FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of undesirable effects listed in Table 2 is defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Slovenian: Pogostnost neželenih učinkov iz preglednice 2 je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000
English: Paclitaxel at doses below the human therapeutic dose was associated with low fertility and foetal toxicity in rats.
Slovenian: Paklitaksel v odmerkih, manjših od terapevtskega odmerka za človeka, so povezovali z nizko plodnostjo in fetalno toksičnostjo pri podganah.
English: • severe lack of oxygen, arising from abnormal breathing
Slovenian: • hudo pomanjkanje kisika, ki je posledica nenormalnega dihanja;
English: • symptoms of allergic reaction during the infusion, such as:
Slovenian: • pozorni bodo na pojav simptomov alergijskih reakcij med infundiranjem, kot so:
English: The median number of cycles with administration of GCSF was 3 (1;6) and the mean value 3.1, each in both groups.
Slovenian: Mediano število ciklov dajanja GCSF je bilo 3 (1, 6), povprečna vrednost v obeh skupinah pa je znašala 3,1.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: The high interindividual variability in clearance is believed to be a consequence of variability in hepatic enzyme activity.
Slovenian: Velika raznolikost med bolnicami pri očistku je domnevno posledica raznolikosti v delovanju jetrnih encimov.
English: Hazard ratio (95% CI) a Primary population in non-inferiority analysis was predefined as the PP population
Slovenian: Razmerje tveganja (IZ 95 %) a Primarna populacija pri analizi neinferiornosti je bila vnaprej določena kot populacija PP.
English: In vitro studies using different cell systems have shown paclitaxel to be clastogenic inducing chromosomal aberrations, micronuclei and DNA damage.
Slovenian: Študije in vitro z različnimi celičnimi sistemi so pokazale, da je paklitaksel klastogen in povzroča kromosomske aberacije, nastanek mikronukleusov in poškodbe DNK.
English: The paclitaxel infusion was followed by carboplatin after an interval of 30 minutes in both treatment arms.
Slovenian: Infuziji paklitaksela je v obeh krakih zdravljenja po 30-minutnem intervalu sledil karboplatin.
English: Other medicines and Apealea
Slovenian: Druga zdravila in zdravilo Apealea
English: Pregnant and breast-feeding staff should not handle Apealea.
Slovenian: Noseče in doječe osebje ne sme ravnati z zdravilom Apealea.
English: Overall, there were higher rates of serious adverse events with paclitaxel micellar (41%) than with solvent-based paclitaxel (27%).
Slovenian: Splošno gledano je bil večji delež resnih neželenih dogodkov pri micelarnem paklitakselu (41 %) kot pri paklitakselu na osnovi topila (27 %).
English: • disturbed blood clotting mechanisms in the body
Slovenian: • moteni mehanizmi strjevanja krvi v telesu;
English: Pharmacokinetic data for patients with total bilirubin > 5 × ULN are not available.
Slovenian: Farmakokinetični podatki za bolnice s skupno količino bilirubina > 5 × ULN niso na voljo.
English: Q3W 250 mg/m2 + carboplatin (N = 311)
Slovenian: Q3W 250 mg/m2 + karboplatin (N = 311)
English: There is no known antidote for paclitaxel overdose.
Slovenian: Ni znanega antidota pri prevelikem odmerjanju paklitaksela.
English: Only a few patients had ECOG performance status of 2.
Slovenian: Le pri nekaj bolnicah je bil rezultat zmogljivosti po lestvici ECOG 2.
English: Apealea is not recommended during pregnancy, as paclitaxel may cause serious birth defects.
Slovenian: Zdravilo Apealea ni priporočljivo med nosečnostjo, saj lahko paklitaksel povzroči resne prirojene okvare.
English: Likewise, total plasma clearance varied about 5-fold from 8 to 41 L/hour.
Slovenian: Podobno se je skupni očistek iz plazme razlikoval približno petkratno in je znašal med 8 in 41 l/h.
English: Uncommon: Alanine aminotransferase increased a See Description of selected adverse reactions.
Slovenian: zvišana raven alanin-aminotransferaze a Glejte opis izbranih neželenih učinkov.
English: Swirl the vial again in upright position for approximately 20 seconds, then gently invert it five times.
