FrancophonIA/ELRC3.0 huggingface dataset:
English: • A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as: - diabetes mellitus with vascular symptoms - severe hypertension - severe dyslipoproteinaemia
Maltese: • Riskju għoli ta' tromboemboliżmu arterjali minħabba fatturi multipli ta' riskju (ara sezzjoni 4.4) jew il-preżenza ta' fattur wieħed ta' riskju serju bħal: - dijabete mellitus b'sintomi vaskulari - pressjoni għolja severa - dislipoproteinemija severa
English: Psychiatric disorders common
Maltese: Disturbi psikjatriċi komuni
English: Jaundice cholestatic*† Cholestasis*†
Maltese: Suffejra kolestatika*†
English: Norelgestromin-containing CHC (6-12 events)
Maltese: CHC li fih norgestimate (5-7 avvenimenti)
English: • with increasing age (beyond about 35 years);
Maltese: • ma żieda fl-età (wara madwar 35 sena);
English: Obesity (body mass index over 30 kg/m²)
Maltese: Ħxuna żejda (indiċi tal-piż tal-ġisem ta' iktar minn 30 kg/m2)
English: With the use of higher dosed COCs (50 microgram ethinyl estradiol) the risk of endometrial and ovarian cancer is reduced.
Maltese: Bl-użu ta' kontraċettivi orali kkombinati li għandhom dożi ogħla (50 mikrogramma ethinyl estradiol), ir-riskju ta' kanċer tal-endometriju u tal-ovarji jitnaqqas.
English: Hepatic metabolism of norelgestromin occurs and metabolites include norgestrel, which is largely bound to SHBG, and various hydroxylated and conjugated metabolites.
Maltese: Iseħħ metaboliżmu epatiku ta' norelgestromin u l-metaboliti tiegħu jinkludu norgestrel, li huwa filbiċċa l-kbira imwaħħal mas-SHBG u metaboliti varji idroksilati u konjugati oħrajn.
English: • Acne, skin rash, skin itching or skin irritation
Maltese: • Akne, raxx fil-ġilda, ħakk fil-ġilda, jew irritazzjoni fil-ġilda
English: After 10 years, the risk is the same as for people who have never used the combined hormonal contraceptive.
Maltese: Wara 10 snin, ir-riskju huwa l-istess bħal dak ta' nies li qatt ma użaw kontraċettiv ormonali kkombinat.
English: Concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin may increase the risk of ALT elevations (see sections 4.3 and 4.4).
Maltese: L-użu flimkien ma' mediċini li fihom ombitasvir/paritaprevir/ritonavir u dasabuvir, b'ribavirin jew mingħajru jistgħu jżidu r-riskju ta' żidiet fil-livelli tal-ALT (ara sezzjonijiet 4.3 u 4.4).
English: • Breast tenderness.
Maltese: • Neħħiha malli tiftakar.
English: Psychiatric disorders
Maltese: Disturbi Psikjatriċi
English: • Undiagnosed abnormal genital bleeding
Maltese: • Fsada ġenitali abnormali mingħajr dijanjożi
English: The increased risk gradually goes down after stopping the combined hormonal contraceptive.
Maltese: Iż-żieda fir-riskju tonqos b'mod gradwali wara li jitwaqqaf il-kontraċettiv ormonali kkombinat.
English: Date of first authorisation: 22 August 2002.
Maltese: Data tal-ewwel awtorizzazzjoni: 22 ta' Awwissu 2002.
English: EVRA is contraindicated in women with hepatic impairment (see section 4.3).
Maltese: EVRA hija kontraindikata f'nisa b'indeboliment tal-fwied (ara sezzjoni 4.3).
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: 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).
Maltese: Tagħrif dwar norgestimate (is-sustanza qabel issir norelgestromin) flimkien ma' ethinyl estradiol fl-annimali nisa indika nuqqas fil-fertilità u fl-effiċjenza tal-implantazzjoni (far), żieda fir-risorbiment tal-fetu (far, fenek) u b'dożi qawwija, nuqqas fil-vijabbiltà u fertilità tal-frieħ nisa (far).
