FrancophonIA/ELRC3.0 huggingface dataset:
English: One hour following a single dose of 75 mg inhaled aztreonam (at approximately peak plasma concentration), the mean plasma level in patients with CF was 0.59 µg/ml.
Croatian: Srednja vrijednost razine u plazmi bolesnika s CF-om jedan sat nakon jednokratne doze od 75 mg inhaliranog aztreonama (približno u vrijeme vršne koncentracije u plazmi) iznosila je 0,59 µg/ml.
English: - Do not put the intravenous (injectable) form of aztreonam in the Altera Nebuliser Handset.
Croatian: - U ručni atomizator Altera nemojte stavljati intravenski (za injekciju) oblik aztreonama.
English: The adjusted mean percent change from baseline to Day 28 in FEV1 % predicted was 8.35 and 0.55 in the Cayston and TNS groups, respectively (treatment difference: 7.80; p = 0.0001; 95% CI: 3.86, 11.73).
Croatian: Prilagođena prosječna promjena u postocima u odnosu na početak do 28. dana u predviđenom FEV1% iznosila je 8,35 i 0,55 u skupinama koje su primale Cayston odnosno TNS (razlika u liječenju: 7,80; p = 0,0001; 95% intervala pouzdanosti:3,86; 11,73).
English: Studies were conducted using the Altera Nebuliser System to administer Cayston.
Croatian: Ispitivanja su provedena uporabom atomizatora Altera za primjenu Caystona.
English: Each 28-day pack of Cayston contains 84 vials of lyophilised Cayston and 88 solvent ampoules.
Croatian: Svako pakiranje Caystona za 28-dnevnu primjenu sadrži 84 bočice liofiliziranog Caystona i 88 ampula s otapalom.
English: The adjusted mean actual change from baseline in FEV1 % predicted across 3 treatment courses was 2.05 and -0.66 in the Cayston and TNS groups, respectively (treatment difference: 2.70; p = 0.0023; 95% CI: 0.98, 4.43).
Croatian: Prilagođena prosječna aktualna promjena u odnosu na početak u predviđenoj vrijednosti FEV1% kroz tri kure liječenja iznosila je 2,05 odnosno -0,66 u skupinama koje su primale Cayston odnosno TNS (razlika u liječenju: 2,70; p= 0,0023; 95% intervala pouzdanosti: 0,98; 4,43).
English: Gilead Sciences S.r.l.
Croatian: Italia Gilead Sciences S.r.l.
English: Sputum concentrations
Croatian: Koncentracije u iskašljaju
English: It is recommended that Cayston be administered immediately after reconstitution with solvent.
Croatian: Preporučuje se primijeniti Cayston odmah nakon rekonstitucije pomoću otapala.
English: In a 24-week active-controlled study of Cayston therapy, no increases in P. aeruginosa MIC50 (± 2 dilution change) were observed, whereas MIC90 increased to 4 times the initial MIC. At the end of the study, the percentage of patients with aztreonam MIC for P. aeruginosa above the parenteral breakpoint (> 8 µg/ml) increased from 34% at baseline to 49%, the percentage of patients with P. aeruginosa resistant to at least 1 betalactam antibiotic increased from 56% at baseline to 67%, and the percentage of patients with P. aeruginosa resistant to all 6 beta-lactam antibiotics tested increased from 13% at baseline to 18%.
Croatian: Na kraju ispitivanja postotak bolesnika s MIK aztreonamom za P. aeruginosa iznad granice osjetljivosti utvrđene kod intravenske primjene aztreonama (8 µg/ml) povećao se s 34% na početku na 49%, a postotak bolesnika s P. aeruginosa rezistentnih na barem jedan beta-laktamski antibiotik povećao se s 56% na početku na 67%, a postotak bolesnika s P. aeruginosa rezistentnih na svih 6 testiranih beta-laktamskih antibiotika povećao se s 13% na početku na 18%.
English: Breathe normally (inhale and exhale) through the mouthpiece.
Croatian: Normalno dišite (udišite i izdišite) kroz nastavak za usta.
