FrancophonIA/ELRC3.0 huggingface dataset:
English: • For patients who have already started treatment (i.e. those who have had their biopsies taken) company has made arrangements to store any existing biopsies so that treatment can be completed unless patients and their treating surgeons have explicitly indicated that they no longer wish to complete treatment with MACI.
Croatian: • Za bolesnike koji su već započeli liječenje (primjerice one kojima je uzeta biopsija), tvrtka je postigla dogovor za pohranjivanje svih postojećih biopsija tako da se terapija može završiti osim ako bolesnici i njihovi kirurzi koji ih liječe izričito ne naznače da više ne žele završiti liječenje MACI
English: (frequency cannot be estimated from the available data)
Croatian: (učestalost se ne može procijeniti iz dostupnih podataka)
English: *Number (%) of patients
Croatian: * broj bolesnika (%)
English: IntronA with food and drink and alcohol
Croatian: IntronA s hranom, pićem i alkoholom
English: The elimination half-life was approximately two hours.
Croatian: Poluvrijeme eliminacije bilo je otprilike 2 sata.
English: Volume (mL)
Croatian: Volumen (ml)
English: You may need urgent medical attention or hospitalisation.
Croatian: Možda će Vam trebati hitna medicinska pomoć ili hospitalizacija.
English: There are no data on long term effects on sexual maturation.
Croatian: Nema podataka o dugotrajnim učincima na spolno sazrijevanje.
English: This can be discussed with your doctor.
Croatian: O tome možete razgovarati sa svojim liječnikom.
English: Patients with advanced disease may require a daily dose of 5 million IU.
Croatian: Bolesnicima s uznapredovalom bolešću može biti potrebna dnevna doza od 5 milijuna IU.
English: The effect on human pregnancy is not known.
Croatian: Učinak na trudnoću u ljudi nije poznat.
English: These three main classes are themselves not homogeneous and may contain several different molecular species of interferon.
Croatian: Te tri glavne vrste same po sebi nisu homogene i mogu sadržavati nekoliko različitih molekularnih vrsta interferona.
English: Date of first authorisation: 9 March 2000 Date of latest renewal: 9 March 2010
Croatian: Datum posljednje obnove odobrenja: 9. ožujka 2010.
English: Be sure to tell your doctor if you are taking the Chinese herbal medicine shosaikoto.
Croatian: Svakako obavijestite liječnika ako uzimate kineski biljni lijek shosaikoto.
English: Some children did not reach their projected height within 10-12 years after completing treatment.
Croatian: Neka djeca nisu dostigla svoju planiranu visinu unutar 10-12 godina nakon završetka liječenja.
English: This will lessen the chance for ribavirin to be left in the woman's body.
Croatian: To će umanjiti mogućnost da se ribavirin nađe u tijelu žene.
English: 6 IU/kg/day for 3 months.
Croatian: 6 IU/kg na dan tijekom 3 mjeseca.
English: Do not attempt to inject yourself unless you are sure you understand the procedure and requirement of self-injection.
Croatian: Ne pokušavajte si dati injekciju sami ako niste sigurni da razumijete postupak i uvjete davanja injekcije.
English: The dosage will vary according to the disease being treated.
Croatian: Doza će se razlikovati ovisno o bolesti koja se liječi.
English: These are all very serious side effects.
Croatian: Sve su ovo vrlo ozbiljne nuspojave.
English: Interferons may affect the oxidative metabolic process.
Croatian: Interferoni mogu utjecati na oksidativne metaboličke procese.
English: Some children have had a decrease in their rate of growth (height and weight).
Croatian: Neka djeca su imala smanjenu brzinu rasta (visine i težine).
English: It has demonstrated significant immunomodulatory activity in vitro.
Croatian: Pokazao je značajno imunomodulacijsko djelovanje in vitro.
English: This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.
Croatian: Ovo stanje dovodi do teške anemije, čiji simptomi uključuju neuobičajen umor i nedostatak energije.
English: IntronA can be put back in the refrigerator at any time during this seven-day period.
