natgillin/translations-raw huggingface dataset:
For intravenous use only after reconstitution and dilution.
Za intravensko uporabo le po rekonstituciji in razredčitvi.
On the basis of the scientific conclusions for trastuzumab the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing trastuzumab is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za trastuzumab odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo trastuzumab, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
If you stop using Herzuma
Če ste prenehali uporabljati zdravilo Herzuma
Store in a refrigerator (2ºC - 8ºC).
Shranjujte v hladilniku (2 °C-8 °C).
An absolute benefit of 13 percentage points in favour of the trastuzumab arm was estimated in terms of 3-year event-free survival rate (65% versus 52%).
Absolutna korist 13 odstotnih točk v prid skupini, ki je prejemala trastuzumab, je bila ocenjena v smislu 3-letnega preživetja brez bolezni (65 % proti 52 %).
*Cmin,ss = Cmin at steady state **Cmax,ss = Cmax at steady state *** time to 90% of steady state
*Cmin, ss = Cmin v stanju dinamičnega ravnovesja **Cmax, ss = Cmax v stanju dinamičnega ravnovesja *** čas do 90 % stanja dinamičnega ravnovesja
At the time of a safety update after a median of 3.5 - 3.8 years follow up, an analysis of DFS reconfirms the magnitude of the benefit shown in the definitive analysis of DFS.
Ob pregledu varnosti po mediani spremljanja 3,5 do 3,8 leta je analiza preživetja brez bolezni ponovno potrdila velikost koristi, prikazane v končni analizi preživetja brez bolezni.
Treatment with Herzuma alone or with a taxane may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer).
Samostojno zdravljenje z zdravilom Herzuma ali v kombinaciji s taksanom lahko vpliva na srce, še posebno, če ste se kdaj zdravili z antraciklinom (taksani in antraciklini sta dve drugi vrsti zdravil, ki se uporabljata za zdravljenje raka).
The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 μg/mL for the Michaelis-Menten constant (Km) for the MBC, EBC and AGC patients.
Vrednosti parametrov nelinearnega izločanja so bile 8,81 mg/dan za največjo hitrost izločanja (Vmax) in 8,92 µg/ml za Michaelis-Mentenovo konstanto (Km) za bolnike z MBC, EBC in AGC.
• abnormal thinking
• nenormalno razmišljanje
• feeling weak and unwell
• občutek šibkosti in slabo počutje
 you have ever had or are currently using a medicine called doxorubicin or epirubicin (medicines used to treat cancer).
• prejemate ali ste kadar koli prejeli zdravilo, ki se imenuje doksorubicin ali epirubicin (zdravili, ki se uporabljata za zdravljenje raka).
• Tumour lysis syndrome (a group of metabolic complications occurring after cancer treatment characterized by high blood levels of potassium and phosphate, and low blood levels of calcium).
• Sindrom razpada tumorja (skupina presnovnih zapletov, ki se pojavijo po zdravljenju raka, za katero so značilne visoke vrednosti kalija in fosfata ter nizke vrednosti kalcija v krvi).
 you have early breast cancer, with high levels of a protein called HER2.
• imate zgodnjega raka dojk, pri katerem so izražene velike količine beljakovine, ki se imenuje HER2;
t1/2 range from Cmax,ss to Cmin,ss (day)
Obseg t1/2 od Cmax, ss do Cmin, ss (dan)
If a pregnant woman is treated with Herzuma, or if a patient becomes pregnant while receiving Herzuma or within 7 months following the last dose of Herzuma, close monitoring by a multidisciplinary team is desirable.
Če se noseča ženska zdravi z zdravilom Herzuma ali če bolnica zanosi med zdravljenjem z zdravilom Herzuma ali v obdobju 7 mesecev po prejemu zadnjega odmerka zdravila Herzuma, je zaželeno, da jo skrbno spremlja multidisciplinarna ekipa.
Date of first authorisation: 9 February 2018 Date of latest renewal:
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 9. februar 2018
Do not take Herzuma if:  you are allergic to trastuzumab, to murine (mouse) proteins or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Herzuma, če: • ste alergični na trastuzumab, murine (mišje) beljakovine ali katero koli sestavino tega zdravila
Your doctor may prescribe Herzuma for the treatment of breast and gastric cancer when:
Vaš zdravnik vam lahko zdravilo Herzuma predpiše za zdravljenje raka dojk in raka želodca, če:
AC→PH (vs. AC→P) (NSABP B-31 and NCCTG N9831)*
AC → PH (v primerjavi z AC → P) (NSABP B-31 in NCCTG N9831)*
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa; oznaka ATC: L01XC03.
