natgillin/translations-raw huggingface dataset:
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.
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.
Absorption of granisetron is rapid and complete, though oral bioavailability is reduced to about 60% as a result of first pass metabolism.
Granisetron se hitro in popolnoma absorbira, vendar je pri peroralnem zaužitju zaradi presnove prvega prehoda biološka uporabnost zmanjšana na 60 %.
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika, medicinsko sestro ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
This belongs to a group of medicines called ‘5-HT3 receptor antagonists' or ‘anti-emetics'.
Spada v skupino zdravil, ki se imenujejo antagonisti receptorjev 5-HT3 ali 'antiemetiki'.
There is insufficient clinical evidence to recommend administration of these tablets to children.
Pediatrična populacija Ni dovolj kliničnih dokazov, da bi se uporaba teh tablet priporočala za otroke.
Granisetron is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5-HT3) receptors.
Granisetron je močan antiemetik in visoko selektiven antagonist 5-hidroksitriptaminskih (5-HT3) receptorjev.
It depends on your age, weight, and whether you are being given the medicine to prevent, or treat, nausea and vomiting.
Odvisen je od vaše starosti, telesne mase in ali vam je bilo zdravilo dano za preprečevanje ali zdravljenje slabosti in bruhanja.
In the case of overdose with the tablets, symptomatic treatment should be given.
V primeru prevelikega odmerjanja s tabletami je potrebno simptomatsko zdravljenje.
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.
Pri štirikratnem povečanju začetnega profilaktičnega odmerka granisetrona ni bilo razlike v deležu bolnikov odzivnih na zdravljenje ali v trajanju nadzora simptomov.
The following table of listed adverse reactions is derived from clinical trials and post-marketing data associated with Kytril and other 5-HT3 antagonists.
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.
Children will be given Kytril by injections into the vein as described above with the dose depending on the child's weight.
Otroci bodo prejeli zdravilo Kytril z injekcijo v veno, kot je opisano zgoraj, odmerki pa so odvisni od otrokove telesne mase.
The solution for injection is primary packed in standard colourless glass ampoules with 1 ml 3 ml nominal volume [To be completed nationally]
Raztopina za injiciranje je pakirana v standardnih brezbarvnih steklenih ampulah z nominalno prostornino1 ml. [izpolni država članica]
• phenobarbital, a medicine used to treat epilepsy
• fenobarbital, zdravilo za zdravljenje epilepsije;
Pharmacological properties of granisetron
Farmakološke lastnosti granisetrona
• skin rashes or an allergic skin reaction or “nettle-rash” or “hives” (urticaria).
• kožni izpuščaj ali alergična kožna reakcija ali koprivnica (urtikarija).
Oral bioavailability is generally not influenced by food.
Hrana v splošnem ne vpliva na peroralno biološko uporabnost.
The chemoreceptor trigger zones are located at the caudal end of the fourth ventricle (area postrema).
Sprožilna področja za kemoreceptorje se nahajajo v zadnjem delu četrtega prekata (area postrema).
• 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)
• 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);
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).
V študijah pri zdravih osebah ni bilo dokazov o kakršnem koli medsebojnem delovanju med granisetronom in benzodiazepini (lorazepam), nevroleptiki (haloperidol) ali antiulkusnimi zdravili (cimetidin).
Do not take Kytril tablets
Ne vzemite tablet Kytril
Symptoms of overdose include mild headaches.
Znaki prevelikega odmerjanja vključujejo blag glavobol.
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).
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).
• 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”.
• 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.
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.
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.
Mean plasma half-life in patients by the oral and intravenous route is approximately 9 hours, with a wide inter-subject variability.
Srednji razpolovni čas v plazmi bolnikov po peroralnem ali intravenskem dajanju je približno 9 ur, vendar se pri posameznih bolnikih zelo razlikuje.
The first dose of Kytril should be administered within 1 hour before the start of therapy.
Prvi odmerek zdravila Kytril je treba zaužiti eno uro pred začetkom zdravljenja.
Radioligand binding studies have demonstrated that granisetron has negligible affinity for other receptor types including 5-HT and dopamine D2 binding sites.
