FrancophonIA/ELRC3.0 huggingface dataset:
English: Injection site reactions (e.g. erythema, induration/swelling, pain/tenderness); fever  38 °C, irritability, crying, drowsiness, restless sleep.
Slovenian: Splošne težave in spremembe na mestu aplikacije: reakcije na mestu injiciranja (n. pr. eritem, zatrdlina/oteklina, bolečina/občutljivost), telesna temperatura  38 °C, razdražljivost, jok,
English: Prevenar suspension for injection in pre-filled syringe Pneumococcal saccharide conjugated vaccine, adsorbed
Slovenian: Prevenar suspenzija za injiciranje v napolnjeni injekcijski brizgi konjugirano pnevmokokno saharidno cepivo, adsorbirano
English: For children from 2 years through 5 years of age, a single dose immunisation schedule was used.
Slovenian: Otroci v starosti od 2 do 5 let so bili imunizirani z enim samim odmerkom.
English: 1 or 10 vials without syringe/needles.
Slovenian: 1 ali 10 vial brez brizg in brez igel.
English: OUTER CARTON TEXT - 10 pre-filled syringes pack with separate needle
Slovenian: BESEDILO NA ŠKATLI - 10 napolnjenih injekcijskih brizg z ločeno iglo
English: Infants aged 2 - 6 months: the primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
Slovenian: Dojenčki od 2. do 6. meseca starosti: primarno zaporedje za dojenčke sestavljajo trije odmerki po 0,5 ml; prvi odmerek damo običajno pri 2 mesecih starosti; med naslednjima odmerkoma mora biti najmanj enomesečni presledek.
English: Tympanostomy tube placement was reduced by 24 % (95 % CI: 12, 35) in the per-protocol analysis and by 23 % (95 % CI: 11, 34) in the intent-to-treat analysis.
Slovenian: Vstavitev timpanične cevke se je zmanjšala za 24 % (95-odstotni interval zaupanja: 12, 35) pri otrocih, ki so opravili vsa cepljenja skladno s protokolom cepljenja, in za 23 % (95-odstotni interval zaupanja: 11, 34) pri otrocih, ki so jih cepili.
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born  28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Slovenian: Pri dajanju odmerkov primarne imunizacije veliko prezgodaj rojenim nedonošenčkom (rojenim pred ali v 28. tednu nosečnosti), še posebno tistim z respiratorno nezrelostjo v anamnezi, je treba upoštevati možnost pojava apneje in potrebo po 48-urnem do 72-urnem spremljanju pljučnega delovanja.
English: In the Kaiser Permanente trial, efficacy was 87.5 % (95 % CI: 7, 99) against bacteraemic pneumonia due to vaccine serotypes of S. pneumoniae.
Slovenian: V študiji Kaiser Permanente je bila učinkovitost v preprečevanju pnevmokokne pljučnice, ki jo spremlja bakteriemija, proti serotipom bakterije S. pneumoniae, ki so bili vključeni v cepivo, 87,5 %
English: The estimate of vaccine serotype specific efficacy was 94 % (95 % CI: 81, 99) in the intent-to-treat population and 97 % (95 % CI: 85, 100) in the per protocol (fully immunized) population (40 cases).
Slovenian: Ocena serotipično specifične učinkovitosti cepiva je bila 94 % (95odstotni interval zaupanja: 81, 99) v skupini otrok, ki naj bi jih cepili (intent-to-treat), in 97 % (95-odstotni interval zaupanja: 85, 100) v skupini otrok, ki so opravili vsa cepljenja skladno s protokolom cepljenja (40 primerov).
English: Multipack presentation of 5 packs of 10 pre-filled syringes without needles.
Slovenian: Pakiranje s 5 seti s po 10 napolnjenimi injekcijskimi brizgami brez igel.
English: Reactogenicity was higher in children receiving whole cell pertussis vaccines concurrently.
Slovenian: Reakcije po cepljenju so bile izrazitejše pri otrocih, ki so istočasno prejeli tudi cepivo proti oslovskemu kašlju, ki je vsebovalo celotne celice.
English: However, the overall benefit was a 34 % (95 % CI: 21, 45) reduction in the incidence of all pneumococcal AOM.
