FrancophonIA/ELRC3.0 huggingface dataset:
English: Moreover, this medicinal product should be used with caution in patients receiving concomitant orally administered active substances with a narrow therapeutic range that are primarily metabolized by CYP3A4, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, and quinidine.
Slovenian: Nadalje je treba to zdravilo previdno uporabljati pri bolnikih, ki sočasno prejemajo peroralne učinkovine z ozkim terapevtskim oknom, ki se presnavljajo predvsem prek CYP3A4, na primer ciklosporin, takrolimus, sirolimus, everolimus, alfentanil, diergotamin, ergotamin, fentanil in kinidin.
English: What Akynzeo looks like and contents of the pack
Slovenian: Izgled zdravila Akynzeo in vsebina pakiranja
English: Total systemic exposure to intravenous palonosetron increased by approximately 28% in patients with severe impairment relative to healthy subjects.
Slovenian: Celotna sistemska izpostavljenost intravenskemu palonosetronu je bila pri bolnikih s hudo okvaro približno 28 % večja kot pri zdravih osebah.
English: This medicinal product also contains 20 mg of sucrose in each capsule.
Slovenian: To zdravilo vsebuje tudi 20 mg saharoze na eno kapsulo.
English: Human plasma protein binding of netupitant and its two major metabolites M1 and M3 is > 99% at concentrations ranging from 10 to 1500 ng/mL.
Slovenian: Vezava netupitanta in njegovih dveh glavnih presnovkov M1 in M3 na beljakovine v človeški plazmi je pri koncentracijah od 10 ng/ml do 1500 ng/ml večja od 99 %.
English: There was a supra-proportional increase in Cmax and AUC parameters for doses from 10 mg to 300 mg.
Slovenian: Pri odmerkih od 10 mg do 300 mg je prišlo do nadsorazmernega povečanja parametrov Cmax in AUC.
English: After single oral doses using buffered solution mean maximum palonosetron concentrations (Cmax) and area under the concentration-time curve (AUC0-∞) were dose proportional over the dose range of 3.0 to 80 mcg/kg in healthy subjects.
Slovenian: Po enkratnih peroralnih odmerkih s pufrano raztopino so bile povprečne največje koncentracije palonosetrona (Cmax) in površina pod krivuljo koncentracija-čas (AUC0-∞) pri zdravih osebah sorazmerne odmerku v razponu odmerkov od 3,0 µg/kg do 80 µg/kg.
English: Akynzeo is used to help prevent adults with cancer feeling sick (nausea) or being sick (vomiting) while having cancer treatment called ‘chemotherapy'.
Slovenian: Zdravilo Akynzeo se uporablja pri odraslih ljudeh z rakom za preprečevanje občutka slabosti (navzee) ali bruhanja, ko prejemajo zdravljenje za raka, ki mu pravimo »kemoterapija«.
English: Major secondary endpoints Complete response Acute phase
Slovenian: Glavni sekundarni kriteriji Popoln odziv
English: The mean fraction of an oral dose of netupitant excreted unchanged in urine is less than 1%; a total of 3.95% and 70.7% of the radioactive dose was recovered in the urine and faeces, respectively.
Slovenian: Povprečna frakcija peroralnega odmerka netupitanta, ki se nespremenjena izloči v urin, je manj kot 1 %; v urinu so odkrili 3,95 %, v blatu pa 70,7 % radioaktivnega odmerka.
English: Palonosetron is mainly metabolised by CYP2D6, with minor contribution by CYP3A4 and CYP1A2 isoenzymes.
Slovenian: Palonosetron se večinoma presnavlja prek CYP2D6, z manjšim prispevkom izoencimov CYP3A4 in CYP1A2.
English: Akynzeo is taken before the chemotherapy to prevent sickness and feelings of sickness from developing.
Slovenian: Zdravilo Akynzeo vzemite pred kemoterapijo za preprečevanje bruhanja in občutka slabosti.
English: Non-clinical studies indicate that netupitant and its metabolites and the combination with palonosetron only at very high concentrations may block ion channels involved in ventricular de- and re-polarisation and prolong action potential duration.
