FrancophonIA/ELRC3.0 huggingface dataset:
English: INCIVO in combination with peginterferon alfa and ribavirin was evaluated in 74 HCV-1 infected, post-liver transplant patients without cirrhosis receiving either tacrolimus or cyclosporine A. At the initiation of INCIVO treatment, doses of co-administered tacrolimus or cyclosporine A need to be markedly reduced, including a prolongation in the dosing interval for tacrolimus, in order to maintain therapeutic plasma concentrations of the immunosuppressant.
Croatian: INCIVO je bio procijenjen u kombinaciji s peginterferonom alfa i ribavirinom u 74 bolesnika s HCV-1 infekcijom nakon transplantacije jetre bez ciroze koji su dobivali ili takrolimus ili ciklosporin A.
English: It is important to stay hydrated with fluids during INCIVO combination treatment.
Croatian: INCIVO važno je održavanje hidracije organizma tekućinom.
English: SVR in patients with undetectable HCV RNA (target not detected) at weeks 4 and 12
Croatian: SVR u bolesnika s nemjerljivom HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu SVR u bolesnika koji nisu imali nemjerljivu HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu
English: Prior relapsers
Croatian: Relaps
English: T12/PR48: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks; Pbo/PR: placebo for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks
Croatian: T12/PR48: INCIVO tijekom 12 tjedana s peginterferonom alfa-2a i ribavirinom tijekom 48 tjedana; Pbo/PR: placebo tijekom 12 tjedana s peginterferonom alfa-2a i ribavirinom tijekom 48 tjedana
English: T12/PR: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks; Pbo/PR: placebo for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks
Croatian: T12/PR: INCIVO tijekom 12 tjedana s peginterferonom alfa-2a i ribavirinom tijekom 24 ili 48 tjedana; Pbo/PR: placebo tijekom 12 tjedana s peginterferonom alfa-2a i ribavirinom tijekom 48 tjedana
English: A total of 352 (65%) patients had undetectable HCV RNA (target not detected) at weeks 4 and 12.
Croatian: Nemjerljiv HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu imalo je ukupno 352 (65%) bolesnika.
English: AUC 0.80 (0.76-0.85) Cmax 0.79 (0.74-0.84) Cmin 0.85 (0.75-0.98) ↑ atazanavir AUC 1.17 (0.97-1.43) Cmax 0.85 (0.73-0.98) Cmin 1.85 (1.40-2.44) inhibition of CYP3A by telaprevir
Croatian: ↔telaprevir AUC 1,07 (1,00-1,15) Cmax 1,07 (0,98-1,16) Cmin 1,14 (1,04-1,26) ↑ raltegravir AUC 1,31 (1,03-1,67) Cmax 1,26 (0,97-1,62) Cmin 1,78 (1,26-2,53)
English: Table 3: Adverse drug reactions to INCIVO (taken in combination with peginterferon alfa and ribavirin) in HCV-infected patients in clinical trials a and post-marketing Adverse Drug Reactions INCIVO, peginterferon alfa, and ribavirin combination therapy oral candidiasis anaemia thrombocytopenia b, lymphopenia hypothyroidism hyperuricaemia b, hypokalaemia gout dysgeusia, syncope
Croatian: Tablica 3: Nuspojave INCIVA (koji se uzima u kombinaciji s peginterferonom alfa i ribavirinom) u bolesnika zaraženih HCV-om u kliničkim ispitivanjima a i postmarketinški
English: Your doctor should check your rash to determine how to manage it.
Croatian: Kako bi mogao odrediti kako liječiti osip, liječnik Vas treba pregledati.
English: T12(DS)/PR % (n/N) ≥ 1 log10 reduction in HCV RNA at week 4
Croatian: Sniženje HCV RNK ≥ 1 log10 u 4. tjednu
English: Dose modification of INCIVO is not required when administered to hepatitis C patients with mild hepatic impairment (Child-Pugh A, score 5-6).
Croatian: Kad se INCIVO primjenjuje u bolesnika s hepatitisom C i blagim oštećenjem funkcije jetre (Child-Pugh A, rezultat 5-6), prilagodba doze nije potrebna.
