FrancophonIA/ELRC3.0 huggingface dataset:
English: Psychiatric and Central Nervous System (CNS): Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Pegasys therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Croatian: Psihijatrijski poremećaji i središnji živčani sustav (SŽS): U nekih su bolesnika tijekom liječenja lijekom Pegasys primijećeni teški učinci na SŽS, posebno depresija, samoubilačke sklonosti i pokušaji samoubojstva.
English: • Pegasys 180 mcg/week for 72 weeks
Croatian: • Pegasys 180 mikrograma/tjedan kroz 72 tjedna
English: If treatment with alfa interferon is judged necessary in these patients, the presence of psychiatric co-morbidities and the potential for other substance use should be carefully assessed and adequately managed before initiating therapy.
Croatian: Ako se liječenje interferonom alfa u takvih bolesnika ocijeni neophodnim, prije započinjanja liječenja treba pažljivo provjeriti postoje li popratne psihijatrijske bolesti ili rizik od uživanja sredstava ovisnosti te ih na odgovarajući način zbrinuti.
English: The response rate was lower in patients with no to minimal increase in ALT level at baseline (see Section 5.1).
Croatian: Stopa odgovora na liječenje bila je niža u bolesnika u kojih razina ALT-a na početku liječenja nije bila povišena ili je bila minimalno povišena (vidjeti dio 5.1).
English: Please be sure to read the ribavirin package leaflet also.
Croatian: Obavezno pročitajte i uputu o lijeku za ribavirin.
English: The conjugation of PEG reagent (bis-monomethoxypolyethylene glycol) to interferon alfa-2a forms a pegylated interferon alfa-2a (Pegasys).
Croatian: Konjugacijom PEG reagensa (bis-monometoksipolietilenglikol) s interferonom alfa-2a, dobiven je pegilirani interferon alfa-2a (Pegasys).
English: Table 7: Ribavirin dosing recommendations for paediatric patients with chronic hepatitis C aged 5 to 17 years
Croatian: Tablica 7: Preporuke za doziranje ribavirina za pedijatrijske bolesnike s kroničnim hepatitisom C u dobi od 5 do 17 godina
English: Study NV15942
Croatian: Ispitivanje NV15942
English: The negative predictive value for sustained response in patients treated with Pegasys in monotherapy was 98%.
Croatian: Negativna prediktivna vrijednost za trajni odgovor u bolesnika liječenih samo lijekom Pegasys bila je
English: Similarly for patients with cirrhosis or transition to cirrhosis, the frequencies of withdrawal from Pegasys treatment and ribavirin treatment were higher in the 72-week treatment arms (13% and 15%) than in the 48-week arms (6% and 6%).
Croatian: Slično tome, u bolesnika s cirozom ili razvojem ciroze, učestalost prekida liječenja lijekom Pegasys i prekida liječenja ribavirinom bila je veća u grupama koje su liječene 72 tjedna (13% odnosno 15%) nego u grupama koje su liječene 48 tjedana (6% odnosno 6%).
English: Ribavirin therapy is contraindicated in women who are pregnant.
Croatian: U trudnica je liječenje ribavirinom kontraindicirano.
English: 1 ml of solution for injection in vial (Type I glass) with stopper (rubber butyl).
Croatian: 1 ml otopine za injekciju u bočici (staklo tipa I) s čepom (butilna guma).
English: Table 11: Performance of individual biomarkers at Week 12 of therapy in CHB HBeAg-positive and HBeAg-negative patients according to genotype
Croatian: Tablica 11: Prognostičke vrijednosti pojedinih bioloških biljega u 12. tjednu liječenja u HBeAg-pozitivnih i HBeAg-negativnih bolesnika s kroničnim hepatitisom B prema genotipu
English: Consideration should be given to replacing zidovudine in a combination anti-retroviral therapy regimen if this is already established.
Croatian: Ukoliko je došlo do anemije, treba razmotriti zamjenu zidovudina u režimu kombinirane antiretrovirusne terapije.
English: Patients infected with HCV genotype 2 or 3 who have detectable HCV RNA at week 4, regardless of pre-treatment viral load should receive 24 weeks of therapy.
Croatian: Bolesnici zaraženi HCV-om genotipa 2 ili 3 kod kojih je HCV RNK mjerljiva u 4. tjednu, bez obzira na količinu virusa prije liječenja, moraju biti podvrgnuti liječenju 24 tjedna.
