natgillin/translations-raw huggingface dataset:
Gastrointestinal hemorrhage and perforation, ileus and intestinal obstruction have also been reported (see section 4.4).
Prijavljeni su i gastrointestinalno krvarenje i perforacija, ileus i opstrukcija crijeva (vidjeti dio 4.4).
Hypotension Deep vein thrombosis Hypertension Orthostatic hypotension Hot flush Flushing
Krvožilni poremećaji hipotenzija duboka venska tromboza hipertenzija ortostatska hipotenzija valunzi crvenilo praćeno osjećajem vrućine
Neutropenic complications included neutropenic infections (0.5%), neutropenic sepsis (0.8%), and septic shock (1.1%), which in some cases resulted in a fatal outcome.
(0,8%) i septički šok (1,1%), koji su u nekim slučajevima rezultirali smrtnim ishodom.
In patients with moderate hepatic impairment (total bilirubin >1.5 to ≤ 3.0 x ULN), the maximum tolerated dose (MTD) was 15 mg/m2.
Kod bolesnika s umjerenim oštećenjem jetrene funkcije (ukupan bilirubin >1,5 do ≤ 3,0 x GGN), najviša podnošljiva doza bila je 15 mg/m2.
The most commonly (≥5%) occurring grade ≥3 adverse reactions in the cabazitaxel group were neutropenia (81.7%), leukopenia (68.2%), anaemia (10.5%), febrile neutropenia (7.5%), diarrhoea
Najčešće nuspojave stupnja ≥ 3 u skupini koja je primala kabazitaksel bile su neutropenija (81,7%), leukopenija (68,2%), anemija (10,5%), febrilna neutropenija (7,5%) i proljev (6,2%).
The concentrate and solvent vials must be used immediately.
Bočice s koncentratom i otapalom moraju se upotrijebiti odmah.
From a microbiological point of view, the infusion solution should be used immediately.
S mikrobiološkog stajališta, otopina za infuziju mora se primijeniti odmah.
Each vial of 1.5 ml (nominal volume) of concentrate contains 60 mg cabazitaxel.
Jedna bočica s 1,5 ml koncentrata (nominalni volumen) sadrži 60 mg kabazitaksela.
PVC infusion containers and polyurethane infusion sets should not be used.
Ne smiju se koristiti PVC infuzijski spremnici niti poliuretanski infuzijski setovi.
In vitro cabazitaxel did not inhibit Multidrug-Resistant Proteins (MRP): MRP1 and MRP2 or Organic Cation Transporter (OCT1).
Multidrug-Resistant Proteins, MRP) MRP1 i MRP2 niti prijenosnike organskih kationa (engl.
After initial dilution with the entire solvent, each ml of solution contains 10 mg cabazitaxel.
Nakon početnog razrjeđenja s cjelokupnom količinom otapala, jedan ml otopine sadrži 10 mg kabazitaksela.
A statistically significantly higher percentage (p<0.001) of patients showed a PSA response in the 25 mg/m2 group (42.9%) compared to the 20 mg/m2 group (29.5%).
(p<0,001) bolesnika u skupini s 25 mg/m2 (42,9%) pokazao je učinak na razinu PSA u usporedbi sa skupinom s 20 mg/m2 (29,5%).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4.5 ml (ethanol 96% and water for injections).
4,5 ml (96%-tni etanol i voda za injekcije).
Package leaflet: Information for the patient JEVTANA 60 mg concentrate and solvent for solution for infusion cabazitaxel
Uputa o lijeku: Informacije za bolesnika JEVTANA 60 mg koncentrat i otapalo za otopinu za infuziju kabazitaksel
(vomiting).
satnu infuziju).
Solution for IV infusion after final dilution (see package leaflet).
Otopina za i.v. infuziju nakon konačnog razrjeđenja (vidjeti Uputu o lijeku).
Cabazitaxel should not be used during breast-feeding.
. Kabazitaksel se ne smije koristiti tijekom dojenja.
• liver problems occur during the treatment.
• ako tijekom liječenja razvijete probleme s jetrom.
Its common name is cabazitaxel.
Uobičajeni naziv je kabazitaksel.
