natgillin/translations-raw huggingface dataset:
In a separate study, a total of 413 patients undergoing initial and repeat cycles of chemotherapy (including carboplatin, cisplatin, oxaliplatin, and doxorubicin regimens), were randomized to receive either Akynzeo (n=309) or aprepitant and palonosetron (n=104).
V ločeni študiji je bilo skupno 413 bolnikov, ki so prejemali začetne ali ponovljene cikle kemoterapije (vključno z režimi s karboplatinom, cisplatinom, oksaliplatinom in doksorubicinom), randomizirano v skupino za prejemanje zdravila Akynzeo (n = 309) ali skupino za prejemanje aprepitanta in palonosetrona (n = 104).
The recommended oral dexamethasone dose should be reduced by approximately 50 % when coadministered with netupitant/palonosetron capsules (see section 4.5 and clinical studies administration schedule in section 5.1).
Priporočeni peroralni odmerek deksametazona je treba ob sočasni uporabi s kapsulami netupitanta in palonosetrona zmanjšati za približno 50 % (glejte poglavje 4.5 in načrt dajanja zdravil v kliničnih študijah v poglavju 5.1).
• chest pain (not related to the heart)
• bolečine v prsih (ki niso povezane s srcem),
Adverse reactions are listed below by MedDRA body system organ class and frequency.
Neželeni učinki so navedeni spodaj po organskih sistemih in pogostnosti po MedDRA.
Netupitant was shown to cross the blood brain barrier with a NK1 receptor occupancy of 92.5%, 86.5%, 85.0%, 78.0%, and 76.0% in striatum at 6, 24, 48, 72, and 96 hours, respectively, after administration of 300 mg netupitant.
NK1 92,5 %, 86,5 %, 85,0 %, 78,0 % oziroma 76,0 % v striatumu po 6, 24, 48, 72 oziroma 96 urah, in sicer po dajanju 300 mg netupitanta.
What you need to know before you take Akynzeo
Kaj morate vedeti, preden boste vzeli zdravilo Akynzeo
Interaction with CYP3A4 substrates:
Medsebojno delovanje s substrati za CYP3A4:
Chemotherapeutic agents that are substrates for CYP3A4
Kemoterapevtska zdravila, ki so substrati za CYP3A4
Netupitant/palonosetron capsules should not be used during breast-feeding.
Kapsule netupitanta in palonosetrona se med dojenjem ne smejo uporabljati.
The study demonstrated no clinically important effects on ECG parameters: the largest point estimate of the placebo and baseline corrected QTc interval was 7.0 ms (one-sided upper 95% confidence limit 8.8 ms), observed 16 hours after the administration of supratherapeutic doses (600 mg netupitant and 1.5 mg palonosetron).
Študija ni pokazala klinično pomembnih učinkov na parametre EKG: največja točkovna ocena intervala QTc, korigirana s placebom in izhodiščno vrednostjo, je bila 7,0 ms (zgornja meja 95-% enostranskega intervala zaupanja je bila 8,8 ms), opažena 16 ur po dajanju supraterapevtskih odmerkov (600 mg netupitanta in 1,5 mg palonosetrona).
Netupitant No effect on fertility has been observed in animal studies.
Pri študijah na živalih niso opazili vpliva na plodnost.
The European Medicines Agency has waived the obligation to submit the results of studies with Akynzeo in all subsets of the paediatric population in prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based and moderately emetogenic cancer chemotherapy (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Akynzeo za vse podskupine pediatrične populacije za preprečevanje akutne in zakasnjene navzee in bruhanja pri zelo emetogeni kemoterapiji na osnovi cisplatina in zmerno emetogeni kemoterapiji za zdravljenje raka (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Furthermore, netupitant may also affect the efficacy of chemotherapeutic agents that need activation by CYP3A4 metabolism.
Poleg tega lahko netupitant vpliva tudi na učinkovitost kemoterapevtskih zdravil, pri katerih je potrebna aktivacija prek presnove s CYP3A4.
