FrancophonIA/ELRC3.0 huggingface dataset:
English: - When you remove the transdermal patch, check your skin and tell your doctor if you notice a serious skin reaction (if your skin is very red, itchy or you notice any blisters).
Slovenian: - Ko transdermalni obliž odstranite, preglejte kožo in povejte zdravniku, če opazite resno kožno reakcijo (če je koža zelo rdeča, srbeča ali so na njej mehurji).
English: Things to remember when using the transdermal patch - Do not keep or store the transdermal patch outside the sealed sachet.
Slovenian: Kaj morate vedeti, ko uporabljate transdermalni obliž - Ne hranite transdermalnega obliža zunaj zataljene vrečice.
English: For serotonergic medicinal products (e.g. SSRIs and SNRIs), there have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic medicinal products (including SSRIs and SNRIs).
Slovenian: V zvezi s serotoninergičnimi zdravili (npr. zaviralci SSRI in SNRI) so poročali o serotoninskem sindromu po sočasni uporabi antagonistov 5-HT3 z drugimi serotoninergičnimi zdravili (vključno z zaviralci SSRI in SNRI).
English: Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Slovenian: Zaradi simptomov, podobnih serotoninskemu sindromu, se priporoča ustrezno opazovanje bolnikov.
English: The granisetron transdermal patch was applied 24 to 48 hours prior to the first dose of chemotherapy, and kept in place for 7 days.
Slovenian: Transdermalni obliž z granisetronom so namestili 24 do 48 ur pred prvim odmerkom kemoterapije in ga pustili na mestu 7 dni.
English: If you stop using SANCUSO
Slovenian: Če ste prenehali uporabljati zdravilo SANCUSO
English: Not known
Slovenian: občasni neznana
English: The study was designed to show non-inferiority of SANCUSO to oral granisetron.
Slovenian: Študija je bila zasnovana tako, da bi pokazala neinferiornost zdravila SANCUSO v primerjavi s peroralnim granisetronom.
English: No correlation between creatinine clearance and total clearance was observed in cancer patients, indicating no influence of renal impairment on the pharmacokinetics of granisetron.
Slovenian: Med očistkom kreatinina in celotnim očistkom pri bolnikih z rakom niso opazili korelacije, kar kaže, da ledvična okvara ne vpliva na farmakokinetiko granisetrona.
English: - SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
Slovenian: - Zaviralci SNRI (zaviralci ponovnega privzema serotonina in noradrenalina) se uporabljajo za zdravljenje depresije in/ali anksioznosti ter vključujejo venlafaksin in duloksetin.
English: Granisetron is cleared primarily by hepatic metabolism.
Slovenian: Granisetron se odstranjuje predvsem s presnovo v jetrih.
English: The sticky side of the transdermal patch is covered by a two-piece rigid plastic film.
Slovenian: Lepljiva stran transdermalnega obliža je pokrita s čvrsto plastično podlogo iz dveh delov.
English: If you are being treated with chemotherapy that is moderately or highly capable of making you feel sick, you may still be sick despite treatment with anti-sickness medicine, including this medicine.
Slovenian: Če se zdravite s kemoterapevtiki, ki zmerno ali močno prožijo siljenje na bruhanje in bruhanje, se lahko še vedno pojavlja bruhanje kljub zdravljenju z ustreznimi zdravili, vključno s tem zdravilom.
English: If the transdermal patch becomes unstuck
Slovenian: Če se transdermalni obliž odlepi
English: If your arms are not suitable areas to apply the transdermal patch your doctor may ask you to put it on your abdomen.
Slovenian: Če ni primerno, da bi si nalepili transdermalni obliž na zgornji ud, vam bo zdravnik mogoče predlagal, da si ga nalepite na trebuh.
English: Remove a sachet from the box and tear it open using the slit provided.
Slovenian: Vzemite vrečico iz škatlice in jo raztrgajte po že pripravljeni zarezi.