Step 2.1
Korak 2.1
Note: Both the JEVTANA 60 mg/1.5 ml concentrate vial (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and the solvent vial (fill volume: 5.67 ml) contain an overfill to compensate for liquid loss during preparation.
Napomena: Obje bočice, bočica s lijekom JEVTANA 60 mg/1,5 ml koncentrat (volumen punjenja: 73,2 mg kabazitaksela/1,83 ml) i bočica s otapalom (volumen punjenja: 5,67 ml) sadrže dodatnu količinu punjenja kako bi se nadoknadio gubitak tekućine tijekom pripreme.
Alopecia Dry skin Erythema
Poremećaji kože i potkožnog tkiva alopecija suha koža eritem
Patients should be re-treated only when neutrophils recover to a level ≥1,500/mm3 (see section 4.3).
Bolesnici se smiju ponovno liječiti tek kada se broj neutrofila vrati na razinu od ≥ 1500 stanica/mm3
Vaccination with a live attenuated vaccine should be avoided in patients receiving cabazitaxel.
U bolesnika koji primaju kabazitaksel potrebno je izbjegavati cijepljenje živim atenuiranim cjepivom.
OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC
DRUGO(A) POSEBNO(A) UPOZORENJA, AKO JE POTREBNO
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SOLVENT for JEVTANA
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
The maximum tolerated dose (MTD) of cabazitaxel was 20 and 15 mg/m2, respectively.
Najviša podnošljiva doza kabazitaksela bila je 20, odnosno 15 mg/m2.
• you have feeling of numbness, tingling, burning or decreased sensation in your hands or feet.
• ako osjećate utrnulost, trnce, pečenje ili imate oslabljen osjet u šakama ili stopalima.
Table 4 - Overall survival in EFC11785 study in cabazitaxel 25 mg/m2 arm versus cabazitaxel 20 mg/m2 arm (Intent-to-treat analysis) - Efficacy primary endpoint
Ukupno preživljenje u EFC11785 ispitivanju u skupini s 25 mg/m2 kabazitaksela naspram skupine s 20 mg/m2 kabazitaksela (analiza podataka populacije predviđene za liječenje) - Primarna mjera ishoda djelotvornosti
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.
Ova dodatna količina osigurava da se nakon razrjeđivanja s cjelokupnom količinom priloženog otapala za lijek JEVTANA iz bočice može izvući minimalni volumen od 6 ml pripremljene otopine koja sadrži 10 mg/ml lijeka JEVTANA, što odgovara deklariranoj količini lijeka od 60 mg po bočici.
Concomitant medicinal products use
Istodobna primjena drugih lijekova
Treatment delay or dose reduction may be necessary for grade ≥3 diarrhoea (see section 4.2).
U slučaju proljeva stupnja ≥ 3 možda će biti nužno odgoditi terapiju ili smanjiti dozu (vidjeti dio 4.2).
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.
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
Cabazitaxel is extensively metabolised by the liver.
Kabazitaksel se ekstenzivno metabolizira u jetri.
Primary prophylaxis with G-CSF should be considered in patients with high-risk clinical features (age >65 years, poor performance status, previous episodes of febrile neutropenia, extensive prior radiation ports, poor nutritional status, or other serious comorbidities) that predispose them to increased complications from prolonged neutropenia.
prethodne epizode febrilne neutropenije, prethodno ekstenzivno zračenje, slaba ishranjenost ili drugi ozbiljni komorbiditeti) koje su predispozicija za povećane komplikacije uslijed produljene neutropenije.
A dedicated study in 43 cancer patients with hepatic impairment showed no influence of mild (total bilirubin >1 to ≤1.5 x ULN or AST >1.5 x ULN) or moderate (total bilirubin >1.5 to ≤3.0 x ULN) hepatic impairment on cabazitaxel pharmacokinetics.
Posebna studija na 43 onkološka bolesnika s oštećenjem jetrene funkcije pokazala je da blago (ukupan bilirubin >1 do ≤ 1,5 x GGN ili AST >1,5 x GGN) ili umjereno (ukupan bilirubin >1,5 do ≤ 3 x GGN) oštećenje jetrene funkcije ne utječe na farmakokinetiku kabazitaksela.
