FrancophonIA/ELRC3.0 huggingface dataset:
English: The Reference Member State was Sweden and in the first wave of the mutual recognition procedure, the concerned Member States which have already granted the marketing authorisation were Germany and Poland.
Slovenian: Referenčna država članica je bila Švedska, Nemčija in Poljska pa sta bili v prvem delu postopka medsebojnega priznavanja zadevni državi članici, ki sta že odobrili dovoljenje za promet z zdravilom.
English: Alendronate HEXAL and associated names, 10 mg tablets, contains alendronic acid as sodium alendronate trihydrate, which is a bisphosphonate indicated in the treatment of post-menopausal osteoporosis.
Slovenian: Zdravilo Alendronat HEXAL in z njim povezana imena, 10 mg tablete, vsebuje alendronsko kislino v obliki natrijevega alendronata trihidrata, ki je bifosfonat indiciran pri zdravljenju pomenopavzalne osteoporoze.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Alendronate HEXAL and associated names International Non-Proprietary Name (INN): alendronic acid (as sodium alendronate trihydrate)
Slovenian: Alendronat HEXAL in z njim povezana imena Mednarodno nelastniško ime (INN): alendronska kislina (kot natrijev alendronat trihidrat)
English: This clinical sign has been reported very rarely from the field.
Slovenian: Zelo redko so o teh kliničnih znakih poročali iz terena.
English: EU/2/09/105/001 EU/2/09/105/002
Slovenian: EU/2/09/105/002
English: ATC vet code: QI02AA08
Slovenian: Oznaka ATC vet: QI02AA08
English: Malta Agrimed Limited
Slovenian: Agrimed Limited
English: 1st injection: from 3 months of age.
Slovenian: 1. injekcija: od 3 meseca starosti.
English: On day 2 after vaccination, rectal temperatures had returned to normal values.
Slovenian: Drugi dan po cepljenju se je rektalna temperatura vrnila na normalno vrednost.
English: Date of last renewal: 07/11/2014
Slovenian: Datum podaljšanja dovoljenjaza promet: 07/11/2014
English: - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports)
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pri več kot 1 živali od 10 živali med enim ciklom zdravljenja) - pogosti (pri več kot 1 a manj kot 10 živali od 100 živali) - občasni (pri več kot 1 a manj kot 10 živali od 1.000 živali) - redki (pri več kot 1 a manj kot 10 živali od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intramuscular use.
Slovenian: NAČIN IN POT(I) UPORABE Za intramuskularno uporabo.
English: Aluminium hydroxide (Al3+)
Slovenian: Aluminijev hidroksid (Al3+)
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals, unless otherwise required.
Slovenian: Cikel rednih posodobljenih poročil o varnosti zdravila (PSUR) se ponovno začne z oddajo šestmesečnih poročil (vključene so vse odobrene oblike zdravila) v obdobju naslednjih dveh let, ki mu sledi oddaja dveh letnih poročil za naslednji dve leti, po tem obdobju pa se poročila oddajajo v triletnih obdobjih, razen če je zahtevano drugače.
English: France Zoetis France
Slovenian: Zoetis France
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box 1 x 20ml / Carton box 1 x 100 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla 1 x 20ml / Kartonska škatla 1 x 100 ml
English: The vaccine can be used during pregnancy.
Slovenian: Cepivo se lahko uporablja v obdobju brejosti.
English: Pharmacotherapeutic group: Inactivated viral vaccines - bluetongue virus vaccine.
Slovenian: Farmakoterapevtska skupina: inaktivirana protivirusna cepiva - cepivo proti virusu modrega jezika.
English: Rue Laid Burniat 1 1348 Louvain-la-Neuve
Slovenian: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIJA
English: Local reactions of more than 2 cm are common after 2 fold overdose while reactions of up to 5 cm may occasionally occur after overdose administration, these resolve within a maximum of 57 days.
Slovenian: Lokalne reakcije po dajanju 2-krat prevelikega odmerka, ki so večje od 2 cm so pogoste, medtem ko se reakcije do 5 cm po prevelikem odmerjanju pojavijo občasno in izginejo najkasneje v 57 dneh.
