natgillin/translations-raw huggingface dataset:
The infusion can be associated with allergic reactions, so the patient should be monitored during and after the infusion.
Infundiranje zdravila lahko sproži alergijsko reakcijo, zato je treba bolnico med infundiranjem in po njem nadzorovati.
For metastatic cancer, Herceptin is given every week or every three weeks, and the treatment is continued for as long as it remains effective.
Pri metastatskem raku se zdravilo Herceptin odmerja tedensko ali vsake tri tedne, zdravljenje pa poteka, dokler je učinkovito.
For early cancer, Herceptin is given every three weeks for a year or until it stops being effective.
Pri zgodnjem raku se zdravilo Herceptin odmerja vsake tri tedne eno leto oziroma, dokler je učinkovito.
Herceptin can also be given weekly when used in combination with other anticancer medicines.
Prav tako se lahko zdravilo Hercpetin odmerja tedensko, kadar ga uporabljamo v kombinaciji z drugimi zdravili proti raku.
For full details, see the Summary of Product Characteristics (also part of the EPAR).
Za podrobne podatke o odmerjanju glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki prepozna in se veže na posebno strukturo (imenovano antigen) na površini nekaterih celic v telesu.
Trastuzumab has been designed to bind to 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Trastuzumab se veže na HER2, tj. receptor za 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
HER2, a receptor for epidermal growth factor, which is found on the surface of certain tumour cells.
Reproduction is authorised provided the source is acknowledged. epidermalni rastni dejavnik, ki se nahaja na površini nekaterih tumorskih celic.
By binding to the receptor, trastuzumab activates certain cells of the immune system (the body ’ s natural defences), which then kill the tumour cells.
Z vezavo na receptor učinkovina trastuzumab aktivira določene celice imunskega sistema (naravna obramba telesa), ki nato uničijo tumorske celice.
Trastuzumab also prevents HER2 from breaking, which otherwise leads to a signal for the tumour cells to grow.
Trastuzumab prav tako prepreči razpad HER2, ki bi sicer sprožil znak za rast tumorja.
About a quarter of breast cancers express large amounts of HER2.
Približno četrtina rakov dojk izraža veliko količino HER2.
All studies of Herceptin have been in cancers that express HER2.
Vse študije zdravila Herceptin so bile opravljene na rakih, ki izražajo HER2.
In metastatic breast cancer, Herceptin given once a week has been studied in four main studies.
Pri metastatskem raku dojk je bilo zdravilo Herceptin, ki se daje enkrat tedensko, raziskano v štirih glavnih študijah.
These studies measured how many patients responded to treatment.
V eni študiji so raziskovali samostojno uporabo zdravila Herceptin pri 222 bolnicah, pri katerih druge predhodne kemoterapije niso bile uspešne, drugi dve pa sta raziskovali uporabo zdravila Herceptin v kombinaciji z dvema drugima zdraviloma proti raku (s paklitakselom pri 469 bolnicah; z docetakselom pri 188 bolnicah).
The fourth study compared the combination of Herceptin and anastrozole (an aromatase inhibitor) with anastrozole alone in 208 patients.
V četrti študiji so zdravilo Herceptin v kombinaciji z anastrozolom (inhibitor aromataze) primerjali z zdravljenjem z anastrazolom samim pri 208 bolnicah.
The main measure of effectiveness was the ‘ median progression-free survival’ (the length of time until 50% of the patients had experienced a worsening of their disease or had died).
Glavno merilo učinkovitosti je bil „ srednji čas preživetja brez napredovanja bolezni “ (čas, v katerem se je pri 50% bolnic stanje bolezni poslabšalo ali pa so umrle).
Four additional studies looked at the response to Herceptin given once every three weeks, either on its own (two studies in a total of 177 patients), in combination with paclitaxel (in 32 patients) or in combination with docetaxel, with or without capecitabine (another anticancer medicine) in 225 patients.
