FrancophonIA/ELRC3.0 huggingface dataset:
English: Study LA16-0102 compared the efficacy of Ferriprox with that of deferoxamine in decreasing cardiac iron overload and in improving cardiac function (as measured by LVEF) in transfusion-dependent thalassaemia patients.
Maltese: L-istudju LA16-0102 qabbel l-effikaċja ta' Ferriprox ma' dik ta' deferoxamine biex jitnaqqas il-ħadid kardijaku eċċessiv u sabiex tiżdied il-funzjoni kardijaka (kif imkejjel b'LVEF) f'pazjenti bit-talassimja dipendenti mit-trasfużjoni.
English: Based on the reported adverse interaction that can occur between deferoxamine and vitamin C, caution should be used when administering deferiprone and vitamin C concurrently.
Maltese: Skond l-interazzjoni avversa rrappurtata li tista' sseħħ bejn deferoxamine u l-vitamina Ċ, għandha tingħata attenzjoni meta deferiporne u l-vitamina Ċ jingħataw ma' xulxin.
English: Increased levels of serum liver enzymes have been reported in some patients taking deferiprone.
Maltese: Livelli ogħla ta' enzimi tal-fwied fis-serum ġew irrapportati f'xi pazjenti li ħadu deferiprone.
English: Even though agranulocytosis only affects 1 to 2 out of 100 users, it is important to monitor your blood on a regular basis.
Maltese: Anke jekk l agrunuloċitosi taffettwa minn 1 sa 2 utenti minn kull 100, huwa importanti li timmonitorja id demm tiegħek fuq bażi regolari.
English: The neurological disorders progressively regressed after deferiprone discontinuation.
Maltese: Disturbi newroloġiċi naqsu b'mod progressiv wara li deferiprone twaqqaf.
English: Peak serum concentrations of the glucuronide occur 2 to 3 hours after administration of deferiprone.
Maltese: metabolit glucuronide u kumpless ħadid-deferiprone.
English: PHARMACEUTICAL FORM AND CONTENTS 50 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: Peppermint oil
Maltese: Piż tal-Ġisem
English: Combination therapy with deferoxamine is not recommended when monotherapy with either chelator is adequate or when serum ferritin falls below 500 µg/l.
Maltese: It-terapija ta' kombinazzjoni mhix irrakkomandata meta l-monoterapija ma kwalunkwe kelatur tkun inadegwata jew meta l-ferritin fis serum jaqa' għal inqas minn 500 µg/l.
English: Agranulocytosis and neutropenia usually resolve upon discontinuation of Ferriprox, but fatal cases of agranulocytosis have been reported.
Maltese: L-agranuloċitożi u n-newtropenija ġeneralment jirriżolvu malwaqfien ta' Ferriprox, imma każijiet fatali ta' agranuloċitożi ġew rapportati.
English: Deferiprone use should be discontinued if neurological disorders are observed (see sections 4.8 and
Maltese: Intwera li deferiprone jikkawża n-newtropenija, li tinkludi agranuloċitosi (ara sezzjoni 4.8
English: The safety of concurrent use of deferiprone and vitamin C has not been formally studied.
Maltese: Is-sigurtà ta' l-użu flimkien ta' deferiprone u l-vitamina Ċ għadha ma ġietx studjata formalment.
English: Data from the published literature on iron balance studies in patients with thalassaemia major show that the use of Ferriprox concurrently with deferoxamine (coadministration of both chelators during the same day, either simultaneously or sequentially, e.g., Ferriprox during the day and deferoxamine during the night), promotes greater iron excretion than either drug alone.
Maltese: Dejta ristretta hija disponibbli fuq l-użu kkombinat ta' Ferriproxu deferasirox, u kawtela għandha tiġi applikata meta jiġi kkonsidrat l-użu ta' din il-kombinazzjoni.
English: High density polyethylene (HDPE) bottle with a child resistant polypropylene cap and a desiccant.
