FrancophonIA/ELRC3.0 huggingface dataset:
English: On 25 February 2016, the European Medicines Agency (EMA) confirmed recommendations1 to minimise the risk of diabetic ketoacidosis in patients taking SGLT2 inhibitors (a class of type 2 diabetes medicines).
Croatian: Europska agencija za lijekove (EMA) 25. veljače 2016. potvrdila je preporuke 1 o svođenju rizika od dijabetičke ketoacidoze u bolesnika koji uzimaju SGLT2 inhibitore (lijekove za liječenje dijabetesa razreda tipa 2) na najmanju moguću mjeru.
English: In addition, EMA recommended temporarily stopping SGLT2 inhibitors in patients who are undergoing major surgery or are in hospital due to serious illness.
Croatian: Osim toga, EMA je preporučila privremeni prekid liječenja SGLT2 inhibitorima u bolesnika koji trebaju biti podvrgnuti većem kirurškom zahvatu ili koji su u bolnici zbog teške bolesti.
English: • If you have any of the symptoms above while taking an SGLT2 inhibitor, contact a doctor or the nearest hospital straightaway even if your sugar level is not particularly high.
Croatian: • Ako imate bilo koji od navedenih simptoma tijekom uzimanja SGLT2 inhibitora, smjesta se obratite liječniku ili otiđite u najbližu bolnicu, čak i ako nemate izrazito visoku razinu šećera u krvi.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Croatian: Procjenu je prvotno proveo Odbor za procjenu rizika na području farmakovigilancije (PRAC), odbor odgovoran za procjenu sigurnosnih pitanja u području lijekova za humanu uporabu, koji je iznio niz preporuka.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Croatian: Preporuke PRAC-a poslane su Odboru za lijekove za humanu uporabu (CHMP), odgovornom za pitanja koja se odnose na lijekove za humanu uporabu, koji je usvojio konačno mišljenje Agencije.
English: Finally, EMA reminded healthcare professionals that SGLT2 inhibitors are not authorised for type 1 diabetes, noting that cases of ketoacidosis have also occurred during off-label use and clinical trials in type 1 diabetes.
Croatian: Naposljetku, EMA je podsjetila zdravstvene djelatnike na to da SGLT2 inhibitori nisu odobreni za dijabetes tipa 1 uz napomenu da su slučajevi ketoacidoze zabilježeni i tijekom uporabe lijeka bez odobrenja i kliničkih ispitivanja dijabetesa tipa 1.
English: Diabetic ketoacidosis is a serious complication of diabetes caused by low insulin levels.
Croatian: Dijabetička ketoacidoza ozbiljno je stanje pri kojem dolazi do komplikacije dijabetesa zbog niskih razina inzulina.
English: • Always consider the possibility of diabetic ketoacidosis in patients taking SGLT2 inhibitors who have non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Croatian: • Uvijek imajte u vidu mogućnost da se stanje dijabetičke ketoacidoze razvilo u bolesnika koji uzimaju SGLT2 inhibitore, a koji imaju nespecifične simptome kao što su mučnina, povraćanje, anoreksija, bol u trbuhu, prekomjerna žeđ, poteškoće pri disanju, smetenost, neuobičajen umor ili pospanost.
English: A number of these cases were atypical with patients having only moderately raised blood sugar levels and some of them occurred during offlabel use and clinical trials in patients with type 1 diabetes.
Croatian: Brojni su slučajevi bili atipični jer su bolesnici imali tek umjereno povećane razine šećera u krvi, a neki od slučajeva zabilježeni su tijekom uporabe lijeka bez odobrenja i kliničkih ispitivanja na bolesnicima s dijabetesom tipa 1.
English: Following a review of the cases, EMA recommended updating the product information of SGLT2 inhibitors to list diabetic ketoacidosis as a rare adverse reaction (affecting up to 1 in 1,000 patients).
Croatian: Nakon ponovnog ocjenjivanja dotičnih slučajeva, EMA je preporučila izmjenu informacija o proizvodu za SGLT2 inhibitore kako bi se dijabetička ketoacidoza uvrstila na popis rijetkih nuspojava (koja se može javiti u do 1 na 1000 bolesnika).
English: • Healthcare professionals are reminded that SGLT2 inhibitors are only authorised for treating type 2 diabetes.
Croatian: • Zdravstvene radnike ponovno se podsjeća na to da su SGLT2 inhibitori odobreni samo za liječenje dijabetesa tipa 2.
