FrancophonIA/ELRC3.0 huggingface dataset:
English: Monitor for ADRs related to ceritinib.
Croatian: Nadzirati bolesnike zbog mogućih nuspojava povezanih s ceritinibom.
English: Coombs-negative anisocytosis and poikilocytosis were observed in rats, but not in mice or dogs.
Croatian: U štakora, no ne i u miševa i pasa, uočene su anizocitoza i poikilocitoza negativne na Coombsov test.
English: • Kaletra tablets can be taken with or without food.
Croatian: • Kaletra tablete mogu se uzimati neovisno o uzimanju hrane.
English: PARTICULARS TO APPEAR ON THE ON THE IMMEDIATE PACKAGING 100 mg/25 mg tablets - bottle label
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU 100 mg/25 mg tablete - naljepnica na boci
English: Kaletra film-coated tablets are yellow debossed with [Abbott logo] and “KA”.
Croatian: Kaletra filmom obložene tablete su žute boje s utisnutim [logotipom Abbotta] i oznakom “KA”.
English: Kaletra must not be administered once daily in combination with efavirenz.
Croatian: U kombinaciji s efavirenzom Kaletra se ne smije davati jednom dnevno.
English: Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected children above the age of 2 years, adolescents and adults.
Croatian: Kaletra je indicirana za liječenje odraslih, adolescenata i djece starije od 2 godine inficiranih virusom humane imunodeficijencije (HIV-1), u kombinaciji s ostalim antiretrovirusnim lijekovima.
English: Increased plasma concentrations of neratinib which may increase the potential for serious and/or life-threatening reactions (see section 4.5).
Croatian: Povišena koncentracija neratiniba u plazmi, što može povećati mogućnost nastupa ozbiljnih i/ili po život opasnih reakcija (vidjeti dio 4.5).
English: • inflammation of the pancreas;
Croatian: • zatajenje bubrega;
English: Caution should be exercised and reduced doses should be considered when Kaletra is co-administered with rosuvastatin (see section 4.4).
Croatian: Kada se Kaletra daje istodobno s rosuvastatinom nužan je oprez i mora se razmotriti smanjenje doza (vidjeti dio 4.4).
English: Each ml contains: lopinavir 80 mg and ritonavir 20 mg.
Croatian: Svaki ml sadrži: 80 mg lopinavira i 20 mg ritonavira.
English: AUC: ↑ 13-fold
Croatian: AUC: ↑ 13 puta
English: Thereby, increasing the risk of serious arrhythmias from these agents (see section 4.5).
Croatian: Time je povišen rizik od ozbiljnih aritmija uzrokovanih ovim tvarima (vidjeti dio 4.5).
English: All patients converted to open-label Kaletra at the 400/100 mg twice daily dose between week 48 and week 72.
Croatian: Između 48. i 72. tjedna svi bolesnici prešli su na otvorenu primjenu lijeka Kaletra 400/100 mg dva puta dnevno.
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with protease inhibitors.
Croatian: A i B liječenih inhibitorima proteaze zabilježeno je pojačano krvarenje, uključujući spontano stvaranje kožnih hematoma i hemartroze.
English: Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of lomitapide are expected to increase.
Croatian: Zbog inhibicije CYP3A lopinavirom/ritonavirom, očekuje se povećanje koncentracija lomitapida.
English: Collar
Croatian: Obruč
English: Each ml of Kaletra oral solution contains 80 mg of lopinavir and 20 mg of ritonavir.
Croatian: Svaki ml Kaletra oralne otopine sadrži 80 mg lopinavira i 20 mg ritonavira.
English: Co-administration of Kaletra with tadalafil is not recommended.
Croatian: Istodobna primjena lijeka Kaletra i tadalafila nije preporučena.
