FrancophonIA/ELRC3.0 huggingface dataset:
English: Stratification factors at randomisation were race (Japanese versus mainland Chinese versus other East Asian versus non-East Asian, as stated by the patient), and EGFR mutation status (exon 19 deletion versus the L858R mutation in exon 21).
Croatian: Čimbenici stratifikacije pri randomizaciji bili su: rasa (Japanci naspram Kineza iz unutrašnjosti te drugi istočni Azijati naspram Azijata iz drugih područja, kako se koji bolesnik izjasnio) i status mutacije EGFR-a (delecija u egzonu 19 naspram mutaciji L858R u egzonu 21).
English: 662) and 0.889 (95% CI: 0.568, 1.391), respectively.
Croatian: Stratificirani HR-0,589 (95 % CI: 0,469;
English: EGFR mutation status should be established prior to initiation of dacomitinib therapy (see section 4.4).
Croatian: Prije početka terapije dakomitinibom potrebno je utvrditi status mutacije EGFR-a (vidjeti dio 4.4).
English: • For Grade ≥ 3 rash, erythematous or exfoliative skin conditions, withhold dacomitinib.
Croatian: • U slučaju osipa, eritematoznih ili eksfolijativnih stanja kože stupnja ≥ 3: privremeno prekinite primjenu dakomitiniba.
English: Table 4.
Croatian: Tablica 4.
English: In addition, based on a population pharmacokinetic analysis using data from 1381 patients, that included 158 patients with mild hepatic impairment defined by National Cancer Institute (NCI) criteria [total bilirubin ≤ Upper Limit of Normal (ULN) and Aspartate Aminotransferase (AST) > ULN, or total bilirubin > 1.0 to 1.5 × ULN and any AST; N=158], mild hepatic impairment had no effect on the pharmacokinetics of dacomitinib.
Croatian: Nadalje, na temelju farmakokinetičke analize populacije korištenjem podataka dobivenih od 1381 bolesnika, među kojima je bilo 158 bolesnika s blagim oštećenjem funkcije jetre definiranim prema kriterijima Nacionalnog instituta za rak [ukupni bilirubin
English: Initiate treatment (e.g., antibiotics, topical steroids, and emollients).
Croatian: Započnite s liječenjem kožnih poremećaja (npr. antibioticima, topikalnim steroidima i emolijensima).
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Dispose unused medicinal product in accordance with local requirements.
Croatian: POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU
English: The stratification factors were Race (Japanese vs mainland Chinese and other East Asian vs non-East Asian) and EGFR mutation status (exon 19 deletion vs the L858R mutation in exon 21) at randomisation per IWRS.
Croatian: Čimbenici stratifikacije bili su rasa (Japanci naspram Kineza iz unutrašnjosti te drugi istočni Azijati naspram Azijata iz drugih područja) i status mutacije EGFR-a (delecija u egzonu 19 naspram mutaciji L858R u egzonu 21) pri randomizaciji prema interaktivnom sustavu mrežnog odgovora.
English: Because many medicinal products are excreted in human milk, and because of the potential for serious adverse reactions in breast-fed infants from exposure to dacomitinib, mothers should be advised against breast-feeding while receiving this medicinal product.
Croatian: Majke treba savjetovati da ne doje dok uzimaju ovaj lijek jer se mnogi lijekovi izlučuju u majčino mlijeko te zbog mogućnosti pojave ozbiljnih nuspojava u dojenčadi prilikom izlaganja dakomitinibu.
English: • For Grade 2 rash, erythematous or exfoliative skin conditions, no dose modification is required.
Croatian: • U slučaju osipa, eritematoznih ili eksfolijativnih stanja kože stupnja 2: nije potrebna prilagodba doze.
English: Upon recovery to Grade ≤ 1, resume dacomitinib with a reduction of 1 dose level.
Croatian: Nakon oporavka na stupanj ≤ 1 nastavite s primjenom dakomitiniba u dozi smanjenoj za jednu razinu.
English: g Pruritus includes the following PTs: Pruritus, Rash pruritic.
Croatian: Pruritus uključuje sljedeće preporučene pojmove: pruritus, pruritični osip.
English: Across the dacomitinib program, hepatic failure led to a fatal outcome in 1 patient.
Croatian: Tijekom programa liječenja dakomitinibom u 1 bolesnika je zatajenje funkcije jetre završilo smrtnim ishodom.
