FrancophonIA/ELRC3.0 huggingface dataset:
English: What Ferriprox looks like and contents of the pack Ferriprox 1000 mg tablets are white to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “1000” on one side, plain on the other.
Croatian: Tablete Ferriproxa od 1000 mg su bijele do bjelkaste filmom obložene tablete u obliku kapsula, s otisnutom oznakom „APO“ s jedne strane razdjelne crte i „1000“ s druge na jednoj strani tablete, te bez oznaka s druge strane.
English: Tel: + 421-2-59 30 00 60
Croatian: Chiesi Slovakia s.r.o. Tel: + 421-2-59 30 00 60
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 500 mg film-coated tablets Ferriprox 1000 mg film-coated tablets
Croatian: Ferriprox 500 mg filmom obložene tablete Ferriprox 1000 mg filmom obložene tablete
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Croatian: Proizvođač odgovoran za puštanje serije lijeka u promet:
English: Deferiprone must not be used by breast-feeding mothers.
Croatian: Žene koje doje ne smiju uzimati deferipron.
English: Ferriprox 1000 mg film-coated tablets
Croatian: Ferriprox 1000 mg filmom obložene tablete
English: White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “1000” on one side, plain on the other.
Croatian: Bijele do bjelkaste filmom obložene tablete oblika kapsule, s otisnutom oznakom „APO“ s jedne strane razdjelne crte i „1000“ s druge strane na jednoj strani tablete, te bez oznaka s druge strane.
English: Ferriprox 500 mg film-coated tablets
Croatian: Ferriprox 500 mg filmom obložene tablete
English: White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “500” on one side, plain on the other.
Croatian: Bijele do bjelkaste filmom obložene tablete oblika kapsule, s otisnutom oznakom „APO“ s jedne strane razdjelne crte i „500“ s druge strane na jednoj strani tablete, te bez oznaka s druge strane.
English: Hydrochloric acid, concentrated, for pH adjustment Artificial cherry flavour
Croatian: 6.1 Popis pomoćnih tvari voda, pročišćena hidroksietilceluloza glicerol (E422) kloridna kiselina, koncentrirana, za prilagodbu pH
English: Nausea
Croatian: Plodnost
English: See tables below for recommended doses for body weights at 10 kg increments.
Croatian: Preporučene doze prema tjelesnoj težini, s porastom za po 10 kg, vidjeti u tablicama u nastavku.
English: Titanium dioxide
Croatian: Ovojnica hipromeloza makrogol titanijev dioksid
English: Ferriprox 1000 mg film-coated tablets deferiprone
Croatian: Ferriprox 1000 mg filmom obložene tablete deferipron
English: Discoloration of urine
Croatian: Promjena boje mokraće
English: Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide
Croatian: Ferriprox 500 mg filmom obložene tablete Jezgra tablete celuloza, mikrokristalična magnezijev stearat silicijev dioksid, koloidni
English: Ferriprox 500 mg film-coated tablets deferiprone
Croatian: Ferriprox 500 mg filmom obložene tablete deferipron
English: − if you are currently taking medicines known to cause neutropenia or agranulocytosis (see “Other medicines and Ferriprox”).
Croatian: (pogledajte dio „Drugi lijekovi i Ferriprox“).
English: Тел.
Croatian: Ltd.
English: Concurrent use of iron chelators is not recommended in patients whose serum ferritin falls below 500 µg/l due to the risk of excessive iron removal.
Croatian: Istodobna primjena kelatora željeza se ne preporučuje kod bolesnika čiji serumski feritin padne ispod
English: Tablet core
Croatian: Tablica doziranja
English: Neutropenia Agranulocytosis
Croatian: Prijavljivanje nuspojava
English: Dose table for Ferriprox 500 mg film-coated tablets
Croatian: Tablica doziranja za Ferriprox 500 mg filmom obložene tablete Tjelesna težina
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/108/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/108/004
English: Hydroxypropyl cellulose
Croatian: umjetna aroma trešnje ulje paprene metvice
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/108/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/108/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/108/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/108/002
English: − reddish/brown discoloration of urine
Croatian: - mučnina - povraćanje - crvenkasto/smeđa boja mokraće
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 500 mg film-coated tablets deferiprone
Croatian: Uputa o lijeku: Informacije za korisnika Ferriprox 500 mg filmom obložene tablete deferipron
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 1000 mg film-coated tablets deferiprone
Croatian: Uputa o lijeku: Informacije za korisnika Ferriprox 1000 mg filmom obložene tablete deferipron
English: Summary of the safety profile
Croatian: 4.8 Nuspojave Sažetak sigurnosnog profila lijeka
English: Several databases were consulted.
