FrancophonIA/ELRC3.0 huggingface dataset:
English: NovoMix 30 gave almost identical results as biphasic human insulin 30 (a combination of 30% rapidacting and 70% intermediate-acting human insulin) in 294 adults with type 1 diabetes (when the pancreas cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively), and in 167 patients aged between 10 and 17 years with type 1 diabetes.
Croatian: Lijek NovoMix imao je skoro identične rezultate kao bifazični humani inzulin 30 (kombinacija 30 % brzodjelujućeg i 70 % srednjedugodjelujućeg humanog inzulina) u 294 odrasle osobe sa šećernom bolešću tipa 1 (kada gušterača ne može proizvesti inzulin) ili šećernom bolešću tipa 2 (kada tijelo ne može učinkovito koristiti inzulin) i u 167 bolesnika u dobi od 10 do 17 godina sa šećernom bolešću tipa 1.
English: The most common side effect with NovoMix (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose levels).
Croatian: Najčešća nuspojava lijeka NovoMix (koja se može javiti u više od 1 na 10 osoba) jest hipoglikemija (niske razine glukoze u krvi).
English: Why is NovoMix authorised in the EU?
Croatian: Zašto je lijek NovoMix odobren u EU-u?
English: The dose of NovoMix depends on the patient's blood glucose levels, which should be tested regularly to find an effective dose.
Croatian: Doza lijeka NovoMix ovisi o razini glukoze u krvi bolesnika koju redovito treba pratiti kako bi se odredila učinkovita doza.
English: NovoMix medicines contain the active substance insulin aspart (100 units/ml) combined with protamine to make it longer acting.
Croatian: Lijekovi NovoMix sadrže djelatnu tvar aspart inzulin (100 jedinica/ml) u kombinaciji s protaminom za duže djelovanje.
English: Several studies have found NovoMix to be effective either at reducing glycosylated haemoglobin (HbA1c, a substance which indicates how well blood glucose is controlled over 12 to 28 weeks) or in reducing blood glucose levels after a meal.
Croatian: U nekoliko ispitivanja utvrđeno je da lijek NovoMix djeluje na smanjenje glikoziliranog hemoglobina (HbA1c, tvari koja pokazuje koliko dobro se glukoza u krvi kontrolira tijekom razdoblja od 12 do 28 tjedana) i na smanjenje razina glukoze u krvi nakon obroka.
English: NovoMix 50 and NovoMix 70 gave better overall control of blood glucose than biphasic human insulin 30 in 664 patients with type 1 or type 2 diabetes.
Croatian: Lijekovima NovoMix 50 i NovoMix 70 moglo se bolje kontrolirati razinu glukoze u krvi nego bifazičnim humanim inzulinom 30 u 664 bolesnika sa šećernom bolešću tipa 1 ili 2.
English: The active substance in NovoMix, insulin aspart, is absorbed faster by the body than natural insulin and it starts working soon after it is injected.
Croatian: Djelatna tvar u lijeku NovoMix, aspart inzulin, brže se apsorbira u tijelu od prirodnog inzulina i počinje djelovati ubrzo nakon ubrizgavanja lijeka.
English: NovoMix contains both insulin aspart and a longer-acting form called insulin aspart protamine, which is absorbed more slowly and works for longer.
Croatian: NovoMix sadrži aspart inzulin i njegov oblik produljenog djelovanja, aspart inzulin s protaminom, koji se apsorbira sporije i dulje djeluje.
English: NovoMix acts in the same way as naturally produced insulin and helps glucose from the blood to enter cells.
Croatian: NovoMix djeluje na isti način kao i prirodno proizvedeni inzulin te pomaže da glukoza iz krvi dospije u stanice.
English: NovoMix is a range of insulin medicines used to treat patients who have diabetes and need insulin to keep their blood glucose (sugar) level controlled.
Croatian: NovoMix je niz inzulinskih lijekova koji se koriste za liječenje dijabetesa (šećerne bolesti) kada je bolesnicima potreban inzulin kako bi držali razinu glukoze (šećera) u krvi pod kontrolom.
English: How does NovoMix work?
Croatian: Kako djeluje NovoMix?
