FrancophonIA/ELRC3.0 huggingface dataset:
English: Irbesartan 75 mg Film-coated Tablets irbesartan
Croatian: Irbesartan 75 mg Filmcoated Tablets irbesartan
English: Omega 3 Strides Arcolab International omega-3-acid-ethyl esters 90
Croatian: Omega 3 Strides Arcolab International etilni[90]esteri omega-3 kiselina
English: Amlodipina + Valsartan Aurovitas, Amlodipin/Valsartan PUREN (in Germany)
Croatian: Amlodipin/Valsartan PUREN (u Njemačkoj)
English: 1000 mg Capsule, soft Oral use
Croatian: 1 000 mg kapsula, meka peroralna primjena
English: Naproxen 500 mg tablets naproxen
Croatian: Naproxen 500 mg tablets naproksen
English: ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 4 mg / 1.25 mg
Croatian: ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamid 4 mg/1,25 mg
English: Slovak Republic Proenzi s.r.o.
Croatian: Rumunjska Proenzi s.r.o.
English: ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 2 mg/ 0.625 mg
Croatian: ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamid 2 mg/0,625 mg
English: Bupropion-neuraxpharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung bupropion
Croatian: Bupropion-neuraxpharm 300 mg Tabletten mit veränderter
English: Levonorgestrel/Ethinylestradiol Famy Care 125 mikrogramů/30 mikrogramů ethinylestradiol / levonorgestrel
Croatian: Levonorgestrel/Ethinylestr adiol Famy Care 125 mikrogramů/30 mikrogramů etinilestradiol/levonor gestrel
English: 0.5 mg Capsule, soft Oral use
Croatian: 0,5 mg kapsula, meka peroralna primjena
English: Belgium Aurobindo Pharma BV
Croatian: Aurobindo Pharma BV
English: Carbimazole 5mg Tablets carbimazole
Croatian: Carbimazole 5mg Tablets karbimazol
English: Betahistyna Bluefish betahistine dihydrochloride
Croatian: Betahistyna Bluefish betahistin dihidroklorid
English: Hydroxyzine CRISTERS
Croatian: Hydroxyzine CRISTERS hidroksizin
English: Hydroxyzine ZENTIVA
Croatian: Hydroxyzine ZENTIVA hidroksizin
English: Maexeni 150/30 microgram Film Coated Tablets ethinylestradiol / levonorgestrel
Croatian: Maexeni 150/30 microgram Film Coated Tablets etinilestradiol/levonor gestrel mg/0,125 mg
English: Dawa Limited Carbimazole 5mg Tablets carbimazole
Croatian: Dawa Limited Carbimazole 5mg Tablets karbimazol
English: Dicloxacillin Alternova dicloxacillin
Croatian: Dicloxacillin Alternova dikloksacilin
English: Voriconazol Glob voriconazol
Croatian: Voriconazol Glob vorikonazol
English: Bupropion 1A Pharma 300 mg - Tablette mit veränderter Wirkstofffreisetzung bupropion
Croatian: Bupropion 1A Pharma 300 mg - Tablette mit veränderter
English: Naproxen Aurobindo 250 mg, tabletten
Croatian: Naproxen Aurobindo 250 mg, tabletten naproksen
English: Hydroxyzine ARROW hydroxyzine
Croatian: Hydroxyzine ARROW hidroksizin
English: Bupropion Sandoz 300 mgTablette mit veränderter Wirkstofffreisetzung bupropion
Croatian: Bupropion Sandoz 300 mg - Tablette mit veränderter Wirkstofffreisetzung bupropion
English: Betahistina Bluefish betahistine dihydrochloride
Croatian: Betahistina Bluefish betahistin dihidroklorid
English: Vzole 200 mg film-coated tablets voriconazol
Croatian: Vzole 200 mg film-coated tablets vorikonazol
English: Vzole 50 mg film-coated tablets voriconazol
Croatian: Vzole 50 mg film-coated tablets vorikonazol
English: Evolan Pharma AB
Croatian: Evolan Pharma AB Loperamid ABECE
English: Naproxeno Aurobindo
Croatian: Naproxeno Aurobindo naproksen
English: Voriconazolo Aurobindo voriconazol
Croatian: Voriconazolo Aurobindo vorikonazol
English: Voriconazole Milpharm 200 mg film-coated tablets voriconazol
Croatian: Voriconazole Milpharm 200 mg film-coated tablets vorikonazol
