FrancophonIA/ELRC3.0 huggingface dataset:
English: Experience with tocofersolan therapy in patients with renal impairment or underlying liver impairment has demonstrated no need to adapt the dose regimen of Vedrop (see section 4.4).
Croatian: Iskustvo s terapijom tokofersolanom u bolesnika s oštećenjem bubrega ili postojećim oštećenjem jetre ukazalo je da nije potrebno prilagođavati režim doziranja lijeka Vedrop (vidjeti dio 4.4).
English: What Vedrop is and what it is used for What you need to know before you take Vedrop How to take Vedrop
Croatian: Što je Vedrop i za što se koristi Što morate znati prije nego počnete uzimati Vedrop Kako uzimati Vedrop
English: - Vedrop must not be used in newborn premature babies.
Croatian: - Vedrop se ne smije primjenjivati u prerano rođene novorođenčadi.
English: In a similar study tocofersolan showed a higher bioavailability than a water-miscible reference vitamin E in paediatric patients with chronic cholestasis (n=6), absorption was significantly higher on both plasma concentration maximum increase (p=0.008) and AUC (p=0.0026).
Croatian: U sličnoj studiji na pedijatrijskim bolesnicima s kroničnom kolestazom (n=6) tokofersolan je pokazao veću bioraspoloživost od referentnog vitamina E pomiješanog s vodom, apsorpcija je bila značajno viša s porastom maksimalne koncentracije u plazmi (p=0.008) i AUC (p=0.0026).
English: It is recommended to monitor the coagulation function when administered with anti-vitamins K treatment (see section 4.4).
Croatian: Preporučuje se praćenje funkcije koagulacije kad se lijek primjenjuje uz terapiju antagonistima vitamina K (vidjeti dio 4.4).
English: Due to inhibition of P-Glycoprotein transporter, tocofersolan may also enhance intestinal absorption of other concomitant fat-soluble vitamins (A, D, E, K) or that of highly lipophilic medicinal products (such as steroids, antibiotics, antihistamines, cyclosporine, tacrolimus).
Croatian: Zbog inhibicije P-glikoproteinskog transportera, tokofersolan može također povećati crijevnu apsorpciju drugih vitamina topljivih u mastima (A, D, E, K) ili visoko lipofilnih lijekova (poput steroida, antibiotika, antihistaminika, ciklosporina, takrolimusa).
English: Talk to your doctor before taking Vedrop if you have:
Croatian: Obavijestite svog liječnika prije uzimanja lijeka Vedrop ukoliko imate:
English: The MAH shall provide yearly updates on any new information concerning efficacy and safety of the product in patients with congenital chronic cholestasis or hereditary cholestasis.
Croatian: Nositelj odobrenja će godišnje priložiti nadopune u vezi s bilo kakvim novim informacijama o učinkovitosti i neškodljivosti lijeka kod pacijenata s kongenitalnom kroničnom kolestazom ili hereditarnom kolestazom.
English: It is used to treat lack of vitamin E due to digestive malabsorption (where nutrients from the food are not easily absorbed during digestion) in patients from birth (full term newborns) up to 18 years of age suffering from chronic cholestasis (a hereditary or congenital disease where bile cannot flow from the liver to the intestine).
Croatian: Koristi se za liječenje nedostatka vitamina E uzrokovanog probavnom malapsorpcijom (kada se hranjive tvari iz hrane ne apsorbiraju lako tijekom probave) u bolesnika od rođenja (novorođenčad rođena u terminu) do 18. godine života koji boluju od kronične kolestaze (nasljedne ili prirođene bolesti u kojoj žuč ne može teći iz jetre u crijeva).
English: • Rash (eruption on the skin)
Croatian: • Osip (izbijanje promjena na koži)
English: Inform your doctor if you want to breast-feed.
Croatian: Obavijestite svog liječnika ukoliko želite dojiti.
English: The dose should be adjusted according to plasma vitamin E level.
Croatian: Dozu treba prilagoditi prema razini vitamina E u plazmi.
English: Urine represents a minor elimination route of vitamin E (as glucuro-conjugate).
Croatian: Mokraća predstavlja minoran put eliminacije vitamina E (u obliku glukokonjugata).
English: The hydrolysis of tocofersolan occurs in the gut lumen.
Croatian: Hidroliza tokofersolana događa se u lumenu crijeva.
