FrancophonIA/ELRC3.0 huggingface dataset:
English: Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioural signs or symptoms.
Croatian: Liječnici moraju uzeti u obzir pojavu PML-a u diferencijalnoj dijagnozi u bolesnika s novim ili pogoršanim neurološkim, kognitivnim ili bihevioralnim znakovima ili simptomima.
English: Progressive multifocal leukoencephalopathy (PML)
Croatian: Progresivna multifokalna leukoencefalopatija (PML)
English: PML was reported 6 months to several years after treatment with cladribine.
Croatian: Slučajevi PML-a prijavljeni su šest mjeseci do nekoliko godina nakon liječenja kladribinom.
English: Serious skin reactions
Croatian: Ozbiljne reakcije kože
English: Medicinal products concerned: cladribine-containing products authorised for oncology indications.
Croatian: Predmetni lijekovi: lijekovi koji sadrže kladribin odobreni za onkološke indikacije.
English: Some patients with spirochete infections may experience a Jarisch-Herxheimer reaction shortly after doxycycline treatment is started.
Croatian: U nekih bolesnika zaraženih spirohetama može se javiti Jarisch-Herxheimerova reakcija nedugo nakon početka liječenja doksiciklinom.
English: Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
Croatian: Liječnici bi trebali biti svjesni da se simptomi alergije mogu ponovno pojaviti nakon prekida simptomatske terapije.
English: Rare: skin eruption that is characterised by the rapid appearance of areas of red skin studded with small pustules (small blisters filled with white/yellow fluid).
Croatian: Rijetko: izbijanje kožnih promjena (erupcija) obilježeno brzom pojavom crvenih područja kože s malim pustulama (mali mjehurići ispunjeni bijelom/žutom tekućinom).
English: High anion gap metabolic acidosis is a serious disease that must have urgent treatment.
Croatian: Metabolička acidoza s povišenim anionskim procjepom ozbiljna je bolest koju treba hitno liječiti.
English: In case of AGEP diagnosis, acetazolamide should be discontinued and any subsequent administration of acetazolamide contraindicated.
Croatian: Ako se dijagnosticira AGEP, primjenu acetazolamida potrebno je prekinuti, a svaka naknadna primjena acetazolamida je kontraindicirana.
English: Suggested evaluation for PML includes neurology consultation, magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JC virus (JCV) DNA by polymerase chain reaction (PCR) or a brain biopsy with testing for JCV.
Croatian: Predložena dijagnostička obrada za utvrđivanje PML-a uključuje neurološki pregled, oslikavanje mozga pomoću magnetne rezonance, analizu cerebrospinalnog likvora na DNK JC virusa (JCV) metodom lančane reakcije polimerazom (PCR) ili biopsijom mozga s testiranjem na JCV.
English: Talk to your doctor <or> <pharmacist> <or nurse> before <taking> <using> <product name> At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.
Croatian: U bilo kojem trenutku za vrijeme ili nakon liječenja, odmah obavijestite svog liječnika ili medicinsku sestru ako: vam se pojavi zamagljen vid, gubitak vida ili dvostruka slika, poteškoće u govoru, slabost u ruci ili nozi, promjene u načinu hoda ili problemi s ravnotežom, trajna utrnulost, smanjen osjet ili gubitak osjeta, gubitak pamćenja ili smetenost.
English: If flucloxacillin is continued after cessation of paracetamol, it is advisable to ensure that there are no signals of HAGMA, as there is a possibility of flucloxacillin maintaining the clinical picture of HAGMA (see section 4.5).
Croatian: Ako se liječenje flukloksacilinom nastavi nakon prekida primjene paracetamola, uputno je utvrditi da ne postoje znakovi HAGMA-e, jer je moguće da flukloksacilin održava kliničku sliku HAGMA-e (vidjeti dio 4.5).
English: If symptoms or signs of AGEP, SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, roxithromycin treatment should be discontinued.
Croatian: Ako su prisutni simptomi ili znakovi AGEP-a, SJS-a ili TEN-a (npr. progresivni kožni osip često s mjehurićima ili mukoznim lezijama), potrebno je prekinuti liječenje roksitromicinom.
English: Metabolism and nutrition disorders Frequency ‘not known': increased appetite
Croatian: Poremećaji metabolizma i prehrane Učestalost „nepoznata”: povećan apetit
English: As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported.
