FrancophonIA/ELRC3.0 huggingface dataset:
English: General disorders and administration site conditions fever chills, catheter site pain
Croatian: Opći poremećaji i reakcije na mjestu primjene vrućica zimica, bol na mjestu katetera
English: Respiratory, thoracic and mediastinal disorders dyspnoea nasal congestion, pharyngolaryngeal pain, tachypnoea, bronchospasm, cough, dyspnoea paroxysmal nocturnal, hypoxia, rales, wheezing
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja kongestija nosa, faringolaringealna bol, tahipneja, bronhospazam, kašalj, paroksizmalna noćna dispneja, hipoksija, krepitacije, piskanje
English: Remove the volume of medicine equal to the calculated loading dose (Step 1) from the vial.
Croatian: Izvucite iz bočice volumen lijeka jednak izračunatoj udarnoj dozi (Korak 1).
English: What Caspofungin Accord is
Croatian: Što je Caspofungin Accord
English: Gastrointestinal disorders nausea, diarrhoea, vomiting abdominal pain, abdominal pain upper, dry mouth, dyspepsia, stomach discomfort, abdominal distension, ascites, constipation, dysphagia, flatulence
Croatian: Poremećaji probavnog sustava mučnina, proljev, povraćanje bol u abdomenu, bol u gornjem dijelu abdomena, suha usta, dispepsija, nelagoda u želucu, distenzija abdomena, ascites, konstipacija, disfagija, flatulencija
English: Hepatic impairment: In adult patients with mild and moderate hepatic impairment, the AUC is increased about 20 and 75 %, respectively.
Croatian: Oštećenje funkcije jetre: u odraslih bolesnika s blagim oštećenjem funkcije jetre AUC se povećala za oko 20%, a u onih s umjerenim oštećenjem funkcije jetre za 75%.
English: When caspofungin is co-administered to paediatric patients (12 months to 17 years of age) with these same inducers of metabolic enzymes (see section 4.5), a caspofungin dose of 70-mg/m2 daily (not to exceed an actual daily dose of 70 mg)
Croatian: Kad se kaspofungin u pedijatrijskih bolesnika (u dobi od 12 mjeseci do 17 godina) istodobno primjenjuje s istim induktorima metaboličkih enzima (vidjeti dio 4.5) potrebno je razmotriti primjenu doze kaspofungina od 70 mg/m2
English: Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller3 Formula)
Croatian: Prije pripreme infuzije izračunajte površinu tijela (PT) bolesnika pomoću sljedeće formule: (Mostellerova3 formula)
English: Caspofungin Accord 70 mg powder for concentrate for solution for infusion 10 mL Type I clear glass vial with bromobutyl rubber stopper and orange aluminium seal with transparent plastic flip off button.
Croatian: Caspofungin Accord 70 mg prašak za koncentrat za otopinu za infuziju Prozirna bočica od 10 ml, staklo tipa I, s čepom od bromobutilne gume i narančastim aluminijskim zatvaračem s prozirnom plastičnom „flip-off“ kapicom.
English: b. Visually inspect the reconstituted solution for particulate matter or discolouration during reconstitution and prior to infusion.
Croatian: Vizualno provjerite rekonstituiranu otopinu kako biste utvrdili da ne sadrži vidljive čestice ili da nije promijenila boju tijekom rekonstitucije i prije infuzije.
English: Clinical studies in healthy adult volunteers show that the pharmacokinetics of caspofungin are not altered to a clinically relevant extent by itraconazole, amphotericin B, mycophenolate, nelfinavir, or tacrolimus.
Croatian: Klinička ispitivanja u zdravih odraslih dobrovoljaca pokazuju da itrakonazol, amfotericin B, mikofenolat, nelfinavir i takrolimus ne mijenjaju farmakokinetiku kaspofungina u mjeri koja bi bila klinički značajna.
English: Skin and subcutaneous tissue disorders rash, pruritus, erythema, hyperhidrosis erythema multiforme, rash macular, rash maculo-papular, rash pruritic, urticaria, dermatitis allergic, pruritus generalised, rash erythematous, rash generalised, rash morbilliform, skin lesion
Croatian: Poremećaji kože i potkožnog tkiva osip, svrbež, eritem, hiperhidroza multiformni eritem, makularni osip, makulopapularni osip, pruritični osip, urtikarija, alergijski dermatitis, generalizirani pruritus, eritematozni osip, generalizirani osip, morbiliformni osip, kožne lezije toksična epidermalna nekroliza i StevensJohnsonov sindrom (vidjeti dio 4.4).