Slovenian: V celoti gledano je bilo pri cepljenih otrocih statistično za 34 % (95-odstotni interval zaupanja: 21, 45) manj akutnega vnetja srednjega ušesa, povzročenega s pnevmokoki.
English: The effect of the vaccine in the per-protocol analysis was a 9 % reduction (95 % CI: 3, 15) in recurrent AOM (defined as 3 episodes in six months or 4 episodes in one year) or a 23 % (95 % CI: 7, 36) reduction for recurrent AOM (5 episodes in six months or 6 episodes in one year).
Slovenian: Pri otrocih, ki so opravili vsa cepljenja skladno s protokolom cepljenja, se je ponovno akutno vnetje srednjega ušesa (ki je bilo definirano kot 3 izbruhi v pol leta ali 4 izbruhi v enem letu) zmanjšalo za 9 % (95-odstotni interval zaupanja: 3, 15), ponovno akutno vnetje srednjega ušesa (definirano kot 5 izbruhov v pol leta ali 6 izbruhov v enem letu) pa za 23 % (95-odstotni interval zaupanja: 7, 36).
English: OUTER CARTON TEXT - 1 pre-filled syringe pack with separate needle
Slovenian: BESEDILO NA ŠKATLI - 1 napolnjena injekcijska brizga z ločeno iglo
English: The vaccine is a suspension for injection and provided in a single-dose pre-filled syringe (0.5 ml).
Slovenian: Prevenar je cepivo v obliki suspenzije za injiciranje; v vsaki napolnjeni injekcijski brizgi je en odmerek (0,5 ml).
English: The primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
Slovenian: Primarno zaporedje za dojenčke sestavljajo trije odmerki po 0,5 ml; prvi odmerek običajno pri 2 mesecih, med ostalima odmerkoma mora biti najmanj enomesečni presledek.
English: Typically, your child should receive an initial course of three injections followed by a booster dose
Slovenian: Običajno Običajno bo otrok med osnovnim cepljenjem prejel tri odmerke cepiva, temu bo sledil obnovitveni odmerek.
English: OUTER CARTON TEXT - 10 pre-filled syringes pack without needle
Slovenian: BESEDILO NA ŠKATLI - 10 napolnjenih injekcijskih brizg brez igle
English: OUTER CARTON TEXT - 1 vial pack with syringe/needles
Slovenian: BESEDILO NA ŠKATLI - pakiranje z 1 vialo z brizgo/iglama
English: Component of a multipack comprising 5 packs, each containing 10 single-dose (0.5 ml) pre-filled syringes
Slovenian: suspenzija za injiciranje v napolnjeni injekcijski brizgi Zavitek s 5 zavitki, od katerih vsak vsebuje 10 enoodmernih (0,5 ml) napolnjenih injekcijskih brizg
English: OUTER CARTON TEXT- 10 vials pack
Slovenian: BESEDILO NA ŠKATLI - pakiranje po 10 vial
English: Pneumococcal polysaccharide serotype 14*
Slovenian: En odmerek po 0,5 ml vsebuje: pnevmokokni polisaharid serotip 4*
English: Prophylactic antipyretic medication is recommended: - for all children receiving Prevenar simultaneously with vaccines containing whole cell pertussis because of higher rate of febrile reactions (see section 4.8).
Slovenian: Profilaktično dajanje zdravil proti zvišani telesni temperaturi je priporočljivo: - pri vseh otrocih, ki so prejeli Prevenar in so bili istočasno cepljeni tudi s cepivom proti oslovskemu kašlju, ki vsebuje celotne celice, zaradi pogostih vročinskih reakcij (glejte poglavje
English: PRE-FILLED SYRINGE LABEL
Slovenian: BESEDILO NA NAPOLNJENI INJEKCIJSKI BRIZGI
English: 6.1 List of excipients
Slovenian: 5.3 Predklinični podatki o varnosti
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION
Slovenian: A. IZDELOVALEC BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
English: Infants aged 7 - 11 months: two doses, each of 0.5 ml, with an interval of at least 1 month between doses.
