FrancophonIA/ELRC3.0 huggingface dataset:
English: If changes do occur, they are generally without clinical significance.
Slovenian: Če se spremembe pojavijo, ponavadi niso klinično značilne.
English: • problems sleeping (insomnia)
Slovenian: • težave s spanjem (nespečnost);
English: The doctor will work out how much to give you.
Slovenian: Zdravnik bo ugotovil, koliko zdravila vam mora dati.
English: Because the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much.
Slovenian: Ker vam bo injekcijo dal zdravnik ali medicinska sestra, je malo verjetno, da ga boste prejeli preveč.
English: The tablets should be swallowed whole with water.
Slovenian: Tablete se morajo pogoltniti cele z vodo.
English: You will be treated depending on your symptoms.
Slovenian: Zdravili vas bodo glede na vaše simptome.
English: However, when administered in higher doses and over a prolonged period of time the risk of carcinogenicity cannot be ruled out.
Slovenian: Vendar, če ga dajemo v višjih odmerkih in v daljšem časovnem obdobju, tveganja za kancerogenost ni mogoče izključiti.
English: The safety and efficacy of granisetron tablets in children have not yet been established.
Slovenian: Varnost in učinkovitost granisetron tablet pri otrocih še nista bili dokazani.
English: This additional dose should not be administered until at least 10 minutes after the initial infusion.
Slovenian: Ta dodatni odmerek se ne sme dati vsaj 10 minut po začetni infuziji.
English: If you do stop taking your medicine, your symptoms may return.
Slovenian: Če zdravilo prenehate jemati, se simptomi lahko povrnejo.
English: One additional dose may be administered within a 24 hour-period if required.
Slovenian: Če je treba se lahko da en dodatni odmerek v 24 urah.
English: {Name and address} {tel} {fax} {e-mail}
Slovenian: {Ime in naslov} {tel.} {fax} {e-mail}
English: These tablets are only for use in adults.
Slovenian: Te tablete so samo za odrasle.
English: Carcinogenicity studies revealed no special hazard for humans when used in the recommended human dose.
Slovenian: Študije kancerogenosti niso pokazale nobenih posebnih tveganj za ljudi, kadar se uporablja v priporočenih odmerkih za človeka.
English: It is unknown whether granisetron or its metabolites are excreted in human milk.
Slovenian: Ni znano, če se granisetron ali njegovi metaboliti izločajo v materino mleko.
English: Do not stop taking your medicine before the treatment is finished.
Slovenian: Zdravila ne prenehajte jemati pred končanim zdravljenjem.
English: Despite these changes, no dosage adjustment is necessary (see section 4.2).
Slovenian: Kljub tej spremembi prilagajanje odmerka ni potrebno (glejte poglavje 4.2).
English: Other side effects that may be experienced while taking this medicine are: Very common: affects more than 1 user in 10
Slovenian: Drugi neželeni učinki, ki jih lahko izkusite pri jemanju tega zdravila so: Zelo pogosti: pojavijo se pri več kot 1 bolniku od 10 bolnikov
English: This medicine contains lactose (a type of sugar).
Slovenian: Zdravilo vsebuje laktozo (vrsto sladkorja).
English: The injection will be given to you by a doctor or nurse.
Slovenian: Injekcijo vam bo dal zdravnik ali medicinska sestra.
English: However, there is no modification of the cardiac frequency, blood pressure or the ECG trace.
Slovenian: Vendar pa sprememb srčne frekvence, krvnega tlaka ali v zapisu EKG ni.
English: Keep container in the outer carton in order to protect from light.
Slovenian: Vsebnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: The signs may include swelling of the throat, face, lips and mouth, difficultly in breathing or swallowing.
Slovenian: Znaki so lahko otekanje grla, obraza, ustnic in ust, težave pri dihanju in požiranju.
English: Children should not take these tablets.
Slovenian: Otroci teh tablet ne smejo jemati.
English: Granisetron is extensively distributed, with a mean volume of distribution of approximately 3 l/kg.
