FrancophonIA/ELRC3.0 huggingface dataset:
English: You will be requested to bring back remaining AMGLIDIA oral suspension to your doctor at each consultation.
Croatian: Od Vas će se zatražiti da donesete preostalu oralnu suspenziju AMGLIDIA prilikom svakog posjeta liječniku.
English: Always ask your child's doctor for advice in such circumstances.
Croatian: U takvim okolnostima uvijek upitajte liječnika svojeg djeteta za savjet.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost se određuje kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nije poznato (ne može se procijeniti iz dostupnih podataka).
English: Dosage adjustments and long-term management
Croatian: Prilagodba doze i dugoročno upravljanje liječenjem
English: Available data are described in section 5.2.
Croatian: Dostupni podaci opisani su u dijelu 5.2. Preskakanje doze
English: The risk of low blood sugar is increased if the medicine is not taken with a meal, is taken with alcohol, or if combined with certain medicines.
Croatian: Opasnost od niske razine šećera u krvi povećava se ako se lijek ne uzima uz obrok, uzima se s alkoholom ili u kombinaciji s određenim lijekovima.
English: This medicine may cause allergic reactions, which may be serious in isolated cases, including difficulties to breath, low blood pressure and shock.
Croatian: Ovaj lijek može uzrokovati alergijske reakcije koje u izoliranim slučajevima mogu postati ozbiljne, uključujući poteškoće s disanjem, nizak krvni tlak i šok.
English: Two cases of severe hypoglycaemia were observed, which were considered related to the medicinal product.
Croatian: Zabilježena su dva slučaja teške hipoglikemije koja se smatraju povezanima s lijekom.
English: Kidney failure does not affect its elimination as long as creatinine clearance remains above 30 ml/min.
Croatian: Zatajenje bubrega ne utječe na njegovo izlučivanje dok god klirens kreatinina ostaje iznad 30 ml/min.
English: After such a severe episode of hypoglycaemia, the child and family should see the child's doctor to check the appropriateness of the dose of glibenclamide suspension.
Croatian: Nakon takve teške epizode hipoglikemije, dijete i obitelj trebaju posjetiti liječnika kako bi provjerili prikladnost doze suspenzije glibenklamida.
English: Other medicines and AMGLIDIA
Croatian: Drugi lijekovi i AMGLIDIA
English: For each administration
Croatian: Za svaku primjenu
English: Note: if air gets into the syringe, empty the syringe into the bottle and start the procedure again.
Croatian: Napomena: ako zrak zapne u štrcaljki, ispraznite sadržaj štrcaljke u bočicu i ponovite postupak.
English: Tell your child's doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Croatian: Obavijestite liječnika ili ljekarnika svojeg djeteta ako ono uzima, nedavno je uzelo ili bi moglo uzimati bilo koje druge lijekove.
English: Potential risk
Croatian: Potencijalni rizik
English: Patients with G6PD enzyme deficiency
Croatian: Bolesnici s nedostatkom enzima G6PD
English: After enrolment, patients continued taking their usual doses of glibenclamide tablets for 1 month.
Croatian: Nakon uključivanja bolesnici su nastavili primati uobičajene doze tableta glibenklamida tijekom 1 mjeseca.
English: Once steady state is reached, capillary blood glucose does no longer need to be daily monitored except in clinical situations at risk of metabolic unbalance (see below).
Croatian: Kada se postigne stanje dinamičke ravnoteže, glukozu u kapilarnoj krvi ne treba više svakodnevno pratiti, osim u kliničkim situacijama u kojima postoji rizik od metaboličke neravnoteže (vidjeti ispod).
English: In case of milk feeding, recommendation is given to administer the suspension 15 minutes before child's milk feeding.
Croatian: U slučaju hranjenja mlijekom, preporučuje se primjena suspenzije 15 minuta prije hranjenja.
English: It is important you do not adjust yourself the doses of either AMGLIDIA or insulin, unless specifically directed to do so by your child's doctor.
Croatian: Važno je da sami ne prilagođavate doze lijeka AMGLIDIA ili inzulina, osim ako Vam to liječnik Vašeg djeteta nije izričito rekao.