Croatian: Kao i s drugim makrolidima, prijavljene su rijetke ozbiljne alergijske reakcije, uključujući akutnu generaliziranu egzantematoznu pustulozu (AGEP).
English: Desloratadine; loratadine - Weight increased in children (EPITT no 18906)
Croatian: Desloratadin; loratadin - povećana tjelesna težina u djece (EPITT br. 18906)
English: Cladribine - Progressive multifocal leukoencephalopathy (PML) (EPITT no 18875)
Croatian: Kladribin - progresivna multifokalna leukoencefalopatija (PML) (EPITT br. 18875)
English: Patients at high risk for HAGMA are in particular those with severe renal impairment, sepsis or malnutrition especially if the maximum daily doses of paracetamol are used.
Croatian: Posebno su visokom riziku od HAGMA-e izloženi bolesnici s teškim oštećenjem bubrega, sepsom ili pothranjeni bolesnici, osobito ako se primjenjuju maksimalne dnevne doze paracetamola.
English: Loratadine
Croatian: Loratadin
English: Frequency ‘not known': weight increased, increased appetite
Croatian: Učestalost „nepoznata”: povećana tjelesna težina, povećan apetit
English: This occurs shortly after starting doxycycline treatment for infections with spirochete such as Lyme disease.
Croatian: Do toga dolazi nedugo nakon što se infekcije spirohetama poput lajmske bolesti počnu liječiti doksiciklinom.
English: Cases of PML, including fatal cases, have been reported with cladribine.
Croatian: Pri primjeni kladribina prijavljeni su slučajevi PML-a, uključujući slučajeve sa smrtnim ishodom.
English: Contact a doctor immediately if you experience a serious skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis).
Croatian: Odmah se obratite liječniku ako imate ozbiljne reakcije kože: crveni, ljuskasti osip s izbočinama ispod kože i mjehurićima (egzantematozna pustuloza).
English: What you need to know before taking <product name> Warnings and precautions
Croatian: Što morate znati prije nego počnete <uzimati> <primjenjivati> <naziv lijeka> Upozorenja i mjere opreza
English: Severe bullous reactions
Croatian: Ozbiljne kožne reakcije
English: If a widespread, severe skin rash occurs, including skin blistering or peeling, as well as signs of flu and fever (Stevens-Johnson syndrome), a general unwell feeling, fever, chills and muscle aches (toxic epidermal necrolysis), or a red, scaly rash with bumps under the skin and blisters (acute generalised exanthematous pustulosis), refer to a doctor immediately since these skin effects may be lifethreatening.
Croatian: Ako se pojavi široko rasprostranjen teški kožni osip uključujući mjehuriće na koži ili ljuštenje kože, kao i znakovi gripe i vrućice (Stevens-Johnsonov sindrom), opće loše osjećanje, vrućica, zimica i bolovi u mišićima (toksična epidermalna nekroliza) ili crveni, ljuskasti osip s izbočinama ispod kože i mjehurićima (akutna generalizirana egzantematozna pustuloza), odmah se javite liječniku jer ti učinci na kožu mogu biti opasni po život.
English: As with erythromycin and other macrolides, rare serious allergic reactions, including angioneurotic oedema and anaphylaxis (rarely fatal), dermatologic reactions including acute generalised exanthematous pustulosis (AGEP), Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (rarely fatal) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported.
Croatian: Kao s eritromicinom i drugim makrolidima, prijavljene su rijetke ozbiljne alergijske reakcije, uključujući angioneurotski edem i anafilaksiju (rijetko sa smrtnim ishodom), dermatološke reakcije uključujući akutnu generaliziranu egzantematoznu pustulozu (AGEP), Stevens-Johnsonov sindrom (SJS), toksičnu epidermalnu nekrolizu (TEN) (rijetko sa smrtnim ishodom) i reakciju na lijek s eozinofilijom i sistemskim simptomima (DRESS).
English: What you need to know before you take <product name>
Croatian: Što morate znati prije uzimanja <naziv lijeka>
English: Azithromycin; clarithromycin; erythromycin; roxithromycin - Acute generalised exanthematous pustulosis (AGEP) (EPITT no 18891)
Croatian: Azitromicin; klaritromicin; eritromicin; roksitromicinakutna generalizirana egzantematozna pustuloza (AGEP) (EPITT br. 18891)
English: If any of the side effects listed below occur, contact your doctor as soon as possible: - the Jarisch-Herxheimer reaction which causes fever, chills, headache, muscle pain, and skin rash that is usually self-limiting.
