FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of emtricitabine + tenofovir alafenamide was evaluated through 144 weeks in an open-label clinical study (GS-US-292-0112), in which 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
Croatian: Ispitivanja (GS-US-292-0112) u kojem je 248 bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni (n = 6) ili im je virus bio suprimiran (n = 242) s blagim do umjerenim oštećenjem funkcije bubrega (procijenjena brzina glomerularne filtracije Cockcroft-Gaultovom metodom [eGFRCG]: 30-69 ml/min) dobivali su emtricitabin + tenofoviralafenamid u kombinaciji s elvitegravirom + kobicistatom u obliku tablete s fiksnom kombinacijom.
English: Antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Rilpivirine
Croatian: Antivirusni lijekovi Ledipasvir/sofosbuvir (90 mg/400 mg jedanput na dan)/
English: Rilpivirine-containing regimen
Croatian: Režim koji uključuje rilpivirin
English: Emtricitabine + tenofovir alafenamide
Croatian: Odrasli Emtricitabin + tenofoviralafenamid Emtricitabin + tenofoviralafenamid FTCa
English: Lansoprazole Rabeprazole Pantoprazole Esomeprazole Dexlansoprazole
Croatian: Pantoprazol Esomeprazol Dekslanzoprazol
English: Midazolam (1 mg, intravenously, single dose)/ Tenofovir alafenamide
Croatian: Midazolam (1 mg intravenski,
English: Famotidine (40 mg single dose taken 2 hours before rilpivirine)/ Rilpivirine1
Croatian: Famotidin (jedna doza od 40 mg uzeta 2 sata prije rilpivirina)/
English: AUC: ↑ 6% Cmin: ↓ 4% Cmax: ↑ 10%
Croatian: Simeprevir: AUC: ↑ 6% Cmax: ↓ 4% Cmax: ↑ 10%
English: PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil (50 mg single dose)/ Rilpivirine1
Croatian: INHIBITORI FOSFODIESTERAZE TIPA 5 (PDE-5)
English: AUC: ↓ 42% Cmin: ↓ 48% Cmax: ↓ 31%
Croatian: AUC: ↓ 42% Cmin: ↓ 48% Cmax: ↓ 31% Indukcija CYP3A
English: You must remain under the care of your doctor while taking Odefsey.
Croatian: Za vrijeme uzimanja lijeka Odefsey morate ostati pod nadzorom svog liječnika.
English: No virologic data in Week 48 or 144 window Discontinued study drug due to AE or deathe
Croatian: HIV-1 RNK ≥ 50 kopija/mld Bez viroloških podataka u okviru 48. ili 144. tjedna Prekid liječenja ispitivanim lijekom zbog štetnih događaja ili smrtie Prekid liječenja ispitivanim lijekom iz drugih razloga i posljednje dostupne vrijednosti
English: In treatment-naïve adult patients
Croatian: U odraslih bolesnika koji prethodno nisu bili liječeni
English: HIV-1 infected adult patients with mild to moderate renal impairment In Study GS-US-292-0112, the efficacy and safety of E/C/F/TAF FDC tablet were evaluated in an open-label clinical study of 242 HIV-1 infected, virologically suppressed patients with mild to moderate renal impairment (eGFRCG: 30-69 mL/min).
Croatian: U otvorenom kliničkom Ispitivanju GS-US-292-0112 na 242 virološki suprimirana bolesnika zaražena virusom HIV-1 s blagim do umjerenim oštećenjem funkcije bubrega (eGFRCG: 30-69 ml/min) procijenjena je djelotvornost i sigurnost E/C/F/TAF tablete s fiksnom kombinacijom.
English: Co-administration is likely to cause significant decreases in the plasma concentrations of rilpivirine (induction of CYP3A) and tenofovir alafenamide (induction of P-gp).
