FrancophonIA/ELRC3.0 huggingface dataset:
English: It was also noted that autoimmune thyroiditis was reported in the recent fatal case as well as in one of the Hy's law adjudicated cases; therefore treatment initiation is not recommended in patients with history of concurrent autoimmune conditions.
Croatian: Također je evidentirano da je zabilježen autoimuni tireoiditis u nedavnom fatalnom slučaju, kao i u jednom od riješenih slučajeva „Hyjeva zakona”.
English: Ambroxol and bromhexine medicines have been authorised in: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
Croatian: Lijekovi koji sadrže ambroksol i bromheksin odobreni su u: Austriji, Belgiji, Bugarskoj, Cipru, Hrvatskoj, Češkoj Republici, Danskoj, Estoniji, Finskoj, Francuskoj, Njemačkoj, Grčkoj, Mađarskoj, Islandu, Irskoj, Italiji, Latviji, Litvi, Luksemburgu, Malti, Nizozemskoj, Norveškoj, Poljskoj, Portugalu, Rumunjskoj, Slovačkoj, Sloveniji, Španjolskoj i Švedskoj.
English: The review of ambroxol and bromhexine was initiated on 4 April 2014 at the request of Belgium, under Article 31 of Directive 2001/83/EC.
Croatian: Ponovno ocjenjivanje ambroksola i bromheksina započeto je 4. travnja 2014. na zahtjev Belgije u skladu s člankom 31. Direktive 2001/83/EZ.
English: 14 January 2016 EMA/168579/2015
Croatian: EMA/168579/2015
English: As these medicines have been authorised via national procedures, approved uses are not the same in all EU countries.
Croatian: Budući da su ti lijekovi odobreni u okviru nacionalnih postupaka, odobrene primjene nisu iste u svim zemljama EU-a.
English: Frequencies of these side effects are unknown.
Croatian: Učestalost tih nuspojava nije poznata.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States.
Croatian: 1 CMDh je regulatorno tijelo za lijekove sastavljeno od predstavnika svih država članice Europske unije (EU).
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Croatian: Ponovno ocjenjivanje proveo je Odbor za procjenu rizika u području farmakovigilancije (PRAC), odbor odgovoran za procjenu sigurnosnih pitanja u pogledu lijekova za humanu uporabu, koji je iznio niz preporuka.
English: The majority of these medicines are available over the counter, whereas some are prescription-only medicines, depending on the condition to be treated and how the treatment is given.
Croatian: Većina tih lijekova dostupna je bez liječničkog recepta, no neki od njih izdaju se samo na liječnički recept, što ovisi o oboljenju koje je potrebno liječiti i načinu na koji se terapija primjenjuje.
English: Reports of severe allergic reactions and SCARs in patients taking the medicines are rare, and the frequencies of these side effects are unknown.
Croatian: Prijave o teškim alergijskim reakcijama i SCAR-ovima u bolesnika koji uzimaju te lijekove rijetke su, a učestalost tih nuspojava nije poznata.
English: This position was then sent to the European Commission which issued an EU-wide legally binding decision on 14/01/2016.
Croatian: To je stajalište zatim poslano Europskoj komisiji, koja je 14. siječnja 2016. objavila odluku koja je zakonski obvezujuća na području cijelog EU-a.
English: As the CMDh position was adopted by majority vote, it was sent to the European Commission, which endorsed it and issued an EU-wide legally binding decision.
Croatian: Budući da je CMDh-ovo stajalište usvojeno većinom glasova, poslano je Europskoj komisiji, koja ga je odobrila i objavila u odluci koja je zakonski obvezujuća na području cijelog EU-a.
English: The CMDh first adopted a position by majority vote in February 2015, following which the European Commission requested clarifications on the PRAC recommendation and CMDh position.
Croatian: CMDh je prvo većinom glasova usvojio stajalište u veljači 2015., a zatim je Europska komisija zatražila objašnjenje PRAC-ove preporuke i CMDh-ova stajališta.
English: • If you experience skin reactions such as skin swellings or rash, stop treatment immediately and contact your doctor.
Croatian: • Ako primijetite kožne reakcije kao što su kožne otekline ili osip, smjesta prekinite liječenje i obratite se svom liječniku.
English: • If you are taking ambroxol or bromhexine and have any questions or concerns speak to your doctor of pharmacist.
Croatian: • Ako uzimate ambroksol ili bromheksin i imate bilo kakvih pitanja ili nedoumica, obratite se svom liječniku ili ljekarniku.
