FrancophonIA/ELRC3.0 huggingface dataset:
English: • Adults and elderly Clopidogrel should be given as a single daily dose of 75 mg.
Slovenian: Klopidogrel se mora dajati kot enkratni dnevni odmerek 75 mg.
English: In particular, in a post-hoc analysis in 2,172 patients (17% of the total CURE population) who underwent stent placement (Stent-CURE), the data showed that clopidogrel compared to placebo, demonstrated a significant RRR of 26.2% favouring clopidogrel for the co-primary endpoint (CV death, MI, stroke) and also a significant RRR of 23.9% for the second co-primary endpoint (CV death, MI, stroke or refractory ischaemia).
Slovenian: Zlasti post hoc analiza podatkov 2.172 bolnikov (17 % celotne populacije CURE), ki so jim namestili žilno opornico (Stent-CURE), je ob klopidogrelu v primerjavi s placebom pokazala značilno, 26,2 % zmanjšanje RT za sestavljen primarni opazovani dogodek (srčnožilna smrt, miokardni infarkt, možganska kap) in tudi značilno, 23,9 % zmanjšanje RT za drug sestavljen primarni opazovani dogodek (srčno-žilna smrt, miokardni infarkt, možganska kap ali neodzivna ishemija).
English: cross reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population)*
Slovenian: (glejte poglavje 4.4)* , insulinski avtoimuni sindrom, ki lahko povzroči resno hipoglikemijo, zlasti pri bolnikih s podtipom HLA DRA4 (pogostejši pri japonski populaciji)*
English: Rare side effect (may affect up to 1 in 1000 people): Vertigo, enlarged breasts in males.
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): Vrtoglavica, povečane dojke pri moških.
English: What you need to know before you take Clopidogrel Apotex
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Clopidogrel Apotex
English: Clopidogrel Apotex contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Slovenian: Zdravilo Clopidogrel Apotex vsebuje klopidogrel in spada v skupino zdravil, ki se imenujejo zaviralci agregacije trombocitov.
English: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300-mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily).
Slovenian: Akutni koronarni sindrom brez elevacije ST-spojnice (nestabilna angina ali miokardni infarkt brez Qzobca):zdravljenje moramo začeti z udarnim odmerkom 300 mg klopidogrela in nadaljevati s 75 mg enkrat na dan (s 75 mg do 325 mg acetilsalicilne kisline (ASA) dnevno).
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI), ODGOVORNI ZA SPROŠČANJE SERIJE
English: The 2x2 factorial design COMMIT trial included 45,852 patients presenting within 24 hours of the onset of the symptoms of suspected MI with supporting ECG abnormalities (i.e. ST elevation, ST depression or left bundle-branch block).
Slovenian: V študijo COMMIT z 2x2 faktorsko raziskovalno zasnovo je bilo vključenih 45.852 bolnikov v 24 urah po nastopu simptomov, ki bi lahko kazali na miokardni infarkt, z neustreznimi vrednostmi EKG, ki so to potrjevale (elevacija ST-spojnice, depresija ST-spojnice ali levokračni blok).
English: Do not take Clopidogrel Apotex:
Slovenian: Ne jemljite zdravila Clopidogrel Apotex:
English: If Clopidogrel Apotex is supplied in PVC/PE/PVDC/aluminium blisters, store below 25°C.
Slovenian: Zdravilo Clopidogrel Apotex, ki je na voljo v PVC/PE/PVDC/alu pretisnih omotih, shranjujte pri temperaturi do 25°C.
English: Subsequent metabolism of the 2-oxo-clopidogrel intermediate metabolite results in formation of the active metabolite, a thiol derivative of clopidogrel.
Slovenian: Nadaljnja presnova vmesnega presnovka 2oksoklopidogrela povzroči nastanek aktivnega presnovka, ki je tiolski derivat klopidogrela.
English: They are supplied in PVC/PE/PVDC/Alu blisters or in PA/ALL/PVC-Alu blisters packed in cartons containing 7, 14, 28, 30, 50, 56, 84, 90 or 100 film-coated tablets.
Slovenian: Na voljo so v PVC/PE/PVDC/alu pretisnih omotih ali PA/ALL/PVC-alu pretisnih omotih, pakiranih v škatlah, ki vsebujejo 7, 14, 28, 30, 50, 56, 84, 90 ali 100 filmsko obloženih tablet.
English: Clopidogrel Apotex contains lactose.
Slovenian: Zdravilo Clopidogrel Apotex vsebuje laktozo.