Slovenian: Dojenčki, stari od 7 do 11 mesecev: dva odmerka po 0,5 ml; presledek med njima mora bit najmanj 1 mesec.
English: Limited results from open label studies showed an acceptable response to MMR and varicella.
Slovenian: Omejene izkušnje iz odprtih študij kažejo na primeren imunski odgovor na cepivo MMR (mumps, ošpice, rdečke) in cepivo proti noricam.
English: As otitis media is caused by many organisms other than pneumococcal serotypes represented in the vaccine, protection against all otitis media is expected to be
Slovenian: Ker vnetje srednjega ušesa poleg pnevmokoknih serotipov, zastopanih v cepivu, povzročajo še številni drugi mikroorganizmi, pričakujemo, da bo zaščita pred vnetjem srednjega ušesa glede na vse
English: OUTER CARTON TEXT - 1 pre-filled syringe pack without needle
Slovenian: BESEDILO NA ŠKATLI - 1 napolnjena injekcijska brizga brez igle
English: Significant increases in antibody (measured by ELISA) to all vaccine serotypes were seen after administration of single doses of Prevenar to children aged 2 to 5 years.
Slovenian: Po dajanju posameznih odmerkov cepiva Prevenar otrokom, starim 2 do 5 let, so ugotovili znaten porast protiteles (izmerjen z ELISA) proti vsem v cepivo vključenim serotipom.
English: Apnoea in very premature infants ( 28 weeks of gestation) (see section 4.4).
Slovenian: Apneja pri veliko prezgodaj rojenih nedonošenčkih (rojenih pred ali v 28. tednu nosečnosti) (glejte
English: Pack sizes of 1 and 10 vials without syringe/needles.
Slovenian: Pakiranji s po 1 vialo in s po 10 vialami brez brizge/igel.
English: Children aged 12 - 23 months: two doses, each of 0.5 ml, with an interval of at least 2 months between doses.
Slovenian: Mali otroci, stari od 12 do 23 mesecev: dva odmerka po 0,5 ml; med obema odmerkoma mora biti vsaj dvomesečni interval.
English: Prophylactic antipyretic medication is recommended: - for all children receiving Prevenar simultaneously with vaccines containing whole cell pertussis because of higher rate of febrile reactions - for children with seizure disorders or with a prior history of febrile seizures.
Slovenian: Profilaktično dajanje zdravil proti zvišani temperaturi je priporočljivo: - pri otrocih, ki istočasno prejmejo cepivo Prevenar in cepivo proti oslovskemu kašlju, ki vsebuje celotne celice, ker se pri njih pogosteje pojavi zvišana telesna temperatura.
English: Prophylactic antipyretic medication is recommended: - for all children receiving Prevenar simultaneously with vaccines containing whole cell pertussis because
Slovenian: Profilaktično dajanje zdravil proti zvišani telesni temperaturi je priporočljivo: - pri otrocih, ki istočasno prejmejo cepivo Prevenar in cepivo proti oslovskemu kašlju, ki vsebuje celotne celice, ker se pri njih pogosteje pojavi zvišana telesna temperatura.
English: Adverse reactions reported in clinical trials or from the post-marketing experience are listed in the following table per system organ class and per frequency and this is for all age groups.
Slovenian: Navedeni so po skupinah organskih sistemov in po pogostnosti in vključujejo otroke vseh starostnih skupin.
English: Children aged 12 - 23 months: two doses, each of 0.5 ml, with an interval of at least 2 months between
Slovenian: Otroci, stari od 12 do 23 mesecev: dva odmerka po 0,5 ml; presledek med odmerkoma naj bo najmanj
English: DATE OF REVISION OF THE TEXT
Slovenian: BESEDILO NA VIALI
English: Injection site swelling/induration and erythema >2.4 cm, tenderness interfering
Slovenian: • rdečina, oteklina ali zatrdlina na mestu injiciranja, večja od 2,4 cm; bolečina na mestu injiciranja, ki ovira gibljivost okončine
English: 10 single-dose (0.5 ml) pre-filled syringes with separate needle.