English: Vedrop contains vitamin E (in the form of tocofersolan).
Croatian: Vedrop sadrži vitamin E (u obliku tokofersolana).
English: It is unknown whether tocofersolan is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se tokofersolan izlučuje u majčino mlijeko u ljudi.
English: Vedrop contains 0.18 mmoles (4.1 mg) sodium per ml.
Croatian: Vedrop sadrži 0,18 mmol (4,1 mg) natrija po mililitru (ml).
English: If you take large doses of Vitamin E, you may experience temporary diarrhoea and stomach ache.
Croatian: Ukoliko uzmete visoke doze vitamina E, možete dobiti prolazni proljev ili tupe bolove u trbuhu.
English: The active substance d-alpha-tocopherol-polyethylene glycol 1000 succinate (tocofersolan) is a pro-drug; the active metabolite is the d-alpha-tocopherol.
Croatian: Djelatna tvar d-alfa-tokoferol-polietilenglikol 1000 sukcinat (tokofersolan) je predlijek; aktivni metabolit je d-alfa-tokoferol.
English: Vedrop is indicated in vitamin E deficiency due to digestive malabsorption in paediatric patients with congenital chronic cholestasis or hereditary chronic cholestasis, from birth (full term newborns) up to 18 years of age.
Croatian: Vedrop je indiciran kod deficijencije vitamina E zbog probavne malapsorpcije u pedijatrijskih bolesnika s kongenitalnom kroničnom kolestazom ili hereditarnom kroničnom kolestazom, od rođenja (terminska novorođenčad) do 18 godina starosti.
English: The treatment with Vedrop should be initiated and supervised by a physician experienced in the management of patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis.
Croatian: Liječenje Vedropom treba započeti i nadgledati liječnik s iskustvom u liječenju bolesnika koji imaju kongenitalnu kroničnu kolestazu ili hereditarnu kroničnu kolestazu.
English: • Keep this medicine out of the sight and reach of children.
Croatian: • Ovaj lijek čuvajtepogleda i dohvata djece.
English: The 1 ml oral syringe is graduated from 0.05 to 1 ml in steps of 0.05 ml.
Croatian: Oralna štrcaljka od 1 ml je graduirana od 0,05 do 1 ml u razmacima od 0,05 ml.
English: The 2 ml oral syringe is graduated from 0.1 to 2 ml in steps of 0.1 ml.
Croatian: Oralna štrcaljka od 2 ml je graduirana od 0,1 do 2 ml u razmacima od 0,1 ml.
English: Swallow the solution with or without water.
Croatian: Progutatajte otopinu sa ili bez vode.
English: BATCH NUMBER EU/1/09/533/001 10 ml bottle EU/1/09/533/00 2 20 ml bottle EU/1/09/533/003 60 ml bottle
Croatian: EU/1/09/533/001 boca od 10 ml EU/1/09/533/002 boca od 20 ml EU/1/09/533/003 boca od 60 ml
English: EXP Discard one month after first opening.
Croatian: Rok valjanosti Lijek odbacite mjesec dana od prvog otvaranja.
English: Fat-soluble vitamins (such as vitamin A, D, E or K) or highly fat-soluble medicines (such as corticoids, ciclosporin, tacrolimus, antihistamine).
Croatian: Vitamine topive u mastima (poput vitamina A, D, E ili K) ili lijekove koji su dobro topivi u mastima (poput kortikosteroida, ciklosporina, takrolimusa, antihistaminika).
English: Use only with the oral syringe provided in the box.
Croatian: Primjenjujte ju samo uz pomoć oralne štrcaljke koja se nalazi u kutiji.
English: If you forget to take Vedrop
Croatian: Ako ste zaboravili uzeti Vedrop
English: To calculate the dose of Vedrop to be administered, divide the prescribed dose of d-alpha-tocopherol (in mg) by 50.
Croatian: Da biste izračunali dozu Vedropa koju treba primijeniti, podijelite propisanu dozu d-alfa-tokoferola (u mg) s 50.
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Croatian: Zabilježene nuspojave su navedene niže, prema organskom sustavu i učestalosti.
English: As data on patients with renal impairment are limited, Vedrop should be administered with caution and under close monitoring of the renal function in patients with renal impairment e.g. dehydrated patients (see section 4.2).