Maltese: Flixkun ta' polyethylene ta' densità għolja (HDPE) b'tapp tal-polypropylene li huwa reżistenti għal ftuħ mit-tfal u b'dessikant.
English: - History of agranulocytosis.
Maltese: − Żomm dan il-fuljett.
English: Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Maltese: Ferriprox jintuża biex jiġi ttrattat il-livell eċċessiv ta' ħadid ikkaġunat minn trasfużjonijiet frekwenti f'pazjenti b'talassemija meta t-terapija attwali ta' kelazzjoni hija kontraindikata jew inadegwata.
English: Clear, reddish orange-coloured liquid.
Maltese: Likwidu ta' lewn oranġjo ħamrani ċar.
English: Dose table for Ferriprox 1000 mg film-coated tablets Body weight (kg)
Maltese: Tabella tad-dożi għal Ferriprox 1000 mg pilloli miksija b'rita
English: Data from pooled clinical studies in patients with systemic iron overload show that 63% of the episodes of agranulocytosis occurred within the first six months of treatment, 74% within the first year and 26% after one year of therapy.
Maltese: Tagħrif minn studji kliniċi miġbura minn pazjenti b'tagħbija żejda sistematika ta' ħadid wera li 63% tal-episodji ta' agranuloċitożi seħħew fl-ewwel sitt xhur ta' trattament, 74% fl-ewwel sena u 26% wara l-ewwel sena ta' terapija.
English: What Ferriprox looks like and contents of the pack Ferriprox 500 mg tablets are white to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “500” on one side, plain on the other.
Maltese: Il-pilloli ta' Ferriprox 500 mg huma ta' lewn abjad għal off-white, f'għamla ta' kapsula, miksija b'rita,
English: − diarrhoea
Maltese: pillola.
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 1000 mg film-coated tablets deferiprone
Maltese: Ferriprox 1000 mg pilloli miksija b'rita Kull pillola fiha 1000 mg ta' deferiprone
English: Crospovidone
Maltese: Treddigħ
English: Dose adjustments when used with other iron chelators In patients for whom monotherapy is inadequate, Ferriprox may be used with deferoxamine at the standard dose (75 mg/kg/day) but should not exceed 100 mg/kg/day.
Maltese: Aġġustamenti fid-doża meta jintuża ma' kelaturi oħra tal-ħadid F'pazjenti li għalihom il-monoterapija hija inadegwata, Ferriprox jista' jintuża ma' deferoxamine fiddoża standard (75 mg/kg/jum) imma m'għandux jaqbeż 100 mg/kg/jum.
English: Sixty-one patients with cardiac iron overload, previously treated with deferoxamine, were randomized to continue deferoxamine (average dose 43 mg/kg/day; N=31) or to switch to Ferriprox (average dose 92 mg/kg/day N=29).
Maltese: Wieħed u sittin pazjent b'ħadid kardijaku eċċessiv, li qabel kienu jingħataw kura b'deferoxamine, kienu magħżula b'mod każwali sabiex ikomplu fuq deferoxamine (doża medja ta' 43 mg/kg/jum; N=31) jew biex jaqilbu għal fuq Ferriprox (doża medja ta' 92 mg/kg/jum; N=29).
English: − nausea
Maltese: FEJN MA
English: Ferriprox in combination with another chelator (see section 4.4) is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction (see section 4.2).
Maltese: Ferriprox f'kombinazzjoni ma' kelatur ieħor (ara sezzjoni 4.4) hu indikat f'pazjenti b'talassimja maġġuri meta l-monoterapija bi kwalunkwe kelatur ieħor tal-ħadid tkun ineffettiva, jew meta lprevenzjoni jew konsegwenzi li jistgħu jkunu ta' theddida għall-ħajja ta' kkargar eċċessiv ta' ħadid (prinċipalment l-ikkargar kardijaku eċċessiv) jiġġustifika korrezzjoni rapida jew intensiva (ara sezzjoni 4.2).