Slovenian: suspenzija za injiciranje v napolnjeni injekcijski brizgi 10 enoodmernih (0,5 ml) napolnjenih injekcijskih brizg z ločeno iglo
English: 1 single-dose (0.5 ml) pre-filled syringe with separate needle.
Slovenian: suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 enoodmerna (0,5 ml) napolnjena injekcijska brizga z ločeno iglo
English: Multipack comprising 5 packs, each containing 10 single-dose (0.5 ml) pre-filled syringes without needle.
Slovenian: suspenzija za injiciranje v napolnjeni injekcijski brizgi 10 enoodmernih (0,5 ml) napolnjenih injekcijskih brizg brez igle
English: There are no data available to indicate whether the administration of 23-valent pneumococcal polysaccharide vaccine to unprimed children or to children primed with Prevenar might result in hyporesponsiveness to further doses of
Slovenian: Ni podatkov, ki bi kazali, ali uporaba 23-valentnega pnevmokoknega polisaharidnega cepiva pri otrocih,
English: 13 January 2012
Slovenian: 13. januar 2012
English: The final opinion was converted into a Decision by the European Commission on 13 January 2012.
Slovenian: Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 13. januarja 2012.
English: The Committee adopted a positive opinion on 13 October 2011.
Slovenian: Odbor je 13. oktobra 2011 sprejel pozitivno mnenje.
English: The referral procedure started on 6 April 2011.
Slovenian: Napotitveni postopek se je začel 6. aprila 2011.
English: Opinion following an Article 35
Slovenian: Mnenje v zvezi z napotitvijo iz člena 35
English: The Committee appointed Dr Karolina Törneke as rapporteur and Dr Claire Chauvin as co-rapporteur.
Slovenian: Odbor je za poročevalko določil dr. Karolino Törneke, za soporočevalko pa dr. Claire Chauvin.
English: International non-proprietary names (inn): ceftiofur and cefquinome
Slovenian: Mednarodna nelastniška imena (INN): ceftiofur in cefkvinom
English: Written explanations were provided by the applicants/marketing authorisation holders on 22 August 2011.
Slovenian: Predlagatelji/imetniki dovoljenja za promet z zdravilom so 22. avgusta 2011 podali pisne obrazložitve.
English: and to address the risk associated with potential misuse in poultry and the need for specific measures, in particular the need for warning sentences in the product information.
Slovenian: in za obravnavo tveganj, povezanih z možno zlorabo pri reji perutnine, in potrebe po posebnih ukrepih, zlasti potrebe po opozorilnih stavkih v navodilu za uporabo.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended summary of product characteristics and package leaflet in the Annex III.
Slovenian: Seznam imen zadevnih zdravil je v Prilogi I. Znanstveni zaključki so v Prilogi II skupaj s spremenjenim povzetkom glavnih značilnosti zdravila in navodilom za uporabo, ki sta v Prilogi III.
English: Veterinary Medicines and Product Data Management
Slovenian: Zdravila za uporabo v veterinarski medicini in upravljanje s podatki o zdravilu
English: Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the overall benefit-risk balance for these products remains positive subject to the recommended changes of the product information and that variations are necessary to the terms of the marketing authorisation for all veterinary medicinal products containing systemically administered (parenteral and
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov, ki sta jo pripravili poročevalki, je CVMP menil, da ostaja splošno razmerje med koristmi in tveganji za ta zdravila pozitivno ob upoštevanju priporočenih sprememb navodila za uporabo in da so potrebne spremembe pogojev dovoljenja za promet z zdravilom za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo cefalosporine 3. in 4. generacije za sistemsko (parenteralno in peroralno) uporabo, ki so namenjeni uporabi pri živalskih vrstah za proizvodnjo živil.
English: On 17 March 2011, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC, regarding all veterinary medicinal products containing systemically administered (parenteral and oral) 3
Slovenian: Dne 17. marca 2011 je Evropska komisija Agenciji predložila obvestilo o napotitvi v skladu s členom 35 Direktive 2001/82/ES v zvezi z vsemi zdravili za uporabo v veterinarski medicini, ki vsebujejo sistemsko (parenteralno in peroralno) uporabljene cefalosporine 3. in 4. generacije, ki se uporabljajo pri živalskih vrstah za proizvodnjo živil.
