FrancophonIA/ELRC3.0 huggingface dataset:
English: Examples include: - you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage, - your insulin pen does not work properly, - you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever, - you are taking or have taken certain other medicines (see section 2, "Other medicines and
Croatian: Primjeri: - ako niste injicirali inzulin ili ako niste injicirali dovoljno inzulina, ili ako je djelotvornost inzulina smanjena, primjerice zbog nepravilnog čuvanja, - ako Vaša inzulinska brizgalica ne radi ispravno, - ako vježbate manje nego obično, ako ste pod stresom (emocionalno uznemireni ili uzbuđeni)
English: Do not inject with the needle at an angle.
Croatian: Nemojte injicirati dozu tako da iglu držite pod kutom.
English: How to handle Semglee pen
Croatian: Kako rukovati brizgalicom Semglee
English: Sodium hydroxide (for pH adjustment)
Croatian: Natrijev hidroksid (za prilagodbu pH) Voda za injekcije
English: Semglee is a long-acting insulin.
Croatian: Semglee je dugodjelujući inzulin.
English: A - Always prime a new pen needle before each injection.
Croatian: - Prije svakog injiciranja novu brizgalicu s iglom uvijek napunite.
English: It may take several twists to release the needle.
Croatian: Za to bi moglo biti potrebno nekoliko okretaja.
English: Before using Semglee pen, the instructions for use included in the package leaflet must be read carefully.
Croatian: Prije uporabe brizgalice Semglee moraju se pažljivo pročitati upute za uporabu koje su sastavni dio upute o lijeku.
English: Before using Semglee pre-filled pen, the instructions for use included in the package leaflet must be read carefully.
Croatian: Prije uporabe napunjene brizgalice Semglee moraju se pažljivo pročitati upute za uporabu koje su sastavni dio upute o lijeku.
English: NAME OF THE MEDICINAL PRODUCT Semglee 100 units/ml solution for injection in pre-filled pen
Croatian: NAZIV LIJEKA Semglee 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici
English: Lipohypertrophy Lipoatrophy
Croatian: Poremećaji kože i potkožnog tkiva lipohipertrofija lipoatrofija
English: - you change the area of skin where you inject insulin (for example from the thigh to the upper arm), - you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.
Croatian: vjerojatnije javljati ujutro nego tijekom noći), - ako Vam je razina šećera u krvi gotovo normalna ili nije stabilna, - ako promijenite područje na koži u koje injicirate inzulin (primjerice s bedra na nadlakticu), - ako bolujete od teške jetrene ili bubrežne bolesti ili neke druge bolesti kao što je hipotireoza.
English: Subcutaneous use
Croatian: Brizgalice u uporabi
English: Always store the pen with the cap on, to prevent contamination.
Croatian: Na brizgalicu prilikom pohrane uvijek vratite zatvarač kako bi se spriječilo onečišćenje.
English: Semglee 100 units/ml solution for injection in pre-filled pen.
Croatian: Semglee 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici.
English: Hepatic impairment
Croatian: Neupotrijebljene brizgalice
English: Select your dose
Croatian: Odabir doze
English: Read these Instructions for Use as well as the package leaflet carefully before using Semglee pre-filled pen and each time you get another pen.
Croatian: Prije uporabe napunjene brizgalice Semglee i prilikom svake nabave nove brizgalice pažljivo pročitajte ove Upute za uporabu i uputu o lijeku.
English: Oedema
Croatian: Abdomen
English: Subcutaneous use.
Croatian: Za potkožnu primjenu.
English: Retinopathy
Croatian: Liječenje
English: Mylan bvba/sprl
Croatian: ▬ Inzulin glargin - NPH inzulin
English: • The expiration date has not passed.
Croatian: • upotrijebit ćete odgovarajuću vrstu inzulina, • rok valjanosti nije istekao.
English: The cartridge is assembled in a disposable pen injector.
Croatian: Uložak je ugrađen u brizgalicu za jednokratnu uporabu.
English: Envarsus should be taken once daily with water, on an empty stomach.
Croatian: Envarsus treba uzimati jednom dnevno s vodom, na prazan želudac.
English: This summary was last updated in 07-2014.
Croatian: Sažetak je posljednji put ažuriran: 07.2014.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Envarsus on 18 July 2014.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za Envarsus vrijedi na području Europske unije od 18. srpnja 2014.