English: What benefits of NovoMix have been shown in studies?
Croatian: Koje su koristi od lijeka NovoMix utvrđene u ispitivanjima?
English: For the full list of side effects and restrictions of NovoMix, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava i ograničenja povezanih s lijekom NovoMix potražite u uputi o lijeku.
English: How is NovoMix used?
Croatian: Kako se NovoMix primjenjuje?
English: Pharmaceutical form
Croatian: Farmaceutsk i oblik
English: 100 x 1 tablets (unit dose)
Croatian: 100 x 1 tableta ((jedinična doza)
English: MA (EU) Number Invented name
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakiranje Veličina pakiranja EU/1/15/1080/001 Zurampic
English: Content (concentration)
Croatian: Obsah (koncentrace)
English: MA (EU) number (Invented) name
Croatian: Registrační (EU) Číslo
English: Strength Pharmaceutical Form
Croatian: Léková forma Cesta podání
English: Immediate Packaging
Croatian: Velikosti balení
English: Sealant powder
Croatian: Vnitřní Obal
English: Solution for injection vial (glass)
Croatian: Otopina za injekciju bočica (staklo)
English: After 12 weeks, the viral load had fallen by more than 95%.
Croatian: Nakon 12 tjedana, virusno opterećenje smanjilo se za više od 95 %.
English: The full EPAR for Combivir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Combivir nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Combivir lamivudine / zidovudine
Croatian: Combivir lamivudin / zidovudin
English: In children (below 12 years of age) weighing between 14 and 30 kg, the dose depends on their weight.
Croatian: U djece (mlađe od 12 godina) tjelesne težine između 14 i 30 kg, doza ovisi o njihovoj težini.
English: Other information about Combivir
Croatian: Ostale informacije o lijeku Combivir
English: What measures are being taken to ensure the safe and effective use of Combivir?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Combivir?
English: This is a summary of the European Public Assessment Report (EPAR) for Combivir.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Combivir.
English: The two groups also had similar rises in CD4 cell counts.
Croatian: Obje skupine također su imale sličan porast broja CD4 stanica.
English: Both active substances have been available in the EU for a number of years: lamivudine has been authorised as Epivir since 1996 and zidovudine has been available in the EU since the mid-1980s.
Croatian: Obje djelatne tvari godinama su dostupne na području EU-a: lamivudin je od 1996. odobren kao lijek Epivir, a zidovudin je dostupan na području EU-a od sredine-1980-ih.
English: Why is Combivir approved?
Croatian: Zašto je Combivir odobren?
English: Patients who cannot swallow tablets may crush the tablets, adding the powder to a small amount of food or drink and swallowing it immediately.
Croatian: Bolesnici koji ne mogu progutati tablete, mogu ih zdrobiti i dodati maloj količini hrane ili pića te odmah progutati.
English: If patients need to stop taking lamivudine or zidovudine, or need to take different doses because of problems with their kidneys, liver or blood, they will need to take medicines containing lamivudine or zidovudine separately.
Croatian: Ako bolesnici moraju prekinuti liječenje lamivudinom ili zidovudinom ili su im potrebne drugačije doze zbog problema s bubrezima, jetrom ili krvlju, morat će odvojeno uzimati lijekove koji sadrže lamivudin ili zidovudin.
English: Combivir is available as tablets containing lamivudine 150 mg and zidovudine 300 mg.
Croatian: Combivir je dostupan u obliku tableta koje sadrže 150 mg lamivudina i 300 mg zidovudina.
English: What is Combivir and what is it used for?
Croatian: Što je Combivir i za što se koristi?
English: CD4 cells (also called CD4 T cells) are white blood cells that are important for fighting infections, but they are killed by HIV.
Croatian: CD4 stanice (nazivaju se još i CD4 T stanice) bijele su krvne stanice koje su važne u suzbijanju infekcija, ali ih HIV ubija.
English: It also presented information on the predicted blood levels of the two substances in children taking the two substances combined in one tablet.
Croatian: Također je iznijela podatke o predviđenim razinama dviju tvari u krvi djece koja su te dvije tvari uzimala kombinirane u jednoj tableti.
English: Because lamivudine and zidovudine have been available in the EU for a number of years, the company presented information from earlier studies of the two substances taken together.