Croatian: Konzultirano je nekoliko baza podataka.
English: These events occur rarely.
Croatian: Ti su događaji rijetki.
English: The wording agreed by the PhVWP is entirely implemented only in 11 Member States.
Croatian: Tekst koji je dogovorila skupina PhVWP u potpunosti je prihvaćen samo u 11 članica država.
English: After an initially higher risk (the first year), the risk drops to a constant lower level.
Croatian: Nakon početnog višeg rizika (prva godina), rizik pada na konstantnu nižu razinu.
English: This was also one of the main points that the expert group meeting recommended to PRAC.
Croatian: To je također bila jedna od glavnih točaka koju je na sastanku stručna skupina preporučila PRAC-u.
English: The product was authorised firstly in Germany in 1985 and followed the rest of the EU countries.
Croatian: Lijek je dobio odobrenje najprije u Njemačkoj 1985. godine, a zatim su slijedile ostale zemlje Europske unije (EU).
English: In 30% of cases the indication for prescription was unknown.
Croatian: U 30% slučajeva indikacija za propisivanje nije bila poznata.
English: Information received after cut-off date 30 January 2013
Croatian: Podaci primljeni poslije 30. siječnja 2013.
English: In that study there was a significant subjective improvement in hirsutism, however no objective evaluation was performed.
Croatian: U tom je ispitivanju bilo značajnog subjektivnog poboljšanja hirzutizma, međutim, nije provedena objektivna evaluacija.
English: Risk minimisation measures
Croatian: Mjere minimizacije rizika
English: No study collected such data and therefore this design limitation must be kept in mind when interpreting the data.
Croatian: Nijedno ispitivanje nije prikupljalo takve podatke pa je stoga potrebno voditi računa o tom ograničenju plana ispitivanja kada se interpretiraju podaci.
English: CMDh position
Croatian: Mišljenje CMDh
English: The IMS prescription data have limited value because they do not include a category of “contraception in the absence of acne”.
Croatian: IMS podaci o propisivanju imaju ograničenu vrijednost jer ne uključuju kategoriju "kontracepcija u odsutnosti akni".
English: Contraceptive effect
Croatian: Kontracepcijski učinak
English: It is evident that in the current approved indications in EU, off-label use is observed.
Croatian: Očito je da je u trenutačno odobrenim indikacijama u EU opažena primjena izvan odobrenih indikacija.
English: Following the media attention after the initiation of the referral procedure a number of reports were submitted reciprocally.
Croatian: Poslije medijske pažnje a nakon početka postupka revizije, recipročno je podnesen određeni broj izvješća.
English: The time to relief of symptoms is at least three months and the effects are more pronounced with longer treatment duration.
Croatian: Vrijeme do ublažavanja simptoma iznosi najmanje tri mjeseca a učinci su izrazitiji uz dulje trajanje liječenja.
English: Of these 175 cases, 15 reported fatal outcome (4 medically confirmed and 11 non-medically confirmed consumer reports).
Croatian: Od tih 175 slučajeva, u 15 je zabilježen smrtni ishod (4 medicinski potvrđena i 11 koji nisu bili medicinski potvrđeni).
English: • The PRAC also concluded that there was need for further risk minimisation measures such as information to patients and healthcare professionals.
Croatian: • PRAC također zaključuje da postoji potreba za daljnjim mjerama minimizacije rizika kao što su informacije za bolesnike i zdravstvene djelatnike.
English: One of these 968 cases was reported from clinical trial ME94162 / AI58.
Croatian: Jedan od tih 968 slučajeva bio je iz kliničkog ispitivanja ME94162 / AI58.
English: *calculated as the total number of cycles, n=21,196, minus the number of cycles, n=450, in which medication was missed.
Croatian: *izračunato kao ukupni broj ciklusa, n=21,196, manje broj ciklusa n=450 u kojima je uzimanje lijeka propušteno.