English: Hydroxypropylcellulose (E463) Mannitol (E421) Crospovidone (type A) Citric acid, monohydrate Macrogol 6000
Slovenian: Jedro: hidroksipropilceluloza (E463) manitol (E421) krospovidon (vrsta A) citronska kislina monohidrat makrogol 6000 mikrokristalna celuloza stearinska kislina smukec
English: Clopidogrel Apotex contains lactose:
Slovenian: Zdravilo Clopidogrel Apotex vsebuje laktozo:
English: NSAIDs: in a clinical study conducted in healthy volunteers, the concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss.
Slovenian: Nesteroidna protivnetna zdravila (NSAIDs); “Non-Steroidal Anti-Inflammatory Drugs”: v klinični študiji, izvedeni pri zdravih prostovoljcih, je sočasna uporaba klopidogrela in naproksena povečala okultno izgubo krvi iz prebavil.
English: Packs of 7, 14, 28, 30, 50, 56, 84, 90 or 100 film-coated tablets.
Slovenian: Pakiranja po 7, 14, 28, 30, 50, 56, 84, 90 ali 100 filmsko obloženih tablet.
English: The other ingredients are (see section 2 ‘Clopidogrel Apotex contains lactose'): Tablet core: hydroxypropylcellulose (E463), mannitol (E421), crospovidone (type A), citric acid monohydrate, microcrystalline cellulose, macrogol 6000, stearic acid, talc Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172) and titanium dioxide (E171),
Slovenian: Pomožne snovi so (glejte poglavje 2: »Zdravilo Clopidogrel Apotex vsebuje laktozo«: Jedro tablete: hidroksipropilceluloza (E463), manitol (E421), krospovidon (vrsta A), citronska kislina monohidrat, mikrokristalna celuloza, makrogol 6000, stearinska kislina, smukec
English: If you forget to take Clopidogrel Apotex
Slovenian: Če ste pozabili vzeti zdravilo Clopidogrel Apotex
English: Musculo-skeletal bleeding (haemarthrosis), arthritis,
Slovenian: Mišično-skeletne krvavitve (hemartroza), artritis, artralgija, mialgija
English: If Clopidogrel Apotex is supplied in all aluminium blisters, it does not require any special storage conditions.
Slovenian: Za shranjevanje zdravila Clopidogrel Apotex, ki je na voljo v aluminijastih pretisnih omotih, niso potrebna posebna navodila.
English: In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p=0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Slovenian: Pri analizi vključenih bolnikov (“intention to treat analysis”) so v skupini, ki je prejemala klopidogrel, opazili 939 dogodkov in v skupini, ki je prejemala ASA, 1.020 dogodkov (zmanjšanje relativnega tveganja (RT) 8,7 %, [95 % IZ: 0,2 do 16,4]; p=0,045), kar ustreza preprečevanju pojava novega ishemičnega dogodka na vsakih 1000 bolnikov, zdravljenih 2 leti, dodatnim 10 [IZ: 0 do 20] bolnikom.
English: - ST segment elevation acute myocardial infarction: clopidogrel should be given as a single daily dose of 75 mg initiated with a 300-mg loading dose in combination with ASA and with or without thrombolytics.
Slovenian: Akutni miokardni infarkt z elevacijo ST-spojnice: klopidogrel je treba dajati v enkratnem dnevnem odmerku 75 mg, zdravljenje pa je treba začeti s 300 mg udarnim odmerkom v kombinaciji z ASA ter z/brez uporabe trombolitikov.
English: Store below 25°C (for PVC/PE/PVDC/aluminium blisters)
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25°C (za PVC/PE/PVDC/alu pretisne omote).
English: Therefore clopidogrel should be used with caution in these patients (see section 4.2).
Slovenian: Zato moramo pri tej skupini bolnikov klopidogrel uporabljati previdno (glejte poglavje 4.2).
English: Clopidogrel Apotex 75 mg film-coated tablets clopidogrel
Slovenian: Clopidogrel Apotex 75 mg filmsko obložene tablete klopidogrel
English: The Cmax of the active metabolite is twice as high following a single 300-mg clopidogrel loading dose as it is after four days of 75-mg maintenance dose.
Slovenian: Cmax aktivnega presnovka je po 300-mg polnilnem odmerku klopidogrela dvakrat večja kot po štirih dneh uporabe vzdrževalnega odmerka 75 mg. Cmax je dosežena približno 30 do 60 minut po uporabi zdravila.
