FrancophonIA/ELRC3.0 huggingface dataset:
English: Haematological abnormalities in HCV/HIV co-infected patients HCV/HIV co-infected patients receiving peginterferon alfa-2b/ribavirin treatment and HAART may be at increased risk to develop haematological abnormalities (as neutropenia, thrombocytopenia and anaemia) compared to HCV mono-infected patients.
Croatian: Hematološki poremećaji u bolesnika s istodobnom infekcijom HCV-om i HIV-om U odnosu na bolesnike inficirane samo HCV-om, bolesnici s istodobnom infekcijom HCV-om i HIV-om koji primaju kombinaciju peginterferon alfa-2b/ribavirin i HAART mogu imati povećan rizik za razvoj hematoloških poremećaja (kao što su neutropenija, trombocitopenija i anemija).
English: 11 months) + ribavirin (1,000/1,200 mg/day), (n = 514).
Croatian: IU triput na tjedan) + ribavirin (1000/1200 mg na dan), (n=505).
English: Talk to your doctor before taking this medicine if you, or the child you are caring for: - have had a severe nervous or mental disorder or have a history of substance abuse (e.g. alcohol or drugs).
Croatian: Obratite se svom liječniku prije nego uzmete ovaj lijek, ako ste Vi ili dijete o kojem skrbite: - imali teški neurološki ili psihički poremećaj ili uzimali neko sredstvo ovisnosti (npr. alkohol ili droge), Primjena ovog lijeka nije dozvoljena u djece i adolescenata koji imaju ili su nekada imali teško psihijatrijsko stanje (vidjeti dio "Nemojte uzimati ViraferonPeg" gore).
English: oC).
Croatian: A.
English: Hearing impaired/loss, tinnitus, vertigo
Croatian: oštećenje/gubitak sluha, tinitus, vrtoglavica
English: Anaemia, leucopenia, neutropenia
Croatian: anemija, leukopenija, neutropenija
English: 9/l, and < 1.5 x 10
Croatian: 9/l i < 1,5 x 10
English: Dyspepsia, gastroesophageal reflux disease, stomatitis, mouth ulceration, glossodynia, gingival bleeding, constipation, flatulence, haemorrhoids, cheilitis, abdominal distension, gingivitis, glossitis, tooth disorder
Croatian: dispepsija, gastroezofagealna refluksna bolest, stomatitis, ulceracije u ustima, glosodinija, krvarenje iz desni, konstipacija, flatulencija, hemoroidi, heilitis, abdominalna distenzija, gingivitis, glositis, poremećaji zuba
English: • Remove the pre-filled pen from the carton.
Croatian: • Izvadite napunjenu brizgalicu iz kutije.
English: Photosensitivity reaction, rash maculo-papular, skin exfoliation, pigmentation disorder, dermatitis atopic, skin discolouration Musculoskeletal and connective tissue disorders Very common:
Croatian: reakcija fotoosjetljivosti, makulopapularni osip, ljuštenje kože, poremećaj pigmentacije, atopijski dermatitis, promjene boje kože Poremećaji mišićno-koštanog sustava i vezivnog tkiva Vrlo često:
English: ViraferonPeg - ampoule of solvent
Croatian: ViraferonPeg - ampula s otapalom
English: ViraferonPeg is available in different pack sizes: - 1 pre-filled pen containing powder and solvent for solution for injection, 1 needle ("Push-On Needle"),
Croatian: ViraferonPeg je dostupan u različitim veličinama pakiranja: - 1 napunjena brizgalica koja sadrži prašak i otapalo za otopinu za injekciju 1 igla (potisna igla)
English: Use in adults - ViraferonPeg in combination treatment This medicine, when given with ribavirin capsules, is usually given at a dose of 1.5 microgram per kilogram of body weight once a week.
Croatian: Kad se uzima u kombinaciji s kapsulama ribavirina, ovaj lijek se obično primjenjuje u dozi od 1,5 mikrograma po kilogramu tjelesne težine, jedanput na tjedan.
English: If treatment with alpha 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 procijeni da je liječenje alfa interferonom u takvih bolesnika neophodno, prije započinjanja liječenja treba pažljivo provjeriti postoje li psihijatrijske bolesti ili rizik od uživanja sredstava ovisnosti te ih na odgovarajući način zbrinuti.
English: A complete set of instructions is provided in the Annex to the Package Leaflet.
