FrancophonIA/ELRC3.0 huggingface dataset:
English: The Applicant provided written explanations on 7 April 2008.
Slovenian: Predlagatelj je predložil pisna pojasnila dne 7. aprila 2008.
English: These Member States were not able to reach an agreement and Sweden referred the reasons for disagreement to the EMEA on 27 September 2007.
Slovenian: Te države članice niso uspele doseči soglasja, zato je Švedska dne 27. septembra 2007 njihove razloge za nestrinjanje predložila agenciji EMEA.
English: International Non-Proprietary Name (INN): fentanyl citrate
Slovenian: Mednarodno nelastniško ime (INN): fentanil citrat
English: The Reference Member State was Sweden and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain and United Kingdom.
Slovenian: Referenčna država članica je bila Švedska, zadevne države članice pa so bile Avstralija, Belgija, Ciper, Češka republika, Danska, Estonija, Finska, Francija, Nemčija, Grčija, Madžarska, Islandija, Irska, Italija, Latvija, Litva, Luksemburg, Norveška, Poljska, Portugalska, Slovaška republika, Slovenija, Španija in Združeno kraljestvo.
English: This refers to the bridging strategy of the Applicant and was considered to be a serious public health concern.
Slovenian: To se nanaša na predlagateljevo strategijo za premostitev in se upošteva kot resen zadržek v zvezi z javnim zdravjem.
English: OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR
Slovenian: MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29(4)1 ZA ZDRAVILO
English: A positive opinion was adopted by consensus on 26 June 2008
Slovenian: Odbor je dne 26. junija 2008 soglasno sprejel pozitivno mnenje.
English: Significant difference has been identified with regard to the need for further clinical efficacy and safety data for the evaluation of the benefit/risk and the lack of PK data under normal conditions of use of the product.
Slovenian: Pomembne razlike so bile ugotovljene v zvezi s potrebo po nadaljnjih podatkih o klinični učinkovitosti in varnosti za oceno koristi/tveganj ter s pomanjkanjem podatkov o farmakokinetiki v normalnih okoliščinah uporabe zdravila.
English: During their June 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Rapinyl and associated names, that the objections raised by Germany, France, Norway and United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, Labelling and Package Leaflet of the Reference Member State should be amended.
Slovenian: Med srečanjem junija 2008 je CHMP na podlagi vseh predloženih podatkov in znanstvene razprave v okviru Odbora predstavil svoje mnenje, da je razmerje med koristmi ter tveganji za zdravilo Rapinyl in povezana imena ugodno ter da ugovori, ki so jih podali Nemčija, Francija, Norveška in Združeno kraljestvo, ne smejo preprečiti odobritve dovoljenja za promet z zdravilom, pa tudi da je treba povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo referenčne države članice spremeniti.
English: Rapinyl and associated names, 50µg, 100µg, 200µg, 300µg, 400µg, 600µg, 800µg, sublingual tablets is indicated for the management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.
Slovenian: Zdravilo Rapinyl in povezana imena, 50 µg, 100 µg, 200 µg, 300 µg, 400 µg, 600 µg in 800 µg, v obliki podjezičnih tablet je namenjeno za zdravljenje prebijajoče bolečine pri odraslih bolnikih, katerih kronične bolečine zaradi raka se zdravi z opioidi.
English: ProStrakan Ltd submitted applications for Rapinyl and associated names, 50µg, 100µg, 200µg, 300µg, 400µg, 600µg, 800µg, sublingual tablets.
Slovenian: Družba ProStrakan Ltd. je predložila vloge za zdravilo Rapinyl in povezana imena, 50 µg, 100 µg, 200 µg, 300 µg, 400 µg, 600 µg, 800 µg, v obliki podjezičnih tablet.
English: 22014 Incheon REPUBLIC OF KOREA
Slovenian: 22014 Incheon REPUBLIKA KOREJA
English: Appropriate aseptic technique should be used.
