natgillin/translations-raw huggingface dataset:
It affects the cells that produce mucus and digestive juices. 
Utječe na stanice koje proizvode sluz i probavne sokove.
A further study involved 60 children aged 2 to 5 years with cystic fibrosis who had the F508del mutation in the CFTR gene. 
Dodatno ispitivanje provedeno je na 60-ero djece u dobi od dvije do pet godina s cističnom fibrozom koja su imala mutaciju F508del u genu CFTR.
This gene makes the CFTR protein, which is involved in regulating the production of mucus and digestive juices. 
Taj gen proizvodi bjelančevinu CFTR, koja djeluje na regulaciju proizvodnje sluzi i probavnih sokova.
What benefits of Orkambi have been shown in studies? 
Koje su koristi od lijeka Orkambi utvrđene u ispitivanjima?
It should be prescribed only to patients confirmed to have the F508del mutation in both copies of the CFTR gene. 
Trebao bi se propisivati samo bolesnicima u kojih je utvrđena mutacija F508del u objema kopijama gena CFTR.
Orkambi has been shown to improve lung function and lung ventilation in patients with cystic fibrosis from 6 years of age. 
Utvrđeno je da lijek Orkambi poboljšava funkciju i ventilaciju pluća u bolesnika s cističnom fibrozom u dobi od šest godina i starijih.
This mutation affects the gene for a protein called cystic fibrosis transmembrane conductance regulator (CFTR) which is involved in regulating the production of mucus and digestive juices. 
Ta mutacija utječe na gen za bjelančevinu pod nazivom transmembranski regulator provodljivosti (engl. skraćeno CFTR), koji djeluje na regulaciju proizvodnje sluzi i probavnih tekućina.
In cystic fibrosis, the secretions become thick and cause blockage. 
Pri cističnoj fibrozi izlučevine postaju guste i uzrokuju začepljenja.
For the full list of all side effects and restrictions with Orkambi, see the package leaflet. 
Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Orkambi potražite u uputi o lijeku.
These actions make mucus and digestive juices less thick. 
Ta djelovanja razrjeđuju sluz i probavne sokove.
How is Orkambi used? 
Kako se Orkambi primjenjuje?
Orkambi contains the active substances lumacaftor and ivacaftor. 
Orkambi sadrži djelatne tvari lumakaftor i ivakaftor.
22 March 2013 EMA/402540/2013 
22. ožujka 2013 EMA/402540/2013
Patients were followed for a median of 3.9 years. 
Bolesnici su praćeni tijekom medijana vremena od 3,9 godina.
Healthcare professionals should follow these recommendations: 
Zdravstveni djelatnici trebaju se pridržavati ovih preporuka:
Contact our press officers Monika Benstetter or Martin Harvey Allchurch 
Obratite se našim dužnosnicima za odnose s javnošću Monika Benstetter ili Martin Harvey Allchurch
Of those enrolled, 14,741 were from Europe and 10,932 were from China. 
Od uključenih ispitanika, njih 14 471 bilo je iz Europe, a 10 932 iz Kine.
They were available as modified release tablets (meaning that the two active substances are released at different rates over a few hours). 
Dostupne su kao tablete s modificiranim oslobađanjem (što znači da se dvije djelatne tvari otpuštaju pri različitim brzinama tijekom nekoliko sati).
The medicine has been marketed under one of these trade names by Merck Sharp & Dohme Ltd in all EU Member States, except Bulgaria, France and Romania. 
Lijek je stavljen na tržište pod jednom od ovih trgovačkih naziva od strane tvrtke Merck, Sharp i Dohme Ltd u svim državama članicama EU-a osim u Bugarskoj, Francuskoj i Rumunjskoj.
Further information on the PRAC recommendation and the background to this review can be found on Agency's website. 
Daljnje informacije o preporukama PRAC-a i pozadini ove procjene mogu se naći na web stranici Agencije.
Tredaptive, Pelzont and Trevaclyn suspended across the EU 
Tredaptive, Pelzont i Trevaclyn suspendirani širom EU-a
In higher doses, it reduces the levels of fat in the blood via a mechanism that is not fully understood. 
