FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with Potactasol should only be given under the supervision of a doctor experienced in the use of chemotherapy.
Croatian: Terapija lijekom Potactasol smije se primjenjivati samo pod nadzorom liječnika s iskustvom u primjeni kemoterapije.
English: Therefore, the CHMP's view was that, as for Hycamtin, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da, kao u slučaju lijeka Hycamtin, koristi nadmašuju utvrđeni rizik.
English: The Committee recommended that Potactasol be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje lijeka Potactasol u promet.
English: When used with cisplatin in cervical cancer, Potactasol is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1).
Croatian: U slučaju primjene sa cisplatinom za liječenje raka vrata maternice, Potactasol primjenjuje se 1., 2. i 3. dana (pri čemu se cisplatin primjenjuje 1. dan).
English: The dose of Potactasol to be used depends on the type of cancer that it is being used to treat and the patient's weight and height.
Croatian: Doza lijeka Potactasol, koju treba primijeniti, ovisi o tipu raka koji se liječi te tjelesnoj težini i visini bolesnika.
English: Why has Potactasol been approved?
Croatian: Zašto je lijek Potactasol odobren?
English: It is available as a powder to be made up into a solution for infusion (drip) into a vein.
Croatian: Postoji kao koncentrat za otopinu za infuziju (drip) u venu.
English: The active substance in Potactasol, topotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Croatian: Djelatna tvar lijeka Potactasol, topotekan, je protutumorski lijek koji se ubraja u grupu „inhibitora topoisomeraze".
English: It is used on its own to treat patients with:
Croatian: Koristi se kao monoterapija za liječenje bolesnika s:
English: This summary was last updated in 10-2015.
Croatian: Sažetak je posljednji put ažuriran u 10.
English: When Potactasol is used on its own for ovarian cancer, it is given by infusion over 30 minutes.
Croatian: U slučaju kada se Potactasol primjenjuje kao monoterapija za liječenje karcinoma jajnika, primjenjuje se infuzijom tijekom 30 minuta.
English: What is Potactasol?
Croatian: Što je Potactasol?
English: Doses of Potactasol may need to be adjusted or treatment delayed, depending on side effects.
Croatian: Ovisno o nuspojavama može biti potrebna prilagodba doza lijeka Potactasol ili se terapija treba odgoditi.
English: Potactasol is a medicine that contains the active substance topotecan.
Croatian: Potactasol je lijek koji sadrži djelatnu tvar topotekan.
English: Potactasol is a cancer medicine.
Croatian: Potactasol je lijek protiv raka.
English: Because Potactasol is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Potactasol generički VMP te je bioekvivalent referentnom VMP-u, smatra se da su njegove koristi i rizici isti kao i oni referentnog VMP-a.
English: Potactasol is a ‘generic medicine'.
Croatian: Potactasol je „generički lijek”.
English: What is Potactasol used for?
Croatian: Za što se Potactasol koristi?
English: How does Potactasol work?
Croatian: Kako djeluje Potactasol?
English: For full details, see the summary of product characteristics, also part of the EPAR.
Croatian: Za više informacija vidjeti sažetak opisa svojstava lijeka (također dio EPAR-a).
English: How has Potactasol been studied?
Croatian: Kako je Potactasol ispitivan?
English: How is Potactasol used?
Croatian: Kako se Potactasol koristi?
English: Strength Pharmaceutical Form
Croatian: Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja
English: 60 sachets + 2 syringes (1 ml) + 2 syringes (3 ml) + 2 syringes (10 ml) + 2 mixing cups
Croatian: 60 vrećica + 2 štrcaljke (1 ml) + 2 štrcaljke (3 ml) + 2 štrcaljke (10 ml) + 2 čaše za miješanje
English: Granules for oral suspension sachet (PET/Alu/LLDPE)
Croatian: (PET/Alu/LLDPE)
English: For more information, see here.
Croatian: Za više informacije pogledajte ovdje.
English: What is Masican?
Croatian: Što je Masican?
English: 21 March 2014 EMA/167920/2014 EMEA/H/C/002670
Croatian: EMA/167920/2014 EMEA/H/C/002670
English: The applicant requested a re-examination of the opinion.
Croatian: Podnositelj zahtjeva zahtijevao je ponovni pregled mišljenja.
English: The main measure of effectiveness was progression-free survival (how long the patients lived without the disease getting worse).
Croatian: Glavna mjera djelotvornosti bilo je preživljenje bez napredovanja bolesti (koliko su dugo bolesnici živjeli bez pogoršavanja bolesti).
English: What were the CHMP's main concerns that led to the refusal?
Croatian: Koja je bila glavna bojazan CHMP-a koja je uzrokovala odbijanje?
English: What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Croatian: Koje posljedice ima ovo povlačenje za bolesnike u kliničkim ispitivanjima ili programima milosrdnog davanja lijeka?