English: Patients occasionally may have very high glucose values, i.e. > 20 mmol/L (> 360 mg/dL).
Croatian: Bolesnici povremeno mogu imati vrlo povišene vrijednosti glukoze, tj. > 20 mmol/l (> 360 mg/dl).
English: The glycosylated haemoglobin level should be measured every three months to assess the child's metabolic equilibrium.
Croatian: Razinu glikoliziranog hemoglobina treba mjeriti svaka tri mjeseca radi procjene metaboličke ravnoteže djeteta.
English: What AMGLIDIA looks like and contents of the pack
Croatian: Kako AMGLIDIA izgleda i sadržaj pakiranja
English: − hypersensitivity to the active substance, other sulphonylureas or sulphonamides or to any of the excipients listed in section 6.1;
Croatian: − preosjetljivost na djelatnu tvar, ostale derivate sulfonilureje ili sulfonamide ili neku od pomoćnih tvari navedenih u dijelu 6.1;
English: Then push the plunger to remove as many air bubbles as possible from the syringe (figure 4B).
Croatian: Zatim gurnite klip kako biste uklonili što više zračnih mjehurića iz štrcaljke (slika 4B).
English: The elimination half-lives were similar for the two suspensions (almost 8 hours) and a little shorter than those observed with the crushed Daonil tablets.
Croatian: Poluvijek eliminacije bio je sličan za obje suspenzije (skoro 8 sati) i malo kraći od poluvijeka eliminacije zdrobljenih tableta Daonil.
English: Those not already mentioned above, which could happen in children as well are listed below.
Croatian: Nuspojave koje nisu prethodno navedene, a mogle bi se pojaviti i u djece navedene su u nastavku.
English: You must check your child's blood sugar (capillary blood sugar) and give AMGLIDIA as soon as you realise you have forgotten to use it.
Croatian: Trebate provjeriti razinu šećera u krvi svojeg djeteta (šećer u kapilarnoj krvi) i dati mu lijek AMGLIDIA čim primijetite da ste ga zaboravili primijeniti.
English: The syringe is packed in a transparent bag.
Croatian: Štrcaljka je pakirana u prozirnoj vrećici.
English: If ketonuria is detected, you must inject insulin immediately according to the procedure defined beforehand with your child's doctor and contact him/her or his/her team for advice.
Croatian: Ako uočite ketonuriju, djetetu trebate odmah injektirati inzulin u skladu s postupkom koji je prethodno odredio liječnik Vašeg djeteta i obratiti se tom liječniku ili njegovu timu za savjet.
English: The symptoms of moderate hypoglycaemia, without loss of consciousness or neurological signs, must be completely corrected by taking sugar, adjusting the dose and/or changing dietary behaviour.
Croatian: Simptomi umjerene hipoglikemije bez gubitka svijesti ili neuroloških znakova trebaju se u potpunosti poništiti uzimanjem šećera, prilagodbom doze i/ili promjenom u hranjenju.
English: Increase liver enzymes
Croatian: Povećanje jetrenih enzima
English: The 5 mL syringe has to be used for volumes greater than 1 mL.
Croatian: Štrcaljka od 5 ml treba se koristiti za volumen veći od 1 ml.
English: Glibenclamide is strongly bound to plasma albumin (99%), which may account for certain drug interactions, but is not easily detached by acidic medicinal products.
Croatian: Glibenklamid se snažno veže za albumin u plazmi (99 %) što može utjecati na interakcije s određenim lijekovima, ali ne može se lako odvojiti pomoću kiselih lijekova.
English: G6PD is an enzyme evolved in sugar metabolism.
Croatian: G6PD je enzim koji sudjeluje u metabolizmu šećera.
English: You should only use the syringe which has been prescribed by your doctor.
Croatian: Smijete se koristiti samo štrcaljkom koju je propisao vaš liječnik.
English: It is recommended to wait for the child has swallowed the medicine before reverting back to lying position.
Croatian: Preporučuje se da pričekate dok dijete ne proguta lijek prije nego što ga stavite u ležeći položaj.
