FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE13.
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinskih kinaz, oznaka ATC: L01XE13.
English: • if you have liver problems.
Slovenian: • če imate težave z jetri.
English: • if you have a history of eye problems such as severe dry eyes, inflammation of the transparent layer at the front of the eye (cornea) or ulcers involving the outer part of the eye, or if you use contact lenses.
Slovenian: • če ste imeli v preteklosti težave z očmi, na primer hudo suhost oči, vnetje prozornega sprednjega dela očesa (roženice) ali razjede, ki so zajele zunanji del očesa, ali če uporabljate kontaktne leče.
English: GIOTRIF film-coated tablets are available in packs containing 1, 2 or 4 perforated unit dose blisters.
Slovenian: GIOTRIF filmsko obložene tablete so na voljo v pakiranjih s po 1, 2, ali 4 perforiranimi pretisnimi omoti za enkratni odmerek.
English: • If your next scheduled dose is due within 8 hours, skip the missed dose and take your next dose at the usual time.
Slovenian: • Če je naslednji redni odmerek predviden znotraj osmih ur, pozabljeni odmerek izpustite in vzemite naslednjega ob običajnem času.
English: Available pharmacokinetic data in animals have shown excretion of afatinib in milk (see section 5.3).
Slovenian: Razpoložljivi farmakokinetični podatki pri živalih kažejo na izločanje afatiniba v mleko (glejte poglavje 5.3).
English: 55216 Ingelheim am Rhein GERMANY
Slovenian: 55216 Ingelheim am Rhein NEMČIJA
English: Adequate contraceptive methods should be used during therapy and for at least 1 month after the last dose.
Slovenian: Med zdravljenjem in še najmanj 1 mesec po zadnjem odmerku morajo uporabljati ustrezno kontracepcijo.
English: If you experience treatment-related symptoms affecting your eye sight (e.g. redness and/or irritation of the eye, dry eye, tearing, light-sensitivity) or your ability to concentrate and react, it is recommended that you do not drive or use machines until the side effect disappears (see section 4 Possible side effects).
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če opazite z zdravljenjem povezane simptome, ki poslabšajo vaš vid (npr. pordelost in/ali vnetje očesa, suho oko, solzenje, občutljivost za svetlobo) ali sposobnost za zbranost in odzivanje, je priporočljivo, da ne vozite ali uporabljate strojev, dokler neželeni učinek ne bo izginil (glejte poglavje 4 Možni neželeni učinki).
English: Anti-diarrhoeal medicinal products should be readily available to the patients so that treatment can be initiated at first signs of diarrhoea and continued until loose bowel movements cease for 12 hours.
Slovenian: Bolnikom morajo biti hitro in enostavno dostopni, tako da jih lahko začnejo jemati ob prvih znakih driske in nadaljujejo, dokler se izločanje mehkega blata ne zaustavi za 12 ur.
English: • if you have a history of lung inflammation (interstitial lung disease).
Slovenian: • če ste imeli v preteklosti pljučno vnetje (intersticijsko pljučno bolezen).
English: Smoking history, alcohol consumption (limited data), or presence of liver metastases had no significant impact on the pharmacokinetics of afatinib.
Slovenian: Anamneza kajenja in pitja alkohola (o njiju je malo podatkov) ali prisotnost jetrnih metastaz niso pomembneje vplivali na farmakokinetiko afatiniba.
English: This medicinal product is for oral use.
Slovenian: Zdravilo je namenjeno peroralni uporabi.
English: • Swallow the tablet whole with a glass of still water.
Slovenian: • Tableto pogoltnite celo s kozarcem negazirane vode.
English: Based on this, it is likely that afatinib is excreted in human milk.
Slovenian: Zato je možno, da se afatinib izloča v materino mleko.
English: Table 1: Dose adjustment information for adverse reactions
Slovenian: Preglednica 1: Prilagoditev odmerka zaradi neželenih reakcij
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da nekaterih sladkorjev ne prenašate, se z njim posvetujte, preden boste vzeli to zdravilo.
English: NSCLC tumours with common activating EGFR mutations (Del 19, L858R) and several less common EGFR mutations in exon 18 (G719X) and exon 21 (L861Q) are particularly sensitive to afatinib treatment in non-clinical and clinical settings.