Croatian: S obzirom da su podaci kod bolesnika s oštećenjem bubrega ograničeni, Vedrop treba primjenjivati s oprezom te uz pažljivo praćenje bubrežne funkcije kod bolesnika s poremećajem rada bubrega, npr. dehidriranih bolesnika (vidjeti dio 4.2).
English: It should be taken into consideration by patients on a controlled sodium diet.
Croatian: To treba uzeti u obzir kod bolesnika na dijeti s ograničenim unosom natrija.
English: Each ml contains 6 mg sodium methyl parahydroxybenzoate (E219), 4 mg sodium ethyl parahydroxybenzoate (E215) and 0.18 mmoles (4.1 mg) of sodium.
Croatian: Svaki ml sadrži 6 mg natrijeva metilparahidroksibenzoata (E219), 4 mg natrijeva etilparahidroksibenzoata (E215) i 0,18 mmol (4,1 mg) natrija.
English: What Vedrop contains - The active substance is tocofersolan.
Croatian: Što Vedrop sadrži - Djelatna tvar je tokofersolan.
English: - The other ingredients are: potassium sorbate, sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) (see end of section 2 for further information on these 2 ingredients), glycerol, disodium phosphate dodecahydrate, concentrated hydrochloric acid, purified water.
Croatian: - Drugi sastojci su: kalijev sorbat, natrijev metilparahidroksibenzoat (E219), natrijev etilparahidroksibenzoat (E215) (pogledajte kraj dijela 2 za više informacija o ova dva sastojka), glicerol, natrijev hidrogenfosfat dodekahidrat, koncentrirana klorovodična kiselina, pročišćena voda.
English: The following table gives the volume of oral solution in function of patients' weights.
Croatian: Sljedeća tablica prikazuje volumen oralne otopine s obzirom na bolesnikovu tjelesnu težinu.
English: Vedrop should be used with caution and liver functions closely monitored.
Croatian: Vedrop treba primijeniti s oprezom te pažljivo pratiti jetrenu funkciju.
English: Oral syringes with housing of LDPE and piston of polystyrol.
Croatian: Oralne štrcaljke s kućištem od LDPE i klipom od polistirola.
English: Oral solution volume (ml)
Croatian: Volumen oralne otopine (ml)
English: Each box contains one bottle and one oral syringe (a 1 ml syringe with a 10 ml or 20 ml bottle, a 2 ml syringe with a 60 ml bottle).
Croatian: Svaka kutija sadrži jednu bocu i jednu oralnu štrcaljku (štrcaljku od 1 ml uz boce od 10 ml ili 20 ml, štrcaljku od 2 ml uz bocu od 60 ml).
English: Type III brown glass bottle with a child-resistant screw cap of HDPE and LDPE seal.
Croatian: Smeđa staklena boca tipa III sa zaštitnim navojnim poklopcem HDPE za djecu i zatvaračem LDPE.
English: Dose of Vedrop (in ml) = dose of d-alpha-tocopherol (in mg)
Croatian: Doza Vedropa (u ml) = doza d-alfa-tokoferola (u mg)
English: The dose should be prescribed in mg of d-alpha-tocopherol in the form of tocofersolan.
Croatian: Dozu treba propisati u mg d-alfa-tokoferola u obliku tokofersolana.
English: See the package leaflet for further information.
Croatian: Pogledajte Uputu o lijeku za dodatne informacije.
English: The dose will be adjusted by your doctor according to your vitamin E blood level.
Croatian: Liječnik će prilagoditi dozu prema razini vitamina E u Vašoj krvi.
English: INFORMATION IN BRAILLE Vedrop 50 mg/ml
Croatian: Vedrop 50 mg/ml
English: Uncommon: asthenia, headache
Croatian: Manje često: astenija, glavobolja
English: For tocofersolan no clinical data on exposed pregnancies are available.
Croatian: Nisu dostupni klinički podaci o utjecaju tokofersolana na trudnoću.
English: Vedrop 50 mg/ml oral solution Tocofersolan
Croatian: Vedrop 50 mg/ml oralna otopina tokofersolan
English: As large doses of vitamin E have been reported to increase bleeding tendency in vitamin-K deficient patients or those taking oral anti-vitamins K treatment, it is therefore recommended to monitor the prothrombin time and international normalised ratio (INR).