English: Make sure that you use correct strength of the medicine and the appropriate oral syringe prescribed by your doctor to avoid accidental administration of too high or too low amounts.
Croatian: Pobrinite se da koristite ispravnu jačinu lijeka i odgovarajuću štrcaljku za usta koju Vam je propisao liječnik kako biste izbjegli slučajnu primjenu previsoke ili preniske doze.
English: In pregnant women insulin is recommended for blood sugar control.
Croatian: U trudnica se preporučuje inzulin za kontrolu šećera u krvi.
English: MAO inhibitors
Croatian: MAO inhibitori
English: There were no reported episodes of severe hypoglycaemia.
Croatian: Nisu zabilježene epizode teške hipoglikemije.
English: The MAH shall ensure that, in each Member State where Amglidia is marketed, all healthcare professionals who are expected to prescribe Amglidia, have access to the following educational guide:
Croatian: MAH će osigurati da u svakoj državi članici u kojoj se lijek Amglidia stavlja u promet svi zdravstveni radnici koji će propisivati lijek Amglidia imaju pristup sljedećem edukacijskom vodiču:
English: If very low blood sugar occurs that affects consciousness, emergency services should be called and an intravenous glucose injection performed.
Croatian: Ako vrlo niska razina šećera u krvi utječe na svijest, treba pozvati hitnu službu i primiti intravenoznu injekciju glukoze.
English: If no improvement is seen (unchanged insulin dose, similar glycaemic control and no improvement in neurology), AMGLIDIA should be discontinued.
Croatian: Ako se ne primijeti nikakvo poboljšanje (nepromijenjena doza inzulina, slična kontrola glikemije i izostanak neurološkog poboljšanja), potrebno je prekinuti primjenu lijeka AMGLIDIA.
English: • If the patient is prescribed a different presentation, the prescriber should highlight to the patient the packaging differences between the different presentations (focus on colour differentiation, warning statements on carton, thickness and length of the provided syringe).
Croatian: • Ako se bolesniku propisuje drugačije pakiranje, liječnik koji ga propisuje treba naglasiti bolesniku da različit sadržaj pakiranja odgovaraju različitim pakiranjima (istaknuti razliku u boji, upozorenja na pakiranju, debljinu i duljinu isporučene štrcaljke).
English: Ciclosporin used to prevent rejection of the transplanted organ
Croatian: Ciklosporin koji se upotrebljava za sprječavanje odbacivanja transplantiranog organa
English: - if your child has ketoacidosis (high blood levels of acid substances called ketones).
Croatian: - ako Vaše dijete ima ketoacidozu (visoku razinu kiselih tvari pod nazivom ketoni u krvi).
English: Safety and efficacy of Amglidia in elderly patients has not been established since the medicinal product is indicated in the paediatric population.
Croatian: Sigurnost i djelotvornost lijeka AMGLIDIA u starijih bolesnika nije utvrđena jer je lijek indiciran za pedijatrijsku populaciju.
English: The bottle does not need to be shaken before administration.
Croatian: Bočicu ne treba protresti prije primjene.
English: The average dose reported in the literature (clinical trials and case reports) is of approximately 0.5 mg/kg/day.
Croatian: Prosječna doza objavljena u literaturi (klinička ispitivanja i izvješća o slučajevima) iznosi oko 0,5 mg/kg/dan.
English: If there is no alternative, the decision for each patient must consider the danger of haemolysis and the potential benefit expected from the treatment.
Croatian: Ako alternativno liječenje ne postoji, prilikom odluke o liječenju svakog bolesnika u obzir se treba uzeti opasnost od hemolize i moguća korist od liječenja.
English: Talk to your doctor before your child is given AMGLIDIA.
Croatian: Obratite se svom liječniku prije nego što Vaše dijete počne dobivati lijek AMGLIDIA.
English: Clinical studies appear to suggest that CYP2C9 contributes significantly to glibenclamide metabolism in vivo.
Croatian: Čini se da klinička ispitivanja upućuju na to da CYP2C9 značajno doprinosi metabolizmu glibenklamida in vivo.