Študije vezave z radioligandi so pokazale zanemarljivo afiniteto granisetrona za druge tipe receptorjev vključno s 5-HT receptorji in za dopaminska vezavna mesta D2.
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.
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.
There is limited amount of data from the use of granisetron in pregnant women.
Podatkov o uporabi granisetrona pri nosečnicah je malo.
Each tablet contains 138.76 mg of lactose monohydrate.
Ena tableta vsebuje 138,76 mg laktoze monohidrata.
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.
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.
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.
Iz obširnega programa določanja odmerka je razvidno, da antiemetični učinek ni neposredno povezan z danim odmerkom ali koncentracijo granisetrona v plazmi.
Dexamethasone has been used concomitantly at doses up to 20 mg once a day orally.
Deksametazon je bil sočasno uporabljen v odmerku do 20 mg enkrat na dan. Pediatrična populacija
As a precautionary measure, breast-feeding should not be advised during treatment with Kytril.
Iz previdnostnih razlogov se med zdravljenjem z zdravilom Kytril dojenje ne sme svetovati.
Serotonin is the main neurotransmitter responsible for emesis after chemo- or radio-therapy.
Serotonin je glavni nevrotransmiter odgovoren za bruhanje po kemo- ali radioterapiji.
In particular, tell your doctor, nurse or pharmacist if you are taking the following medicines:
Še posebej obvestite svojega zdravnika, medicinsko sestro ali farmacevta, če jemljete naslednja zdravila:
Total control of postoperative nausea and vomiting during the first 2 hours after surgery was observed in most patients.
Pri večini bolnikov so opazili popolno kontrolo pooperativne slabosti in bruhanja v prvih 2 urah po operaciji.
6.2 Incompatibilities [To be completed nationally]
6.2 Inkompatibilnosti [izpolni država članica]
Hypersensitivity to the active substance or any of the excipients.
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
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.
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.
SPECIAL STORAGE CONDITIONS Do not store above 30ºC.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30°C.
A dose of 10-40 μg/kg body weight (up to 3 mg) should be administered as an i.v.
Odmerek 10-40 µg/kg telesne mase (do 3 mg) mora biti dan kot i.v.
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.
Prospektivna, multicentrična, randomizirana, dvojno slepa študija s paralelnimi skupinami je ovrednotila 157 otrok, starih od 2 do 16 let med načrtovanim operativnim posegom.
1 mg twice a day or 2 mg once a day for up to one week following radiotherapy or chemotherapy.
1 mg dvakrat na dan ali 2 mg enkrat na dan, do enega tedna po končani radioterapiji ali zdravljenju s kemoterapijo.
The tablets are white to almost white triangular biconvex tablets imprinted with K2 on one side.
Tablete so bele do skoraj bele, trikotne bikonveksne tablete z odtisnjeno oznako K2 na eni strani.
The tablets are white to almost white triangular biconvex tablets imprinted with K1 on one side.
Tablete so bele do skoraj bele, trikotne bikonveksne tablete z odtisnjeno oznako K1 na eni strani.
The solution should be diluted to 5ml per mg.
Raztopina mora biti razredčena na 5 ml na mg.
In patients with pre-existing arrhythmias or cardiac conduction disorders this might lead to clinical consequences.
Pri bolnikih z že obstoječimi srčnimi aritmijami ali motnjami srčnega prevajanja lahko to privede do kliničnih posledic.
You may be given more injections to stop your sickness after the first dose.
Za prekinitev slabosti boste lahko po prvem odmerku prejeli več injekcij.
As a precautionary measure, it is preferable to avoid the use of granisetron during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi granisetrona bolje izogibati.
This is because Kytril can affect the way some medicines work.
Zdravilo Kytril lahko vpliva na delovanje drugih zdravil.
Urinary excretion of unchanged granisetron averages 12% of dose while that of metabolites amounts to about 47% of dose.
S sečem se v povprečju izloči 12 % odmerka v nespremenjeni obliki, 47 % odmerka pa kot presnovki.
The active substance is granisetron.
Zdravilna učinkovina je granisetron.
Each tablet contains 69.38 mg of lactose monohydrate.
Ena tableta vsebuje 69,38 mg laktoze monohidrata.