English: Further information can be found in the summary of the risk management plan.
Croatian: Više informacija pročitajte u sažetku plana upravljanja rizicima.
English: The full EPAR and risk management plan summary for Envarsus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije (EPAR) za lijek Envarsus, kao i plan upravljanja rizicima možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Doctors should monitor the levels of tacrolimus in the blood to check that they stay within certain limits.
Croatian: Liječnici trebaju nadzirati razine takrolimusa u krvi kako bi bile u okviru određenih granica.
English: These ‘prolonged-release' tablets allow tacrolimus to be released slowly from the tablet over several hours and in a form that the body can absorb easily, so that it need be given only once a day.
Croatian: Tablete s „produženim otpuštanjem” omogućuju da se takrolimus polako ispušta tijekom nekoliko sati i u obliku koje tijelo može lako apsorbirati, tako da ga je potrebno uzimati samo jednom dnevno.
English: Doses of Envarsus are calculated based on the patient's weight.
Croatian: Doze Envarsusa računaju se na temelju težine bolesnika.
English: Envarsus is available as prolonged-released tablets containing tacrolimus (0.75, 1 and 4 mg).
Croatian: Envarsus je dostupan u obliku tableta s produženim otpuštanjem koje sadrže takrolimus (0,75, 1 i 4 mg).
English: It is not intended to provide practical advice on how to use Envarsus.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja Envarsusa.
English: Patients were either switched to treatment with Envarsus once daily or continued Prograf treatment twice daily.
Croatian: Bolesnici su prebačeni na liječenje Envarsusom jednom dnevno ili su nastavili s liječenjem Prografom dvaput dnevno.
English: The main measure of effectiveness in both studies was the number of patients who had treatment failure (death, failure or rejection of the transplanted organ, or loss of the patient from follow-up) after 12 months.
Croatian: Glavno mjerilo učinkovitosti u obje studije bio je broj bolesnika na kojima liječenje nije bilo uspješno (smrt, otkazivanje ili odbacivanje presađenog organa ili naknadni gubitak pacijenta) nakon 12 mjeseci.
English: Black patients may require higher doses than white patients.
Croatian: Crnoputim bolesnicima možda će biti potrebne više doze nego bjeloputim.
English: Why is Envarsus approved?
Croatian: Zašto je Envarsus odobren?
English: Treatment is adjusted according to the medicine's blood levels and the patient's response.
Croatian: Liječenje se prilagođava na temelju razine lijeka u krvi i reakcije bolesnika na lijek.
English: Patients may also have abnormal results in liver function tests.
Croatian: Bolesnici mogu imati neuobičajene rezultate testova funkcije jetara.
English: Treatment failure occurred in 18.3% patients treated with Envarsus (49 out of 268), and 19.6% given Prograf (54 out of 275).
Croatian: Liječenje je bilo neuspješno kod 18,3 % bolesnika liječenih Envarsusom (49 od 268) i 19,6 % bolesnika liječenih Prografom (54 od 275).
English: Envarsus is a ‘hybrid medicine'.
Croatian: Envarsus je „hibridni lijek”.
English: In the prevention of rejection, doses should start at 0.17 mg per kg of body weight daily in patients who have had a kidney transplant, and 0.11 to 0.13 mg per kg daily in those who have had a liver transplant.
Croatian: Radi sprječavanja odbacivanja organa doze trebaju početi od 0,17 mg po kg tjelesne težine dnevno kod bolesnika s presađenim bubregom, te od 0,11 do 0,13 mg po kg dnevno kod bolesnika kojima je presađena jetra.
English: Failure rates were 2.5% in both groups (4 of 162 patients treated with Envarsus, and 4 of 162 treated with Prograf).
Croatian: Stopa neuspjeha u obje skupine iznosila je 2,5 % (4 od 162 bolesnika liječenih Envarsusom i 4 od 162 bolesnika liječenih Prografom).
English: What measures are being taken to ensure the safe and effective use of Envarsus?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Envarsus?
English: This means that Envarsus is similar to a ‘reference medicine' that contains the same active substance but Envarsus has been formulated in a different way and is available at different doses.
Croatian: To znači da je Envarsus sličan „referentnom lijeku” koji sadrži istu djelatnu tvar, ali je Envarsus formuliran na drugi način i dostupan je u drugačijim dozama.