U višim dozama reducira razine masnoća u krvi putem mehanizma koji nije objašnjen do kraja.
• The review of Tredaptive, Pelzont and Trevaclyn was initiated at the request of the European Commission on 19 December 2012, under Article 20 of Regulation (EC) No 726/2004 following the procedural steps laid out in Article 107j and 107k of Directive 2001/83/EC. 
• Procjena lijekova Tredaptive, Pelzont i Trevaclyn započela je na zahtjev Europske komisije 19.prosinca 2012. godine u skladu s člankom 20 Uredbe (EK) br. 726/2004 nakon postupaka iznesenih u članku 107j i 107k Direktive 2001/83/EK.
The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the Agency's final opinion. 
Preporuke PRAC-a poslane su Povjerenstvu za humane lijekove (CHMP) koje je odgovorno za sva pitanja u vezi lijekova za primjenu na ljudima, a koje je usvojilo konačnu odluku Agencije.
It was first used as a medicine to modify blood fat levels in the mid-1950s, but its use has been limited because of its side effects, particularly flushing (reddening of the skin). 
Prvi put je korišten kao lijek za promjenu razina masnoće u krvi sredinom pedesetih godina ali je njegova upotreba ograničena zbog njegovih nuspojava, posebice zbog zajapurenosti (crvenilo kože).
Such treatment is ultimately aimed to reduce the risk of heart attacks, strokes and other conditions affecting the heart and blood vessels. 
Takvo liječenje ima kao konačni cilj redukciju rizika od srčanih napadaja, moždanih udara i drugih stanja koja zahvaćaju srce i krvne žile.
• The two active substances, nicotinic acid and laropiprant, have different functions. 
• Dvije djelatne tvari, nikotinska kiselina i laropiprant, imaju različite funkcije.
• The HPS2-THRIVE study was a large, long-term study involving 25,673 patients considered to be at high risk for cardiovascular events due to a history of occlusive vascular disease. 
• Ispitivanje HPS2-THRIVE je bilo veliko, dugoročno ispitivanje koje je uključivalo 25 673 bolesnika koji su smatrani da su pod velikim rizikom od kardiovaskularnih bolesti zbog anamneze okluzivne vaskularne bolesti.
The European Commission asked the Agency to assess the impact of the new data from the HPS2-THRIVE study, and to issue an opinion on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU. 
Europska komisija zatražila je od Agencija da ispita utjecaj novih podataka iz ispitivanja HPS2-THIRVE i da izda mišljenje o tome da li treba zadržati, izmijeniti, suspendirati ili povući odobrenje širom EU-a.
In addition, a higher frequency of non-fatal but serious side effects was seen in patients taking these medicines. 
Osim toga, viša frekvencija nesmrtonosnih ali ozbiljnih nuspojava uočena je u bolesnika koji su uzimali te lijekove.
The Agency's recommendations are based on the new data from the HPS2-THRIVE study: 
Preporuke Agencije temelje se na novim podacima iz ispitivanja HPS2-THRIVE:
The review of Tredaptive, Pelzont and Trevaclyn was initiated in December 2012 after new data from a large, long-term study called HPS2-THRIVE became available. 
Procjena Tredaptiva, Pelzonta i Trevaclyna započela je u prosincu 2012 nakon što su postali dostupni novi podaci iz dugoročnog, velikog ispitivanja zvanog HPS2-THRIVE.
Nicotinic acid is a naturally occurring substance used in low doses as a vitamin (known as niacin or vitamin B3). 
Nikotinska kiselina je prirodna tvar koja se koristi u niskim dozama kao vitamin (poznat kao niacin ili vitamin B3).
• You should make a non-urgent appointment with your doctor to review your treatment. 
• Trebate zakazati redoviti sastanak s liječnikom kako bi se procijenilo vaše liječenje.
Patients were treated with simvastatin 40 mg or simvastatin 40 mg plus ezetimibe 10 mg to achieve a total cholesterol level of less than 3.5 mmol/l, and were then randomised to nicotinic acid / laropiprant or placebo. 
Bolesnici su liječeni simvastatinom 40 mg ili simvastatinom 40 mg plus ezetimib 10 mg kako biste postigla ukupna razina kolesterola manja od 3,5 mmol/l i bili su randomizirani na primanje nikotinske kiseline/laropipranta ili placeba.
