FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Odprte tube shranjujte pri temperaturi do 25 °C ter jih zaščitite pred močno svetlobo in vročino (npr. pred neposredno sončno svetlobo).
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.
Slovenian: Pojav motnje kože, kožnih razjed, bolečine in izpuščajev kot posledica uporabe zdravila je bil pogostejši pri bolnikih, ki so uporabili zdravilo Panretin gel štirikrat dnevno v primerjavi s tistimi, ki so ga nanašali manj pogosto.
English: What Panretin is and what it is used for What you need to know before you use Panretin How to use Panretin
Slovenian: Kaj je zdravilo Panretin in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Panretin Kako uporabljati zdravilo Panretin Možni neželeni učinki
English: Gel should not be applied on or near eyes or mucosal surfaces of the body.
Slovenian: Gel se ne sme nanesti na ali v bližino oči oz. drugih telesnih sluznic.
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).
Slovenian: V dveh kontroliranih, multicentričnih, randomiziranih, dvojno slepih študijah faze III s paralelnimi skupinami, so ugotavljali učinkovitost zdravila Panretin gel za zdravljenje indeksiranih kožnih lezij KS (razpredelnica 4).
English: - Do not apply the gel to healthy skin around a KS lesion.
Slovenian: - Gela ne nanašajte na zdravo kožo okoli KS lezije.
English: Men using Panretin should take precautions to ensure that their female partners do not become pregnant.
Slovenian: Moški, ki uporabljajo zdravilo Panretin, morajo z ustreznimi ukrepi zagotoviti, da njihove partnerice ne zanosijo.
English: Dermal toxicity may become treatment-limiting, with intense erythema, oedema, and vesiculation.
Slovenian: Dermalna toksičnost lahko postane omejujoča za zdravljenje, spremljana z intenzivnim eritemom, edemom ter nastankom mehurjev.
English: Panretin gel contains alcohol, keep away from naked flame.
Slovenian: Zdravilo Panretin gel vsebuje alkohol, zavarujte pred odprtim ognjem.
English: Animal toxicology studies showed increased DEET toxicity when DEET was included as part of the formulation.
Slovenian: V toksikoloških raziskavah na živalih so ugotovili povečano toksičnost DEET, kadar je bil le-ta prisoten med sestavinami izdelka.
English: Clinical chemistry evaluations revealed biologically relevant significant increases in the mean BUN and alkaline phosphatase values in females after the 28-day treatment.
Slovenian: Klinično-kemični podatki so pokazali biološko relevantno povečanje srednje vrednosti BUN-a ter vrednosti alkalne fosfataze pri ženskah po 28-dnevnem zdravljenju.
English: The adverse events seen with Panretin gel are similar to those seen with other topical retinoids.
Slovenian: Neželeni učinki, opaženi pri uporabi zdravila Panretin gel, so podobni tistim, opaženim pri drugih lokalnih retinoidih.
English: OUTER CARTON TEXT AND TUBE LABEL TEXT
Slovenian: BESEDILO NA ŠKATLI IN NALEPKI TUBE
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.
Slovenian: Pogostost uporabe se lahko postopoma poveča na tri do štiri nanose dnevno, kar je odvisno od odpornosti posamezne lezije, sicer pa je treba upoštevati obdobje najmanj dveh tednov pred povečanjem odmerka.
English: Systemic toxicity following acute overdose with topical application of Panretin gel is unlikely.
Slovenian: Sistemska toksičnost po akutnem prevelikem odmerjanju z zdravilom Panretin gel je malo verjetna.
English: Panretin belongs to a group of medicines that are related to vitamin A and known as retinoids.
Slovenian: Zdravilo Panretin spada v skupino zdravil, ki je sorodna vitaminu A in jo imenujemo retinoidi.
English: Uncommon (can occur in less than 1 in 100 but in more than 1 in 1000 patients treated): Infection
Slovenian: Občasno (ki se lahko pojavijo pri manj kot enem od 100, toda pri več kot enem od 1.000 zdravljenih bolnikov):
English: Panretin is not approved for use in children and adolescents under 18 years of age.
Slovenian: Zdravilo Panretin ni primerno za uporabo pri otrocih in mladostnikih do 18 let.
English: Table 1 Grading of local dermal irritation GRADE
Slovenian: Razpredelnica 1 Razvrščanje glede na lokalno draženje kože STOPNJA
English: The opening of the Panretin tube is covered by a metal safety seal.