English: As ambroxol- and bromhexine-containing medicines are all authorised nationally, the PRAC recommendation was forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), for a position.
Croatian: Budući da su svi lijekovi koji sadrže ambroksol i bromheksin odobreni na nacionalnoj razini, preporuka PRAC-a proslijeđena je Koordinacijskoj skupini za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh) radi usvajanja stajališta.
English: A revised CMDh position was subsequently adopted, by majority vote in November 2015.
Croatian: Naknadno je u studenome 2015. većinom glasova usvojeno revidirano CMDh-ovo stajalište.
English: The recommendations were originally made by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed the previously known risk of allergic reactions and also identified a small risk of SCARs, a group of skin conditions which include erythema multiforme and Stevens-Johnson syndrome.
Croatian: Preporuke je izvorno sastavio Odbor za procjenu rizika u području farmakovigilancije (PRAC) pri EMA-i, koji je potvrdio postojanje prethodno poznatog rizika od alergijskih reakcija i također utvrdio postojanje malog rizika od SCAR-ova, skupine kožnih bolesti koje uključuju multiformni eritem (erythema multiforme) i Stevens-Johnsonov sindrom.
English: As a result, SCARs are now listed as side effects in the product information for these medicines, and patients are to stop treatment immediately if symptoms of SCARs occur.
Croatian: Kao rezultat toga, SCAR-ovi su sada uvršteni u nuspojave u informacijama o lijeku za te lijekove, a bolesnici trebaju smjesta prekinuti liječenje tim lijekovima ako imaju simptome SCAR-ova.
English: Some of these injectable formulations are also used to increase lung development before birth.
Croatian: Neke od tih formulacija za ubrizgavanje injekcijom primjenjuju se i za poticanje razvoja pluća prije rođenja.
English: Injectable formulations are also used to prevent and treat lung complications following surgery.
Croatian: Formulacije za ubrizgavanje injekcijom primjenjuju se također za sprečavanje i liječenje plućnih komplikacija nakon operacija.
English: Ambroxol and bromhexine expectorants: safety information updated
Croatian: Ekspektoransi koji sadrže ambroksol i bromheksin: ažurirane sigurnosne informacije
English: Ambroxol- and bromhexine-containing medicines are marketed as single products or as fixed combination products with various other active ingredients.
Croatian: Lijekovi koji sadrže ambroksol i bromheksin stavljaju se na tržište kao pojedinačni proizvodi ili kao fiksna kombinacija s raznim drugim djelatnim sastojcima.
English: In making the recommendations, the PRAC evaluated available data on ambroxol and bromhexine, including reports of severe allergic reactions or SCARs.
Croatian: Pri izradi preporuka PRAC je proveo ocjenjivanje dostupnih podataka o ambroksolu i bromheksinu, uključujući prijave o teškim alergijskim reakcijama i SCAR-ovima.
English: Ambroxol formulations for injection are also used in premature and newborn babies to treat respiratory distress syndrome, a condition in which the baby's lungs are too immature for the baby to breathe properly.
Croatian: Primjenjuju se također formulacije ambroksola za ubrizgavanje injekcijom, i to u prijevremeno rođene ili novorođene djece za liječenje respiratornog distres sindroma, stanja pri kojemu djetetova pluća nisu dovoljno zrela da bi ono moglo ispravno disati.
English: The medicines are widely available in the EU for use as expectorants (to help clear mucus from the airways).
Croatian: Ti su lijekovi široko dostupni za primjenu u EU-u kao ekspektoransi (lijekovi za olakšavanje iskašljavanja sluzi iz dišnih putova).
English: Ambroxol and bromhexine are mainly used by mouth as expectorants to help make the mucus thinner and therefore easier to be cleared away in patients with short- or long-term diseases of the lungs or airways.
Croatian: Ambroksol i bromheksin uglavnom se uzimaju kroz usta kao ekspektoransi radi razrjeđivanja sluzi u dišnim putovima u svrhu olakšavanja iskašljavanja te sluzi u bolesnika s kratkotrajnim ili dugotrajnim bolestima pluća ili dišnih putova.
English: On 18 November 2015, the CMDh1 endorsed by majority vote recommendations to update the product information for ambroxol- and bromhexine-containing medicines with information about the small risk of severe allergic reactions and severe cutaneous adverse reactions (SCARs).
Croatian: CMDh1 je 18. studenoga 2015. većinom glasova usvojio preporuke za ažuriranje informacija o lijeku za lijekove koji sadrže ambroksol i bromheksin informacijama o malom riziku od teških alergijskih reakcija i teških kožnih nuspojava (SCAR-ova).
