FrancophonIA/ELRC3.0 huggingface dataset:
English: For example, give the first injection into the right side of the abdomen, choose the left side for the second injection, then move to the right thigh for the third, and so on through the diagram until all suitable areas of the body have been used.
Croatian: Primjerice dajte prvu injekciju na desnu stranu trbuha, a potom odaberite lijevu stranu za drugu injekciju; zatim se pomaknite na desno bedro za treću injekciju i tako sve kroz dijagram dok niste iskoristili sva prikladna područja.
English: These symptoms may be reduced by taking paracetamol or nonsteroidal anti-inflammatory medicines such as ibuprofen.
Croatian: Ti se simptomi mogu smanjiti uzimanjem paracetamola ili nesteroidnih protuupalnih lijekova kao što je ibuprofen.
English: However, the duration of exposure during the first trimester is uncertain, because data were collected when interferon beta use was contraindicated during pregnancy, and treatment likely interrupted when pregnancy was detected and/or confirmed.
Croatian: Međutim, trajanje izloženosti tijekom prvog tromjesečja nije sa sigurnošću poznato, jer su podaci prikupljani kada je primjena interferona beta bila kontraindicirana tijekom trudnoće, a liječenje vjerojatno prekinuto kad je otkrivena i/ili potvrđena trudnoća.
English: Serum samples in controlled clinical trials were collected every 3 months for monitoring of development of antibodies to Betaferon.
Croatian: Uzorci seruma u kontroliranim kliničkim ispitivanjima prikupljani su svaka tri mjeseca u svrhu praćenja razvoja protutijela na Betaferon.
English: The two studies showed inconsistent results for the primary endpoint time to confirmed progression, representing delay of disability progression:
Croatian: Dva ispitivanja pokazuju nedosljedne rezultate primarnog ishoda, vremena do potvrđene progresije, koje predstavlja odgodu u napretku invalidnosti:
English: There are sparse and inconclusive data on patients who have developed neutralising activity and have completed Betaferon therapy.
Croatian: Postoje oskudni i neuvjerljivi podaci za bolesnike koji su razvili neutralizirajuću aktivnost te su dovršili terapiju lijekom Betaferon.
English: If reactions are severe, Betaferon should be discontinued and appropriate medical intervention instituted.
Croatian: Ako su reakcije teške, Betaferon treba prekinuti i primijeniti odgovarajuću medicinsku intervenciju.
English: # During the BENEFIT follow-up study, no change in the known risk profile of Betaferon was observed.
Croatian: # Tijekom ispitivanja praćenja BENEFIT nije primijećena promjena u poznatom profilu rizika lijeka
English: The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available data, but the data do not suggest an increased risk so far.
Croatian: Rizik od spontanih pobačaja kod trudnica izloženih interferonu beta ne može se pravilno procijeniti na temelju trenutno dostupnih podataka, ali ti podaci zasad ne ukazuju na povećan rizik.
English: See ‘Warnings and precautions' in section 2 for more information and what to do, if you experience an injection site reaction.
Croatian: Pogledajte „Upozorenja i mjere opreza“ u dijelu 2 za više informacija o tome što učiniti u slučaju reakcije na mjestu injiciranja.
English: Betaferon can reduce the number and severity of the attacks, and slow the progression of disability.
Croatian: Betaferon može smanjiti broj i jačinu napadaja te usporiti napredak invalidnosti.
English: Always double-check your dosage.
Croatian: Uvijek provjerite dozu koju primjenjujete.
English: Betaferon must be used with caution, and your doctor will monitor you for worsening of your heart condition, particularly during the start of treatment.
Croatian: Betaferon se mora koristiti oprezno, a Vaš će Vas liječnik pratiti zbog mogućeg pogoršanja rada srca, posebice tijekom početka liječenja.
English: In the Betaferon pack you will find:
Croatian: U pakiranju lijeka Betaferon naći ćete:
English: Suicide attempt (see also section 4.4), Emotional lability
Croatian: (vidjeti također dio 4.4.), emocionalna labilnost
English: You should inject Betaferon into the fatty layer between the skin and muscle (that is, subcutaneously, about 8 to 12 mm under the skin).
Croatian: Betaferon trebate injicirati u masno tkivo između kože i mišića (tj. supkutano, otprilike 8 do 12 mm pod kožu).
English: Nephrotic Syndrome
Croatian: Nefrotski sindrom
English: Betaferon is injected under the skin so any food or drink you consume is not thought to have any effect on Betaferon.