English: Naproxen Aurobindo 500 mg, tabletten
Croatian: Naproxen Aurobindo 500 mg, tabletten naproksen
English: Voriconazole Milpharm 50 mg film-coated tablets voriconazol
Croatian: Voriconazole Milpharm 50 mg film-coated tablets vorikonazol
English: Hydroxyzinhydrochlorid EQL Pharma hydroxyzine
Croatian: Hydroxyzinhydrochlorid EQL Pharma hidroksizin
English: Voriconazol Aurobindo 200 mg, filmomhulde tabletten voriconazol
Croatian: Voriconazol Aurobindo 200 mg, filmomhulde tabletten vorikonazol
English: Carbimazole 20 mg Tablets carbimazole
Croatian: Carbimazole 20 mg Tablets karbimazol
English: Voriconazol PUREN 200 mg Filmtabletten voriconazol
Croatian: Voriconazol PUREN 200 mg Filmtabletten vorikonazol
English: voriconazole Arrow voriconazol
Croatian: voriconazole Arrow vorikonazol
English: Esters ethyliques d'acides omega-3 Strides omega-3-acid-ethyl esters 90
Croatian: ELC Group s.r.o. Esters ethyliques d'acides omega-3 Strides etilni[90]esteri omega-3 kiselina
English: Voriconazol PUREN 50 mg Filmtabletten voriconazol
Croatian: Voriconazol PUREN 50 mg Filmtabletten vorikonazol
English: Voriconazol Aurobindo 50 mg, filmomhulde tabletten voriconazol
Croatian: Voriconazol Aurobindo 50 mg, filmomhulde tabletten vorikonazol
English: 4 mg /1.25 mg
Croatian: perindopril/indapamid 4 mg/1,25 mg
English: Hydroxyzine MYLAN
Croatian: Hydroxyzine MYLAN hidroksizin
English: Naproxen 250 mg tablets naproxen
Croatian: Naproxen 250 mg tablets naproksen
English: Hydroxyzine EQL Pharma hydroxyzine
Croatian: Hydroxyzine EQL Pharma hidroksizin
English: Betahistin Sandoz 8 mg betahistine
Croatian: Betahistin Sandoz 8 mg betahistin
English: Ethinylestradiol / Levonorgeshel Famy Care 30 mikrogramm 125 mikrogramm tablette ethinylestradiol / levonorgestrel
Croatian: Ethinylestradiol/Levonorge shel Famy Care 30 mikrogramm 125 mikrogramm tablette etinilestradiol/levonor gestrel mg/0,125 mg
English: Metformin 1000 mg Filmcoated tablet metformin hydrochloride
Croatian: Metformin 1000 mg Filmcoated tablet metformin hidroklorid 1 000 mg filmom obložena tableta
English: 375 mg Capsule, hard Oral use
Croatian: 375 mg kapsula, tvrda peroralna primjena
English: Memantine Dawa 20mg filmcoated tablets memantine
Croatian: Memantine Dawa 20mg filmcoated tablets memantin
English: Dawa Limited Carbimazole 20mg Tablets carbimazole
Croatian: Dawa Limited Carbimazole 20mg Tablets karbimazol
English: Betahistin Sandoz 16 mg betahistine
Croatian: Betahistin Sandoz 16 mg betahistin
English: 1 g
Croatian: KG
English: Metformin 850 mg Film-coated tablet metformin hydrochloride
Croatian: Metformin 850 mg Filmcoated tablet metformin hidroklorid 850 mg filmom obložena tableta
English: Voriconazol Aurovitas voriconazol
Croatian: Voriconazol Aurovitas vorikonazol
English: Carbimazole 20mg Tablets carbimazole
Croatian: Carbimazole 20mg Tablets karbimazol
English: Aripiprazole 30 mg tablets aripiprazole
Croatian: Aripiprazole 30 mg tablets aripiprazol
English: Memantine Dawa 10mg filmcoated tablets memantine
Croatian: Memantine Dawa 10mg filmcoated tablets memantin
English: Metformin 500 mg Film-coated tablet metformin hydrochloride
Croatian: Metformin 500 mg Filmcoated tablet metformin hidroklorid 500 mg filmom obložena tableta
English: Naproxen Aurobindo
Croatian: Naproxen Aurobindo naproksen
English: Etrixenal 250 mg tabletes naproxen
Croatian: ETRIXENAL 250 MG TABLETY
English: 20 mg Oro-dispersible tablet
Croatian: 20 mg raspadljiva tableta za usta
English: 150 mg Capsule, hard Oral use
Croatian: 150 mg kapsula, tvrda peroralna primjena
English: Tadalafil Milpharm 20 mg filmcoated tablets
Croatian: Tadalafil Milpharm 20 mg film-coated tablets