Štiri dodatne študije so raziskovale odziv na zdravilo Herceptin, ki se daje enkrat na tri tedne, bodisi samostojno (dve študiji na skupno 177 bolnicah), v kombinaciji s paklitakselom (32 bolnic) ali pa v kombinaciji z docetakselom s kapecitabinom ali brez njega (drugim zdravilom proti raku) pri 225 bolnicah.
In early breast cancer, Herceptin has been studied over one to two years in one main study that involved over 3,000 patients who had been first treated with surgery, chemotherapy or radiotherapy.
Pri zgodnjem raku dojke so zdravilo Herceptin v obdobju enega do dveh let preskušali z eno glavno študijo, v katero je bilo vključenih 3000 bolnic, ki so bile najprej operirane ali zdravljene s kemoterapijo ali radioterapijo (študija HERA, ki še poteka).
Half of the patients received Herceptin, while the other half did not receive it.
Polovica bolnic je prejemala zdravilo Herceptin, druga polovica pa ne.
The study measured the time until the cancer re-appeared anywhere in the body.
Študija je merila čas do vnovičnega pojava raka kjer koli v telesu.
In metastatic breast cancer, the first study showed that 15% of the patients who had failed on other types of chemotherapy responded to Herceptin.
Pri metastatskem raku dojk je prva študija pokazala, da se je 15% bolnic, pri katerih druge vrste zdravljenja s kemoterapijo niso bile uspešne, odzvalo na zdravilo Herceptin.
When Herceptin was used in addition to paclitaxel, the response rate was 48%, compared with 17% for paclitaxel on its own.
Kjer so zdravilo Herceptin uporabljali skupaj z zdravilom paklitaksel, je bil odziv 48% (v primerjavi s 17% pri samostojni uporabi zdravila paklitaksel).
With docetaxel, 61% of the patients responded, compared with 34% for docetaxel on its own.
Pri zdravilu docetaksel se je odzvalo 61% bolnic v primerjavi s 34% pri samostojni uporabi zdravila docetaksel.
When Herceptin was used in combination with anastrozole, the median progression-free survival was 4.8 months, compared with 2.4 months in the patients taking anastrozole on its own.
Kadar je bilo zdravilo Herceptin uporabljeno v kombinaciji z anastrozolom, je bil srednji čas preživetja brez napredovanja bolezni 4, 8 meseca, v primerjavi z 2, 4 meseca pri bolnicah, ki so prejemale samo anastrozol.
The additional studies showed that the effectiveness of three-weekly Herceptin was similar to that seen in studies of once-weekly Herceptin.
Dodatne študije so pokazale, da je učinkovitost uporabe zdravila Herceptin, ki se daje enkrat na tri tedne, enaka učinkovitosti pri tedenskem dajanju zdravila Herceptin.
8% of the patients who received Herceptin experienced a re-appearance of their cancer (127 out of 1,693), compared with 13% of the patients who did not receive it (219 out of 1,693).
Pri študiji zgodnjega raka dojk je tveganje za ponovni pojav raka v prvem letu zmanjšano za približno polovico: med potekom študije se je rak ponovno pojavil pri 8% bolnic, ki so prejemale zdravilo Herceptin (127 od 1693), v primerjavi s 13% bolnic, ki zdravila niso prejemale (219 od 1693).
Herceptin can cause cardiotoxicity (harm to the heart), including heart failure.
Zdravilo Herceptin lahko povzroči kardiotoksičnost (poškoduje srce), vključno s srčnim popuščanjem.
Care should be taken if it is given to patients who already have heart problems, and all patients need to be monitored during treatment to check their heart.
Posebna skrb je potrebna, kadar ga uporabljajo bolnice, ki že imajo težave s srcem, pri vseh bolnicah pa je treba med zdravljenjem srce nadzorovati.
The most common side effects with Herceptin (seen in more than 1 patient in 10) are abdominal (tummy) pain, asthenia (weakness), chest pain, chills, fever, headache, pain, diarrhoea, nausea (feeling sick), vomiting, arthralgia (joint pain), myalgia (muscle pain) and skin rashes.