Croatian: IntronA se može vratiti u hladnjak bilo kada tijekom tog sedmodnevnog razdoblja.
English: • Genotype 1: The recommended duration of treatment is one year.
Croatian: • Genotip 1: preporučeno trajanje liječenja je godinu dana.
English: Any or all of these activities may contribute to interferon's therapeutic effects.
Croatian: Pojedino ili sva navedena djelovanja mogu pridonijeti terapijskim učincima interferona.
English: Overall Response a (n=118)
Croatian: Ukupan odgovor a (n=118)
English: The majority of patients in these clinical trials were treated for one year.
Croatian: Većina bolesnika u ovim kliničkim ispitivanjima primala je terapiju godinu dana.
English: Insert the needle into the pinched skin at an angle of 45° to 90°.
Croatian: Ubodite iglom nabor kože pod kutom od 45° do 90°.
English: What IntronA looks like and contents of the pack
Croatian: Kako IntronA izgleda i sadržaj pakiranja
English: Do not use this medicine if you notice changes in the appearance of IntronA.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite promjene u izgledu lijeka IntronA.
English: IntronA is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: IntronA se smije koristiti tijekom trudnoće jedino ako moguća korist opravdava mogući rizik za plod.
English: Interactions between IntronA and other medicinal products have not been fully evaluated.
Croatian: Interakcije između lijeka IntronA i drugih lijekova nisu u potpunosti ispitane.
English: IntronA must be used with caution in fertile men.
Croatian: IntronA mora se primjenjivati uz oprez u plodnih muškaraca.
English: Intravenous infusion:
Croatian: Intravenska infuzija:
English: The treatment is to be temporarily discontinued during and after surgery.
Croatian: Liječenje se mora privremeno prekinuti tijekom i nakon operacije.
English: What IntronA is and what it is used for
Croatian: Što je IntronA i za što se koristi
English: Other medicines and IntronA
Croatian: Drugi lijekovi i IntronA
English: Authorized Representative: BD, Laagstraat 57, B-9140 Temse, Belgium
Croatian: Ovlašteni predstavnik: BD, Laagstraat 57, B-9140 Temse, Belgija
English: Neoplasm (unspecified)
Croatian: novotvorina (nespecificirana)
English: The optimal duration of therapy with IntronA alone is not yet fully established, but a therapy of between 12 and 18 months is advised.
Croatian: Optimalno trajanje liječenja samo lijekom IntronA još nije potpuno utvrđeno, no savjetuje se liječenje u trajanju između 12 i 18 mjeseci.
English: IntronA is given either daily (5 or 7 times a week), or three times a week, every other day, for example on Monday, Wednesday, and Friday.
Croatian: IntronA se daje ili svaki dan (5 ili 7 dana u tjednu) ili triput na tjedan, svaki drugi dan, npr. ponedjeljkom, srijedom i petkom.
English: What IntronA contains
Croatian: Što IntronA sadrži
English: With your other hand hold the syringe as you would a pencil.
Croatian: Drugom rukom uzmite štrcaljku i držite je kao olovku.
English: Table 6 Sustained virological response rates (n a,b
Croatian: Table 6. Stope trajnog virološkog odgovora (n a,b
English: Pyrexia and fatigue were often reversible within 72 hours of interruption or cessation of treatment.
Croatian: Pireksija i umor često su se povlačili u roku od 72 sata nakon prekida ili završetka liječenja.
English: You should brush your teeth thoroughly twice daily and have regular dental examinations.
Croatian: Trebate temeljito prati zube dvaput dnevno i obavljati redovite kontrolne preglede zuba.
English: The clear and colourless solution is contained in a glass vial.
Croatian: Bistra i bezbojna otopina nalazi se u staklenoj bočici.
English: Treatment must be initiated by a physician experienced in the management of the disease.
Croatian: Liječenje mora započeti liječnik s iskustvom u liječenju takve bolesti.
English: Be sure to discuss this with your doctor.
Croatian: Svakako o tome razgovarajte sa svojim liječnikom.
