FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical Complete Response (CCR) %
Croatian: Potpuni klinički odgovor (CCR) %
English: In-use: Any remaining tube should be discarded 90 days after first opening.
Croatian: U primjeni: Tubu s preostalim sadržajem treba baciti 90 dana nakon prvog otvaranja.
English: Only two serious adverse reactions were reported (sepsis and cellulitis in the same patient).
Croatian: Bile su prijavljene samo dvije ozbiljne nuspojave (sepsa i celulitis u istog bolesnika).
English: Do not use a double dose to make up for forgotten individual doses.
Croatian: Nemojte primijeniti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: The incidence of severe skin rash was independent of the duration of treatment (10% in both cases).
Croatian: Incidencija teškog kožnog osipa bila je neovisna o trajanju liječenja (10% u oba slučaja).
English: Therefore, there is a low potential for interactions with systemic medicinal products.
Croatian: Stoga postoji mala mogućnost interakcija sa sistemskim lijekovima.
English: Other medicines and Panretin
Croatian: Drugi lijekovi i Panretin
English: However, an increased rate of fused sternebrae was observed.
Croatian: Međutim, opažena je povećana stopa fuzije sternebra.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek ne smije se miješati s drugim lijekovima.
English: Date of first authorization: 11 October 2000 Date of latest renewal: 27 September 2010
Croatian: Datum posljednje obnove odobrenja: 27. rujan 2010
English: Sometimes it is necessary to interrupt treatment, your doctor will inform you about this.
Croatian: Ponekad je potrebno i prekinuti liječenje, o čemu će Vas obavijestiti liječnik.
English: Precautions to be taken before handling or administering the medicinal product Patients should wash their hands before and after applications; it is not necessary to wear gloves.
Croatian: Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Bolesnici moraju oprati ruke prije i nakon primjene; nije potrebno nositi rukavice.
English: No specific studies on fertility have been conducted in men or women.
Croatian: Nisu provedena posebna ispitivanja učinaka na plodnost u muškaraca i žena.
English: No case of overdose has been reported.
Croatian: Nije zabilježen niti jedan slučaj predoziranja.
English: What Panretin is and what it is used for
Croatian: Što je Panretin i za što se koristi
English: Occlusive dressings should be avoided.
Croatian: Okluzivne povoje treba izbjegavati.
English: DEFINING CLINICAL SIGNS
Croatian: DEFINIRAJUĆI KLINIČKI ZNAKOVI
English: How to apply Panretin: For cutaneous use (on the skin) only Apply Panretin twice a day to start with, once in the morning and once in the evening.
Croatian: Kako nanositi Panretin: Samo za kožnu primjenu (na kožu) Za početak, primjenjujte Panretin dva puta na dan, jedanput ujutro i jedanput navečer.
English: However there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.
Croatian: Međutim, određeni faktori (npr. oštećena kožna barijera, prekomjerna uporaba) mogu pridonijeti povećanoj sistemskoj izloženosti.
English: The frequency of adverse events are classified as very common (≥1/10), common (≥1/100 to <1/10), and uncommon (≥1/1,000 to <1/100).
Croatian: Nuspojave se po učestalosti klasificiraju kao vrlo često (≥1/10), često (≥1/100 i <1/10) i manje često (≥1/1000 i <1/100).
English: TREATMENT ADJUSTMENTS
Croatian: PRILAGODBE LIJEČENJA
English: In Study 2a (N = 99), the overall response rate increased to 56.1%.
Croatian: U Ispitivanju 2a (N = 99), stopa ukupnog odgovora povećala se na 56,1%.
English: DO NOT use Panretin if you are pregnant or thinking of becoming pregnant.
Croatian: NEMOJTE primjenjivati Panretin ako ste trudni ili planirate trudnoću.
English: Clear yellow gel.
Croatian: Bistri žuti gel.
English: Store in the original container in order to protect from light.