English: ● the medicine is any colour besides colourless to light yellow
Croatian: ● ako lijek nije bezbojan do svijetložut
English: For information on predictive values for ontreatment response, see section 5.1.
Croatian: Za informacije o prediktivnim vrijednostima odgovora tijekom liječenja vidjeti dio 5.1. Kronični hepatitis C
English: Liver and renal graft rejections have been reported with Pegasys, alone or in combination with ribavirin.
Croatian: Odbacivanje jetrenog i bubrežnog presatka prijavljeno je kod liječenja samo lijekom Pegasys ili u kombinaciji s ribavirinom.
English: Decreases in haemoglobin, neutrophils, platelets or increased ALT may require dose reduction or permanent discontinuation from treatment (see section 4.2).
Croatian: Sniženje vrijednosti hemoglobina, neutrofila i trombocita ili porast vrijednosti ALT-a može zahtijevati smanjenje doze ili Trajan prekid liječenja (vidjeti dio 4.2).
English: In study WV16240, the primary efficacy endpoints were HBeAg seroconversion and HBV-DNA below 105 copies/ml.
Croatian: U ispitivanju WV16240 primarni pokazatelji djelotvornosti bili su HBeAg serokonverzija i HBV-DNK manje od kopija/ml.
English: 1 level reduction (mcg)
Croatian: 1. razina smanjenja (mikrogrami)
English: copies/mL.
Croatian: kopija/ml
English: May cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Croatian: Može izazvati toksične reakcije te anafilaktoidne reakcije u dojenčadi i djece mlađe od 3 godine.
English: 2 level reduction (mcg)
Croatian: 2. razina smanjenja (mikrogrami)
English: The duration of treatment with Pegasys in combination with ribavirin in paediatric patients with CHC depends on viral genotype.
Croatian: Trajanje liječenja lijekom Pegasys u kombinaciji s ribavirinom u pedijatrijskih bolesnika s kroničnim hepatitisom C ovisi o genotipu virusa.
English: In 13 patients with ESRD requiring chronic HD, administration of Pegasys 135 mcg once weekly resulted in 34% lower peginterferon alfa-2a exposure than in patients with normal renal function.
Croatian: U 13 bolesnika u terminalnoj fazi bubrežne bolesti kojima je bila potrebna kronična hemodijaliza, primjena lijeka Pegasys u dozi od 135 mikrograma jedanput tjedno dovela je do 34% niže izloženosti peginterferonu alfa-2a nego u bolesnika s normalnom funkcijom bubrega.
English: Reports of fatal hepatic failure as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactataemia/lactic acidosis have been reported with use of ribavirin.
Croatian: U slučajevima primjene ribavirina, zabilježene su pojave zatajenja jetre sa smrtnim ishodom, kao i periferna neuropatija, pankreatitis i simptomatska hiperlaktatemija/laktička acidoza.
English: Patients infected with HCV genotype 1 who have detectable HCV RNA at week 4 regardless of pre-treatment viral load should receive 48 weeks of therapy.
Croatian: Bolesnici zaraženi HCV-om genotipa 1 u kojih je HCV RNK mjerljiva u 4. tjednu, bez obzira na količinu virusa prije liječenja, moraju biti podvrgnuti liječenju tijekom 48 tjedana.
English: Table 2: Predictive value of week 12 virological response at the recommended dosing regimen while on Pegasys combination therapy in adult patients with chronic hepatitis C Genotype
Croatian: Tablica 2: Prediktivna vrijednost virološkog odgovora u 12. tjednu primjene preporučenog načina doziranja kombinirane terapije lijekom Pegasys u odraslih bolesnika s kroničnim hepatitisom C
English: Chronic hepatitis B - adult patients
Croatian: Kronični hepatitis B - odrasli bolesnici
English: ● The active substance is peginterferon alfa-2a.
Croatian: • Djelatna tvar je peginterferon alfa-2a.
English: Keep the pre-filled pen pressed on the skin for 10 seconds for injection to complete.
Croatian: Da ubrizgavanje bude potpuno, držite napunjenu brizgalicu pritisnutu na kožu 10 sekundi.
English: Alcohol pad
Croatian: Vatu natopljenu alkoholom
English: 3 level reduction (mcg)
Croatian: 3. razina smanjenja (mikrogrami)
English: From the NR16141study, 14 children 2 to 8 years of age with CHC received Pegasys monotherapy at a dose of: 180 mcg x BSA of the child/1.73 m2.
