FrancophonIA/ELRC3.0 huggingface dataset:
English: Only use sodium chloride 9 mg/mL (0.9 %) solution for injection as a diluent.
Slovenian: Kot redčilo uporabljajte le natrijev klorid 9 mg/ml (0,9 %) raztopino za injiciranje.
English: Discontinuation of necitumumab in patients who experience a VTE or ATE should be considered after a thorough benefit risk assessment for the individual patient.
Slovenian: Pri bolnikih, pri katerih se pojavijo venski trombembolični dogodki in arterijski trombembolični dogodki, je treba po natančni oceni koristi in tveganj za posameznega bolnika razmisliti o prekinitvi zdravljenja z necitumumabom.
English: In a clinical trial in advanced non-squamous NSCLC, venous thromboembolic events (VTEs) were reported in approximately 11 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 8 % in the pemetrexed and cisplatin alone arm) and mainly presented as pulmonary embolism and deep vein thrombosis.
Slovenian: V kliničnih preskušanjih z napredovalim neskvamoznim NSCLC so o venskih trombemboličnih dogodkih poročali pri približno 11 % bolnikov, zdravljenih z necitumumabom v kombinaciji s pemetreksedom in cisplatinom (v primerjavi z 8 % v skupini s pemetreksedom in cisplatinom) in so večinoma predstavljali pljučno embolijo in globoko vensko trombozo.
English: There was no relationship between immunogenicity and IRRs or treatment emergent adverse events.
Slovenian: Povezanosti med imunogenostjo in preobčutljivostnimi reakcijami/reakcijami, povezanimi z infuzijo ali neželenimi učinki zaradi zdravljenja ni bilo.
English: Eyelash trichomegaly Isolated cases of Grade 1 trichomegaly have been reported in patients treated with necitumumab.
Slovenian: Pri bolnikih, zdravljenih z necitumumabom, so poročali o osamljenih primerih trihomegalije stopnje 1.
English: Common Phlebitis
Slovenian: Pogosti flebitis
English: Do not freeze or shake the infusion solution.
Slovenian: NE ZAMRZUJTE IN NE PRETRESAJTE raztopine za infundiranje.
English: DO NOT FREEZE OR SHAKE the infusion solution.
Slovenian: Ne zamrzujte in ne pretresajte raztopine za infundiranje.
English: This medicine contains 76 mg sodium per dose.
Slovenian: Zdravilo Portrazza vsebuje natrij To zdravilo vsebuje 76 mg natrija na odmerek.
English: Necitumumab recognises and binds specifically to a protein on the surface of some cancer cells.
Slovenian: Necitumumab prepozna beljakovino, ki jo najdemo na površini nekaterih rakastih celic, in se veže specifično nanjo.
English: Seek medical help immediately if you experience any of the following:
Slovenian: Če opazite katerega od spodaj naštetih učinkov, morate takoj poiskati zdravniško pomoč:
English: Dose and administration
Slovenian: Odmerek in dajanje
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Portrazza 800 mg sterile concentrate necitumumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Portrazza 800 mg sterilni koncentrat necitumumab
English: Common (≥1/100 to <1/10)
Slovenian: Pogosti (≥ 1/100 do < 1/10) Občasni (≥ 1/1.000 do < 1/100)
English: The relative risk of VTE or ATE was approximately three-fold higher in patients with a reported history of VTE or ATE.
Slovenian: Relativno tveganje venskih trombemboličnih dogodkov ali arterijskih trombemboličnih dogodkov je bilo približno trikrat višje pri bolnikih, ki so poročali o anamnezi venskih trombemboličnih dogodkov ali arterijskih trombemboličnih dogodkov.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Med zdravilom Portrazza in gemcitabinom/cisplatinom niso opazili medsebojnega delovanja.
English: Cardiorespiratory arrest or sudden death was reported in 2.8% (15/538) of patients treated with necitumumab in combination with gemcitabine and cisplatin compared to 0.6% (3/541) of patients treated with chemotherapy alone.
Slovenian: zdravljenih z necitumumabom v kombinaciji z gemcitabinom in cisplatinom v primerjavi z 0,6 % (3/541) bolnikov, ki so bili zdravljeni le s kemoterapijo.
