natgillin/translations-raw huggingface dataset:
The clinical benefit of dabigatran with regard to stroke and SEE prevention and decreased risk of ICH compared to warfarin is preserved across individual subgroups, e.g. renal impairment, age, concomitant medication use such as anti-platelets or P-gp inhibitors.
Klinički pozitivni učinci dabigatrana, bolja prevencija moždanog udara i SE te smanjeni rizik od ICH u usporedbi s varfarinom, uočeni su u svim podskupinama, primjerice, u onih s oštećenjem bubrega, starije dobi, istodobno liječenih antitrombocitnim lijekovima ili P-gp inhibitorima.
The clinical benefit of YENTREVE compared with placebo has not been demonstrated in women with mild SUI, defined in randomised trials as those with IEF < 14 per week.
Klinička korist lijeka YENTREVE u usporedbi s placebom nije pokazana u žena s blagom SUI, koje su u randomiziranim ispitivanjima definirane kao bolesnice s < 14 UEI na tjedan.
The clinical benefit, as measured by overall survival, was seen in all pre-specified patient subgroups, including those defined by age, sex, performance status, location of primary tumour, number of organs involved and duration of metastatic disease.
Kliničko poboljšanje, mjereno ukupnim preživljenjem, uočeno je u svim unaprijed definiranim podskupinama bolesnika, uključujući i one određene dobi, spolom, sposobnošću za normalan život, sijelom primarnog tumora, brojem zahvaćenih organa i trajanjem metastatske bolesti.
The clinical consequences of the inhibition of the metabolism of bupropion via CYP2B6 enzyme and the consequent changes in the bupropion-hydroxybupropion ratio are currently unknown, but could potentially lead to reduced efficacy of naltrexone / bupropion.
Kliničke posljedice inhibicije metabolizma bupropiona putem enzima CYP2B6 i posljedične promjene u omjeru bupropion-hidroksibupropion trenutno nisu poznate, ali mogu potencijalno dovesti do smanjenja djelotvornosti naltrekson / bupropiona.
The clinical consequences of the lower post-primary and post-booster immune responses observed after the two-dose primary schedule are not known.
Klinički značaj smanjenog imunološkog odgovora nakon primovakcinacije kao i nakon dodatne doze primijećenih nakon rasporeda primarnog cijepljenja s dvije doze nije poznat.
The clinical data are limited and an increased risk of cutaneous reactions in patients with a history of NNRTI-associated cutaneous reactions cannot be excluded.
Klinički podaci su ograničeni te se ne može isključiti povećani rizik kožnih reakcija kod bolesnika koji su prethodno imali slučajeve kožnih reakcija povezanih s nenukleozidnim inhibitorima povratne transkriptaze (NNRTI).
The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6 g/dl or < 3.75 mmol/l) may require higher maintenance doses than those whose initial anaemia is less severe (Hb > 8 g/dl or > 5 mmol/l).
Dostupni klinički podaci pokazuju da bolesnici s vrlo niskim početnim vrijednostima hemoglobina (<6 g/dl ili <3,75 mmol/l) mogu zahtijevati veće doze održavanja nego oni kod kojih je početna anemija manje izražena (Hb >8 g/dl ili >5 mmol/l).
The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6 g/dl or < 3.75 mmol/l) may require higher maintenance doses than those whose initial anaemia is less severe (Hb > 8 g/dl or > 5 mmol/l).
Dostupni klinički podaci pokazuju da bolesnici s vrlo niskim početnim vrijednostima hemoglobina (<6 g/dl ili <3,75 mmol/l) mogu zahtijevati veće doze održavanja nego oni kod kojih je početna anemija manje teška (Hb >8 g/dl ili >5 mmol/l).
The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/dl or < 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or> 4.25 mmol/l).
Dostupni klinički podaci pokazuju da bolesnici čije su početne vrijednosti hemoglobina vrlo niske (<6,8 g/dl ili <4,25 mmol/l), mogu zahtijevati veće doze održavanja u odnosu na bolesnike s višim početnim vrijednostima hemoglobina (> 6,8 g/dl ili 4,25 mmol/l).
