FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients may require dosing interruption and/or dose reduction of therapy with dacomitinib (see section 4.2).
Slovenian: Pri bolnikih bo morda treba prekiniti zdravljenje z dakomitinibom in/ali zmanjšati odmerek dakomitiniba (glejte poglavje 4.2).
English: The median duration of any grade and Grade ≥ 3 diarrhoea was 20 weeks and 1 week, respectively (see section 4.4).
Slovenian: Mediano trajanje diareje katerekoli stopnje je bilo 20 tednov, mediano trajanje diareje stopnje ≥ 3 pa 1 teden (glejte poglavje 4.4).
English: Dacomitinib was clastogenic in the in vitro human lymphocyte chromosome aberration assay at cytotoxic concentrations.
Slovenian: Dakomitinib je bil klastogen v preskusu kromosomskih aberacij v človeških limfocitih in vitro pri citotoksičnih koncentracijah.
English: Dry skin includes the following PTs: Dry skin, Xerosis.
Slovenian: Suha koža vključuje naslednja priporočena izraza: suha koža, kseroza.
English: Patients with a history of ILD have not been studied.
Slovenian: Bolnikov z ILD v anamnezi niso preučevali.
English: c Interstitial lung disease includes the following PTs: Interstitial lung disease, Pneumonitis.
Slovenian: Intersticijska bolezen pljuč vključuje naslednja priporočena izraza: intersticijska bolezen pljuč, pnevmonitis.
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.
Slovenian: Stratifikacijski dejavniki so bili rasa (Japonci v primerjavi s celinskimi Kitajci in drugi Vzhodnoazijci v primerjavi z Nevzhodnoazijci) in status mutacij EGFR (delecija v eksonu 19 v primerjavi z mutacijo L858R v eksonu 21) ob randomizaciji glede na IWRS.
English: Your doctor may decrease the dose of your medicine depending on how well you tolerate it.
Slovenian: Glede na to, kako dobro prenašate zdravilo, vam zdravnik lahko zmanjša odmerek zdravila.
English: • Alteration in taste
Slovenian: • sprememba okušanja
English: In 6 healthy male subjects given a single-oral dose of [
Slovenian: Pri 6 zdravih moških preskušancih, ki so prejeli enkraten peroralni odmerek radioaktivno označenega [
English: Concomitant use of medicinal products predominantly metabolised by CYP2D6 should be avoided (see section 4.4).
Slovenian: Izogibati se je treba sočasni uporabi zdravil, ki se pretežno presnavljajo preko CYP2D6 (glejte poglavje 4.).
English: a Hypokalaemia includes the following preferred terms (PTs): Blood potassium decreased, Hypokalaemia.
Slovenian: Hipokaliemija vključuje naslednja priporočena izraza: zmanjšanje vrednosti kalija v krvi, hipokaliemija.
English: Upon recovery to Grade ≤ 1, resume dacomitinib at the same dose level or consider a reduction of 1 dose level.
Slovenian: Po izboljšanju na stopnjo ≤ 1 nadaljujte zdravljenje z dakomitinibom v enakem odmerku ali pa razmislite o zmanjšanju za 1 odmerno raven.
English: Interstitial lung disease (ILD/Pneumonitis)
Slovenian: Prilagajanje odmerka intersticijska bolezen pljuč (ILD - Interstitial Lung Disease/pnevmonitis)
English: Metabolism and nutrition disorders Decreased appetite Hypokalemia b
Slovenian: Presnovne in prehranske motnje pomanjkanje apetita hipokaliemija
English: A total of 452 patients were randomised 1:1 to dacomitinib or gefitinib in a multicentre, multinational, randomised, open-label Phase 3 study.
Slovenian: V multicentrični, multinacionalni, randomizirani, odprti študiji 3. faze so randomizirali skupno 452 bolnikov v razmerju 1 : 1 na dakomitinib ali gefitinib.
English: Diarrhoea, including severe diarrhoea, has been very commonly reported during treatment with Vizimpro (see section 4.8).
Slovenian: Med zdravljenjem z zdravilom Vizimpro so zelo pogosto poročali o diareji, vključno s hudo diarejo (glejte poglavje 4.8).
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).