English: NAME OF THE MEDICINAL PRODUCT Portrazza 800 mg concentrate for solution for infusion
Slovenian: IME ZDRAVILA Portrazza 800 mg koncentrat za raztopino za infundiranje
English: Thromboprophylaxis should be considered after careful assessment of a patient's risk factors (including the increased risk of serious bleeding in patients with tumour cavitation or tumour involvement of large central blood vessels).
Slovenian: Po natančni oceni bolnikovih dejavnikov tveganja (vključno s povečanim tveganjem za resno krvavitev pri bolnikih s kavitacijo tumorja ali prepletenostjo tumorja z velikimi osrednjimi krvnimi žilami) je treba razmisliti o tromboprofilaksi.
English: Adverse drug reactions (ADRs) which were reported in patients with squamous non-small cell lung cancer are listed below in MedDRA body system organ class, frequency and grade of severity.
Slovenian: Tabelarični seznam neželenih učinkov Neželeni učinki zdravila, o katerih so poročali pri bolnikih s skvamoznim nedrobnoceličnim pljučnim rakom, so navedeni spodaj po organskih sistemih, pogostnosti in resnosti glede na podatkovno bazo MedDRA. Pogostnost je navedena v skladu z naslednjim dogovorom:
English: Clinically relevant toxicities with respect to the elderly and those patients with Eastern Cooperative Oncology Group (ECOG) performance status score 2 (ECOG PS2) were similar to the overall population in patients receiving necitumumab plus chemotherapy consisting of gemcitabine and cisplatin.
Slovenian: (Eastern Cooperative Oncology Group) (ECOG PS2) so bile podobne kot v celokupni populaciji bolnikov, ki so prejemali necitumumab in kemoterapijo, sestavljeno iz gemcitabina in cisplatina.
English: Based on population pharmacokinetic approach (PopPK), the mean volume of distribution at steady state (Vss) for necitumumab was 6.97 L (CV
Slovenian: Po načelih populacijske farmakokinetike (PopPK) je povprečni porazdelitveni volumen za necitumumab v stanju dinamičnega ravnovesja (Vss) znašal
English: See section 4 for more details about infusion-related reactions which may occur during or after the infusion.
Slovenian: povezanih z infuzijo, ki se lahko pojavijo med infuzijo ali po njej.
English: Sodium citrate dihydrate (E331) Citric acid anhydrous (E330) Sodium chloride Glycine (E640)
Slovenian: 6.1 Seznam pomožnih snovi natrijev citrat dihidrat (E331) brezvodna citronska kislina (E330) natrijev klorid glicin (E640) manitol (E421) polisorbat 80 (E433) voda za injekcije
English: Patients received a maximum of six cycles of chemotherapy in each arm; patients in the Portrazza+GC arm who had no progression continued to receive single-agent Portrazza until disease progression, unacceptable toxicity, or withdrawal of consent.
Slovenian: Bolniki so v vsaki od skupin prejeli največ šest ciklov kemoterapije; bolniki v skupini Portrazza+GC, pri katerih bolezen ni napredovala,
English: Vascular disorders Common Venous thromboembolic events
Slovenian: Pogosti venski trombembolični dogodki
English: Table 1 - Management recommendations for hypersensitivity/infusion-related reactions
Slovenian: Preobčutljivostne reakcije/reakcije, povezane z infuzijo Preglednica 1 - Priporočila za obravnavanje preobčutljivostnih reakcij/reakcij, povezanih z infuzijo
English: Common Hypersensitivity reactions/infusionrelated reactions
Slovenian: Pogosti preobčutljivostne reakcije/reakcije, povezane z infuzijo
English: Name and address of the manufacturer(s) responsible for batch release Lilly, S.A.
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega za sproščanje serij
English: Common (may affect up to 1 in 10 people) - headache - coughing up blood (haemoptysis) - nosebleed (epistaxis) - strange tastes; metallic taste (dysgeusia) - eye inflammation (conjunctivitis) - blood clots in the arteries - urinary tract infection (bladder and/or kidneys) - pain when passing urine (dysuria) - difficulty in swallowing (dysphagia) - muscle spasms - inflammation of veins in the legs (phlebitis) - allergic reactions - pain in your mouth and throat (oropharyngeal pain)
Slovenian: - glavobol - izkašljevanje krvi (hemoptiza) - krvavitev iz nosu (epistaksa) - nenavadni okusi v ustih; kovinski okus (disgevzija)
English: Portrazza may also cause changes in the results of blood tests.
