FrancophonIA/ELRC3.0 huggingface dataset:
English: • Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration.
Croatian: • Vizualno pregledajte rekonstituiranu otopinu prije primjene kako biste isključili prisutnost vidljivih čestica ili promjenu boje.
English: Each pack contains one powder vial, one solvent vial and a device for reconstitution (BAXJECT II Hi-Flow).
Croatian: Jedno pakiranje sadrži jednu bočicu s praškom, jednu bočicu s otapalom i uređaj za pripremu (BAXJECT II Hi-Flow).
English: ADYNOVI Paediatric patients (6-<12 years) N = 17 Dose: 50 ± 10 IU/kg
Croatian: ADYNOVI Pedijatrijski bolesnici (6-<12 godina) N= 17 Doza: 50 ± 10 IU/kg
English: Remove the blue cap from the BAXJECT II Hi-Flow device (Figure E).
Croatian: Skinite plavi zatvarač s uređaja BAXJECT II Hi-Flow (slika E).
English: ADYNOVI Paediatric patients (< 6 years) N = 14 Dose: 50 ± 10 IU/kg
Croatian: ADYNOVI Pedijatrijski bolesnici (< 6 godina) N= 14 Doza: 50 ± 10 IU/kg
English: - rash, hives, wheals, generalised itching, - swelling of lips and tongue, - difficulty in breathing, wheezing, tightness in the chest, - general feeling of being unwell, - dizziness and loss of consciousness.
Croatian: - osip, koprivnjača ili svrbež po cijelom tijelu, - oticanje usana i jezika, - otežano disanje, piskanje pri disanju, stezanje u prsima - opće loše osjećanje, - omaglica ili gubitak svijesti.
English: Powder and solvent vials preassembled in BAXJECT III system.
Croatian: Bočice s praškom i otapalom, već pričvršćene u sustav BAXJECT III.
English: The reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Rekonstituirani lijek treba vizualno pregledati prije primjene kako biste provjerili sadrži li bilo kakve vidljive čestice ili je došlo do promjene boje.
English: Prophylaxis
Croatian: Proljev
English: Reconstitution with the BAXJECT III system Do not use if the lid is not completely sealed on the blister
Croatian: Ne koristiti ako pokrov na blisteru nije u potpunosti zalijepljen.
English: - The solvent vial contains 5 ml of sterilised water for injections.
Croatian: - Bočica s otapalom sadrži 5 ml sterilizirane vode za injekcije.
English: The active substance rurioctocog alfa pegol is a covalent conjugate of the protein octocog alfa* with a 20 kDa polyethylene glycol (PEG).
Croatian: Djelatna tvar rurioktokog alfa pegol kovalentni je konjugat proteina oktokoga alfa * s polietilenglikolom (PEG) od 20 kDa.
English: Connect the syringe to BAXJECT III.
Croatian: Spojite štrcaljku na uređaj BAXJECT III.
English: It is strongly recommended that every time ADYNOVI is administered, the name and batch number of the product are recorded.
Croatian: Strogo se preporučuje se da se svaki put kod primjene doze lijeka ADYNOVI evidentira naziv i broj serije lijeka.
English: Rurioctocog alfa pegol is a covalent conjugate of octocog alfa consisting of 2,332 amino acids with polyethylene glycol (PEG) reagent (MW 20 kDa).
Croatian: Rurioktokog alfa pegol je pegilirani rekombinantni ljudski faktor VIIIpune duljine produljenog poluvijeka.Rurioktokog alfa pegol kovalentni je konjugat oktokoga alfa koji se sastoji od 2332 aminokiseline s reagensom polietilenglikolom (PEG) (MW 20 kDa).
English: - The solvent vial contains 2 ml of sterilised water for injections.
Croatian: - Bočica s otapalom sadrži 2 ml sterilizirane vode za injekcije.
English: 1 powder vial, 1 vial with 5 ml solvent, 1 BAXJECT II Hi-Flow device.
Croatian: Prašak i otapalo za otopinu za injekciju 1 bočica s praškom, 1 bočica s 5 ml otapala, 1 uređaj BAXJECT II Hi-Flow.
English: What ADYNOVI contains - The active substance is rurioctocog alfa pegol (pegylated human coagulation factor VIII
Croatian: Što ADYNOVI sadrži - Djelatna tvar je rurioktokog alfa pegol (pegilirani ljudski faktor koagulacije VIII dobiven tehnologijom rekombinantne DNK).
English: 1 powder vial, 1 vial with 2 ml solvent, 1 BAXJECT II Hi-Flow device.