Slovenian: Odprtina tube zdravila Panretin gel je pokrita s kovinskim varnostnim tesnilom.
English: - The other ingredients are ethanol, macrogol 400, hydroxypropylcellulose, and butylhydroxytoluene.
Slovenian: - Druge sestavine so etanol, makrogol 400, hidroksopropilceluloza in butilhidroksitoluen.
English: Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with AIDSrelated Kaposi's sarcoma (KS) when:
Slovenian: Zdravilo Panretin gel je namenjeno lokalnemu zdravljenju kožnih lezij pri bolnikih s Kaposijevim sarkomom (KS), ki je posledica AIDS, in sicer če:
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.
Slovenian: Po zdravljenju z 0,5 % gelom alitretinoina so bile srednje koncentracije v plazmi pri podganjih samicah večinoma pod spodnjo dokazljivo mejo (5 nMol) ter koncentracije v plazmi pri samcih okoli 200 nMol.
English: Table 3 shows the following application-site drug-related adverse reactions were reported during clinical studies in patients with KS.
Slovenian: Preglednica 3 prikazuje sledeče neželene učinke zdravila na mestu aplikacije, o katerih so poročali bolniki s KS med kliničnimi študijami.
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.
Slovenian: Učinkovitost zdravila Panretin gel pri zdravljenju KS lezij se lahko poveže z ugotovljeno sposobnostjo alitretinoina za inhibicijo rasti KS celic in vitro.
English: It is recommended that daily dietary intake of vitamin A should not exceed the Recommended Dietary Intake value.
Slovenian: Priporočamo, da dnevno zaužita količina vitamina A s hrano ne presega priporočene vrednosti dnevnega zaužitja vitaminov s hrano (RDI vrednost).
English: Panretin may cause unwanted irritation or redness on healthy skin.
Slovenian: Zdravilo Panretin gel lahko povzroča neželeno draženje ali pordelost zdrave kože.
English: Also contains ethanol, macrogol 400, hydroxypropylcellulose, butylhydroxytoluene.
Slovenian: Vsebuje tudi etanol, makrogol 400, hidroksopropilcelulozo, butilhidroksitoluen.
English: However, mineral oil should not be applied for at least two hours before or after the application of Panretin.
Slovenian: Mineralno olje pa se ne sme nanesti najmanj dve uri pred in po nanosu zdravila Panretin.
English: • It may take up to 12 weeks for any improvement to show.
Slovenian: • Do prvih znakov izboljšanja lahko mine tudi do 12 tednov.
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.
Slovenian: Bolnikom ne priporočamo uporabe zdravila Panretin gel hkrati z izdelki, ki vsebujejo N,N-dietil-m-toluamid (DEET), kar je običajna sestavina pri sredstvih za zaščito pred insekti (repelenti).
English: Table 4 Best response according to ACTG criteria for vehicle controlled phase Study 1 (TID, QID)
Slovenian: Razpredelnica 4 Najboljši odziv po merilih skupine kliničnih študij za AIDS (ACTG) za fazo s kontrolo vehikla
English: Always use the cap to close the tube tightly after each use.
Slovenian: Po vsaki uporabi tesno zaprite tubo s pokrovčkom.
English: How to use Panretin
Slovenian: Kako uporabljati zdravilo Panretin
English: - If you think that the effect of Panretin is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: - Če menite, da je učinek zdravila premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
English: When dermal irritation improves to Grade 0 or 1, treatment may be restarted at twice daily, increasing every two weeks as tolerated.
Slovenian: Ko se razdraženost kože zmanjša do stopnje 0 ali 1, lahko zdravljenje ponovno uvedemo z dvema nanosoma dnevno.
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.
Slovenian: Uporaba se lahko nadaljuje pri lezijah, ki so se v tem času odzvale na zdravilo, sicer pa pod pogojem, da se odziv še izboljša ali vsaj ohrani ter da bolnik zdravilo še naprej prenaša.
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.
Slovenian: Vendar pa ni gotovo, do katere mere utegne lokalno zdravljenje z zdravilom Panretin gel povečati koncentracijo 9-cis-retinoidne kisline nad vrednost, ki se pojavlja naravno v plazmi žensk s KS. Iz tega razloga je zdravilo Panretin med nosečnostjo ali pri ženskah, ki načrtujejo nosečnost, kontraindicirano (glejte poglavje 3.4).