English: See also section 4.3 for medicinal products which are contraindicated with INCIVO.
Croatian: Za lijekove koji su kontraindicirani s INCIVOM, vidjeti također dio 4.3.
English: regimen results in the same daily dose with similar drug exposures of telaprevir, the relative drug interactions are expected to be similar.
Croatian: Očekuje se da će relativne interakcije lijekova biti slične, ako se uzme u obzir da shema uzimanja 1125 mg b.i.d. dovodi do istih dnevnih doza sa sličnim izloženostima telapreviru.
English: Cmin 1.10 (0.97-1.24) induction of CYP3A by carbamazepine, and inhibition of CYP3A by telaprevir
Croatian: ↓ telaprevir ↑ rifabutin rifabutin inducira CYP3A, a telaprevir inhibira
English: Patients with undetectable HCV RNA (target not detected) at weeks 4 and 12
Croatian: Nemjerljiv HCV RNK (cilj nije izmjeren) u 4. i
English: SVR in patients who did not have undetectable HCV RNA (target not detected) at weeks 4
Croatian: Nazivnik je bio broj bolesnika s nemjerljivim HCV RNK (cilj nije izmjeren) na kraju liječenja
English: ↓ ethinylestradiol AUC 0.72 (0.69-0.75) Cmax 0.74 (0.68-0.80) Cmin 0.67 (0.63-0.71) ↔ norethindrone AUC 0.89 (0.86-0.93) Cmax 0.85 (0.81-0.89) Cmin 0.94 (0.87-1.00) mechanism unknown
Croatian:  telaprevir AUC 0,46 (0,41-0,52) Cmax 0,47 (0,41-0,52) Cmin 0,48 (0,40-0,56) ↔ lopinavir AUC 1,06 (0,96-1,17) Cmax 0,96 (0,87-1,05) Cmin 1,14 (0,96-1,36) mehanizam nije poznat
English: Refer to the Summary of Product Characteristics for ribavirin for information regarding dose reduction and/or discontinuation of ribavirin.
Croatian: Za informacije o smanjenju doze i/ili prekidu primjene ribavirina pogledajte Sažetak opisa svojstava lijeka za ribavirin.
English: to treat fungal infections (antifungals)
Croatian: za liječenje upalnog artritisa (sredstva protiv uloga) za liječenje određenih infekcija (antimikobakterijski lijekovi)
English: Serious skin reactions including rash with systemic symptoms, progressive severe rash,
Croatian: Ozbiljne kožne reakcije uključujući osip sa sistemskim simptomima, progresivni teški osip, sumnja ili dijagnoza generalizirane bulozne erupcije, DRESS, SJS/TEN, akutna generalizirana egzantematozna pustuloza,
English: See the package leaflets for peginterferon alfa and ribavirin for a list of their contraindications (e.g. pregnancy precautions for men and women) since INCIVO must be used in combination with peginterferon alfa and ribavirin.
Croatian: S obzirom da se INCIVO mora primjenjivati u kombinaciji s peginterferonom alfa i ribavirinom, kontraindikacije za peginterferon alfa i ribavirina pogledajte u pripadajućoj uputi o lijeku (npr. mjere zaštite od trudnoće za muškarce i žene).
English: Treatment-Experienced Patients by Subgroup
Croatian: Bolesnice reproduktivne dobi i njihovi partneri
English: Increases in serum uric acid occur very commonly during treatment with INCIVO in combination with peginterferon alfa and ribavirin.
Croatian: Tijekom liječenja INCIVOM u kombinaciji s peginterferonom alfa i ribavirinom vrlo često dolazi do povišenja mokraćne kiseline u serumu.
English: (target not detected) at weeks 4 and 12 of treatment, the SVR rate was 89% (25/28) and the relapse rate was 7%.
Croatian: U bolesnika s prethodnim relapsom u terapijskoj skupini T12/PR24 u kojih je HCV RNK bio nemjerljiv (cilj nije izmjeren) u 4. i 12. tjednu liječenja, stopa SVR iznosila je 89% (25/28), a stopa relapsa 7%.
