FrancophonIA/ELRC3.0 huggingface dataset:
English: Cirrhosis was determined by liver biopsy (METAVIR F4) for 14 patients, FibroScan >14.6 kPa for
Croatian: Ciroza je bila određena biopsijom jetre (METAVIR F4) za 14 bolesnika, FibroScan >14,6 kPa za 11 bolesnika ili rezultat FibroTesta ≥0,75 te indeks omjera aspartat aminotransferaza (AST): trombociti (APRI) >2 za 7 bolesnika.
English: Concerning recommended regimens with different HCV genotypes, see section 4.2.
Croatian: Za preporučene režime liječenja s obzirom na različite genotipove HCV-a, vidjeti dio 4.2. Za virološku i kliničku aktivnost protiv pojedinog genotipa, vidjeti dio 5.1.
English: Refer to the respective Summary of Product Characteristics for drug interaction information for other medicinal products in the regimen.
Croatian: Za informacije o interakcijama ostalih lijekova u režimu, pročitajte Sažetke opisa svojstava tih lijekova.
English: daclatasvir + sofosbuvir N=21
Croatian: daklatazvir + sofosbuvir N=21
English: Simeprevir 150 mg once daily (daclatasvir 60 mg once daily)
Croatian: Preporuke za istodobnu primjenu simeprevir 150 mg jedanput na dan (daklatazvir 60 mg jedanput na dan)
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with cobicistat or other strong inhibitors of CYP3A4.
Croatian: Dozu lijeka daklinza potrebno je smanjiti na 30 mg jedanput na dan kada se primjenjuje istodobno s kobicistatom ili drugim snažnim inhibitorima CYP3A4.
English: Triazolam Alprazolam
Croatian: Preporuke za istodobnu primjenu triazolam alprazolam
English: Table 13: Treatment outcomes, daclatasvir in combination with peginterferon alfa and ribavirin (pegIFN/RBV), treatment-naïve patients with HCV genotype 4
Croatian: HCV genotipa 4. Tablica 13: Ishodi liječenja, daklatazvir u kombinaciji s peginterferonom alfa i ribavirinom
English: NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg tablets daclatasvir
Croatian: NAZIV LIJEKA Daklinza 60 mg tablete daklatazvir
English: Prior telaprevir or boceprevir failures daclatasvir + sofosbuvir N=70
Croatian: Bolesnici koji nisu odgovorili na prethodno liječenje telaprevirom ili boceprevirom daklatazvir + sofosbuvir N=70
English: Ribavirin Dosing Guideline
Croatian: Smjernica za doziranje ribavirina
English: Daklinza 60 mg film-coated tablets
Croatian: Daklinza 60 mg filmom obložene tablete
English: ↔ Ribavirin AUC: 0.94 (0.80, 1.11) Cmax: 0.94 (0.79, 1.11) Cmin: 0.98 (0.82, 1.17)
Croatian: AUC: 0,94 (0,80; 1,11) Cmax: 0,94 (0,79; 1,11) Cmin: 0,98 (0,82; 1,17)
English: No dose adjustment of Daklinza is required.
Croatian: Nije potrebno prilagođavati dozu lijeka Daklinza.
English: SVR rates were comparable regardless of HIV regimen, age, race, gender, IL28B allele status, or baseline HCV RNA level.
Croatian: Stope SVR-a bile su usporedive neovisno o režimu liječenja HIV-a, dobi, rasi, spolu, statusu alela
English: ↔ Daclatasvir AUC: 1.15 (1.07, 1.24) Cmax: 0.67 (0.61, 0.74)
Croatian: AUC: 1,15 (1,07, 1,24) Cmax: 0,67 (0,61, 0,74)
English: Treatment-naïve
Croatian: • ošamućenost
English: Increase in gastric pH
Croatian: Povećanje želučanog pH.
