natgillin/translations-raw huggingface dataset:
In humans, deferiprone is eliminated mainly via the kidneys; 75% to 90% of the ingested dose is reported as being recovered in the urine in the first 24 hours, in the form of free deferiprone, the glucuronide metabolite and the iron-deferiprone complex. 
zaužitega odmerka pojavi v urinu v prvih 24 urah, in sicer v obliki prostega deferiprona,
Hydrochloric acid, concentrated, for pH adjustment Artificial cherry flavour 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi prečiščena voda hidroksietilceluloza glicerol (E422) klorovodikova kislina, koncentrirana, za uravnavanje pH
Clear, reddish orange-coloured liquid. 
Prozorna, rdečeoranžna tekočina.
See table below for recommended doses for body weights at 10 kg increments. 
Priporočljive odmerke za telesne mase na vsakih
(eGFR): healthy volunteers (eGFR ≥ 90 mL/min/1.73m2), mild renal impairment (eGFR 
≥ 90 ml/min/1,73 m2), blaga levična okvara (eGFR 60-89 ml/min/1,73 m2), zmerna ledvična okvara
Not known (frequency cannot be estimated from the available data): - allergic reactions including skin rash or hives 
- povečanje apetita Neznana pogostost (pogostosti ni mogoče določiti iz razpoložljivih podatkov):
Investigations 
ZDRAVILA
Immediately interrupt deferiprone if the patient experience infection. 
Če se pri bolniku pojavi okužba, takoj prekinite zdravljenje z deferipronom.
These events occur rarely. 
Omenjeni dogodki so redki.
Information received after cut-off date 30 January 2013 
Podatki, prejeti po presečnem datumu 30. januar 2013
Several databases were consulted. 
Pregledanih je bilo več podatkovnih zbirk.
In 30% of cases the indication for prescription was unknown. 
V 30 % primerov indikacija za predpis zdravila ni bila znana.
The wording agreed by the PhVWP is entirely implemented only in 11 Member States. 
Besedilo, ki ga je odobrila delovna skupina, se v celoti uporablja samo v 11 državah članicah.
Overall, VTE could be fatal in 1-2% of the cases. 
VTE je lahko smrtna v 1-2 % primerov.
This was also one of the main points that the expert group meeting recommended to PRAC. 
To je bil tudi eden glavnih predlogov, ki jih je odboru PRAC posredovala strokovna skupina.
CMDh position 
Stališče CMDh
Following the media attention after the initiation of the referral procedure a number of reports were submitted reciprocally. 
Po medijsko odmevnem začetku napotitvenega postopka so bila recipročno predložena številna poročila.
In that study there was a significant subjective improvement in hirsutism, however no objective evaluation was performed. 
V tej študiji so opazili znatno subjektivno izboljšanje hirzutizma, vendar pa niso izvedli objektivnega ocenjevanja.
In some Member States is also authorised for alopecia androgenetica. 
V nekaterih državah članicah so odobrena tudi za androgeno alopecijo.
The reporting frequency is less than the incidence of VTE as reported in epidemiological studies. 
Pogostost poročanja je manjša kot pojavnost VTE, zabeležena v epidemioloških študijah.
There were no cases reporting ATE with a fatal outcome. 
V nobenem primeru niso poročali o ATE s smrtnim izidom.
After an initially higher risk (the first year), the risk drops to a constant lower level. 
Visoko tveganje na začetku (med prvim letom) se kasneje zmanjša na konstantno nižjo raven.
Total number of cycles number of pregnancies Pearl Index two-sided 95% confidence interval 
Skupaj število ciklusov število nosečnosti Pearlov indeks dvostranski 95-odstotni interval zaupanja
Contraceptive effect 
Kontracepcijski učinek
Of these 175 cases, 15 reported fatal outcome (4 medically confirmed and 11 non-medically confirmed consumer reports). 
V 15 od teh 175 primerov so poročali o smrtnem izidu (4 zdravniško potrjena in 11 zdravniško nepotrjenih poročil potrošnikov).
It is evident that in the current approved indications in EU, off-label use is observed. 
Očitno je, da je pri trenutno odobrenih indikacijah v EU prisotna uporaba, ki ni skladna z indikacijami.
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. 
To ne pomeni večje pojavnosti pri tej starostni skupini, ampak zgolj višjo stopnjo poročanja, saj izpostavljenost bolnic ni bila podana v starostnih kategorijah.
Misdiagnosis is a realistic possibility since TE has diffuse symptoms and is a rare event in population of healthy young women. 