English: No case of overdose has been reported that has led to acute clinical manifestations.
Croatian: Nisu prijavljeni slučajevi predoziranja koji bi imali akutne kliničke manifestacije.
English: Not all dose forms and strengths are appropriate for some indications.
Croatian: Svi oblici i jačine doza nisu primjereni za sve indikacije.
English: Three major classes of interferons have been identified: alpha, beta and gamma.
Croatian: Utvrđene su tri glavne vrste interferona: alfa, beta i gama.
English: Although the optimal (minimum) dose for full clinical benefit is unknown, patients must be treated at the recommended dose, with dose reduction for toxicity as described.
Croatian: Iako optimalna (minimalna) doza za postizanje potpune kliničke koristi nije poznata, bolesnici se moraju liječiti preporučenim dozama, uz opisano smanjenje doze zbog toksičnosti.
English: Hepatomegaly Hepatotoxicity, (including fatality)
Croatian: hepatomegalija hepatotoksičnost (uključujući fatalnu)
English: Loss of consciousness has occurred very rarely, mostly in elderly patients treated at high doses.
Croatian: Gubitak svijesti se javlja vrlo rijetko, većinom u starijih bolesnika liječenih visokim dozama.
English: Another 4 % had a transient decrease below the lower limit of normal.
Croatian: Dodatnih 4% imalo je prolazno sniženje vrijednosti TSH ispod donje granice normale.
English: Your doctor will determine the exact dosage schedule and regimen according to your needs.
Croatian: Liječnik će odrediti točan raspored doziranja i doze u skladu s Vašim potrebama.
English: *AUC12 (ng.hr/mL) for ribavirin; AUC0-24 (IU.hr/mL) for IntronA
Croatian: * AUC12 (ng.h/ml) za ribavirin; AUC0-24 (IU.h/ml) za IntronA
English: Although interferon is generally recognised as being species specific, toxicity studies in animals were conducted.
Croatian: Iako se općenito smatra da su interferoni specifični za vrstu, provedena su istraživanja toksičnosti na životinjama.
English: Therefore, check with your doctor or pharmacist about drinking alcoholic beverages, or taking sleeping pills, sedatives or strong pain medicines.
Croatian: Stoga se posavjetujte sa svojim liječnikom ili ljekarnikom o uzimanju alkoholnih pića, tableta za spavanje, sedativa ili jakih lijekova protiv bolova.
English: Driving and using machines Do not drive or use machines if you become drowsy, tired, or confused from using this medicine.
Croatian: Nemojte voziti niti upravljati strojevima ako ste zbog uzimanja ovog lijeka omamljeni, umorni ili smeteni.
English: Genotype 2/3/4 (n=26)
Croatian: Genotip 2/3/4 (n=26)
English: Use IntronA exactly as prescribed by your doctor.
Croatian: Primjenjujte IntronA točno onako kako Vam je propisao liječnik.
English: Other in-use storage times and conditions are the responsibility of the user.
Croatian: Drugačije vrijeme i uvjeti čuvanja lijeka u primjeni odgovornost su korisnika.
English: The pharmacokinetics of IntronA and ribavirin (dose-normalized) are similar in adults and children or adolescents.
Croatian: Farmakokinetike lijeka IntronA i ribavirina (normalizirane doze) slične su u odraslih i djece ili adolescenata.
English: Seventy percent (68/97) of all enrolled subjects completed this study of which 75 % (42/56) were sustained responders.
Croatian: Sedamdeset posto (68/97) svih uključenih ispitanika završilo je ovo ispitivanje, od kojih je 75% (42/56) imalo trajan virološki odgovor.
English: if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
Croatian: - ako imate ili ste prethodno imali infekciju virusom hepatitisa B, jer će Vas liječnik možda htjeti pomnije pratiti.
English: If you have them, you may have had a serious allergic reaction to IntronA.
Croatian: Ako ih dobijete, možda imate tešku alergijsku reakciju na IntronA.
