FrancophonIA/ELRC3.0 huggingface dataset:
English: • May treat with SOMAVERT; however, monitor LTs monthly for at least 1 year after initiation of therapy and then bi-annually for the next year.
Croatian: Međutim, nakon početka terapije, testove jetrene funkcije potrebno je pratiti svakog mjeseca tijekom najmanje godinu dana, a potom dva puta godišnje tijekom sljedeće godine.
English: - The solvent is water for injections.
Croatian: Otapalo je voda za injekcije.
English: What SOMAVERT looks like and contents of the pack SOMAVERT is presented as a powder and a solvent for injection (either 10 mg, 15 mg, 20 mg, 25 mg or 30 mg pegvisomant in a vial and 1 ml of solvent in a pre-filled syringe).
Croatian: SOMAVERT je dostupan u obliku praška i otapala za injekciju (10 mg, 15 mg, 20 mg, 25 mg ili 30 mg pegvisomanta u bočici i 1 ml otapala u napunjenoj štrcaljki).
English: Store the carton(s) of powder vials in the refrigerator at 2°C to 8°C and away from direct sunlight.
Croatian: Čuvajte bočice sa praškom u vanjskom pakiranju čuvajte u hladnjaku na temperaturi od 2°C do 8°C i dalje od izravne sunčeve svjetlosti.
English: • Twist the safety needle firmly onto the syringe as far as it will go.
Croatian: • Čvrsto zavrnite sigurnosnu iglu na štrcaljku sve do kraja.
English: Growth hormone-secreting tumours
Croatian: Tumori koji izlučuju hormon rasta
English: These substances decrease the action of GH and levels of IGF-I circulating in the blood.
Croatian: Ove tvari smanjuju djelovanje hormona rasta i inzulinu sličnog čimbenika rasta-1 (IGF-1) koji cirkuliraju krvnim optokom.
English: Table A: Recommendations for initiation of SOMAVERT treatment based on baseline LTs and for periodic monitoring of LTs during SOMAVERT treatment
Croatian: Tablica A: Preporuke za početak liječenja lijekom SOMAVERT temeljene na početnim vrijednostima testova jetrene funkcije i preporuke za periodičko praćenje testova jetrene funkcije tijekom liječenja lijekom SOMAVERT
English: - The other ingredients are glycine, mannitol (E421), disodium phosphate anhydrous and sodium dihydrogen phosphate monohydrate.
Croatian: Pomoćne tvari su glicin, manitol (E421), natrijev hidrogenfosfat bezvodni i natrijev dihidrogenfosfat, hidrat.
English: For recommendations regarding initiation of SOMAVERT, based on baseline liver tests (LTs) and recommendations for monitoring of liver tests while on SOMAVERT, refer to Table A.
Croatian: Za preporuke o početku liječenja lijekom SOMAVERT na temelju početnih vrijednosti testova jetrene funkcije i preporuke za praćenje testova jetrene funkcije tijekom liječenja lijekom SOMAVERT, vidjeti tablicu A.
English: Gently dissolve the powder with a slow, swirling motion.
Croatian: Lagano otopite prašak polaganim kružnim pokretima.
English: You must tell your doctor if you have previously used other medicines for the treatment of acromegaly or medicines for the treatment of diabetes.
Croatian: Ako ste prethodno uzimali druge lijekove za liječenje akromegalije ili dijabetesa, morate o tome obavijestiti svog liječnika.
English: Interaction with other medicinal products and other forms of interaction No interaction studies have been performed.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija
English: • Push the plunger rod down slowly until all the liquid has emptied into the vial.
Croatian: • Polako pritiskajte klip prema dolje dok se sva tekućina ne isprazni u bočicu.
English: SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection
Croatian: SOMAVERT 10 mg prašak i otapalo za otopinu za injekciju SOMAVERT 15 mg prašak i otapalo za otopinu za injekciju SOMAVERT 20 mg prašak i otapalo za otopinu za injekciju SOMAVERT 25 mg prašak i otapalo za otopinu za injekciju SOMAVERT 30 mg prašak i otapalo za otopinu za injekciju
English: Store the powder vial(s) in a refrigerator.
Croatian: Bočicu(e) sa praškom čuvati u hladnjaku.
English: • Push the plunger rod down slowly until the barrel is empty.