English: • Hypersensitivity to retinoids in general, to the active substance alitretinoin or to any of the excipients listed in section 6.1.
Slovenian: • Splošna preobčutljivostjo za retinoide, za učinkovino alitretinoin ali katero koli pomožno snov,
English: Carefully applying the gel only to the area of the KS lesion will help to lessen any irritation or redness that may occur.
Slovenian: S previdnim nanosom gela le na predel KS lezije boste pomagali omiliti morebitno draženje ali pordelost kože.
English: Observed effects at the application site included erythema, epidermal thickening, scaling and loosening of the stratum corneum.
Slovenian: Opaženi učinki na mestu aplikacije so vsebovali eritem, epidermalno otekanje, luskavico in odstopanje rožene plasti.
English: Panretin does not treat KS that is inside the body.
Slovenian: Zdravilo Panretin se ne uporablja za zdravljenje KS, ki se pojavi v telesu.
English: Retinoids as a class have been associated with photosensitivity.
Slovenian: Celotno skupino retinoidov povezujejo z občutljivostjo za svetlobo.
English: Women of child-bearing potential must use effective contraception during, and up to one month after cessation of treatment.
Slovenian: Ženske v rodni dobi morajo ves čas zdravljenja in še en mesec po zdravljenju uporabljati učinkovito kontracepcijo.
English: In cell-based in vitro assays, alitretinoin showed weak phototoxic potential.
Slovenian: V celičnih in vitro testih je alitretinoin pokazal le šibak fototoksični potencial.
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.
Slovenian: - Takoj po uporabi si s krpico za enkratno uporabo obrišite prst(e), ki ste ga (jih) uporabili za nanos gela, kot tudi vse dele zdrave kože, ki so prišli v stik z gelom.
English: Response rates were analysed both by the patient as the unit of analysis and by the lesion.
Slovenian: Stopnje odziva so analizirali po bolnikih in lezijah kot enotah analize.
English: In an oral dose-ranging study in rabbits, alitretinoin induced gross malformations at a dose 35 times the topical human dose.
Slovenian: V študiji s peroralnimi odmerki pri kuncih je alitretinoin induciral hude malformacije pri 35-krat večjem odmerku v primerjavi z lokalnim odmerkom pri ljudeh.
English: If you use more Panretin than you should There has been no experience with overdose of Panretin.
Slovenian: Če ste uporabili večji odmerek zdravila Panretin, kot bi smeli Ni poročil o primerih prevelikega odmerjanja zdravila Panretin gel.
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.
Slovenian: Če je tesnilo predrto ali če sploh ni vidno pri prvem odpiranju ovojnine, zdravila NE SMETE UPORABITI.
English: As for Grade 3 irritation.
Slovenian: Kot pri draženju po stopnji 3.
English: Place a generous coating of gel over the whole surface of each lesion that you want to treat.
Slovenian: Nanesite zadostno količino gela na celotno površino lezij(e), ki jih (jo) želite zdraviti.
English: The phototoxicity potential of alitretinoin was assessed based on its chemical properties and data from a battery of in vitro tests.
Slovenian: Fototoksičnost alitretinoina so ocenili na osnovi kemičnih lastnosti ter podatkov iz nabora in vitro testov.
English: Patients should apply Panretin to cutaneous KS lesions using sufficient gel so as to cover each lesion with a generous coating.
Slovenian: Bolniki nanesejo zdravilo Panretin na kožne KS lezije, in sicer tako, da z zadostno količino gela pokrijejo vsako lezijo z ustrezno plastjo.
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.
Slovenian: Na teoretični osnovi ni potrebna prilagoditev odmerka pri bolnikih z ledvično insuficienco ali boleznijo jeter, vsekakor pa je treba zdravljenje teh bolnikov natančno spremljati.
English: Vehicle N=72
Slovenian: Vehikel N=72
English: If a complete response of a lesion occurs, no further application of Panretin gel should be made to the responding lesion.
Slovenian: Če se doseže celotni odziv lezije, nadaljnja uporaba zdravila Panretin gel na taki leziji ni več potrebna.
English: Proper application will leave some gel visible on the surface of the lesion when you are finished.
Slovenian: Pri pravilnem nanosu mora nekaj gela ostati vidnega na površini lezije.