English: cough, nasal congestion, wheezing, pharyngolaryngeal pain, dyspnoea
Croatian: kašalj, kongestija nosa, piskanje pri disanju, bol u ždrijelu i grkljanu, dispneja
English: No dose adjustment is necessary in cases of renal impairment since the systemic concentration of aztreonam following inhaled administration of Cayston is very low (approximately 1% of the concentration resulting from a dose of 500 mg aztreonam for injection).
Croatian: U slučajevima oštećenja funkcije bubrega nije potrebna prilagodba doze jer je sistemska koncentracija aztreonama nakon primjene Caystona inhalacijom vrlo mala (približno 1% koncentracije koja se postiže dozom od 500 mg aztreonama za injekciju).
English: Use a bronchodilator before each dose of Cayston.
Croatian: Prije svake doze Caystona uzmite bronhodilatator.
English: EU/1/09/543/001: 28-day pack of Cayston EU/1/09/543/002: 28-day pack of Cayston plus one Altera Nebuliser Handset
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/543/001: pakiranje Caystona za 28-dnevnu primjenu EU/1/09/543/002: pakiranje Caystona za 28-dnevnu primjenu te jedan ručni atomizator Altera
English: Package leaflet: Information for the user Cayston 75 mg powder and solvent for nebuliser solution
Croatian: Uputa o lijeku: Informacije za korisnika Cayston 75 mg prašak i otapalo za otopinu za atomizator aztreonam
English: No dose adjustment is necessary in cases of hepatic impairment.
Croatian: U slučajevima oštećenja funkcije jetre nije potrebna prilagodba doze.
English: How to store Cayston
Croatian: Kako čuvati Cayston
English: Individual patients' sputum aztreonam concentrations exhibited considerable variability.
Croatian: Koncentracije aztreonama u iskašljaju pojedinih bolesnika pokazale su znatnu varijabilnost.
English: What Cayston looks like and contents of the pack
Croatian: GILEAD SCIENCES Kako Cayston izgleda i sadržaj pakiranja
English: Systemic concentration of aztreonam following inhaled administration of Cayston is low compared to a standard dose of aztreonam for injection (approximately 1% of the concentration resulting from a dose of 500 mg aztreonam for injection).
Croatian: Sistemske koncentracije aztreonama nakon inhalacije Caystona male su u usporedbi s onima nakon standardne doze aztreonama za injekciju (približno 1% koncentracije koja se postiže dozom od 500 mg aztreonama za injekciju).
English: Safely dispose of the metal seal.
Croatian: Na siguran način odložite metalni prsten u otpad.
English: It's best to use Cayston immediately after you have made up the solution.
Croatian: Cayston je najbolje primijeniti odmah nakon priprave otopine.
English: In contrast, the serum concentration of aztreonam following administration of aztreonam for injection (500 mg) is approximately 54 µg/ml.
Croatian: Suprotno tome, koncentracija aztreonama u serumu nakon primjene aztreonama za injekciju (u dozi od 500 mg) iznosi približno
English: Powder and solvent for nebuliser solution.
Croatian: Prašak i otapalo za otopinu za atomizator.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CAYSTON OUTER CARTON (With a Blue Box - Not for co-packaging with the Altera Nebuliser Handset)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE CAYSTONA (S plavim okvirom - ne pakira se zajedno s ručnim atomizatorom Altera)
English: For inhalation use only.
Croatian: Samo za inhaliranje.
English: GILEAD
Croatian: DRUGO GILEAD
English: Cross-reactivity may occur in patients with a history of allergy to beta-lactam antibiotics, such as penicillins, cephalosporins, and/or carbapenems.
Croatian: U bolesnika koji su već imali alergiju na beta-laktamske antibiotike, primjerice peniciline, cefalosporine i/ili karbapeneme, može doći do križne reaktivnosti.
English: You can use either an eBase Controller or an eFlow rapid Control Unit with the Altera Handset.
Croatian: Altera možete koristiti i eBase Controller i kontrolnu jedinicu eFlow rapid.
English: Cayston needs to be mixed with a solvent before being inhaled through the Altera Nebuliser.
Croatian: Cayston je prije inhalacije pomoću atomizatora Altera potrebno pomiješati s otapalom.
English: Gilead Sciences Ireland UC Teл.