Croatian: Cjelovite upute nalaze se u prilogu Upute o lijeku.
English: Reconstituting ViraferonPeg powder for injection
Croatian: Priprema ViraferonPeg praška za injekciju
English: METAVIR Fibrosis score F2
Croatian: METAVIR rezultat fibroze
English: Rhabdomyolysis, myositis, rheumatoid arthritis Renal and urinary disorders Common:
Croatian: rabdomioliza, miozitis, reumatoidni artritis Poremećaji bubrega i mokraćnog sustava Često:
English: The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha interferons.
Croatian: Tijekom liječenja interferonima alfa prijavljen je razvoj autoprotutijela i autoimunih poremećaja.
English: Aplastic anaemia
Croatian: aplastična anemija
English: Table 3b Reduced ViraferonPeg dose (0.25 g/kg) for the 0.5 g/kg monotherapy regimen in adults Body weight (kg)
Croatian: Tablica 3b Smanjenje doze lijeka ViraferonPeg (0,25 µg/kg) u odraslih bolesnika koji primaju dozu od 0,5 µg/kg u monoterapiji Tjelesna težina (kg)
English: Excipients with known effect: Each pre-filled pen contains 40 mg of sucrose per 0.5 ml.
Croatian: Pomoćne tvari s poznatim učinkom Jedna napunjena brizgalica sadrži 40 mg saharoze u 0,5 ml.
English: The vial, ampoule and injection materials intended for single use must be discarded.
Croatian: Bočicu, ampulu i pribor za injiciranje namijenjen za jednokratnu primjenu morate zbrinuti.
English: Please refer to the ribavirin SmPC for capsules or oral solution when ViraferonPeg is to be used in combination with ribavirin.
Croatian: Molimo pročitajte Sažetak opisa svojstava lijeka za ribavirin kapsule ili oralnu otopinu ako će se ViraferonPeg primjenjivati u kombinaciji s ribavirinom.
English: After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Croatian: Nakon pripreme za primjenu, pripremljenu otopinu treba upotrijebiti odmah ili u roku od 24 sata ako se čuva u hladnjaku (2°C - 8°C).
English: With one hand, pinch a fold of loose skin.
Croatian: Jednom rukom uhvatite između dva prsta dio kože koji nije jako napet.
English: The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Croatian: Zbog povećanog rizika za razvoj anemije ne preporučuje se istodobna primjena ribavirina i zidovudina (vidjeti dio 4.4).
English: Arthritis, back pain, muscle spasms, pain in extremity
Croatian: artritis, bol u leđima, grčevi mišića, bol u ekstremitetima
English: The following other side effects (not listed above) have occurred with the combination of this medicine and ribavirin capsules (adults) in HCV/HIV co-infected patients receiving HAART: - oral candidiasis (oral thrush), - defective metabolism of fat, - CD4 lymphocytes decreased, - appetite decreased, - back pain, - hepatitis, - limb pain, - and various laboratory blood values abnormalities.
Croatian: Ostale nuspojave (nisu prethodno navedene) koje su se javile kod primjene ovog lijeka u kombinaciji s kapsulama ribavirina (odrasli) u bolesnika s istodobnom infekcijom virusima HCV i HIV koji primaju vrlo djelotvornu antiretrovirusnu terapiju su: - kandidijaza usta (gljivična infekcija u ustima), - narušen metabolizam masti, - smanjen broj CD4 limfocita, - smanjen tek, - bol u leđima, - hepatitis, - bol u udovima, - i razni poremećaji nalaza laboratorijskih pretraga krvi.
English: ViraferonPeg combination therapy (bitherapy or tritherapy) Bitherapy (ViraferonPeg with ribavirin): applies to all adult and paediatric patients 3 years of age and older.
Croatian: Dvojna terapija (ViraferonPeg s ribavirinom): vrijedi za sve odrasle i pedijatrijske bolesnike u dobi od 3 godine i starije.
English: For special handling information see section 6.6.
Croatian: Za posebne mjere za rukovanje lijekom, vidjeti dio 6.6.
English: Eleven percent of subjects (5/46) treated for 24 weeks and 13 % of subjects (6/48) treated for 48 weeks were observed to have a decrease from pre-treatment baseline of > 30 height-for-age percentiles to the end of the 5 year long-term follow-up.