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: Treatment of any lesion that has fully resolved on clinical assessment should be discontinued.
Croatian: Liječenje svake lezije koja se prema kliničkoj procjeni potpuno povukla treba prekinuti.
English: If this seal has been punctured or is not visible when you first open the package, DO NOT USE and return the product to your pharmacy.
Croatian: Ako je taj pečat probušen ili nije vidljiv kad prvi put otvorite pakiranje, NEMOJTE KORISTITI lijek i vratite ga u ljekarnu.
English: Definite pink to red coloration
Croatian: Jasno ružičasta do crvena obojenost
English: Serum LDL was increased in both male and female groups at Day 29.
Croatian: Serumski LDL bio je povećan u skupinama mužjaka i ženki 29. dana.
English: For any information about this medicine please contact the local representative of the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet.
English: 4 = Very severe
Croatian: 4 = vrlo teški
English: In study 1, of 110 responding patients, 36 (33%) relapsed, while all but four still being on active treatment.
Croatian: U Ispitivanju 1, od 110 bolesnika s odgovorom na liječenje, 36 (33%) je imalo relaps, dok su svi osim njih četvero i dalje bili na aktivnom liječenju.
English: It is recommended that HIV-infected mothers do not breast-feed their children to exclude the risk of transmission of the virus.
Croatian: Majkama zaraženima HIV-om ne preporučuje se dojiti djecu kako bi se isključio rizik od prijenosa virusa.
English: Proper application will leave some gel visible on the surface of the lesion when you are finished.
Croatian: Kod ispravne primjene ostati će nešto vidljivog gela na površini lezije nakon što završite s nanošenjem.
English: A subset of these patients were followed during treatment of up to 64 lesions (range 4-64, median 11.5 lesions) for up to 44 weeks (range 2-44, median 15 weeks).
Croatian: Podskupina ovih bolesnika bila je praćena tijekom liječenja do 64 lezije (raspon 4-64, medijan 11,5 lezija) u trajanju do 44 tjedna (raspon 2-44, medijan 15 tjedana).
English: Stable Disease %
Croatian: Stabilna bolest %
English: Number of Responding
Croatian: Broj odgovora
English: The incidence of mild/moderate rash (all events regardless of causality) was less in patients treated for less than 16 weeks than in those treated for 16 weeks or more (mild, 33% v 63%; moderate, 29% v 43%).
Croatian: Incidencija blagog/umjerenog osipa (svi slučajevi bez obzira na uzrok) bila je manja u bolesnika liječenih kraće od 16 tjedana nego u onih liječenih 16 tjedana ili dulje (blagi, 33% nasuprot 63%; umjeren, 29% nasuprot 43%).
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: • UVJETI ILI OGRANIČENJA VEZANA UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: In the open label phase of Study 1 (N = 184), the overall response rate increased to 66.7%.
Croatian: U otvorenoj fazi Ispitivanja 1 (N = 184) stopa ukupnog odgovora povećala se na 66,7%.
English: Place a generous coating of gel over the whole surface of each lesion that you want to treat.
Croatian: Nanesite obilati sloj gela preko čitave površine svake lezije koju želite liječiti.
English: The projected time for lesions that were in partial response (PR) to later attain clinical complete response (CCR) was 168 days.
Croatian: Predviđeno vrijeme u kojem su lezije koje su postigle djelomični odgovor (PR) kasnije postigle potpuni klinički odgovor (CCR) iznosilo je 168 dana.
English: None
Croatian: Nijedan
English: If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.
Croatian: Ako se ovaj lijek primjenjuje tijekom trudnoće ili ako bolesnica zatrudni tijekom uzimanja ovog lijeka, liječenje se mora prekinuti.
English: Like all medicines, Panretin can have side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Panretin može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Opened tubes of Panretin gel must not be stored above 25C, and should be protected from exposure to strong light and heat (e.g., direct sunlight).