English: ↔ Midazolam AUC: 0.87 (0.83, 0.92) Cmax: 0.95 (0.88, 1.04)
Croatian: AUC: 0,87 (0,83; 0,92) Cmax: 0,95 (0,88; 1,04)
English: daclatasvir + sofosbuvir N=13
Croatian: daklatazvir + sofosbuvir N=13
English: ↔ Tacrolimus AUC: 1.00 (0.88, 1.13) Cmax: 1.05 (0.90, 1.23)
Croatian: AUC: 1,00 (0,88; 1,13) Cmax: 1,05 (0,90; 1,23)
English: daclatasvir + sofosbuvir + ribavirin N=56
Croatian: daklatazvir + sofosbuvir + ribavirin N=56
English: Expected due to inhibition of P-gp by daclatasvir:
Croatian: Budući da daklatazvir inhibira P-gp,
English: Skin and subcutaneous tissue disorders common rash, alopecia, pruritus, dry skin Musculoskeletal and connective tissue disorders common arthralgia, myalgia arthralgia, myalgia
Croatian: Poremećaji kože i potkožnog tkiva često osip, alopecija, pruritus, suha koža
English: CYP3A4 inhibition by ritonavir
Croatian: Ritonavir inhibira CYP3A4
English: Coadministration of Daklinza with St. John's wort or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Croatian: Istodobna primjena lijeka Daklinza s gospinom travom ili drugim snažnim induktorima CYP3A4 je kontraindicirana (vidjeti dio 4.3).
English: Verapamil
Croatian: daklatazvir
English: ANTIFUNGALS Ketoconazole 400 mg once daily (daclatasvir 10 mg single dose)
Croatian: ANTIFUNGICI ketokonazol 400 mg jedanput na dan
English: Common (may affect up to 1 in 10 people): difficulty sleeping dizziness migraine nausea (feeling sick), diarrhoea, abdominal pain joint pain, aching or tender muscles, not caused by exercise
Croatian: Često (mogu se javiti u do 1 na 10 osoba): smanjen tek tegobe sa spavanjem, razdražljivost omaglica migrena nedostatak zraka, kašalj, kongestija nosa (začepljen nos)
English: End of treatment HCV RNA undetectable
Croatian: Nemjerljiva razina HCV RNK
English: Treatment-naïve N=101
Croatian: Prethodno liječeni* N=51
English: daclatasvir + sofosbuvir + ribavirin N=20
Croatian: daklatazvir + sofosbuvir + ribavirin N=20
English: Expected due to CYP3A4 induction by the antimycobacterial:
Croatian: Budući da antimikobakterijski lijekovi induciraju CYP3A4, očekuje se:
English: A third treatment group in study ALLY-2 included 50 HCV treatment-naïve HIV co-infected patients who received daclatasvir and sofosbuvir for 8 weeks.
Croatian: HIV-om koji prethodno nisu primali liječenje za HCV i koji su u ovom ispitivanju primali daklatazvir i sofosbuvir tijekom 8 tjedana.
English: Bristol-Myers Squibb B.V. Tel: + 31 (0)30 300 2222
Croatian: Bristol-Myers Squibb spol. s r.o. Tel: +386 1 2355 100
English: No dose adjustment of Daklinza or escitalopram is required.
Croatian: Nije potrebno prilagođavati dozu lijeka Daklinza ni escitaloprama.
English: The Summary of Product Characteristics for the other medicinal products in the regimen should also be consulted before initiation of therapy with Daklinza.
Croatian: Prije početka liječenja lijekom Daklinza, treba pročitati i Sažetke opisa svojstava drugih lijekova koji se primjenjuju u tom režimu.
English: IMMUNOSUPPRESSANTS Cyclosporine 400 mg single dose (daclatasvir 60 mg once daily)
Croatian: ciklosporin u pojedinačnoj dozi od 400 mg (daklatazvir 60 mg jedanput na dan)
English: Vascular disorders common hot flush
Croatian: Krvožilni poremećaji često navala vrućine
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/001 28 tablets (calendar pack) EU/1/14/939/002 28 x 1 tablet
Croatian: EU/1/14/939/001 28 tableta (kalendarski označeno pakiranje)
English: Tablet film-coat
Croatian: Tablični prikaz nuspojava
English: Tacrolimus 5 mg single dose (daclatasvir 60 mg once daily)
Croatian: takrolimus u pojedinačnoj dozi od 5 mg (daklatazvir 60 mg jedanput na dan)
English: *PK parameters for daclatasvir when administered with peginterferon alfa and ribavirin in this study were similar to those observed in a study of HCVinfected subjects administered daclatasvir monotherapy for 14 days.
Croatian: *U ovom su ispitivanju farmakokinetički parametri daklatazvira pri istodobnoj primjeni s peginterferonom alfa i ribavirinom bili slični onima primijećenima u ispitivanju
English: BRISTOL-MYERS SQUIBB, S.A.
Croatian: Bristol-Myers Squibb B.V.