English: Article 35 of Directive 2001/82/EC Revised reflection paper on use of 3rd and 4th generation cephalosporins in food producing animals in the EU: development of resistance and impact on human and animal health (EMEA/CVMP/SAGAM/81730/2006-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004307.pdf
Slovenian: th generation cephalosporins in food producing animals in the EU: development of resistance and impact on human and animal health [Revidiran dokument o stališču v zvezi z uporabo cefalosporinov 3. in 4. generacije pri živalskih vrstah za proizvodnjo živil v EU: razvoj odpornosti in vpliv na zdravje ljudi in živali] (EMEA/CVMP/SAGAM/81730/2006-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004307.pdf
English: Opinion following an Article 35 referral for all veterinary medicinal products containing systemically administered (parenteral and oral) 3rd and 4th generation cephalosporins intended for use in food producing species
Slovenian: za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo cefalosporine 3. in 4. generacije za sistemsko (parenteralno in peroralno) uporabo, ki so namenjeni uporabi pri živalskih vrstah za proizvodnjo živil
English: generation cephalosporins in food producing animals in the European Union: development of resistance and impact on human and animal health (EMEA/CVMP/SAGAM/81730/2006-Rev.1)
Slovenian: CVMP je zaprosil za mnenje v zvezi z vključitvijo nasveta o preudarni rabi teh zdravil proti mikrobom v skladu z revidiranim dokumentom o stališču v zvezi z uporabo 3. in 4. generacije cefalosporinov pri živalskih vrstah za proizvodnjo živil v Evropski uniji: razvoj odpornosti in vpliv na zdravje ljudi in živali (EMEA/CVMP/SAGAM/81730/2006-Rev.1)
English: The CVMP was requested to give its opinion regarding the inclusion of prudent use advice for these antimicrobials in line with the revised reflection paper on the use of 3
Slovenian: Revised reflection paper on use of 3
English: oral) 3
Slovenian: rd and 4
English: 200 tablets
Slovenian: 200 tablet
English: Film-coated tablet Oral use bottle (HDPE)
Slovenian: peroralna uporaba plastenka (HDPE)
English: Date of first authorisation: 28 August 2000 Date of latest renewal: 28 August 2010
Slovenian: Datum prve odobritve: 28. avgust 2000 Datum zadnjega podaljšanja: 28. avgust 2010
English: Other side effects were similar.
Slovenian: Drugi neželeni učinki so bili podobni.
English: 1000 New Horizons Way Vacaville, CA 95688 USA
Slovenian: 1000 New Horizons Way Vacaville, CA 95688 ZDA
English: For the comparative safety profile see section 4.8.
Slovenian: Za primerjalni varnostni profil glejte poglavje 4.8.
English: Allow the vial to stand undisturbed for approximately 5 minutes.
Slovenian: Pustite stati vialo pri miru približno pet minut.
English: If not used immediately, preparation should take place in controlled and validated aseptic conditions.
Slovenian: Če ni uporabljeno takoj, mora priprava potekati v kontroliranih in validiranih aseptičnih pogojih.
English: (evening of day 1 to morning of day 15 of each cycle)
Slovenian: (zvečer prvega dne do jutra dneva 15 vsakega cikla)
English: Hyaluronidase is found in most tissues of the human body.
Slovenian: Hialuronidaza je prisotna v večini tkiv v telesu.
English: Primary efficacy analysis
Slovenian: Primarna analiza učinkovitosti
English: Some of the severe events occurred on the day of the injection.
Slovenian: Nekateri od hudih dogodkov so se pojavili na dan injiciranja.
English: There were also more local reactions at the site of injection and more increases in blood pressure.
Slovenian: Več je bilo tudi lokalnih reakcij na mestu injiciranja in več zvišanj krvnega tlaka.
English: The bioactivity of D7D and the clinical impact of the elevation of this metabolite was unclear.
Slovenian: Biološka aktivnost D7D in klinični vpliv zaradi dviga ravni tega metabolita nista bila jasna.
English: The rabbit study was performed to specifically examine local tolerance aspects.
Slovenian: Namen študije pri zajcih je bil specifično proučiti aspekte lokalnega prenašanja.