Patients treated with Herzuma are at increased risk for developing CHF (New York Heart Association [NYHA] Class II - IV) or asymptomatic cardiac dysfunction.
Pri bolnikih, ki so se zdravili z zdravilom Herzuma, obstaja večje tveganje za pojav kongestivnega srčnega popuščanja (New York Heart Association - NYHA, razred II-IV) ali asimptomatične motnje v delovanju srca.
 you have ever had any other treatment for cancer.
• ste se že zdravili zaradi raka.
Always keep this medicine in the closed original pack at a temperature of 2ºC - 8ºC in a refrigerator.
Zdravilo shranjujte v dobro zaprti originalni ovojnini pri temperaturi 2 °C-8 °C, v hladilniku.
The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarised in Table 6:
Rezultati učinkovitosti študije BO16348 po medianem času spremljanja 12 mesecev* in 8 let** so povzeti v preglednici 6.
As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during Herzuma therapy and for 7 months after the last dose.
Ker se humani IgG izloča v materino mleko, potencialni škodljivi vpliv na otroka pa ni znan, naj ženske ne dojijo med zdravljenjem z zdravilom Herzuma in še 7 mesecev po zadnjem odmerku.
• You should use effective contraception during treatment with Herzuma and for at least 7 months after treatment has ended.
• Med zdravljenjem z zdravilom Herzuma in vsaj še 7 mesecev po zaključku zdravljenja morate uporabljati učinkovito kontracepcijo.
No long-term animal studies have been performed to establish the carcinogenic potential of Herzuma, or to determine its effects on fertility in males.
Za ugotovitev kancerogenega potenciala zdravila Herzuma ali učinkov na plodnost pri moških niso opravili nobenih dolgotrajnih študij na živalih.
What you need to know before you use Herzuma
Kaj morate vedeti, preden boste uporabili zdravilo Herzuma
The safety of continuation or resumption of Herzuma in patients who experience cardiac dysfunction has not been prospectively studied.
Varnosti nadaljevanja ali ponovnega dajanja zdravila Herzuma pri bolnikih, pri katerih se je pojavila motnja v delovanju srca, niso proučevali prospektivno.
During a Herzuma infusion, chills, fever and other flu like symptoms may occur.
Med infuzijo zdravila Herzuma se lahko pojavijo mrzlica, zvišana telesna temperatura in drugi simptomi, podobni gripi.
As animal reproduction studies are not always predictive of human response, trastuzumab should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus.
Izsledki študij o vplivu na sposobnost za razmnoževanje pri živalih ne veljajo vedno tudi za ljudi, zato se moramo uporabi trastuzumaba med nosečnostjo izogibati, razen v primerih, ko pričakovana korist za mater upravičuje tveganje za plod.
What Herzuma is and what it is used for
Kaj je zdravilo Herzuma in za kaj ga uporabljamo
For early breast cancer, metastatic breast cancer and metastatic gastric cancer, Herzuma is given every 3 weeks.
Pri zgodnji obliki raka dojk, metastatskem raku dojk in metastatskem raku želodca se zdravilo Herzuma daje vsake 3 tedne.
No incompatibilities between Herzuma and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Med zdravilom Herzuma in polivinilkloridnimi, polietilenskimi ali polipropilenskimi vrečami inkompatibilnosti niso opazili.
Women of childbearing potential should be advised to use effective contraception during treatment with Herzuma and for 7 months after treatment has concluded (see section 5.2).
Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem z zdravilom Herzuma ter še 7 mesecev po zaključku zdravljenja uporabljajo učinkovito kontracepcijo (glejte poglavje 5.2).
Combination treatment with trastuzumab and anastrozole
Kombinirano zdravljenje s trastuzumabom in anastrozolom
In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with trastuzumab intravenous developed antibodies against trastuzumab.
V študiji neoadjuvantnem-adjuvantnegazgodnjega raka dojk (BO22227) z mediano spremljanja, ki je presegla 70 mesecev, so se pri 10,1 % bolnikov (30/296), zdravljenih z intravensko obliko trastuzumaba, razvila protitelesa proti trastuzumabu.
There is no relevant use of Herzuma in the paediatric population.
Zdravilo Herzuma ni namenjeno za uporabo pri pediatrični populaciji.
If you receive Herzuma with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the patient information leaflets for these products.
Če prejemate zdravilo Herzuma z drugimi zdravili za zdravljenje raka, kot so paklitaksel, docetaksel, zaviralec aromataze, kapecitabin, 5-fluorouracil ali cisplatin, preberite tudi navodila za uporabo teh zdravil.