English: • Advise your patients that they should stop treatment immediately if symptoms of progressive skin rash occur.
Croatian: • Bolesnike je potrebno savjetovati da u slučaju pojave progresivnog kožnog osipa smjesta prekinu uzimanje lijeka.
English: For ambroxol, lozenge formulations are also available to relieve sore throat.
Croatian: Za ambroksol su također dostupne formulacije u obliku pastila koje ublažuju grlobolju.
English: EU Member States, and is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Croatian: CMDh regulatorno je tijelo sastavljeno od predstavnika svih država članica EU-a, a odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove odobrene u okviru nacionalnih postupaka na području EU-a.
English: Risk of allergy and skin reactions included in the product information
Croatian: U informacije o proizvodu uključene su informacije o riziku od alergijskih i kožnih reakcija
English: • The risk of anaphylactic reactions and SCARs with ambroxol or bromhexine is low.
Croatian: • Rizik od anafilaktičkih reakcija i SCAR-ova povezanih s primjenom ambroksola i bromheksina nizak je.
English: • As ambroxol is a metabolite of bromhexine, the risk of anaphylactic and severe cutaneous reactions is considered to apply also to bromhexine.
Croatian: • Budući da je ambroksol metabolit bromheksina, smatra se da se rizik od anafilaktičkih reakcija i teških kožnih nuspojava odnosi i na bromheksin.
English: • Anaphylactic reactions and severe cutaneous adverse reactions (SCARs), including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis, have been reported in patients receiving ambroxol.
Croatian: • U bolesnika koji uzimaju ambroksol zabilježena je pojava anafilaktičkih reakcija i teških kožnih nuspojava (SCAR-ova), uključujući multiformni eritem, Stevens-Johnsonov sindrom / toksičnu epidermalnu nekrolizu i akutnu generaliziranu egzantematoznu pustulozu.
English: • There is a small risk of allergy and skin reactions with ambroxol and bromhexine used as expectorants to clear mucus in the airways.
Croatian: • Pri uporabi ambroksola i bromheksina koji se primjenjuju kao ekspektoransi za iskašljavanje sluzi iz dišnih putova postoji mali rizik od pojave alergijskih i kožnih reakcija.
English: Pharmaceutical forms
Croatian: Farmaceutski oblik
English: 3505 Lemesos Cyprus terbutaline
Croatian: 3505 Lemesos Cyprus terbutalin
English: Norway AstraZeneca AS Innspurten 15
Croatian: Norveška AstraZeneca AS Innspurten 15
English: DK-2605 Brøndby
Croatian: DK-2605 Brøndby Denmark
English: Austria AstraZeneca Österreich GmbH
Croatian: AstraZeneca Österreich GmbH
English: Cyprus Medochemie Ltd 1-10 Constantinoupoleos Street
Croatian: Medochemie Ltd 1-10 Constantinoupoleos Street
English: France AstraZeneca 1, place Renault 92844 Rueil Malmaison Cedex
Croatian: Francuska AstraZeneca 1, place Renault 92844 Rueil Malmaison Cedex
English: Torre 3 - 12, 1099-036 Portugal isoxsuprine
Croatian: Torre 3 - 12, 1099-036 Portugal izoksuprin
English: AstraZeneca UK Limited 600 Capability Green Luton, LU1 3LU United Kingdom terbutaline
Croatian: AstraZeneca UK Limited 600 Capability Green Luton, LU1 3LU United Kingdom terbutalin
English: Hungary AstraZeneca Kft. Bocskai út 134-146.
Croatian: Bocskai út 134-146.
English: GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France
Croatian: Francuska Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France
English: Sweden AstraZeneca AB SE - 151 85 Södertälje Sweden terbutaline
Croatian: AstraZeneca AB SE - 151 85 Södertälje Sweden terbutalin
English: Ireland GlaxoSmithKline (Ireland) Limited
Croatian: GlaxoSmithKline (Ireland) Limited
English: Laboratoire Renaudin Z A. Errobi
Croatian: Francuska Laboratoire Renaudin Z A.