Croatian: Budući da su lavudin i zidovudin dostupni u Europskoj uniji već godinama, tvrtka je dostavila podatke iz prijašnjih ispitivanja o ovim dvjema tvarima kada se uzimaju zajedno.
English: It is not intended to provide practical advice on how to use Combivir.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Combivir.
English: The company also compared Combivir to separate tablets of lamivudine and zidovudine in 75 patients aged over 12 years who had not taken treatment for HIV infection before.
Croatian: Tvrtka je također usporedila primjenu lijeka Combivir i zasebnih tableta lamivudina i zidovudina u 75 bolesnika starijih od 12 godina koji prije nisu bili liječeni protiv infekcije HIV-om.
English: Combivir does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Combivir ne liječi infekciju HIV-om niti AIDS, ali može zaustaviti narušavanje imunološkog sustava te razvoj infekcija i bolesti povezanih s AIDS-om.
English: Combivir was absorbed in the same way as the separate tablets.
Croatian: Combivir se apsorbirao na isti način kao i zasebne tablete.
English: The European Commission granted a marketing authorisation valid throughout the EU for Combivir on 18 March 1998.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Combivir u promet koje vrijedi na prostoru Europske unije od 18. ožujka 1998.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Combivir's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučilo je da koristi lijeka Combivir nadmašuju s njim povezane rizike te je preporučilo davanje odobrenja za stavljanje lijeka u promet.
English: Treatment with Combivir should be started by a doctor who has experience in the management of HIV infection.
Croatian: Liječenje Combivirom treba započeti liječnik s iskustvom u liječenju infekcije HIV-om.
English: CHMP considered that combining the active ingredients in a single tablet may be of advantage because it can improve how well patients stick to the prescribed treatment and this can help to prevent HIV becoming resistant to treatment.
Croatian: CHMP smatra da kombinacija dvaju sastojaka u jednoj tableti može biti korisna jer može poboljšati način na koji se bolesnici pridržavaju propisanog liječenja, što može pomoći spriječiti otpornost HIV-a na liječenje.
English: Combivir must not be used by patients with low neutrophil counts (a type of white blood cell) or anaemia (low red blood cell counts).
Croatian: Combivir ne smiju uzimati bolesnici s niskim brojem neutrofila (vrsta bijelih krvnih stanica) ili anemijom (niski broj crvenih krvnih stanica).
English: The recommended doses of Combivir in children produced similar levels of the two active substances as in older patients.
Croatian: Preporučene doze lijeka Combivir u djece dovele su do sličnih razina dviju djelatnih tvari kao i u starijih bolesnika.
English: Both active substances in Combivir, lamivudine and zidovudine, are nucleoside reverse transcriptase inhibitors (NRTIs).
Croatian: Obje djelatne tvari lijeka Combivir, lamivudin i zidovudin, nukleozidni su inhibitori reverzne transkriptaze (NRTI).
English: To support its recommendations for Combivir doses in children, the company presented studies of the levels of lamivudine and zidovudine in the blood of children taking the medicines separately.
Croatian: Kako bi potkrijepila svoje preporuke za doze lijeka Combivir u djece, tvrtka je iznijela podatke ispitivanja razina lamivudina i zidovudina u krvi djece koja su te lijekove uzimala zasebno.
English: The studies showed that the active substances taken together could reduce viral loads (the level of HIV in the blood) and allow CD4 cell counts to rise after up to one year of treatment.
Croatian: Ispitivanja su pokazala da djelatne tvari uzimane zajedno mogu smanjiti virusno opterećenje (razinu HIV-a u krvi) i omogućiti porast broja stanica CD4 nakon liječenja do godine dana.
English: Children taking Combivir should be closely monitored and the doctor may need to adjust the dose in case of side effects on their digestive system.
Croatian: Djecu koja uzimaju Combivir treba pažljivo pratiti, a liječnik će im možda trebati prilagoditi dozu u slučaju nuspojava u probavnom sustavu.
English: They work in similar ways by blocking the activity of reverse transcriptase, an enzyme made by the HIV virus that allows it to reproduce itself in the cells it has infected.