Croatian: • Polagano pritiskajte klip prema dolje dok se tijelo štrcaljke ne isprazni.
English: Store the pre-filled syringe(s) below 30C or store in a refrigerator (2ºC - 8°C).
Croatian: Čuvati napunjenu štrcaljku ispod 30C ili u frižideru (2ºC - 8°C).
English: Store the pre-filled syringe(s) below 30C or store in a refrigerator (2C - 8C).
Croatian: Napunjenu štrcaljku(e) čuvati na temperaturi ispod ispod 30C ili čuvati u frižideru (2C - 8C).
English: SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection pegvisomant
Croatian: SOMAVERT 10 mg prašak i otapalo za otopinu za injekciju SOMAVERT 15 mg prašak i otapalo za otopinu za injekciju SOMAVERT 20 mg prašak i otapalo za otopinu za injekciju SOMAVERT 25 mg prašak i otapalo za otopinu za injekciju SOMAVERT 30 mg prašak i otapalo za otopinu za injekciju pegvisomant
English: 1/100 to <1/10
Croatian: ≥ 1/100 i <1/10
English: Skin and subcutaneous tissue disorders hyperhidrosis, contusion, pruritusb, rashb face oedema, dry skin, increased tendency to bruise, night sweats, erythema b, urticaria b angioedemab
Croatian: osip edem lica, suha koža, povećana sklonost modricama, noćno znojenje, eritem b, urtikarija angioedem
English: How to store SOMAVERT Contents of the pack and other information
Croatian: Kako SOMAVERT izgleda i sadržaj pakiranja
English: Non-clinical data revealed no special hazard for humans based on studies of repeated dose toxicity in rat and monkey.
Croatian: Temeljem ispitivanja toksičnosti ponovljenih doza na štakorima i majmunima, neklinički podaci nisu utvrdili nikakve posebne opasnosti za čovjeka.
English: Mild to serious allergic (anaphylactic) reactions have been reported in some patients taking SOMAVERT.
Croatian: U nekih bolesnika koji uzimaju SOMAVERT zabilježene su blage do ozbiljne alergijske (anafilaktičke) reakcije.
English: Table B. Clinical recommendations based on abnormal liver test results while on SOMAVERT
Croatian: Kliničke preporuke na temelju odstupanja u rezultatima testova jetrene funkcije tijekom liječenja lijekom SOMAVERT
English: Remove syringe cap
Croatian: Skinite zatvarač štrcaljke
English: Dispose
Croatian: Odlomite
English: Uncommon (≥1/1,000 to <
Croatian: Manje često (≥ 1/1000 i <1/100)
English: • Tilt both the vial and syringe at an angle, as shown.
Croatian: • Nagnite i bočicu i štrcaljku pod kutom, kako je prikazano.
English: • May treat with SOMAVERT.
Croatian: • Moguće je liječenje lijekom SOMAVERT.
English: SOMAVERT 20 mg, 25 mg and 30 mg Pack sizes of 1 and 30 vial(s), pre-filled syringe(s) and safety needle(s) Not all pack sizes may be marketed.
Croatian: SOMAVERT 20 mg, 25 mg i 30 mg Veličine pakiranja od 1 i 30 bočice(a), napunjene(ih) štrcaljke(i) i sigurnosne(ih) igle (igala)
English: • Increased levels of substances that measure the function of the liver.
Croatian: • povišene vrijednosti tvari u krvi pomoću kojih se određuje funkcija jetre, što se može vidjeti iz rezultata krvnih pretraga
English: The 25 mg strength of the medicinal product contains 0.5 mg of sodium per vial of powder.
Croatian: Lijek jačine 25 mg sadrži 0,5 mg natrija po bočici s praškom.
English: • A pre-filled syringe with solvent.
Croatian: • Napunjenu štrcaljku s otapalom.
English: Contact your doctor immediately if you develop any of these symptoms.
Croatian: Ako razvijete bilo koji od ovih simptoma, potrebno je odmah obavijestiti liječnika.
English: Prior to the start of SOMAVERT, patients should have an assessment of baseline levels of liver tests [serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL), and alkaline phosphatase (ALP)].
Croatian: Prije početke primjene lijeka SOMAVERT potrebno je procijeniti početne vrijednosti testova jetrene funkcije u bolesnika [ALT-a i AST-a u serumu, ukupnog bilirubina u serumu i alkalne fosfataze].