Croatian: U ispitivanju NR16141, 14 djece u dobi od 2 do 8 godina s kroničnim hepatitisom C primalo je monoterapiju lijekom Pegasys u dozi od 180 mikrograma x djetetov BSA/1,73 m2.
English: When increases in ALT levels are progressive despite dose reduction, or are accompanied by increased bilirubin or evidence of hepatic decompensation, therapy should be discontinued (see section 4.4).
Croatian: Nastavi li ALT i dalje progresivno rasti usprkos smanjenju doze odnosno ukoliko je rast praćen i povišenim bilirubinom ili znakovima dekompenzacije jetre, liječenje treba prekinuti (vidjeti dio 4.4).
English: In a direct comparison with 90 micrograms, the 180 micrograms-dose was associated with superior sustained virological response in patients with cirrhosis, but in a study in non-cirrhotic patients very similar results were obtained with doses of 135 micrograms and 180 micrograms.
Croatian: Odgovor na dozu kod liječenja samo lijekom Pegasys U izravnoj usporedbi s dozom od 90 mikrograma, doza od 180 mikrograma pokazala je bolji trajni virološki odgovor u bolesnika s cirozom, dok su u ispitivanju bolesnika bez ciroze dobiveni rezultati za doze od 135 mikrograma i 180 mikrograma bili vrlo slični.
English: Lift the pre-filled pen straight up (90° angle).
Croatian: Podignite napunjenu brizgalicu okomito (pod kutom od 90°).
English: Reproductive system disorders: Impotence (inability to maintain an erection) General disorders: Chest pain, flu-like illness, malaise (not feeling well), lethargy, hot flushes, thirst
Croatian: Poremećaji reprodukcijskog sustava: impotencija (nemogućnost zadržavanja erekcije) Opći poremećaji: bol u prsištu, bolest nalik gripi, opće loše stanje, letargija, napadi vrućine, žeđ
English: ● With one hand, pinch a fold of loose skin.
Croatian: Jednom rukom uhvatite nabor kože.
English: A prolongation of the menstrual cycle has been seen with peginterferon alfa-2a in female monkeys (see section 5.3).
Croatian: Pri primjeni peginterferona alfa-2a u ženki majmuna opaženo je produljenje menstrualnog ciklusa (vidjeti dio 5.3).
English: Haematologic laboratory abnormalities observed during the first 20 weeks of the trial included anaemia (26% of patients experienced a haemoglobin level of <10 g/dl), neutropenia (30% experienced an ANC
Croatian: Laboratorijski hematološki poremećaji primijećeni tijekom prvih 20 tjedana ispitivanja obuhvaćali su anemiju (u 26% bolesnika razina hemoglobina bila je < 10 g/dl), neutropeniju (u 30% bolesnika
English: Chest pain, influenza like illness, malaise, lethargy, hot flushes, thirst
Croatian: bol u prsištu, bolest nalik gripi, slabost, letargija, navale vrućine, žeđ
English: Available in packs of 1, 4 or a multipack of 12 (2 packs of 6) pre-filled syringes.
Croatian: Dostupno je pakiranje s 1, 4 ili višestruko pakiranje s 12 (2 pakiranja s po 6) napunjenih štrcaljki.
English: ● if you are allergic to peginterferon-alfa-2a, to any interferon or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na peginterferon alfa-2a, bilo koji interferon ili neki drugi sastojak ovog lijeka
English: Patients with severe renal impairment receiving Pegasys 180 mcg once weekly showed a 60% higher peginterferon alfa-2a exposure than patients with normal renal function, therefore a reduced dose of Pegasys 135 mcg once weekly is recommended in patients with severe renal impairment.
Croatian: Bolesnici s teškim oštećenjem bubrežne funkcije koji su primali Pegasys u dozi od 180 mikrograma jedanput tjedno imali su 60% veću izloženost peginterferonu alfa-2a nego bolesnici s normalnom funkcijom bubrega; stoga se u bolesnika s teškim oštećenjem bubrežne funkcije preporučuje niža doza lijeka Pegasys od 135 mikrograma jedanput tjedno.
English: ● Clean and disinfect the skin where the injection is to be made with a cleansing swab.
Croatian: Vatom za čišćenje očistite i dezinficirajte mjesto na koži u koje ćete ubrizgati injekciju.