English: The median EC50 of lopinavir against isolates with 0 − 3, 4 − 5, 6 − 7 and 8 − 10 mutations at the above amino acid positions was 0.8, 2.7 13.5 and 44.0-fold higher than the EC50 against wild type
Croatian: − 3, 4 − 5, 6 − 7 i 8 − 10 mutacija na mjestima gore navedenih aminokiselina bio je, redom, 0,8; 2,7;
English: Kaletra 200 mg/50 mg film-coated tablets
Croatian: Kaletra 200 mg/50 mg filmom obložene tablete
English: M97-765 is a randomised, double-blind trial evaluating Kaletra at two dose levels (400/100 mg and 400/200 mg, both twice daily) plus nevirapine (200 mg twice daily) and two nucleoside reverse transcriptase inhibitors in 70 single protease inhibitor experienced, non-nucleoside reverse transcriptase inhibitor naïve patients.
Croatian: 400/200 mg dvaput na dan u oba slučaja) plus nevirapin (200 mg dvaput na dan) te dvaju nukleozidnih inhibitora reverzne transkriptaze u 70 bolesnika koji su prethodno primali jedan inhibitor proteaze, ali ne i nenukleozidne inhibitore reverzne transkriptaze.
English: CYP3A4 inhibition likely due to lopinavir/ritonavir.
Croatian: Moguća je inhibicija CYP3A4 zbog učinka lopinavira/ritonavira.
English: Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of quetiapine are expected to increase.
Croatian: Zbog inhibicije CYP3A lopinavirom/ritonavirom mogu se očekivati povećane koncentracije kvetiapina.
English: Kaletra must not be administered once daily in combination with nevirapine.
Croatian: U kombinaciji s nevirapinom Kaletra se ne smije davati jednom dnevno.
English: The steady state pharmacokinetic parameters of lopinavir in HIV-infected patients with mild to moderate hepatic impairment were compared with those of HIV-infected patients with normal hepatic function in a multiple dose study with lopinavir/ritonavir 400/100 mg twice daily.
Croatian: Farmakokinetički pokazatelji lopinavira u stanju dinamičke ravnoteže, u ispitivanju pri višekratnim dozama lopinavira/ritonavira od 400/100 mg dvaput na dan u bolesnika zaraženih HIV-om, s blagim do umjerenim oštećenjem funkcije jetre uspoređeni su s onima u bolesnika zaraženih HIV-om u kojih je funkcija jetre bila uredna.
English: AUC: ↑ 13-fold Due to CYP3A inhibition by lopinavir/ritonavir.
Croatian: AUC: ↑ 13 puta Zbog inhibicije CYP3A lopinavirom/ritonavirom.
English: Ombitasvir/paritaprevir/ritonavir with or without dasabuvir
Croatian: Ombitasvir/paritaprevir/ritonavir u kombinaciji s dasabuvirom ili bez njega
English: Due to CYP3A inhibition by lopinavir/ritonavir.
Croatian: Zbog inhibicije CYP3A lopinavirom/ritonavirom.
English: Cmax Cpredose μg /mL
Croatian: Cprije početka liječenja μg /mL
English: It is not recommended to co-administer Kaletra and simeprevir.
Croatian: Ne preporučuje se istodobna primjena lijeka Kaletra i simeprevira.
English: Film-coated tablet Pale yellow debossed with [Abbott logo] and “KC”.
Croatian: Filmom obložena tableta Blijedožute boje, s utisnutim [logotipom Abbotta] i oznakom “KC”.
English: Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children aged from 14 days and older.
Croatian: Kaletra je indicirana za liječenje odraslih, adolescenata i djece u dobi od 14 dana i starije inficiranih virusom humane imunodeficijencije (HIV-1), u kombinaciji s ostalim antiretrovirusnim lijekovima.
English: Moderate increases in clarithromycin AUC are expected due to CYP3A inhibition by lopinavir/ritonavir.
Croatian: Očekuje se umjereno povećanje AUC zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A.
English: Concentrations are expected to increase due to CYP3A inhibition by lopinavir/ritonavir.
Croatian: Očekuje se povećanje koncentracija zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A.
English: Mean baseline CD4+ T-cell count was 838 cells/mm3 and mean baseline plasma HIV-1 RNA was 4.7 log10 copies/ml.
