FrancophonIA/ELRC3.0 huggingface dataset:
English: Why is Semglee authorised in the EU?
Croatian: Zašto je lijek Semglee odobren u EU-u?
English: What are the risks associated with Semglee?
Croatian: Koji su rizici povezani s lijekom Semglee?
English: Insulin glargine, the active substance in Semglee, enters the bloodstream more slowly than human insulin after injection and so it works for longer.
Croatian: Inzulin glargin, djelatna tvar u lijeku Semglee, ulazi u krvotok sporije od ljudskog inzulina nakon ubrizgavanja i stoga dulje djeluje.
English: Extensive laboratory studies comparing Semglee with Lantus have shown that insulin glargine in Semglee is highly similar to that in Lantus in terms of chemical structure, purity and biological activity.
Croatian: Opsežna laboratorijska ispitivanja u kojima je lijek Semglee uspoređen s lijekom Lantus pokazala su da je inzulin glargin u lijeku Semglee vrlo sličan onome u lijeku Lantus u pogledu kemijske strukture, čistoće i biološke aktivnosti.
English: It is given by injection under the skin in the belly, the thigh, or the upper arm.
Croatian: Ubrizgava se injekcijom pod kožu abdomena, bedra ili nadlaktice.
English: The dose of Semglee is worked out for each patient and depends on the patient's blood glucose (sugar) level and treatment with other insulin medicines.
Croatian: Doza lijeka Semglee prilagođava se za svakog bolesnika i ovisi o razini glukoze (šećera) u krvi u bolesnika i terapijama drugim lijekovima koji sadržavaju inzulin koje bolesnik prima.
English: How is Semglee used?
Croatian: Kako se Semglee koristi?
English: Therefore, the Agency's view was that, as for Lantus, the benefit of Semglee outweighs the identified risk and it can be authorised in the EU.
Croatian: Stoga je stav Agencije da korist kod lijeka Semglee, kao i kod lijeka Lantus, nadmašuje identificirani rizik te da lijek može biti odobren u EU-u.
English: Semglee can also be used with diabetes medicines taken by mouth in patients who have type 2 diabetes.
Croatian: Lijek Semglee može se primjenjivati i s lijekovima za liječenje dijabetesa koji se uzimaju kroz usta u bolesnika s dijabetesom tipa 2.
English: Semglee is a replacement insulin that acts in the same way as the body's own insulin and helps glucose enter cells from the blood.
Croatian: Lijek Semglee zamjenski je inzulin koji djeluje na isti način kao inzulin samog tijela i pomaže u tome da glukoza ulazi u stanice iz krvi.
English: Additional studies showed that Semglee is absorbed into the body in the same way as the reference medicine, Lantus, and could be considered to act similarly on blood glucose.
Croatian: Dodatna su ispitivanja pokazala da se lijek Semglee apsorbira u tijelo na isti način kao referentni lijek Lantus te da se može smatrati da ima slično djelovanje na glukozu u krvi.
English: Semglee is a medicine used to treat diabetes in patients from 2 years of age.
Croatian: Semglee je lijek za liječenje dijabetesa u bolesnika u dobi od dvije godine i više.
English: What benefits of Semglee have been shown in studies?
Croatian: Koje su koristi lijeka Semglee utvrđene u ispitivanjima?
English: Semglee is available in pre-filled disposable pens and can only be obtained with a prescription.
Croatian: Lijek Semglee dostupan je u napunjenim brizgalicama za jednokratnu uporabu i izdaje se samo na liječnički recept.
English: For the full list of side effects and restrictions with Semglee, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Semglee potražite u uputi o lijeku.
English: How does Semglee work?
Croatian: Kako djeluje Semglee?
English: It contains the active substance insulin glargine.
Croatian: Lijek sadržava djelatnu tvar inzulin glargin.
English: Symptoms may disappear completely or partly.
Croatian: Simptomi mogu nestati u potpunosti ili djelomično.