• increased muscle tone or tension (hypertonia)
• povečan mišični tonus ali napetost
More patients experienced at least one grade 3 or 4 adverse event in the 2-year treatment arm (20.4%) compared with the 1-year treatment arm (16.3%).
Več bolnikov je doživelo najmanj en neželeni dogodek stopnje 3 ali 4 v skupini z dvoletnim zdravljenjem (20,4 %) v primerjavi s skupino z enoletnim zdravljenjem (16,3 %).
The exploratory analyses of covariates with information in only a subset of patients suggested that patients with greater shed HER2-ECD level had faster nonlinear clearance (lower Km) (p < 0.001).
Eksplorativne analize sospremenljivk, opravljene samo s podatki za podskupino bolnikov, kažejo, da so imeli bolniki z višjimi vrednostmi odcepljenega HER2-ECD antigena hitrejši nelinearni očistek (nižjo Km) (p < 0,001).
No. patients with event
Število bolnikov z dogodkom
Amongst the most serious and/or common adverse reactions reported in trastuzumab usage to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Med najbolj resnimi in/ali pogostimi neželenimi učinki, o katerih so do zdaj poročali pri uporabi trastuzumaba, so motnje v delovanju srca, reakcije, povezane z infundiranjem, hematotoksičnost (še posebno nevtropenija), okužbe in pljučni neželeni učinki.
• pain in the arms and/or legs
• bolečina v rokah in/ali nogah
After reconstitution with sterile water for injection the reconstituted solution is physically and chemically stable for 7 days at 2ºC - 8ºC.
Po rekonstituciji s sterilno vodo za injekcije je pripravljena raztopina fizikalno in kemično stabilna 7 dni pri temperaturi od 2 °C-8 °C.
* defined as absence of any invasive cancer both in the breast and axillary nodes
* Definiran kot odsotnost kakršnega koli invazivnega raka v dojkah in aksilarnih bezgavkah IZ = interval zaupanja
In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of Herzuma, or longer if a continuous decrease of LVEF is observed.
Pri bolnikih, ki prejemajo kemoterapijo z antraciklini, je priporočljivo nadaljnje spremljanje, ki ga je treba izvajati letno do 5 let po zadnjem dajanju zdravila Herzuma ali dlje, če iztisni delež levega prekata (LVEF) stalno pada.
 you have metastatic breast cancer (breast cancer that has spread beyond the original tumour) with high levels of HER2.
• imate metastatskega raka dojk (raka dojk, ki se je razširil še na druga mesta zunaj prvotnega tumorja), pri katerem so izražene velike količine HER2.
In patients receiving trastuzumab after completion of adjuvant chemotherapy, the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of trastuzumab and a body mass index (BMI) > 25 kg/m
Pri bolnikih, ki so prejemali trastuzumab po zaključku adjuvantne kemoterapije, je bilo tveganje za pojav motnje v delovanju srca povezano z višjim kumulativnim odmerkom antraciklina, ki so ga dajali pred uvedbo trastuzumaba in visokim indeksom telesne mase (body mass index - BMI) > 25 kg/m
Should an infusion reaction occur the infusion should be discontinued or the rate of infusion slowed and the patient should be monitored until resolution of all observed symptoms (see section 4.2).
Če se pojavi infuzijska reakcija, je potrebno infundiranje zdravila Herzuma prekiniti ali upočasniti njegovo hitrost in bolnika nadzorovati, dokler vsi simptomi ne izzvenijo (glejte poglavje 4.2).
Trastuzumab may persist in the circulation for up to 7 months after stopping Herzuma treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Trastuzumab je lahko po prenehanju zdravljenja z zdravilom Herzuma v krvnem obtoku prisoten do 7 mesecev glede na populacijsko farmakokinetično analizo vseh razpoložljivih podatkov (glejte poglavje 5.2).
Instructions for reconstitution and dilution:
Navodila za rekonstitucijo in redčenje:
 Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients listed in section 6.1.
• Preobčutljivost za trastuzumab, murine beljakovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m infused over 3 hours) with or without trastuzumab.
Bolnike, ki so predhodno prejemali adjuvantno kemoterapijo na osnovi antraciklinov, so zdravili s paklitakselom (175 mg/m infundirano v 3 urah) samim ali skupaj s trastuzumabom.