English: In patients with HCV RNA between 100 IU/ml and 1,000 IU/ml at week 12,
Croatian: Od bolesnika s koncentracijom HCV RNK između 100 IU/ml i 1000 IU/ml u 12. tjednu trajni virološki odgovor postiglo je 2/8 (25%) bolesnika.
English: Use of peginterferon alfa 2a or 2b Two types of peginterferon alfa (2a and 2b) were studied in the Phase 2a open label, randomised
Croatian: U fazi II randomiziranog ispitivanja otvorenog tipa C208 ispitivale su se dvije vrste peginterferona alfa (2a i 2b) u bolesnika koji prethodno nisu bili liječeni.
English: and patients receiving telaprevir 750 mg every 8 hours (q8h).
Croatian: ↓ telaprevir 1 125 mg svakih 8 sati (u odnosu na 750 mg svakih 8 sati)
English: )/PR N = 369 % (n/N)
Croatian: T12(b.i.d.)/PR N = 369 % (n/N)
English: Duration of treatment - Treatment-naïve adults and prior treatment relapsers Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks (see figure 1).
Croatian: INCIVO se mora početi uzimati u kombinaciji s peginterferonom alfa i ribavirinom i primjenjivati tijekom 12 tjedana (vidjeti Sliku 1).
English: Contact your doctor immediately if you get a skin rash.
Croatian: Ako dobijete kožni osip, odmah se javite liječniku.
English: ↑ alprazolam AUC 1.35 (1.23-1.49) Cmax 0.97 (0.92-1.03)
Croatian: Cmin 1,93 (1,55-2,41)
English: You must read the package leaflets for peginterferon alfa and ribavirin for additional information.
Croatian: Za dodatne informacije, morate pročitati upute o lijeku za peginterferon alfa i ribavirin.
English: After weaning, rat pup body weight gain silica colloidal anhydrous sodium lauryl sulphate croscarmellose sodium sodium stearyl fumarate
Croatian: Po prestanku sisanja, porast tjelesne težine mladunčadi štakora vratio se na kalcijev hidrogenfosfat, bezvodni silicijev dioksid, koloidni, bezvodni
English: All treatment regimens had a 48-week duration of peginterferon alfa-2a and ribavirin treatment.
Croatian: U svim terapijskim skupinama liječenje peginterferonom alfa-2a i ribavirinom trajalo je 48 tjedana.
English: - who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders (see
Croatian: INCIVO je indiciran u kombinaciji s peginterferonom alfa i ribavirinom za liječenje odraslih bolesnika s kroničnim hepatitisom C genotipa 1 i kompenziranom bolešću jetre (uključujući cirozu): - koji prethodno nisu bili liječeni, - koji su prethodno bili liječeni samo interferonom alfa (pegiliranim ili nepegiliranim) ili u kombinaciji s ribavirinom, uključujući bolesnike s relapsom, s djelomičnim terapijskim odgovorom i one koji nisu odgovorili na ranije liječenje (vidjeti dijelove 4.4 i 5.1).
English: Ribavirin dose reduction is the preferred strategy for managing treatment-emergent anaemia.
Croatian: Za zbrinjavanje anemije nastale liječenjem, prednost se daje smanjenju doze ribavirina.
English: When administered twice daily (b.i.d.
Croatian: Ako uzimate INCIVO dva puta na dan (ujutro i navečer)
English: Treatment Outcome Treatment-Naïve Patients N = 64 % (n/N)
Croatian: Bolesnici s iskustvom u liječenju prema podskupini S prethodnim relapsom N = 29 % (n/N)
English: Treatment is started at a low dose, which the doctor may then increase slowly until an appropriate dose is reached.
Croatian: Liječenje započinje s malom dozom, koju liječnik potom može polako povećavati dok ne dosegne odgovarajuću dozu.
English: Enzepi is available as capsules (5,000; 10,000; 25,000 and 40,000 units).
Croatian: Lijek Enzepi je dostupan u obliku kapsula (5 000, 10 000, 25 000 i 40 000 jedinica).