English: Application site irritation Application site reactions (application site pain, application site pruritus, application site erythema, application site rash, application site irritation) *
Slovenian: Bolezni kože in podkožja draženje na mestu aplikacije reakcije na mestu aplikacije (bolečina na mestu aplikacije, srbenje na mestu aplikacije, eritem na mestu aplikacije, izpuščaj na mestu aplikacije, draženje na mestu aplikacije)*
English: No clinically relevant interactions between SANCUSO and emetogenic cancer chemotherapies have been seen.
Slovenian: Klinično pomembnih interakcij med zdravilom SANCUSO in emetogenimi kemoterapevtiki za zdravljenje raka niso ugotovili.
English: Apply a single transdermal patch 24 to 48 hours before chemotherapy, as appropriate.
Slovenian: Namestite en transdermalni obliž 24 do 48 ur pred kemoterapijo, kot je pač potrebno.
English: As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following its administration.
Slovenian: Granisetron lahko zmanjša motiliteto spodnjega dela črevesa, zato moramo spremljati bolnike z znaki subakutne obstrukcije črevesa po uporabi granisetrona.
English: The transdermal patch may be applied up to a maximum of 2 days (48 hours) before chemotherapy.
Slovenian: Transdermalni obliž si lahko nalepite do največ 2 dni (48 ur) pred kemoterapijo.
English: Transdermal use.
Slovenian: transdermalna uporaba
English: Concurrent administration of a single intravenous bolus of 0.01 mg/kg (maximum 1 mg) granisetron at the same time a SANCUSO transdermal patch was applied was investigated in healthy subjects.
Slovenian: Pri zdravih preiskovancih so raziskali dajanje enega intravenskega bolusa po 0,01 mg/kg (največji odmerek 1 mg) granisetrona sočasno z aplikacijo transdermalnega obliža zdravila SANCUSO.
English: Adverse reactions from clinical studies and spontaneous reports with SANCUSO are listed in the table below.
Slovenian: Neželeni učinki iz kliničnih študij in spontana poročila o neželenih učinkih zdravila SANCUSO so navedeni v spodnji preglednici.
English: However, no clinically relevant effects on ECG have been observed in clinical studies with SANCUSO, including a through QT study in 240 healthy subjects (section 5.1).
Slovenian: Vendar pa v kliničnih študijah z zdravilom SANCUSO, vključno s temeljito študijo QT pri 240 zdravih prostovoljcih, niso opazili klinično pomembnih učinkov na EKG (poglavje 5.1).
English: What SANCUSO looks like and contents of the pack
Slovenian: Izgled zdravila SANCUSO in vsebina pakiranja
English: Although no evidence of an increased incidence of adverse reactions have been observed in patients with renal or hepatic impairment receiving granisetron orally and intravenously, based on granisetron pharmacokinetics, a degree of caution must be exercised in this population.
Slovenian: Čeprav niso opazili znakov zvečane pogostnosti neželenih učinkov pri bolnikih z okvarami ledvic ali jeter, ki so prejemali granisetron peroralno in intravensko, na podlagi farmakokinetike granisetrona, moramo biti pri tej skupini bolnikov nekoliko previdnejši.
English: How to use SANCUSO
Slovenian: Kako uporabljati zdravilo SANCUSO
English: The transdermal patch will still contain active substance following use.
Slovenian: Transdermalni obliž po uporabi še vedno vsebuje učinkovino.
English: No consistent gender effects on pharmacokinetics were observed in clinical studies with SANCUSO, with a large inter-individual variability reported in both sexes.
Slovenian: V kliničnih študijah z zdravilom SANCUSO niso opazili nikakršnih skladnih učinkov spola na farmakokinetiko, so pa pri obeh spolih poročali o veliki variabilnosti med posameznimi osebami.
English: If the transdermal patch starts to become unstuck, the same transdermal patch may be secured to the same area of skin.
Slovenian: Če se transdermalni obliž odlepi, lahko isti transdermalni obliž ponovno pritrdite na isti predel kože.
English: The transdermal patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen.