Napačna diagnoza je stvarna možnost, saj se TED kaže z razpršenimi simptomi in se redko pojavi pri populaciji zdravih mladih žensk.
One of these 968 cases was reported from clinical trial ME94162 / AI58. 
O enem od teh 968 primerov so poročali iz kliničnega preskušanja ME94162/AI58.
• The PRAC also concluded that there was need for further risk minimisation measures such as information to patients and healthcare professionals. 
• PRAC je zaključil tudi, da so potrebni dodatni ukrepi za zmanjšanje tveganja, na primer informacije za bolnice in zdravstvene delavce.
Similar to acne treatment, percentages of improvement vary per study, and depend on the methods applied for evaluation of effects. 
Podobno kot pri zdravljenju aken so bili odstotki izboljšanja v posameznih študijah različni, saj so bili odvisni od uporabljenih metod za ocenjevanje učinkov.
*calculated as the total number of cycles, n=21,196, minus the number of cycles, n=450, in which medication was missed. 
*izračunana kot skupno število ciklusov, n = 21 196, zmanjšano za število ciklusov, n = 450, pri katerih je bilo zdravilo izpuščeno.
When diagnosis is not made and no treatment is started, or when the thrombosis does not give any clear symptoms, the clot can move upwards to the lung (pulmonary embolism) or the brain (cerebral embolism). 
Če se ne postavi diagnoze in začne zdravljenja ali če se tromboza ne kaže z jasnimi simptomi, lahko strdek potuje navzgor v pljuča (pljučna embolija) ali možgane (možganska embolija).
Post-marketing safety surveillance studies 
Študije spremljanja varnosti v obdobju trženja
The IMS prescription data have limited value because they do not include a category of “contraception in the absence of acne”. 
Podatki o predpisovanju zdravila IMS so le delno uporabni, saj ne vključujejo kategorije „kontracepcija ob odsotnosti aken“.
Conclusions on safety 
Zaključki glede varnosti
Cyproterone has the strongest anti-androgen activity. 
Ciproteron ima najmočnejši antiandrogeni učinek.
This missing information would be essential to assess the true motives of the prescribers in choosing one product over another. 
Te manjkajoče informacije bi bile ključne za ugotovitev pravih razlogov, zaradi katerih zdravniki izberejo eno zdravilo namesto drugega.
Guideline on clinical investigation of steroid contraceptives in women. 
Smernice za klinične raziskave steroidnih kontracepcijskih sredstev pri ženskah.
Conclusions on efficacy 
Zaključki glede učinkovitosti
Arterial thromboembolic events may be lifethreatening or may have a fatal outcome. 
Arterijski trombembolični dogodki so lahko življenjsko nevarni oziroma se lahko končajo s smrtnim izidom.
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. 
Študijo INAS-SCORE so začeli izvajati po začetku trženja zdravila Qlaira (dienogest/estradiol valerat, shema z zmanjševanjem odmerka) v Evropi (septembra 2009) in ZDA (oktobra 2010), gre pa za prospektivno neintervencijsko študijo varnosti po odobritvi dovoljenja za promet, ki so jo izvedli v Avstriji, Franciji, Nemčiji, Italiji, na Poljskem, Švedskem, v Združenem kraljestvu in Združenih državah.
The PRAC also agreed on the need of a risk management plan to be submitted as these medicinal products do not have an EU risk management plan in place. 
PRAC se je dogovoril tudi, da je treba predložiti načrt za obvladovanje tveganja, saj za tovrstna zdravila ni na voljo načrta EU za obvladovanje tveganja.
They include benzoylperoxide, retinoids, antibiotics, salicylic acid, and azelaic acid. 
Med njimi so benzoilperoksid, retinoidi, antibiotiki, salicilna kislina in azelainska kislina.
This is expected in view of the differences in anti-androgenic properties of cyproterone, drospirenone and desogestrel. 
To je bilo mogoče pričakovati zaradi razlik v antiandrogenih lastnostih ciproterona, drospirenona in dezogestrela.
Acne without androgenic features 
Akne brez androgenih lastnosti
Alopecia androgenetica 
Androgena alopecija
Cohort studies 
Kohortne študije
Scientific conclusions and grounds for variation to the terms of the marketing authorisations subject to conditions 
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravili pod določenimi pogoji
Due to the observational nature of these two studies comparing newly marketed combined oral contraceptives with a comparator group there was no restriction of the comparator group to specific oral hormonal combinations. 