English: Breathing disorders: Shortness of breath with activity, nose bleeds, nose and throat inflammation, infections of the nose and sinuses (air-filled spaces found in the bones of the head and face), runny nose, sore throat
Croatian: Poremećaji dišnog sustava: nedostatak zraka pri fizičkoj aktivnosti, krvarenje iz nosa, upala nosa ili grla, infekcije nosa i sinusa (zrakom ispunjenih prostora koji se nalaze u kostima glave i lica), curenje nosa, grlobolja
English: Pinch and hold a fold of skin at the injection site with your free hand, such that the needle-shield can rest on the skin-fold firmly and safely.
Croatian: Uhvatite kožu u nabor i držite je prstima slobodne ruke na mjestu injekcije tako da se štitnik igle čvrsto osloni na kožni nabor.
English: Study NV15495
Croatian: Ispitivanje NV15495
English: All patients received ribavirin (1000 or 1200 mg/day) in combination with Pegasys.
Croatian: Svi su bolesnici uz Pegasys primali i ribavirin (1000 ili 1200 mg/dan).
English: INFORMATION IN BRAILLE pegasys 90 mcg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU pegasys 90 mcg
English: Wheezing Interstitial pneumonitis including fatal outcome, pulmonary embolism
Croatian: rinitis, grlobolja piskanje intersticijski pneumonitis uključujući smrtni ishod, plućna embolija plućna arterijska hipertenzija
English: Place used pre-filled pen and cap in a puncture-proof disposable container that is available through your pharmacy or healthcare provider.
Croatian: Stavite iskorištenu brizgalicu i zatvarač u spremnik za odlaganje koji se ne može probušiti, a kojega možete dobiti u svojoj ljekarni ili od svojega zdravstvenog radnika.
English: Pegasys in combination with ribavirin is indicated for the treatment of CHC in treatment-naïve children and adolescents 5 years of age and older who are positive for serum HCV-RNA.
Croatian: Pegasys je u kombinaciji s ribavirinom indiciran za liječenje kroničnog hepatitisa C u djece i adolescenata u dobi od 5 ili više godina koji prethodno nisu bili liječeni i koji imaju pozitivan nalaz HCV RNK u serumu.
English: All patients should have a baseline eye examination.
Croatian: Prije početka liječenja, svi bolesnici trebaju napraviti pregled očiju.
English: Interferon alfa-2a 6 MIU/3 MIU
Croatian: Interferon alfa-2a 6 MIU/3
English: In clinical trials with Pegasys in HBV, marked transaminase flares have been accompanied by mild changes in other measures of hepatic function and without evidence of hepatic decompensation.
Croatian: Znatan nagli porast razina transaminaza primijećen u kliničkim ispitivanjima lijeka Pegasys pri liječenju HBV-a bio je popraćen blagim promjenama u drugim parametrima jetrenih funkcija i bez znakova dekompenzacije jetre.
English: Blindness transient, retinal exudates, visual impairment eye irritation, eye pain, eye pruritis
Croatian: Poremećaji oka prolazna sljepoća, eksudati u mrežnici, poremećaj vida, iritacija oka, bol u oku, svrbež oka
English: Very rare Frequency not known
Croatian: Manje često Rijetko
English: With the exception of pyrexia, the frequency of the majority of the reported adverse reactions was notably less in CHB patients treated with Pegasys monotherapy compared with CHC patients treated with Pegasys monotherapy (see Table 9).
Croatian: Izuzev vrućice, učestalost većine prijavljenih nuspojava bila je zamjetno niža u bolesnika s kroničnim hepatitisom B koji su primali monoterapiju lijekom Pegasys u usporedbi s bolesnicima s kroničnim hepatitisom C koji su primali monoterapiju lijekom Pegasys (vidjeti tablicu 9).
English: Table 1: Dosing recommendations for combination therapy for adult patients with chronic hepatitis C
Croatian: Tablica 1: Preporučene doze za kombiniranu terapiju kod odraslih bolesnika s kroničnim hepatitisom C
English: In study NV17317 in patients infected with viral genotype 2 or 3, all patients received Pegasys 180 mcg sc qw and a ribavirin dose of 800 mg and were randomised to treatment for either 16 or 24 weeks.
Croatian: U ispitivanju NV17317 na bolesnicima zaraženim virusnim genotipom 2 ili 3, svi su bolesnici primali Pegasys u dozi od 180 mikrograma primijenjenih supkutano jedanput tjedno i ribavirin u dozi od 800 mg, a randomizirani su za liječenje ili 16 ili 24 tjedna.