English: Partial Response (PR) % 34.3
Slovenian: Delni odziv (PR) %
English: Most patients can continue to use Panretin by altering the number of times a day it is applied.
Slovenian: Večina bolnikov lahko nadaljuje z uporabo zdravila Panretin gel s prilagojenim številom dnevnih nanosov zdravila.
English: Not for application to the eyes or mucous membranes.
Slovenian: Ni primerno za nanos v oči ali na sluznice.
English: The range and frequency of detection of quantifiable plasma 9-cis-retinoic acid concentrations in patients with KS applying the medicinal product to up to 64 lesions were comparable to respective values in untreated patients.
Slovenian: Obseg in pogostost odkritja merljive koncentracije 9-cis-retinoidne kisline v plazmi pri KS bolnikih, ki jim je bilo zdravilo nanešeno na do 64 lezij, sta bila primerljiva z zadevnimi vrednostmi pri bolnikih, ki se niso zdravili.
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.
Slovenian: Uporaba zdravila se lahko podaljša za lezije, pri katerih se je pokazalo zmanjšanje po višini oz. površini do 12. tedna pod pogojem, da se pokaže nadaljnje izboljšanje oz. vsaj ohranitev odziva ter da bolnik zdravilo še naprej prenaša.
English: Haemorrhage (bleeding at or around lesions), Oedema (oedema, swelling, inflammation), Peripheral oedema
Slovenian: Žilne bolezni hemoragija (krvavitev na mestu lezije ali okrog nje), edem (edem, oteklina, vnetje), periferni edem flebitis, bolezni ožilja
English: The gel must be allowed to dry for three to five minutes before covering with clothing.
Slovenian: Preden se izpostavljeni deli kože pokrijejo z oblačili, se mora gel sušiti tri do pet minut.
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.
Slovenian: Varnostni ukrepi pred rokovanjem z zdravilom ali njegovim nanosom Pred in po nanosu naj si bolniki umijejo roke.
English: AIDS-related Kaposi's sarcoma is infrequent in women.
Slovenian: Kaposijev sarkom kot posledica AIDS je redek pojav pri ženskah.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: Izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: With continued application of Panretin redness and irritation may increase and swelling at the site of the application may develop.
Slovenian: Z nadaljnjo uporabo zdravila Panretin gel se lahko pordelost in draženje kože povečata ter se razvijejo otekline na mestu aplikacije.
English: The following side effects have been noted on the skin where Panretin has been applied:
Slovenian: Opazili so sledeče neželene učinke na delih kože, na katere je bilo naneseno zdravilo Panretin gel:
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.
English: There are no data regarding the efficacy of Panretin gel when applied to complicated lesions (e.g., when lymphoedema is present).
Slovenian: Ni podatkov oučinkovitosti zdravila Panretin gel pri nanosu na komplicirane lezije (npr.v prisotnosti limfedema).
English: You do not need to rub the gel into the lesion.
Slovenian: Ni potrebno, da gel na lezijo nanesete z vtiranjem.
English: Care should be taken not to bring your baby into contact with areas of your skin treated recently with Panretin.
Slovenian: Bodite posebej pozorni, da vaš otrok ne pride v stik z deli kože, ki ste jih pravkar zdravili z zdravilom Panretin gel.
English: Vehicle (N=72)
Slovenian: Vehikel (N=72)
English: lips, vagina, tip of the penis, rectum, or anus.
Slovenian: glavica penisa, rektum ali anus.
English: Very common (can occur in more than 1 in 10 patients treated): Rash, scaling, irritation, redness Cracking, scabbing, crusting, draining, oozing Pain, burning, soreness
Slovenian: Zelo pogosto (ki se lahko pojavijo pri več kot enem od 10 zdravljenih bolnikov): Izpuščaji, luskavica, draženje, pordelost
English: Do not breast-feed your baby while you are using Panretin.
Slovenian: Ne dojite svojega otroka če uporabite zdravilo Panretin gel.
English: Orally administered retinoids have been associated with congenital abnormalities.
Slovenian: Retinoidi, ki jih dajemo peroralno, so povezani s prirojenimi nepravilnostmi.
English: Driving and using machines Panretin is unlikely to affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Le malo verjetno je, da bi zdravilo Panretin gel vplivalo na sposobnost vožnje ali upravljanja s stroji.