These included bleeding (intracranial and gastro-intestinal), myopathy, infections and new-onset diabetes. 
Ti uključuju krvarenje (intrakranijalno i u probavnom sustavu), miopatiju, infekcije i nove napadaje dijabetesa.
• Doctors should review their patients' treatment in order to discontinue treatment with these medicines, which are no longer available in the EU. 
• Liječnici trebaju razmotriti liječenje svojih pacijenata kako bi se prekinulo liječenje ovim lijekovima koji nisu više dostupni u EU-u.
The CHMP opinion was based on a recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend these medicines. 
Mišljenje CHMP-a temeljilo se na preporuci Povjerenstva za procjenu rizika u farmakovigilanciji (PRAC) za suspenziju ovih lijekova.
• Tredaptive, Pelzont and Trevaclyn contain two active substances: nicotinic acid (1,000 mg) and laropiprant (20 mg). 
• Tredaptive, Pelzont i Trevaclyn sadrže dvije djelatne tvari: nikotinsku kiselinu (1 000 mg) i laropiprant (20 mg).
• An increase in the incidence of non-fatal but serious adverse events was seen. 
• Uočen je porast incidencije nesmrtonosnih ali ozbiljnih nuspojava.
More information on the HPS2-THRIVE study is available below. 
Više informacija o ispitivanju HPS2-THRIVE dostupno je u nastavku.
• The Agency recommended the suspension of Tredaptive, Pelzont or Trevaclyn following the review of new evidence which indicated that the benefits of these medicines no longer outweigh their risks for patients. 
• Agencija je preporučila suspenziju lijekova Tredaptive, Pelzont ili Trevaclyn nakon pregleda novih dokaza koji ukazuju da dobrobiti ovih lijekova više ne nadmašuju njihove rizike za bolesnike.
The CHMP encouraged patients currently taking these medicines to make a non-urgent appointment with their doctor to discuss their treatment. 
CHMP je potaknuo pacijente koji trenutno uzimaju ove lijekove da zakažu redovitu kontrolu kod svog liječnika kako bi raspravili svoje liječenje.
The CHMP opinion was sent to the European Commission, which endorsed it and issued a final legally binding decision on 22 March 2013. 
Mišljenje CHMP-a poslano je Europskoj komisiji koja ga je potvrdila i izdala konačnu, pravno obvezujuću odluku 22. ožujka 2013. godine.
• Tredaptive, Pelzont and Trevaclyn are identical medicines authorised throughout the EU on 3 July 2008 for the treatment of dyslipidaemia in combination with a statin when statin treatment alone is not sufficient, or alone in patients unable to take statins. 
• Tredaptive, Pelzont i Trevaclyn identični su lijekovi odobreni širom EU-a 3. srpnja 2008. godine za liječenje dislipidemije u kombinaciji sa statinima kada liječenje samim statinima nije dovoljno ili samim statinima u bolesnica koji ne mogu uzimati statine.
Doctors should no longer prescribe these medicines and should review patients' treatment options 
Liječnici više ne propisuju ove lijekove i trebaju razmotriti opcije liječenja za pacijente
• The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision on 22 March 2013. 
• Mišljenje CHMP-a proslijeđeno je Europskoj komisiji koja je izdalo pravno obvezujuću odluku 22. ožujka 2013.
Laropiprant has no effect on cholesterol but it reduces flushing, by blocking the receptors for a substance called ‘prostaglandin D2' which is released when nicotinic acid is taken and which dilates (widens) the blood vessels in the skin. 
Laropiprant nema učinka na kolesterol ali smanjuje zajapurenost blokadom receptora za tvar zvanu „prostaglandin D2” koja se oslobađa prilikom unosa nikotinske kiseline i koja dilatira (širi) krvne žile kože.
• A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC). 
• Povjerenstvo za ocjenu rizika u farmakovigilanciji (PRAC) prvo je provelo pregled ovih podataka.
Having reviewed the results of the study, the CHMP concluded that the benefits of Tredaptive, Pelzont and Trevaclyn no longer outweigh the risks and that their marketing authorisations should be suspended. 
