FrancophonIA/ELRC3.0 huggingface dataset:
English: JEVTANA should only be prepared and administered by personnel trained in handling cytotoxic agents.
Slovenian: Zdravilo JEVTANA sme pripravljati in dajati le osebje, usposobljeno za ravnanje s citotoksičnimi zdravili.
English: PVC infusion containers or polyurethane infusion sets should not be used for the preparation and administration of the infusion solution.
Slovenian: Infuzijskih vsebnikov iz PVC ali kompletov za infundiranje iz poliuretana se ne sme uporabljati za pripravo in dajanje infuzijske raztopine.
English: You are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because JEVTANA may alter male fertility.
Slovenian: Priporočljivo je tudi, da se pred zdravljenjem posvetujete o shranitvi semena, kajti zdravilo JEVTANA lahko vpliva na plodnost moškega.
English: This is very common (may affect more than 1 in 10 people).
Slovenian: Ta je zelo pogosta (pojavi se lahko pri več kot 1 od 10 ljudi).
English: Grade ≥ 3 neutropenia
Slovenian: Nevtropenija ≥ 3. stopnje
English: Solution for IV infusion after final dilution (see package leaflet).
Slovenian: Raztopina za intravensko infundiranje po končnem redčenju (glejte navodilo za uporabo).
English: • stomach upsets including feeling sick (nausea), being sick (vomiting), diarrhoea or constipation
Slovenian: • prebavne težave, vključno s slabostjo v želodcu, bruhanjem, drisko ali zaprtjem
English: Pregnant staff should not handle the product.
Slovenian: Nosečnice, ki so del tega zdravstvenega osebja, ne smejo ravnati z zdravilom.
English: Dose modifications should be made if patients experience the following adverse reactions (Grades refer to Common Terminology Criteria for Adverse Events [CTCAE 4.0]): Table 1 - Recommended dose modifications for adverse reaction in patients treated with cabazitaxel
Slovenian: Če se bolnikom pojavijo naslednji neželeni učinki (stopnje so po CTCAE 4.0 [Common Terminology Criteria for Adverse Events]), je treba odmerek prilagoditi.
English: • feeling of numbness, tingling, burning or decreased sensations in hands and feet
Slovenian: • občutek omrtvičenosti, mravljinčenja, pekoč občutek ali zmanjšano zaznavanje v dlaneh in stopalih
English: Cardiac disorders* Atrial fibrillation Tachycardia
Slovenian: atrijska fibrilacija tahikardija
English: Gastrointestinal hemorrhage and perforation, ileus and intestinal obstruction have also been reported (see section 4.4).
Slovenian: Opisani so bili tudi gastrointestinalna krvavitev in perforacija, ileus in zapora črevesa (glejte poglavje 4.4).
English: • blood clot in the leg
Slovenian: • krvni strdek v nogi
English: Concentrate Polysorbate 80 Citric acid
Slovenian: Koncentrat Polisorbat 80
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
Slovenian: Zdravnik se bo o tem z vami pogovoril in vam bo pojasnil možna tveganja in koristi vašega zdravljenja.
English: After initial dilution of the concentrate with the solvent Chemical and physical in-use stability has been demonstrated for 1 hour at ambient temperature (15°C-30°C).
Slovenian: Kemična in fizikalna stabilnost med uporabo sta dokazani za 1 uro temperature okolice (15°C-30°C).
English: There was an improvement in PFS in the JEVTANA arm compared to mitoxantrone arm, 2.8 (2.4-3.0) months versus 1.4 (1.4-1.7) respectively, HR (95%CI) 0.74 (0.64-0.86), p<0.0001.
Slovenian: V kraku z zdravilom JEVTANA je bilo PBN boljše kot v kraku z mitoksantronom: 2,8 (2,4-3,0) meseca v primerjavi z 1,4 (1,4-1,7) meseca, ROg (95 % IZ) 0,74 (0,64-0,86), p < 0,0001.
English: If co-administration with a strong CYP3A inhibitor cannot be avoided, close monitoring for toxicity and a cabazitaxel dose reduction should be considered (see sections 4.2 and 4.5).
Slovenian: Če se sočasni uporabi močnega zaviralca CYP3A ni mogoče izogniti, je treba bolnike skrbno spremljati glede toksičnih učinkov in razmisliti je treba o znižanju odmerka kabazitaksela (glejte poglavji 4.2 in 4.5).
