natgillin/translations-raw huggingface dataset:
Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in (section 4.4) Warnings and Precautions. 
Podrobnosti o dejavnostih za zmanjšanje tveganja v skladu z evropskim načrtom za obvladovanje tveganja (RMP) so navedene v poglavju Posebna opozorila in previdnostni ukrepi (poglavje 4.4).
In addition, treatment of lower body weight patients with Herceptin subcutaneous fixed dose in adjuvant EBC was not associated with increased safety risk, adverse events and serious adverse events, compared to the higher body weight patients. 
Poleg tega adjuvantno zdravljenje bolnikov z zgodnjim rakom dojk s fiksnim odmerkom subkutane oblike zdravila Herceptin in manjšo telesno maso ni bilo povezano z večjim tveganjem za varnost, večjim številom neželenih učinkov in resnih neželenih učinkov v primerjavi z bolniki z večjo telesno maso.
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 %).
- capecitabine - 1000 mg/m2 orally twice daily for 14 days every 3 weeks for 6 cycles 
kapecitabin - 1000 mg/m2 peroralno dvakrat na dan 14 dni vsake 3 tedne, skupaj 6 ciklov
* Observed with combination therapy following anthracyclines and combined with taxanes 
* Opaženo pri kombinirani uporabi po antraciklinih in sočasno s taksani.
Other side effects can occur at any time during treatment with Herceptin. 
Drugi neželeni učinki se lahko pojavijo kadar koli med zdravljenjem z zdravilom Herceptin.
Table 6 Efficacy Results from Study BO16348 
Rezultati učinkovitosti študije BO16348
Cysts and polyps) 
(vključno s cistami in polipi)
Some of these symptoms can be serious and some patients have died (see the section “Warnings and precautions”). 
Nekateri od teh simptomov so lahko resni in opisani so primeri smrti (glejte poglavje Opozorila in previdnostni ukrepi).
• performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products. 
· Pripravo mora izvesti usposobljeno osebje v aseptičnih pogojih v skladu s pravili dobre prakse,
(95 % CI) 
(95-% IZ)
In patients receiving Herceptin after completion of adjuvant chemotherapy, the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of Herceptin and a body mass index (BMI) >25 kg/m2. 
Pri bolnikih, ki so prejemali zdravilo Herceptin 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 zdravila Herceptin in visokim indeksom telesne mase (body mass index - BMI) > 25 kg/m2.
Serious reactions to intravenous Herceptin have been treated successfully with supportive therapy such as oxygen, beta-agonists, and corticosteroids. 
Resne reakcije po intravensko dajanem zdravilu Herceptin so uspešno zdravili s podpornim zdravljenjem, kot so kisik, beta agonisti in kortikosteroidi.
A volume overage of 4 % ensures that the labelled dose of 150 mg can be withdrawn from each vial. 
Štiri odstoten presežek volumna omogoča, da na nalepki naveden odmerek 150 mg res odvzamemo iz viale.
METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use only. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Le za subkutano uporabo.
Description of selected adverse reactions with the subcutaneous formulation 
Opis izbranih neželenih učinkov pri subkutani obliki
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 0.9 % sodium chloride solution. 
Primerno količino raztopine je potrebno odvzeti iz viale in dodati polivinilkloridni, polietilenski ali polipropilenski infuzijski vrečki, ki vsebuje 250 ml 0,9 % raztopine natrijevega klorida.
The local reactions included erythema, pruritus, oedema, rash and pain at the site of the injection. 
Lokalne reakcije so vključevale eritem, pruritus, edem, izpuščaj in bolečino na mestu injiciranja.
Serious reactions have been treated successfully with supportive therapy such as oxygen, betaagonists, and corticosteroids. 
Resne reakcije so uspešno zdravili s podpornim zdravljenjem, kot so kisik, beta agonisti in kortikosteroidi.
If other medicines for subcutaneous use are used during the treatment course with Herceptin, a different injection site should be used. 