Croatian: Betaferon se injicira potkožno tako da se smatra da konzumacija bilo koje hrane ili pića nema učinka na
English: Inspection prior to use
Croatian: Provjera prije uporabe
English: Other sources of information Detailed information on this medicine is available on the European Medicines Agency website:
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove:
English: If you are injecting less than 1 ml with the titration pack there might not be any air bubbles, however for full dose injection some air bubbles might turn up.
Croatian: Ako injicirate manje od 1 ml s titracijskim pakiranjem možda neće biti mjehurića zraka, no tijekom injiciranja pune doze mogu se pojaviti neki mjehurići zraka.
English: 47% versus placebo
Croatian: 47 % naspram placeba
English: Your doctor or nurse will help you to learn the process of self-administration.
Croatian: Vaš liječnik ili medicinska sestra pomoći će Vam da naučite postupak samoinjiciranja.
English: Frequency not known
Croatian: Učestalost nepoznata
English: This study consisted of two phases, a placebo-controlled phase followed by a pre-planned follow-up phase.
Croatian: To se ispitivanje sastojalo od dvije faze pri čemu je placebom kontroliranu fazu slijedila prethodno planirana faza praćenja.
English: - Clean the injection site with an alcohol wipe and let it air-dry.
Croatian: - Očistite mjesto injiciranja s tupferom natopljenim alkoholom i pustite da se osuši.
English: * produced by genetic engineering from a strain of Escherichia coli.
Croatian: ∗ proizvedeno genetičkim inženjerstvom iz soja Escherichia coli.
English: From these retrospective subgroup analyses there was evidence to suggest that relapses as well as pronounced EDSS progression (EDSS >1 point or >0.5 point for EDSS ≥6 in the previous two years) can help to identify patients with active disease.
Croatian: Iz ovih retrospektivnih analiza podskupina vidljiv je dokaz koji ukazuje da relapsi baš kao i izražena progresija na EDSS ljestvici (EDSS > 1 bod ili > 0,5 za EDSS ≥6 u prethodne dvije godine) mogu pomoći u identifikaciji bolesnika s aktivnom bolešću.
English: Generally, dose titration is recommended at the start of treatment.
Croatian: Općenito se preporučuje titracija doze na početku liječenja.
English: In the absence of clinical evidence for liver damage and after normalisation of liver enzymes a reintroduction of therapy could be considered with appropriate follow-up of hepatic functions.
Croatian: U nedostatku kliničkog dokaza oštećenja jetre te nakon normalizacije jetrenih enzima, može se razmotriti ponovno uvođenje lijeka u terapiju uz odgovarajući nadzor jetrenih funkcija.
English: This makes it easier to remember and easier to plan a block of time when you will not be interrupted.
Croatian: Tako ćete lakše zapamtiti vrijeme injiciranja te odvojiti vrijeme kad Vas nitko neće prekidati.
English: Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Betaferon (see section 4.2).
Croatian: Općenito, preporučuje se titracija doze na početku liječenja kako bi se povećala podnošljivost na Betaferon (vidjeti dio 4.2).
English: Your doctor will regularly check the way you inject yourself, particularly if you have experienced injection site reactions.
Croatian: Vaš će liječnik redovito provjeravati način na koji si dajete injekciju, posebice ako ste iskusili reakcije na mjestu injiciranja.
English: It reduces the number of hospital stays due to the disease and prolongs the time without relapses.
Croatian: Smanjuje broj hospitalizacija uzrokovanih bolešću te produljuje vrijeme bez relapsa.
English: However, if you are not able to do so, it will be suitable for use for 3 hours, if kept at 2-8 °C (in a refrigerator).
Croatian: Međutim, ako ne možete odmah upotrijebiti otopinu, ona će biti pogodna za primjenu tijekom 3 sata ako ju čuvate na temperaturi od 2 do 8 °C (u hladnjaku).
English: Infections and infestations Infection
Croatian: Infekcije i infestacije
English: Moreover, an autoinjector was used by the majority of patients throughout the study.
Croatian: Pored toga, tijekom ispitivanja većina bolesnika koristila je autoinjektor.
English: ► Stop using Betaferon and tell your doctor immediately if any of these happens to you.
Croatian: Prestanite uzimati Betaferon i odmah obavijestite svog liječnika ako Vam se dogodi išta od gore navedenog.
English: What Betaferon is
Croatian: Što je Betaferon
English: Betaferon may cause serious side effects.
Croatian: Betaferon može uzrokovati ozbiljne nuspojave.
English: In the placebo-controlled phase, Betaferon delayed the progression from the first clinical event to CDMS in a statistically significant and clinically meaningful manner.