Overall survival (OS) was the primary efficacy endpoint of the study.
Primarni ishod djelotvornosti studije bilo je ukupno preživljenje (engl. overall survival, OS).
Delay treatment until improvement, then reduce cabazitaxel dose from 25 mg/m2 to 20 mg/m2.
Odgoditi liječenje do poboljšanja, a zatim smanjiti dozu kabazitaksela s 25 mg/m2 na 20 mg/m2.
Preparation steps
Koraci za pripremu lijeka
Table 5 - Summary of safety data for cabazitaxel 25 mg/m2 arm versus cabazitaxel 20 mg/m2 arm in EFC11785 study
Tablica 5 - Sažetak sigurnosnih podataka u skupini s 25 mg/m2 kabazitaksela naspram skupine s 20 mg/m2 kabazitaksela u EFC11785 ispitivanju CBZ20+PRED n=580
• blood clot in the leg
• krvni ugrušak u nozi
Patients treated with cabazitaxel may receive prophylactic G-CSF, as per American Society of Clinical Oncology (ASCO) guidelines and/or current institutional guidelines, to reduce the risk or manage neutropenia complications (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Bolesnici koji se liječe kabazitakselom mogu profilaktički primiti G-CSF, sukladno smjernicama ASCO-a (American Society of Clinical Oncology) i/ili važećim smjernicama ustanove u kojoj se liječe,
• you have severe or long-lasting diarrhoea, you feel sick (nausea) or you are being sick (vomiting).
• ako imate težak ili dugotrajan proljev, ako imate mučninu ili povraćate.
Neutropenia was the most common adverse reaction leading to medicinal product discontinuation
Neutropenija je bila najčešća nuspojava koja je uzrokovala prekid primjene lijeka (2,4%).
This fill volume has been established during the development and the overfill ensures, after the addition of the entire content of the solvent vial to the content of JEVTANA 60 mg concentrate vial, a concentration of the premix solution of 10 mg/ml JEVTANA.
Ovaj volumen punjenja utvrđen je tijekom razvoja lijeka i ta dodatna količina osigurava da se nakon dodavanja cjelokupnog sadržaja bočice s otapalom u sadržaj bočice s koncentratom lijeka JEVTANA 60 mg postigne koncentracija pripremljene otopine od 10 mg/ml lijeka JEVTANA.
The risk of interaction with OATP1B1 substrates (e.g. statins, valsartan, repaglinide) is possible, notably during the infusion duration (1 hour) and up to 20 minutes after the end of the infusion.
(npr. statinima, valsartanom, repaglinidom), naročito za vrijeme trajanja infuzije (1 sat) i do 20 minuta nakon završetka infuzije.
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.
Zabilježena je značajno veća stopa tumorskog odgovora od 14,4% (95% CI: 9,6-19,3) u bolesnika liječenih lijekom JEVTANA u odnosu na 4,4% (95% CI: 1,6-7,2) u bolesnika u skupini koja je primala mitoksantron, p = 0,0005.
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the supplied solvent by partially inverting the vial.
Aseptički izvucite cjelokupan sadržaj priloženog otapala pomoću štrcaljke s iglom, djelomično okrećući bočicu naopako.
Do not use JEVTANA if:
Nemojte primjenjivati lijek JEVTANA :
Pregnant staff should not handle it.
Zdravstvene radnice koje su trudne ne smiju rukovati ovim lijekom.
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).
Dokazana kemijska i fizikalna stabilnost lijeka u primjeni je 1 sat, uz čuvanje na temperaturi okoline (15°C - 30°C).
Cases of peripheral neuropathy, peripheral sensory neuropathy (e.g., paraesthesias, dysaesthesias) and peripheral motor neuropathy have been observed in patients receiving cabazitaxel.
U bolesnika koji su primali kabazitaksel zabilježeni su slučajevi periferne neuropatije, periferne senzorne neuropatije (npr. paraestezije, dizestezije) i periferne motoričke neuropatije.
The concentrate vial (fill: 73.2 mg of cabazitaxel/1.83 ml) and the solvent vial (5.67 ml) contain an overfill to compensate for liquid loss during preparation.
