FrancophonIA/ELRC3.0 huggingface dataset:
English: Application site reactions, such as transient local applications site burning, pain, erythema and pruritus are common or very common.
Slovenian: Reakcije na mestu uporabe, kot so prehodni pekoč občutek na mestu uporabe, bolečina, eritem ter srbečica, so pogoste ali zelo pogoste.
English: Patches should not be held near eyes or mucous membranes.
Slovenian: Obližev se ne sme aplicirati v bližino oči ali sluznic.
English: Cleansing gel will be left on your skin for one minute and then wiped off to remove any remaining medicine that may be left on your skin after treatment.
Slovenian: Čistilni gel bo na koži učinkoval eno minuto, nato ga je treba obrisati, da se odstrani morebitno preostalo zdravilo, ki utegne ostati na koži po zdravljenju.
English: Do not use Qutenza patches at home.
Slovenian: Ne uporabljajte obližev Qutenza doma.
English: Qutenza is a single use patch and can be cut to match the size and shape of the treatment area.
Slovenian: Zdravilo Qutenza je obliž za enkratno uporabo, ki ga je mogoče razrezati, tako da ustreza velikosti in obliki zdravljenega predela.
English: In clinical trials, patients were pre-treated with topical lidocaine (4%), lidocaine (2.5%)/prilocaine (2.5%) or with 50 mg of tramadol.
Slovenian: V kliničnih preskušanjih so na zdravljeni predel predhodno topikalno nanesli 4 % lidokain, 2,5% lidokain /2,5% prilokain ali bolniku dali 50 mg tramadola peroralno.
English: to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (cannot be estimated from the available data).
Slovenian: Neuropathy) in bolečo diabetično periferno nevropatijo: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do < 1/100) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Adverse reactions were transient, self limiting and usually mild to moderate in intensity.
Slovenian: Neželeni učinki so bili prehodni, običajno blage do zmerne intenzivnosti in so izzveneli sami.
English: Each 50 g tube of cleansing gel for Qutenza contains 0.2 mg/g butylhydroxyanisole (E320).
Slovenian: Ena 50 g tuba čistilnega gela za zdravilo Qutenza vsebuje 0,2 mg/g butilhidroksianizola (E320).
English: Cough, throat irritation
Slovenian: Občasni kašelj, draženje grla
English: EU/1/09/524/001 1 patch EU/1/09/524/002 2 patches
Slovenian: EU/1/09/524/001 1 obliž EU/1/09/524/002 2 obliža
English: The Qutenza patch is supplied with a tube of cleansing gel, which contains no active substance.
Slovenian: Obližu Qutenza je priložena tuba čistilnega gela, ki ne vsebuje zdravilnih učinkovin.
English: In case of suspected overdose, the patches should be removed gently, cleansing gel should be applied for one minute and then wiped off with dry gauze and the area should be gently washed with soap and water.
Slovenian: V primeru suma na preveliko odmerjanje je treba obliže nežno odstraniti, aplicirati čistilni gel, ga pustiti učinkovati eno minuto in ga nato obrisati s suho gazo, predel pa nežno umiti z milom in vodo.
English: The outer surface of the backing layer is imprinted with ‘capsaicin 8%'.
Slovenian: Na zunanji plasti je vtisnjena oznaka „capsaicin 8 %“.
English: In addition, there have been reported cases of burns, including second degree burns, in patients treated with capsaicin patches (see section 4.8).
Slovenian: Dodatno so pri bolnikih, zdravljenih z obliži s kapsaicinom, poročali o pojavih opeklin, vključno z opeklinami druge stopnje (glejte poglavje 4.8).
English: The active substance is capsaicin.
Slovenian: Učinkovina je kapsaicin.
English: Qutenza is not recommended for treatment in patients under 18 years of age.
Slovenian: Uporaba zdravila Qutenza pri bolnikih, mlajših od 18 let, ni priporočljiva.
English: • to provide supportive treatment if patients experience increased pain during Qutenza administration
Slovenian: • zagotavljanju podpornega zdravljenja, če se bolečina med apliciranjem obližev Qutenza povečuje;
English: If topical anaesthetic is used prior to patch application proceed with 3, otherwise move to 5.