English: Extavia with food and drink
Croatian: Extavia s hranom i pićem
English: You will need the medicine:
Croatian: Trebat će Vam lijek:
English: • Getting off to a good start!
Croatian: • Važan je dobar početak!
English: The instructions include the following main steps:
Croatian: U uputama su navedeni sljedeći glavni koraci:
English: Experience with exposure during the second and third trimesters is very limited.
Croatian: Iskustvo s izloženošću tijekom drugog i trećeg tromjesečja vrlo je ograničeno.
English: Currently it is not possible to predict which patients belong to this group.
Croatian: Trenutačno nije moguće predvidjeti koji bolesnici pripadaju toj skupini.
English: Component of a 3-month multipack.
Croatian: Sastavni dio 3-mjesečnog višestrukog pakiranja.
English: - If you have ever had an allergic reaction to latex.
Croatian: Ako ste ikada imali alergijsku reakciju na lateks.
English: - Try to give yourself the injection at the same time each day.
Croatian: Nastojte si davati injekciju u isto vrijeme svakoga dana.
English: It can cause temporary disability, such as difficulty walking.
Croatian: Ono može uzrokovati privremenu onesposobljenost, poput poteškoća u hodanju.
English: Do not inject a double dose to make up for a forgotten individual dose.
Croatian: Nemojte ubrizgati dvostruku dozu kako biste nadoknadili zaboravljenu pojedinačnu dozu.
English: Start with your first injection (or your last injection if you are not a new Extavia user).
Croatian: Započnite sa svojom prvom injekcijom (ili Vašom zadnjom injekcijom ako niste novi korisnik Extavije).
English: 10 - Hold the vial between your thumb and fingers.
Croatian: 10 - Držite bočicu između palca i ostalih prstiju.
English: This can lead to shock (collapse) and even be fatal.
Croatian: To može dovesti do šoka (kolapsa) te čak biti i smrtonosno.
English: - Never re-use syringes or needles.
Croatian: - Nikada ne upotrebljavajte ponovno igle i štrcaljke.
English: Extavia itself does not affect the heart directly.
Croatian: Sama Extavia ne utječe izravno na srce.
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 i lakše planirati razdoblje u kojem Vas nitko neće ometati.
English: Weight increased, Weight decreased
Croatian: Povećanje težine, smanjenje težine
English: It is best to use your thumb rather than your nail, as your nail could break.
Croatian: Najbolje je upotrijebiti palac umjesto nokta, jer Vam se nokat može slomiti.
English: Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Croatian: Na temelju podataka u životinja (vidjeti dio 5.3), postoji mogućnost povećanog rizika od spontanog pobačaja.
English: What Extavia is and what it is used for
Croatian: Što je Extavia i za što se koristi
English: Patients with mild disease and those unable to walk were not studied.
Croatian: Bolesnici s blagom bolešću i oni koji ne mogu hodati nisu bili ispitivani.
English: Urticaria, Pruritus, Alopecia
Croatian: Urtikarija, Pruritus, Alopecija
English: 60% (53) of these patients returned to negative status based on the last available assessment within the 5-year period.
Croatian: 60% (53) tih bolesnika vratilo se na negativan status na temelju posljednje dostupne pretrage u razdoblju od 5 godina.
English: This is called a Rotation Cycle.
Croatian: To se naziva ciklus promjene.
English: Suicide attempt (see also section 4.4), Emotional lability
Croatian: Pokušaj samoubojstva (vidjeti također dio 4.4), Emocionalna labilnost
English: Push the plunger to the 1 ml mark (or to the volume prescribed by your doctor).
Croatian: Pogurnite klip na oznaku za 1 ml (ili do volumena kojeg je propisao Vaš liječnik).
English: • Important tips to keep in mind
Croatian: • Važne stvari koje morate zapamtiti
English: - Prepare each dose only when you are ready for an injection.