English: Symptoms include rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.
Croatian: Simptomi uključuju brz gubitak težine, mučninu ili povraćanje, bol u trbuhu, prekomjernu žeđ, brzo i duboko disanje, smetenost, neuobičajenu pospanost ili umor, slatki miris daha, okus slatkoće ili metala u ustima ili drugačiji miris mokraće ili znoja.
English: Healthcare professionals should therefore consider the possibility of ketoacidosis in patients taking SGLT2 inhibitors who have symptoms consistent with the condition even if blood sugar levels are not high.
Croatian: Stoga zdravstveni radnici trebaju imati u vidu da mogućnost pojave ketoacidoze može postojati i u bolesnika koji uzimaju SGLT2 inhibitore, a koji imaju simptome karakteristične za to stanje čak i u slučaju kada razine šećera u krvi nisu visoke.
English: If diabetic ketoacidosis is suspected or confirmed, treatment with SGLT2 inhibitors should be stopped immediately and should not be re-started unless another cause for the ketoacidosis is identified and resolved.
Croatian: U slučaju sumnje u pojavu dijabetičke ketoacidoze ili potvrde da takvo stanje postoji, liječenje SGLT2 inhibitorima potrebno je smjesta prekinuti i ono se ne smije ponovno započeti, osim u slučaju kada se utvrdi i otkloni neki drugi uzrok ketoacidozi.
English: Sodium-glucose co-transporter-2 (SGLT2) inhibitors are medicines used to treat type 2 diabetes.
Croatian: Inhibitori natrij-glukoze kotransportera 2 (SGLT2) lijekovi su koji se koriste za liječenje dijabetesa tipa
English: By blocking the action of SGLT2, these medicines cause more glucose to be removed through the urine, thereby reducing the levels of glucose in the blood.
Croatian: Onemogućavanjem djelovanja bjelančevine SGLT2, ti lijekovi omogućuju uklanjanje veće količine glukoze putem mokraće čime se smanjuju razine glukoze u krvi.
English: Healthcare professionals should exercise caution with SGLT2 inhibitors in patients with risk factors for ketoacidosis and inform patients of these factors.
Croatian: Zdravstveni radnici trebaju biti na oprezu u pogledu primjene SGLT2 inhibitora u bolesnika s čimbenicima rizika od ketoacidoze te trebaju obavijestiti bolesnike o tim čimbenicima.
English: Patients taking these medicines should be aware of the symptoms of diabetic ketoacidosis, including rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.
Croatian: Bolesnici koji uzimaju te lijekove trebaju biti upoznati sa simptomima dijabetičke ketoacidoze koji uključuju brz gubitak težine, mučninu ili povraćanje, bol u trbuhu, prekomjernu žeđ, brzo i duboko disanje, smetenost, neuobičajenu pospanost ili umor, slatki miris daha, okus slatkoće ili metala u ustima ili drugačiji miris mokraće ili znoja.
English: • Some of the cases of diabetic ketoacidosis in people taking SGLT2 inhibitors did not show the very high sugar levels normally associated with this condition.
Croatian: • U nekim od slučajeva dijabetičke ketoacidoze u osoba koje uzimaju SGLT2 inhibitore nisu postojale vrlo visoke razine šećera u krvi koje se obično povezuje s takvim stanjem.
English: They block a protein in the kidneys called SGLT2, which absorbs glucose back from the urine into the bloodstream as the blood is filtered in the kidneys.
Croatian: Oni onemogućuju djelovanje bjelančevina u bubrezima koji se naziva SGLT2, a koji apsorbira glukozu natrag iz mokraće u krvotok prilikom pročišćavanja krvi u bubrezima.
English: • Diabetic ketoacidosis is a serious complication of diabetes.
Croatian: • Dijabetička ketoacidoza ozbiljno je stanje pri kojem dolazi do komplikacije dijabetesa.
English: • Exercise caution in patients with risk factors for ketoacidosis and inform patients of these factors.
Croatian: • Budite na oprezu u slučaju bolesnika s čimbenicima rizika od ketoacidoze i obavijestite takve bolesnike o tim čimbenicima.
English: • Rare cases of diabetic ketoacidosis have occurred in people with type 2 diabetes taking diabetes medicines known as SGLT2 inhibitors.
Croatian: • Rijetki slučajevi dijabetičke ketoacidoze zabilježeni su u osoba s dijabetesom tipa 2 koje uzimaju lijekove za liječenje dijabetesa koji su poznati pod nazivom SGLT2 inhibitori.