Če med zdravljenjem z zdravilom Herceptin subkutano uporabljate tudi druga zdravila, morate uporabiti drugo mesto injiciranja.
For instructions on use and handling of Herceptin subcutaneous formulation refer to section 6.6. 
Za navodila za pripravo in ravnanje s subkutano obliko zdravila Herceptin glejte poglavje 6.6.
Very rarely, patients with severe breathing difficulties before treatment have died when they were given Herceptin. 
Zelo redko je pri bolnikih, ki so imeli hude težave z dihanjem pred začetkom zdravljenja, pri uporabi zdravila Herceptin prišlo do smrtnih primerov;
carboplatin and trastuzumab; CI = confidence interval 
ki jima sledita docetaksel in trastuzumab; IZ = interval zaupanja
Injury, poisoning and procedural complications 
Poškodbe in zastrupitve in zapleti pri posegih kontuzija
Herceptin in the control arm, the addition of Herceptin to paclitaxel chemotherapy resulted in a 52 % decrease in the risk of disease recurrence. 
Herceptin v kontrolni skupini, je dodatek zdravila Herceptin kemoterapiji s paklitakselom zmanjšal tveganje za ponovitev bolezni za 52 %.
SISH technology is however, recommended to allow for the parallel evaluation of tumor histology and morphology. 
Vendar pa je za paralelno oceno histologije in morfologije tumorja priporočljiva tehnika SISH.
In this trial, 87 % of patients entered had disease that was IHC3+, and 95 % of patients entered had disease that was IHC3+ and/or FISH-positive. 
V tem preskušanju je 87 % vključenih bolnikov imelo bolezen, ki je bila IHC 3+, 95 % vključenih bolnikov pa je imelo bolezen,
• acute accumulation of fluid in the lungs 
· akutno nabiranje tekočine v pljučih
+1 Hypotension 
+1hipotenzija vazodilatacija
If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping Herceptin. 
Če je mogoče, se po prekinitvi zdravljenja z zdravilom Herceptin do 7 mesecev izogibamo zdravljenju z antraciklini.
There are no immunogenicity data available for Herceptin in gastric cancer. 
Za uporabo zdravila Herceptin pri raku želodca ni na voljo podatkov o imunogenosti.
If you experience any of the above symptoms when your treatment with Herceptin has finished, you should see your doctor and tell them that you have previously been treated with Herceptin. 
Če se kateri koli izmed zgornjih simptomov pojavi po končanem zdravljenju z zdravilom Herceptin, obiščite zdravnika in ga obvestite o tem, da ste se zdravili z zdravilom Herceptin.
Herceptin subcutaneous formulation is a ready to use solution which should not be mixed or diluted with other products. 
Zdravilo Herceptin v subkutani obliki je raztopina, ki je pripravljena za uporabo in se je ne sme mešati ali raztapljati z drugimi zdravili.
If you receive Herceptin 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 Herceptin z drugimi zdravili za zdravljenje raka, kot so paklitaksel, docetaksel, zaviralec aromataze, kapecitabin, 5-fluorouracil ali cisplatin, preberite tudi navodila za uporabo teh zdravil.
Lower bound one-sided 97.5% CI for the difference in pCR** *Confidence interval for one sample binomial using Pearson-Clopper method **Continuity correction of Anderson and Hauck (1986) has been used in this calculation 
Neodzivni bolniki točen 95-% interval zaupanja za delež pCR* razlika v pCR (s.c. skupina minus iv. skupina) spodnja meja enostranskega 97,5-% intervala zaupanja za razliko v deležu pCR** *interval zaupanja za binomsko porazdelitev z enim vzorcem po Pearson-Clopperjevi metodi **V računu je bil uporabljena korekcija za kontinuiteto po Andersonu in Haucku (1986)
Cardiac assessments, as performed at baseline, should be repeated every 3 months during treatment and every 6 months following discontinuation of treatment until 24 months from the last administration of Herceptin. 