Slovenian: Z vialo v pokončnem položaju spet krožite približno 20 sekund, nato jo petkrat nežno zasukajte.
English: • hernia
Slovenian: • hernija;
English: Patients experiencing severe reactions should not be re-challenged with paclitaxel.
Slovenian: Pri bolnicah, ki imajo hude reakcije, se paklitaksela ne sme ponovno uvesti, da jih ne bi znova izzvali.
English: From a microbiological point of view, unless the method of opening and reconstituting precludes the risks of microbial contamination, the product should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo porabiti takoj, razen če je način odpiranja in rekonstitucije tak, da je tveganje onesnaženja z mikrobi preprečeno.
English: Peripheral sensory neuropathy represented the most common reaction and was reported in 16% of patients.
Slovenian: Periferna senzorična nevropatija je predstavljala večino neželenih učinkov in o njej so poročali pri 16 % bolnic.
English: During and after infusion of Apealea, paclitaxel rapidly leaves the plasma compartment with a distribution half-life of about 0.6 hours.
Slovenian: Paklitaksel med infundiranjem zdravila Apealea in po njem hitro zapusti predel s plazmo s porazdelitvenim razpolovnim časom približno 0,6 ure.
English: After reconstitution, this medicine contains approximately up to 1.6 g sodium (component of cooking salt) per dose.
Slovenian: To zdravilo po rekonstituciji vsebuje do približno 1,6 g natrija (sestavina kuhinjske soli) na odmerek.
English: Q3W 175 mg/m2 + carboplatin (N = 333)
Slovenian: Q3W 175 mg/m2 + karboplatin (N = 333)
English: Most of the patients enrolled in the study had ECOG performance status of 0 or 1 (≥ 96%), in similar proportions between the treatment arms.
Slovenian: Večina bolnic, ki so se prijavile v študijo, je imela stanje zmogljivosti po lestvici ECOG 0 ali 1 (≥ 96 %); razmerje je bilo podobno v obeh krakih zdravljenja.
English: Protect from light and allow the vial to stand for three to five minutes.
Slovenian: Vialo zaščitite pred svetlobo in jo pustite stati od tri do pet minut.
English: Nausea (38%), vomiting (22%) and diarrhoea (15%) were among the most commonly reported adverse reactions in the study.
Slovenian: Bolezni prebavil Navzea (38 %), bruhanje (22 %) in driska (15 %) so bili neželeni učinki, o katerih so v študiji poročali najpogosteje.
English: Each vial contains 3.77 mg (0.164 mmol) sodium.
Slovenian: Ena viala vsebuje 3,77 mg (0,164 mmol) natrija.
English: During the course of the pivotal study, 46% of the peripheral neuropathies as well as the majority (78%) of the associated reactions resolved.
Slovenian: Med osrednjo študijo je izzvenelo 46 % perifernih nevropatij in večina (78 %) povezanih neželenih učinkov.
English: If any sign of extravasal injection occurs, take immediate action: terminate the infusion, aspirate fluid from the catheter/cannula before the needle is withdrawn, infuse the affected area with sterile saline or lactated or acetated Ringer's solution and closely monitor the area.
Slovenian: Če se pojavi kakršen koli znak injiciranja zunaj žile, nemudoma ukrepajte: prenehajte infundiranje, izsesajte tekočino iz katetra/kanile, preden izvlečete iglo, infundirajte prizadeto območje s sterilno fiziološko raztopino ali raztopino Ringerjevega laktata ali acetata ter območje skrbno spremljajte.
English: The reconstituted product should not be diluted.
Slovenian: Rekonstituirano zdravilo se ne sme redčiti.
English: Patients who experience severe pain or other reactions to the infusion of Apealea are recommended to be considered for a central venous catheter.
Slovenian: Pri bolnicah, ki občutijo močno bolečino ali se pri njih pojavijo druge reakcije na infundiranje zdravila Apealea, se priporoča uporaba osrednjega venskega katetra.
English: • epithelial ovarian cancer - a cancer of the ovary, the organ that produces a woman's egg cells
Slovenian: • epitelijski rak jajčnikov - rak jajčnikov, tj. organa, ki pri ženskah proizvaja jajčeca;
English: Patients with severe renal impairment (GFR < 30 mL/min) should not be treated with paclitaxel (see section 5.2).