Zaradi opazovalne narave teh dveh študij, v katerih primerjajo kombinirana peroralna kontracepcijska sredstva, ki so bila na novo dana na trg, s primerjalno skupino, v primerjalni skupini ni bilo omejitev glede specifičnih peroralnih hormonskih kombinacij.
In both studies all enrolled women receiving a prescription for an oral contraceptive were questioned about the reason for the prescription at baseline (after having received the prescription). 
V obeh študijah so vse vključene ženske, ki so prejele recept za peroralna kontracepcijska sredstva, povprašali o razlogih za predpis recepta ob izhodišču (potem ko so prejele recept).
No study collected such data and therefore this design limitation must be kept in mind when interpreting the data. 
Ker v nobeni od študij niso zbrali tovrstnih podatkov, je treba te pomanjkljivosti pri zasnovi upoštevati pri razlaganju rezultatov.
Patients were between 13 and 63 years old (mean 27 years, median 25 years) at the time of the event. 
Bolnice so bile v času dogodka stare od 13 do 63 let (povprečje 27 let, mediana 25 let).
In addition, there are other known alternative pharmacological treatments for severe androgenic symptoms (especially hirsutism). 
Prav tako obstajajo druga alternativna farmakološka zdravljenja za resne simptome androgenizacije (zlasti hirzutizem).
The only difference in clinical outcome was a significantly improved Ferriman Gallwey (FG) score at 12 months when cyproterone acetate was compared with flutamide. 
Edina razlika v kliničnem izidu je bilo znatno izboljšanje rezultata na FerrimanGallweyevi (FG) lestvici po 12 mesecih, ko so ciproteron acetat primerjali s flutamidom.
No age was reported for 91 (9.4%) patients. 
O starosti niso poročali pri 91 (9,4 %) bolnicah.
The time to relief of symptoms is at least three months and the effects are more pronounced with longer treatment duration. 
Za izboljšanje simptomov so potrebni najmanj trije meseci, učinki pa so večji, če zdravljenje traja dlje časa.
Furthermore PRAC agreed on other changes to the product information, additional pharmacovigilance activities and risk minimisation measures to address the risk of thromboembolic events. 
PRAC se je dogovoril tudi o drugih spremembah informacij o zdravilu, dodatnih dejavnostih farmakovigilance in ukrepih za zmanjšanje tveganja, da bi zmanjšali tveganje za trombembolične dogodke.
The combined therapy with CPA/EE and CPA 10 mg has a different safety profile as reflected in the labelling of CPA 10 mg. 
Kombinirano zdravljenje s CPA/EE in CPA 10 mg ima drugačen varnostni profil, kot je označeno pri CPA 10 mg.
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. 
88 (9,1 %) poročil o neželenih učinkih je bilo povezanih z bolnicami, mlajšimi od 18 let, 639 (66 %) bolnic je bilo starih od 18 do 35 let, 150 (15,5 %) poročil pa je bilo povezanih z bolnicami, starejšimi od 35 let.
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. 
Podatki o učinkovitosti CPA/EE pri androgeni alopeciji so z izjemo podatkov o mehanizmu delovanja skopi, saj je bila izvedena le ena majhna študija (DeCecco L et al., 1987), v kateri so opazili omejene koristne učinke.
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. 
ITM za te bolnice je bil med 15 in 54 (povprečje 24, mediana 23), medtem ko so ITM nad 30 kg/m2 zabeležili v 33 (3,4 %) primerih.
Regarding acne without androgenic features, one study compared CPA/EE with systemic antibiotic tetracycline and showed similar efficacy (Greenwood R, et al., 1985). 
V zvezi z aknami brez androgenih lastnosti so v eni študiji CPA/EE primerjali s sistemskim antibiotikom tetraciklinom in opazili podobno učinkovitost (Greenwood, R. et al., 1985).
In view of the risks of VTE and ATE the PRAC considered there was a need to ensure that all relevant information for the safe use of these products should be applied across authorised products and therefore agreed on the wording for all relevant sections dealing with the risk of VTE/ATE. 
Glede tveganja za VTE in ATE je PRAC menil, da je treba zagotoviti, da se pri vseh odobrenih zdravilih navedejo vse pomembne informacije o varni uporabi teh zdravil, zato je določil besedila za vsa poglavja, ki obravnavajo tveganje za VTE/ATE.
The updated total number of cases through 6 Mar 2013 amounts to 1143 reports with TE. 