Croatian: K ili onih liječenih oralnim antagonistima vitamina K, preporučuje se praćenje protrombinskog vremena te internacionalnog normaliziranog omjera (INR).
English: Driving and using machines Vedrop is not likely to affect your ability to drive and use machines.
Croatian: Nije vjerojatno da će Vedrop utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Not known: abdominal pain
Croatian: Često: proljev Nepoznato: bol u trbuhu
English: 2- Put the oral syringe included in the pack in the bottle.
Croatian: 2- Umetnite u bocu oralnu štrcaljku koja se nalazi u pakovanju.
English: Each bottle contains 10 ml, 20 ml or 60 ml of oral solution.
Croatian: Svaka boca sadrži 10 ml, 20 ml ili 60 ml otopine za oralnu primjenu.
English: Uncommon: serum sodium abnormal, serum potassium abnormal, transaminases increase
Croatian: Manje često: poremećaj natrija u serumu, poremećaj kalija u serumu, povišene transaminaze
English: Vedrop should be administered with caution in patients with underlying liver impairment and under close monitoring of the hepatic functions in such patients (see section 4.2).
Croatian: Vedrop treba kod bolesnika s postojećim oštećenjem jetre primjenjivati s oprezom i uz pažljivo praćenje jetrene funkcije (vidjeti dio 4.2).
English: Large vitamin E doses may cause diarrhoea, abdominal pain, and other gastrointestinal disturbances.
Croatian: Visoke doze vitamina E mogu dovesti do proljeva, bolova u trbuhu te drugih probavnih tegoba.
English: Excipients: sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215).
Croatian: Pomoćne tvari: natrijev metilparahidroksibenzoat (E219), natrijev etilparahidroksibenzoat (E215).
English: How to take Vedrop
Croatian: Kako uzimati vedrop
English: Bottle of 60 ml and 2 ml oral syringe.
Croatian: Boca od 60 ml i oralna štrcaljka od 2 ml.
English: Vedrop contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215), which may cause allergic reactions (possibly delayed).
Croatian: Vedrop sadrži metilparahidroksibenzoat (E219) i natrijev etilparahidroksibenzoat (E215), koji mogu dovesti do alergijskih reakcija (koje mogu biti odgođene).
English: One graduation of the 1 ml oral syringe corresponds to 2.5 mg of d-alpha-tocopherol in the form of tocofersolan.
Croatian: Jedan razmak na oralnoj štrcaljki od 1 ml odgovara 2,5 mg d-alfa-tokoferola u obliku tokofersolana.
English: How to store Vedrop
Croatian: Kako čuvati Vedrop
English: Vedrop contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) which may cause allergic reactions (possibly delayed).
Croatian: Vedrop sadrži natrijev metilparahidroksibenzoat (E219) te natrijev etilparahidroksibenzoat (E215) koji mogu uzrokovati alergijske reakcije (koje mogu biti odgođene).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Bottle label - 10 ml, 20 ml and 60 ml bottles
Croatian: Naljepnica na boci - boce od 10 ml, 20 ml i 60 ml
English: Boxes containing: one 10 ml bottle and one 1 ml oral syringe one 20 ml bottle and one 1 ml oral syringe one 60 ml and one 2 ml oral syringe
Croatian: jednu bocu od 10 ml te jednu oralnu štrcaljku od 1 ml jednu bocu od 20 ml te jednu oralnu štrcaljku od 1 ml jednu bocu od 60 ml te jednu oralnu štrcaljku od 2 ml
English: One graduation of the 2-ml oral syringe corresponds to 5 mg of d-alpha-tocopherol in the form of tocofersolan.
Croatian: Jedan razmak na oralnoj štrcaljki od 2 ml odgovara 5 mg d-alfa-tokoferola u obliku tokofersolana.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na poseban i ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio
English: Bottle of 20 ml and 1 ml oral syringe.
Croatian: Boca od 20 ml i oralna štrcaljka od 1 ml.
English: Bottle of 10 ml and 1 ml oral syringe.
Croatian: Boca od 10 ml i oralna štrcaljka od 1 ml.