Slovenian: Stratifikacijski dejavniki ob randomizaciji so bili rasa (Japonci v primerjavi s celinskimi Kitajci v primerjavi z drugimi Vzhodnoazijci v primerjavi z Nevzhodnoazijci po navedbah bolnikov) in status mutacij EGRF (delecija v eksonu 19 v primerjavi z mutacijo L858R v eksonu 21).
English: In vitro, dacomitinib has a low potential to induce CYP1A2, CYP2B6, or CYP3A4 at clinically relevant concentrations.
Slovenian: In vitro ima dakomitinib v klinično pomembnih koncentracijah majhen potencial za indukcijo CYP1A2, CYP2B6 ali CYP3A4.
English: Initiate treatment with anti-diarrhoeal medicinal products (e.g., loperamide) at first onset of diarrhoea.
Slovenian: Ob prvem pojavu diareje začnite zdravljenje z antidiaroiki (npr. loperamid).
English: Tell your doctor right away if you have any new or worsening symptoms including difficulty in breathing, shortness of breath, or cough with or without phlegm (mucous), or fever.
Slovenian: Če se vam pojavijo kakršnikoli novi simptomi ali se simptomi poslabšajo, vključno s težavami pri dihanju, kratko sapo ali kašljem s sluzjo ali brez nje ali vročino, o tem takoj obvestite zdravnika.
English: The median time to the first episode of any grade exfoliative skin conditions was 6 weeks and the median time to the worst episode of exfoliative skin conditions was 6 weeks.
Slovenian: Mediani čas do prve epizode eksfoliativnih kožnih bolezni katerekoli stopnje je bil 6 tednov, mediani čas do najhujše epizode eksfoliativnih kožnih bolezni pa 6 tednov.
English: Transaminases increased (alanine aminotransferase increased, aspartate aminotransferase increased, transaminases increased) have been reported during treatment with Vizimpro (see section 4.8).
Slovenian: Med zdravljenjem z zdravilom Vizimpro so poročali o zvečanju vrednosti transaminaz (zvečanje vrednosti alanin-aminotransferaze, zvečanje vrednosti aspartat-aminotransferaze, zvečanje vrednosti transaminaz) (glejte poglavje 4.8).
English: Initiate treatment (e.g., antibiotics, topical steroids, and emollients).
Slovenian: Začnite zdravljenje (npr. antibiotiki, topikalni steroidi in emolienti).
English: • For Grade ≥ 3 diarrhoea, withhold dacomitinib.
Slovenian: • Pri diareji stopnje ≥ 3 prekinite zdravljenje z dakomitinibom.
English: Weight decreased a Only adverse reactions with ≥ 10% incidence in the dacomitinib arm are included.
Slovenian: Vključeni so samo neželeni učinki z incidenco ≥ 10 % v skupini, ki je prejemala dakomitinib.
English: In addition, hepatocellular necrosis with transaminase increases and hepatocellular vacuolation were observed in rats only.
Slovenian: Poleg tega so samo pri podganah opazili hepatocelično nekrozo z zvečanimi vrednostmi transaminaz in vakuolizacijo jetrnih celic.
English: Encourage adequate oral fluid intake during diarrhoea.
Slovenian: V času trajanja diareje bolnika spodbujajte k zadostnemu uživanju tekočin.
English: Recommended dose modifications for Vizimpro adverse reactions Dose level
Slovenian: Priporočeno prilagajanje odmerkov v primeru neželenih učinkov zdravila Vizimpro
English: g Pruritus includes the following PTs: Pruritus, Rash pruritic.
Slovenian: Pruritus vključuje naslednja priporočena izraza: pruritus, pruritični izpuščaj.
English: • Nausea or vomiting
Slovenian: • občutek siljenja na bruhanje ali bruhanje
English: Co-administration of dacomitinib with agents that increase gastric pH
Slovenian: Sočasno dajanje dakomitiniba in zdravil, ki povečajo vrednost pH v želodcu
English: In faeces, dacomitinib, O-desmethyl dacomitinib, a cysteine conjugate of dacomitinib, and a mono-oxygenated metabolite of dacomitinib were the major drug-related components.