73,2 mg kabazitaksela/1,83 ml) i bočica s otapalom (volumen punjenja: 5,67 ml) sadrže dodatnu količinu punjenja kako bi se nadoknadio gubitak tekućine tijekom pripreme.
1 ml concentrate contains 40 mg cabazitaxel.
1 ml koncentrata sadrži 40 mg kabazitaksela.
This is common (may affect up to 1 in 10 people).
To je česta nuspojava (može se javiti u najviše 1 na 10 osoba).
Haematological abnormalitiesc (%)
Hematološka odstupanjac (%)
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.
U skupini koja je primala lijek JEVTANA je u odnosu na skupinu koja je primala mitoksantron zabilježeno poboljšanje u preživljenju bez progresije bolesti (PFS) i to 2,8 (2,4-3,0) mjeseci u odnosu na 1,4 (1,4-1,7) mjeseca, HR (95% CI): 0,74 (0,64-0,86), p < 0,0001.
Reproductive system and breast disorders
Poremećaji reproduktivnog sustava i dojki bol u zdjelici
This includes medicines obtained without a prescription.
Lijek se izdaje na recept.
Grade ≥ 3 adverse reactionsb (%)
Nuspojave stupnja ≥ 3b (%) Klinička neutropenija
Patients with a hypersensitivity reaction must stop treatment with JEVTANA (see section 4.3).
Bolesnici u kojih su se razvile teške reakcije preosjetljivosti ne smiju više primati terapiju lijekom JEVTANA (vidjeti dio 4.3).
Patients with mild hepatic impairment (total bilirubin >1 to ≤1.5 x Upper Limit of Normal (ULN) or AST >1.5 x ULN), should have cabazitaxel dose reduced to 20 mg/m2.
Kod bolesnika s blagim oštećenjem jetrene funkcije (ukupan bilirubin >1 do ≤1,5 x iznad gornje granice normalnih vrijednosti (GGN) ili AST > 1,5 x GGN), potrebno je smanjiti dozu kabazitaksela na 20 mg/m2.
If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Ako lijek dođe u dodir sa sluznicom, mjesto treba odmah temeljito isprati vodom.
• stomach upsets including feeling sick (nausea), being sick (vomiting), diarrhoea or constipation
• nelagoda u trbuhu uključujući mučninu, povraćanje, proljev ili zatvor
• feeling of numbness, tingling, burning or decreased sensations in hands and feet
• utrnulost, trnci, pečenje ili smanjen osjet u šakama ili stopalima
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.
Medijan progresije PSA iznosio je 6,4 mjeseci (95% CI: 5,1-7,3) u bolesnika u skupini liječenoj lijekom JEVTANA u usporedbi s 3,1 mjesecom (95% CI: 2,2-4,4) u skupini koja je primala mitoksantron, HR: 0,75 mjeseci (95% CI: 0,63-0,90), p = 0,0010.
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.
(klorobutil guma) i aluminijskim prstenom sa svijetlozelenim plastičnim "flip-off" poklopcem, koja sadrži 1,5 ml koncentrata (nominalni volumen).
The MTD of cabazitaxel in patients with severe hepatic impairment was not established.
Najveća podnošljiva doza kabazitaksela u bolesnika s teškim oštećenjem jetrene funkcije nije ustanovljena.
• 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).
• otapalo: 4,5 ml otapala u prozirnoj staklenoj bočici od 15 ml (staklo tip I), zatvorenoj sivim gumenim zatvaračem (klorobutil guma), aluminijskim prstenom zlatne boje i bezbojnim plastičnim "flip-off" poklopcem.
In vitro studies have shown that cabazitaxel is mainly metabolised through CYP3A (80% to 90%) (see section 5.2).
Ispitivanja in vitro pokazala su da se kabazitaksel većinom metabolizira pomoću CYP3A (80% do
Adequate hydration should be ensured throughout treatment with cabazitaxel.
Tijekom cjelokupnog liječenja kabazitakselom potrebno je osigurati primjerenu hidraciju.
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).
U slučaju perzistentne periferne neuropatije stupnja ≥ 2 dozu kabazitaksela potrebno je smanjiti s 25 mg/m2 na 20 mg/m2 (vidjeti dio 4.2).