English: • Sweating, itching, rash, tendency to bruise.
Croatian: • znojenje, svrbež, osip, sklonost nastanku modrica
English: Keep the vial(s) in their outer carton in order to protect from light.
Croatian: Bočicu(e) čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Keep the powder vials in their outer carton in order to protect from light.
Croatian: Držati bočicu sa praškom u vanjskom pakiranju radi zaštite od svjetlosti.
English: Attach safety needle
Croatian: Poklopac za iglu Sigurnosna igla
English: PC:
Croatian: EXP:
English: • Eye pain
Croatian: • bol u oku
English: Eye disorders eye pain asthenopia
Croatian: Poremećaji oka bol u oku astenopija
English: Therefore, pegvisomant should not be used in breast-feeding women.
Croatian: Stoga se pegvisomant ne smije primjenjivati u dojilja.
English: - SOMAVERT 20 mg: One vial of powder contains 20 mg pegvisomant.
Croatian: SOMAVERT 20 mg: jedna bočica s praškom sadrži 20 mg pegvisomanta.
English: 30 pre-filled syringes of solvent 30 injection needles
Croatian: 30 bočica s praškom 30 napunjenih štrcaljki s otapalom 30 igala za injekciju
English: Caution: Do not let anything touch the vial stopper.
Croatian: Oprez: Pazite da čep bočice ne dođe ni sa čim u doticaj.
English: Store the powder vial(s) in a refrigerator (2C - 8C).
Croatian: Čuvati prašak u bočici (bočicama) u hladnjaku (2°C - 8°C).
English: • A cotton ball.
Croatian: • Pamučna vatica.
English: asthenia, pyrexia a see Description of selected adverse reactions below b ADR related to hypersensitivity reaction
Croatian: bolest slična influenci, umor, astenija, pireksija neuobičajeno osjećanje, otežano cijeljenje, glad vidjeti niže Opis odabranih nuspojava b nuspojave koje se odnose na reakcije preosjetljivost
English: 1 pre-filled syringe of solvent 1 injection needle
Croatian: 1 bočica s praškom 1 napunjena štrcaljka s otapalom 1 igla za injekciju
English: - SOMAVERT 25 mg: One vial of powder contains 25 mg pegvisomant.
Croatian: SOMAVERT 25 mg: jedna bočica s praškom sadrži 25 mg pegvisomanta.
English: Administration of pegvisomant should be discontinued if signs of liver disease persist.
Croatian: U slučaju perzistiranja znakova bolesti jetre primjenu pegvisomanta treba prekinuti.
English: The 15 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder.
Croatian: Lijek jačine 15 mg sadrži 0,4 mg natrija po bočici s praškom.
English: • Throw the cap away; it is not needed again.
Croatian: • Bacite zatvarač; nećete ga više trebati.
English: SOMAVERT 20 mg powder and solvent for solution for injection One vial contains 20 mg of pegvisomant.
Croatian: SOMAVERT 20 mg prašak i otapalo za otopinu za injekciju Jedna bočica sadrži 20 mg pegvisomanta.
English: where it blocks growth hormone binding, and thus interferes with intracellular growth hormone signal transduction.
Croatian: Pegvisomant se veže za receptore hormona rasta na površini stanica gdje sprječava vezanje hormona rasta i tako ometa unutarstanični prijenos signala hormona rasta.
English: - SOMAVERT 30 mg: One vial of powder contains 30 mg pegvisomant.
Croatian: SOMAVERT 30 mg: jedna bočica s praškom sadrži 30 mg pegvisomanta.
English: • Feeling abnormal, impaired healing.
Croatian: • loše opće osjećanje, otežano cijeljenje.
English: • Discontinue SOMAVERT immediately.
Croatian: • Odmah prekinuti s primjenom lijeka SOMAVERT.
English: SOMAVERT 25 mg powder and solvent for solution for injection One vial contains 25 mg of pegvisomant.
Croatian: SOMAVERT 25 mg prašak i otapalo za otopinu za injekciju Jedna bočica sadrži 25 mg pegvisomanta.
English: - SOMAVERT 10 mg: One vial of powder contains 10 mg pegvisomant.
Croatian: SOMAVERT 10 mg: jedna bočica s praškom sadrži 10 mg pegvisomanta.
English: - SOMAVERT 15 mg: One vial of powder contains 15 mg pegvisomant.