Preglede srca, enake kot je bil osnovni, je treba med zdravljenjem ponoviti vsake 3 mesece in vsakih 6 mesecev po končanem zdravljenju do 24 mesecev po prejemu zadnjega odmerka zdravila Herceptin.
AC→PH (vs. AC→P) (NSABP B-31 and NCCTG N9831)* 
AC ® PH (v primerjavi z AC ® P) (NSABP B-31 in NCCTG N9831)
The systemic reactions included hypersensitivity, hypotension, tachycardia, cough, and dyspnoea. 
Sistemske reakcije so vključevale preobčutljivost, hipotenzijo, tahikardijo, kašelj in dispnejo.
Patients should be observed for six hours after the first injection and for two hours after subsequent injections for signs or symptoms of administration-related reactions (see sections 4.4 and 4.8). 
Bolniki morajo biti pod nadzorom šest ur po prvem injiciranju zdravila in dve uri po nadaljnjih aplikacijah zaradi možnosti znakov in simptomov reakcij, povezanih z aplikacijo zdravila (glejte poglavji 4.4 in 4.8).
Congestive heart failure (NYHA Class II - IV) is a common adverse reaction associated with the use of Herceptin 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 Herceptin; povezan je bil tudi s smrtnim izidom (glejte poglavje 4.4).
(vs. AC→D) (BCIRG 006) 
DCarbH (v primerjavi z AC ® D) (BCIRG 006)
Median months Overall Response Rate, % 34.5 % 47.3 % 1.70a (1.22, 2.38) 0.0017 
34,5 % 47,3 % 1,70a (1,22;
Risk factors for a cardiac event identified in four large adjuvant studies included advanced age (> 50 years), low LVEF (<55%) at baseline, prior to or following the initiation of paclitaxel treatment, decline in LVEF by 10-15 points, and prior or concurrent use of anti-hypertensive medicinal products. 
Dejavniki tveganja za pojav neželenega učinka, povezanega s srcem, ki so jih opazili v štirih velikih adjuvantnih študijah, so vključevali starost nad 50 let, majhno osnovno vrednost LVEF (< 55 %), majhno vrednost LVEF pred začetkom zdravljenja s paklitakselom ali po njem, upad LVEF za 10 do 15 točk in predhodno ali sočasno uporabo zdravil za zniževanje krvnega tlaka.
Fertility There is no fertility data available. 
Plodnost Podatkov o vplivu na plodnost ni.
The incidence of symptomatic cardiac dysfunction was 1.7% in the Herceptin arm . 
Pogostnost simptomatske motnje v delovanju srca je bila v skupini, ki je prejemala zdravilo Herceptin, 1,7 %.
After aseptic reconstitution with sterile water for injection, chemical and physical stability of the reconstituted solution has been demonstrated for 48 hours at 2°C - 8°C. 
Po aseptični rekonstituciji s sterilno vodo za injekcije je kemijska in fizikalna stabilnost rekonstituirane raztopine dokazana za 48 ur pri temperaturi od 2 °C-8 °C.
• 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
No reductions in the dose of Herceptin were made during clinical trials. 
Med kliničnimi preskušanji niso zmanjševali odmerka zdravila Herceptin.
As animal reproduction studies are not always predictive of human response, Herceptin should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus. 
Izsledki študij o vplivu na sposobnost za razmnoževanje pri živalih ne veljajo vedno tudi za ljudi, zato se moramo uporabi zdravila Herceptin med nosečnostjo izogibati, razen v primerih, ko pričakovana korist za mater upravičuje tveganje za plod.
The efficacy results from the BCIRG 006 are summarized in Tables 8 and 9. 
Rezultati učinkovitosti iz preskušanja BCIRG 006 so povzeti v preglednicah 8 in 9.
If left ventricular ejection fraction (LVEF) percentage drops ≥ 10 points from baseline AND to below 
Če odstotek iztisnega deleža levega prekata (LVEF) pade za ≥ 10 točk od začetne vrednosti IN pod
Instructions for aseptic reconstitution: 
Navodila za aseptično rekonstitucijo
Patients who receive anthracyclines after stopping Herceptin may possibly be at increased risk of cardiac dysfunction. 