English: Hepatic neoplasm*† Breast cancer*† Cervix carcinoma*† Hepatic adenoma*† Uterine leiomyoma Fibroadenoma of breast
Maltese: Dawn is-sejbiet juru li l-effikaċja klinika tinżamm anke jekk bidla skedata tal-garża tinqabeż b'jumejn sħaħ.
English: • if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see ‘Blood clot [thrombosis] section below).
Maltese: • jekk tinnota sinjali possibbli ta' embolu tad-demm li jista' jfisser li inti qed tbati minn embolu fir-riġel (i.e. trombożi tal-vini profondi), embolu fil-pulmun (i.e. emboliżmu pulmonari),
English: Fertility Women may experience a delay in conception following discontinuation of EVRA.
Maltese: Fertilità In-nisa jistgħu jdumu biex jinqabdu tqal wara li titwaqqaf EVRA.
English: Because it contains two hormones, EVRA is called a ‘combined hormonal contraceptive'.
Maltese: Peress illi fiha żewg ormoni, EVRA hija msejħa ‘kontraċettiv ormonali kkombinat'.
English: Abdominal distension rare
Maltese: Disturbi fil-qalb rari
English: Swelling
Maltese: Treddigħ
English: • If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism.
Maltese: • Jekk embolu jivvjaġġa mir-riġel u jeħel fil-pulmun, jista' jikkawża emboliżmu pulmonari.
English: • St. John's wort (an herbal therapy used for depression)
Maltese: John's Wort (hypericum perforatum).
English: • if you are very overweight (body mass index or BMI over 30 kg/m
Maltese: • jekk għandek ħafna piż żejjed (indiċi tal-massa tal-ġisem jew BMI ta' iktar minn 30 kg/m2);
English: It is thought that etoricoxib increases ethinyl estradiol levels because it inhibits sulfotransferase activity thereby inhibiting ethinyl estradiol metabolism.
Maltese: Huwa maħsub li etoricoxib iżid il-livelli ta' ethinyl estradiol minħabba li huwa jinibixxi l-attività ta' sulfotransferase u b'hekk jimpedixxi lmetaboliżmu ta' ethinyl estradiol.
English: For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you use EVRA”.
Maltese: Għal informazzjoni aktar dettaljata dwar ir-riskji differenti mit-teħid ta' kontraċettivi ormonali kombinati, jekk jogħġbok ara sezzjoni 2 “X'għandek tkun taf qabel tuża EVRA”.
English: Šmartinska cesta 53
Maltese: Partikularment iktar minn 35 sena
English: - Out of 10,000 women who are using a combined hormonal contraceptive that contains etonorgestrel or norelgestromin such as EVRA between about 6 and 12 women will develop a blood clot in a year.
Maltese: - Minn 10,000 mara li qed jużaw kontraċettiv ormonali kombinat li fih etonorgestrel jew norelgestromin bħal EVRA bejn madwar 6 u 12-il mara se jiżviluppaw embolu tad-demm f'sena.
English: EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch
Maltese: EVRA 203 mikrogramma /24 siegħa + 33.9 mikrogramma /24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda
English: Arterial thrombosis**†
Maltese: Inċident ċerebrovaskulari**†
English: Results from an EVRA study of extended wear of single contraceptive transdermal 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).
Maltese: Riżultati minn studju ta' EVRA fejn garża kontraċettiva waħda li tipprovdi mediċina li tgħaddi minn ġol-ġilda 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).
English: EVRA is available in the following pack sizes: Cartons containing 3, 9 or 18 patches in individual foil-lined sachets, wrapped per three in a transparent perforated plastic film.
Maltese: Kaxex tal-kartun li fihom 3, 9, jew 18-il garża fi qratas individwali infurrati bil-fojl, imgeżwrin tlieta, tlieta f'rita tal-plastik trasparenti imtaqqba.
English: Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE.
Maltese: Prodotti li jkun fihom levonorgestrel, norgestimate jew norethisterone huma assoċjati mar-riskju l-iktar baxx ta' VTE.
English: This may include curettage.
Maltese: Dan jista' jinkludi curettage.
