FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the risks associated with Novem?
Croatian: Koji su rizici povezani s VMP-om Novem?
English: If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Croatian: Ako su vam potrebne dodatne informacije o medicinskom stanju ili liječenju životinje, obratite se veterinaru.
English: Other information about Novem:
Croatian: Ostale informacije o lijeku Novem
English: • diarrhoea in calves of over one week of age and young, non-lactating cattle together with oral re hydration therapy (medicines given by mouth to restore water levels in the body)
Croatian: • proljeva u teladi starije od tjedan dana i mladih goveda koja nisu u laktaciji, u kombinaciji s oralnom rehidracijskom terapijom (lijekovi davani kroz usta kako bi se razina vode u organizmu vratila u normalu)
English: The withdrawal period is 15 days for meat and five days for milk.
Croatian: Razdoblje karencije iznosi 15 dana za meso te pet dana za mlijeko.
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Novem.
Croatian: Osobe koje su preosjetljive (alergične) na nesteroidne protuupalne lijekove (NSAIL-ove) moraju izbjegavati kontakt s VMP-om Novem.
English: Novem contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Croatian: Novem sadrži meloksikam, koji pripada skupini lijekova zvanih nesteroidni protuupalni lijekovi (NSAIL).
English: • pain following minor soft tissue surgery such as castration
Croatian: • boli nakon manjeg zahvata na mekom tkivu kao što je kastracija
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Novem's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Novem nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: Similarly, treatment combining rehydration solution and Novem was shown to be superior to rehydration solution alone.
Croatian: Slično tome, liječenje kombinacijom rehidracijske otopine i Novema pokazalo se boljim od primjene samo rehidracijske otopine.
English: • acute respiratory infection (infection of the lungs and airways) together with antibiotics
Croatian: • akutne respiratorne infekcije (infekcije pluća i dišnih puteva) u kombinaciji s antibioticima
English: Novem is an anti-inflammatory medicine used in cattle and pigs.
Croatian: Novem je protuupalni lijek za stoku i svinje.
English: • pain following dehorning in calves
Croatian: • bolova nakon odrožnjavanja teladi
English: How does Novem work?
Croatian: Kako djeluje Novem?
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption.
Croatian: Razdoblje karencije je vrijeme koje treba proći od primjene VMP-a do klanja životinje i korištenja mesa ili mlijeka za prehranu ljudi.
English: In pigs, Novem is used to treat:
Croatian: U svinja se Novem koristi za liječenje:
English: Novem is available as a solution for injection and can only be obtained with a prescription.
Croatian: Novem je dostupan kao otopina za injekciju i izdaje se samo na veterinarski recept.
English: How is Novem used?
Croatian: Kako se Novem koristi?
English: For more information about treatment with Novem, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Novem vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svom veterinaru ili ljekarniku.
English: This document is a summary of the European Public Assessment Report.
Croatian: Ovaj dokument je sažetak europskoga javnog izvješća (EPAR) o procjeni veterinarsko-medicinskog proizvoda.
English: In cattle and pigs both subcutaneous and intramuscular administration are well tolerated; only a slight temporary swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Croatian: Uu manje od 10 % goveda liječenih u kliničkim ispitivanjima, opaženo je nakon supkutane primjene samo neznatno privremeno oticanje na mjestu primjene injekcije.
English: What benefits of Novem have been shown in studies?
Croatian: Koje su koristi VMP-a Novem utvrđene u ispitivanjima?
English: • acute mastitis (inflammation of the udder) together with the main treatment with antibiotics.
Croatian: • akutnog mastitisa (upala vimena) u kombinaciji s osnovnom antibiotskom terapijom.
English: • infections that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia
Croatian: • infekcija do kojih dolazi nakon prasenja, na primjer puerperalna septikemija i toksemija (sindrom mastitis-metritis-agalakcija) uz odgovarajuće osnovno liječenje antibioticima.
English: The MAH should reformulate the product, to include a level of magnesium which is justified based on the most recent knowledge in the area.
Croatian: Nositelj odobrenja treba reformulirati lijek kako bi se uključila razina magnezija koja je opravdana na temelju najnovijeg znanja u danom području.
English: The MAH should liaise with the Reference Member State to agree on the appropriate procedure to be used for the fulfilment of this condition.