Slovenian: Bolnice s hudo okvarjenim delovanjem ledvic (GFR < 30 ml/min) se ne smejo zdraviti s paklitakselom (glejte poglavje 5.2).
English: • cisplatin: a medicine to treat cancer
Slovenian: • cisplatin: zdravilo za zdravljenje raka.
English: What you need to know before you are given Apealea Do not use Apealea if you:
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Apealea Ne uporabljajte zdravila Apealea:
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Slovenian: Možni neželeni učinki Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnicah.
English: • carbamazepine, phenytoin: medicines to treat epilepsy and certain pain conditions
Slovenian: • karbamazepin, fenitoin: zdravili za zdravljenje epilepsije in nekaterih bolečinskih stanj;
English: The frequency of paclitaxel-related hypersensitivity reactions was similar in both groups (5% of the patients receiving paclitaxel micellar and 7% of the patients receiving solvent-based paclitaxel), whereas a higher frequency of carboplatin-related hypersensitivity reactions was observed in the group receiving paclitaxel micellar (12% vs 7%).
Slovenian: Pogostnost preobčutljivostnih reakcij, povezanih s paklitakselom, je bila podobna v obeh skupinah (5-odstotna pri bolnicah, ki so prejemale micelarni paklitaksel oziroma 7-odstotna pogostnost pri bolnicah, ki so prejemale paklitaksel na osnovi topila), večja pogostnost preobčutljivostnih reakcij zaradi karboplatina pa je bila opažena v skupini, ki je prejemala micelarni paklitaksel (12 % v primerjavi s 7 %).
English: Other associated reactions were reported in 10% of the patients and were mostly (98%) mild to moderate (CTCAE grade ≤ 2).
Slovenian: O drugih povezanih neželenih učinkih so poročali pri 10 % bolnic; ti so bili večinoma (v 98 % primerov) blagi do zmerni (stopnja ≤ 2 po CTCAE).
English: When paclitaxel is given before cisplatin, the safety profile of solvent-based paclitaxel is consistent with that reported for single-agent use.
Slovenian: Kadar se paklitaksel daje pred cisplatinom, je varnostni profil paklitaksela na osnovi topila skladen s tistim, o katerem so poročali pri njegovi samostojni uporabi.
English: In this limited number of patients, anorexia, fatigue, myalgia, arthralgia, peripheral sensory neuropathy, and diarrhoea were observed more frequently compared to patients younger than 65 years.
Slovenian: Pri tem omejenem številu bolnic so anoreksijo, utrujenost, mialgijo, artralgijo, periferno senzorično nevropatijo in drisko opazili pogosteje kot pri bolnicah, mlajših od 65 let.
English: No pharmacologically active metabolite has been found.
Slovenian: Ni bilo ugotovljenega farmakološko aktivnega presnovka.
English: Based on the published literature, in vitro studies indicate that the presence of cimetidine, ranitidine, dexamethasone, or diphenhydramine does not affect protein binding of paclitaxel.
Slovenian: Na podlagi objavljene literature študije in vitro kažejo, da prisotnost cimetidina, ranitidina, deksametazona ali difenhidramina ne vpliva na vezavo paklitaksela na beljakovine.
English: * Solutions containing both Ca2+ and Mg2+ should have a total (combined) concentration of Ca2+ and Mg2+ within the range of 1.0 to 3.5 mmol/L.
Slovenian: * Raztopine, ki vsebujejo Ca2+ in Mg2+, morajo imeti skupno (združeno) koncentracijo Ca2+ in Mg2+ v razponu med 1,0 in 3,5 mmol/l.
English: Withhold treatment until recovery to < grade 2
Slovenian: Odložite zdravljenje do izboljšanja stanja do stopnje < 2
English: − build-up of water in tissue because of blocked lymph vessel
Slovenian: − kopičenje vode v tkivih zaradi zapore limfne žile;
English: The usual dose is 250 mg/m2 body surface area given every three weeks for up to six treatments.
Slovenian: Običajni odmerek je 250 mg/m2 telesne površine, ki se daje vsake tri tedne v največ šestih ciklih zdravljenja.