Slovenian: V blatu so bile glavne iz zdravila izhajajoče komponente dakomitinib, O-dezmetil dakomitinib, cisteinski konjugat dakomitiniba in monooksigenirani presnovek dakomitiniba.
English: 2-sided p-valueb
Slovenian: 2-stranska vrednostp
English: OTHER
Slovenian: drugo
English: The most frequently reported (> 5%) reasons for dose reductions due to any adverse reactions in patients receiving dacomitinib were rash (32.2%), nail disorder (16.5%), and diarrhoea
Slovenian: Razlogi za zmanjšanje odmerka zaradi kateregakoli neželenega učinka, o katerih so najpogosteje poročali (> 5 %) pri bolnikih, ki so prejemali dakomitinib, so bili izpuščaj (32,2 %), bolezni nohtov (16,5 %) in diareja (7,5 %).
English: Consider adding broad spectrum oral or intravenous antibiotics if any of these conditions worsen to greater than or equal to Grade 2 severity.
Slovenian: Če se resnost katere od teh bolezni poslabša do stopnje 2 ali višje stopnje, razmislite o dodajanju širokospektralnih peroralnih ali intravenskih antibiotikov.
English: ILD/pneumonitis, which could be fatal, has been reported in patients receiving Vizimpro (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo Vizimpro, so poročali o ILD/pnevmonitisu, ki sta lahko smrtna (glejte poglavje 4.8).
English: • For Grade ≥ 3 rash, erythematous or exfoliative skin conditions, withhold dacomitinib.
Slovenian: • Pri izpuščaju, eritematoznih ali eksfoliativnih kožnih boleznih stopnje ≥ 3 prekinite zdravljenje z dakomitinibom.
English: The median time to the first episode of any grade ILD/pneumonitis was 16 weeks and the median time to the worst episode of ILD/pneumonitis was 16 weeks in patients receiving dacomitinib.
Slovenian: Mediani čas do prve epizode ILD/pnevmonitisa katerekoli stopnje pri bolnikih, ki so prejemali dakomitinib, je bil 16 tednov, mediani čas do najhujše epizode ILD/pnevmonitisa pa je bil 16 tednov.
English: Diarrhoea* Stomatitis d
Slovenian: Bolezni prebavil diareja* stomatitis bruhanje navzea
English: Transaminases increased
Slovenian: Zvečanje vrednosti transaminaz
English: Vizimpro 15 mg film-coated tablets Vizimpro 30 mg film-coated tablets Vizimpro 45 mg film-coated tablets dacomitinib
Slovenian: Vizimpro 15 mg filmsko obložene tablete Vizimpro 30 mg filmsko obložene tablete Vizimpro 45 mg filmsko obložene tablete dakomitinib
English: No starting dose adjustments are required when administering Vizimpro to patients with mild or moderate renal impairment (creatinine clearance [CrCl] ≥ 30 mL/min).
Slovenian: Kadar zdravilo Vizimpro dajemo bolnikom z blago ali zmerno okvaro ledvic (očistek kreatinina [CrCl - Creatinine Clearance] ≥ 30 ml/min), prilagajanje začetnega odmerka ni potrebno.
English: Initiate treatment or provide additional treatment (e.g., oral antibiotics and topical steroids).
Slovenian: Začnite zdravljenje ali zagotovite dodatna zdravila (npr. peroralni antibiotiki in topikalni steroidi).
English: • For Grade 2 rash, erythematous or exfoliative skin conditions, no dose modification is required.
Slovenian: • Pri izpuščaju, eritematoznih ali eksfoliativnih kožnih boleznih stopnje 2 prilagajanje odmerka ni potrebno.
English: • Withhold dacomitinib during ILD/Pneumonitis diagnostic evaluation.
Slovenian: • Med diagnostično obravnavo ILD/pnevmonitisa prekinite zdravljenje z dakomitinibom.
English: • if you have any symptoms of a liver problem which may include: yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea coloured) urine, light-coloured bowel movements (stools).
Slovenian: • pojavijo kakršnikoli simptomi težav z jetri, ki lahko vključujejo: porumenelost kože ali beločnic
English: Abbreviations: CI=confidence interval; EGFR=epidermal growth factor receptor; HR=hazard ratio; IRC=independent radiologic central; ITT=Intent-to-treat; IWRS=interactive web response system; N/n=total number; NSCLC=non-small cell lung cancer; PFS=progression-free survival; DoR=Duration of Response.
