FrancophonIA/ELRC3.0 huggingface dataset:
English: Please let your doctor or nurse know if you have pain or if the painkillers you have been given are not taking the pain away.
Slovenian: Povejte zdravniku ali medicinski sestri, če vas boli ali če zdravila proti bolečinam, ki ste jih prejeli, niso odpravila bolečine.
English: No specific systemic symptoms are known to be associated with overdose.
Slovenian: Ni znanih specifičnih sistemskih simptomov, povezanih s prevelikim odmerjanjem.
English: Harmful for those suffering from alcoholism.
Slovenian: Škodljivo za osebe z alkoholizmom.
English: You must test this carefully by exposing the back of your hand to the sun for 5 minutes.
Slovenian: To morate previdno preizkusiti tako, da hrbtno stran roke za 5 minut izpostavite sončni svetlobi.
English: If it is absolutely necessary to go outdoors during the hours of daylight, you must be careful to cover up all your skin including your face and hands and wear dark glasses.
Slovenian: Če se morate nujno odpraviti iz hiše v času dnevne svetlobe, si morate pazljivo pokriti vso kožo, vključno z obrazom in dlanmi, in nositi sončna očala.
English: You can then repeat the test.
Slovenian: Po teh 24-ih urah lahko ponovite preizkus.
English: Treatment should be supportive.
Slovenian: Uvesti je treba podporno zdravljenje.
English: On the first day after the skin test, you can stay in direct sunlight for 15 minutes.
Slovenian: Prvi dan po kožnem preizkusu lahko ostanete na neposredni sončni svetlobi 15 minut.
English: The effects of Foscan on fertility in humans have not been studied.
Slovenian: Učinkov zdravila Foscan na plodnost pri ljudeh niso raziskali.
English: Published clinical research has shown that the duration and intensity of photosensitivity at the recommended dose of 0.15 mg/kg were reduced by one third relative to a dose of 0.3 mg/kg.
Slovenian: Objavljene klinične raziskave so pokazale, da sta bila trajanje in intenzivnost fotosenzitivnosti pri predpisanem odmerku 0,15 mg/kg manjša za tretjino v primerjavi z odmerkom 0,3 mg/kg.
English: There is no enterohepatic recirculation of these metabolites.
Slovenian: Enterohepatična recirkulacija teh metabolitov ne obstaja.
English: This means that normal daylight or bright indoor lighting could give you skin burns.
Slovenian: To pomeni, da vam normalna dnevna svetloba ali močna svetloba v notranjem prostoru lahko povzroči opekline na koži.
English: Day 15 onward Your sensitivity to light is gradually getting back to normal.
Slovenian: 15. dan in naprej Vaša občutljivost za svetlobo se postopoma vrača na normalno raven.
English: Each field is to be illuminated once only at each treatment.
Slovenian: Vsako polje mora biti pri posameznem zdravljenju obsevano le enkrat.
English: If you do not follow these instructions, you may get severe sunburn that leads to permanent scarring.
Slovenian: Če se teh navodil ne boste držali, lahko dobite hude sončne opekline, kar bo pustilo trajne brazgotine.
English: Illumination of the tumour should only be carried out if the potential benefit justifies the potential risk of excessive necrosis.
Slovenian: Obsevanje tumorja naj se izvaja le, če potencialna korist upravičuje potencialno tveganje za prekomerno nekrozo.
English: This risk can be controlled in the clinical situation by minimising direct exposure to light (see section 4.4).
Slovenian: To tveganje je v klinični situaciji mogoče nadzorovati z minimaliziranjem neposredne izpostavljenosti svetlobi (glejte poglavje 4.4).
English: Foscan contains ethanol (alcohol):
Slovenian: Zdravilo Foscan vsebuje etanol (alkohol):
English: Although no other developmental effects were observed, the applied doses were not sufficiently in excess of the human therapeutic dose to provide an adequate margin of safety.
Slovenian: Čeprav drugih učinkov na razvoj niso opazili, uporabljeni odmerki niso dovolj prekoračili terapevtskega odmerka za ljudi, da bi zagotovil primerno mejo varnosti.
English: Normally, people are able to begin to return to normal outdoor lighting after 15 days.