Croatian: Prašak i otapalo za otopinu za injekciju 1 bočica s praškom, 1 bočica s 2 ml otapala, 1 uređaj BAXJECT II Hi-Flow.
English: Calcium chloride dihydrate Tris(hydroxymethyl)aminomethane Polysorbate 80
Croatian: Manitol trehaloza dihidrat histidin glutation natrijev klorid kalcijev klorid dihidrat tris(hidroksimetil)aminometan polisorbat 80
English: After reconstitution
Croatian: Nakon pripreme:
English: Blood and lymphatic system disorders Factor VIII inhibition
Croatian: Poremećaji krvi i limfnog sustava
English: Remove the blue cap from the BAXJECT III device.
Croatian: Skinite plavi zatvarač s uređaja BAXJECT III.
English: You should be aware of the early signs of allergic reactions such as rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, and dizziness.
Croatian: Morate znati da su rani znakovi alergijskih reakcija: osip, koprivnjača, svrbež po cijelom tijelu, oticanje usana i jezika, otežano disanje, piskanje pri disanju, stezanje u prsima, opće loše osjećanje i omaglica.
English: Connect the syringe to the BAXJECT II Hi-Flow device.
Croatian: Spojite štrcaljku s uređajem BAXJECT II Hi-Flow.
English: If you get any side effects, talk to your doctor.
Croatian: Ako imate dvojbe, obratite se svom liječniku.
English: nac nac
Croatian: np c np c
English: ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection ADYNOVI 1000 IU / 5 ml powder and solvent for solution for injection ADYNOVI 2000 IU / 5 ml powder and solvent for solution for injection
Croatian: ADYNOVI 250 IU/5 ml prašak i otapalo za otopinu za injekciju ADYNOVI 500 IU/5 ml prašak i otapalo za otopinu za injekciju ADYNOVI 1000 IU/5 ml prašak i otapalo za otopinu za injekciju ADYNOVI 2000 IU/5 ml prašak i otapalo za otopinu za injekciju
English: The median overall ABR was 2.0 (IQR: 3.9) for the 65 subjects in the per-protocol population and the median ABRs for spontaneous and joint bleeding episodes were both 0 (IQR: 1.9).
Croatian: za 65 ispitanika u populaciji liječenoj prema planu ispitivanja, a medijan ASK-a za spontane epizode krvarenja i epizode krvarenja u zglobovima bili su 0 (interkvartilni raspon: 1,9).
English: • Do not refrigerate the solution after preparation.
Croatian: • Ne odlažite otopinu u hladnjak nakon pripreme.
English: ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection ADYNOVI 1000 IU / 2 ml powder and solvent for solution for injection
Croatian: ADYNOVI 250 IU/2 ml prašak i otapalo za otopinu za injekciju ADYNOVI 500 IU/2 ml prašak i otapalo za otopinu za injekciju ADYNOVI 1000 IU/2 ml prašak i otapalo za otopinu za injekciju
English: After reconstitution the solution should be clear, colourless and free from particles.
Croatian: Nakon pripreme otopina treba biti bistra, bezbojna i bez vidljivih čestica.
English: hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, and dizziness.
Croatian: svrbež po cijelom tijelu, oticanje usana i jezika, otežano disanje, piskanje pri disanju, stezanje u prsima, opće loše osjećanje i omaglica.
English: 1 powder vial and 1 vial with 5 ml solvent preassembled in BAXJECT III system.
Croatian: Prašak i otapalo za otopinu za injekciju 1 bočica s praškom i 1 bočica s 5 ml otapala, već pričvršćene u sustav BAXJECT III.
English: After reconstitution this medicinal product contains 0.45 mmol sodium (10 mg) per vial.
Croatian: Nakon rekonstitucije ovaj lijek sadrži 0,45 mmol (10 mg) natrija po bočici, što je potrebno uzeti u obzir kod bolesnika na prehrani s ograničenjem unosa natrija.
English: Factor VIII inhibitors (for patients who have received previous treatment with Factor VIII (more than 150 days of treatment))
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 bolesnika) navale crvenila, alergijska reakcija (preosjetljivost) Inhibitori faktora VIII (za bolesnike koji su ranije liječeni faktorom VIII (više od 150 dana liječenja))
English: Figure E
Croatian: Slika E
English: Do not refrigerate the solution after preparation.
Croatian: Nemojte odlagati u hladnjak nakon pripreme.
English: 1 vial: 2000 IU rurioctocog alfa pegol, 400 IU/ml after reconstitution.
Croatian: 1 bočica: 2000 IU rurioktokog alfa pegola, 400 IU/ml nakon pripreme otopine.
