FrancophonIA/ELRC3.0 huggingface dataset:
English: If the patient has missed a dose of trastuzumab by one week or less, then the usual maintenance dose (weekly regimen: 2 mg/kg; three-weekly regimen: 6 mg/kg) should be administered as soon as possible.
Croatian: Ako je bolesnik propustio primiti dozu trastuzumaba za tjedan dana ili manje, nužno je što prije primijeniti uobičajenu dozu održavanja (tjedni ciklusi: 2 mg/kg; trotjedni ciklusi: 6 mg/kg).
English: EBC in the HERA trial was limited to operable, primary, invasive adenocarcinoma of the breast, with axillary nodes positive or axillary nodes negative if tumors at least 1 cm in diameter.
Croatian: Rani rak dojke u ispitivanju HERA bio je ograničen isključivo na operabilni, primarni, invazivni adenokarcinom dojke, s pozitivnim ili negativnim aksilarnim čvorovima ako je promjer tumora iznosio najmanje 1 cm.
English: 1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injections in the vial containing the lyophilised Ogivri, directing the stream into the lyophilised cake.
Croatian: 1) Sterilnom štrcaljkom polagano ubrizgajte odgovarajući volumen (naveden gore) sterilne vode za injekcije u bočicu koja sadrži liofilizirani Ogivri, usmjeravajući mlaz u liofilizirani kolačić.
English: N
Croatian: U
English: Volume (mL) = Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Croatian: tjelesna težina (kg) × doza (8 mg/kg za udarnu dozu ili 6 mg/kg za dozu održavanja) 21 (mg/ml, koncentracija rekonstituirane otopine)
English: What you need to know before you are given Ogivri Do not use Ogivri:
Croatian: Što morate znati prije nego počnete primati Ogivri
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = confidence interval * At the time of the definitive analysis of DFS.
Croatian: A: doksorubicin, C: ciklofosfamid, P: paklitaksel, D: docetaksel, Carb: karboplatin, H: trastuzumab CI = interval pouzdanosti * U trenutku konačne analize preživljenja bez bolesti.
English: It may take up to 7 months for Ogivri to be removed from the body.
Croatian: Da bi se Ogivri uklonio iz tijela, potrebno je i do 7 mjeseci.
English: At 8 years, the survival rate was estimated to be 86.9 % in the AC→PH arm and 79.4 % in the AC→P arm, an absolute benefit of 7.4 % (95 % CI 4.9 %, 10.0 %).
Croatian: Procijenjena stopa preživljenja nakon 8 godina iznosila je 86,9% u skupini liječenoj AC→PH kemoterapijom te 79,4% u skupini koja je primala AC→P kemoterapiju, što ukazuje na apsolutnu korist od 7,4% (95% CI 4,9%; 10,0%).
English: 1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of water for injections in the vial containing the lyophilised Ogivri, directing the stream into the lyophilised cake.
Croatian: 1) Sterilnom štrcaljkom polagano ubrizgajte odgovarajući volumen (naveden gore) vode za injekcije u bočicu koja sadrži liofilizirani lijek Ogivri, usmjeravajući mlaz u liofilizirani kolačić.
English: Ogivri 150 mg powder for concentrate for solution for infusion This medicine contains 115.2 mg sorbitol in each vial.
Croatian: Ogivri 150 mg prašak za koncentrat za otopinu za infuziju Ovaj lijek sadrži 115,2 mg sorbitola u jednoj bočici.
English: Table 9 Overview of efficacy analyses BCIRG 006 AC→D versus AC→DH Parameter
Croatian: Tablica 9. Pregled analize djelotvornosti u ispitivanju BCIRG 006; AC→D naspram AC→DH
English: AUC0-21days (mcg.day/mL)
Croatian: AUC0-21dan (µg.dan/ml)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Ogivri 150 mg powder for concentrate for solution for infusion One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Ogivri 150 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 150 mg trastuzumaba, humaniziranog IgG1 monoklonskog protutijela proizvedenog u kulturi stanica sisavaca u suspenziji (stanice jajnika kineskog hrčka) i pročišćenog afinitetnom i ionsko-izmjenjivačkom kromatografijom uključujući specifičnu inaktivaciju virusa i postupke uklanjanja.
