FrancophonIA/ELRC3.0 huggingface dataset:
English: This information does not take the place of talking to your doctor or nurse about your medical condition or your treatment.
Croatian: Ove upute ne zamjenjuju razgovor s liječnikom ili medicinskom sestrom o Vašem zdravstvenom stanju ili liječenju.
English: A patient should not administer two doses of Plegridy within 7 days of each other.
Croatian: Bolesnik ne smije primijeniti dvije doze Plegridyja unutar 7 dana.
English: Day 28 and then every two weeks after that (125 micrograms)
Croatian: 28. dan, a nakon toga svaka dva tjedna (125 mikrograma)
English: • If less than 7 days to the next planned dose: Patients should begin a new 2 week dosing schedule starting from when they administer their missed dose.
Croatian: • Ako ima manje od 7 dana do sljedeće planirane doze: Bolesnici trebaju započeti novi 2-tjedni raspored doziranja počevši od dana kada su primijenili propuštenu dozu.
English: This is normal and does not need to be expelled before your injection.
Croatian: To je normalno i mjehuriće nije potrebno istisnuti prije injekcije.
English: In case of over-dose, patients may be hospitalized for observation and appropriate supportive treatment should be given.
Croatian: U slučajevima predoziranja, bolesnike se može hospitalizirati radi promatranja te treba uvesti prikladno suportivno liječenje.
English: The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred.
Croatian: Povremeno treba pregledati postupak samostalnog davanja injekcije od strane bolesnika, pogotovo ako je došlo do reakcije na mjestu injiciranja.
English: This regular schedule helps to deliver the treatment as evenly as possible.
Croatian: Ovaj redoviti raspored pomaže da liječenje bude ujednačeno.
English: Try to use Plegridy at the same time on the same day, every time you inject.
Croatian: Nastojte primjenjivati Plegridy u isto vrijeme na isti dan, svaki put kad dajete injekciju.
English: It is important to continue using Plegridy regularly.
Croatian: Važno je nastaviti redovito primjenjivati Plegridy.
English: Patients with relapsing-remitting MS have periods when the disease is not active (remission) in between flare-ups of symptoms (relapses).
Croatian: Bolesnici s relapsnom remitirajućom multiplom sklerozom imaju razdoblja kada bolest nije aktivna (remisija) između razdoblja kada simptomi pogoršaju (relapsi).
English: Do not use this medicine after the expiry date which is stated on the carton and the label after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake „EXP“.
English: Mean [Median] no. of new or newly enlarging T2 hyperintense lesions (range)
Croatian: Srednja vrijednost [medijan] broja novih ili novo povećanih T2 hiperintenzivnih lezija (raspon)
English: Your pen is now ready to inject.
Croatian: Brizgalica je sad spremna za ubrizgavanje.
English: Day 14
Croatian: 14. dan
English: Find a well-lit, clean, flat surface to work on like a table.
Croatian: Pronađite dobro osvijetljenu, čistu i ravnu radnu površinu poput stola.
English: Less than 1% of Plegridy treated patients experienced a serious hypersensitivity event (e.g. angioedema, urticaria) and they recovered promptly after treatment with anti-histamines and/or corticosteroids.
Croatian: Manje od 1% bolesnika liječenih Plegridyjem doživjelo je ozbiljan slučaj preosjetljivosti (npr. angioedem, urtikarija) i oporavili su se odmah nakon liječenja antihistaminicima i/ili kortikosteroidima.
English: Three simple ways to help reduce the impact of flu-like symptoms:
Croatian: Tri su jednostavna načina da se smanji utjecaj simptoma nalik gripi:
English: Your doctor will tell you how long you need to keep using Plegridy.
Croatian: Liječnik će Vam reći koliko dugo ćete trebati primjenjivati Plegridy.
English: The start and end of flu-like symptoms are different for every patient.
Croatian: Simptomi nalik gripi počinju i prestaju različito kod svakog bolesnika.
English: Patients may develop antibodies to Plegridy.