Slovenian: Tumorji NSCLC s pogostimi aktivirajočimi mutacijami EGFR (Del 19, L858R) in številnimi manj pogostimi mutacijami EGFR v eksonu 18 (G719X) in eksonu 21 (L861Q) so v nekliničnem in kliničnem okolju posebej občutljivi za zdravljenje z afatinibom.
English: Uncommon side effects (may affect up to 1 in 100 people): • Inflammation of the pancreas (pancreatitis)
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): • vnetje trebušne slinavke (pankreatitis)
English: • Sulfasalazine, used to treat inflammation/infection.
Slovenian: • sulfasalazina, za zdravljenje vnetja ali okužbe;
English: Studies in animals have shown no signs of teratogenicity up to and including maternally lethal dose levels.
Slovenian: Študije na živalih niso pokazale znakov teratogenosti do ravni odmerkov (in vključno z njimi), ki so bili smrtni za mater.
English: Fertility studies in humans have not been performed with afatinib.
Slovenian: Študij o plodnosti pri človeku z afatinibom niso izvajali.
English: • that is identified by a change (mutation) in the gene for EGFR.
Slovenian: • s spremembo (mutacijo) gena EGFR.
English: Food should not be consumed for at least 3 hours before and at least 1 hour after taking this medicinal product (see sections 4.5 and 5.2).
Slovenian: Jedo naj vsaj 3 ure pred jemanjem zdravila ali najmanj 1 uro po njem (glejte poglavji 4.5 in 5.2).
English: Following administration of an oral solution of 15 mg afatinib, 85.4% of the dose was recovered in the faeces and 4.3% in urine.
Slovenian: Po peroralnem odmerku 15 mg afatiniba v obliki peroralne raztopine se je 85,4% odmerka izločilo z blatom, 4,3% pa z urinom.
English: In some cases your doctor may need to interrupt treatment and reduce your dose or stop treatment:
Slovenian: Zdravnik bo morda moral zdravljenje začasno prekiniti in zmanjšati odmerek zdravila ali zdravljenje trajno prekiniti:
English: Gender Female patients had a 15% higher plasma exposure (AUCτ,ss, body weight corrected) than male patients.
Slovenian: Pri ženskah je bila plazemska izpostavljenost za 15% večja (AUCτ,ss, popravljeno za telesno maso) kot pri moških.
English: Table 7 shows outcomes in the subgroups of patients with two common EGFR mutations - Del 19 and L858R.
Slovenian: V preglednici 7 so predstavljeni izidi pri podskupinah bolnikov z dvema pogostima mutacijama EGFR - Del 19 in L858R.
English: Breast-feeding Do not breast-feed while taking this medicine as a risk to the breast-fed child cannot be excluded.
Slovenian: Dojenje Med jemanjem tega zdravila ne dojite, ker tveganja za dojenega otroka ni možno izključiti.
English: The tablet should be dropped into the water without crushing it, and stirred occasionally for up to 15 min until it is broken up into very small particles.
Slovenian: Tableto je treba spustiti v vodo nezdrobljeno, jo pustiti raztapljati 15 minut in jo občasno premešati, dokler ne razpade v zelo majhne delce.
English: Symptoms such as acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist.
Slovenian: Pri simptomih, kot so akutno vnetje očesa ali njegovo poslabšanje, solzenje, občutljivost za svetlobo, meglen vid, očesna bolečina ali rdeče oko, je potrebna takojšnja napotitev k specialistu oftalmologu.
English: Patients were enrolled in the first-line (N=61) or second-line setting (N=68) (i.e. after failure of 1 prior chemotherapy regimen).
Slovenian: Bolniki so zdravilo GIOTRIF prejemali kot zdravilo prve (N = 61) ali druge linije (N = 68) (to je po enem neuspešnem režimu kemoterapije).
English: Following oral administration of GIOTRIF, Cmax of afatinib were observed approximately 2 to 5 hours post dose.
Slovenian: Po peroralnem jemanju zdravila GIOTRIF je Cmax afatiniba največja po približno 2 do 5 urah.
English: • Inflammation of the lungs (uncommon, may affect up to 1 in 100 people) called “interstitial lung disease”.