Although there are some limitations when using Cairo-Bishop criteria for diagnosis leading to underestimation of the number of cases, the update of the Product Information to include TLS with a frequency unknown is endorsed, because trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Čeprav so ob uporabi Cairo-Bishopovih meril za diagnozo prisotne nekatere omejitve, ki vodijo v podcenitev števila primerov, je smiselna posodobitev Informacij o zdravilu, v katere je treba vključiti sindrom razpada tumorja z neznano pogostnostjo, ker je trastuzumab močan mediator citotoksičnosti, povzročene s celicami, odvisnimi od protiteles (antibody-dependent cell-mediated cytotoxicity - ADCC).
- in combination with neoadjuvant chemotherapy followed by adjuvant Herzuma therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).
- v kombinaciji z neoadjuvantno kemoterapijo, čemur sledi adjuvantno zdravljenje z zdravilom Herzuma, za lokalno napredovalo (tudi vnetno) bolezen ali tumorje > 2 cm v premeru (glejte poglavji 4.4 in 5.1).
 you have had heart failure, coronary artery disease, heart valve disease (heart murmurs), high blood pressure, taken any high blood pressure medicine or are currently taking any high blood pressure medicine.
• ste imeli srčno popuščanje, koronarno arterijsko bolezen, bolezen srčnih zaklopk (šum na srcu), visok krvni tlak, če jemljete ali ste jemali zdravila proti visokemu krvnemu tlaku;
A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab * At median duration of follow up of 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm ** p value for OS did not cross the pre-specified statistical boundary for comparison of AC→PH vs. AC→P
A: doksorubicin; C: ciklofosfamid; P: paklitaksel; H: trastuzumab; IZ: interval zaupanja * Po mediani spremljanja 1,8 leta za bolnike v skupini AC → P in 2,0 leta za bolnike v skupini AC → PH. ** Vrednost p za celokupno preživetje ni presegla vnaprej določene statistične meje za primerjavo AC → PH z AC → P.
Congestive heart failure (NYHA Class II - IV) is a common adverse reaction associated with the use of Herzuma and has been associated with a fatal outcome (see section 4.4).
Kongestivno srčno popuščanje, NYHA razred II-IV, je pogost neželeni učinek, povezan z uporabo zdravila Herzuma; povezan je bil tudi s smrtnim izidom (glejte poglavje 4.4).
The frequency of progression in the liver was significantly reduced in patients treated with the combination of trastuzumab and paclitaxel, compared to paclitaxel alone (21.8% versus 45.7%; p=0.004).
Pogostnost napredovanja v jetrih je bila signifikantno zmanjšana pri bolnikih, zdravljenih s kombinacijo trastuzumaba in paklitaksela, v primerjavi s samim paklitakselom (21,8 % v primerjavi s 45,7 %; p = 0,004).
The highest rate of cardiac dysfunction was seen in patients receiving trastuzumab concurrently with anthracycline/cyclophosphamide (27%), and was significantly higher than for anthracycline/cyclophosphamide alone (7% - 10%).
Najvišji delež motenj v delovanju srca je bil pri bolnikih, ki so trastuzumab prejemali sočasno z antraciklinom/ciklofosfamidom (27 %), bil je signifikantno višji kot pri jemanju samega antraciklina/ciklofosfamida (7 do 10 %).
• sleepiness (somnolence)
• zaspanost (somnolenca)
If you experience any of the above symptoms when your treatment with Herzuma has finished, you should see your doctor and tell them that you have previously been treated with Herzuma.
Če se kateri koli izmed zgornjih simptomov pojavi po končanem zdravljenju z zdravilom Herzuma, obiščite zdravnika in ga obvestite o tem, da ste se zdravili z zdravilom Herzuma.
Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki na viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
In a method comparison study (study D008548), a high degree of concordance (> 95%) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients.
V študiji za primerjavo metod (študija D008548) so med tehnikama SISH in FISH za ugotavljanje amplifikacije gena HER2 pri bolnikih z rakom želodca ugotovili visoko stopnjo ujemanja (> 95 %).
150 mg Unopened vial
150 mg Neodprta viala
City North Business Campus Stamullen, Co. Meath K32 YD60 Ireland
City North Business Campus Stamullen, Co. Meath K32 YD60 Irska
Administration in combination with an aromatase inhibitor
Odmerjanje v kombinaciji z zaviralcem aromataze
In 3 pivotal clinical trials of adjuvant trastuzumab given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic Congestive Heart Failure) was similar in patients who were administered chemotherapy alone (i.e. did not receive trastuzumab) and in patients who were administered trastuzumab sequentially after a taxane (0.3 - 0.4%).