English: Vizimpro is for oral use.
Croatian: Lijek Vizimpro je namjenjen za peroralnu primjenu.
English: Among NSCLC patients treated with dacomitinib 45 mg daily, there have been isolated reports of hepatotoxicity in 4 (1.6%) patients.
Croatian: Prijavljeni su izolirani slučajevi hepatotoksičnosti u 4 (1,6 %) bolesnika koji boluju od NSCLC-a i liječe se dakomitinibom u dozi od 45 mg na dan.
English: Magnesium stearate
Croatian: Umor Astenija
English: Palmar-plantar erythrodysaesthesia syndrome Skin fissures Dry skin f
Croatian: Sindrom palmarnoplantarne eritrodizestezije Kožne fisure
English: Each film-coated tablet contains 121 mg of lactose monohydrate.
Croatian: Pomoćne tvari s poznatim učinkom Jedna filmom obložena tableta sadrži 121 mg laktoza hidrata.
English: Based on in vitro data, dacomitinib may have the potential to inhibit the activity of P-glycoprotein (P-gp) (in the gastrointestinal [GI] tract), Breast Cancer Resistance Protein (BCRP) (systemically and GI tract), and organic cation transporter (OCT)1 at clinically relevant concentrations (see section 5.2).
Croatian: Breast Cancer Resistance Protein, BCRP) (sistemski i u gastrointestinalnom traktu) i transportera organskih kationa (OCT)1 pri klinički značajnim koncentracijama (vidjeti dio 5.2).
English: Vizimpro 15 mg film-coated tablets Vizimpro 30 mg film-coated tablets Vizimpro 45 mg film-coated tablets dacomitinib
Croatian: Vizimpro 15 mg filmom obložene tablete Vizimpro 30 mg filmom obložene tablete Vizimpro 45 mg filmom obložene tablete dakomitinib
English: e Stomatitis includes the following PTs: Aphthous ulcer, Cheilitis, Dry mouth, Mucosal inflammation, Mouth ulceration, Oral pain, Oropharyngeal pain, Stomatitis.
Croatian: Stomatitis uključuje sljedeće preporučene pojmove: aftozni ulkus, heilitis, suha usta, upala sluznice, ulceracije usta, bol u ustima, orofaringealna bol, stomatitis.
English: How to store Vizimpro
Croatian: Kako čuvati lijek Vizimpro
English: ILD/pneumonitis, which could be fatal, has been reported in patients receiving Vizimpro (see section 4.8).
Croatian: U bolesnika koji su primali lijek Vizimpro prijavljen je ILD/pneumonitis koji može dovesti do smrtnog ishoda (vidjeti dio 4.8).
English: Weight decreased a Only adverse reactions with ≥ 10% incidence in the dacomitinib arm are included.
Croatian: Uključene su samo nuspojave s ≥ 10 % incidencije u skupini liječenoj dakomitinibom.
English: Diarrhoea* Stomatitis d
Croatian: Proljev* Stomatitis Povraćanje Mučnina
English: Initiate treatment or provide additional treatment (e.g., oral antibiotics and topical steroids).
Croatian: Započnite s liječenjem kožnih poremećaja ili omogućite dodatno liječenje (npr. peroralnim antibioticima i topikalnim steroidima).
English: What Vizimpro looks like and contents of the pack Vizimpro 15 mg film-coated tablets are supplied as blue film-coated, round biconvex tablets, debossed with “Pfizer” on one side and “DCB15” on the other.
Croatian: Kako Vizimpro izgleda i sadržaj pakiranja - Vizimpro 15 mg filmom obložene tablete dolaze kao plave, okrugle, bikonveksne filmom obložene tablete s utisnutom oznakom „Pfizer“ na jednoj strani te „DCB15“ na drugoj strani.
English: No starting dose adjustments are required when administering Vizimpro to patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.
Croatian: Prilikom primjene lijeka Vizimpro u bolesnika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem jetre početnu dozu nije potrebno prilagođavati.
English: Each film-coated tablet contains 81 mg of lactose monohydrate.
Croatian: Pomoćne tvari s poznatim učinkom Jedna filmom obložena tableta sadrži 81 mg laktoza hidrata.
English: Diarrhoea, including severe diarrhoea, has been very commonly reported during treatment with Vizimpro (see section 4.8).