Croatian: Na kraju 5-godišnjeg dugotrajnog praćenja, u 11% djece (5/46) liječene 24 tjedna te 13% djece (6/48) liječene 48 tjedana primijećen je pad za > 30 percentila na percentilnoj krivulji rasta za dob u odnosu na vrijednost prije početka liječenja.
English: The solvent is presented in a 2 ml ampoule (Type I flint glass).
Croatian: Otapalo se nalazi u staklenoj ampuli (kristalno staklo tipa I) volumena 2 ml.
English: SN: NN
Croatian: NN:
English: ViraferonPeg monotherapy dose reduction guidelines in adults
Croatian: Smjernice za smanjenje doze lijeka ViraferonPeg u monoterapiji u odraslih
English: HCV-RNA negative or ≥ 2 log decrease in viral load
Croatian: HCV-RNK negativna ili virusno opterećenje manje za ≥ 2 log
English: Infections and infestations
Croatian: Ozljede i trovanja
English: Reminder: Please also read the “Do not take” section of the Package Leaflet for ribavirin and boceprevir before using them in combination with this medicine.
Croatian: Podsjetnik: molimo pročitajte i dio "Nemojte uzimati" u uputi o lijeku za ribavirin i boceprevir prije nego što ih uzmete u kombinaciji s ovim lijekom.
English: Carton 120 micrograms
Croatian: Kutija 120 mikrograma
English: Carton 150 micrograms
Croatian: Kutija 150 mikrograma
English: Chest pain, chest discomfort, injection site pain, malaise, face oedema, oedema peripheral, feeling abnormal, thirst
Croatian: bol u prsištu, nelagoda u prsištu, bol na mjestu injiciranja, malaksalost, edem lica, periferni edem, neuobičajeno osjećanje, žeđ
English: Interferon alfa-2b 3 MIU
Croatian: Interferon alfa-2b (3 mil.IU.)
English: 15 SEC
Croatian: 15 SEK
English: a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week ViraferonPeg and subjects ≥ 75 kg received 150 µg/week ViraferonPeg.
Croatian: IU = milijun internacionalnih jedinica; a: p-vrijednost dobivena Cochran-Mantel Haenszelovim hi-kvadrat testom; b: p-vrijednost dobivena hi-kvadrat testom. c: ispitanici teški < 75 kg primali su 100 μg lijeka ViraferonPeg na tjedan, a ispitanici teški ≥ 75 kg primali su 150 μg lijeka ViraferonPeg na tjedan. d: doza ribavirina iznosila je 800 mg za bolesnike < 60 kg, 1000 mg za bolesnike 60-75 kg, te 1200 mg za bolesnike > 75 kg.
English: Patients were randomized to receive either ViraferonPeg (100 or 150 µg/week based on weight) plus ribavirin (800-1,200 mg/day based on weight) or interferon alfa-2b (3 MIU TIW) plus ribavirin (800-1,200 mg/day based on weight).
Croatian: Bolesnici su bili randomizirani tako da su primali ViraferonPeg (100 ili 150 μg na tjedan ovisno o tjelesnoj težini) i ribavirin (800-1200 mg na dan ovisno o tjelesnoj težini) ili interferon alfa-2b (3 mil.
English: As monotherapy the ViraferonPeg regimen is 0.5 or 1.0 g/kg/week.
Croatian: U monoterapiji lijekom ViraferonPeg primjenjuje se režim u dozi od 0,5 ili 1,0 μg/kg na tjedan.
English: Injection site reaction, injection site pruritus, injection site rash injection site dryness, injection site pain, feeling cold
Croatian: reakcija na mjestu injiciranja, svrbež na mjestu injiciranja, osip na mjestu injiciranja, suhoća na mjestu injiciranja, bol na mjestu injiciranja, osjećaj hladnoće
English: Careful co-administration of theophylline with the product (ViraferonPeg) is recommended.
Croatian: Preporučuje se oprez kod istodobne primjene teofilina s ovim lijekom (ViraferonPeg).
English: Table 4 Effect of Peginterferon alfa-2b on Co-administered Medicines
Croatian: Tablica 4 Učinak peginterferona alfa-2b na lijekove u istodobnoj primjeni
English: Use the reconstituted solution (solution you prepared by adding water for injection to the ViraferonPeg powder) immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Croatian: Pripremljenu otopinu (otopinu koju ste pripremili dodavanjem vode za injekcije u ViraferonPeg prašak) primijenite odmah ili u roku od 24 sata, ako se čuva u hladnjaku (2°C-8°C).
