FrancophonIA/ELRC3.0 huggingface dataset:
English: Percentages calculated as number of patients with responding lesions divided by total number of patients in the initial blinded phase.
Croatian: Postotci izračunati kao broj bolesnika s lezijama koje su odgovorile na liječenje podijeljen s ukupnim brojem bolesnika u početnoj slijepoj fazi.
English: What you need to know before you use Panretin
Croatian: Što morate znati prije nego počnete primjenjivati Panretin
English: Local dermal irritation may be graded according to the five-point scale shown in Table 1.
Croatian: Lokalna nadraženost kože može se odrediti prema ljestvici s pet stupnjeva prikazanoj u Tablici 1.
English: Based on the plasma concentrations observed in patients, milk concentrations of 9-cis-retinoic acid probably pose a low risk for the infant.
Croatian: Na temelju koncentracija u plazmi opaženih u bolesnika, koncentracije 9-cis-retinoične kiseline u mlijeku vjerojatno predstavljaju mali rizik za dojenče.
English: After opening the tube for application, the tube cap must be replaced and closed tightly to provide an airtight seal.
Croatian: Nakon otvaranja tube za primjenu, zatvarač tube se mora vratiti na mjesto i čvrsto zatvoriti kako ne bi propuštao zrak.
English: lips, vagina, tip of the penis, rectum, or anus.
Croatian: nosnice, usta, usne, rodnica, vrh penisa, rektum ili anus.
English: Treatment of lesions that have not shown a decrease in area and/or height by week 12 should be discontinued.
Croatian: Potrebno je prekinuti liječenje lezija čija se površina i/ili visina nije smanjila do 12. tjedna.
English: It is important that you consult your doctor, who will tell you what to do.
Croatian: Važno je da se obratite liječniku, koji će
English: Animal toxicology studies showed increased DEET toxicity when DEET was included as part of the formulation.
Croatian: Toksikološka ispitivanja na životinjama pokazala su povećanu toksičnost DEET-a kad je DEET bio sastavni dio formulacije.
English: On a theoretical basis, no dose adjustment is necessary in patients with renal insufficiency or liver disease, but these patients should be closely monitored and treatment frequency reduced, or withdrawn, if they experience adverse effects.
Croatian: Teoretski, nije potrebna prilagodba doze u bolesnika s insuficijencijom bubrega ili bolešću jetre, ali takve je bolesnike potrebno pažljivo pratiti te smanjiti učestalost ili prekinuti liječenje ako nastupe nuspojave.
English: There was no clinical evidence in the vehicle-controlled studies of interactions with systemic antiretroviral agents, including protease inhibitors; macrolide antibiotics and azole antifungals.
Croatian: U ispitivanjima u kojima se kao kontrola koristila podloga nije bilo kliničkih dokaza interakcija sa sistemskim antiretrovirusnim tvarima, uključujući inhibitore proteaze; makrolidne antibiotike i azolne antimikotike.
English: There are no data regarding the efficacy of Panretin gel when applied to complicated lesions (e.g., when lymphoedema is present).
Croatian: Nema podataka o djelotvornosti gela Panretin kad se nanosi na komplicirane lezije (npr., kad je prisutan limfedem).
English: • Treatment of KS lesions in close proximity to other skin disorders.
Croatian: • Liječenje lezija KS koje su vrlo blizu drugim kožnim promjenama.
English: There were no reports of photosensitivity associated with the use of Panretin gel in the clinical studies.
Croatian: Nije bilo prijava fotoosjetljivosti povezane s primjenom Panretin gela u kliničkim ispitivanjima.
English: Table 2 Adjustment guidelines for treatment-limiting toxicity LOCAL DERMAL IRRITATION
Croatian: Tablica 2 Smjernice za prilagodbu kod liječenja ograničenog toksičnošću LOKALNA NADRAŽENOST KOŽE
English: Men using Panretin should take precautions to ensure that their female partners do not become pregnant.
Croatian: Muškarci koji koriste Panretin gel trebaju primjenjivati mjere opreza kako bi osigurali da njihove partnerice ne zatrudne.
