FrancophonIA/ELRC3.0 huggingface dataset:
English: The infusion solution should be inspected visually for particulate matter prior to administration.
Croatian: Prije primjene otopinu za infuziju vizualno pregledajte da vidite sadrži li neke čestice.
English: EU/1/18/1312/001 EU/1/18/1312/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1312/002
English: Xerava 50 mg powder for concentrate for solution for infusion eravacycline
Croatian: NAZIV LIJEKA Xerava 50 mg prašak za koncentrat za otopinu za infuziju eravaciklin
English: Xerava 50 mg powder for concentrate for solution for infusion
Croatian: NAZIV LIJEKA Xerava 50 mg prašak za koncentrat za otopinu za infuziju
English: Calculate the required volume of the reconstituted solution based on the patient's weight and inject into a 100 mL infusion bag.
Croatian: Za bolesnike tjelesne težine od ≥ 40 kg do 49 kg: izračunajte potreban volumen rekonstituirane otopine na temelju tjelesne težine bolesnika i ubrizgajte u vrećicu za infuziju od 100 ml.
English: NAME OF THE MEDICINAL PRODUCT
Croatian: FARMACEUTSKI PODATCI
English: For single use only, any unused solution should be discarded.
Croatian: Svu neupotrijebljenu otopinu treba baciti.
English: General disorders and administration site conditions Infusion site reactionsc a. Thrombophlebitis includes the preferred terms thrombophlebitis and infusion site thrombosis b. Phlebitis includes the preferred terms phlebitis, infusion site phlebitis, superficial phlebitis and injection site phlebitis c. Infusion site reactions includes the preferred terms injection site erythema, infusion site hypoaesthesia,
Croatian: b. Flebitis uključuje preporučene pojmove flebitis, flebitis na mjestu infuzije, površinski flebitis i flebitis na mjestu injekcije.
English: Susceptibility testing breakpoints
Croatian: Granične vrijednosti pri ispitivanju osjetljivosti
English: Each vial contains 50 mg of eravacycline.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 50 mg eravaciklina.
English: Further information on Nordimet can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nordimet.
Croatian: Više informacija o lijeku Nordimet dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/nordimet.
English: Nordimet should be injected under the skin once a week on the same day each week.
Croatian: Lijek Nordimet trebao bi se injicirati pod kožu jedanput tjedno, uvijek na isti dan u tjednu.
English: Nordimet (methotrexate)
Croatian: Nordimet (metotreksat)
English: The company provided data from the published literature on methotrexate.
Croatian: Tvrtka je priložila podatke iz objavljene literature o metotreksatu.
English: Nordimet is a ‘hybrid medicine'.
Croatian: Nordimet je „hibridni lijek”.
English: What measures are being taken to ensure the safe and effective use of Nordimet?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Nordimet?
English: What is Nordimet and what is it used for?
Croatian: Što je Nordimet i za što se koristi?
English: Nordimet is a medicine used to treat the following inflammatory conditions:
Croatian: Nordimet je lijek koji se koristi za liječenje sljedećih upalnih stanja:
English: This means that it is similar to a ‘reference medicines' containing the same active substance, but Nordimet is available in more strengths.
Croatian: To znači da je sličan „referentnom lijeku” koji sadrži istu djelatnu tvar, ali je lijek Nordimet dostupan u više jačina.
English: The dose injected each week depends on which condition it is being used for and how well the treatment is working and, for children, on the child's height and weight.
Croatian: Doza koja se injicira svakoga tjedna ovisi o bolesti koja se liječi i tome koliko je liječenje učinkovito, a u djece ovisi o tjelesnoj težini i visini.
English: In most cases, methotrexate medicines are used for long-term treatment.
Croatian: Lijekovi koji sadrže metotreksat većinom se primjenjuju za dugoročne terapije.
English: Nordimet received a marketing authorisation valid throughout the EU on 18 August 2016.
Croatian: Lijek Nordimet dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 18. kolovoza
English: Side effects reported with Nordimet are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Nordimet pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: It should be prescribed only by doctors with expertise in the use of methotrexate and a full understanding of the risks of methotrexate treatment.
Croatian: Trebaju ga propisivati samo liječnici iskusni u primjeni metotreksata, koji u potpunosti razumiju rizike povezane s liječenjem metotreksatom.
English: The company that markets Nordimet will send out follow-up questionnaires for dosing errors that result in overdose.