Slovenian: Uporabiti je potrebno ustrezno aseptično tehniko.
English:  Risk Management Plan (RMP)
Slovenian: • Načrt za obvladovanje tveganj (RMP)
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če se zdravilo ne uporabi takoj, so časi in pogoji shranjevanja odgovornost uporabnika.
English: WestEnd Office Building B torony Hungary
Slovenian: WestEnd Office Building B torony Madžarska
English: • Your doctor will advise you of the risks and benefits of taking Herzuma during pregnancy.
Slovenian: • Zdravnik vam bo svetoval glede tveganja in koristi uporabe zdravila Herzuma v času nosečnosti.
English: Herzuma is not recommended for anyone under the age of 18 years.
Slovenian: Zdravilo Herzuma ni priporočljivo za mlajše od 18 let.
English: The patient who missed the dose should not wait until the next planned cycle.
Slovenian: Bolnik, ki izpusti odmerek, naj ne čaka do naslednjega planiranega cikla.
English: Trastuzumab can cause breathing difficulties, especially when it is first given.
Slovenian: Trastuzumab lahko povzroči težave z dihanjem, še zlasti, ko ga prejmete prvič.
English: which was followed by
Slovenian: temu je sledil
English: For intravenous use only
Slovenian: Le za intravensko uporabo
English: The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions.
Slovenian: Zdravilo ni namenjeno shranjevanju po rekonstituciji in razredčitvi, razen če je to potekalo v kontroliranih in validiranih aseptičnih pogojih.
English: Other side effects that have been reported with Herzuma use (frequency cannot be estimated from the available data):
Slovenian: Drugi neželeni učinki, o katerih so poročali v zvezi z uporabo zdravila Herzuma (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
English: Units 2100, 2110, 2120 and 2130 Phase 18, Central Park Bridgend Industrial Estate, Bridgend, CF31 3TY, UNITED KINGDOM
Slovenian: Units 2100, 2110, 2120 and 2130 Phase 18, Central Park Bridgend Industrial Estate Bridgend, CF31 3TY Velika Britanija
English: In this section, the following categories of frequency have been used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: V tem poglavju so neželeni učinki navedeni po pogostnosti na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: For storage conditions after reconstitution of the medicinal product, see section 6.3 and 6.6.
Slovenian: Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavji 6.3 in 6.6.
English: Herzuma should only be given by a doctor or nurse.
Slovenian: Zdravilo Herzuma lahko daje le zdravnik ali medicinska sestra.
English: If diluted aseptically, it may be stored for 24 hours (do not store above 30ºC).
Slovenian: Če je raztopljena v aseptičnih pogojih, jo lahko shranjujemo do 24 ur (ne shranjujte pri temperaturi nad 30 °C).
English: Biotech Services International Limited Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend
Slovenian: Biotec Services International Limited Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend
English: (32 - ne)
Slovenian: (32 - no)
English: This medicinal product must not be diluted with glucose solutions since these cause aggregation of the protein.
Slovenian: Tega zdravila se ne sme redčiti z raztopinami glukoze, ker le-te povzročajo agregacijo beljakovin.
English: Overexpression of HER2 is observed in 20% - 30% of primary breast cancers.
Slovenian: Čezmerno izražanje HER2 so opazili pri 20 % do 30 % primarnega raka dojk.
English: Only patients with a large amount of HER2 will be treated with Herzuma.
Slovenian: Le bolniki z velikim številom HER2 bodo zdravljeni z zdravilom Herzuma.
English: No formal medicinal product interaction studies have been performed.
Slovenian: Formalnih študij medsebojnega delovanja z zdravili niso izvedli.
English: When Herzuma binds to HER2 it stops the growth of such cells and causes them to die.
Slovenian: Ko se zdravilo Herzuma veže na HER2, zaustavi rast teh celic in povzroči njihovo smrt.
English: These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with trastuzumab.