Your first dose of Kytril will usually be given an hour before your radio- or chemotherapy.
Običajno boste prvi odmerek zdravila Kytril prejeli eno uro pred začetkom radio- ali kemoterapije.
The maximum dose of Kytril to be administered over 24 hours should not exceed 3 mg.
Največji odmerek zdravila Kytril dan v 24 urah ne sme preseči 3 mg.
The dose of Kytril varies from one patient to another.
Odmerek zdravila Kytril je pri bolnikih različen.
Neurological mechanisms, serotonin-mediated nausea and vomiting
Nevrološki mehanizem, s serotoninom povzročena slabost in bruhanje
Very rare (<1/10,000)
Zelo redki: < 1/10.000
The released serotonin activates vagal neurons via the 5-HT3 receptors which lead ultimately to a severe emetic response mediated via the chemoreceptor trigger zone within the area postrema.
Sproščeni serotonin aktivira nevrone vagusnega živca preko receptorjev 5-HT3, kar obvezno vodi v močan emetični odgovor preko sprožilnega področja za kemoreceptor v area postrema.
• abnormal involuntary movements, such as shaking, muscle rigidity and muscle contractions.
• patološki nehoteni gibi, kot so tresenje, togost mišic in mišični krči.
The most frequently reported adverse reactions for Kytril are headache and constipation, which may be transient.
Najpogosteje poročana neželena učinka pri zdravilu Kytril sta glavobol in zaprtje, ki pa sta lahko prehodna.
If you think you have forgotten to take your medicine speak to your doctor or nurse.
Če menite, da ste pozabili vzeti zdravilo, se posvetujte z vašim zdravnikom ali medicinsko sestro.
The most Kytril you will be given is 9 mg a day.
Največji odmerek zdravila Kytril, ki ga lahko prejmete, je 9 mg na dan.
Extrapyramidal Reactions
Občasni ekstrapiramidne reakcije
In patients concurrently treated with medicinal products known to prolong QT interval and/or which are arrhythmogenic, this may lead to clinical consequences (see section 4.4).
Pri bolnikih, ki se hkrati zdravijo z zdravili, ki podaljšajo interval QT in/ali so aritmogena, lahko to privede do kliničnih posledic (glejte poglavje 4.4).
For the prevention of PONV, administration should be completed prior to induction of anaesthesia.
Za preprečevanje pooperativne slabosti in bruhanja mora biti dajanje zdravila zaključeno pred uvajanjem anestezije.
• a medicine called ketoconazole used in the treatment of fungal infections
• zdravilo, imenovano ketokonazol, za zdravljenje glivičnih okužb;
Doses of up to 38.5 mg of Kytril as a single injection have been reported, with symptoms of mild headache but no other reported sequelae.
Pri odmerkih do 38,5 mg zdravila Kytril, danih kot enkratna injekcija, so poročali o blagem glavobolu, o drugih posledicah pa niso poročali.
However, if you are worried talk to your doctor or nurse.
Vendar pa, če ste zaskrbljeni, se posvetujte z vašim zdravnikom ali medicinsko sestro.
• if you are allergic (hypersensitive) to granisetron or any of the other ingredients of Kytril (listed in Section 6: Further information).
• če ste alergični (preobčutljivi ) na granisetron ali katerokoli sestavino zdravila Kytril (navedeno v poglavju 6.
Pharmacotherapeutic group: Antiemetics and antinauseants, Serotonin (5HT3) antagonists.
Farmakoterapevtska skupina: antiemetiki in zdravila proti slabosti, Antagonisti serotonina (5HT3).
If you take more Kytril than you should
Če ste prejeli večji odmerek zdravila Kytril, kot bi smeli
Nonetheless it is advisable to monitor both ECG and clinical abnormalities when treating patients concurrently with drugs known to prolong the QT (see section 4.5).
Kljub temu se priporoča spremljanje EKG in kliničnih nepravilnosti pri bolnikih, sočasno zdravljenih z zdravili, ki podaljšajo QT interval (glejte poglavje 4.5).
Interaction with neurotropic and other active substances through its activity on P 450-cytochrome has been reported (see section 4.5).