English: In PVC/PE/PVDC/aluminium blisters, store below 25°C.
Slovenian: V PVC/PE/PVDC/alu pretisnih omotih shranjujte pri temperaturi do 25°C.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Apotex 75 mg film-coated tablets
Slovenian: IME ZDRAVILA Clopidogrel Apotex 75 mg filmsko obložene tablete
English: 2333 CN, Leiden The Netherlands
Slovenian: 2333 CN, Leiden Nizozemska
English: Common side effects (may affect up to 1 in 10 people: Diarrhoea, abdominal pain, indigestion or heartburn.
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): driska, bolečina v trebuhu, slaba prebava ali zgaga.
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.
Slovenian: - omeprazol ali esomeprazol, zdravila za zdravljenje težav z želodcem, - flukonazol ali vorikonazol, zdravila za zdravljenje glivičnih okužb, - efavirenz, zdravilo za zdravljenje infekcij z virusom HIV (virus humane imunske pomanjkljivosti), - karbamazepin, zdravilo za zdravljenje nekaterih oblik epilepsije, - moklobemid, zdravila za zdravljenje depresije.
English: Other medicines and Clopidogrel Apotex
Slovenian: Druga zdravila in zdravilo Clopidogrel Apotex:
English: The number of patients who reached the primary endpoint (time to first occurrence of stroke, MI, non-CNS systemic embolism or vascular death) was 832 (22.1%) in the group treated with clopidogrel + ASA and 924 (24.4%) in the placebo + ASA group (relative risk reduction of 11.1%; 95% CI of 2.4% to 19.1%; p=0.013), primarily due to a large reduction in the incidence of strokes.
Slovenian: Primarni opazovani dogodek (čas do prvega pojava možganske kapi, MI, sistemske embolije (ne v osrednjem živčevju) ali žilne smrti) je doseglo v skupini s klopidogrelom + ASA 832 (22,1 %) bolnikov in v skupini s placebom + ASA 924 (24,4 %) bolnikov (relativno zmanjšanje tveganja 11,1 %, 95 % IZ: od 2,4 % do 19,1 %, p=0,013), predvsem kot posledica velikega zmanjšanja incidence možganskih kapi.
English: What Clopidogrel Apotex looks like and contents of the pack
Slovenian: Izgled zdravila Clopidogrel Apotex in vsebina pakiranja
English: The decrease was associated with a 39% (loading dose) and 21% (maintenance dose) reduction of inhibition of platelet aggregation.
Slovenian: Povprečno zavrtje agregacije trombocitov se je zmanjšalo za 39 % (začetniodmerek) oz. 21 % (vzdrževalni odmerek).
English: After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min), inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Slovenian: Po večkratnih odmerkih 75 mg klopidogrela na dan, je bila s hudo ledvično boleznijo (očistek kreatinina 5 do 15 ml/min) inhibicija z ADP sprožene agregacije trombocitov manjša (25 %) od tiste, opažene pri zdravih osebah.
English: Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema,
Slovenian: Bulozen dermatitis (toksična epidermalna nekroliza, StevensJohnsonov sindrom, multiformni eritem, akutna generalizirana eksantematozna pustuloza (AGEP)), angioedem, z zdravili povzročen sindrom preobčutljivosti (sindrom DIHS, DrugInduced
English: Gyanecomastia
Slovenian: Ginekomastija
English: Clopidogrel Apotex 75 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Clopidogrel Apotex 75 mg
English: While you are taking Clopidogrel Apotex:
Slovenian: Ko jemljete zdravilo Clopidogrel Apotex:
English: drug induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS),
Slovenian: Hypersensitivity Syndrome), kožni izpuščaj z eozinofilijo in sistemskimi simptomi, kot posledica zdravljenja z zdravilom (sindrom DRESS, Drug Rash with Eosinophilia and Systemic Symptoms), eritematozen ali eksfoliativen izpuščaj, urtikarija, ekcem, lihen planus
English: 2D barcode carrying the unique identifier included.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako
English: How to take Clopidogrel Apotex
Slovenian: Kako jemati zdravilo Clopidogrel Apotex
English: Marketing Authorisation Holder: Apotex Europe B.V.
Slovenian: Imetnik dovoljenja za promet z: Apotex Europe B.V.
English: You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or
Slovenian: imate stanje otrdelih arterij (znano tudi kot aterosklerozo), in ste predhodno doživeli srčni napad, kap ali imeli stanje, ki je znano kot periferna arterijska bolezen, ali ste doživeli hudo obliko bolečine v prsih, znano kot „nestabilna angina“ ali „miokardni infarkt“ (srčni napad).