English: The plasma levels of unbound paclitaxel, i.e. the concentration that represents pharmacologically active paclitaxel in the body, were demonstrated to be bioequivalent (Cmax and AUC) after administration of albumin-bound paclitaxel and Apealea.
Slovenian: Za ravni nevezanega paklitaksela v plazmi, tj. v koncentraciji, ki predstavlja farmakološko aktivni paklitaksel v telesu, se je izkazalo, da so bioekvivalentne (Cmax in AUC) po dajanju paklitaksela, vezanega na albumin, in zdravila Apealea.
English: No studies have been performed to evaluate drug-drug interactions between Apealea and other medicinal products.
Slovenian: Študij za oceno medsebojnega delovanja zdravila Apealea z drugimi zdravili niso izvedli.
English: Paclitaxel has been shown in vitro to be a substrate for the influx transporter proteins OATP1B3 and OATP1A2.
Slovenian: V študiji in vitro se je pokazalo, da je paklitaksel substrat za privzemni prenašalni beljakovini OATP1B3 in OATP1A2.
English: For CTCAE grade ≥ 2 sensory or motor neuropathy withhold treatment until resolution to < grade 2, followed by a dose reduction for all subsequent courses (see section 4.2).
Slovenian: Za senzorično ali motorično nevropatijo stopnje ≥ 2 po CTCAE odložite zdravljenje do izboljšanja do stopnje < 2, nato zmanjšajte odmerek za vse nadaljnje cikle (glejte poglavje 4.2).
English: Do not shake.
Slovenian: Ne stresajte.
English: Therefore, frequent complete blood cell counts should be performed during treatment with Apealea.
Slovenian: Zato je treba med zdravljenjem z zdravilom Apealea pogosto preverjati celotno krvno sliko.
English: The non-inferiority criterion was met for PFS with the upper bound limit of the one-sided 97.5% confidence interval (CI) for the associated hazard ratio being less than 1.2.
Slovenian: Merilo neinferiornosti za PFS je bilo izpolnjeno, z zgornjo mejo enostranskega 97,5odstotnega intervala zaupanja (IZ) za povezano razmerje ogroženosti manj kot 1,2.
English: Patients treated with paclitaxel and cisplatin may have an increased risk of renal failure as compared to cisplatin alone in gynaecological cancers.
Slovenian: Pri bolnicah, ki se zdravijo s paklitakselom in cisplatinom, utegne biti povečano tveganje ledvične odpovedi v primerjavi s samostojnim dajanjem cisplatina pri ginekoloških rakih.
English: • ketoconazole, or other medicines to treat fungal infections
Slovenian: • ketokonazol ali druga zdravila za zdravljenje glivičnih okužb;
English: Contents of the pack and other information What Apealea contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Apealea
English: The corresponding median number of cycles (min;max) for the two groups were 6 (1;12) and 6 (1;9), respectively.
Slovenian: Mediano število ciklov (min, maks) pri teh dveh skupinah je bilo pri prvi skupini 6 (1, 12) in pri drugi 6 (1, 9).
English: When solvent-based paclitaxel was given after cisplatin, patients showed a more profound myelosuppression and an approximately 20% decrease in paclitaxel clearance.
Slovenian: Kadar se je paklitaksel na osnovi topila dajal za cisplatinom, pa sta se pri bolnicah pokazala izrazitejša mielosupresija in približno 20-odstotno zmanjšanje očistka paklitaksela.
English: Neutropenia resolved to ≥ 1.5 × 109/L before the next course of treatment.
Slovenian: Stanje nevtropenije se je izboljšalo na ≥ 1,5 × 109/l pred naslednjim ciklom zdravljenja.
English: Studies in animals being treated with paclitaxel have shown decreased fertility (see section 5.3).
Slovenian: Študije na živalih, ki so jih zdravili s paklitakselom, so pokazale zmanjšano plodnost (glejte poglavje 5.3).
English: Apealea is for intravenous use.
Slovenian: Zdravilo Apealea je namenjeno intravenski uporabi.
English: An open, randomised, multicentre study was conducted in 789 women with recurrent epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer to compare Apealea (paclitaxel micellar) in combination with carboplatin with solvent-based paclitaxel in combination with carboplatin.