Slovenian: - bolečina v vaših ustih in grlu (orofaringealna bolečina) Zdravilo Portrazza lahko povzroči tudi spremembe v krvnih testih.
English: Monitor patients during and following the infusion for signs of hypersensitivity and infusion-related reactions with resuscitation equipment and appropriate medical resources readily available.
Slovenian: Med infundiranjem in po njem morate bolnike spremljati in biti pozorni na znake preobčutljivostnih reakcij in reakcij,
English: Common Dysuria
Slovenian: Pogosti disgevzija
English: Hypersensitivity/infusion-related reactions (IRRs) were reported with necitumumab.
Slovenian: Preobčutljivostne reakcije/reakcije, povezane z infuzijo Pri uporabi necitumumaba so poročali o preobčutljivostnih reakcijah/reakcijah, povezanih z infuzijo.
English: Severe VTEs were reported in approximately 4 % of patients.
Slovenian: O hudih venskih trombemboličnih dogodkih so poročali pri približno 4 % bolnikov.
English: Pre-emptive skin treatment including skin moisturiser, sun screen, topical steroid cream (1 % hydrocortisone) and an oral antibiotic (e.g. doxycycline) may be useful in the management of dermatologic reactions as clinically appropriate.
Slovenian: Profilaktično zdravljenje kože, vključno s sredstvom za vlaženje kože, sredstvom za zaščito kože pred soncem, topikalno steroidno kremo (1 % hidrokortizon) in peroralnim antibiotikom (npr.
English: BATCH NUMBER Lot
Slovenian: Dvostranska p vrednost testa log-rankc
English: Portrazza must not be administered as an intravenous bolus or push.
Slovenian: Zdravila Portrazza ne smete dajati v obliki intravenskega bolusa ali hitre intravenske injekcije.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: A separate infusion line must be used and the line must be flushed with sodium chloride 9 mg/mL (0.9%) solution for injection at the end of the infusion.
Slovenian: Za infuzijo morate uporabiti ločeno infuzijsko linijo, ki jo morate ob koncu infundiranja sprati z natrijevim kloridom 9 mg/ml (0,9%) raztopino za injiciranje.
English: How to store Portrazza
Slovenian: Shranjevanje zdravila Portrazza
English: Cardiovascular comorbidities, performance status and the likely tolerability to chemotherapy with add-on necitumumab should therefore be thoroughly evaluated prior to the initiation of treatment in patients above 70 years of age.
Slovenian: Zato je treba pred začetkom zdravljenja pri bolnikih, starejših od 70 let, natančno oceniti sočasna srčno-žilna obolenja, stanja zmogljivosti in verjetnost prenašanja kemoterapije z dodatkom necitumumaba.
English: Excipient with known effect Each 50 mL vial contains approximately 76 mg sodium.
Slovenian: Ena 50-mililitrska viala vsebuje približno 76 mg natrija.
English: Posology adjustments
Slovenian: Prilagajanje odmerjanja
English: What you need to know before you are given Portrazza
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Portrazza Zdravila Portrazza ne smete prejeti:
English: Arterial thromboembolic events (ATEs) were reported in approximately 4 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 6 % in the pemetrexed and cisplatin alone arm) and mainly present as stroke and myocardial infarction.
Slovenian: O arterijskih trombemboličnih dogodkih so poročali pri približno 4 % bolnikov, zdravljenih z necitumumabom v kombinaciji s pemetreksedom in cisplatinom (v primerjavi s 6 % v skupini s pemetreksedom in cisplatinom) in so večinoma predstavljali kap in miokardni infarkt.
English: The pharmacokinetics of gemcitabine/cisplatin were not affected when co-administered with necitumumab and the pharmacokinetics of necitumumab were not affected when co-administered with gemcitabine/cisplatin.
Slovenian: Na farmakokinetiko gemcitabina/cisplatina sočasno dajanje necitumumaba ni vplivalo.