English: ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 8 mg / 2.5 mg
Croatian: ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamid 8 mg/2,5 mg tableta
English: 15 mg Oro-dispersible tablet
Croatian: 15 mg raspadljiva tableta za usta
English: Aripiprazole 5 mg tablets aripiprazole
Croatian: Aripiprazole 5 mg tablets aripiprazol
English: Arrow Génériques amlodipine / valsartan Arrow amlodipine / valsartan 10 mg/160 mg
Croatian: Arrow Génériques amlodipine/valsartan Arrow amlodipin/valsartan 10 mg/160 mg
English: 250 mg Capsule, hard Oral use
Croatian: 250 mg kapsula, tvrda peroralna primjena
English: 300 mg modified-release tablet
Croatian: 300 mg tableta s prilagođenim oslobađanjem
English: Aripiprazole 10 mg tablets aripiprazole
Croatian: Aripiprazole 10 mg tablets aripiprazol
English: 10 mg Oro-dispersible tablet
Croatian: 10 mg raspadljiva tableta za usta
English: Betahistine Sandoz 24 mg betahistine
Croatian: Betahistine Sandoz 24 mg betahistin
English: Arrow Génériques amlodipine / valsartan Arrow amlodipine / valsartan 5 mg/160 mg
Croatian: Arrow Génériques amlodipine/valsartan Arrow amlodipin/valsartan 5 mg/160 mg
English: 2 mg /0.625 mg
Croatian: perindopril/indapamid 2 mg/0,625 mg
English: Amlodipina + Valsartan Aurovitas amlodipine / valsartan 10 mg/160 mg
Croatian: Amlodipina + Valsartan Aurovitas amlodipin/valsartan 10 mg/160 mg
English: Betahistin Sandoz 24 mg betahistine
Croatian: Betahistin Sandoz 24 mg betahistin
English: 500 mg Capsule, hard Oral use
Croatian: 500 mg kapsula, tvrda peroralna primjena
English: Hydroxyzine Sandoz hydroxyzine
Croatian: Hydroxyzine SANDOZ hidroksizin
English: Amlodipine-Valsartan AB amlodipine / valsartan 10 mg/160 mg
Croatian: Amlodipine-Valsartan AB amlodipin/valsartan 10 mg/ 160 mg
English: Memantin Pharmascope 20 mg Filmtabletten memantine
Croatian: Memantin Pharmascope 20 mg Filmtabletten memantin
English: Amlodipina + Valsartan Aurovitas amlodipine / valsartan 5 mg /160 mg
Croatian: Amlodipina + Valsartan Aurovitas amlodipin/valsartan 5 mg/160 mg
English: Amlodipine-Valsartan AB amlodipine / valsartan 5 mg/160 mg
Croatian: Amlodipine-Valsartan AB amlodipin/valsartan 5 mg/ 160 mg
English: metformin hydrochloride
Croatian: betahistin dihidroklorid
English: Tadalafil Milpharm 10 mg filmcoated tablets
Croatian: Tadalafil Milpharm 10 mg film-coated tablets
English: Sarpin amlodipine / valsartan 10 mg /160 mg
Croatian: Sarpin amlodipin/valsartan 10 mg/160 mg
English: Memantin Pharmascope 10 mg Filmtabletten memantine
Croatian: Memantin Pharmascope 10 mg Filmtabletten memantin
English: Aripiprazole 15 mg tablets aripiprazole
Croatian: Aripiprazole 15 mg tablets aripiprazol
English: Memantine Pharmascope 10 mg filmomhulde tabletten memantine
Croatian: Memantine Pharmascope 10 mg filmomhulde tabletten memantin
English: Memantine Pharmascope 20 mg filmomhulde tabletten memantine
Croatian: Memantine Pharmascope 20 mg filmomhulde tabletten memantin
English: Pharmaceuticals AB
Croatian: Bluefish Pharmaceuticals AB
English: Hydroxyzine SANDOZ
Croatian: Hydroxyzine Sandoz hidroksizin
English: Tadalafil Milpharm 5 mg filmcoated tablets
Croatian: Tadalafil Milpharm 5 mg film-coated tablets
English: 8 mg/2.5 mg
Croatian: perindopril/indapamid 8 mg/2,5 mg tableta
English: Tablet
Croatian: naproksen
English: Atyxine hydroxyzine
Croatian: Atyxine hidroksizin
English: 300 mg Modified-release tablet
Croatian: 300 mg tablete s prilagođenim oslobađanjem
English: Amlodipine/ Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipine / valsartan 10 mg /160 mg