Croatian: U placebom kontroliranoj fazi Betaferon je odgodio napredak od prvog kliničkog događaja do CDMS na statistički značajan i klinički značajan način.
English: 5 - Holding the syringe like a pencil or a dart, push the needle straight into the skin at a 90˚ angle with a quick, firm motion.
Croatian: 5 - Držeći štrcaljku kao olovku ili pikado strelicu gurnite iglu ravno u kožu pod kutom od 90° brzim i čvrstim pokretom.
English: Your doctor will rule out any other reasons which could explain these symptoms before you are treated.
Croatian: Vaš će liječnik prije početka liječenja isključiti sve druge razloge koji bi mogli objasniti te simptome.
English: A large amount of data (more than 1000 pregnancy outcomes) from interferon beta registries, national registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure or exposure during the first trimester of pregnancy.
Croatian: Velika količina podataka (više od 1000 ishoda trudnoća) iz registara interferona beta, nacionalnih registara i iskustva nakon stavljanja lijeka u promet pokazuje da nema povećanog rizika od većih urođenih anomalija nakon izlaganja prije začeća ili izloženosti tijekom prvog tromjesečja trudnoće.
English: Betaferon serum levels were followed in patients and volunteers by means of a not completely specific bioassay.
Croatian: Serumske razine lijeka Betaferon praćene su u pacijenata i dobrovoljaca putem ne potpuno specifičnog biološkog određivanja.
English: To reduce the risk of getting injection site reactions you must:
Croatian: Da bi se smanjio rizik od nastanka reakcije na mjestu injiciranja morate:
English: Therapy with Betaferon was well accepted as indicated by a high rate of trial completion (93% in the Betaferon group).
Croatian: Terapija s lijekom Betaferon bila je dobro prihvaćena na što upućuje visoki stupanj dovršetka ispitivanja (93 % u skupini koja je primala Betaferon).
English: The available data for the additional three years are consistent with sustained treatment efficacy of Betaferon over the whole time period.
Croatian: Dostupni podaci za dodatne tri godine u skladu su s održanom djelotvornošću liječenja lijekom Betaferon tijekom čitavog vremenskog razdoblja.
English: Patients who develop neutropenia should be monitored closely for the development of fever or infection.
Croatian: Bolesnike koji su razvili neutropeniju treba pomno nadzirati zbog razvoja vrućice ili infekcije.
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: If you stop using Betaferon
Croatian: Ako prestanete primjenjivati Betaferon
English: No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Croatian: Nisu provedena službena klinička ispitivanja ili farmakokinetičke studije na djeci ili adolescentima.
English: There is evidence that the patients included in this study had overall less active disease than in the other study in secondary progressive multiple sclerosis.
Croatian: Postoje dokazi da su bolesnici koji su uključeni u to ispitivanje ukupno gledano imali manje aktivnu bolest nego u drugom ispitivanju sekundarne progresivne multiple skleroze.
English: (0.54% w/v))
Croatian: (0,54 % m/V)),
English: - Select an injection site for your first injection.
Croatian: - Odaberite mjesto injiciranja za svoju prvu injekciju.
English: To help you rotate the injection sites appropriately, we recommend that you keep a record of the date and location of your injection.
Croatian: Kako bismo Vam pomogli da pravilno rotirate mjesta injiciranja, preporučamo da vodite bilješke o datumu i mjestu injiciranja.
English: After preparing the solution you should use it immediately.
Croatian: Nakon pripreme otopinu morate odmah upotrijebiti.
English: This allows any air bubbles to rise to the top of the solution.
Croatian: To omogućava da se mjehurići zraka podižu na vrh otopine.
English: As rodents do not react to human interferon beta, repeated dose studies were carried out with rhesus monkeys.
Croatian: S obzirom da glodavci ne reagiraju na ljudski interferon beta, ispitivanja ponovljenih doza provedena su na rezus-majmunima.
English: • small amounts of mannitol, a naturally occurring sugar and human albumin, a protein.
Croatian: • male količine manitola, prirodnog šećera i ljudskog albumina, proteina.
English: Betaferon injections given every other day do not lead to serum level increases, and the pharmacokinetics does not seem to change during therapy.
Croatian: Injekcije lijeka Betaferon koje se daju svaki drugi dan ne povećavaju razinu u serumu, a farmakokinetika se ne mijenja tijekom terapije.
English: Betaferon has been shown to cut down the number of attacks and make them less severe.
Croatian: Pokazalo se da Betaferon smanjuje broj napadaja te ih čini manje jakim.
English: Advice on which areas to choose is given in the first part of this Annex.
Croatian: Savjet o tome koje dijelove tijela odabrati za injiciranje dan je u prvom dijelu ovog Dodatka.