English: Pegasys given alone or in combination with ribavirin is usually given at a dose of 180 micrograms once a week.
Croatian: Pegasys primijenjen sam ili u kombinaciji s ribavirinom obično se primjenjuje jedanput tjedno u dozi od 180 mikrograma.
English: ● The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, acetic acid and water for injections.
Croatian: • Drugi sastojci su natrijev klorid, polisorbat 80, benzilni alkohol, natrijev acetat, acetatna kiselina i voda za injekcije.
English: • Pegasys 180 mcg/week for 48 weeks
Croatian: • Pegasys 180 mikrograma/tjedan kroz 48 tjedana
English: Never re-attach protective cap after removal.
Croatian: Zaštitni zatvarač, nakon što ste ga skinuli, nikad ne vraćajte natrag.
English: The strength indicates the quantity of the interferon alfa-2a moiety of peginterferon alfa-2a without consideration of the pegylation.
Croatian: Iskazana količina odnosi se na interferon alfa-2a u peginterferonu alfa-2a, dakle bez pegilacije.
English: Genotype 4 with RVR*
Croatian: Genotip 4 s RVR*
English: *Results indicate undetectable HCV-RNA defined as HCV RNA less than 50 IU/ml at 24 weeks post-treatment using the AMPLICOR HCV test v2.
Croatian: *rezultati ukazuju na nemjerljivu razinu HCV-RNK, definiranu kao nalaz HCV RNK manji od 50 IU/ml 24 tjedna nakon liječenja primjenom AMPLICOR HCV testa verzija 2. **predviđeno trajanje liječenja bilo je 48 tjedana bez obzira na genotip
English: Available in packs containing 1, 4 or 12 pre-filled pens.
Croatian: Dostupno u pakiranjima koja sadrže 1, 4 ili 12 napunjenih brizgalica.
English: Available in packs of 1 or 4 vials.
Croatian: Dostupno je pakiranje s 1 ili 4 bočice.
English: Heart and blood vessel disorders: Rapid heart rate, pulsation of the heart beats, swelling in the extremities, flushing
Croatian: Poremećaji srca i krvnih žila: brzi otkucaji srca, pulsiranje otkucaja srca, oticanje udova, navale crvenila
English: ● Remove the needle guard from the syringe needle (5).
Croatian: Uklonite zaštitni poklopac s igle štrcaljke (5).
English: Table 23: HBeAg seroconversion rates (%) by HBV genotype and baseline ALT levels Group A (Pegasys treatment) (N=101)
Croatian: Tablica 23: Stope HBeAg serokonverzije (%) prema genotipu HBV-a i početnoj vrijednosti ALT-a
English: ● Inject the solution by gently pushing the plunger all the way down to the appropriate graduation.
Croatian: Ubrizgajte otopinu lagano potiskujući klip sve do odgovarajuće oznake.
English: Neoplasms benign and malignant disorders: Liver tumour Immune system disorders: Sarcoidosis (areas of inflamed tissue occurring throughout the body), inflammation of the thyroid
Croatian: Poremećaji imunološkog sustava: sarkoidoza (područja upaljenog tkiva po cijelom tijelu), upala štitne žlijezde
English: Tell your doctor immediately if you notice any of the following side effects: severe chest pain; persistent cough; irregular heartbeat; trouble breathing; confusion; depression; severe stomach pain; blood in stool (or black, tarry stools); severe nosebleed; fever or chills; problems with your eyesight.
Croatian: Ako se pojavi bilo koja od sljedećih nuspojava odmah se obratite liječniku: jaka bol u prsnom košu, uporan kašalj, nepravilni otkucaji srca, poteškoće s disanjem, smetenost, depresija, jaka bol u trbuhu, krv u stolici (crna stolica, nalik na katran), jako krvarenje iz nosa, vrućica ili zimica, poteškoće s vidom.
English: • Combination with telbivudine (see section 4.5)
Croatian: • kombinacija lijeka Pegasys i telbivudina (vidjeti dio 4.5).
English: In a clinical trial of non-responder patients to prior pegylated interferon alfa-2b/ribavirin, which exposed patients to either 48 or 72 weeks of treatment, the frequency of withdrawal for adverse events or laboratory abnormalities from Pegasys treatment and ribavirin treatment was 6% and 7%, respectively, in the 48 week arms and 12% and 13%, respectively, in the 72 week arms.