Croatian: Istodobna primjena će vjerojatno prouzročiti značajno smanjenje koncentracije rilpivirina (indukcija CYP3A) i tenofoviralafenamida (indukcija P-gp) u plazmi.
English: AUC: ↑ 49% Cmin: ↑ 76% Cmax: ↑ 30%
Croatian: AUC: ↑ 49% Cmin: ↑ 76% Cmax: ↑ 30% Inhibicija CYP3A
English: Women of childbearing potential/contraception in males and females The use of Odefsey should be accompanied by the use of effective contraception.
Croatian: Uz primjenu lijeka Odefsey mora se koristiti učinkovita kontracepcija.
English: -0.3% (95% CI: -4.2% to 3.7%)
Croatian: 2,0% (95% CI: -0,7% do 4,7%)
English: At Week 144, 83.1% (197/237 patients) maintained HIV-1 RNA < 50 copies/mL after switching to E/C/F/TAF FDC tablet.
Croatian: Nakon prebacivanja na tabletu s fiksnom kombinacijom E/C/F/TAF, 83,1% (197/237 bolesnika) bolesnika je u 144. tjednu zadržalo HIV-1 RNK < 50 kopija/ml.
English: Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Tenofovir alafenamide
Croatian: Ledipasvir/sofosbuvir (90 mg/400 mg jedanput na dan)/
English: PROTON PUMP INHIBITORS Omeprazole (20 mg once daily)/ Rilpivirine1
Croatian: Omeprazol (20 mg jedanput na dan)/rilpivirin1
English: There are a limited amount of data (less than 300 pregnancy outcomes) from the use of rilpivirine and tenofovir alafenamide in pregnant women (see sections 4.4, 5.1 and 5.2).
Croatian: Podaci o primjeni rilpivirina i tenofoviralafenamida u trudnica su ograničeni (manje od 300 trudnoća)
English: Antacids should only be administered either at least 2 hours before or at least 4 hours after Odefsey.
Croatian: 2 sata prije ili najmanje 4 sata nakon lijeka Odefsey.
English: No dose adjustment of Odefsey is required in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis; however, Odefsey should generally be avoided but may be used with caution in these patients if the potential benefits are considered to outweigh the potential risks (see sections 4.4 and 5.2).
Croatian: Međutim, iako Odefsey općenito treba izbjegavati u ovih bolesnika, može ga se primijeniti s oprezom ako se smatra da su moguće koristi veće od mogućih rizika (vidjeti dijelove 4.4 i 5.2).
English: AUC: ↑ 32% Cmax: ↑ 3%
Croatian: Tenofoviralafenamid: AUC: ↑ 32% Cmax: ↑ 3%
English: immune reactivation syndrome1 Metabolism and nutrition disorders Very common:
Croatian: Poremećaji metabolizma i prehrane
English: AUC: ↑ 5% Cmax: ↓ 4%
Croatian: Sofosbuvir: AUC: ↑ 5% Cmax: ↓ 4%
English: The mean baseline CD4+ cell count was 697 cells/mm3 (range
Croatian: Srednja vrijednost početnog broja CD4+ stanica bila je 697 stanica/mm3 (raspon 79-1951).
English: HMG CO-A REDUCTASE INHIBITORS Atorvastatin (40 mg once daily)/ Rilpivirine1
Croatian: Atorvastatin (40 mg jedanput na dan)/rilpivirin1
English: 0.4% (95% CI: -3.0% to 3.8%) 5.4% (95% CI: 1.5% to 9.2%)
Croatian: 5,4% (95% CI: 1,5% do 9,2%)
English: Virologically suppressed adults in Study GS-US-292-0109
Croatian: GS-US-292-0109
English: 5 Adverse reaction identified through post-marketing surveillance for emtricitabine-containing products.
Croatian: Nuspojava prepoznata tijekom praćenja lijekova koji sadrže emtricitabin nakon njihova stavljanja u promet.