English: Envarsus can also be used to treat organ rejection in adult patients when other immunosuppressive medicines (medicines that reduce the activity of the immune system) are not effective.
Croatian: Envarsus se može koristiti i za liječenje odbacivanja organa u odraslih bolesnika kada drugi imunosupresivni lijekovi (lijekovi koji smanjuju aktivnost imunološkog sustava) nisu učinkoviti.
English: What is Envarsus and what is it used for?
Croatian: Što je Envarsus i za što se koristi?
English: Envarsus must not be used in patients who are hypersensitive (allergic) to tacrolimus or any of the other ingredients, nor in those who are allergic to substances called macrolides (which include antibiotics such as erythromycin).
Croatian: Envarsus ne smiju koristiti bolesnici koji su preosjetljivi (alergični) na takrolimus ili bilo koji drugi sastojak, ni oni koji su alergični na tvari koje se nazivaju makrolidi (što obuhvaća antibiotike poput eritromicina).
English: Tacrolimus reduces the activity of certain cells in the immune system, called T-cells, that are primarily responsible for attacking the transplanted organ (organ rejection).
Croatian: Takrolimus smanjuje aktivnost pojedinih stanica imunološkog sustava, koje se nazivaju T-stanice, a primarno su odgovorne za napadanje presađenih organa (odbacivanje organa).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the approved doses of Envarsus have been shown to have a comparable quality, safety and effectiveness to Advagraf and Prograf.
Croatian: Povjerenstvo Agencije za humane lijekove (CHMP) odlučilo je da odobrena doza Envarsus-a posjeduje kvalitetu, sigurnost i djelotvornost usporedive s Advagraf-om i Prograf-om.
English: Envarsus tacrolimus
Croatian: Envarsus takrolimus
English: Envarsus has been shown to be at least as effective as Prograf in two main studies in patients with kidney transplants.
Croatian: Envarsus je dokazano barem jednako učinkovit kao Prograf prema dvije glavne studije provedene na bolesnicima s presađenim bubrezima.
English: It is used for the long-term treatment of adult patients who have had a kidney or a liver transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Croatian: Koristi se za dugoročno liječenje odraslih bolesnika kojima je presađen bubreg ili jetra kako bi se spriječilo odbacivanje organa (kada imunološki sustav napada presađeni organ).
English: This is a summary of the European public assessment report (EPAR) for Envarsus.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Envarsus.
English: The company also provided studies on the levels of tacrolimus in the body after taking Envarsus, which showed that it produced levels of tacrolimus that have been previously shown to be effective in treating and preventing rejection, and reported results in 29 patients who were given Envarsus starting after a liver transplant, none of whom rejected the transplanted organ during the 360 days following transplantation.
Croatian: Tvrtka je ponudila studije o razinama takrolimusa u tijelu nakon uzimanja Envarsusa koje su pokazale da postiže razine takrolimusa koje su se prethodno pokazale učinkovitima u liječenju i sprječavanju odbacivanja, te su zabilježeni rezultati kod 29 bolesnika koji su započeli liječenje Envarsusom nakon presađivanja jetre, od kojih kod nijednoga nije došlo do odbacivanja presađenog organa 360 dana nakon presađivanja.
English: In addition, because of the formulation/dosage differences between Envarsus and Advagraf, clinical studies in patients were also provided.
Croatian: Nadalje, zbog razlika u sastavu/doziranju između Envarsusa i Advagrafa, priložene su i kliničke studije bolesnika.
English: Envarsus is often given with other immunosuppressive medicines following the transplant.
Croatian: Envarsus se često daje s drugim imunosupresivnim lijekovima nakon presađivanja organa.
English: A risk management plan has been developed to ensure that Envarsus is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Envarsus.
English: Because Envarsus is similar to the reference medicine Advagraf, the applicant provided comparative data on Advagraf.
Croatian: Budući da je Envarsus sličan referentnom lijeku Advagrafu, podnositelj je ponudio komparativne podatke o Advagrafu.
English: The second study compared Envarsus with Prograf as part of standard treatment in 543 patients with a newly transplanted kidney.
Croatian: U drugoj studiji napravljena je usporedba Envarsusa s Prografom kao dijelom standardnog liječenja 543 bolesnika s novopresađenim bubrezima.
English: Lower doses may be needed in patients with reduced liver function.
