FrancophonIA/ELRC3.0 huggingface dataset:
English: The recent Cochrane review (Arowojolu, AO. et al., 2012), which evaluated efficacy of combined oral contraceptives in acne, reported that regarding the differences in the comparative effectiveness of the contraceptives, data were too limited for any conclusive comparison.
Maltese: Ir-reviżjoni riċenti ta' Cochrane (Arowojolu, AO. et al., 2012), li evalwat l-effikaċja ta' kontraċettivi orali kkombinati fl-akne, irraportat li fir-rigward tad-differenzi fl-effikaċja komparattiva tal-kontraċettivi, iddejta kienet limitata wisq biex jista' jsir xi tqabbil konklussiv.
English: Compared with a corresponding reporting frequency ranging between 0.8 and 1.5 per 100,000 women-years during the previous six PSUR periods, there is no evidence of an overall increased reporting frequency of thrombotic /thromboembolic events.
Maltese: Meta mqabbla ma' frekwenza korrispondenti ta' rapportar li tvarja bejn 0.8 u 1.5 għal kull 100,000 mara-snin matul is-sitt perjodi preċedenti tal-PSUR, ma hemm l-ebda evidenza ta' żieda fil-frekwenza globali ta' rapportar ta' avvenimenti trombotiċi /tromboemboliċi.
English: These studies (INAS-OC and INAS-SCORE) investigate the safety of the combined oral contraceptive drugs YAZ (3 mg drospirenone/0.020mg ethinylestradiol) and Qlaira (dienogest/estradiol valerate, step down dose regimen) respectively.
Maltese: Dawn l-istudji jinvestigaw is-sigurtà tal-kontraċettivi orali kkombinati YAZ (3 mg drospirenone/0.020mg ethinylestradiol) u Qlaira (dienogest/estradiol valerate, reġimen ta' tnaqqis fid-doża) rispettivament.
English: Two studies compared CPA/EE (2mg/0.035mg) with levonorgestrel/EE (LNG/EE).
Maltese: 035mg) ma' levonorgestrel/EE (LNG/EE).
English: Contraceptive effect
Maltese: L-effett kontraċettiv
English: Total number of cycles number of pregnancies Pearl Index two-sided 95% confidence interval
Maltese: Total għadd ta' ċikli għadd ta' tqaliet Indiċi Pearl intervall ta' kunfidenza ta' 95% b'żewġ naħat
English: The MAH of the originator has submitted in the annual Periodic Safety Update Reports (PSURs) for CPA/EE information on thromboembolic events.
Maltese: Fir-Rapporti Perjodiċi ta' Aġġornament dwar is-Sikurezza (PSURs) għal CPA/EE l-MAH tal-oriġinatur ippreżenta informazzjoni dwar avvenimenti tromboemboliċi.
English: The overall global spontaneous reporting rate for all cases reporting any thrombotic /thromboembolic event is 1.3 per 100,000 women-years.
Maltese: Ir-rata totali globali ta' rapportar spontanju għall-każijiet kollha li rrapportaw xi avveniment trombotiku/tromboemboliku hija ta' 1.3 għal kull 100,000 mara-snin.
English: The PRAC concluded that the risk-benefit balance of cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal product(s) in the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age remains favourable subject to the restrictions, warnings, other changes to the product information, additional pharmacovigilance activities and additional risk minimisation measures agreed.
Maltese: 035mg) fil-kura ta' akne moderata sa severa relatata ma' sensittività għall-androġeni (bi jew mingħajr seborrea) u/jew irsutiżmu, f'nisa ta' età riproduttiva jibqa' favorevoli soġġett għar-restrizzjonijiet, twissijiet, tibdil ieħor lill-informazzjoni dwar il-prodott, attivitajiet addizzjonali ta' farmakoviġilanza u miżuri addizzjonali għall-minimizzazzjoni tar-riskji miftiehma.
English: Furthermore, concomitant use of another hormonal contraceptive being reported as an additional suspected drug was documented in 21 (2.2%) of received TE cases; 20 patients received concomitantly various COCs and one case reported concomitant intrauterine device (IUD) (levonorgestrel-releasing intrauterine system) use.
Maltese: Barra minn hekk, l-użu konkomitanti ta' kontraċettiv ormonali ieħor rapportat bħala mediċina addizzjonali suspettata kien dokumentat f'21 (2.2%) każ ta' TE riċevuti; 20 pazjent irċevew diversi COCs b'mod konkomitanti u każ wieħed irrapporta l-użu ta' apparat konkomitanti fl-utru (IUD) (sistema li terħi levonorgestrel fl-utru).