The clinical data obtained in patients with Sickle Cell Syndrome have not shown evidence of adverse reactions of hydroxycarbamide on hepatic and renal function.
Klinički podaci prikupljeni od bolesnika sa sindromom anemije srpastih stanica ne ukazuju na nuspojave hidroksikarbamida na funkciju jetre i bubrega.
The clinical data to support the use of Sovaldi in patients with genotype 5 and 6 HCV infection is very limited (see section 5.1).
Klinički podaci koji mogu poduprijeti primjenu Sovaldija u bolesnika s infekcijom HCV-om genotipa 5 i 6 vrlo su ograničeni (vidjeti dio 5.1).
The clinical decision for use of Diacomit in children with SMEI less than 3 years of age needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks (see section 4.2).
Kliničku odluku o uporabi stiripentola u djece sa SMEI, a dobi od 3 godine i mlađe, treba donijeti ponaosob za svakog bolesnika uzimajući u obzir potencijalnu kliničku korist i rizike ( vidjeti dio 4.2).
The clinical decision for use of Diacomit in children with SMEI less than 3 years of age needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks (see section 4.2).
Kliničku odluku o uporabi stiripentola u djece sa SMEI, a dobi od 3 godine i mlađe, treba donijeti ponaosob za svakog bolesnika uzimajući u obzir potencijalnu kliničku korist i rizike (vidjeti dio 4.2).
The clinical decision for use of Diacomit in children with SMEI less than 3 years of age needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks.
Klinička odluka za uporabu Diacomita u djece sa SMEI mlađe od 3 godine mora se donijeti za svakog bolesnika ponaosob i uzimajući u obzir moguće kliničke prednosti i moguće rizike.
The clinical decision for use of stiripentol in pregnancy needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks.
Kliničku odluku o uporabi stiripentola treba donijeti ponaosob za svaku Bolesnicicu uzimajući u obzir potencijalnu kliničku korist i rizike.
The clinical decision for use of stiripentol in pregnancy needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks.
Kliničku odluku o uporabi stiripentola treba donijeti ponaosob za svaku Bolesnicu uzimajući u obzir potencijalnu kliničku korist i rizike.
The clinical effect of
Klinički učinak ove
The clinical effect of the decreased exposure has not been formally assessed but it is likely to be clinically significant.
Klinički učinak smanjene izloženosti nije formalno evaluiran, ali je vjerojatno klinički značajan.
The clinical effect of this dose adjustment has not been adequately
prilagodbe doze nije dostatno
The clinical efficacy and safety of DARZALEX for the treatment of patients with relapsed and refractory multiple myeloma was demonstrated in two open-label studies.
Klinička djelotvornost i sigurnost lijeka DARZALEX u liječenju bolesnika s relapsnim i refraktornim multiplim mijelomom dokazane su u dva otvorena ispitivanja.
The clinical efficacy and safety of Galafold have been evaluated in two Phase 3 pivotal trials and an open-label extension (OLE) trial.
Klinička djelotvornost i sigurnost lijeka Galafold ocijenjene su u dvama pivotalnim ispitivanjima faze 3 te u otvorenom nastavku ispitivanja.
The clinical efficacy and safety of Lonsurf were evaluated in an international, randomised, double- blind, placebo-controlled Phase III study (RECOURSE) in patients with previously treated metastatic colorectal cancer.
Klinička djelotvornost i sigurnost Lonsurfa je ispitivana u internacionalnom, randomiziranom, dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju faze III (RECOURSE) u bolesnika s prethodno liječenim metastatskim kolorektalnim karcinomom.
The clinical efficacy and safety of Lyxumia were evaluated in nine randomised double-blind, placebo-controlled clinical studies including 4,508 patients with type 2 diabetes (2,869 patients randomised to lixisenatide, 47.5% men and 52.5% women, and 517 were ≥65 years of age).
Klinička djelotvornost i sigurnost primjene lijeka Lyxumia procijenjene su u devet randomiziranih, dvostruko slijepih, placebom kontroliranih kliničkih ispitivanja koja su uključila 4508 bolesnika sa šećernom bolešću tipa 2 (2869 bolesnika randomiziranih na liksisenatid, od kojih 47,5% muškaraca i 52,5% žena te 517 u dobi od ≥65 godina).