Slovenian: Izvedena je bila nezaslepljena, randomizirana, multicentrična študija s 789 ženskami z recidivnim epitelijskim rakom jajčnikov, primarnim peritonealnim rakom in rakom jajcevodov, za primerjavo zdravila Apealea (micelarni paklitaksel) v kombinaciji s karboplatinom s paklitakselom na osnovi topila v kombinaciji s karboplatinom.
English: Paclitaxel is an antineoplastic medicinal product and as with other potentially toxic compounds, caution should be exercised in handling Apealea.
Slovenian: Paklitaksel je antineoplastično zdravilo in tako kot z drugimi potencialno toksičnimi spojinami je treba tudi z zdravilom Apealea ravnati previdno.
English: Alternatively, the vial may be placed on a shaker and rotated for up to 20 minutes, while being protected from light (orbital shake pattern; 200-250 rpm).
Slovenian: Vialo lahko tudi postavite na stresalnik in jo vrtite do 20 minut, pri tem mora biti zaščitena pred svetlobo (orbitalni vzorec stresanja; 200-250 vrt/min).
English: Apealea has moderate influence on the ability to drive or use machines.
Slovenian: Zdravilo Apealea ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: There was no statistically significant difference in PFS or OS between the two treatment arms.
Slovenian: Med obema krakoma zdravljenja ni bilo statistično značilne razlike v PFS ali OS.
English: A similar effect can be anticipated for Apealea (paclitaxel micellar).
Slovenian: Podoben učinek je mogoče pričakovati pri zdravilu Apealea
English: • coma, feeling very sleepy, drowsy and/or being deeply unresponsive
Slovenian: • koma, velika zaspanost, omotičnost in/ali izrazita neodzivnost;
English: In the clinical study, the proportion of patients receiving six treatment cycles was 81% in the group treated with paclitaxel micellar and 87% in the group receiving solvent-based paclitaxel.
Slovenian: V klinični študiji je bil delež bolnic, ki so prejele šest ciklov zdravljenja, v skupini, ki je prejemala micelarni paklitaksel, 81 % in v skupini, ki je prejemala paklitaksel na osnovi topila, 87 %.
English: • pain for instance in arms, legs, breast or at site of tumour
Slovenian: • bolečine, na primer v rokah, nogah, dojkah ali na mestu tumorja;
English: Patients with hepatic impairment have not been studied with Apealea but may be at increased risk of toxicity, particularly from myelosuppression.
Slovenian: Okvara jeter Pri bolnicah z okvaro jeter uporabe zdravila Apealea niso preučevali, vendar bi pri njih lahko bilo povečano tveganje za toksičnost, zlasti zaradi mielosupresije.
English: Moderate cases may require premedication with corticosteroids, antihistamines and/or H2 antagonists for the following treatment cycles.
Slovenian: Pri zmernih reakcijah utegne biti v nadaljnjih ciklih zdravljenja potrebna premedikacija s kortikosteroidi, antihistaminiki in/ali antagonisti H2.
English: b The dose of carboplatin should be reduced by 1 AUC unit for treatment cycles following the occurrence of febrile neutropenia or low platelet count (< 75 × 109/L).
Slovenian: b Odmerek karboplatina je treba zmanjšati za eno enoto AUC za cikle zdravljenja po pojavitvi febrilne nevtropenije ali nizkega števila krvnih ploščic (< 75 × 109/l).
English: Local reactions at the infusion site are very common during Apealea infusions.
Slovenian: Lokalne reakcije na mestu infundiranja so med infundiranjem zdravila Apealea zelo pogoste.
English: • erythromycin, rifampicin: medicines to treat bacterial infections
Slovenian: • eritromicin, rifampicin: zdravili za zdravljenje bakterijskih okužb;
English: The powder should be greenish-yellow to yellow.
Slovenian: Prašek mora biti zelenkasto rumene do rumene barve.