Croatian: Bolesnici mogu razviti protutijela na Plegridy.
English: What Plegridy looks like and contents of the pack
Croatian: Kako Plegridy izgleda i sadržaj pakiranja
English: If you accidentally prick yourself or someone else with the needle in Plegridy, the area affected should be washed immediately with soap and water and a doctor or nurse should be contacted as soon as possible.
Croatian: Ako slučajno ubodete sebe ili nekog drugog iglom u Plegridyju, zahvaćeno područje odmah operite vodom i sapunom i obratite se liječniku ili medicinskoj sestri što je prije moguće.
English: Proportion of subjects relapsed HR
Croatian: Udio ispitanika s relapsom HR
English: Treatment with Plegridy can help to prevent you from getting worse, although it will not cure MS.
Croatian: Liječenje Plegridyjem može pomoći u sprečavanju pogoršanja bolesti, iako neće izliječiti multiplu sklerozu.
English: Note: After the pen has been removed from the injection site, the needle cover will lock to protect against needle injury.
Croatian: Napomena: nakon što se brizgalica podigne s mjesta injekcije, pokrov igle će se zaključati radi zaštite od ozljede ubodom na iglu.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Plegridy in one or more subsets of the paediatric population in treatment of multiple sclerosis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Plegridy u jednoj ili više podskupina pedijatrijske populacije u liječenju multiple skleroze (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Do not use the same injection site for consecutive injections.
Croatian: Nemojte koristiti isto mjesto davanja injekcije za uzastopne injekcije.
English: Step 2: Collect your supplies and wash your hands
Croatian: 2. korak: Prikupite pribor i operite ruke
English: Data from studies with other interferon beta compounds did not show teratogenic potential.
Croatian: Podaci iz istraživanja s drugim spojevima interferona beta nisu pokazali teratogeni potencijal.
English: This might happen several weeks to several years after starting Plegridy.
Croatian: To bi se moglo dogoditi nekoliko tjedana do nekoliko godina nakon početka primjene lijeka Plegridy.
English: • Pull the needle straight out (See Figure K).
Croatian: • Izvucite iglu ravno van (pogledajte sliku K).
English: The safety and efficacy of Plegridy in patients over the age of 65 have not been sufficiently studied due to the limited number of such patients included in clinical trials.
Croatian: Sigurnost i djelotvornost Plegridyja u bolesnika starijih od 65 godina nisu dovoljno ispitane zbog ograničenog broja takvih bolesnika u kliničkim ispitivanjima.
English: If the patient experiences any break in the skin, which may be accompanied by swelling or drainage of fluid from the injection site, the patient should be advised to speak with their doctor.
Croatian: Ako je bolesnik iskusio bilo kakvo oštećenje na koži, što može biti popraćeno oticanjem ili istjecanjem tekućine na mjestu injiciranja, bolesnika treba savjetovati da razgovara sa svojim liječnikom.
English: Reversibility of the effects on menstrual cycle length was demonstrated.
Croatian: Pokazalo se da su učinci na duljinu menstrualnog ciklusa reverzibilni.
English: Additional supplies which are not included in the pack (see Figure B):
Croatian: Dodatni pribor koji nije uključen u pakiranje (pogledajte sliku B):
English: • Plegridy can be removed from and returned to the refrigerator if necessary.
Croatian: • Plegridy se može izvaditi iz hladnjaka i vratiti u hladnjak po potrebi.
English: Giving your injection Step 4: Choose and clean your injection site
Croatian: Davanje injekcije 4. korak: Izaberite i očistite mjesto za injekciju
English: Subjects with end stage renal disease requiring 2-3 times haemodialysis weekly showed similar AUC and Cmax as compared to subjects with normal renal function.
Croatian: Ispitanici u završnom stadiju bolesti bubrega kojima je potrebna hemodijaliza 2 do 3 puta tjedno, pokazali su sličan AUC i Cmax u usporedbi s ispitanicima s normalnom funkcijom bubrega.
