FrancophonIA/ELRC3.0 huggingface dataset:
English: Warnings and precautions If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Apotex:
Croatian: Ako se na Vas odnosi bilo koje od dolje navedenih stanja morate obavijestiti liječnika, prije nego što uzmete Clopidogrel Apotex:
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Apotex
Croatian: Ako se bilo što od navedenog odnosi na Vas, ili niste sigurni, obratite se svom liječniku prije uzimanja Clopidogrel Apotexa.
English: Clopidogrel Apotex with food and drink Clopidogrel Apotex may be taken with or without food.
Croatian: Apotex se može uzimati s obrokom ili bez obroka.
English: Gyanecomastia
Croatian: Ginekomastija
English: If you stop taking Clopidogrel Apotex
Croatian: Ako prestanete uzimati Clopidogrel Apotex:
English: Tel:+34 91.486.15.65
Croatian: APOTEX ESPAÑA S.L. Tel:+34 91.486.15.65
English: How to store Clopidogrel Apotex
Croatian: Kako čuvati Clopidogrel Apotex
English: Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema,
Croatian: bulozni dermatitis (toksična epidermalna nekroliza, Stevens Johnsonov sindrom, erythema multiforme, akutna generalizirana egzantematozna pustuloza (AGEP)), angioedem, sindrom preosjetljivosti izazvane lijekom, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (engl.
English: Clopidogrel Apotex 75 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Clopidogrel Apotex 75 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS containing 7, 14, 28, 30, 50, 56, 84, 90 or 100 film-coated tablets 1.
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI koji sadržavaju 7, 14, 28, 30, 50, 56, 84 ili 100 filmom obloženih tableta 1. NAZIV LIJEKA
English: Marketing Authorisation Holder: Apotex Europe B.V.
Croatian: Nositelj odobrenja: Apotex Europe B.V.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Apotex Europe B.V.
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Apotex Europe B.V.
English: If you forget to take Clopidogrel Apotex
Croatian: Ako ste zaboravili uzeti Clopidogrel
English: Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Croatian: Jedna filmom obložena tableta sadrži 75 mg klopidogrela (u obliku klopidogrelbesilata).
English: Breast-feeding
Croatian: Clopidogrel
English: abnormal liver function test
Croatian: Oštećenje funkcije jetre
English: Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Croatian: Manje česte nuspojave(mogu se javiti u manje od 1 na 100 osoba): glavobolja, čir želuca, povraćanje, mučnina, zatvor, povećano stvaranje plinova u želucu ili crijevima, osip, svrbež, omaglica, osjećaj trnaca i utrnulosti.
English: efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections, carbamazepine, a medicine to treat some forms of epilepsy, moclobemide, medicine to treat depression.
Croatian: - omeprazol ili esomeprazol, lijekove za smanjenje želučanih tegoba, - flukonazol ili vorikonazol, lijekove koji se primjenjuju za liječenje gljivičnih infekcija, - efavirenz, lijek koji se primjenjuje za liječenje HIV (virus humane imunodeficijencije) infekcija, - karbamazepin, lijek koji se primijenjuje za liječenje nekih oblika epilepsije, - moklobemid, lijek za liječenje depresije. - repaglinid, lijek za liječenje dijabetesa, - paklitaksel, lijek za liječenje raka.
English: Film:
Croatian: Film ovojnica:
English: Musculo-skeletal bleeding (haemarthrosis), arthritis,
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva mišićno-koštano krvarenje (hemartroza), artritis, artralgija, mijalgija
English: You have experienced a severe type of chest pain known as ‘unstable angina' or ‘myocardial infarction' (heart attack).
Croatian: imate otvrdnuće arterija (koje se još zove ateroskleroza) te ste već imali srčani udar, moždani udar ili imate stanje koje se zove bolest perifernih arterija, ili ste imali teški oblik boli u prsištu, poznat pod nazivom “nestabilna angina” ili “infarkt miokarda” (srčani udar).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON for blisters of 7, 14, 28, 30, 50, 56, 84, 90 or 100 film-coated tablets
Croatian: KUTIJE za blistere sa 7, 14, 28, 30, 50, 56, 84, 90 ili 100 filmom obloženih tableta
English: 2333 CN, Leiden The Netherlands
Croatian: Archimedesweg 2 2333 CN, Leiden Nizozemska
English: - signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions').
Croatian: Odmah kontaktirajte svog liječnika ako primijetite: vrućicu, znakove infekcije ili izrazitog umora; ti simptomi mogu biti posljedica rijetkog smanjenja broja nekih krvnih stanica; znakove oštećenja funkcije jetre kao što su žuta boja kože ili očiju (žutica), bez obzira jesu li povezani s krvarenjem koje se pojavljuje kao crvene točkice ispod kože i/ili zbunjenošću (vidjeti dio 2.