Slovenian: Če pred uporabo obliža uporabite topikalni anestetik, nadaljujte s točko 3, drugače pojdite na točko 5.
English: Do not take Qutenza patches away from the clinic.
Slovenian: Ne jemljite obližev Qutenza iz bolnišnice.
English: When treating feet, Qutenza patches can be wrapped around the dorsal, lateral and plantar surfaces of each foot to completely cover the treatment area.
Slovenian: Pri zdravljenju stopal lahko obliže Qutenza ovijete okoli dorzalne, lateralne in plantarne površine obeh stopal, da popolnoma prekrijete področje zdravljenja.
English: Before placing the Qutenza patches on the skin, your doctor or nurse may apply a numbing gel or cream or give you an oral pain medicine to reduce potential stinging.
Slovenian: Pred apliciranjem obližev Qutenza na kožo vam bosta zdravnik ali medicinska sestra morda nanesla anestetični gel ali kremo ali dala peroralno zdravilo za lajšanje bolečine za zmanjšanje morebitnega zbadanja.
English: A reproductive toxicology study in rats showed a reduction in the number and percent of motile sperm and the number of pregnancies (see section 5.3).
Slovenian: Študija vpliva na sposobnost razmnoževanja na podganah je pokazala zmanjšanje števila in odstotka gibljivih semenčic in števila brejosti pri podganah (glejte poglavje 5.3) .
English: You may experience pain relief between 1 and 3 weeks after treatment.
Slovenian: Olajšanje bolečin se vam lahko pojavi v 1 do 3 tednih.
English: These precautions should be taken to avoid unintentional contact with the patches or other materials that have come in contact with the treated areas.
Slovenian: Previdnost je potrebna, da po pomoti ne pride do dotika obližev ali drugih materialov, ki so bili v stiku z zdravljenimi predeli.
English: If you have unstable or poorly controlled high blood pressure or had heart problems, your doctor will consider the risk of side effects to your heart or blood pressure due to the potential stress of the procedure before treating you with Qutenza.
Slovenian: Če imate nestabilen ali slabo nadzorovan visok krvni tlak ali ste imeli težave s srcem, bo zdravnik ocenil tveganje neželenih učinkov na srce ali krvni tlak zaradi morebitnega stresa kot posledice postopka, preden bo uporabil zdravilo Qutenza.
English: Cleansing gel should be wiped off with dry gauze to remove any remaining capsaicin from the skin.
Slovenian: Čistilni gel je treba obrisati s suho gazo, tako da se odstrani morebitni preostali kapsaicin s kože.
English: Patients experiencing pain during and after patch application should be provided with supportive treatment such as local cooling (such as a cool compress) or oral analgesics (i.e. short acting opioids).
Slovenian: Bolnikom, ki imajo bolečine med nameščanjem in po nameščanju obliža, je treba zagotoviti podporno zdravljenje, na primer lokalno hlajenje (s hladno kompreso) ali peroralne analgetike (tj. kratkodelujoče opioide).
English: For more detailed instructions, please refer to the Summary of Product Characteristics or the package leaflet.
Slovenian: Podrobnejša navodila so na voljo v Povzetku glavnih značilnosti zdravila ali v navodilu za uporabo.
English: After opening the sachet, Qutenza should be applied within 2 hours.
Slovenian: Po odprtju vrečke je zdravilo Qutenza treba aplicirati v 2 urah.
English: • if you are allergic to capsaicin, chilli peppers or any other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Qutenza • če ste alergični na kapsaicin, čili ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Qutenza must be used only on dry, intact (unbroken) skin and not on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.
Slovenian: Zdravilo Qutenza je treba aplicirati na suho, nepoškodovano (nerazpokano) kožo, vendar ne na obraz, lasišče in/ali v bližino sluznic.
English: Most quantifiable levels were observed at the time of Qutenza removal, with a clear trend towards disappearance by 3 to 6 hours after Qutenza removal.