English: Each inner carton contains 2 pens in a protective plastic tray.
Croatian: Svaka unutarnja kutija sadrži 2 brizgalice u zaštitnom plastičnom spremniku.
English: • If you have a skin reaction and it does not clear up in a few days, contact your doctor or nurse.
Croatian: • Ako imate kožnu reakciju i ona se ne povuče za nekoliko dana, obratite se liječniku ili medicinskoj sestri.
English: Note: Do not touch or blow on this area again before giving your injection.
Croatian: Napomena: Nemojte ponovno dodirivati ili puhati na ovo područje prije davanja injekcije.
English: • Wash your hands with soap and water.
Croatian: • Operite ruke vodom i sapunom.
English: Therefore, the long-term safety of chronic administration of Plegridy to patients cannot be assessed on the basis of these studies.
Croatian: Stoga se dugotrajna sigurnost kronične primjene Plegridyja u bolesnika ne može procijeniti na temelju tih istraživanja.
English: Patients with RRMS, with at least 2 relapses within the prior 3 years, and 1 relapse in the prior year, with an EDSS score of ≤5.0
Croatian: Bolesnici s RRMS-om, s najmanje 2 relapsa u prethodne 3 godine, i 1 relapsom u prethodnoj godini s EDSS ocjenom ≤5,0
English: Injection Site open here
Croatian: Mjesto davanja injekcije otvoriti ovdje
English: At very high doses, anovulatory and abortifacient effects were observed in animals.
Croatian: opaženi su anovulatorni i abortivni učinci u životinja.
English: • Find a well-lit, clean, flat surface to work on, like a table.
Croatian: • Pronađite dobro osvijetljenu, čistu i ravnu radnu površinu poput stola.
English: c. Check the medicine window and make sure the Plegridy medicine is clear and colourless.
Croatian: c. Provjerite prozorčić za lijek kako biste bili sigurni da je lijek Plegridy bistar i bezbojan.
English: The experience in the randomised, uncontrolled phase (year 2) of the ADVANCE study and in the extension study ATTAIN (treatment received for up to 4 years) was consistent with the experience in the 1 year placebo-controlled phase of the ADVANCE study.
Croatian: Iskustvo iz ispitivanja ADVANCE u fazi koja je bila randomizirana i bez kontrolne skupine (2. godina) i iz nastavka ispitivanja ATTAIN (liječenje je trajalo do 4 godine) bilo je u skladu s iskustvom u 1. godini placebom kontrolirane faze ispitivanja ADVANCE.
English: This tells you that the injection is happening (see Figure G).
Croatian: To znači da se odvija ubrizgavanje (pogledajte sliku G).
English: The clinical studies indicate that multiple sclerosis patients can receive Plegridy and corticosteroids during relapses.
Croatian: Klinička ispitivanja su pokazala da bolesnici s multiplom sklerozom smiju istovremeno primati Plegridy i kortikosteroide tijekom relapsa.
English: • Each pen can be used once only.
Croatian: • Jedna brizgalica smije se upotrijebiti samo jedanput.
English: Plegridy should be used carefully with medicines that are broken down in the body by a group of proteins called “cytochrome P450” (e.g. some medicines used for epilepsy or depression).
Croatian: Plegridy treba oprezno koristiti s lijekovima koje u tijelu razgrađuje skupina proteina pod nazivom „citokrom P450“ (npr. neki lijekovi koji se koriste za liječenje epilepsije ili depresije).
English: The efficacy and safety of Plegridy was assessed from the placebo-controlled first year of a 2 year randomised, double-blind, clinical study in patients with relapsing remitting multiple sclerosis (the ADVANCE study).
Croatian: Djelotvornost i sigurnost Plegridyja procijenjene su iz placebom kontrolirane prve godine 2-godišnjeg, randomiziranog, dvostruko slijepog kliničkog ispitivanja u bolesnika s relapsnom remitirajućom multiplom sklerozom (RRMS) (ispitivanje ADVANCE).
