FrancophonIA/ELRC3.0 huggingface dataset:
English: • evaluate the initial marketing authorisation application of all medicines in the EU.
Slovenian: • ocenjuje vloge za prvotno izdajo dovoljenja za promet z zdravilom v EU: za veliko večino zdravil, ki so na voljo v EU, je bilo dovoljenje izdano na nacionalni ravni.
English: • Search human medicines
Slovenian: • Išči zdravila za uporabo v humani medicini;
English: The completed DoIs for management staff are available on the EMA website under Agency structure.
Slovenian: Izpolnjene izjave o interesih za vodstveno osebje so na voljo v razdelku o sestavi agencije EMA.
English: For more information, see Transparency.
Slovenian: Dodatne informacije so na voljo v razdelku Preglednost.
English: Breach-of-trust procedure
Slovenian: Postopek za obravnavo zlorabe zaupanja
English: Staff members
Slovenian: Zaposleni
English: • Search veterinary medicines
Slovenian: • Išči zdravila za uporabo v veterinarski medicini.
English: • Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary The data requirements and standards governing the authorisation of medicines are the same in the EU, irrespective of the authorisation route.
Slovenian: Zahteve glede podatkov in standardi, ki urejajo izdajanje dovoljenj za zdravila, so v vsej EU enaki, ne glede na to, po kateri poti je bilo dovoljenje izdano.
English: − diabetes;
Slovenian: − sladkorne bolezni,
English: The Agency works by:
Slovenian: V ta namen:
English: Date of first authorisation: 20 April 2012 Date of latest renewal: 9 January 2017
Slovenian: Datum prve odobritve: 20. april 2012 Datum zadnjega podaljšanja: 9 januar 2017
English: *Spontaneous reports
Slovenian: *spontana poročila
English: Showering or washing
Slovenian: Tuširanje ali umivanje
English: Dosing as for adults (see sections 4.4 and 5.2).
Slovenian: Odmerjanje je enako kot pri odraslih (glejte poglavji 4.4 in 5.2).
English: External heat
Slovenian: Zunanja toplota
English: Complete control by day is illustrated below.
Slovenian: Popolna kontrola po dnevih je prikazana v nadaljevanju.
English: This medicine should not be used by children or adolescents under 18 years.
Slovenian: Otroci in mladostniki, mlajši od 18 let, tega zdravila ne smejo uporabljati.
English: Exposure to sunlight
Slovenian: Izpostavljanje sončni svetlobi
English: The safety and efficacy of SANCUSO in children aged 0 to 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila SANCUSO pri otrocih, starih 0 do 18 let, še nista bili dokazani.
English: 78% of patients were white, with 12% Asian and 10% Hispanic/Latino.
Slovenian: 78 % bolnikov je bilo belcev, 12 % Azijcev in 10 % Latinoameričanov.
English: Body Mass Index (BMI)
Slovenian: Indeks telesne mase (BMI)
English: After intravenous injection, approximately 12% of the dose is excreted unchanged in the urine of healthy subjects in 48 hours.
Slovenian: Po intravenskem injiciranju se približno 12 % odmerka izloči nespremenjenega v urinu zdravih oseb v 48 urah.
English: Any increase in corticosteroid use during the study was reported as rescue treatment.
Slovenian: O vsakem zvečanju uporabe kortikosteroidov med študijo so poročali kot o rešilnem zdravilu.
English: Within the system organ class, the adverse reactions are listed by frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Znotraj organskih sistemov so neželeni učinki navedeni po pogostnosti z uporabo naslednjih kategorij: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Do not remove the transdermal patch from the sachet until you are ready to use it.
Slovenian: Ne vzemite transdermalnega obliža iz vrečice, dokler niste pripravljeni na to, da ga boste uporabili.
English: The remainder of the dose is excreted as metabolites, with 49% in the urine and 34% in the faeces.
Slovenian: Preostanek odmerka se izloči v obliki presnovkov, in sicer 49 % v urinu, 34 % pa v blatu.