English: Studies have not been performed to determine the carcinogenic potential of alitretinoin.
Croatian: Nisu provedena ispitivanja kojima bi se odredila kancerogenost alitretinoina.
English: Do not breast-feed your baby while you are using Panretin.
Croatian: Nemojte dojiti Vaše dijete za vrijeme primjenjivanja Panretina.
English: The dermal toxicity typically begins as erythema; with continued application of Panretin gel erythema may increase and oedema may develop.
Croatian: Kožna toksičnost obično počinje kao eritem; s nastavkom primjene Panretin gela eritem se može pojačati i može se razviti edem.
English: Each carton contains one tube of gel.
Croatian: Jedna kutija sadrži jednu tubu gela.
English: Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with AIDSrelated Kaposi's sarcoma (KS) when:
Croatian: Panretin gel je indiciran za topikalno liječenje kožnih lezija u bolesnika s Kaposijevim sarkomom (KS) povezanim s AIDS-om kada:
English: In contrast to these findings in rats, plasma concentrations of 9-cis-retinoic acid in patients with KS applying Panretin gel never exceeded 0.638 ng/ml (2.13 nMol).
Croatian: Za razliku od ovih nalaza u štakora, koncentracije 9-cis-retinoične kiseline u plazmi bolesnika s KS koji su primjenjivali Panretin gel nikada nisu prelazile vrijednost od 0,638 ng/ml (2,13 nMol).
English: The regulation of gene expression by alitretinoin controls the process of cellular differentiation and proliferation in both normal and neoplastic cells.
Croatian: Regulacija ekspresije gena alitretinoinom kontrolira proces stanične diferencijacije i proliferacije u zdravih i neoplastičnih stanica.
English: Deep red, swelling and oedema with or without signs of bullae formation and necrosis
Croatian: Tamno crvenilo, oticanje i edem sa ili bez znakova stvaranja bula i nekroze
English: Observed increases in mean heart-to-final body weight differences were attributed principally to the difference in the terminal body weights.
Croatian: Opažena povećanja srednjih vrijednosti razlika u omjeru mase srca prema ukupnoj tjelesnoj masi bila su pripisana prvenstveno razlici u ukupnoj tjelesnoj masi.
English: The phototoxicity potential of alitretinoin was assessed based on its chemical properties and data from a battery of in vitro tests.
Croatian: Fototoksični potencijal alitretinoina bio je procijenjen na temelju njegovih kemijskih svojstava i podataka iz baterije testova in vitro.
English: The application frequency can be increased stepwise to three or four times a day according to individual lesion tolerance, allowing no less than two weeks between dose increases.
Croatian: Učestalost primjene može se postupno povećati na tri ili četiri puta na dan sukladno podnošljivosti pojedine lezije, s time da između povećanja doze ne smije proteći manje od dva tjedna.
English: Patients should initially apply Panretin twice a day to cutaneous KS lesions.
Croatian: U početku bolesnici trebaju nanositi Panretin na kožne lezije KS dva puta na dan.
English: If a complete response of a lesion occurs, no further application of Panretin gel should be made to the responding lesion.
Croatian: Ako nastupi potpuni odgovor lezije, na tu leziju nije potrebno dalje primjenjivati Panretin gel.
English: 1 g of gel contains 1 mg alitretinoin (0.1%).
Croatian: 1 g gela sadrži 1 mg alitretinoina (0,1%).
English: Clinical pathology evaluations revealed significant increases in absolute polymorphonuclear leukocyte counts, monocyte counts, percentage of monocytes and decreases in percentage of lymphocyte differential white blood cell counts on day 29 of rats treated with alitretinoin 0.5% gel.
Croatian: Kliničke procjene patologije otkrile su značajna povećanja apsolutnog broja polimorfonuklearnh leukocita, monocita, postotka monocita i smanjenja postotka limfocita u diferencijalnoj bijeloj krvnoj slici 29. dana u štakora liječenih alitretinoin 0,5% gelom.
English: 1 = Mild
Croatian: 1 = blagi
English: Contains alcohol, keep away from naked flame.