English: The full EPAR for Enzepi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Enzepi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Capsules should be swallowed whole and not chewed or crushed.
Croatian: Kapsule se trebaju progutati cijele i ne smiju se žvakati ili drobiti.
English: Other information about Enzepi
Croatian: Ostale informacije o lijeku Enzepi
English: In one main study involving 96 patients, treatment with Enzepi led to the absorption of 84% of the fats consumed by patient over 72 hours compared with 85% absorption with the already authorised medicine.
Croatian: U jednom glavnom ispitivanju koje je uključivalo 96 bolesnika, liječenje lijekom Enzepi dovelo je do apsorpcije 84 % masnoća koje je bolesnik konzumirao u 72 sata, u usporedbi s 85 %-tnom apsorpcijom kod već odobrenog lijeka.
English: For patients who cannot swallow capsules, the capsules may be opened and the content mixed with a small amount of acidic food such as fruit puree which should be swallowed immediately without chewing.
Croatian: Bolesnicima koji ne mogu progutati kapsule one se mogu otvoriti i njihov sadržaj pomiješati s malom količinom kisele hrane kao što je voćni pire, koji treba odmah progutati bez žvakanja.
English: What measures are being taken to ensure the safe and effective use of Enzepi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Enzepi?
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Croatian: Objašnjava kako je Agencija ocijenila proizvod da bi preporučila njegovo odobrenje u EU-u te uvjete za njegovu primjenu.
English: What is Enzepi and what is it used for?
Croatian: Što je Enzepi i za što se koristi?
English: Enzepi should be taken during meals or snacks with a drink of water or juice.
Croatian: Lijek Enzepi treba uzimati tijekom obroka ili međuobroka s vodom ili sokom.
English: This is a summary of the European public assessment report (EPAR) for Enzepi.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Enzepi.
English: Why is Enzepi approved?
Croatian: Zašto je Enzepi odobren?
English: The appropriate dose depends on the symptoms of the disease, amount of fat in the stool, fat content of the diet and the patient's weight.
Croatian: Odgovarajuća doza ovisi o simptomima bolesti, količini masnoća u stolici, udjelu masnoća u prehrani i težini bolesnika.
English: A lack of these enzymes leads to poor growth, weight loss, abdominal pain and diarrhoea.
Croatian: Nedostatak tih enzima uzrokuje premali rast, gubitak težine, abdominalnu bol i proljev.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Enzepi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Enzepi nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: It is not intended to provide practical advice on how to use Enzepi.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Enzepi.
English: Enzepi pancreas powder
Croatian: Enzepi prašak gušterače
English: Enzepi is a medicine used to treat adults and children whose pancreas does not produce enough enzymes (a condition known as pancreatic insufficiency) due to cystic fibrosis or other conditions such as pancreatic cancer.
Croatian: Enzepi je lijek koji se koristi za liječenje odraslih osoba i djece čija gušterača ne proizvodi dovoljno enzima (stanje poznato kao insuficijencija gušterače) zbog cistične fibroze ili drugih bolesti, poput raka gušterače.
English: The CHMP considered that the use of pancreas powder to treat pancreatic insufficiency has been well established in medical practice for more than 20 years.
Croatian: CHMP je zaključio da je korištenje praška gušterače u liječenju insuficijencije gušterače ustaljeno u medicinskoj praksi više od 20 godina.
English: Enzepi will therefore help the body absorb nutrients better, especially fats.
Croatian: Lijek Enzepi stoga pomaže tijelu da bolje apsorbira hranjive tvari, osobito masnoće.
English: Enzepi was shown to be as effective as the already well-known marketed medicine.
Croatian: Lijek Enzepi pokazao se jednako djelotvornim kao i već dobro poznat lijek koji je u prometu.
English: In clinical trials most side effects were mild to moderate in severity.
Croatian: U kliničkim ispitivanjima većina nuspojava bila je blaga do umjerena po ozbiljnosti.
English: The most common side effects with Enzepi (which may affect more than 1 in 100 people) are effects on the gut (abdominal pain, bloating, diarrhoea, vomiting, constipation and nausea) and headache.