English: Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Slovenian: Ena filmsko obložena tableta vsebuje 75 mg klopidogrela v obliki klopidogrelijevega besilata.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Apotex Europe B.V.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Apotex Europe B.V.
English: • If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
Slovenian: - Če ste alergični na klopidogrel ali katerokoli sestavino tega zdravila (navedeno v poglavju 6); - Če imate zdravstveno stanje, ki trenutno povzroča krvavitev, kot je rana na želodcu ali krvavitev v možganih; - Če imate hudo jetrno obolenje.
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
Slovenian: Kartonska škatla za pretisne omote s 7, 14, 28, 30, 50, 56, 84, 90 ali 100 filmsko obloženimi tabletami
English: Do not stop the treatment unless your doctor tells you so.
Slovenian: Če ste prenehali jemati zdravilo Clopidogrel Apotex Ne prekinite zdravljenja razen, če tako odloči zdravnik.
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group .The incidence of major bleeding was similar between groups.
Slovenian: V študiji CLARITY je v skupini s klopidogrelom in ASA prišlo do splošnega povečanja krvavitev v primerjavi s skupino s placebom in ASA.
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.
Slovenian: PRETISNI OMOTI, ki vsebujejo 7, 14, 28, 30, 50, 56, 84, 90 ali 100 filmsko obloženih tablet 1.
English: Acute liver failure, hepatitis,
Slovenian: Akutna odpoved jeter, hepatitis, nenormalni testi jetrne funkcije
English: myalgia
Slovenian: Obloga
English: Clopidogrel was not shown to alter fertility in animal studies.
Slovenian: Šudije na živalih niso pokazale, da bi klopidogrel vplival na plodnost.
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis
Slovenian: Krvavitev v prebavila in retroperitonealna krvavitev s smrtnim izidom, pankreatitis, kolitis (vključno z ulceroznim ali limfocitnim kolitisom), stomatitis
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Izdaja zdravila je le na recept.
English: Bruising
Slovenian: Modrice
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 16.10.2009
English: • if you have a risk of bleeding such as - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
Slovenian: • če imate tveganje za krvavitev, kot je: zdravstveno stanje s tveganjem za notranjo krvavitev (kot je rana na želodcu); krvna motnja, zaradi katere ste bolj nagnjeni k notranji krvavitvi (krvavitev v tkivih, organih ali sklepih vašega telesa); nedavna huda poškodba; nedaven kirurški poseg (vključno na zobeh); načrtovan kirurški poseg (vključno na zobeh) v naslednjih 7 dneh;
English: If a dose is missed:
Slovenian: Drugo sočasno zdravljenje:
English: How to store Clopidogrel Apotex
Slovenian: Kaj vsebuje zdravilo Clopidogrel Apotex
English: b The study was designed to show non-inferiority.
Slovenian: b Študija je bila zasnovana tako, da prikaže ne-manjvrednost.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26th May 2016
Slovenian: Datum prve odobritve: 26. maj 2016
English: pH : Between 3.0 to 3.9
Slovenian: Vrednost pH: od 3,0 do 3,9
English: 1 x 5 ml vial
Slovenian: 1 x viala 5 ml
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including:
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z:
English: Osmlolarity : 260-320 mOsm/l
Slovenian: Osmolarnost: 260-320 mOsm/l
English: 97.5 % CI b
Slovenian: 97,5 % CIb
English: If affected, do not drive or use any tools or machines.
Slovenian: Če se vam to zgodi, ne upravljajte motornih vozil in ne uporabljajte orodij ali strojev.
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).
Slovenian: Ne uporabljajte zdravila Palonosetron Accord: če ste alergični na palonosetron ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Children and Adolescents (aged 1 month to 17 years):
Slovenian: Otroci in mladostniki (stari 1 mesec do17 let)
English: However, as for other 5-HT3 antagonists, caution should be exercised in the use of palonosetron in patients who have or are likely to develop prolongation of the QT interval.
Slovenian: Toda, kot pri drugih 5-HT3 antagonistih je potrebna previdnost pri uporabi palonosetrona pri bolnikih, ki imajo ali pri katerih se bo verjetno razvilo podaljšanje intervala QT.
English: The safety and efficacy of palonosetron in children aged less than 1 month have not been established.
Slovenian: Varnost in učinkovitost palonosetrona pri otrocih, mlajših od 1 meseca, nista bili dokazani.