English: Acute liver failure, hepatitis,
Croatian: Poremećaji jetre i žuči akutno zatajenje jetre, hepatitis, abnormalni nalazi jetrene funkcije
English: Bullous dermatitis (toxic epidermal necrolysis,
Croatian: Coronary Artery Bypass Graft).
English: Talc
Croatian: Serija
English: Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence
Croatian: Poremećaji probavnog sustava gastrointestinalno krvarenje, proljev, bol u trbuhu, dispepsija ulkus želuca i dvanaesnika, gastritis, povraćanje, mučnina, konstipacija, flatulencija retroperitonealno krvarenje gastrointestinalno i retroperitonealno krvarenje s fatalnim ishodom, pankreatitis, kolitis (uključujući ulcerozni ili limfocitni kolitis), stomatitis
English: - If you have other heart problems.
Croatian: Ako imate druge teškoće sa srcem.
English: b The study was designed to show non-inferiority.
Croatian: b Ispitivanje je osmišljeno da pokaže neinferiornost.
English: Children and Adolescents (aged 1 month to 17 years):
Croatian: Pedijatrijska populacija Djeca i adolescenti (u dobi od 1 mjeseca do 17 godina):
English: c Chi-square test.
Croatian: c Hi-kvadrat test.
English: This medicinal product should be administered by a healthcare professional under appropriate medical supervision.
Croatian: Ovaj lijek treba davati zdravstveni djelatnik pod odgovarajućim liječničkim nadzorom.
English: Palonosetron Accord should be injected over 30 seconds.
Croatian: Palonosetron Accord treba ubrizgati tijekom 30 sekundi.
English: The safety and efficacy of palonosetron in children aged less than 1 month have not been established.
Croatian: Sigurnost primjene i djelotvornost palonozetrona u djece mlađe od 1 mjeseca nisu ustanovljene.
English: Wessling Hungary Kft Fòti ùt 56, Budapest H-1047, Hungary
Croatian: Wessling Hungary Kft Fòti ùt 56, Budimpešta H-1047, Mađarska
English: It is not known whether palonosetron accord will cause any harmful effects when used during pregnancy.
Croatian: Nije poznato hoće li Palonosetron Accord prouzročiti bilo kakve štetne učinke ako se primjenjuje tijekom trudnoće.
English: Do not use Palonosetron Accord: - if you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Palonosetron Accord: ako ste alergični na palonozetron ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Palonosetron at the recommended dose is widely distributed in the body with a volume of distribution of approximately 6.9 to 7.9 l/kg.
Croatian: Palonosetron se u preporučenoj dozi naširoko raspodjeljuje po tijelu, uz volumen distribucije od približno 6,9 do 7,9 l/kg.
English: The antiemetic activity was observed during 0-24 hours, 24-120 hours and 0-120 hours.
Croatian: Antiemetička aktivnost promatrana je u trajanju 0-24 sata, 24-120 sati i 0-120 sati.
English: - If you have an imbalance of certain minerals in your blood such as potassium and magnesium which has not been treated.
Croatian: Ako imate neravnotežu nekih minerala u krvi kao npr. kalija i magnezija, a to nije bilo liječeno.
English: Children and adolescents (aged 1 month to 17 years) The doctor will decide the dose, depending on bodyweight, however the maximum dose is 1500 micrograms.
Croatian: Djeca i adolescenti (u dobi od 1 mjeseca do 17 godina) Liječnik će odrediti dozu ovisno o tjelesnoj težini, ali najveća doza je 1500 mikrograma.
English: If you are pregnant or think you might be, your doctor will not administer palonosetron accord to you unless it is clearly necessary.
Croatian: Ako ste trudni ili mislite da biste mogli biti, Vaš liječnik Vam neće propisati Palonosetron Accord osim ako procijeni da je to zaista potrebno.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important
Croatian: • Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: H-1047
Croatian: Budimpešta H-1047
English: These have the ability to block the action of the chemical, serotonin, which can cause nausea and vomiting.
Croatian: Oni imaju sposobnost blokirati djelovanje kemijske tvari serotonina, koja može prouzročiti mučninu i povraćanje.
English: 3 years Upon opening of the vial, use immediately and discard any unused solution.
Croatian: 3 godine Nakon otvaranja bočice, otopinu odmah upotrijebite, a svu neiskorištenu otopinu zbrinite.
English: Very rare (<1/10,000) adverse reactions were reported post-marketing.