Slovenian: Običajno se ljudje lahko pričnejo vračati na normalno zunanjo svetlobo po 15 dneh.
English: Increased damage to tissue was noted.
Slovenian: Opazili so porast poškodb tkiva.
English: In the event of an overdose, laser treatment would result in deeper tumour necrosis than would be expected with the recommended dose.
Slovenian: V primeru prevelikega odmerka bi lasersko zdravljenje povzročilo globljo nekrozo tumorja, kot bi bilo pričakovano pri predpisanem odmerku.
English: Temoporfin does not concentrate in the tissues.
Slovenian: Temoporfin se ne koncentrira v tkivih.
English: Keep the curtains drawn and use light bulbs of 60 W or less.
Slovenian: Zavese naj bodo zagrnjene, uporabljajte svetilke z močjo 60 W ali manj.
English: Foscan should not be used during pregnancy unless the clinical condition of the woman requires treatment with temoporfin.
Slovenian: Zdravila Foscan ne smete uporabljati pri nosečnicah, razen če klinično stanje nosečnice zahteva zdravljenje s temoporfinom.
English: Injection site pain is transient and can be reduced by slowing the injection rate.
Slovenian: Bolečina na mestu injiciranja je prehodna in jo lahko zmanjšamo z upočasitvijo hitrosti injiciranja.
English: Animal studies have shown some haematological and blood chemistry changes (decreased platelets, erythrocytes and haemoglobin, increased neutrophils, fibrinogen, bilirubin, triglyceride and cholesterol).
Slovenian: Študije na živalih so pokazale nekatere hematološke spremembe in spremembe v sestavi krvi (zmanjšano število trombocitov, eritrocitov in hemoglobina; povečano število nevtrofilcev, fibrinogena, bilirubina, trigliceridov in holesterola).
English: Calculate the required dose of Foscan according to the bodyweight of the patient.
Slovenian: Potrebni odmerek zdravila Foscan izračunajte glede na telesno maso bolnika.
English: If you do not see any skin redness in the next 24 hours, you can gradually increase your time outdoors during the week.
Slovenian: Če se v naslednjih 24-ih urah ne pojavijo rdečine na koži, lahko v tem tednu postopoma povečujete svoj čas na prostem.
English: An extensive volume of distribution is observed that is intermediate between total and extracellular body water.
Slovenian: Opazili so obsežen volumen porazdelitve, ki je vmesen med celotno in zunajcelično telesno tekočino.
English: Each pack contains 1 glass vial and a filter.
Slovenian: Vsaka škatla vsebuje 1 stekleno vialo in filter.
English: In a clinical trial of 147 patients with advanced head and neck squamous cell carcinoma, tumour response, defined as a reduction of a minimum of 50 % of the tumour mass for a minimum of four weeks, was observed in 25 % after a single treatment.
Slovenian: V kliničnem preskušanju, izvedenem na 147 bolnikih z napredovalim ploščatoceličnim karcinomom glave in vratu, se je odzivnost tumorja, definirana kot 50-odstotno zmanjšanje mase tumorja za najmanj 4 tedne, pokazala pri 25 % bolnikov po enem zdravljenju.
English: You can now begin to go outside during daylight hours.
Slovenian: Zdaj lahko začnete hoditi iz hiše tudi v času dnevne svetlobe.
English: If there is no redness, you can gradually increase your exposure to sunlight day by day.
Slovenian: Če se rdečina ne pojavi, lahko postopoma, dan za dnem, povečujete svojo izpostavljenost sončni svetlobi.
English: Do not sunbathe.
Slovenian: Ne sončite se.
English: Prophylactic treatment with corticosteroids should be considered.
Slovenian: V poštev pride profilaktično zdravljenje s kortikosteroidi.
English: The resulting complications (i.e. dyspnoea or even airway obstruction leading to, for instance, intubation or tracheotomy) should be anticipated.
Slovenian: dispnea ali celo obstrukcija zračnih poti, zaradi katere je potrebna na primer intubacija ali traheotomija) moramo predvideti.
English: Unplanned or emergency surgical procedures where Foscan has been administered within the previous 30 days must be undertaken only if absolutely necessary and the potential benefits outweigh the risk to the patient.