English: Note: temporary immobilisation including air travel > 4 hours can also be a risk factor for VTE, particularly in women with other risk factors
Maltese: Nota: immobilizzazzjoni temporanja li tinkludi vvjaġġar bl-ajru ta' >4 sigħat, tista' wkoll tkun fattur ta' riskju għal VTE, partikularment f'nisa b'fatturi oħrajn ta' riskju
English: Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
Maltese: Ipertrigliċeridemija ġiet assoċjata ma' żieda firriskju li tiżviluppa pankreatite (infjammazzjoni tal-frixa);
English: EVRA contains two types of sex hormones, a progestogen called norelgestromin and an oestrogen called ethinyl estradiol.
Maltese: EVRA fiha żewġ tipi ta' ormoni sesswali, progestogen li jismunorelgestromin u oestrogen li jismuethinyl estradiol.
English: In women on long-term treatment with enzyme-inducing active substances, another reliable, non-hormonal, method of contraception is recommended.
Maltese: F'nisa fuq trattament fit-tul b'sustanzi attivi li jinduċu l-enzimi, huwa rrakkomandat metodu ieħor affidabbli ta' kontraċezzjoni, mhux tal-ormoni.
English: • You had a skin rash with blisters during pregnancy (called ‘herpes gestationis');
Maltese: • Għandek raxx fil-ġilda bl-infafet waqt it-tqala (imsejjħa ‘herpes gestationis');
English: The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use.
Maltese: L-użu ta' kwalunkwe kontraċettiv ormonali kombinat (CHC) iżid ir-riskju ta' tromboemboliżmu venuż (VTE) meta mqabbel mal-ebda użu.
English: In case of any doubt, an additional barrier contraceptive method should be used by women on protease inhibitor or non-nucleoside reverse transcriptase inhibitor therapy.
Maltese: F'każ ta' xi dubju, għandu jintuża metodu kontraċettiv ieħor ta' barriera minn nisa li jkunu fuq terapija b'inibitur ta'protease jew inibitur ta' reverse transcriptase mhux nucleoside.
English: Uncommon side effects (may affect up to 1 in 100 women):
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa mara waħda minn kull 100):
English: Venous thrombosis**†
Maltese: Trombożi fil-vini**†
English: Third layer: polyethylene terephthalate (PET) film, polydimethylsiloxane coating.
Maltese: It-tielet saff: rita ta' polyethylene terephthalate (PET), kisja ta' polydimethylsiloxane.
English: • Muscle spasms
Maltese: • Treddigħ mrażżan
English: Important information to follow when using the patch
Maltese: Informazzjoni importanti li għandek issegwi meta tpoġġi garża
English: Chloasma is often not fully reversible.
Maltese: Spiss, kloasma ma tkunx kompletament riversibbli.
English: Table: Risk factors for VTE Risk factor
Maltese: Tabella: Fatturi ta' riskju għal VTE Fattur ta' riskju
English: Rarely, there may be serious lasting effects or, very rarely, they may be fatal.
Maltese: B'mod rari, jista' jkun hemm effetti serji fit-tul, jew, b'mod rari ħafna, jistgħu jkunu fatali.
English: See enclosed leaflet for disposal instructions.
Maltese: • jekk għandek id-dijabete.
English: • bosentan (a medicine for high blood pressure in the blood vessels in the lungs)
Maltese: • bosentan (mediċina għall-pressjoni għolja fil-vini u l-arterji tal-pulmun)
English: • if you have SLE (systemic lupus erythematosus; a disease affecting your natural defence system);
Maltese: • jekk għandek lupus eritematosus sistemiku (SLE - marda li taffettwa s-sistema ta' difiża naturali tiegħek);
English: • Dizziness
Maltese: Twissijiet
English: • some antiretroviral medicines used to treat HIV/AIDS and Hepatitis C virus infections (so called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such asritonavir,
Maltese: • ċerti mediċini antiretrovirali użati għat-trattament tal-HIV/AIDS u infezzjonijiet bil-virus tal
English: If you switch from the oral contraceptive pill to EVRA If you are switching from an oral contraceptive pill to this medicine:
Maltese: Jekk taqleb mill-pillola orali ta' kontraċezzjoni għal EVRA Jekk se taqleb minn pillola orali ta' kontraċezzjoni għal din il-mediċina:
English: Rare side effects (may affect up to 1 in 1,000 women):
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa mara waħda minn kull 1,000):
English: Exploratory analyses were performed to determine whether in the Phase III studies (n=3,319) the population characteristics of age, race and weight were associated with pregnancy.