Croatian: Gilead Sciences Ireland UC
English: Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 2 401 35 50
Croatian: België/Belgique/Belgien Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 2 401 35 50
English: Additionally, aztreonam-treated patients had fewer hospitalisations due to respiratory events (40 versus 58, p = 0.044) and fewer respiratory events requiring the use of i.v.
Croatian: Pored toga, bolesnici liječeni aztreonamom imali su nižu stopu hospitalizacija zbog problema s dišnim sustavom (40 nasuprot 58, p = 0,044) te manje problema s dišnim sustavom koji su zahtijevali primjenu intravenskih ili inhalacijskih antipseudomonalnih antibiotika (84 nasuprot 121, p = 0,004) u odnosu na bolesnike liječene TNS-om.
English: - Joint pain - Lower lung function test results
Croatian: - smanjenje rezultata testova funkcije pluća
English: Cayston has no or negligible influence on the ability to drive or use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Cayston ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Cayston 75 mg powder and solvent for nebuliser solution.
Croatian: Cayston 75 mg prašak i otapalo za otopinu za atomizator.
English: arthralgia
Croatian: artralgija
English: Each powder vial contains 75 mg aztreonam.
Croatian: Jedna bočica s praškom sadrži 75 mg aztreonama.
English: Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 2 401 35 79
Croatian: Luxembourg/Luxemburg Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 2 401 35 79
English: The emergence of parenteral P. aeruginosa resistance to aztreonam or other beta-lactam antibiotics may have potential consequences for the treatment of acute pulmonary exacerbations with systemic antibiotics.
Croatian: Pojava rezistencije P. aeruginosa na aztreonam ili druge beta-laktamske antibiotike kod parenteralne primjene može imati potencijalne posljedice na liječenje akutnih plućnih egzacerbacija sistemskim antibioticima.
English: The emergence of parenteral P. aeruginosa resistance to aztreonam and other beta-lactam antibiotics may have potential consequences for the treatment of acute pulmonary exacerbations with systemic antibiotics.
Croatian: Pojava rezistencije P. aeruginosa na aztreonam i druge beta-laktamske antibiotike kod parenteralne primjene može imati posljedice na liječenje akutnih plućnih egzacerbacija sa sistemskim antibioticima.
English: Put the prepared Cayston solution in the Altera Nebuliser Handset (see below).
Croatian: Pripravljenu otopinu Caystona stavite u ručni atomizator Altera (vidjeti dolje).
English: rash1
Croatian: osip1
English: 88 single-use 1 ml ampoules of solvent
Croatian: 84 bočice za jednokratnu upotrebu 88 ampula s otapalom volumena 1 ml za jednokratnu upotrebu
English: - Take Cayston 3 times a day in repeated cycles of 28 days on therapy followed by 28 days off Cayston therapy.
Croatian: Preporučena doza je: - Cayston uzimajte 3 puta na dan u ponavljanim ciklusima od 28 dana terapije nakon čega slijedi 28 dana bez terapije Caystonom.
English: After reconstitution the nebuliser solution contains 75 mg aztreonam.
Croatian: Nakon rekonstitucije otopina za atomizator sadrži 75 mg aztreonama.
English: The liquid is squeezed out of one solvent ampoule into the glass vial.
Croatian: U staklenu se bočicu istisne tekućina iz jedne ampule s otapalom.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT AMPOULE LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA AMPULI S OTAPALOM
English: Powder vial and solvent ampoule:
Croatian: Bočica s praškom i ampula s otapalom:
English: • 28-day pack of Cayston
Croatian: • pakiranje Caystona za 28-dnevnu primjenu
English: A total of 137 paediatric patients aged 6 to 17 years with chronic P. aeruginosa infection and FEV1 ≤ 75% predicted have received Cayston in Phase 2 and Phase 3 clinical studies (6-12 years, n = 35; 13-17 years, n = 102).