English: daclatasvir + sofosbuvir + ribavirin N=9
Croatian: daklatazvir + sofosbuvir + ribavirin N=9
English: daclatasvir + sofosbuvir + ribavirin N=5
Croatian: daklatazvir + sofosbuvir + ribavirin N=5
English: No dose adjustment of Daklinza or maraviroc is required.
Croatian: Nije potrebno prilagođavati dozu lijeka Daklinza ni maraviroka.
English: Daclatasvir in combination with peginterferon alfa and ribavirin Baseline NS5A RAVs (at M28T, Q30, L31, and Y93 for genotype 1a; at L31 and Y93 for genotype 1b) increase the risk for non-response in treatment-naive patients infected with genotype 1a and genotype 1b infection.
Croatian: Početne varijante NS5A koje su povezane s rezistencijom (M28T, Q30, L31 i Y93 za genotip 1a; L31
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/005 28 tablets (calendar pack) EU/1/14/939/006 28 x 1 tablet
Croatian: EU/1/14/939/005 28 tableta (kalendarski označeno pakiranje)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride).
Croatian: Jedna filmom obložena tableta sadrži 30 mg daklatazvira (u obliku daklatazavir diklorida).
English: Respiratory, thoracic and mediastinal disorders common dyspnoea, dyspnoea exertional, cough, nasal congestion
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja često dispneja, dispneja u naporu, kašalj, kongestija nosa
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 90 mg of daclatasvir (as dihydrochloride).
Croatian: Jedna filmom obložena tableta sadrži 90 mg daklatazvira (u obliku daklatazavir diklorida).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 60 mg of daclatasvir (as dihydrochloride).
Croatian: Jedna filmom obložena tableta sadrži 60 mg daklatazvira (u obliku daklatazvir diklorida).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/003 28 tablets (calendar pack) EU/1/14/939/004 28 x 1 tablet
Croatian: EU/1/14/939/003 28 tableta (kalendarski označeno pakiranje)
English: Impact of baseline NS5A RAVs on cure rates
Croatian: Utjecaj početnih varijanti proteina NS5A koje su povezane s rezistencijom na stope izlječenja
English: Dose modification, interruption and discontinuation Dose modification of Daklinza to manage adverse reactions is not recommended.
Croatian: Ne preporučuje se prilagođavanje doze lijeka Daklinza radi zbrinjavanja nuspojava.
English: ND
Croatian: U
English: ↑ Dabigatran etexilate
Croatian: očekuje se: ↑ dabigatran eteksilat
English: ↓ Daclatasvir
Croatian: ↔ midazolam
English: Expected due to CYP3A4 inhibition by the antibacterial:
Croatian: Budući da antibakterijski lijekovi inhibiraju CYP3A4, očekuje se: ↑ daklatazvir
English: P-gp inhibition by daclatasvir
Croatian: Daklatazvir inhibira P-gp.
English: Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) Tenofovir disoproxil fumarate 300 mg once daily (daclatasvir 60 mg once daily)
Croatian: tenofovir dizoproksilfumarat 300 mg jedanput na dan (daklatazvir 60 mg jedanput na dan)
English: Expected due to CYP3A4 inhibition by boceprevir:
Croatian: Budući da boceprevir inhibira CYP3A4,
English: Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: + 40 (0)21 272 16 00
Croatian: Bristol-Myers Squibb spol. s r.o. Tel: + 420 221 016 111
English: Daklinza is given for 24 weeks, in combination with 24-48 weeks of peginterferon alfa and ribavirin: - If HCV RNA is undetectable at both treatment weeks 4 and 12, all 3 components of the regimen should be continued for a total duration of 24 weeks.
Croatian: Daklinza se primjenjuje tijekom 24 tjedna, u kombinaciji s 24 - 48 tjedana liječenja peginterferonom alfa i ribavirinom:
English: Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 90 mg daclatasvir.
Croatian: Jedna filmom obložena tableta sadrži daklatazvir diklorid u količini koja odgovara 90 mg daklatazvira Pomoćne tvari s poznatim učinkom
English: No dose adjustment of Daklinza or dolutegravir is required.
Croatian: Nije potrebno prilagođavati dozu lijeka Daklinza ni dolutegravira.