The clinical efficacy and safety of Lyxumia were evaluated in nine randomised double-blind, placebo-controlled clinical studies including 4,508 patients with type 2 diabetes (2,869 patients randomised to lixisenatide, 47.5% men and 52.5% women, and 517 were ≥65 years of age.
Klinička djelotvornost i sigurnost primjene lijeka Lyxumia procijenjene su u devet randomiziranih, dvostruko slijepih, placebom kontroliranih kliničkih ispitivanja koja su uključila 4508 bolesnika sa šećernom bolešću tipa 2 (2869 bolesnika randomiziranih na liksisenatid, od kojih 47,5% muškaraca i 52,5% žena te 517 u dobi od ≥65 godina).
The clinical efficacy and safety of Stivarga have been evaluated in an international, multi-center, randomized, double-blind, placebo-controlled phase III study (GRID) in patients with gastrointestinal stromal tumors (GIST) previously treated with 2 tyrosine kinase inhibitors (imatinib and sunitinib).
Klinička djelotvornost i sigurnost lijeka Stivarga procijenjene su u međunarodnom, multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III (GRID) u bolesnika s gastrointestinalnim stromalnim tumorima (GIST) koji su prethodno bili liječeni dvama inhibitorima tirozin-kinaze (imatinibom i sunitinibom).
The clinical efficacy and safety of Stivarga have been evaluated in an international, multi-centre, randomised, double-blind, placebo-controlled phase III study (CORRECT) in patients with metastatic colorectal cancer who have progressed after failure of standard therapy.
Klinička djelotvornost i sigurnost lijeka Stivarga procijenjene su u međunarodnom, multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III (CORRECT) u bolesnika s metastatskim KRK-om koji je napredovao nakon neuspjeha standardne terapije.
The clinical efficacy in study AUX-CC- 862 was similar to that reported in studies CORD I and CORD II.
Klinička djelotvornost u ispitivanju AUX-CC-862 bila je slična onoj zabilježenoj u ispitivanjima CORD I i CORD II.
The clinical efficacy of Incruse administered once daily was evaluated in 904 adult patients who received umeclidinium bromide or placebo from two pivotal Phase III clinical studies with a clinical diagnosis of COPD; a 12-week study (AC4115408) and a 24-week study (DB2113373).
Klinička djelotvornost lijeka Incruse primijenjenog jedanput na dan ocijenjena je u dva ključna klinička ispitivanja faze III u 904 odrasla bolesnika s kliničkom dijagnozom KOPB-a koji su primali umeklidinijev bromid ili placebo: jednom 12-tjednom (AC4115408) i jednom 24-tjednom ispitivanju (DB2113373).
The clinical efficacy of maraviroc (in combination with other antiretroviral medicinal products) on plasma HIV RNA levels and CD4+ cell counts have been investigated in two pivotal ongoing, randomized, double blind, multicentre studies (MOTIVATE 1 and MOTIVATE 2, n=1076 ) in patients infected with CCR5 tropic HIV-1 as determined by the Monogram Trofile Assay.
Klinička djelotvornost maraviroka (u kombinaciji s drugim antiretrovirusnim lijekovima) na razinu HIV RNA u plazmi i broj CD4+ stanica ispitivani su u dva pivotalna još uvijek aktivna randomizirana, dvostruko slijepa, multicentrična ispitivanja (MOTIVATE 1 i MOTIVATE 2, n=1076), koja se provode kod bolesnika zaraženih CCR5-tropnim HIV-1 utvrđenim Monogram Trofile testom.
The clinical efficacy of Viramune prolonged-release is based on 48-week data from a randomised, double-blind, double-dummy phase 3 study (VERxVE – study 1100.1486) in treatment-naïve patients and on 24-week data from a randomised, open-label study in patients who transitioned from Viramune immediate-release tablets administered twice daily to Viramune prolonged-release tablets administered once daily (TRANxITION – study 1100.1526).