English: Conclusions on safety
Croatian: Zaključci o sigurnosti
English: Grounds for PRAC recommendation Whereas
Croatian: Razlozi za preporuke PRAC-a
English: Arterial thromboembolic events may be lifethreatening or may have a fatal outcome.
Croatian: Događaji arterijske tromboembolije mogu biti životno opasne ili mogu imati smrtni ishod.
English: They include benzoylperoxide, retinoids, antibiotics, salicylic acid, and azelaic acid.
Croatian: One uključuju benzoilperoksid, retinoide, antibiotike, salicilnu kiselinu i azelaičnu kiselinu.
English: In the Cochrane review on treatment of hirsutism nine clinical studies qualified for inclusion.
Croatian: U Cochraneovom pregledu liječenja hirzutizma devet kliničkih ispitivanja kvalificiralo se za uključivanje.
English: 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.
Croatian: PRAC se također složio u vezi s potrebom podnošenja plana upravljanja rizikom jer ti lijekovi nemaju izrađen EU plan upravljanja rizikom.
English: 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).
Croatian: Kada se postavi dijagnoza, a ne započne liječenje ili kada nema nikakvih jasnih simptoma tromboze, ugrušak može krenuti prema plućima (plućna embolija) ili prema mozgu (cerebralna embolija).
English: In addition, there are other known alternative pharmacological treatments for severe androgenic symptoms (especially hirsutism).
Croatian: Osim toga, postoje druge alternativne farmakološke terapije za teške simptome androgenemije (osobito hirzutizma).
English: The MAH- of the originator product sponsored 10 phase-III clinical trials providing information on safety of these medicinal products.
Croatian: Nositelj odobrenja lijeka sponzorirao je 10 kliničkih ispitivanja faze III koja su omogućila informacije o sigurnosti tih lijekova.
English: b. the marketing authorisation holders should implement risk minimisation measures;
Croatian: b. nositelji odobrenja trebaju provesti mjere minimizacije rizika;
English: Weight and height were reported for 258 (26.7%) of 968 patients.
Croatian: Težina i visina zabilježene su za 258 (26,7%) od 968 bolesnica.
English: Conclusions on efficacy
Croatian: Zaključci o djelotvornosti
English: Most reports were from patients between 18-35 years of age (66%).
Croatian: Većina izvješća odnosila se na bolesnice u dobi od 18 do 35 godina (66%).
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.
Croatian: Podaci o djelotvornosti CPA/EE u alopeciji androgenetica, osim za mehanizam djelovanja, ograničen je na jedno malo ispitivanje (DeCecco L et al, 1987) u kojemu su uočeni neki ograničeni korisni učinci.
English: Misdiagnosis is a realistic possibility since TE has diffuse symptoms and is a rare event in population of healthy young women.
Croatian: Kriva dijagnoza je realna mogućnost jer tromboembolija ima difuzne simptome i rijedak je događaj u populaciji zdravih mladih žena.
English: This is expected in view of the differences in anti-androgenic properties of cyproterone, drospirenone and desogestrel.
Croatian: To se očekuje s obzirom na razlike u anti-androgenim svojstvima između ciproterona, drospirenona i dezogestrela.
English: Also there are certain hereditary thrombophilic defects that increase the risk.
Croatian: nasljedni trombofilski defekti koji povećavaju rizik.
English: No age was reported for 91 (9.4%) patients.
Croatian: Dob nije zabilježena za 91 bolesnicu (9,4%).
English: The reporting frequency is less than the incidence of VTE as reported in epidemiological studies.
Croatian: Učestalost prijava je manja od incidencije VTE prema izvještavanju epidemioloških ispitivanja.
English: Patients were between 13 and 63 years old (mean 27 years, median 25 years) at the time of the event.
Croatian: U vrijeme događaja bolesnice su bile u dobi između 13 i 63 godine (prosjek 27 godina, medijan 25 godina).
English: Seborrhoea
Croatian: Seboreja
English: In some Member States is also authorised for alopecia androgenetica.
Croatian: U nekim zemljama članicama odobren je također za mušku ćelavost (alopecia androgenetica).
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.
Croatian: To ne pokazuje veću incidenciju u toj dobnoj skupini nego samo veću stopu prijava za tu dobnu skupinu, jer izloženost bolesnica nije bila navedena ni za jednu dobnu kategoriju.
English: c. the marketing authorisations should be varied.