English: 3 = Severe
Slovenian: 3 = Hudo
English: Stinging, tingling
Slovenian: Otekline, vnetje
English: Panretin gel is for cutaneous use and is unlikely to have an effect on the ability to drive and use machines.
Slovenian: Zdravilo Panretin gel je namenjeno uporabi na koži in nima ali ima le zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: It is unlikely that the undesirable systemic side effects associated with oral retinoids will be observed with the use of Panretin gel because the range and frequency of quantifiable 9-cis-retinoic acid plasma levels concentrations after application of the medicinal product were comparable to the range and frequency of quantifiable plasma concentrations of circulating, naturally occurring 9-cis-retinoic acid in untreated individuals.
Slovenian: Malo verjetno je, da se neželeni sistemski stranski učinki, povezani z oralnimi retinoidi, opazijo tudi pri uporabi zdravila Panretin gel, ker sta bila obseg in pogostost merljive koncentracije 9-cis-retinoidne kisline v plazmi po aplikaciji zdravila primerljiva z obsegom in pogostostjo merljive koncentracije 9-cis-retinoidne kisline, ki kroži in se naravno pojavlja pri posameznikih, ki se ne zdravijo.
English: Alitretinoin was studied for genotoxic potential using the Ames test, the in vivo mouse micronucleus assay, the chromosomal aberration test in human lymphocytes, and the CHO cell mutation test.
Slovenian: Genotoksični potencial alitretinoina so raziskali z Ames-ovim testom, in vivo mikronukleus testom na miših, testom kromosomske aberacije pri človeških limfocitih, ter CHO testom mutacije celic.
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.
Slovenian: Plodne ženske morajo v času zdravljenja kot tudi en mesec po prenehanju zdravljenja z zdravilom Panretin gel (glejte poglavje 4.6) uporabljati učinkovito kontracepcijsko sredstvo.
English: Occlusive dressings should be avoided.
Slovenian: Tesno prilegajoča se oblačila niso primerna.
English: To open for the first time, use the pointed portion of the cap to puncture the metal safety seal.
Slovenian: Za prvo odpiranje morate s koničastim delom pokrovčka preluknjati kovinsko varnostno tesnilo na tubi.
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.
Slovenian: V kliničnih študijah z bolniki s kožnimi lezijami, ki so nastale zaradi KS povezanega z AIDS, so določili koncentracijo 9-cis-retinoidne kisline v plazmi, in sicer po ponavljajoči se večkratni dnevni aplikaciji zdravila Panretin gel za čas do 60 dni.
English: The side effects are most likely to appear at the site where Panretin was applied and typically begins as redness.
Slovenian: Neželeni učinki se večinoma pojavijo na delih kože, na katere ste nanesli zdravilo Panretin gel ter se običajno začnejo s pordelostjo kože.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serije Eisai Manufacturing Limited
English: There were no biologically relevant haematology differences or serum chemistry differences after the 14-day period.
Slovenian: LDL v serumu je bil zvišan tako pri skupinah moških kot žensk na 29. dan. Ni bilo biološko relevantnih hematoloških sprememb ali kemičnih sprememb seruma v obdobju po 14 dneh.
English: Bleeding
Slovenian: Krvavenje
English: This dose in rabbits resulted in plasma concentrations more than 60 times the highest observed plasma concentration in patients with KS following topical application of Panretin gel.
Slovenian: Ta odmerek je pri kuncih povzročil 60-krat višjo koncentracijo v plazmi v primerjavi z najvišjo opaženo koncentracijo v plazmi pri bolnikih s KS po lokalni aplikaciji zdravila Panretin gel.
English: Sometimes it is necessary to interrupt treatment, your doctor will inform you about this.
Slovenian: Včasih pa je potrebno zdravljenje prekiniti.
English: Vehicle N=134
Slovenian: Vehikel N=134
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.
Slovenian: Zdravilo Panretin gel nima vloge pri preprečevanju ali zdravljenju visceralnega KS.
English: In rabbits, alitretinoin was shown to be teratogenic at a dose which resulted in plasma concentrations about 60 times the highest observed plasma concentration in male patients with KS following topical application of the gel.
Slovenian: Pri kuncih se je alitretinoin pokazal kot teratogen pri odmerkih, pri katerih je bila koncentracija v plazmi 60-krat višja od najvišje opažene koncentracije v plazmi pri moških bolnikih po lokalni uporabi gela.