English: Genotype 1  2 million copies/mL Genotype 1 > 2 million copies/mL
Croatian: Genotip 1 ≤ 2 milijuna kopija/ml Genotip 1 > 2 milijuna kopija/ml
English: If you are injecting this medicine yourself, you will be instructed how to prepare and give the injection.
Croatian: Ako si injekciju dajete sami, dobit ćete upute kako da pripremite i date injekciju.
English: This means that IntronA is injected with a short needle into the fatty tissue just under the skin.
Croatian: To znači da se IntronA injicira kroz kratku iglu u masno tkivo neposredno ispod kože.
English: Ribavirin 15 mg/kg/day as 2 divided doses (n = 17)
Croatian: Ribavirin 15 mg/kg na dan podijeljeno u 2 doze (n=17)
English: What IntronA is and what it is used for What you need to know before you use IntronA How to use IntronA
Croatian: Što je IntronA i za što se koristi Što morate znati prije nego počnete primjenjivati IntronA
English: If you have the impression that the effect of IntronA is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako Vam se čini da je učinak lijeka IntronA prejak ili preslab, obratite se svom liječniku ili ljekarniku.
English: Dose modifications were required in 30 % of patients, most commonly for anaemia and neutropaenia.
Croatian: Prilagodba doze bila je potrebna u 30% bolesnika, najčešće zbog anemije i neutropenije.
English: You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
Croatian: Razmislite o tome da zatražite pomoć člana obitelji ili bliskog prijatelja koji će Vas upozoriti na znakove depresije ili promjene ponašanja.
English: Dosages that are to be administered 3 times a week are best given every other day.
Croatian: Doze koje se moraju primjenjivati triput na tjedan najbolje je davati svaki drugi dan.
English: • Genotype 2/3: The recommended duration of treatment is 24 weeks.
Croatian: • Genotipovi 2 ili 3: preporučeno trajanje liječenja je 24 tjedna.
English: The interferons are a family of small protein molecules with molecular weights of approximately 15,000 to 21,000 daltons.
Croatian: Interferoni su skupina malih proteinskih molekula molekularne težine od oko 15 000 do 21 000 daltona.
English: - if you are a man who is taking ribavirin, do not have sex with a pregnant woman unless you use a condom.
Croatian: - ako ste muškarac koji uzima ribavirin, ne smijete imati spolne odnose s trudnicom bez uporabe kondoma.
English: Efficacy was defined as sustained virologic response, 6 months after the end of treatment.
Croatian: Djelotvornost se definirala kao trajan virološki odgovor 6 mjeseci nakon završetka liječenja.
English: - Epilepsy and/or compromised central nervous system (CNS) function (see section 4.4).
Croatian: - Epilepsija i/ili ugroženost funkcije središnjeg živčanog sustava (SŽS) (vidjeti dio 4.4).
English: Growth rate decrease (height and/or weight decrease for age)
Croatian: smanjena brzina rasta (smanjenje tjelesne visine i/ili težine za dob)
English: The infusion must be prepared immediately prior to use.
Croatian: Infuzija se mora pripremiti neposredno prije primjene.
English: More than 14 genetically distinct human alpha interferons have been identified.
Croatian: Poznato je više od 14 genetski različitih humanih alfa interferona.
English: During treatment for hepatitis B or C the recommended testing schedule is at weeks 1, 2, 4, 8, 12, 16, and every other month, thereafter, throughout treatment.
Croatian: Tijekom liječenja hepatitisa B ili C preporučeni raspored provođenja pretraga je u 1., 2., 4., 8., 12. i 16. tjednu te nakon toga svaki drugi mjesec sve dok traje liječenje.
English: Need for adequate hydration
Croatian: Potreba za primjerenom hidracijom
English: Laboratory Tests
Croatian: Laboratorijske pretrage
English: If the medicine is not used during the seven-day period, it should be discarded.
Croatian: Ako se lijek ne upotrijebi tijekom tog sedmodnevnog razdoblja, treba ga baciti.
English: Monitoring of lipid levels is, therefore, recommended.
Croatian: Stoga se preporučuje praćenje razine lipida.