English: One patient with emergent resistance (M184M/I) was identified in a clinical study of virologically suppressed patients who switched from a regimen containing emtricitabine + tenofovir disoproxil fumarate to E/C/F/TAF in a fixed-dose combination (FDC) tablet (GS-US-292-0109, n = 959).
Croatian: + tenofovirdizoproksilfumarat na E/C/F/TAF u tableti s fiksnom kombinacijom (FDC) (GS-US-292-0109, n = 959) zabilježen je jedan bolesnik s novonastalom rezistencijom (M184M/I).
English: ODE
Croatian: A.
English: (n = 313)c
Croatian: (n = 959)
English: Omeprazole:
Croatian: Očekivano:
English: emtricitabine, rilpivirine and tenofovir alafenamide.
Croatian: emtricitabin/rilpivirin/tenofoviralafenamid
English: Packaging
Croatian: Naziv
English: This effect was maintained for almost one year.
Croatian: Taj učinak zadržao se gotovo godinu dana.
English: The recommended dose is 11 mg per kilogram body weight, and the infusion should last around one hour.
Croatian: Preporučena doza je 11 mg po kilogramu tjelesne težine, a infuzija treba trajati oko jedan sat.
English: The Agency also acknowledged that there is an unmet medical need for these patients.
Croatian: Agencija je također zaključila da u tih bolesnika postoji neispunjena medicinska potreba.
English: Sylvant (siltuximab)
Croatian: Sylvant (siltuksimab)
English: Sylvant is given every three weeks, until the patient no longer benefits from treatment.
Croatian: Sylvant se daje svaka tri tjedna sve dok bolesnik ne prestane imati koristi od terapije.
English: The most serious side effect is anaphylactic reaction (a severe allergic reaction).
Croatian: Najozbiljnija nuspojava je anafilaktična reakcija (teška alergijska reakcija).
English: What is Sylvant and what is it used for?
Croatian: Što je Sylvant i za što se koristi?
English: A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Croatian: Monoklonsko protutijelo je vrsta proteina proizvedenog da bi prepoznalo i vezalo se na određenu strukturu u tijelu (pod nazivom antigen).
English: Further information on Sylvant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Sylvant možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The company will ensure that healthcare professionals who are expected to use the medicine are provided with information on how to enter their patients in the registry.
Croatian: Tvrtka će se pobrinuti da se zdravstvene radnike za koje se očekuje da će primjenjivati lijek obavijesti o tome kako će upisivati svoje bolesnike u registar.
English: Sylvant received a marketing authorisation valid throughout the EU on 22 May 2014.
Croatian: Lijek Sylvant dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 22. svibnja 2014.
English: Siltuximab has been designed to attach to a protein in the body called interleukin 6 (IL-6).
Croatian: Siltuksimab je namijenjen za vezanje na protein u tijelu pod nazivom interleukin 6 (IL-6).
English: It is given by infusion (drip) into a vein.
Croatian: Daje se intravenskom infuzijom (drip).
English: Sylvant can only be obtained with a prescription and treatment should be given by qualified healthcare professionals and under appropriate medical supervision.
Croatian: Sylvant se može dobiti samo na recept, a liječenje moraju provoditi za to osposobljeni zdravstveni radnici pod odgovarajućim medicinskim nadzorom.
English: What measures are being taken to ensure the safe and effective use of Sylvant?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Sylvant?
English: Other information about Sylvant
Croatian: Ostale informacije o lijeku Sylvant
English: What are the risks associated with Sylvant?
Croatian: Koji su rizici povezani s lijekom Sylvant?
English: The effect of the medicine was compared with placebo (a dummy treatment) and the main measure of effectiveness was the proportion of patients who responded to treatment for at least 18 weeks, as shown by a 50% reduction (‘partial response') or complete disappearance (‘complete response') of tumours and symptoms of the disease.