English: • herpes simplex (a viral infection), viral airways infections
Slovenian: • herpes simpleks (virusna okužba), virusne okužbe dihal;
English: Acceptable ion concentrations for calcium and magnesium in lactated and acetated Ringer's solutions suitable for reconstitution
Slovenian: Dopustni ionski koncentraciji kalcija in magnezija v Ringerjevi raztopini laktata ali acetata, primerni za rekonstitucijo
English: Anaemia as serious adverse event occurred in 5% of the patients, thrombocytopenia and leukopenia in 3% and 6% of the patients, respectively.
Slovenian: Anemija kot resen neželeni dogodek se je pojavila pri 5 % bolnic, trombocitopenija pri 3 % bolnic in levkopenija pri 6 % bolnic.
English: On average, the paclitaxel elimination rate was 20% higher in males compared to in females.
Slovenian: V povprečju je bila stopnja izločanja paklitaksela pri moških za 20 %
English: This was in agreement with the mean fu after albumin-bound paclitaxel infusion which varied between 5.5% and 4.5% over time.
Slovenian: To je bilo v skladu s povprečnim nevezanim deležem paklitaksela po infundiranju paklitaksela, vezanega na albumin, ki se je glede na čas po infundiranju gibal med 5,5 in 4,5 %.
English: Apealea is indicated to be used in combination with carboplatin (see section 4.1).
Slovenian: Zdravilo Apealea je indicirano za uporabo v kombinaciji s karboplatinom (glejte poglavje 4.1).
English: Apealea may cause adverse reactions such as fatigue (very common) and dizziness (common) that may affect the ability to drive or use machinery.
Slovenian: Zdravilo Apealea lahko povzroči neželene učinke, kot so utrujenost (zelo pogosta) in omotica (pogosta), ki lahko vplivajo na sposobnost vožnje in upravljanja strojev.
English: After reconstitution, each mL of solution contains up to approximately 3.60 mg (0.157 mmol) sodium.
Slovenian: Po rekonstituciji en ml raztopine vsebuje do približno 3,60 mg (0,157 mmol) natrija.
English: The dose-dependency of frequency and severity of neurotoxicity was not studied for Apealea, but has been observed for other paclitaxel formulations in other indications.
Slovenian: Pri zdravilu Apealea niso preučevali pogostnosti in resnosti nevrotoksičnosti v odvisnosti od odmerka, so pa ta pojav opazili pri drugih formulacijah s paklitakselom pri drugih indikacijah.
English: Compatibility with administration sets made of DEHP-free PVC (i.e. polyvinyl chloride without the plasticizer di-(2-ethylhexyl) phthalate) has been demonstrated.
Slovenian: Dokazana je bila združljivost s sistemi za dajanje iz PVC brez DEHP (tj. iz polivinil klorida brez plastifikatorja di-[2-etilheksil] ftalat), medtem ko združljivost s sistemi za dajanje, ki vsebujejo DEHP, ni bila dokazana.
English: In comparison to the patients receiving solvent-based paclitaxel, there were more patients in the group receiving paclitaxel micellar who experienced haematological toxicities with grade 3 and 4.
Slovenian: V primerjavi z bolnicami, ki so prejemale paklitaksel na osnovi topila, je bilo v skupini bolnic, ki so prejemale micelarni paklitaksel, več bolnic, pri katerih so se pojavile hematološke toksičnosti stopnje 3 in 4.
English: Median time to death or disease progression [months] (95% CI)
Slovenian: Smrt ali napredovanje, n (%) Mediani čas do smrti ali napredovanja bolezni (v mesecih) (IZ 95 %)
English: Neutropenia is a dose-dependent and dose-limiting adverse reaction.
Slovenian: Nevtropenija je neželeni učinek, ki je odvisen od odmerka in omejuje odmerek.
English: Table 2 lists adverse reactions associated with the administration of Apealea in combination with carboplatin observed in a clinical study (N = 391) and adverse reactions from post-marketing experience.
Slovenian: V preglednici 2 so navedeni neželeni učinki, povezani z dajanjem zdravila Apealea v kombinaciji s karboplatinom, ki so jih opazili v klinični študiji (N = 391) in neželeni učinki iz obdobja po prihodu zdravila na trg.
English: Premedication was not mandated prior to infusion of paclitaxel micellar.
Slovenian: Predmedikacija pred infuzijo micelarnega paklitaksela ni bila obvezna.