Croatian: Najčešće nuspojave lijeka Enzepi (mogu se javiti u više od 1 na 100 osoba) su učinak na crijeva (abdominalna bol, nadutost, proljev, povraćanje, zatvor i mučnina) i glavobolja.
English: What are the risks associated with Enzepi?
Croatian: Koji su rizici povezani s lijekom Enzepi?
English: Enzepi can only be obtained with a prescription.
Croatian: Lijek Enzepi izdaje se samo na recept.
English: For more information about treatment with Enzepi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Enzepi pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svojem liječniku ili ljekarniku.
English: The most important serious side effects observed with all pancreatic enzyme medicines are anaphylactic (allergic) reactions and fibrosing colonopathy (scarring and thickening of the bowel wall).
Croatian: Najvažnije ozbiljne nuspojave zabilježene kod svih lijekova s enzimima gušterače su anafilaktičke (alergijske) reakcije i fibrozirajuća kolonopatija (ožiljkaste promjene i zadebljanja crijevne stijenke).
English: Pancreas powder is a well-known substance that has been authorised in the treatment of pancreatic insufficiency for many years.
Croatian: Prašak gušterače je dobro poznata tvar koja je dugi niz godina odobrena za liječenje insuficijencije gušterače.
English: In terms of safety, Enzepi's side effects are comparable to other marketed products.
Croatian: U pogledu sigurnosti nuspojave lijeka Enzepi usporedive su s drugim lijekovima koji su u prometu.
English: Enzepi has been shown to be as effective as an already authorised medicine containing pancreas powder and used in pancreatic insufficiency.
Croatian: Lijek Enzepi pokazao se jednako djelotvornim kao i već odobren lijek koji sadrži prašak gušterače i koristi se kod insuficijencije gušterače.
English: The active substance of Enzepi, pancreas powder, is intended to replace missing enzymes in patients whose pancreas does not produce sufficient amounts of them.
Croatian: Djelatna tvar lijeka Enzepi, prašak gušterače, namijenjen je zamjeni enzima koji nedostaju u bolesnika čija gušterača ne proizvodi dovoljne količine enzima.
English: The active substance in Enzepi is pancreas powder which is obtained from pig pancreas.
Croatian: Djelatna tvar u lijeku Enzepi je prašak gušterače, koji se dobiva iz svinjske gušterače.
English: For practical information about using Enzepi, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Enzepi pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Pancreas enzymes are needed to digest fats, carbohydrates and proteins.
Croatian: Enzimi gušterače potrebni su za probavu masnoća, ugljikohidrata i bjelančevina.
English: How does Enzepi work?
Croatian: Kako djeluje Enzepi?
English: It contains enzymes that help with the digestion of fats, carbohydrates and proteins.
Croatian: On sadrži enzime koji pomažu pri probavi masnoća, ugljikohidrata i bjelančevina.
English: What benefits of Enzepi have been shown in studies?
Croatian: Koje su koristi lijeka Enzepi utvrđene u ispitivanjima?
English: For the full list of restrictions and all side effects reported with Enzepi, see the package leaflet.
Croatian: Potpuni popis svih ograničenja i nuspojava zabilježenih pri primjeni lijeka Enzepi potražite u uputi o lijeku.
English: How is Enzepi used?
Croatian: Kako se Enzepi koristi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Enzepi have been included in the summary of product characteristics and the package leaflet.
Croatian: U sažetku opisa svojstava lijeka i uputi o lijeku također se nalaze preporuke i mjere opreza za sigurnu i učinkovitu primjenu lijeka Enzepi kojih se zdravstveni radnici i bolesnici trebaju pridržavati.
English: EU/1/16/1156/001 ZINPLAVA
Croatian: EU/1/16/1156/001 ZINPLAVA 25mg/mlKoncentrat za otopinu za infuziju
English: Intravenous use vial (glass)
Croatian: Intravenska primjena bočica (staklo)
English: Blepharitis; keratitis.
Croatian: Blefaritis; keratitis.
English: Such reactions may be allergic in nature.
Croatian: Takve reakcije mogu biti alergijske prirode.