English: These include low insulin-producing capacity in the pancreas, a sudden drop in a patient's insulin dose, increased insulin requirement (due to illness, surgery or alcohol abuse) or conditions that can restrict food intake or lead to severe dehydration.
Croatian: Ti čimbenici uključuju nizak kapacitet proizvodnje inzulina u gušterači, iznenadno smanjenje doze inzulina, povećanu potrebu za inzulinom (zbog bolesti, operacije ili prekomjerne konzumacije alkohola) ili stanja u kojima može biti ograničen unos hrane ili koja mogu dovesti do teške dehidracije.
English: These include low reserve of insulin-secreting cells, a sudden reduction in insulin dose, an increased requirement for insulin (due to illness, surgery or alcohol abuse) and conditions that restrict food intake or can lead to severe dehydration.
Croatian: Ti čimbenici uključuju male rezerve stanica koje izlučuju inzulin, iznenadno smanjenje doze inzulina, povećanu potrebu za inzulinom (zbog bolesti, operacije ili prekomjerne konzumacije alkohola) i stanja u kojima je ograničen unos hrane ili koja mogu dovesti do teške dehidracije.
English: Rare cases of this condition, including life-threatening ones, have occurred in patients taking SGLT2 inhibitors for type 2 diabetes and a number of these cases have been atypical, with patients not having blood sugar levels as high as expected.
Croatian: U bolesnika koji uzimaju SGLT2 inhibitore za dijabetes tipa 2 zabilježeni su rijetki slučajevi ovog stanja, što uključuje stanja opasna po život, a brojni od tih slučajeva bili su atipični jer bolesnici nisu imali u onoj mjeri visoke razine šećera u krvi koliko je bilo očekivano.
English: • Stop treatment with SGLT2 inhibitors immediately if diabetic ketoacidosis is suspected or confirmed, and do not re-start treatment unless another clear precipitating factor for the condition is identified and resolved.
Croatian: • U slučaju sumnje na pojavu dijabetičke ketoacidoze ili potvrde da takvo stanje postoji smjesta prekinite liječenje SGLT2 inhibitorima i ne započinjite ponovno liječenje, osim u slučaju kada se utvrdi i otkloni neki drugi jasan precipitirajući čimbenik koji uzrokuje takvo stanje.
English: Patients should contact a doctor or the nearest hospital straightaway if they have any of these symptoms.
Croatian: Ako imaju bilo koji od tih simptoma, bolesnici se moraju smjesta obratiti liječniku ili otići u najbližu bolnicu.
English: • Stop treatment with SGLT2 inhibitors temporarily in patients undergoing major surgical procedures or hospitalised due to acute serious medical illnesses.
Croatian: • U slučaju bolesnika koji trebaju biti podvrgnuti većim kirurškim zahvatima ili koji su hospitalizirani zbog akutne teške medicinske bolesti, privremeno prekinite liječenje SGLT2 inhibitorima.
English: • Rare cases of diabetic ketoacidosis, including life-threatening ones, have occurred in patients taking SGLT2 inhibitors, used to treat type 2 diabetes.
Croatian: • U bolesnika koji uzimaju SGLT2 inhibitore koji se koriste za liječenje dijabetesa tipa 2 zabilježeni su rijetki slučajevi dijabetičke ketoacidoze, uključujući slučajeve opasne po život.
English: 1 pre-filled syringe
Croatian: 1 napunjena štrcaljka bočica (staklena)
English: It should be taken with food.
Croatian: Mora se uzimati s hranom.
English: The main measure of effectiveness was based on the number of patients whose disease got worse or who died.
Croatian: Glavna mjera djelotvornosti temeljena je na broju bolesnika čija se bolest pogoršala ili koji su preminuli.
English: Treatment should start with a low dose that is gradually increased over the first 14 days of treatment.
Croatian: Liječenje treba započeti s malom dozom koja se postepeno povećava tijekom prvih 14 dana terapije.
English: The standard dose for adults is 100 or 200 mg, once or twice a day.
Croatian: Standardna doza za odrasle osobe iznosi 100 ili 200 mg, jednom ili dvaput na dan.
English: It is available as an oral solution (80 mg/ml), as a powder for oral solution (100 mg sachets), as capsules (100 mg) and as tablets (100 mg).