Croatian: Vrlo rijetke nuspojave (<1/10 000) bile su zabilježene nakon puštanja gotovog lijeka u promet.
English: The low total body clearance and large volume of distribution resulted in a terminal elimination halflife in plasma of approximately 40 hours.
Croatian: Nizak ukupni tjelesni klirens i veliki volumen distribucije rezultirao je terminalnim poluvijekom eliminacije u plazmi od približno 40 sati.
English: L/h/kg
Croatian: g/kg
English: Wessling Hungary Kft. Fóti út 56.
Croatian: Wessling Hungary Kft Fòti ùt 56
English: If affected, do not drive or use any tools or machines.
Croatian: Ako na Vas tako djeluje, nemojte voziti niti rukovati alatima ili strojevima.
English: Accord Healthcare Limited Ground floor, Sage House 319, Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom
Croatian: Accord Healthcare Limited Ground floor, Sage House 319, Pinner Road, North Harrow Middlesex HA1 4HF Ujedinjeno Kraljevstvo
English: ° From post-marketing experience * Includes the following: burning, induration, discomfort and pain
Croatian: Na temelju iskustva nakon puštanja lijeka u promet *Uključuje sljedeće: žarenje, induracija, nelagoda i bol
English: Noninferiority criteria were met if the lower bound of the 97.5% confidence interval for the difference in Complete Response rates of intravenous palonosetron minus intravenous ondansetron was larger than -15%.
Croatian: Kriteriji neinferiornosti bili su ispunjeni ako je donja granica intervala pouzdanosti od 97,5%, za razliku u stopama potpunog odgovora za intravenski palonozetron minus intravenski ondanzetron, bila veća od -15%.
English: A lower bound greater than -15 % demonstrates non-inferiority between palonosetron and comparator.
Croatian: Donja granica veća od -15% pokazuje neinferiornost između palonozetrona i usporednog lijeka.
English: Available in pack of 1 vial containing 5 ml of solution.
Croatian: Dostupan je u pakiranju od 1 bočice koja sadrži 5 ml otopine.
English: 24 - 120 hours 0 - 120 hours No Nausea (Likert Scale)
Croatian: 24 - 120 sati 0 - 120 sati Bez mučnine (Likertova ljestvica)
English: It is not known if palonosetron accord is found in breast milk.
Croatian: Nije poznato može li se Palonosetron Accord naći u majčinu mlijeku.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza ‘EXP'.
English: These are limited data on the use of palonosetron in the prevention of nausea and vomiting in children under 2 years of age.
Croatian: Ovo su ograničeni podaci o primjeni palonozetrona za sprječavanje mučnine i povraćanja u djece mlađe od 2 godine.
English: Palonosetron Accord is used for the prevention of nausea and vomiting associated with cancer chemotherapy in adults, adolescents and children over one month of age.
Croatian: Palonosetron Accord se koristi za sprječavanje mučnine i povraćanja povezanih s kemoterapijom raka u odraslih bolesnika, adolescenata i djece starije od mjesec dana.
English: Palonosetron Accord belongs to a group of medicines known as serotonin (5HT3) antagonists.
Croatian: Palonosetron Accord pripada skupini lijekova poznatih kao antagonisti serotonina (5HT3).
English: In clinical studies in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to palonosetron, were headache (9 %) and constipation (5 %).
Croatian: U kliničkim ispitivanjima u odraslih s dozom od 250 mikrograma (ukupno 633 bolesnika) najčešće opažene nuspojave, barem moguće povezane s primjenom palonozetrona, bile su glavobolja (9%) i konstipacija. (5%).
English: - If you have a personal or family history of alterations in heart rhythm (QT prolongation).
Croatian: Ako u osobnoj povijesti bolesti ili obiteljskoj povijesti bolesti imate promjenu srčanog ritma (produljenje QT intervala).
English: Palonosetron is eliminated by dual route, about 40 % eliminated through the kidney and with approximately 50 % metabolised to form two primary metabolites, which have less than 1 % of the 5HT3 receptor antagonist activity of palonosetron.
Croatian: Palonozetron se izlučuje dvojnim putem; oko 40% uklanja se bubregom a približno 50% metaboliziranog lijeka tvori dva primarna metabolita, koji imaju manje od 1% djelovanja palonozetrona kao antagonista 5HT3 receptora.
English: It is not recommended to take palonosetron accord in the days following chemotherapy unless you are receiving another chemotherapy cycle.
Croatian: Ne preporučuje se primjenjivati Palonosetron Accord u dane nakon kemoterapije, osim ako primate sljedeći ciklus kemoterapije.