Croatian: Djeluju na sličan način onemogućujući djelovanje reverzne transkriptaze, enzima koji proizvodi virus HIV-a i koji mu omogućuje reprodukciju u stanicama koje su njime zaražene.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Combivir have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Combivir nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The main measures of effectiveness were the change in viral load and CD4 cell counts in the blood.
Croatian: Glavni ishodi djelotvornosti bile su promjene virusnog opterećenja i broja CD4 stanica u krvi.
English: What are the risks associated with Combivir?
Croatian: Koji su rizici povezani s lijekom Combivir?
English: Children weighing less than 14 kg will need to use separate oral solutions containing lamivudine and zidovudine.
Croatian: Djeca tjelesne težine manje od 14 kg trebaju uzimati zasebne oralne otopine koje sadrže lamivudin i zidovudin.
English: The company also compared how the body absorbed the Combivir combination tablet and the separate tablets.
Croatian: Tvrtka je također usporedila kako tijelo apsorbira kombiniranu tabletu Combivira u odnosu na zasebne tablete.
English: For more information about treatment with Combivir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Combivir pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: The recommended dose of Combivir for patients over 12 years of age who weigh at least 30 kg is one tablet taken twice a day.
Croatian: Za bolesnike starije od 12 godina i tjelesne težine najmanje 30 kg, preporučena doza lijeka Combivir je jedna tableta dva puta na dan.
English: Combivir, an antiviral medicine, is used in combination with at least one other antiviral medicine to treat patients infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Combivir, antivirusni lijek koristi se u kombinaciji s još najmanje jednim antivirusnim lijekom za liječenje bolesnika zaraženih virusom humane imunodeficijencije (HIV), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Patients taking Combivir and those taking the two active substances separately had similar falls in viral load.
Croatian: Bolesnici koji su uzimali Combivir i oni koji su uzimali dvije djelatne tvari svaku zasebno, imali su slično smanjenje virusnog opterećenja.
English: The most common side effects with Combivir (which may affect more than 1 patient in 10) are diarrhoea and nausea (feeling sick).
Croatian: Najčešće su nuspojave lijeka Combivir (koje se mogu javiti u više od 1 na 10 bolesnika) proljev i mučnina.
English: How is Combivir used?
Croatian: Kako se Combivir koristi?
English: For practical information about using Combivir, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Combivir bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Combivir, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Kad se uzima u kombinaciji s najmanje još jednim antivirusnim lijekom, Combivir smanjuje koncentraciju HIV-a u krvi i održava je niskom.
English: What benefit of Combivir have been shown in studies?
Croatian: Koje su koristi lijeka Combivir utvrđene u ispitivanjima?
English: How does Combivir work?
Croatian: Kako djeluje Combivir?
English: For the full list of all the side effects of Combivir and restrictions on its use, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Combivir potražite u uputi o lijeku.
English: Combivir contains two active substances, lamivudine and zidovudine.
Croatian: Combivir sadrži dvije djelatne tvari, lamivudin i zidovudin.
English: If symptoms persist for longer than a week, a doctor should be consulted.
Croatian: Ako se simptomi ne povuku nakon tjedan dana, potrebno je savjetovati se s liječnikom.
English: The studies indicated that 1,8 cineole might have an effect in diseases of the airways.
Croatian: Ova ispitivanja ukazuju da bi 1,8-cineol mogao imati učinak na bolesti dišnih putova.
English: At the time of the HMPC assessment, no side effects had been reported with these medicines when used in the way described above.
Croatian: U vrijeme ocjene HMPC-a, nije bilo prijavljenih nuspojava s ovim lijekovima, ako su lijekovi korišteni kako je prethodno navedeno.
English: Eucalyptus leaf EMA/HMPC/300235/2013
Croatian: Eukaliptusov list EMA/HMPC/300235/2013
English: In its assessment, the HMPC considered the results of laboratory tests as well as studies in patients looking in particular at the effects of a component of eucalyptus leaf, called 1,8 cineole (also known as eucalyptol).
Croatian: HMPC je prilikom ocjene razmotrio rezultate laboratorijskih testova kao i ispitivanja u bolesnika, te je pritom posebnu pozornost obratio na učinke sastojka eukaliptusovog lista, naziva 1,8-cineol (poznatog također pod nazivom eukaliptol).
