FrancophonIA/ELRC3.0 huggingface dataset:
English: Kytril was first approved in Europe in France, through the national procedure on 12 April 1991.
Slovenian: Zdravilo Kytril so v Evropi prvič odobrili v Franciji z nacionalnim postopkom dne 12. aprila 1991.
English: Not all strengths may be registered in all EU Member States.
Slovenian: Vse jakosti morda niso registrirane v vseh državah članicah EU.
English: Although there are some differences in wording, there are no significant discrepancies in this section.
Slovenian: Čeprav je bilo v besedilu nekaj razlik, večjih razhajanj v tem poglavju ni bilo.
English: In Europe, the product is available as film-coated tablets (1 mg and 2 mg) and solutions for injection (1 mg/1 ml, 3 mg/3 ml, 3 mg/1 ml and 3 mg/5 ml).
Slovenian: V Evropi je zdravilo na voljo v obliki filmsko obloženih tablet (1 mg in 2 mg) in raztopin za injiciranje (1 mg/1 ml, 3 mg/3 ml, 3 mg/1 ml in 3 mg/5 ml).
English: The safety and efficacy of Kytril tablets in children have not yet been established and no data are available.
Slovenian: Varnost in učinkovitost tablet Kytril pri otrocih še nista bili dokazani in na voljo niso nobeni podatki.
English: In the development programme four double-blind randomised placebo controlled clinical studies were conducted (Studies 276, 278, 285 and 503).
Slovenian: V razvojnem programu so bile izvedene štiri dvojno slepe s placebom nadzorovane randomizirane klinične študije (študije 276, 278, 285 in 503).
English: Overall summary of the scientific evaluation of Kytril and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Kytril in povezanih imen (glejte Dodatek I)
English: PSUR 1028611 also details an episode of dystonia following granisetron.
Slovenian: V PSUR 1028611 so navedene tudi informacije o epizodi distonije po uporabi granisetrona.
English: It is therefore endorsed by the CHMP not to have pregnancy/lactation as a contraindication in section 4.3 but as information in section 4.6 (pregnancy and lactation).
Slovenian: CHMP je tako potrdil, da se nosečnost/dojenje ne vključi kot kontraindikacija v poglavje 4.3, ampak kot informacija v poglavje 4.6 (nosečnost in dojenje).
English: The treatment of delayed CINV has not been investigated in clinical trials.
Slovenian: Zdravljenja zakasnele CINV niso preučevali v kliničnih preskušanjih.
English: The term ‘headache' has been included as it is clearly described in the clinical studies and the literature as a very common adverse event.
Slovenian: Vključen je bil izraz „glavobol“, saj je v kliničnih študijah in literaturi jasno opisan kot zelo pogost neželeni učinek.
English: According to the current European SmPC guideline (September 2009), the following contraindication was included: “hypersensitivity to the active substance or to any of the excipients”.
Slovenian: V skladu z veljavno evropsko smernico za povzetek glavnih značilnosti zdravila (september 2009) so bile vključene naslednje kontraindikacije: „preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.“
English: Postoperative nausea and vomiting (PONV), is defined as nausea and/or vomiting occurring within 24 hours after surgery.
Slovenian: Pooperacijska slabost in bruhanje (PONV) sta opredeljena kot slabost in/ali bruhanje, ki se pojavi v 24 urah po operaciji.
English: The work-sharing PSUR covering period 19 Feb 2006 - 19 Dec 2008 (SK/H/PSUR/0004/001) refers to a case report of an extrapyramidal reaction following administration of granisetron.
Slovenian: Skupno dopolnjeno redno poročilo o varnosti zdravila za obdobje od 19. februarja 2006 do 19. decembra 2008 (SK/H/PSUR/0004/001) navaja klinični primer ekstrapiramidalne reakcije po uporabi granisetrona.
English: Considering the few clinical trials performed in children, the CHMP agreed that an age range need not be mentioned.
Slovenian: Glede na majhno število izvedenih kliničnih preskušanj pri otrocih se je CHMP strinjal, da ni treba navajati starostnega razpona.