English: The maximum tolerated dose (MTD) of cabazitaxel was 20 and 15 mg/m2, respectively.
Slovenian: Največji tolerirani odmerek (MTD - maximally tolerated dose) kabazitaksela je bil 20 mg/m2 (blaga okvara) oziroma 15 mg/m2 (zmerna okvara).
English: Once reconstituted, the resultant solution contains 10 mg/ml of cabazitaxel.
Slovenian: Po pripravi nastala raztopina vsebuje 10 mg/ml kabazitaksela
English: METHOD OF ADMINISTRATION Dilute with the ENTIRE supplied solvent.
Slovenian: POSTOPEK UPORABE Redčite z CELOTNIM priloženim vehiklom .
English: Cabazitaxel treatment should be discontinued in case of any degradation of renal function to renal failure ≥CTCAE 4.0 Grade 3.
Slovenian: V primeru kakršnega koli poslabšanja delovanja ledvic do odpovedi ledvic ≥ 3. stopnje po CTCAE 4.0 je treba zdravljenje s kabazitakselom prekiniti.
English: OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
English: • muscle spasm
Slovenian: • kratka sapa
English: What JEVTANA is and what it is used for What you need to know before you are given JEVTANA How to use JEVTANA
Slovenian: Kaj je zdravilo JEVTANA in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo JEVTANA Kako uporabljati zdravilo JEVTANA Možni neželeni učinki
English: 1 ml concentrate contains 40 mg cabazitaxel.
Slovenian: 1 ml koncentrata vsebuje 40 mg kabazitaksela.
English: • you have severe or long-lasting diarrhoea, you feel sick (nausea) or you are being sick (vomiting).
Slovenian: • če imate hudo ali dolgotrajno drisko, čutite slabost v želodcu ali bruhate.
English: JEVTANA should not be used during breast-feeding.
Slovenian: Zdravila JEVTANA se ne sme jemati med obdobjem dojenja.
English: Renal colic Haematuria Pollakiuria Hydronephrosis Urinary retention Urinary incontinence Ureteric obstruction
Slovenian: Bolezni sečil akutna odpoved ledvic odpoved ledvic dizurija ledvična kolika hematurija polakisurija hidronefroza zastoj urina inkontinenca urina obstrukcija sečevoda
English: One single useclear glass vial, closed with a grey chlorobutyl rubber closure sealed by an aluminium cap with a light green plastic flip-off cover, containing 1.5 ml (nominal volume) concentrate.
Slovenian: Ena viala za enkratno uporabo iz bistrega stekla, zaprta s sivim zamaškom iz klorobutilne gume, zapečatenim z aluminijskim pokrovčkom s svetlozeleno plastično snemno zaporko, ki vsebuje 1,5 ml (nominalni volumen) koncentrata.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Single-use vials.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Viale za enkratno uporabo.
English: One single use clear glass vial, closed with a grey chlorobutyl rubber closure sealed by a gold colour aluminium cap with a colourless plastic flip-off cover, containing 4.5 ml (nominal volume) solvent.
Slovenian: Ena viala za enkratno uporabo iz bistrega stekla, zaprta s sivim zamaškom iz klorobutilne gume, zapečatenim z aluminijskim pokrovčkom zlate barve z brezbarvno plastično snemno zaporko, ki vsebuje 4,5 ml (nominalni volumen) vehikla.
English: Delay treatment until improvement or resolution, then reduce cabazitaxel dose from 25 mg/m2 to
Slovenian: Odložite zdravljenje do izboljšanja, potem odmerek kabazitaksela zmanjšajte s 25 mg/m2 na
English: The use of JEVTANA should be confined to units specialised in the administration of cytotoxics and it should only be administered under the supervision of a physician experienced in the use of anticancer chemotherapy.
Slovenian: Uporabljati se ga sme le pod nadzorstvom zdravnika, ki ima izkušnje z onkološko kemoterapijo.
English: Risk of renal failure
Slovenian: Tveganje odpovedi ledvic
English: Grade ≥ 3 adverse reactionsb (%)
Slovenian: Neželeni učinki ≥ 3. stopnjeb (%)
English: Very common (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 ljudi):
English: Preparation and administration precautions
Slovenian: Previdnostni ukrepi za pripravo in uporabo
English: Cases of peripheral neuropathy, peripheral sensory neuropathy (e.g., paraesthesias, dysaesthesias) and peripheral motor neuropathy have been observed in patients receiving cabazitaxel.