Pri bolnikih, ki prejemajo antracikline po prenehanju zdravljenja z zdravilom Herceptin, lahko obstaja večje tveganje za motnje v delovanju srca.
This dose should be administered subcutaneously over 2-5 minutes every three weeks. 
Odmerek je treba dati subkutano v 2 do 5 minutah vsake tri tedne.
If you receive Herceptin in combination with chemotherapy, some of them may also be due to the chemotherapy. 
Če prejemate skupaj z zdravilom Herceptin tudi kemoterapijo, so lahko nekateri neželeni učinki nastali tudi zaradi kemoterapije.
In the final population PK model, in addition to primary tumor type, body-weight, serum aspartate aminotransferase and albumin were identified as a statistically significant covariates affecting the exposure of trastuzumab. 
V končnem populacijskem farmakokinetičnem modelu so bile kot statistično pomembne sospremenljivke, ki vplivajo na izpostavljenost trastuzumabu, poleg vrste primarnega tumorja opredeljene tudi telesna masa, serumska aspartat-aminotransferaza in albumin.
If patients have a continued decrease in left ventricular function, but remain asymptomatic, the physician should consider discontinuing therapy if no clinical benefit of Herceptin therapy has been seen. 
Pri bolnikih s kontinuiranim upadanjem funkcije levega prekata, ki ostajajo asimptomatični, naj zdravnik razmisli o ukinitvi zdravljenja z zdravilom Herceptin, če klinična korist ni bila opazna.
Herceptin should not be mixed or diluted with other products. 
Zdravila Herceptin ne smemo mešati ali redčiti z drugimi zdravili.
Switching treatment between Herceptin intravenous and Herceptin subcutaneous formulation and vice versa 
Prehod z zdravljenja z zdravilom Herceptin v intravenski obliki na subkutano obliko in obratno
What Herceptin looks like and contents of the pack 
Izgled zdravila Herceptin in vsebina pakiranja
Study MO28048 investigating the safety and tolerability of Herceptin subcutaneous formulation as adjuvant therapy in HER2 positive EBC patients who were enrolled in either a Herceptin subcutaneous vial cohort (N=1868 patients, including 20 patients receiving neoadjuvant therapy) or a Herceptin subcutaneous administration system cohort (N=710 patients, including 21 patients receiving neoadjuvant therapy) resulted in no new safety signals. 
V študiji MO28048, v kateri so ocenjevali varnost in prenosljivost subkutane oblike zdravila Herceptin pri adjuvantnem zdravljenju bolnikov s HER2-pozitivnim zgodnjim rakom dojk, ki so bili vključeni v skupino, ki je prejemala subkutano obliko zdravila Herceptin v viali (n = 1868 bolnikov, vključno z 20, ki so prejemali neoadjuvantno zdravljenje), ali v skupino, ki je prejemala subkutano obliko zdravila Herceptin v aplikacijskem sistemu (n = 710 bolnikov, vključno z 21, ki so prejemali neoadjuvantno zdravljenje), niso odkrili novih varnostnih signalov.
These events may occur as part of an infusion-related reaction or with a delayed onset. 
Lahko se pojavijo v okviru infuzijskih reakcij ali zapoznelo.
Patients assigned to receive Herceptin were given an initial loading dose of 8 mg/kg, followed by 6 mg/kg every three weeks for either one or two years. 
Bolniki, ki so bili določeni za prejemanje zdravila Herceptin, so prejeli začetni uvajalni odmerek 8 mg/kg telesne mase, nato pa so prejemali eno ali dve leti 6 mg/kg telesne mase vsake tri tedne.
The efficacy results from study BO16348 following 12 months* and 8 years** median follow-up are summarized in the Table 5: 
Rezultati učinkovitosti študije BO16348 po medianem času spremljanja 12 mesecev* in 8 let** so povzeti v preglednici 5.