English: If you are prescribed IntronA in combination with ribavirin, ribavirin can be very damaging to an unborn baby, thus both female and male patients must take special precautions in their sexual activity if there is any chance for pregnancy to occur: - if you are a girl or a woman of childbearing age, you must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped.
Croatian: Ako Vam je propisan IntronA u kombinaciji s ribavirinom, ribavirin može biti jako štetan za nerođeno dijete te stoga i ženski i muški bolesnici moraju poduzeti posebne mjere opreza pri spolnoj aktivnosti ako postoji ikakva mogućnost trudnoće: - ako ste djevojka ili žena u generativnoj dobi, morate imati negativan test na trudnoću prije liječenja, svaki mjesec za vrijeme liječenja te tijekom 4 mjeseca nakon prestanka liječenja.
English: Genotype 1 (n=92)
Croatian: Genotip 1 (n=92)
English: Moderate and usually reversible pancytopenia has been reported.
Croatian: Prijavljena je umjerena i obično reverzibilna pancitopenija.
English: If you are scheduled to inject this medicine every day, and you accidentally missed a full day's dose, continue treatment at the usual dose the following day.
Croatian: Ako prema rasporedu morate primiti injekciju ovog lijeka svaki dan i slučajno ste propustili primijeniti cijelu dnevnu dozu, nastavite liječenje tako da sljedeći dan uzmete uobičajenu dozu.
English: - if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing, or hives) while on this medicine seek medical help immediately.
Croatian: - ako razvijete simptome teške alergijske reakcije (kao što su otežano disanje, piskanje pri disanju ili koprivnjača) dok uzimate ovaj lijek, odmah potražite liječničku pomoć.
English: Ribavirin concentration in seminal fluid is approximately two-fold higher compared to serum.
Croatian: Koncentracije ribavirina u sjemenoj su tekućini približno dvostruko veće nego u serumu.
English: The mechanism behind these events is not known (see sections 4.3, 4.4 and 4.5 of the telbivudine SPC).
Croatian: Mehanizam u podlozi tih događaja nije poznat (vidjeti dijelove 4.3, 4.4 i 4.5 u Sažetku opisa svojstava lijeka za telbivudin).
English: Pulmonary arterial hypertension - a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Croatian: Plućna arterijska hipertenzija - bolest jakog suženja krvnih žila u plućima što rezultira visokim krvnim tlakom u krvnim žilama koje prenose krv iz srca u pluća.
English: Human interferon receptors, as isolated from human lymphoblastoid (Daudi) cells, appear to be highly asymmetric proteins.
Croatian: Čini se da su ljudski interferonski receptori, izolirani iz humanih limfoblastoidnih (Daudi) stanica, izrazito asimetrični proteini.
English: It is recommended that patients be treated with IntronA alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
Croatian: Preporučuje se liječiti bolesnike samo lijekom IntronA najmanje 3 do 4 mjeseca, nakon čega se mora odrediti status HCV-RNK.
English: They exhibit selectivity for human but not murine interferons, suggesting species specificity.
Croatian: Selektivni su za humane, ali ne i mišje interferone, što ukazuje na postojanje specifičnosti za vrstu.
English: Cases of stroke (cerebrovascular events) have been reported.
Croatian: Prijavljeni su i slučajevi moždanog udara (cerebrovaskularni događaji).
English: Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Croatian: Bolesnici moraju temeljito prati zube dva puta na dan i redovito obavljati preglede zuba.
English: However, certain monkey species, eg, rhesus monkeys, are susceptible to pharmacodynamic stimulation upon exposure to human type 1 interferons.
Croatian: Ipak, određene vrste majmuna, npr. rhesus majmuni, osjetljive su na farmakodinamičku stimulaciju nakon izlaganja humanim interferonima tipa 1.
English: Auto-antibodies and autoimmune disorders
Croatian: Autoantitijela i autoimuni poremećaji
English: §, virilism
Croatian: §, virilizacija
English: While being treated with IntronA, your doctor may want you to drink extra fluids to help prevent low blood pressure.