The incidence of grade ≥3 anaemia, increased AST, ALT, and bilirubin based on laboratory abnormalities were 10.5%, 0.7%, 0.9%, and 0.6%, respectively.
incidencija povišenih vrijednosti AST-a 0,7%, incidencija povišenih vrijednosti ALT-a 0,9%, a incidencija povišenih vrijednosti bilirubina 0,6%.
If you are not sure, talk to your doctor before having JEVTANA.
porazgovarajte s liječnikom prije nego što primite lijek JEVTANA.
Contains an overfill.
Sadrži dodatnu količinu punjenja.
Number of patients with deaths (%) Median survival (months) (95% CI) Hazard Ratio (HR)1 (95% CI)
Ukupno preživljenje broj umrlih bolesnika (%) medijan preživljenja (mjeseci) (95% CI)
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.
39,2% u bolesnika liječenih lijekom JEVTANA (95% CI: 33,9-44,5) u odnosu na 17,8% u bolesnika liječenih mitoksantronom (95% CI: 13,7-22,0), p = 0,0002.
Always dilute the concentrate for solution for infusion with the entire supplied solvent before adding to infusion solution.
Prije dodavanja lijeka u infuzijsku otopinu potrebno je uvijek razrijediti koncentrat za otopinu za infuziju cjelokupnim priloženim otapalom.
Step 2.3
Korak 2.3
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).
Potrebno je izbjegavati istodobnu primjenu sa snažnim inhibitorima CYP3A jer oni mogu povisiti koncentraciju kabazitaksela u plazmi (vidjeti dijelove 4.2 i 4.5).
• skin feeling hot or flushed
• osjećaj užarenosti ili crvenila na koži
Co-administration with strong CYP3A inducers should be avoided since they may decrease plasma concentrations of cabazitaxel (see sections 4.2 and 4.5).
Potrebno je izbjegavati istodobnu primjenu sa snažnim induktorima CYP3A jer oni mogu sniziti koncentraciju kabazitaksela u plazmi (vidjeti dijelove 4.2 i 4.5).
Shelf life and special precautions for storage
Rok valjanosti i posebne mjere za čuvanje lijeka
The adverse reactions reported at rates of at least 5% higher in patients 65 years of age or greater compared to younger patients were diarrhoea (42.9% vs. 32.6%), fatigue (30.2% vs. 19.4%), asthenia (22.4% vs. 13.1%), constipation (20.2% vs. 12.6%), clinical neutropenia (12.9% vs. 6.3%), febrile neutropenia (11.2% vs. 4.6%) and dyspnoea (9.5% vs. 3.4%).
naspram 32,6%), umor (30,2% naspram 19,4%), astenija (22,4% naspram 13,1%), konstipacija (20,2% naspram 12,6%), klinička neutropenija (12,9% naspram 6,3%), febrilna neutropenija (11,2% naspram 4,6%) i dispneja (9,5% naspram 3,4%).
Step 2.4
Korak 2.4
Gastrointestinal (GI) hemorrhage and perforation, ileus, colitis, including fatal outcome, have been reported in patients treated with cabazitaxel (see section 4.8).
U bolesnika liječenih kabazitakselom prijavljeni su gastrointestinalno krvarenje i perforacija, ileus, kolitis, uključujući slučajeve sa smrtnim ishodom (vidjeti dio 4.8).
There was no statistically difference with regards to the other secondary endpoints (PFS, tumour and pain response, tumour and pain progression, and four subcategories of FACT-P).
(preživljenje bez progresije bolesti, učinak liječenja na tumor i bol, progresija tumora i boli te četiri FACT-P (engl.
Step 1.5
Korak 1.5
• low blood potassium
• niska razina kalija u krvi
The most commonly (≥10%) occurring adverse reactions in all grades were anaemia (97.3%), leukopenia (95.7%), neutropenia (93.5%), thrombocytopenia (47.4%), and diarrhoea (46.6%).
(95,7%), neutropenija (93,5%), trombocitopenija (47,4%) i proljev (46,6%).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL for SOLVENT
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
Very common Common disorders
Common Terminology
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
Dozu je potrebno prilagoditi ako se u bolesnika pojave sljedeće nuspojave (stupnjevi su određeni prema verziji 4,0 Zajedničkih terminoloških kriterija za nuspojave (engl.