Slovenian: Nenačrtovani ali nujni kirurški posegi v primerih, kjer je bilo v preteklih 30 dneh injicirano zdravilo Foscan, naj se izvajajo le, če je to absolutno potrebno in če možne koristi odtehtajo tveganje za bolnika.
English: Tissue outside the target area must be shielded completely to avoid photoactivation by scattered or reflected light.
Slovenian: Tkivo zunaj ciljnega področja mora biti v celoti zaščiteno, da ne pride do fotoaktivacije zaradi razpršene ali odbite svetlobe.
English: Ten patients achieved a tumour response due to re-treatment.
Slovenian: Pri 10 bolnikih so dosegli odziv tumorja po ponovnem zdravljenju.
English: Remove the intravenous cannula immediately following the injection.
Slovenian: Intravensko kanilo odstranite takoj po injiciranju.
English: What you need to know before you use Foscan
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Foscan
English: Attach the filter to the syringe (Figure 2).
Slovenian: Pritrdite filter na brizgo (slika 2).
English: What Foscan is and what it is used for
Slovenian: Kaj je zdravilo Foscan in za kaj ga uporabljamo
English: CALCULATION OF DOSE
Slovenian: IZRAČUN ODMERKA
English: Illumination of airways may lead to local inflammation and oedema.
Slovenian: Obsevanje zračnih poti lahko povzroči lokalno vnetje in edem.
English: • The amount of alcohol in this medicine may impair your ability to drive or use machines for a few hours after injection.
Slovenian: • Količina alkohola v tem zdravilu lahko za nekaj ur po injekciji zmanjša vašo sposobnost vožnje ali upravljanja s stroji.
English: Tumour responses are enhanced in patients with fully illuminated lesions of 10 mm or less in depth.
Slovenian: Odziv tumorja je povečan pri bolnikih s popolnoma obsevanimi lezijami, globokimi 10 mm ali manj.
English: Attach the syringe and filter to the cannula.
Slovenian: Pritrdite brizgo in filter na kanilo.
English: Due to the generation of reactive oxygen species, temoporfin poses a minor risk of mutagenicity.
Slovenian: Zaradi generiranja reaktivnih kisikovih spojin temoporfin predstavlja manjše tveganje za mutagenezo.
English: You can gradually return to normal indoor lighting.
Slovenian: Postopoma se lahko vrnete na normalno razsvetljavo v hiši.
English: The dose is 0.15 mg/kg body weight.
Slovenian: Odmerek je 0,15 mg/kg telesne mase.
English: The genotoxicity of temoporfin has been investigated to a limited extent.
Slovenian: Genotoksičnost temoporfina je bila le delno preučena.
English: Do NOT flush with aqueous solutions such as sodium chloride 9 mg/ml (0.9 %) solution for injection or water for injections.
Slovenian: NE izpirajte z vodnimi raztopinami, npr. z raztopino natrijevega klorida za injiciranje 9 mg/ml (0,9 %) ali vodo za injekcije.
English: Do not use Foscan - if you are allergic to temoporfin or any of the other ingredients of this medicine (listed in section 6), - if you are hypersensitive (allergic) to porphyrins, - if you have porphyria, or any other disease that is made worse by light, - if the tumour being treated goes through a large blood vessel, - if you are going to have an operation in the next 30 days, - if you have an eye disease which needs examination with bright light in the next 30 days, - if you are already being treated with a photosensitising agent.
Slovenian: Ne uporabljajte zdravila Foscan: - če ste alergični na temoporfin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6), - če ste preobčutljivi (alergični) na porfirine, - če imate porfirijo ali katero koli drugo bolezen, katere stanje se na svetlobi lahko poslabša, - če tumor, ki ga zdravite, sega skozi večjo žilo v telesu, - če boste v naslednjih 30 dneh imeli operacijo, - če imate očesno bolezen, zaradi katere boste v naslednjih 30 dneh imeli pregled z močno lučjo, - če se že zdravite z zdravilom, ki povzroča preobčutljivost za svetlobo.
English: Foscan is used for the treatment of head and neck cancer in patients who cannot be treated with other therapies.
Slovenian: Zdravilo Foscan se uporablja za zdravljenje raka glave in vratu pri bolnikih, ki jih ni mogoče zdraviti z drugimi načini zdravljenja.
