FrancophonIA/ELRC3.0 huggingface dataset:
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Croatian: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer NIZOZEMSKA
English: Shelf life of the veterinary medicinal product as packaged for sale for 10, 20, 50 ml vials: 2 years Shelf life of the veterinary medicinal product as packaged for sale for 100, 200, 250, 500 ml vials: 1 year.
Croatian: Rok trajanja veterinarskog medicinskog proizvoda kad je zapakiran za prodaju: za bočice od 100, 200, 250, 500 ml: 1 godina.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Bluetongue virus serotype 8: 500 antigenic units/ml.
Croatian: NAVOĐENJE DJELATNIH I DRUGIH TVARI Virus bolesti plavog jezika serotip 8: 500 antigenih jedinica/ml.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP.Once broached use within 8 hours, provided the product is not subject to temperatures above 37 °C or contaminated.
Croatian: Nakon otvaranja koristiti u roku od 8 sati, pod uvjetom da proizvod nije bio izložen temperaturama iznad 37 °C ili kontaminiran.
English: Special precautions for use in animals
Croatian: Posebna upozorenja za upotrebu kod životinja:
English: Intervet International BV Wim de Körverstraat 35, 5831 AN Boxmeer The NETHERLANDS
Croatian: Intervet International BV Wim de Körverstraat 35, 5831 Boxmeer NIZOZEMSKA
English: As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Croatian: S obzirom da trajanje imuniteta još nije u potpunosti određeno, bilo kakva shema revakcinacije treba biti usuglašena s nadležnim tijelom ili s odgovornim veterinarom, uzimajući u obzir lokalnu epidemiološku situaciju.
English: Intervet International GmbH Osterather Strasse 1a 50739 Köln
Croatian: Osterather Strasse 1a
English: As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation
Croatian: S obzirom da trajanje imuniteta još nije u potpunosti određeno, bilo kakva shema revakcinacije treba biti usuglašena s nadležnim tijelom ili s odgovornim veterinarom, uzimajući u obzir lokalnu epidemiološku situaciju Goveda
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (10, 20, 50, 100, 200, 250 or 500 ml) PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vials (100, 200, 250 or 500 ml PET vials)
Croatian: PODACI NA VANJSKOM PAKOVANJU Kartonska kutija (10, 20, 50, 100, 200, 250 ili 500 ml )
English: Cattle from 6 weeks of age: injection of two doses of 1 ml, administered with an interval of approximately 3 weeks.
Croatian: Goveda od 6 tjedana starosti: injekcije od dvije doze od 1 ml, dati u razmaku od oko 3 tjedna.
English: WITHDRAWAL PERIOD Withdrawal period: zero days
Croatian: KARENCIJA Karencija: nula dana
English: To stimulate active immunity in cattle from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia*.
Croatian: Za poticanje aktivnog imuniteta u goveda od 6 tjedana starosti protiv virusa plavog jezika serotipa 8
English: Sheep from 1 month of age: subcutaneous injection of a single dose of 1 ml.
Croatian: Primarno cijepljenje: Ovce od 1 mjeseca starosti: potkožna injekcija jedne doze od 1 ml.
English: Bluetongue virus serotype 8 (prior to inactivation): 500 antigenic units*.
Croatian: Virusa bolesti plavog jezika serotip 8 (prije inaktivacije): 500 * antigenih jedinica. (* Izaziva odgovor virus neutralizacijskih antitijela u pilića od ≥ 5,0 log2)
English: Cattle from 6 weeks of age: subcutaneous injection of two doses of 1 ml, administered with an interval of approximately 3 weeks.
Croatian: Primarno cijepljenje: Goveda od 6 tjedana starosti: potkožna injekcija dvije doze od 1 ml, u intervalu od otprilike 3 tjedna.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: TARGET SPECIES Cattle and sheep
Croatian: Goveda i ovce
English: Any person intending to manufacture, import, possess, sell, supply and use Bovilis BTV8 must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Croatian: BTV8, prije proizvodnje, uvoza, posjedovanja, prodaje, opskrbljivanja i/ili upotrebe mora se savjetovati o važećoj odredbi cijepljenja s nadležnim tijelom države članice.
English: To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia*.