English: DO NOT USE ANY DILUENTS CONTAINING GLUCOSE, as Caspofungin Accord is not stable in diluents containing glucose.
Croatian: NE KORISTITE OTAPALA KOJA SADRŽE GLUKOZU jer Caspofungin Accord nije stabilan u otopinama koje sadrže glukozu.
English: Cases of Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported after post-marketing use of caspofungin.
Croatian: Nakon stavljanja kaspofungina u promet prijavljeni su slučajevi Stevens-Johnsonovog sindroma (SJS) i toksične epidermalne nekrolize (TEN).
English: In adult patients with mild and moderate hepatic impairment, the AUC is increased about 20% and 75 %, respectively.
Croatian: U odraslih bolesnika s blagim oštećenjem jetre AUC je povećana oko 20%, a u bolesnika s umjerenim oštećenjem jetre oko 75%.
English: Caspofungin Accord 50 mg powder for concentrate for solution for infusion 10 mL Type I clear glass vial with bromobutyl rubber stopper and red aluminium seal with transparent plastic flip off button.
Croatian: Caspofungin Accord 50 mg prašak za koncentrat za otopinu za infuziju Prozirna bočica od 10 ml, staklo tipa I, s čepom od bromobutilne gume i crvenim aluminijskim zatvaračem s prozirnom plastičnom „flip-off“ kapicom.
English: Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller2 Formula)
Croatian: Prije pripreme infuzije, izračunajte površinu tijela (PT) bolesnika pomoću sljedeće formule: (Mostellerova2 formula)
English: How Caspofungin Accord works
Croatian: Kako Caspofungin Accord djeluje
English: Visually inspect the infusion solution for particulate matter or discolouration.
Croatian: Vizualno provjerite infuzijsku otopinu da ne sadrži vidljive čestice ili da nije promijenila boju.
English: Weight: Weight was found to influence caspofungin pharmacokinetics in the population pharmacokinetic analysis in adult candidiasis patients.
Croatian: Tjelesna težina: ispitivanja farmakokinetike u bolesnika s kandidijazom pokazala su da tjelesna težina utječe na farmakokinetiku kaspofungina.
English: Close monitoring of liver enzymes should be considered if caspofungin and cyclosporin are used concomitantly.
Croatian: Pri istodobnoj primjeni kaspofungina i ciklosporina potrebno je pozorno pratiti jetrene enzime.
English: • Chills
Croatian: (kg)
English: Metabolism and nutrition disorders hypokalemia fluid overload, hypomagnesaemia, anorexia, electrolyte imbalance, hyperglycaemia, hypocalcaemia, metabolic acidosis
Croatian: prehrane neravnoteža elektrolita, hiperglikemija, hipokalcemija, metabolička acidoza
English: Close monitoring of liver enzymes should be considered if the two medicinal products are used concomitantly.
Croatian: Pri istodobnoj primjeni ova dva lijeka potrebno je pozorno pratiti jetrene enzime.
English: In young children and toddlers (ages 12 to 23 months) receiving caspofungin at 50 mg/m2 daily
Croatian: U male djece (u dobi od 12 do 23 mjeseca), koja su primala kaspofungin u dozi od 50 mg/m2 na dan
English: DO NOT USE ANY DILUENTS CONTAINING GLUCOSE as CASPOFUNGIN ACCORD is not stable in diluents containing glucose.
Croatian: NE KORISTITE OTAPALA KOJA SADRŽE GLUKOZU jer CASPOFUNGIN ACCORD nije stabilan u otopinama koje sadrže glukozu.
English: Limited data suggest that less common non-Candida yeasts and non-Aspergillus moulds are not covered by caspofungin.
Croatian: Ograničeni podaci pokazuju da kaspofungin nije prikladna terapija za rjeđe sojeve kvasaca koji nisu iz roda Candida i plijesni koje nisu iz roda Aspergillus.