English: Such a reaction has been reported with topical 5-fluorouracil.
Slovenian: Takšne vrste reakcija je znana pri topikalni uporabi 5-fluorouracila.
English: If at any time you notice a prickly or burning feeling or see skin reddening after exposure to sun, wait until this disappears before exposing your skin to light for this length of time again.
Slovenian: Če kadarkoli na koži občutite ščemeč ali žareč občutek ali opazite, da koža po izpostavljenosti sončni svetlobi postaja rdeča, počakajte, da ti znaki izginejo, preden svojo kožo ponovno izpostavite sončni svetlobi za enako obdobje.
English: Photoactivation induces local tissue damage resulting in acute inflammatory response.
Slovenian: Fotoaktivacija sproži lokalno tkivno okvaro, ki povzroči akutni vnetni odziv.
English: • Sunglasses with side panels: for eyes and skin around eyes.
Slovenian: • Sončna očala s stransko zaščito: za oči in kožo okrog oči.
English: Remember to avoid direct sunlight coming through the window or direct light from household appliances such as reading lamps.
Slovenian: Ne pozabite se izogibati neposredni sončni svetlobi, ki prihaja skozi okno, ali neposredni svetlobi iz gospodinjskih aparatov, na primer bralnih luči.
English: Temoporfin is bound to plasma lipoproteins and high density proteins such as albumin in the blood.
Slovenian: Temoporfin se veže na plazemske lipoproteine in na proteine z visoko gostoto, npr. na albumin v krvi.
English: Two major metabolites of temoporfin are eliminated into the bile.
Slovenian: Dva glavna metabolita temoporfina se izločata v žolč.
English: LASER ILLUMINATION OF TREATMENT SITE
Slovenian: LASERSKO OBSEVANJE MESTA ZDRAVLJENJA
English: To avoid photosensitivity problems, it is advised not to drive during the first 15 days after injection, and to use machines only if it is practical to do so under subdued lighting conditions according to the recommended lighting precautions (see section 4.4).
Slovenian: Da bi se izognili težavam zaradi preobčutljivosti za svetlobo, se priporoča, da bolniki v prvih 15 dneh po injiciranju ne vozijo in s stroji upravljajo le, če je to praktično izvedljivo pri ublaženi svetlobi, skladno s priporočenimi varnostnimi ukrepi glede svetlobe (glejte poglavje 4.4).
English: Studies have shown that Foscan is non-irritant.
Slovenian: Študije so pokazale, da zdravilo Foscan ni iritirajoče.
English: The low number of treated patients did not allow identification of adverse reactions, which may be categorised as uncommon and rare.
Slovenian: Zaradi majhnega števila zdravljenih bolnikov ni bilo možno ugotoviti neželenih učinkov, ki so opredeljeni kot občasni in redki.
English: Skin photosensitivity reactions are caused by visible light; therefore ultraviolet sunscreens provide no protection.
Slovenian: Fotosenzitivnostne reakcije na koži povzroči vidna svetloba; zato kreme za sončenje z UV zaščitnimi faktorji ne nudijo nobene zaščite.
English: No metabolites are seen in the systemic circulation.
Slovenian: V sistemski cirkulaciji metabolitov niso opazili.
English: Foscan photodynamic therapy must only be administered in specialist oncology centres in which a multidisciplinary team assesses patient treatment and under the supervision of physicians experienced in photodynamic therapy.
Slovenian: Fotodinamično zdravljenje z zdravilom Foscan se lahko izvaja le v specialističnih onkoloških centrih, kjer multidisciplinarna ekipa določi zdravljenje bolnika, in pod nadzorom zdravnikov, ki že imajo izkušnje s fotodinamičnim zdravljenjem.
English: This blackness is caused by dead cancer cells (necrosis).
Slovenian: To počrnitev povzročajo odmrle rakaste celice (nekroza).
English: If there is redness, you should avoid direct sunlight for another 24 hours.
Slovenian: Če se rdečina pojavi, se morate neposredni sončni svetlobi izogibati še naslednjih 24 ur.
English: It is therefore important that during photoactivation by laser illumination care should be taken to protect normal tissue surrounding the tumour from photoactivation by proper illumination and shielding techniques.