Slovenian: Ta zdravila (ali kateri koli antraciklin) lahko poškodujejo srčno mišico in zvečajo tveganje za nastanek težav s srcem ob uporabi trastuzumaba;
English: Herzuma is not genotoxic.
Slovenian: Zdravilo Herzuma ni genotoksično.
English: Herzuma is given as an intravenous infusion (“drip”) directly into your veins.
Slovenian: Zdravilo Herzuma se daje kot intravenska infuzija (»s kapljanjem«) neposredno v vaše žile.
English: Therefore, these patients should not be treated with Herzuma (see section 4.3).
Slovenian: Zato takih bolnikov ne smemo zdraviti z zdravilom Herzuma (glejte poglavje 4.3).
English:  you have severe breathing problems at rest due to your cancer or if you need oxygen treatment.
Slovenian: • imate hude težave z dihanjem v mirovanju zaradi raka ali če potrebujete zdravljenje s kisikom.
English: 20 Academy -ro 51 beon-gil Yeonsu-gu
Slovenian: CELLTRION INC., 20 Academy-ro 51 beon-gil Yeonsu-gu
English: Bridgend Industrial Estate Bridgend, CF31 3RT United Kingdom
Slovenian: Bridgend Industrial Estate Bridgend, CF31 3RT Velika Britanija
English: FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin a: Odds ratio
Slovenian: FP+H: fluoropirimidin/cisplatin + trastuzumab FP: fluoropirimidin/cisplatin a: razmerje obetov
English: If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Herzuma treatment.
Slovenian: Če bodo pri vas nastopili kakršni koli znaki srčnega popuščanja (to je, da vaše srce ne črpa krvi v zadostni meri), bo zdravnik delovanje vašega srca preveril pogosteje (vsakih šest do osem tednov); lahko prejmete zdravila proti srčnemu popuščanju ali pa boste morda morali prenehati z zdravljenjem z zdravilom Herzuma.
English: However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydro-doxorubicinone, D7D).
Slovenian: Trastuzumab pa lahko zviša celokupno izpostavljenost enemu metabolitu doksorubicina (7-deoksi-13-dihidro-doksorubicinonu, D7D).
English: The European Medicines Agency has waived the obligation to submit the results of studies with trastuzumab in all subsets of the paediatric population for breast and gastric cancer (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij s trastuzumabom za vse podskupine pediatrične populacije pri raku dojk in raku želodca (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: In the pivotal trial (BO16216), trastuzumab and anastrozole were administered from day 1.
Slovenian: V ključni študiji (BO16216) so trastuzumab in anastrozol dajali od 1. dne dalje.
English: Herzuma may affect your ability to drive a car or operate machines.
Slovenian: Zdravilo Herzuma lahko vpliva na vašo sposobnost za vožnjo ali upravljanje strojev.
English: Other side effects can occur at any time during treatment with Herzuma, not just related to an infusion.
Slovenian: Drugi neželeni učinki se lahko pojavijo kadar koli med zdravljenjem z zdravilom Herzuma in niso povezani le z infuzijo.
English:  Periodic safety update reports
Slovenian: • Redno posodobljena poročila o varnosti zdravila
English: Do not stop using this medicine without talking to your doctor first.
Slovenian: Ne prenehajte uporabljati tega zdravila brez posvetovanja s svojim zdravnikom.
English: Use of other reconstitution solvents should be avoided.
Slovenian: Uporaba drugih vehiklov za rekonstitucijo ni dovoljena.
English:  you suffer from breathlessness, especially if you are currently using a taxane.
Slovenian: • težko dihate, še posebno, če se trenutno zdravite s taksani.
English: 1 Year N = 1702***
Slovenian: trastuzumab 1 leto n = 1702***
English: Patients experiencing infusion-related symptoms (see section 4.4) should be advised not to drive and use machines until symptoms abate.