English: In addition, there were still outstanding problems related to quality control during its manufacture.
Croatian: Pored toga, još uvijek postoje neriješeni problemi povezani s kontrolom kvalitete lijeka tijekom njegove proizvodnje.
English: The study was a ‘phase II study', an exploratory study designed to see if a medicine is worth investigating further.
Croatian: Ispitivanje je bilo „ispitivanje faze II”, eksplorativno ispitivanje osmišljeno kako bi se vidjelo je li lijek vrijedan daljnjeg ispitivanja.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Croatian: Ako sudjelujete u kliničkom ispitivanju ili u programu milosrdnog davanja lijeka te Vam je potrebno više informacija o terapiji, obratite se liječniku koji Vas liječi.
English: Refusal of the marketing authorisation for Masican (masitinib) EMA/167920/2014
Croatian: Odbijanje zahtjeva za odobrenjem lijeka Masican (masitinib) EMA/167920/2014
English: Finally, there were concerns about the quality control of the medicine during manufacture, which led to uncertainties about the impurities that patients would be exposed to.
Croatian: Naposljetku, postojale su bojazni o kontroli kvalitete lijeka tijekom proizvodnje koje su uzrokovale nesigurnosti oko nečistoća kojima bi bolesnici bili izloženi.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 March 2014.
Croatian: Nakon razmatranja temelja za ovaj zahtjev, CHMP je ponovno pregledao početno mišljenje i potvrdio odbijanje odobrenja za stavljanje lijeka u promet 20. ožujka 2014.
English: During the re-examination, although the medicine's safety was of less concern, the Committee still had major concerns about the medicine's benefits.
Croatian: Tijekom ponovnog pregleda, iako je sigurnost lijeka predstavljala manju bojazan, Povjerenstvo je još uvijek imalo velike bojazni oko koristi lijeka.
English: At the time of the initial evaluation, the CHMP was concerned that the study was not designed to compare Masican with sunitinib and that it was difficult to interpret the results.
Croatian: U vrijeme inicijalne procjene, CHMP je bio zabrinut da ispitivanje nije bilo dizajnirano kako bi se usporedio Masican sa sunitinibom te da je teško protumačiti rezultate.
English: By blocking these receptors, Masican might help in controlling cell division and thereby slow down the growth of the cancer.
Croatian: Blokadom ovih receptora Masican može pomoći u kontroli diobe stanica i tako usporiti rast karcinoma.
English: On 21 November 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masican, intended for the treatment of malignant gastrointestinal stromal tumour (GIST).
Croatian: Dana 21. studenog 2013. godine, Povjerenstvo za humane lijekove (CHMP) usvojilo je negativno mišljenje i preporučilo odbijanje odobrenja za stavljanje u promet lijeka Masican koji je namijenjen za liječenje malignog gastrointestinalnog stromalnog tumora (GIST).
English: The study included a group of patients treated with Masican and one group treated with sunitinib, another medicine of the same class.
Croatian: Ispitivanje je uključivalo skupinu bolesnika liječenih lijekom Masican i jednu skupinu liječenih sunitinibom, drugim lijekom iste klase.
English: The CHMP was also concerned that safety data were only available for a few patients treated with Masican at the proposed dose and this did not allow a proper evaluation of the medicine's side effects.
Croatian: CHMP je također bio zabrinut da su sigurnosni podaci bili dostupni samo za nekoliko bolesnika liječenih lijekom Masican pri predloženoj dozi i to nije omogućilo ispravnu procjenu nuspojava lijeka.
English: Masican was expected to be used to treat gastrointestinal stromal tumour (GIST), a cancer of the stomach and bowel, in adults whose cancer cannot be removed surgically or has spread and is getting worse despite treatment with imatinib, another medicine used to treat this cancer.
Croatian: Očekivalo se da će se Masican koristiti za liječenje gastrointestinalnog stromalnog tumora (GIST), karcinoma trbuha i crijeva u odraslih čiji se karcinom ne može ukloniti kirurški ili se proširio te se pogoršava unatoč liječenju imatinibom, drugim lijekom za liječenje ovog karcinoma.
English: Therefore, the Committee concluded that there were insufficient data to establish the benefits of Masican.
Croatian: Stoga je Povjerenstvo zaključilo da nema dovoljno podataka kako bi se utvrdile koristi lijeka Masican.
English: Refusal of the marketing authorisation for Masican (masitinib)
Croatian: Odbijanje zahtjeva za odobrenjem lijeka Masican (masitinib)
English: Although the group of patients treated with Masican appeared to live longer than those treated with sunitinib, the possibility that this was a chance finding could not be ruled out because of the exploratory nature of the study and because other supportive evidence was lacking.