Slovenian: Granisetron se porazdeljuje v velikem obsegu, srednji volumen porazdelitve je približno 3 l/kg.
English: No specific interaction studies have been conducted in anaesthetised patients.
Slovenian: Specifičnih študij medsebojnega delovanja pri anesteziranih bolnikih niso izvedli.
English: Treatment (acute nausea)
Slovenian: Zdravljenje (akutna slabost)
English: There is no specific antidote for Kytril.
Slovenian: Specifičnega antidota za zdravilo Kytril ni.
English: These tablets are not recommended in children.
Slovenian: Teh tablet se ne priporoča pri otrocih.
English: • changes in the heartbeat (rhythm) and changes seen on ECG readings (electrical recordings of the heart)
Slovenian: • spremembe bitja srca (ritma) in spremembe vidne na EKG zapisu (električnem zapisu delovanja srca;
English: The effect of the injection may be improved by the use of medicines called adrenocortical steroids.
Slovenian: Učinek injekcije se lahko izboljša z uporabo t.i. kortikosteroidov.
English: This structure lacks an effective blood-brain barrier, and will detect emetic agents in both the systemic circulation and the cerebrospinal fluid.
Slovenian: Tej strukturi manjka učinkovita krvnomožganska pregrada in bo zato zaznala emetično snov v sistemskem obtoku in cerebrospinalni tekočini.
English: *Occurred at a similar frequency in patients receiving comparator therapy Description of selected adverse reactions
Slovenian: * Pojavili so se podobno pogosto kot pri bolnikih s primerjalnim zdravljenjem Opis izbranih neželenih učinkov
English: Kytril can be given as an injection into the veins (intravenous).
Slovenian: Zdravilo Kytril se lahko da kot injekcija v veno (intravensko).
English: The solution for injection is a clear, colourless liquid.
Slovenian: Raztopina za injiciranje je bistra, brezbarvna tekočina.
English: There will be at least 10 minutes between each injection.
Slovenian: Med vsako injekcijo mora preteči vsaj 10 minut.
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 ionskih kanalčkih srca je pokazala, da lahko granisetron vpliva na repolarizacijo srca z zaviranjem kalijevih kanalčkov HERG.
English: Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, zmanjšano aktivnostjo laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Important information about some of the ingredients of Kytril
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Kytril
English: Elevated hepatic transaminases*
Slovenian: Pogosti zvišane jetrnih transaminaz*
English: • allergic reactions (anaphylaxis).
Slovenian: • alergične reakcije (anafilaktična reakcija).
English: Also some other medicines can affect the way these tablets work.
Slovenian: Prav tako lahko druga zdravila vplivajo na delovanje teh tablet.
English: Also some other medicines can affect the way this injection works.
Slovenian: Prav tako lahko druga zdravila vplivajo na delovanje teh injekcij.
English: Frequency categories are as follows: Very common: 1/10;
Slovenian: Razvrstitve pogostnosti so naslednje: Zelo pogosti ≥ 1/10;
English: There is no evidence to date for an increased incidence of adverse events in patients with hepatic disorders.
Slovenian: Do sedaj ni dokazov o povečani pojavnosti neželenih dogodkov pri bolnikih z boleznijo jeter.
English: Granisetron is metabolized primarily in the liver by oxidation followed by conjugation.
Slovenian: Granisetron se primarno presnavlja v jetrih z oksidacijo, ki ji sledi konjugacija.
English: The maximum dose to be administered over 24 hours should not exceed 9 mg.
Slovenian: Največji odmerek dan v 24 urah ne sme preseči 9 mg.
English: • changes in how your liver is working shown by blood tests
Slovenian: • spremembe delovanja ledvic vidne pri krvnih testih;
English: Granisetron Intravenous use
Slovenian: granisetron intravenska uporaba
English: Like all medicines, Kytril can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Kytril neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: The dose will usually be either one or two 1 mg tablets or one 2 mg tablet once a day, but your doctor may decide to increase your dose to upto nine 1 mg tablets a day.