Croatian: Dostupan je kao peroralna otopina (80 mg/ml), kao prašak za oralnu otopinu (vrećice od 100 mg), kao kapsule (100 mg) i kao tablete (100 mg).
English: The recommended dose for adults (aged 18 years or over) is 600 mg twice a day.
Croatian: Preporučena doza za odrasle osobe (u dobi od 18 godina ili starijih) iznosi 600 mg dvaput na dan.
English: Norvir does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Norvir ne liječi infekciju HIV-om ili AIDS, no može odgoditi oštećenje imunosnog sustava i razvoj infekcija i bolesti povezanih s AIDS-om.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Norvir on 26 August 1996.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Norvir na snazi u Europskoj uniji od 26. kolovoza 1996.
English: CD4 T cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Croatian: CD4 T stanice su bijele krvne stanice koje su važne jer pomažu u borbi protiv infekcija, ali HIV ih ubija.
English: This means that it blocks a viral enzyme called protease, which is involved in the reproduction of HIV.
Croatian: To znači da blokira virusni enzim zvani proteaza koji je uključen u reprodukciju HIV-a.
English: In the first study of Norvir as an antiviral medicine, 16% of the Norvir-treated patients (86 out of 543) experienced a worsening of disease or died, compared with 33% of the patients taking placebo (181 out of 547).
Croatian: U prvom ispitivanju lijeka Norvir kao antivirotika, 16% bolesnika liječenih lijekom Norvir (86 od 543) iskusilo je pogoršanje bolesti ili je umrlo, u usporedbi s 33% bolesnika koji su uzimali placebo (181 od 547).
English: Some medicines cannot be taken with Norvir when it is used in this way.
Croatian: Pojedini lijekovi ne mogu se uzimati s lijekom Norvir, kada se lijek koristi na taj način.
English: Other information about Norvir
Croatian: Ostale informacije o lijeku Norvir
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down its rate of multiplication.
Croatian: Kad je enzim blokiran, virus se ne razmnožava na normalan način, što smanjuje njegovu stopu replikacije.
English: What measures are being taken to ensure the safe and effective use of Norvir?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Norvir?
English: The main measure of effectiveness was the change in the levels of HIV in the blood (viral load) and CD4 T cell levels in the blood (CD4 cell count).
Croatian: Glavna mjera djelotvornosti bila je promjena u koncentracijama HIV-a u krvi (virusno opterećenje) i koncentracijama CD4 T stanica u krvi (broj CD4 stanica).
English: This causes an increase of antiviral levels in the blood of such medicines and thus it boosts their antiviral activity.
Croatian: To uzrokuje povećanje koncentracije takvih lijekova u krvi te stoga pojačava njihovo antivirotičko djelovanje.
English: When it is used as an HIV medicine, the most common side effects with Norvir (seen in more than 1 patient in 10) are dysgeusia (taste disturbances), paraesthesia (unusual tingling sensations) around the mouth and in the limbs, headache, dizziness, peripheral neuropathy (damage to the nerves in the limbs), pharyngitis (sore throat), mouth and throat pain, cough, abdominal pain (stomach ache), nausea (feeling sick), diarrhoea, vomiting, dyspepsia (heartburn), pruritis (itching), rash, joint and back pain, tiredness, flushing and feeling hot.
Croatian: Ako se koristi kao lijek protiv HIV-a, najčešće nuspojave lijeka Norvir (mogu se javiti u više od 1 na 10 bolesnika) su disgezija (poremećaj okusa), parestezija (osjećaj neobičnog peckanja) oko usta i zglobova, glavobolja, vrtoglavica, periferna neuropatija (oštećenje živaca u udovima), faringitis (bolno grlo), bol u ustima i grlu, kašalj, abdominalna bol (trbuhobolja), mučnina (osjećaj slabosti), proljev, povraćanje, dispepsija (žgaravica), pruritus (svrbež), osip, bol u zglobu i leđima, iscrpljenost, valovi vrućine i osjećaj vrućine.
English: This is a summary of the European public assessment report (EPAR) for Norvir.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Norvir.
English: Information on these studies can be found in the EPAR summaries for the other medicines.
Croatian: Informacije o ovim ispitivanjima dostupne su u sažetku EPAR za ostale lijekove.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Norvir.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Norvir.
English: The combination of Norvir and zidovudine was less effective than Norvir alone, although the reasons for this were unclear.
Croatian: Kombinacija lijeka Norvir i zidovudina bila je manje djelotvorna od monoterapije lijekom Norvir, iako razlozi za isto nisu bili jasni.