Croatian: Otvorene tube Panretin gela ne smiju se čuvati na temperaturi iznad 25 °C i trebaju se zaštititi od izlaganja jakoj svjetlosti i toplini (npr. izravnoj sunčevoj svjetlosti).
English: Package leaflet: Iinformation for the user
Croatian: Uputa o lijeku: Informacije za korisnika
English: After that, your doctor will decide how often you should apply the gel depending on the response of your KS and any side effects.
Croatian: Nakon toga će Vaš liječnik odlučiti koliko često trebate nanositi gel, ovisno o odgovoru Kaposijevog sarkoma i mogućim nuspojavama.
English: Keep away from naked flame.
Croatian: Čuvajte ga daleko od otvorenog plamena.
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: LO1XX22
Croatian: Farmakoterapijska skupina: ostali neoplastici, ATK oznaka: L01XX22
English: Once activated, these receptors function as ligand dependent transcription factors that regulate the expression of specific genes.
Croatian: Nakon aktivacije, ti receptori funkcioniraju kao transkripcijski čimbenici ovisni o ligandu koji reguliraju ekspresiju posebnih gena.
English: Carcinogenesis, mutagenesis, impairment of fertility
Croatian: Kancerogeneza, mutageneza, narušena plodnost
English: If your side effects become too uncomfortable, with intense redness and irritation, rash, swelling, or pain, you should ask your doctor for advice on adjusting the dosage of your treatment.
Croatian: Ako učinci postanu previše neugodni, uz jako crvenilo i nadraženost, osip, oticanje ili bol, morate potražiti savjet liječnika kako da prilagodite dozu liječenja.
English: If you use more Panretin than you should There has been no experience with overdose of Panretin.
Croatian: Ako primijenite više Panretina nego što ste trebali Nema iskustava s predoziranjem Panretinom.
English: - Do not apply the gel on or near sensitive parts of your body such as eyes, nostrils, mouth,
Croatian: - Nemojte nanositi gel na osjetljive dijelove tijela ili u njihovoj blizini, kao što su oči,
English: Wash your hands using soap and water and wipe the healthy skin touched by the gel.
Croatian: Operite ruke sapunom i vodim i obrišite zdravu kožu koja je bila u dodiru s gelom.
English: The opening of the Panretin tube is covered by a metal safety seal.
Croatian: Otvor tube Panretina prekriven je metalnim sigurnosnim pečatom.
English: Progressive Disease %
Croatian: Progresivna bolest %
English: However, alitretinoin is teratogenic so both men and women should take adequate precautions to avoid female partners becoming pregnant.
Croatian: Međutim, alitretinoin je teratogen, tako da i muškarci i žene trebaju primjenjivati odgovarajuće mjere opreza kako bi se izbjegla trudnoća u partnerica.
English: Overall Response %
Croatian: Ukupni odgovor %
English: - If you think that the effect of Panretin is too strong or too weak, talk to your doctor or pharmacist.
Croatian: - Ako mislite da je učinak Panretina prejak ili preslab, obratite se svom liječniku ili ljekarniku.
English: Adverse events include verbatim terms in parentheses.
Croatian: Nuspojave uključuju doslovne izraze u zagradama.
English: - Avoid showering, bathing, or swimming for at least three hours after any application.
Croatian: - Izbjegavajte tuširanje, kupanje i plivanje najmanje tri sata nakon svake primjene gela.
English: In one trial, 29% of the lesions that had reached a partial response (PR) but had not attained clinical complete response (CCR) within the first 12 weeks of treatment developed a CCR during continuing treatment beyond 12 weeks.
Croatian: U jednom ispitivanju, 29% lezija koje su pokazale djelomični odgovor (PR) ali nisu postigle potpuni klinički odgovor (CCR) unutar prvih 12 tjedana liječenja dostigle su CCR tijekom nastavka liječenja nakon 12. tjedna.
English: Study 2 was followed by an open label study (Study 2a), which included only patients electing to continue from Study 2.