Klinička djelotvornost Viramunea s produljenim oslobađanjem zasniva se na 48-tjednim podacima iz randomiziranog, dvostruko-slijepog ispitivanja faze 3 na dvostrukom placebu (VERxVE – ispitivanje 1100.1486) o liječenju prethodno neliječenih bolesnika te na 24-tjednim podacima iz randomiziranog, otvorenog ispitivanja na bolesnicima koji su se prebacili s Viramune tableta s trenutnim oslobađanjem dvaput dnevno na Viramune tablete s produljenim oslobađanjem jednom dnevno (TRANxITION – ispitivanje 1100.1526).
The clinical efficacy of Viramune prolonged-release is based on 48-week data from arandomised, double-blind, double-dummy phase 3 study (VERxVE – study 1100.1486) in treatment-naïve patients and on 24-week data from a randomised, open-label study in patients who transitioned from Viramune immediate-release tablets administered twice daily to Viramune prolonged-release tablets administered once daily (TRANxITION – study 1100.1526).
Klinička djelotvornost Viramunea s produljenim oslobađanjem zasniva se na 48-tjednim podacima iz randomiziranog, dvostruko-slijepog ispitivanja faze 3 na dvostrukom placebu (VERxVE – ispitivanje 1100.1486) o liječenju prethodno neliječenih bolesnika te na 24-tjednim podacima iz randomiziranog, otvorenog ispitivanja na bolesnicima koji su se prebacili s Viramune tableta s trenutnim oslobađanjem dvaput dnevno na Viramune tablete s produljenim oslobađanjem jednom dnevno (TRANxITION – ispitivanje 1100.1526).
The clinical evidence for the efficacy and safety of ticagrelor is derived from two phase 3 trials:
Klinički dokazi o djelotvornosti i sigurnosti tikagrelora dobiveni su iz dva klinička ispitivanja faze 3:
The clinical evidence for the efficacy of dabigatran etexilate is derived from the RE-LY study (Randomized Evaluation of Long –term anticoagulant therapy) a multi-centre, multi-national, randomized parallel group study of two blinded doses of dabigatran etexilate (110 mg and 150 mg twice daily) compared to open-label warfarin in patients with atrial fibrillation at moderate to high risk of stroke and SEE.
Klinički dokaz djelotvornosti dabigatraneteksilata potječe iz RE-LY studije (Randomizirana ocjena dugotrajne antikoagualcijske terapije - Randomized Evaluation of Long–term anticoagulant therapy) multicentričnog, multinacionalnog, randomiziranog ispitivanja na paralelnim skupinama, s dvije dvostruko slijepe doze dabigatraneteksilata (110 mg i 150 mg dvaput dnevno) u usporedbi s “otvorenim” varfarinom u bolesnika s fibrilacijom atrija i umjerenim do visokim rizikom od moždanog udara i SE-a.
The clinical evidence for the efficacy of dabigatran etexilate is derived from the RE-LY study (Randomized Evaluation of Long–term anticoagulant therapy) a multi-centre, multi-national, randomized parallel group study of two blinded doses of dabigatran etexilate (110 mg and 150 mg twice daily) compared to open-label warfarin in patients with atrial fibrillation at moderate to high risk of stroke and SEE.
Klinički dokaz djelotvornosti dabigatraneteksilata potječe iz RE-LY studije (Randomizirana ocjena dugotrajne antikoagualcijske terapije - Randomized Evaluation of Long–term anticoagulant therapy) multicentričnog, multinacionalnog, randomiziranog pokusa paralelnih grupa, s dvije dvostruko slijepe doze dabigatraneteksilata (110 mg i 150 mg dvaput dnevno) u usporedbi s “otvorenim” varfarinom u bolesnika s fibrilacijom atrija i umjerenim do visokim rizikom od moždanog udara i SE-a.
The clinical experience in other species is very limited (Lichtheimia spp. n=2, Cunninghamella spp. n=1, Actinomucor elegans n=1).
Kliničko iskustvo s drugim vrstama je vrlo ograničeno (Lichtheimia spp. n=2, Cunninghamella spp. n=1, Actinomucor elegans n=1).
The clinical experience in patients > 75 years is very limited (see section 5.2).
Kliničko iskustvo u bolesnika starijih od 75 godina je vrlo oskudno (vidjeti dio 5.2).