Slovenian: Okrajšave: IZ = interval zaupanja; EGFR = receptor za epidermalni rastni dejavnik (epidermal growth factor receptor); HR = razmerje ogroženosti (hazard ratio); IRC = neodvisni centralni radiološki pregled (independent radiologic central); ITT = populacija, ki so jo nameravali zdraviti (intent-to-treat);
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Treatment with dacomitinib should be withheld pending investigation of these symptoms.
Slovenian: Med preiskovanjem teh simptomov je treba zdravljenje z dakomitinibom prekiniti.
English: Adverse reactions are listed according to system organ class (SOC).
Slovenian: Neželeni učinki so razvrščeni glede na organski sistem.
English: • Cracks in the skin
Slovenian: • razpoke na koži
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.
Slovenian: Mediani čas do prve epizode zvečanja vrednosti transaminaz katerekoli stopnje pri bolnikih, ki so prejemali dakomitinib, je bil približno 12 tednov, mediani čas do najhujše epizode zvečanja vrednosti transaminaz pa 12 tednov.
English: Diarrhoea
Slovenian: diareja
English: • For Grade 1 diarrhoea, no dose modification is required.
Slovenian: • Pri diareji stopnje 1 prilagajanje odmerka ni potrebno.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijska bolezen pljuč*
English: 1 fatal event was reported in the dacomitinib arm.
Slovenian: V skupini, ki je prejemala dakomitinib, so poročali o 1 dogodku s smrtnim izidom.
English: Start oral antibiotics and topical steroids in patients who develop exfoliative skin conditions.
Slovenian: Pri bolnikih, pri katerih se pojavijo eksfoliativne kožne bolezni, uvedite peroralne antibiotike in topikalne steroide.
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.
Slovenian: Kadar zdravilo Vizimpro dajemo bolnikom z blago (razred A po klasifikaciji Child-Pugh) ali zmerno (razred B po klasifikaciji Child-Pugh) okvaro jeter, prilagajanje začetnega odmerka ni potrebno.
English: Palmar-plantar erythrodysaesthesia syndrome Skin fissures Dry skin f
Slovenian: Bolezni kože in podkožja izpuščaj sindrom palmarnoplantarne eritrodisestezije suha koža pruritus bolezni nohtov alopecija
English: The median duration of any grade and Grade ≥ 3 rash and erythematous skin conditions was 53 weeks and 2 weeks, respectively.
Slovenian: Mediano trajanje izpuščaja in eritematoznih kožnih bolezni katerekoli stopnje je bilo 53 tednov, mediano trajanje izpuščaja in eritematoznih kožnih bolezni stopnje ≥ 3 pa je bilo 2 tedna.
English: Each film-coated tablet contains 121 mg of lactose monohydrate.
Slovenian: Pomožne snovi z znanim učinkom: Ena filmsko obložena tableta vsebuje 121 mg laktoze monohidrata.
English: Each film-coated tablet contains 81 mg of lactose monohydrate.
Slovenian: Pomožne snovi z znanim učinkom: Ena filmsko obložena tableta vsebuje 81 mg laktoze monohidrata.
English: Tiredness and eye irritation can occur in patients taking Vizimpro.
Slovenian: Pri bolnikih, ki jemljejo zdravilo Vizimpro, se lahko pojavita utrujenost in draženje oči.
English: Grade 3
Slovenian: Preglednica 3.
English: Stomatitis e
Slovenian: Okvara ledvic
English: INFORMATION IN BRAILLE Vizimpro 30 mg
Slovenian: Vizimpro 30 mg
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.
Slovenian: Izpuščaj (imenovan tudi izpuščaj in eritematozne kožne bolezni) vključuje naslednje priporočene izraze: akne, akneiformni dermatitis, eritem, multiformni eritem, izpuščaj, eritematozni izpuščaj, generalizirani izpuščaj, makulozni izpuščaj, makulopapulozni izpuščaj, papulozni izpuščaj.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Vizimpro:
Slovenian: Pred začetkom jemanja zdravila Vizimpro se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: In humans, dacomitinib undergoes oxidation and glutathione conjugation as the major metabolic pathways.