Croatian: SOMAVERT 15 mg: jedna bočica s praškom sadrži 15 mg pegvisomanta.
English: • Insert the needle to its full depth into the pinched skin.
Croatian: • U kožni nabor ubodite iglu cijelom njenom duljinom.
English: • A vial of Somavert powder.
Croatian: • Bočicu sa Somavert praškom.
English: SOMAVERT 15 mg powder and solvent for solution for injection One vial contains 15 mg of pegvisomant.
Croatian: SOMAVERT 15 mg prašak i otapalo za otopinu za injekciju Jedna bočica sadrži 15 mg pegvisomanta.
English: SOLVENT PRE-FILLED SYRINGE
Croatian: NAPUNJENA ŠTRCALJKA S OTAPALOM
English: SOMAVERT 10 mg powder and solvent for solution for injection One vial contains 10 mg of pegvisomant.
Croatian: SOMAVERT 10 mg prašak i otapalo za otopinu za injekciju Jedna bočica sadrži 10 mg pegvisomanta.
English: Common to <1/10)
Croatian: Često (≥ 1/100 i <1/10)
English: Fertility, pregnancy and lactation Women of childbearing potential
Croatian: 4.6 Plodnost, trudnoća i dojenje
English: SOMAVERT 30 mg powder and solvent for solution for injection One vial contains 30 mg of pegvisomant.
Croatian: SOMAVERT 30 mg prašak i otapalo za otopinu za injekciju Jedna bočica adrži 30 mg pegvisomanta.
English: After reconstitution, 1 ml of solution contains 20 mg of pegvisomant.
Croatian: Nakon pripreme, 1 ml otopine sadrži 20 mg pegvisomanta
English: After reconstitution, 1 ml of solution contains 30 mg of pegvisomant.
Croatian: Nakon pripreme, 1 ml otopine sadrži 30 mg pegvisomanta
English: After reconstitution, 1 ml of solution contains 25 mg of pegvisomant.
Croatian: Nakon pripreme, 1 ml otopine sadrži 25 mg pegvisomanta
English: SOMAVERT 20 mg powder for injection pegvisomant SC
Croatian: SOMAVERT 20 mg prašak za injekciju pegvisomant s.c.
English: SOMAVERT 25 mg powder for injection pegvisomant SC
Croatian: SOMAVERT 25 mg prašak za injekciju pegvisomant s.c.
English: After reconstitution, 1 ml of solution contains 15 mg of pegvisomant.
Croatian: Nakon pripreme, 1 ml otopine sadrži 15 mg pegvisomanta
English: What SOMAVERT contains - The active substance is pegvisomant.
Croatian: Djelatna tvar je pegvisomant.
English: SOMAVERT 30 mg powder for injection pegvisomant SC
Croatian: SOMAVERT 30 mg prašak za injekciju pegvisomant s.c.
English: SOMAVERT 20 mg powder for solution for injection pegvisomant
Croatian: SOMAVERT 20 mg prašak za otopinu za injekciju pegvisomant
English: SOMAVERT 30 mg powder for solution for injection pegvisomant
Croatian: SOMAVERT 30 mg prašak za otopinu za injekciju pegvisomant
English: SOMAVERT 25 mg powder for solution for injection pegvisomant
Croatian: SOMAVERT 25 mg prašak za otopinu za injekciju pegvisomant
English: Fatty tissue of the skin can build-up at the site of injection.
Croatian: Na mjestu primjene injekcije može doći do nakupljanja masnog potkožnog tkiva.
English: Disodium phosphate anhydrous Sodium dihydrogen phosphate monohydrate Water for Injections
Croatian: glicin manitol (E421) natrijev hidrogenfosfat, bezvodni natrijev dihidrofosfat, hidrat voda za injekcije
English: SOMAVERT 10 mg powder for solution for injection pegvisomant
Croatian: SOMAVERT 10 mg prašak za otopinu za injekciju pegvisomant
English: SOMAVERT 10 mg powder for injection pegvisomant SC
Croatian: SOMAVERT 10 mg prašak za injekciju pegvisomant s.c.
English: After reconstitution, 1 ml of solution contains 10 mg of pegvisomant.