English: The MAH provided an overview of 6 cohort studies (of which 2 with additional nested case-control analyses) and 7 case-control studies assessing the VTE risk associated with CPA/EE and one cohort study assessing the ATE risk associated with CPA/EE.
Maltese: Il-MAH ipprovda ħarsa ġenerali ta' 6 studji ta' koorti (li minnhom 2 b'analiżi addizzjonali nested casecontrol) u 7 studji ta' kontroll fuq il-każ li evalwaw ir-riskju ta' VTE assoċjat ma' CPA/EE u studju uniku ta' koorti li evalwa r-riskju ta' ATE assoċjat ma' CPA/EE.
English: CPA/EE (2mg/0.035mg) is often used in combination with cyproterone 10 mg (CPA 10 mg) in different daily doses to increase anti-androgenic effects.
Maltese: 035mg) jintuża f'kombinazzjoni ma' cyproterone 10 mg (CPA 10 mg) f'dożi differenti ta' kuljum biex iżid l-effetti antiandroġeniċi.
English: In a recent study (Lidegaard, 2012) the comparative analyses of the relative risk for thrombotic stroke and myocardial infarction between the various progestins, including levonorgestrel, and non-use are in the same magnitude and do not show differences between the various progestins.
Maltese: Fi studju riċenti (Lidegaard, 2012) l-analiżi komparattiva tar-riskju relattiv għal puplesija trombotika u infart mijokardijaku bejn il-proġestini varji, inkluż levonorgestrel, u n-nuqqas ta' użu qegħdin fl-istess kobor u ma juru l-ebda differenzi bejn ilproġestini varji.
English: The only difference in clinical outcome was a significantly improved Ferriman Gallwey (FG) score at 12 months when cyproterone acetate was compared with flutamide.
Maltese: L-unika differenza fl-eżitu kliniku kien titjib sinifikanti fil-punteġġ Ferriman Gallwey (FG) fit-12-il xahar meta cyproterone acetate kien imqabbel ma' flutamide.
English: Subsequent studies (Lidegaard et al. 2003, Seaman et al. 2004), the latter addressing the issue of confounding, concluded that the absolute risk of VTE among women taking CPA/EE is not significantly greater than for women on COCs.
Maltese: Studji sussegwenti (Lidegaard et al. 2003, Seaman et al. 2004), li tal-aħħar indirizza l-kwistjoni ta' fatturi ta' konfużjoni, ikkonkludew li r-riskju assolut ta' VTE fost nisa li qed jieħdu CPA/EE mhuwiex sinifikantement akbar milli għal nisa fuq COCs.
English: Thromboembolic events are known, rare adverse drug reactions associated with the use of estrogenprogestogen containing preparations including CPA/EE (2mg/0.035mg).
Maltese: Avvenimenti tromboemboliċi huma reazzjonijiet avversi rari, magħrufa tal-mediċina assoċjati mal-użu ta' preparazzjonijiet li fihom l-estroġenu-proġestoġen inkluż CPA/EE (2mg/0.
English: The estimate is based on the calculated patient exposure of 75,417,345 women-years and 52 reports of arterial embolic and thrombotic events worldwide.
Maltese: L-istima hija bbażata fuq l-espożizzjoni globali kkalkolata tal-pazjent ta' 75,417,345 mara-snin u 52 rapport ta' avvenimenti emboliċi u trombotiċi arterjali madwar id-dinja.
English: More recent studies assessing the VTE risk in users of various COCs and CPA/EE (including Lidegaard 2009, Hylckama 2009) had major methodological flaws (missing data for confounders) that raise questions about the validity of their conclusions.
Maltese: Studji aktar riċenti li evalwaw ir-riskju ta' VTE f'utenti ta' bosta COCs u CPA/EE (inkluż Lidegaard 2009, Hylckama 2009) kellhom difetti metodoloġiċi kbar (dejta nieqsa għall-fatturi ta' konfużjoni) li jqajmu mistoqsijiet dwar il-validità tal-konklużjonijiet tagħhom.
English: The estimate is based on the calculated patient exposure of 75,417,345 women-years and 789 reports of venous embolic and thrombotic events worldwide.