Croatian: Ukupno 137 pedijatrijskih bolesnika u dobi od 6 do 17 godina s kroničnom infekcijom P. aeruginosa i predviđenim FEV1 ≤ 75% primili su Cayston u kliničkim ispitivanjima faze 2 i faze 3 (od 6 do
English: Sodium chloride Water for injections
Croatian: Prašak L-lizin Otapalo natrijev klorid voda za injekcije
English: Cayston 75 mg powder and solvent for nebuliser solution aztreonam
Croatian: Cayston 75 mg prašak i otapalo za otopinu za atomizator aztreonam
English: Among patients with multidrug-resistant P. aeruginosa, improvements in respiratory symptoms and pulmonary function were observed following treatment with Cayston.
Croatian: Nakon liječenja Caystonom u bolesnika s bakterijom P. aeruginosa rezistentnom na više lijekova primijećena su poboljšanja dišnih simptoma i plućne funkcije.
English: Patients should use a bronchodilator before each dose of Cayston.
Croatian: Prije svake doze Caystona bolesnici trebaju primjeniti bronhodilatator.
English: lung function test decreased1 1 See section Description of selected adverse reactions
Croatian: 1 Vidjeti dio Opis odabranih nuspojava
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Cayston VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI Caystona
English: Lung function test decreased
Croatian: smanjenje rezultata testiranja funkcije pluća1
English: injection in rats at daily doses up to 750 mg/kg without adverse effects.
Croatian: Ispitivanja utjecaja na plodnost te teratološka, perinatalna i postnatalna ispitivanja aztreonama za intravensku injekciju provedena su na štakorima u dnevnim dozama do 750 mg/kg bez štetnih učinaka.
English: 44 single-use 1 ml ampoules of solvent
Croatian: 42 bočice za jednokratnu upotrebu 44 ampule s otapalom volumena 1 ml za jednokratnu upotrebu
English: Contents of the pack and other information What Cayston and the solvent contain
Croatian: Moguće nuspojave Kako čuvati Cayston Sadržaj pakiranja i druge informacije
English: Cayston may be taken in repeated cycles of 28 days on therapy followed by 28 days off Cayston therapy.
Croatian: Cayston se može uzimati u ponavljanim ciklusima od 28 dana terapije nakon čega slijedi 28 dana bez uzimanja lijeka.
English: Cayston should not be mixed with any other medicinal products in the Altera Nebuliser Handset.
Croatian: Cayston se u ručnom atomizatoru Altera ne smije miješati ni s kojim drugim lijekom.
English: The co-primary endpoints were non-inferiority of Cayston to TNS in relative change from baseline to Day 28 in FEV1 % predicted and superiority of Cayston to TNS in actual change from baseline in
Croatian: Koprimarni ishodi bili su neinferiornost Caystona u odnosu na TNS u relativnoj promjeni u odnosu na početak do 28. dana u predviđenoj vrijednosti FEV1% te superiornost Caystona u odnosu na TNS u aktualnoj promjeni u odnosu na početak u predviđenoj vrijednosti FEV1% tijekom tri kure liječenja (prosjek aktualne promjene predviđenog FEV1% primijećenog na kraju svake kure liječenja).
English: • Pack containing one 28-day pack of Cayston plus one Altera Nebuliser Handset
Croatian: • pakiranje koje sadrži jedno pakiranje Caystona za 28-dnevnu primjenu te jedan ručni atomizator
English: Caystonis an antibiotic used to suppress chronic lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis.
Croatian: Cayston je antibiotik koji se primjenjuje u bolesnika s cističnom fibrozom u dobi od 6 godina i starijih za suzbijanje kronične infekcije pluća koju uzrokuje bakterija
English: The in vitro antimicrobial susceptibility test methods used for parenteral aztreonam therapy can be used to monitor the susceptibility of P. aeruginosa isolated from CF patients.
Croatian: Za praćenje osjetljivosti P. aeruginosa izolirane u bolesnika s CF-om mogu poslužiti postupci in vitro ispitivanja osjetljivosti na antimikrobne lijekove koji se koriste kod parenteralne terapije aztreonamom.
English: Gilead Sciences s.r.o.
Croatian: Slovenská republika Gilead Sciences Slovakia s.r.o.
English: antipseudomonal antibiotics related to respiratory events compared to TNS-treated patients (p = 0.0025).
Croatian: Bolesnicima liječenim aztreonamom trebalo je više vremena da osjete potrebu za intravenskim antipseudomonalnim antibioticima za liječenje događaja u dišnom sustavu u usporedbi s bolesnicima koji su liječeni TNS-om (p = 0,0025).