English: Belgium SCS Boehringer Ingelheim SA Avenue Ariane 16
Croatian: SCS Boehringer Ingelheim SA Avenue Ariane 16
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Croatian: Dodatak I Popis naziva, farmaceutskih oblika, jačina lijekova, putova primjene,
English: Belgium fenoterol
Croatian: The Netherlands fenoterol
English: Sant Joan Despi Barcelona 08970
Croatian: Barcelona 08970
English: Partusisten, concentraat voor oplossing voor intraveneuze infusie 50 microgram/ml
Croatian: Partusisten, concentraat voor oplossing voor intraveneuze infusie 50 microgram/ml koncentrat za otopinu za infuziju
English: Karolkowa 22/24 01-207 Warszawa Poland
Croatian: Warszawskie Zakłady Farmaceutyczne Polfa S.A. ul. Karolkowa 22/24 01-207 Warszawa Poland
English: Romania GLAXO WELLCOME UK Limited
Croatian: Rumunjska GLAXO WELLCOME UK Limited
English: Luxembourg Eumedica S.A. Av. Winston Churchill 67 B-1180 Bruxelles Belgium ritodrine
Croatian: Luksemburg Eumedica S.A. Av. Winston Churchill 67 B-1180 Bruxelles Belgium ritodrin
English: Film- coated tablet
Croatian: Bricanyl filmom obložena tableta
English: Ventolin 1mg/ml Concentrate for Solution for Intravenous Infusion
Croatian: Ventolin 1mg/ml Concentrate for Solution for Intravenous Infusion koncentrat za otopinu za intravensku infuziju
English: ATALINE syrup 1.5 mg/5ml
Croatian: ATALINE syrup 1.5 mg/5ml sirup
English: SALBUMOL 1 mg, suppository
Croatian: SALBUMOL 1 mg, suppository čepić rektalno
English: Laboratorio Reig Jofre SA. Gran Capita 10
Croatian: Španjolska Laboratorio Reig Jofre SA.
English: Cvetkova ulica 29 1000 Ljubljana Slovenija
Croatian: 1000 Ljubljana Slovenija
English: Grunwaldzka 189 60-322 Poznań Poland fenoterol
Croatian: GlaxoSmithKline Pharmaceuticals S.A. ul. Grunwaldzka 189 60-322 Poznań Poland fenoterol
English: Ventolin solution à diluer pour perfusion
Croatian: Ventolin solution à diluer pour perfusion otopina za injekciju u venu
English: France terbutaline
Croatian: France terbutalin
English: B-1300 wavre
Croatian: B-1300 Wavre Belgium
English: Norway terbutaline
Croatian: Norway terbutalin
English: Denmark GlaxoSmithKline Pharma A/S
Croatian: GlaxoSmithKline Pharma A/S
English: 1817 MS Alkmaar The Netherlands fenoterol
Croatian: 1817 MS Alkmaar
English: B-1200 Woluwe-Saint
Croatian: B-1200 Woluwe-Saint-Lambert Belgium fenoterol
English: Hungary terbutaline
Croatian: Hungary terbutalin
English: Boehringer Ingelheim Pharma GmbH & Co. KG Binger Str. 173
Croatian: Boehringer Ingelheim Pharma GmbH & Co.
English: VENTOLIN®, soluţie injectabilă, 0,5 mg/ml
Croatian: VENTOLIN®, soluţie injectabilă, 0,5 mg/ml otopina za injekciju parenteralno
English: Belgium EUMEDICA N.V. Av. Winston Churchill 67 B-1180 Bruxelles Belgium ritodrine
Croatian: Av. Winston Churchill 67 B-1180 Bruxelles Belgium ritodrin
English: Greece ritodrine
Croatian: Greece ritodrin
English: Italy ritodrine
Croatian: Italy ritodrin
English: Spain ritodrine
Croatian: Spain ritodrin
English: Solution for injection/infusion
Croatian: otopina za injekciju/infuziju
English: Bricanyl Syrup 0.3mg/ml
Croatian: Bricanyl Syrup 0,3mg/ml oralna otopina
English: Italy isoxsuprine
Croatian: Italy izoksuprin
English: Luxembourg GlaxoSmithKline Pharmaceuticals S.A./N.V.
Croatian: Luksemburg GlaxoSmithKline Pharmaceuticals S.A./N.V.