Maltese: Din l-istima hija bbażata fuq l-espożizzjoni kkalkolata tal-pazjent ta' 75,417,345 mara-snin u 789 rapport ta' avvenimenti emboliċi u trombotiċi venużi madwar id-dinja.
English: Off Label Use
Maltese: Falliment tal-metodu
English: This is expected in view of the differences in anti-androgenic properties of cyproterone, drospirenone and desogestrel.
Maltese: Dan huwa mistenni fid-dawl tad-differenzi fil-karatteristiċi antiandroġeniċi ta' cyproterone, drospirenone u desogestrel.
English: Misdiagnosis is a realistic possibility since TE has diffuse symptoms and is a rare event in population of healthy young women.
Maltese: Id-dijanjosi żbaljata hija possibbiltà realistika peress li TE għandu sintomi diffużi u huwa avveniment rari f'popolazzjoni ta' nisa żgħażagħ b'saħħithom.
English: *calculated as the total number of cycles, n=21,196, minus the number of cycles, n=450, in which medication was missed.
Maltese: *ikkalkolat bħala l-għadd totali ta' ċikli, n=21,196, nieqes l-għadd ta' ċikli, n=450, li fihom ilmediċina ma tteħditx.
English: Clinical studies
Maltese: L-istudji kliniċi
English: In women with androgenic sensitive skin conditions, the efficacy in moderate and severe acne with/without seborrhoea and/or hirsutism is demonstrated in more than 30 sponsored and nonsponsored trials, including comparative trials, uncontrolled trials, and pilot studies.
Maltese: F'nisa b'kundizzjonijiet tal-ġilda sensittivi għall-androġeni, l-effikaċja fl-akne moderata u severa bi/mingħajr seborrea u/jew irsutiżmu ntweriet f'aktar minn 30 prova sponsorjati u mhux sponsorjati, inkluż provi komparattivi, provi mhux ikkontrollati, u studji pilota.
English: The study (currently ongoing) seeks to assess the risks of short- and longterm use of Qlaira (dienogest/estradiol valerate, step down dose regimen) and of oral contraceptives and including CPA/EE (2mg/0.035mg).
Maltese: L-istudju (li għaddej bħalissa) ifittex li jevalwa rriskji tal-użu fuq perjodu qasir u twil ta' Qlaira (dienogest/estradiol valerate, reġimen ta' tnaqqis fiddoża) u ta' kontraċettivi orali u inkluż CPA/EE (2mg/0.
English: In the Cochrane review on treatment of hirsutism nine clinical studies qualified for inclusion.
Maltese: Fir-reviżjoni ta' Cochrane dwar il-kura tal-irsutiżmu disa' studji kliniċi kkwalifikaw għall-inklużjoni.
English: • The PRAC considered the procedure under Article 107i of Directive 2001/83/EC, for cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products.
Maltese: • Il-PRAC ikkunsidra l-proċedura taħt l-Artikolu 107i tad-Direttiva 2001/83/KE, għal prodotti mediċinali li fihom cyproterone acetate/ ethinylestradiol (2mg/0.
English: In July 2002, the Pharmacovigilance Working Party (PhVWP) discussed the increased venous thromboembolic (VTE) and arterial thromboembolic (ATE) risks and concluded that the use of cyproterone acetate/ethinylestradiol (2mg/0.035mg) should be restricted taking into account the thromboembolic events.
Maltese: F'Lulju 2002, il-Grupp ta' Ħidma ta' Farmakoviġilanza (PhVWP) iddiskuta ż-żieda fir-riskji tromboemboliċi venużi (VTE) u tromboemboliċi arterjali (ATE) u kkonkluda li l-użu ta' cyproterone acetate/ethinylestradiol (2mg/0.
English: A total of 1672 users of CPA/EE (2mg/0.035mg) -containing preparations were enrolled in the study representing 7.5% of the total study population.
Maltese: Fl-istudju ħadu sehem total ta' 1672 utent ta' preparazzjonijiet li fihom CPA/EE (2mg/0.035mg) li jirrappreżentaw 7.5% talpopolazzjoni totali tal-istudju.
English: Thromboembolic events are adverse events which usually occur in a vein of the leg (deep vein thrombosis).
Maltese: Avvenimenti tromboemboliċi huma avvenimenti avversi li ġeneralment iseħħu f'vina tas-sieq (trombożi tal-vini fil-fond).
English: To assess venous and arterial thromboembolic effects from clinical studies with CPA/EE, only clinical studies that documented adverse events are discussed here.