Slovenian: • Vnetje pljuč (občasno, pojavi se lahko pri največ 1 od 100 bolnikov) imenovano "intersticijska pljučna bolezen".
English: Based on the mechanism of action, all EGFR targeting medicinal products including GIOTRIF have the potential to cause foetal harm.
Slovenian: Zaradi mehanizma delovanja lahko vsa zdravila, ki delujejo na EGFR, tudi zdravilo GIOTRIF, škodljivo učinkujejo na plod.
English: During treatment, ocular adverse reactions (conjunctivitis, dry eye, keratitis) have been reported in some patients (see section 4.8) which may affect patients ability to drive or use machines.
Slovenian: Pri nekaterih bolnikih so med zdravljenjem poročali o neželenih učinkih na oči (konjunktivitis, suho oko, keratitis) (glejte poglavje 4.8), ki lahko zmanjšajo bolnikovo sposobnost za vožnjo ali upravljanje strojev.
English: The acquisition of a secondary T790M mutation is a major mechanism of acquired resistance to afatinib and gene dosage of the T790M-containing allele correlates with the degree of resistance in vitro.
Slovenian: Pridobitev sekundarne mutacije T790M je eden izmed poglavitnih mehanizmov pridobljene odpornosti na afatinib in odmerek gena, ki vsebuje alel T790M, je v korelaciji s stopnjo odpornosti in vitro.
English: • Severe blistering or peeling of skin (suggestive of Stevens-Johnson syndrome and toxic epidermal necrolysis)
Slovenian: • huda mehurjavost in luščenje kože (kaže na Stevens-Johnsonov sindrom in toksično epidermalno nekrolizo)
English: 3 4 Any Grade
Slovenian: 3 4 vse stopnje
English: • If your next scheduled dose is more than 8 hours away, take the missed dose as soon as you remember.
Slovenian: • Če je do naslednjega rednega odmerka več kot 8 ur, vzemite izpuščeni odmerek takoj, ko se spomnite.
English: There is no relevant use of GIOTRIF in the paediatric population in the indication of NSCLC.
Slovenian: Uporaba zdravila GIOTRIF pri pediatrični populaciji pri indikaciji NSCLC ni smotrna.
English: Duration of response Months (median)
Slovenian: Trajanje odziva meseci (mediana)
English: Similar to LUX-Lung 3, patients with previously untreated NSCLC were screened for EGFR mutations using TheraScreen
Slovenian: Podobno kot v preskušanju LUX-Lung 3 so predhodno nezdravljene bolnike z NSCLC presejali glede na prisotnost mutacij EGFR z metodo TheraScreen
English: Both trials demonstrated significant improvement in PFS of EGFR mutation positive patients treated with GIOTRIF compared to chemotherapy.
Slovenian: V obeh preskušanjih je bilo opaženo bistveno izboljšanje PFS pri bolnikih s pozitivno mutacijo EGFR, ki so prejemali zdravilo GIOTRIF, v primerjavi z bolniki, ki so prejemali kemoterapijo.
English: In cases of suspected overdose, GIOTRIF should be withheld and supportive care initiated.
Slovenian: Pri sumu na prevelik odmerek je treba jemanje zdravila GIOTRIF prekiniti in uvesti podporno oskrbo.
English: Strong P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital or St. John's wort (Hypericum perforatum)) may decrease exposure to afatinib (see section 4.4).
Slovenian: Močni induktorji P-gp (tudi, a ne samo, rifampicin, karbamazepin, fenitoin, fenobarbital ali šentjanževka (Hypericum perforatum)) lahko zmanjšajo izpostavljenost afatinibu (glejte poglavje 4.4).
English: ILD-like adverse reactions were reported in 0.7% of afatinib treated patients.
Slovenian: Neželene reakcije, podobne kot pri bolezni IPB, so opazili pri 0,7 % bolnikih, ki so bili zdravljeni z afatinibom.
English: The most frequent ADRs were diarrhoea and skin related adverse events (see section 4.4) as well as stomatitis and paronychia (see also Table 3, 4 and 5).
Slovenian: Najpogostejše neželene reakcije so bile driska in kožni neželeni dogodki (glejte poglavje 4.4) ter stomatitis in paronihija (glejte tudi preglednice 3, 4 in 5).
English: As a precautionary measure, women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with GIOTRIF.