Croatian: Učinak lijeka uspoređen je s placebom (prividno liječenje), a glavna mjera učinkovitosti bio je udio bolesnika s odgovorom na liječenje od najmanje 18 tjedana, iskazanim kao smanjenje od 50 % („djelomičan odgovor”) ili potpuni nestanak („potpuni odgovor”) tumora i simptoma bolesti.
English: During the first 12 months of treatment the patient should have a blood test before each dose of Sylvant, and every nine weeks afterwards; treatment may need to be delayed in patients whose blood tests are abnormal or who have certain side effects.
Croatian: Tijekom prvih 12 mjeseci liječenja treba provoditi pretrage krvi bolesnika prije svake doze lijeka Sylvant, a poslije toga svakih devet tjedana; u bolesnika u kojih pretrage krvi pokažu odstupanja ili se pojave neke nuspojave, liječenje možda treba odgoditi.
English: The Agency concluded that Sylvant has shown beneficial effect by reducing tumour size and symptoms in patients with multicentric Castleman's disease, and that this positive effect seems to be maintained over time.
Croatian: Agencija je zaključila da je lijek Sylvant pokazao povoljan učinak smanjivši veličinu tumora i simptome bolesti u bolesnika s multicentričnom Castlemanovom bolešću, te da izgleda da se taj pozitivni učinak održava.
English: Side effects reported with Sylvant are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Sylvant pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Symptoms can include tiredness, sweating at night, fever, peripheral neuropathy (pins and needles due to nerve damage) and swelling of liver and spleen.
Croatian: Simptomi mogu uključivati umor, noćno znojenje, vrućicu, perifernu neuropatiju (trnce zbog oštećenja živaca) i oticanje jetre i slezene.
English: For more information about using Sylvant, see the summary of product characteristics or contact a doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Sylvant pogledajte sažetak opisa svojstava lijeka ili se obratite liječniku ili ljekarniku.
English: The company that markets Sylvant is required to set up a patient registry to provide further data on long-term safety.
Croatian: Tvrtka koja stavlja lijek Sylvant u promet mora uspostaviti registar bolesnika kako bi se dobili dodatni podatci o dugoročnoj sigurnosti primjene.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sylvant have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Sylvant nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Why is Sylvant authorised in the EU?
Croatian: Zašto je lijek Sylvant odobren u EU-u?
English: Side effects of Sylvant were considered acceptable but further long-term data are to be collected.
Croatian: Nuspojave lijeka Sylvant smatraju se prihvatljivima, ali potrebno je i dalje prikupljati dugoročne podatke.
English: The most common side effects with Sylvant (which may affect more than 1 in 5 people) are infections (including upper respiratory tract infections such as those of the throat and nose), itching, rash, joint pain and diarrhoea.
Croatian: Najčešće nuspojave lijeka Sylvant (koje se mogu pojaviti u više od 1 na 5 osoba) jesu infekcije (uključujući infekcije gornjih dišnih puteva kao što su infekcije grla i nosa), svrbež, osip, bol u zglobovima i proljev.
English: Castleman's disease is rare, and Sylvant was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 November 2007.
Croatian: Castlemanova bolest je rijetka bolest, a lijek Sylvant dobio je status „lijeka za rijetku bolest” 30. studenoga 2007.
English: An overview of Sylvant and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Sylvant i zašto je odobren u EU-u
English: By attaching to IL-6, siltuximab blocks its activity and stops abnormal cell growth, thus reducing the size of the lymph nodes and the symptoms of the disease.
Croatian: Spajanjem na IL-6, siltuksimab blokira njegovu aktivnost i zaustavlja abnormalan rast stanica čime smanjuje veličinu limfnih čvorova i simptome bolesti.
English: Sylvant has been investigated in one main study involving 79 adults with multicentric Castleman's disease who did not have HIV or HHV-8 infection.
Croatian: Lijek Sylvant ispitivan je u jednom glavnom ispitivanju u koje je bilo uključeno 79 odraslih osoba s multicentričnom Castlemanovom bolešću koje nisu bile zaražene HIV-om ili virusom HHV-8.