Croatian: Tvrtka koja stavlja lijek Nordimet u promet poslat će kontrolne upitnike o pogreškama u doziranju koje rezultiraju predoziranjem.
English: Other information about Nordimet
Croatian: Ostale informacije o lijeku Nordimet
English: The reference medicine for Nordimet is Lantarel FS.
Croatian: Referentni lijek za lijek Nordimet je Lantarel FS.
English: An overview of Nordimet and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Nordimet i zašto je odobren u EU-u
English: Why is Nordimet authorised in the EU?
Croatian: Zašto je lijek Nordimet odobren u EU-u?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nordimet have also 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 Nordimet nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: • severe disabling psoriasis, a disease causing red, scaly patches on the skin, when other treatments have not worked well enough;
Croatian: • teške onesposobljavajuće psorijaze, bolesti koja uzrokuje crvene ljuskave lezije na koži, kada druge terapije nisu bile dovoljno djelotvorne;
English: The European Medicines Agency concluded that Nordimet was comparable to its reference medicine.
Croatian: Europska agencija za lijekove zaključila je da je lijek Nordimet usporediv s referentnim lijekom.
English: No additional studies were needed as Nordimet is a hybrid medicine that is given by injection and contains the same active substance as the reference medicine, Lantarel FS.
Croatian: Nisu bila potrebna dodatna ispitivanja jer je Nordimet hibridni lijek koji se injicira i sadrži istu djelatnu tvar kao i referentni lijek Lantarel FS.
English: Nordimet is available as various strengths of injection and it can only be obtained with a prescription.
Croatian: Nordimet je dostupan u obliku injekcije različitih jačina i izdaje se samo na recept.
English: What are the risks associated with Nordimet?
Croatian: Koji su rizici povezani s lijekom Nordimet?
English: The most serious side effects include reduced production of blood cells, damage to the lung, liver, kidneys and nerves, thromboembolism (problems caused by clots in blood vessels), and severe allergic and skin reactions.
Croatian: Najozbiljnije nuspojave uključuju smanjenu proizvodnju krvnih stanica, oštećenje pluća, jetre, bubrega i živaca, tromboemboliju (probleme izazvane ugrušcima u krvnim žilama) i teške alergijske i kožne reakcije.
English: As for all medicines, data on the use of Nordimet are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Nordimet kontinuirano se prate.
English: For more information about using Nordimet, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Nordimet pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The Agency therefore decided that Nordimet's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Stoga je Agencija zaključila da koristi od lijeka Nordimet nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The most common side effects with Nordimet (which may affect more than 1 in 10 people) are effects in the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing changes in the liver.
Croatian: Najčešće nuspojave lijeka Nordimet (koje se mogu javiti u više od 1 na 10 osoba) jesu one koje zahvaćaju probavni sustav (kao što su upala sluznice usne šupljine, probavne tegobe, bol u trbuhu, slabost i gubitak apetita) te krvne pretrage koje pokazuju promjene u jetri.
English: It must not be used if the patient is pregnant, breastfeeding or is receiving live vaccines.
Croatian: Ne smije se primjenjivati u trudnica, dojilja ili ako se bolesnici cijepe živim cjepivima.
English: • active rheumatoid arthritis, a disease causing inflammation in joints;
Croatian: • aktivnog reumatoidnog artritisa, bolesti koja uzrokuje upalu zglobova;
English: The way methotrexate, the active substance in Nordimet, works in patients with arthritis and psoriasis is not completely understood, but the benefits of methotrexate are thought to be due to its ability to reduce inflammation and suppress an overactive immune system.
Croatian: Nije u potpunosti jasno na koji način metotreksat, djelatna tvar u lijeku Nordimet, djeluje u bolesnika s artritisom i psorijazom, ali se smatra da koristi od metotreksata proizlaze iz njegove sposobnosti ublažavanja upale i supresije prekomjerno aktivnog imunosnog sustava.
English: Nordimet must not be used in patients who abuse alcohol or those with liver or severe kidney problems, blood disorders, weakened immune system (body defences), severe or long-term infections such as tuberculosis and HIV infection, mouth ulcers, inflammation in the mouth, and ulcers in the digestive system.