Croatian: Nositelj odobrenja treba surađivati s referentnom državom članicom kako bi se dogovorio o odgovarajućem postupku koji će se koristiti za ispunjavanje ovog uvjeta.
English: Annex III Condition for lifting the suspension of the marketing authorisations
Croatian: Uvjeti za ukidanje suspenzije odobrenja za stavljanje lijeka u promet
English: Condition for lifting the suspension of the marketing authorisations for Numeta G13%E and associated names
Croatian: Uvjeti za skidanje suspenzije odobrenja za stavljanje lijeka u promet za lijek Numeta G13%E i pridružene nazive.
English: For the suspension of the marketing authorisations of Numeta G13%E to be lifted, the National competent authorities of Member States shall verify that the following conditions are fulfilled by the MAH:
Croatian: Za povlačenje suspenzije odobrenja za stavljanje lijeka u promet Numeta G13%E, nadležna nacionalna tijela država članica moraju potvrditi je nositelj odobrenja ispunio sljedeće uvjete:
English: The patient should take the tablets at around the same time each day, usually in the morning.
Croatian: Bolesnica treba uzimati tablete otprilike u isto vrijeme svakoga dana, obično ujutro.
English: The full EPAR for Kisqali can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Kisqali nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The usual recommended dose is 3 tablets (600 mg) once daily for 21 days followed by a 7-day break to complete a 28-day treatment course.
Croatian: Preporučena doza su 3 tablete (600 mg) jedanput na dan uzastopno tijekom 21 dana, a nakon toga slijedi 7 dana bez terapije čime je dovršen ciklus liječenja od 28 dana.
English: Kisqali ribociclib
Croatian: Kisqali ribociklib
English: Treatment courses should be continued for as long as the medicine continues to work and the patient does not get unacceptable side effects.
Croatian: Cikluse liječenja treba nastaviti sve dok lijek djeluje, a bolesnica nema neprihvatljive nuspojave.
English: The mean measure of effectiveness was how long the women lived without their disease getting worse (progression-free survival).
Croatian: Glavna mjera djelotvornosti bilo je vrijeme koje je proteklo, a da se bolest u žena nije pogoršala (preživljenje bez napredovanja bolesti).
English: Other information about Kisqali
Croatian: Ostale informacije o lijeku Kisqali
English: What measures are being taken to ensure the safe and effective use of Kisqali?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Kisqali?
English: What is Kisqali and what is it used for?
Croatian: Što je Kisqali i za što se koristi?
English: This is a summary of the European public assessment report (EPAR) for Kisqali.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Kisqali.
English: By blocking CDK4 and CDK6, Kisqali slows the growth of HR-positive breast cancer cells.
Croatian: Blokiranjem CDK4 i CDK6, Kisqali usporava rast HR-pozitivnih stanica raka dojke.
English: Kisqali can only be used when the cancer cells have receptors for certain hormones on their surface (HR-positive) and do not have large quantities of another receptor called HER2 (HER2-negative).
Croatian: Kisqali se može primjenjivati samo onda kada stanice raka na svojoj površini imaju receptore za određene hormone (HR-pozitivne) i nemaju velike količine drugog receptora pod nazivom HER2 (HER2negativne).
English: Kisqali is available as 200-mg tablets.
Croatian: Lijek Kisqali dostupan je u obliku tableta od 200 mg.
English: Women taking Kisqali with letrozole lived on average 25.3 months without the disease getting worse compared with 16.0 months in those taking placebo with letrozole.
Croatian: Žene koje su uzimale Kisqali i letrozol živjele su u prosjeku 25,3 mjeseca bez pogoršanja bolesti, u usporedbi sa 16,0 mjeseci za žene koje su uzimale placebo i letrozol.
English: The active substance in Kisqali, ribociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which are important for regulating the way cells grow and divide.
Croatian: Djelatna tvar u lijeku Kisqali, ribociklib, blokira aktivnost enzima poznatih kao kinaze ovisne o ciklinima (CDK) 4 i 6, koje su važne za regulaciju načina na koji stanice rastu i dijele se.
English: The European Medicines Agency decided that Kisqali's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Europska agencija za lijekove odlučila je da koristi lijeka Kisqali nadmašuju s njim povezane rizike te je preporučila njegovo odobrenja za primjenu u Europskoj uniji.
English: Kisqali must not be used in patients who are hypersensitive (allergic) to any of the ingredients or to peanuts or soya.