English: 1 vial: 250 IU rurioctocog alfa pegol, 125 IU/ml after reconstitution.
Croatian: 1 bočica: 250 IU rurioktokog alfa pegola, 125 IU/ml nakon pripreme otopine.
English: 1 powder vial and 1 vial with 2 ml solvent preassembled in BAXJECT III system.
Croatian: Prašak i otapalo za otopinu za injekciju 1 bočica s praškom i 1 bočica s 2 ml otapala, već pričvršćene u sustav BAXJECT III.
English: (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničen recept. (pogledajte Prilog I: Sažetak opisa svojstava lijeka, dio 4.2).
English: 1 vial: 500 IU rurioctocog alfa pegol, 250 IU/ml after reconstitution.
Croatian: 1 bočica: 500 IU rurioktokog alfa pegola, 250 IU/ml nakon pripreme otopine.
English: After reconstitution the solution should be clear, colourless and free from foreign particles.
Croatian: Nakon rekonstitucije otopina treba biti bistra, bezbojna i bez vidljivih čestica.
English: 1 vial: 500 IU rurioctocog alfa pegol, 100 IU/ml after reconstitution.
Croatian: 1 bočica: 500 IU rurioktokog alfa pegola, 100 IU/ml nakon pripreme otopine.
English: After reconstitution, the solution is clear, colourless and free from foreign particles.
Croatian: Nakon pripreme otopina je bistra, bezbojna i bez vidljivih čestica.
English: ASSEMBLY LABEL (BAXJECT III SYSTEM)
Croatian: Rekonstitucija pomoću sustava BAXJECT III
English: Excipient related considerations
Croatian: Razmatranja povezana s pomoćnom tvari
English: The dose of ADYNOVI is calculated depending on your body weight and the factor VIII levels to be achieved.
Croatian: Vaše tjelesne težine i razina faktora VIII koje se žele postići.
English: Solutions that are cloudy or have deposits should not be used.
Croatian: Nemojte koristiti otopine koje su mutne ili imaju taloge.
English: 1 vial: 1000 IU rurioctocog alfa pegol, 200 IU/ml after reconstitution.
Croatian: 1 bočica: 1000 IU rurioktokog alfa pegola, 200 IU/ml nakon pripreme otopine.
English: ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 100 IU/ml after reconstitution with 5 ml solvent.
Croatian: ADYNOVI 500 IU/5 ml prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 500 IU ljudskog koagulacijskog faktora VIII (rDNK), rurioktokog alfa pegola, što odgovara koncentraciji od 100 IU/ml nakon rekonstitucije s 5 ml otapala.
English: 1 vial: 1000 IU rurioctocog alfa pegol, 500 IU/ml after reconstitution.
Croatian: 1 bočica: 1000 IU rurioktokog alfa pegola, 500 IU/ml nakon pripreme otopine.
English: Store in the original package in order to protect from light.
Croatian: Kraj tromjesečnog čuvanja na sobnoj temperaturi: Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: 1 vial: 250 IU rurioctocog alfa pegol, 50 IU/ml after reconstitution.
Croatian: 1 bočica: 250 IU rurioktokog alfa pegola, 50 IU/ml nakon pripreme otopine.
English: ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 125 IU/ml after reconstitution with 2 ml solvent.
Croatian: ADYNOVI 250 IU/2 ml prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 250 IU ljudskog koagulacijskog faktora VIII (rDNK), rurioktokog alfa pegola, što odgovara koncentraciji od 125 IU/ml nakon rekonstitucije s 2 ml otapala.
English: ADYNOVI 2000 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 400 IU/ml after reconstitution with 5 ml solvent.
Croatian: ADYNOVI 2000 IU/5 ml prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 2000 IU ljudskog koagulacijskog faktora VIII (rDNK), rurioktokog alfa pegola, što odgovara koncentraciji od 400 IU/ml nakon rekonstitucije s 5 ml otapala.
English: Posology
Croatian: Primjena
English: A separate BAXJECT II Hi-Flow device is required to reconstitute each vial of ADYNOVI with the solvent.
Croatian: Za rekonstituciju svake nove bočice lijeka ADYNOVI s otapalom potreban je novi uređaj BAXJECT II Hi-Flow.
English: ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 50 IU/ml after reconstitution with 5 ml solvent.
Croatian: ADYNOVI 250 IU/5 ml prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 250 IU ljudskog koagulacijskog faktora VIII (rDNK), rurioktokog alfa pegola, što odgovara koncentraciji od 50 IU/ml nakon rekonstitucije s 5 ml otapala.