Slovenian: Pri bolnikih, ki so prejemali kabazitaksel, so bili opaženi primeri periferne senzorične nevropatije (npr. parestezije, dizestezije) in periferne motorične nevropatije.
English: Adverse reactions are listed in table 2 according to MedDRA system organ class and frequency categories.
Slovenian: Neželeni učinki so navedeni v preglednici 2 po organskih sistemih in kategorijah pogostnosti MedDRA. Znotraj vsake skupine, je pogostnost neželenih učinkov navedena po padajoči resnosti.
English: • feeling anxious
Slovenian: • občutek tesnobnosti
English: NAME OF THE MEDICINAL PRODUCT JEVTANA 60 mg concentrate and solvent for solution for infusion.
Slovenian: IME ZDRAVILA JEVTANA 60 mg koncentrat in vehikel za raztopino za infundiranje
English: • swelling of the feet or legs
Slovenian: • otekanje stopal ali nog
English: CAUTION: Two-step dilution required.
Slovenian: OPOZORILO: Zahtevano je redčenje v dveh korakih.Pred uporabo preberite priloženo navodilo.
English: Step 2.3
Slovenian: Korak 2.3
English: Co-administration with strong CYP3A inducers should be avoided since they may decrease plasma concentrations of cabazitaxel (see sections 4.2 and 4.5).
Slovenian: Sočasni uporabi močnih induktorjev CYP3A se je potrebno izogibati, ker lahko zmanjšajo koncentracijo kabazitaksela v plazmi (glejte poglavji 4.2 in 4.5).
English: Delay treatment until neutrophil count is >1,500 cells/mm3, then reduce cabazitaxel dose from 25 mg/m2 to 20 mg/m2.
Slovenian: Odložite zdravljenje, dokler ni število nevtrofilcev > 1.500 celic/mm3, potem odmerek kabazitaksela zmanjšajte s 25 mg/m2 na
English: Step 2.4
Slovenian: Korak 2.4
English: The PSA response was 39.2% in patients on JEVTANA arm (95%CI: 33.9-44.5) versus 17.8% of patients on mitoxantrone (95%CI: 13.7-22.0), p=0.0002.
Slovenian: Odziv PSA je bil pri bolnikih, ki so prejemali zdravilo JEVTANA, 39,2 % (95 % IZ: 33,9-44,5) in pri bolnikih, ki so prejemali mitoksantron, 17,8 % (95 % IZ: 13,7-22,0), p = 0,0002.
English: There was a median PSA progression of 6.4 months (95%CI: 5.1-7.3) for patients in JEVTANA arm, compared to 3.1 months (95%CI: 2.2-4.4) in the mitoxantrone arm, HR 0.75 months (95%CI: 0.63-0.90), p=0.0010.
Slovenian: V kraku z zdravilom JEVTANA je bilo mediano napredovanje PSA 6,4 mesece (95 % IZ: 5,1-7,3) in v kraku z mitoksantronom 3,1 meseca (95 % IZ: 2,2-4,4), ROg 0,75 meseca (95 % IZ: 0,63-0,90), p = 0,0010.
English: Patients with a hypersensitivity reaction must stop treatment with JEVTANA (see section 4.3).
Slovenian: Bolniki z anamnezo preobčutljivostnih reakcij ne smejo znova dobiti zdravila JEVTANA (glejte poglavje 4.3).
English: Co-administration with strong CYP3A inhibitors should be avoided since they may increase the plasma concentrations of cabazitaxel (see sections 4.2 and 4.5).
Slovenian: Sočasni uporabi močnih zaviralcev CYP3A se je potrebno izogibati, ker lahko povečajo koncentracijo kabazitaksela v plazmi (glejte poglavji 4.2 in 4.5).
English: The dose of cabazitaxel should be reduced from 25 mg/m2 to 20 mg/m2 for persistent grade >2 peripheral neuropathy (see section 4.2).
Slovenian: V primeru dolgotrajne periferne nevropatije > 2. stopnje, je treba odmerek kabazitaksela zmanjšati s 25 mg/m2 na 20 mg/m2 (glejte poglavje 4.2).
English: Each 1.5 ml vial of concentrate contains 60 mg cabazitaxel.
Slovenian: Ena 1,5 ml viala s koncentratom vsebuje 60 mg kabazitaksela.