Croatian: Tijekom liječenja lijekom Vizimpro vrlo često je bio zabilježen proljev, uključujući teški proljev (vidjeti dio 4.8).
English: • Nail problems
Croatian: • Problemi s noktima
English: The median duration of any grade and Grade ≥ 3 rash and erythematous skin conditions was 53 weeks and 2 weeks, respectively.
Croatian: Medijan trajanja osipa i eritematoznih stanja kože bilo kojeg stupnja iznosio je 53 tjedna, a kod osipa i eritematoznih stanja kože stupnja ≥ 3 iznosio je 2 tjedna.
English: The median time to the first episode of any grade diarrhoea was 1 week and the median time to the worst episode of diarrhoea was 2 weeks in patients receiving dacomitinib.
Croatian: Medijan vremena do prve epizode bilo kojeg stupnja proljeva iznosio je 1 tjedan, a medijan vremena do najgore epizode proljeva iznosio je 2 tjedna u bolesnika koji su primali dakomitinib.
English: Interstitial lung disease*c
Croatian: Intersticijska plućna bolest*
English: Effect of dacomitinib and O-desmethyl dacomitinib on CYP enzymes In vitro, dacomitinib and its metabolite O-desmethyl dacomitinib have a low potential to inhibit the activities of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP3A4/5 at clinically relevant concentrations.
Croatian: O-dezmetil dakomitinib imaju mali potencijal za inhibiciju aktivnosti CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ili CYP3A4/5 pri klinički relevantnim koncentracijama.
English: The active substance is dacomitinib (as dacomitinib monohydrate).
Croatian: Što Vizimpro sadrži - Djelatna tvar je dakomitinib (u obliku dakomitinib hidrata).
English: • Peeling skin
Croatian: • Suha koža
English: e Rash (also referred to as Rash and erythematous skin conditions) includes the following PTs: Acne, Dermatitis acneiform, Erythema, Erythema multiforme, Rash, Rash erythematous, Rash generalised, Rash macular, Rash maculo-papular, Rash papular.
Croatian: Osip (poznat i pod nazivom osip i eritematozna stanja kože) uključuje sljedeće standardne pojmove: akne, akneiformni dermatitis, eritem, multiformni eritem, osip, eritematozni osip, generalizirani osip, makularni osip, makulopapularni osip, papularni osip. Suha koža uključuje sljedeće preporučene pojmove: suha koža, kseroza.
English: INFORMATION IN BRAILLE Vizimpro 30 mg
Croatian: Vizimpro 30 mg
English: The median time to the first episode of any grade of transaminases increased was approximately 12 weeks and the median time to the worst episode of transaminases increased was 12 weeks in patients receiving dacomitinib.
Croatian: Medijan vremena do prve epizode bilo kojeg stupnja povećanja razina transaminaza iznosio je približno 12 tjedana, a medijan vremena do najgore epizode povećanja razina transaminaza iznosio je
English: INFORMATION IN BRAILLE Vizimpro 45 mg
Croatian: Vizimpro 45 mg
English: In patients who develop severe elevations in transaminases while taking dacomitinib, treatment should be interrupted (see section 4.2).
Croatian: Potrebno je prekinuti liječenje u bolesnika u kojih se jako poveća razina transaminaza tijekom primjene dakomitiniba (vidjeti dio 4.2).
English: Microcrystalline cellulose Sodium starch glycolate
Croatian: Jezgra tablete laktoza hidrat mikrokristalična celuloza natrijev škroboglikolat magnezijev stearat
English: INFORMATION IN BRAILLE Vizimpro 15 mg
Croatian: Vizimpro 15 mg
English: Rash may occur or worsen in areas exposed to sun. Sun protection with protective clothing and sunscreen is recommended.
Croatian: Preporučuje se prije izlaganja suncu zaštititi odjećom i preparatima za zaštitu od sunca.
English: Rash, erythematous and exfoliative skin conditions have been reported in patients treated with Vizimpro (see section 4.8).
Croatian: U bolesnika liječenih lijekom Vizimpro prijavljeni su osip, eritematozna i eksfolijativna stanja kože (vidjeti dio 4.8).
English: OTHER
Croatian: Drugo
English: Upon recovery, resume dacomitinib with a reduction of 1 dose level.
Croatian: Nakon oporavka nastavite s primjenom dakomitiniba u dozi smanjenoj za jednu razinu.