Nakon pregleda rezultata ispitivanja, CHMP je zaključio da dobrobiti lijekova Tredaptive, Pelzont i Trevaclyn više ne nadmašuju rizike i njihova odobrenja za stavljanje u promet treba suspendirati.
On 17 January 2013, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) confirmed the recommendation to suspend the marketing authorisations of Tredaptive, Pelzont and Trevaclyn (nicotinic acid / laropiprant) used to treat adults with dyslipidaemia (abnormally high blood levels of fats such as triglycerides and cholesterol). 
Povjerenstvo za humane lijekove Europske agencija za lijekove (CHMP) 17. siječnja 2013. godine potvrdilo je preporuku za suspenziju odobrenja za stavljanje u promet lijekova Tredaptive, Pelzont i Trevaclyn (nikotinska kiselina/laropiprant) koji se koriste za liječenje odraslih s dislipidemijom (nenormalno visokih razina masnoća u krvi poput triglicerida i kolesterola).
As taking Tredaptive, Pelzont and Trevaclyn together with a statin has no additional benefit in reducing the risk of major vascular events compared with statin therapy alone and taking into account the increased risk of serious side effects, the CHMP recommended the suspension of these medicines. 
S obzirom da uzimanje Tredaptiva, Pelzonta i Trevaclyna skupa sa statinima nije imalo značajnu dobrobit u smanjenju rizika od velikog vaskularnog događaja u usporedbi s terapijom samim statinima te uzimajući u obzir povećani rizik od ozbiljnih nuspojava, CHMP je preporučio suspenziju ovih lijekova.
• If you are taking Tredaptive, Pelzont or Trevaclyn you will have to discontinue treatment, as these medicines are no longer available in the EU. 
• Ako uzimate Tredaptive, Pelzont ili Trevaclyn morat ćete prekinuti liječenje jer ti lijekovi više nisu dostupni u EU-u.
• Tredaptive, Pelzont and Trevaclyn are identical medicines used to treat adults with dyslipidaemia (abnormally high blood levels of fats such as triglycerides and cholesterol). 
• Tredaptive, Pelzont i Trevaclyn su identični lijekovi koji se koriste za liječenje odraslih osoba s dislipidemijom (nenormalno visokim razinama masnoća u krvi kao što su trigliceridi i kolesterol).
• The study was designed to assess the effect of adding nicotinic acid / laropiprant to statins on a composite endpoint of major vascular events, which included the combination of coronary death, non-fatal heart attack, stroke and revascularisation. 
• Ispitivanje je osmišljeno kako bi se proučio učinak dodavanja nikotinske kiseline/laropipranta statinima na kompozitni ishod za velike vaskularne događaje koji su uključivali kombinaciju koronarne smrti, nesmrtonosni srčani udar, moždani udar i revaskularizaciju.
• Pharmacists should refer patients on new or repeated prescriptions for Tredaptive, Pelzont and Trevaclyn to the treating doctor. 
• Ljekarnici trebaju poslati bolesnika liječnicima po nove ili ponovljene recepte za Tredaptive, Pelzont i Trevaclyn.
Doctors should no longer prescribe Tredaptive, Pelzont or Trevaclyn and should review patients' treatment options. 
Liječnici ne smiju više propisivati Tredaptive, Pelzont ili Trevaclyn i trebaju razmotriti opcije liječenja bolesnika.
• Treatment with nicotinic acid / laropiprant together with a statin did not result in a statistically significant reduction in major vascular events such as heart attack and stroke compared with statin therapy alone. 
• Liječenje nikotinskom kiselinom /laropiprantom skupa sa statinima nije rezultirala statistički značajnom redukcijom velikih vaskularnih događaja poput srčanog i moždanog udara u usporedbi sa samom terapijom statinima.
• In light of the unfavourable benefit-risk balance of Tredaptive, Pelzont and Trevaclyn, doctors should no longer prescribe these medicines to their patients. 
• U svjetlu nepovoljnog omjera dobrobiti i rizika Tredaptiva, Pelzonta i Trevaclyna, liječnici ne smiju više propisivati te lijekove pacijentima.