Croatian: Sadrži alkohol, čuvati daleko od otvorenog plamena.
English: Always use the cap to close the tube tightly after each use.
Croatian: Nakon svake uporabe, tubu uvijek čvrsto zatvorite zatvaračem.
English: When dermal irritation improves to Grade 0 or 1, treatment may be restarted at twice daily, increasing every two weeks as tolerated.
Croatian: Kad se nadraženost kože poboljša do stupnja 0 ili 1, može se ponovno početi s liječenjem dva puta na dan, povećavajući dozu svaka dva tjedna ovisno o podnošljivosti.
English: Do not cover the treated lesions with any bandage or other material.
Croatian: Nemojte pokrivati liječeno područje zavojima ili drugom tkaninom.
English: However, mineral oil should 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 Panretin gela.
English: - CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Croatian: • UVJETI ILI OGRANIČENJA VEZANA UZ OPSKRBU I UPORABU LIJEKA ZADANI NOSITELJU ODOBRENJA
English: However, it is not currently certain to what extent topical treatment with Panretin gel would increase 9-cis-retinoic acid plasma concentrations, in women with KS above naturally occurring levels; therefore, Panretin is contraindicated ( see section 4.3) in pregnancy, or in women planning a pregnancy.
Croatian: Međutim, trenutno nije sigurno u kojoj bi mjeri topikalno liječenje Panretin gelom povećalo koncentracije 9-cis-retinoične kiseline iznad fizioloških razina u plazmi žena s KS; stoga je Panretin kontraindiciran (vidjeti dio 4.3) tijekom trudnoće, kao i u žena koje planiraju trudnoću.
English: Retinoids as a class have been associated with photosensitivity.
Croatian: Skupina retinoida povezana je s fotoosjetljivošću.
English: Very red, with oedema, with or without vesiculation
Croatian: Izraženo crvenilo, s edemom, sa ili bez nastanka vezikula
English: Although the molecular action of alitretinoin is thought to be mediated through interaction with the retinoid receptors, the exact mechanism of action of this medicinal product in the topical treatment of cutaneous lesions of AIDS-related KS is unknown.
Croatian: Iako se smatra da je molekularno djelovanje alitretinoina posredovano interakcijom s retinoidnim receptorima, točan mehanizam djelovanja ovog lijeka u topikalnom liječenju kožnih lezija Kaposijevog sarkoma povezanog s AIDS-om nije poznat.
English: Protocol-specified dose regimen was application twice a day (BD) only, with downward adjustments for toxicity.
Croatian: Režim doziranja određen planom ispitivanja sastojao se od primjene samo dva puta na dan (BD), uz prilagodbu na niže doze u slučaju toksičnosti.
English: Protocol-specified dose regimen was application three times a day (TID) escalating to four times a day (QID) after two weeks, with downward adjustments for toxicity.
Croatian: Režim doziranja određen planom ispitivanja sastojao se od primjene tri puta na dan (TID) koja se povećala na četiri puta na dan (QID) nakon dva tjedna, uz prilagodbu na niže doze u slučaju toksičnosti.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2)
English: - Immediately after application, wipe the finger(s) you have used to apply the gel and any healthy skin touched by the gel with a disposable tissue.
Croatian: - Odmah nakon primjene obrišite prst(e) kojim(a) ste nanosili gel i svu zdravu kožu s kojom je gel došao u kontakt maramicom koju ćete onda baciti.
English: However, the incidence of other equally common drug-related adverse events such as pruritus, oedema, exfoliative dermatitis and dry skin did not appear to increase as a function of the frequency of application.
Croatian: Međutim, čini se da se incidencija drugih jednako čestih nuspojava povezanih s lijekom kao što su pruritus, edem, eksfolijativni dermatitis i suha koža ne povećava s učestalošću primjene.
English: Guidelines for treatment adjustments necessitated by local dermal treatment-related toxicity are specified in Table 2.
Croatian: Smjernice za konkretnu prilagodbu liječenja zbog lokalne kožne toksičnosti povezane s liječenjem navedene su u Tablici 2.