English: As there are no studies in pregnant women, it is not known whether granisetron is excreted in milk.
Slovenian: Ker pri nosečnicah niso bile izvedene nobene študije, ni znano, ali se granisetron izloča v mleko.
English: There is evidence that hepatic enzyme induction with phenobarbital in human volunteers resulted in an increase in total plasma clearance and intravenous Kytril of approximately 25 %.
Slovenian: Na voljo so dokazi, da je indukcija jetrnih encimov s fenobarbitalom pri prostovoljcih povzročila povečanje celotnega plazemskega očistka intravenoznega zdravila Kytril za približno 25 %.
English: Granisetron, the active ingredient of Kytril is a highly selective antagonist of 5-hydroxytryptamine (5-HT3) receptors and displays potent antiemetic activity.
Slovenian: Granisetron, zdravilna učinkovina v zdravilu Kytril, je visoko selektivni antagonist receptorjev 5hidroksitriptamina (5-HT3), ki kaže močno antiemetično delovanje.
English: As Kytril (granisetron) was included in the list of products for SmPC harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended, due to the divergent national decisions taken by Member States, the European Commission notified the European Medicines Agency of an official referral under Article 30(2) of Directive 2001/83/EC, as amended in order to resolve divergences amongst the nationally authorised Summary of Product Characteristics (SmPC), and thus to harmonise its divergent SmPC across the EU.
Slovenian: Ker je bilo zaradi različnih nacionalnih odločitev držav članic zdravilo Kytril (granisetron) vključeno na seznam zdravil za uskladitev povzetka glavnih značilnosti zdravila, ki ga je v skladu s členom 30(2) Direktive 2001/83/ES, kakor je bila spremenjena, pripravil CMD(h); je Evropska komisija obvestila Evropsko agencijo za zdravila o uradni napotitvi v skladu s členom 30(2) Direktive 2001/83/ES, kakor je bila spremenjena, da bi odpravili razlike med nacionalno odobrenimi povzetki glavnih značilnosti zdravila in uskladili različne povzetke glavnih značilnosti zdravila po vsej EU.
English: However they may potentially become significant in increased risk subpopulations such as patients with cardiac co-morbidities, patients receiving cardiotoxic chemotherapy or patients having concomitant electrolyte abnormalities as described in section 4.4.
Slovenian: Vendar pa obstaja možnost, da postanejo te spremembe pomembne pri podskupinah s povečanim tveganjem, kot so bolniki s sočasnimi srčnimi obolenji, bolniki, ki prejemajo kardiotoksično kemoterapijo, ali bolniki s sočasnimi elektrolitskimi motnjami, kot je navedeno v poglavju 4.4.
English: Implications that Kytril may cause cancer is in humans are currently considered to be unfounded.
Slovenian: Navedbe, da bi lahko zdravilo Kytril pri ljudeh povzročalo raka, tako veljajo za neutemeljene.
English: Nausea and vomiting is experienced in most patients undergoing chemotherapy and radiotherapy, and may be classified as: - Acute onset; occurring within 24 h of initial administration of chemotherapy or radiotherapy - Delayed onset; occurring 24 h to several days after administration of chemotherapy or radiotherapy
Slovenian: Slabost in bruhanje se pojavita pri večini bolnikov, ki se zdravijo s kemoterapijo in radioterapijo, ter se lahko opredelita kot: - akuten pojav, ki nastopi v 24 urah po začetnem odmerku kemoterapije ali radioterapije; - zakasnel pojav, ki nastopi od 24 ur do nekaj dni po odmerku kemoterapije ali radioterapije.
English: A pooled analysis for studies 276 and 278 was performed.
Slovenian: Izvedena je bila združena analiza za študiji 276 in
English: Taking into consideration the comments by the CHMP, the wording of section 5.3 has been amended by the MAH, taking into account the safety margins based on mg/kg basis and the appropriate study durations.