Croatian: Srednja početna vrijednost broja CD4+ T-stanica iznosila je na početku terapije 838 stanica/ mm3, a srednja početna vrijednost broja kopija HIV-1 RNK iznosila je 4,7 log10 kopija/ml.
English: Each ml contains lopinavir 80 mg and ritonavir 20 mg.
Croatian: Svaki ml sadrži 80 mg lopinavira i 20 mg ritonavira.
English: Clinical monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with Kaletra.
Croatian: Pri primjeni ovih lijekova istodobno s lijekom Kaletra preporučuje se kliničko praćenje liječenja i nuspojava.
English: Serum concentrations of apalutamide may be increased due to CYP3A inhibition by lopinavir/ritonavir.
Croatian: Serumske koncentracije apalutamida mogu biti povišene zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A.
English: Concentrations may be reduced due to induction of CYP3A by the herbal preparation St John's wort.
Croatian: Koncentracije mogu biti smanjene zbog indukcijskog učinka gospine trave na CYP3A.
English: Venetoclax
Croatian: Venetoklaks
English: Medicinal product class
Croatian: FARMACEUTSKI PODACI
English: The adverse reactions are displayed by system organ class.
Croatian: Nuspojave su navedene prema organskim sustavima.
English: Increased plasma concentrations of sildenafil.
Croatian: Povišena koncentracija sildenafila u plazmi.
English: Amiodarone, Dronedarone Amiodarone, Dronedarone: Concentrations may be increased due to CYP3A4 inhibition by lopinavir/ritonavir.
Croatian: Felodipin, nifedipin, nikardipin: Koncentracije mogu biti povećane zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A.
English: Kaletra must not be administered once daily in combination with phenytoin.
Croatian: U kombinaciji s fenitoinom Kaletra se ne smije davati jednom dnevno.
English: • tremor;
Croatian: • nevoljno drhtanje;
English: BID)
Croatian: beklometazon).
English: • antiviral medicine used to treat chronic hepatitis C virus (HCV) infection in adults (e.g. glecaprevir/pibrentasvir, simeprevir and sofosbuvir/velpatasvir/voxilaprevir );
Croatian: (npr. glekaprevir/pibrentasvir, simeprevir i sofosbuvir/velpatasvir/voksilaprevir);
English: Cmax: ↓ 47%
Croatian: Cmin: ↓ 70% Cmax: ↓ 47%
English: Analysis of resistance in PI-experienced patients
Croatian: Analiza rezistencije u bolesnika koji nisu primali antitretrovirusne lijekove
English: − digoxin;
Croatian: • proljev;
English: The adult dose of Kaletra tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2. For children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m2 and able to swallow tablets, please refer to the Kaletra 100 mg/25 mg tablets Summary of Product Characteristics.
Croatian: Za djecu lakšu od 40 kg i površine tijela od 0,5 do 1,4 m² koja mogu progutati tabletu, koristite sažetak opisa svojstava lijeka za Kaletra tablete 100 mg/25 mg.
English: • diarrhoea;
Croatian: • hemoroidi;
English: Use the 5 ml oral dosing syringe to prepare a dose.
Croatian: Za odmjeravanje doze upotrijebite štrcaljku od 5 ml za primjenu kroz usta.
English: Each ml of Kaletra contains 80 mg of lopinavir and 20 mg of ritonavir.
Croatian: Svaki mililitar lijeka Kaletra sadrži 80 mg lopinavira i 20 mg ritonavira.
English: The use of vardenafil with Kaletra is contraindicated (see section 4.3).
Croatian: Istodobna primjena vardenafila i lijeka Kaletra je kontraindicirana (vidjeti dio 4.3).
English: Concentrations may be decreased due to CYP3A induction by dexamethasone.
Croatian: Koncentracije mogu biti smanjene zbog indukcijskog učinka deksametazona na
English: Opioids
Croatian: Hemofilija
English: Caution should be exercised in administering carbamazepine or phenobarbital with Kaletra.
Croatian: Pri primjeni karbamazepina ili fenobarbitala istodobno s lijekom Kaletra nužan je oprez.