Maltese: Biex jiġu evalwati avvenimenti tromboemboliċi venużi u arterjali minn studji kliniċi b'CPA/EE, hawnhekk qegħdin jiġu diskussi biss studji kliniċi li ddokumentaw avvenimenti avversi.
English: This translates into the global spontaneous reporting rate of 0.10 fatal TE reports per 100,000 womenyears with CPA/EE (2mg/0.035mg).
Maltese: Dan isarraf fir-rata globali ta' rapportar spontanju ta' 0.10 rapporti fatali ta' TE għal kull 100,000 marasnin b'CPA/EE (2mg/0.
English: Palombo-Kinne E, et al., 2009) comparing CPA/EE (2mg/0.035mg) with dienogest containing combined oral contraceptive and with norgestimate containing combined oral contraceptive also showed similar efficacy.
Maltese: Żewġ studji (A18566, 2004, Palombo-Kinne E, et al., 2009) li qabblu CPA/EE (2mg/0.035mg) ma' kontraċettiv orali kkombinat li fih dienogest u ma' kontraċettiv orali kkombinat li fih norgestimate wrew ukoll effikaċja simili.
English: Therefore retrieved cases of reporting TE adverse reactions from worldwide sources comprise also cases occurring in association with CPA/EE (2mg/0.035mg) in combination with CPA 10 mg (n = 48 [5%] cases in total).
Maltese: 035mg) f'kombinazzjoni ma' CPA 10 mg (n = 48 [5%] każ totali).
English: Guideline on clinical investigation of steroid contraceptives in women.
Maltese: 2 Linja Gwida dwar l-investigazzjoni klinika ta' kontraċettivi sterojdi fin-nisa.
English: Several databases were consulted.
Maltese: Bosta dejtabejżis kienu kkonsultati.
English: There is only sparse data on arterial thrombotic and thromboembolic diseases with CPA/EE (2mg/0.035mg) or cyproterone acetate alone.
Maltese: Hemm biss dejta skarsa dwar mard trombotiku arterjali u tromboemboliku b'CPA/EE (2mg/0.035mg) jew b'cyproterone acetate waħdu.
English: The IMS Prescriptions Insight Data for France (ANSM benefit/risk review, 5 Feb 2013) suggest that CPA/EE (2mg/0.035mg) containing medicines are prescribed for contraception.
Maltese: Dejta minn IMS Prescriptions Insight għal Franza (reviżjoni tal-benefiċċju/riskju tal-ANSM, 5 ta' Frar 2013) tissuġġerixxi li mediċini li fihom CPA/EE (2mg/0.
English: This is the case in 54% of the 60% of prescriptions written by general practitioners (i.e. 32.4% of all prescriptions) and in 75% of the 36% of prescriptions written by gynaecologists (27.8% of all prescriptions), which implies that around 60% of all French prescriptions for CPA/EE (2mg/0.035mg) relate to contraception and therefore would be off-label use taking into account the indication only in acne in France.
Maltese: Dan huwa l-każ f'54% mis-60% tal-preskrizzjonijiet miktuba minn tobba (jiġifieri 32.4% talpreskrizzjonijiet kollha) u f'75% tas-36% tal-preskrizzjonijiet miktuba minn ġinekoloġi (27.8% talpreskrizzjonijiet kollha), li jimplika li madwar 60% tal-preskrizzjonijiet Franċiżi kollha għal CPA/EE (2mg/0.
English: A total of 52 (5.4%) of 968 retrieved cases reported one or more ATEs in association with CPA/EE (2mg/0.035mg) use.
Maltese: Total ta' 52 (5.4%) minn 968 każ miksuba rrapportaw ATE wieħed jew aktar b'rabta mal-użu ta' CPA/EE (2mg/0.
English: The PRAC endorsed a Direct Healthcare Professional Communication (DHPC), to communicate the outcome of the present review and to communicate to the healthcare professionals the updated indication and to highlight the risk of the thromboembolic events.
Maltese: Il-PRAC approva Komunikazzjoni Diretta lill-Professjonisti tal-Kura tas-Saħħa (DHPC), biex jikkomunika r-riżultat tar-reviżjoni attwali u biex jikkomunika lill-professjonisti tal-kura tas-saħħa l-indikazzjoni aġġornata u biex jenfasizza r-riskju tal-avvenimenti tromboemboliċi.
English: Arterial thromboembolic events may be lifethreatening or may have a fatal outcome.