English: ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 250 IU/ml after reconstitution with 2 ml solvent.
Croatian: ADYNOVI 500 IU/2 ml prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 500 IU ljudskog koagulacijskog faktora VIII (rDNK), rurioktokog alfa pegola, što odgovara koncentraciji od 250 IU/ml nakon rekonstitucije s 2 ml otapala.
English: ADYNOVI 1000 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 200 IU/ml after reconstitution with 5 ml solvent.
Croatian: ADYNOVI 1000 IU/5 ml prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 1000 IU ljudskog koagulacijskog faktora VIII (rDNK), rurioktokog alfa pegola, što odgovara koncentraciji od 200 IU/ml nakon rekonstitucije s 5 ml otapala.
English: ADYNOVI 1000 IU / 2 ml powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 500 IU/ml after reconstitution with 2 ml solvent.
Croatian: ADYNOVI 1000 IU/2 ml prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 1000 IU ljudskog koagulacijskog faktora VIII (rDNK), rurioktokog alfa pegola, što odgovara koncentraciji od 500 IU/ml nakon rekonstitucije s 2 ml otapala.
English: Turn the system upside down (powder vial now on top).Draw the reconstituted solution into the syringe by pulling the plunger back slowly.
Croatian: Okrenite sustav naopako (tako da jebočica s otopljenim praškom na vrhu).
English: ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Croatian: ADYNOVI 250 IU/2 ml prašak i otapalo za otopinu za injekciju rurioktokog alfa pegol (pegilirani rekombinantni ljudski koagulacijski faktor VIII)
English: ADYNOVI 2000 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Croatian: ADYNOVI 2000 IU/5 ml prašak i otapalo za otopinu za injekciju rurioktokog alfa pegol (pegilirani rekombinantni ljudski koagulacijski faktor VIII)
English: Diarrhoea
Croatian: Mučnina
English: ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Croatian: ADYNOVI 250 IU/5 ml prašak i otapalo za otopinu za injekciju rurioktokog alfa pegol (pegilirani rekombinantni ljudski koagulacijski faktor VIII)
English: ADYNOVI 1000 IU / 2 ml powder for injection rurioctocog alfa pegol IV
Croatian: ADYNOVI 1000 IU/2 ml prašak za injekciju rurioktokog alfa pegol i.v.
English: ADYNOVI 500 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Croatian: ADYNOVI 500 IU/5 ml prašak za injekciju rurioktokog alfa pegol i.v.
English: ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Croatian: ADYNOVI 500 IU/5 ml prašak i otapalo za otopinu za injekciju rurioktokog alfa pegol (pegilirani rekombinantni ljudski koagulacijski faktor VIII)
English: ADYNOVI 500 IU / 2 ml powder for injection rurioctocog alfa pegol IV
Croatian: ADYNOVI 500 IU/2 ml prašak za injekciju rurioktokog alfa pegol i.v.
English: ADYNOVI 1000 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Croatian: ADYNOVI 1000 IU/2 ml prašak i otapalo za otopinu za injekciju rurioktokog alfa pegol (pegilirani rekombinantni ljudski koagulacijski faktor VIII)
English: ADYNOVI 2000 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Croatian: ADYNOVI 2000 IU/5 ml prašak za injekciju rurioktokog alfa pegol i.v.
English: ADYNOVI 1000 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Croatian: ADYNOVI 1000 IU/5 ml prašak i otapalo za otopinu za injekciju rurioktokog alfa pegol (pegilirani rekombinantni ljudski koagulacijski faktor VIII)
English: ADYNOVI 1000 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Croatian: ADYNOVI 1000 IU/5 ml prašak za injekciju rurioktokog alfa pegol i.v.
English: ADYNOVI 250 IU / 2 ml powder for injection rurioctocog alfa pegol IV
Croatian: ADYNOVI 250 IU/2 ml prašak za injekciju rurioktokog alfa pegol i.v.
English: ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Croatian: ADYNOVI 500 IU/2 ml prašak i otapalo za otopinu za injekciju rurioktokog alfa pegol (pegilirani rekombinantni ljudski koagulacijski faktor VIII)
English: ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol
Croatian: ADYNOVI 250 IU/5 ml prašak i otapalo za otopinu za injekciju rurioktokog alfa pegol
English: ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol
Croatian: ADYNOVI 250 IU/2 ml prašak i otapalo za otopinu za injekciju rurioktokog alfa pegol
English: ADYNOVI 250 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Croatian: ADYNOVI 250 IU/5 ml prašak za injekciju rurioktokog alfa pegol i.v.