Croatian: Obratite se svom liječniku što prije ako razvijete neku od nuspojava navedenih u nastavku: - Jarisch-Herxheimerova reakcija koja uzrokuje vrućicu, zimicu, glavobolju, bol u mišićima i kožni osip koji je obično samoograničavajući.
English: Desloratadine
Croatian: Desloratadin
English: There is a risk of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used concomitantly with paracetamol, particularly in certain groups of patients at risk, e.g. patients with severe renal impairment, sepsis or malnutrition, especially if the maximum daily doses of paracetamol are used.
Croatian: Postoji rizik od poremećaja krvi i tekućina (metabolička acidoza s povišenim anionskim procjepom) do kojeg dolazi pri povećanju kiselosti plazme kod istodobne primjene flukloksacilina i paracetamola, posebno u određenim skupinama bolesnika izloženih riziku, npr. u bolesnika s teškim oštećenjem bubrega, sepsom ili u pothranjenih bolesnika, osobito ako se primjenjuju maksimalne dnevne doze paracetamola.
English: Acetazolamide - Acute generalised exanthematous pustulosis (AGEP) (EPITT no 18892)
Croatian: Acetazolamid - akutna generalizirana egzantematozna pustuloza (AGEP) (EPITT br. 18892)
English: Doxycycline - Doxycycline induced Jarisch-Herxheimer reaction (EPITT no 18937)
Croatian: Doksiciklin - Jarisch-Herxheimerova reakcija izazvana doksiciklinom (EPITT br. 18937)
English: Frequency ‘not known': weight increased
Croatian: Učestalost „nepoznata”: povećana tjelesna težina
English: After co-administration of flucloxacillin and paracetamol, a close monitoring is recommended in order to detect the appearance of acid-base disorders, namely HAGMA, including the search of urinary 5oxoproline.
Croatian: Preporučuje se pomno praćenje bolesnika nakon istodobne primjene flukloksacilina i paracetamola kako bi se otkrila pojava poremećaja acidobazne ravnoteže, to jest HAGMA-e, uključujući pretragu na 5-oksoprolin u urinu.
English: Additional follow-up and evaluation may be warranted if no alternative diagnosis can be established.
Croatian: Ako se ne ustanovi druga dijagnoza, daljnje praćenje i procjenjivanje bolesnika može biti opravdano.
English: An association with prolonged lymphopenia has been reported in several of these cases.
Croatian: U nekoliko od tih slučajeva prijavljena je povezanost s produljenom limfopenijom.
English: Skin and subcutaneous tissue disorders Rare: acute generalised exanthematous pustulosis (AGEP)
Croatian: Poremećaji kože i potkožnog tkiva Rijetko: akutna generalizirana egzantematozna pustuloza (AGEP)
English: The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthematous pustulosis (AGEP) (see section 4.8).
Croatian: Posebna upozorenja i mjere opreza pri uporabi Generalizirani eritem s pustulama praćen vrućicom koji se javlja na početku liječenja može biti simptom akutne generalizirane egzantematozne pustuloze (AGEP) (vidjeti dio 4.8).
English: Flucloxacillin - High anion gap metabolic acidosis (HAGMA) (EPITT no 18844)
Croatian: Flukloksacilin - metabolička acidoza s povišenim anionskim procjepom (HAGMA) (EPITT br. 18844)
English: Very rare cases of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used concomitantly with paracetamol, generaly in the presence of risk factors (see section 2).
Croatian: Vrlo rijetki slučajevi poremećaja krvi i tekućina (metabolička acidoza s povišenim anionskim procjepom) do kojeg dolazi pri povećanju kiselosti plazme kod istodobne primjene flukloksacilina i paracetamola, uglavnom uz prisutnost čimbenika rizika (vidjeti dio 2.).
English: Post marketing experience: very rare cases of high anion gap metabolic acidosis, when flucloxacillin is used concomitantly with paracetamol, generaly in the presence of risk factors (see section 4.4.)
Croatian: Iskustvo nakon stavljanja lijeka u promet: vrlo rijetki slučajevi metaboličke acidoze s povišenim anionskim procjepom pri istodobnoj primjeni flukloksacilina i paracetamola, uglavnom uz prisutnost čimbenika rizika (vidjeti dio 4.4)
English: Erythromycin
Croatian: Eritromicin
English: Caution is advised when flucloxacillin is administered concomitantly with paracetamol due to the increased risk of high anion gap metabolic acidosis (HAGMA).