English: Sylvant is a medicine that is used to treat multicentric Castleman's disease in adults who are not infected with human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8).
Croatian: Sylvant je lijek koji se koristi za liječenje multicentrične Castlemanove bolesti u odraslih osoba koje nisu zaražene virusom humane imunodeficijencije (HIV) ni virusom herpesa tipa 8 (HHV-8).
English: As for all medicines, data on the use of Sylvant are continuously monitored.
Croatian: Kao za sve lijekove, podaci o primjeni lijeka Sylvant kontinuirano se prate.
English: Patients with Castleman's disease produce too much IL-6 and this is thought to contribute to the abnormal growth of certain cells in the lymph nodes.
Croatian: Bolesnici s Castlemanovom bolešću proizvode previše IL-6 i smatra se da to pridonosi abnormalnom rastu nekih stanica u limfnim čvorovima.
English: Castleman's disease is a disorder of the lymphatic system (a network of vessels that transport fluid from tissues through the lymph nodes and into the bloodstream) in which cells in lymph nodes start growing abnormally, causing benign tumours.
Croatian: Castlemanova bolest poremećaj je limfnog sustava (mreže limfnih žila koje prenose tekućinu iz tkiva kroz limfne čvorove te u krvotok) pri kojem stanice u limfnim čvorovima počnu abnormalno rasti i uzrokuju dobroćudne tumore.
English: Sylvant was more effective than placebo in reducing tumour size and disease symptoms: 17 out of 53 patients who received Sylvant showed a partial response and one showed a complete response, compared with none of the 26 patients who received placebo.
Croatian: Lijek Sylvant bio je učinkovitiji od placeba u smanjenju veličine tumora i simptoma bolesti: u usporedbi sa skupinom od 26 bolesnika koji su primali placebo i nisu pokazali nikakav odgovor, od 53 bolesnika koji su primali lijek Sylvant 17 ih je pokazalo djelomičan odgovor, a jedan bolesnik potpuni odgovor.
English: The European Medicines Agency decided that Sylvant's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Sylvant nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: What benefits of Sylvant have been shown in studies?
Croatian: Koje su koristi od lijeka Sylvant utvrđene u ispitivanjima?
English: How does Sylvant work?
Croatian: Kako djeluje Sylvant?
English: How is Sylvant used?
Croatian: Kako se Sylvant koristi?
English: The active substance in Sylvant, siltuximab, is a monoclonal antibody.
Croatian: Djelatna tvar lijeka Sylvant, siltuksimab, monoklonsko je protutijelo.
English: Multicentric means that the disease affects several lymph nodes as well as other organs in the body.
Croatian: Bolest je multicentrična jer zahvaća nekoliko limfnih čvorova te druge organe u tijelu.
English: Sylvant contains the active substance siltuximab.
Croatian: Sylvant sadrži djelatnu tvar siltuksimab.
English: For the full list of side effects and restrictions of Sylvant, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja potražite u uputi o lijeku.
English: The capsules are opened and the granules are placed in the child's mouth.
Croatian: Kapsule se otvaraju, a granule se stavljaju u usta djeteta.
English: The dose is chosen to be lowest possible that controls the child's symptoms.
Croatian: Treba primjenjivati najnižu moguću dozu kojom se kontroliraju djetetovi simptomi.
English: The full EPAR for Alkindi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Alkindi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The child should then be given water or milk to swallow the granules.
Croatian: Nakon primjene djetetu treba dati vodu ili mlijeko kako bi progutalo granule.
English: Cortisol is needed to control many body processes (including inflammation and the control of sugar and mineral levels) and is sometimes referred to as the ‘stress hormone' because it helps the body respond to stress.
Croatian: Kortizol je potreban za kontroliranje brojnih procesa u organizmu (uključujući upale i kontrolu razina šećera i minerala) i ponekad se naziva „hormonom stresa” jer pomaže organizmu da odgovori na stres.