English: Table 4 Best response according to ACTG criteria for vehicle controlled phase Study 1 (TID, QID)
Croatian: Tablica 4 Najbolji odgovor prema kriterijima ACTG-a u fazi kontroliranoj podlogom
English: In an oral dose-ranging study in rabbits, alitretinoin induced gross malformations at a dose 35 times the topical human dose.
Croatian: U ispitivanju niza oralnih doza u kunića, alitretinoin je izazvao velike malformacije pri dozi 35 puta većoj od topikalne doze u ljudi.
English: For those lesions that have shown a decrease in height and/or area by week 12, applications may be continued providing that there is continued improvement or at least maintenance of the response and that the product continues to be tolerated.
Croatian: Kod onih lezija čija se visina i/ili površina smanjila do 12 tjedna, može se nastaviti s primjenom pod uvjetom da postoji neprekidno poboljšanje ili barem održanje odgovora te da se lijek i dalje podnosi.
English: Women of child-bearing potential must use a reliable form of contraception during treatment with Panretin gel (see section 4.6) and until one month after cessation of treatment.
Croatian: Žene reproduktivne dobi moraju koristiti pouzdane oblike kontracepcije tijekom liječenja Panretinom (vidjeti dio 4.6) i još mjesec dana nakon prestanka liječenja.
English: Following treatment with alitretinoin 0.5% gel, mean plasma concentrations in the female rats were generally below the lower limit of quantitation (5 nMol) and mean plasma concentrations in the male rats were about 200 nMol.
Croatian: Nakon liječenja alitretinoin 0,5% gelom, prosječne koncentracije u plazmi ženki štakora općenito su bile ispod donje granice određivanja (5 nMol), a prosječne koncentracije u plazmi mužjaka štakora bile su oko 200 nMol.
English: - Do not use insect repellents containing DEET (N,N-diethyl-m-toluamide) or other products containing DEET while using Panretin.
Croatian: Nemojte primjenjivati sredstva za odbijanje insekata koja sadrže DEET (N,N-dietil-m-toluamid) ili druga sredstva koja sadrže DEET kad primjenjujete Panretin.
English: - A mild soap is recommended when bathing or showering.
Croatian: - Kod tuširanja i kupanja preporučuje se koristiti blagi sapun.
English: Table 3 Adverse reactions reported in patients in clinical trials
Croatian: Tablica 3 Nuspojave zabilježene u bolesnika u kliničkim ispitivanjima
English: Systemic toxicity following acute overdose with topical application of Panretin gel is unlikely.
Croatian: Sistemska toksičnost nakon akutnog predoziranja pri topikalnoj primjeni gela Panretin nije vjerojatna.
English: Patients should apply Panretin to cutaneous KS lesions using sufficient gel so as to cover each lesion with a generous coating.
Croatian: Bolesnici trebaju nanijeti Panretin na kožne lezije KS u dovoljnoj količini tako da svaka lezija bude pokrivena izdašnim slojem gela.
English: Duration of application
Croatian: Trajanje primjene
English: Showering, bathing, or swimming for at least three hours after any application should be avoided.
Croatian: Tuširanje, kupanje ili plivanje treba izbjegavati najmanje tri sata nakon nanošenja gela.
English: 2 = Moderate
Croatian: 2 = umjereni
English: When applying Panretin gel, 69.1% of patients experienced adverse drug reactions at the application site.
Croatian: Kod primjene Panretin gela, 69,1% bolesnika primijetilo je nuspojave na mjestu primjene.
English: To open for the first time, use the pointed portion of the cap to puncture the metal safety seal.
Croatian: Kada prvi put otvarate tubu, poslužite se ušiljenim dijelom zatvarača kako biste probušili metalni sigurnosni pečat.
English: Also contains ethanol, macrogol 400, hydroxypropylcellulose, butylhydroxytoluene.
Croatian: Također sadrži etanol, makrogol 400, hidroksipropilcelulozu, butilhidroksitoluen.
English: Avoid the use of other products on your treated KS lesions such as insect repellents that you use on your skin.