Slovenian: Pri ljudeh sta glavni presnovni poti dakomitiniba oksidacija in konjugacija z glutationom.
English: Initiate treatment (e.g., oral antibiotics and topical steroids).
Slovenian: Začnite zdravljenje (npr. peroralni antibiotiki in topikalni steroidi).
English: Upon recovery to Grade ≤ 1, resume dacomitinib with a reduction of 1 dose level.
Slovenian: Po izboljšanju na stopnjo ≤ 1 nadaljujte zdravljenje z dakomitinibom v odmerku, zmanjšanem za 1 odmerno raven.
English: INFORMATION IN BRAILLE Vizimpro 45 mg
Slovenian: Vizimpro 45 mg
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.
Slovenian: Mediani čas do prve epizode izpuščaja in eritematoznih kožnih bolezni katerekoli stopnje pri bolnikih, ki so prejemali dakomitinib, je bil približno 2 tedna, mediani čas do najhujše epizode izpuščaja in eritematoznih kožnih bolezni pa 7 tednov.
English: 662) and 0.889 (95% CI: 0.568, 1.391), respectively.
Slovenian: Vrednosti HR za PFS glede na pregled IRC pri azijskih in neazijskih bolnikih sta bili 0,509 (95 % IZ: 0,391; 0,662) oziroma 0,889 (95 % IZ: 0,568; 1,391).
English: Rash, erythematous and exfoliative skin conditions have been reported in patients treated with Vizimpro (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom Vizimpro, so poročali o izpuščaju ter eritematoznih in eksfoliativnih kožnih boleznih (glejte poglavje 4.8).
English: C] dacomitinib, the most abundant circulating metabolite was O-desmethyl dacomitinib.
Slovenian: C] dakomitiniba v enkratnem odmerku 45 mg je bil v obtoku najizdatneje prisoten presnovek O-dezmetil dakomitinib.
English: LIST OF EXCIPIENTS Contains lactose.
Slovenian: Vsebuje laktozo.
English: e Stomatitis includes the following PTs: Aphthous ulcer, Cheilitis, Dry mouth, Mucosal inflammation, Mouth ulceration, Oral pain, Oropharyngeal pain, Stomatitis.
Slovenian: Stomatitis vključuje naslednje priporočene izraze: aftozna razjeda, heilitis, suha usta, vnetje sluznice, razjede v ustih, bolečina v ustih, orofaringealna bolečina, stomatitis.
English: • Eyes inflammation
Slovenian: • vnetje oči
English: The active substance is dacomitinib (as dacomitinib monohydrate).
Slovenian: Kaj vsebuje zdravilo Vizimpro - Učinkovina je dakomitinib (v obliki dakomitinibijevega monohidrata).
English: INFORMATION IN BRAILLE Vizimpro 15 mg
Slovenian: Vizimpro 15 mg
English: The median duration of any grade and Grade ≥ 3 transaminases increased was 11 weeks and 1 week, respectively.
Slovenian: Mediano trajanje zvečanja vrednosti transaminaz katerekoli stopnje je bilo 11 tednov, mediano trajanje zvečanja vrednosti transaminaz stopnje ≥ 3 pa 1 teden.
English: Vizimpro 45 mg film-coated tablets
Slovenian: Vizimpro 45 mg filmsko obložene tablete
English: Decreased appetite Hypokalaemiaa
Slovenian: Presnovne in prehranske motnje pomanjkanje apetita hipokaliemija dehidracija
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER STRIPS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Dose modification
Slovenian: Prilagajanja odmerkov
English: Gastrointestinal disorders Diarrhoea d
Slovenian: Bolezni prebavil diareja stomatitis navzea
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.
Slovenian: - Filmsko obložene tablete zdravila Vizimpro 45 mg so na voljo kot modre, okrogle, bikonveksne, filmsko obložene tablete z vtisnjeno oznako ''Pfizer'' na eni strani in ''DCB45'' na drugi strani.
English: • For Grade 1 exfoliative skin conditions, no dose modification is required.
Slovenian: • Pri eksfoliativnih kožnih boleznih stopnje 1 prilagajanje odmerka ni potrebno.