English: The granules can also be sprinkled on a spoonful of soft food and given to the child immediately.
Croatian: Granule se također mogu posuti na žlicu kašaste hrane i odmah dati djetetu.
English: The company also carried out studies to show that it is ‘bioequivalent' to the reference medicine.
Croatian: Tvrtka je također provela ispitivanja koja su pokazala da je on „bioekvivalentan” referentnom lijeku.
English: A lack of the hormone causes several symptoms, including weight loss, muscle weakness, tiredness and low blood pressure.
Croatian: Manjak hormona uzrokuje nekoliko simptoma, uključujući gubitak tjelesne težine, slabost mišića, umor i niski krvni tlak.
English: Alkindi hydrocortisone
Croatian: Alkindi hidrokortizon
English: As for every medicine, the company provided studies on the quality of Alkindi.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Alkindi.
English: This means that it is similar to a ‘reference medicine' containing the same active substance (in this case Hydrocortisone Tablets Auden Mckenzie), but Alkindi is available in a different form (granules instead of tablets) and has been developed for children only.
Croatian: To znači da je sličan „referentnom lijeku” koji sadrži istu djelatnu tvar (u ovom slučaju tablete hidrokortizona Auden Mckenzie), ali lijek Alkindi je dostupan u drugačijem obliku (u obliku granula umjesto tableta) i razvijen je samo za djecu.
English: This is a summary of the European public assessment report (EPAR) for Alkindi.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Alkindi.
English: What is Alkindi and what is it used for?
Croatian: Što je Alkindi i za što se koristi?
English: It must also not be used in children with difficulty swallowing or in premature babies who haven't started feeding by mouth.
Croatian: Također se ne smije primjenjivati u djece koja imaju poteškoće s gutanjem hrane ili u nedonoščadi koja se još ne može hraniti kroz usta.
English: What measures are being taken to ensure the safe and effective use of Alkindi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Alkindi?
English: Alkindi is a ‘hybrid medicine'.
Croatian: Alkindi je „hibridni lijek”.
English: Hydrocortisone replaces the natural cortisol that is missing in children whose adrenal glands do not produce enough of the hormone, thereby helping to relieve their symptoms.
Croatian: Hidrokortizon zamjenjuje prirodni kortizol koji nedostaje djeci čije nadbubrežne žlijezde ne proizvode dovoljno hormona, čime pomaže ublažavanju njihovih simptoma.
English: Alkindi is a medicine for children (from birth to up to 18 years of age) whose adrenal glands cannot make enough of a hormone called cortisol.
Croatian: Alkindi je lijek za djecu (od rođenja do 18 godina starosti) čije nadbubrežne žlijezde ne mogu proizvesti dovoljno hormona koji se naziva kortizol.
English: The European Medicines Agency concluded that the benefits of Alkindi are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Alkindi nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
English: Alkindi is also available in a form suitable for children and it is easier to give a precise dose with Alkindi than with other treatments which require crushing tablets and weighing up the right dose.
Croatian: Alkindi je dostupan u obliku prikladnom za djecu i lakše je davati točnu dozu lijeka Alkindi u usporedbi s ostalim oblicima liječenja, koji zahtijevaju usitnjavanje tableta i odmjeravanje točne doze.
English: These include changes in behaviour, nausea, inflammation in the lining of the stomach and changes in blood potassium levels and excess acid in the blood.
Croatian: Nuspojave uključuju promjene u ponašanju, mučninu, upalu želučane sluznice i promjene u razini kalija u krvi te višak kiseline u krvi.
English: Alkindi produces similar levels of hydrocortisone in the blood to a reference medicine already authorised in the EU.
Croatian: Alkindi proizvodi slične razine hidrokortizona u krvi kao i referentni lijek koji je već odobren u Europskoj uniji (EU).