Slovenian: Največje ravni so bile opažene v trenutku odstranitve zdravila Qutenza, vendar z jasnim trendom upadanja, dokler niso v 3 do 6 urah po odstranitvi zdravila Qutenza upadle na vrednost nič.
English: Cleansing Gel for use with Qutenza
Slovenian: Čistilni gel za uporabo z zdravilom Qutenza
English: After removal of Qutenza, cleansing gel should be applied liberally to the treatment area and left on for at least one minute.
Slovenian: Po odstranitvi zdravila Qutenza je treba na zdravljeni predel izdatno nanesti čistilni gel in ga pustiti učinkovati najmanj eno minuto.
English: A teratology study conducted in rabbits did not show any potential for embryofetal toxicity.
Slovenian: Študija teratogenosti na kuncih ni pokazala možnosti embriofetotoksičnosti.
English: Qutenza is available in packs containing one or two sachets of individually sealed cutaneous patches and a 50 g tube of cleansing gel.
Slovenian: Zdravilo Qutenza je na voljo v pakiranjih, ki vsebujejo po eno ali dve vrečici posamično pakiranih dermalnih obližev in 50-gramsko tubo čistilnega gela.
English: If Qutenza comes in contact with skin not intended to be treated, cleansing gel should be applied for one minute and wiped off with dry gauze to remove any remaining capsaicin from the skin surface.
Slovenian: Če pride zdravilo Qutenza v stik s kožo, ki ni predvidena za zdravljenje, je treba za eno minuto nanesti čistilni gel ter ga nato obrisati s suho gazo, da se s površine kože odstrani morebitni preostali kapsaicin.
English: • to warn patients about the risk of causal local reactions (e.g. contact dermatitis) and of irritation of the eyes and mucous membranes associated with the cleansing gel of Qutenza.
Slovenian: • opozoriti bolnike o tveganju lokalne kožne reakcije (npr. kontaktnega dermatitisa) ter draženju oči in sluznic, ki jih lahko povzroči čistilni gel za zdravilo Qutenza.
English: 640 micrograms of capsaicin per cm 2 of patch (8% w/w).
Slovenian: 640 mikrogramov kapsaicina na cm 2 obliža (8% m/m).
English: Each patch is 14 cm x 20 cm (280 cm2) and consists of an adhesive side containing the active substance and an outer surface backing layer.
Slovenian: Obliž je velik 14 cm x 20 cm (280 cm2) ter je sestavljen iz lepljive strani, ki vsebuje zdravilno učinkovino, in zunanje plasti.
English: What Qutenza is and what it is used for What you need to know before Qutenza is used How to use Qutenza
Slovenian: Kaj je zdravilo Qutenza in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Qutenza Kako uporabljati zdravilo Qutenza Možni neželeni učinki
English: • in patients using high doses of opioids and with suspected high opioid tolerance: to put in place an alternative pain reduction strategy prior to initiating Qutenza treatment, as these patients may not respond to oral opioid analgesics when used for acute pain during and following the treatment procedure
Slovenian: • pri bolnikih, ki uporabljajo visoke odmerke opioidov in pri katerih obstaja sum na visoko toleranco na opioide, oblikovati alternativno strategijo za lajšanje bolečin pred pričetkom zdravljenja z zdravilom Qutenza, saj se ti bolniki morda ne bodo odzvali na peroralne opioidne analgetike, ki jih prejmejo za lajšanje akutne bolečine med postopkom zdravljenja in po njem;
English: • to use caution when administering Qutenza in patients with reduced sensation in the feet and in those at increased risk for such changes in sensory function
Slovenian: • previdni uporabi zdravila Qutenza pri bolnikih z zmanjšanim zaznavanjem v stopalih in bolnikih z večjim tveganjem za takšne spremembe senzorične funkcije
English: Polyethylene Terephthalate (PET) Film, inner side siliconized printing ink containing Pigment White 6
Slovenian: Zunanja plast prevleka iz polietilentereftalata (PET) s silikoniziranim notranjim delom tiskarsko črnilo s Pigment White 6
English: Qutenza has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Qutenza nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Sniffing or inhaling close to the Qutenza patches may cause coughing, throat irritation or sneezing.