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.
Slovenian: Mediani čas do prve epizode diareje katerekoli stopnje pri bolnikih, ki so prejemali dakomitinib, je bil 1 teden, mediani čas do najhujše epizode diareje pa 2 tedna.
English: Each film-coated tablet contains dacomitinib monohydrate equivalent to 30 mg dacomitinib.
Slovenian: Ena filmsko obložena tableta vsebuje dakomitinibijev monohidrat v količini, ki ustreza 30 mg dakomitiniba.
English: Each film-coated tablet contains dacomitinib monohydrate equivalent to 45 mg dacomitinib.
Slovenian: Ena filmsko obložena tableta vsebuje dakomitinibijev monohidrat v količini, ki ustreza 45 mg dakomitiniba.
English: Vizimpro 30 mg film-coated tablets
Slovenian: Vizimpro 30 mg filmsko obložene tablete
English: Blue film-coated, 9.0 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB45” on the other.
Slovenian: Modra, okrogla, bikonveksna filmsko obložena tableta velikosti 9,0 mm, z vtisnjeno oznako ''Pfizer'' na eni strani in ''DCB45'' na drugi 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.
Slovenian: Bolezni nohtov vključujejo naslednje priporočene izraze: vraščen noht, krvavitev v podnohtju, vnetje podnohtja, obarvanje nohta, bolezni nohtov, okužba nohta, toksičnost za nohte, onihoklaza, oniholiza, onihomadeza, paronihija.
English: Rash may occur or worsen in areas exposed to sun. Sun protection with protective clothing and sunscreen is recommended.
Slovenian: Priporočljivo je, da se pred soncem zaščitite z zaščitnimi oblačili in kremo za zaščito pred soncem.
English: Each film-coated tablet contains 40 mg of lactose monohydrate.
Slovenian: Pomožne snovi z znanim učinkom: Ena filmsko obložena tableta vsebuje 40 mg laktoze monohidrata.
English: Conjunctivitis b
Slovenian: PRILOGA I
English: EXPIRY DATE EXP
Slovenian: EXP
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.
Slovenian: - Filmsko obložene tablete zdravila Vizimpro 30 mg so na voljo kot modre, okrogle, bikonveksne, filmsko obložene tablete z vtisnjeno oznako ''Pfizer'' na eni strani in ''DCB30'' na drugi strani.
English: Dose modification and management for Vizimpro adverse reactions Adverse reactions
Slovenian: Prilagajanje odmerkov in ukrepanje v primeru neželenih učinkov zdravila Vizimpro
English: Transaminases increasedj Weight decreased
Slovenian: Preiskave zvečanje vrednosti transaminaz zmanjšanje telesne mase
English: Blue film-coated, 7.5 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB30” on the other.
Slovenian: Modra, okrogla, bikonveksna filmsko obložena tableta velikosti 7,5 mm, z vtisnjeno oznako ''Pfizer'' na eni strani in ''DCB30'' na drugi strani.
English: Microcrystalline cellulose Sodium starch glycolate
Slovenian: 6.1 Seznam pomožnih snovi jedro tablete laktoza monohidrat mikrokristalna celuloza natrijev karboksimetilškrob magnezijev stearat filmska obloga
English: Blue film-coated, 6.35 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB15” on the other.
Slovenian: Modra, okrogla, bikonveksna filmsko obložena tableta velikosti 6,35 mm, z vtisnjeno oznako ''Pfizer'' na eni strani in ''DCB15'' na drugi strani.
English: i Nail disorder includes the following PTs: Ingrowing nail, Nail discolouration, Nail disorder, Nail infection, Nail toxicity, Onychoclasis, Onycholysis, Onychomadesis, Paronychia.
Slovenian: Bolezni nohtov vključujejo naslednje priporočene izraze: vraščen noht, obarvanje nohta, bolezni nohtov, okužba nohta, toksičnost za nohte, onihoklaza, oniholiza, onihomadeza, paronihija.
English: Each film-coated tablet contains dacomitinib monohydrate equivalent to 15 mg dacomitinib.
Slovenian: Ena filmsko obložena tableta vsebuje dakomitinibijev monohidrat v količini, ki ustreza 15 mg dakomitiniba.