Croatian: Amlodipine/ Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipin/valsartan 10 mg/160 mg
English: Amlodipina/Valsartan Aurobindo 10 mg/160 mg comprimate filmate amlodipine / valsartan 10 mg/160 mg
Croatian: Amlodipina/Valsartan Aurobindo 10 mg/160 mg comprimate filmate amlodipin/valsartan 10 mg/160 mg
English: Amlodipine/ Valsartan Aurobindo 5/160 mg, filmomhulde tabletten amlodipine / valsartan 5 mg /160 mg
Croatian: Amlodipine/ Valsartan Aurobindo 5/160 mg, filmomhulde tabletten amlodipin/valsartan 5 mg/160 mg
English: Amlodipine/ Valsartan Aurobindo 5/80 mg, filmomhulde tabletten amlodipine / valsartan 5 mg /80 mg
Croatian: Amlodipine/ Valsartan Aurobindo 5/80 mg, filmomhulde tabletten amlodipin/valsartan 5 mg/80 mg filmom obložena tableta
English: Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipine / valsartan 5 mg /160 mg
Croatian: Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipin/valsartan 5 mg/160 mg
English: Napritum
Croatian: Napritum naproksen
English: amlodipine / valsartan 5 mg /160 mg
Croatian: amlodipin/valsartan 5 mg/160 mg
English: NRIM Limited)
Croatian: BCM Limited
English: Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipine / valsartan 5 mg /80 mg
Croatian: Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipin/valsartan 5 mg/80 mg filmom obložena tableta
English: amlodipine / valsartan 10 mg /160 mg
Croatian: amlodipin/valsartan 10 mg/160 mg
English: Arrow Génériques amlodipine / valsartan Arrow amlodipine / valsartan 5 mg/80 mg
Croatian: Arrow Génériques amlodipine/valsartan Arrow amlodipin/valsartan 5 mg/80 mg filmom obložena tableta
English: The Netherlands Pharmascope Ltd.
Croatian: Nizozemska Pharmascope
English: acide ursodesoxycholique Inopharm ursodeoxycholic acid 500 mg Film-coated tablet
Croatian: acide ursodesoxycholique Inopharm ursodeoksikolatna kiselina
English: Amlodipina + Valsartan Aurovitas amlodipine / valsartan 5 mg /80 mg
Croatian: Amlodipina + Valsartan Aurovitas amlodipin/valsartan 5 mg/80 mg filmom obložena tableta
English: Metformine Almus metformin hydrochloride
Croatian: Metformine Almus metformin hidroklorid 500 mg tableta
English: ursodeoxycholic acid 500 mg Film-coated tablet
Croatian: Metformina Almus metformin hidroklorid 500 mg filmom obložena tableta
English: Amlodipine-Valsartan AB amlodipine / valsartan 5 mg/80 mg
Croatian: Amlodipine-Valsartan AB amlodipin/valsartan 5 mg/80 mg filmom obložena tableta
English: 0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled pens (multipack)
Croatian: 6 (3x2) napunjenih brizgalica (višestruko pakovanje)
English: 0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled syringes with needle safety device (multipack)
Croatian: 6 (3x2) napunjenih štrcaljki sa sigurnosnom zaštitom igle (višestruko pakovanje)
English: 0.8 ml (40 mg/0.8ml) 2 pre-filled syringes with needle safety device
Croatian: 2 napunjene štrcaljke sa sigurnosnom zaštitom igle
English: 0.8 ml (40 mg/0.8ml) 1 pre-filled syringe with needle safety device
Croatian: 1 napunjena štrcaljka sa sigurnosnom zaštitom igle
English: Other changes
Croatian: Ostale promjene
English: The areas harmonised include:
Croatian: Područja usklađivanja uključuju:
English: 21 March 2014
Croatian: 21. ožujka 2014.
English: The European Commission issued a decision on 21 March 2014.
Croatian: Europska komisija usvojila je odluku dana 21. ožujka 2014.
English: What is Rocephin?
Croatian: Što je Rocephin?
English: Rocephin is marketed in the following EU Member States: Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Luxembourg, Malta, the Netherlands, Portugal, Romania, Sweden and the United Kingdom, as well as Iceland.