Therefore, Akynzeo can be administered without dosage adjustment in patients with renal impairment.
Zato lahko zdravilo Akynzeo brez prilagoditve odmerka dajemo bolnikom z okvaro ledvic.
Highly Emetogenic Chemotherapy (HEC) study
Študija zelo emetogene kemoterapije (HEC)
The medicines in Akynzeo attach to the receptors in the nervous system through which serotonin and substance P work: netupitant (an NK1 receptor antagonist) blocks the receptors for substance P, and palonosetron (a 5HT3 receptor antagonist) blocks certain receptors for serotonin.
Zdravili, ki ju vsebuje zdravilo Akynzeo, se pritrdita na receptorje v živčevju, prek katerih delujeta serotonin in snov P: netupitant (ki je antagonist receptorjev NK1) zavira receptorje za snov P, palonosetron (ki je antagonist receptorjev 5-HT3) pa zavira določene receptorje za serotonin.
This medicinal product should be used with caution in patients receiving concomitant orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range (see section 4.5).
To zdravilo je treba uporabljati previdno pri bolnikih, ki sočasno peroralno prejemajo učinkovine, ki se primarno presnavljajo prek CYP3A4 in imajo ozko terapevtsko območje (glejte poglavje 4.5).
Serotonin then activates 5-HT3 receptors located on vagal afferents to initiate the vomiting reflex.
Serotonin nato aktivira receptorje 5-HT3 na vagalnih aferentnih vlaknih in s tem sproža refleks bruhanja.
In a multicenter, randomized, parallel, double-blind, controlled clinical study of 694 patients, the efficacy and safety of single doses of oral netupitant in combination with oral palonosetron was compared with a single oral dose of palonosetron in cancer patients receiving a chemotherapy regimen that included cisplatin (median dose = 75 mg/m2).
V multicentrični, randomizirani, paralelni, dvojno slepi, aktivno nadzorovani klinični študiji s 694 bolniki so primerjali učinkovitost in varnost enkratnih odmerkov peroralnega netupitanta v kombinaciji s peroralnim palonosetronom in enkratnega peroralnega odmerka palonosetrona pri bolnikih z rakom, ki so prejemali režim kemoterapije, ki je vključeval cisplatin (mediani odmerek = 75 mg/m2).
• decreased blood flow to the heart muscle (myocardial ischemia)
• zmanjšan dotok krvi v srčno mišico (miokardna ishemija),
Primary endpoint Complete response Overall phase Major secondary endpoints Complete response Acute phase Delayed phase No emesis Acute phase Delayed phase Overall phase No significant nausea Acute phase Delayed phase Overall phase Acute phase: 0 to 24 hours post-cisplatin treatment.
Primarni kriterij Popoln odziv Celotna faza Glavni sekundarni kriteriji Popoln odziv Akutna faza Zakasnjena faza Brez bruhanja Akutna faza Zakasnjena faza Celotna faza Brez znatne navzee Akutna faza Zakasnjena faza
Inhibition of the efflux transported BCRP and glucuronidation isozyme UGT2B7 by netupitant and its metabolites is unlikely and, if it occurs, of scarce clinical relevance.
Zaviranje izločevalnega prenašalca BCRP in glukuronidacijskega izocima UGT2B7 s strani netupitanta in njegovih presnovkov ni verjetno, če pa do njega pride, ima zelo majhno klinično pomembnost.
Table 2: Oral Antiemetic treatment regimen -- HEC study
Preglednica 2: Režim peroralnega antiemetičnega zdravljenja -- študija HEC
In a pooled analysis, females had a higher netupitant exposure compared to males; there was a 1.31-fold increase in Cmax, a 1.02 fold increase for AUC and a 1.36 fold increase in half-life.
V združeni analizi je bila izpostavljenost netupitantu pri ženskah večja kot pri moških; Cmax je bila večja za 1,31-krat, AUC za 1,02-krat in razpolovni čas za 1,36-krat.