Najpogostejši neželeni učinki (opaženi pri več kot 1 bolnici od 10) so bolečine v trebuhu, astenija (oslabelost), bolečine v prsnem košu, mrzlica, povišana telesna temperatura, glavobol, bolečina, driska, navzeja (slabost), bruhanje, artralgija (bolečine v sklepih), mialgija (bolečine v mišicah) in kožni izpuščaji.
For the full list of all side effects reported with Herceptin, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Herceptin, glejte navodilo za uporabo.
Herceptin should not be used in people who are hypersensitive (allergic) to trastuzumab or to any of the other ingredients.
Zdravila Herceptin ne smejo jemati osebe, ki so preobčutljive za (alergične na) trastuzumab ali na katero koli drugo sestavino zdravila.
It should also not be used in patients who have serious breathing problems when they are at rest because of their cancer, or who need oxygen therapy.
Prav tako ga ne smejo jemati bolnice, ki imajo zaradi raka v mirovanju velike težave z dihanjem ali potrebujejo zdravljenje s kisikom.
The Committee for Medicinal Products for Human Use (CHMP) decided that Herceptin’ s benefits are greater than its risks for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and patients with HER2 positive early breast cancer.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Herceptin pri zdravljenju bolnic z metastatskim rakom, katerih tumorji imajo čezmerno izražen HER2, in bolnic z zgodnjo obliko HER2 pozitivnega raka dojk večje od z njim povezanih tveganj.
The Committee recommended that Herceptin be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Herceptin odobri dovoljenje za promet.
2/ 3 Other information about Herceptin:
2/ 3 Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Herceptin?
The European Commission granted a marketing authorisation valid throughout the European Union for Herceptin to Roche Registration Limited on 28 August 2000.
Evropska komisija je dovoljenje za promet z zdravilom Herceptin, veljavno po vsej Evropski uniji, odobrila družbi Roche Registration Limited dne 28. avgusta 2000.
The marketing authorisation was renewed on 28 August 2005.
Dovoljenje za promet je bilo podaljšano 28. avgusta 2005.
The full EPAR for Herceptin can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Herceptin je na voljo tukaj.
Herceptin 150 mg Powder for concentrate for solution for infusion
Herceptin 150 mg prašek za koncentrat za raztopino za infundiranje
1 vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody manufactured from a mammalian cell line (Chinese hamster ovary, CHO) by continuous perfusion.
Ena viala vsebuje 150 mg trastuzumaba, humaniziranega IgG1 monoklonskega protitelesa, izoliranega iz celične kulture sesalcev (CHO - jajčnika kitajskega hrčka) s kontinuirano perfuzijo.
Reconstituted Herceptin solution contains 21 mg/ ml of trastuzumab.
Pripravljena raztopina zdravila Herceptin vsebuje 21 mg/ ml trastuzumaba.
Herceptin is a white to pale yellow lyophilised powder.
Zdravilo Herceptin je bel do rahlo rumen liofiliziran prašek.
Metastatic Breast Cancer (MBC)
Metastatski rak dojk
Herceptin is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2:
Zdravilo Herceptin je indicirano za zdravljenje bolnikov z metastatsko obliko raka dojk, katerih tumorji imajo čezmerno izražen HER2:
a) as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease.
a) kot monoterapija za zdravljenje tistih bolnikov, ki so predhodno za svojo metastatsko bolezen že prejemali najmanj dve liniji kemoterapije.
Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
Bolniki s hormonsko odvisnimi tumorji, pri katerih je bolezen napredovala po predhodnem hormonskem zdravljenju, razen če bolniki za takšno zdravljenje niso bili primerni.
b) in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.
b) v kombinaciji s paklitakselom za zdravljenje tistih bolnikov, ki še niso prejemali kemoterapije za metastatsko bolezen in za katere antraciklini niso primerni.
c) in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
c) v kombinaciji z docetakselom za zdravljenje tistih bolnikov, ki še niso prejemali kemoterapije za metastatsko bolezen.
d) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer, not previously treated with trastuzumab.
d) v kombinaciji z zaviralcem aromataze za zdravljenje bolnic v postmenopavzi z metastatsko obliko raka dojk s pozitivnimi hormonskimi receptorji, ki predhodno niso bile zdravljene z trastuzumabom.