Slovenian: Iz previdnosti je treba ženskam v rodni dobi svetovati, naj se med zdravljenjem z zdravilom GIOTRIF izogibajo zanositvi.
English: In 61 patients treated in the first-line setting, confirmed ORR was 65.6% and DCR was 86.9% according to independent review.
Slovenian: Pri 61 bolnikih, ki so zdravilo prejemali kot prvo linijo zdravljenja, je bila potrjena stopnja objektivnega odziva na zdravljenje (ORR) 65,6%, stopnja nadzora bolezni (DCR) pa 86,9%, kar je pokazal neodvisni pregled podatkov.
English: Each blister contains 7 x 1 film-coated tablets and is packed in an aluminium pouch together with a desiccant sachet that should not be swallowed.
Slovenian: Vsak pretisni omot vsebuje 7-krat 1 filmsko obloženo tableto in je pakiran v aluminijasti vrečki s sušilnim sredstvom, ki ga ne smete zaužiti.
English: What you need to know before you take GIOTRIF
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo GIOTRIF
English: Effects of P-gp inducers on afatinib
Slovenian: Učinki P-gp induktorjev na afatinib
English: Drop the tablet into the water without crushing it, and occasionally stir for up to 15 min until the tablet is broken up into very small particles.
Slovenian: Tableto spustite v vodo, ne smete je drobiti, pustite jo raztapljati do 15 minut in občasno premešajte, dokler ne bo razpadla na zelo majhne delce.
English: However, this medicinal product has not been studied in patients with abnormal left ventricular ejection fraction (LVEF) or those with significant cardiac history.
Slovenian: Toda tega zdravila niso preskušali pri bolnikih z nenormalno iztisno frakcijo levega prekata (LVEF) ali pomembnejšo anamnezo srčnih bolezni.
English: • Verapamil, quinidine, amiodarone - used to treat heart conditions.
Slovenian: • verapamil, kinidin, amiodaron - za zdravljenje bolezni srca,
English: Patients with mild and moderate hepatic impairment as identified by abnormal liver tests did not correlate with any significant change in afatinib exposure.
Slovenian: Pri bolnikih z blago in zmerno jetrno okvaro, ki so jo pokazali nenormalni izvidi jetrnih preiskav, ni bilo korelacije s pomembnejšo spremembo izpostavljenosti afatinibu.
English: The T790M mutation is found in approximately 50% of patients' tumours upon disease progression on afatinib, for which T790M targeted EGFR TKIs may be considered as a next line treatment option.
Slovenian: Mutacija T790M je prisotna pri približno 50 % bolnikov s tumorjem, ki prejemajo afatinib v času napredovanja bolezni, pri katerih bi zaviralci receptorja EGFR TK, usmerjeni na T790M, lahko predstavljali naslednji alternativni način zdravljenja.
English: The efficacy results are provided in Figure 1, Tables 6 and 7.
Slovenian: Podatki o učinkovitosti so prikazani na sliki 1 ter navedeni v preglednicah 6 in 7.
English: NCI Common Terminology Criteria for Adverse Events In case of diarrhoea, anti-diarrhoeal medicinal products (e.g. loperamide) should be taken immediately and continued for persistent diarrhoea until loose bowel movements cease.
Slovenian: Common Terminology Criteria for Adverse Events po NCI (National Cancer Institute) Če se pojavi driska, naj bolnik nemudoma vzame zdravilo proti driski (npr. loperamid) in ga pri persistentni driski jemlje, dokler je blato mehko.
English: PFS benefit was accompanied by improvement in disease-related symptoms and delayed time to deterioration (see Table 11).
Slovenian: Učinkovitost PFS je bila opažena skupaj z izboljšanjem simptomov, povezanih z boleznijo, in zapoznelim časom do poslabšanja (glejte preglednico 11).
English: In oral repeated-dose studies for up to 26 weeks in rats or 52 weeks in minipigs the main effects were identified in the skin (dermal changes, epithelial atrophy and folliculitis in rats), the gastrointestinal tract (diarrhoea, erosions in the stomach, epithelial atrophy in rats and minipigs) and the kidneys (papillary necrosis in rats).