Do not take Akynzeo if:
Ne jemljite zdravila Akynzeo:
When this medicinal product is used concomitantly with medicinal products that induce CYP3A4 activity, netupitant plasma concentrations could be reduced and this may result in decreased efficacy.
Pri sočasni uporabi tega zdravila in zdravil, ki spodbujajo delovanje CYP3A4, lahko pride do znižanja plazemskih koncentracij netupitanta, kar lahko privede do zmanjšane učinkovitosti.
In particular tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
Še posebej opozorite svojega zdravnika, farmacevta ali medicinsko sestro, če jemljete katero od naslednjih zdravil:
What Akynzeo is and what it is used for
Kaj je zdravilo Akynzeo in za kaj ga uporabljamo
Netupitant is a moderate inhibitor of CYP3A4 and can increase the exposure of chemotherapeutic agents that are substrates for CYP3A4 e.g. docetaxel (see section 4.5).
Netupitant je zmeren zaviralec CYP3A4 in lahko poveča izpostavljenost kemoterapevtskim zdravilom, ki so substrati za CYP3A4, npr. docetakselu (glejte poglavje 4.5).
Moderately Emetogenic Chemotherapy (MEC) study
Študija zmerno emetogene kemoterapije (MEC)
No relevant changes of netupitant and palonosetron pharmacokinetics were observed.
Relevantnih sprememb farmakokinetike netupitanta in palonosetrona niso opazili.
This medicinal product can increase plasma concentrations of concomitantly administered medicinal products that are metabolised via CYP3A4.
To zdravilo lahko zviša plazemske koncentracije sočasno uporabljenih zdravil, ki se presnavljajo prek CYP3A4.
Palonosetron is eliminated from the body through both renal excretion and metabolic pathways, with the latter mediated via multiple CYP enzymes.
Palonosetron se izloča iz telesa prek ledvičnega izločanja in presnovnih poti, ki jih posreduje več encimov CYP.
Primary endpoint Complete response
Primarni kriterij Popoln odziv
• feeling hot, reddening of the face or other areas of the skin (feeling flushed)
• občutek vročine, pordelost obraza ali drugih predelov kože (napad rdečice),
Exposure to erythromycin and midazolam was increased approximately 1.3 and 2.4 fold, respectively, when each was co-administered with netupitant.
Izpostavljenost eritromicinu in midazolamu se je ob sočasnem dajanju vsakega od njiju z netupitantom povečala za približno 1,3-krat oziroma 2,4-krat.
No specific studies were performed to evaluate netupitant in patients with renal impairment.
Specifične študije za oceno netupitanta pri bolnikih z okvaro ledvic niso bile opravljene.
In a multicenter, randomized, parallel, double-blind, active-controlled, superiority study, the efficacy and safety of a single oral dose of Akynzeo was compared with a single oral dose of palonosetron 0.5 mg in cancer patients scheduled to receive the first cycle of an anthracycline and cyclophosphamide regimen for the treatment of a solid malignant tumor.
V multicentrični, randomizirani, paralelni, dvojno slepi, aktivno nadzorovani študiji superiornosti so primerjali učinkovitost in varnost enkratnega peroralnega odmerka zdravila Akynzeo in enkratnega peroralnega odmerka 0,5 mg palonosetrona pri bolnikih z rakom in načrtovanim prejemom prvega cikla režima zdravljenja čvrstega malignega tumorja z antraciklinom in ciklofosfamidom.
Delayed phase: 25 to 120 hours post-cisplatin treatment.
Zakasnjena faza: 25 do 120 ur po zdravljenju s cisplatinom.
Administration of the CYP3A4 inducer rifampicin with Akynzeo alone decreased the AUC of netupitant 5.2 fold and Cmax 2.6 fold.