English: The primary endpoint was overall survival which was defined as the time from the date of randomization to the date of death from any cause.
Slovenian: Primarni končni cilj preskušanja je bilo celokupno preživetje, ki so ga definirali kot čas od dneva randomizacije do dneva smrti iz katerega koli vzroka.
English: D-82377 Penzberg Germany
Slovenian: D-82377 Penzberg
English: Not known
Slovenian: Ni znano,
English: 21 months.
Slovenian: 21 mesecev
English: Malta (See United Kingdom)
Slovenian: Malta (See Ireland)
English: Herceptin is not genotoxic.
Slovenian: Zdravilo Herceptin ni genotoksično.
English: Herceptin can cause breathing difficulties, especially when it is first given.
Slovenian: Zdravilo Herceptin lahko povzroči težave z dihanjem, še zlasti, ko ga prejmete prvič.
English: Periodic Safety Update Reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive
Slovenian: Zahteve glede predložitve rednega posodobljega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: It has been associated with a fatal outcome.
Slovenian: Povezan je bil s smrtnim izidom.
English: • sweating
Slovenian: · znojenje
English: Children and adolescents Herceptin is not recommended for anyone under the age of 18 years.
Slovenian: Uporaba pri otrocih in mladostnikih Zdravilo Herceptin ni priporočljivo za mlajše od 18 let.
English: Non-clinical data for recombinant human hyaluronidase reveal no special hazard for humans based on conventional studies of repeated dose toxicity including safety pharmacology endpoints.
Slovenian: Predklinični podatki o rekombinantni humani hialuronidazi ne kažejo posebnega tveganja za ljudi na osnovi konvencionalnih študij toksičnosti ponavljajočih se odmerkov, vključno z varnostnimi farmakološkimi končnimi točkami.
English: Herceptin should only be given by a doctor or nurse.
Slovenian: Zdravilo Herceptin lahko daje le zdravnik ali medicinska sestra.
English: • Risk Management Plan (RMP)
Slovenian: ZDRAVILA · Načrt za obvladovanje tveganja (RMP)
English: The frequency of occurrence of hypoprothrombinemia is not known.
Slovenian: Pogostnost pojavljanja hipoprotrombinemije ni znana.
English: • swelling or bleeding at the back of the eyes
Slovenian: · otekanje ali krvavitev v ozadju oči
English: Specific percentages for these are not available.
Slovenian: natančnih odstotkih ni podatkov.
English: dihydro-doxorubicinone, D7D).
Slovenian: dihidro-doksorubicinonu, D7D).
English: Do not stop using this medicine without talking to your doctor first.
Slovenian: Ne prenehajte uporabljati tega zdravila brez posvetovanja z zdravnikom.
English: When Herceptin binds to HER2 it stops the growth of such cells and causes them to die.
Slovenian: Ko se zdravilo Herceptin veže na HER2, zaustavi rast teh celic in povzroči njihovo smrt.
English: All doses should be taken at the right time every three weeks.
Slovenian: Vse odmerke morate prejeti v ustreznem času vsake tri tedne.
English: Do not dilute with glucose solutions since these cause aggregation of the protein.
Slovenian: Ne redčite z raztopinami glukoze, ker le-te povzročajo agregacijo beljakovin.
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: It is not known whether Herceptin can affect reproductive capacity.
Slovenian: Ni znano, ali lahko zdravilo Herceptin škodljivo vpliva na sposobnost za razmnoževanje.
English: No. patients with event (%)
Slovenian: Št. bolnikov z dogodkom (%)
English: No grade 4 or grade 5 adverse events were reported.
Slovenian: O neželenih učinkih stopnje 4 ali 5 niso poročali.
English: • allergic reactions
Slovenian: · alergijske reakcije
English: Greater than 70 % of patients enrolled exhibited 3+ overexpression.
Slovenian: Več kot 70 % vključenih bolnikov je izkazovalo čezmerno izražanje stopnje 3+.
English: However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13
Slovenian: Trastuzumab pa lahko zviša celokupno izpostavljenost enemu metabolitu doksorubicina (7-deoksi-13