Slovenian: Zato je pomembno, da med fotoaktivacijo z lasersko svetlobo poskrbite za zaščito normalnega tkiva okrog tumorja pred fotoaktivacijo s pravilnimi tehnikami obsevanja in zaščite.
English: SAFETY INFORMATION
Slovenian: PODATKI O VARNOSTI
English: Foscan may also damage the tissue that is surrounding the tumour.
Slovenian: Zdravilo Foscan lahko poškoduje tudi tkivo okrog tumorja.
English: A second course of treatment may be given at the discretion of the treating physician in patients where additional tumour necrosis and removal is deemed appropriate, with a recommended minimum interval of 4 weeks between treatments.
Slovenian: Drugo zdravljenje lahko po preudarku lečeči zdravnik predpiše bolnikom, pri katerih meni, da sta potrebni dodatna nekroza tumorja in odstranitev, s priporočenim minimalnim intervalom 4 tednov med posameznimi zdravljenji.
English: • Your doctor or nurse will give you Foscan by a slow injection into a vein, which will take approximately 6 minutes.
Slovenian: • Zdravnik ali medicinska sestra vam bo zdravilo Foscan dal s počasno injekcijo v žilo, kar bo trajalo približno 6 minut.
English: Press the syringe plunger to fill all dead space within the filter.
Slovenian: Potisnite bat brizge, da zapolnite ves prazen prostor v filtru.
English: but this will not last long.
Slovenian: Foscan, a to ne bo trajalo dolgo.
English: For intravenous use Read the package leaflet before use.
Slovenian: za intravensko uporabo Pred uporabo preberite priloženo navodilo.
English: After 2 to 4 days, the treated area will turn black.
Slovenian: Čez 2 do 4 dni bo zdravljeni predel počrnel.
English: To stop this, you must follow carefully the instructions for gradual exposure to increasing light levels indoors over the first week and outdoor, shaded light during the second week after treatment (please see the table at the end of this leaflet).
Slovenian: Da bi to preprečili, se morate natančno držati navodil za postopno izpostavljanje vedno večji intenziteti svetlobe v notranjih prostorih prvi teden in zunanji svetlobi v senci drugi teden po zdravljenju (glejte preglednico na koncu teh navodil).
English: Continue pressing the plunger to expel excess Foscan until the required volume is left in the syringe, allowing sufficient to cover the dead space in the intravenous cannula (Figure 3).
Slovenian: Še naprej potiskajte bat, da iztisnete odvečno količino zdravila Foscan, dokler zahtevana količina zdravila ne ostane v brizgi, pri tem pa pustite dovolj, da zapolnite prazen prostor v intravenozni kanili (slika 3).
English: Pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy are also at risk.
Slovenian: Nevarno je tudi za nosečnice in doječe matere, otroke in skupine z velikim tveganjem, kot so bolniki z jetrnimi obolenji ali epilepsijo.
English: • Closed shoes: for feet.
Slovenian: • Zaprte čevlje: za stopala.
English: Vascular rupture: see section 4.3
Slovenian: Neznani: ruptura krvne žile: glejte poglavje 4.3
English: If you are given more Foscan than you should
Slovenian: Če ste dobili večji odmerek zdravila Foscan, kot bi smeli
English: Very common side effects (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti neželeni učinki (lahko se pojavijo pri več kot 1 od 10 bolnikov)
English: ADMINISTRATION OF FOSCAN (96 hours prior to laser illumination of treatment site)
Slovenian: INJICIRANJE ZDRAVILA FOSCAN (96 ur pred obsevanjem zdravljenega mesta z lasersko svetlobo)
English: • Wide-brimmed hat: for head, neck, nose and ears.
Slovenian: • Klobuk s širokim robom: za glavo, vrat, nos in ušesa.
English: You must follow carefully the instructions on preventing skin burns.
Slovenian: Natančno se morate držati navodil za preprečevanje opeklin na koži.
English: Continue to wear dark, closely woven clothing.
Slovenian: Še naprej nosite temna, gosto tkana oblačila.
English: An in vitro study with human liver tissue has shown no potential for drug interaction through inhibition of cytochrome P-450 enzymes by temoporfin.