English: This metabolite lacks iron-binding capability due to inactivation of the 3-hydroxy group of deferiprone.
Maltese: Dan il-metabolit m'għandux ilkapaċità li jeħel mal-ħadid minħabba l-inattivazzjoni tal-grupp 3-hydroxy ta' deferiprone.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One tablet contains 500 mg deferiprone.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola fiha 500 mg ta' deferiprone.
English: Ferriprox 500 mg film-coated tablets Tablet core
Maltese: Ferriprox 500 mg pilloli miksija b'rita Il-qalba tal-pillola
English: Therefore, it is not recommended to concomitantly ingest aluminium-based antacids and deferiprone.
Maltese: Għalhekk mhux irrakkomandat li tieħu antaċidi bbażati fuq l-aluminju u deferiprone flistess ħin.
English: The most serious adverse reaction reported in clinical trials with deferiprone was agranulocytosis, defined as an absolute neutrophil count less than 0.5 x 109/l, which occurred in approximately 1% of patients.
Maltese: L-aktar reazzjoni avversa serja rrapportata fil-provi kliniċi b'deferiprone kienet agranuloċitosi, imfissra bħala għadd assolut ta' newtrofili ta' inqas minn 0.5x109/l li seħħet f'madwar 1% tal-pazjenti.
English: What Ferriprox looks like and contents of the pack Ferriprox oral solution is a clear, reddish orange coloured liquid.
Maltese: Is-soluzzjoni orali Ferriprox hija likwidu ċar, ta' lewn oranġjo ħamrani.
English: Seborrhoea
Maltese: Is-seborrea
English: Clinical safety
Maltese: Is-sigurtà klinika
English: Alopecia androgenetica
Maltese: L-alopeċja androġenetica
English: Information received after cut-off date 30 January 2013
Maltese: L-informazzjoni riċevuta wara d-data tal-għeluq tat-30 ta' Jannar 2013
English: Overall, VTE could be fatal in 1-2% of the cases.
Maltese: B'mod ġenerali, VTE jista' jkun fatali f'1-2% tal-każijiet.
English: Of these 175 cases, 15 reported fatal outcome (4 medically confirmed and 11 non-medically confirmed consumer reports).
Maltese: Minn dawn il-175 każ, 15 irrapportaw eżitu fatali (4 rapporti mill-konsumaturi medikament ikkonfermati u 11 mhux medikament ikkonfermati).
English: One of these 968 cases was reported from clinical trial ME94162 / AI58.
Maltese: Wieħed minn dawn id-968 każ kien rapportat mill-prova klinika ME94162 / AI58.
English: Most reports were from patients between 18-35 years of age (66%).
Maltese: Ħafna mir-rapporti kienu minn pazjenti bejn it-18-35 sena (66%).
English: The overall global spontaneous reporting rate for all cases reporting any TE event at data lock point (DLP) 06 Mar 2013 is estimated as 1.5 per 100,000 women-years, 1.4 non-fatal TE reports per 100,000 women-years, and 0.1 fatal TE reports per 100,000 women-years with CPA/EE (91 fatal cases (8%) in total of 1143 cases).
Maltese: Ir-rata globali ta' rapportar spontanju għall-każijiet kollha li rrapportaw xi avveniment TE fid-data lock point (DLP) tas-6 ta' Marzu 2013 hija stmata ta' 1.5 għal kull 100,000 mara-snin, 1.4 rapporti TE mhux fatali għal kull 100,000 mara-snin, u 0.1 rapport TE fatali għal kull 100,000 mara-snin b'CPA/EE (91 każ fatali (8%) f'total ta' 1143 każ).
English: In addition, co-suspected drugs, such as citalopram, thalidomide, olanzapine, antineoplastic agents, natalizumab, methylprednisolone sodium succinate, antibiotics or isotretinoin were reported for 20 (2.1%) patients.