Slovenian: Vdihavanje ali inhaliranje v bližini obližev Qutenza lahko povzroči kašelj, draženje grla ali kihanje.
English: Do not touch Qutenza or other materials that have come in contact with the treated areas as it may cause burning and stinging.
Slovenian: Ne dotikajte se zdravila Qutenza ali drugih materialov, ki so bili v stiku z zdravljenimi predeli, saj to lahko povzroči pekoč in zbadajoč občutek.
English: Used and unused patches and all other materials that have been in contact with the treated area should be disposed of immediately after use by sealing them in a polyethylene medical waste bag and placing in an appropriate medical waste container.
Slovenian: Uporabljene in neuporabljene obliže ter vse druge materiale, ki so bili v stiku z zdravljenim predelom, je treba čim prej po uporabi odstraniti, zatesnjene v polietilensko vrečko za medicinske odpadke, in jih odložiti v ustrezen vsebnik za medicinske odpadke.
English: After opening sachet: apply Qutenza within 2 hours.
Slovenian: Po odprtju vrečke: zdravilo Qutenza aplicirajte v 2 urah
English: Clip excessive hair.
Slovenian: Ostrižite odvečne dlake.
English: The most commonly reported adverse reactions were transient local application site burning, pain, erythema and pruritus.
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali, so bili prehodni lokalni pekoč občutek, bolečina, eritemi in pruritus na mestu aplikacije.
English: • If you feel that your heart is beating too fast, too slow or is beating abnormally.
Slovenian: • če imate občutek, da vam srce bije prehitro, prepočasi ali pa neenakomerno o občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
English: If sensory loss is detected or worsens, Qutenza treatment should be reconsidered.
Slovenian: V primeru ugotovljenega senzoričnega izpada ali poslabšanja senzorične funkcije, je treba zdravljenje z zdravilom Qutenza ponovno pretehtati.
English: Contact your doctor straightaway if the following effects happen:
Slovenian: Takoj se posvetujte z zdravnikom, če se pri vas pojavijo naslednji učinki:
English: Do not sniff or inhale close to the Qutenza patches as this may cause coughing or sneezing.
Slovenian: Ne vdihavajte ali inhalirajte v bližini obližev Qutenza, saj lahko to povzroči kašelj ali kihanje.
English: You may be given pain medicines to take for the pain you experience with Qutenza therapy.
Slovenian: Morda boste prejeli zdravila za lajšanje bolečin, ki jih občutite med zdravljenjem z zdravilom Qutenza.
English: The other ingredients of the Qutenza cutaneous patch are:
Slovenian: Druge sestavine dermalnega obliža Qutenza:
English: Health care professionals should wear nitrile gloves when handling patches and cleansing treatment areas.
Slovenian: Zdravstveni delavci morajo med ravnanjem z obliži in čiščenjem zdravljenih predelov nositi nitrilne rokavice.
English: What Qutenza looks like and contents of the pack
Slovenian: Izgled zdravila Qutenza in vsebina pakiranja
English: • Decreased taste, reduced sensations in limbs, eye irritation, cough, throat irritation, nausea,
Slovenian: • zmanjšan okus, zmanjšana občutljivost v okončinah, draženje oči, kašelj, draženje grla, slabost,
English: Application site urticaria, application site paraesthesia, application site dermatitis, application site hyperaesthesia, application site inflammation, application site reaction, application site irritation, application site bruising, peripheral oedema
Slovenian: Občasni urtikarija na mestu aplikacije, parestezija na mestu aplikacije, dermatitis na mestu aplikacije, hiperestezija na mestu aplikacije, vnetje na mestu aplikacije, reakcija na mestu aplikacije, draženje na mestu aplikacije, podplutba na mestu aplikacije, periferni edemi
English: Efficacy of a single 30-minute application of Qutenza to the feet has been shown in controlled clinical trials conducted in patients with painful Human Imunodeficiency Virus - Associated Neuropathy (HIV-AN) and painful diabetic peripheral neuropathy.