Slovenian: Bolnik lahko nosi transdermalni obliž do 7 dni, odvisno od trajanja kemoterapevtske sheme.
English: This leaflet was last revised in July 2018
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: The transdermal patch should not be cut into pieces.
Slovenian: Transdermalnega obliža ni dovoljeno razrezati v več kosov.
English: No clinical studies have been performed specifically to investigate the pharmacokinetics of SANCUSO in patients with renal or hepatic impairment.
Slovenian: Kliničnih študij posebej za to, da bi se raziskala farmakokinetika zdravila SANCUSO pri bolnikih z okvarami ledvic ali jeter, niso opravili.
English: Due to a gradual increase in plasma levels of granisetron following application of the transdermal patch, a slower onset of efficacy compared to 2 mg oral granisetron may be observed at the start of chemotherapy; the patch should be applied 24-48 hours before chemotherapy.
Slovenian: Zaradi postopnega naraščanja plazemske koncentracije granisetrona po namestitvi transdermalnega obliža opažamo v začetku kemoterapije počasnejši nastop učinkovitosti kot pri 2-miligramskem peroralnem granisetronu; obliž je treba nalepiti 24-48 ur pred kemoterapijo.
English: Thin, translucent, matrix-type, rectangular-shaped transdermal patch with rounded corners.
Slovenian: transdermalni obliž Tanek, prosojen, pravokotno oblikovan transdermalni obliž matrične vrste z zaobljenimi vogali.
English: After removal, the used transdermal patch should be folded firmly in half, adhesive side inwards and then discarded out of the reach of children.
Slovenian: Ko bolnik uporabljeni transdermalni obliž odstrani, naj ga čvrsto prepogne na pol z lepljivo stranjo navznoter in ga nato zavrže zunaj dosega otrok.
English: Uncommon side effects are: - headache, a feeling of “spinning” even when you are standing still (vertigo) - decreased appetite, weight loss - flushing (or redness) - feeling sick (nausea), retching, dry mouth - pain in your joints - swelling due to water retention (oedema) - changes in liver function tests (if you are having blood tests, tell the doctor or nurse that you have been given SANCUSO).
Slovenian: - siljenje na bruhanje (navzea), spahovanje, suha usta, - bolečine v sklepih, - otekanje zaradi zastajanja vode (edemi), - spremembe testov jetrnih funkcij (če vam vzamejo kri za preiskave, povejte zdravniku ali medicinski sestri, da so vam dali zdravilo SANCUSO).
English: - Hypersensitivity reactions, e.g. anaphylaxis, urticaria - Insomnia - Headache - Extrapyramidal reactions - Somnolence - Dizziness - QT prolongation - Constipation - Diarrhoea - Elevated hepatic transaminases - Rash - Asthenia
Slovenian: - glavobol, - ekstrapiramidne reakcije, - zaspanost, - omotica, - podaljšanje intervala QT, - zaprtost, - driska, - zvišane jetrne transaminaze,
English: Consequently, SANCUSO is indicated for use in patients where oral anti-emetic administration is complicated by factors making swallowing difficult.
Slovenian: Zato je transdermalni obliž SANCUSO indiciran za uporabo pri bolnikih, pri katerih peroralno uporabo antiemetikov zapletajo dejavniki, ki otežujejo požiranje.
English: Put the transdermal patch on a clean, dry, healthy area of skin on the outside part of your upper arm.
Slovenian: Transdermalni obliž si nalepite na čist, suh, zdrav predel kože na zunanji strani nadlakta.
English: Class effects Class effects for granisetron seen with other formulations (oral and intravenous) include the following:
Slovenian: Učinki skupine Učinki skupine granisetrona, ki jih najdemo pri drugih pripravkih (peroralnih in intravenskih),
English: Patients must be advised to cover the transdermal patch application site, e.g. with clothing, if there is a risk of exposure to sunlight throughout the period of wear and for 10 days following its removal.
Slovenian: Bolnikom moramo priporočiti, naj mesto aplikacije transdermalnega obliža pokrijejo, na primer z oblačili, za ves čas nošenja obliža in še za 10 dni po njegovi odstranitvi, če obstaja nevarnost izpostavljanja sončni svetlobi.