English: Availability of resuscitation equipment must be ensured.
Croatian: Mora se osigurati dostupnost opreme za oživljavanje.
English: a) Grade 1:
Croatian: a) Stupanj 1:
English: Such patients should be closely monitored.
Croatian: Takve bolesnike potrebno je pažljivo pratiti.
English: The recommended infusion period is 120 minutes.
Croatian: Preporučeno vrijeme infuzije je 120 minuta.
English: Tell your doctor if you are pregnant or if you are not using reliable contraception (speak to your doctor if you are not sure).
Croatian: Recite svom liječniku ako ste trudni ili ako ne koristite pouzdanu kontracepciju (razgovarajte sa svojim liječnikom ako niste sigurni).
English: • severe breathing difficulties which develop rapidly
Croatian: • teške poteškoće disanja koje se brzo razvijaju
English: They can occur despite the use of premedication.
Croatian: Mogu nastati usprkos primjeni premedikacije.
English: RAS is one of the most frequently activated family of oncogenes in human cancers.
Croatian: RAS je jedna od najčešće aktiviranih obitelji onkogena u humanim karcinomima.
English: • loss of appetite, leading to weight decrease
Croatian: • gubitak apetita koji uzrokuje smanjenje težine
English: Before the first dose, you will receive an antiallergic medicine in order to reduce the risk of an allergic reaction.
Croatian: Prije prve doze, primiti ćete antialergijski lijek radi smanjenja rizika od alergijske reakcije.
English: Your doctor will calculate the correct dose of Erbitux for you because it depends on your body surface area.
Croatian: Liječnik će izračunati ispravnu dozu Erbituxa za Vas jer ona ovisi o Vašoj tjelesnoj površini.
English: • haemoglobin < 9 g/dL
Croatian: • hemoglobin < 9 g/dl
English: For details, see section 5.1.
Croatian: Za pojedinosti vidjeti dio 5.1.
English: Variable/ statistic
Croatian: varijabla/statistika
English: Current data on the development of HACAs is limited.
Croatian: Postojeći podaci o razvoju HACA su ograničeni.
English: On the basis of this data and since no independent review of imaging data was conducted, results in relation to mutation status are considered non-interpretable.
Croatian: Na temelju ovih podataka te s obzirom da nije provedena neovisna revizija slikovnih podataka, rezultati u vezi statusa mutacija ne smatraju se pogodnima za interpretaciju.
English: In this study EGFR expression was not an inclusion criterion.
Croatian: U ovom ispitivanju ekspresija EGFR nije bila kriterij uključivanja.
English: As a result of this binding, the cancer cell can no longer receive the messages it needs for growth, progression and metastasis.
Croatian: Kao rezultat tog vezivanja, stanica raka ne može više primati poruke koje treba za rast, napredovanje ili metastaziranje.
English: continue slow infusion under close supervision b) Grade 2:
Croatian: nastavite sporu infuziju pod pažljivim nadzorom b) Stupanj 2:
English: The pharmacokinetic results were comparable to those in adults.
Croatian: Farmakokinetički podaci bili su usporedivi s onima u odraslih osoba.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste dobili bez recepta.
English: KRAS mutational status was available for 2072 patients.
Croatian: KRAS mutacijski status bio je dostupan za 2072 bolesnika.
English: Merck Healthcare KGaA Frankfurter Straße 250 64293 Darmstadt Germany
Croatian: Merck Healthcare KGaA Frankfurter Straße 250 64293 Darmstadt Njemačka
English: 1.5 to 6.2 L/m2).
Croatian: 6,2 l/m2).
English: Skin reactions*.
Croatian: Kožne reakcije*.
English: If you have any further questions, ask your doctor.
Croatian: Ako imate dodatnih pitanja, obratite se liječniku.
English: Stevens-Johnson syndrome/toxic epidermal necrolysis.
Croatian: Stevens-Johnsonov sindrom/toksična epidermalna nekroliza.
English: If such symptoms occur, please inform your doctor as soon as possible.
Croatian: Ako se pojave ovi simptomi, molimo obavijestite svog liječnika što je prije moguće.