English: Table 1 Undesirable effects reported with intravenous trastuzumab monotherapy or in combination with chemotherapy in pivotal clinical trials (N = 8386) and in post-marketing System organ class
Croatian: Nuspojave prijavljene kod primjene intravenske formulacije trastuzumaba u monoterapiji ili u kombinaciji s kemoterapijom u pivotalnim kliničkim ispitivanjima (N=8386) i nakon stavljanja lijeka u promet
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake „Rok valjanosti“.
English: The test method for HER2 overexpression used to determine eligibility of patients in the pivotal trastuzumab monotherapy and trastuzumab plus paclitaxel clinical trials employed immunehistochemical staining for HER2 of fixed material from breast tumours using the murine monoclonal antibodies CB11 and 4D5.
Croatian: Metoda testiranja povećane ekspresije HER2, primijenjena u pivotalnim kliničkim ispitivanjima u svrhu odabira bolesnica pogodnih za monoterapiju trastuzumabom ili liječenje kombinacijom trastuzumaba i paklitaksela, uključivala je imunohistokemijske metode određivanja HER2 u materijalu uzetom iz tumora dojke pomoću CB11 i 4D5 mišjih monoklonskih protutijela.
English: The addition of trastuzumab to paclitaxel chemotherapy also resulted in a 37 % decrease in the risk of death.
Croatian: Dodavanje trastuzumaba kemoterapiji paklitakselom rezultiralo je i smanjenjem rizika od smrti za
English: Mylan Healthcare d.o.o.
Croatian: Mylan Healthcare B.V.
English: Ogivri 420 mg powder for concentrate for solution for infusion This medicine contains 322.6 mg sorbitol in each vial.
Croatian: Ogivri 420 mg prašak za koncentrat za otopinu za infuziju Ovaj lijek sadrži 322,6 mg sorbitola u jednoj bočici.
English: If LVEF has not improved, or declined further, or symptomatic CHF has developed, discontinuation of trastuzumab should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks.
Croatian: Ako se LVEF ne poboljša ili se još više smanji, ili ako se razvije simptomatsko kongestivno zatajenje srca, potrebno je ozbiljno razmotriti mogućnost prekida terapije trastuzumambom, osim u slučaju kada koristi za pojedinog bolesnika nadmašuju rizike.
English: Ogivri should be carefully handled during reconstitution.
Croatian: Tijekom rekonstitucije, lijekom Ogivri treba rukovati oprezno.
English: In an exploratory subgroup analysis performed in the TOGA (BO18255) trial there was no apparent benefit on overall survival with the addition of trastuzumab in patients with ECOG PS 2 at baseline [HR 0.96 (95 % CI 0.51-1.79)], non-measurable [HR 1.78 (95 % CI 0.87-3.66)] and locally advanced disease [HR 1.20 (95 % CI 0.29-4.97)].
Croatian: U eksplorativnoj analizi podskupina provedenoj u ispitivanju ToGA (BO18255) nije bilo vidljive koristi u ukupnom preživljenju od uključivanja trastuzumaba u terapiju bolesnika s ECOG 2 statusom na početku liječenja [HR 0,96 (95% CI 0,51 - 1,79)], kod bolesnika s nemjerljivom [HR 1,78 (95% CI 0,87 - 3,66)] i lokalno uznapredovalom bolešću [HR 1,20 (95% CI 0,29 - 4,97)].
English: Table 5 Efficacy results from the non-comparative monotherapy and combination therapy studies Parameter
Croatian: Tablica 5. Rezultati djelotvornosti iz nekomparativnih ispitivanja monoterapije i kombinirane terapije
English: Solutions of Ogivri for intravenous infusion are physically and chemically stable in polyvinylchloride, polyethylene or polypropylene bags containing sodium chloride 9 mg/mL (0.9 %) solution for injection for 24 hours at temperatures not exceeding 30°C.
Croatian: Otopina lijeka Ogivri za intravensku infuziju u polivinilkloridnoj, polietilenskoj ili polipropilenskoj vrećici, koja sadrži otopinu 9 mg/ml (0,9%) natrijevog klorida za injekciju, fizički je i kemijski stabilna tijekom 24 sata na temperaturama ne višim od 30 °C.