English: No formal studies have been conducted to evaluate the effect of renal impairment on the PK of necitumumab.
Slovenian: Formalne študije, ki bi ocenjevale učinek ledvične okvare na farmakokinetiko necitumumaba, niso bile opravljene.
English: No formal studies have been conducted to evaluate the effect of hepatic impairment on the PK of necitumumab.
Slovenian: Formalne študije, ki bi ocenjevale učinek okvare jeter na farmakokinetiko necitumumaba, niso bile opravljene.
English: The physician educational material package should also contain: o The Summary of Product Characteristics o Patient Information Leaflet
Slovenian: Paket izobraževalnega gradiva za zdravnike mora vsebovati tudi:
English: America, Europe, and Australia vs. South America, South Africa, and India vs. Eastern Asia])
Slovenian: c Stratificirano z randomizacijskimi stratumi (ocena stanja zmogljivosti po ECOG [0-1 v primerjavi z 2] in geografsko regijo [Severna Amerika, Evropa in Avstralija v primerjavi z Južno Ameriko, Južno Afriko in Indijo v primerjavi z Vzhodno Azijo])
English: In a phase 2 clinical trial investigating necitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone (106 versus 55 patients, 2:1 randomisation) as the first-line therapy in patients with Stage IV metastatic squamous NSCLC, a higher rate of death, including death due to infection, was observed for the necitumumab plus paclitaxel/carboplatin arm during the first 4 months (see also section 4.4), with a later trend towards improved survival after 4 months.
Slovenian: vključno s smrtjo zaradi okužb v skupini z necitumumabom v kombinaciji s paklitakselom in karboplatinom v prvih štirih mesecih (glejte tudi poglavje 4.4), s kasnejšim trendom v smeri izboljšanja preživetja po štirih mesecih.
English: For IV use after dilution.
Slovenian: Za intravensko uporabo po redčenju.
English: Blood clots in the veins
Slovenian: OVOJNINAH OZNAKA NA VIALI
English: Progression free survival Number of events (n) Median - months (95 % CI) Hazard ratio (95 % CI) b, c Two-sided log-rank p-value c a Abbreviations: CI = confidence interval b Hazard ratio is expressed as treatment/control and estimated from Cox model c Stratified by the randomization strata (ECOG PS [0-1 vs. 2], and geographic region [North
Slovenian: Dvostranska p vrednost testa log-rankc a Okrajšave: IZ = interval zaupanja b Razmerje tveganja je izraženo kot zdravljenje/kontrola in ocenjeno s pomočjo Coxovega modela.
English: Severe VTEs were reported in approximately 6 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 4 % in the pemetrexed and cisplatin alone arm).
Slovenian: O hudih venskih trombemboličnih dogodkih so poročali pri približno 6 % bolnikov, zdravljenih z necitumumabom v kombinaciji s pemetreksedom in cisplatinom (v primerjavi s 4 % v skupini s pemetreksedom in cisplatinom).
English: Severe ATEs were reported in approximately 3 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 4 % in the pemetrexed and cisplatin alone arm).
Slovenian: O hudih arterijskih trombemboličnih dogodkih so poročali pri približno 3 % bolnikov, zdravljenih z necitumumabom v kombinaciji s pemetreksedom in cisplatinom (v primerjavi s 4 % v skupini s pemetreksedom in cisplatinom).
English: Handling instructions Portrazza 800 mg concentrate for solution for infusion necitumumab
Slovenian: Navodilo za uporabo Portrazza 800 mg koncentrat za raztopino za infundiranje necitumumab
English: Portrazza 800 mg concentrate for solution for infusion necitumumab
Slovenian: Portrazza 800 mg koncentrat za raztopino za infundiranje necitumumab
English: Eye disorders
Slovenian: - vnetje očesa (konjunktivitis)
English: Alcobendas
Slovenian: ZDRAVILA
English: Severe ATEs were reported in 3 % of patients.
Slovenian: O hudih arterijskih trombemboličnih dogodkih so poročali pri približno 3 % bolnikov.
English: No animal studies have been specifically conducted to evaluate the effect of necitumumab on reproduction and foetal development; however, based on its mechanism of action and animal models where EGFR expression is disrupted, necitumumab may cause foetal harm or developmental anomalies.