Croatian: Izbjegavajte primjenu drugih pripravaka na lezije Kaposijevog sarkoma koje liječite, kao što su sredstva za odbijanje insekata koja se nanose na kožu.
English: The efficacy of Panretin gel in treating KS lesions may be related to the demonstrated ability of alitretinoin to inhibit the in vitro growth of KS cells.
Croatian: Djelotvornost gela Panretin u liječenju lezija KS može biti povezana s dokazanom sposobnošću alitretinoina da in vitro inhibira rast stanica KS.
English: Pale skin
Croatian: Za kožu.
English: Adverse events associated with the use of Panretin gel in AIDS-related KS occurred almost exclusively at the site of application.
Croatian: Nuspojave povezane s primjenom Panretin gela kod KS povezanog s AIDS-om nastale su gotovo isključivo na mjestu primjene.
English: In cell-based in vitro assays, alitretinoin showed weak phototoxic potential.
Croatian: U staničnim in vitro testovima, alitretinoin je pokazao da ima slab fototoksični potencijal.
English: Care should be taken not to bring the neonate into skin contact with areas to which Panretin has been recently applied.
Croatian: Potrebno je paziti da novorođenče ne dođe u kontakt s područjima kože na koja je nedavno nanesen Panretin.
English: Observed effects at the application site included erythema, epidermal thickening, scaling and loosening of the stratum corneum.
Croatian: Opaženi učinci na mjestu primjene uključivali su eritem, epidermalno zadebljanje, ljuskanje i popuštanje rožnatog sloja.
English: Table 5 provides the individual lesion response rates for patients being treated with Panretin gel in the Phase III studies.
Croatian: Tablica 5 prikazuje stope odgovora pojedinih lezija u bolesnika liječenih gelom Panretin u ispitivanjima faze III.
English: - Avoid prolonged exposure of the treated area to sunlight or other ultraviolet (UV) light (such as tanning lamps).
Croatian: - Izbjegavajte dugotrajno izlaganje liječenog područja kože sunčevom svjetlu ili drugom ultraljubičastom (UV) svjetlu (npr. u solariju).
English: It is not recommended for patients to apply Panretin gel concurrently with products that contain N,N-diethyl-m-toluamide (DEET ), a common component of insect repellent products.
Croatian: Ne preporučuje se primjenjivati Panretin gel istodobno s pripravcima koji sadrže N,N-dietil-m-toluamid (DEET), uobičajeni sastojak sredstava za odbijanje insekata.
English: Panretin gel is for cutaneous use and is unlikely to have an effect on the ability to drive and use machines.
Croatian: Panretin gel je namijenjen za kožnu primjenu i nije vjerojatno da će imati učinak na sposobnost upravljanja vozilima i rada sa strojevima.
English: The side effects are most likely to appear at the site where Panretin was applied and typically begins as redness.
Croatian: Nuspojave će se najvjerojatnije pojaviti na mjestu nanošenja Panretina i obično počinju kao crvenilo.
English: There are no data regarding the use of Panretin gel in patients with renal insufficiency or liver disease.
Croatian: Nema podataka o primjeni Panretin gela u bolesnika s insuficijencijom bubrega ili bolešću jetre.
English: • You may need to reduce the number of daily applications, or stop using Panretin for a short while, if you develop unwanted skin effects.
Croatian: • Ako razvijete neželjene učinke na koži, možda ćete trebati smanjiti broj primjena u danu ili neko vrijeme prestati primjenjivati Panretin.
English: Clinical chemistry evaluations revealed biologically relevant significant increases in the mean BUN and alkaline phosphatase values in females after the 28-day treatment.
Croatian: Kliničke procjene biokemije otkrile su značajna povećanja prosječnih vrijednosti biološki važnih BUN-a i alkalne fosfataze u ženki nakon 28 dana liječenja.
English: When used in accordance with the prescribing information topically administered retinoids are generally assumed to result in low systemic exposure due to minimal dermal absorption.