English: Serum concentrations may be increased due to CYP3A and P-gp inhibition by lopinavir/ritonavir.
Croatian: Serumske koncentracije mogu biti povišene zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A i P-gp.
English: triamcinolone).
Croatian: svojstava lijeka za vorapaksar).
English: Colloidal anhydrous silica Macrogols type 3350 (Polyethylene glycol 3350) Yellow ferric oxide E172
Croatian: Film ovojnica: poli(vinilni alkohol) titanijev dioksid talk makrogol 3350 (polietilenglikol 3350) željezov oksid, žuti E172
English: The Kaletra tablets dosage should be increased to 500/125 mg twice daily when co-administered with nevirapine.
Croatian: Kada se daje istodobno s nevirapinom, doza lijeka Kaletra u tabletama mora se povećati na 500/125 mg dvaput na dan.
English: • mouth sores or ulcerations, inflammation of the stomach and intestine;
Croatian: • odumiranje kosti uzrokovano njenom slabom prokrvljenošću; • rane i čirevi u usnoj šupljini, upala želuca i crijeva;
English: In another open-label pharmacokinetic study, 19 HIV-infected pregnant women received lopinavir/ritonavir 400/100 mg twice daily as part of combination antiretroviral therapy during pregnancy from before conception.
Croatian: mg/100 mg lopinavira/ritonavira dvaput na dan kao dio kombinirane terapije antiretrovirusnim lijekovima tijekom trudnoće, a koja je započeta prije začeća.
English: Cmax: ↑ 55%
Croatian: Cmax: ↑ 3,5 puta
English: The pharmacokinetics of Kaletra 100/25 mg tablet twice-daily weight-band dosing without nevirapine have been studied in a total of 53 paediatric patients.
Croatian: mg tableta čije je doziranje vezano uz tjelesnu težinu primijenjenih dvaput dnevno ispitana je u ukupno 53 pedijatrijska bolesnika.
English: Dasabuvir: ↔
Croatian: Sakvinavir: ↔
English: Concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir.
Croatian: Koncentracije mogu biti povećane zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A.
English: Use the 2 ml oral dosing syringe to prepare a dose.
Croatian: Za odmjeravanje doze upotrijebite štrcaljku od 2 ml za primjenu kroz usta.
English: Side effects where frequency is not known:
Croatian: Nuspojave nepoznate učestalosti:
English: AUC: ↑ 4-fold
Croatian: AUC: ↑ 3 puta
English: Cmax: ↑ 4.7-fold Due to CYP3A inhibition by lopinavir/ritonavir.
Croatian: AUC: ↑ 4 puta Zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A.
English: Very common Upper respiratory tract infection Common
Croatian: Infekcije gornjeg dišnog sustava
English: Co-administration of Kaletra with sildenafil is contraindicated (see section 4.3).
Croatian: Istodobna primjena lijeka Kaletra i sildenafila je kontraindicirana (vidjeti dio 4.3).
English: • If the ‘ml' mark on the collar is less than the prescribed dose, draw up more solution to the prescribed dose.
Croatian: • Ako je broj „ml“ u ravnini obruča manji od propisane doze,
English: Antimycobacterials Bedaquiline (single dose)
Croatian: Antimikobakterici Bedakilin
English: − If you get any effects, talk to your doctor or pharmacist.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Serum concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir.
Croatian: Serumske koncentracije mogu biti povećane zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A.
English: The Kaletra tablets dosage should be increased to 500/125 mg twice daily when co-administered with efavirenz.
Croatian: Kada se daje istodobno s efavirenzom, dozu lijeka Kaletra u tabletama mora se povećati na 500/125 mg dvaput na dan.