Croatian: Nakon pripreme, 1 ml otopine sadrži 10 mg pegvisomanta
English: SOMAVERT 15 mg powder for solution for injection pegvisomant
Croatian: SOMAVERT 15 mg prašak za otopinu za injekciju pegvisomant
English: SOMAVERT 15 mg powder for injection pegvisomant SC
Croatian: SOMAVERT 15 mg prašak za injekciju pegvisomant s.c.
English: • Constipation, feeling sick, being sick, feeling bloated, indigestion, gas.
Croatian: • zatvor stolice, mučnina, povraćanje, osjećaj nadutost, probavne smetnje, vjetrovi
English: 1 ml of solvent, 1 ml of the solution contains 20 mg pegvisomant.
Croatian: Nakon pripreme s 1 ml otapala, 1 ml otopine sadrži 20 mg pegvisomanta.
English: SOMAVERT 20 mg powder and solvent for solution for injection pegvisomant
Croatian: SOMAVERT 20 mg prašak i otapalo za otopinu za injekciju pegvisomant
English: 1 ml of solvent, 1 ml of the solution contains 25 mg pegvisomant.
Croatian: Nakon pripreme s 1 ml otapala, 1 ml otopine sadrži 25 mg pegvisomanta.
English: Excipient with known effect The 30 mg strength of the medicinal product contains 0.6 mg of sodium per vial of powder.
Croatian: Lijek jačine 30 mg sadrži 0,6 mg natrija po bočici s praškom.
English: SOMAVERT 25 mg powder and solvent for solution for injection pegvisomant
Croatian: SOMAVERT 25 mg prašak i otapalo za otopinu za injekciju pegvisomant
English: Evidence of obstructive biliary tract disease should be ruled out in patients with elevations of ALT and AST or in patients with a prior history of treatment with any somatostatin analogue.
Croatian: U bolesnika s povišenim ALT-om i AST-om ili u bolesnika koji su prethodno bili liječeni nekim analogom somatostatina potrebno je isključiti opstruktivnu bolest žučnog trakta.
English: SOMAVERT 10 mg powder and solvent for solution for injection pegvisomant
Croatian: SOMAVERT 10 mg prašak i otapalo za otopinu za injekciju pegvisomant
English: 1 ml of solvent, 1 ml of the solution contains 15 mg pegvisomant.
Croatian: Nakon pripreme s 1 ml otapala, 1 ml otopine sadrži 15 mg pegvisomanta.
English: SOMAVERT 30 mg powder and solvent for solution for injection pegvisomant
Croatian: SOMAVERT 30 mg prašak i otapalo za otopinu za injekciju pegvisomant
English: SOMAVERT 15 mg powder and solvent for solution for injection pegvisomant
Croatian: SOMAVERT 15 mg prašak i otapalo za otopinu za injekciju pegvisomant
English: You must mix Somavert with a liquid (diluent) before you can use it.
Croatian: Da biste mogli primijeniti lijek, morate pomiješati Somavert s tekućinom (otapalom).
English: 1 ml of solvent, 1 ml of the solution contains 10 mg pegvisomant.
Croatian: Nakon pripreme s 1 ml otapala, 1 ml otopine sadrži 10 mg pegvisomanta.
English: Excipient with known effect The 10 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder.
Croatian: Lijek jačine 10 mg sadrži 0,4 mg natrija po bočici s praškom.
English: You may need to read it again - If you have any further questions, ask your doctor, pharmacist or nurse.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri
English: • Eyestrain, inner ear problems.
Croatian: • brzo zamaranje očiju, problemi s unutarnjim uhom.
English: 1 ml of solvent, 1 ml of the solution contains 30 mg pegvisomant.
Croatian: Nakon pripreme s 1 ml otapala, 1ml otopine sadrži 30mg pegvisomanta.
English: Excipient with known effect: The 20 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder.
Croatian: Lijek jačine 20 mg sadrži 0,4 mg natrija po bočici s praškom.
English: Glycine
Croatian: • proljev
English: • Snap off the syringe cap.
Croatian: • Odlomite zatvarač štrcaljke.
English: Make needle safe
Croatian: Osigurajte iglu
English: Posology and method of administration
Croatian: 4.2 Doziranje i način primjene
English: Remove vial cap
Croatian: Uklonite zatvarač bočice
English: Disodium phosphate anhydrous Sodium dihydrogen phosphate monohydrate
Croatian: glicin manitol (E421) natrijev hidrogenfosfat, bezvodni natrijev dihidrogenfosfat, hidrat
English: The majority of patients recovered from infection.