Maltese: Barra minn hekk, mediċini kosuspettati, bħal citalopram, thalidomide, olanzapine, aġenti antineoplastiċi, natalizumab, methylprednisolone sodium succinate, antibijotiċi jew isotretinoin kienu rapportata għal 20 (2.1%) pazjent.
English: Weight and height were reported for 258 (26.7%) of 968 patients.
Maltese: Il-piż u t-tul kienu rapportata għal 258 (26.7%) minn 968 pazjent.
English: These 968 cases comprise 7% of the total number of ADR reports received cumulatively through 30 Jan 2013 (n = 13,875 in total).
Maltese: Dawn id-968 każ ikopru 7% tal-għadd totali ta' rapporti ta' ADR riċevuti b'mod kumulattiv mit30 ta' Jannar 2013 (n = total ta' 13,875).
English: They include benzoylperoxide, retinoids, antibiotics, salicylic acid, and azelaic acid.
Maltese: Dawn jinkludu benzoylperoxide, retinojdi, antibijotiċi, aċidu saliċiliku, u aċidu azelaic.
English: The combined therapy with CPA/EE and CPA 10 mg has a different safety profile as reflected in the labelling of CPA 10 mg.
Maltese: It-terapija kkombinata b'CPA/EE u CPA 10 mg għandha profil differenti ta' sigurtà kif rifless fit-tikkettar ta' CPA 10 mg.
English: Cyproterone has the strongest anti-androgen activity.
Maltese: Cyproterone għandu l-aktar attività antiandroġenika qawwija.
English: Early studies reported that the risk of (idiopathic) VTE in users of CPA/EE is greater in comparison to users of levonorgestrel-containing COC, or conventional COC respectively, with low estrogen (<50μg) (Vasilakis-Scaramozza & Jick 2001, Seaman et al, 2003).
Maltese: Studji tal-bidu rrapportaw li r-riskju ta' VTE (idjopatiku) f'utenti ta' CPA/EE huwa akbar meta mqabbel ma' utenti ta' COC li fihom levonorgestrel, jew COC konvenzjonali rispettivament, b'estroġenu baxx (<50μg) (Vasilakis-Scaramozza u Jick 2001, Seaman et al, 2003).
English: In total, 76 (7.9%) of 968 ADR reports with TE events reported fatal outcomes; 66 were medically confirmed and 10 were non-medically confirmed consumer reports.
Maltese: B'kollox, 76 (7.9%) minn 968 rapport ta' ADR b'avvenimenti TE irrapportaw eżitu fatali; 66 kienu medikament ikkonfermati u 10 kienu rapporti mill-konsumaturi li ma kinux medikament ikkonfermati.
English: 88 (9.1%) ADR reports referred to patients less than 18 years of age, 639 (66%) patients were between 18 and 35 years of age and 150 (15.5%) reports referred to patients older than 35 years of age.
Maltese: 88 (9.1%) rapport ta' ADR irriferew għal pazjenti ta' anqas minn 18-il sena, 639 (66%) pazjent kienu bejn it-18 u t-35 sena u 150 (15.5%) rapport irriferew għal pazjenti akbar minn 35 sena.
English: As of last PSUR (reporting period 01 Jun 2011 ─ 31 May 2012, DLP: 31 May 2012), the reporting frequency of all (arterial, venous and unspecified) thrombotic / thromboembolic events received during the reporting period was 1.3 per 100,000 womenyears.
Maltese: Sa mill-aħħar PSUR (perjodu ta' rappurtar 01 Ġunju 2011 31 ta' Mejju 2012, DLP: 31 ta' Mejju 2012), il-frekwenza tar-rapportar ta' avvenimenti trombotiċi/tromboemboliċi kollha (arterjali, venużi u mhux speċifikati) riċevuti matul ilperjodu ta' rapportar kien ta' 1.3 għal kull 100,000 mara-snin.
English: Known risk factors for VTE include history of VTE, pregnancy, trauma, surgery, immobilisation (e.g. after surgery or long flights), obesity and smoking (i.e. all situations of a prothrombotic state).