Slovenian: Predklinične študije kažejo, da lahko netupitant in njegovi presnovki ter kombinacija s palonosetronom le ob zelo visokih koncentracijah blokirajo ionske kanalčke, ki sodelujejo pri ventrikularni depolarizaciji in repolarizaciji, ter podaljšajo trajanje akcijskega potenciala.
English: • high levels of creatine phosphokinase/ creatine phosphokinase MB - which indicates sudden decreased blood flow to the heart muscle (shown in blood tests)
Slovenian: • visoke ravni kreatin fosfokinaze/kreatin fosfokinaze MB, kar kaže na nenadno zmanjšanje dotoka krvi v srčno mišico (vidno pri krvnih preiskavah);
English: In 82 healthy subjects given a single oral dose of netupitant 300 mg, maximum plasma netupitant concentration (Cmax) was 486 ±268 ng/mL (mean ± SD) and median time to maximum concentration (Tmax) was 5.25 hours, the AUC was 15032 ± 6858 h.ng/mL.
Slovenian: Pri 82 zdravih osebah, ki so prejele enkraten peroralni odmerek 300 mg netupitanta, je bila največja plazemska koncentracija netupitanta (Cmax) 486 ± 268 ng/ml (povprečje ± SD), mediani čas do največje koncentracije (Tmax) je bil 5,25 ur, AUC pa je bila 15032 ± 6858 h.ng/ml.
English: Administration of the CYP3A4 inhibitor ketoconazole with netupitant/palonosetron capsules increased the AUC of netupitant 1.8 fold and Cmax 1.3 fold when compared to the administration of netupitant/palonosetron capsules alone.
Slovenian: Dajanje zaviralca CYP3A4 ketokonazola s kapsulami netupitanta in palonosetrona je povečalo AUC netupitanta za 1,8-krat in Cmax za 1,3-krat v primerjavi z dajanjem samih kapsul netupitanta in palonosetrona.
English: At a dose of 300 mg in humans, netupitant is a substrate and moderate inhibitor of CYP3A4.
Slovenian: Ob odmerku 300 mg je netupitant pri ljudeh substrat in zmeren zaviralec CYP3A4.
English: Total systemic exposure to intravenous palonosetron increased by approximately 28% in severe renal impairment relative to healthy subjects.
Slovenian: Celotna sistemska izpostavljenost intravenskemu palonosetronu je bila pri hudi ledvični okvari približno 28 % večja kot pri zdravih osebah.
English: Other medicines and Akynzeo
Slovenian: Druga zdravila in zdravilo Akynzeo
English: In a pilot dose range finding study in rabbits, cleft palate, microphtalmia and aphakia were observed in four foetuses from one litter in the 30 mg/kg/day group.
Slovenian: V pilotni študiji iskanja razpona odmerka pri kuncih so pri štirih plodovih iz enega legla v skupini z odmerkom 30 mg/kg/dan opazili razcep neba, mikrooftalmijo in afakijo.
English: Overall: 0 to 120 hours post-cisplatin treatment.
Slovenian: Celotna faza: 0 do 120 ur po zdravljenju s cisplatinom.
English: In 12 cancer patients given a single oral dose of palonosetron 0.5 mg one hour prior to chemotherapy, Cmax was 0.93 ± 0.34 ng/mL and Tmax was 5.1 ± 5.9 hours.
Slovenian: Pri 12 bolnikih z rakom, ki so prejeli enkraten peroralni 0,5 mg odmerek palonosetrona eno uro pred kemoterapijo, je bila Cmax 0,93 ± 0,34 ng/ml in Tmax je bil 5,1 ± 5,9 ur.
English: 135 patients who received a single oral dose (netupitant 300 mg and palonosetron 0.5 mg) and 136 patients who received oral palonosetron 0.5 mg alone.
Slovenian: Učinkovitost zdravila Akynzeo so ocenili pri 135 bolnikih, ki so prejeli enkraten peroralni odmerek (300 mg netupitanta in 0,5 mg palonosetrona), ter 136 bolnikih, ki so prejeli samo peroralni odmerek 0,5 mg palonosetrona.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Akynzeo.
Slovenian: Če za vas velja kar koli od zgoraj naštetega ali pa ste negotovi, se pred jemanjem zdravila Akynzeo posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: A high fat meal did not affect the Cmax and AUC of oral palonosetron.