English: Cases of interstitial pneumonia/pneumonitis and interstitial lung disease, sometimes fatal have been reported with an unknown frequency (cannot be estimated from the available data) (see section 4.4).
Slovenian: Z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) so poročali o intersticijski pljučnici/pnevmonitisu in intersticijski pljučni bolezni, včasih s smrtnim izidom (glejte poglavje 4.4).
English: Step 1.5
Slovenian: Korak 1.5
English: Grade >2 peripheral neuropathy
Slovenian: Periferna nevropatija ≥ 2. stopnje
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom ali z medicinsko sestro.
English: The safety of JEVTANA in combination with prednisone or prednisolone was evaluated in 371 patients with metastatic castration resistant prostate cancer who were treated with 25 mg/m2
Slovenian: Varnost zdravila JEVTANA v kombinaciji s prednizonom ali prednizolonom so ocenili pri 371 bolnikih z metastatskim, na kastracijo odpornim rakom prostate, ki so v randomizirani, odprti kontrolirani študiji 3. faze prejemali 25 mg/m2 kabazitaksela enkrat na tri tedne.
English: Gastrointestinal (GI) hemorrhage and perforation, ileus, colitis, including fatal outcome, have been reported in patients treated with cabazitaxel (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih s kabazitakselom, so bili opisani gastrointestinalne krvavitve in perforacija, ileus, kolitis, vključno s smrtnim izidom (glejte poglavje 4.8).
English: • you have fever.
Slovenian: • mrzlica.
English: • If you get any side effects talk to your doctor, pharmacist or nurse.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: This overfill ensures that after dilution with the entire content of the accompanying solvent for JEVTANA, there is a minimal extractable premix volume of 6 ml containing 10 mg/ml JEVTANA which corresponds to the labelled amount of 60 mg per vial.
Slovenian: To večje polnjenje raztopine zagotavlja, da nastala mešanica koncentrata in celotne vsebine vehikla za zdravilo JEVTANA po redčenju vsebuje 10 mg/ml zdravila JEVTANA (vsaj 6 ml uporabne količine), kar ustreza 60 mg na vialo.
English: PSA secondary endpoints were positive in the JEVTANA arm.
Slovenian: Sekundarni opazovani dogodki PSA so bili v kraku z zdravilom JEVTANA pozitivni.
English: There was a significant higher rate of tumour response of 14.4% (95%CI: 9.6-19.3) in patients in the JEVTANA arm compared to 4.4% (95%CI: 1.6-7.2) for patients in the mitoxantrone arm, p=0.0005.
Slovenian: V kraku z zdravilom JEVTANA je bil delež odziva tumorja značilno večji (14,4 %, 95 % IZ: 9,6-19,3) kot v kraku z mitoksantronom (4,4 %, 95 % IZ: 1,6-7,2), p = 0,0005.
English: Always dilute the concentrate for solution for infusion with the entire supplied solvent before adding to infusion solution.
Slovenian: Preden koncentrat za raztopino za infundiranje dodate raztopinam za infundiranje, ga morate vedno redčiti s celotnim priloženim vehiklom.
English: • uncomfortable feeling in the stomach, heart burn or belching
Slovenian: • nelagodje v želodcu, zgaga ali spahovanje
English: Step 1.3
Slovenian: Korak 1.3
English: Sanofi S.p.A Tel: +39 02 39394275
Slovenian: Tel: +39 02 39394275
English: Step 2.2
Slovenian: Korak 2.2
English: No major deviation to the dose proportionality was observed from 10 to 30 mg/m² in patients with advanced solid tumours (n=126).
Slovenian: Pri bolnikih z napredovalimi parenhimskimi tumorji (n = 126) v območju od 10 do 30 mg/m2 niso ugotovili večjega odstopanja od sorazmernosti odmerku.
English: Delay treatment until improvement or resolution, and until neutrophil count is >1,500 cells/mm3, then reduce cabazitaxel dose from 25 mg/m2 to
Slovenian: Febrilna nevtropenija ali nevtropenična okužba Odložite zdravljenje do izboljšanja ali izginotja in dokler ni število nevtrofilcev > 1.500 celic/mm3, potem odmerek kabazitaksela zmanjšajte s 25 mg/m2 na 20 mg/m2.