Slovenian: Bolnikom, pri katerih se pojavijo simptomi, povezani z infundiranjem (glejte poglavje 4.4), je treba svetovati, naj ne upravljajo vozil in strojev, dokler ti ne izzvenijo.
English: Placental transfer of trastuzumab during the early (days 20 - 50 of gestation) and late (days 120 - 150 of gestation) foetal development period was observed.
Slovenian: Opazili so prehod trastuzumaba prek placente v zgodnjem obdobju (20. do 50. dan gestacije) in v poznem obdobju (120. do 150. dan gestacije) razvoja ploda.
English: • dry mouth and skin
Slovenian: • suha usta in koža
English: Although the number of cases identified by a search of the safety database and meeting the CairoBishop criteria for diagnosis was low, it is endorsed that a contributing factor of trastuzumab to tumour lysis syndrome (TLS) could not be excluded.
Slovenian: Čeprav je bilo število primerov, ki so jih ugotovili z iskanjem po podatkovni zbirki o varnosti in ki izpolnjujejo Cairo-Bishopova merila za diagnozo, majhno, je potrjeno, da dejavnika, ki ga k sindromu razpada tumorja prispeva trastuzumab, ni mogoče izključiti.
English: (12.3 - ne)
Slovenian: (12,3 - no)
English: Other medicines and Herzuma
Slovenian: Druga zdravila in zdravilo Herzuma
English: Therefore, from the mechanism of action there is evidence that trastuzumab can cause tumour lysis syndrome.
Slovenian: Iz mehanizma delovanja namreč obstajajo dokazi, da trastuzumab lahko povzroči sindrom razpada tumorja.
English: The presence of anti-trastuzumab antibodies had no impact on pharmacokinetics, efficacy (determined by pathological Complete Response [pCR] and event free survival [EFS]) and safety determined by occurrence of administration related reactions (ARRs) of trastuzumab intravenous.
Slovenian: Prisotnost protiteles proti trastuzumabu ni vplivala na farmakokinetiko, učinkovitost (določeno s patološkim popolnim odgovorom [pCR] in preživetjem brez dogodka (Event Free Survival [EFS])) in varnost, določeno s pojavom reakcij, povezanih z aplikacijo trastuzumaba v intravenski obliki.
English: (6.2 - ne)
Slovenian: (6,2 - no)
English: Trastuzumab 1 Year N = 1693
Slovenian: trastuzumab 1 leto n = 1693
English: The dose of Herzuma depends on your body weight.
Slovenian: Odmerek zdravila Herzuma je odvisen od vaše telesne mase.
English: Herzuma loading dose should be administered as a 90-minute intravenous infusion.
Slovenian: Uvajalni odmerek zdravila Herzuma se daje kot 90-minutna intravenska infuzija.
English: The median duration of follow-up in the trastuzumab arm was 3.8 years.
Slovenian: Mediana spremljanja v skupini, ki je prejemala trastuzumab, je bila 3,8 let.
English: For instructions on reconstitution of Herzuma intravenous formulation before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije zdravila Herzuma v intravenski obliki pred dajanjem glejte poglavje 6.6.
English: For intravenous use only after reconstitution and dilution.
Slovenian: Za intravensko uporabo le po rekonstituciji in razredčitvi.
English: Chemo + trastuzumab (n=115)
Slovenian: Kemoterapija + trastuzumab (n = 115)
English: 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
Slovenian: 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.
English: If you stop using Herzuma
Slovenian: Če ste prenehali uporabljati zdravilo Herzuma
English: Store in a refrigerator (2ºC - 8ºC).
Slovenian: Shranjujte v hladilniku (2 °C-8 °C).
English: 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%).
Slovenian: 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 %).