Your doctor may prescribe Herceptin for the treatment of breast cancer when: 
Vaš zdravnik vam lahko zdravilo Herceptin predpiše za zdravljenje raka dojk, če:
From a microbiological point of view, the reconstituted solution and Herceptin infusion solution should be used immediately. 
Z mikrobiološkega stališča je treba pripravljeno raztopino zdravila Herceptin za infundiranje uporabiti takoj.
So far, no results are available which compare the efficacy of Herceptin administered with chemotherapy in the adjuvant setting with that obtained in the neo-adjuvant/adjuvant setting. 
Trenutno še ni na voljo rezultatov, ki bi primerjali učinkovitost zdravila Herceptin, danega skupaj s kemoterapijo pri adjuvantnem zdravljenju, z učinkovitostjo pri neoadjuvantnem/adjuvantnem zdravljenju.
They can be treated with an analgesic/antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine. 
Lahko se zdravijo z analgetikom/antipiretikom, kot je meperidin ali paracetamol, ali antihistaminikom, kot je difenhidramin.
Causing excessive foaming during reconstitution or shaking the reconstituted Herceptin may result in problems with the amount of Herceptin that can be withdrawn from the vial. 
Povzročitev pretiranega penjenja med rekonstitucijo ali tresenje že pripravljene raztopine zdravila Herceptin lahko povzroči težave s količino zdravila Herceptin, ki ga odvzamemo iz viale.
Herceptin contains the active substance trastuzumab, which is a monoclonal antibody. 
Zdravilo Herceptin vsebuje učinkovino trastuzumab, ki je monoklonsko protitelo.
In addition, caution should be exercised in treating patients with increased cardiac risk, e.g. hypertension, documented coronary artery disease, CHF, LVEF of <55%, older age. 
Previdnost je potrebna tudi pri zdravljenju bolnikov s povečanim srčnim tveganjem, npr. hipertenzijo, dokumentirano koronarno arterijsko boleznijo, kongestivnim srčnim popuščanjem, LVEF
The efficacy results from Study MO16432 are summarized in Table 11. 
Rezultati učinkovitosti študije MO16432 so povzeti v preglednici 11.
In the joint analysis of the NSABP B-31 and NCCTG N9831 studies, EBC was limited to women with operable breast cancer at high risk, defined as HER2-positive and axillary lymph node positive or HER2 positive and lymph node negative with high risk features (tumor size > 1 cm and ER negative or tumor size > 2 cm, regardless of hormonal status). 
V skupni analizi preskušanj NSABP B-31 in NCCTG N9831 je bil zgodnji rak dojk omejen na ženske z operabilnim rakom dojk z visokim tveganjem, opredeljenim kot pozitivna oblika HER2 s pozitivnimi aksilarnimi bezgavkami ali pozitivna oblika HER2 z negativnimi bezgavkami z dejavniki visokega tveganja (velikost tumorja > 1 cm in negativni estrogenski receptorji ali velikost tumorja > 2 cm neodvisno od hormonskega statusa).
Breast inflammation/mastitis 
Motnje reprodukcije in dojk vnetje dojk/mastitis
No incompatibilities between Herceptin and polyvinylchloride, polyethylene or polypropylene bags have been observed. 
Med zdravilom Herceptin in polivinilkloridnimi, polietilenskimi ali polipropilenskimi vrečkami inkompatibilnosti niso opazili.
• you are allergic to trastuzumab (the active substance of Herceptin), murine (mouse) proteins, or any of the other ingredients of this medicine (listed in section 6). 
· ste alergični na trastuzumab (učinkovino zdravila Herceptin), murine (mišje) beljakovine ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
• dry eyes 
· suhe oči
Your doctor may prescribe Herceptin for the treatment of breast and gastric cancer when: 
Vaš zdravnik vam lahko zdravilo Herceptin predpiše za zdravljenje raka dojk in raka želodca, če:
Patients should be observed for ARRs for six hours after the first injection and for two hours after subsequent injections. 