English: It may harm them,
Slovenian: - vročinski oblivi (ali rdečina),
English: If you have forgotten to apply your transdermal patch at the right time, apply it as soon as you remember, and tell your doctor as soon as possible before your chemotherapy treatment.
Slovenian: Če ste pozabili pravočasno uporabiti transdermalni obliž, si ga namestite, takoj ko se spomnite, in to povejte zdravniku čimprej pred kemoterapijo.
English: If the transdermal patch is lost or becomes damaged go back to your doctor.
Slovenian: Če se transdermalni obliž izgubi ali poškoduje, se vrnite k zdravniku.
English: The used transdermal patch will still contain some granisetron and should be disposed of immediately as described in section 5.
Slovenian: Uporabljeni transdermalni obliž še vedno vsebuje nekaj granisetrona in ga je treba takoj zavreči, kot je opisano v poglavju 5.
English: This medicine is for transdermal use.
Slovenian: To zdravilo je namenjeno za transdermalno uporabo.
English: If it does not, tell your doctor.
Slovenian: Če ne bo izginila, povejte zdravniku.
English: Granisetron may be affected by direct natural or artificial sunlight, see section 5.3 for further information.
Slovenian: Direktna naravna ali umetna sončna svetloba lahko vpliva na granisetron; glejte poglavje 5.3 za več informacij.
English: - Contact with water during bathing or showering will not change the way SANCUSO works.
Slovenian: - Stik z vodo med kopanjem ali tuširanjem ne bo spremenil delovanja zdravila SANCUSO.
English: - Use only one transdermal patch at a time.
Slovenian: - Uporabite samo en transdermalni obliž hkrati.
English: The most commonly reported adverse reaction in clinical studies was constipation, occurring in approximately 8.7% of patients.
Slovenian: Neželeni učinek, o katerem v kliničnih študijah najpogosteje poročajo, je zaprtost, ki se pojavlja pri približno 8,7 % bolnikov.
English: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands
Slovenian: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, Nizozemska
English: The mean plasma half-life in healthy subjects is 4-6 hours and in patients is 9-12 hours.
Slovenian: Srednji plazemski razpolovni čas pri zdravih preiskovancih je 4-6 ur, pri bolnikih pa 9-12 ur.
English: If you use more SANCUSO than you should, simply remove the extra patch(es) and contact your doctor.
Slovenian: Če ste uporabili več zdravila SANCUSO, kot ga potrebujete, preprosto odstranite dodatni obliž (ali dodatne obliže) in obvestite zdravnika.
English: Symptomatic treatment should be given.
Slovenian: Indicirano je simptomatsko zdravljenje.
English: Do not use this medicine after the expiry date which is stated on the outer carton and the sachet after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vrečici poleg oznake ‘EXP‘.
English: In the event of overdose, the transdermal patch should be removed.
Slovenian: V primeru prevelikega odmerjanja je treba transdermalni obliž odstraniti.
English: Tell your doctor or nurse before using this treatment if any of the following applies to you: - if you have been told you have a heart disorder or disease - if you have pain in your stomach or your stomach is swollen - if you have problems with your kidneys or liver.
Slovenian: Povejte svojemu zdravniku ali medicinski sestri, preden vzamete to zdravilo, če za vas velja kaj od naslednjega: - če so vam povedali, da imate težave s srcem ali kakšno bolezen srca, - če imate bolečine v trebuhu ali otekel trebuh, - če imate težave z ledvicami ali jetri.
English: There is no specific antidote for granisetron.
Slovenian: Specifičnega antidota za granisetron ni na voljo.
English: Granisetron is mainly metabolised to 7-hydroxygranisetron and 9'N-desmethylgranisetron.
Slovenian: Granisetron se v glavnem presnavlja v 7-hidroksigranisetron in 9'N-desmetilgranisetron.
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: This medicine may not work as well and/or may affect your skin if exposed to direct sunlight or the light from sunlamps or tanning beds.
Slovenian: To zdravilo mogoče ne bo tako dobro delovalo in/ali lahko vpliva na vašo kožo, če bo izpostavljena neposredni sončni svetlobi ali svetlobi v solariju ali ležečem solariju.