English: Hazard Ratio (95 % CI) p = 0.0555
Croatian: Omjeri hazarda (95% CI) p = 0,0555
English: HER2 over expression should be detected using an immunohistochemistry (IHC)-based assessment of fixed tumour blocks; HER2 gene amplification should be detected using in situ hybridisation using either SISH or FISH on fixed tumour blocks.
Croatian: Povećana ekspresija HER2 se utvrđuje imunohistokemijskom (IHC) metodom procjene fiksiranih blokova tumorskog tkiva; HER2 genska amplifikacija utvrđuje se hibridizacijom in situ npr. SISH ili FISH na fiksiranim blokovima tumorskog tkiva.
English: Administration in combination with paclitaxel or docetaxel In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of trastuzumab (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.
Croatian: U pivotalnim kliničkim ispitivanjima (H0648g, M77001) paklitaksel ili docetaksel primjenjivan je dan nakon prve doze trastuzumaba (za dozu vidjeti sažetak opisa svojstava lijeka za paklitaksel ili docetaksel) i neposredno nakon sljedećih doza trastuzumaba ako je bolesnik dobro podnio prethodnu dozu trastuzumaba.
English: The appropriate amount of solution should be withdrawn from the vial and added to a polyvinylchloride, polyethylene or polypropylene infusion bag containing 250 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Odgovarajuću količinu otopine potrebno je izvući iz bočice i dodati u polivinilkloridnu, polietilensku ili polipropilensku infuzijsku vrećicu koja sadrži 250 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju.
English: AUCss, 0-21days (mcg.day/mL)
Croatian: AUCss, 0-21 dan (µg.dan/ml)
English: Only patients with a large amount of HER2 will be treated with Ogivri.
Croatian: Lijekom Ogivri liječit će se samo bolesnici s visokom razinom HER2.
English: No disease-free survival (DFS) benefit was noticed in this subgroup of patients (hazard ratio = 1.16, 95 % CI [0.73, 1.83] for DCarbH (TCH) versus AC→D (AC→T); hazard ratio 0.97, 95 % CI [0.60, 1.55] for AC→DH (AC→TH) versus AC→D).
Croatian: Nije primijećena prednost u pogledu preživljenja bez bolesti u toj podskupini bolesnica (omjer hazarda = 1,16; 95% CI [0,73; 1,83] za skupinu DCarbH (TCH), naspram AC→D (AC→T); omjer hazarda od 0,97; 95% CI [0,60; 1,55] za AC→DH (AC→TH) naspram AC→D.
English: Doxorubicin and cyclophosphamide were administered concurrently as follows: - intravenous push doxorubicin, at 60 mg/ m2, given every 3 weeks for 4 cycles.
Croatian: Doksorubicin i ciklofosfamid su primijenjeni istodobno na sljedeći način: - brza intravenska injekcija doksorubicina u dozi od 60 mg/m², svaka 3 tjedna, u 4 ciklusa.
English: Rare side effects: may affect up to 1 in 1000 people
Croatian: Rijetke nuspojave: mogu se javiti u do 1 na 1000 osoba
English: ** Median duration of long term follow-up for the Joint Analysis clinical studies was 8.3 years (range: 0.1 to 12.1) for the AC→PH arm and 7.9 years (range: 0.0 to 12.2) for the AC→P arm; Median duration of long term follow-up for the BCIRG 006 study was 10.3 years in both the AC→D arm (range: 0.0 to 12.6) arm and the DCarbH arm (range: 0.0 to 13.1), and was 10.4 years (range: 0.0 to 12.7) in the AC→DH arm
Croatian: 8,3 godine (raspon: 0,1 do 12,1) u skupini koja je primala AC→PH kemoterapiju te 7,9 godina (raspon: 0,0 do 12,2) u skupini koja je primala AC→P kemoterapiju; medijan trajanja dugoročnog praćenja za ispitivanje BCIRG 006 iznosio je 10,3 godine i u skupini koja je primala AC→D (raspon: 0,0 do 12,6) i u onoj koja je primala DCarbH kemoterapiju (raspon: 0,0 do 13,1), dok je u skupini koja je primala AC→DH kemoterapiju iznosio 10,4 godine (raspon: 0,0 - 12,7)
English: Cmax (mcg/mL)
Croatian: Cmax (µg/ml)
English: Subsequent trastuzumab maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively.