Bolnike je treba zaradi pojava reakcij, povezanih z aplikacijo, opazovati šest ur po prvem injiciranju in dve uri po nadaljnjih injiciranjih.
Patients with history of myocardial infarction (MI), angina pectoris requiring medical treatment, history of or existing CHF (NYHA Class II -IV), LVEF of < 55%, other cardiomyopathy, cardiac arrhythmia requiring medical treatment, clinically significant cardiac valvular disease, poorly controlled hypertension (hypertension controlled by standard medical treatment eligible), and hemodynamic effective pericardial effusion were excluded from adjuvant and neoadjuvant EBC pivotal trials with Herceptin and therefore treatment cannot be recommended in such patients. 
Bolniki z anamnezo miokardnega infarkta, angino pektoris, ki jo je treba zdraviti, anamnezo kongestivnega srčnega popuščanja ali prisotnim kongestivnim srčnim popuščanjem (NYHA razred IIIV), LVEF < 55 %, drugimi kardiomiopatijami, srčno aritmijo, ki jo je treba zdraviti, klinično pomembno boleznijo srčnih zaklopk, slabo uravnano hipertenzijo (hipertenzijo, ki bi bila primerno nadzorovana s standardnim zdravljenjem) in hemodinamsko efektivno perikardialno efuzijo niso bili vključeni v adjuvantna in neoadjuvantna ključna preskušanja zgodnjega raka dojk z zdravilom Herceptin.
The efficacy results from Study MO16432 are summarized in Table 12. 
Rezultati učinkovitosti študije MO16432 so povzeti v preglednici 12.
Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. 
Zdravilo Herceptin je v kombinaciji s kapecitabinom ali 5-fluorouracilom in cisplatinom indicirano za zdravljenje odraslih bolnikov s HER2-pozitivnim metastatskim adenokarcinomom želodca ali gastroezofagealnega prehoda, ki še niso prejemali zdravil za zdravljenje raka za metastatsko bolezen.
Immune system disorders Hypersensitivity 
Bolezni imunskega sistema preobčutljivost
• You have metastatic breast cancer (breast cancer that has spread beyond the original tumour) with high levels of HER2. 
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.
Clinically significant interactions between Herceptin and the concomitant medicinal products used in clinical trials have not been observed. 
V kliničnih preskušanjih niso opazili klinično pomembnega medsebojnega delovanja med zdravilom Herceptin in zdravili, ki so jih bolniki jemali sočasno.
The safety profile of Herceptin subcutaneous formulation (evaluated in 298 and 297 patients treated with the intravenous and subcutaneous formulations respectively) from the pivotal trial in EBC was overall similar to the known safety profile of the intravenous formulation. 
Varnostni profil subkutane oblike zdravila Herceptin (ocenjen s podatki 298 bolnikov, zdravljenih z intravensko obliko, in 297 bolnikov, zdravljenih s subkutano obliko zdravila Herceptin) v ključnem preskušanju pri zgodnjem raku dojk je bil celokupno podoben znanemu varnostnemu profilu intravenske oblike.
Median TTP (months) (95 %CI) 
Mediana TTP (meseci) (95-% IZ)
Herceptin intravenous infusion should be administered by a healthcare provider prepared to manage anaphylaxis and an emergency kit should be available. 
Intravensko infuzijo zdravila Herceptin mora dajati zdravstveno osebje, usposobljeno za ukrepanje ob anafilaksiji; na voljo mora biti oprema za urgentno ukrepanje.
In the pivotal metastatic trials of intravenous Herceptin, the incidence of cardiac dysfunction varied between 9 % and 12 % when it was combined with paclitaxel compared with 1 % - 4 % for paclitaxel alone. 
V ključnih preskušanjih z intravensko danim zdravilom Herceptin pri metastatski bolezni je bila incidenca motenj v delovanju srca pri bolnikih, ki so zdravilo prejemali sočasno s paklitakselom, v razponu od 9 do 12 % v primerjavi z 1 do 4 % pri samostojnem jemanju paklitaksela.