English: The underlying mechanisms are not fully understood, but because of the high doses employed and since palonosetron is intended for single application in humans, these findings are not considered relevant for clinical use.
Croatian: Osnovni mehanizmi nisu potpuno poznati, ali budući da se radi o visokim dozama a palonozetron je namijenjen za jednokratnu primjenu u ljudi, ti se nalazi ne smatraju značajnima za kliničku uporabu.
English: Given the prespecified non-inferiority margin of -10%, the stratum adjusted Mantel-Haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (CR), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated.
Croatian: Uz prethodno određenu granicu neinferiornosti od -10%, prema Mantel-Haenszelovom statističkom intervalu pouzdanosti za neinferiornost prilagođenom za slojeve za razliku u primarnom ishodu, potpuni odgovor (CR), bio je [-10,5, 1,7%]; dakle, neinferiornost nije dokazana.
English: The following common or uncommon adverse reactions were reported for palonosetron, none were reported at a frequency of >1%.
Croatian: Sljedeće česte ili manje česte nuspojave zabilježene su za palonozetron, pri čemu nijedna nije zabilježena uz učestalost od >1 %.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ Otopina za injekciju
English: Fertility There are no data concerning the effect of palonosetron on fertility.
Croatian: Plodnost Nema podataka o učinku palonozetrona na plodnost.
English: Palonosetron accord will be given as a slow infusion into a vein.
Croatian: Palonosetron Accord će biti primijenjen u obliku spore infuzije u venu.
English: A doctor or nurse will normally inject palonosetron accord about 30 minutes before the start of chemotherapy.
Croatian: Liječnik ili medicinska sestra će Vam ubrizgati Palonosetron Accord otprilike 30 minuta prije početka kemoterapije.
English: Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for palonosetron overdose.
Croatian: Ispitivanja dijalize nisu bila provedena, međutim, zbog velikog volumena distribucije, dijaliza se ne čini djelotvornim liječenjem za predoziranje palonozetronom.
English: Most patients were non-naive to chemotherapy (78.5%) across all treatment groups.
Croatian: Većina bolesnika u svim terapijskim skupinama prethodno je primala kemoterapiju (78,5%).
English: These conditions include patients with a personal or family history of QT prolongation, electrolyte abnormalities, congestive heart failure, bradyarrhythmias, conduction disturbances and in patients taking anti-arrhythmic agents or other medicinal products that lead to QT prolongation or electrolyte abnormalities.
Croatian: To uključuje bolesnike s osobnom ili obiteljskom anamnezom produljenja QT intervala, nepravilnostima elektrolita, kongestivnim zatajenjem srca, bradiaritmijama, poremećajima provodljivosti te u bolesnika koji uzimaju antiaritmike ili druge lijekove koji dovode do produljenja QT intervala ili nepravilnosti elektrolita.
English: Other medicines and Palonosetron Accord
Croatian: Drugi lijekovi i Palonosetron Accord
English: In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to palonosetron.
Croatian: U kliničkim ispitivanjima opažene su sljedeće nuspojave koje su možda ili vjerojatno bile povezane s primjenom palonozetrona.
English: What Palonosetron Accord is and what it is used for 2.
Croatian: Što je Palonosetron Accord i za što se koristi 2.
English: High doses of palonosetron (each dose causing at least 30 times the human therapeutic exposure) applied daily for two years caused an increased rate of liver tumours, endocrine neoplasms (in thyroid, pituitary, pancreas, adrenal medulla) and skin tumours in rats but not in mice.
Croatian: Visoke doze palonozetrona (jedna doza najmanje 30 puta veća od doze primijenjene u terapijske svrhe u čovjeka) primijenjene svakodnevno tijekom dvije godine prouzročile su povećanu učestalost tumora jetre, neoplazme endokrinog sustava (u štitnjači, hipofizi, gušterači, nadbubrežnoj žlijezdi) i tumore kože u štakora ali ne u miševa.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 mcg/5 ml
Croatian: 5. SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICILIJEKA 250 µg/5 ml
English: Palonosetron Accord is indicated in paediatric patients 1 month of age and older for.
Croatian: Palonosetron Accord je indiciran u pedijatrijskih bolesnika u dobi od 1 mjeseca i starijih za:
English: Pharmacokinetic simulations indicate that the overall exposure (AUC0-∞) of 0.25 mg intravenous palonosetron administered once daily for 3 consecutive days was similar to a single intravenous dose of 0.75 mg, although Cmax of the 0.75 mg single dose was higher.