Slovenian: Ob upoštevanju pripomb CHMP je imetnik dovoljenja za promet z zdravilom dopolnil besedilo poglavja 5.3, tako da je upošteval varnostne meje na podlagi razmerja mg/kg in ustrezno trajanje študij.
English: Pharmacokinetics in the paediatric population with i.v administration was explored and reported to be similar to that in adult patients.
Slovenian: Raziskali so tudi farmakokinetiko pri pediatrični populaciji po intravenskem dajanju in poročali, da je bila podobna tisti pri odraslih bolnikih.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: The wording concerning QT prolongation and 5-HT3 antagonists has been reviewed and approved as part of the Article 46 procedure, and the approved wording regarding QTc prolongation has been included in section 4.5 as well as in sections 4.4 and 4.8.
Slovenian: Besedilo v zvezi s podaljšanjem intervala QT in antagonisti 5-HT3 je bilo pregledano in odobreno kot del postopka v skladu s členom 46, potrjeno besedilo glede podaljšanja intervala QTc pa je bilo vključeno v poglavje 4.5 ter v poglavji 4.4 in
English: There are no studies in pregnant women and it is not known whether Kytril is excreted in human milk.
Slovenian: Pri nosečnicah niso bile izvedene nobene študije in ni znano, ali se zdravilo Kytril izloča v človeško mleko.
English: Section 4.7 - Effects on ability to drive and use machines The proposed SmPC text reflects the recommendations regarding section 4.7 in the European SmPC guideline.
Slovenian: Poglavje 4.7 - Vpliv na sposobnost vožnje in upravljanja s stroji Predlagano besedilo povzetka glavnih značilnosti zdravila odraža priporočila v zvezi s poglavjem 4.7 v evropski smernici za povzetek glavnih značilnosti zdravila.
English: The CHMP considered the MAH's proposed wording in section 5.2 to be acceptable with the addition that the pharmacokinetics of oral administration is linear up to 2.5-fold of the recommended dose in adults and also that the plasma concentration does not correlate unequivocally with the antiemetic efficacy of the substance for both the tablets and solution for injection formulations.
Slovenian: CHMP je menil, da je predlagano besedilo imetnika dovoljenja za promet z zdravilom za poglavje 5.2 sprejemljivo z dopolnitvijo, da je farmakokinetika pri peroralni uporabi linearna do 2,5kratnega priporočenega odmerka pri odraslih ter da plazemska koncentracija ni jasno povezana z antiemetično učinkovitostjo snovi tako pri formulaciji tablet kot pri formulaciji raztopine za injiciranje.
English: In response to the LoOI the MAH discussed their own safety data as well as data in published trials and well known databases, and it was agreed that extrapyramidal reactions would be included as an adverse event in section 4.8 of the SmPC.
Slovenian: V odgovorih na seznam nerešenih vprašanj je imetnik dovoljenja za promet z zdravilom obravnaval tako lastne podatke o varnosti kot tudi podatke iz objavljenih preskušanj in dobro znanih podatkovnih zbirk in dogovorjeno je bilo, da se ekstrapiramidalne reakcije vključijo kot neželeni učinek v poglavje 4.8 povzetka glavnih značilnosti zdravila.
English: In addition following further CHMP discussion, diarrhoea, (frequently reported adverse event in the pooled studies 276 and 278 and in the integrated summary of safety) and elevations in hepatic transaminases (observed in the CDS) were also included as adverse reactions.
Slovenian: Po nadaljnji razpravi v CHMP sta bila med neželene učinke vključena tudi driska (neželeni učinek, o katerem so pogosto poročali v združenih študijah 276 in 278 ter v celostnem povzetku varnosti) in zvišanje jetrnih transaminaz (opaženo na podatkovnem listu s temeljnimi podatki).
English: Section 4.5- Interaction with other medicinal products and other forms of interaction There is a need to apply caution when giving medication, which is known to prolong the QT interval, concurrently with 5-HT3 antagonists such as Kytril.
Slovenian: Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Pri dajanju zdravila, za katero je znano, da podaljšuje interval QT, sočasno z antagonisti 5-HT3, kot je zdravilo Kytril, je potrebna previdnost.