Slovenian: Učinkovitost enkratne 30 minut trajajoče uporabe zdravila Qutenza na stopalih je bila dokazana v kontroliranih kliničnih preskušanjih z bolniki z bolečo nevropatijo, povezano z virusom humane imunske pomanjkljivosti (HIV-AN - Human Imunodeficiency Virus - Associated Neuropathy) in bolečo diabetično periferno nevropatijo.
English: Efficacy of a single 60-minute application of Qutenza to locations other than the feet has been shown in controlled clinical trials conducted in patients with postherpetic neuralgia (PHN).
Slovenian: Učinkovitost enkratne 60 minut trajajoče uporabe zdravila Qutenza na drugih mestih so dokazali v kontroliranih kliničnih preskušanjih bolnikov s postherpetično nevralgijo (PHN - postherpetic neuralgia).
English: What you need to know before Qutenza is used
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Qutenza
English: Capsaicin-induced alterations in cutaneous nociceptors are reversible and it has been reported and observed that normal function (the detection of noxious sensations) returns within weeks in healthy volunteers.
Slovenian: Poročali in opazili so, da se je normalno delovanje (zaznavanje škodljivih dražljajev) pri zdravih prostovoljcih povrnilo v nekaj tednih.
English: Dispose of cleansing gel tube by sealing in a polyethylene bag along with other used Qutenza components and placing in an appropriate medical waste container.
Slovenian: Tubo čistilnega gela odstranite zatesnjeno v polietilenski vrečki skupaj z drugimi uporabljenimi deli kompleta zdravila Qutenza ter jih odložite v ustrezen vsebnik za medicinske odpadke.
English: Qutenza 179 mg cutaneous patch
Slovenian: Qutenza 179 mg dermalni obliž
English: These items may sting your fingers if you touch them.
Slovenian: Dotik s temi predmeti lahko povzroči pekoč občutek v prstih.
English: There are no studies of the effects of Qutenza on the ability to drive and use machines.
Slovenian: Študije učinkov zdravila Qutenza na sposobnost upravljanja vozil in strojev niso bile izvedene.
English: Appropriate medical care should be provided if shortness of breath develops.
Slovenian: Če pride do oteženega dihanja, je potrebna ustrezna zdravstvena oskrba.
English: Gently clean with soap and water and dry thoroughly.
Slovenian: Predel nežno očistite z milom in vodo ter ga dobro osušite.
English: No detectable levels of metabolites were observed in any subject.
Slovenian: Pri nobenem bolniku ni bilo opaziti zaznavnih ravni presnovkov.
English: The capsaicin contained in Qutenza is intended for delivery into the skin.
Slovenian: Kapsaicin, ki ga vsebuje zdravilo Qutenza, je predviden za sproščanje v kožo.
English: How to use Qutenza
Slovenian: Kako uporabljati zdravilo Qutenza
English: Therefore, Qutenza is unlikely to have any direct effects on your ability to concentrate or your ability to drive or use machinery.
Slovenian: Zato je malo verjetno, da bi imelo zdravilo Qutenza neposredne učinke na sposobnost konrentracije ali sposobnost upravljanja vozil in strojev.
English: The gel or cream should be removed prior to applying Qutenza and the skin washed and dried thoroughly.
Slovenian: Gel ali kremo je treba pred uporabo zdravila Qutenza odstraniti, kožo oprati ter posušiti.
English: Dispose of used and unused patches, gauze wipes and all other materials placed in contact with the treated area by sealing in a polyethylene bag and placing in an appropriate medical waste container.
Slovenian: Uporabljene in neuporabljene obliže, omote gaz ter vse druge materiale, ki so bili v stiku z zdravljenim predelom, odstranite zatesnjene v polietilenski vrečki in jih odložite v ustrezen vsebnik za medicinske odpadke.
English: Qutenza 179 mg cutaneous patch capsaicin
Slovenian: Qutenza 179 mg dermalni obliž kapsaicin
English: Your doctor or nurse may wear gloves, and sometimes a mask and protective glasses, while handling the Qutenza patches.
Slovenian: Med pripravo obližev Qutenza lahko zdravnik ali medicinska sestra nosita rokavice, včasih tudi masko ter zaščitna očala.
English: Qutenza should be cut prior to removal of the release liner.