Maltese: Avvenimenti tromboemboliċi arterjali jistgħu jkunu ta' periklu għallħajja jew jistgħu jkunu fatali.
English: The data on efficacy of CPA/EE in alopecia androgenetica, except for the mechanism of action, is limited to one small study (DeCecco L et al, 1987) in which some limited beneficial effects were noted.
Maltese: Id-dejta dwar l-effikaċja ta' CPA/EE fl-alopeċja androġenetika, ħlief għall-mekkaniżmu ta' azzjoni, hija limitata għal studju wieħed żgħir (DeCecco L et al, 1987) li fih kienu nnotati xi effetti benefiċjali limitati.
English: This translates into reporting rate of 1.05 ADR reports per 100,000 women-years with CPA/EE (2mg/0.035mg).
Maltese: Dan isarraf f'rata ta' rapportar ta' 1.05 rapporti ta' ADR għal kull 100,000 mara-snin b'CPA/EE (2mg/0.
English: The comparison of Pearl Indices in the EURAS study demonstrated the Pearl Index of CPA/EE (2mg/0.035mg) to be 0.37 (95% CI 0.19-0.65), which is comparable with that obtained for approved combined contraceptives (which vary between 0.48 and 0.63).
Maltese: 37 (95% CI 0.19-0.65), li huwa komparabbli ma' dak li nkiseb għal kontraċettivi kkombinati approvati (li jistgħu jvarjaw bejn 0.48 u 0.63).
English: This does not indicate a higher incidence in this age group but only a higher reporting rate in this age group, as patient exposure has not been provided in age categories.
Maltese: Dan ma jindikax inċidenza ogħla f'dan il-grupp ta' età imma biss rata ogħla ta' rapportar f'dan il-grupp ta' età, peress li l-espożizzjoni tal-pazjenti ma ġietx ipprovduta fil-kategoriji tal-età.
English: Epidemiological studies have suggested an association between the use of COCs in general and an increased risk of arterial thrombotic and thromboembolic diseases such as myocardial infarction, and of cerebrovascular accidents.
Maltese: Studji epidemjoloġiċi ssuġġerew rabta bejn l-użu ta' COCs inġenerali u żieda fir-riskju ta' mard trombotiku u tromboemboliku arterjali bħal infart mijokardijaku, u ta' inċidenti ċerebrovaskulari.
English: With exception of study report AI58, no cases of VTEs or ATEs were reported in patients from the 10 MAH- sponsored clinical trials with (CPA/EE) (2mg/0.035mg).
Maltese: Bl-eċċezzjoni tar-rapport tal-istudju AI58, ma kienu rrapportati l-ebda każijiet ta' VTEs jew ATEs f'pazjenti mill-10 provi kliniċi sponsorjati mill-MAH b'(CPA/EE) (2mg/0.
English: Cyproterone acetate exerts its anti-androgenic effect by blocking androgen receptors.
Maltese: Cyproterone acetate jeżerċita l-effett antiandroġeniku tiegħu billi jimblokka riċetturi tal-androġeni.
English: CPA/EE (2mg/0.035mg) was prescribed according to the indication (i.e. androgenic symptoms) in 40% of cases and prescribed off-label in 31% (as a contraceptive or for menstrual irregularities).
Maltese: 035mg) kien preskritt skont l-indikazzjoni (jiġifieri sintomi androġenċi) u f'31% kien preskritt mingħajr tikketta (bħala kontraċettiv jew għal irregolaritajiet mestrwali).
English: An increased risk for thrombotic / thromboembolic events (that may be fatal in 1-2% of cases) is listed in the Core company data sheet (CCDS) for CPA/EE (2mg/0.035mg).
Maltese: Iż-żieda fir-riskju għal avvenimenti trombotiċi / tromboemboliċi (li jistgħu jkunu fatali f'1-2% tal-każijiet) hija elenkata flIskeda tad-dejta ewlenija tal-kumpanija (CCDS) għal CPA/EE (2mg/0.
English: None of the studies presents information on the fatality rate of VTE among CPA/EE users, except for the Seaman 2003 study stating that none of the 179 VTE events, including the 23 events among CPA/EE (2mg/0.035mg) exposed, was fatal.
Maltese: L-ebda wieħed mill-istudji ma jippreżenta informazzjoni dwar ir-rata ta' fatalità ta' VTE fost utenti ta' CPA/EE, ħlief fl-istudju Seaman 2003 li jiddikjara li l-ebda wieħed mill-179 avveniment ta' VTE, inkluż it-23 avveniment esposti fost CPA/EE (2mg/0.