Croatian: - Pripremite svaku dozu tek kad ste spremni za injekciju.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Croatian: Kao što je slučaj sa svim terapijskim proteinima, postoji mogućnost pojave imunogenosti.
English: If more than 3 hours pass, discard the medicine and prepare a new injection.
Croatian: Ako prođe više od 3 sata, bacite lijek i pripremite novu injekciju.
English: These may be symptoms of a serious allergic reaction, which may become life threatening.
Croatian: To bi mogli biti simptomi teške alergijske reakcije, koja bi mogla postati opasna po život.
English: ·kg and 5 hours, respectively.
Croatian: ·kg odnosno 5 sati.
English: If you are especially sensitive, this might influence your ability to drive or use machines.
Croatian: Ako ste osobito osjetljivi, to bi moglo utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
English: Follow-up of patients is continuing in order to provide additional data.
Croatian: Naknadno praćenje bolesnika se nastavlja kako bi se dobili dodatni podaci.
English: Your doctor will closely monitor you during treatment.
Croatian: Liječnik će Vas pomno nadzirati tijekom liječenja.
English: Always double-check your dosage.
Croatian: Uvijek dvaput provjerite dozu koju primjenjujete.
English: Advice on which areas to choose is given in the first part of this Annex.
Croatian: Savjet o tome koja područja tijela odabrati dan je u prvom dijelu ovog Dodatka.
English: Date of first authorisation: 20 May 2008 Date of latest renewal: 20 May 2013
Croatian: Datum prvog odobrenja: 20. svibnja 2008.
English: If you come back to an area after one Rotation Cycle choose the most distant injection site within this area.
Croatian: Ako se vraćate na područje nakon jednog ciklusa rotacije odaberite najdalje mjesto injiciranja unutar tog područja.
English: ► Talk to your doctor if you inject too much Extavia or injected too often.
Croatian: Razgovarajte sa svojim liječnikom ako injicirate previše Extavije ili ga injicirate prečesto.
English: Extavia is indicated for the treatment of:
Croatian: Extavia je indicirana za liječenje:
English: Moreover, an autoinjector was used by the majority of patients throughout the study.
Croatian: Nadalje, većina je bolesnika tijekom cijelog ispitivanja koristila autoinjektor.
English: Neutralising antibodies are not produced in all patients.
Croatian: Neutralizirajuća protutijela ne stvaraju se u svih bolesnika.
English: No investigations on fertility have been conducted (see section 5.3).
Croatian: Nisu provedena nikakva istraživanja plodnosti (vidjeti dio 5.3).
English: However, if you are not able to do so, it will remain usable for a period of 3 hours, if kept in a refrigerator (2°C - 8°C).
Croatian: Međutim, ako ne možete to učiniti, ostat će iskoristiva tijekom sljedeća 3 sata ako se drži u hladnjaku (2°C - 8°C).
English: If you have already been using Extavia start with the area that has not been used during the last rotation cycle (i.e. the past 16 days).
Croatian: Ukoliko već primjenjujete Extaviju započnite s područjem koje nije bilo korišteno u posljednjem ciklusu promjene (odnosno u posljednjih 16 dana).
English: - If you have monoclonal gammopathy.
Croatian: Ako imate monoklonalnu gamapatiju.
English: In one single genotoxicity study (Ames test), no mutagenic effect has been observed.
Croatian: Tijekom jednokratnog ispitivanja genotoksičnosti (Ames test) nisu primijećeni mutageni učinci.
English: Put the vial on the table.
Croatian: Stavite bočicu na stol.
English: Do not push the plunger.
Croatian: Ne gurajte klip.
English: Significant effects were also obtained in patients with less disseminated and less active disease at the time of the first event.
Croatian: Značajni su učinci dobiveni i u bolesnika s manje diseminiranom i manje aktivnom bolešću u vrijeme prvog događaja.
English: Extavia is injected under the skin so any food or drink you consume is not thought to have any effect on Extavia.