English: Your doctor may perform tests to check your kidney function.
Croatian: Vaš liječnik može napraviti testove kako bi provjerio funkciju Vaših bubrega.
English: Asymptomatic elevations of serum transaminases, in most cases mild and transient, occurred very commonly in patients treated with Betaferon during clinical trials.
Croatian: Asimptomatska povišenja serumskih transaminaza, koja su u većini slučajeva blaga i prolazna, vrlo se često događaju u bolesnika koji se liječe lijekom Betaferon tijekom kliničkih ispitivanja.
English: For skin disinfection use an appropriate disinfectant.
Croatian: Za dezinfekciju kože upotrijebite odgovarajući dezinficijens.
English: The following instructions and pictures explain how to prepare Betaferon for injection and how to inject Betaferon yourself.
Croatian: Sljedeće upute i slike pojašnjavaju kako ćete samostalno pripremiti Betaferon za injekciju i kako ga samostalno injicirati.
English: − Keep your syringes and syringe disposal unit out of the sight and reach of children; lock the supplies away if possible.
Croatian: Držite štrcaljke i otpadni materijal izvan pogleda i dohvata djece; zaključajte ih ukoliko je to moguće.
English: If an area becomes sore, talk to your doctor or nurse about choosing other injection sites.
Croatian: Ako je područje bolno, razgovarajte s liječnikom ili medicinskom sestrom o odabiru drugog područja za injiciranje.
English: Subgroup analyses according to baseline factors demonstrated evidence of efficacy on progression to CDMS in all subgroups evaluated.
Croatian: Analize podskupina prema početnim čimbenicima pokazale su da postoji dokaz djelotvornosti za progresiju stanja do CDMS u svim procijenjenim podskupinama.
English: No formal interaction studies have been carried out to find out whether Betaferon affects other medicines or is affected by them.
Croatian: Nisu provedena službena ispitivanja interakcija da bi se otkrilo da li Betaferon utječe na druge lijekove ili drugi lijekovi utječu na Betaferon.
English: Only hold the blue plastic adapter when removing.
Croatian: Prilikom uklanjanja držite samo plavi plastični nastavak.
English: An in vitro cell transformation test gave no indication of tumorigenic potential.
Croatian: Test stanične transformacije in vitro ne ukazuje na tumorogeni potencijal lijeka.
English: However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving Betaferon 8.0 million IU subcutaneously every other day is similar to that seen in adults.
Croatian: No, ograničeni objavljeni podaci ukazuju na to da je sigurnosni profil u adolescenata u dobi između 12 i 16 godina koji primaju Betaferon 8,0 milijuna IU supkutano svaki drugi dan sličan onom u odraslih.
English: The occurrence of elevations in serum transaminases should lead to close monitoring and investigation.
Croatian: Pojava povišenja serumskih transaminaza zahtijeva pomno praćenje i pretrage.
English: This applies also to the titration pack.
Croatian: To je također primjenjivo na titracijsko pakiranje.
English: You may need extra monitoring by your doctor.
Croatian: Možda će Vas liječnik dodatno pratiti.
English: − If you have a heart disease, the flu-like symptoms, which often occur at the start of treatment, may prove stressful to you.
Croatian: Ako imate bolest srca, simptomi nalik gripi koji se često javljaju na početku liječenja mogu biti vrlo stresni za Vas.
English: No interaction studies with anti-epileptics have been carried out.
Croatian: Nisu provedena ispitivanja interakcija s antiepilepticima.
English: If you become depressed while you are on Betaferon, you may need special treatment and your doctor will closely monitor you and may also consider stopping your treatment.
Croatian: Ako ste postali deprimirani za vrijeme liječenja lijekom Betaferon možda ćete trebati posebno liječenje, a Vaš će Vas liječnik nadzirati te možda razmotriti prekid liječenja.
English: The most serious were reported in patients taking other medicines or who were suffering from diseases that can affect the liver (e.g. alcohol abuse, severe infection).
Croatian: Najozbiljnija izvješća zabilježena su u bolesnika koji uzimaju druge lijekove ili koji su imali bolesti koje mogu utjecati na jetru (primjerice, zlouporaba alkohola, teška infekcija).
English: Patients receiving Betaferon showed a reduction in frequency (30%) and severity of clinical relapses, as well as the number of hospitalisations due to disease.
Croatian: Bolesnici koji primaju Betaferon pokazali su smanjenje učestalosti (30 %) te težine kliničkih relapsa, kao i broja hospitalizacija koje su uzrokovane bolešću.