English: • Eyes inflammation
Croatian: • Upala očiju
English: Vizimpro 45 mg film-coated tablets are supplied as blue film-coated, round biconvex tablet, debossed with “Pfizer” on one side and “DCB45” on the other.
Croatian: - Vizimpro 45 mg filmom obložene tablete dolaze kao plave, okrugle, bikonveksne filmom obložene tablete s utisnutom oznakom „Pfizer“ na jednoj strani te „DCB45“ na drugoj strani.
English: Skin and subcutaneous tissue disorders Rash e
Croatian: Poremećaji kože i potkožnog tkiva Osip
English: Initiate treatment with anti-diarrhoeal medicinal products (e.g., loperamide) at first onset of diarrhoea.
Croatian: Pri prvoj pojavi proljeva potrebno je započeti liječenje lijekovima protiv proljeva (npr. loperamidom).
English: 1 fatal event was reported in the dacomitinib arm.
Croatian: U skupini liječenoj dakomitinibom zabilježen je 1 događaj sa smrtnim ishodom.
English: Vizimpro 45 mg film-coated tablets
Croatian: Vizimpro 45 mg filmom obložene tablete
English: Blue film-coated, 9.0 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB45” on the other.
Croatian: Plava, okrugla, bikonveksna filmom obložena tableta veličine 9,0 mm s utisnutom oznakom „Pfizer“ na jednoj strani te „DCB45“ na drugoj strani.
English: The median duration of any grade and Grade ≥ 3 exfoliative skin conditions was 10 weeks and approximately 2 weeks, respectively.
Croatian: Medijan trajanja eksfolijativnih stanja kože bilo kojeg stupnja iznosio je 10 tjedana, a kod eksfolijativnih stanja kože stupnja ≥ 3 iznosio je približno 2 tjedna.
English: Vizimpro 30 mg film-coated tablets are supplied as blue film-coated, round biconvex tablet, debossed with “Pfizer” on one side and “DCB30” on the other.
Croatian: - Vizimpro 30 mg filmom obložene tablete dolaze kao plave, okrugle, bikonveksne filmom obložene tablete s utisnutom oznakom „Pfizer“ na jednoj strani te „DCB30“ na drugoj strani.
English: h Nail disorder includes the following PTs: Ingrowing nail, Nail bed bleeding, Nail bed inflammation, Nail discolouration, Nail disorder, Nail infection, Nail toxicity, Onychoclasis, Onycholysis, Onychomadesis, Paronychia.
Croatian: Poremećaj noktiju uključuje sljedeće preporučene pojmove: urasli nokat, krvarenje iz ležišta nokta, upala ležišta nokta, promjena boje nokta, poremećaj noktiju, infekcija nokta, toksično oštećenje nokta, onihoklazija, oniholiza, onihomadeza, paronihija.
English: Each film-coated tablet contains 40 mg of lactose monohydrate.
Croatian: Pomoćne tvari s poznatim učinkom Jedna filmom obložena tableta sadrži 40 mg laktoza hidrata.
English: Blue film-coated, 7.5 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB30” on the other.
Croatian: Plava, okrugla, bikonveksna filmom obložena tableta veličine 7,5 mm s utisnutom oznakom „Pfizer“ na jednoj strani te „DCB30“ na drugoj strani.
English: Blue film-coated, 6.35 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB15” on the other.
Croatian: Plava, okrugla, bikonveksna filmom obložena tableta veličine 6,35 mm s utisnutom oznakom „Pfizer“ na jednoj strani te „DCB15“ na drugoj strani.
English: • For Grade 1 exfoliative skin conditions, no dose modification is required.
Croatian: • U slučaju eksfolijativnih stanja kože stupnja 1: nije potrebna prilagodba doze.
English: Initiate treatment (e.g., oral antibiotics and topical steroids).
Croatian: Započnite s liječenjem kožnih poremećaja (npr. peroralnim antibioticima i topikalnim steroidima).
English: From the small number of patients in the moderate group [total bilirubin > 1.5 to 3 × ULN and any AST; N=5], there is no evidence for a change in dacomitinib pharmacokinetics.