Maltese: Fatturi magħrufa ta' riskju għal VTE jinkludu storja ta' VTE, tqala, trawma, kirurġija, immobilizzazzjoni (eż. wara kirurġija jew titjiriet fit-tul), obeżità u tipjip (jiġifieri s-sitwazzjonijiet kollha ta' stat protrombotiku).
English: In the INAS-SCORE study 20.2% of use is in contraception from a total of 1094 users of CPAcontaining preparations which represents 5.5% of the total study population.
Maltese: Fl-istudju INAS-SCORE 20.2% tal-użu huwa fil-kontraċezzjoni minn total ta' 1094 utent ta' preparazzjonijiet li fihom CPA li jirrappreżenta 5.5% tal-popolazzjoni totali tal-istudju.
English: The MAH- of the originator product sponsored 10 phase-III clinical trials providing information on safety of these medicinal products.
Maltese: Il-MAH- tal-prodott oriġinatur sponsorja 10 provi kliniċi tal-fażi-III li jipprovdu informazzjoni dwar issigurtà ta' dawn il-prodotti mediċinali.
English: Several observational studies have assessed the VTE risk with use of CPA/EE (2mg/0.035mg).
Maltese: Bosta studji osservazzjonali evalwaw ir-riskju ta' VTE bl-użu ta' CPA/EE (2mg/0.035mg).
English: Age was reported for 877 of 968 (90.6%) patients.
Maltese: L-età kienet irrapportata għal 877 minn 968 (90.
English: BMI for these patients was between 15 and 54 (mean 24, median 23), whereas BMI over 30 kg/m2 was documented in 33 (3.4%) of these reports.
Maltese: Il-BMI għal dawn il-pazjenti kien bejn 15 u 54 (medja ta' 24, medjan ta' 23), filwaqt li BMI 'l fuq minn 30 kg/m2 kien dokumentat fi 33 (3.4%) minn dawn ir-rapporti.
English: INAS-SCORE was initiated after the launch of Qlaira (dienogest/estradiol valerate, step down dose regimen) in Europe (September 2009) and USA (October 2010) and is a prospective noninterventional post-approval safety study conducted in Austria, France, Germany, Italy, Poland, Sweden, UK and the US.
Maltese: INAS-SCORE inbeda wara t-tnedija ta' Qlaira (dienogest/estradiol valerate, reġimen ta' tnaqqis fiddoża) fl-Ewropa (Settembru 2009) u fl-Istati Uniti tal-Amerika (Ottubru 2010) u huwa studju prospettiv, mhux ta' intervent ta' sigurtà wara l-approvazzjoni li sar fl-Awstrija, fi Franza , fil-Ġermanja, fl-Italja, fil-Polonja, fl-Iżvezja, fir-Renju Unit u fl-Istati Uniti.
English: Regarding acne without androgenic features, one study compared CPA/EE with systemic antibiotic tetracycline and showed similar efficacy (Greenwood R, et al., 1985).
Maltese: Fir-rigward tal-akne mingħajr karatteristiċi androġenċi, studju wieħed qabbel CPA/EE ma' antibijotiku tetraċiklin sistemiku u wera effikaċja simili (Greenwood R, et al., 1985).
English: Concomitant medications
Maltese: Il-mediċina konkomitanti
English: 892 (92.1%) of 968 cases reported non-fatal TE in association with CPA/EE (2mg/0.035mg) use, of which 760 were medically confirmed.
Maltese: 892 (92.1%) minn 968 każ irrapportaw TE mhux fatali b'rabta mal-użu ta' CPA/EE (2mg/0.035mg), li minnhom 760 kienu medikament ikkonfermati.
English: Pearl Index based on CPA/EE (2mg/0.035mg) clinical trial data (Study 8186, Aydinlik et al., 1990) Method failure
Maltese: Tabella 1 L-Indiċi Pearl ibbażat fuq dejta mill-prova klinika (Studju 8186, Aydinlik et al., 1990)ta' CPA/EE (2mg/0.