English: The transdermal patch should not be placed on skin that is red, irritated or damaged.
Slovenian: Transdermalnega obliža ne smemo namestiti na kožo, ki je rdeča, vneta ali poškodovana.
English: Granisetron distributes freely between plasma and red blood cells.
Slovenian: Granisetron se prosto porazdeli med plazmo in rdeče krvničke.
English: The safety profile of SANCUSO is derived from controlled clinical trials and from post-marketing experience.
Slovenian: Varnostni profil zdravila SANCUSO je rezultat kontroliranih kliničnih preskušanj in izkušenj po prihodu zdravila na trg.
English: Continue to keep the application site covered for a further 10 days after removing the transdermal patch.
Slovenian: Mesto uporabe naj bo pokrito še nadaljnjih 10 dni po odstranitvi transdermalnega obliža.
English: Carcinogenicity studies showed no special hazard for humans when used at the recommended dose.
Slovenian: Študije kancerogenosti niso pokazale posebnega tveganja za ljudi, če se zdravilo uporablja v priporočenem odmerku.
English: Use of concomitant corticosteroids
Slovenian: Sočasna uporaba kortikosteroidov
English: SANCUSO can affect the way some medicines work.
Slovenian: Zdravilo SANCUSO lahko vpliva na to, kako delujejo nekatera zdravila.
English: - The active substance is granisetron.
Slovenian: - Učinkovina je granisetron.
English: Also some other medicines can affect the way SANCUSO works.
Slovenian: Prav tako lahko nekatera druga zdravila vplivajo na to, kako deluje zdravilo SANCUSO.
English: Given the wide variability in pharmacokinetic parameters of granisetron and the good tolerance well above the recommended dose, dose adjustment in patients with functional hepatic impairment is not necessary.
Slovenian: Ob veliki variabilnosti farmakokinetičnih parametrov granisetrona in dobre tolerance za odmerke, precej večje od priporočenih, prilagajanje odmerjanja pri bolnikih s funkcijsko okvaro jeter ni potrebno.
English: The majority of adverse reactions were mild or moderate in severity.
Slovenian: Večina neželenih učinkov je bila po izraženosti blaga ali zmerna.
English: Radioligand binding studies have demonstrated that granisetron has negligible affinity for other receptor types, including 5HT1, 5HT2, 5HT4 and dopamine D2 binding sites.
Slovenian: Raziskave vezave radioaktivno označenih ligandov so pokazale, da ima granisetron zanemarljivo afiniteto za druge vrste receptorjev, med drugim za 5HT1, 5HT2, 5HT4 in vezavna mesta D2 za dopamin.
English: The population randomised into the trial included 48% males and 52% females aged 16 to 86 years receiving moderately emetogenic (ME) or highly emetogenic (HE) multi-day chemotherapy.
Slovenian: Populacija, ki je bila randomizirana v preskušanje, je obsegala 48 % moških in 52 % žensk, starih 16 do 86 let, ki so prejemali zmerno emetogeno (ME) ali zelo emetogeno (HE) večdnevno kemoterapijo.
English: After intravenous dosing, the mean plasma clearance ranged from 33.4 to 75.7 l/h in healthy subjects and from 14.7 to 33.6 l/h in patients with wide inter-subject variability.
Slovenian: Po intravenskem odmerku je srednji plazemski očistek segal od 33,4 do 75,7 l/h pri zdravih osebah in od 14,7 do 33,6 l/h pri bolnikih s široko variabilnostjo med posameznimi preiskovanci.
English: Tell your doctor immediately if you develop constipation or if your stomach becomes painful or swollen.
Slovenian: Nemudoma obvestite svojega zdravnika, če se pojavi zaprtost ali če trebuh postane boleč ali otekel.
English: Be careful not to stick the transdermal patch to itself and avoid touching the sticky side of the transdermal patch.
Slovenian: Pazite, da se transdermalni obliž ne bo zlepil sam s sabo in da se ne boste dotaknili lepljive strani transdermalnega obliža.