Slovenian: Kljub temu pa na podlagi mehanizma delovanja necitumumaba in živalskih modelov z moteno izraženostjo EGFR
English: Venous thromboembolic events (VTE) and arterial thromboembolic events (ATE), including fatal cases, were observed with necitumumab in combination with gemcitabine and cisplatin (see also section 4.8).
Slovenian: so opazili pri zdravljenju z necitumumabom v kombinaciji z gemcitabinom in cisplatinom (glejte tudi poglavje 4.8).
English: Common Headache Common Dysgeusia
Slovenian: Pogosti disfagija
English: Women of childbearing potential/contraception in females Based on its mechanism of action and animal models where EGFR expression is disrupted, necitumumab may cause foetal harm or developmental anomalies.
Slovenian: Na podlagi mehanizma delovanja necitumumaba in živalskih modelov z moteno izraženostjo EGFR
English: To administer using empty intravenous infusion containers Aseptically transfer 50 mL of necitumumab medicine into an empty intravenous container and add 200 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection to the container to bring the total volume to 250 mL.
Slovenian: Če uporabljate prazne vsebnike za intravensko infuzijo: Aseptično prenesite 50 ml necitumumaba v prazen vsebnik za intravensko infuzijo in dodajte v vsebnik 200 ml sterilnega natrijevega klorida 9 mg/ml (0,9%) raztopine za injiciranje, tako da bo za skupna končna prostornina v vsebniku znašala 250 ml. Vsebnik nežno obrnite, da zagotovite zadostno mešanje.
English: To administer using empty intravenous infusion containers Aseptically transfer 50 mL of necitumumab medicinal product into an empty intravenous container and add 200 mL of sodium chloride 9 mg/mL (0.9 %) solution for injection to the container to bring the total volume to 250 mL.
Slovenian: Če uporabljate prazne vsebnike za intravensko infuzijo Aseptično prenesite 50 ml necitumumaba v prazen vsebnik za intravensko infuzijo in dodajte v vsebnik 200 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje, tako da bo za skupna končna prostornina v vsebniku znašala 250 ml. Vsebnik nežno obrnite, da zagotovite zadostno mešanje.
English: Gastrointestinal disorders
Slovenian: Trihomegalija trepalnic
English: In vivo studies in cell line-derived xenograft models of human cancer, including non-small cell lung carcinoma, demonstrate that necitumumab has antitumor activity both in monotherapy and in combination with gemcitabine and cisplatin.
Slovenian: da ima necitumumab protitumorsko delovanje tako v monoterapiji kot v kombinaciji z gemcitabinom in cisplatinom.
English: To administer using pre-filled intravenous infusion containers Aseptically remove 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection from the prefilled 250 mL container and transfer 50 mL of necitumumab medicine into the container to bring the final volume in the container back to 250 mL.
Slovenian: Aseptično odvzemite 50 ml natrijev klorid 9 mg/ml (0,9%) raztopine za injiciranje iz napolnjenega 250-mililitrskega vsebnika in prenesite 50 ml necitumumaba v vsebnik, tako da bo za skupna končna prostornina v vsebniku znova znašala 250 ml. Vsebnik nežno obrnite, da zagotovite zadostno mešanje.
English: Sodium restricted diet
Slovenian: Zelo pogosti zmanjšana telesna masa
English: How you are given Portrazza 4.
Slovenian: Shranjevanje zdravila Portrazza 6.
English: Common Urinary tract infection
Slovenian: Pogosti okužba sečil
English: Hypomagnesaemiac
Slovenian: Zelo pogosti hipofosfatemijac
English: Grade ≥ 3
Slovenian: PRILOGA III
English: Following improvement to Grade ≤ 2, resume at reduced dose of 400 mg.
Slovenian: ≤ 2 nadaljujte z zmanjšanim odmerkom 400 mg. • Če se simptomi pri odmerku 600 mg še en cikel ne poslabšajo,
English: Ελλάδα
Slovenian: Po redčenju
English: 11 January 2019
Slovenian: 11. januar 2019
English: Hetero Europe S.L.
Slovenian: Podjetje Hetero Europe S.L.