Croatian: Kisqali se ne smije primjenjivati u bolesnica koje su preosjetljive (alergične) na neki od sastojaka lijeka ili na kikiriki ili soju.
English: Why is Kisqali approved?
Croatian: Zašto je lijek Kisqali odobren?
English: What are the risks associated with Kisqali?
Croatian: Koji su rizici povezani s lijekom Kisqali?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kisqali 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 Kisqali nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The Agency considered that Kisqali's pattern of side effects has been fairly well established and the side effects appear manageable.
Croatian: Agencija smatra da je obrazac nuspojava lijeka Kisqali prilično dobro utvrđen i čini se da se nuspojave mogu kontrolirati.
English: Kisqali can only be obtained with a prescription and treatment should be started by a doctor experienced in the use of cancer treatments.
Croatian: Kisqali se izdaje samo na liječnički recept, a liječenje mora započeti liječnik koji ima iskustva u liječenju raka.
English: Kisqali is used with an aromatase inhibitor (a cancer medicine that reduces oestrogen).
Croatian: Kisqali se primjenjuje s inhibitorom aromataze (lijekom protiv raka koji smanjuje razinu estrogena).
English: If the patient gets severe side effects the doctor may reduce the dose of Kisqali, or interrupt or stop treatment with the medicine.
Croatian: Ako se u bolesnice razviju teške nuspojave, liječnik može smanjiti dozu lijeka Kisqali, privremeno prekinuti ili trajno zaustaviti liječenje tim lijekom.
English: Kisqali was found to be effective in one main study involving 668 women with HR-positive, HER2negative breast cancer.
Croatian: Djelotvornost lijeka Kisqali dokazana je u jednom glavnom ispitivanju koje je uključilo 668 žena s HRpozitivnim, HER2-negativnim rakom dojke.
English: It is not intended to provide practical advice on how to use Kisqali.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Kisqali.
English: Kisqali is a cancer medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in postmenopausal women.
Croatian: Kisqali je lijek protiv raka, a primjenjuje se za liječenje uznapredovalog ili metastatskog raka dojke (raka koji se proširio na druge dijelove tijela) u žena u postmenopauzi.
English: The most common severe side effects with Kisqali (which may affect more than 1 in 50 people) are low levels of white blood cells, nausea, vomiting, tiredness, back pain, abnormal blood tests for liver function and low levels of phosphate in the blood (hypophosphataemia).
Croatian: Najčešće teške nuspojave lijeka Kisqali (koje se mogu pojaviti u više od 1 na 50 osoba) jesu niska razina bijelih krvnih stanica, mučnina, povraćanje, umor, bol u leđima, odstupanja u krvnim pretragama za funkciju jetre i niske razine fosfata u krvi (hipofosfatemija).
English: Kisqali used with an aromatase inhibitor increased the time it took for the disease to get worse in postmenopausal women with HR-positive and HER2negative breast cancer that is advanced or metastatic.
Croatian: Lijek Kisqali primjenjivan s inhibitorom aromataze produljio je vrijeme proteklo do pogoršanja bolesti u žena u postmenopauzi s HR-pozitivnim i HER2-negativnim rakom dojke koji je uznapredovao ili metastazirao.
English: The most common side effects with Kisqali (which may affect more than 1 in 5 people) are low levels of white blood cells, headache, back pain, nausea (feeling sick), vomiting, diarrhoea, constipation, tiredness, hair loss and rash.
Croatian: Najčešće nuspojave lijeka Kisqali (koje se mogu pojaviti u više od 1 na 5 osoba) jesu niska razina bijelih krvnih stanica, glavobolja, bol u leđima, mučnina, povraćanje, proljev, zatvor, umor, gubitak kose i osip.
English: How does Kisqali work?
Croatian: Kako djeluje Kisqali?
English: In this study, women received either Kisqali with letrozole (an aromatase inhibitor) or placebo (a dummy treatment) with letrozole.
Croatian: U tom ispitivanju žene su primale ili Kisqali s letrozolom (inhibitor aromataze) ili placebo (prividno liječenje) s letrozolom.
English: What benefits of Kisqali have been shown in studies?
Croatian: Koje su koristi lijeka Kisqali dokazane u ispitivanjima?
English: For practical information about using Kisqali, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Kisqali bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: Kisqali contains the active substance ribociclib.
Croatian: Kisqali sadrži djelatnu tvar ribociklib.