Croatian: U kliničkom ispitivanju provedenom u bolesnika koji nisu odgovorili na ranije liječenje pegiliranim interferonom alfa-2b/ribavirinom, a u kojem su bolesnici liječeni u trajanju od 48 ili 72 tjedna, učestalost prekida liječenja lijekom Pegasys i prekida liječenja ribavirinom zbog nuspojava ili laboratorijskih poremećaja bila je 6% odnosno 7% u grupi koja je liječena 48 tjedana te 12% odnosno 13% u grupi koja je liječena 72 tjedna.
English: In the NV17424 (PEDS-C) study, previously untreated paediatric patients 5 to 17 years of age (55% <12 years old) with compensated CHC and detectable HCV RNA were treated with Pegasys 180 mcg x BSA/1.73 m2 once weekly for 48 weeks with or without ribavirin 15 mg/kg/day.
Croatian: U ispitivanju NV17424 (PEDS-C) su prethodno neliječeni pedijatrijski bolesnici u dobi od 5 do 17 godina (55% mlađi od 12 godina) s kompenziranim kroničnim hepatitisom C i mjerljivom razinom HCV RNK liječeni lijekom Pegasys u dozi od 180 mikrograma x BSA/1,73 m2 jedanput tjedno tijekom 48 tjedana, sa ili bez ribavirina u dozi od 15 mg/kg na dan.
English: Chronic hepatitis C in adult patients
Croatian: Kronični hepatitis C u odraslih bolesnika
English: Patients with moderate renal impairment receiving Pegasys 180 mcg once weekly exhibited similar peginterferon alfa-2a plasma exposures compared to patients with normal renal function.
Croatian: Bolesnici s umjerenim oštećenjem bubrežne funkcije koji su primali Pegasys u dozi od 180 mikrograma jedanput tjedno imali su sličnu izloženost peginterferonu alfa-2a u plazmi kao i bolesnici s normalnom funkcijom bubrega.
English: To remove air bubbles from the syringe, hold the syringe with the needle pointing up.
Croatian: Da biste iz štrcaljke uklonili mjehuriće zraka, primite štrcaljku s iglom okrenutom prema gore.
English: The virological responses of HCV monoinfected patients treated with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load and in relation to genotype, pre-treatment viral load and rapid virological response at week 4 are summarised in Table 14 and Table 15, respectively.
Croatian: Virološki odgovori bolesnika zaraženih HCV-om liječenih kombinacijom lijeka Pegasys i ribavirina ovisno o genotipu i količini virusa prije liječenja te ovisno o genotipu, količini virusa prije liječenja i brzom virološkom odgovoru u 4. tjednu sažeti su u tablici 14, odnosno tablici 15.
English: In paediatric patients, ribavirin treatment-associated toxicities, such as treatment-emergent anaemia, will be managed by reduction of the full dose.
Croatian: Toksičnosti povezane s liječenjem ribavirinom, poput anemije koja se javi zbog liječenja, u pedijatrijskih se bolesnika zbrinjavaju smanjivanjem pune doze.
English: How to inject Pegasys
Croatian: Kako ubrizgati Pegasys
English: In CHC clinical trials with adult patients, isolated increases in ALT (≥ 10x upper limit of normal [ULN], or ≥ 2x BL for patients with a BL ALT ≥ 10x ULN) which resolved without dose-modification were observed in 8 of 451 patients treated with combination therapy.
Croatian: U kliničkim ispitivanjima kroničnog hepatitisa C u odraslih bolesnika, u 8 od 451 bolesnika koji su primali kombinaciju lijekova, zamijećeni su izolirani slučajevi povećanja razina ALT-a (≥10x od gornje granice normale [GGN], odnosno ≥2x od početne vrijednosti u bolesnika čija je početna vrijednosti ALT-a bila ≥10x GGN) koje je riješeno bez promjene doze.
English: In another clinical trial, non-responder patients with advanced fibrosis or cirrhosis (Ishak score of 3 to 6) and baseline platelet counts as low as 50,000 cells/mm3 were treated for 48 weeks.
Croatian: U jednom drugom kliničkom ispitivanju, bolesnici s uznapredovalom fibrozom ili cirozom (stupanj od 3 do 6 po Ishaku) i najnižim početnim brojem trombocita od 50 000 stanica/mm
English: 500 to < 750 cells/mm3
Croatian: 500 do <750