English: Change your injection site each time.
Croatian: Svaki puta dajte injekciju na drugo mjesto na tijelu.
English: Hepatic decompensation in HCV/HIV co-infected patients with advanced cirrhosis Co-infected patients with advanced cirrhosis receiving HAART may be at increased risk of hepatic decompensation and death.
Croatian: Bolesnici s istodobnom infekcijom HCV-om i HIV-om i uznapredovalom cirozom jetre koji primaju vrlo djelotvornu antiretrovirusnu terapiju mogu imati povećan rizik od dekompenzacije jetre i smrti.
English: Psoriasis, photosensitivity reaction, rash maculo-papular, dermatitis, erythematous rash, eczema, night sweats, hyperhidrosis, acne, furuncle, erythema, urticaria, abnormal hair texture, nail disorder
Croatian: psorijaza, reakcija fotoosjetljivosti, makulopapularni osip, dermatitis, eritematozni osip, ekcem, noćno znojenje, hiperhidroza, akne, furunkuloza, eritem, urtikarija, neuobičajena tekstura kose, poremećaj noktiju
English: Patients with undetectable HCV-RNA at treatment week 12 and SVR upon retreatment interferon alpha/ribavirin peginterferon alpha/ribavirin
Croatian: Bolesnici s nemjerljivom HCV-RNK u 12. tjednu liječenja i trajnim virološkim odgovorom (SVR) nakon ponovljenog liječenja interferon alfa/ribavirin peginterferon alfa/ribavirin Ukupna populacija*
English: Clear and colourless solvent.
Croatian: Bistro i bezbojno otapalo.
English: ViraferonPeg 0.5 microgram/kg
Croatian: ViraferonPeg 0,5 mikrograma/kg
English: Be sure the tip of needle is in the ViraferonPeg reconstituted solution.
Croatian: Pazite da se vrh igle nalazi u pripremljenoj ViraferonPeg otopini.
English: 1 vial of powder, 1 ampoule of solvent
Croatian: 1 bočica s praškom, 1 ampula s otapalom
English: Dial dose
Croatian: Odaberite dozu
English: Retreatment duration greater than 48 weeks in non-responder patients with genotype 1 has not been studied with pegylated interferon alfa-2b and ribavirin combination therapy.
Croatian: U bolesnika s genotipom 1 koji nisu postigli virološki odgovor nije se ispitivalo ponovljeno liječenje kombiniranom terapijom pegiliranim interferonom alfa-2b i ribavirinom u trajanju duljem od 48 tjedana.
English: The following treatment-related adverse reactions were reported in adults in clinical trials or through post-marketing surveillance in patients treated with peginterferon alfa-2b, including ViraferonPeg monotherapy or ViraferonPeg/ribavirin.
Croatian: Sljedeće nuspojave povezane s liječenjem prijavljene su u odraslih osoba u kliničkim ispitivanjima ili tijekom praćenja nakon stavljanja lijeka u promet u bolesnika liječenih peginterferonom alfa-2b, uključujući ViraferonPeg u monoterapiji ili kombinaciju ViraferonPeg/ribavirin.
English: Sarcoidosis
Croatian: sarkoidoza
English: Interferon alfa-2b has been shown to be abortifacient in primates.
Croatian: Pokazalo se da interferon alfa-2b izaziva pobačaje u primata.
English: Reproduction studies of ViraferonPeg have not been performed.
Croatian: Nisu provedena istraživanja utjecaja lijeka ViraferonPeg na reprodukciju.
English: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
Croatian: Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem Poremećaji mišićno-koštanog sustava i vezivnog tkiva Vrlo često:
English: Second dose reduction to ViraferonPeg 0.5 µg/kg
Croatian: Drugo smanjenje doze lijeka ViraferonPeg na 0,5 μg/kg
English: The following instructions explain how to inject this medicine yourself.
Croatian: Sljedeće upute objašnjavaju kako ćete sami sebi dati injekciju lijeka ViraferonPeg.