Slovenian: V raziskavah toksičnosti ponovljenih odmerkov, ki so trajale pri podganah do 26 tednov in pri mini prašičkih 52 tednov, so se največji učinki pokazali na koži (kožne spremembe, atrofija epitelija in folikulitis pri podganah), prebavilih (driska, erozije v želodcu, atrofija epitelija pri podganah in mini prašičkih) in ledvicah (papilarna nekroza pri podganah).
English: If used during pregnancy or if the patient becomes pregnant while or after receiving GIOTRIF, she should be informed of the potential hazard to the foetus.
Slovenian: Če ga jemlje nosečnica ali če bolnica med ali po zdravljenju s tem zdravilom zanosi, jo je potrebno seznaniti z možnim tveganjem za plod.
English: Each blister is packed together with a desiccant sachet in a laminated aluminium pouch and contains 7 x 1 film-coated tablets.
Slovenian: Vsak pretisni omot je pakiran v laminirani aluminijasti vrečki s sušilnim sredstvom in vsebuje 7-krat 1 filmsko obloženo tableto.
English: • Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);
Slovenian: • odraslih bolnikov, ki se še niso zdravili z zaviralcem receptorja za epidermalni rastni dejavnik (EGFR - epidermal growth factor receptor) TK z lokalno napredovalim ali metastaznim nedrobnoceličnim pljučnim rakom (NSCLC - non-small cell lung cancer) z aktivacijsko(imi) mutacijo(ami) EGFR;
English: Pemetrexed/ Cisplatin N=111
Slovenian: pemetreksed/ cisplatin N = 111
English: Overdose in 2 healthy adolescents involving the ingestion of 360 mg each of afatinib (as part of a mixed drug ingestion) was associated with adverse events of nausea, vomiting, asthenia, dizziness, headache, abdominal pain and elevated amylase (< 1.5 times ULN).
Slovenian: Prevelik odmerek afatiniba, ki sta ga vzela 2 zdrava mladostnika, in sicer vsak po 360 mg (pri zaužitju mešanice zdravil), je povzročil neželene reakcije: navzea, bruhanje, astenijo, omotico, glavobol, trebušno bolečino in povečanje amilaze (< 1,5-kratna ULN).
English: Median PFS (months), Overall Trial Population 18-months PFS rate 24-months PFS rate
Slovenian: Mediana preživetja brez napredovanja bolezni (PFS) (meseci), skupna populacija iz preskušanja stopnja PFS po 18 mesecih stopnja PFS po 24 mesecih
English: A study in rats up to the maximum tolerated doses revealed no significant impact on pre-/postnatal development.
Slovenian: Raziskava, v kateri so podganam dajali odmerke do največjih, ki so jih še prenesle, ni odkrila pomembnejšega vpliva na razvoj pred kotitvijo in po njej.
English: Do not use this medicine after the expiry date which is stated on the carton, the pouch and the blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, na vrečki in na pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: 89% of patients had common EGFR mutations (Del 19 or L858R).
Slovenian: 89 % bolnikov je imelo pogoste mutacije EGFR (Del 19 ali L858R).
English: Resume with dose reduction by 10 mg decrements a
Slovenian: ponovno uvesti ob zmanjševanju odmerka po10 mg naenkrat a
English: Patients who received at least 4 cycles of platinum-based therapy in the first line setting were subsequently randomized 1:1 to daily GIOTRIF 40 mg or erlotinib 150 mg until progression.
Slovenian: Bolnike, ki so prejeli vsaj 4 cikle terapije na osnovi platine v prvi liniji zdravljenja, so nato naključno razvrstili (1:1) v skupino z zdravilom GIOTRIF 40 mg enkrat na dan ali v skupino z zdravilom erlotinib 150 mg do napredovanja.
English: Figure 1: Kaplan-Meier curve for PFS by independent review by treatment group in trial LUX-Lung 3 (Overall Population)
Slovenian: Slika 1: Kaplan-Meierjeva krivulja PFS v neodvisnem pregledu podatkov po zdravljenih skupinah v preskušanju LUX-Lung 3 (vsa populacija)
English: There is no specific antidote for overdose with this medicinal product.
Slovenian: Za prevelik odmerek zdravila ni antidota.
English: Among 795 patients randomized, the majority were males (84%), white (73%), current or former smokers (95%) with baseline performance status ECOG 1 (67%) and ECOG 0 (33%).