Croatian: Većina bolesnika oporavila se od infekcije.
English: Each arm enrolled 186 patients.
Croatian: U svaku skupinu uključeno je 186 bolesnika.
English: TLS was observed most frequently during the first month of treatment.
Croatian: TLS je zapažen najčešće tijekom prvog mjeseca liječenja.
English: Disease stage IB/II
Croatian: Faza bolesti IB/II
English: Response in skin and blood was evaluated every 4 weeks.
Croatian: Odgovor na razini kože i krvi procjenjivan je svakih 4 tjedana.
English: 2132NP Hoofddorp Netherlands
Croatian: 2132NP Hoofddorp Nizozemska
English: However, the medicine can cause tiredness in some people, so take particular care when driving and using machines until you are certain that this medicine does not affect you.
Croatian: Međutim, lijek može izazvati umor u nekih ljudi, stoga budite posebno oprezni kada vozite i koristite strojeve sve dok ne budete sigurni da ovaj lijek ne utječe na vas.
English: Blood (n)
Croatian: Krv (n)
English: This medicine should not be used in children and adolescents below 18 years of age.
Croatian: Ovaj lijek se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina.
English: <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) te nepoznato (ne može se procijeniti iz dostupnih podataka).
English: reducing to ≤ 3.8% of subjects after two or more infusions.
Croatian: smanjujući se do ≤ 3.8% ispitanika nakon dvije ili više infuzija.
English: The incidence of infusion related reactions was highest after the first infusion (28.8% of subjects),
Croatian: Incidencija reakcija vezanih uz infuziju bila je najviša nakon prve infuzije (28,8% ispitanika),
English: To start with, the infusions will be given once a week for the first 5 doses, then once every 2 weeks.
Croatian: infuzije će biti davane jedanput tjedno za prvih 5 doza, a zatim jedanput svaka 2 tjedna.
English: Patients should be carefully monitored during and after infusion.
Croatian: Bolesnike je za potrebno pažljivo nadzirati tijekom i nakon infuzije.
English: Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed child cannot be excluded during this short period.
Croatian: Poznato je da se ljudski IgG izlučuje u majčinom mlijeku tijekom prvih dana nakon rođenja, te se smanjuje do niskih koncentracija odmah nakon toga; posljedično tome, ne može se isključiti rizik za dojeno dijete tijekom tog kratkog razdoblja.
English: Safety post last dose
Croatian: Sigurnost nakon zadnje doze
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza.
English: When the symptoms go away, POTELIGEO can normally continue to be given, but more slowly.
Croatian: Kada se simptomi povuku, POTELIGEO se može normalno nastaviti davati, ali sporije.
English: You must tell your doctor or nurse if you are pregnant, breast-feeding, think you may be pregnant, or are planning to have a baby.
Croatian: Morate reći svom liječniku ako ste trudni, dojite, mislite da biste mogli biti trudni ili planirate imati dijete.
English: On a power model analysis, no deviation from dose proportionality was evident.
Croatian: U analizi modela snage, nije bilo vidljivo odstupanje od proporcionalnosti za dozu.
English: In patients with stage IB/II disease, given the limited number of subjects with a response and immaturity of the data, no conclusion on duration of response can be made.
Croatian: U bolesnika s bolešću u stadiju IB/II, s obzirom na ograničen broj ispitanika s odgovorom i nezrelost podataka, ne može se donijeti zaključak o trajanju odgovora.
English: The subjects had a medical history including various risk factors.
Croatian: Ispitanici su imali povijest bolesti i razne faktore rizika.
English: Patients who have risk factors associated with cardiac disease should be monitored and appropriate precautions taken.
Croatian: Bolesnike koji imaju faktore rizika povezane s bolesti srca treba pratiti i poduzeti prikladne mjere opreza.
English: The IRRs were mostly mild or moderate in severity, although there have been a few reports of severe reactions (Grade 3).
Croatian: IRR su bile uglavnom blage ili umjerene težine, iako je bilo nekoliko prijava teških reakcija (3. stupnja).
English: If this happens, the infusion may need to be stopped and you may require additional treatment.
Croatian: Ako se to dogodi, infuziju je potrebno prekinuti i može Vam biti potrebno dodatno liječenje.