English: Carton 80 micrograms
Croatian: Kutija 80 mikrograma
English: Table 6 Adverse reactions reported in adults in clinical trials or through post-marketing surveillance in patients treated with peginterferon alfa-2b, including ViraferonPeg monotherapy or ViraferonPeg + ribavirin
Croatian: Tablica 6 Nuspojave prijavljene u odraslih osoba u kliničkim ispitivanjima ili tijekom praćenja nakon stavljanja lijeka u promet u bolesnika liječenih peginterferonom alfa-2b, uključujući ViraferonPeg u monoterapiji ili ViraferonPeg + ribavirin
English: Sustained Virologic Response (SVR) is defined as undetectable HCV-RNA at 24 weeks post-treatment (Table 14).
Croatian: Trajan virološki odgovor definiran je kao nemjerljiva HCV-RNK u 24. tjednu nakon završetka liječenja (Tablica 14).
English: Cases of hepatitis B re-activation (some with severe consequences) have been reported in patients coinfected with hepatitis B and C viruses treated with interferon.
Croatian: U bolesnika istodobno zaraženih virusima hepatitisa B i C koji se liječe interferonom prijavljeni su slučajevi reaktivacije hepatitisa B (neki od njih s teškim posljedicama).
English: Anti-thyroid antibody positive
Croatian: pozitivna protutijela na tiroglobulin
English: Table 3c Reduced ViraferonPeg dose (0.5 g/kg) for the 1.0 g/kg monotherapy regimen in adults Body weight (kg)
Croatian: Tablica 3c Smanjenje doze lijeka ViraferonPeg (0,5 µg/kg) u odraslih bolesnika koji primaju dozu od 1,0 µg/kg u monoterapiji Tjelesna težina (kg)
English: Common side effects (may affect up to 1 in 10 people): - chest pain, changes in the way your heart beats, - confusion, - difficulty remaining alert, numbness or tingling feeling, - pain in your lower back or side, difficulty or inability to pass urine, - problems with your eyes or your eyesight or hearing, - severe or painful reddening of your skin or mucous membrane, - severe bleeding from your nose, gums or any other part of your body.
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba): - bol u prsnom košu, promjene u načinu otkucaja srca, - smetenost, - poteškoće u održavanju budnosti, utrnulost ili trnci, - bol u križima ili slabinama; otežano mokrenje ili nemogućnost mokrenja, - problemi s očima ili vidom ili sluhom, - jako ili bolno crvenilo kože ili sluznice, - jako krvarenje iz nosa, desni ili bilo kojeg drugog dijela tijela.
English: Use the reconstituted solution (solution you prepared by mixing the powder and the liquid in the prefilled pen) immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Croatian: Pripremljenu otopinu (otopinu koju ste pripremili miješanjem praška i tekućine u napunjenoj brizgalici) primijenite odmah ili u roku od 24 sata, ako se čuva u hladnjaku (2°C-8°C).
English: Injection site necrosis
Croatian: nekroza na mjestu injiciranja
English: Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with chronic hepatitis C treated with interferon.
Croatian: U bolesnika s kroničnim hepatitisom C liječenih interferonom prijavljeni su slučajevi sindroma VogtKoyanagi-Harada (VKH).
English: These are thigh, outer surface of the upper arm (you may need the assistance of another person to use this site) and abdomen (except the navel or waistline).
Croatian: Najbolja mjesta za injekciju su područja gdje se između kože i mišića nalazi sloj masnog tkiva, kao što su: bedro, vanjska strana nadlaktice (možda ćete trebati pomoć druge osobe za ovo mjesto) ili trbuh (osim pupka i područja struka).
English: ViraferonPeg/ribavirin retreatment of prior treatment failures In a non-comparative trial, 2,293 patients with moderate to severe fibrosis who failed previous treatment with combination alpha interferon/ribavirin were retreated with ViraferonPeg, 1.5 micrograms/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Croatian: U nekomparativnom ispitivanju su 2293 bolesnika s umjerenom do teškom fibrozom, u kojih prethodno liječenje interferonom alfa u kombinaciji s ribavirinom nije bilo uspješno, ponovno liječena lijekom ViraferonPeg u supkutanoj dozi od 1,5 mikrograma/kg jedanput na tjedan u kombinaciji s ribavirinom u dozi prilagođenoj tjelesnoj težini.