Croatian: ≤ gornja granica normale (GGN) i aspartat aminotransferaza (AST) > GGN ili ukupni bilirubin > 1,0 do 1,5 × GGN i bilo koji AST; N=158], nađeno je da blago oštećenje funkcije jetre nije utjecalo na farmakokinetiku dakomitiniba.Prilikom analize malog broja bolesnika u umjerenoj skupini [ukupni bilirubin > 1,5 to 3 × GGN i bilo koji AST; N=5] nisu nađeni dokazi o promjeni u farmakokinetici dakomitiniba.
English: Vizimpro 30 mg film-coated tablets
Croatian: Vizimpro 30 mg filmom obložene tablete
English: i Nail disorder includes the following PTs: Ingrowing nail, Nail discolouration, Nail disorder, Nail infection, Nail toxicity, Onychoclasis, Onycholysis, Onychomadesis, Paronychia.
Croatian: Poremećaj noktiju uključuje sljedeće preporučene pojmove: urasli nokat, promjena boje nokta, poremećaj noktiju, infekcija nokta, toksično oštećenje nokta, onihoklazija, oniholiza, onihomadeza, paronihija.
English: • For Grade ≥ 3 diarrhoea, withhold dacomitinib.
Croatian: • U slučaju proljeva stupnja ≥ 3: privremeno prekinite primjenu dakomitiniba.
English: • if you develop skin rash.
Croatian: • dobijete osip na koži.
English: Duration of Response in Responders (per IRC) Number of responders per IRC review, n
Croatian: Preživljenje bez progresije bolesti (prema IRC-u) Broj bolesnika u kojih se pojavio događaj, n (%)
English: • For Grade 1 diarrhoea, no dose modification is required.
Croatian: • U slučaju proljeva stupnja 1: nije potrebna prilagodba doze.
English: • For Grade 1 rash or erythematous skin conditions, no dose modification is required.
Croatian: • U slučaju osipa ili eritematoznih stanja kože stupnja 1: nije potrebna prilagodba doze.
English: Lactose monohydrate
Croatian: Eksfolijacija kože Hipertrihoza
English: Vizimpro 15 mg film-coated tablets
Croatian: Vizimpro 15 mg filmom obložene tablete
English: Dose modification and management for Vizimpro adverse reactions Adverse reactions
Croatian: Opći poremećaji i reakcije na mjestu primjene Astenija
English: The other ingredients are:
Croatian: HR referentna skupina:
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 45 mg tablets dacomitinib
Croatian: Vizimpro 45 mg tablete dakomitinib
English: • Cracks in the skin
Croatian: • Puknuća kože
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 30 mg tablets dacomitinib
Croatian: Vizimpro 30 mg tablete dakomitinib
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg dacomitinib (as dacomitinib monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 30 mg dakomitiniba (u obliku dakomitinib hidrata).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 45 mg dacomitinib (as dacomitinib monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 45 mg dakomitiniba (u obliku dakomitinib hidrata).
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets
Croatian: 30 filmom obloženih tableta
English: Objective Response Rate (per IRC) Objective Response Rate % (95% CI)
Croatian: Medijan PFS-a u mjesecima (95 % CI) HR (95% CI) p-vrijednost dvostranog testa Stopa objektivnog odgovora (prema IRC-u) Stopa objektivnog odgovora % (95 % CI) p-vrijednost dvostranog testa Trajanje odgovora u bolesnika s odgovorom na terapiju (prema IRC-u)
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 15 mg tablets dacomitinib
Croatian: Vizimpro 15 mg tablete dakomitinib
English: Adverse reactions are listed according to system organ class (SOC).
Croatian: Nuspojave su razvrstane prema klasifikaciji organskih sustava.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg dacomitinib (as dacomitinib monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 15 mg dakomitiniba (u obliku dakomitinib hidrata).
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 45 mg film-coated tablets dacomitinib
Croatian: Vizimpro 45 mg filmom obložene tablete dakomitinib
English: The median time to the first episode of any grade rash and erythematous skin conditions was approximately 2 weeks and the median time to the worst episode of rash and erythematous skin conditions was 7 weeks in patients receiving dacomitinib.
Croatian: U bolesnika koji su primali dakomitinib, medijan vremena do prve epizode bilo kojeg stupnja osipa i eritematoznih stanja kože iznosio je približno 2 tjedna, a medijan vremena do najgore epizode osipa i eritematoznih stanja kože iznosio je 7 tjedana.
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 30 mg film-coated tablets dacomitinib
Croatian: Vizimpro 30 mg filmom obložene tablete dakomitinib
English: Tiredness and eye irritation can occur in patients taking Vizimpro.