Dajanje spodbujevalca CYP3A4 rifampicina samo z zdravilom Akynzeo je zmanjšalo AUC netupitanta za 5,2-krat in Cmax za 2,6-krat.
Akynzeo 300 mg/0.5 mg hard capsules netupitant/palonosetron
Akynzeo 300 mg/0,5 mg trde kapsule netupitant/palonosetron
Neither netupitant nor palonosetron have been evaluated in patients with end-stage renal disease.
Niti netupitant niti palonosetron nista bila ocenjena pri bolnikih s končnim stadijem okvare ledvic.
At the time of the study, anthracyclinecyclophosphamide containing chemotherapy regimens were considered to be moderately emetogenic.
V času študije so režimi kemoterapije z antraciklinom in ciklofosfamidom veljali za zmerno emetogene.
• The recommended dose is one capsule (each capsule contains 300 mg of netupitant and 0.5 mg of palonosetron).
• Priporočeni odmerek je ena kapsula (ena kapsula vsebuje 300 mg netupitanta in 0,5 mg palonosetrona).
• some chemotherapy medicines - such as docetaxel or etoposide
• nekatera zdravila za kemoterapijo, kot sta docetaksel ali etopozid;
• dexamethasone - can be used to treat feeling and being sick
• deksametazon, ki se lahko uporablja za zdravljenje občutka slabosti in bruhanja;
Table 4: Oral Antiemetic treatment regimen - MEC study
Preglednica 4: Režim peroralnega antiemetičnega zdravljenja - študija MEC
Delayed phase Overall phase No significant nausea Acute phase
Akutna faza Celotna faza Brez bruhanja Akutna faza Zakasnjena faza Celotna faza
Consequently, concomitant administration with strong CYP3A4 inhibitors (e.g., ketoconazole) should be approached with caution and concomitant administration with strong CYP3A4 inducers (e.g. rifampicin) should be avoided.
Zato je pri sočasnem dajanju z močnimi zaviralci CYP3A4 (npr. ketokonazol) potrebna previdnost, sočasnemu dajanju z močnimi spodbujevalci CYP3A4 (npr. rifampicin) pa se je treba izogibati.
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.
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.
What Akynzeo looks like and contents of the pack
Izgled zdravila Akynzeo in vsebina pakiranja
Total systemic exposure to intravenous palonosetron increased by approximately 28% in patients with severe impairment relative to healthy subjects.
Celotna sistemska izpostavljenost intravenskemu palonosetronu je bila pri bolnikih s hudo okvaro približno 28 % večja kot pri zdravih osebah.
This medicinal product also contains 20 mg of sucrose in each capsule.
To zdravilo vsebuje tudi 20 mg saharoze na eno kapsulo.
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.
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 %.
There was a supra-proportional increase in Cmax and AUC parameters for doses from 10 mg to 300 mg.
Pri odmerkih od 10 mg do 300 mg je prišlo do nadsorazmernega povečanja parametrov Cmax in AUC.
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.
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.
Akynzeo is used to help prevent adults with cancer feeling sick (nausea) or being sick (vomiting) while having cancer treatment called ‘chemotherapy'.
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«.
Major secondary endpoints Complete response Acute phase
Glavni sekundarni kriteriji Popoln odziv
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.
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.
Palonosetron is mainly metabolised by CYP2D6, with minor contribution by CYP3A4 and CYP1A2 isoenzymes.
Palonosetron se večinoma presnavlja prek CYP2D6, z manjšim prispevkom izoencimov CYP3A4 in CYP1A2.
Akynzeo is taken before the chemotherapy to prevent sickness and feelings of sickness from developing.
Zdravilo Akynzeo vzemite pred kemoterapijo za preprečevanje bruhanja in občutka slabosti.
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.
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.
• high levels of creatine phosphokinase/ creatine phosphokinase MB - which indicates sudden decreased blood flow to the heart muscle (shown in blood tests)
• visoke ravni kreatin fosfokinaze/kreatin fosfokinaze MB, kar kaže na nenadno zmanjšanje dotoka krvi v srčno mišico (vidno pri krvnih preiskavah);
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.