English: For more information about treatment with Kisqali, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Kisqali pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: How is Kisqali used?
Croatian: Kako se lijek Kisqali koristi?
English: This may not be relevant for the target population.
Croatian: To možda nije relevantno za ciljanu populaciju.
English: Date of first authorisation: 24th May 2018
Croatian: Datum prvog odobrenja: 24. svibnja 2018.
English: Up to 10
Croatian: Do 10
English: Clinical data are not available.
Croatian: Klinički podaci nisu dostupni.
English: However, reduced alertness may also be of concern when participating in road traffic.
Croatian: Međutim, smanjena pažnja može također biti zabrinjavajuća pri sudjelovanju u cestovnom prometu.
English: This can sometimes be severe and prolonged.
Croatian: Ponekad može biti teška i produljena.
English: Biological analyses:
Croatian: Biološke analize:
English: Alcohol (Alcohol present in medicines)
Croatian: Alkohol (alkohol koji se nalazi prisutan u lijekovima)
English: After first opening 30 days.
Croatian: Nakon prvog otvaranja 30 dana.
English: Tel: + 33 (0)1 58 28 16 80 Fax: + 33 (0)1 58 28 16 90
Croatian: + 33 (0)1 58 28 16 80 Faks: + 33 (0)1 58 28 16 90
English: - This medicine has been prescribed for your child only.
Croatian: - Ovaj je lijek propisan samo Vašem djetetu.
English: Animal studies do not indicate a teratogenic potential.
Croatian: Ispitivanja na životinjama ne ukazuju na teratogeni potencijal.
English: In very rare cases, an intolerance to alcohol may occur.
Croatian: U vrlo rijetkim slučajevima može se pojaviti intolerancija na alkohol.
English: The medicine should be given at the same time each day.
Croatian: Lijek treba primjenjivati svaki dan u isto vrijeme.
English: Do not give a double dose to make up for a forgotten dose.
Croatian: Nemojte primijeniti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: You must talk to a doctor if your child does not feel better or if he/she feels worse after a few days.
Croatian: Obavezno se obratite liječniku ako se Vaše dijete ne osjeća bolje ili se osjeća lošije nakon nekoliko dana.
English: It is administered directly into the child's mouth.
Croatian: Primjenjuje se izravno u usta djeteta.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Croatian: Ovaj lijek uvijek koristite točno onako kako vam je rekao liječnik ili ljekarnik.
English: If your child presents any of theses symptoms, you should immediately go to the nearest emergency department.
Croatian: Ako Vaše dijete pokazuje bilo koji od tih simptoma, trebate odmah otići u najbližu hitnu službu.
English: Pre-breakfast glucose may be very slow to fall.
Croatian: Razina glukoze prije doručka može vrlo sporo padati.
English: Keep the bottle tightly closed.
Croatian: Bočicu držite čvrsto zatvorenom.
English: Effect of interaction
Croatian: Učinak interakcije
English: In isolated cases, photosensitivity may occur.
Croatian: U izoliranim slučajevima može doći do fotoosjetljivosti.
English: Summary of the safety profile:
Croatian: Sažetak sigurnosnog profila:
English: This medicinal product is contraindicated in the following cases:
Croatian: Ovaj je lijek kontraindiciran u sljedećim slučajevima:
English: AMGLIDIA with alcohol
Croatian: AMGLIDIA s alkoholom
English: Patients must be closely monitored for at least 48 hours and, depending on the patient's condition at this time, the physician will decide if additional monitoring is necessary.
Croatian: Bolesnike treba pažljivo pratiti barem 48 sati i, ovisno o stanju bolesnika, liječnik će tada odlučiti je li potrebno dodatno praćenje.
English: This medicine is not intended to be used in pregnant women and patients planning a pregnancy should inform their doctor.
Croatian: Ovaj lijek nije namijenjen za trudnice, a žene koje planiraju trudnoću o tome trebaju obavijestiti svojeg liječnika.
English: - Increase in sensitivity of the skin to sunlight.
Croatian: - povećana osjetljivost kože na sunčevu svjetlost
English: Adolescents are not in need of this oral suspension formulation.
Croatian: Adolescentima nije potreban ovakav oblik oralne suspenzije.