Croatian: Za bolesnike sa smanjenom funkcijom jetre možda će biti potrebne niže doze.
English: Switching or changes in immunosuppressive medicines should be started and monitored by experienced transplant doctors.
Croatian: Promjenu lijeka ili izmjene u doziranju imunosupresivnih lijekova treba pokrenuti i nadgledati liječnik koji ima iskustva s bolesnicima kojima su presađeni organi.
English: The first study involved 326 patients who had already had a kidney transplant and were being treated with Prograf and other immunosuppressants to prevent rejection.
Croatian: Prva studija obuhvatila je 326 bolesnika kojima su već presađeni bubrezi te su liječeni Prografom i drugim imunosupresivnim lijekovima radi prevencije odbacivanja.
English: Other information about Envarsus
Croatian: Ostale informacije o lijeku Envarsus
English: The reference medicine for Envarsus is Advagraf.
Croatian: Referentni lijek za Envarsus je Advagraf.
English: These studies compared Envarsus with Prograf, a widely used and well-established tacrolimus medicine that releases tacrolimus more quickly.
Croatian: Studije uspoređuju Envarsus s Prografom, široko korištenim i dobro utvrđenim lijekom s akrolimusom koji takrolimus otpušta brže.
English: For more information about treatment with Envarsus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Envarsus pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Envarsus can only be obtained with a prescription and should only be prescribed by doctors experienced in immunosuppressive medicines and in the management of transplant patients.
Croatian: Envarsus se može dobiti samo na recept i mora ga prepisati liječnik koji ima iskustva s imunosupresivnim lijekovima i tretmanom bolesnika s presađenim organima.
English: What are the risks associated with Envarsus?
Croatian: Koji su rizici povezani s lijekom Envarsus?
English: In addition, the company that markets Envarsus will provide educational material for healthcare professionals who are likely to prescribe or dispense Envarsus, reminding them of its authorised uses and dosage, and the need for care if switching patients between different forms of tacrolimus.
Croatian: Nadalje, tvrtka koja prodaje Envarsus dužna je ponuditi obrazovne materijale za zdravstvene djelatnike koji će propisivati ili davati Envarsus, kao podsjetnik o odobrenim načinima upotrebe i dozama, te potrebnoj razini skrbi kada bolesnik prelazi s jednog na drugi vid uzimanja takrolimusa.
English: Because tacrolimus is absorbed into the body differently from Envarsus than from other tacrolimus medicines, when switching patients who are already being treated with any other formulation of tacrolimus they should be given a dose of Envarsus 30% less than their existing dose.
Croatian: Budući da takrolimus iz Envarsusa tijelo apsorbira drugačije nego u slučaju drugih lijekova s takrolimusom, pri prelasku bolesnika koji je liječen nekom drugom formulom takrolimusa na Envarsus, njihova početna doza Envarsusa treba biti 30 % niža od doze prethodnog lijeka.
English: Tacrolimus, the active substance in Envarsus, is an immunosuppressive medicine.
Croatian: Takrolimus, djelatna tvar Envarsusa, je imunosupresivni lijek.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Envarsus, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Envarsus uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Envarsus is a medicine that contains the active substance tacrolimus.
Croatian: Envarsus je lijek koji sadrži djelatnu tvar takrolimus.
English: These starting doses may also be tried for the treatment of rejection.
Croatian: Početne doze moguće je primijeniti i za sprečavanje odbacivanja organa.
English: For practical information about using Envarsus, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Envarsus bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: Therefore, the CHMP's view was that, as for other authorised forms of tacrolimus, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a kako koristi nadmašuju utvrđene rizike, kao i kod drugih ovlaštenih oblika takrolimusa.
English: The most commonly reported side effects with Envarsus (seen in more than 1 patient in 10) are tremor (shaking), headache, nausea (feeling sick), diarrhoea, kidney problems, hyperglycaemia (raised blood glucose levels), diabetes, hyperkalaemia (raised blood potassium levels), hypertension (high blood pressure) and insomnia (difficulty sleeping).
Croatian: hiperglikemija (povišena razina glukoze u krvi), dijabetes, hiperkalemija (povišena razina kalija u krvi), hipertenzija (visoki krvni tlak) i nesanica (poteškoće sa spavanjem).
English: The Committee recommended that Envarsus be given marketing authorisation.