Croatian: Farmakokinetičke simulacije pokazuju da je sveukupna izloženost (AUC0-) dozi od 0,25 mg palonozetrona intravenski primijenjenog jedanput na dan tijekom 3 uzastopna dana, bila slična jednoj intravenskoj dozi od 0,75 mg, iako je Cmax jedne doze od 0,75 mg bio viši.
English: Volume of distribution c,d, L/kg a PK parameters expressed as Geometric Mean (CV) except forT1/2, which is median.
Croatian: Volumen distribucijec, d, l/kg a Farmakokinetički parametri izraženi kao geometrijska sredina (CV) osim za t½ koji je medijan vrijednosti.
English: EU/1/16/1104/001
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1104/001
English: What Palonosetron Accord is and what it is used for
Croatian: Što je Palonosetron Accord i za što se koristi
English: The proportion of patients without emesis during 0-72 hours post-operatively was similar after palonosetron 1 mcg/kg or 3 mcg/kg (88% vs 84%).
Croatian: Udio bolesnika bez emeze u trajanju od 0-72 sata poslije operacije bio je sličan nakon primjene palonozetrona 1 µg/kg ili 3 µg/kg (88% naspram 84%).
English: After a single intravenous dose of 10 micrograms/kg [14C]-palonosetron, approximately 80 % of the dose was recovered within 144 hours in the urine with palonosetron representing approximately 40 % of the administered dose, as unchanged active substance.
Croatian: Nakon jedne intravenske doze od 10 mikrograma/kg [14C]-palonozetrona, otprilike 80% doze izluči se unutar 144 sata u mokraći, pri čemu palonozetron predstavlja približno 40% primijenjene doze kao nepromijenjena djelatna tvar.
English: Serotonergic Drugs (e.g. SSRIs and SNRIs)
Croatian: Serotoninergični lijekovi (npr. SSRI i SNRI)
English: Following single dose intravenous infusion of palonosetron 20 mcg/kg, peak plasma concentrations (CT) reported at the end of the 15 minute infusion were highly variable in all age groups and tended to be lower in patients < 6 years than in older paediatric patients.
Croatian: Nakon jednokratne intravenske infuzije palonozetrona u dozi od 20 µg/kg, vršne koncentracije u plazmi (CT) zabilježene na kraju 15-minutne infuzije bile su visoko varijabilne u svim dobnim skupinama i u bolesnika u dobi <6 godina kretale su se u nižim vrijednostima nego u starijih pedijatrijskih bolesnika.
English: Accord Healthcare Ltd Ground Floor Sage House 319 Pinner Road North Harrow Middlesex
Croatian: Accord Healthcare Ltd Ground floor Sage House 319 Pinner Road North Harrow Middlesex HA1 4HF Ujedinjeno Kraljevstvo
English: Important information about some of the ingredients of Palonosetron Accord This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free'.
Croatian: Važne informacije o nekim sastojcima lijeka Palonosetron Accord Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po bočici, tj. zanemarive količine natrija.
English: These may affect up to 1 in 10 people
Croatian: Često mogu se javiti u do 1 na 10 osoba
English: The primary efficacy endpoint, Complete Response (CR: no 1o0miting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group.
Croatian: Primarni ishod djelotvornosti, potpuni odgovor (CR: izostanak povraćanja, dizanja želuca i bez primjene antiemetičkog simptomatskog lijeka) tijekom prva 24 sata poslije operacije bilo je postignuto u 78,2% bolesnika u skupini koja je primala palonozetron i 82,7% u skupini koja je primala ondanzetron.
English: These were classified as common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100).
Croatian: Klasificirane su kao česte (≥1/100 i <1/10) ili manje česte (≥1/1000 i <1/100).
English: In a clinical study, no significant pharmacokinetic interaction was shown between a single intravenous dose of palonosetron and steady state concentration of oral metoclopramide, which is a CYP2D6 inhibitor.
Croatian: U kliničkom ispitivanju nije ustanovljena značajna farmakokinetička interakcija između jedne intravenske doze palonozetrona i koncentracije oralnog metoklopramida, inhibitora CYP2D6, u stanju dinamičke ravnoteže.
English: In paediatric clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic chemotherapy, 402 patients received a single dose of palonosetron (3, 10 or 20 mcg/kg).
Croatian: U pedijatrijskim kliničkim ispitivanja za sprječavanje mučnine i povraćanja uzrokovanog umjereno ili visoko emetogenom kemoterapijom, 402 bolesnika primila su jednu dozu palonozetrona (3, 10 ili 20 µg/kg).
English: What you need to know before you are given Palonosetron Accord
Croatian: Što morate znati prije nego počnete primati Palonosetron Accord