English: SALBUMOL FORT 5 mg / 5 ml solution for infusion
Croatian: SALBUMOL FORT 5 mg / 5 ml solution for infusion otopina za infuziju u venu
English: SALBUTAMOL MYLAN 5 mg/5 ml, solution for infusion
Croatian: SALBUTAMOL MYLAN 5 mg/5 ml, solution for infusion otopina za infuziju u venu
English: A-1037 Vienna
Croatian: Schwarzenbergplatz 7 A-1037 Vienna Austria terbutalin
English: Prolonged-release tablet
Croatian: Dilum Retard tableta s produljenim oslobađanjem
English: Solution for injection Concentrate for solution for injection
Croatian: otopina za injekciju koncentrat za otopinu za injekciju
English: Ventolin solution injectable
Croatian: Ventolin solution injectable otopina za injekciju u venu
English: Concentrate for infusion
Croatian: Partusisten koncentrat za otopinu za infuziju
English: Bricanyl 500 micrograms/ml solution for injection or infusion
Croatian: Bricanyl 500 micrograms/ml solution for injection or infusion otopina za injekciju ili infuziju potkožno, u mišić, u venu
English: Bricanyl Depot
Croatian: Bricanyl oralna otopina
English: Boehringer Ingelheim B.V. Comeniusstraat 6
Croatian: Nizozemska Boehringer Ingelheim B.V.
English: BRICANYL 0.5 mg/1 ml Solution for injection
Croatian: BRICANYL 0.5 mg/1 ml Solution for injection otopina za injekciju u venu, potkožno
English: Ventolin 500 micrograms/ml Solution for Injection
Croatian: Ventolin 500 micrograms/ml Solution for Injection otopina za infuziju potkožno, u mišić, u venu
English: Salbutamol Tablets BP 4mg
Croatian: Salbutamol Tabletas BP 4mg
English: Lambert
Croatian: Errobi
English: VENTOLIN 4MG 4mg
Croatian: VENTOLIN 4MG 4mg oralna otopina
English: PRE-PAR 50MG/5ML 50mg/5ml
Croatian: PRE-PAR 50MG/5ML 50mg/5ml otopina za injekciju u venu
English: Pre-Par solution injectable
Croatian: Pre-Par solution injectable otopina za injekciju/infuziju
English: Bricanyl 0,5 mg/ml oldatos injekció
Croatian: Bricanyl 0,5 mg/ml oldatos injekció otopina za injekciju ili infuziju
English: Solution for injection Intravenous use, Intramuscular use,
Croatian: Ventolin Solution for Intravenous Infusion otopina za injekciju u venu, potkožno
English: GlaxoSmithKline Pharmaceuticals S.A. ul.
Croatian: GlaxoSmithKline Pharmaceuticals S.A./N.V.
English: Partusisten intrapartal
Croatian: oralna otopina
English: Syrup
Croatian: Cipar
English: SALBUMOL 0,5 mg/1 ml, solution for injection
Croatian: SALBUMOL 0,5 mg/1 ml, solution for injection otopina za injekciju u venu, u mišić, potkožno
English: Takeda Austria GmbH St.-Peter-Straße 25 A -4020 Linz Austria hexoprenaline Gynipral 25 μgKonzentrat zur
Croatian: Takeda Austria GmbH St.-Peter-Straße 25 A -4020 Linz Austria heksoprenalin Gynipral 25 μgKonzentrat zur
English: Solution for injection Parenteral use
Croatian: Bricanyl otopina za injekciju parenteralno
English: Fenoterol Teva 0.05mg/ml
Croatian: Fenoterol Teva 0,05mg/ml otopina za injekciju
English: NYCOMED Austria GmbH St.-Peter-Straße 25 A -4020 Linz Austria hexoprenaline GYNIPRAL 0,5 mg,
Croatian: NYCOMED Austria GmbH St.-Peter-Straße 25 A -4020 Linz Austria heksoprenalin GYNIPRAL 0,5 mg,
English: GSK d.o.o.