Slovenian: Med 795 naključno razvrščenimi bolniki je bila večina moških (84 %), belcev (73 %), trenutnih ali nekdanjih kadilcev (95 %) z izhodiščnim stanjem zmogljivosti ECOG 1 (67 %) in ECOG 0 (33 %).
English: This medicinal product should be taken without food.
Slovenian: Zdravila bolniki ne smejo jemati s hrano.
English: Oral administration of single doses to mice and rats indicated a low acute toxic potential of afatinib.
Slovenian: Pri peroralnem dajanju enkratnih odmerkov mišim in podganam je afatinib izkazal majhno akutno toksičnost.
English: GIOTRIF in patients with NSCLC of squamous histology
Slovenian: Zdravilo GIOTRIF pri bolnikih z NSCLC s ploščatocelično histologijo
English: When the strong P-gp and BCRP inhibitor ritonavir (200 mg twice a day for 3 days) was administered 1 hour before a single dose of 20 mg GIOTRIF, exposure to afatinib increased by 48% (area under the curve (AUC0-∞)) and 39% (maximum plasma concentration (Cmax)).
Slovenian: Ko so močni zaviralec P-gp in BCRP ritonavir (200 mg dvakrat na dan 3 dni) vnesli 1 uro pred enkratnim 20-mg odmerkom zdravila GIOTRIF, se je izpostavljenost afatinibu povečala za 48% (površina pod krivuljo (AUC0-∞)) oz. 39% (najvišja plazemska koncentracija (Cmax)).
English: The respective total systemic exposure (AUC) was either slightly above (2.2 times in rats) or below (0.3 times in rabbits) compared with levels in patients.
Slovenian: Celokupna sistemska izpostavljenost (AUC) je nekoliko presegla (2,2-krat pri podganah) ali bila pod (0,3-krat pri kuncih) ravnijo pri bolnikih.
English: The overall survival hazard ratio in patients < 65 years of age was 0.68 (95% CI 0.55, 0.85) and in patients 65 years of age and older it was 0.95 (95% CI 0.76, 1.19).
Slovenian: Razmerje tveganja skupnega preživetja pri bolnikih < 65 let je bilo 0,68 (95-% IZ 0,55, 0,85) in pri bolnikih, starih 65 let ali več, 0,95 (95-% IZ 0,76, 1,19).
English: Based on the available clinical trial data, there is no suggestion that this medicinal product causes an adverse reaction on cardiac contractility.
Slovenian: Dosegljivi podatki iz kliničnih raziskav ne kažejo na neželene učinke zdravila na kontraktilnost srca.
English: Female gender, lower body weight, and underlying renal impairment Higher exposure to afatinib has been observed in female patients, patients with lower body weight and those with underlying renal impairment (see section 5.2).
Slovenian: Ženski spol, manjša telesna masa in obstoječa ledvična okvara Pri ženskah, bolnikih z manjšo telesno maso in bolnikih z obstoječo ledvično okvaro so ugotovili večjo izpostavljenost afatinibu (glejte poglavje 5.2).
English: The highest total systemic exposure (AUC0-24) in female rats was less than that observed in patients (0.23 times).
Slovenian: Največja skupna sistemska izpostavljenost (AUC0-24) pri podganjih samicah, je bila manjša kot pri bolnikih (0,23-krat).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim (logo)
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Boehringer Ingelheim (logo)
English: Dose adjustment for adverse reactions
Slovenian: Prilagoditev odmerka zaradi neželenih reakcij
English: The dose should not be escalated in any patients with a prior dose reduction.
Slovenian: Bolnikom, katerim smo odmerek kdaj prej zmanjšali, ga ne smemo povečati.
English: Eye irritation or inflammation may occur (conjunctivitis/keratoconjunctivitis occurs commonly and keratitis uncommonly).
Slovenian: Pojavita se lahko draženje ali vnetje v očesu (konjunktivitis ali keratokonjunktivitis, ki se pojavita pogosto in keratitis, ki se pojavi občasno).
English: Tell your doctor if you have sudden or worsening of eye symptoms such as pain or redness or dry eye.
Slovenian: Obvestite zdravnika, če se pojavijo nenadni ali napredujoči simptomi v obliki bolečine, pordelosti ali suhosti očesa.