Maltese: Saru analiżi esploratorji biex jiddeterminaw jekk fl-istudji tal-Fażi III (n=3,319) il-karatteristiċi talpopolazzjoni ta' età, razza u piż kinux assoċjati ma' tqala.
English: • The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous thrombosis).
Maltese: • L-użu ta' kontraċettivi ormonali kombinati ma ġiex assoċjat ma' żieda fir-riskju ta' emboli taddemm fil-vina (trombożi fil-vini).
English: Each transdermal patch releases an average of 203 micrograms of NGMN and 33.9 micrograms of EE per 24 hours.
Maltese: 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.
English: Medical tests
Maltese: TAL-PRODOTT MEDIĊINALI
English: Backing layer: low-density pigmented polyethylene outer layer, polyester inner layer.
Maltese: Is-saff ta' rinforz: polyethylene pigmentat ta' densità baxxa fis-saff ta' barra, polyester fil-parti interna.
English: - Please be alert and see your doctor if you get symptoms of a blood clot (see section 2 “Blood clots”).
Maltese: - Jekk jogħġbok kun allerta u ara lit-tabib tiegħek jekk taħseb li jista' jkollok sintomi ta' embolu tad-demm (ara sezzjoni 2 "Emboli tad-demm").
English: Nausea common
Maltese: Nawsja komuni
English: Photosensitivity reaction Dermatitis contact Urticaria
Maltese: Reazzjoni ta' sensittività għad-dawl Dermatite tal-kuntatt Urtikarja
English: Hormonal contraceptives may affect the metabolism of certain other active substances.
Maltese: Kontraċettivi ormonali jistgħu jaffettwaw il-metaboliżmu ta' ċerti sustanzi attivi oħrajn.
English: Table 1 below reflects the adverse reactions reported in clinical trials and from post-marketing experience.
Maltese: It-tabella 1 hawn taħt tirrifletti ir-reazzjonijiet avversi li ġew irrappurtati fi provi kliniċi u minn esperjenza ta' wara t-tqegħid fis-suq.
English: • painless blurring of vision which can progress to loss of vision.
Maltese: • Iċċekkja kuljum biex tiżgura li l-garża ma waqatx.
English: Rash pustular* Application site pustules Neoplasms benign, malignant and unspecified (incl cysts and polyps) rare
Maltese: Raxx bil-ponot* Ponot żgħar fis-sit tal-applikazzjoni Neoplażmi beninni, malinni, u dawk mhux speċifikati (inkluż ċesti u polipi) rari
English: • if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also in section “Other medicines and EVRA”).
Maltese: • jekk inti għandek epatite Ċ u qed tieħu l-prodotti mediċinali li fihom ombitasvir/paritaprevir/ritonavir u dasabuvir (ara wkoll f'sezzjoni “Mediċini oħra u EVRA”).
English: - Worsening of endogenous depression, of epilepsy, of Crohn's disease and of ulcerative colitis has been reported during COC use.
Maltese: - Id-depressjoni endogenika, l-epilessija, il-marda ta' Crohn u l-kolite bl-ulċeri ġew irrapportati li marru għall-agħar waqt l-użu tal-kontraċettivi orali kkombinati.
English: Following removal of a transdermal patch, the mean elimination half-lives of norelgestromin and ethinyl estradiol were approximately 28 hours and 17 hours, respectively.
Maltese: Wara li titneħħa l-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda, il-half-life medja ta' eliminazzjoni ta' norelgestromin u ethinyl estradiol kienu bejn wieħed u ieħor ta' 28 u 17-il siegħa rispettivament.