Slovenian: In vitro študija s tkivom človeških jeter je pokazala, da ni možnosti medsebojnega delovanja z drugimi zdravili preko inhibicije encimov citokroma P-450 s temoporfinom.
English: The local adverse reactions are characteristic of an acute tissue inflammatory response induced by photoactivation and commonly include oedema and pain followed by necrosis (see section 4.4).
Slovenian: Lokalni neželeni učinki so značilni za akutne vnetne reakcije tkiva, ki ga povzroči fotoaktivacija, in navadno vključujejo edem in bolečino, ki jima sledi nekroza (glejte poglavje 4.4).
English: • You may be sensitive to light for more than 15 days.
Slovenian: • Možno je, da boste na svetlobo ostali preobčutljivi več kot 15 dni.
English: Thus, an in-line filter must be used as a precautionary measure and is provided in the package.
Slovenian: Zato je potrebno kot varnostni ukrep uporabiti zaporedni filter, ki je priložen v pakiranju.
English: By 15 days post-infusion, temoporfin plasma concentration has declined to background such that patients are generally able to begin a gradual return to normal outdoor lighting conditions.
Slovenian: Do 15. dneva po injiciranju koncentracija temoporfina v plazmi pade na nivo, pri katerem so bolniki v glavnem sposobni postopne vrnitve na normalne svetlobne razmere na prostem.
English: Some pulse oximeters may produce light of a wavelength close to that used for the photoactivation of Foscan.
Slovenian: Nekateri pulzni oksimetri oddajajo svetlobo z valovno dolžino blizu tiste, ki se uporablja za fotoaktivacijo zdravila Foscan.
English: The photodynamic effect may also lead to damage of the surrounding tissue that may cause fistula, perforation, or vascular rupture as well as infection and subsequent sepsis.
Slovenian: Fotodinamični efekt lahko povzroči tudi okvaro okolnega tkiva, ta pa fistulo, perforacijo ali rupturo krvnih žil, pa tudi infekcijo in poznejšo sepso.
English: Temoporfin is a low clearance substance with a terminal plasma half-life of 65 hours in patients.
Slovenian: Temoporfin je spojina z nizkim očistkom in s končnim plazemskim razpolovnim časom 65 ur pri bolnikih.
English: Excipients with known effect Each ml contains 376 mg of ethanol anhydrous and 560 mg of propylene glycol.
Slovenian: Pomožne snovi z znanim učinkom: En ml vsebuje 376 mg brezvodnega etanola in 560 mg propilenglikola.
English: Common: Anaemia
Slovenian: Pogosti: anemija
English: • After the laser treatment, you may feel pain in the treated area, e.g. pain in your face or headache.
Slovenian: • Po zdravljenju z lasersko svetlobo boste morda občutili bolečino v zdravljenem predelu, na primer bolečino v obrazu ali glavobol.
English: • You may not be given the laser treatment.
Slovenian: • Morda ne boste zdravljeni z lasersko svetlobo.
English: If extravasation occurs, protect the area from light for at least 3 months.
Slovenian: Če pride do ekstravazacije, je treba mesto zaščititi pred svetlobo za najmanj 3 mesece.
English: There are no data from the use of temoporfin in pregnant women.
Slovenian: Podatkov o uporabi temoporfina pri nosečnicah ni.
English: Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy.
Slovenian: Zdravilo Foscan je indicirano za paliativno zdravljenje bolnikov z napredovalim ploščatoceličnim rakom glave in vratu, pri katerih prejšnja zdravljenja niso bila uspešna in niso primerni za radioterapijo, kirurški poseg ali sistemsko kemoterapijo.
English: Time after Foscan Injection
Slovenian: Čas po injiciranju zdravila Foscan
English: • This product contains 48 vol % ethanol (alcohol), i.e up to 4.2 g per dose, equivalent to 84 ml of beer, 35 ml wine per dose.
Slovenian: • To zdravilo vsebuje 48 vol % etanola (alkohola), to je do 4,2 g na odmerek, kar ustreza 84 ml piva, 35 ml vina na odmerek.
English: Once removed from its package, this medicine must be used immediately.
Slovenian: Po odstranitvi iz pakiranja je treba zdravilo takoj porabiti.