Croatian: Za Ispitivanjem 2 slijedilo je otvoreno ispitivanje (Ispitivanje 2a), koje je uključilo samo bolesnike iz Ispitivanja 2 koji su odabrali nastaviti sudjelovanje.
English: Take special care with Panretin - Panretin is not approved for use in children and adolescents under 18 years of age.
Croatian: Budite posebno oprezni s Panretinom - Panretin nije odobren za primjenu u djece i adolescenata mlađih od 18 godina.
English: What Panretin contains - The active substance is alitretinoin.
Croatian: Što Panretin sadrži - Djelatna tvar je alitretinoin.
English: Study 1, 6 index lesions; Study 2, up to 8 index lesions Each index lesion assessed individually for response.
Croatian: Ispitivanje 1, 6 indeksnih lezija; Ispitivanje 2, do 8 indeksnih lezija Odgovor procijenjen za svaku indeksnu leziju pojedinačno.
English: - Avoid scratching the treated areas.
Croatian: - Nemojte grebati liječena područja.
English: This level is about 1/100 the mean concentration measured in male rats.
Croatian: Ova razina je oko 1/100 prosječne koncentracije izmjerene u mužjaka štakora.
English: Panretin may cause unwanted irritation or redness on healthy skin.
Croatian: Panretin može prouzročiti neželjenu nadraženost ili crvenilo zdrave kože.
English: What Panretin is and what it is used for What you need to know before you use Panretin How to use Panretin
Croatian: Što je Panretin i za što se koristi Što morate znati prije nego počnete primjenjivati Panretin Kako primjenjivati Panretin
English: Alitretinoin may cause harm to the foetus.
Croatian: Alitretinoin može naškoditi fetusu.
English: - lesions are not ulcerated or lymphoedematous - treatment of visceral KS is not required - lesions are not responding to systemic antiretroviral therapy - radiotherapy or chemotherapy are not appropriate
Croatian: - lezije nisu ulcerirane niti limfedematozne - nije potrebno liječenje visceralnog KS - lezije ne odgovaraju na sistemsku antiretrovirusnu terapiju - radioterapija ili kemoterapija nisu primjerene
English: The frequency of application should be adjusted for each lesion independently.
Croatian: Učestalost primjene potrebno je prilagoditi neovisno za svaku leziju.
English: There were no biologically relevant haematology differences or serum chemistry differences after the 14-day period.
Croatian: Nije bilo biološki važnih hematoloških razlika ili razlika u biokemijskim nalazima seruma nakon 14-dnevnog razdoblja.
English: • Hypersensitivity to retinoids in general, to the active substance alitretinoin or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na retionide općenito, djelatnu tvar alitretinoin ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: However, because of the potential for undesirable effects from Panretin gel in infants being breast-fed, mothers must discontinue breast-feeding prior to using the medicinal product and not initiate breast-feeding while using the medicinal product.
Croatian: Međutim, zbog mogućnih neželjenih učinaka Panretin gela u dojene dojenčadi, majke moraju prekinuti dojenje prije početka primjene ovog lijeka i ne smiju započeti dojiti dok primjenjuju ovaj lijek.
English: As for Grade 3 irritation.
Croatian: Kao za stupanj 3 nadraženosti.
English: The following side effects have been noted on the skin where Panretin has been applied:
Croatian: Sljedeće nuspojave opažene su na koži na koju se nanosi Panretin:
English: Table 5 Index/indicator lesion 1 responses within patients during the first 12 weeks on study in initial blinded phase Patients with given number of index/indicator lesion responses (CCR or PR) Study 1
Croatian: Tablica 5 Odgovori indeksnih/indikatorskih lezija 1 u bolesnika tijekom prvih 12 tjedna ispitivanja u početnoj slijepoj fazi Bolesnici s odgovorom zadanog broja indeksnih/indikatorskih lezija (CCR ili PR) Ispitivanje 1
English: Do not use Panretin: - if you are allergic to alitretinoin or to similar medicines containing retinoids - if you are allergic to any of the other ingredients of this medicine (listed in section 6) - if you are pregnant - if you are planning a pregnancy - if you are breast-feeding - on KS lesions close to any other skin complaint
Croatian: Nemojte primjenjivati Panretin: - ako ste alergični na alitretinoin ili slične lijekove koji sadrže retinoide - ako ste alergični na neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako ste trudni - ako planirate trudnoću - ako dojite - na lezije Kaposijevog sarkoma koje su u blizini drugih kožnih promjena
English: Panretin gel can be expected to have local therapeutic effects only and it has no role in the prevention or treatment of visceral KS.