English: Oral solution contains: alcohol (42.4% v/v), high fructose corn syrup, propylene glycol (15.3% w/v), purified water, glycerol, povidone, magnasweet-110 flavour (mixture of monoammonium glycyrrhizinate and glycerol),
Croatian: Sadržaj oralne otopine: etanol (42,4% V/V) kukuruzni sirup bogat fruktozom propilenglikol (15,3% m/V)
English: Finger grip
Croatian: Oštećenje bubrega
English: AUC: ↑ 2.17-fold Cmax: ↑ 2.04-fold Ctrough: ↑ 2.36-fold (inhibition of CYP3A/efflux transporters)
Croatian: AUC: ↑ 2,17 puta Cmax: ↑ 2,04 puta Cnajniži: ↑ 2,36 puta
English: • Periodic Safety Update Reports
Croatian: Sažetak sigurnosnog profila
English: Sorbitan laurate Colloidal anhydrous silica Sodium stearyl fumarate
Croatian: Sadržaj tablete: kopovidon sorbitanlaurat silicijev dioksid, koloidni, bezvodni natrijev stearilfumarat
English: AUC: ↑ 153%
Croatian: AUC: ↑ 153% Cmax: ↑ 55%
English: What Kaletra is and what it is used for What you need to know before you or your child takes Kaletra How to take Kaletra
Croatian: Vi ili Vaše dijete počnete uzimati lijek Kaletra Kako uzimati lijek Kaletra
English: Tip
Croatian: OBLIK
English: Serum concentrations may be increased due to CYP3A inhibition by ritonavir.
Croatian: Serumske koncentracije mogu biti povišene zbog inhibicijskog učinka ritonavira na CYP3A4.
English: AUC: ↑ 2-fold
Croatian: AUC: ↑ 2 puta
English: MARKETING AUTHORISATION NUMBER
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Cardiac events have been reported with Kaletra in preclinical studies; therefore, the potential cardiac effects of Kaletra cannot be currently ruled out (see sections 4.8 and 5.3).
Croatian: Prijavljena je pojava srčanih nuspojava pri davanju lijeka Kaletra u pretkliničkim ispitivanjima; stoga se moguće srčane nuspojave lijeka Kaletra zasad ne mogu isključiti
English: Blisters packs - polyvinyl chloride (PVC) blisters with fluoropolymer foil backing Two pack sizes are available: - carton containing 120 film-coated tablets - multipack containing 120 (3 cartons of 40) film-coated tablets
Croatian: - Kutija koja sadrži 120 filmom obloženih tableta - Višestruko pakiranje koje sadrži 120 (3 kutije s 40) filmom obloženih tableta.
English: • hair loss;
Croatian: • gubitak kose;
English: PARTICULARS TO APPEAR ON THE ON THE IMMEDIATE PACKAGING 200 mg/50 mg tablets - Bottle label
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU 200 mg/50 mg tablete
English: Very common Diarrhoea, nausea Common
Croatian: Manje često Tinitus, vrtoglavica
English: The use of rivaroxaban is not recommended in patients receiving concomitant treatment with Kaletra (see section 4.4).
Croatian: Ne preporučuje se primjena rivaroksabana kod bolesnika koji se istodobno liječe lijekom Kaletra
English: Hypersensitivity including urticaria and angioedema
Croatian: Preosjetljivost uključujući urtikariju i angioedem Manje često Upalni sindrom imunološke rekonstitucije
English: M98-957 is a randomised, open-label study evaluating Kaletra treatment at two dose levels (400/100 mg and 533/133 mg, both twice daily) plus efavirenz (600 mg once daily) and nucleoside reverse transcriptase inhibitors in 57 multiple protease inhibitor experienced, non-nucleoside reverse transcriptase inhibitor naïve patients.
Croatian: mg dvaput na dan u oba slučaja) plus efavirenz (600 mg jedanput na dan) i nukleozidnih inhibitora reverzne transkriptaze u 57 bolesnika koji su ranije primali više inhibitora proteaze, ali ne i nenukleozidne inhibitore reverzne transkriptaze.
English: • dry mouth;
Croatian: • suha usta;
English: Due to P-gp and/or CYP3A4 inhibition by ritonavir.
Croatian: Zbog inhibicijskog učinka ritonavira na P-gp i/ili CYP3A4.