Croatian: Lijek Nordimet ne smije se primjenjivati u bolesnika koji prekomjerno konzumiraju alkohol ili u onih koji imaju teške probleme s jetrom ili bubrezima, poremećaje krvi, oslabljen imunosni sustav (sustav obrane tijela), teške ili dugotrajne infekcije poput tuberkuloze i infekcije virusom HIV-a, ulkuse u usnoj šupljini, upale usne šupljine i ulkuse u probavnom sustavu.
English: How does Nordimet work?
Croatian: Kako djeluje Nordimet?
English: Nordimet contains the active substance methotrexate.
Croatian: Nordimet sadrži djelatnu tvar metotreksat.
English: Because Nordimet has the same composition as the reference medicine its benefits are taken as being the same as those of Lantarel FS.
Croatian: Budući da je sastav lijeka Nordimet jednak sastavu referentnog lijeka, njegove se koristi smatraju jednakima koristima od lijeka Lantarel FS.
English: What benefits of Nordimet have been shown in studies?
Croatian: Koje su koristi od lijeka Nordimet utvrđene u ispitivanjima?
English: • severe psoriatic arthritis, inflammation of the joints that occurs in patients with psoriasis.
Croatian: • teškog psorijatičnog artritisa, upale zglobova koja se javlja u bolesnika s psorijazom.
English: For the full list of side effects and restrictions of Nordimet, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s primjenom lijeka Nordimet potražite u uputi o lijeku.
English: • severe juvenile idiopathic arthritis (JIA), a joint disease in children, when medicines known as
Croatian: • teškog oblika juvenilnog idiopatskog artritisa (JIA), bolesti zglobova u djece, u kojih lijekovi pod nazivom NSAIL-ovi (nesteroidni protuupalni lijekovi) nisu bili dovoljno djelotvorni;
English: How is Nordimet used?
Croatian: Kako se Nordimet primjenjuje?
English: EU/1/17/1214/001 Bavencio
Croatian: EU/1/17/1214/001 Bavencio 20 mg/ml
English: 10 mL
Croatian: U venu bočica (staklo) 10 ml
English: 20 mg/mL Concentrate for solution for infusion
Croatian: Koncentrat za otopinu za infuziju
English: The study continued for over three years.
Croatian: Ispitivanje je trajalo tri godine.
English: The full EPAR for Mimpara can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Mimpara nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Mimpara and what is it used for?
Croatian: Što je Mimpara i za što se koristi?
English: ‘Secondary' means that it is caused by another condition (serious kidney disease) while ‘primary' means there is no other cause.
Croatian: „Sekundarni” znači da je uzrokovan drugim poremećajem (ozbiljna bolest bubrega), a „primarni” znači da ne postoji drugi uzrok.
English: Mimpara is a medicine used to treat:
Croatian: Mimpara je lijek koji se primjenjuje u liječenju:
English: What measures are being taken to ensure the safe and effective use of Mimpara?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Mimpara?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mimpara on 22 October 2004.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Mimpara u promet koje je vrijedi na prostoru Europske unije od 22. listopada 2004.
English: The capsules should not be swallowed whole but should be opened and the granules sprinkled in food or liquid.
Croatian: Kapsule se ne gutaju cijele već ih treba otvoriti i granule posipati po hrani ili u tekućinu.
English: Other information about Mimpara
Croatian: Ostale informacije o lijeku Mimpara
English: This means that it mimics the action of calcium in the body.
Croatian: To znači da da oponaša djelovanje kalcija u tijelu.
English: This is a summary of the European public assessment report (EPAR) for Mimpara.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni lijeka (EPAR) Mimpara.
English: What are the risks associated with Mimpara?
Croatian: Koji su rizici povezani s lijekom Mimpara?
English: The European Medicines Agency therefore concluded that Mimpara's benefits outweigh the risks and recommended that it be given marketing authorisation.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi lijeka Mimpara nadmašuju s njim povezane rizike te je preporučila davanje odobrenja za stavljanje lijeka u promet.
English: Of these, 45 went on to a fourth, long-term study looking at the effectiveness of Mimpara over a total of almost six years.
Croatian: Od njih je 45 bolesnika obuhvaćeno četvrtim, dugoročnim ispitivanjem djelotvornosti lijeka Mimpara, u ukupnom trajanju od gotovo šest godina.
English: It is not intended to provide practical advice on how to use Mimpara.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Mimpara.
English: Why is Mimpara approved?
Croatian: Zašto je lijek Mimpara odobren?
English: With regard to the medicine's safety, side effects seen in patients are considered manageable.