English: Thromboembolic events
Maltese: L-avvenimenti tromboemboliċi
English: Fatal cases
Maltese: Il-każijiet mhux fatali
English: No age was reported for 91 (9.4%) patients.
Maltese: Għal 91 (9.4%) pazjent ma kien hemm l-ebda età rrapportata.
English: These events occur rarely.
Maltese: Dawn l-avvenimenti jseħħu b'mod rari.
English: The MAH conducted a systematic review of the scientific literature (cut-off date: 14 Feb 2013) in MEDLINE, EMBASE, Derwent Drug File, and BIOSIS Previews on clinical studies covering cardiovascular diseases and CPA/EE(2mg/0.035mg).
Maltese: Il-MAH wettaq reviżjoni sistematika tal-letteratura xjentifika (data tal-għeluq: 14 ta' Frar 2013) f'MEDLINE, EMBASE, Derwent Drug File, u BIOSIS Previews dwar studji kliniċi li koprew mard kardjovaskulari u CPA/EE(2mg/0.
English: The reporting frequency is less than the incidence of VTE as reported in epidemiological studies.
Maltese: Il-frekwenza ta' rapportar hija anqas mill-inċidenza ta' VTE kif irrapportat fi studji epidemjoloġiċi.
English: CPA/EE (2mg/0.035mg) containing medicinal products have anti-androgenic effects.
Maltese: Prodotti mediċinali li fihom CPA/EE (2mg/0.035mg) għandhom effetti antiandroġeniċi.
English: Of these 76 reports, 67 (88.2%) cases reported pulmonary embolism with or without reported DVT or unspecified thrombosis, 8 (10.5%) reports described cerebral events, and 1 (1.3%) reported events of dyspnoea, disseminated intravascular coagulation and circulatory disorder in context of multi-organ failure, acute hepatic failure, coma hepatic, bone marrow failure, fungal sepsis, pneumonia and histiocytosis haematophagic in a female patient with condition of alcohol abuse, acute myeloid leukaemia, polychemotherapy and antibiotics therapy.
Maltese: 5%) rapporti ddeskrivew avvenimenti ċerebrali, u avveniment 1 (1.3%) irrapporta qtugħ ta' nifs, koagulazzjoni intravaskulari mxerrda u disturb ċirkolatorju fil-kuntest ta' falliment ta' ħafna organi, insuffiċjenza epatika akuta, koma epatika, insuffiċjenza tal-mudullun, sepsis fungali, pnewmonja u histiocytosis haematophagic f'pazjenta b'kundizzjoni tal-abbuż tal-alkoħol, lewkimja majelojde akuta, polychemotherapy u terapija b'antibijotiċi.
English: There were no cases reporting ATE with a fatal outcome.
Maltese: Ma kien hemm l-ebda każijiet li rrapportaw ATE b'eżitu fatali.
English: Arterial thromboembolic events
Maltese: L-avvenimenti tromboemboliċi arterjali
English: In INAS-OC study 28.1% of use is in contraception, from a total of 1672 users of CPA-containing preparations enrolled in the study, representing 7.5% of the total study population.
Maltese: Fl-istudju INAS-OC 28.1% tal-użu huwa fil-kontraċezzjoni, minn total ta' 1672 utent ta' preparazzjonijiet li fihom CPA li ħadu sehem fl-istudju, li jirrappreżenta 7.5% tal-popolazzjoni totali talistudju.
English: Cegedim Promotional data show 32% of use in contraception only, while Longitudinal data show 3.4% use in contraception only; the Pharmalink Panel data for Germany show 53% of contraceptive use, of which 75% the reason given is for acne and 25% for other reasons.
Maltese: Dejta Promozzjonali minn Cegedim turi użu ta' 32% f'kontraċezzjoni biss, filwaqt li dejta Lonġitudinali turi użu ta' 3.4% f'kontraċezzjoni biss; id-dejta minn Pharmalink Panel għall-Ġermanja turi użu ta' 53% bħala kontraċettiv, li f'75% minnhom ir-raġuni mogħtija hija għall-akne u 25% għal raġunijiet oħra.