Croatian: Kada se topikalni retinoidi primjenjuju u skladu s informacijama o lijeku, u načelu se smatra da dovode do male sistemske izloženosti zbog minimalne apsorpcije kroz kožu.
English: Panretin does not treat KS that is inside the body.
Croatian: Panretin ne liječi Kaposijev sarkom u unutrašnjosti tijela.
English: Local dermal toxicity associated with Panretin gel therapy generally resolved with treatment adjustment or discontinuation (see section 4.2).
Croatian: Panretin općenito se povlačila s prilagodbom ili prekidom liječenja (vidjeti dio 4.2).
English: However, patients must be cautioned to minimise exposure of treated areas to sunlight or other ultraviolet (UV) light.
Croatian: Međutim, bolesnike se mora upozoriti da smanje izlaganje liječenih područja sunčevom ili drugom ultraljubičastom (UV) svjetlu (vidjeti dio 5.3).
English: Table 3 shows the following application-site drug-related adverse reactions were reported during clinical studies in patients with KS.
Croatian: Tablica 3 prikazuje sljedeće nuspojave na mjestu primjene povezane s lijekom koje su bile zabilježene u kliničkim ispitivanjima u bolesnika s KS.
English: 1 g of gel contains 1 mg of alitretinoin.
Croatian: 1 g gela sadrži 1 mg alitretinoina
English: Orally administered retinoids have been associated with congenital abnormalities.
Croatian: Peroralno primijenjeni retinoidi povezani su s urođenim manama.
English: Plasma concentrations of 9-cis-retinoic acid were evaluated during clinical studies in patients with cutaneous lesions of AIDS-related KS after repeated multiple-daily dose application of Panretin gel for up to 60 weeks.
Croatian: Koncentracije 9-cis-retinoične kiseline u plazmi bile su procijenjene tijekom kliničkih ispitivanja u bolesnika s kožnim lezijama KS povezanog s AIDS-om nakon opetovane višekratne dnevne primjene doze Panretin gela u trajanju do 60 tjedana.
English: You do not need to rub the gel into the lesion.
Croatian: Gel ne morate utrljavati u leziju.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti, nuspojave su navedene silaznim slijedom prema ozbiljnosti.
English: Carefully applying the gel only to the area of the KS lesion will help to lessen any irritation or redness that may occur.
Croatian: Pažljivo nanošenje gela samo na područje lezije Kaposijevog sarkoma pridonijet će smanjenju moguće nadraženosti i crvenila koji mogu nastati.
English: The adverse events seen with Panretin gel are similar to those seen with other topical retinoids.
Croatian: Nuspojave primijećene s Panretin gelom slične su nuspojavama primijećenima pri primjeni drugih topikalnih retinoida.
English: Care should be taken not to bring your baby into contact with areas of your skin treated recently with Panretin.
Croatian: Pazite da dijete ne dođe u kontakt s područjima kože na koja ste nedavno nanijeli Panretin.
English: Panretin therapy should only be initiated and maintained by specialist physicians experienced in the treatment of patients with KS.
Croatian: Terapiju Panretinom smije započeti i održavati samo liječnik specijalist s iskustvom u liječenju bolesnika s Kaposijevim sarkomom.
English: You need to avoid applying the gel to the healthy skin around the lesion.
Croatian: Morate izbjegavati nanošenje gela na zdravu kožu oko lezije.
English: It is recommended that Panretin should be applied to lesions for an initial period of up to 12 weeks.
Croatian: Za početak se preporučuje primjenjivati Panretin na lezije u razdoblju do 12 tjedana.
English: Panretin gel should not be used concurrently with products containing DEET.
Croatian: Panretin gel se ne smije primjenjivati istodobno s lijekovima koji sadrže DEET.
English: AIDSrelated Kaposi's sarcoma is infrequent in this population.
Croatian: Kaposijev sarkom povezan s AIDS-om nije čest u ovoj populaciji.
English: Women of child-bearing potential must use effective contraception during, and up to one month after cessation of treatment.
Croatian: Žene reproduktivne dobi moraju koristiti djelotvornu kontracepciju za vrijeme i mjesec dana nakon završetka liječenja.