English: Centre Spécialités Pharmaceutiques 76-78 Avenue du midi 63800 Cournon d'Auvergne France
Croatian: Centre Spécialités Pharmaceutiques 76-78 Avenue du midi 63800 Cournon d'Auvergne Francuska
English: At risk patients
Croatian: Rizični bolesnici
English: If you give more AMGLIDIA to your child than you should
Croatian: Ako date više lijeka AMGLIDIA svojem djetetu nego što ste trebali
English: You should check capillary blood sugar of your child and follow the instructions described in section 4.
Croatian: Trebali biste provjeriti šećer u kapilarnoj krvi svojeg djeteta i slijediti upute opisane u dijelu 4.
English: Glibenclamide should not be given during pregnancy.
Croatian: Glibenklamid se ne smije davati tijekom trudnoće.
English: What AMGLIDIA is and what it is used for
Croatian: Što je AMGLIDIA i za što se koristi
English: Contents of the pack and other information What AMGLIDIA contains
Croatian: Sadržaj pakiranja i druge informacije Što AMGLIDIA sadrži
English: The plasma glibenclamide levels in the simulated paediatric population were approximately 30%-60% lower than the adult levels.
Croatian: Razine glibenklamida u plazmi u simuliranoj pedijatrijskoj populaciji bile su približno 30 % do 60 % niže nego u odraslih.
English: Hospitalisation may then prove necessary and sugar may have to be administered for several days.
Croatian: Možda će biti potrebna hospitalizacija i primjena šećera nekoliko dana.
English: Contains sodium and benzoate, see leaflet for further information.
Croatian: Sadrži natrij i benzoat, vidjeti uputu za dodatne informacije.
English: See your doctor, nurse or your hospital pharmacist immediately.
Croatian: Odmah posjetite liječnika, medicinsku sestru ili bolničkog ljekarnika.
English: Microvascular complications were reported in 7/81(9%) patients; there were no macrovascular complications.
Croatian: Mikrovaskularne komplikacije zabilježene su u 7 od 81 bolesnika (9 %); nije bilo makrovaskularnih komplikacija.
English: Bullous eruptions, exfoliative dermatitis, erythema multiforme have occasionally been reported in adults.
Croatian: Bulozne erupcije, eksfolijacijski dermatitis, multiformi eritem povremeno su zabilježeni u odraslih.
English: Always give the medicine before feeding,
Croatian: Lijek uvijek primjenjujte prije hranjenja.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti u skladu s nacionalnim propisima.
English: Do not lay the child down directly after administration.
Croatian: Nemojte poleći dijete odmah nakon primjene.
English: Anabolic steroids and male sex hormones
Croatian: Anabolički steroidi i muški spolni hormoni
English: The nearest volume to the calculated one should be used.
Croatian: Treba koristiti volumen koji je najbliži izračunatom volumenu.
English: Healthcare professionals or patients should never use another syringe than the one provided in the box to avoid dosing errors which could result in serious harm.
Croatian: Zdravstveni radnici ili bolesnici nikada se ne smiju koristiti drugom štrcaljkom osim one koja se nalazi u pakiranju kako bi se spriječilo pogrešno doziranje koje može dovesti do ozbiljne štete.
English: Overall, the safety profile of Glibenclamide is in line with the safety profile of others sulfonylureas.
Croatian: Sveukupno, sigurnosni profil glibenklamida u skladu je sa sigurnosnim profilom drugih sulfonilureja.
English: In all cases, HbA1c must be monitored every three months.
Croatian: U svim slučajevima razina HbA1c mora se pratiti svaka tri mjeseca.
English: Before each administration, it should be verified that the correct strength and syringe are used.
Croatian: Prije svake primjene treba provjeriti koristi li se odgovarajuća jačina i štrcaljka.
English: The minimum active concentration for the effect is considered to be 30-50 ng/mL glibenclamide.
Croatian: Minimalna aktivna koncentracija za taj učinak smatra se da iznosi 30 - 50 ng/ml glibenklamida.
English: Benzoate salt may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).
Croatian: Benzoat može pogoršati žuticu (žutilo kože i očiju) u novorođenčadi (do 4 tjedna starosti).
English: Glibenclamide is completely metabolised by the liver into 3 inactive metabolites excreted via bile (60%) and urine (40%); elimination is complete in 45 to 72 hours.
Croatian: Glibenklamid potpuno metabolizira jetra u 3 neaktivna metabolita koja se izlučuju putem žuči (60 %) i urina (40 %); eliminacija se dovršava za 45 do 72 sata.