Slovenian: Obrok z veliko vsebnostjo maščobe ni vplival na Cmax in AUC peroralnega palonosetrona.
English: The symptoms of overdose may include headache, dizziness, constipation, anxiety, palpitations, euphoric mood and pain in the legs.
Slovenian: Simptomi prevelikega odmerka lahko vključujejo glavobol, omotico, zaprtje, tesnobnost, palpitacije, evforično razpoloženje in bolečine v nogah.
English: This medicinal product may contain a trace of lecithin derived from soya.
Slovenian: To zdravilo lahko vsebuje sledi lecitina, ki izvira iz soje.
English: • medicines with a narrow therapeutic range that are primarily metabolized by CYP3A4, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl,
Slovenian: • zdravila z ozkim terapevtskim oknom, ki se presnavljajo predvsem preko CYP3A4, na primer ciklosporin, takrolimus, sirolimus, everolimus, alfentanil, diergotamin, ergotamin, fentanil in kinidin;
English: In healthy subjects given palonosetron capsules 0.5 mg, the terminal elimination half-life (t½) of palonosetron was 37 ± 12 hours (mean ± SD), and in cancer patients, t½ was 48 ± 19 hours.
Slovenian: Pri zdravih osebah, ki so zaužile kapsule z 0,5 mg palonosetrona, je bil končen razpolovni čas izločanja (t½) palonosetrona 37 ± 12 ur (povprečje ± SD), pri bolnikih z rakom pa je bil t½ 48 ± 19 ur.
English: Netupitant/palonosetron capsules have moderate influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Kapsule netupitanta in palonosetrona imajo zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: This medicine contains 7 mg of sorbitol in each hard capsule.
Slovenian: To zdravilo vsebuje 7 mg sorbitola na eno trdo kapsulo.
English: By blocking the actions of substance P and serotonin in this way, the medicines help prevent the stimulation of the vomiting centre and the resulting sickness.
Slovenian: Na ta način zdravili preprečujeta delovanje snovi P in serotonina ter pomagata preprečiti spodbujanje centra za bruhanje in posledično slabost in bruhanje.
English: Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations.
Slovenian: Glede na študije in vitro palonosetron v klinično relevantnih koncentracijah ne zavira ali spodbuja izoencimov citokroma P450.
English: Pack size of one hard capsule or 4 x 1 hard capsules in perforated unit dose blisters.
Slovenian: Velikost pakiranja: ena trda kapsula ali 4 x 1 trda kapsula v perforiranem deljivem pretisnem omotu s posameznimi odmerki.
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking this medicine.
Slovenian: Če ste negotovi, se pred jemanjem tega zdravila posvetujte z zdravnikom, farmacevtom ali medicinsko sestro;
English: Caution is recommended when netupitant is combined with an oral substrate of this enzyme (e.g.zidovudine, valproic acid, morphine).
Slovenian: Priporočamo previdnost pri uporabi netupitanta v kombinaciji s peroralnim substratom tega encima (npr. zidovudin, valprojska kislina, morfin).
English: Hypoaesthesia Somnolence
Slovenian: Bolezni živčevja glavobol omotica hipestezija somnolenca
English: It may also contain a trace of lecithin derived from soya.
Slovenian: Poleg tega lahko vsebuje tudi sledi lecitina, pridobljenega iz soje.
English: There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone or in combination with other serotonergic medicinal products (including selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs).
Slovenian: Pri uporabi antagonistov 5-HT3 samih ali v kombinaciji z drugimi serotonergičnimi zdravili (vključno s selektivnimi zaviralci ponovnega privzema serotonina (SSRI) in zaviralci ponovnega privzema serotonina in noradrenalina (SNRI)) so poročali o serotoninskem sindromu.
English: The signs may include tremor, agitation, sweating, myoclonic movements, hypertonia and fever.
Slovenian: Znaki lahko vključujejo tresenje, nemir, znojenje, mioklonične gibe, hipertonijo in zvišano telesno temperaturo.
English: If you forget to take Akynzeo
Slovenian: Če ste pozabili vzeti zdravilo Akynzeo
English: Non-clinical studies indicate that palonosetron, only at very high concentrations, may block ion channels involved in ventricular de- and re-polarisation and prolong action potential duration.