English: In some children glycemic control can be better achieved when AMGLIDIA is administered 3 times or 4 times daily.
Croatian: U neke djece postiže se bolja kontrola glikemije kada se lijek AMGLIDIA primjenjuje 3 ili 4 puta dnevno.
English: AMGLIDIA is a white and odourless oral suspension.
Croatian: AMGLIDIA je bijela oralna suspenzija bez mirisa.
English: ACE inhibitors (used to treat hypertension) (such as captopril and enalapril)
Croatian: ACE inhibitori (upotrebljava se za liječenje hipertenzije) (na primjer kaptopril i enalapril)
English: If the child does not suck, slowly press the plunger of the syringe so that the suspension trickles into the mouth.
Croatian: Ako dijete ne siše, polako pritisnite klip štrcaljke tako da suspenzija uđe u usta.
English: Prior to launch of Amglidia in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of an educational material for Amglidia, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka Amglidia u promet u svakoj državi članici nositelj odobrenja za stavljanje lijeka u promet (MAH) mora s nacionalnim regulatornim tijelom dogovoriti sadržaj i oblik edukacijskog materijala za lijek Amglidia, uključujući sredstva komunikacije, distribucijske načine i sve druge aspekte programa.
English: If at the end of a 5 to 6-week period, there is no evidence of a response with insulin doses similar to those at starting, administration of doses up to 2 mg/kg/day for a week may be tried.
Croatian: Ako na kraju razdoblja od 5 do 6 tjedana nema dokaza o odgovoru uz doze inzulina slične kao i na početku liječenja, mogu se pokušati primjenjivati doze od 2 mg/kg/dan u trajanju od jednog tjedna.
English: Repeat the same protocol every week until insulin independence is achieved.
Croatian: Svaki tjedan primjenjujte isti režim dok se ne postigne neovisnost o inzulinu.
English: Beta-receptor blockers (such as propranolol used to treat high blood pressure, control irregular or fast heart beats, help prevent additional heart attack)
Croatian: Blokatori beta receptora (kao što je propranolol koji se upotrebljava za liječenje visokog krvnog tlaka, kontrolu nepravilnih ili ubrzanih otkucaja srca, sprječavanje dodatnih srčanih udara)
English: A summary of the interactions detailed above and further interactions are summarised in the table below.
Croatian: Sažetak prethodno navedenih interakcija i dodatnih interakcija naveden je u tablici u nastavku.
English: If you forget to give AMGLIDIA, there is a risk of high blood sugar.
Croatian: Ako ste zaboravili primijeniti lijek AMGLIDIA, postoji opasnost od visoke razine šećera u krvi.
English: Do not use any other syringe to administer AMGLIDIA.
Croatian: Ne koristite nikakve druge štrcaljke za primjenu lijeka AMGLIDIA.
English: Blood affections generally reversible when treatment stops.
Croatian: Poremećaji krvi Poremećaji krvi obično su reverzibilni nakon prekida liječenja.
English: The doctor may start insulin therapy again, when ketonemia or ketonuria were found to be responsible for the major vomiting.
Croatian: Liječnik može ponovno uvesti inzulinsku terapiju ako se ustanovi da su ketonemija ili ketonurija odgovorne za obilno povraćanje.
English: There is a risk of high blood sugar.
Croatian: Postoji opasnost od visoke razine šećera u krvi.
English: Bosentan used to treat high blood pressure in the blood vessels between the heart and the lungs.
Croatian: Bosentan koji se upotrebljava za liječenje visokog krvnog tlaka u krvnim žilama između srca i pluća.
English: Based on a limited amount of published data, the use of glibenclamide during the 1st trimester does not seem to cause an increase in congenital malformations.
Croatian: Na temelju ograničenih objavljenih podataka, čini se da primjena glibenklamida tijekom 1. tromjesečja trudnoće ne uzrokuje povećanje kongenitalnih malformacija.
English: It is recommended that such patients change treatment to insulin.
Croatian: Preporučuje se da se te bolesnice prebace na liječenje inzulinom.