Croatian: Za vrijeme liječenja lijekom IntronA liječnik će možda tražiti da pijete više tekućine kako bi se spriječio razvoj niskog krvnog tlaka.
English: Duration of treatment for children and adolescents
Croatian: Trajanje liječenja u djece i adolescenata
English: IntronA treatment must be discontinued after 8 to 12 weeks of treatment if at least a partial haematological remission or a clinically meaningful cytoreduction has not been achieved.
Croatian: Liječenje lijekom IntronA mora se obustaviti nakon 8 do 12 tjedana liječenja ako se nije postigla barem djelomična hematološka remisija ili klinički značajna citoredukcija.
English: - if you notice unusual bleeding or bruising check with your doctor immediately.
Croatian: - ako primijetite neuobičajeno krvarenje ili modrice, odmah se javite liječniku.
English: - if you have advanced decompensated (uncontrolled) liver disease.
Croatian: - ako imate uznapredovalu, dekompenziranu (nekontroliranu) bolest jetre.
English: IntronA 3 MIU/m 2 3 times a week (n = 54)
Croatian: IntronA 3 milijuna IU/m 2 triput na tjedan (n=54)
English: All patients in these trials received 3 MIU of IntronA three times a week.
Croatian: Svi su bolesnici u ovim ispitivanjima primali 3 milijuna IU lijeka IntronA triput na tjedan.
English: As maintenance therapy in patients who have achieved objective remission (more than 50 % reduction in myeloma protein) following initial induction chemotherapy.
Croatian: Kao terapija održavanja u bolesnika koji su postigli objektivnu remisiju (smanjenje mijelomskih proteina za više od 50%) nakon početne uvodne kemoterapije.
English: Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with IntronA.
Croatian: Narkotici, hipnotici i sedativi moraju se primjenjivati uz oprez kada se koriste istodobno s lijekom IntronA.
English: Ribavirin causes serious birth defects when administered during pregnancy.
Croatian: Ribavirin uzrokuje ozbiljne porođajne anomalije kad se primjenjuje u trudnoći.
English: In adult patients receiving interferon in combination with ribavirin, the achieved sustained response rate is 47 %.
Croatian: U odraslih bolesnika koji primaju interferon u kombinaciji s ribavirinom, postignuta stopa trajnog terapijskog odgovora iznosi 47%.
English: The clinical incidence of neutralising factors developing in cancer patients treated systemically is 2.9 % and in chronic hepatitis patients is 6.2 %.
Croatian: Klinička incidencija neutralizirajućih čimbenika koji se razvijaju u sistemski liječenih bolesnika s karcinomom iznosi 2,9%, a u bolesnika s kroničnim hepatitisom 6,2%.
English: Final adult height was available for 14 of those children and demonstrated that 12 continued to show height deficits > 15 percentiles, 10 to 12 years after the end of treatment.
Croatian: Konačna visina u odrasloj dobi bila je dostupna za 14 navedene djece te je za njih 12 pokazala deficit rasta > 15 percentila, 10 do 12 godina nakon završetka liječenja.
English: However, as for any pharmacologically active compound, symptomatic treatment with frequent monitoring of vital signs and close observation of the patient is indicated.
Croatian: Međutim, kao i kod svake farmakološki djelatne tvari, indicirano je simptomatsko liječenje uz često praćenje vitalnih znakova i poman nadzor bolesnika.
English: If you forget to use IntronA
Croatian: Ako ste zaboravili primijeniti IntronA
English: Moreover, the safety and efficacy of telbivudine in combination with interferons for the treatment of chronic hepatitis B has not been demonstrated.
Croatian: Nadalje, nije dokazana sigurnost i djelotvornost telbivudina u kombinaciji s interferonima u liječenju kroničnog hepatitisa B.
English: Injury and poisoning Common:
Croatian: Ozljede i trovanja često:
English: Pharmacotherapeutic group: interferon alfa-2b, ATC code: L03A B05
Croatian: Farmakoterapijska skupina: interferon alfa-2b, ATK oznaka: L03A B05