Croatian: Sljedeću dozu održavanja trastuzumaba (tjedni ciklusi: 2 mg/kg; trotjedni ciklusi: 6 mg/kg) treba primijeniti 7 dana nakon toga ako bolesnik prima tjedni raspored doziranja, odnosno 21 dan nakon toga ako prima trotjedni raspored doziranja.
English: Response rate (95 %CI)
Croatian: Stopa odgovora (95% CI)
English: Comparison of PK results from two phase II studies (BO15935 and M77004) and one phase III study (H0648g) in which patients were treated concomitantly with trastuzumab and paclitaxel and two phase II studies in which trastuzumab was administered as monotherapy (W016229 and MO16982), in women with HER2-positive MBC indicates that individual and mean trastuzumab trough serum concentrations varied within and across studies but there was no clear effect of the concomitant administration of paclitaxel on the pharmacokinetics of trastuzumab.
Croatian: Usporedbom farmakokinetičkih rezultata iz dvaju ispitivanja faze II (BO15935 i M77004), jednoga ispitivanja faze III (H0648g) u kojemu su bolesnice istodobno liječene trastuzumabom i paklitakselom te dvaju ispitivanja faze II u kojima je trastuzumab primjenjivan u monoterapiji (W016229 i MO16982) u žena s HER2-pozitivnim metastatskim rakom dojke, utvrđeno je da pojedinačne i srednje najniže koncentracije trastuzumaba u serumu variraju unutar svakoga ispitivanja i između svih ispitivanja, ali nije utvrđen jasan učinak istodobne primjene paklitaksela na farmakokinetiku trastuzumaba.
English: Pharmacokinetic data from studies BO15935 and M77004 in women with HER2-positive MBC suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-α hydroxylpaclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab (8 mg/kg or 4 mg/kg intravenous loading dose followed by 6 mg/kg q3w or 2 mg/kg q1w intravenous, respectively).
Croatian: Farmakokinetički podaci iz ispitivanja BO15935 i M77004 u žena s HER2-pozitivnim metastatskim rakom dojke ukazali su da prisutnost trastuzumaba (intravenska udarna doza od 8 mg/kg, odnosno 4 mg/kg, nakon koje slijedi intravenska doza od 6 mg/kg svaka 3 tjedna, odnosno 2 mg/kg jedanput tjedno) nije promijenila izloženost paklitakselu i doksorubicinu (i njihovim glavnim metabolitima 6-α hidroksil-paklitakselu, POH, i doksorubicinolu, DOL).
English: If patients have been treated concurrently with a full course of low-dose anthracyclines and trastuzumab in the neoadjuvant setting, no additional cytotoxic chemotherapy should be given after surgery.
Croatian: Ako su bolesnici u sklopu neoadjuvantnog liječenja istodobno primali antracikline u niskim dozama i trastuzumab, nakon operacije ne smiju primati nikakvu drugu citotoksičnu kemoterapiju.
English: After a median follow-up of 12 months, the hazard ratio (HR) for disease free survival (DFS) was 0.54 (95 % CI 0.44, 0.67) which translates into an absolute benefit, in terms of a 2-year disease-free survival rate, of 7.6 percentage points (85.8 % versus 78.2 %) in favour of the trastuzumab arm.
Croatian: Nakon medijana praćenja od 12 mjeseci, omjer hazarda (engl. hazard ratio, HR) za preživljenje bez simptoma bolesti (engl. disease-free survival, DFS) iznosio je 0,54 (95% CI 0,44; 0,67), što znači da je apsolutno povoljan u smislu dvogodišnjeg preživljenja bez simptoma bolesti s razlikom od 7,6 postotnih bodova (85,8% naspram 78,2%) u korist skupine liječene trastuzumabom.
English: Each 420 mg vial of Ogivri is reconstituted with 20 mL of sterile water for injections (not supplied).
Croatian: Svakih 420 mg lijeka Ogivri rekonstituira se sa 20 ml sterilne vode za injekcije (nije priložena u pakiranju).