English: Renal impairment
Croatian: Virološki neuspjeh*
English: 7.5 mg/ml Solution for injection
Croatian: Abilify 7,5 mg/ ml
English: Intramuscular use vial (glass)
Croatian: U mišić bočica (staklo)
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom multiply, and so its reduction in the blood causes the cells to die.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom razmnožava i stoga smanjenje njezine prisutnosti u krvi uzrokuje odumiranje stanica.
English: The full EPAR and risk management plan summary for Spectrila can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Spectrila nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Spectrila
Croatian: Ostale informacije o lijeku Spectrila
English: What measures are being taken to ensure the safe and effective use of Spectrila?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Spectrila?
English: What is Spectrila and what is it used for?
Croatian: Što je Spectrila i za što se koristi?
English: Spectrila is given every 3 days by infusion (drip) into a vein, with the dose depending on the patient's age and body surface area.
Croatian: Spectrila se daje svaka tri dana intravenskom infuzijom (drip), a doza ovisi o dobi i tjelesnoj površini bolesnika.
English: This is a summary of the European public assessment report (EPAR) for Spectrila.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Spectrila.
English: Normal cells, by contrast, can produce their own asparagine and are less affected by the medicine.
Croatian: Suprotno tome, normalne stanice mogu proizvoditi vlastiti asparagin i na njih lijek manje utječe.
English: The healthcare professional should only give the medicine in a hospital setting where resuscitation equipment is available.
Croatian: Zdravstveni djelatnik treba primjenjivati ovaj lijek samo u bolničkom okruženju u kojem je dostupna oprema za reanimaciju.
English: A risk management plan has been developed to ensure that Spectrila is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Spectrila.
English: In a study in 199 children with ALL, Spectrila was as effective as another asparaginase medicine (both used in combination with other medicines) in reducing blood asparagine: 95% of patients treated with Spectrila and 94% of those treated with the other medicine containing asparaginase had complete depletion (reduction) of blood asparagine.
Croatian: Studija provedena na 199 djece s ALL-om pokazala je da je lijek Spectrila učinkovit kao drugi lijek koji sadrži asparaginazu (oba se koriste u kombinaciji s drugim lijekovima) u smanjenju asparagina u krvi: kod 95 % bolesnika liječenih lijekom Spectrila i 94 % bolesnika liječenih drugim lijekom koji sadrži asparaginazu došlo je do potpune deplecije (smanjenja) asparagina u krvi.
English: Why is Spectrila approved?
Croatian: Zašto je lijek Spectrila odobren?
English: What are the risks associated with Spectrila?
Croatian: Koji su rizici povezani s lijekom Spectrila?
English: It is not intended to provide practical advice on how to use Spectrila.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Spectrila.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that the benefits of Spectrila are greater than the risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Spectrila nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Spectrila asparaginase
Croatian: Spectrila asparaginaza
English: The most common side effects with Spectrila (which may affect more than 1 in 10 people) are allergic reactions (including flushing, rash, low blood pressure, hives and difficulty breathing), diarrhoea, nausea, vomiting, abdominal pain, tiredness, swelling (caused by fluid build-up), high blood sugar, and low blood levels of albumin (a protein) and other abnormalities in blood tests.
Croatian: Najčešće nuspojave lijeka Spectrila (mogu se javiti u više od 1 na 10 osoba) su alergijske reakcije (uključujući crvenilo, svrbež, nizak krvni lak, osip i poteškoće u disanju), proljev, mučnina, povraćanje, abdominalna bol, umor, oticanje (uzrokovano nakupljanjem tekućine), povišeni šećer u krvi i smanjenje razine albumina (protein) u krvi te drugi abnormalni nalazi krvnih pretraga.
English: Although the data in adults are limited, there is substantial clinical experience of asparaginase medicines in adults, and the benefits of Spectrila in adults can be expected to be similar.
Croatian: Iako su postojeći podaci o učinku u odraslih bolesnika ograničeni, postoji znatno kliničko iskustvo u primjeni asparaginaze u odraslih i očekuje se da su koristi od lijeka Spectrila slične i kod njih.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Spectrila, 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 Spectrila nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.