The clinical experience in patients over 75 years of age is limited.
Kliničko iskustvo s bolesnicima starijima od 75 godina je ograničeno.
The clinical experience in patients with moderate renal impairment is very limited and the use of prolonged-release exenatide is not recommended.
Kliničko iskustvo u bolesnika s umjerenim oštećenjem bubrega vrlo je oskudno pa se primjena eksenatida s produljenim oslobađanjem ne preporučuje.
The clinical experience in patients ≥75 years is limited.
Kliničko iskustvo u bolesnika u dobi ≥75 godina je ograničeno.
The clinical experience of MabThera subcutaneous formulation in Non-Hodgkin’s lymphoma is based on data from a phase III clinical trial (SABRINA BO22334) in patients with follicular lymphoma (FL) and a phase Ib dose-finding/dose-confirmation trial (SparkThera BP22333) in patients with FL.
Kliničko iskustvo s primjenom lijeka MabThera u formulaciji za supkutanu primjenu u liječenju ne-Hodgkinova limfoma temelji se na podacima iz kliničkog ispitivanja faze III (SABRINA BO22334) u bolesnika s folikularnim limfomom (FL) te ispitivanja faze Ib namijenjenog utvrđivanju/potvrđivanju doze (SparkThera BP22333) u bolesnika s FL-om.
The clinical implication of these findings has not been demonstrated.
Klinička implikacija ovih rezultata nije demonstrirana.
The clinical implications of such an association are unknown; however, the potential for an increased frequency and severity of efavirenz-associated adverse events cannot be excluded.
Klinički značaj ove povezanosti nije poznat, međutim, ne može se isključiti mogućnost učestalijih i težih nuspojava povezanih s primjenom efavirenza.
The clinical implications of the effects on PRA are not known at the present time.
Trenutno nisu poznate kliničke implikacije u učinku na APR.
The clinical implications of this finding are currently unknown.
Klinička implikacija ovog rezultata trenutno nije poznata.
The clinical manifestations of Gaucher disease can adversely affect quality of life.
Kliničke manifestacije Gaucherove bolesti mogu loše utjecati na kvalitetu života.
The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 12 weeks after the end of treatment.
Klinički ishod liječenja može se procijeniti nakon oporavka liječene kože, otprilike 12 tjedana nakon završetka liječenja.
The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 4-8 weeks after the end of treatment.
Klinički ishod terapije može se procijeniti nakon oporavka liječene kože, otprilike 4 – 8 tjedana nakon završetka liječenja.
The clinical program (AMPLIFY: apixaban versus enoxaparin/warfarin, AMPLIFY-EXT: apixaban versus placebo) was designed to demonstrate the efficacy and safety of apixaban for the treatment of DVT and/or PE (AMPLIFY), and extended therapy for the prevention of recurrent DVT and/or PE following 6 to 12 months of anticoagulant treatment for DVT and/or PE (AMPLIFY-EXT).
Klinički program (AMPLIFY: apiksaban u odnosu na enoksaparin/varfarin, AMPLIFY-EXT: apiksaban u odnosu na placebo) osmišljen je kako bi pokazao djelotvornost i sigurnost apiksabana u liječenju DVT i/ili PE (AMPLIFY) i produženoj terapiji u prevenciji ponavljajućih DVT i/ili PE nakon liječenja antikoagulansom za DVT i/ili PE (AMPLIFY-EXT) u trajanju od 6 do 12 mjeseci.
The clinical programme for Savene (dexrazoxane) included two open, single-arm, multicentre studies.
Klinički program za Savene (deksrazoksan) je uključivao dva otvorena ispitivanja jedne skupine u više centara.
The clinical protection of the pertussis component of Infanrix, against WHO-defined typical pertussis ( 21 days of paroxysmal cough) was demonstrated after 3-dose primary immunisation in the studies tabulated below:
Klinička zaštita komponente pertusis cjepiva Infanrix protiv tipičnog pertusisa prema definiciji SZO ( 21 dan paroksizmalnog kašlja) pokazana je nakon 3-doznog primarnog cijepljenja u ispitivanjima navedenima u sljedećoj tablici:
The clinical relevance of antibodies to mouse protein, if these do indeed arise, is not known.