English: Reconstitution of Caspofungin Accord
Croatian: Rekonstitucija lijeka Caspofungin Accord
English: There is no clinical experience in adult patients with severe hepatic impairment and in paediatric patients with any degree of hepatic impairment.
Croatian: Ne postoji kliničko iskustvo s primjenom kaspofungina u odraslih bolesnika s teškim oštećenjem funkcije jetre, kao ni u pedijatrijskih bolesnika s bilo kojim stupnjem oštećenja funkcije jetre.
English: Among patients with candidaemia, favourable response rates at the end of IV study therapy were comparable for caspofungin (72 % [66/92]) and amphotericin B (63 % [59/94]) in the primary efficacy analysis (MITT analysis) [% difference 10.0 (95.0 % CI -4.5, 24.5)].
Croatian: Na kraju ispitivanja intravenske terapije primarna analiza djelotvornosti (MITT analiza) pokazala je da je stopa povoljnog odgovora na kaspofungin (72% [66/92]) u bolesnika s kandidemijom bila usporediva s onom na amfotericin B (63% [59/94]) [% razlike 10,0 (95,0% CI, -4,5, 24,5)].
English: • Belly pain, upper belly pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, passing gas, stomach discomfort, swelling due to build-up of fluid around the belly
Croatian: • Bolovi u trbuhu, bolovi u gornjem dijelu trbuha, nadutost, zatvor, otežano gutanje, suha usta, probavne tegobe, vjetrovi, nelagoda u trbuhu, oticanje zbog nakupljanja tekućine oko trbuha
English: 35 mg for moderate hepatic impairment (from one 70 mg vial)
Croatian: 35 mg pri umjerenom oštećenju funkcije jetre (iz jedne bočice od 70 mg)
English: Caspofungin Accord 70 mg powder for concentrate for solution for infusion Each vial contains 70 mg caspofungin (as acetate).
Croatian: Caspofungin Accord 70 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 70 mg kaspofungina (u obliku kaspofunginacetata).
English: Reconstituted solutions should be visually inspected for particulate matter or discolouration.
Croatian: Rekonstituiranu otopinu morate vizualno provjeriti da ne sadrži vidljive čestice ili da nije promijenila boju.
English: Sodium hydroxide (to adjust the pH)
Croatian: 6.1 Popis pomoćnih tvari saharoza manitol sukcinatna kiselina natrijev hidroksid (za podešavanje pH)
English: These limited data are supported by the outcome of the empirical therapy study.
Croatian: Ishod ispitivanja empirijskog liječenja u skladu je s ovim podacima.
English: Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller Formula)
Croatian: Prije pripreme infuzije izračunajte površinu tijela (PT) bolesnika pomoću sljedeće formule: (Mostellerova formula)
English: Determine the actual daily maintenance dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation:
Croatian: Odredite stvarnu dnevnu dozu održavanja koja će se primjenjivati u pedijatrijskog bolesnika koristeći površinu tijela bolesnika (izračunatu prema gornjoj formuli) i sljedeću jednadžbu: PT (m2) × 50 mg/m2 = dnevna doza održavanja
English: 35 mg for moderate hepatic impairment (from one 50 mg vial)
Croatian: 35 mg pri umjerenom oštećenju funkcije jetre (iz jedne bočice od 50 mg)
English: When co-administering inducers of metabolic enzymes, an increase in the daily dose of caspofungin to 70 mg, following the 70 mg loading dose, should be considered in adult patients (see section 4.2).
Croatian: Kad se u odraslih bolesnika istodobno primjenjuju induktori metaboličkih enzima, nakon udarne doze od 70 mg, potrebno je razmotriti povišenje doze kaspofungina na 70 mg jedanput na dan (vidjeti dio 4.2).
English: Stringent definitions, modelled after the Mycoses Study Group Criteria, were used for diagnosis of invasive aspergillosis and for response to therapy (favourable response required clinically significant improvement in radiographs as well as in signs and symptoms).
Croatian: Dijagnoza invazivne aspergiloze i odgovor na liječenje (povoljnim odgovorom smatralo se klinički značajno poboljšanje s radiografskom potvrdom, kao poboljšanje znakova i simptoma) bili su strogo definirani prema mjerilima Skupine za ispitivanje mikoza (engl., Mycoses Study Group Criteria).
English: Do not mix with diluents containing glucose, as Caspofungin Accord is not stable in diluents containing glucose.