Croatian: Potreban je oprez pri istodobnoj primjeni flukloksacilina i paracetamola zbog povećanog rizika od metaboličke acidoze s povišenim anionskim procjepom (engl. high anion gap metabolic acidosis, HAGMA).
English: Azithromycin
Croatian: Azitromicin
English: Not known: acute generalised exanthematous pustulosis (AGEP)
Croatian: Nepoznato: akutna generalizirana egzantematozna pustuloza (AGEP)
English: Clarithromycin
Croatian: Klaritromicin
English: Cases of severe bullous skin reactions such as Stevens Johnson syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis (AGEP), have been reported with roxithromycin.
Croatian: Pri primjeni roksitromicina prijavljeni su slučajevi teških buloznih kožnih reakcija poput StevensJohnsonovog sindroma, toksične epidermalne nekrolize i akutne generalizirane egzantematozne pustuloze (AGEP).
English: Acute generalised exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome, toxic epidermal necrolysis and drug rash with eosinophilia and systemic symptoms (DRESS)), clarithromycin therapy should be discontinued immediately and appropriate treatment should be urgently initiated.
Croatian: U slučaju teških akutnih reakcija preosjetljivosti, poput anafilaksije, teških kožnih nuspojava (SCAR, engl. severe cutaneous adverse reactions) (npr. akutna generalizirana egzantematozna pustuloza (AGEP), Stevens-Johnsonov sindrom, toksična epidermalna nekroliza i reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS)), potrebno je odmah prekinuti terapiju klaritromicinom i hitno započeti s odgovarajućim liječenjem.
English: Patients with suspected PML should not receive further treatment with cladribine.
Croatian: Daljnje liječenje kladribinom treba obustaviti u bolesnika u kojih postoji sumnja na PML.
English: Roxithromycin
Croatian: Roksitromicin
English: What you need to know before you <take> <use> <product name>
Croatian: <ili medicinskoj sestri> prije nego <uzmete> <primijenite> <naziv lijeka>
English: Interaction with other medicinal products and other forms of interaction Caution should be taken when flucloxacillin is used concomitantly with paracetamol as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risk factors.
Croatian: Potreban je oprez pri istodobnoj primjeni flukloksacilina i paracetamola jer je istodobno uzimanje tih lijekova povezano s metaboličkom acidozom s povišenim anionskim procjepom, posebno u bolesnika u kojih su prisutni čimbenici rizika. (vidjeti dio 4.4)
English: This summary was last updated in 10-2014.
Croatian: Ovaj sažetak je posljednji put ažuriran u 10.2014.
English: Side effects are similar in children and adolescents.
Croatian: Nuspojave su slične kod djece i adolescenata.
English: The full EPAR for Prezista can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Prezista nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prezista on 12 February 2007.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Prezista na snazi u Europskoj uniji od 12. veljače 2007.
English: What measures are being taken to ensure the safe and effective use of Prezista?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Prezista?
English: When the enzyme is blocked, the virus does not reproduce normally and its rate of replication slows down.
Croatian: Kad je enzim blokiran, virus se ne razmnožava na normalan način, a njegova stopa replikacije se smanjuje.
English: It is available as tablets (75, 150, 300, 400, 600, and 800 mg) and as an oral suspension (100 mg/ml).
Croatian: Dostupan je u obliku tableta (75, 150, 300, 400, 600 i 800 mg) te kao oralna suspenzija (100 mg/ml).
English: Other information about Prezista
Croatian: Ostale informacije o lijeku Prezista
English: This allows a lower dose of darunavir to be used for the same antiviral effect.
Croatian: To omogućava upotrebu niže doze darunavira za isti antivirusni učinak.
English: The 300- and 600-mg tablets contain a colouring agent called sunset yellow (E110), which can cause allergies.
Croatian: Tablete od 300 i 600 mg sadrže boju zvanu sunset yellow (E110) koja može uzrokovati alergije.
English: It blocks an enzyme called protease, which is involved in the reproduction of HIV.
Croatian: Blokira enzim zvani proteaza koji je uključen u reprodukciju HIV-a.
English: Immune reconstitution syndrome happens when the patient's immune system starts working again and fights existing infections, causing inflammation at the site of the infection.