Croatian: U pogledu sigurnosti lijeka, smatra se da je nuspojave uočene u bolesnika moguće kontrolirati.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mimpara 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 Mimpara nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The main measure of effectiveness was the number of patients whose blood calcium levels fell by more than 1 mg per decilitre by the time a maintenance dose had been found (between two and 16 weeks after the start of the study).
Croatian: Glavno mjerilo djelotvornosti bio je broj bolesnika kojima je razina kalcija u krvi pala za više od 1 mg po decilitru prije no što je ustanovljena doza održavanja (između dva i 16 tjedana nakon početka ispitivanja).
English: Mimpara is available as tablets and as granules in capsules, to be taken with food or shortly after a meal.
Croatian: Lijek Mimpara dostupan je u obliku tableta i granula u kapsulama, koje se uzimaju s hranom ili nedugo nakon obroka.
English: For more information about treatment with Mimpara, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Mimpara pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: In hyperparathyroidism, the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to high levels of blood calcium, bone and joint pain and deformities of the arms and legs.
Croatian: U oboljelih od hiperparatireoidizma paratiroidne žlijezde u vratu proizvode previše paratiroidnog hormona (PTH), koji može uzrokovati visoku razinu kalcija u krvi, bol u kostima i zglobovima i deformitete ruku i nogu.
English: Secondary hyperparathyroidism
Croatian: Sekundarni hiperparatireoidizam
English: The main measure of effectiveness was the reduction of PTH levels by 30%.
Croatian: Glavno mjerilo djelotvornosti bilo je smanjenje razine paratiroidnog hormona od 30 %.
English: What benefits of Mimpara have been shown during the studies?
Croatian: Koje su koristi lijeka Mimpara dokazane u ispitivanjima?
English: In patients with secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once a day, while in children the daily starting dose depends on the child's weight.
Croatian: U bolesnika sa sekundarnim hiperparatireoidizmom preporučena početna doza za odrasle osobe je 30 mg jedanput dnevno, a dnevna početna doza u djece ovisi o tjelesnoj težini djeteta.
English: Mimpara must not be used in patients with hypocalcaemia (low blood calcium levels).
Croatian: Lijek Mimpara ne smije se primjenjivati u bolesnika s hipokalcemijom (niska razina kalcija u krvi).
English: Mimpara produced a decrease in blood calcium of more than 1 mg/dl in 62% of the cancer patients (18 out of 29) and in 88% of the patients with primary hyperparathyroidism (15 out of 17).
Croatian: Lijek Mimpara uzrokovao je smanjenje kalcija u krvi iznad 1 mg/dl u 62 % bolesnika oboljelih od raka (18 od 29) i 88 % bolesnika oboljelih primarnog hiperparatireoidizma (15 od 17).
English: The most common side effects with Mimpara (in more than 1 patient in 10) are nausea (feeling sick) and vomiting.
Croatian: Najčešće nuspojave lijeka Mimpara (u više od 1 na 10 bolesnika) su mučnina (slabost) i povraćanje.
English: How does Mimpara work?
Croatian: Kako djeluje Mimpara?
English: • secondary hyperparathyroidism (overactive parathyroid glands) in adults and children aged 3 years and older with serious kidney disease who need dialysis (to clear their blood of waste products).
Croatian: • sekundarnog hiperparatireoidizma (prekomjerno aktivne paratiroidne žlijezde) u odraslih osoba i djece u dobi od tri godine i starije koji boluju od ozbiljne bolesti bubrega i trebaju dijalizu (čišćenje krvi od štetnih produkata);
English: For practical information about using Mimpara, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Mimpara bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: The reduction in PTH levels also leads to a decrease in blood calcium levels.
Croatian: Smanjivanje razine paratiroidnog hormona također snižava razinu kalcija u krvi.
English: By increasing the sensitivity of these receptors, cinacalcet leads to a reduction in the production of PTH by the parathyroid glands.
Croatian: Povećanjem osjetljivosti tih receptora cinacalcet uzrokuje smanjenje proizvodnje paratiroidnog hormona u paratiroidnim žlijezdama.
English: The active substance in Mimpara, cinacalcet, is a calcimimetic agent.
Croatian: Djelatna tvar lijeka Mimpara, cinacalcet, je kalcimimetik.