Croatian: Rocephin je stavljen na tržište u sljedećim državama članicama EU: Belgiji, Danskoj, Finskoj, Francuskoj, Njemačkoj, Grčkoj, Mađarskoj, Irskoj, Italiji, Latviji, Luksemburgu, Malti, Nizozemskoj, Portugalu, Rumunjskoj, Švedskoj i Ujedinjenom Kraljevstvu, kao i na Islandu.
English: Why was Rocephin reviewed?
Croatian: Zašto je Rocephin pregledan?
English: Rocephin is authorised in the EU via national procedures.
Croatian: Rocephin je odobren u EU putem nacionalnih postupaka.
English: This prevents the bacteria from building their cell walls, and eventually kills them.
Croatian: Ovo sprječava bakterije da izgrade svoje stanične stjenke, te ih naposljetku ubija.
English: • bacterial meningitis;
Croatian: • bakterijski meningitis;
English: Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion)
Croatian: Pitanja i odgovori o lijeku Rocephin i povezanim nazivima (ceftriakson, 250 mg, 500 mg, 1 g, 2 g, prašak za otopinu za injekciju ili infuziju)
English: The CHMP also harmonised other sections of the SmPC including section 4.3 (contraindications), 4.4 (special warnings and precautions for use) and 4.6 (pregnancy and lactation).
Croatian: CHMP je također uskladio ostale dijelove SPC-a uključujući dio 4.3 (kontraindikacije), 4.4 (posebna upozorenja i mjere opreza pri uporabi) i 4.6 (trudnoća i dojenje).
English: It is also available in the EU under other trade names: Rocefin, Rocephalin, Rocephalin cum lidocain, Rocephine.
Croatian: Dostupan je u EU pod drugim zaštićenim nazivima: Rocefin, Rocephalin, Rocephalin cum lidocain, Rocephine.
English: In adults and children over 12 years of age, the recommended dose varies between 1 and 4 g of Rocephin once daily depending on the condition it is used to treat.
Croatian: U odraslih osoba i djece starije od 12 godina, preporučena doza varira između 1 i 4 g lijeka Rocephin jednom na dan ovisno o stanju za čije se liječenje primjenjuje.
English: The CHMP concluded that Rocephin should be used to treat the following infections in adults and children, which were already approved in several but not all EU Member States:
Croatian: CHMP je zaključio da se Rocephin treba primjenjivati za liječenje slijedećih upala u odraslih i djece, koje su već odobrene u nekoliko, no ne u svim državama članicama EU:
English: On 23 January 2014, the European Medicines Agency completed a review of Rocephin.
Croatian: Dana 23. siječnja 2014., Europska agencija za lijekove završila je pregled lijeka Rocephin.
English: Rocephin should preferably be given into a vein by injection over a period of 5 minutes or by infusion (drip) over at least 30 minutes, or else by deep intramuscular injection.
Croatian: Rocephin treba po mogućnosti primjenjivati u venu injekcijom tijekom razdoblja od 5 minuta ili infuzijom (dripom) tijekom najmanje 30 minuta ili inače dubokom intramuskularnom injekcijom.
English: Having harmonised the indications, the CHMP also harmonised the recommendations on how to use Rocephin in adults and children.
Croatian: Nakon što su indikacije usklađene, CHMP je također uskladio i preporuke o načinu primjene lijeka Rocephin u odraslih i djece.
English: Ceftriaxone belongs to the group ‘cephalosporins'; it works by attaching to proteins on the surface of bacteria.
Croatian: Ceftriakson ubraja se u grupu "cefalosporina"; djeluje vezujući se na protein na površini bakterije.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Croatian: To je rezultiralo razlikama u načinu primjene lijeka diljem država članica, što je vidljivo iz sažetaka opisa svojstava lijeka (SPC-a), etiketa i uputa o lijeku u državama gdje je lijek stavljen u promet.
English: Rocephin is a medicine that contains the active substance ceftriaxone.
Croatian: Rocephin je lijek koji sadrži djelatnu tvar ceftriakson.
English: In children below 12 years of age, the recommended dose of Rocephin depends on body weight and the condition it is used to treat.
Croatian: U djece mlađe od 12 godina, preporučena doza lijeka Rocephin ovisni o tjelesnoj težini i stanju za čije se liječenje primjenjuje.
English: • intra-abdominal infections (infections within the abdomen);
Croatian: • intraabdominalne infekcije (infekcije unutar abdomena);
English: • bacterial endocarditis (an infection in the heart).
Croatian: • bakterijski endokarditis (infekcija u srcu).