Klinički značaj protutijela na mišje proteine, u slučaju da se njihova razina doista povisi, nije poznato.
The clinical relevance of HACA formation in MabThera-treated patients is unclear.
Nije jasna klinička važnost stvaranja HACA antitijela u bolesnika liječenih lijekom MabThera.
The clinical relevance of reduced in vitro susceptibility to lopinavir has been examined by assessing the virologic response to lopinavir/ritonavir therapy, with respect to baseline viral genotype and phenotype, in 56 patients previous failing therapy with multiple protease inhibitors.
Klinički značaj smanjene osjetljivosti na lopinavir in vitro određen je procjenom virološkog odgovora na terapiju lopinavirom/ritonavirom u odnosu na početni virusni genotip i fenotip u 56 bolesnika koji prethodno nisu reagirali na terapiju s više inhibitora proteaze.
The clinical relevance of such findings remains, however, not well defined.
Međutim kliničko značenje ovog nalaza nije utvrđeno.
The clinical relevance of the development of anti-rituximab or anti-rHuPH20 antibodies after treatment with MabThera subcutaneous formulation is not known.
Klinički značaj razvoja antitijela na rituksimab ili antitijela na rHuPH20 nakon liječenja formulacijom lijeka MabThera za supkutanu primjenu nije poznat.
The clinical relevance of the haemagglutination inhibition (HI) titre 1:40 in children is unknown.
Klinička važnost titra inhibicije hemaglutinacije (HI) 1:40 u djece nije poznata.
The clinical relevance of the haemagglutination inhibition (HI) titre 1:40 in children is unknown.
Nije poznat klinički značaj hemaglutinacijskog inhibicijskog (HI) titra 1:40 u djece.
The clinical relevance of the haemagglutination inhibition (HI) titre 1:40 in children is unknown.
Nije poznat klinički značaj titra inhibicije hemaglutinacije (HI) 1:40 u djece.
The clinical relevance of the haemagglutination inhibition (HI) titre 1:40 in children is unknown.
Nije poznata klinička važnost hemaglutinacijskog inhibicijskog (HI) titra 1:40 u djece.
The clinical relevance of the skin lesions is not known, however clinical correlates to skin lesions in monkeys have not been observed in human clinical trials of saxagliptin.
Klinički značaj kožnih lezija nije poznat, međutim, klinički korelati kožnim lezijama u majmuna nisu primijećeni u kliničkim ispitivanjima saksagliptina u ljudi.
The clinical relevance of the skin lesions is not known, however clinical correlates to skin lesions in monkeys have not been observed in human clinical trials of saxagliptin.
Klinički značaj kožnih lezija nije poznat, no u kliničkim ispitivanjima saksagliptina u ljudi nisu opaženi klinički korelati kožnih lezija u majmuna.
The clinical relevance of the theoretical risk of tumour cell mobilisation is not fully elucidated.
Klinički značaj teorijskog rizika mobilizacije tumorskih stanica nije u potpunosti razjašnjen.
The clinical relevance of the waning of hSBA antibody titres against group A is unknown.
Klinička važnost opadanja titra protutijela protiv grupe A kada se koristi hSBA nije poznata.
The clinical relevance of the waning of hSBA antibody titres against group A is unknown.
Klinička važnost opadanja titra protutijela protiva grupe A kada se koristi hSBA nije poznata.
The clinical relevance of these antibodies is not known; nevertheless the pharmacokinetics, efficacy (determined by pathological Complete Response [pCR]) and safety determined by occurrence of administration related reactions (ARRs) of Herceptin intravenous and Herceptin subcutaneous did not appear to be adversely affected by these antibodies.
Klinički značaj tih protutijela nije poznat; međutim, ta protutijela naizgled nisu negativno utjecala na farmakokinetiku, djelotvornost (određenu potpunim patološkim odgovorom [engl. pathological complete response, pCR]) niti sigurnost (određenu na temelju nastupa reakcija povezanih s primjenom lijeka) lijeka Herceptin za intravensku primjenu niti lijeka Herceptin za supkutanu primjenu.