English: Norvir can be used as a ‘‘pharmacokinetic enhancer' (booster' to increase the blood levels of other antiviral medicines that belong to the same group as Norvir (protease inhibitors) called amprenavir, atazanavir, fosamprenavir, lopinavir, saquinavir, tipranavir and darunavir.
Croatian: Norvir se može koristiti kao „farmakokinetički pojačivač“ („booster“ za povećanje koncentracija krvi drugih antivirotika koji se ubrajaju u istu grupu kao Norvir (inhibitori proteaze) naziva amprenavir, atazanavir, fosamprenavir, lopinavir, sakvinavir, tipranavir i darunavir.
English: At higher doses, ritonavir acts as a ‘protease inhibitor'.
Croatian: U većim dozama ritonavir djeluje kao "inhibitor proteaze".
English: Norvir has been studied as an antiviral medicine in two main studies involving 1,446 patients.
Croatian: Norvir je ispitan kao antivirotik u dva glavna ispitivanja koja su obuhvatila 1.446 bolesnika.
English: What is Norvir?
Croatian: Što je Norvir?
English: Norvir must not be used in patients who have severe problems with their liver or patients who are taking St John's wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Norvir and are harmful at high levels in the blood.
Croatian: Norvir se ne smije koristiti u bolesnika koji imaju ozbiljne probleme s jetrom ili bolesnicima koji uzimaju gospinu travu (biljni pripravak koji se koristi za liječenje depresije) ili lijekova koji se razgrađuju na isti način kao Norvir i štetni su u velikom koncentracijama u krvi.
English: Norvir is a medicine that contains the active substance ritonavir.
Croatian: Norvir je lijek koji sadrži djelatnu tvar ritonavir.
English: A risk management plan has been developed to ensure that Norvir is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Norvir.
English: When the active substance, ritonavir, acts as a ‘booster' it does so by slowing down the rate at which certain antiviral medicines given in combination with ritonavir are broken down in the body.
Croatian: Kada djelatna tvar, ritonavir, djeluje kao „booster“, ona usporava brzinu kojom tijelo razgrađuje određene antivirotike koji se daju u kombinaciji s ritonavirom.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Norvir, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Norvir nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Norvir is used in combination with other HIV medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: U kombinaciji s ostalim lijekovima protiv HIV-a, Norvir se koristi za liječenje bolesnika starijih od dvije godine zaraženih virusom humane imunodeficijencije tipa 1 (HIV 1), koji uzrokuje sindrom stečene imunodeficijencije (SIDA).
English: Why has Norvir been approved?
Croatian: Zašto je Norvir odobren?
English: What is the risk associated with Norvir?
Croatian: Koji su rizici povezani s lijekom Norvir?
English: Norvir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Norvir primijenjen u kombinaciji s drugim antivirusnim lijekovima smanjuje količinu HIV-a u krvi i održava je niskom.
English: The first compared Norvir with placebo (a dummy treatment) in 1,090 adults, as an add-on to the antiviral medicines the patients were already taking.
Croatian: Prvo je usporedilo lijek Norvir s placebom (lažnim liječenjem) u 1.090 odraslih osoba, kao dodatak antiviroticima koje su bolesnici već uzimali.
English: Treatment with Norvir should be given by a doctor who has experience in the treatment of HIV infection.
Croatian: Liječenje lijekom Norvir mora započeti liječnik s iskustvom u liječenju infekcija HIV-om.
English: In the second study, patients taking Norvir had greater reductions in viral load and increases in CD4 cell counts than those taking zidovudine alone.
Croatian: U drugom ispitivanju, bolesnici koji su uzimali lijek Norvir imali su veće smanjenje u virusnom opterećenju i povećanju u broju CD4 stanica u odnosu na one koji su uzimali samo zidovudin.
English: Norvir can also be used as an HIV medicine, where it acts directly against the virus.
Croatian: Norvir se može također koristiti kao lijek protiv HIV-a koji djeluje izravno protiv virusa.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom bolesnike, preporučena doza ovisi o površini tijela (izračunato pomoću visine i tjelesne težine bolesnika).
English: The CHMP decided that Norvir's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Norvir nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The effects of Norvir as an antiviral medicine in combination with other antiviral medicines were also studied in four studies of children.
Croatian: Djelovanje lijeka Norvir kao antivirotika u kombinaciji s drugim antiviroticima također je ispitano u četiri ispitivanja djece.