Slovenian: Predklinične študije kažejo, da lahko palonosetron le ob zelo visokih koncentracijah blokira ionske kanalčke, ki sodelujejo pri ventrikularni depolarizaciji in repolarizaciji, ter podaljša trajanje akcijskega potenciala.
English: After administration of a single oral dose of 300 mg netupitant, mean plasma netupitant/plasma radioactivity ratios ranged from 0.13 to 0.49 over 96 h post-dose.
Slovenian: Po dajanju enkratnega peroralnega odmerka 300 mg netupitanta so v 96 urah po odmerku povprečna razmerja radioaktivnosti netupitanta in plazme segala od 0,13 do 0,49.
English: • low levels of ‘neutrophils' - a kind of white blood cell which fight infections (shown in blood tests)
Slovenian: • nizke ravni »nevtrofilcev«, ki so vrsta belih krvničk, ki se borijo z okužbami (vidno pri krvnih preiskavah);
English: As palonosetron may increase large bowel transit time, patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration (see section
Slovenian: Ker lahko palonosetron podaljša čas prehoda skozi debelo črevo, je treba bolnike z anamnezo zaprtja ali znaki subakutne zapore črevesa po dajanju zdravila spremljati (glejte poglavje 4.8).
English: In addition, eye swelling, dyspnoea and myalgia as adverse reactions have been reported with oral palonosetron but not observed during the development of this medicinal product.
Slovenian: Poleg tega so pri peroralnem palonosetronu poročali o neželenih učinkih otekanju oči, dispneji in mialgiji, vendar jih med razvojem tega zdravila niso opazili.
English: Shellac glaze (partially esterified) Black iron oxide (E172) Propylene glycol (E1520)
Slovenian: Tiskarsko črnilo glazura iz šelaka (delno estrificiranega) črni železov oksid (E172) propilenglikol (E1520)
English: After a single dose of approximately 0.75 mg intravenous palonosetron, the total body clearance of palonosetron in healthy subjects was 160 ± 35 mL/h/kg (mean ± SD) and renal clearance was 66.5± 18.2 mL/h/kg.
Slovenian: Po enkratnem odmerku približno 0,75 mg intravenskega palonosetrona je bil celoten telesni očistek palonosetrona pri zdravih osebah 160 ± 35 ml/h/kg (povprečje ± SD), ledvični očistek pa je bil 66,5 ± 18,2 ml/h/kg.
English: Mild to moderate renal impairment does not significantly affect palonosetron PK parameters.
Slovenian: Blaga do zmerna okvara ledvic nima pomembnega vpliva na FK parametre palonosetrona.
English: If you stop taking Akynzeo
Slovenian: Če ste prenehali jemati zdravilo Akynzeo
English: Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters.
Slovenian: Blaga do zmerna okvara ledvic nima znatnega vpliva na farmakokinetične parametre palonosetrona.
English: Netupitant is mainly metabolized by CYP3A4; therefore, co-administration with medicinal products that inhibit or induce CYP3A4 activity may influence plasma concentrations of netupitant.
Slovenian: Netupitant se večinoma presnavlja prek CYP3A4, zaradi česar lahko sočasno dajanje z drugimi zdravili, ki zavirajo ali spodbujajo delovanje CYP3A4, vpliva na plazemske koncentracije netupitanta.
English: Chemotherapeutic medicinal products (docetaxel, etoposide, cyclophosphamide) Exposure to docetaxel and etoposide was increased 37% and 21%, respectively, when co-administered with netupitant/palonosetron capsules.
Slovenian: Zdravila za kemoterapijo (docetaksel, etopozid, ciklofosfamid) Ob sočasnem dajanju s kapsulami netupitanta in palonosetrona se je izpostavljenost docetakselu in etopozidu povečala za 37 % oziroma 21 %.
English: • stomach problems including stomach discomfort, feeling bloated, nausea, pain, indigestion,
Slovenian: • težave z želodcem, vključno z občutkom nelagodja v želodcu, občutkom napihnjenosti,
English: An ECG study was conducted in adult male and female healthy volunteers with oral netupitant either 200 or 600 mg administered in combination with oral palonosetron 0.5 or 1.5 mg, respectively.