Zadnje skupno število primerov TED, o katerih so poročali do 6. marca 2013, znaša 1 143.
Thromboembolic events are adverse events which usually occur in a vein of the leg (deep vein thrombosis). 
Trombembolični dogodki so neželeni dogodki, ki običajno prizadenejo veno noge (globoka venska tromboza).
In addition the PRAC stressed that these products should not be given concomitantly with other hormonal contraceptives. 
Poleg tega je PRAC poudaril, da se ta zdravila ne smejo uporabljati sočasno z drugimi hormonskimi kontracepcijskimi sredstvi.
Weight and height were reported for 258 (26.7%) of 968 patients. 
O telesni masi in višini so poročali pri 258 (26,7 %) od 968 bolnic.
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). 
Znani dejavniki tveganja za VTE vključujejo VTE v anamnezi, nosečnost, poškodbo, kirurški poseg, imobilizacijo (npr. po kirurškem posegu ali daljših poletih), debelost in kajenje (tj. vse primere protrombotičnega stanja).
In the Cochrane review on treatment of hirsutism nine clinical studies qualified for inclusion. 
V pregled, ki ga je skupina Cochrane izvedla v zvezi z zdravljenjem hirzutizma, je bilo vključenih devet kliničnih študij.
In addition, usage patterns of CPA/EE and COCs for oral contraception may differ significantly. 
Poleg tega se vzorci uporabe CPA/EE in kombiniranih peroralnih kontracepcijskih sredstev za peroralno kontracepcijo lahko zelo razlikujejo.
For the treatment of hirsutism alone (mostly in PCOS patients), 13 studies demonstrated efficacy versus other treatments. 
Učinkovitost pri zdravljenju samo hirzutizma (večinoma pri bolnicah s PCOS) v primerjavi z drugimi zdravili so dokazali v 13 študijah.
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. 
Imetnik dovoljenja za promet je predložil pregled 6 kohortnih študij (pri čemer je za 2 priložil tudi analize primerov s kontrolami) in 7 študij primerov s kontrolami, v katerih so ocenjevali tveganje za VTE, povezano s CPA/EE, in eno kohortno študijo, v kateri so ocenjevali tveganje za ATE, povezano s CPA/EE.
The calculations met the precision requirements of the Guideline on clinical investigation of steroid contraceptives in women2. 
Izračuni so bili skladni z zahtevami po natančnosti, opredeljenimi v Smernicah za klinične raziskave steroidnih kontracepcijskih sredstev pri ženskah2.
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. 
Promocijski podatki družbe Cegedim kažejo 32 % primerov uporabe samo za kontracepcijo, medtem ko longitudinalni podatki kažejo 3,4 % primerov uporabe samo za kontracepcijo; panelni podatki družbe Pharmalink za Nemčijo kažejo 53 % primerov uporabe za kontracepcijo, od tega so bile v 75 % primerov razlog za recept akne, v 25 % pa nekaj drugega.
No comparative safety data vs products that are registered for the treatment for acne/hirsutism/PCOS are presented. 
Podatki o varnosti v primerjavi z zdravili, ki so registrirana za zdravljenje aken/hirzutizma/PCOS, niso bili predloženi.
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. 
V kasnejših študijah (Lidegaard et al., 2003, Seaman et al., 2004) - v drugi so obravnavali vprašanje sočasnih dejavnikov - so ugotovili, da absolutno tveganje za VTE med ženskami, ki jemljejo CPA/EE, ni znatno večje kot pri ženskah, ki jemljejo kombinirana peroralna kontracepcijska sredstva.
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. 
Pri ženskah s kožnimi obolenji, povezanimi z občutljivostjo za androgene, so učinkovitost pri zmernih do hudih oblikah aken z ali brez seboreje in/ali hirzutizmu dokazali v več kot 30 sponzoriranih in nesponzoriranih preskušanjih, vključno s primerjalnimi preskušanji, nenadzorovanimi preskušanji in pilotnimi študijami.
Treatment of hirsutism 
Zdravljenje hirzutizma
Most reports were from patients between 18-35 years of age (66%). 
O dogodkih so največkrat poročale bolnice, stare od 18-35 let (66 %).
ANSM considered the risk of venous and arterial thromboembolism (VTE and ATE) to outweigh the benefits in treating acne. 
ANSM je presodila, da je tveganje za vensko in arterijsko trombembolijo (VTE in ATE) večje od koristi zdravil pri zdravljenju aken.
Post-marketing reporting 
Poročanje v obdobju trženja
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. 