Early Breast Cancer (EBC)
Zgodnji rak dojk
Herceptin is indicated for the treatment of patients with HER2 positive early breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see 5.1).
Zdravilo Herceptin je indicirano za zdravljenje bolnikov z zgodnjo obliko HER2 pozitivnega raka dojk po operaciji, kemoterapiji (neoadjuvantni ali adjuvantni) in radioterapiji (če je primerno) (glejte poglavje 5. 1).
Herceptin should only be used in patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see 4.4 and 5.1).
Zdravilo Herceptin se uporablja le za bolnike, katerih tumorji imajo ali čezmerno izražen HER2 ali amplifikacijo gena HER2, določeno s točno in validirano metodo (glejte poglavji 4. 4 in 5. 1).
2 4.2 Posology and method of administration
2 4. 2 Odmerjanje in način uporabe
HER2 testing is mandatory prior to initiation of Herceptin therapy (see 4.4 and 5.1).
Pred pričetkom zdravljenja z zdravilom Herceptin je potrebno testiranje na HER2 (glejte poglavji 4. 4 in 5. 1).
Herceptin treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy (see 4.4).
Zdravljenje z zdravilom Herceptin mora vpeljati zdravnik z izkušnjami s citotoksično kemoterapijo (glejte poglavje 4. 4).
MBC Weekly schedule:
Tedenski režim pri metastatskem raku dojk:
The following loading and subsequent doses are recommended for monotherapy and in combination with paclitaxel, docetaxel or an aromatase inhibitor.
Za monoterapijo in kombinacijo s paklitakselom, docetakselom ali zaviralcem aromataze so priporočeni uvajalni in nadaljnji odmerki naslednji:
Loading dose The recommended initial loading dose of Herceptin is 4 mg/ kg body weight.
Uvajalni odmerek Priporočen uvajalni odmerek zdravila Herceptin je 4 mg/ kg telesne mase.
Subsequent doses The recommended weekly dose of Herceptin is 2 mg/ kg body weight, beginning one week after the loading dose.
Nadaljnji odmerki Priporočen tedenski odmerek zdravila Herceptin je 2 mg/ kg telesne mase, z začetkom en teden po uvajalnem odmerku.
Method of administration Herceptin is administered as a 90-minute intravenous infusion.
Način uporabe Zdravilo Herceptin se daje kot 90 minutna intravenska infuzija.
Patients should be observed for at least six hours after the start of the first infusion and for two hours after the start of the subsequent infusions for symptoms like fever and chills or other infusion-related symptoms (see 4.4 and 4.8).
Bolniki morajo biti pod nadzorom vsaj šest ur po začetku prve infuzije in dve uri po začetku nadaljnjih infuzij zaradi nevarnosti pojava simptomov, kot so zvišana telesna temperatura, mrzlica in drugi simptomi, povezani z infuzijo (glejte poglavji 4. 4 in 4. 8).
Interruption of the infusion may help control such symptoms.
Prekinitev infuzije nam lahko pomaga pri nadzoru teh simptomov.
If the initial loading dose was well tolerated, the subsequent doses can be administered as a 30-minute infusion.
Če bolniki uvajalni odmerek dobro prenašajo, lahko naslednje odmerke damo v 30 minutni infuziji.
Emergency equipment must be available.
Oprema za oživljanje mora biti na razpolago.
Administration in combination with Paclitaxel or docetaxel In the pivotal trials, paclitaxel or docetaxel was administered the day following the first dose of Herceptin (for dose, see the Summary of Product Characteristics for paclitaxel or docetaxel) and immediately after the subsequent doses of Herceptin if the preceding dose of Herceptin was well tolerated.
Odmerjanje v kombinaciji s paklitakselom ali docetakselom V ključnih študijah so paklitaksel ali docetaksel dali en dan po uvajalnem odmerku zdravila Herceptin (za odmerek glejte Povzetek glavnih značilnosti za paklitaksel ali docetaksel) in takoj po nadaljnjih odmerkih zdravila Herceptin, če je bolnik predhoden odmerek zdravila Herceptin dobro prenašal.