Croatian: Extavia se ubrizgava pod kožu tako da se smatra da hrana ili piće koje uzmete nema nikakvog učinka na Extaviju.
English: There is no evidence for benefit in terms of confirmed disability progression in the majority of patients receiving “immediate” treatment.
Croatian: Nema dokaza o koristi s obzirom na potvrđeni napredak invalidnosti u većine bolesnika koji su „neposredno“ primili terapiju.
English: Powder: Human albumin, mannitol.
Croatian: Prašak: ljudski albumin, manitol.
English: If you are allergic to latex, talk to your doctor before using Extavia.
Croatian: Ako ste alergični na lateks, obratite se svom liječniku prije nego što primijenite Extaviju.
English: How Extavia helps fight your disease
Croatian: Kako Extavia pomaže pobijediti bolest
English: This is often associated with an increase in certain blood fats (triglycerides).
Croatian: To je često povezano s povišenjem određenih masnoća u krvi (triglicerida).
English: These blood tests will be in addition to the tests which are normally done to monitor your MS.
Croatian: Te će krvne pretrage biti dodatak uz pretrage koje se obično provode za praćenje Vašeg MS-a.
English: Pharmacotherapeutic group: Immunostimulants, interferons, ATC Code: L03AB08
Croatian: Farmakoterapijska skupina: Imunostimulansi, interferoni, ATK oznaka: L03AB08
English: For skin disinfection use an appropriate disinfectant recommended by your pharmacist.
Croatian: Za dezinfekciju kože upotrijebite odgovarajuće dezinfekcijsko sredstvo koje Vam preporuči ljekarnik.
English: Any disease other than multiple sclerosis that could better explain signs and symptoms of the patient had to be excluded.
Croatian: Bilo koja bolest osim multiple skleroze, koja bi bolje mogla objasniti znakove i simptome bolesnika, trebala je biti isključena.
English: The powder should dissolve completely without shaking.
Croatian: Prašak bi se trebao u potpunosti otopiti bez protresanja.
English: This is called demyelination.
Croatian: To se naziva demijelinizacijom.
English: You should inject this medicine into the fatty layer between the skin and muscle (that is, subcutaneously, about 8 mm to 12 mm under the skin).
Croatian: Trebate injicirati lijek u masno tkivo između kože i mišića (to jest, potkožno, otprilike 8 mm do 12 mm pod kožu).
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 u 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: Human albumin Mannitol (E421)
Croatian: Prašak ljudski albumin manitol (E421)
English: - The functioning of your thyroid gland will be checked regularly or whenever thought necessary by your doctor for other reasons.
Croatian: Vaše štitne žlijezde provjeravat će se redovito ili kad god to Vaš liječnik bude smatrao potrebnim iz drugih razloga.
English: Interferons are proteins produced by the body that help it fight against attacks on the immune system such as viral infections.
Croatian: Interferoni su proteini koje proizvodi tijelo, a koji pomažu u borbi protiv napada na imunološki sustav kao što su virusne infekcije.
English: This study consisted of two phases, a placebocontrolled phase followed by a pre-planned follow-up phase.
Croatian: Ovo se ispitivanje sastojalo od dvije faze, placebom kontrolirane faze nakon koje je uslijedila unaprijed planirana faza naknadnog praćenja.
English: Extavia may cause side effects in the central nervous system (see section 4 “Possible side effects”).
Croatian: Extavia može uzrokovati nuspojave u središnjem živčanom sustavu (pogledajte dio 4 „Moguće nuspojave“).
English: Infections and infestations Infection
Croatian: Infekcije i infestacije Infekcija
English: On our example schedule each area is split again into 6 injection sites (which adds up to 48 injection sites altogether), left and right: upper, middle and lower part of each area.
Croatian: Na našem oglednom rasporedu svako je područje podijeljeno u 6 područja injiciranja (što ukupno čini 48 mjesta za injiciranje), lijevi i desni: gornji, srednji i donji dio svakog područja.