Slovenian: Odmerek bo običajno ena ali dve 1-mg tableti ali ena 2-mg tableta enkrat na dan, vendar vam lahko vaš zdravnik poveča odmerek do devet 1-mg tablet na dan.
English: The solution for injection is for use in adults and children from 2 years old.
Slovenian: Raztopina za injiciranje se uporablja pri odraslih in otrocih starih 2 leti in več.
English: The other ingredients are sodium chloride, water for injections, citric acid monohydrate, hydrochloric acid and sodium hydroxide for pH (acidity) adjustment.
Slovenian: Pomožne snovi so natrijev klorid, voda za injekcije, citronska kislina monohidrat, klorovodikova kislina in natrijev hidroksid za uravnavanje pH.
English: • the antibiotic erythromycin used to treat bacterial infections.
Slovenian: • antibiotik eritromicin, za zdravljenje bakterijskih okužb.
English: In the case of overdose with the injection, symptomatic treatment should be given.
Slovenian: V primeru prevelikega odmerjanja z injekcijo je potrebno simptomatskoo zdravljenje.
English: The major compounds are 7-OH-granisetron and its sulphate and glycuronide conjugates.
Slovenian: Glavne spojine so 7hidroksi granisetron in njegov sulfat ter konjugat glukuronida.
English: There are no special precautions required for its use in either elderly patients or those patients with renal or hepatic impairment.
Slovenian: Posebna previdnost za uporabo pri starejših bolnikih ali pri bolnikih z ledvično in jetrno okvaro ni potrebna.
English: In children, after single intravenous doses, pharmacokinetics are similar to those in adults when appropriate parameters (volume of distribution, total plasma clearance) are normalized for body weight.
Slovenian: Pri otrocih je bila farmakokinetika po enkratnem intravenskem odmerku podobna tisti pri odraslih, kadar so bili ustrezni parametri (volumen porazdelitve, celokupni plazemski očistek) normalizirani glede na telesno težo.
English: Absorption of granisetron is rapid and complete, though oral bioavailability is reduced to about 60% as a result of first pass metabolism.
Slovenian: Granisetron se hitro in popolnoma absorbira, vendar je pri peroralnem zaužitju zaradi presnove prvega prehoda biološka uporabnost zmanjšana na 60 %.
English: Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika, medicinsko sestro ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: This belongs to a group of medicines called ‘5-HT3 receptor antagonists' or ‘anti-emetics'.
Slovenian: Spada v skupino zdravil, ki se imenujejo antagonisti receptorjev 5-HT3 ali 'antiemetiki'.
English: There is insufficient clinical evidence to recommend administration of these tablets to children.
Slovenian: Pediatrična populacija Ni dovolj kliničnih dokazov, da bi se uporaba teh tablet priporočala za otroke.
English: Granisetron is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5-HT3) receptors.
Slovenian: Granisetron je močan antiemetik in visoko selektiven antagonist 5-hidroksitriptaminskih (5-HT3) receptorjev.
English: It depends on your age, weight, and whether you are being given the medicine to prevent, or treat, nausea and vomiting.
Slovenian: Odvisen je od vaše starosti, telesne mase in ali vam je bilo zdravilo dano za preprečevanje ali zdravljenje slabosti in bruhanja.
English: In the case of overdose with the tablets, symptomatic treatment should be given.
Slovenian: V primeru prevelikega odmerjanja s tabletami je potrebno simptomatsko zdravljenje.
English: A fourfold increase in the initial prophylactic dose of granisetron made no difference in terms of either the proportion of patient responding to treatment or in the duration of symptoms control.
Slovenian: Pri štirikratnem povečanju začetnega profilaktičnega odmerka granisetrona ni bilo razlike v deležu bolnikov odzivnih na zdravljenje ali v trajanju nadzora simptomov.
English: The following table of listed adverse reactions is derived from clinical trials and post-marketing data associated with Kytril and other 5-HT3 antagonists.