English: No information is available on the use of the vaccine in animals with maternally derived antibodies however the vaccine has been shown safe and efficacious in seropositive cattle.
Slovenian: Na voljo ni nobenih informacij o uporabi cepiva pri živalih z maternalnimi protitelesi, kljub temu pa se je uporaba cepiva pri seropozitivnih živalih izkazala za varno in učinkovito.
English: Type I glass bottle (10 doses) or type II glass bottle (50 doses) with butyl elastomer closure
Slovenian: 6.5 Vrsta ovojnine in vsebina Viala iz stekla tipa I (10 odmerkov) ali stekla tipa II (50 odmerkov) z zamaškom iz butilnega elastomera Velikost pakiranja
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
English: *(Cycling value (Ct) ≥ 36 by a validated RT- PCR method, indicating no presence of viral genome).
Slovenian: *(Ciklična vrednost (Ct) ≥ 36 pri validirani metodi RT_PCR, kar kaže, da virusni genom ni prisoten) Začetek imunosti: 25 dni po drugem odmerku.
English: To stimulate active immunity against bluetongue virus, serotype 8 in cattle.
Slovenian: Za stimulacijo aktivne imunosti proti virusu modrega jezika, serotip 8, pri govedu.
English: In one laboratory safety study, no adverse reactions were observed after the first injection of a single dose of vaccine to calves.
Slovenian: V eni študiji o varnosti pri teletih ni bilo po prvem dajanju enega odmerka opaziti nobenih neželenih učinkov.
English: Lietuva Oriola Vilnius UAB
Slovenian: Oriola Vilnius UAB
English: Active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus, serotype 8.
Slovenian: Aktivna imunizacija goveda, starejšega od 3 mesecev, za preprečitev* viremije, ki jo povzroča virus modrega jezika, serotip 8.
English: PACKAGE LEAFLET FOR: ZULVAC 8 Bovis suspension for injection for cattle
Slovenian: NAVODILO ZA UPORABO ZULVAC 8 Bovis suspenzija za injiciranje za govedo
English: Italia Zoetis Italia S.r.l.
Slovenian: Zoetis Italia S.r.l.
English: ADVICE ON CORRECT ADMINISTRATION In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used.
Slovenian: NASVET O PRAVILNI UPORABI ZDRAVILA Da se izognete naključni kontaminaciji cepiva med uporabo, je pri večjih pakiranjih priporočljivo uporabljati sistem multiinjekcijskega cepljenja.
English: Special precautions for use in animals: Only use in healthy animals
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih: Cepite samo zdrave živali.
English: Any person intending to manufacture, import, possess, sell, supply and use ZULVAC 8 Bovis must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Slovenian: Vsakdo, ki namerava izdelovati,uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati ZULVAC 8 BOVIS, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom, posedovanjem, prodajo,
English: Österreich Zoetis Österreich GmbH
Slovenian: Deutschland Zoetis Deutschland GmbH
English: The manufacture, import, possession, sale, supply and/or use of ZULVAC 8 BOVIS may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Slovenian: Izdelava,uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba ZULVAC 8 BOVIS je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: PHARMACEUTICAL FORM Off-white or pink suspension for injection
Slovenian: Belkasta do rožnata suspenzija za injiciranje
English: 20 ml (10 doses) 100 ml (50 doses)
Slovenian: VELIKOST PAKIRANJA 20 ml (10 odmerkov) 100 ml (50 odmerkov)
English: PHARMACEUTICAL FORM Suspension for injection.
Slovenian: Suspenzija za injiciranje
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROSTITEV SERIJE
English: After administration of a double dose, a slight and transient but significant increase in the mean rectal temperature of 0.7 ºC was recorded in the vaccinated calves during the first 24 hours.
Slovenian: Po dajanju dvojnega odmerka so pri cepljenih teletih v prvih 24 urah opazili rahlo in prehodno vendar signifikantno povišanje rektalne temperature za 0,7 ºC.
English: Pack of 1 bottle of 10 doses (20 ml).