English: Subgroup analyses according to baseline factors demonstrated evidence of efficacy in all subgroups evaluated.
Croatian: Analize podskupina prema početnim čimbenicima dokazale su djelotvornost u svim ocjenjivanim podskupinama.
English: You may need extra monitoring by your doctor.
Croatian: Liječnik će možda dodatno trebati nadzirati Vaše stanje.
English: You need to choose a new site for each injection to allow the area time to recover and help prevent infection.
Croatian: Morate odabrati novo mjesto za svaku injekciju kako bi se području omogućilo dovoljno vremena da se oporavi te pomoglo spriječiti infekciju.
English: Your doctor also needs to know the following whilst you are using Extavia:
Croatian: Vaš liječnik također mora znati sljedeće dok uzimate Extaviju:
English: At the present time, it is not known for how long the patient should be treated.
Croatian: Trenutačno nije poznato koliko bi se dugo bolesnici trebali liječiti.
English: The decision to continue or discontinue treatment should be based on clinical disease activity rather than on neutralising activity status.
Croatian: Odluka o nastavku ili prekidu liječenja treba se temeljiti na kliničkoj aktivnosti bolesti, a ne na statusu neutralizirajuće aktivnosti.
English: The persistence of the treatment effect was observed although the majority of patients from the placebo-group was treated with Extavia in the third year of the study.
Croatian: Ustrajnost terapijskog učinka bila je uočena, iako je većina bolesnika iz placebo skupine bila liječena Extavijom u trećoj godini ispitivanja.
English: - Always place the used syringes in the proper disposal unit.
Croatian: - Uvijek odlažite iskorištene štrcaljke u odgovarajuću posudu za otpad.
English: The development of neutralising activity is associated with a reduction in clinical efficacy only with regard to relapse activity.
Croatian: Razvoj neutralizirajuće aktivnosti povezan je sa smanjenjem kliničke djelotvornosti samo kad je riječ o relapsnoj aktivnosti.
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 was likely interrupted when the pregnancy was detected and/or confirmed.
Croatian: Međutim, trajanje izloženosti tijekom prvog tromjesečja nije sigurno, jer su podaci bili prikupljeni kad je primjena interferona beta bila kontraindicirana tijekom trudnoće, a liječenje je vjerojatno bilo prekinuto kad je trudnoća otkrivena i/ili potvrđena.
English: This is a disorder of the immune system where an abnormal protein is found in the blood.
Croatian: To je poremećaj imunološkog sustava kod kojeg se u krvi nalaze poremećeni proteini.
English: Do not attempt to inject yourself until you are sure that you understand how to prepare the injection solution and give the injection to yourself.
Croatian: Ne pokušavajte sami primjeniti lijek dok niste sigurni da ste razumjeli kako pripremiti otopinu za injekciju i kako si je sami dati.
English: Nephrotic syndrome, glomerulosclerosis (see section 4.4)* , #
Croatian: Nefrotski sindrom, glomeruloskleroza (vidjeti dio 4.4)* , #
English: Administration of Extavia injections every other day does not lead to serum level increase, and the pharmacokinetics do not seem to change during therapy.
Croatian: Primjena Extavije injekcijama svaki drugi dan ne dovodi do povećanja razine u serumu, pa se čini da se farmakokinetika ne mijenja tijekom terapije.
English: - If you have had depression or are depressed or previously had thoughts of suicide.
Croatian: Ako ste imali depresiju ili ste depresivni ili ste imali prethodne misli o samoubojstvu.
English: - Always use a sterile (aseptic) technique as described in here.
Croatian: - Uvijek upotrebljavajte sterilne (aseptičke) tehnike injiciranja koje su opisane u nastavku.
English: Experience with other interferons suggest a potential for impairment of male and female fertility.
Croatian: Iskustva s drugim interferonima ukazuju na moguće oštećenje plodnosti kod muškaraca i žena.