English: Each vial contains aztreonam lysine equivalent to 75 mg aztreonam.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka bočica sadrži aztreonamlizin što odgovara 75 mg aztreonama.
English: After reconstitution, each ml of the nebuliser solution contains 75 mg aztreonam (as lysine).
Croatian: Nakon priprave jedan mililitar otopine za atomizator sadrži 75 mg aztreonama (u obliku aztreonamlizina).
English: EU/1/09/543/002: 28-day pack of Cayston plus one Altera Nebuliser Handset
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/543/002: pakiranje Caystona za 28-dnevnu primjenu te jedan ručni atomizator Altera
English: dose was recovered in the urine by 8 hours, and urinary excretion was essentially complete by 12 hours.
Croatian: U zdravih bolesnika 60%-70% jedne intramuskularne ili intravenske doze otkriveno je u urinu nakon 8 sati, a izlučivanje urinom bilo je dovršeno za 12 sati.
English: doses, the serum concentrations are comparable at 1 hour (1.5 hours from the start of i.v.
Croatian: Koncentracije u serumu usporedive su jedan sat (1,5 sati nakon početka intravenske infuzije) nakon davanja identičnih pojedinačnih intramuskularnih ili intravenskih doza, a poslije toga krivulje koncentracije u serumu imaju sličan nagib.
English: Aztreonam
Croatian: Carrigtohill
English: - Do not put other medicines in the Altera Nebuliser Handset.
Croatian: - U ručni atomizator Altera nemojte stavljati nikakve druge lijekove.
English: Treatment with up to nine 28-day courses of 75 mg 3 times a day Cayston therapy resulted in clinically important improvements in respiratory symptoms, pulmonary function, and sputum
Croatian: U razdoblju između početka i 28. dana u bolesnika liječenih jednom kurom Caystona plućna funkcija i dišni simptomi značajno su se poboljšali.
English: Remove the medicine cap by twisting anticlockwise.
Croatian: Skinite čep za lijek okrećući ga u smjeru suprotnom od kazaljke na satu.
English: EU/1/09/543/001: 28-day pack of Cayston
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/543/001: pakiranje Caystona za 28-dnevnu primjenu
English: Haemoptysis
Croatian: Hemoptiza
English: Pharmacokinetic studies have not been performed in patients with renal or hepatic impairment.
Croatian: U bolesnika s oštećenom funkcijom bubrega ili jetre nisu provedena ispitivanja farmakokinetičkih svojstava.
English: Step A: With the blue cap tab facing toward you, place the vial on a flat surface.
Croatian: Korak A: Postavite bočicu na ravnu površinu tako da jezičac plave kapice bude okrenut prema Vama.
English: Do not put other medicinal products in the Altera Nebuliser Handset.
Croatian: U ručni atomizator Altera nemojte stavljati nikakve druge lijekove.
English: Renal and hepatic impairment
Croatian: Oštećenje funkcije bubrega i jetre
English: After reconstitution, immediate use of Cayston is recommended.
Croatian: Preporučuje se primijeniti Cayston odmah nakon rekonstitucije.
English: Caution is advised when administering Cayston to patients if they have a history of beta-lactam allergy.
Croatian: Kad se Cayston primjenjuje u bolesnika koji su već imali alergije na beta-laktamske antibiotike, savjetuje se oprez.
English: Pour all of the prepared Cayston from the vial into the Altera Nebuliser Handset medicine reservoir (Figure 3a).
Croatian: 3. Izlijte sav pripravljeni Cayston iz bočice u spremnik za lijek ručnog atomizatora Altera
English: Tell your doctor if you have any of these effects.
Croatian: Ako imate bilo koju od ovih pojava, obavijestite svog liječnika.
English: Powder vial: Type I amber glass vial with siliconised grey rubber stopper and aluminium tear off overseal with a blue cap.
Croatian: I sa silikoniziranim sivim gumenim čepom i aluminijskim prstenom s plavom kapicom.
English: Hepatic impairment
Croatian: Tablični sažetak nuspojava
English: bronchodilator mucolytics and lastly, Cayston.