English: Metabolism and nutrition disorders uncommon
Maltese: Sensittività eċċessiva Disturbi fil-metaboliżmu u n-nutrizzjoni mhux komuni
English: Sachets are wrapped per three in a transparent perforated plastic film and packed in a cardboard carton.
Maltese: Il-qratas huma imgeżwrin tlieta tlieta f'rita tal-plastik trasparenti mtaqqba u ppakkjati f'kaxxa talkartun.
English: Immune system disorders uncommon
Maltese: Distubi fis-sistema immuni mhux komuni
English: The active substances are released over 7 days with an average of 203 micrograms norelgestromin and 34 micrograms ethinyl estradiol being released each 24 hours.
Maltese: Is-sustanzi attivi jintreħew fuq perjodu ta' 7 ijiem b'medja ta' 203 mikrogramma norelgestromin u 34 mikrogramma ethinyl estradiol jintreħew kull 24 siegħa.
English: Serious ill effects have not been reported following accidental ingestion of large doses of oral contraceptives.
Maltese: Ma ġewx irrapportati effetti serji ħżiena wara inġestjoni aċċidentali ta' dożi kbar ta' kontraċettivi orali.
English: EVRA is contraindicated if a woman has one serious or multiple risk factors for ATE that puts her at high risk of arterial thrombosis (see section 4.3).
Maltese: EVRA hu kontraindikat jekk mara jkollha fattur wieħed serju jew fatturi multipli ta' riskju għal ATE li jpoġġuha f'riskju għoli ta' trombożi arterjali (ara sezzjoni 4.3).
English: 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.
Maltese: Effetti tal-età, il-piż tal-ġisem u l-erja tas-superfiċje tal-ġisem L-effetti tal-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 waħdanin ta' 7 ijiem ta' EVRA.
English: Hypersensitivity
Maltese: Immaniġġar
English: Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma
Maltese: Immobilizzazzjoni fit-tul, operazzjoni maġġuri, xi operazzjoni fis-saqajn jew pelvis, newrokirurġija, jew trawma maġġuri
English: The risk for venous thromboembolic complications in CHC users may increase substantially in a woman with additional risk factors, particularly if there are multiple risk factors (see table).
Maltese: Ir-riskju ta' kumplikazzjonijiet tromboemboliċi venużi f'utenti ta' CHC jista' jiżdied b'mod sostanzjali f'mara b'fatturi addizzjonali ta' riskju, partikularment jekk hemm fatturi multipli ta' riskju (ara t-tabella).
English: Cerebrovascular accident**† Cerebral haemorrhage*† Abnormal taste*
Maltese: Zokkor fid-demm mhux normali*†
English: For initiation instructions see ‘How to start EVRA' below.
Maltese: Għall-istruzzjonijiet tal-bidu ara ‘Kif tibda EVRA' hawn taħt.
English: Hepatic lesion*
Maltese: Neoplażmu epatiku*†
English: • Abnormal liver function related to acute or chronic hepatocellular disease
Maltese: • Funzjoni abnormali tal-fwied relatata ma' mard epatoċellulari akut jew kroniku
English: A definitive relationship between hormonal contraceptive use and clinical hypertension has not been established.
Maltese: Għadha ma ġietx stabbilita relazzjoni definittiva bejn l-użu tal-kontraċettivi ormonali u l-pressjoni għolja klinika.
English: Symptoms of a cerebrovascular accident can include: - sudden numbness or weakness of the face, arm or leg, especially on one side of the body; - sudden trouble walking, dizziness, loss of balance or coordination; - sudden confusion, trouble speaking or understanding; - sudden trouble seeing in one or both eyes; - sudden, severe or prolonged headache with no known cause; - loss of consciousness or fainting with or without seizure.
Maltese: Sintomi ta' inċident ċerebrovaskulari jistgħu jinkludu: - tnemnim jew dgħufija għal għarrieda fil-wiċċ, driegħ jew riġel, speċjalment fuq naħa waħda tal ġisem; - ikollok problemi f'daqqa biex timxi, sturdament, telf tal-bilanċ jew koordinazzjoni; - konfużjoni għal għarrieda, problemi biex titkellem jew tifhem; - problemi f'daqqa biex tara minn għajn waħda jew miż-żewġ għajnejn; - uġigħ ta' ras sever f'daqqa jew fit-tul mingħajr ebda kawża magħrufa; - tintilef minn sensik jew iħossok ħażin bi jew mingħajr aċċessjoni.