Croatian: Ne smije se miješati s otapalima koja sadrže glukozu jer Caspofungin Accord nije stabilan u otopinama koje sadrže glukozu.
English: Uncommon (≥1/1,000 to <1/100)
Croatian: Manje često (≥1/1000 i
English: INSTRUCTIONS FOR USE IN ADULT PATIENTS (Caspofungin Accord 50 mg)
Croatian: UPUTE ZA UPORABU U ODRASLIH BOLESNIKA (Caspofungin Accord 50 mg)
English: Step 2 Addition of reconstituted Caspofungin Accord to patient infusion solution Diluents for the final solution for infusion are: sodium chloride solution for injection 9 mg/mL, or lactated Ringer's solution should be used.
Croatian: Otapala koja se moraju koristiti za pripremu konačne otopine za infuziju su: otopina natrijevog klorida za injekcije od 9 mg/ml ili Ringerova otopina s laktatom.
English: How to store Caspofungin Accord
Croatian: Kako primjenjivati Caspofungin Accord
English: Caspofungin Accord 50 mg powder for concentrate for solution for infusion Caspofungin Accord 70 mg powder for concentrate for solution for infusion
Croatian: Caspofungin Accord 50 mg prašak za koncentrat za otopinu za infuziju Caspofungin Accord 70 mg prašak za koncentrat za otopinu za infuziju
English: Caspofungin Accord 50 mg powder for concentrate for solution for infusion Caspofungin Accord 70 mg powder for concentrate for solution for infusion caspofungin
Croatian: Caspofungin Accord 50 mg prašak za koncentrat za otopinu za infuziju Caspofungin Accord 70 mg prašak za koncentrat za otopinu za infuziju kaspofungin
English: Eye disorders ocular icterus, vision blurred, eyelid oedema, lacrimation increased
Croatian: Poremećaji oka očni ikterus, zamagljen vid, edem vjeđa, pojačano suzenje
English: INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS (Caspofungin Accord 70 mg)
Croatian: UPUTE ZA UPORABU U PEDIJATRIJSKIH BOLESNIKA (Caspofungin Accord 70 mg)
English: Distribution, rather than excretion or biotransformation, is the dominant mechanism influencing plasma clearance.
Croatian: Glavni mehanizam koji utječe na klirens iz plazme je raspodjela, a ne izlučivanje ili biotransformacija.
English: Paediatric Patients: In adolescents (ages 12 to 17 years) receiving caspofungin at 50 mg/m2 daily (maximum 70 mg daily),
Croatian: U adolescenata (u dobi od 12 do 17 godina), koji su primali kaspofungin u dozi od 50 mg/m2 na dan
English: What Caspofungin Accord is used for
Croatian: Za što se Caspofungin Accord koristi
English: INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS (Caspofungin Accord 50 mg)
Croatian: UPUTE ZA UPORABU U PEDIJATRIJSKIH BOLESNIKA (Caspofungin Accord 50 mg)
English: For caspofungin, there were no effects on fertility in studies conducted in male and female rats up to 5 mg/kg/day.
Croatian: Primjena kaspofungina u dozi od 5 mg/kg/dan u istraživanjima provedenim na mužjacima i ženkama štakora nije utjecala na plodnost.
English: The first study, which enrolled 82 patients between 2 to 17 years of age, was a randomized, doubleblind study comparing caspofungin (50 mg/m2 IV once daily following a 70-mg/m2 loading dose on
Croatian: Prvo ispitivanje, koje je uključivalo 82 bolesnika u dobi od 2 do 17 godina, bilo je randomizirano, dvostruko slijepo ispitivanje u kojem se kaspofungin (50 mg/m2 i.v. jedanput na dan nakon udarne doze od 70 mg/m2 prvog dana [doza nije smjela biti veća od 70 mg na dan]) uspoređivao s liposomalnim amfotericinom B (3 mg/kg i.v. na dan) u omjeru 2:1 (56 bolesnika primalo je kaspofungin, a 26 liposomalni amfotericin B) u empirijskom liječenju pedijatrijskih bolesnika s perzistentnom vrućicom i neutropenijom.
English: Caspofungin was negative in in vitro assays for potential genotoxicity as well as in the in vivo mouse bone marrow chromosomal test. No long-term studies in animals have been performed to evaluate the carcinogenic potential.