English: Between 43% and 55% of these patients converted to a stable antibody negative status (based on two consecutive negative titres) during the subsequent observational period of the trial concerned.
Croatian: Između 43% i 55% tih bolesnika prešlo je u stabilan negativan status protutijela (na temelju dva uzastopna negativna titra) tijekom narednog razdoblja promatranja u dotičnom ispitivanju.
English: Each cycle will be 8 injections (16 days), given in area 1 through to area 8 in turn.
Croatian: Svaki ciklus sastoji se od 8 injekcija (16 dana) koje se redom daju od područja 1 do područja 8.
English: However, there are some data available in adolescents aged from 12 to 17 years which suggest that the safety of Extavia in this group is the same as in adults.
Croatian: Međutim, postoje neki raspoloživi podaci u adolescenata u dobi od 12 do 17 godina koji upućuju na to da je sigurnost Extavije u toj skupini jednaka kao i za odrasle osobe.
English: Note: Do not shake the vial as this may cause excessive foaming.
Croatian: Napomena: Ne tresite bočicu budući da to može uzrokovati prekomjerno pjenjenje.
English: ► Tell your doctor, if any of the above applies to you.
Croatian: Obavijestite svog liječnika ako se išta od gore navedenog odnosi na Vas.
English: It is not yet clear whether these neutralising antibodies reduce the effectiveness of the treatment.
Croatian: Nije još jasno smanjuju li ta neutralizirajuća protutijela djelotvornost liječenja.
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 i za uputu što učiniti ako osjetite reakciju na mjestu primjene.
English: The injection site must be changed regularly.
Croatian: Mjesto primjene potrebno je redovito mijenjati.
English: 6 - Inject the medicine (by pushing the plunger slowly and steadily all the way in until the syringe is empty).
Croatian: 6 - Injicirajte lijek (gurajući klip polako i ravnomjerno do kraja dok se ne štrcaljka ne isprazni).
English: Some analyses suggest that this effect might be more pronounced in patients with higher titre levels of neutralising activity.
Croatian: Neke analize upućuju na to da bi taj učinak mogao biti izraženiji u bolesnika s višim razinama titara neutralizirajuće aktivnosti.
English: The robustness of the treatment effect was also shown by the delay of progression to multiple sclerosis according to the McDonald criteria.
Croatian: Jačina terapijskog učinka dokazana je i odgodom progresije u multiplu sklerozu prema McDonaldovim kriterijima.
English: Extavia can reduce the number and severity of the attacks, and slow the progression of disability.
Croatian: Extavia može smanjiti broj i jačinu napadaja te usporiti napredak invalidnosti.
English: Your doctor may decide together with you to change the time intervals for dose increase depending on side effects you may experience at the start of treatment.
Croatian: Vaš liječnik može odlučiti zajedno s Vama o promjeni vremenskog intervala za povećanje doze, ovisno o nuspojavama koje ste možda iskusili od početka liječenja.
English: The available data for the additional three years are consistent with sustained treatment efficacy of Extavia over the whole time period.
Croatian: Dostupni podaci za dodatne tri godine u skladu su s održanom djelotvornošću liječenja Extavijom tijekom cijelog vremenskog razdoblja.
English: Other things to consider when using Extavia:
Croatian: Ostale stvari koje morate razmotriti prilikom uzimanja Extavije:
English: * produced by genetic engineering from strain of Escherichia coli.
Croatian: * proizveden genetičkim inženjerstvom iz soja bakterije Escherichia coli.
English: 12 - Ensure the plunger stays fully pushed in before proceeding to the next step, as it may have moved.
Croatian: 12 - Provjerite da je klip gurnut do kraja prije nego što prijeđete na sljedeći korak, budući da je moguće da se pomakne.
English: If clinically needed, the use of Extavia may be considered during pregnancy.
Croatian: Ako je to klinički potrebno, može se razmotriti primjena Extavije tijekom trudnoće.