English: Table 3: Clinical and MRI results
Croatian: Tablica 3. Klinički i MR rezultati
English: How Plegridy works Plegridy seems to work by stopping the body's immune system from damaging your brain and spinal cord.
Croatian: Čini se da Plegridy djeluje tako što sprječava imunološki sustav tijela da ošteti mozak i leđnu moždinu.
English: Injection site erythema was the most commonly reported injection site reaction.
Croatian: Eritem na mjestu injiciranja je bio najčešće prijavljena reakcija na mjestu injiciranja.
English: An initiation pack is available containing the first 2 doses (63 micrograms and 94 micrograms).
Croatian: Dostupno je pakiranje za početak liječenja koje sadrži prve dvije doze (63 mikrograma i 94 mikrograma).
English: If clinically needed, the use of Plegridy may be considered during pregnancy.
Croatian: U slučaju kliničke potrebe primjena lijeka Plegridy može se uzeti u obzir tijekom trudnoće.
English: MS is a long term illness that affects the central nervous system (CNS), including the brain and spinal cord, in which the body's immune system (its natural defences) damages the protective layer (myelin) that surrounds the nerves in the brain and spinal cord.
Croatian: Multipla skleroza je dugotrajna bolest koja pogađa središnji živčani sustav (SŽS), uključujući mozak i leđnu moždinu, kod koje imunološki sustav organizma (njegova prirodna obrana) oštećuje zaštitne ovojnice (mijelin) koje okružuju živčana vlakna u mozgu i leđnoj moždini.
English: • Keep the needle inserted in for 5 seconds (see Figure J).
Croatian: • Držite iglu umetnutu 5 sekundi (pogledajte sliku J).
English: • Choose an injection site and wipe the skin with an alcohol wipe.
Croatian: • Izaberite mjesto za injekciju i obrišite kožu vatom natopljenom alkoholom.
English: Prophylactic and concurrent use of anti-inflammatory, analgesic and/or antipyretic treatments may prevent or ameliorate flu-like symptoms sometimes experienced during interferon treatment (see section 4.8).
Croatian: Profilaktička i istodobna primjena protuupalnih lijekova, analgetika i/ili antipiretika, može spriječiti ili ublažiti simptome nalik gripi koji se ponekad javljaju tijekom liječenja interferonom (vidjeti dio 4.8).
English: Do not lift your pen off your injection site until the clicking sounds stop and you see green ticks in the injection status window.
Croatian: Nemojte podići brizgalicu s mjesta injekcije prije nego što prestane zvuk otkucavanja i ugledate zelene kvačice u prozorčiću stanja injekcije.
English: Patients exhibiting depression should be monitored closely during therapy and treated appropriately.
Croatian: Bolesnike koji pokazuju simptome depresije treba pomno nadzirati tijekom liječenja i primjereno liječiti.
English: This should be considered when switching patients between pegylated and non-pegylated interferons (see section 5.1).
Croatian: To treba uzeti u obzir kod prebacivanja bolesnika između nepegiliranog i pegiliranog interferona (vidjeti dio 5.1).
English: Efficacy of Plegridy has been demonstrated over placebo.
Croatian: Djelotvornost Plegridyja dokazana je u usporedbi s placebom.
English: These will be performed before you start using Plegridy, regularly after treatment with Plegridy has been initiated and then periodically during treatment, even if you have no particular symptoms.
Croatian: To će se provesti prije početka primjene Plegridyja, redovito nakon početka liječenja Plegridyjem te zatim periodički tijekom liječenja, čak i ako nemate nikakve posebne simptome.
English: Which pack
Croatian: Koje pakiranje
English: In clinical studies, a total of 1468 patients received Plegridy for up to 278 weeks with an overall exposure equivalent of 4217 person-years.
Croatian: U kliničkim je ispitivanjima ukupno 1468 bolesnika primalo Plegridy do 278 tjedana, pri čemu je ukupna izloženost bila jednaka 4217 bolesnik-godina.