English: ANSM considered the risk of venous and arterial thromboembolism (VTE and ATE) to outweigh the benefits in treating acne.
Maltese: L-ANSM ikkunsidrat li r-riskju ta' tromboemboliżmu fil-vini u fl-arterji (VTE u ATE) jegħleb ilbenefiċċji fil-kura tal-akne.
English: A recent published study comparing CPA/EE (2mg/0.035mg) and drospirenone/EE, and desogestrel/EE showed that after 6 months these medicinal products were equally efficacious but after 12 months CPA/EE (2mg/0.035mg) showed the strongest anti-androgenic effect, followed by drospirenone/EE, and desogestrel/EE as the weakest.
Maltese: 035mg) u drospirenone/EE, u desogestrel/EE wera li wara 6 xhur dawn il-prodotti mediċinali kienu ugwalment effikaċi imma wara sena CPA/EE (2mg/0.
English: However, based on the best evidence available, the authors concluded that the treatment containing cyproterone acetate improved acne better than a levonorgestrel-containing treatment; that treatment with cyproterone acetate showed better acne outcomes than one with desogestrel, but the studies produced conflicting results; and finally that drospirenone-containing treatment appeared to be more effective than norgestimate or nomegestrol acetate-containing treatment but less effective than treatment with cyproterone acetate.
Maltese: Madankollu, abbażi tal-aqwa evidenza disponibbli, l-awturi kkonkludew li kura li fiha cyproterone acetate tejbet l-akne aħjar minn kura li fiha levonorgestrel; li l-kura b'cyproterone acetate wriet riżultati aħjar għall-akne minn dik b'desogestrel, imma l-istudji pproduċew riżultati konfliġġenti; u fl-aħħar nett li kura li fiha drospirenone dehret li kienet aktar effettiva minn kura li fiha norgestimate jew nomegestrol acetate imma anqas effettiva minn kura b'cyproterone acetate.
English: • The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience on the safety of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products, as well as stakeholders' submissions in particular with regards to the risk of thromboembolic events.
Maltese: • Il-PRAC irreveda d-dejta kollha disponibbli minn studji kliniċi, studji farmakoepidemjoloġiċi, milletteratura pubblika, l-esperjenza ta' wara t-tqegħid fis-suq dwar is-sigurtà ta' prodotti mediċinali li fihom cyproterone acetate/ethinylestradiol (2mg/0.
English: INAS-OC is a prospective, non-interventional, active surveillance study designed to assess the risk of short- and long-term use of YAZ (3 mg drospirenone/0.020mg ethinylestradiol), Yasmin (3 mg drospirenone/0.030mg ethinylestradiol) and of oral contraceptives and CPA/EE (2mg/0.035mg), conducted in 6 European countries and United States.
Maltese: INAS-OC huwa studju prospettiv, mhux ta' intervent, ta' sorveljanza attiva ddisinjat biex jevalwa rriskju tal-użu fuq perjodu qasir u twil ta' YAZ (3 mg drospirenone/0.020mg ethinylestradiol), Yasmin (3 mg drospirenone/0.
English: In conclusion, the thromboembolic events are known adverse drug reactions associated with the use of estrogen-progestogen containing preparations.
Maltese: Bħala konklużjoni, l-avvenimenti tromboemboliċi huma reazzjonijiet avversi magħrufa tal-mediċina assoċjati mal-użu ta' preparazzjonijiet li fihom l-estroġenu-proġestoġen.
English: In study AI58, one patient on CPA/EE developed VTE.
Maltese: Fl-istudju AI58, pazjent wieħed fuq CPA/EE żviluppa
English: This translates into reporting rate of 0.07 ADR reports per 100,000 women-years with CPA/EE (2mg/0.035mg).
Maltese: Dan isarraf f'rata ta' rapportar ta' 0.07 rapporti ta' ADR għal kull 100,000 mara-snin b'CPA/EE (2mg/0.
English: In comparison with other medical treatment options, no clinical differences in hirsutism were detected when CPA/EE (2mg/0.035mg) was compared to other medicinal products (spironolactone, finasteride, GnRH analogues, ketoconazole).
Maltese: 035mg) kien imqabbel ma' prodotti mediċinali oħra (spironolactone, finasteride, analogi ta' GnRH, ketoconazole).