English: or diarrhoea.
Maltese: jew dijarrea.
English: Your risk is higher:
Maltese: Fatturi ta' riskju għal ATE
English: Pitting oedema*
Maltese: Kanċer tas-sider*†
English: Warnings
Maltese: Sentejn
English: After an abortion or miscarriage that occurs before 20 weeks gestation, EVRA may be started immediately.
Maltese: Wara abort jew korriment li jseħħ qabel l-20 ġimgħa tqala, EVRA tista' tinbeda immedjatament.
English: Pruritus generalised
Maltese: Edima ġenerali
English: EVRA acts through the mechanism of gonadotropin suppression by the estrogenic and progestational actions of ethinyl estradiol and norelgestromin.
Maltese: EVRA taħdem permezz tal-mekkaniżmu tat-trażżin tal-gonadotropin bl-azzjonijiet estroġeniċi u proġestazzjonali ta' ethinyl estradiol u norelgestromin.
English: CONT-004 EVRA
Maltese: KONT-004
English: Face oedema*
Maltese: Kolestażi*†
English: • if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation);
Maltese: • jekk għandek xi problema f'qalbek (disturb fil-valvoli, disturb fir-ritmu ta' taħbit tal-qalb li jissejjaħ fibrillazzjoni atrijali);
English: Generalised oedema Oedema peripheral Application site reactions**
Maltese: Reazzjonijiet fis-sit tal-applikazzjoni**
English: If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.
Maltese: Jekk tesperjenza bidliet fil-burdata u sintomi depressivi, ikkuntattja lit-tabib tiegħek minnufih biex tirċievi parir mediku addizzjonali.
English: • if you have varicose veins.
Maltese: • Jekk għandek vini varikużi.
English: In rare cases, liver tumours which are not cancer have been found in women taking combined hormonal contraceptives.
Maltese: F'każijiet rari, tumuri fil-fwied li ma humiex kanċer instabu f'nisa li jieħdu kontraċettivi ormonali kkombinati.
English: Muscle spasms
Maltese: Kanċer tal-fwied
English: The decision to prescribe EVRA should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with EVRA compares with other CHCs (see sections 4.3 and 4.4).
Maltese: Id-deċiżjoni li tingħata riċetta għal EVRA għandha tikkunsidra l-fatturi tar-riskji kurrenti tal-mara individwali, partikularment dawk għal tromboemboliżmu venuż (VTE), u kif ir-riskju ta' VTE b'EVRA jipparaguna ma' CHCs oħrajn (ara sezzjonijiet 4.3 u 4.4).
English: • Itchy skin
Maltese: • Spażmi fil-muskoli
English: 3 transdermal patches 9 transdermal patches 18 transdermal patches
Maltese: Uża dawn l-istikers fuq il-kalendarju biex jgħinuk tiftakar meta għandek tibdel il-garża tiegħek
English: About 2 out of 10,000 women
Maltese: Madwar 2 minn kull 10,000 mara
English: Whether this is also applies to the lower dosed combined hormonal contraceptives remains to be confirmed.
Maltese: Jista' jkun illi n-nisa li jieħdu kontraċettiv ormonali kkombinat jiġu invistati iktar ta' spiss.
English: Following application of EVRA, norelgestromin and ethinyl estradiol levels in serum reach a plateau by approximately 48 hours.
Maltese: Wara l-applikazzjoni ta' EVRA, il-livelli ta' norelgestromin u ethinyl estradiol fis-serum jieqfu milli jkomplu jiżdiedu bejn wieħed u ieħor mat-48 siegħa.
English: Pruritus Skin reaction Skin irritation uncommon
Maltese: Disturbi vaskulari mhux komuni
English: How to store EVRA
Maltese: X'fiha EVRA