The results of the study, which are still preliminary, indicated that taking nicotinic acid / laropiprant together with a statin has no significant additional benefit in reducing the risk of major vascular events such as heart attack and stroke, compared with statin therapy alone. 
Rezultati ispitivanja koji su još uvijek preliminarni, ukazali su da uzimanje nikotinske kiseline/laropipranta skupa sa statinima nema značajnu dodatnu dobrobit u smanjenju rizika od većih vaskularnih oštećenja poput srčanog i moždanog udara u usporedbi s terapijom samim statinima.
1123 Budapest Hungary 
1123 Budapest Mađarska
85-619 Bydgoszcz Poland 
85-619 Bydgoszcz Poljska
Avenida de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain 
Avenida de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Španjolska
92700 Colombes France 
92700 Colombes Francuska
Alkotás u. 53., MOM Park F épület 
53., MOM Park F épület
Nicergolin tablet 
Nicergolin tableta
SANOFI AVENTIS France 1-13, boulevard Romain Rolland 
SANOFI AVENTIS Francuska 1-13, boulevard Romain Rolland
Pfizer Corporation Austria GmbH 
Pfizer Corporation Austrija GmbH
Industriestrasse 25, D-83607 Holzkirchen, Germany 
Industriestrasse 25, D-83607 Holzkirchen, Njemačka
Via Scarlatti Domenico, 31 20124 Milano Italy 
Via Scarlatti Domenico, 31 20124 Milano Italija
Largo Umberto Boccioni, 1 21040 Origgio - Varese Italy 
Largo Umberto Boccioni, 1 21040 Origgio - Varese Italija
Pfizer Europe MA EEIG Ramsgate Road CT13 9 NJ Kent, Sandwich United Kingdom 
Pfizer Europe MA EEIG Ramsgate Road CT13 9 NJ Kent, Sandwich Ujedinjeno Kraljevstvo
Angenerico spa Via Nocera Umbra, 75 00181 Roma Italy 
Angenerico spa Via Nocera Umbra, 75 00181 Roma Italija
QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest France 
QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest Francuska
Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states 
Dodatak I Popis naziva, farmaceutskog(ih) oblika, jačine(a) lijek(ov)a, put(ev)a primjene, nositelj(a) odobrenja za stavljanje lijeka u promet u državama članicama
B-dul Theodor Pallady nr. 44C Sector 3, Bucureşti, Romania 
B-dul Theodor Pallady nr. 44C Sector 3, Bucureşti, Rumunjska
S.C. LABORMED PHARMA S.A. Bd. Theodor Pallady nr. 44 B, sector 3, Bucureşti, Romania 
S.C. LABORMED PHARMA S.A. Bd. Theodor Pallady nr. 44 B, sector 3, Bucureşti, Rumunjska
Ergotop 10 mgTabletten tablet 
Ergotop 10 mgTabletten tableta
SERMION 5 mg, poudre pour solution pour perfusion powder for solution for infusion intravenous use 
SERMION 5 mg, poudre pour solution pour perfusion prašak za otopinu za infuziju u venu
NICERGOLINA SANDOZ 30 mg tablet 
NICERGOLINA SANDOZ 30 mg tableta
Luxembourg film-coated tablets oral use 
Luksemburg filmom obložene tablete
Sandoz d.d.,Verovškova 57, 1000 Ljubljana, Slovenia 
Sandoz d.d.,Verovškova 57, 1000 Ljubljana, Slovenija
s r.o., Praha Stroupežnického 17 
Češka Republika Pfizer, spol. s r.o., Praha Stroupežnického 17
Pfizer Italia srl Via Isonzo, 71 04100 Latina Italy 
Pfizer Italia srl Via Isonzo, 71 04100 Latina Italija
4 mg/4 ml powder and solvent for solution for injection intramuscular and intravenous use 
4 mg/4 ml prašak i otapalo za otopinu za injekciju u mišić i u venu
10 mg/ml powder and solvente per oral solution 
10 mg/ml prašak i otapalo za oralnu otopinu
Pfizer Italia S.r.l., Borgo San Michele S.S. 156 Km. 