English: - SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
Slovenian: - Zaviralci SSRI (selektivni zaviralci ponovnega privzema serotonina) se uporabljajo za zdravljenje depresije in/ali anksioznosti ter vključujejo fluoksetin, paroksetin, sertralin,
English: Remove the transdermal patch at least 1 day (24 hours) after completing your chemotherapy.
Slovenian: Odstranite transdermalni obliž vsaj 1 dan (24 ur) po dokončanju kemoterapije.
English: Metabolism and nutrition disorders Decreased appetite
Slovenian: Presnovne in prehranske motnje zmanjšan tek občasni
English: Furthermore, no interaction has been observed between granisetron and emetogenic cancer therapies.
Slovenian: Prav tako niso ugotovili medsebojnega delovanja med granisetronom in emetogenimi kemoterapevtiki za zdravljenje raka.
English: While holding the remaining half of the rigid plastic film, apply the transdermal patch to the skin on the outside part of your upper arm.
Slovenian: Držite preostalo polovico čvrste plastične podloge in prilepite transdermalni obliž na kožo na zunanji strani nadlakta.
English: Wash your hands after applying the transdermal patch.
Slovenian: Po namestitvi transdermalnega obliža si umijte roke.
English: You must talk to a doctor if you do not feel better or if you feel worse after the first day of chemotherapy.
Slovenian: Če se po prvem dnevu kemoterapije ne počutite bolje ali če se počutite slabše, se morate pogovoriti z zdravnikom.
English: No differences in the metabolic profiles of granisetron were observed between the oral and transdermal uses.
Slovenian: Biotransformacija Opazili niso nobenih razlik v presnovnih profilih granisetrona pri peroralni in transdermalni uporabi.
English: Take the transdermal patch out of the sachet.
Slovenian: Vzemite transdermalni obliž iz vrečice.
English: Avoid these activities while wearing this transdermal patch.
Slovenian: Ko nosite ta transdermalni obliž, se tem dejavnostim izogibajte.
English: The transdermal patch should be applied to clean, dry, intact healthy skin on the outer part of the upper arm.
Slovenian: Transdermalni obliž je treba namestiti na čisto, suho, nepoškodovano zdravo kožo na zunanji strani nadlakta.
English: Talk to your doctor if you want to remove the patch before the end of your chemotherapy treatment course (up to 7 days).
Slovenian: Če želite obliž odstraniti pred koncem zdravljenja s kemoterapijo (do 7 dni), se posvetujte s svojim zdravnikom.
English: SANCUSO transdermal patches did not show any potential for photoirritation or photosensitivity when tested in vivo in guinea-pigs.
Slovenian: Transdermalni obliži SANCUSO pri testiranju in vivo na budrah niso pokazali potenciala za fotoiritacijo ali fotosenzibilnost.
English: Preclinical data did not reveal any special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproductive toxicity and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij varnostne farmakologije, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: When tested for skin sensitising potential in guinea pigs, SANCUSO showed a low potential for irritancy.
Slovenian: Ko so zdravilo SANCUSO testirali glede potenciala senzitizacije kože na budrah, je zdravilo kazalo majhen potencial draženja.
English: Adverse reactions are presented in order of decreasing seriousness within each frequency grouping.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: No significant effect on QTc prolongation was observed for SANCUSO.
Slovenian: Pri zdravilu SANCUSO niso opazili pomembnega vpliva na podaljšanje intervala QTc.
English: The transdermal patch should be removed a minimum of 24 hours after completion of chemotherapy.
Slovenian: Bolnik mora odstraniti transdermalni obliž najmanj 24 ur po dokončanju kemoterapije.
English: - You should avoid external heat (for example hot water bottles or heat pads) on the area of the transdermal patch.
Slovenian: - Izogibajte se zunanji toploti (na primer termoforju ali ogrevalnim blazinam) v predelu transdermalnega obliža.