Croatian: Može se očekivati da Panretin gel ima samo lokalne terapijske učinke i nema ulogu u sprječavanju ili liječenju visceralnog KS.
English: Panretin gel contains alcohol, keep away from naked flame.
Croatian: Panretin gel sadrži alkohol; čuvati daleko od otvorenog plamena.
English: However, treatment should not be restarted if Grade 4 toxicity occurred at an application frequency of less than twice a day.
Croatian: Međutim, ne smije se ponovno početi s liječenjem ako je toksičnost stupnja 4 nastupila kod učestalosti primjene manje od dva puta na dan.
English: Increased redness, possible oedema
Croatian: Pojačano crvenilo, mogući edem
English: - Allow the gel to dry for three to five minutes before covering a treated area with loose clothing.
Croatian: - Ostavite gel tri do pet minuta da se osuši prije nego što pokrijete liječeno područje laganom odjećom.
English: There are no data on the efficacy of Panretin applied less frequently than twice daily.
Croatian: Nema podataka o djelotvornosti Panretina kad se primjenjuje rjeđe od dva puta na dan.
English: The safety of Panretin gel has been assessed in clinical studies of more than 469 patients with AIDS-related KS, 439 of whom were treated with an alitretinoin concentration of 0.1%.
Croatian: Sigurnost Panretin gela procijenjena je u kliničkim ispitivanjima u više od 469 bolesnika s KS povezanim s AIDS-om, od kojih je 439 bilo liječeno alitretinoinom u koncentraciji od 0,1%.
English: The results suggest that alitretinoin absorbs light in the UV range and is subject to photodegradation to other isomers (predominantly all-trans-retinoic acid).
Croatian: Rezultati ukazuju na to da alitretinoin apsorbira svjetlost iz ultraljubičastog područja i podložan je fotodegradaciji do drugih izomera (pretežno all-trans-retinoične kiseline).
English: It is not known whether this medicinal product is excreted in human milk.
Croatian: Nije poznato izlučuje li se ovaj lijek u majčino mlijeko.
English: Table 1 Grading of local dermal irritation GRADE
Croatian: Tablica 1 Stupnjevanje lokalne nadraženosti kože STUPANJ
English: If application site toxicity occurs, the application frequency can be reduced as described below.
Croatian: Ako na mjestu primjene nastupi toksičnost, učestalost primjene može se smanjiti kako je opisano niže.
English: Panretin is used in patients with AIDS-related Kaposi's sarcoma (KS) and is for the treatment of the KS lesions: - that are on the skin only - which have not responded to your HIV treatment - where the skin or lesion is not broken - where the surrounding skin is not swollen - if your doctor thinks that other treatments are not suitable for you.
Croatian: Panretin se primjenjuje u bolesnika s Kaposijevim sarkomom povezanim s AIDS-om i namijenjen je liječenju lezija Kaposijevog sarkoma: - koje se nalaze samo na koži - koje nisu odgovorile na liječenje HIV-a - kod kojih koža ili lezija nisu oštećene - kod kojih okolna koža nije otečena - ako Vaš liječnik smatra da druga liječenja nisu za Vas primjerena.
English: Most patients can continue to use Panretin by altering the number of times a day it is applied.