Croatian: Sindrom imune rekonstitucije događa se kad bolesnikov imunosni sustav počinje opet funkcionirati i boriti se protiv postojećih infekcija, što uzrokuje upalu na mjestu infekcije.
English: Prezista does not cure HIV infection or AIDS, but it may delay or reverse the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Prezista ne liječi infekciju HV-om ili AIDS, ali može odgoditi ili obrnuti oštećenje imunosnog sustava i razvoj infekcija i bolesti povezanih s AIDS-om.
English: Treatment with Prezista should be started by a healthcare professional who has experience in the management of HIV infection.
Croatian: Liječenje Prezistom treba započeti zdravstveni djelatnik koji ima iskustva u liječenju HIV infekcija.
English: Patients who are allergic to this agent may need to take the lower strength tablets, which do not contain sunset yellow.
Croatian: Bolesnici koji su alergični na ovaj agens možda će trebati uzimati tablete slabije jačine koje ne sadržavaju boju sunset yellow.
English: This is a summary of the European public assessment report (EPAR) for Prezista.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Prezista.
English: What is Prezista?
Croatian: Što je Prezista?
English: A risk management plan has been developed to ensure that Prezista is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Prezista.
English: The main measures of effectiveness were based on the change in HIV levels in the blood (viral load).
Croatian: Glavne mjere djelotvornosti temeljile su se na promjeni u razinama HIV-a u krvi (virusno opterećenje).
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 Prezista.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek Prezista da bi donio svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za njegovu primjenu.
English: Either ritonavir or cobicistat is used with Prezista as a ‘booster'.
Croatian: Ritonavir ili cobicistat se koriste s lijekom Prezista kao „pojačivači”.
English: In adults who had not been treated before, Prezista was as effective as lopinavir.
Croatian: Kod odraslih bolesnika koji nisu prethodno liječeni, lijek Prezista bio je jednako djelotvoran kao i lopinavir.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Prezista, 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 Prezista nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: What is the risk associated with Prezista?
Croatian: Koji su rizici povezani s lijekom Prezista?
English: Prezista must not be taken by patients who have severely reduced liver function, or who are taking certain other medicines which may decrease blood levels of darunavir, ritonavir or cobicistat, and therefore cause a lack of effect.
Croatian: Lijek Prezista ne smiju uzimati bolesnici s ozbiljnim smanjenjem funkcije jetre ili oni koji uzimaju određene druge lijekove koji mogu smanjiti razine darunavira, ritonavira ili cobicistata u krvi te tako prouzročiti izostanak djelovanja.
English: In all of the studies, the patients also took other HIV medicines.
Croatian: U svim ispitivanjima bolesnici su također uzimali druge lijekove protiv HIV-a.
English: These booster medicines slow the rate at which darunavir is broken down, increasing the levels of darunavir in the blood.
Croatian: Ti lijekovi pojačivači usporavaju brzinu razgradnje darunavira te tako povećavaju razinu darunavira u krvi.
English: For more information about treatment with Prezista, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Prezista pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: In adults, Prezista has been studied in six main studies.
Croatian: Kod odraslih bolesnika lijek Prezista ispitivan je u pet glavnih ispitivanja.
English: In adults, the most common side effects with Prezista are diarrhoea, ‘immune reconstitution syndrome', nausea (feeling sick), pyrexia (fever) and rash.
Croatian: Kod odraslih osoba, najčešće nuspojave s lijekom Prezista su proljev, „sindrom imunosne rekonstitucije”, mučnina, pireksija (vrućica) i osip.
English: A dose of 800 mg once a day can also be taken by previously treated patients, provided that the patients are healthy enough and that the HIV virus causing their infection has been shown not to be resistant to Prezista.
Croatian: Dozu od 800 mg jednom na dan također mogu uzimati prethodno liječeni bolesnici pod uvjetom da su dovoljno zdravi i da virus HIVa koji uzrokuje njihovu infekciju nije rezistentan na Prezistu.
English: The medicine is always taken with cobicistat (in adults) or with low-dose ritonavir (in adults and children) plus other HIV medicines, and should be taken with food.
Croatian: Lijek se uvijek uzima s cobicistatom (u odraslih bolesnika) ili niskom dozom ritonavira (u odraslih bolesnika i djece) te drugim lijekovima protiv HIV-a, a treba ga uzimati uz obrok.
English: Prezista, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Prezista, u kombinaciji s drugim lijekovima protiv HIV-a, smanjuje količinu HIV-a u krvi i održava je niskom.