Slovenian: Pri odraslih moških in ženskih zdravih prostovoljcih, ki so jemali 200 mg ali 600 mg netupitanta peroralno v kombinaciji z 0,5 mg oziroma 1,5 mg palonosetrona peroralno, so izvedli študijo EKG.
English: In 36 healthy male and female subjects given a single oral dose of 0.5 mg palonosetron, maximum plasma concentration (Cmax) was 0.81 ± 1.66 ng/mL (mean ± SD) and time to maximum concentration (Tmax) was 5.1 ± 1.7 hours.
Slovenian: Pri 36 zdravih moških in ženskah, ki so prejeli enkraten peroralni odmerek 0,5 mg palonosetrona, je bila največja plazemska koncentracija (Cmax) 0,81 ± 1,66 ng/ml (povprečje ± SD), čas do največje koncentracije (Tmax) pa je bil 5,1 ± 1,7 ur.
English: No dosage adjustment is necessary for patients with mild or moderate hepatic impairment (ChildPugh score 5-8).
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter (stopnje 5-8 po lestvici Child-Pugh) prilagoditev odmerka ni potrebna.
English: Animal data do not indicate direct or indirect harmful effects of palonosetron with the respect to reproductive toxicity (see section
Slovenian: Podatki iz študij na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov palonosetrona na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Interaction between oral netupitant and oral palonosetron:
Slovenian: Medsebojno delovanje med peroralnim netupitantom in peroralnim palonosetronom:
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija levkopenija levkocitoza limfocitoza
English: In vitro data show that netupitant is a P-gp inhibitor.
Slovenian: Podatki in vitro kažejo, da je netupitant zaviralec P-gp.
English: The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) should be considered when coadministering these active substances with netupitant/palonosetron capsules.
Slovenian: Pri midazolamu ali drugih benzodiazepinih, ki se presnavljajo prek CYP3A4 (alprazolam, triazolam), je treba ob sočasnem dajanju s kapsulami netupitanta in palonosetrona upoštevati možne učinke njihovih zvišanih plazemskih koncentracij.
English: In vitro data suggests that netupitant inhibits the efflux of transporter BCRP.
Slovenian: Podatki in vitro nakazujejo, da netupitant zavira prehod prenašalca BCRP skozi membrane.
English: Pack size containing 1 capsule in an aluminium blister or 4 x 1 hard capsules in aluminium perforated unit dose blisters.
Slovenian: Velikost pakiranja je 1 kapsula v aluminijastem pretisnem omotu ali 4 x 1 trda kapsula v aluminijastih perforiranih deljivih pretisnih omotih s posameznimi odmerki.
English: Akynzeo 300 mg/0.5 mg hard capsules
Slovenian: Akynzeo 300 mg/0,5 mg trde kapsule
English: There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic medicinal products (including SSRIs such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram or escitalopram and SNRIs such as venlafaxine or duloxetine) (see section
Slovenian: Po sočasni uporabi antagonistov 5-HT3 in drugih serotonergičnih zdravil (vključno s SSRI, kot so fluoksetin, paroksetin, sertralin, fluvoksamin, citalopram in escitalopram, in SNRI, kot sta venlafaksin in duloksetin) so poročali o serotoninskem sindromu (glejte poglavje 4.4).
English: Table1: Adverse reactions System organ class
Slovenian: Preglednica 1: Neželeni učinki Organski sistem Pogosti
English: Netupitant/palonosetron capsules are unlikely to interact with medicinal products which are P-gp substrates.
Slovenian: Medsebojno delovanje kapsul netupitanta in palonosetrona in zdravil, ki so substrati za P-gp, ni verjetno.
English: Limited data exist in patients with severe hepatic impairment (Child Pugh score ≥ 9).
Slovenian: Za bolnike s hudo okvaro jeter (stopnja ≥9 po lestvici Child-Pugh) je na voljo malo podatkov.
English: • numbness, blurred vision
Slovenian: • omrtvičenost, zamegljen vid;
English: Oral administration of Akynzeo in combination with dexamethasone has been shown to prevent acute and delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in two separate pivotal studies.
Slovenian: Za peroralno dajanje zdravila Akynzeo v kombinaciji z deksametazonom so v dveh ločenih ključnih študijah dokazali, da preprečuje akutno in zakasnjeno navzeo in bruhanje, povezana z zelo in zmerno emetogeno kemoterapijo za zdravljenje raka.