English: Alternative treatments for moderate to severe acne are long-term antibiotics (topical or systemic), keratolytics and retinoids (topical or systemic, with known risks of teratogenicity and subject to a pregnancy prevention plan and regular liver function testing).
Maltese: Kura alternattiva għall-akne moderata sa severa hija bl-antibijotiċi fit-tul (topiċi jew sistemiċi), keratolitiċi u retinojdi (topiċi jew sistemiċi, b'riskji magħrufa ta' teratoġeniċità u soġġetti għal pjan ta' prevenzjoni tat-tqala u testijiet regolari tal-funzjoni tal-fwied).
English: In none of the 118 identified clinical studies described in the scientific literature a venous or arterial thromboembolic/cardiovascular event during course of the study was reported.
Maltese: Fl-ebda wieħed mill-118-il studju kliniku identifikati deskritti fil-letteratura xjentifika ma kien hemm rapportar ta' avveniment tromboemboliku/kardjovaskulari venuż jew arterjali matul il-kors tal-istudju.
English: A total of 175 cases (all serious, medically confirmed (38.3%, n=67 in total) and non-medically confirmed (61.7%, n=108 in total)) reporting thrombotic / thromboembolic events (TE) irrespective of their nature (arterial, venous and unspecified) occurring in female patients in association with CPA/EE (2mg/0.035mg) were received by the MAH from worldwide sources additionally to the 968 TE cases presented in the main analysis.
Maltese: Total ta' 175 każ (kollha serji, medikament ikkonfermati (38.3%, n=67 f'total) u li rrapportaw avvenimenti trombotiċi / tromboemboliċi (TE) li ma kinux medikament ikkonfermati (61.7%, n=108 f'total)) irrispettivament min-natura tagħhom (arterjali, venużi u mhux speċifikati) li seħħew f'pazjenti nisa b'rabta ma' CPA/EE (2mg/0.
English: The IMS prescription data have limited value because they do not include a category of “contraception in the absence of acne”.
Maltese: Id-dejta dwar il-preskrizzjoni tal-IMS għandha valur limitat minħabba li ma tinkludix kategorija ta' “kontraċezzjoni fin-nuqqas tal-akne”.
English: For the period since the global launch of CPA/EE (2mg/0.035mg) through 30 Jan 2013, 968 cases (serious (93%) and non-serious (7%), medically confirmed (85%) and non-medically confirmed (15%) reporting thrombotic/thromboembolic events irrespective of their nature (arterial, venous and unspecified) occurring in female patients were received by the MAH from worldwide sources.
Maltese: 035mg) sat-30 ta' Jannar 2013, 968 każ (serji (93%) u mhux serji (7%), medikament ikkonfermati (85%) u mhux medikament ikkonfermati (15%) li rrapportaw avvenimenti trombotiċi/tromboemboliċi irrispettivament min-natura tagħhom (arterjali, venużi u mhux speċifikati) li seħħew f'pazjenti nisa kienu riċevuti mill-MAH minn sorsi madwar id-dinja.
English: Venous thromboembolic events
Maltese: L-avvenimenti tromboemboliċi venużi
English: The estimate is based on the calculated global patient exposure of 75,417,345 women-years and 968 received TE reports worldwide.
Maltese: L-istima hija bbażata fuq lespożizzjoni globali kkalkolata tal-pazjent ta' 75,417,345 mara-snin u 968 rapport ta' TE li ġew riċevuti minn madwar id-dinja.
English: A total of 789 (81.5%) of 968 retrieved cases reported one or more VTEs in association with CPA/EE (2mg/0.035mg) use.
Maltese: Total ta' 789 (81.5%) minn 968 każ miksuba rrapportaw każ wieħed jew aktar ta' VTE b'rabta mal-użu ta' CPA/EE (2mg/0.