Croatian: Slovenija GSK d.o.o. Cvetkova ulica 29
English: Takeda Austria GmbH St.-Peter-Straße 25 A -4020 Linz Austria hexoprenaline Gynipral 10 μg / 2 ml - Ampullen
Croatian: Takeda Austria GmbH St.-Peter-Straße 25 A -4020 Linz Austria heksoprenalin Gynipral 10 μg / 2 ml - Ampullen otopina za injekciju/infuziju
English: 0.025mg/5m l
Croatian: 0,025mg/5m l koncentrat za otopinu za infuziju
English: NYCOMED Austria GmbH St.-Peter-Straße 25 A -4020 Linz Austria hexoprenaline GYNIPRAL
Croatian: NYCOMED Austria GmbH St.-Peter-Straße 25 A -4020 Linz Austria heksoprenalin Gynipral
English: NYCOMED Austria GmbH St.-Peter-Straße 25 A -4020 Linz Austria hexoprenaline Gynipral
Croatian: NYCOMED Austria GmbH St.-Peter-Straße 25 A -4020 Linz Austria heksoprenalin GYNIPRAL
English: Stonemasons Way
Croatian: Comeniusstraat 6
English: VENTOLIN I.M.-S.C. 0.5mg
Croatian: VENTOLIN I.M.-S.C. 0,5mg otopina za injekciju u mišić, potkožno
English: VASOSUPRINA ILFI 10mg/2ml
Croatian: VASOSUPRINA ILFI 10mg/2ml otopina za injekciju u mišić, u venu
English: Concentrate for solution for injection
Croatian: otopina za injekciju
English: NYCOMED Austria GmbH St.-Peter-Straße 25 A -4020 Linz Austria hexoprenaline GYNIPRAL 10 μg/2 ml
Croatian: Takeda Austria GmbH St.-Peter-Straße 25 A -4020 Linz Austria heksoprenalin GYNIPRAL 10 MCG/2 ML
English: Rectal use
Croatian: Put primjene
English: Spain
Croatian: Švedska
English: --1 Live non-pathogenic Escherichia coli O8:K87* (F4ac):.......................1.3x108 to 9.0x108 CFU** Live non-pathogenic Escherichia coli O141:K94* (F18ac): ...............2.8x108 to 3.0x109 CFU**
Croatian: --1 Živa nepatogena Escherichia coli O8:K87* (F4ac):.......................1.3x108 do 9.0x108 CFU** Živa nepatogena Escherichia coli O141:K94* (F18ac): ...............2.8x108 do 3.0x109 CFU**
English: * not attenuated ** CFU - colony forming units
Croatian: * neatenuirano ** CFU - jedinice koje stvaraju kolonije
English: 4 vials Zero days
Croatian: 4 bočice Nula dana
English: EU (MA) Number Invented name
Croatian: EU (MA) broj
English: (Invented) name
Croatian: (Zaštiće no) ime
English: 0.6 ml (20 mg/ml) 1 vial
Croatian: 2 bočice + 2 sterilne štrcaljke za injekciju + 4 alkoholom natopljena jastučića
English: EU/1/18/1278/001 Carmustine Obvius 100 mg Powder and solvent for solution for infusion
Croatian: EU/1/18/1278/001 Carmustine Obvius 100 mg Prašak i otapalo za otopinu za infuziju
English: Powder: 100 mg Solvent: 3 ml
Croatian: Prašak: 100 mg Otapalo: 3 ml
English: Intravenous use Powder: vial (glass) Solvent: ampoule (glass)
Croatian: Prašak: bočica (staklena) Otapalo: ampula (staklena)
English: Pack size
Croatian: Intravenska primjena
English: - 3 years.
Croatian: - 3 godine.
English: See instructions below.
Croatian: Pogledajte upute niže.
English: Date of latest renewal: 22/05/2014
Croatian: Datum posljednje obnove: 22.05.2014.
English: Your doctor will not prescribe OSSEOR for you if you are at particular risk.
Croatian: Vaš liječnik Vam neće propisati OSSEOR ako imate visoki rizik.
English: What OSSEOR is and what it is used for
Croatian: Što je OSSEOR i za što se koristi
English: You should not leave more than 24 hours before you drink it.
Croatian: Otopina ne smije stajati duže od 24 sata prije nego ju popijete.
English: OSSEOR can treat your severe osteoporosis only if you continue to take it.
Croatian: OSSEOR može liječiti Vašu tešku osteoporozu samo ako nastavite uzimati lijek.
English: However, these effects were mild and short-lived and usually did not cause the patients to stop taking their treatment.
Croatian: Ove su nuspojave bile blage i kratkotrajne pa obično nisu dovodile do toga da bolesnici prekinu liječenje.
English: It is important that you continue taking OSSEOR for as long as your doctor prescribes the medicine.
Croatian: Važno je da nastavite uzimati OSSEOR sve dok Vam Vaš liječnik propisuje lijek.
English: The risk of these skin reactions in patients of Asian origin, particularly Han Chinese, may be predicted.
Croatian: Rizik od nastanka ovih kožnih reakcija može se predvidjeti kod bolesnika azijskog porijekla, osobito Han Kineza.
English: Talk to your doctor or pharmacist before taking OSSEOR: - if you are at risk of heart disease, this includes high blood pressure, high cholesterol,
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete OSSEOR: - ako imate rizik za srčanu bolest, što uključuje visoki krvni tlak, visoku razinu kolesterola,