English: Each sachet contains one transdermal patch stuck onto a rigid plastic film.
Slovenian: Vsaka vrečica vsebuje en transdermalni obliž, prilepljen na čvrsto plastično podlogo.
English: SANCUSO is a thin, clear, rectangular-shaped transdermal patch with rounded corners, stuck onto a rigid plastic film.
Slovenian: Zdravilo SANCUSO je tanek, prosojen, pravokotno oblikovan transdermalen obliž z zaobljenimi vogali, prilepljen na čvrsto plastično podlogo.
English: Each 52 cm2 transdermal patch contains 34.3 mg of granisetron, releasing 3.1 mg of granisetron per 24 hours.
Slovenian: En transdermalni obliž s površino 52 cm2 vsebuje 34,3 mg granisetrona in sprosti 3,1 mg granisetrona na 24 ur.
English: Granisetron has been shown to block both sodium and potassium channels, which could affect cardiac depolorisation and repolarisation and therefore PR, QRS, and QT intervals.
Slovenian: Pokazali so, da granisetron blokira tako natrijeve kot kalijeve kanalčke, kar bi lahko vplivalo na depolarizacijo in repolarizacijo srca in s tem na intervale PR, QRS in QT. Ti podatki pomagajo pojasniti mehanizme, s katerimi lahko nastanejo nekatere od elektrokardiografskih sprememb (posebno podaljšanje QT in QRS), povezanih s to skupino substanc.
English: When to apply and remove the transdermal patch
Slovenian: Kdaj si namestite in odstranite transdermalni obliž
English: No dose adjustments are necessary for the elderly or patients with renal or hepatic impairment.
Slovenian: Pri starejših bolnikih in pri bolnikih z okvarami ledvic ali jeter prilagajanje odmerka ni potrebno.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v sklepih občasni
English: If it is not possible to apply the transdermal patch to the arm, it can be applied to the abdomen.
Slovenian: Če ni možno namestiti transdermalnega obliža na nadlaket, ga lahko nalepimo na trebuh.
English: Apply a transdermal patch at least 1 day (24 hours) before you are scheduled to have chemotherapy treatment.
Slovenian: Namestite transdermalni obliž vsaj 1 dan (24 ur) pred načrtovano kemoterapijo.
English: This medicine delivers the active substance slowly and constantly through your skin and into your blood stream for the duration that you are wearing the transdermal patch.
Slovenian: Ves čas uporabe transdermalnega obliža prehaja učinkovina iz zdravila počasi in stalno skozi kožo v krvni obtok.
English: No clinically relevant effects have been observed in clinical studies with SANCUSO.
Slovenian: V kliničnih študijah z zdravilom SANCUSO niso opazili klinično pomembnih učinkov.
English: You can continue to shower and wash normally while wearing the transdermal patch.
Slovenian: Ko nosite transdermalni obliž, se lahko normalno tuširate in umivate.
English: Each carton contains one transdermal patch.
Slovenian: Ena škata vsebuje en transdermalni obliž.
English: Wear the transdermal patch all the time during your chemotherapy.
Slovenian: Med kemoterapijo nosite transdermalni obliž ves čas.
English: Immune system disorder
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije neznana
English: No clear relationship between renal function (as measured by creatinine clearance) and granisetron clearance was identified in population PK modelling.
Slovenian: Pri modeliranju populacijske farmakokinetike niso ugotovili nikakršne jasne povezave med funkcijo ledvic (merjeno z očistkom kreatinina) in očistkom granisetrona.
English: Adverse reactions reported for SANCUSO System Organ Class
Slovenian: Preglednica 1: Neželeni učinki zdravila SANCUSO, o katerih poročajo Organski sistem
English: External heat (for example hot water bottles or heat pads) should be avoided on the area of the transdermal patch.
Slovenian: Bolnik naj se izogiba zunanji toploti (na primer vročemu termoforju ali ogrevalnim blazinam) v predelu transdermalnega obliža.
English: Each carton contains 1 transdermal patch.