Croatian: Rezultati in vitro ispitivanja potencijalne genotoksičnosti kaspofungina bili su negativni, kao i rezultati in vivo kromosomskog testa na koštanoj srži miša.
English: the caspofungin plasma AUC0-24 hr was generally comparable to that seen in adults receiving caspofungin at 50 mg daily.
Croatian: (maksimalno 70 mg na dan) AUC0-24 h kaspofungina u plazmi bila je općenito usporediva s onom kakva je uočena u odraslih osoba koje su primale kaspofungin u dozi od 50 mg na dan.
English: Vascular disorders phlebitis thrombophlebitis, flushing, hot flush, hypertension, hypotension
Croatian: Krvožilni poremećaji flebitis tromboflebitis, crvenilo uz osjećaj vrućine, navale vrućine, hipertenzija, hipotenzija
English: c. Caspofungin Accord is formulated to provide the full labelled vial dose (70 mg) when 10 mL is withdrawn from the vial.
Croatian: Caspofungin Accord je pripravljen tako da se izvlačenjem 10 ml iz bočice sigurno dobije puna doza navedena na naljepnici bočice (70 mg).
English: Two hundred twenty-four patients were included in the primary efficacy analysis (MITT analysis) of response at the end of IV study therapy; favourable response rates for the treatment of invasive candidiasis were comparable for caspofungin (73 % [80/109]) and amphotericin B (62 % [71/115]) [% difference 12.7 (95.6 % CI -0.7, 26.0)].
Croatian: Stopa povoljnog odgovora invazivne kandidijaze na liječenje kaspofunginom (73% [80/109]) mogla se usporediti sa stopom za amfotericin B (62% [71/115]) [% razlike 12,7 (95,6 % CI, -0,7, 26,0)].
English: Caspofungin Accord 70 mg powder for concentrate caspofungin
Croatian: Caspofungin Accord 70 mg prašak za koncentrat kaspofungin i.v. primjena
English: In neonates and infants (<3 months) receiving caspofungin at 25 mg/m2 daily (corresponding mean daily dose of 2.1 mg/kg), caspofungin peak concentration (C1 hr) and caspofungin trough concentration (C24 hr) after multiple doses were comparable to that seen in adults receiving caspofungin at 50 mg daily.
Croatian: (što odgovara prosječnoj dnevnoj dozi od 2,1 mg/kg), vršna koncentracija kaspofungina (C1 h) i najniža koncentracija kaspofungina (C24 h) nakon višekratnih doza bile su usporedive s onima primijećenima u odraslih koji su primali kaspofungin u dozi od 50 mg na dan.
English: c. Caspofungin Accord is formulated to provide the full labeled vial dose (50 mg) when 10 mL is withdrawn from the vial.
Croatian: Caspofungin Accord je pripravljen tako da se izvlačenjem 10 ml iz bočice sigurno dobije puna doza navedena na naljepnici bočice (50 mg).
English: A reduction of the daily dose to 35 mg is recommended for adults with moderate hepatic impairment.
Croatian: U odraslih bolesnika s umjerenim oštećenjem funkcije jetre preporučuje se snižavanje dnevne doze na 35 mg.
English: Caspofungin Accord 50 mg powder for concentrate caspofungin
Croatian: Caspofungin Accord 50 mg prašak za koncentrat kaspofungin i.v. primjena
English: INSTRUCTIONS FOR USE IN ADULT PATIENTS (Caspofungin Accord 70 mg) Step 1 Reconstitution of conventional vials
Croatian: UPUTE ZA UPORABU U ODRASLIH BOLESNIKA (Caspofungin Accord 70 mg) Korak 1.
English: Determine the actual loading dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation:
Croatian: Odredite stvarnu udarnu dozu koja se mora primijeniti u pedijatrijskog bolesnika pomoću površine tijela bolesnika (izračunate prema gornjoj formuli) i sljedeće jednadžbe: PT (m2) × 70 mg/m2 = udarna doza
English: • If you get any side effects, talk to your doctor, nurse or pharmacist.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, medicinsku sestru ili ljekarnika.