English: Decreased appetite Hypokalaemia
Slovenian: Presnovne in prehranske motnje zmanjšan apetit hipokaliemija
English: Palonosetron Degeneration of seminiferous epithelium has been observed in rat study (see section 5.3).
Slovenian: Pri študiji na podganah so opazili degeneracijo semenskega epitelija (glejte poglavje 5.3).
English: When netupitant/palonosetron capsules are used concomitantly with another CYP3A4 inhibitor, netupitant plasma concentrations could be elevated.
Slovenian: Ob sočasni uporabi kapsul netupitanta in palonosetrona z drugim zaviralcem CYP3A4 lahko pride do zvišanja plazemskih koncentracij netupitanta.
English: As such, no dosage adjustment is necessary for patients with mild to moderate hepatic impairment.
Slovenian: Zato pri bolnikih z blago do zmerno okvaro jeter prilagoditev odmerka ni potrebna.
English: Each hard capsule contains 7 mg of sorbitol and 20 mg of sucrose.
Slovenian: Pomožne snovi z znanim učinkom: Ena trda kapsula vsebuje 7 mg sorbitola in 20 mg saharoze.
English: Dosage adjustment is not considered necessary in patients with mild to severe renal impairment.
Slovenian: Prilagoditev odmerka pri bolnikih z blago do hudo okvaro ledvic predvidoma ni potrebna.
English: • medicines for depression or anxiety called SNRIs (serotonin noradrenaline re-uptake inhibitors)
Slovenian: • zdravila za depresijo ali anksioznost, ki jim pravimo SNRI (zaviralci ponovnega privzema serotonina in noradrenalina), kot sta venlafaksin ali duloksetin.
English: No consistent effect was seen with cyclophosphamide after netupitant co-administration.
Slovenian: Pri ciklofosfamidu po sočasnem dajanju netupitanta niso opazili konsistentnih učinkov.
English: Capsule shell Gelatin
Slovenian: Ovojnica kapsule želatina glicerol sorbitol
English: • you have a blockage in your gut, or you have had constipation in the past • you or one of your close relatives has ever had a heart problem called ‘QT interval prolongation'
Slovenian: • če ste vi ali kateri od vaših bližnjih sorodnikov kadar koli imeti težavo s srcem, ki ji pravimo
English: Co-administration with ketoconazole did not affect the pharmacokinetics of palonosetron.
Slovenian: Sočasno dajanje s ketokonazolom ni vplivalo na farmakokinetiko palonosetrona.
English: Netupitant and Palonosetron Combinate Capsule:
Slovenian: Kombinirana kapsula netupitanta in palonosetronijevega hidroklorida:
English: These conditions include patients with a personal or family history of QT prolongation, electrolyte abnormalities, congestive heart failure, bradyarrhythmia, conduction disturbances and in patients taking anti-arrhythmic medicinal products or other medicinal products that lead to QT prolongation or electrolyte abnormalities.
Slovenian: Ta stanja zajemajo bolnike z osebno ali družinsko anamnezo podaljšanja intervala QT, motenj elektrolitov, kongestivnega srčnega popuščanja,
English: The signs may include hives, itch, angioedema, low blood pressure, throat tightness, chest tightness, dyspnoea, loss of consciousness.
Slovenian: Znaki lahko vključujejo urtikarijo, srbenje, angioedem, znižan krvni tlak, stiskanje v žrelu, stiskanje v prsih, dispnejo, izgubo zavesti.
English: Each hard capsule contains three tablets (300 mg of netupitant), and one soft capsule (palonosetron hydrochloride equivalent to 0.5 milligrams of palonosetron).
Slovenian: Ena trda kapsula vsebuje tri tablete (300 mg netupitanta) in eno mehko kapsulo (palonosetronijev klorid v količini, ki ustreza 0,5 miligramom palonosetrona).
English: As such, the oral dexamethasone dose should be reduced by approximately 50% when co-administered with netupitant/palonosetron capsules (see section 4.2).
Slovenian: Zato je treba ob sočasnem dajanju s kapsulami netupitanta in palonosetrona peroralni odmerek deksametazona zmanjšati za približno 50 % (glejte poglavje 4.2).