Croatian: Za poticanje aktivnog imuniteta ovaca od 1 mjeseca starosti protiv virusa plavog jezika serotipa 8
English: GERMANY
Croatian: KARENCIJA
English: PROHIBITION OF SALE, SUPPLY AND/OR USE
Croatian: Svaka osoba koja namjerava proizvesti, uvesti, posjedovati, prodavati, opskrbljivati i koristiti Bovilis
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Croatian: 14. RIJEČI “ČUVATI IZVAN POGLEDA
English: CLINICAL PARTICULARS
Croatian: FARMACEUTSKI
English: However specific guidance on switching from other antipsychotics has not been proposed due to limited data.
Croatian: Međutim, posebne smjernice o prelasku s drugih antipsihotika nisu predložene zbog ograničenih podataka.
English: Also patients with severe renal impairment may require a lower initial dose, with subsequent adjustments.
Croatian: Isto tako, u bolesnika s teškim oštećenjem bubrega može biti potrebna manja početna doza, uz naknadne prilagodbe.
English: Contraindications relating to children less than 3 years of age and breastfeeding women were not included due to the lack of adequate data to support such contraindications.
Croatian: Kontraindikacije u vezi s djecom mlađom od tri godine i dojiljama nisu uključene zbog nedostatka prikladnih podataka koji idu u prilog takvim kontraindikacijama.
English: Overall summary of the scientific evaluation by the CHMP
Croatian: Cjelokupan sažetak znanstvene ocjene CHMP-a
English: The contraindications in section 4.3 were also amended to include the wording related to the contraindication of cardiotoxic risk of haloperidol.
Croatian: Kontraindikacije iz odjeljka 4.3 izmijenjene su i kako bi se uključio tekst u vezi s kontraindikacijom rizika od kardiotoksičnosti haloperidola.
English: Haldol Decanoate has been approved nationally in the EU with many differences in the wording of the summary of product characteristics (SmPC), in the various Member States.
Croatian: Haldol Decanoate odobren je u EU-u na nacionalnoj razini uz mnogo razlika u tekstu sažetka opisa svojstava lijeka u različitim državama članicama.
English: Based on the review of all available data and the consultations with the Healthcare Professionals Organisations (HCPOs), the CHMP recommended the following revision and harmonisation of the product information for Haldol Decanoate and associated names.
Croatian: Na temelju pregleda svih dostupnih podataka i savjetovanja s organizacijama zdravstvenih radnika, CHMP je predložio sljedeću izmjenu i usklađivanje informacija o lijeku za Haldol Decanoate i povezane nazive.
English: After intramuscular injection (IM), Haldol Decanoate is gradually released from muscle tissue and hydrolysed slowly into free haloperidol, which enters the systemic circulation.
Croatian: Nakon intramuskularnog ubrizgavanja injekcijom Haldol Decanoate postupno se otpušta iz mišićnog tkiva i sporo hidrolizira u slobodni haloperidol, koji ulazi u sustavnu cirkulaciju.
English: In patients with hepatic impairment, it is recommended to halve the initial dose, since haloperidol is extensively metabolised in the liver.
Croatian: U bolesnika s oštećenjem jetre preporučuje se prepoloviti početnu dozu jer se haloperidol u velikoj mjeri metabolizira u jetri.
English: As Haldol Decanoate is an injectable long-acting depot formulation recommended to be used every 4 weeks, in order to avoid medication errors in which either haloperidol injectable or haloperidol decanoate are administered in error, the MAH has committed to conduct further post-marketing safety analysis after completion of the Art 30 referral, while assessing the need for changing the name of the medicinal product thereafter.
Croatian: Budući da je Haldol Decanoate formulacija dugog djelovanja za ubrizgavanje injekcijom u depo obliku čija se upotreba preporučuje svaka četiri tjedna kako bi se izbjegle medikacijske pogreške prilikom kojih su haloperidol za ubrizgavanje injekcijom ili haloperidol dekanoat pogrešno primjenjivani, nositelj odobrenja za stavljanje lijeka u promet obvezao se na provođenje dodatne analize sigurnosti nakon izdavanja odobrenja za stavljanje lijeka u promet po dovršetku postupka upućivanja iz članka 30., procjenjujući pritom potrebu za promjenom naziva lijeka nakon toga.
English: The active substance haloperidol is a potent central dopamine type 2 receptor antagonist, lacking antihistaminergic or anticholinergic activity at recommended doses, and exerts minimal alpha 1 adrenergic activity.
Croatian: Djelatna tvar haloperidol potentan je antagonist centralnih dopaminskih receptora D2, a pri preporučenim dozama ne pokazuje antihistaminergičko ili antikolinergičko djelovanje, uz minimalno alfa-1 adrenergičko djelovanje.