Administration in combination with an aromatase inhibitor In the pivotal trial Herceptin and anastrozole were administered from day 1.
Odmerjanje v kombinaciji z zaviralcem aromataze V ključni študiji so zdravilo Herceptin in anastrozol dajali od 1. dne dalje.
There were no restrictions on the relative timing of Herceptin and anastrozole at administration (for dose, see the Summary of Product Characteristics for anastrozole or other aromatase inhibitors).
Časovnih omejitev glede dajanja zdravila Herceptin in anastrozola ni bilo (za odmerjanje glejte Povzetek glavnih značilnosti za anastrozol ali druge zaviralce aromataz).
Duration of treatment Herceptin should be administered until progression of disease.
Trajanje zdravljenja Zdravilo Herceptin dajemo dokler bolezen ne napreduje.
MBC 3-weekly schedule:
3- tedenski režim pri metastatskem raku dojk:
Alternatively the following loading and subsequent doses are recommended for monotherapy and in combination with paclitaxel, docetaxel or an aromatase inhibitor.
Za monoterapijo in kombinacijo s paklitakselom, docetakselom ali zaviralcem aromataze so priporočeni tudi naslednji uvajalni in nadaljnji odmerki:
Initial loading dose of 8 mg/ kg body weight, followed by 6 mg/ kg body weight 3 weeks later and then 6 mg/ kg repeated at 3-weekly intervals administered as infusions over approximately 90 minutes.
Začetni uvajalni odmerek je 8 mg/ kg telesne mase, po 3 tednih sledi 6 mg/ kg telesne mase in nato 6 mg/ kg telesne mase v tritedenskih razmakih kot 90 minutna infuzija.
EBC 3-weekly schedule:
3- tedenski režim pri zgodnjem raku dojk:
In the HERA trial, Herceptin was initiated after completions of standard chemotherapy (most commonly, anthracycline-containing regimens or anthracyclines plus a taxane).
V kliničnem preskušanju HERA so zdravilo Herceptin uvedli po zaključku standardne kemoterapije (najpogosteje po kemoterapiji, ki je vključevala antraciklinski ali antraciklinski in taksanski derivat).
3 Initial loading dose of 8 mg/ kg body weight, followed by 6 mg/ kg body weight 3 weeks later and then 6 mg/ kg repeated at 3-weekly intervals administered as infusions over approximately 90 minutes.
Uvajalni odmerek je 8 mg/ kg telesne mase, po 3 tednih sledi 6 mg/ kg telesne mase in nato 6 mg/ kg
Patients with early breast cancer should be treated for 1 year or until disease recurrence.
Bolnike z zgodnjo obliko raka je potrebno zdraviti 1 leto ali do ponovitve bolezni.
EBC weekly schedule:
Tedenski režim pri zgodnjem raku dojk:
In the adjuvant setting, Herceptin has also been investigated as a weekly regimen (an initial loading dose of 4 mg/ kg followed by 2 mg/ kg every week for one year) concomitantly with paclitaxel (administered weekly (80 mg/ m2) or every 3 weeks (175 mg/ m2) for a total of 12 weeks) following 4 cycles of AC (doxorubicin 60 mg/ m2 IV push concurrently with cyclophosphamide 600 mg/ m2 over 20– 30 minutes).
Pri adjuvantnem zdravljenju so proučevali tudi tedensko dajanje zdravila Herceptin (uvajalni odmerek 4 mg/ kg telesne mase, nato 2 mg/ kg telesne mase vsak teden eno leto) skupaj s paklitakselom (danim tedensko (80 mg/ m2) ali vsake tri tedne (175 mg/ m2) skupno 12 tednov) po 4 ciklih antraciklina in ciklofosfamida (doksorubicin 60 mg/ m2 v obliki hitre intravenske infuzije in ciklofosfamid 600 mg/ m2 v 20−30 minutah).