English: Do not take Daklinza if you are allergic to daclatasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet) if you are taking (by mouth or other ways that affect the whole body) any of the following medicines - phenytoin, carbamazepine, oxcarbazepine or phenobarbital, used to treat epileptic seizures - rifampicin, rifabutin or rifapentine, antibiotics used to treat tuberculosis - dexamethasone, a steroid used to treat allergic and inflammatory diseases - medicines containing St. John's wort (Hypericum perforatum, a herbal preparation).
Croatian: ako uzimate (kroz usta ili na drugi način koji utječe na cijelo tijelo) neki od sljedećih lijekova - fenitoin, karbamazepin, okskarbazepin ili fenobarbital, koji se koriste za liječenje epileptičkih napadaja
English: ANTICONVULSANTS
Croatian: ANTIMIKOBAKTERIJSKI
English: Expected due to CYP3A4 inhibition by atazanavir/cobicistat: ↑ Daclatasvir
Croatian: CYP3A4, očekuje se: ↑ daklatazvir flukonazol
English: Expected due to CYP3A4 inhibition by the antifungal:
Croatian: Budući da kobicistat inhibira CYP3A4 očekuje se ↑ daklatazvir
English: Response was rapid (at Week 4 91% of daclatasvir-treated patients had HCV RNA <LLOQ).
Croatian: Ishodi liječenja iz ispitivanja AI444042 prikazani su u Tablici 13. Odgovor je bio brz (u 4. tjednu je 91% bolesnika liječenih daklatazvirom imalo HCV RNK <LLOQ).
English: If you get any side effects, talk to your doctor or pharmacist.
Croatian: Uputama o lijeku, obratite se svom liječniku ili ljekarniku.
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz 600 mg once daily (daclatasvir 60 mg once daily/120 mg once daily)
Croatian: efavirenz 600 mg jedanput na dan (daklatazvir 60 mg jedanput na dan/120 mg jedanput na dan)
English: Bristol-Myers Squibb GmbH & Co. KGaA Tel: + 49 89 121 42-0
Croatian: KGaA Tel: + 49 89 121 42-0
English: Darunavir/cobicistat
Croatian: Preporuke za istodobnu primjenu darunavir/kobicistat
English: Hepatic impairment
Croatian: Prethodno neliječeni bolesnici
English: ANTIVIRALS, HIV or HBV Protease inhibitors (PIs) Atazanavir 300 mg/ritonavir 100 mg once daily (daclatasvir 20 mg once daily)
Croatian: atazanavir 300 mg/ritonavir 100 mg jedanput na dan (daklatazvir 20 mg jedanput na dan)
English: AUC: 1.37 (1.24, 1.52) Cmax: 1.30 (1.03, 1.64) Cmin: 1.17 (1.03, 1.32)
Croatian: ↔↑ buprenorfin AUC: 1,37 (1,24, 1,52)Cmax: 1,30 (1,03;
English: Palpitations
Croatian: ANTIDEPRESIVI
English: Expected due to CYP3A4 and P-gp inhibition by verapamil:
Croatian: Budući da verapamil inhibira CYP3A4 i
English: ANTIMYCOBACTERIALS Rifampicin 600 mg once daily (daclatasvir 60 mg single dose)
Croatian: LIJEKOVI rifampicin 600 mg jedanput na dan
English: NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg film-coated tablets daclatasvir
Croatian: Daklinza 30 mg filmom obložene tablete daklatazvir
English: Hypromellose
Croatian: IMUNOSUPRESIVI
English: Category/ Substitution, n (%)
Croatian: HCV-om genotipa 1 - 3 koji nisu postigli SVR12 Kategorija/ supstitucija, n (%)
English: Expected due to CYP3A4 induction by the anticonvulsant:
Croatian: CYP3A4, očekuje se:
English: Fainting
Croatian: • nesvjesticu
English: Other HCV antivirals
Croatian: Prethodno neliječeni za HCV
English: Expected: ↔ Daclatasvir
Croatian: očekuje se: ↑ daklatazvir
English: Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: +371 67708347
Croatian: Bristol-Myers Squibb spol. s r.o. TEL: +385 1 2078 508
English: Virologic failure
Croatian: ↔ ciklosporin
English: Digoxin 0.125 mg once daily (daclatasvir 60 mg once daily)
Croatian: LIJEKOVI S DJELOVANJEM NA KARDIOVASKULARNI SUSTAV Antiaritmici digoksin 0,125 mg jedanput na dan (daklatazvir 60 mg jedanput na dan)
English: BRISTOL-MYERS SQUIBB A.E. Τηλ: + 30 210 6074300
Croatian: Τηλ: + 30 210 6074300
English: Route of administration Immediate Packaging Pack size
Croatian: Put primjene Unutarnje pakovanje
English: 90 (3 x 30) tablets
Croatian: 90 (3 x 30) tableta
English: Pharmaceutical Form Route of Administration
Croatian: Farmaceutski oblik Put primjene
English: Packaging Package size l t o r
Croatian: Veličina pakovanja koncentrat za otopinu za infuziju
English: EU Number
Croatian: EMA broj postupka ime
English: Therefore, your doctor may decide that you should not use this medicine.