English: 2132NP Hoofddorp The Netherlands Tel: +31 (0) 237200822
Slovenian: Tel. +31 (0) 237200822
English: This variability is similar to the known high variability in granisetron pharmacokinetics after oral or intravenous administration.
Slovenian: Ta variabilnost je podobna znani veliki variabilnosti v farmakokinetiki granisetrona po peroralni ali intravenski uporabi.
English: Used transdermal patches still contain active ingredients, which may be harmful to others.
Slovenian: Rabljeni transdermalni obliži vsebujejo še nekaj učinkovine, ki lahko škodujejo drugim.
English: The newly applied transdermal patch should be removed in line with the timing recommended above.
Slovenian: Na novo nalepljeni transdermalni obliž je treba odstraniti ob času, ki je priporočen zgoraj.
English: A study in cloned human cardiac ion channels has shown that granisetron has the potential to affect cardiac repolarisation via blockade of hERG potassium channels.
Slovenian: Študija na kloniranih človeških srčnih ionskih kanalčkih je pokazala, da ima granisetron lahko vpliv na srčno repolarizacijo preko blokade kalijevih kanalčkov tipa hERG.
English: The known pharmacokinetic profile of the transdermal patch over the period of wear (7 days) was not affected.
Slovenian: To ni vplivalo na znani farmakokinetični profil transdermalnega obliža v času nošenja (7 dni).
English: In clinical trials with SANCUSO, application site reactions were reported which were generally mild in intensity and did not lead to discontinuation of use.
Slovenian: V kliničnih preskušanjih z zdravilom SANCUSO so poročali o reakcijah na mestu aplikacije, ki so bile na splošno blage po intenzivnosti in zaradi njih ni bilo treba prekiniti uporabe.
English: Do not put SANCUSO on areas that have been treated with creams, oils, lotions, powders or other skin products that could keep the transdermal patch from sticking well to your skin.
Slovenian: Ne nalepite si zdravila SANCUSO na predele, namazane s kremami, olji, losjoni, praški ali drugimi pripravki za kožo, zaradi katerih se transdermalni obliž mogoče ne bi dobro prilepil na kožo.
English: Other medicines and SANCUSO
Slovenian: Druga zdravila in zdravilo SANCUSO
English: - The transdermal patch may be affected by direct sunlight or exposure to sunlamps.
Slovenian: - Na transdermalni obliž lahko vplivata neposredna sončna svetloba ali izpostavljanje sončnim solarijem.
English: CC was defined as no vomiting and/or retching, no more than mild nausea and no rescue medicine from the first administration until 24 hours after the start of the last day's administration of multi-day chemotherapy.
Slovenian: CC je bila opredeljena takole: nobenega bruhanja in/ali spahovanje, kvečjemu blaga navzea in nobenega rešilnega zdravila od prve uporabe do 24 ur po začetku dajanja večdnevne kemoterapije zadnjega dne.
English: Each transdermal patch is packed in a sachet and should be applied directly after the sachet has been opened.
Slovenian: Vsak transdermalni obliž je zapakiran v vrečici in ga je treba uporabiti takoj po odprtju vrečice.
English: While you are wearing the transdermal patch you must keep it covered, e.g. under clothing, if there is a risk of exposure to sunlight or sunlamps.
Slovenian: Medtem ko uporabljate transdermalni obliž, pazite, da bo pokrit, na primer pod oblačili, če obstaja tveganje izpostavljanja sončni svetlobi ali sončnim solarijem.
English: Plasma protein binding is approximately 65%.
Slovenian: Približno 65 % se ga veže na plazemske beljakovine.
English: Hypersensitivity to the active substance, to other 5-HT3 receptor antagonists or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino, na druge antagoniste receptorjev 5-HT3 ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: After transdermal patch application, the apparent granisetron plasma half-life in healthy subjects was prolonged to approximately 36 hours due to the slow absorption rate of granisetron through the skin.
Slovenian: Po namestitvi transdermalnega obliža se je navidezni razpolovni čas granisetrona v plazmi pri zdravih osebah podaljšal na približno 36 ur zaradi počasne absorpcije granisetrona skozi kožo.