English: Table A: Schedule for dose titration* treatment day dose volume
Croatian: Tablica A: Raspored za titraciju doze*
English: However, this did not seem to be associated with a reduction in clinical efficacy (with regard to time to clinically definite multiple sclerosis (CDMS), time to confirmed EDSS progression and relapse rate).
Croatian: Međutim, čini se da to nije povezano sa smanjenjem kliničke djelotvornosti (s obzirom na vrijeme do klinički jasne multiple skleroze (engl. clinically definite multiple sclerosis, CDMS), vrijeme do potvrđene progresije na EDSS ljestvici te stopu relapsa).
English: No separate investigations were performed regarding the influence of Betaferon on the cardiovascular system, respiratory system and the function of endocrine organs.
Croatian: Nisu provedena zasebna ispitivanja utjecaja lijeka Betaferon na srčanožilni sustav, dišni sustav te funkciju endokrinih organa.
English: The treatment effect occurred in patients at all levels of disability investigated and independent of relapse activity.
Croatian: Učinak liječenja javio se u bolesnika na svim razinama ispitivane invalidnosti i neovisno o aktivnosti relapsa.
English: For subcutaneous injection.
Croatian: Za supkutanu injekciju.
English: The placebo-controlled phase lasted for 2 years or until the patient developed clinically definite multiple sclerosis (CDMS), whichever came first.
Croatian: Placebom kontrolirana faza trajala je dvije godine ili sve dok bolesnik nije razvio klinički definitivnu multiplu sklerozu (CDMS), što god da je od toga dvoje bilo prvo.
English: Betaferon should be administered with caution to patients with previous or current depressive disorders, in particular to those with antecedents of suicidal ideation (see section 4.3).
Croatian: Betaferon treba primjenjivati s oprezom u bolesnika s prethodnim ili postojećim depresivnim poremećajima, posebice u onih s prethodnim suicidalnim idejama (vidjeti dio 4.3).
English: There is no information on the use of Betaferon in children under 12 years of age.
Croatian: Nema informacija o primjeni lijeka Betaferon u djece ispod 12 godina starosti.
English: This product contains human albumin and hence carries a potential risk for transmission of viral diseases.
Croatian: Ovaj lijek sadrži ljudski albumin te stoga nosi mogući rizik od prijenosa virusnih bolesti.
English: - if you are allergic (hypersensitive) to natural or recombinant interferon beta, human albumin or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični (preosjetljivi) na prirodni ili rekombinantni interferon beta, ljudski albumin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: ‘Possible side effects').
Croatian: 4. „Moguće nuspojave“).
English: Single Event suggestive of Multiple Sclerosis (BENEFIT) #
Croatian: Pojedinačni događaj koji ukazuje na multiplu sklerozu (BENEFIT) #
English: − use a sterile (aseptic) injection technique,
Croatian: − koristiti sterilnu (aseptičnu) tehniku injiciranja,
English: However, this has not been investigated in vivo and its clinical significance is uncertain.
Croatian: Međutim, to nije ispitano u in vivo uvjetima te klinička važnost takve interakcije nije sigurna.
English: If clinically needed, the use of Betaferon may be considered during pregnancy.
Croatian: Ako je klinički potrebno, primjena lijeka Betaferon se može razmotriti tijekom trudnoće.
English: Interferons belong to the family of cytokines, which are naturally occurring proteins.
Croatian: Interferoni pripadaju obitelji citokina, proteina koji se javljaju u prirodi.
English: An abnormal response by the body's immune system is thought to play an important part in the process which damages the CNS.
Croatian: Smatra se da abnormalni odgovor imunološkog sustava organizma ima važnu ulogu u procesu oštećenja središnjeg živčanog sustava.
English: Contents of the pack and other information Annex - self injection procedure
Croatian: Sadržaj pakiranja i druge informacije Dodatak - postupak samoinjiciranja
English: Using Betaferon with other medicines that modify the immune system response is not recommended, except anti-inflammatory medicines called corticosteroids or the adrenocorticotropic hormone (ACTH).
Croatian: Primjena lijeka Betaferon s drugim lijekovima koji mijenjaju odgovor imunološkog sustava se ne preporučuje, osim protuupalnih lijekova zvanih kortikosteroidi ili adrenokortikotropni hormon (ACTH).
English: From various studies mean clearance rates and half-lives of disposition phases from serum were estimated to be at most 30 ml·min-1·kg-1 and 5 hours, respectively.
Croatian: Različita ispitivanja su pokazala da srednja brzina klirensa i poluvijekovi dispozicijskih faza u serumu iznose najviše 30 ml·min-1·kg-1, odnosno 5 sati.