Croatian: Povjerenstvo je preporučilo izdavanje odobrenja za stavljanje u promet lijeka Envarsus.
English: What benefits of Envarsus have been shown in studies?
Croatian: Koje su koristi lijeka Envarsus dokazane u ispitivanjima?
English: How is Envarsus used?
Croatian: Kako se Envarsus koristi?
English: For further details see the package leaflet.
Croatian: Za dodatne informacije vidjeti uputu o lijeku.
English: How does Envarsus work?
Croatian: Kako djeluje Envarsus?
English: For the full list of all side effects reported with Envarsus see the package leaflet
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Envarsus potražite u uputi o lijeku.
English: The full EPAR for Adynovi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Adynovi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It can be used in adults and children from 12 years of age.
Croatian: Može se primjenjivati u odraslih osoba i djece koja imaju 12 i više godina.
English: Other information about Adynovi
Croatian: Ostale informacije o lijeku Adynovi
English: Since this could potentially cause problems especially in children below 12 years of age, Adynovi is only approved for use in adults and children from 12 years of age.
Croatian: Budući da to može potencijalno uzrokovati probleme, osobito u djece mlađe od 12 godina, lijek Adynovi odobrava se za primjenu samo u odraslih osoba i djece u dobi od 12 ili više godina.
English: Why is Adynovi approved?
Croatian: Zašto je Adynovi odobren?
English: This is a summary of the European public assessment report (EPAR) for Adynovi.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Adynovi.
English: What measures are being taken to ensure the safe and effective use of Adynovi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Adynovi?
English: What is Adynovi and what is it used for?
Croatian: Što je Adynovi i za što se koristi?
English: Around 83% of bleeding episodes resolved with one injection.
Croatian: Otprilike 83 % epizoda krvarenja zaustavljeno je jednom injekcijom lijeka.
English: Adynovi rurioctocog alfa pegol
Croatian: Adynovi rurioktokog alfa pegol
English: During this period, around 38% of patients (25 out of 66) had no bleeding episodes, and none of the patients developed antibodies against Adynovi, which can cause the medicine to stop working.
Croatian: Tijekom tog razdoblja, otprilike 38 % bolesnika (25 od 66) nije imalo epizode krvarenja, a nijedan od bolesnika nije razvio protutijela na lijek Adynovi koja mogu onemogućiti njegovo djelovanje.
English: The European Medicines Agency decided that Adynovi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Adynovi nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
English: Hypersensitivity (allergic) reactions are uncommon with Adynovi (affecting up to 1 in 100 people) and may include swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest and wheezing.
Croatian: Reakcije preosjetljivosti (alergijske reakcije) rijetke se pri primjeni lijeka Adynovi (javljaju se u do 1 na 100 osoba), a uključuju oticanje, žarenje i peckanje na mjestu injekcije, zimicu, navalu crvenila, osip praćen svrbežom, glavobolju, koprivnjaču, nizak krvni tlak, letargiju, mučninu i povraćanje, nemir, brzo kucanje srca, stezanje u prsima i piskanje pri disanju.
English: In a study involving 138 adults and adolescents aged 12 years or above, 120 patients given Adynovi as a twice-weekly preventive treatment had, on average, around 4 bleeding episodes a year, and 17 patients given Adynovi for treating bleedings ‘on demand' had around 43 bleeding episodes a year.
Croatian: U ispitivanju koje je uključivalo 138 odraslih osoba i adolescenata u dobi od 12 ili više godina, 120 bolesnika koji su dvaput tjedno primali lijek Adynovi kao preventivnu terapiju imalo je u prosjeku otprilike četiri epizode krvarenja godišnje, dok je 17 bolesnika kojima se lijek Adynovi davao za liječenje krvarenja na zahtjev imalo otprilike 43 epizoda krvarenja godišnje.
English: Around 96% of bleeding episodes resolved with one or two injections of Adynovi.
Croatian: Otprilike 96 % epizoda krvarenja zaustavljeno je jednom ili dvjema injekcijama lijeka Adynovi.
English: The active substance in Adynovi, rurioctocog alfa pegol, works in the body in the same way as human factor VIII.
Croatian: Djelatna tvar lijeka Adynovi, rurioktokog alfa pegol, u tijelu djeluje na isti način kao ljudski faktor VIII.
English: It is not intended to provide practical advice on how to use Adynovi.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Adynovi.