English: INFORMATION IN BRAILLE Vedrop 50 mg/ml UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton box - 10 ml, 20 ml and 60 ml bottle
Croatian: Kartonska kutija - boca od 10 ml, 20 ml i 60 ml
English: Taken up by cells, the alpha-tocopherol moiety appears in chylomicrons in the lymph in a manner identical to vitamin E absorbed from the diet. Cellular uptake does not require receptors, binding proteins or metabolic processes and does not occur by pinocytosis.
Croatian: Unos u stanicu ne zahtijeva receptore, vezne proteine ili metaboličke procese te se ne događa putem pinocitoze.
English: Each ml contains 50 mg of d-alpha-tocopherol, in the form of tocofersolan, corresponding to 74.5 IU of tocopherol.
Croatian: Svaki ml sadrži 50 mg d-alfa-tokoferola, u obliku tokofersolana, što odgovara 74.5 IU tokoferola.
English: Each ml contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, corresponding to 74.5 IU of tocopherol.
Croatian: Svaki ml sadrži 50 mg d-alfa-tokoferola u obliku tokofersolana, što odgovara 74.5 IU tokoferola.
English: Each ml of solution contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, corresponding to 74.5 IU of tocopherol.
Croatian: Svaki ml otopine sadrži 50 mg d-alfa-tokoferola u obliku tokofersolana, što odgovara 74,5 IU tokoferola.
English: Vedrop is a slightly viscous pale yellow oral solution in a brown glass bottle which is closed with a childresistant cap.
Croatian: Vedrop je blago viskozna blijedožuta oralna otopina u smeđoj staklenoj boci koja je zatvorena zaštitnim poklopcem za djecu.Boce sadrže 10 ml, 20 ml ili 60 ml oralne otopine.
English: Skin and subcutaneous tissue disorders Uncommon: alopecia, pruritus, rash General disorders and administration site conditions
Croatian: Manje često: alopecija, svrbež, osip
English: Sodium methyl parahydroxybenzoate (E219) Sodium ethyl parahydroxybenzoate (E215) Glycerol
Croatian: 6.1 Popis pomoćnih tvari kalijev sorbat natrijev metilparahidroksibenzoat (E219) natrijev etilparahidroksibenzoat (E215) glicerol natrijev hidrogenfosfat dodekahidrat kloridna kiselina, koncentrirana pročišćena voda
English: If you get any side effects, talk to your doctor or pharmacist.
Croatian: Prije prekida terapije lijekom Vedrop obratite se svom liječniku ili ljekarniku.
English: • Itching
Croatian: • Proljev
English: Slightly viscous, pale yellow solution.
Croatian: Blago viskozna, blijedožuta otopina.
English: NAME OF THE MEDICINAL PRODUCT Vedrop 50 mg/ml oral solution
Croatian: Vedrop 50 mg/ml oralna otopina
English: 1China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan and Thailand.
Croatian: 1Kina, Hong Kong, Indonezija, Japan, Malezija, Filipini, Singapur, Tajvan i Tajland.
English: 31110 Noáin (Navarra) Spain
Croatian: 31110 Noáin (Navarra) Španjolska
English: Uncommon Hepatitis**
Croatian: Hepatitis**
English: “m” is medians in months.
Croatian: “m” su medijani u mjesecima.
English: What to do if you forget to take a tablet depends on how long it is until your next dose.
Croatian: Što ćete učiniti ako ste zaboravili uzeti tabletu, ovisi o tome koliko je vremena preostalo do Vaše sljedeće doze:
English: In that study, sensitivity was 43.1%, specificity was 100%.
Croatian: U tom je ispitivanju osjetljivost iznosila 43,1%, a specifičnost 100%.
English: • You can take the tablet with or without food.
Croatian: • Tabletu možete uzeti s hranom ili bez hrane.
English: b “m” is medians in months.
Croatian: b “m” su medijani u mjesecima.
English: - Barbiturates (a type of medicine used for sleeping problems).
Croatian: - Barbiturate (vrsta lijekova koji se koriste za liječenje poteškoća sa spavanjem).
English: The blisters may be packed into aluminium pouches.
Croatian: Blisteri mogu biti zapakirani u aluminijske vrećice.
English: The tablet may be taken with or without food, at about the same time each day.
Croatian: Tableta se može uzimati s hranom ili bez nje, otprilike u isto vrijeme svakoga dana.
English: Trial outcome index results were supportive of FACT-L and LCS results a
Croatian: Indeksirani ishodi ispitivanja podržali su FACT-L i LCS rezultate a
English: - Rifampicin (for tuberculosis).