Croatian: c. odobrenja za stavljanje lijeka u promet treba varirati.
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.
Croatian: Ispitivanje INAS-SCORE započelo je nakon puštanja u promet kontracepcije Qlaira (dienogest/estradiol valerat, u režimu prema nižim dozama) u Europi (rujan 2009.) i Sjedinjenim Državama (listopad 2010.) i to prospektivno neintervencijsko sigurnosno ispitivanje provodilo se nakon odobrenja u Austriji, Francuskoj, Njemačkoj, Italiji, Poljskoj, Švedskoj, Velikoj Britaniji i Sjedinjenim Državama.
English: Guideline on clinical investigation of steroid contraceptives in women.
Croatian: 2 Smjernice kliničkog istraživanja steroidnih kontraceptiva u žena.
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.
Croatian: Kombinirana terapija s CPA/EE i CPA 10 mg ima drugačiji sigurnosni profil kako je naznačeno u obilježavanju za CPA 10 mg.
English: Overall, VTE could be fatal in 1-2% of the cases.
Croatian: Sveukupno, venska tromboembolija može imati smrtni ishod u 1-2% slučajeva.
English: Cyproterone acetate exerts its anti-androgenic effect by blocking androgen receptors.
Croatian: Ciproteron acetat iskazuje svoj antiandrogeni učinak blokiranjem receptora za androgene.
English: It also reduces androgen synthesis by a negative feedback effect on the hypothalamo-pituitary-ovarian axis.
Croatian: Također, smanjuje sintezu androgena povratnim negativnim učinkom na hipotalamus-pituitarno-ovarijsku os.
English: The calculations met the precision requirements of the Guideline on clinical investigation of steroid contraceptives in women2.
Croatian: Izračuni su ispunili zahtjeve za preciznost Smjernica kliničkog istraživanja steroidnih kontraceptiva u žena2.
English: To assess venous and arterial thromboembolic effects from clinical studies with CPA/EE, only clinical studies that documented adverse events are discussed here.
Croatian: Da bi se procijenili venski i arterijski tromboembolijski učinci u kliničkim ispitivanjima s CPA/EE ovdje se raspravlja samo o kliničkim ispitivanjima koja dokumentiraju štetne događaje.
English: Similar to acne treatment, percentages of improvement vary per study, and depend on the methods applied for evaluation of effects.
Croatian: Slično kao i za liječenje akni, postoci poboljšanja variraju prema ispitivanju i ovise o metodama primijenjenim za procjenu učinaka.
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.
Croatian: Promidžbeni podaci Cegedim Promotional pokazuju 32% upotrebe samo za kontracepciju, dok Longitudinal podaci pokazuju 3,4% upotrebe samo za kontracepciju; podaci Pharmalink Panel za Njemačku pokazuju upotrebu kontraceptiva od 53% od čega su za 75% razlog bile akne a 25% drugi razlozi.
English: For the treatment of hirsutism alone (mostly in PCOS patients), 13 studies demonstrated efficacy versus other treatments.
Croatian: Za liječenje samo hirzutizma (većinom u bolesnica sa sindromom policističnih jajnika), 13 ispitivanja pokazalo je djelotvornost naspram drugih terapija.
English: 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).
Croatian: U oba ispitivanja svim uključenim ženama koje su dobile recept za neki peroralni kontraceptiv na početku su postavljana pitanja o razlogu propisivanja (kada su već dobile recept).
English: Regarding acne without androgenic features, one study compared CPA/EE with systemic antibiotic tetracycline and showed similar efficacy (Greenwood R, et al., 1985).
Croatian: S obzirom na akne bez osobina djelovanja androgena, jedno je ispitivanje usporedilo CPA/EE i sistemski antibiotik tetraciklin i pokazala se slična djelotvornost (Greenwood R, et al., 1985).
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.
Croatian: Indeks tjelesne mase (BMI) tih bolesnica bio je između 15 i 54 (prosjek 24, medijan 23), dok je BMI veći od 30 kg/m2 dokumentiran za 33 (3,4%) bolesnice iz tih izvješća.
English: The PRAC also recommended further changes to the product information including that the need to continue treatment should be evaluated periodically knowing that the time to relief of symptoms is at least three months.