English: Given that the maximum dose of oral haloperidol in the elderly is 5 mg/day and applying the conversion factor of 15, the maximum haloperidol decanoate dose must not be in excess of 75 mg/4wk in the elderly unless elderly patients have already received higher haloperidol (oral or decanoate) doses for long-standing schizophrenia with acceptable tolerability.
Croatian: Budući da je najveća doza oralnog haloperidola u starijih bolesnika 5 mg dnevno te primjenjujući faktor preračuna od 15, najveća doza haloperidol dekanoata ne smije premašivati 75 mg svaka četiri tjedna u starijih bolesnika, osim ako oni već nisu pokazali prihvatljivu podnošljivost prilikom primanja veće doze haloperidola (oralnog ili dekanoata) za dugotrajnu shizofreniju.
English: The final indication agreed for Haldol decanoate is for the maintenance treatment of schizophrenia and schizoaffective disorder in adult patients currently stabilised with oral haloperidol.
Croatian: Konačna indikacija usuglašena za Haldol Decanoate jest terapija održavanja za shizofreniju i shizofreni poremećaj u odraslih bolesnika koji su trenutačno stabilizirani oralnim haloperidolom.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product (and its associated names), the European Commission (EC) notified the European Medicines Agency's Secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve the divergences amongst the nationally approved SmPCs and thus to harmonise its divergent SmPCs across the EU.
Croatian: Zbog različitih odluka na nacionalnoj razini koje su donijele države članice u pogledu odobrenja za ovaj proizvod (i povezane nazive) Europska je komisija (EK) obavijestila tajništvo Europske agencije za lijekove o pokretanju službenog postupka upućivanja u skladu s člankom 30.
English: The proposal for the posology wording in section 4.2 has been revised with regard to transition from oral haloperidol, continuation of treatment, and supplementation with non-decanoate haloperidol up to the maximum oral dose, in adults and the elderly.
Croatian: Prijedlog teksta o doziranju iz odjeljka 4.2 revidiran je u pogledu prelaska s oralnog haloperidola, nastavka liječenja i dodavanja haloperidola koji nije u obliku dekanoata sve do najveće oralne doze za odrasle i starije bolesnike.
English: Haldol Decanoate - an ester of haloperidol and decanoic acid, is a depot antipsychotic belonging to the butyrophenone group.
Croatian: Haldol Decanoate, ester haloperidola i dekanske kiseline, antipsihotik je u depo obliku iz skupine butirofenona.
English: Based on clinical trial data, guideline recommendations and expert consultations by the marketing authorisation holder (MAH) and by the HCPOs, a conversion factor of 10 to 15 is supported when switching from oral haloperidol to the longacting injectable (LAI) Haldol Decanoate.
Croatian: Na temelju podataka iz kliničkih ispitivanja, preporuka iz smjernica i stručnih savjetovanja koje su proveli nositelj odobrenja za stavljanje lijeka u promet i organizacije zdravstvenih radnika, podržani faktor preračuna za prelazak s oralnog haloperidola na Haldol Decanoate dugog djelovanja za ubrizgavanje injekcijom iznosi od 10 do 15.
English: Annex II Scientific conclusions
Croatian: Prilog II.
English: A critical evaluation of the MAH's proposed harmonised SmPC is discussed below.
Croatian: O kritičkoj evaluaciji usklađenog sažetka opisa svojstava lijeka koji je predložio nositelj odobrenja za stavljanje lijeka u promet raspravlja se u nastavku.
English: It is given independent of meals and preferably at the same time each day.
Croatian: Daje se neovisno o obrocima i po mogućnosti u isto vrijeme svaki dan.
English: Patients were followed up on average for 3.8 years.
Croatian: Bolesnike se u prosjeku pratilo tijekom razdoblja od 3,8 godina.
English: These side effects usually pass after a few days or weeks of treatment.
Croatian: Te nuspojave obično prolaze nakon nekoliko dana ili tjedana liječenja.
English: The full EPAR for Victoza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Victoza nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Victoza liraglutide
Croatian: Victoza liraglutid
English: Cardiovascular events occurred in 13% (608 out of 4668) of patients taking Victoza compared with 14.9% (694 out of 4672) of patients taking placebo.
Croatian: Kardiovaskularni događaji nastupili su u 13 % (608 od 4 668) bolesnika koji su primali lijek Victoza, u usporedbi s 14,9 % (694 od 4 672) bolesnika koji su primali placebo.