English: Granisetron crosses intact skin into the systemic circulation by a passive diffusion process.
Slovenian: Granisetron prehaja skozi intaktno kožo v sistemski krvni obtok s procesom pasivne difuzije.
English: However, when administered in higher doses and over a prolonged period of time, the risk of carcinogenicity cannot be ruled out but with the short application period recommended for the transdermal delivery system, a carcinogenic risk for humans is not expected.
Slovenian: Če pa zdravilo dajemo v večjih odmerkih in daljši čas, tveganja kancerogenosti ni mogoče izključiti, pri kratkem obdobju uporabe, ki je priporočeno za transdermalni sistem dajanja zdravila, pa ne pričakujemo kancerogenega tveganja za ljudi.
English: In the event of a transdermal patch becoming completely or partially detached, the original transdermal patch should be reattached in the same position using medical tape (if necessary).
Slovenian: Če se transdermalni obliž popolnoma ali deloma odlepi, moramo originalni transdermalni obliž pritrditi nazaj na isto mesto z medicinskim lepilnim trakom (če je potrebno).
English: Granisetron is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5HT3 receptors).
Slovenian: Granisetron je močan antiemetik in zelo selektiven antagonist receptorjev za 5-hidroksitriptamin (5HT3).
English: In the pivotal SANCUSO study, the concomitant use of corticosteroids, e.g. dexamethasone, was permitted provided it was part of the chemotherapy regimen.
Slovenian: V ključni študiji zdravila SANCUSO je bila dovoljena sočasna uporaba kortikosteroidov, na primer deksametazona, pod pogojem, da je bila del kemoterapevtske sheme.
English: Following routine haematological monitoring, the transdermal patch should only be applied to patients whose chemotherapy treatment is unlikely to be delayed in order to reduce the possibility of unnecessary exposure to granisetron.
Slovenian: Po rutinskem hematološkem spremljanju se sme transdermalni obliž uporabiti samo pri bolnikih, pri katerih odložitev kemoterapevtskega zdravljenja ni verjetna, s čimer se zmanjša možnost nepotrebne izpostavljenosti granisetronu.
English: If severe reactions, or a generalised skin reaction occur (e.g. allergic rash, including erythematous, macular, papular rash or pruritus), the transdermal patch must be removed.
Slovenian: Če se pojavijo težke reakcije ali generalizirana kožna reakcija (na primer alergijski izpuščaj, vključno z eritematoznim, makularnim, papularnim izpuščajem ali pruritusom), je treba transdermalni obliž odstraniti.
English: Mean Cmax was 3.9 ng/ml (range 0.7 - 9.5 ng/ml), with a between subject variability of 77%.
Slovenian: Srednja Cmax je bila 3,9 ng/ml (razpon 0,7 - 9,5 ng/ml), variabilnost med preiskovanci pa 77 %.
English: What SANCUSO is and what it is used for
Slovenian: Kaj je zdravilo Sancuso in za kaj ga uporabljamo
English: Each transdermal patch is packaged in a heat-sealed sachet composed of polyester-coated paper/aluminium/LLDPE.
Slovenian: En transdermalni obliž je pakiran v toplotno zataljeni vrečici, sestavljeni iz papirja, prevlečenega s poliestrom/aluminija/LLDPE.
English: The signs may include red, raised itchy bumps
Slovenian: Znaki lahko vključujejo rdeče, privzdignjene srbeče bulice.
English: Press firmly making sure there is good contact with the skin, especially around the edges.
Slovenian: Čvrsto ga pritisnite in se prepričajte, da je v tesnem stiku s kožo, posebno okrog robov.
English: In vitro studies using human liver microsomes indicate that CYP1A1 is the major enzyme responsible for the 7-hydroxylation of granisetron, whereas CYP3A4 contributes to 9'desmethylation.
Slovenian: Raziskave in vitro, v katerih so uporabljali mikrosome človeških jeter, kažejo, da je glavni encim, odgovoren za 7hidroksilacijo granisetrona, CYP1A1, medtem ko CYP3A4 prispeva k 9'desmetilaciji.