Croatian: - Rifampicin (za liječenje tuberkuloze).
English: • Severe skin reactions (rare) affecting large areas of your body.
Croatian: • teške kožne reakcije (rijetko) koje zahvaćaju velike površine tijela.
English: • Take the tablet at about the same time each day.
Croatian: • Uzmite tabletu u približno isto vrijeme svakoga dana.
English: It is recommended that you avoid becoming pregnant during treatment with this medicine because Gefitinib Mylan could harm your baby.
Croatian: Preporučuje se da izbjegavate trudnoću tijekom liječenja ovim lijekom jer Gefitinib Mylan može naškoditi Vašem djetetu.
English: Gefitinib Mylan should not be used during pregnancy unless clearly necessary.
Croatian: Gefitinib Mylan ne smije se primjenjivati tijekom trudnoće, osim ako je to neophodno.
English: NR Not reached.
Croatian: ND Nije dostignuto.
English: Gefitinib did not prolong survival in the overall population.
Croatian: Gefitinib nije produljio preživljenje u ukupnoj populaciji.
English: This may mean that you have an inflammation of the lungs called ‘interstitial lung disease'.
Croatian: To može značiti da imate upalu pluća koja se zove „intersticijska bolest pluća”.
English: Number of patients evaluable for quality of life analyses.
Croatian: Broj bolesnika pogodnih za analizu kvalitete života.
English: Phenotypic switch to small cell lung cancer has also been reported in 5-10% of cases.
Croatian: Fenotipska promjena u rak malih stanica pluća također je zabilježena u 5 - 10% slučajeva.
English: This may affect about 1 in 100 patients taking gefitinib and can be life-threatening.
Croatian: Ona može nastupiti u približno 1 od 100 bolesnika koji uzimaju gefitinib i može biti opasna po život.
English: d Asian ethnicity excludes patients of Indian origin and refers to the racial origin of a patient group and not necessarily their place of birth.
Croatian: Azijatsko porijeklo ne obuhvaća bolesnike indijskog podrijetla i odnosi se na rasno podrijetlo skupine bolesnika, a ne nužno na njihovo mjesto rođenja.
English: • Do not take antacids (to reduce the acid level of your stomach) 2 hours before or 1 hour after taking Gefitinib Mylan.
Croatian: • Nemojte uzimati antacide (za smanjenje kiseline u želucu) 2 sata prije niti 1 sat poslije uzimanja lijeka Gefitinib Mylan.
English: Do not take Gefitinib Mylan: - if you are allergic to gefitinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati lijek Gefitinib Mylan: - ako ste alergični na gefitinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: First line treatment
Croatian: Prva linija liječenja
English: 117 Allée des Parcs 69800 Saint-Priest France
Croatian: 117 Allée des Parcs 69800 Saint Priest Francuska
English: Do not take Gefitinib Mylan if you are breast-feeding for the safety of your baby.
Croatian: Nemojte uzimati lijek Gefitinib Mylan ako dojite radi sigurnosti Vašeg djeteta.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines: - Phenytoin or carbamazepine (for epilepsy).
Croatian: Posebice, recite svom liječniku ili ljekarniku ako uzimate neki od sljedećih lijekova: - Fenitoin ili karbamazepin (za liječenje epilepsije).
English: Allergic reactions (1.1%), including angioedema and urticaria.
Croatian: Alergijske reakcije (1,1%), uključujući angioedem i urtikariju
English: - Warfarin (a so-called oral anticoagulant, to prevent blood clots).
Croatian: - Varfarin (takozvani oralni antikoagulans, za sprječavanje stvaranja ugrušaka krvi).
English: Asymptomatic laboratory elevations in blood creatinine.
Croatian: Asimptomatsko povišenje laboratorijskih vrijednosti kreatinina u krvi
English: This side effect is uncommon; however, some patients have died from this.
Croatian: Ova nuspojava javlja se manje često; ipak, neki su bolesnici umrli od nje.
English: The safety and efficacy of Gefitinib Mylan in children and adolescents aged less than 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Gefitinib Mylan u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: Mean absolute bioavailability is 59% in cancer patients.
Croatian: Srednja apsolutna bioraspoloživost iznosi 59% u bolesnika s rakom.