English: Interferons are a family of naturally occurring proteins that are induced by cells in response to biological and chemical stimuli, and mediate numerous cellular responses that have been classified as antiviral, antiproliferative, and immunomodulatory in nature.
Croatian: Interferoni pripadaju skupini prirodnih proteina koje stvaraju stanice kao odgovor na biološke i kemijske stimulanse, te posreduju u brojnim staničnim odgovorima koji su klasificirani kao protuvirusni, protuproliferativni i imunomodulacijski odgovori.
English: The liquid in the syringe must be clear and colourless.
Croatian: Tekućina u štrcaljki mora biti bistra i bezbojna.
English: The safety and effectiveness of Plegridy in this age group are not known.
Croatian: Sigurnost i djelotvornost Plegridyja u ovoj dobnoj skupini nisu poznate.
English: - If you have used more than one injection of Plegridy in a 7-day period, contact your doctor or nurse straight away.
Croatian: - Ako ste primijenili više od jedne injekcije Plegridyja u razdoblju od 7 dana odmah se obratite svom liječniku ili medicinskoj sestri za savjet.
English: You should see a yellow plunger.
Croatian: Morate vidjeti žuti klip.
English: (See Figure H).
Croatian: (pogledajte sliku I).
English: In patients experiencing flu-like symptoms, the median time to onset was 10 hours (interquartile range, 7 to 16 hours) after injection, and the median duration was 17 hours (interquartile range, 12 to 22 hours).
Croatian: U bolesnika sa simptomima nalik gripi, medijan vremena od injekcije do nastupa simptoma iznosio je 10 sati (interkvartilni raspon od 7 do 16 sati), a medijan trajanja 17 sati (interkvartilni raspon od 12 do 22 sata).
English: No serious cardiovascular events were reported in patients who received Plegridy in the ADVANCE study.
Croatian: Nije bilo prijavljenih ozbiljnih kardiovaskularnih događaja u bolesnika koji su primali Plegridy u ispitivanju ADVANCE.
English: Do not use the pen if:
Croatian: Nemojte koristiti brizgalicu:
English: Use caution when removing the needle cover to avoid getting a needle stick injury.
Croatian: Budite oprezni dok uklanjate pokrov igle kako se ne biste ozlijedili ubodom na iglu.
English: They gradually get less as you keep using your injections.
Croatian: Ti se simptomi postupno smanjuju tijekom primjene Vaših injekcija.
English: It is recommended that a healthcare professional trains patients in the proper technique for self-administering subcutaneous injections using the pre-filled syringe/pre-filled pen.
Croatian: Preporučuje se da zdravstveni radnik poduči bolesnike o ispravnoj tehnici za samostalno davanje supkutane injekcije pomoću napunjene štrcaljke / napunjene brizgalice.
English: Precautions to be taken before handling or administering the medicinal product Once removed from the refrigerator, Plegridy should be allowed to warm to room temperature (up to 25°C) for about 30 minutes prior to injection.
Croatian: Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Jednom kad se izvadi iz hladnjaka, Plegridy se mora ostaviti da se ugrije na sobnu temperaturu (do 25°C) otprilike 30 minuta prije davanja injekcije.
English: Speak to your doctor or pharmacist about how much to take and how long to take it.
Croatian: Posavjetujte se sa svojim liječnikom ili ljekarnikom o tome koliko i kako dugo ćete uzimati jedan od ta dva lijeka.
English: Less than 1% of patients who received Plegridy during the placebo controlled phase of the ADVANCE study discontinued treatment due to flu-like symptoms.
Croatian: Manje od 1% bolesnika koji su primali Plegridy tijekom placebom kontrolirane faze ispitivanja ADVANCE, prekinulo je liječenje zbog simptoma nalik gripi.
English: Following repeat dosing of 125 micrograms doses every two weeks by subcutaneous administration, the volume of distribution uncorrected for bioavailability (mean±SE) was 481 ± 105 L.