Croatian: U bolesnika koji uzimaju lijek Vizimpro može se pojaviti umor i nadražaj očiju.
English: • if you develop diarrhoea.
Croatian: • dobijete proljev.
English: 2-sided p-valueb
Croatian: Razina doze
English: • Permanently discontinue dacomitinib if ILD/Pneumonitis is confirmed.
Croatian: • Ako je potvrđen ILD/pneumonitis, potrebno je trajno prekinuti primjenu dakomitiniba.
English: Tel: +34 91 490 99 00
Croatian: España Pfizer, S.L Tel: +34 91 490 99 00
English: • Tiredness
Croatian: • Svrbež
English: Dose modification and management guidelines for specific adverse reactions are provided in Table 2 (see sections 4.4 and
Croatian: Ako je potrebno smanjenje doze, dozu lijeka Vizimpro treba smanjiti na način opisan u tablici 1. Smjernice za prilagodbu doze i liječenje kod pojave specifičnih nuspojava nalaze se u tablici 2 (vidjeti dijelove 4.4 i
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 15 mg film-coated tablets dacomitinib
Croatian: Vizimpro 15 mg filmom obložene tablete dakomitinib
English: Each film-coated tablet contains dacomitinib monohydrate equivalent to 45 mg dacomitinib.
Croatian: Vizimpro 45 mg filmom obložene tablete Jedna filmom obložena tableta sadrži dakomitinib hidrat što odgovara 45 mg dakomitiniba.
English: Gastrointestinal disorders
Croatian: Poremećaji probavnog sustava Proljev
English: España
Croatian: Danmark
English: Each film-coated tablet contains dacomitinib monohydrate equivalent to 30 mg dacomitinib.
Croatian: Vizimpro 30 mg filmom obložene tablete Jedna filmom obložena tableta sadrži dakomitinib hidrat što odgovara 30 mg dakomitiniba.
English: Vomiting
Croatian: Mučnina
English: Each film-coated tablet contains dacomitinib monohydrate equivalent to 15 mg dacomitinib.
Croatian: Vizimpro 15 mg filmom obložene tablete Jedna filmom obložena tableta sadrži dakomitinib hidrat što odgovara 15 mg dakomitiniba.
English: • Loss of appetite
Croatian: • Gubitak teka
English: Skin-related adverse reactions
Croatian: Nuspojave povezane s kožom
English: 75 mg Solution for injection
Croatian: 75 mg Otopina za injekciju
English: 2 pre-filled syringes + 2 alcohol pads
Croatian: 2 napunjene štrcaljke + 2 jastučića natopljena alkoholom
English: Subcutaneous use Pre-filled syringe (glass)
Croatian: Supkutano napunjena štrcaljka (staklo)
English: MA EU Number (Invented) name
Croatian: Broj (EU) odobrenja
English: ATCvet code: QI05AI01.
Croatian: ATCvet kod: QI05AI01.
English: Date of first authorisation: 6/03/2003 Date of last renewal: 6/03/2013
Croatian: Datum prvog odobrenja: 6/03/2003 Datum posljednjeg produljenja odobrenja: 6/03/2013
English: These measures should help to protect the environment.
Croatian: Ove mjere trebaju pomoći da se zaštiti okoliš.
English: One dose of 1 ml contains:
Croatian: Jedna doza od 1 ml sadrži:
English: 10x1 ml (10 doses).
Croatian: 10 x 1 ml (10 doza)
English: Carbomer ......................................................................................................................................... 4 mg.
Croatian: Karbomer ........................................................................................................................................... 4 mg
English: Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 18 mjeseci.
English: Sodium chloride
Croatian: Natrij klorid
English: After inoculation, the viruses do not multiply in the horse but express the protective proteins.
Croatian: Nakon inokulacije virusi se u konju ne množe, ali izražavaju zaštitne proteine.
English: The active substances being a principle of biological origin intended to produce active immunity are not within the scope of Regulation (EC) 470/2009.
Croatian: Na djelatne tvari koje se sastoje od tvari biološkog podrijetla namijenjene za izazivanje aktivne imunosti se ne primjenjuju odredbe Uredbe (EK) 470/2009.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Croatian: Pitajte svojeg veterinara kako ukloniti veterinarsko medicinski proizvod koji više nije potreban.