MBC and EBC:
Metastatski in zgodnji rak dojk:
For instructions for use and handling refer to 6.6.
Za navodila za pripravo in ravnanje z zdravilom glejte poglavje 6. 6.
Dose reduction No reductions in the dose of Herceptin were made during clinical trials.
Zmanjšanje odmerka V kliničnih preskušanjih odmerkov zdravila Herceptin niso nikoli zmanjševali.
Patients may continue Herceptin therapy during periods of reversible, chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time.
Bolniki lahko nadaljujejo zdravljenje z zdravilom Herceptin tudi med obdobji reverzibilne mielosupresije, ki je posledica kemoterapije, vendar pa jih je v tem času treba skrbno spremljati zaradi zapletov nevtropenije.
Refer to the Summary of Product Characteristics for paclitaxel, docetaxel or aromatase inhibitor for information on dose reduction or delays.
Za zmanjšanje odmerka ali odlog dajanja, glejte Povzetek glavnih značilnosti za paklitaksel, docetaksel ali zaviralec aromataze.
Missed doses during 3-weekly schedule If the patient misses a dose of Herceptin by one week or less, then the usual dose of Herceptin (6 mg/ kg) should be given as soon as possible (do not wait until the next planned cycle).
Izpuščeni odmerki med 3- tedenskim režimom Če je bil pri bolniku izpuščen odmerek zdravila Herceptin za en teden ali manj, mu je treba običajni odmerek zdravila Herceptin (6 mg/ kg telesne mase) dati čimprej (ne čakati do naslednjega planiranega cikla).
Subsequent maintenance Herceptin doses of 6 mg/ kg should then be given every 3 weeks, according to the previous schedule.
Nadaljnje vzdrževalne odmerke zdravila Herceptin po 6 mg/ kg telesne mase dajemo vsake tri tedne glede na prejšnji režim.
If the patient misses a dose of Herceptin by more than one week, a re-loading dose of Herceptin should be given (8 mg/ kg over approximately 90 minutes).
Če je bil pri bolniku izpuščen odmerek zdravila Herceptin za več kot en teden, mu je treba ponovno dati uvajalni odmerek zdravila Herceptin (8 mg/ kg telesne mase v približno 90 minutah).
Subsequent maintenance Herceptin doses of 6 mg/ kg should then be given every 3 weeks from that point.
Nadaljnje vzdrževalne odmerke zdravila Herceptin po 6 mg/ kg telesne mase dajemo vsake tri tedne od tega odmerka dalje.
Special patient populations Clinical data show that the disposition of Herceptin is not altered based on age or serum creatinine (see 5.2).
Posebne skupine bolnikov Klinični podati kažejo, da se razpoložljivost zdravila Herceptin ne spreminja s starostjo ali serumskim kreatininom (glejte poglavje 5. 2).
In clinical trials, elderly patients did not receive reduced doses of Herceptin.
V kliničnih preskušanjih starejši bolniki niso prejemali zmanjšanih odmerkov zdravila Herceptin.
Dedicated pharmacokinetic studies in the elderly and those with renal or hepatic impairment have not been carried out.
Podrobnejše farmakokinetične študije pri starejših in tistih z ledvično ali jetrno okvaro, niso bile opravljene.
However in a population pharmacokinetic analysis, age and renal impairment were not shown to affect trastuzumab disposition.
Farmakokinetične analize skupin niso pokazale vplivov starosti in ledvične okvare na razpoložljivost trastuzumaba.
Paediatric use Herceptin is not recommended for use in children below 18 due to insufficient data on safety and efficacy.
Uporaba pri otrocih Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Herceptin pri otrocih pod 18 leti ni priporočljiva.
Patients with known hypersensitivity to trastuzumab, murine proteins, or to any of the excipients.
Bolniki z znano preobčutljivostjo na trastuzumab, murine beljakovine ali na katerokoli pomožno snov zdravila.
Patients with severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
Bolniki s hudo dispnejo v mirovanju zaradi komplikacij napredovale maligne bolezni ali tisti, ki potrebujejo zdravljenje s kisikom.