Slovenian: Spodnja preglednica vsebuje seznam neželenih učinkov iz kliničnih preskušanj in podatke iz obdobja trženja, ki so povezani z zdravilom Kytril in drugimi antagonisti tipa 5-HT3.
English: Children will be given Kytril by injections into the vein as described above with the dose depending on the child's weight.
Slovenian: Otroci bodo prejeli zdravilo Kytril z injekcijo v veno, kot je opisano zgoraj, odmerki pa so odvisni od otrokove telesne mase.
English: The solution for injection is primary packed in standard colourless glass ampoules with 1 ml 3 ml nominal volume [To be completed nationally]
Slovenian: Raztopina za injiciranje je pakirana v standardnih brezbarvnih steklenih ampulah z nominalno prostornino1 ml. [izpolni država članica]
English: • phenobarbital, a medicine used to treat epilepsy
Slovenian: • fenobarbital, zdravilo za zdravljenje epilepsije;
English: Pharmacological properties of granisetron
Slovenian: Farmakološke lastnosti granisetrona
English: • skin rashes or an allergic skin reaction or “nettle-rash” or “hives” (urticaria).
Slovenian: • kožni izpuščaj ali alergična kožna reakcija ali koprivnica (urtikarija).
English: Oral bioavailability is generally not influenced by food.
Slovenian: Hrana v splošnem ne vpliva na peroralno biološko uporabnost.
English: The chemoreceptor trigger zones are located at the caudal end of the fourth ventricle (area postrema).
Slovenian: Sprožilna področja za kemoreceptorje se nahajajo v zadnjem delu četrtega prekata (area postrema).
English: • have heart problems, are being treated for cancer with a medicine that is known to damage your heart or have problems with levels of salts, such as potassium, sodium or calcium, in your body (electrolyte abnormalities)
Slovenian: • imate težave s srcem, ste se zdravili za rakom z zdravili, za katere je znano, da lahko poškodujejo vaše srce ali imate težave s koncentracijami soli v telesu, kot so kalij, natrij ali kalcij (nepravilne vrednosti elektrolitov);
English: In studies in healthy subjects, no evidence of any interaction has been indicated between granisetron and benzodiazepines (lorazepam), neuroleptics (haloperidol) or anti-ulcer medicinal products (cimetidine).
Slovenian: V študijah pri zdravih osebah ni bilo dokazov o kakršnem koli medsebojnem delovanju med granisetronom in benzodiazepini (lorazepam), nevroleptiki (haloperidol) ali antiulkusnimi zdravili (cimetidin).
English: Do not take Kytril tablets
Slovenian: Ne vzemite tablet Kytril
English: Symptoms of overdose include mild headaches.
Slovenian: Znaki prevelikega odmerjanja vključujejo blag glavobol.
English: On the basis of its kinetics, whilst no dosage adjustment is necessary, granisetron should be used with a certain amount of caution in this patient group (see section 5.2).
Slovenian: Na podlagi njegove kinetike, in ker prilagajanje odmerka ni potrebno, se mora pri tej skupini bolnikov granisetron uporabljati z zmerno previdnostjo (glejte poglavje 5.2).
English: • if you are allergic (hypersensitive) to granisetron or any of the other ingredients of Kytril (listed in section 6: Further information and “Important Information about some of the ingredients Kytril below”.
Slovenian: • če ste alergični (preobčutljivi ) na granisetron ali katerokoli sestavino zdravila Kytril (navedeno v poglavju 6: Dodatne informacije in ''Pomembne informacije o nekaterih sestavinah zdravila Kytril'' spodaj.
English: Although antiemetic properties have been observed for 7-OH-granisetron and indazoline N-desmethyl granisetron, it is unlikely that these contribute significantly to the pharmacological activity of granisetron in man.
Slovenian: Čeprav so opazili antiemetične lastnosti 7-hidroksi granisetrona in indazolin N-demetil granisetrona, je malo verjetno, da značilno prispevata k farmakološkem delovanju granisetrona pri človeku.