Croatian: PRAC je također preporučio daljnje promjene informacije o lijeku uključujući i to da potrebu za nastavkom liječenja valja periodički procjenjivati imajući u vidu da je vrijeme za ublažavanje simptoma najmanje tri mjeseca.
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.
Croatian: Nedavna Cochraneova analiza (Arowojolu, AO. et al., 2012.), koja je procijenila djelotvornost kombiniranih peroralnih kontraceptiva u liječenju akni, izvijestila je da su s obzirom na razlike u usporedbenoj djelotvornosti kontraceptiva, podaci bili previše ograničeni za bilo kakvu zaključnu usporedbu.
English: 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.
Croatian: Zbog opservacijske prirode tih dvaju ispitivanja u kojima su se peroralni kontraceptivi novi na tržištu uspoređivali s usporedbenom skupinom, nije bilo ograničenja usporedbene skupine za određene peroralne hormonske kombinacije.
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.
Croatian: Izvješća o štetnim reakcijama odnosila su se na 88 (9,1%) bolesnica mlađih od 18 godina, 639 (66%) bolesnice imale su između 18 i 35 godina, a 150 (15,5%) izvješća odnosilo se na bolesnice starije od 35 godina.
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.
Croatian: Međutim, na temelju najboljeg dostupnog dokaza, autori su zaključili da je terapija lijekovima koji sadrže ciproteron acetat poboljšala stanje s aknama bolje od terapije lijekovima koji sadrže levonorgestrel; liječenje siproteron acetatom pokazalo je bolje rezultate s obzirom na akne nego liječenje dezogestrelom, ali ispitivanja su dala konfliktne rezultate; konačno, terapije koje su sadržavale drospirenon činilo se djelotvornijim od terapija koje su sadržavale norgestimat ili nomegestrol acetat ali manje djelotvorne nego lijekovi s ciproteron acetatom.
English: Total number of cycles number of pregnancies Pearl Index two-sided 95% confidence interval
Croatian: Pearlov indeks dvostrani 95% interval pouzdanosti
English: This missing information would be essential to assess the true motives of the prescribers in choosing one product over another.
Croatian: Te informacije koje nedostaju bitne su za procjenu stvarnih motiva liječnika koji propisuju lijek za njihov izbor jednog ili drugog lijeka.
English: Furthermore PRAC agreed on other changes to the product information, additional pharmacovigilance activities and risk minimisation measures to address the risk of thromboembolic events.
Croatian: Nadalje, PRAC prihvaća druge promjene informacije o lijeku, dodatne farmakovigilancijske aktivnosti i mjere minimizacije rizika koje se odnose na rizik za tromboembolijske događaje.
English: Furthermore, the data do not systematically provide information on the medical history of the patient (e.g. history of acne or hyperandrogenic symptoms) or clinical findings as doctors tend to fill out the minimum mandatory information for the IMS.
Croatian: Nadalje, podaci sustavno ne pružaju informacije o medicinskoj povijesti bolesnice (npr. anamnezu akni ili simptoma hiperandrogenemije) ili kliničke nalaze kada su liječnici skloni upisati najosnovnije obavezne podatke za IMS.
English: Cyproterone has the strongest anti-androgen activity.
Croatian: Ciproteron ima najjače djelovanje protiv androgena.
English: Thromboembolic events are adverse events which usually occur in a vein of the leg (deep vein thrombosis).
Croatian: Tromboembolijski događaji su štetni događaji koji se obično javljaju u veni noge (duboka venska tromboza).
English: 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.
Croatian: Kao dio mjera minimizacije rizika PRAC prihvaća ažuriranu indikaciju uzimajući u obzir sve podatke i pojašnjavanjem stanja za koja su ti lijekovi indicirani.
English: In addition the PRAC stressed that these products should not be given concomitantly with other hormonal contraceptives.
Croatian: Osim toga PRAC ističe da se ti lijekovi ne smiju davati istodobno s drugim hormonskim kontraceptivima.
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations subject to conditions
Croatian: Znanstveni zaključci i razlozi za promjenu uvjeta davanja odobrenja pod posebnim uvjetima
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.
Croatian: U nedavnom ispitivanju (Lidegaard, 2012.) usporedbene analize relativnog rizika od trombotskog moždanog udara i infarkta miokarda između različitih progestina uključujući levonorgestrel, i njihova ne-upotreba jednake su veličine i ne pokazuju razlike između različitih progestina.