English: • Fever
Croatian: Vrućica
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: If the drug was well tolerated but the patient's fever persisted and clinical condition deteriorated after 5 days of therapy, the dosage of study drug could be increased to 70 mg/day of caspofungin (13.3 % of patients treated) or to 5.0 mg/kg/day of liposomal amphotericin B (14.3 % of patients treated).
Croatian: 70 mg/dan ako je primao kaspofungin (13,3% liječenih bolesnika) ili na 5,0 mg/kg/dan ako je primao liposomalni amfotericin B (14,3% liječenih bolesnika).
English: Forty-nine patients were enrolled and received caspofungin at 50 mg/m2 IV once daily following a 70-mg/m2 loading dose on
Croatian: Od 49 bolesnika koji su primili kaspofungin u dozi od 50 mg/m2 i.v. jedanput na dan (nije smjela biti veća od 70 mg na dan) nakon udarne doze od 70 mg/m2 prvog dana, 48 je bilo uključeno u
English: Preparation of the 50 mg/m2 infusion for paediatric patients >3 months of age (using a 50-mg vial)
Croatian: Priprema doze od 50 mg/m2 u infuziji za pedijatrijske bolesnike u dobi od >3 mjeseca (iz bočice od 50 mg)
English: Preparation of the 70 mg/m2 infusion for paediatric patients > 3 months of age (using a 70-mg vial)
Croatian: Priprema doze od 70 mg/m2 u infuziji za pedijatrijske bolesnike u dobi od >3 mjeseca (iz bočice od 70 mg)
English: Preparation of the 70 mg/m2 infusion for paediatric patients >3 months of age (using a 50-mg vial)
Croatian: Priprema doze od 70 mg/m2 u infuziji za pedijatrijske bolesnike u dobi od >3 mjeseca (iz bočice od 50 mg)
English: Preparation of the 50 mg/m2 infusion for paediatric patients > 3 months of age (using a 70-mg vial)
Croatian: Priprema doze od 50 mg/m2 u infuziji za pedijatrijske bolesnike u dobi od >3 mjeseca (iz bočice od 70 mg)
English: • Joint pain
Croatian: • Upala vene
English: Laboratory abnormalities in liver function tests have been seen in healthy volunteers and adult and paediatric patients treated with caspofungin.
Croatian: U zdravih dobrovoljaca te odraslih i pedijatrijskih bolesnika liječenih kaspofunginom tijekom ispitivanja funkcije jetre primijećeni su laboratorijski poremećaji.
English: Vascular disorders flushing, hypotension
Croatian: Krvožilni poremećaji crvenilo uz osjećaj vrućine, hipotenzija
English: Anaphylaxis has been reported during administration of caspofungin.
Croatian: Pri primjeni kaspofungina bila je prijavljena anafilaksija.
English: 6.6 Special precautions for disposal
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: No dosage adjustment is necessary for patients with renal impairment.
Croatian: U bolesnika s oštećenjem funkcije bubrega nije potrebno prilagođavati dozu.
English: Do not use if the solution is cloudy or has precipitated.
Croatian: Nemojte koristiti otopinu koja je mutna ili sadrži talog.
English: Treatment should continue for 8 weeks.
Croatian: S liječenjem se mora nastaviti tijekom osam tjedana.
English: What is Oxervate and what is it used for?
Croatian: Što je Oxervate i za što se koristi?
English: The recommended dose is 1 drop in the affected eye every 2 hours, 6 times per day.
Croatian: Preporučena doza jest jedna kap u zahvaćeno oko svaka 2 sata, 6 puta na dan.
English: The medicine is only used in adults with moderate or severe disease.
Croatian: Lijek se primjenjuje samo u odraslih s umjerenim ili teškim simptomima bolesti.
English: What are the risks associated with Oxervate?
Croatian: Koji su rizici povezani s lijekom Oxervate?
English: What measures are being taken to ensure the safe and effective use of Oxervate?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Oxervate?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Oxervate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti o lijeku Oxervate nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: It is not intended to provide practical advice on how to use Oxervate.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Oxervate.
English: The European Medicines Agency therefore decided that Oxervate's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je stav Europske agencije za lijekove da koristi lijeka Oxervate nadmašuju s njim povezane rizike te je preporučila davanje odobrenja za njegovu primjenu u EU-u.
English: This is a summary of the European public assessment report (EPAR) for Oxervate.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Oxervate.