English: The CHMP also endorsed the proposal that caution should be exercised in patients with cardiac comorbidities or cardiotoxic chemotherapy and/or concomitant electrolyte abnormalities.
Slovenian: CHMP je potrdil tudi predlog, da je potrebna previdnost pri bolnikih s sočasnimi srčnimi obolenji, bolnikih, ki prejemajo kardiotoksično kemoterapijo, in/ali bolnikih s sočasnimi elektrolitskimi motnjami.
English: Based on the presented data the CHMP agreed that the use of Kytril should preferably be avoided during pregnancy.
Slovenian: Na podlagi predstavljenih podatkov je CHMP potrdil, da se je med nosečnostjo bolje izogibati uporabi zdravila Kytril.
English: Based on the evidence provided, the use of Kytril in PONV was restricted to the solution for injection formulation only.
Slovenian: Na podlagi predloženih dokazov je bila uporaba zdravila Kytril pri PONV omejena samo na formulacijo raztopine za injiciranje.
English: Several in vitro and in vivo studies did not show that Kytril had a genotoxic effect on mammalian cells.
Slovenian: Več študij in vitro ter in vivo ni pokazalo nobenega genotoksičnega učinka zdravila Kytril na celice sesalcev.
English: Section 4.4 - Special warnings and precautions for use As it is well-known that 5-HT3 antagonists lower bowel motility, which is reflected in the literature, the CHMP endorsed the MAH's proposal that patients with signs of sub-acute intestinal obstruction should be monitored following administration of Kytril.
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi Ker je dobro znano, da antagonisti 5-HT3 zmanjšujejo gibljivost črevesja, kar je razvidno tudi iz literature, je CHMP potrdil predlog imetnika dovoljenja za promet z zdravilom, da je treba bolnike s subakutno obstrukcijo črevesja po uporabi zdravila Kytril spremljati.
English: The SmPC wording regarding QT prolongation has been agreed through the Article 46 procedure as follows “As for other 5-HT3 antagonists, ECG changes including QT prolongation have been reported with Kytril (See sections 4.4 and 4.5).” The CHMP endorsed the MAH's proposal to place QT-prolongations as a description of selected adverse events, because the ECG modifications including the QT-prolongation seen were minor and generally not of clinical significance.
Slovenian: Besedilo o podaljšanju intervala QT v povzetku glavnih značilnosti zdravila je bilo potrjeno s postopkom v skladu s členom 46 in se glasi: „Kot pri drugih antagonistih 5-HT3 so tudi pri uporabi zdravila Kytril poročali o spremembah EKG, vključno s podaljšanjem intervala QT (glejte poglavji 4.4 in 4.5).“ CHMP je potrdil predlog imetnika dovoljenja za promet z zdravilom, da se podaljšanje intervala QT vključi v opis izbranih neželenih učinkov, saj so bile opažene spremembe EKG, vključno s podaljšanjem intervala QT, manj pomembne in na splošno brez kliničnega pomena.
English: Solution for injection: ‘Kytril solution for injection is indicated in adults for the prevention and treatment of
Slovenian: Raztopina za injiciranje: „Raztopina za injiciranje Kytril je indicirana pri odraslih za preprečevanje in zdravljenje
English: Taking into account the recommendation of the CHMP and the MAH's proposals, the following wording was agreed for the indication in adults, for the following pharmaceutical forms - tablets and solution for injection:
Slovenian: Ob upoštevanju priporočil CHMP in predlogov imetnika dovoljenja za promet z zdravilom je bilo za farmacevtski obliki - tablete in raztopina za injiciranje - usklajeno naslednje besedilo za indikacijo pri odraslih:
English: It was also endorsed by the CHMP that insomnia should be included in the SmPC as an adverse event, since it occurs with a frequency greater than 2 % compared with placebo, in the clinical study 285.