English: - if your child is allergic to glibenclamide or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako je Vaše dijete alergično na glibenklamid ili neki drugi sastojak ovog lijeka (naveden u dijelu
English: With smaller bodyweight the concentration increased but exceeded the adult plasma levels in minimal extents only for poor metabolizers.
Croatian: Što je tjelesna težina manja, koncentracije su bile veće, no razine u plazmi zabilježene u odraslih prekoračene su minimalno, a primijećeno je samo u loših metabolizatora.
English: Concomitant use of alcohol and glibenclamide should be avoided.
Croatian: Potrebno je izbjegavati istodobnu primjenu glibenklamida i alkohola.
English: Interactions of AMGLIDIA with other medicines are presented in the table below:
Croatian: Interakcije lijeka AMGLIDIA i drugih lijekova navedene su u tablici u nastavku:
English: If a hypoglycaemic coma is diagnosed or suspected, the patient should quickly receive an intravenous injection of concentrated glucose solution (0.5 g/kg body weight as a 30% glucose solution).
Croatian: Ako je dijagnosticirana hipoglikemijska koma ili se sumnja na nju, bolesnik treba brzo primiti intravenoznu injekciju otopine s koncentriranom glukozom (0,5 g/kg tjelesne težine kao 30 %-tnu otopinu glukoze).
English: • The choice of the Amglidia strength should be defined according to the prescribed posology and the patient's body weight.
Croatian: • Odabir jačine lijeka Amglidia treba se odrediti u skladu s propisanim doziranjem i tjelesnom težinom bolesnika.
English: Tell the doctor if you know that your child is affected by G6PD deficiency and contact him/her if you notice that your child is pale as compared to usually.
Croatian: Obavijestite liječnika ako znate da Vaše dijete ima nedostatak enzima G6PD i obratite mu se ako primijetite da je Vaše dijete bljeđe nego inače.
English: The following adverse reactions have been observed in a clinical study (Neogli study).
Croatian: Sljedeće nuspojave primijećene su u kliničkom ispitivanju (ispitivanje Neogli).
English: (In rare cases, it has taken 4 months to wean off insulin completely).
Croatian: rijetkim slučajevima, za potpuno ukidanje inzulinske terapije bilo je potrebno 4 mjeseca).
English: Oral glucose tolerance tests and intravenous glucose tolerance tests revealed good insulin response to glucose and maintained incretin effect after ten years.
Croatian: Oralni test tolerancije na glukozu i intravenski test tolerancije na glukozu pokazali su dobar inzulinski odgovor na glukozu i održavanje inkretinskog učinka nakon deset godina.
English: Increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).
Croatian: Povećanje bilirubinemije nakon odvajanja od albumina može povećati neonatalnu žuticu koja se može razviti u kernikterus (nakupljanje nekonjugiranog bilirubina u moždanom tkivu).
English: Signs of adrenergic counter-regulation to hypoglycaemia may be reduced or absent
Croatian: znakovi adrenergičke proturegulacije hipoglikemije mogu biti smanjeni ili odsutni.
English: Glibenclamide may increase the risk of low blood sugar and therefore have a moderate influence on the ability to drive, to take part in road traffic otherwise or use machines.
Croatian: Glibenklamid može povećati opasnost od niske razine šećera u krvi te bi stoga trebao imati umjeren utjecaj na sposobnost upravljanja vozilima, druge načine sudjelovanja u cestovnom prometu ili rad na strojevima.
English: Clarithromycin is an antibiotic used to treat certain infections
Croatian: Klaritromicin je antibiotik koji se koristi za liječenje određenih infekcija
English: No interaction studies have been performed for the two oral suspensions of glibenclamide (0.6 mg/mL and 6 mg/mL).
Croatian: Nisu provedena ispitivanja o interakciji za dvije oralne suspenzije glibenklamida (0,6 mg/ml i 6 mg/ml).
English: The conversion rate between micronised tablets and the suspension has not been established.
Croatian: Stopa konverzije između mikroniziranih tableta i suspenzije nije utvrđena.