Slovenian: Ena škatla vsebuje 1 transdermalni obliž.
English: - Allergic reactions including urticaria (itchy, red, raised skin rash) and anaphalaxis (a serious allergic reaction which may include sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching) - Difficulty sleeping/disturbed sleep - Excessive sleepiness - Prolonged QT interval in the ECG (changes to the heart rate trace (ECG) indicating a heart rhythm disorder) - Constipation - Diarrhoea - Lack of energy/weakness /Loss of strength
Slovenian: Drugi možni neželeni učinki, povezani z zdravili z granisetronom (pogostnost ni znana): - alergijske reakcije, vključno z urtikarijo (srbeč, rdeč, privzdignjen kožni izpuščaj) in anafilaksijo (resna alergijska reakcija, ki lahko vključuje nenadno sopenje, težave z dihanjem, otekanje vek, obraza ali ustnic, izpuščaj ali srbenje)
English: Keep the transdermal patch in place for the whole time you are having chemotherapy.
Slovenian: Transdermalni obliž naj bo prilepljen ves čas trajanja kemoterapije.
English: How to store SANCUSO
Slovenian: Shranjevanje zdravila SANCUSO
English: SANCUSO 3.1 mg/24 h transdermal patch Granisetron Transdermal use
Slovenian: SANCUSO 3,1 mg/24 h transdermalni obliž granisetron transdermalna uporaba
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila SANCUSO Vsebina pakiranja in dodatne informacije
English: Gently wash the area with soap and water to remove it. Alcohol or other dissolving liquids such as nail polish remover may cause skin irritation and should not be used.
Slovenian: Ne uporabljajte alkohola ali drugih topil, na primer odstranjevalca laka za nohte, ker lahko povzročajo draženje kože.
English: An initial peak in plasma concentrations of granisetron, attributable to the intravenous dose, was reached at 10 minutes post-administration.
Slovenian: Deset minut po dajanju je bil dosežen začeten vrh plazemske koncentracije granisetrona, ki ga lahko pripišemo intravenskemu odmerku.
English: Paediatric population No studies have been performed to investigate the pharmacokinetics of SANCUSO in paediatrics.
Slovenian: Študij, s katerimi bi raziskovali farmakokinetiko zdravila SANCUSO pri pediatričnih bolnikih, niso izvedli.
English: Granisetron was not phototoxic when tested in vitro in a mouse fibroblast cell line.
Slovenian: Pri testiranju in vitro na celični liniji mišjih fibroblastov granisetron ni bil fototoksičen.
English: How to apply the transdermal patch
Slovenian: Kako si nalepite transdermalni obliž
English: SANCUSO 3.1 mg/24 hours transdermal patch
Slovenian: SANCUSO 3,1 mg/24 ur transdermalni obliž
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: In agreement with these data, no clinically relevant interactions have been reported in clinical studies with SANCUSO.
Slovenian: V kliničnih študijah z zdravilom SANCUSO ne poročajo o klinično pomembnem medsebojnem delovanju, kar se ujema s temi podatki.
English: Where to apply the transdermal patch
Slovenian: Kje si nalepite transdermalni obliž
English: In vitro studies have shown that ketoconazole may inhibit the metabolism of granisetron via the cytochrome P450 3A isoenzyme family.
Slovenian: Pri preiskovancih je spodbujanje jetrnih encimov s fenobarbitalom po intravenskem dajanju granisetrona povzročilo zvečanje celotnega plazemskega očistka (približno za 25 %).Študije in vitro so pokazale, da lahko ketokonazol zavre presnovo granisetrona preko izoencimske skupine citokroma P450 3A.
English: - Keep this leaflet.
Slovenian: - izpuščaj,
English: SANCUSO 3.1 mg/24 hours transdermal patch Granisetron
Slovenian: SANCUSO 3,1 mg/24 ur transdermalni obliž granisetron
English: Common Dry mouth, nausea, retching Uncommon
Slovenian: Bolezni prebavil zaprtost pogosti občasni suha usta, navzea, spahovanje