Slovenian: CHMP je tudi potrdil, da je treba v povzetek glavnih značilnosti zdravila kot neželeni učinek vključiti nespečnost, saj se v klinični študiji 285 pojavlja s pogostnostjo, ki je v primerjavi s placebom večja za 2 %.
English: The SmPC has not included cross-sensitivity reactions as a contraindication for Kytril , but instead included appropriate wording in the warnings and precautions section (section 4.4) of the EU harmonised SmPC.
Slovenian: V povzetek glavnih značilnosti zdravila Kytril kot kontraindikacija niso bile vključene reakcije navzkrižne občutljivosti, namesto tega pa je bilo ustrezno besedilo dodano v poglavje z opozorili in previdnostnimi ukrepi (poglavje 4.4) usklajenega povzetka glavnih značilnosti zdravila na ravni EU.
English: The terms hypersensitivity (e.g. anaphylaxis, urticaria) and constipation were included in the proposed SmPC as they are included in the majority of SmPCs, and are also supported by referenced texts and the CDS.
Slovenian: Izraza preobčutljivost (na primer anafilaksa, urtikarija) in zaprtje sta bila vključena v predlagani povzetek glavnih značilnosti zdravila, saj sta vključena v večino povzetkov glavnih značilnosti zdravila, potrjujejo pa ju tudi referenčna besedila in podatkovni list s temeljnimi podatki.
English: The use of granisetron orally in PONV is not recommended.
Slovenian: Peroralna uporaba granisetrona pri PONV ni priporočljiva.
English: Further evidence provided by the MAH support the use of granisetron only in the prevention of delayed CINV and RINV, and not in the treatment of delayed CINV and RINV for both formulations.
Slovenian: Nadaljnji dokazi, ki jih je predložil imetnik dovoljenja za promet z zdravilom, prav tako podpirajo uporabo granisetrona samo pri preprečevanju zakasnele CINV in RINV, ne pa tudi pri zdravljenju zakasnele CINV in RINV za obe formulaciji.
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
Slovenian: • Namen napotitve je bila uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo.
English: Based on the theoretical possibility of cross-sensitivity reactions with granisetron, the MAH has proposed to include cautionary wording in this section of the SmPC.
Slovenian: Na podlagi teoretične možnosti za pojav reakcij navzkrižne občutljivosti ob uporabi granisetrona je imetnik dovoljenja za promet z zdravilom predlagal vključitev opozorilnega besedila v to poglavje povzetka glavnih značilnosti zdravila.
English: There was insufficient evidence for the adverse events agitation, anxiety, arrhythmias, chest pain, coma, dizziness, dysgeusia, hypotension/hypertension, syncope and/or drowsiness/ somnolence, anorexia, nausea, vomiting, abdominal pain, fever, fatigue and weakness/asthenia/tiredness, flulike symptoms, oedema and pain in patients treated with Kytril and the CHMP therefore concurred that these terms could be excluded from the SmPC.
Slovenian: Ker ni bilo zadostnih dokazov, na podlagi katerih bi bilo pri bolnikih, zdravljenih z zdravilom Kytril, kot neželene učinke mogoče potrditi vznemirjenost, tesnobo, aritmije, bolečine v prsih, komo, omotico, disgevzijo, hipotenzijo/hipertenzijo, sinkopo in/ali dremavost/zaspanost, anoreksijo,
English: Considering the lack of data for dystonia, the CHMP agreed with MAH not to include this undesirable effect in the proposed SmPC at this point in time.
Slovenian: Zaradi pomanjkanja podatkov v zvezi z distonijo se je CHMP strinjal z imetnikom dovoljenja za promet z zdravilom, da se v tem trenutku ta neželeni učinek ne vključi v predlagani povzetek glavnih značilnosti zdravila.
English: Following a review of the available data, the MAH has concluded that the use of Kytril orally in PONV should not be recommended, which was supported by the CHMP.
Slovenian: Po pregledu razpoložljivih podatkov je imetnik dovoljenja za promet z zdravilom sklenil, da peroralna uporaba zdravila Kytril pri PONV ni priporočljiva, kar je potrdil tudi CHMP.