English: Postprandial responses involving secretion of insulin and peptide-C continue to be enhanced after at least 6 months of treatment and even over many years in the case of neonatal diabetes by potassium channel disorders.
Croatian: Odgovori nakon obroka koji obuhvaćaju sekreciju inzulina i peptida C i dalje se povećavaju nakon najmanje 6 mjeseci liječenja i čak tijekom mnogo godina u slučaju neonatalnog dijabetesa uzrokovanog poremećajima kalijeva kanala.
English: Special care should be taken when calculating the dose.
Croatian: Potreban je oprez pri određivanju doze.
English: Diabetes symptoms may reappear and may lead to a serious disturbance of the body's metabolism with high blood levels of ketones (ketoacidosis), dehydration and disturbance of the balance of acids in the body.
Croatian: Simptomi dijabetesa mogu se ponovno pojaviti i mogu dovesti do ozbiljnih poremećaja u tjelesnom metabolizmu, odnosno visoke razine ketona u krvi (ketoacidoza), dehidracije i poremećene ravnoteže kiselosti organizma.
English: Glibenclamide may increase ciclosporin plasma concentration and potentially lead to its increased toxicity.
Croatian: Glibenklamid može povećati koncentraciju ciklosporina u plazmi i dovesti do njegove povećane toksičnosti.
English: Transfer to sulfonylureas occurred in childhood with a median [IQR] at transfer of 4.8 years [1.7 - 11.4 years].
Croatian: Prebacivanje na sulfonilureju dogodilo se u djetinjstvu s medijanom dobi [IQR] pri prebacivanju od 4,8 godina [1,7 - 11,4 godine].
English: The symptoms of hypoglycaemia may also be milder or absent where hypoglycaemia develops gradually or where there is autonomic neuropathy.
Croatian: Simptomi hipoglikemije mogu također biti blaži ili nepostojeći ako se hipoglikemija razvija postupno ili u slučaju autonomne neuropatije.
English: Calcium channel blockers
Croatian: Blokatori kalcijskih kanala
English: Rifampicin used to treat infections including tuberculosis
Croatian: Rifampicin koji se upotrebljava za liječenje infekcija uključujući tuberkulozu
English: Due to strong binding of glibenclamide to proteins, dialysis is of no benefit to the patient.
Croatian: Zbog snažnog vezanja glibenklamida za proteine dijaliza neće koristiti bolesniku.
English: Patients with complications were older at age of transfer to sulfonylurea than those without complications (median age at transfer: 20.5 v 4.1 years, p=0.0005).
Croatian: Bolesnici s komplikacijama bili su stariji prilikom prebacivanja na sulfonilureju od onih bez komplikacija (medijan dobi pri prebacivanju: 20,5 u odnosu na 4,1 godinu, p=0,0005).
English: Seventy-five patients (93%) remained on sulphonylurea alone at most recent follow-up and 6/81(7%) were on sulphonylurea and daily insulin.
Croatian: Sedamdeset i pet bolesnika (93 %) nastavilo je primjenjivati samo sulfonilureju na posljednjem pregledu, a 6/81 (7 %) bolesnika uzimalo je sulfonilureju i dnevnu dozu inzulina.
English: You should check your child's blood sugar (capillary blood sugar).
Croatian: Trebate provjeriti razinu šećera u krvi (šećer u kapilarnoj krvi) svojeg djeteta.
English: In some cases these high glucose values seem to settle with the normal dose of AMGLIDIA.
Croatian: Čini se da se u nekim slučajevima te visoke vrijednosti glukoze stabiliziraju uz uobičajenu dozu lijeka AMGLIDIA.
English: In case of nausea glycaemia seems to be maintained and insulin does not need to be re-introduced until the patient is able to take the glibenclamide suspension.
Croatian: U slučaju mučnina, čini se da se glikemija održava i nije potrebno ponovno uvoditi inzulinsku terapiju sve dok bolesnik može uzimati suspenziju glibenklamida.
English: The oral syringe in the carton should be used only with this medicine.
Croatian: Štrcaljka za usta smije se koristiti samo s ovim lijekom.