English: *Cmin,ss = Cmin at steady state **Cmax,ss = Cmax at steady state *** time to 90% of steady state
Slovenian: *Cmin, ss = Cmin v stanju dinamičnega ravnovesja **Cmax, ss = Cmax v stanju dinamičnega ravnovesja *** čas do 90 % stanja dinamičnega ravnovesja
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: • abnormal thinking
Slovenian: • nenormalno razmišljanje
English: • feeling weak and unwell
Slovenian: • občutek šibkosti in slabo počutje
English:  you have ever had or are currently using a medicine called doxorubicin or epirubicin (medicines used to treat cancer).
Slovenian: • prejemate ali ste kadar koli prejeli zdravilo, ki se imenuje doksorubicin ali epirubicin (zdravili, ki se uporabljata za zdravljenje raka).
English: • 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).
Slovenian: • 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).
English:  you have early breast cancer, with high levels of a protein called HER2.
Slovenian: • imate zgodnjega raka dojk, pri katerem so izražene velike količine beljakovine, ki se imenuje HER2;
English: t1/2 range from Cmax,ss to Cmin,ss (day)
Slovenian: Obseg t1/2 od Cmax, ss do Cmin, ss (dan)
English: 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.
Slovenian: 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.
English: Date of first authorisation: 9 February 2018 Date of latest renewal:
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 9. februar 2018
English: 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).
Slovenian: Ne uporabljajte zdravila Herzuma, če: • ste alergični na trastuzumab, murine (mišje) beljakovine ali katero koli sestavino tega zdravila
English: Your doctor may prescribe Herzuma for the treatment of breast and gastric cancer when:
Slovenian: Vaš zdravnik vam lahko zdravilo Herzuma predpiše za zdravljenje raka dojk in raka želodca, če:
English: AC→PH (vs. AC→P) (NSABP B-31 and NCCTG N9831)*
Slovenian: AC → PH (v primerjavi z AC → P) (NSABP B-31 in NCCTG N9831)*
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa; oznaka ATC: L01XC03.
English: Patients treated with Herzuma are at increased risk for developing CHF (New York Heart Association [NYHA] Class II - IV) or asymptomatic cardiac dysfunction.
Slovenian: 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.
English:  you have ever had any other treatment for cancer.
Slovenian: • ste se že zdravili zaradi raka.
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8ºC in a refrigerator.
Slovenian: Zdravilo shranjujte v dobro zaprti originalni ovojnini pri temperaturi 2 °C-8 °C, v hladilniku.
English: The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarised in Table 6:
Slovenian: Rezultati učinkovitosti študije BO16348 po medianem času spremljanja 12 mesecev* in 8 let** so povzeti v preglednici 6.
English: 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.
Slovenian: 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.
English: • You should use effective contraception during treatment with Herzuma and for at least 7 months after treatment has ended.
Slovenian: • Med zdravljenjem z zdravilom Herzuma in vsaj še 7 mesecev po zaključku zdravljenja morate uporabljati učinkovito kontracepcijo.
English: No long-term animal studies have been performed to establish the carcinogenic potential of Herzuma, or to determine its effects on fertility in males.
Slovenian: Za ugotovitev kancerogenega potenciala zdravila Herzuma ali učinkov na plodnost pri moških niso opravili nobenih dolgotrajnih študij na živalih.
English: What you need to know before you use Herzuma
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Herzuma
English: The safety of continuation or resumption of Herzuma in patients who experience cardiac dysfunction has not been prospectively studied.
Slovenian: Varnosti nadaljevanja ali ponovnega dajanja zdravila Herzuma pri bolnikih, pri katerih se je pojavila motnja v delovanju srca, niso proučevali prospektivno.
English: During a Herzuma infusion, chills, fever and other flu like symptoms may occur.
Slovenian: Med infuzijo zdravila Herzuma se lahko pojavijo mrzlica, zvišana telesna temperatura in drugi simptomi, podobni gripi.
English: 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.
Slovenian: 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.
English: What Herzuma is and what it is used for
Slovenian: Kaj je zdravilo Herzuma in za kaj ga uporabljamo