Poročali so o medsebojnem delovanju z nevrotropnimi in drugimi zdravilnimi učinkovinami preko aktivacije citokroma P450 (glejte poglavje 4.5).
The remainder is excreted in faeces as metabolites.
Preostanek odmerka se izloči v obliki presnovkov z blatom.
infusion, diluted in 10-30 ml infusion fluid and administered over 5 minutes prior to the start of chemotherapy.
infuzija, raztopljena v 1030 ml infuzijske tekočine in dana v 5 minutah pred začetkom kemoterapije.
It receives major inputs from the chemoreceptor trigger zones, and a vagal and sympathetic input from the gut.
Večino informacij prejme iz sprožilnega področja za kemoreceptorje, iz črevesja pa vagusne in simpatične informacije.
The efficacy of parenteral granisetron may be enhanced by an additional intravenous dose of an adrenocortical steroid e.g. by 8-20 mg dexamethasone administered before the start of the cytostatic therapy or by 250 mg methyl-prednisolone administered prior to the start and shortly after the end of the chemotherapy.
Uučinkovitost parenteralno danega granisetrona se lahko poveča z dodatnim intravenskim odmerkom kortikosteroida npr. z 8-20 mg deksametazona, danega pred začetkom zdravljenja s citostatiki ali 250 mg metil prednizolona, danega pred začetkom in kmalu po končani kemoterapiji.
The most Kytril you will be given is 3 mg a day.
Največji odmerek zdravila Kytril, ki ga lahko prejmete, je 3 mg na dan.
In rats, granisetron had no harmful effects on reproductive performance or fertility.
Plodnost Granisetron ni imel škodljivih učinkov na sposobnost razmnoževanja in plodnost pri podganah.
WHAT KYTRIL IS AND WHAT IT IS USED FOR Kytril contains a medicine called granisetron.
KAJ JE ZDRAVILO KYTRIL IN ZA KAJ GA UPORABLJAMO Zdravilo Kytril vsebuje zdravilno učinkovino granisetron.
If you forget to take Kytril
Če ste pozabili vzeti zdravilo Kytril
Renal failure
Jetrna okvara
In vitro studies have shown that the cytochrome P450 sub-family 3A4 (involved in the metabolism of some of the main narcotic agents) is not modified by granisetron.
Študije in-vitro so pokazale, da granisetron ne spremeni aktivnosti citokroma P 450 poddružine 3A4 (vpletene v presnovi nekaterih glavnih narkotičnih snovi).
What Kytril looks like and contents of the pack Ampoules - [To be completed nationally]
Izgled zdravila Kytril in vsebina pakiranja Pretisni Omoti - [izpolni država članica]
Chemotherapy- and radiotherapy-induced nausea and vomiting
S kemoterapijo in radioterapijo inducirana slabost in bruhanje
Although QT-prolongation has been observed with 5-HT3 receptors antagonists (see section 4.4), this effect is of such occurrence and magnitude that it does not bear clinical significance in normal subjects.
Čeprav so pri antagonistih receptorjev tipa 5-HT3 opazili podaljšanje QT intervala (glejte poglavje 4.4), je ta učinek takšnega pojava in razsežnosti, da ni klinično pomemben pri zdravih osebah.
6.4 Special precautions for storage [To be completed nationally]
6.4 Posebna navodila za shranjevanje [izpolni država članica]
Although ketaconazole was shown to inhibit the ring oxidation of granisetron in vitro, this action is not considered clinically relevant.
Čeprav so in vitro dokazali, da ketokonazol zavira oksidacijo aromatskega obroča granisetrona, smatrajo, da te spremembe niso klinično pomembne.
Therefore caution should be exercised in patients with cardiac co-morbidities, on cardiotoxic chemotherapy and/or with concomitant electrolyte abnormalities (see section 4.5).
Zato je pri bolnikih, s sočasnimi boleznimi srca, pri bolnikih na kardiotoksični kemoterapiji in/ali s sočasnimi nenavadnimi vrednostmi elektrolitov, potrebna previdnost (glejte poglavje 4.5).
Granisetron administered intravenously has been shown to prevent nausea and vomiting associated with cancer chemotherapy in adults and children 2 to 16 years of age.