English: Rare side effects (may affect up to 1 in 1,000 people) are: - abnormal muscle movements (such as shaking, muscle rigidity and muscle contractions).
Slovenian: Redki neželeni učinki (pojavijo se lahko pri 1 od 1.000 bolnikov) so: - nenormalni mišični gibi (na primer tresenje, mišična togost in mišični krči).
English: It is important to use this medicine during the whole length of your chemotherapy (up to 7 days) to prevent you feeling sick or being sick following your chemotherapy.
Slovenian: Pomembno je, da to zdravilo uporabljate med celotnim trajanjem kemoterapije (do 7 dni), da preprečite siljenje na bruhanje ali bruhanje po kemoterapiji.
English: 5-HT3 receptor antagonists, such as granisetron, may be associated with arrhythmias or ECG abnormalities.
Slovenian: Antagonisti receptorjev 5-HT3, na primer granisetron, so lahko povezani z aritmijami ali nenormalnostmi EKG.
English: Constipation is a common side effect and may affect up to 1 in 10 people.
Slovenian: Zaprtost je pogosten neželeni učinek, pojavi se lahko pri 1 od 10 ljudi.
English: There are no data on the effect of granisetron on human fertility.
Slovenian: Ni podatkov o vplivu granisetrona na plodnost pri ljudeh.
English: Do not re-use the transdermal patch after removal, see below for instructions on transdermal patch removal and disposal (see section 5).
Slovenian: Potem, ko transdermalni obliž odstranite, ga ne smete uporabiti še enkrat, glejte navodila v nadaljevanju o tem, kako odstranite in zavržete transdermalni obliž (glejte poglavje 5).
English: In clinical trials with SANCUSO, there were no treatment-related effects on heart rate or blood pressure.
Slovenian: V kliničnih preskušanjih z zdravilom SANCUSO ni bilo učinkov, povezanih z zdravljenjem, na srčno frekvenco ali krvni tlak.
English: This potentially may have clinical significance in patients with pre-existing arrhythmias or cardiac conduction disorders or patients who are being treated with antiarrhythmics or beta-blockers.
Slovenian: To bi lahko bilo klinično pomembno pri bolnikih z že obstoječimi aritmijami ali motnjami srčne prevodnosti ali pri bolnikih, ki se zdravijo z antiaritmiki ali blokatorji adrenergičnih receptorjev beta.
English: The recommended dose is one single transdermal patch.
Slovenian: Priporočeni odmerek je en sam transdermalni obliž.
English: Following SANCUSO application, granisetron is absorbed slowly, with maximal concentrations reached between 24 and 48 hours.
Slovenian: Po namestitvi transdermalnega obliža SANCUSO se granisetron absorbira počasi, največje koncentracije se dosežejo med 24 in 48 urami.
English: The Multinational Association of Supportive Care in Cancer (MASCC) guidelines recommend the administration of dexamethasone with 5HT3 antagonist prior to chemotherapy.
Slovenian: Smernice Mednarodne zveze za podporno zdravljenje raka (MASCC-Multinational Association of Supportive Care in Cancer) priporočajo uporabo deksametazona z antagonistom 5HT3 pred kemoterapijo.
English: A pivotal, randomised, double-blind, double-dummy, multinational Phase III study compared the efficacy, tolerability and safety of SANCUSO with that of 2 mg oral granisetron once daily in the prevention of nausea and vomiting in a total of 641 patients receiving multi-day chemotherapy.
Slovenian: V ključni randomizirani, dvojno slepi multinacionalni študiji faze III, nadzirani z vzporednim placebom, so primerjali učinkovitost, prenašanje in varnost zdravila SANCUSO z učinkovitostjo, prenašanjem in varnostjo 2-miligramskega odmerka peroralnega granisetrona enkrat na dan za preprečevanje navzee in bruhanja pri vsega skupaj 641 bolnikih, ki so prejemali večdnevno kemoterapijo.