Croatian: Stoga vaš liječnik može odlučiti da ne smijete uzimati ovaj lijek.
English: The experience in children and adolescents is limited.
Croatian: Iskustvo u djece i adolescenata je ograničeno.
English: 117 allée des Parcs 69800 Saint-Priest France
Croatian: 117 allée des Parcs 69800 Saint-Priest Francuska
English: - nausea and headaches.
Croatian: - mučnina i glavobolje.
English: • Any part appears cracked or broken.
Croatian: • Ako bilo koji dio štrcaljke izgleda napuknut ili slomljen.
English: - some changes may occur in your blood, but these will be detected by routine blood tests.
Croatian: - moguće su i promjene u krvi, ali one će se otkriti prilikom rutinskih krvnih pretraga.
English: Fulphila is not recommended for use in children and adolescents due to insufficient data on safety and effectiveness.
Croatian: Fulphila se ne preporučuje za primjenu u djece i adolescenata zbog nedostatnih podataka o sigurnosti i djelotvornosti.
English: Remove the syringe from the refrigerator.
Croatian: Izvadite štrcaljku iz hladnjaka.
English: B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”.
Croatian: B GURAJTE klip polaganim i postojanim pritiskom dok ne osjetite ili ne čujete “škljoc”.
English: If there are particles in it, you must not use it.
Croatian: Ako sadrži vidljive čestice, ne smijete ga koristiti.
English:  Do not try to warm the syringe by using a heat source such as hot water or microwave.
Croatian:  Ne pokušavajte ugrijati štrcaljku korištenjem izvora topline kao što su vruća voda ili mikrovalna pećnica.
English: Common (≥ 1/100 to < 1/10)
Croatian: (≥ 1/100 do < 1/10)
English: Fulphila has not been tested in pregnant women.
Croatian: Fulphila nije ispitivana u trudnica.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 November 2018
Croatian: Datum prvog odobrenja: 20. studenog 2018.
English: Do not warm the syringe in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: Ne zagrijavajte štrcaljku ni na koji drugi način (primjerice, u mikrovalnoj pećnici ili u vrućoj vodi).
English: Sweet's syndrome (acute febrile dermatosis)1,2;
Croatian: Sweetov sindrom (akutna febrilna dermatoza)1,2;
English: Stop using Fulphila and seek medical attention immediately if you notice any of the symptoms described in section 4.
Croatian: Prestanite s primjenom lijeka Fulphila i odmah potražite medicinsku pomoć ako primijetite bilo koji od simptoma opisanih u dijelu 4.
English: If you become pregnant during Fulphila treatment, please inform your doctor.
Croatian: Ukoliko zatrudnite tijekom primjene lijeka Fulphila, molimo obavijestite liječnika.
English: Only use each syringe for one injection.
Croatian: Zapamtite Svaku štrcaljku koristite samo za jedno injiciranje.
English: Do not inject into areas where the skin is tender, bruised, red, or hard.
Croatian: Ne primjenjujte injekciju na područjima gdje je koža osjetljiva, s modricama, crvena ili tvrda.
English: 1 See section “Description of selected adverse reactions” below.
Croatian: 1 Vidjeti dio „Opis odabranih nuspojava“ ispod.
English: Important Before you use a Fulphila pre-filled syringe with automatic needle guard, read this important information:
Croatian: Prije korištenja Fulphila napunjene štrcaljke s automatskim štitnikom za iglu, pročitajte ove važne informacije:
English: Your doctor may decide that it would be more convenient for you to inject Fulphila yourself.
Croatian: Vaš liječnik može odlučiti da će Vam biti pogodnije ako si sami injicirate lijek Fulphila.
English: What Fulphila is and what it is used for
Croatian: Što je Fulphila i za što se koristi
English: Fulphila is for use in adults aged 18 and over.