English: Presented in Table 1 are adverse reactions that have been reported in association with the use of intravenous trastuzumab alone or in combination with chemotherapy in pivotal clinical trials and in the post-marketing setting.
Croatian: Tablici 1. su prikazane nuspojave povezane s primjenom intravenske formulacije trastuzumaba u monoterapiji ili u kombinaciji s kemoterapijom u pivotalnim kliničkim ispitivanjima i nakon stavljanja lijeka u promet.
English: The recommended initial loading dose of trastuzumab is 4 mg/kg body weight.
Croatian: Preporučena početna udarna doza trastuzumaba iznosi 4 mg/kg tjelesne težine.
English: The pharmacokinetics of trastuzumab were evaluated in a population pharmacokinetic model analysis using pooled data from 1,582 subjects, including patients with HER2 positive MBC, EBC, AGC or other tumour types, and healthy volunteers, in 18 Phase I, II and III trials receiving trastuzumab IV. A two-compartment model with parallel linear and non-linear elimination from the central compartment described the trastuzumab concentration-time profile.
Croatian: Farmakokinetika trastuzumaba ocjenjivala se u analizi populacijskog farmakokinetičkog modela, u kojoj su se koristili objedinjeni podaci prikupljeni u 1582 ispitanika, uključujući bolesnike s HER2 pozitivnim metastatskim rakom dojke, ranim rakom dojke, uznapredovalim rakom želuca ili drugim vrstama tumora te zdrave dobrovoljce koji su primali intravensku formulaciju trastuzumaba u 18 ispitivanja faze I, II i III.
English: Ogivri 420 mg powder for concentrate for solution for infusion One vial contains 420 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
Croatian: Ogivri 420 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 420 mg trastuzumaba, humaniziranog IgG1 monoklonskog protutijela proizvedenog u kulturi stanica sisavaca u suspenziji (stanice jajnika kineskog hrčka) i pročišćenog afinitetnom i ionsko-izmjenjivačkom kromatografijom uključujući specifičnu inaktivaciju virusa i postupke uklanjanja.
English: In the BCIRG 006 study for the primary endpoint, DFS, the hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 5.8 percentage points (86.7 % versus 80.9 %) in favour of the AC→DH (trastuzumab) arm and 4.6 percentage points (85.5 % versus 80.9 %) in favour of the DCarbH (trastuzumab) arm compared to AC→D.
Croatian: Za primarnu mjeru ishoda ispitivanja BCIRG 006, preživljenje bez bolesti, omjer hazarda apsolutno je povoljan u smislu trogodišnjeg preživljenja bez bolesti s razlikom od 5,8 postotnih bodova (86,7% naspram 80,9%) u korist AC→DH skupine (trastuzumab) i 4,6 postotnih bodova (85,5% naspram na 80,9%) u korist DCarbH skupine (trastuzumab) u usporedbi s AC→D skupinom.
English: In patients with EBC eligible for neoadjuvant-adjuvant treatment, trastuzumab should be used concurrently with anthracyclines only in chemotherapy-naive patients and only with low-dose anthracycline regimens i.e. maximum cumulative doses of doxorubicin 180 mg/m2 or epirubicin
Croatian: U bolesnika s ranim rakom dojke koji zadovoljavaju uvjete za neoadjuvantno-adjuvantno liječenje, trastuzumab se smije davati istodobno s antraciklinima isključivo u bolesnika koji prije nisu primali kemoterapiju i samo uz protokole s niskim dozama antraciklina tj. onih s najvećom kumulativnom dozom doksorubicina od 180 mg/m² ili epirubicina od 360 mg/m².
English: Median TTP (months) (95 %CI)
Croatian: Medijan TTP (mjeseci) (95% CI)
English: • abdominal (stomach) pain
Croatian: • bol u abdomenu (trbuhu)
English: In this trial, 2 cohorts (one using subcutaneous formulation in vial and one using subcutaneous formulation in administration system) were investigated using a 2-arm, cross-over design with 488 patients being randomized to one of two different three-weekly Trastuzumab treatment sequences (intravenous [Cycles 1-4]→ subcutaneous [Cycles 5-8], or subcutaneous [Cycles 1-4]→ intravenous [Cycles 5-8]).