English: What measures are being taken to ensure the safe and effective use of Victoza?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Victoza?
English: What is Victoza and what is it used for?
Croatian: Što je Victoza i za što se koristi?
English: The main measure of effectiveness was the occurrence of one of three major cardiovascular events: stroke, heart attack or death caused by cardiovascular disease.
Croatian: Glavna mjera djelotvornosti bila je pojava jednoga od triju glavnih kardiovaskularnih događaja: moždanog udara, srčanog udara ili smrti izazvane kardiovaskularnom bolešću.
English: • as an ‘add-on' to other diabetes medicines.
Croatian: • kao „dodatak” drugim lijekovima protiv dijabetesa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Victoza on 30 June 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Victoza u promet koje vrijedi na prostoru Europske unije od 30. lipnja 2009.
English: Other information about Victoza
Croatian: Ostale informacije o lijeku Victoza
English: This is a summary of the European public assessment report (EPAR) for Victoza.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Victoza.
English: This means that it acts in the same way as incretins (hormones produced in the gut) by increasing the amount of insulin released by the pancreas in response to food.
Croatian: To znači da djeluje na isti način kao i inkretini (hormoni koji se proizvode u crijevima), povećavanjem količine inzulina koji se oslobađa u gušterači kao odgovor na unos hrane.
English: In some patients, the dose can be further increased to 1.8 mg one week later to achieve better control of blood glucose.
Croatian: U pojedinih se bolesnika doza može dodatno povećati na 1,8 mg tjedan dana kasnije kako bi se postigla bolja kontrola glukoze u krvi.
English: The study involved 9,340 patients with type 2 diabetes who already had cardiovascular disease (such as angina, heart attack or stroke).
Croatian: U to je ispitivanje bilo uključeno 9340 bolesnika s dijabetesom tipa 2 koji su već imali neku kardiovaskularnu bolest (npr. anginu, srčani ili moždani udar).
English: Victoza is a solution for injection available in pre-filled pens (6 mg/ml).
Croatian: Victoza je otopina za injekciju dostupna u napunjenim brizgalicama (6 mg/ml).
English: HbA1c gives an indication of how well the blood glucose is controlled.
Croatian: HbA1c pokazuje koliko se dobro kontrolira razina glukoze u krvi.
English: It is not intended to provide practical advice on how to use Victoza.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Victoza.
English: Victoza was effective at controlling blood glucose in six main studies involving 4,155 adults with type 2 diabetes.
Croatian: Victoza je bila djelotvorna u kontroli razine glukoze u krvi u šest glavnih ispitivanja koja su obuhvatila 4 155 odraslih osoba s dijabetesom tipa 2.
English: The European Medicines Agency decided that Victoza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Victoza nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za stavljanje lijeka u promet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Victoza 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 Victoza nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: What are the risks associated with Victoza?
Croatian: Koji su rizici povezani s lijekom Victoza?
English: Why is Victoza approved?
Croatian: Zašto je lijek Victoza odobren?
English: In addition to the above studies, Victoza was shown to be effective in reducing adverse cardiovascular (heart and blood vessels) effects.
Croatian: Osim prethodno navedenih ispitivanja, lijek Victoza pokazao se djelotvornim u smanjenju nepovoljnih kardiovaskularnih učinaka (učinaka na srce i krvne žile).
English: The most common side effects with Victoza (seen in more than 1 patient in 10) are nausea and diarrhoea.
Croatian: Najčešće nuspojave lijeka Victoza (uočene kod više od 1 na 10 bolesnika) su mučnina i proljev.
English: In these studies, the main measure of effectiveness was the reduction in the amount of a substance in the blood called glycosylated haemoglobin (HbA1c) after six months or one year of treatment.
Croatian: U tim ispitivanjima glavna mjera djelotvornosti bilo je smanjenje razine tvari naziva glikozilirani hemoglobin (HbA1c) u krvi nakon šest mjeseci ili godinu dana liječenja.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Croatian: Dijabetes tipa 2 bolest je pri kojoj gušterača ne proizvodi dovoljno inzulina za kontrolu razine glukoze (šećera) u krvi ili pri kojoj se tijelo ne može učinkovito koristiti inzulinom.
English: When Victoza is added to existing treatment containing metformin or a thiazolidinedione, the doses of these medicines do not have to be changed.