English: Wessling Hungary Kft Fòti ùt 56, Budapest H-1047, Hungary
Slovenian: Wessling Hungary Kft Fóti út 56, Budapest H-1047, Madžarska
English: Children and adolescents
Slovenian: Otroci in mladostniki:
English: The antiemetic activity was observed during 0-24 hours, 24-120 hours and 0-120 hours.
Slovenian: Antiemetično učinkovitost so opazovali od 0-24 ur, 24-120 ur in 0120 ur.
English: Palonosetron Accord should be injected over 30 seconds.
Slovenian: Zdravilo Palonosetron Accord je potrebno injicirati v 30 sekundah.
English: 3 years Upon opening of the vial, use immediately and discard any unused solution.
Slovenian: 3 leta Po odprtju viale zdravilo takoj porabite in vso neporabljeno raztopino zavrzite.
English: It is not known whether palonosetron accord will cause any harmful effects when used during pregnancy.
Slovenian: Ni znano, ali bo zdravilo Palonosetron Accord povzročilo škodljive učinke med uporabo v nosečnosti.
English: AUC0-∞, h.mcg/L t1/2, hours
Slovenian: AUC0-∞, h·mcg/l t½, ure
English: Available in pack of 1 vial containing 5 ml of solution.
Slovenian: Na voljo je v pakiranju po 1 vialo, ki vsebuje 5 ml raztopine.
English: d Vss is reported for paediatric cancer patients, whereas Vz is reported for adult cancer patients.
Slovenian: d Vss je naveden za pediatrične bolnike z rakom, Vz pa je naveden za odrasle bolnike z rakom.
English: Complete Response (No Emesis and No Rescue Medication)
Slovenian: Popoln odgovor (brez bruhanja in dodatnega zdravljenja)
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Slovenian: Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/ploda, porod ali postnatalni razvoj.
English: Intravenous use.
Slovenian: Za intravensko uporabo.
English: If you are pregnant or think you might be, your doctor will not administer palonosetron accord to you unless it is clearly necessary.
Slovenian: Če ste noseči ali mislite, da ste, vam bo zdravnik dal zdravilo Palonosetron Accord le v primeru, da je to nujno potrebno.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 mcg/5 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 250 mcg/5 ml
English: Adverse reactions were evaluated in paediatric patients receiving palonosetron for up to 4 chemotherapy cycles.
Slovenian: Neželene učinke so ocenjevali pri pediatričnih bolnikih, ki so prejemali palonosetron do 4 kemoterapevtske cikle.
English: Serotonergic Drugs (e.g. SSRIs and SNRIs)
Slovenian: Serotoninergična zdravila (npr. SSRI in SNRI)
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.
Slovenian: Zdravilo Palonosetron Accord se uporablja za preprečevanje slabosti in bruhanja pri kemoterapiji raka pri odraslih bolnikih, mladostnikih in otrocih, starejših od enega meseca.
English: Fertility There are no data concerning the effect of palonosetron on fertility.
Slovenian: Plodnost Ni podatkov o vplivu palonosetrona na plodnost.
English: The objective was to evaluate the ECG effects of intravenous administered palonosetron at single doses of 0.25, 0.75 or 2.25 mg in 221 healthy subjects.
Slovenian: Namen je bil oceniti učinke intravensko danega palonosetrona v enkratnih odmerkih po 0,25, 0,75 ali 2,25 mg na EKG pri 221 zdravih osebah.
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.
Slovenian: Primarni kriterij učinkovitosti, popolni odziv (CR: brez bruhanja, brez siljenja na bruhanje in brez rešilnega zdravila) med prvimi 24 urami po operaciji je doseglo 78,2 % bolnikov v skupini s palonosetronom in 82,7 % v skupini z ondansetronom.
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.
Slovenian: Raziskave z dializo niso bile opravljene, vendar zaradi velikega volumna porazdelitve, zdravljenje z dializo najverjetneje ni učinkovito pri prevelikem odmerku palonosetrona.
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.
Slovenian: Približno 40 % se ga izloči preko ledvic, 50 % pa se ga metabolizira v dva primarna metabolita, ki imata manj kot 1 % aktivnosti antagonista receptorja 5HT3 palonosetrona.
English: Efficacy was based on demonstrating non-inferiority of intravenous palonosetron compared to intravenous ondansetron.
Slovenian: Učinkovitost je temeljila na prikazu ne-manjvrednosti intravenskega palonosterona v primerjavi z intravenskim ondansetronom.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Single use only.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Za enkratno uporabo.