English: Mean plasma half-life in patients by the oral and intravenous route is approximately 9 hours, with a wide inter-subject variability.
Slovenian: Srednji razpolovni čas v plazmi bolnikov po peroralnem ali intravenskem dajanju je približno 9 ur, vendar se pri posameznih bolnikih zelo razlikuje.
English: The first dose of Kytril should be administered within 1 hour before the start of therapy.
Slovenian: Prvi odmerek zdravila Kytril je treba zaužiti eno uro pred začetkom zdravljenja.
English: Radioligand binding studies have demonstrated that granisetron has negligible affinity for other receptor types including 5-HT and dopamine D2 binding sites.
Slovenian: Študije vezave z radioligandi so pokazale zanemarljivo afiniteto granisetrona za druge tipe receptorjev vključno s 5-HT receptorji in za dopaminska vezavna mesta D2.
English: In patients with hepatic impairment due to neoplasic liver involvement, total plasma clearance of an intravenous dose was approximately halved compared to patients without hepatic involvement.
Slovenian: Pri bolnikih z jetrno okvaro, zaradi prisotnosti neoplazije jeter, je celokupni plazemski očistek intravenskega odmerka približno za polovico manjši v primerjavi z bolniki brez jetrne okvare.
English: There is limited amount of data from the use of granisetron in pregnant women.
Slovenian: Podatkov o uporabi granisetrona pri nosečnicah je malo.
English: Each tablet contains 138.76 mg of lactose monohydrate.
Slovenian: Ena tableta vsebuje 138,76 mg laktoze monohidrata.
English: The 5-HT3 receptors are located in three sites: vagal nerve terminals in the gastrointestinal tract and chemoreceptor trigger zones located in the area postrema and the nucleus tractus solidarius of the vomiting center in the brainstem.
Slovenian: Receptorji 5HT3 se nahajajo na treh mestih: na koncu vagusnega živca v gastrointestinalnem traktu in v sprožilnem področju za kemoreceptorje, ki se nahaja v area postrema in v nucleus tractus solidariusu centra za bruhanje v možganskem deblu.
English: It is clear from the extensive dose-finding programme that the antiemetic efficacy is not unequivocally correlated with either administered doses or plasma concentrations of granisetron.
Slovenian: Iz obširnega programa določanja odmerka je razvidno, da antiemetični učinek ni neposredno povezan z danim odmerkom ali koncentracijo granisetrona v plazmi.
English: Dexamethasone has been used concomitantly at doses up to 20 mg once a day orally.
Slovenian: Deksametazon je bil sočasno uporabljen v odmerku do 20 mg enkrat na dan. Pediatrična populacija
English: As a precautionary measure, breast-feeding should not be advised during treatment with Kytril.
Slovenian: Iz previdnostnih razlogov se med zdravljenjem z zdravilom Kytril dojenje ne sme svetovati.
English: Serotonin is the main neurotransmitter responsible for emesis after chemo- or radio-therapy.
Slovenian: Serotonin je glavni nevrotransmiter odgovoren za bruhanje po kemo- ali radioterapiji.
English: In particular, tell your doctor, nurse or pharmacist if you are taking the following medicines:
Slovenian: Še posebej obvestite svojega zdravnika, medicinsko sestro ali farmacevta, če jemljete naslednja zdravila:
English: Total control of postoperative nausea and vomiting during the first 2 hours after surgery was observed in most patients.
Slovenian: Pri večini bolnikov so opazili popolno kontrolo pooperativne slabosti in bruhanja v prvih 2 urah po operaciji.
English: 6.2 Incompatibilities [To be completed nationally]
Slovenian: 6.2 Inkompatibilnosti [izpolni država članica]
English: Hypersensitivity to the active substance or any of the excipients.
Slovenian: Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
English: Following exposure to radiation or catotoxic substances, serotonin (5-HT) is released from enterochromaffine cells in the small intestinal mucosa, which are adjacent to the vagal afferent neurons on which 5-HT3 receptors are located.