English: Rocephin may be used to manage patients with neutropenia (low levels of neutrophils, a type of white blood cell) who also have fever suspected to be caused by bacterial infection, patients with bacteraemia (when the bacteria are detected in the blood) suspected to be caused by any of the infections mentioned above, and for the pre-operative prevention of surgical site infections.
Croatian: Rocephin se može koristiti za upravljanje bolesnicima oboljelima od neutropenije (niske razine neutrofila, tipa bijelih krvnih stanica) za koje se također sumnja da imaju groznicu uzrokovanu bakterijskom infekcijom, bolesnicima oboljelima od bakteremije (ako je bakterija otkrivena u krvi) za koju se sumnja da je uzrokovana bilo kojim prethodno spomenutom infekcijom, te za predoperativnu prevenciju infekcija u mjestu kirurškog zahvata.
English: The CHMP agreed that Rocephin should no longer be used to treat sinusitis (inflammation of the sinuses), pharyngitis (sore throat) and prostatitis (inflammation of the prostate, a gland of the male reproductive system) because not enough clinical data are available to support these indications.
Croatian: CHMP je suglasan da se Rocephin ne smije više koristiti za liječenje sinusitisa (upale sinusa), faringitisa (upale grla) i prostatitisa (upale prostate, žlijezde muškog reproduktivnog sustava) budući da nema dovoljno dostupnih kliničkih podataka koji bi podržali ove indikacije.
English: It is an antibiotic used to treat a wide range of bacterial infections including pneumonia (infection of the lungs) and meningitis (infection of the membranes around the brain and spine).
Croatian: To je antibiotik koji se koristi za liječenje širokog spektra bakterijskih infekcija uključujući pneumoniju (infekciju pluća) i meningitis (infekciju membrane oko mozga i kralježnice).
English: It may also be used to treat disseminated Lyme borreliosis (a bacterial infection spread to humans by infected ticks) in adults and children including neonates from 15 days of age.
Croatian: Može se također koristiti za liječenje diseminirane Lyme borelioze (bakterijske infekcije koju zaraženi krpelji prenose na ljude) u odraslih osoba i djece, uključujući i nedonoščad u dobi od 15 dana i starijih.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Rocephin in the European Union (EU).
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je da postoji potreba za usklađivanjem informacija za propisivanje lijeka Rocephin na razini Europske unije (EU).
English: • hospital- and community-acquired pneumonia (infection of the lungs caught in or outside the hospital);
Croatian: • bolnički i izvanbolnički stečena pneumonija (infekcija pluća stečena u i izvan bolnice);
English: • acute otitis media (infection of the middle ear);
Croatian: • akutni otitis media (upala srednjeg uha);
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Croatian: U svjetlu dostavljenih podataka i znanstvene rasprave unutar Povjerenstva, mišljenje je CHMP-a da SPC-ovi, etikete i upute za uporabu treba uskladiti na razini EU.
English: Rocephin may be used to treat acute exacerbations (flare-ups) of chronic obstructive pulmonary disease in adults.
Croatian: Rocephin se može koristiti za liječenje akutnih egzacerbacije (pogoršanja simptoma) kronične opstruktivne pulmonalne bolesti u odraslih osoba.
English: On 9 December 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Rocephin in the EU.
Croatian: Dana 9. prosinca 2011., Europska komisija uputila je predmet CHMP-u kako bi se uskladila odobrenja za stavljanje u promet lijeka Rocephin na razini EU.
English: • complicated skin and soft tissue infections;
Croatian: • komplicirane infekcije kože i mekog tkiva;
English: • complicated urinary tract infections, including pyelonephritis (kidney infection);
Croatian: • komplicirane infekcije urinarnog trakta, uključujući pielonefritis (upalu bubrega);
English: The company that markets these medicines is Roche.
Croatian: Ove lijekove stavlja u promet tvrtka Roche.
English: • infections of bones and joints;
Croatian: • infekcije kosti i zglobova;
English: • the sexually transmitted infections gonorrhoea and syphilis;
Croatian: • spolno prenosive bolesti poput gonoreje i sifilisa;
English: Rocephin was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Croatian: Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh) identificirala je potrebu za usklađivanjem lijeka Rocephin.
English: 1 dose 5 x 1 dose 10 x 1 dose
Croatian: 1 doza 5 x 1 doza 10 x 1 doza
English: Thereafter a maximum interval of two years is recommended (see scheme).
Croatian: Poslije toga preporučen je maksimalni interval od 2 godine (vidi shemu).