Croatian: Većina bolesnika može nastaviti s primjenom Panretina tako što će se promijeniti broj primjena Panretina u danu.
English: Lesions responding during the first 12 weeks on study, initial blinded phase, confirmed over at least four study weeks (confirmation of response may have occurred after 12 weeks for some lesions in Study 1).
Croatian: Lezije koje su odgovorile tijekom prvih 12 tjedana početne slijepe faze ispitivanja, s potvrđenim odgovorom tijekom najmanje četiri tjedna ispitivanja (potvrda odgovora mogla je biti nakon 12 tjedana za neke lezije u Ispitivanju 1).
English: The safety and efficacy of Panretin gel in children under 18 years has not been established.
Croatian: Sigurnost i djelotvornost Panretin gela u djece u dobi manjoj od 18 godina starosti nisu ustanovljene.
English: Response rates were analysed both by the patient as the unit of analysis and by the lesion.
Croatian: Stope odgovora analizirane su po bolesniku kao jedinici analize i po leziji.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Alitretinoin (9-cis-retinoic acid), a naturally-occurring endogenous hormone related to vitamin A, binds to and activates all known intracellular retinoid receptor subtypes (RAR, RAR, RAR, RXR, RXR, RXR).
Croatian: Alitretinoin (9-cis-retinoična kiselina), fiziološki endogeni hormon sličan vitaminu A, veže se i aktivira sve poznate podvrste unutarstaničnih retinoidnih receptora (RARα, RAR, RAR, RXRα, RXRβ, RXRγ).
English: If you forget to take Panretin
Croatian: Ako ste zaboravili primijeniti Panretin
English: Panretin is not approved for use in children and adolescents under 18 years of age.
Croatian: Panretin nije odobren za primjenu u djece i adolescenata ispod 18 godina starosti.
English: OUTER CARTON TEXT AND TUBE LABEL TEXT
Croatian: TEKST NA KUTIJI I TEKST NA NALJEPNICI TUBE
English: Two controlled, multicentre, randomised, double blind parallel group, Phase III studies provided the data for Panretin gel in the treatment of index cutaneous lesions of KS (Table 4).
Croatian: Dva kontrolirana, multicentrična, randomizirana, dvostruko slijepa ispitivanja faze III na usporednim skupinama osigurala su podatke za Panretin gel u liječenju indeksnih kožnih lezija KS (Tablica 4).
English: The gel must be allowed to dry for three to five minutes before covering with clothing.
Croatian: Gel se mora ostaviti od tri do pet minuta da se osuši prije nego što ga se pokrije tkaninom.
English: The incidence of drug-related skin disorder, skin ulcer, pain and rash appeared to be greater in patients applying Panretin gel four times daily than in those applying it less frequently.
Croatian: Incidencija kožnog poremećaja povezanog s lijekom, kožnog ulkusa, bola i osipa čini se da je veća u bolesnika koji su primjenjivali Panretin gel četiri puta na dan nego u onih koji su ga primjenjivali manje učestalo.
English: In lesions that have responded to treatment during this time, application may be continued provided that the response improves or is maintained and the product continues to be tolerated.
Croatian: Kod lezija koje su odgovorile na liječenje tijekom tog vremena može se nastaviti s primjenom pod uvjetom da se odgovor poboljšava ili održava i da se gel i dalje podnosi.
English: However, mineral oil must not be applied for at least two hours before or after the application of Panretin.
Croatian: Međutim, mineralno ulje ne smije se nanijeti najmanje dva sata prije ili poslije primjene Panretina.
English: While no data are available, it is possible that co-administration of medicinal products which induce CYP isozymes may reduce circulating levels of alitretinoin, with a possible negative effect on the efficacy of Panretin gel.
Croatian: Iako nema dostupnih podataka, postoji mogućnost da će istodobna primjena lijekova koji induciraju izoenzime CYP smanjiti razine cirkulirajućeg alitretinoina, uz mogući negativni učinak na djelotvornost Panretin gela.