English: Cinacalcet works by increasing the sensitivity of the calcium-sensing receptors on the parathyroid glands that regulate parathyroid hormone secretion.
Croatian: Cinacalcet djeluje povećavajući osjetljivost receptora osjetljivih na kalcij koji se nalaze na paratiroidnim žlijezdama koje reguliraju sekreciju paratiroidnog hormona.
English: In these studies, about 40% of the patients taking Mimpara had parathyroid hormone levels below 250 micrograms per litre, compared with about 6% of those taking placebo.
Croatian: Otprilike 40 % bolesnika u tim ispitivanjima koji su primali lijek Mimpara imali su razinu paratiroidnog hormona ispod 250 mikrograma po litri, u usporedbi s otprilike 6 % bolesnika koji su primali placebo.
English: How is Mimpara used?
Croatian: Kako se Mimpara koristi?
English: Parathyroid gland cancer or primary hyperparathyroidism
Croatian: Rak paratiroidnih žlijezda ili primarni hiperparatireoidizam
English: Mimpara brought about a 42% reduction in average PTH levels compared with an increase of 8% in patients taking placebo.
Croatian: Lijek Mimpara uzrokovao je smanjenje prosječne razine paratiroidnog hormona od 42 %, u usporedbi s porastom od 8 % u bolesnika koji su primali placebo.
English: Mimpara has been compared with placebo (a dummy treatment) in three main studies involving 1,136 adults with secondary hyperparathyroidism who were on dialysis because they had a serious kidney disease.
Croatian: Lijek Mimpara uspoređen je s placebom (prividno liječenje) u trima glavnim ispitivanjima koja su obuhvatila 1 136 odrasle osobe sa sekundarnim hiperparatireoidizmom koje su bile na dijalizi jer su imale ozbiljnu bolest bubrega.
English: In children, Mimpara was compared with placebo in a study involving 43 children aged 6 to 18 years with serious kidney disease.
Croatian: U djece je lijek Mimpara uspoređen s placebom u ispitivanju koje je obuhvatilo 43 djece s ozbiljnom bolesti bubrega u dobi od šest do 18 godina.
English: • hypercalcaemia (high blood calcium levels) in adults with cancer of the parathyroid glands or with primary hyperparathyroidism when the parathyroid glands cannot be removed.
Croatian: • hiperkalcemije (visoka razina kalcija u krvi) u odraslih osoba koje boluju od raka paratiroidnih žlijezda ili od primarnog hiperparatireoidizma, kod kojih odstranjenje paratiroidnih žlijezda nije moguće.
English: Mimpara has been studied in a study involving 46 patients with hypercalcaemia, including 29 with parathyroid cancer, and 17 with primary hyperparathyroidism who could not have their parathyroid glands removed or in whom surgery to remove the parathyroid glands was not effective.
Croatian: Ispitivanje lijeka Mimpara obuhvatilo je 46 bolesnika oboljelih od hiperkalcemije, uključujući 29 bolesnika oboljelih od raka paratiroidnih žlijezda i 17 bolesnika oboljelih od primarnog hiperparatireoidizma, kod kojih odstranjenje paratiroidnih žlijezda nije bilo moguće ili operacija odstranjenja paratiroidnih žlijezda nije bila učinkovita.
English: The main measure of effectiveness was the number of patients who had a parathyroid hormone level below 250 micrograms per litre after 6 months.
Croatian: Glavno mjerilo djelotvornosti bio je broj bolesnika kojima je nakon šest mjeseci liječenja razina paratiroidnog hormona bila ispod 250 mikrograma po litri.
English: In patients with hypercalcaemia who also have parathyroid gland cancer or primary hyperparathyroidism, the recommended starting dose of Mimpara for adults is 30 mg twice a day.
Croatian: U odraslih osoba oboljelih od hiperkalcemije i od raka paratiroidnih žlijezda ili od primarnog hiperparatireoidizma preporučena početna doza lijeka Mimpara je 30 mg dvaput dnevno.
English: Studies showed that Mimpara was effective in both adults and children at reducing levels of parathyroid hormone in patients with secondary hyperparathyroidism who were undergoing dialysis for kidney disease.
Croatian: Ispitivanja su pokazala da je lijek Mimpara djelotvoran u odraslih osoba i u djece u smanjivanju razine paratiroidnog hormona u bolesnika sa sekundarnim hiperparatireoidizmom koji su bili na dijalizi zbog bolesti bubrega.