English: Table 14 Rates of response to retreatment in prior treatment failures Patients with undetectable HCV-RNA at treatment week 12 and SVR upon retreatment interferon alpha/ribavirin peginterferon alpha/ribavirin
Croatian: Tablica 14 Stope odgovora na ponovljeno liječenje u bolesnika u kojih je prethodno liječenje bilo neuspješno Bolesnici s nemjerljivom HCV-RNK u 12. tjednu liječenja i trajnim virološkim odgovorom (SVR) nakon ponovljenog liječenja interferon alfa/ribavirin peginterferon alfa/ribavirin Ukupna populacija*
English: A small volume is lost during preparation of this medicine for injection and when the dose is measured and injected.
Croatian: Tijekom pripreme ovog lijeka za primjenu kao i prilikom odmjeravanja i injiciranja doze izgubi se mala količina otopine.
English: Growth and development (children and adolescents) During the course of therapy lasting up to 48 weeks in patients ages 3 through 17 years, weight loss and growth inhibition were common.
Croatian: Za vrijeme liječenja u trajanju do 48 tjedana u bolesnika u dobi od 3 do 17 godina čest je bio gubitak tjelesne težine i zastoj u rastu.
English: Very common side effects (may affect more than 1 in 10 people): - breathing problems (including shortness of breath), - feeling depressed - trouble sleeping, thinking or concentrating, dizziness, - severe stomach pain or cramps, - fever or chills beginning after a few weeks of treatment, - painful or inflamed muscles (sometimes severe),
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba): - tegobe s disanjem (uključujući nedostatak zraka), - depresivnost, - poteškoće sa spavanjem, razmišljanjem ili koncentracijom, omaglica, - jaka bol ili grčevi u trbuhu, - vrućica ili zimica koje se javljaju nakon nekoliko tjedana liječenja, - bolni ili upaljeni mišići (ponekad jako).
English: Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of developing lactic acidosis.
Croatian: Highly Active Anti-Retroviral Therapy, HAART) mogu biti izloženi većem riziku za razvoj laktacidoze.
English: ViraferonPeg 1.0 microgram/kg
Croatian: ViraferonPeg 1,0 mikrograma/kg
English: Effect of Peginterferon alfa-2b on Co-administered Medicines
Croatian: Učinak peginterferona alfa-2b na lijekove u istodobnoj primjeni
English: The pharmacokinetics of ViraferonPeg following a single subcutaneous dose of 1.0 microgram/kg were not affected by age.
Croatian: Dob nije utjecala na farmakokinetiku lijeka ViraferonPeg nakon jedne supkutane doze od 1,0 mikrograma/kg.
English: 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs
Croatian: 4 bočice s praškom, 4 ampule s otapalom, 4 štrcaljke za injekciju, 8 igala za injekciju i 4 tupfera za čišćenje
English: Adults - Duration of treatment - Naïve patients Tritherapy: Refer to the SmPC for boceprevir.
Croatian: Odrasli - trajanje liječenja - bolesnici koji prethodno nisu bili liječeni Trojna terapija: Pročitajte Sažetak opisa svojstava lijeka za boceprevir.
English: Visual disturbance, vision blurred, photophobia, conjunctivitis, eye irritation, lacrimal disorder, eye pain, dry eye
Croatian: poremećaj vida, zamagljen vid, fotofobija, konjunktivitis, iritacija oka, poremećaj suznih žlijezda, bol u oku, suhoća oka
English: Very common side effects (may affect more than 1 in 10 people): - loss of appetite, dizziness, headache, vomiting, nausea, stomach pain, - hair loss, dry skin, pain in joints and muscles, redness at the site of injection, - feeling irritable, tired feeling, feeling unwell, pain, chills, fever, flu-like symptoms, weakness,
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba): - gubitak teka, omaglica, glavobolja, povraćanje, mučnina, bol u trbuhu, - gubitak kose, suha koža, bol u zglobovima i mišićima, crvenilo na mjestu injekcije, - razdražljivost, umor, loše osjećanje, bol, zimica, vrućica, simptomi nalik gripi, slabost,
English: Acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been observed rarely during interferon alfa-2b therapy.
Croatian: Tijekom liječenja interferonom alfa-2b rijetko su opažene akutne reakcije preosjetljivosti (npr. urtikarija, angioedem, bronhokonstrikcija, anafilaksija).
English: 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs
Croatian: 12 bočica s praškom, 12 ampula s otapalom, 12 štrcaljki za injekciju, 24 igle za injekciju i 12 tupfera za čišćenje