English: Eucalyptus leaf is the common name for the whole or cut leaf of the tree Eucalyptus globulus Labill.
Croatian: Eukaliptusov list je uobičajeni naziv za cijeli ili rezani list biljke Eucalyptus globulus Labill.
English: The HMPC conclusions on the use of eucalyptus leaf medicines for the relief of cough associated with a cold are based on their ‘traditional use' in this condition.
Croatian: Zaključci HMPC-a o uporabi lijekova koji sadrže eukaliptusov list za ublažavanje kašlja povezanog s prehladom temelje se na njihovoj „tradicionalnoj uporabi” u ovom stanju.
English: The HMPC recommended that eucalyptus leaf medicines should not be used in children under 30 months of age because of the risk of laryngospasm (contraction of the vocal cords).
Croatian: HMPC preporučio je da se lijekovi koji sadrže eukaliptusov list ne koriste u djece mlađe od 30 mjeseci zbog rizika od laringospazma (kontrakcije glasnica).
English: This summary is not intended to provide practical advice on how to use medicines containing eucalyptus leaf.
Croatian: Svrha ovog sažetka nije pružanje praktičnih savjeta o načinu uporabe lijekova koji sadrže eukaliptusov list.
English: The HMPC concluded that, on the basis of its long-standing use, eucalyptus leaf can be used for the relief of cough associated with a cold.
Croatian: Zaključak HMPC-a je da se, na temelju njegove dugogodišnje uporabe, eukaliptusov list može koristiti za ublažavanje kašlja povezanog s prehladom.
English: Any applications for the licensing of medicines containing eucalyptus leaf have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže eukaliptusov list moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Comminuted preparations of eucalyptus leaf should only be used in adults and children over the age of 12 years, while tincture preparations should only be used in adults due to high content of ethanol (pure alcohol).
Croatian: Usitnjeni pripravci eukaliptusovog lista smiju se koristiti samo u odraslih osoba i djece starije od 12 godina, dok se pripravci tinkture smiju koristiti samo u odraslih osoba zbog velikog udjela etanola (čistog alkohola).
English: Further information on the HMPC assessment of eucalyptus leaf medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Dodatne informacije o HMPC-ovoj ocjeni lijekova koji sadrže eukaliptusov list, uključujući pojedinosti zaključaka Povjerenstva, mogu se pronaći u rubrici 'All documents' na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Information on the use and licensing of eucalyptus leaf medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju za lijekove koji sadrže eukaliptusov list u državama članicama Europske unije mogu se dobiti od nadležnih nacionalnih tijela.
English: Further information on the risks associated with eucalyptus leaf medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više informacija o rizicima povezanim s lijekovima koji sadrže eukaliptusov list, uključujući odgovarajuće mjere opreza za njihovu sigurnu uporabu, možete pronaći u monografiji u rubrici 'All documents' na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Herbal medicines containing eucalyptus leaf are usually available as comminuted herbal material for the preparation of a herbal tea to be drunk, an infusion to be inhaled or a liquid to be taken by mouth.
Croatian: Biljni lijekovi koji sadrže eukaliptusov list obično su dostupni kao usitnjeni biljni materijal za pripravak biljnoga čaja koji se pije, infuza koji se inhalira i tekućine koja se uzima kroz usta.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of eucalyptus leaf.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske uporabe eukaliptusovog lista.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing eucalyptus leaf.
Croatian: Države članice Europske unije uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže eukaliptusov list.
English: EMA/HMPC/300235/2013
Croatian: EMA/HMPC/300235/2013 Povjerenstvo za biljne lijekove (HMPC)
English: Eucalyptus leaf can also be found in combination with other herbal substances in some herbal medicines.
Croatian: Eukaliptusov list prisutan je također i u kombinaciji s drugim biljnim tvarima u određenim biljnim lijekovima.
English: Detailed instruction on how to take eucalyptus leaf medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljne upute o tome kako uzimati lijekove koji sadrže eukaliptusov list i tko ih može uzimati dostupne su u uputi o lijeku koja je priložena uz lijek.