Slovenian: Po izpostavitvi sevanju ali katotoksičnim snovem se serotonin (5-HT) sprosti iz enterokromafinih celic sluznice tankega črevesja, ki so poleg vagusnih aferentnih nevronov, kjer se nahajajo receptorji 5-HT3.
English: SPECIAL STORAGE CONDITIONS Do not store above 30ºC.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30°C.
English: A dose of 10-40 μg/kg body weight (up to 3 mg) should be administered as an i.v.
Slovenian: Odmerek 10-40 µg/kg telesne mase (do 3 mg) mora biti dan kot i.v.
English: Clinical application of granisetron was reported by Candiotti et al. A prospective, multicentre, randomized, double-blind, parallel-group study evaluated 157 children 2 to 16 years of age undergoing elective surgery.
Slovenian: Prospektivna, multicentrična, randomizirana, dvojno slepa študija s paralelnimi skupinami je ovrednotila 157 otrok, starih od 2 do 16 let med načrtovanim operativnim posegom.
English: 1 mg twice a day or 2 mg once a day for up to one week following radiotherapy or chemotherapy.
Slovenian: 1 mg dvakrat na dan ali 2 mg enkrat na dan, do enega tedna po končani radioterapiji ali zdravljenju s kemoterapijo.
English: The tablets are white to almost white triangular biconvex tablets imprinted with K2 on one side.
Slovenian: Tablete so bele do skoraj bele, trikotne bikonveksne tablete z odtisnjeno oznako K2 na eni strani.
English: The tablets are white to almost white triangular biconvex tablets imprinted with K1 on one side.
Slovenian: Tablete so bele do skoraj bele, trikotne bikonveksne tablete z odtisnjeno oznako K1 na eni strani.
English: The solution should be diluted to 5ml per mg.
Slovenian: Raztopina mora biti razredčena na 5 ml na mg.
English: In patients with pre-existing arrhythmias or cardiac conduction disorders this might lead to clinical consequences.
Slovenian: Pri bolnikih z že obstoječimi srčnimi aritmijami ali motnjami srčnega prevajanja lahko to privede do kliničnih posledic.
English: You may be given more injections to stop your sickness after the first dose.
Slovenian: Za prekinitev slabosti boste lahko po prvem odmerku prejeli več injekcij.
English: As a precautionary measure, it is preferable to avoid the use of granisetron during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi granisetrona bolje izogibati.
English: This is because Kytril can affect the way some medicines work.
Slovenian: Zdravilo Kytril lahko vpliva na delovanje drugih zdravil.
English: Urinary excretion of unchanged granisetron averages 12% of dose while that of metabolites amounts to about 47% of dose.
Slovenian: S sečem se v povprečju izloči 12 % odmerka v nespremenjeni obliki, 47 % odmerka pa kot presnovki.
English: The active substance is granisetron.
Slovenian: Zdravilna učinkovina je granisetron.
English: Each tablet contains 69.38 mg of lactose monohydrate.
Slovenian: Ena tableta vsebuje 69,38 mg laktoze monohidrata.
English: Your first dose of Kytril will usually be given an hour before your radio- or chemotherapy.
Slovenian: Običajno boste prvi odmerek zdravila Kytril prejeli eno uro pred začetkom radio- ali kemoterapije.
English: The maximum dose of Kytril to be administered over 24 hours should not exceed 3 mg.
Slovenian: Največji odmerek zdravila Kytril dan v 24 urah ne sme preseči 3 mg.
English: The dose of Kytril varies from one patient to another.
Slovenian: Odmerek zdravila Kytril je pri bolnikih različen.
English: Neurological mechanisms, serotonin-mediated nausea and vomiting
Slovenian: Nevrološki mehanizem, s serotoninom povzročena slabost in bruhanje
English: Very rare (<1/10,000)
Slovenian: Zelo redki: < 1/10.000