Croatian: U bolesnika koji uzimaju višestruke terapije inhalacijom, preporučeni redoslijed primjene je sljedeći: bronhodilatator mukolitici i na kraju Cayston.
English: Gilead Sciences Slovakia s.r.o Tel: + 421 232 121 210
Croatian: Česká republika Gilead Sciences s.r.o. Tel: + 420 910 871 986
English: P. aeruginosa CFU density; no increases in P. aeruginosa MIC50 (± 2 dilution change) were observed,
Croatian: U 24-tjednom aktivno kontroliranom ispitivanju Caystona nije bilo porasta u MIK50 P. aeruginosa (± 2 promjene u razrijeđenosti) dok se MIK90 povećala na četverostruku vrijednost početne MIK.
English: - The powder vial contains 75 mg aztreonam (as lysine).
Croatian: Što Cayston i otapalo sadrže - Bočica s praškom sadrži 75 mg aztreonama (u obliku aztreonamlizina).
English: administration.
Croatian: C.
English: What is Diotop?
Croatian: Što je Diotop?
English: What is the outcome of the review?
Croatian: Koji je rezultat procjene?
English: Why was Diotop reviewed?
Croatian: Zašto je Diotop pregledavan?
English: The two active substances in Diotop have different effects.
Croatian: Dvije djelatne tvari lijeka Diotop imaju različit učinak.
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Croatian: Pregled je proveo EMA-in Odbor za lijekove za humanu uporabu (CHMP), nadležan za pitanja koja se odnose na lijekove za primjenu u ljudi.
English: The review of Diotop was initiated at the request of the United Kingdom, under Article 29(4) of Directive 2001/83/EC.
Croatian: Pregled lijeka Diotop pokrenut je na zahtjev Ujedinjene Kraljevine temeljem članka 29. stavka 4. Direktive 2001/83/EZ.
English: The grounds for the referral were concerns raised by Germany that the data provided by the company were not enough to demonstrate the safety and effectiveness of Diotop.
Croatian: Osnova za postupak upućivanja bila je zabrinutost koju je navela Njemačka, da podatci koje je tvrtka stavila na raspolaganje nisu dovoljni za utvrđivanje sigurnosti i djelotvornosti lijeka Diotop.
English: EMA completes review following disagreement among EU Member States
Croatian: EMA je okončala pregled nakon neslaganja među državama članicama EU-a
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 28 September 2018.
Croatian: Međutim, države članice nisu mogle postići dogovor pa je regulatorna agencija za lijekove Ujedinjene Kraljevine uputila predmet EMA-i na arbitražni postupak 28. rujna 2018.
English: Temmler Pharma GmbH requested that the marketing authorisation for Diotop granted by the UK and Austria in 2016 be recognised in Germany (the ‘concerned Member State').
Croatian: Tvrtka Temmler Pharma GmbH zatražila je da se odobrenje za stavljanje u promet za lijek Diotop koje je na snazi u UK-u i Austriji od 2016. prizna u Njemačkoj („državi članici u pitanju”).
English: The European Commission issued an EU-wide legally binding decision on the marketing authorisation of Diotop on 31/01/2019.
Croatian: Europska komisija izdala je pravno obvezujuću odluku na razini EU-a o odobrenju za stavljanje u promet lijeka Diotop dana 31/01/2019.
English: On 15 November 2018, the European Medicines Agency completed a review of Diotop following a disagreement among EU Member States regarding its authorisation.
Croatian: Europska agencija za lijekove je 15. studenoga 2018. okončala pregled lijeka Diotop nakon neslaganja među državama članicama EU-a u pogledu izdavanja odobrenja za dotični lijek.
English: Both diclofenac and omeprazole have been authorised in the EU for many years.
Croatian: I diklofenak i omeprazol odobreni su u EU-u već niz godina.
English: The company submitted data from the published literature on the use of several NSAIDs (including diclofenac at the dose of 50 to 150 mg a day) and omeprazole in combination.
Croatian: Tvrtka je podnijela podatke iz objavljene literature o primjeni kombinacije više NSAID-ova (uključujući diklofenak u dozi od 50 do 150 mg dnevno) i omeprazola.