Croatian: Kada se Victoza dodaje postojećoj terapiji koja sadrži metformin ili tiazolidinedion, doze tih lijekova ne moraju se mijenjati.
English: Victoza was compared with placebo and all patients also received standard care.
Croatian: Lijek Victoza uspoređen je s placebom (prividno liječenje) i svi su bolesnici imali i standardnu skrb.
English: This helps with the control of blood glucose levels.
Croatian: To pomaže pri kontroli razine glukoze u krvi.
English: Results from this study show that Victoza at a dose of 1.2 mg reduced HbA1c by 0.8 percentage points, whereas Victoza at a dose of 1.8 mg led to reductions of 1.1 percentage points.
Croatian: Rezultati tog ispitivanja pokazuju da je davanje doze lijeka Victoza od 1,2 mg smanjilo razinu HbA1c za 0,8 postotnih bodova, dok je doza lijeka Victoza od 1,8 mg rezultirala smanjenjem od 1,1 postotna boda.
English: The triple therapies containing Victoza led to a reduction of between 1.3 and 1.5 percentage points compared with a reduction equal or less than 0.5 points without Victoza.
Croatian: Trojne terapije koje sadrže lijek Victoza rezultirale su smanjenjem od 1,3 do 1,5 postotnih bodova u usporedbi sa smanjenjem jednakim ili manjim od 0,5 postotnih bodova bez lijeka Victoza.
English: When Victoza is added to treatment with a sulphonylurea or insulin, the doctor should consider lowering the dose of the other medicine to reduce the risk of having hypoglycaemia (low blood glucose).
Croatian: Kada se Victoza dodaje terapiji koja sadrži sulfonilureju ili inzulin, liječnik treba razmotriti snižavanje doze drugog lijeka kako bi se smanjio rizik od hipoglikemije (niske razine glukoze u krvi).
English: For more information about treatment with Victoza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Victoza pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: For practical information about using Victoza, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Victoza bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: Combinations containing Victoza were more effective at controlling blood glucose than combinations without the medicine.
Croatian: Kombinacije koje sadrže lijek Victoza bile su djelotvornije u kontroli glukoze u krvi od kombinacija bez tog lijeka.
English: Victoza is given by the patient once a day by injection under the skin in the abdomen, thigh or upper arm.
Croatian: Bolesnik si samostalno daje lijek Victozu jednom dnevno supkutanim injekcijama (pod kožu) u abdomen, bedro ili nadlakticu.
English: The active substance in Victoza, liraglutide, is an ‘incretin mimetic'.
Croatian: Djelatna tvar u lijeku Victoza je liraglutid, „inkretinski mimetik”.
English: For the full list of all side effects and restrictions with Victoza, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni lijeka Victoza potražite u uputi o lijeku.
English: Victoza is a medicine used in addition to diet and exercise in adults who have type 2 diabetes.
Croatian: Victoza je lijek koji se koristi uz poseban režim prehrane i tjelovježbu za liječenje odraslih osoba oboljelih od dijabetesa tipa 2.
English: Adding Victoza to treatment with basal insulin plus metformin reduced HbA1c by 0.7 percentage points, compared with 0.4 points when adding Victoza to insulin aspart.
Croatian: Dodavanje lijeka Victoza terapiji bazalnim inzulinom i metforminom smanjilo je razinu HbA1c za 0,7 postotnih bodova, u usporedbi s 0,4 boda kad se lijek Victoza dodavao terapiji inzulinom aspartom.
English: What benefits of Victoza have been shown in studies?
Croatian: Koje su koristi od lijeka Victoza utvrđene u ispitivanjima?
English: In another triple therapy study, Victoza was compared with a single dose of a short-acting insulin, insulin aspart, when added to treatment with basal insulin (a long-acting insulin) plus metformin.
Croatian: U drugom ispitivanju trojne terapije lijek Victoza uspoređivao se s jednom dozom inzulina kratkotrajnog djelovanja, inzulina asparta, kad se dodavao terapiji bazalnim inzulinom (inzulinom dugotrajnog djelovanja) i metforminom.
English: The starting dose of Victoza is 0.6 mg. After at least one week, the dose is increased to 1.2 mg.
Croatian: Nakon najmanje tjedan dana doza se povećava na 1,2 mg.
English: This compared with a reduction of 0.5 percentage points with glimepiride.
Croatian: To se može usporediti s uzimanjem glimepirida koji je doveo do smanjenja od 0,5 postotnih bodova.