V treh ključnih kliničnih preskušanjih pri adjuvantnem zdravljenju s trastuzumabom v kombinaciji s kemoterapijo je bila incidenca motenj v delovanju srca stopnje 3/4 (še posebno simptomatskega kongestivnega srčnega popuščanja) podobna pri bolnikih, ki so prejeli le kemoterapijo (to je, da niso prejeli trastuzumaba), in pri bolnikih, ki so prejeli trastuzumab zaporedno po taksanu (0,3 do 0,4 %).
In BCIRG 006 study, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the AC→DH (AC→TH) arm, and 217/1073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤ 90 (either 80 or 90).
V študiji BCIRG 006 je 213/1075 bolnikov v skupini DCarbH (TCH), 221/1074 bolnikov v skupini AC → DH (AC → TH) in 217/1073 bolnikov v skupini AC → D (AC → T) imelo stanje zmogljivosti po Karnofskem ≤ 90 (ali 80 ali 90).
If the patient has missed a dose of Herzuma by more than one week, a re-loading dose of Herzuma should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible.
Če je bolnik izpustil odmerek zdravila Herzuma za več kot en teden, mu je treba čim prej ponovno dati uvajalni odmerek zdravila Herzuma v približno 90 minutah (tedenski režim: 4 mg/kg; 3-tedenski režim: 8 mg/kg).
What Herzuma looks like and contents of the pack
Izgled zdravila Herzuma in vsebina pakiranja
AUCss, 0-21days (μg.day/mL)
AUCss, 0-21. dan (µg.dan/ml)
Herzuma is a biosimilar medicinal product.
Zdravilo Herzuma je podobno biološko zdravilo.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Herzuma neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
MBC and EBC patients had similar PK parameters (e.g. clearance [CL], the central compartment volume [Vc]) and population-predicted steady-state exposures (Cmin, Cmax and AUC).
Bolniki z MBC in EBC so imeli podobne farmakokinetične parametre (npr. očistek, volumen centralnega prostora (Vc)) in izpostavljenosti v stanju dinamičnega ravnovesja (Cmin, Cmax in AUC), predvidene za populacijo.
It is also used in combination with medicines called aromatase inhibitors with patients with high levels of HER2 and hormone receptor-positive metastatic breast cancer (cancer that is sensitive to the presence of female sex hormones).
Uporablja se tudi v kombinaciji z zdravili, imenovanimi zaviralci aromataze, za zdravljenje bolnikov z metastatsko obliko raka dojk z velikimi količinami HER2 in pozitivnimi hormonskimi receptorji (to pomeni, da je tumor občutljiv na prisotnost ženskih spolnih hormonov);
The efficacy results from study BO18225 are summarised in Table 13:
Rezultati učinkovitosti za preskušanje BO18225 so povzeti v preglednici 13.
The incidence of symptomatic cardiac dysfunction was 1.7% in the trastuzumab arm.
Pogostnost simptomatske motnje v delovanju srca je bila v skupini, ki je prejemala trastuzumab, 1,7 %.
The administration of concomitant anastrozole did not appear to influence the pharmacokinetics of trastuzumab.
Sočasno dajanje anastrozola ni imelo vpliva na farmakokinetiko trastuzumaba.
In order to prevent medication errors it is important to check the vial labels to ensure that the medicine being prepared and given is Herzuma (trastuzumab) and not trastuzumab emtansine.
Za preprečitev napak pri dajanju zdravila je pomembno preveriti nalepke na vialah in tako zagotoviti, da je pripravljeno in uporabljeno zdravilo Herzuma (trastuzumab) in ne trastuzumab emtanzin.
If you receive Herzuma in combination with chemotherapy, some of them may also be due to the chemotherapy.
Če prejemate skupaj z zdravilom Herzuma tudi kemoterapijo, so lahko nekateri neželeni učinki nastali tudi zaradi kemoterapije.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
Powder for concentrate for solution for infusion 1 vial
Prašek za koncentrat za raztopino za infundiranje 1 viala
All candidates for treatment with Herzuma, but especially those with prior anthracycline and cyclophosphamide (AC) exposure, should undergo baseline cardiac assessment including history and physical examination, electrocardiogram (ECG), echocardiogram, and/or multigated acquisition (MUGA) scan or magnetic resonance imaging.
Vsi kandidati za zdravljenje z zdravilom Herzuma, posebno tisti, ki so se predhodno zdravili z antraciklini in ciklofosfamidom, morajo opraviti osnovni pregled srca, vključno z anamnezo in fizičnim pregledom, elektrokardiogramom (EKG), ehokardiogramom in/ali radioizotopsko ventrikulografijo ali magnetnoresonančnim slikanjem.