English: • Solvent: 4.5 ml of solvent in a 15 ml clear glass vial (type I) closed with a grey chlorobutyl rubber closure sealed by a gold colour aluminium cap covered with a colourless plastic flip-off cap. Each vial contains 4.5 ml nominal volume (fill volume: 5.67 ml).
Slovenian: • Vehikel: 4,5 ml vehikla v 15-ml viali iz bistrega stekla (tipa I), zaprti s sivim zamaškom iz klorobutilne gume, zapečatenim z aluminijsko zaporko zlate barve, pokrito z brezbarvno plastično snemno zaporko.
English: • Concentrate: 1.5 ml of concentrate in a 15 ml clear glass vial (type I) closed with a grey chlorobutyl rubber closure sealed by an aluminium cap covered with a light green plastic flip-off cap. Each vial contains 60 mg cabazitaxel per 1.5 ml nominal volume (fill volume: 73.2 mg of cabazitaxel/1.83 ml).
Slovenian: • Koncentrat: 1,5 ml koncentrata v 15-ml viali iz bistrega stekla (tipa I), zaprti s sivim zamaškom iz klorobutilne gume, zapečatenim z aluminijsko zaporko, pokrito s svetlozeleno plastično snemno zaporko.
English: Aseptically withdraw the required amount of concentrate-solvent mixture (10 mg/ml of cabazitaxel), with a graduated syringe fitted with a needle.
Slovenian: Z graduirano brizgo, ki ima nameščeno iglo, aseptično izvlecite potrebno količino mešanice koncentrata in vehikla (10 mg/ml kabazitaksela).
English: Step 1.2
Slovenian: Korak 1.2
English: This is common (may affect up to 1 in 10 people).
Slovenian: Ta je pogosta (pojavi se lahko pri največ 1 od 10 ljudi).
English: Step 1.4
Slovenian: Korak 1.4
English: Upper respiratory tract infection Herpes zoster Candidiasis
Slovenian: Infekcijske in parazitske bolezni septični šok sepsa flegmona okužbe sečil gripa cistitis okužba zgornjih dihal herpes zoster kandidoza
English: JEVTANA is contraindicated in patients with severe hepatic impairment (see section 4.3).
Slovenian: Pri bolnikih s hudo okvaro jeter je zdravilo JEVTANA kontraindicirano (glejte poglavje 4.3).
English: • haemorrhoids
Slovenian: • spremenjeno okušanje
English: Neuropathy peripheral Peripheral sensory neuropathy Dizziness Headache Paraesthesia Lethargy
Slovenian: Pogosti periferna senzorična nevropatija omotica glavobol parestezije letargija hipestezija išias
English: Clinical neutropenia Urinary tract infection Peripheral sensory neuropathy
Slovenian: Bolezni živčevja dizgvezija periferna nevropatija
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL for CONCENTRATE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Step 1.1
Slovenian: Korak 1.1
English: • muscle discomfort, aches or pain
Slovenian: • nelagodje, občutljivost ali bolečnost mišic
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk bolečine v predelu medenice
English: Concentrate‐solvent mixture 10 mg/ml
Slovenian: 10 mg/ml mešanica koncentrata in vehikla
English: Cabazitaxel is extensively metabolised by the liver.
Slovenian: Kabazitaksel se izdatno presnovi v jetrih.
English: One ml of concentrate contains 40 mg cabazitaxel.
Slovenian: En mililiter koncentrata vsebuje 40 mg kabazitaksela.
English: Talk to your doctor before getting vaccinations while you are receiving JEVTANA.
Slovenian: Med zdravljenjem z zdravilom JEVTANA se pred kakršnimkoli cepljenjem posvetujte s svojim zdravnikom.
English: Common (may affect up to 1 in 10 people):
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 ljudi):
English: Each vial of concentrate contains 60 mg cabazitaxel.
Slovenian: Ena viala koncentrata vsebuje 60 mg kabazitaksela.
English: The expiry date refers to the last day of that month.
Slovenian: Navodilo je bilo revidirano dne.
English: Cabazitaxel crossed the placenta barrier in rats.
Slovenian: Kabazitaksel pri podganah prehaja skozi placentno pregrado.
English: This overfill ensures that after dilution with the ENTIRE contents of the accompanying solvent, there is solution containing 10 mg/ml cabazitaxel.
Slovenian: Po redčenju s CELOTNO količino spremljajočega vehikla ta prepolnitev zagotavlja, da raztopina vsebuje 10 mg/ml kabazitaksela.
