 002:
9 transdermal patches EU/ 1/ 02/ 223/ 003:
9 gareż li jipprovdu mediċina li tgħaddi minn ġol- ġilda EU/ 1/ 02/ 223/ 003:
18 transdermal patches
18 gareż li jipprovdu mediċina li tgħaddi minn ġol- ġilda
24 MINIMUN PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET LABEL
25 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TAL- QARTAS
Read the package leaflet
Aqra l- fuljett ta ’ tagħrif
Contains 1 transdermal patch
Fih garża waħda li tipprovdi mediċina li tgħaddi minn ġol- ġilda
25 Reminder Stickers
26 Tikketta li titwaħħal biex tfakkrek
Use these stickers on your calendar to help you remember when to change your patch
Uża dawn it- tikketti li jeħlu fuq il - kalendarju biex jgħinuk tiftakar meta għandek tibdel il- garża tiegħek
Current Cycle
Iċ- Ċiklu ta ’ bħal issa
Next Cycle
Iċ- Ċiklu li Jmiss
First Patch (Week 1)
L- Ewwel Garża (Ġimgħa 1)
Second Patch (Week 2)
It- Tieni Garża (Ġimgħa 2)
Third Patch (Week 3)
It- Tielet Garża (Ġimgħa 3)
Remove Patch Get New Patch
Neħħi l- Garża Ġib Garża Ġdida
First patch
L- Ewwel Garża
Patch disposal label
Tikketta biex teħles mill- garża
PATCH DISPOSAL LABEL
TIKKETTA BIEX TEĦLES MILL- GARŻA
To dispose of used patch:
Biex teħles mill- garża użata:
1. place used patch so that the sticky side covers the shaded area 2. remove backing paper 3. close adhesive label and seal 4. discard with solid waste
1. poġġi l- garża użata b’ tali mod li n- naħa li teħel tgħatti l- parti oskura 2. neħħi l- karta ta ’ rinforz 3. għalaq it- tikketta li teħel u ssiġilla 4. armi ma ’ l- iskart solidu
EVRA transdermal patch Norelgestromin and ethinyl estradiol
EVRA garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Norelgestromin u ethinyl estradiol
What EVRA is and what it is used for 2.
X’ inhi EVRA u għalxiex tintuża 2.
Before you use EVRA 3.
Qabel ma tuża EVRA 3.
Risks of using combined hormonal contraceptives 4.
Riskji fl- użu ta ’ kontraċettivi ormonali kombinati 4.
How to use EVRA 5.
Kif għandek tuża EVRA 5.
Possible side effects 6.
X’ effetti oħra jista ’ jkollha 6.
How to store EVRA 7.
Kif taħżen EVRA 7.
What EVRA is and what is it used for
X’ INHI EVRA U GĦALXIEX TINTUŻA
The name of your medicine is EVRA transdermal patch.
L- isem tal- mediċina tiegħek huwa EVRA garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda.
It is called ‘ EVRA’ in this leaflet.
F’ dan il- fuljett hija msejjħa ‘ EVRA ’.
It is used to prevent pregnancy.
Din tintuża sabiex tilqa ’ kontra t- tqala.
EVRA contains two types of hormones: • norelgestromin • ethinyl estradiol Because it contains two hormones, EVRA is called a ‘ combined hormonal contraceptive’.
EVRA fiha żewġ tipi ta ’ ormoni: • norelgestromin • ethinyl estradiol Peress illi fiha żewg ormoni, EVRA hija msejjħa ‘ kontraċettiv ormonali kkombinat ’..
Before you use EVRA
QABEL MA TUŻA EVRA
Do not use EVRA if: • You are allergic (hypersensitive) to norelgestromin, ethinyl estradiol or any of the other ingredients in EVRA (listed in Section 7 below) • You have ever had a heart attack or a type of chest pain called ‘ angina’ • You have ever had a stroke or signs which may lead to stroke.
Tużax EVRA jekk: • Inti allerġiku/ a (tbati minn sensittività eċċessiva) għal norelgestromin, ethinyl estradiol jew kwalunkwe mis- sustanzi l- oħra ta ’ EVRA (elenkati f’ Sezzjoni 7 iktar ‘ l isfel) • Qatt kellek attakk tal- qalb jew uġigħ fis- sider imsejjaħ ‘ anġina ’. • Qatt kellek puplesija jew sintomi li jistgħu jwasslu għal puplesija.