Croatian: Radilo se o ukriženom ispitivanju s dvije skupine, u kojem je 488 bolesnika bilo randomizirano da prima jedan od dvaju različitih trotjednih sljedova liječenja trastuzumabom (intravenski [1. - 4. ciklus] → supkutano [5. - 8. ciklus] ili supkutano [1. - 4. ciklus] → intravenski [5. - 8. ciklus]).
English: The population predicted PK exposure values (median with 5th - 95th Percentiles) and PK parameter values at clinically relevant concentrations (Cmax and Cmin) for MBC, EBC and AGC patients treated with the approved q1w and q3w dosing regimens are shown in Table 14 (cycle 1), Table 15 (steadystate), and Table 16 (PK parameters).
Croatian: Vrijednosti farmakokinetičke izloženosti predviđene za populaciju (medijan i 5. do 95. percentil) i vrijednosti farmakokinetičkih parametara pri klinički značajnim koncentracijama (Cmax i Cmin) za bolesnike s metastatskim rakom dojke, ranim rakom dojke i uznapredovalim rakom želuca koji se liječe odobrenim režimima doziranja jedanput na tjedan i jedanput svaka 3 tjedna prikazane su u Tablici 14. (1. ciklus), Tablici 15. (stanje dinamičke ravnoteže) i Tablici 16. (farmakokinetički parametri).
English: How to store Ogivri
Croatian: Kako čuvati Ogivri
English: A detailed history with regards to HFI symptoms has to be taken of each patient prior to being given this medicinal product.
Croatian: Prije primjene ovog lijeka potrebno je od svakog bolesnika uzeti detaljnu anamnezu s obzirom na simptome nasljednog nepodnošenja fruktoze.
English: The hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 11.8 percentage points (87.2 % versus 75.4 %) in favour of the AC→PH (trastuzumab) arm.
Croatian: Omjer hazarda apsolutno je povoljan u smislu trogodišnjeg preživljenja bez bolesti s razlikom od 11,8 postotnih bodova (87,2% naspram 75,4%) u korist skupine liječene AC→PH kemoterapijom (trastuzumabom).
English: Ogivri 420 mg powder for concentrate for solution for infusion Each 420 mg vial of Ogivri is reconstituted with 20 mL of sterile water for injections (not supplied).
Croatian: Ogivri 420 mg prašak za koncentrat za otopinu za infuziju Svakih 420 mg lijeka Ogivri rekonstituira se sa 20 ml sterilne vode za injekcije (nije priložena u pakiranju).
English: Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40 % of patients who are treated with trastuzumab will experience some form of infusion-related reaction.
Croatian: Procjenjuje se da će otprilike 40% bolesnika u tijeku liječenja trastuzumabom razviti neki oblik infuzijske reakcije.
English: Very common side effects: may affect more than 1 in 10 people
Croatian: Vrlo česte nuspojave: mogu se javiti u više od 1 na 10 osoba
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1341/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1341/001
English: The reconstituted Ogivri results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates.
Croatian: Rekonstituirani Ogivri je bezbojna do blijedožuta prozirna otopina bez vidljivih čestica.
English: In a subsequent trial with prospective monitoring of cardiac function, the incidence of symptomatic CHF was 2.2 % in patients receiving trastuzumab and docetaxel, compared with 0 % in patients receiving docetaxel alone.
Croatian: U kasnijem ispitivanju u kojem se prospektivno pratila srčana funkcija, incidencija simptomatskog kongestivnog zatajenja srca bila je 2,2% u bolesnica koje su primale trastuzumab i docetaksel, u usporedbi s 0% u bolesnica koje su primale samo docetaksel.
English: The results of this sub study suggested that the exposure to the bioactive metabolites (e.g. 5-FU) of capecitabine was not affected by concurrent use of cisplatin or by concurrent use of cisplatin plus trastuzumab.
Croatian: Rezultati ovog podispitivanja ukazali su da istodobna primjena cisplatina ili istodobna primjena cisplatina i trastuzumaba ne utječe na izloženost bioaktivnim metabolitima (npr. 5-FU) kapecitabina.