English: The concentrate solution and the solvent should be clear.
Slovenian: Raztopina v viali s koncentratom in vehikel morata biti bistra.
English: Respiratory disorders
Slovenian: • mišični spazem
English: Constipation
Slovenian: Konstipacija
English: • low blood potassium
Slovenian: • nizek kalij v krvi
English: Package leaflet: Information for the patient JEVTANA 60 mg concentrate and solvent for solution for infusion cabazitaxel
Slovenian: Navodilo za uporabo JEVTANA 60 mg koncentrat in vehikel za raztopino za infundiranje kabazitaksel
English: This overfill ensures that after initial dilution with the ENTIRE content of the solvent vial, the concentration of cabazitaxel is 10 mg/ml.
Slovenian: Po prvotnem redčenju s CELOTNO količino priloženega vehikla ta prepolnitev zagotavlja, da raztopina vsebuje 10 mg/ml kabazitaksela.
English: Cardiac disorders and arrhythmias
Slovenian: Srčne bolezni in motnje srčnega ritma
English: NAME OF THE MEDICINAL PRODUCT JEVTANA 60 mg concentrate and solvent for solution for infusion cabazitaxel
Slovenian: JEVTANA 60 mg koncentrat in vehikel za raztopino za infundiranje kabazitaksel
English: Pyrexia
Slovenian: Hematurija
English: JEVTANA requires TWO dilutions prior to administration.
Slovenian: Zdravilo JEVTANA morate pred uporabo redčiti DVAKRAT.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenijaa* anemija a levkopenijaa trombocitopenijaa febrilna nevtropenija
English: Abdominal pain 43 (11.6) Dyspepsia
Slovenian: s 6,3 %), febrilna nevtropenija (11,2 % v prim.
English: Cabazitaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells.
Slovenian: Deluje tako, da poruši celično mikrotubularno mrežje.
English: Risk of nausea, vomiting, diarrhoea and dehydration If patients experience diarrhoea following administration of cabazitaxel they may be treated with commonly used anti-diarrhoeal medicinal products.
Slovenian: Če se bolnikom po uporabi kabazitaksela pojavi driska, jo je mogoče zdraviti z običajnimi antidiaroiki.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja kašelj orofaringealna bolečina pljučnica
English: Concentratesolvent mixture 10 mg/ml
Slovenian: 10 mg/ml mešanica koncentrata in vehikla vehikla.
English: Malaise
Slovenian: Slabost
English: Febrile neutropenia or neutropenic infection
Slovenian: Periferna senzorična nevropatija
English: Do not use PVC infusion containers or polyurethane infusion sets for the preparation and administration of JEVTANA.
Slovenian: Za pripravo in dajanje zdravila JEVTANA ne uporabljate infuzijskih vsebnikov iz PVC ali kompletov za infundiranje iz poliuretana.
English: Strength Pharmaceutical Form
Slovenian: Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
English: What you need to know before you use <product name>, and 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo <ime zdravila> in 3.
English: Adopted at the 27-30 November 2017 PRAC
Slovenian: Sprejeto na seji odbora PRAC, 27.-30. novembra 2017
English: Insulin (pre-filled pens and cartridges): insulin aspart; insulin bovine; insulin degludec; insulin degludec, insulin aspart; insulin degludec, liraglutide; insulin detemir; insulin glargine; insulin glulisine; insulin human (rDNA); insulin human, insulin isophane; insulin lispro; insulin porcinePotential increased risk of medication error associated with withdrawing insulin from pre-filled pens and cartridges, leading to dysglycaemia (EPITT no 18893)
Slovenian: Insulin (napolnjeni injekcijski peresniki in vložki): insulin aspart; goveji insulin; insulin degludek; insulin degludek, insulin aspart; insulin degludek, liraglutid; insulin detemir; insulin glargin; insulin glulizin; humani insulin (rDNA); humani insulin, insulin izofan; insulin lispro; svinjski insulinmorebitno povečano tveganje za napake pri uporabi zdravil, povezano z odvzemom insulina iz napolnjenih injekcijskih peresnikov in vložkov, ki lahko privede do disglikemije (št. EPITT 18893)
English: Posology and method of administration, and/or 4.4.
Slovenian: Odmerjanje in način uporabe in/ali 4.4.
English: Tofacitinib - Angioedema (EPITT no 18904)
Slovenian: Tofacitinib - angioedem (št. EPITT 18904)