Croatian: Nakon ponovljenog doziranja doze od 125 mikrograma svaka dva tjedna supkutanom primjenom, volumen distribucije bez korekcije za bioraspoloživost (srednja vrijednost ± SE) bio je 481 ± 105 l.
English: • Alcohol wipe
Croatian: • vata natopljena alkoholom
English: The incidence of flu-like symptoms (e.g. influenza-like illness, chills, hyperpyrexia, musculoskeletal pain, myalgia, pain, pyrexia) was highest at the initiation of treatment and generally decreased over the first 6 months.
Croatian: Incidencija simptoma nalik gripi (npr. bolest nalik gripi, zimica, hiperpireksija, mišićno-koštana bol, mialgija, bol, pireksija) bila je najviša na početku liječenja, a općenito se smanjila tijekom prvih 6 mjeseci.
English: Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Croatian: Bolesnicima s mijelosupresijom može biti potrebno intenzivnije praćenje ukupnog broja krvnih stanica s diferencijalnom krvnom slikom i brojem trombocita.
English: Make sure you can see the green stripes in the injection status window (see Figure F).
Croatian: Provjerite vide li se zelene pruge u prozorčiću stanja injekcije (pogledajte sliku F).
English: Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Plegridy should be considered.
Croatian: Potrebno je brzo liječenje nefrotskog sindroma i treba se razmotriti prestanak liječenja Plegridyjem.
English: Nevertheless, patients with pre-existing significant cardiac disease, such as congestive heart failure, coronary artery disease or arrhythmia should be monitored for worsening of their cardiac condition, particularly during initiation of treatment.
Croatian: Međutim, kod bolesnika s postojećim značajnim srčanim bolestima, kao što su kongestivno zatajenje srca, koronarna bolest ili aritmija, mora se pratiti znakove pogoršanja srčane funkcije, posebice tijekom početka liječenja.
English: What you need to know before you use Plegridy 3.
Croatian: Što morate znati prije nego počnete primjenjivati Plegridy 3.
English: Patients should be monitored for symptoms or signs of decreased peripheral blood counts (see section
Croatian: Bolesnike treba pratiti na simptome ili znakove smanjenja broja perifernih krvnih stanica
English: This may cause the pen to accidently lock.
Croatian: To može dovesti do slučajnog zaključavanja brizgalice.
English: - If you are allergic to peginterferon beta-1a, interferon beta-1a or any of the ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na peginterferon beta-1a, interferon beta-1a ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis (see section 5.1).
Croatian: Plegridy je indiciran u odraslih bolesnika za liječenje relapsno remitirajuće multiple skleroze (vidjeti dio 5.1).
English: Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease.
Croatian: Preporučuje se periodičko praćenje ranih znakova ili simptoma, npr. edema, proteinurije i oštećene funkcije bubrega, osobito u bolesnika s većim rizikom od bolesti bubrega.
English: After the injection After Use - Parts of your Plegridy pen (see Figure K):
Croatian: Nakon injekcije Nakon primjene - dijelovi brizgalice Plegridy (pogledajte sliku K):
English: Based on the known pharmacology of interferon beta-1a and clinical experience with interferon beta, the potential for carcinogenicity is expected to be low.
Croatian: Na temelju poznate farmakologije interferona beta-1a i kliničkog iskustva s interferonom beta, očekuje se da je potencijal za kancerogenost malen.
English: This is to reduce the risk of injection site reactions.
Croatian: Kako bi se smanjio rizik od reakcija na mjestu injiciranja,
English: Dose titration at the initiation of treatment may help to ameliorate flu-like symptoms that can occur at treatment initiation with interferons.
Croatian: Titriranje doze na početku liječenja može pomoći da se ublaže simptomi nalik gripi koji se mogu pojaviti na početku liječenja interferonima.
English: The total combined time out of refrigeration at a temperature up to 25°C, should not exceed 30 days.
Croatian: Ukupno vrijeme izvan hladnjaka na temperaturi do 25°C ne smije biti dulje od 30 dana.