Slovenian: 1 viala z 10 odmerki (20 ml).
English: Marketing authorisation holder: Zoetis Belgium SA
Slovenian: Imetnik dovoljenja za promet z zdravilom: Zoetis Belgium SA
English: Intramuscular use:
Slovenian: Intramuskularna uporaba
English: Name and address of the manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L.
Slovenian: Ime in naslov izdelovalca(izdelovalcev) zdravila, odgovornega(odgovornih) za sprostitev serije Zoetis Manufacturing & Research Spain, S.L.
English: After the second injection of a single dose, a slight and transient but significant increase in the mean rectal temperature of 0.4ºC was very commonly recorded in the vaccinated calves during the first 24 hours.
Slovenian: Po drugem dajanju enega odmerka so pri cepljenih teletih v prvih 24 urah zelo pogosto opazili rahlo in prehodno vendar signifikantno povišanje rektalne temperature za 0,4 ºC.
English: Pregnancy: Can be used during pregnancy.
Slovenian: Lahko se uporablja v obdobju brejosti.
English: 100 ml (50 doses)
Slovenian: VELIKOST PAKIRANJA 100 ml (50 odmerkov)
English: Active substance: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1
Slovenian: Inaktiviran virus modrega jezika, serotip 8, sev BTV-8/BEL2006/02 RP* ≥ 1
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) One dose of 2 ml: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
Slovenian: En 2 ml odmerek vsebuje: Inaktiviran virus modrega jezika, serotip 8, sev BTV-8/BEL2006/02
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 20 ml (10 odmerkov)
English: Deutschland Zoetis Deutschland GmbH Tel: +49 30 330063 0
Slovenian: Zoetis Österreich GmbH Tel: +43 1 2701100 110
English: Zoetis Finland Oy Tlf: +358 (0)9 4300 40
Slovenian: Tlf: +358 (0)9 4300 40
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml
Slovenian: PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Nalepka na viali 100 ml
English: Each dose of 2 ml of the vaccine contains:
Slovenian: En 2 ml odmerek:
English: Suomi/Finland Zoetis Finland Oy Puh/Tel: +358 (0)9 4300 40
Slovenian: Puh/Tel: +358 (0)9 4300 40
English: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
Slovenian: En 2 ml odmerek: Inaktiviran virus modrega jezika, serotip 8, sev BTV-8/BEL2006/02
English: Ìsland
Slovenian: Eesti
English: • Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
Slovenian: Simptomatsko zdravljenje kroničnih patoloških kognitivnih in nevrosenzoričnih motenj pri starejših osebah (razen Alzheimerjeve bolezni in drugih demenc)
English: • Ancillary treatment of Raynaud's syndrome
Slovenian: Pomožno zdravljenje Raynaudovega sindroma
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Slovenian: Priloga III Spremembe ustreznih poglavij povzetkov glavnih značilnosti zdravila in navodil za uporabo
English: All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Slovenian: Vsa sklicevanja na zgoraj navedene indikacije je treba izbrisati iz preostalih ustreznih poglavij povzetkov glavnih značilnosti zdravila.
English: All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Slovenian: Vsa sklicevanja na zgoraj navedene indikacije je treba izbrisati iz ustreznih poglavij navodil za uporabo.
English: Patients may remain on treatment unless the disease gets worse or unless they no longer tolerate treatment.
Slovenian: Bolniki lahko nadaljujejo z zdravljenjem, razen če se bolezen poslabša ali če zdravljenja ne prenašajo več.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kadcyla on 15.11.2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Kadcyla, veljavno po vsej Evropski uniji, izdala dne 15. novembra 2013.
English: The full EPAR for Kadcyla can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Kadcyla je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Kadcyla.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kadcyla.
English: What measures are being taken to ensure the safe and effective use of Kadcyla?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kadcyla?
English: Other information about Kadcyla
Slovenian: Druge informacije o zdravilu Kadcyla
English: The dose to be given depends on the patient's bodyweight and the infusion is repeated every 3 weeks.