English: Based solely on the hypersensitivity reaction, the CHMP agreed that rash should also be listed.
Slovenian: Zgolj na podlagi reakcije preobčutljivosti je CHMP potrdil, da se na seznam vključijo tudi izpuščaji.
English: This is consistent with the recommendations and wording of the SmPC guideline.
Slovenian: Besedilo je v skladu s priporočili in besedilom smernice za povzetek glavnih značilnosti zdravila.
English: There is insufficient clinical evidence to recommend administration of Kytril solution for injection to children in the prevention and treatment of RINV and PONV.
Slovenian: Ni zadostnih kliničnih dokazov, na podlagi katerih bi bilo mogoče priporočiti uporabo raztopine za injiciranje Kytril pri otrocih za preprečevanje in zdravljenje RINV in PONV.
English: However as agreed by the CHMP, the administration of Kytril solution for injection is recommended in children aged 2 years and above, only for the prevention and treatment of acute CINV.
Slovenian: Vendar pa je CHMP potrdil, da je uporaba raztopine za injiciranje Kytril priporočena za uporabo pri otrocih, starih dve leti in več, vendar samo za preprečevanje in zdravljenje akutne CINV.
English: Based on the available data, the indication for Kytril solution for injection in the treatment and prevention of delayed CINV was not agreed by the CHMP.
Slovenian: Na podlagi razpoložljivih podatkov CHMP ni potrdil indikacije za zdravljenje in preprečevanje zakasnele CINV za raztopino za injiciranje Kytril.
English: Tablets: ‘Kytril film-coated tablets are indicated in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy.
Slovenian: Tablete: „Filmsko obložene tablete Kytril so indicirane pri odraslih za preprečevanje in zdravljenje akutnih slabosti in bruhanja, povezanih s kemoterapijo in radioterapijo.
English: Therefore the following paediatric indication was agreed by the CHMP, only for Kytril solution for injection: ‘Kytril solution for injection is indicated in children aged 2 years and above for the prevention and treatment of acute nausea and vomiting associated with chemotherapy.'
Slovenian: Tako je CHMP potrdil naslednjo pediatrično indikacijo samo za raztopino za injiciranje Kytril: „Raztopina za injiciranje Kytril je indicirana pri otrocih, starih 2 leti in več, za preprečevanje in zdravljenje akutnih slabosti in bruhanja, povezanih s kemoterapijo.“ Poglavje 4.2 - Odmerjanje in način uporabe
English: Kytril solution for injection is indicated for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.'
Slovenian: Raztopina za injiciranje Kytril je indicirana za preprečevanje zakasnelih slabosti in bruhanja, povezanih s kemoterapijo in radioterapijo.“
English: Harmonisation of the existing SmPCs relating to the clinical sections, for Kytril film-coated tablets and solutions for injection, are discussed below:
Slovenian: Uskladitev obstoječih povzetkov glavnih značilnosti zdravila v zvezi s kliničnimi poglavji za zdravilo Kytril, filmsko obložene tablete in raztopine za injiciranje, je predstavljena v nadaljevanju: Poglavje 4.1 - Terapevtske indikacije
English: The CHMP recommendation that Kytril should be used with a certain amount of caution in hepatically impaired patients was also included by the MAH.
Slovenian: Imetnik dovoljenja za promet z zdravilom je vključil tudi priporočilo CHMP, da je treba zdravilo Kytril pri bolnikih z jetrno okvaro uporabljati z nekaj previdnosti.
English: There is insufficient clinical experience to recommend administration of Kytril tablets to children for CINV, RINV or PONV.
Slovenian: Trenutno ni zadostnih kliničnih izkušenj, na podlagi katerih bi bilo mogoče priporočiti uporabo tablet Kytril pri otrocih s CINV, RINV ali PONV.
English: -acute nausea and vomiting associated with chemotherapy and radiotherapy.
Slovenian: - akutnih slabosti in bruhanja, povezanih s kemoterapijo in radioterapijo; - pooperacijskih slabosti in bruhanja.