V nobeni od 118 obravnavanih kliničnih študij, opisanih v znanstveni literaturi, med potekom študije niso poročali o venskih ali arterijskih trombemboličnih/srčno-žilnih dogodkih.
The MAH- of the originator product sponsored 10 phase-III clinical trials providing information on safety of these medicinal products. 
Imetnik dovoljenja za promet z originalnim zdravilom je finančno podprl izvedbo 10 kliničnih preskušanj III. faze za pridobitev podatkov o varnosti tovrstnih zdravil.
As recent data have demonstrated, restarting or switching COC use after interruption is associated with an excess risk. 
Kot so pokazali novejši podatki, sta ponoven začetek zdravljenja ali zamenjava kombiniranih peroralnih kontracepcijskih sredstev po prekinitvi jemanja povezana s povečanim tveganjem.
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. 
Zadnji pregled skupine Cochrane (Arowojolu, AO. et al., 2012), ki je ocenjevala učinkovitost kombiniranih peroralnih kontracepcijskih sredstev pri aknah, je pokazal, da so podatki glede razlik v primerjalni učinkovitosti kontracepcijskih sredstev preveč omejeni za dokončne zaključke.
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. 
Novejše študije, v katerih so ocenjevali tveganje za VTE pri uporabnicah kombiniranih peroralnih kontracepcijskih sredstev in CPA/EE (vključno z Lidegaard, 2009 in Hylckama, 2009), so imele velike metodološke pomanjkljivosti (manjkajoči podatki za sočasne dejavnike), zaradi katerih je vprašljiva zanesljivost zaključkov.
The primary outcomes of interest are cardiovascular events, in particular the incidence of VTE and ATE, during oral contraception use. 
Primarni opazovani izidi so bili srčno-žilni dogodki, zlasti pojavnost VTE in ATE med uporabo peroralne kontracepcije.
Two large, ongoing post-marketing surveillance studies (INAS-OC and INAS-SCORE) yield incidental data on the use of CPA/EE. 
Dve obsežni študiji, ki potekata v obdobju trženja (INAS-OC in INAS-SCORE), zbirata naključne podatke o uporabi CPA/EE.
As part of the risk minimisation measures the PRAC adopted an updated indication taking all the data into account, and making clear the conditions for which these products are indicated. 
V okviru ukrepov za zmanjšanje tveganja je PRAC sprejel posodobljeno indikacijo v skladu z vsemi podatki in jasno opredelil zdravstvena stanja, za katera so tovrstna zdravila indicirana.
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. 
Poleg tega je bila sočasna uporaba drugega hormonskega kontracepcijskega sredstva zabeležena kot dodaten domnevni vzrok v 21 (2,2 %) primerih TED, o katerih so poročali; 20 bolnic je sočasno uporabljalo različna kombinirana peroralna kontracepcijska sredstva, v enem primeru pa so poročali o uporabi intrauterinega vložka (IUV) (intrauterinega sistema, ki sprošča levonorgestrel).
It has to be noted that Polycystic ovarian syndrome (PCOS) mentioned by HCPs as an indication reflects the use of CPA/EE for the treatment of androgen related symptoms of PCOS such as acne or hirsutism. 
Omeniti je treba, da sindrom policističnih jajčnikov (PCOS), ki ga zdravstveni delavci navajajo kot indikacijo, odraža uporabo CPA/EE za zdravljenje simptomov PCOS, povezanih z androgeni, na primer aken ali hirzutizma.
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. 
Vendar pa so na podlagi najzanesljivejših razpoložljivih podatkov avtorji zaključili, da je zdravljenje s ciproteron acetatom v večji meri izboljšalo akne kot zdravljenje z levonorgestrelom; da so bili izidi zdravljenja aken s ciproteron acetatom boljši od izidov zdravljenja z dezogestrelom, vendar so bili rezultati študij nasprotujoči; ter tudi da je bilo zdravljenje z drospirenonom učinkovitejše od zdravljenja z norgestimatom ali nomegestrol acetatom, vendar manj učinkovito od zdravljenja s ciproteron acetatom.
Grounds for PRAC recommendation Whereas 
Podlaga za priporočilo PRAC
Studies show considerable variability in their relative risk compared to non-use or other COCs and in their absolute risk for VTE. 
Študije so pokazale znatne razlike v relativnem tveganju v primerjavi z neuporabo ali uporabo drugih kombiniranih peroralnih kontracepcijskih sredstev ter v absolutnem tveganju za VTE.