Slovenian: Odmerek, ki ga prejme bolnik, je odvisen od njegove telesne mase, infundiranje pa je treba ponoviti vsake 3 tedne.
English: Kadcyla trastuzumab emtansine
Slovenian: Kadcyla trastuzumab emtanzin
English: In one main study, which involved 991 such patients, those treated with Kadcyla lived on average for 9.6 months without their disease getting worse compared with 6.4 months for patients who were treated with two other anti-cancer medicines, capecitabine and lapatanib.
Slovenian: V eni glavni študiji, v katero je bilo vključenih 991 takih bolnikov, so tisti, ki so bili zdravljeni z zdravilom Kadcyla, v povprečju živeli 9,6 meseca brez poslabšanja bolezni, bolniki, ki so jih zdravili z dvema drugima zdraviloma proti raku, kapecitabinom in lapatanibom, pa 6,4 meseca.
English: A risk management plan has been developed to ensure that Kadcyla is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Kadcyla je bil pripravljen načrt obvladovanja tveganj.
English: What benefits of Kadcyla have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Kadcyla izkazalo v študijah?
English: It attaches to a protein in cells called ‘tubulin', which is important in the formation of the internal ‘skeleton' that cells need to assemble when they divide.
Slovenian: Veže se na beljakovino v celicah, imenovano „tubulin“, ki ima pomembno vlogo pri tvorjenju notranjega „ogrodja“, ki ga morajo celice zgraditi, da se lahko delijo.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kadcyla's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Kadcyla večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: What is Kadcyla and what is it used for?
Slovenian: Kaj je zdravilo Kadcyla in za kaj se uporablja?
English: The most common side effects with Kadcyla (which may affect more than 25% of patients) are nausea (feeling sick), fatigue (tiredness) and headache.
Slovenian: Najpogostejši neželeni učinki zdravila Kadcyla (ki lahko prizadenejo več kot 25 % bolnikov) so navzeja (slabost), utrujenost in glavobol.
English: What are the risks associated with Kadcyla?
Slovenian: Kakšna tveganja so povezana z zdravilom Kadcyla?
English: Because of a potential risk of confusion between Kadcyla and Herceptin due to their similar sounding active substances (trastuzumab emtansine and trastuzumab) the company will provide educational material to all healthcare professionals expected to use Kadcyla or Herceptin to alert them not to use these medicines interchangeably and to inform them of measures they should take to avoid medication errors.
Slovenian: Ker obstaja nevarnost, da bi zaradi podobno zvenečih zdravilnih učinkovin (trastuzumab emtanzin in trastuzumab) zdravilo Kadcyla zamenjali za zdravilo Herceptin, bo družba zagotovila izobraževalno gradivo za vse zdravstvene delavce, ki naj bi uporabljali zdravilo Kadcyla ali Herceptin, da se jih opozori na to, da zdravili med seboj nista zamenljivi, in da se jih seznani z ukrepi, ki jih morajo upoštevati, da preprečijo uporabo napačnega zdravila.
English: Kadcyla can only be used when the cancer has been shown to ‘overexpress HER2': this means that the cancer cell produces on its surface large quantities of a protein which stimulates the growth of the cancer cell and is called HER2 (human epidermal growth factor).
Slovenian: Uporablja se lahko samo, kadar se ugotovi, da rak „čezmerno izraža HER2“: to pomeni, da na površini rakave celice nastajajo velike količine beljakovine, ki spodbuja rast rakave celice, in se imenuje HER2 (humani epidermalni rastni dejavnik).
English: For more information about treatment with Kadcyla, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Kadcyla preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It is used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in adults who previously received trastuzumab and a taxane (type of cancer medicine).
Slovenian: Uporablja se za zdravljenje napredovalega ali metastatskega (ki se je razširil na druge dele telesa) raka dojk pri odraslih, ki so že prejemali trastuzumab in taksan (vrsta zdravila za zdravljenje raka).
English: Why is Kadcyla approved?
Slovenian: Zakaj je bilo zdravilo Kadcyla odobreno?