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.
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.
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.
At a dose of 300 mg in humans, netupitant is a substrate and moderate inhibitor of CYP3A4.
Ob odmerku 300 mg je netupitant pri ljudeh substrat in zmeren zaviralec CYP3A4.
Total systemic exposure to intravenous palonosetron increased by approximately 28% in severe renal impairment relative to healthy subjects.
Celotna sistemska izpostavljenost intravenskemu palonosetronu je bila pri hudi ledvični okvari približno 28 % večja kot pri zdravih osebah.
Other medicines and Akynzeo
Druga zdravila in zdravilo Akynzeo
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.
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.
Overall: 0 to 120 hours post-cisplatin treatment.
Celotna faza: 0 do 120 ur po zdravljenju s cisplatinom.
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.
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.
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.
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.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Akynzeo.
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.
A high fat meal did not affect the Cmax and AUC of oral palonosetron.
Obrok z veliko vsebnostjo maščobe ni vplival na Cmax in AUC peroralnega palonosetrona.
The symptoms of overdose may include headache, dizziness, constipation, anxiety, palpitations, euphoric mood and pain in the legs.
Simptomi prevelikega odmerka lahko vključujejo glavobol, omotico, zaprtje, tesnobnost, palpitacije, evforično razpoloženje in bolečine v nogah.
This medicinal product may contain a trace of lecithin derived from soya.
To zdravilo lahko vsebuje sledi lecitina, ki izvira iz soje.
• medicines with a narrow therapeutic range that are primarily metabolized by CYP3A4, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl,
• zdravila z ozkim terapevtskim oknom, ki se presnavljajo predvsem preko CYP3A4, na primer ciklosporin, takrolimus, sirolimus, everolimus, alfentanil, diergotamin, ergotamin, fentanil in kinidin;
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.
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.
Netupitant/palonosetron capsules have moderate influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Kapsule netupitanta in palonosetrona imajo zmeren vpliv na sposobnost vožnje in upravljanja strojev.
This medicine contains 7 mg of sorbitol in each hard capsule.
To zdravilo vsebuje 7 mg sorbitola na eno trdo kapsulo.
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.
Na ta način zdravili preprečujeta delovanje snovi P in serotonina ter pomagata preprečiti spodbujanje centra za bruhanje in posledično slabost in bruhanje.
Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations.
Glede na študije in vitro palonosetron v klinično relevantnih koncentracijah ne zavira ali spodbuja izoencimov citokroma P450.
Pack size of one hard capsule or 4 x 1 hard capsules in perforated unit dose blisters.
Velikost pakiranja: ena trda kapsula ali 4 x 1 trda kapsula v perforiranem deljivem pretisnem omotu s posameznimi odmerki.
If you are not sure, talk to your doctor, pharmacist or nurse before taking this medicine.
Če ste negotovi, se pred jemanjem tega zdravila posvetujte z zdravnikom, farmacevtom ali medicinsko sestro;
Caution is recommended when netupitant is combined with an oral substrate of this enzyme (e.g.zidovudine, valproic acid, morphine).
Priporočamo previdnost pri uporabi netupitanta v kombinaciji s peroralnim substratom tega encima (npr. zidovudin, valprojska kislina, morfin).
Hypoaesthesia Somnolence
Bolezni živčevja glavobol omotica hipestezija somnolenca
It may also contain a trace of lecithin derived from soya.
Poleg tega lahko vsebuje tudi sledi lecitina, pridobljenega iz soje.
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).
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.
The signs may include tremor, agitation, sweating, myoclonic movements, hypertonia and fever.
Znaki lahko vključujejo tresenje, nemir, znojenje, mioklonične gibe, hipertonijo in zvišano telesno temperaturo.
If you forget to take Akynzeo
Če ste pozabili vzeti zdravilo Akynzeo
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.
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.