Premedication The recommended premedication regimen should be performed at least 30 minutes prior to each administration of JEVTANA with the following intravenous medicinal products to mitigate the risk and severity of hypersensitivity:
Radi smanjivanja rizika i težine reakcija preosjetljivosti, potrebno je primijeniti preporučenu premedikaciju najmanje 30 minuta prije svake primjene lijeka JEVTANA i to intravenskom primjenom sljedećih lijekova:
From a microbiological point of view, the concentrate-solvent mixture should be used immediately.
S mikrobiološkog stajališta, pripremljenu otopinu koncentrata i otapala treba primijeniti odmah.
One ml of concentrate contains 40 mg cabazitaxel.
Jedan ml koncentrata sadrži 40 mg kabazitaksela.
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).
Ako se ne može izbjeći istodobna primjena sa snažnim inhibitorima CYP3A, potrebno je pomno pratiti toksičnost te razmotriti smanjenje doze kabazitaksela (vidjeti dijelove 4.2 i 4.5).
Psychiatric disorders Anxiety Confusional state Nervous system Dysgeusia
Psihijatrijski poremećaji anksioznost smetenost
Delay treatment until improvement or resolution, and until neutrophil count is >1,500 cells/mm3, then reduce cabazitaxel dose from 25 mg/m2 to
Febrilna neutropenija ili neutropenijska infekcija Odgoditi liječenje do poboljšanja ili oporavka te dok broj neutrofila ne dosegne > 1500 stanica/mm3, a zatim smanjiti dozu kabazitaksela s 25 mg/m2 na 20 mg/m2.
Vistor hf.
1 HR (engl.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2)
Ear and labyrinth disorders
Poremećaji uha i labirinta tinitus vrtoglavica
• you are allergic (hypersensitive) to cabazitaxel, to other taxanes, or polysorbate 80 or any of the other excipients of this medicine (listed in section 6),
• ako ste alergični (preosjetljivi) na kabazitaksel, druge taksane ili polisorbat 80 ili neki drugi sastojak ovog lijeka (naveden u dijelu 6), • ako imate premalo bijelih krvnih stanica (broj neutrofila manji ili jednak 1500/mm3)
Step 1.3
Korak 1.3
NAME OF THE MEDICINAL PRODUCT JEVTANA 60 mg concentrate and solvent for solution for infusion.
JEVTANA 60 mg koncentrat i otapalo za otopinu za infuziju.
Step 2.2
Korak 2.2
There was no significant difference in overall survival in this group of patients (HR (95%CI) 0.96 (0.49-1.86)).
(HR (95% CI): 0,96 (0,49-1,86)).
Grade >2 peripheral neuropathy
Periferna neuropatija stupnja ≥ 2
Leukopeniaa
Proljev
All patients should be pre-medicated prior to the initiation of the infusion of cabazitaxel (see section 4.2).
U svih je bolesnika potrebno provesti premedikaciju prije početka primjene infuzije kabazitaksela
Delay treatment until improvement or resolution, then reduce cabazitaxel dose from 25 mg/m2 to
Odgoditi liječenje do poboljšanja ili oporavka, a zatim smanjiti dozu kabazitaksela s 25 mg/m2 na 20 mg/m2.
Step 1.2
Korak 1.2
Each 1.5 ml vial of concentrate contains 60 mg cabazitaxel.
Jedna bočica s 1,5 ml koncentrata sadrži 60 mg kabazitaksela.
NAME OF THE MEDICINAL PRODUCT JEVTANA 60 mg concentrate and solvent for solution for infusion cabazitaxel
JEVTANA 60 mg koncentrat i otapalo za otopinu za infuziju kabazitaksel
Inspect the concentrate vial and the supplied solvent.
Pregledajte bočicu s koncentratom lijeka i priloženo otapalo.
Step 1.4
Korak 1.4
• 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).
• koncentrat: 1,5 ml koncentrata u prozirnoj staklenoj bočici od 15 ml (staklo tip I), zatvorenoj sivim gumenim zatvaračem (klorobutil guma), aluminijskim prstenom i svijetlozelenim plastičnim