Slovenian: Zdravilo Qutenza je treba razrezati pred odstranitvijo zaščitne podloge.
English: Particular attention should be given to diabetic patients with comorbidities of coronary artery disease, hypertension and cardiovascular autonomic neuropathy.
Slovenian: Posebno pozornost je treba nameniti sladkornim bolnikom, ki imajo sočasno bolezen koronarnih arterij, hipertenzijo ali kardiovaskularno avtonomno nevropatijo.
English: If you are using high doses of opioids, you may not respond to oral opioid analgesics when used for acute pain during and following the treatment procedure.
Slovenian: Če uporabljate visoke odmerke opioidov, se morda ne boste odzvali na peroralne opioidne analgetike, ki jih boste prejeli za lajšanje akutne bolečine med postopkom zdravljenja in po njem.
English: Qutenza must be applied to intact, non-irritated, dry skin, and allowed to remain in place for 30 minutes for the feet (e.g. HIV-associated neuropathy, painful diabetic peripheral neuropathy) and 60 minutes for other locations (e.g. postherpetic neuralgia).
Slovenian: Zdravilo Qutenza je treba aplicirati na čisto, nerazdraženo, suho kožo, kjer mora učinkovati 30 minut na predelu stopal (npr. pri nevropatiji, povezani s HIV, boleči diabetični periferni nevropatiji) oz. 60 minut na drugih predelih (npr. pri postherpetični nevralgiji).
English: Breast-feeding should be discontinued during treatment with Qutenza.
Slovenian: Dojenje morate med zdravljenjem z zdravilom Qutenza prekiniti.
English: Sometimes your doctor or nurse may put a bandage on top of the Qutenza patch to keep the patch firmly on your skin.
Slovenian: Zdravnik ali medicinska sestra lahko prek obliža Qutenza ovije obvezo, da ostane obliž trdno na koži.
English: Qutenza has been shown to be effective when used alone or when used in combination with systemic medicinal products for neuropathic pain.
Slovenian: Zdravilo Qutenza se je izkazalo za učinkovito pri samostojni uporabi ali v kombinaciji s sistemskimi zdravili za lajšanje nevropatske bolečine.
English: Your doctor will mark the most painful areas on your skin with a pen or marker.
Slovenian: Zdravnik bo s pisalom ali drugim označevalcem označil najbolj boleče predele kože.
English: Unintended exposure
Slovenian: Naključna izpostavljenost
English: Assuming 1000 cm2 of patch area delivers approximately 1% of capsaicin from the patch to a 60 kg person, the maximum potential exposure to capsaicin is approximately 0.12 mg/kg, once every 3 months.
Slovenian: 1% kapsaicina, je maksimalna potencialna izpostavljenost kapsaicinu približno 0,12 mg/kg vsake 3 mesece.
English: Qutenza cutaneous patch: Store flat in the original sachet and carton.
Slovenian: Qutenza dermalni obliž: shranjujte v vodoravnem položaju v originalni vrečki in škatli.
English: Hair in treatment areas will be clipped.
Slovenian: Na zdravljenem predelu je treba postriči dlake.
English: Cleansing gel for Qutenza contains butylhydroxyanisole
Slovenian: Čistilni gel za uporabo z zdravilom Qutenza vsebuje butilhidroksianizol
English: Temporary, minor changes in heat detection (1°C to 2°C) and sharp sensations were detected at the Qutenza application site in clinical trials with healthy volunteers.
Slovenian: V kliničnih preskušanjih zdravih prostovoljcev so opazili prehodne, blage spremembe zaznavanja toplote (1 °C do 2 °C) in ostre občutke na mestu aplikacije zdravila Qutenza.
English: Patients using high doses of opioids may not respond to oral opioid analgesics when used for acute pain during and following the treatment procedure.
Slovenian: Bolniki, ki uporabljajo visoke odmerke opioidov, se morda ne bodo odzvali na peroralne opioidne analgetike, ki jih prejmejo za lajšanje akutne bolečine med postopkom zdravljenja in po njem.
English: Clean treatment area.
Slovenian: Zdravljeni predel očistite.