Croatian: Fulphila se primjenjuje u odraslih osoba starijih od 18 godina.
English: Fulphila left at room temperature for more than 72 hours should be discarded.
Croatian: Fulphila ostavljena na sobnoj temperaturi dulje od 72 sata mora se baciti.
English: Do not shake Fulphila vigorously as this may affect its activity.
Croatian: Ne tresite snažno lijek Fulphila jer to može utjecati na njegovu aktivnost.
English: After injecting the liquid, remove the needle and let go of your skin.
Croatian: Nakon injiciranja tekućine, izvucite iglu i pustite kožu.
English:  Do not use the pre-filled syringe if it has been dropped on a hard surface.
Croatian:  Ne upotrebljavajte napunjenu štrcaljku ako je prethodno pala na tvrdu površinu.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka mora se jasno zabilježiti.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fulphila therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Nužno je donijeti odluku o tome treba li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Fulphila uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: B Carefully pull the grey needle cap straight out and away from your body.
Croatian: B Pažljivo i ravno povucite sivu kapicu s igle dalje od Vašeg tijela.
English: Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment.
Croatian: Steven-Johnsonov sindrom, koji može biti životno ugrožavajući ili smrtonosan, rijetko je prijavljen kod liječenja pegfilgrastimom.
English: Specific interaction or metabolism studies have not been performed, however, clinical trials have not indicated an interaction of pegfilgrastim with any other medicinal products.
Croatian: Nisu provedena specifična ispitivanja interakcija ili metabolizma, no klinička ispitivanja nisu upućivala na interakciju pegfilgrastima s bilo kojim drugim lijekovima.
English: Fulphila may be used if it is accidentally frozen for a single period of less than 24 hours.
Croatian: Fulphila se može upotrijebiti ako je bila slučajno zamrznuta u jednokratnom razdoblju kraćem od 24 sata.
English: Your doctor will check your blood and urine regularly as Fulphila can harm the tiny filters inside your kidneys (glomerulonephritis).
Croatian: Vaš će liječnik redovito provjeravati Vašu krv i mokraću jer Fulphila može oštetiti sitne filtre unutar Vaših bubrega (glomerulonefritis).
English: Other medicines and Fulphila
Croatian: Drugi lijekovi i Fulphila
English: The frequency category was estimated from a statistical calculation based upon 1,576 patients receiving pegfilgrastim in nine randomised clinical trials.
Croatian: Kategorija učestalosti je procijenjena statističkim izračunom na temelju 1576 bolesnika koji su pegfilgrastim primali u devet randomiziranih kliničkih ispitivanja.
English: BATCH NUMBER Lot:
Croatian: 13. BROJ SERIJE Lot:
English: Stop using Fulphila if you develop these symptoms and contact your doctor or seek medical attention immediately.
Croatian: Prestanite koristiti lijek Fulphila ako razvijete ove simptomi i obratite se liječniku ili odmah potražite medicinsku pomoć.
English: What you need to know before you use Fulphila Do not use Fulphila - if you are allergic to pegfilgrastim, filgrastim or any of the other ingredients of this medicine (listed in section 6).
Croatian: Što morate znati prije nego počnete primjenjivati lijek Fulphila Nemojte primjenjivati lijek Fulphila - ako ste alergični na pegfilgrastim, filgrastim ili neki drugi sastojak ovog lijeka (pogledajte dio 6.).
English:  Do not recycle pre-filled syringes or throw them into household waste.
Croatian: X Nemojte reciklirati iskorištene štrcaljke ili ih bacati u kućni otpad.
English: Check the appearance of Fulphila.
Croatian: Provjerite izgled lijeka Fulphila.
English: In animal models concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Croatian: Na životinjskim modelima se pokazalo da je istodobna primjena pegfilgrastima i 5-fluorouracila (5-FU) ili drugih antimetabolita potencirala mijelosupresiju.
English: Push the plunger all the way down as far as it will go to inject all the liquid.
Croatian: Gurajte klip do kraja dokle god je moguće kako biste injicirali svu tekućinu.
English: Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30°C) it must either be used within 3 days or disposed of.
Croatian: Kada štrcaljku jednom izvadite iz hladnjaka te ona dosegne sobnu temperaturu (ne višu od 30 °C), mora se upotrijebiti u roku od 3 dana ili baciti.