English: The European Commission issued an EU-wide legally binding decision on 11 January 2019.
Slovenian: Evropska komisija je 11. januarja 2019 izdala pravno zavezujoč sklep za vse države članice EU.
English: The review of Paclitaxel Hetero was initiated at the request of Portugal under Article 29 of Directive 2001/83/EC.
Slovenian: Pregled zdravila Paxlitaxel Heterose je začel na zahtevo Portugalske v skladu s členom 29 Direktive 2001/83/ES.
English: However, the Member States were not able to reach an agreement and the Portuguese agency referred the matter to EMA for arbitration on 2 November 2017.
Slovenian: Ker pa države članice niso dosegle soglasja, je portugalska regulativna agencija za zdravila 2. novembra 2017 zadevo napotila na agencijo EMA v arbitražo.
English: It blocks the ability of cancer cells to break down their internal ‘skeleton' that allows them to divide and multiply.
Slovenian: Deluje tako, da zavira sposobnost rakavih celic za razgradnjo njihovega notranjega „ogrodja“, ki jim omogoča, da se delijo in množijo.
English: In particular, the company did not provide direct comparative data with the reference medicine, which is normally required for medicines formulated in micelles.
Slovenian: Podjetje zlasti ni predložilo neposrednih primerjalnih podatkov z referenčnim zdravilom, kar se običajno zahteva pri zdravilih v obliki micel.
English: On 18 October 2018, the European Medicines Agency (EMA) completed a review of Paclitaxel Hetero following a disagreement among EU Member States regarding its authorisation.
Slovenian: Evropska agencija za zdravila (EMA) je 18. oktobra 2018 zaključila pregled zdravila Paclitaxel Hetero po nesoglasju med državami članicami EU v zvezi z izdajo dovoljenja za promet z njim.
English: It was to be available as a concentrate for solution for infusion (6 mg/ml) for the treatment of breast cancer, cancer of the ovaries, non-small cell lung cancer and Kaposi's sarcoma (a cancer of the blood vessels) in patients with acquired immune deficiency syndrome (AIDS).
Slovenian: Na voljo naj bi bilo v obliki koncentrata za raztopino za infundiranje (6 mg/ml) za zdravljenje raka dojk, raka jajčnikov, nedrobnoceličnega raka pljuč in Kaposijevega sarkoma (raka krvnih žil) pri bolnikih s pridobljenim sindromom imunske pomanjkljivosti (aidsom).
English: Viladecans (Barcelona) submitted Paclitaxel Hetero to the Portuguese medicines agency for a decentralised procedure.
Slovenian: Viladecans (Barcelona) je vlogo za zdravilo Paclitaxel Hetero predložilo portugalski regulativni agenciji za zdravila v decentralizirani postopek.
English: The Agency concluded that the benefits of Paclitaxel Hetero do not outweigh its risks, and the marketing authorisation cannot be granted in Portugal or in other Member States of the EU (Germany, the Netherlands and the UK).
Slovenian: Agencija je zaključila, da koristi zdravila Paclitaxel Hetero ne odtehtajo njegovih tveganj in da dovoljenja za promet na Portugalskem in v drugih državah članicah EU (v Nemčiji, na Nizozemskem in v Združenem kraljestvu) ni mogoče izdati.
English: Instead, it submitted indirect comparative data and a study which compared blood levels of paclitaxel in Paclitaxel Hetero with those of another generic paclitaxel medicine, which was not considered sufficient by the Netherlands.
Slovenian: Namesto tega je predložilo posredne primerjalne podatke in študijo, v kateri je primerjalo ravni paklitaksela v krvi, ki jih povzroči zdravilo Paclitaxel Hetero, z ravnmi, ki jih povzroči drugo generično zdravilo s paklitakselom, to pa po mnenju Nizozemske ne zadošča.
English: The grounds for the referral were concerns raised by the Netherlands that the data submitted to support the application were not sufficient to show that Paclitaxel Hetero is ‘bioequivalent' to Taxol.
Slovenian: Razlog za napotitev so bili pomisleki Nizozemske, da podatki, predloženi v podporo vlogi, ne zadoščajo kot dokaz, da je zdravilo Paclitaxel Hetero „bioekvivalentno“ zdravilu Taxol.