English: ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol
Croatian: ADYNOVI 500 IU/5 ml prašak i otapalo za otopinu za injekciju rurioktokog alfa pegol
English: ADYNOVI 2000 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol
Croatian: ADYNOVI 2000 IU/5 ml prašak i otapalo za otopinu za injekciju rurioktokog alfa pegol
English: BLISTER LABEL (BAXJECT III SYSTEM)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NALJEPNICA NA BLISTERU (SUSTAV BAXJECT III)
English: ADYNOVI 1000 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol
Croatian: ADYNOVI 1000 IU/5 ml prašak i otapalo za otopinu za injekciju rurioktokog alfa pegol
English: ADYNOVI 1000 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol
Croatian: ADYNOVI 1000 IU/2 ml prašak i otapalo za otopinu za injekciju rurioktokog alfa pegol
English: ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol
Croatian: ADYNOVI 500 IU/2 ml prašak i otapalo za otopinu za injekciju rurioktokog alfa pegol
English: Preparation and reconstitution using the BAXJECT II Hi-Flow device For reconstitution use only the solvent vial and the reconstitution device provided in the pack.
Croatian: Za rekonstituciju koristiti samo bočicu s otapalom i uređaj za rekonstituciju koji se nalaze u pakiranju.
English: This means that it affects the activity of the immune system (the body's natural defences).
Croatian: To znači da utječe na aktivnost imunosnog sustava (prirodne obrane organizma).
English: Depending on the day, the patient may take one or more medicines or may not take any medicines.
Croatian: Ovisno o danu, bolesnik uzima jedan ili više lijekova ili ne uzima nijedan lijek.
English: Further information on Lenalidomide Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Lenalidomide Accord možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Lenalidomide Accord is taken in repeated 28-day cycles: the patient takes the medicine once a day on certain days over 28 days.
Croatian: Lenalidomide Accord se uzima u opetovanim ciklusima od 28 dana: bolesnici uzimaju lijek jednom dnevno u određene dane tijekom 28 dana.
English: The company has also set up a pregnancy prevention programme in each Member State and will collect information on the medicine's use outside its approved uses.
Croatian: Tvrtka je također pripremila program prevencije trudnoće u svakoj državi članici te će prikupljati informacije o mogućoj primjeni lijeka izvan odobrenih indikacija.
English: The medicine can only be obtained with a prescription and treatment must be monitored by doctors who have experience in the use of cancer medicines.
Croatian: Lijek se izdaje samo na liječnički recept, a liječenje moraju nadzirati liječnici s iskustvom u primjeni lijekova protiv raka.
English: A lower dose should be used in patients who have moderate or more severe reduction in their kidney function.
Croatian: Manju dozu također treba primijeniti u bolesnika s umjerenim ili ozbiljnijim smanjenjem funkcije bubrega.
English: Lenalidomide Accord (lenalidomide)
Croatian: Lenalidomide Accord (lenalidomid)
English: • in combination with dexamethasone, in adults whose disease has been treated at least once in the past.
Croatian: • u kombinaciji s deksametazonom u odraslih čija je bolest bar jedanput prethodno liječena.
English: • on its own, in adults who have had a stem cell transplant (a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells from a donor) to stop the progression of the cancer;
Croatian: • samostalno, u odraslih koji su prošli transplantaciju matičnih stanica (postupak u kojem se koštana srž bolesnika očisti od stanica i zamijeni matičnim stanicama donatora) za zaustavljanje progresije raka;
English: Lenalidomide Accord is available as capsules of various strengths to be taken by mouth.
Croatian: Lenalidomide Accord je dostupan je u kapsulama različitih jačina koje se uzimaju na usta.
English: The dose should be reduced or treatment interrupted depending on whether the disease has worsened, the severity of any side effects and the levels of platelets (components that help the blood to clot) and neutrophils (a type of white blood cell that helps fight infection).
Croatian: Doza se mora smanjiti ili terapiju treba prekinuti ako se bolest pogorša, pri težim nuspojavama i određenim razinama trombocita (komponenti koje pomažu pri zgrušavanju krvi) i neutrofila (vrste bijelih krvnih stanica koje pomažu u borbi protiv upale).
English: The boxes containing Lenalidomide Accord capsules also bear a warning stating that lenalidomide can be harmful to the unborn child.
Croatian: Kutije koje sadrže kapsule lijeka Lenalidomide Accord također sadrže upozorenje o tome da lenalidomid može biti štetan za nerođenu djecu.
English: Side effects reported with Lenalidomide Accord are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Lenalidomide Accord pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.