Pfizer Italia S.r.l. Borgo San Michele SS 156 Km
Nicergolin powder and solvent for solution for injection intramuscular use intravenous use 
Nicergolin prašak i otapalo za otopinu za injekciju u mišić u venu
Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenia capsules, hard oral use 
Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenija kapsule, tvrde
Pfizer Italia S.r.l., Via Isonzo 71, 04100 Latina, Italy film-coated tablets oral use 
Pfizer Italia S.r.l., Via Isonzo 71, 04100 Latina, Italija filmom obložene tablete
Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenia film-coated tablets oral use 
Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenija filmom obložene tablete
Pfizer Italia srl Via Isonzo, 71 04100 Latina Italy soluble tablet 
Pfizer Italia srl Via Isonzo, 71 04100 Latina Italija tableta za oralnu otopinu
NICERGOLINA SANDOZ 30 mg effervescent tablet oral use 
NICERGOLINA SANDOZ 30 mg šumeća tableta kroz usta
Modifiedrelease capsule, hard 
NICERIUM® 30 UNO 30 mg kapsula s prilagođenim oslobađanjem, tvrda
25 October 2013 EMA/565019/2013 
23. listopada 2013. EMA/565019/2013
The review of short-acting beta-agonists was initiated in November 2012 at the request of the Hungarian medicines agency, under Article 31 of Directive 2001/83/EC. 
Pregled kratkodjelujućih beta agonista započet je u studenom 2012. godine na zahtjev mađarske agencije za lijekove, sukladno članku 31. Direktive 2001/83/EZ.
The medicines are called ‘short acting' because they work quickly, usually having an effect in less than five minutes, which lasts for several hours. 
Lijekovi se nazivaju „kratkodjelujući” jer brzo djeluju, i to obično u manje od pet minuta, a djelovanje traje nekoliko sati.
It proposed revising their prescribing information, with reinforced warnings on the cardiovascular risks. 
Preporučio je reviziju informacija za propisivanje, s pojačanim upozorenjima o kardiovaskularnim rizicima.
Healthcare professionals will be informed in writing of the updated recommendations. 
Zdravstveni djelatnici bit će obaviješteni pisanim putem o obnovljenim preporukama.
A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC). 
Pregled ovih podataka proveden je prvo od strane Povjerenstva za ocjenu rizika na području farmakovigilancije (PRAC).
Short-acting beta-agonists have been authorised by national procedures in several European Union (EU) Member States, and have been marketed for many years under various trade names. 
Kratkodjelujući beta-aginisti odobreni su za stavljanje u promet nacionalnim postupcima u nekoliko država članica Europske unije (EU), i nalaze se u prometu nekoliko godina pod različitim trgovačkim nazivima.
This timeframe can allow healthcare professionals to take other measures known to improve the health of the baby around the time of birth. 
Ovaj vremenski okvir omogućuje zdravstvenim djelatnicima da poduzmu druge mjere za koje je poznato da poboljšavaju zdravlje djeteta uoči poroda.
The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU. 
CMDh, tijelo koje predstavlja države članice EU, odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove odobrene putem nacionalnih postupaka na razini EU.
The available data showed that injectable forms are effective at supressing labour contractions in the short term (up to 48 hours). 
Dostupni podaci dokazuju da su injekcijski oblici djelotvorni za kratkoročno suzbijanje porođajnih kontrakcija (do 48 sati).
The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)1 has endorsed by consensus new recommendations to restrict the use of medicines called ‘short-acting beta-agonists'. 
Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh)1 potvrdila je konsenzusom nove preporuke za ograničenje uporabe lijekova naziva „kratkodjelujući beta-agonisti”.
• If you are given these medicines for premature labour in this way, your doctor will monitor you and your baby during treatment and stop treatment if there are any signs of heart problems. 
• Ako uzimate ove lijekove za prijevremeni porod na ovaj način, Vaš će liječnik pratiti Vas i Vaše dijete tijekom terapije te će prekinuti terapiju ako postoje znakovi srčanih problema.
The reviewed data originated from clinical studies, post-marketing reports and the published literature. 
Pregledani podaci potječu iz kliničkih ispitivanja, prijava nakon stavljanja lijeka u promet i objavljene literature.