English: It is not intended to provide practical advice on how to use Kadcyla.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The most common serious side effects are haemorrhage (bleeding), pyrexia (fever), dyspnoea (difficulty breathing), musculoskeletal pain (pain in muscles and bones), thrombocytopenia (low blood platelet counts), abdominal pain (stomach ache), and vomiting.
Slovenian: Najpogostejši resni neželeni učinki so hemoragija (krvavitev), pireksija (povišana telesna temperatura), dispneja (težave z dihanjem), kostno-mišične bolečine (bolečine v mišicah in kosteh), trombocitopenija (nizko število trombocitov), bolečine v trebuhu in bruhanje.
English: In patients who develop allergic reactions or side effects, the treating doctor may have to reduce the dose or stop treatment with Kadcyla.
Slovenian: pri katerih se pojavijo alergijske reakcije ali neželeni učinki, bo lečeči zdravnik morda moral zmanjšati odmerek ali prekiniti zdravljenje z zdravilom Kadcyla.
English: Kadcyla has been shown to significantly delay disease getting worse and to prolong survival in patients with advanced and metastatic breast cancer that expressed HER2 and who were previously treated with trastuzumab and a taxane.
Slovenian: Zdravilo Kadcyla je znatno upočasnilo poslabšanje bolezni in podaljšalo čas preživetja pri bolnikih z napredovalim in metastatskim rakom dojk, ki so imeli izražen HER2 in so že bili zdravljeni s trastuzumabom in taksanom.
English: Patients should be observed during and after the infusion for any infusion-related reactions such as flushing, shivering fits and fever.
Slovenian: Bolnike je treba med infundiranjem in po njem opazovati zaradi morebitnih reakcij, povezanih z infundiranjem, kot so na primer rdečica, napadi mrazenja in poišana telesna temperatura.
English: Regarding Kadcyla's safety, overall side effects were considered to be manageable and the overall safety profile was considered favorable compared with other currently available medicines.
Slovenian: Glede varnosti zdravila Kadcyla je zaključil, da so njegovi neželeni učinki na splošno obvladljivi in da ima v primerjavi z drugimi zdravili, ki so trenutno na voljo, ugoden splošni varnostni profil.
English: • Trastuzumab, a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the protein HER2, which is found in large quantities on the surface of some cancer cells.
Slovenian: • trastuzumaba, ki je monoklonsko protitelo (vrsta beljakovine), ki deluje tako, da prepozna beljakovino HER2, ki je v velikih količinah prisotna na površini nekaterih rakavih celic, in se veže nanjo.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kadcyla, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Kadcyla can only be obtained with a prescription and treatment should be prescribed by a doctor and given under the supervision of a healthcare professional who is experienced in the treatment of cancer patients.
Slovenian: Zdravilo mora predpisati zdravnik, daje pa se lahko samo pod nadzorom zdravstvenega delavca, ki ima izkušnje z zdravljenjem bolnikov z rakom.
English: The active substance in Kadcyla, trastuzumab emtansine, is made up of two active components which are linked together:
Slovenian: Zdravilna učinkovina v zdravilu Kadcyla, trastuzumab emtanzin, je sestavljena iz dveh med seboj povezanih zdravilnih sestavin:
English: Kadcyla is a cancer medicine that contains the active substance trastuzumab emtansine.
Slovenian: Kadcyla je zdravilo za zadravljenje raka, ki vsebuje zdravilno učinkovino trastuzumab emtanzin.
English: Patients treated with Kadcyla also survived for 31 months compared with 25 months for patients treated with capecitabine and lapatinib.
Slovenian: Poleg tega je bil pri bolnikih, ki so jih zdravili z zdravilom Kadcyla, čas preživetja 31 mesecev, pri bolnikih, zdravljenih s kapecitabinom in lapatinibom, pa 25 mesecev.
English: By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the cancer cells.
Slovenian: Ob vezavi na HER2 trastuzumab aktivira celice imunskega sistema, ki nato uničijo rakave celice.
English: About a quarter of breast cancers overexpress HER2.
Slovenian: HER2 je čezmerno izražena pri približno četrtini primerov raka dojke;
English: For practical information about using Kadcyla, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Kadcyla naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.