Za granisetron dan intravensko je bilo dokazano, da prepreči slabost in bruhanje, ki sta posledici zdravljenja raka s kemoterapijo pri odraslih in otrocih starih od 2 do 16 let.
In vitro liver microsomal studies show that granisetron's major route of metabolism is inhibited by ketoconazole, suggestive of metabolism mediated by the cytochrome P-450 3A subfamily (see section 4.5).
V poskusih in vitro na jetrnih mikrosomih je ketokonazol zaviral glavno pot presnove granisetrona, kar nakazuje na presnovo posredovano s citokromom P 450 poddružine 3A (glejte poglavje 4.5).
Administration may be as either a slow intravenous injection (over 30 seconds) or as an intravenous infusion diluted in 20 to 50 ml infusion fluid and administered over 5 minutes.
Lahko se daje kot počasna intravenska injekcija (v 30 sekundah) ali kot 5 minutna intravenska infuzija, razredčena v 20 do 50 ml infuzijske raztopine.
There is insufficient clinical evidence to recommend administration of the solution for injection to children in prevention and treatment of Post-operative nausea and vomiting (PONV).
Na voljo ni zdostnih kliničnih podatkov, da bi priporočali raztopino za injiciranje otrokom za preprečevanje in zdravljenje pooperativne slabosit in bruhanja.
The safety and efficacy of Kytril solution for injection in children aged 2 years and above has been well established for the prevention and treatment (control) of acute nausea and vomiting associated with chemotherapy and the prevention of delayed nausea and vomiting associated with chemotherapy.
Varnost in učinkovitost Kytril raztopine za injiciranje pri otrocih, starih dve leti in več, je bila dokazana za preprečevanje in zdravljenje (nadzor) akutne slabosti in bruhanja, ki sta posledici kemoterapije in za preprečevanje zapoznele slabosti in bruhanja, ki sta posledici kemoterapije.
Pharmacokinetics of the oral administration is linear up to 2.5-fold of the recommended dose in adults.
Farmakokinetika do 2,5-kratnega priporočenega odmerka pri odraslih, danega peroralno, je linearna.
Combination with adrenocortical steroid
Kombinacija s kortikosteroidi
Uncommon 1/1,000 to <1/100 Rare (1/10,000 to <1/1,000) Very rare (<1/10,000)
Občasni ≥ 1/1.000 do < 1/100; Redki ≥ 1/10.000 do < 1/1.000 Zelo redki < 1/10.000
You should not take these tablets if you are pregnant, trying to get pregnant or are breast-feeding, unless your doctor has told you to.
Če ste noseči, poskušate zanositi ali če dojite teh tablet ne smete jemati razen, če vam je tako naročil zdravnik.
Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproductive toxicity and genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, vpliva na sposobnost razmnoževanja in genotoksičnosti ne kažejo posebnega tveganja za ljudi.
You should not have this injection if you are pregnant, trying to get pregnant or are breast-feeding, unless your doctor has told you to.
Če ste noseči, poskušate zanositi ali če dojite, teh injekcij ne smete prejeti razen, če vam je tako naročil zdravnik.
Use in children in the prevention or treatment of feeling or being sick following radio- or chemotherapy
Uporaba pri otrocih za preprečevanje ali zdravljenje slabosti in bruhanja po radio- ali kemoterapiji.
The medicine may be diluted before it is injected.
Zdravilo se lahko pred injiciranjem razredči.
The steroid will be given either as a dose between 8 and 20 mg dexamethasone before your radioor chemotherapy or as 250 mg methyl-prednisolone, which will be given both before and after your radio- or chemotherapy.
Kortikosteroid damo v odmerku med 8 in 20 mg deksametazona pred začetkom radio- ali kemoterapije ali kot 250 mg metilprednizolona, danega pred začetkom in po končani radio- ali kemoterapiji.
The dose will be either one or two 1 mg tablets or one 2 mg tablet once a day for up to a week after your radio- or chemotherapy.
Odmerek bo ena ali dve 1-mg tableti ali ena 2-mg tableta enkrat na dan do enega tedna po radioali kemoterapiji.
• diarrhoea.
• driska.