Croatian: Iako se čini da je skupina bolesnika liječenih lijekom Masican živjela dulje od onih bolesnika liječenih lijekom sunitinib, mogućnost da se radilo o slučajnom nalazu ne može se isključiti zbog eksplorativne prirode ispitivanja i zato jer nema drugog suportivnog dokaza.
English: Therefore the CHMP concluded that the benefits of Masican did not outweigh its risks and maintained the previous recommendation that the medicine be refused marketing authorisation.
Croatian: Stoga je CHMP zaključio da koristi lijeka Masican nisu nadmašile njegove rizike te je zadržao prethodnu preporuku o odbijanju odobrenja za stavljanje lijeka u promet.
English: The active substance in Masican, masitinib, is a tyrosine-kinase inhibitor.
Croatian: Djelatna tvar u lijeku Masican, masitinib je inhibitor tirozin kinaze.
English: Masican is an anticancer medicine that contains the active substance masitinib.
Croatian: Masican je lijek protiv karcinoma koji sadrži djelatnu tvar masitinib.
English: Masican was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 21 December 2004 for the treatment of malignant GIST.
Croatian: Masicanu je dodijeljen status „lijeka siročeta” (lijeka za liječenje rijetkih bolesti) 21. prosinca 2004. godine za liječenje malignog GIST-a.
English: The applicant presented results of a main study in 44 patients with GIST that could not be removed surgically or that had spread and was resistant to imatinib treatment.
Croatian: Podnositelj zahtjeva predložio je rezultate glavnog ispitivanja na 44 bolesnika s GIST-om koji se nije mogao ukloniti kirurški ili koji se proširio te je bio rezistentan na imatinib.
English: These enzymes can be found in some receptors on the
Croatian: Ovaj je enzim nađen u nekim receptorima na površini kanceroznih stanica
English: surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Croatian: uključujući i receptore koji su uključeni u stimulaciju nekontrolirane diobe stanice.
English: What was Masican expected to be used for?
Croatian: Koja je bila očekivana namjena lijeka Masican?
English: How is Masican expected to work?
Croatian: Koje je bilo očekivano djelovanje lijeka Masican?
English: It is given to newborn calves once a day for one week.
Croatian: Daje se novorođenoj teladi jedanput dnevno tijekom jednog tjedna.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom dolazi do izlučivanja u izmet.
English: For prevention of diarrhoea, treatment should start within 24 to 48 hours of birth; for reducing diarrhoea, treatment should start within 24 hours of the start of diarrhoea.
Croatian: Za prevenciju proljeva s liječenjem treba započeti unutar 24 do 48 sati od rođenja; za smanjenje proljeva s liječenjem treba započeti unutar 24 sata od početka proljeva.
English: Halagon halofuginone
Croatian: Halagon halofuginon
English: The infection is known as cryptosporidiosis.
Croatian: Ta infekcija poznata je pod nazivom kriptosporidioza.
English: The full EPAR for Halagon can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Halagon nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.
Croatian: Objašnjava kako je Agencija ocijenila ovaj veterinarsko-medicinski proizvod (VMP), kako bi preporučila njegovo odobrenje u Europskoj uniji (EU) i uvjete za njegovu primjenu.
English: Halagon should be given after feeding.
Croatian: VMP Halagon treba davati nakon hranjenja.
English: Halagon can only be obtained with a prescription and is available as an oral solution (liquid to be given by mouth).
Croatian: Halagon se izdaje samo na recept i dostupan je kao oralna otopina (tekućina koja se daje u usta).
English: The withdrawal period for meat from newborn calves treated with Halagon is 13 days.
Croatian: Razdoblje karencije za meso novorođene teladi liječene VMP-om Halagon iznosi 13 dana.
English: The company provided data on the quality and manufacture of Halagon.
Croatian: Proizvođač je dostavio podatke o kvaliteti i proizvodnji VMP-a Halagon.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Halagon has been shown to have comparable quality to Halocur.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno da Halagon posjeduje usporedivu kvalitetu s VMP-om Halocur.
English: The European Commission granted a marketing authorisation valid throughout the EU for Halagon on 13 December 2016.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Halagon na snazi u Europskoj uniji od 13/12/2016.
English: What is Halagon and what is it used for?
Croatian: Što je Halagon i za što se koristi?
English: Halagon is a ‘generic medicine'.
Croatian: Halagon je „generički VMP”.
English: It is not intended to provide practical advice on how to use Halagon.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju VMP-a Halagon.
English: What are the benefits and risks of Halagon?
Croatian: Koje su koristi i rizici VMP-a Halagon?
English: No additional studies were needed as Halagon is a water based oral solution containing the same active substance and other ingredients as the reference medicine, in the same concentrations.
Croatian: Nisu bila potrebna dodatna ispitivanja jer je VMP Halagon oralna otopina na bazi vode koja sadrži istu djelatnu tvar i druge sastojke u istim koncentracijama kao i referentni VMP.
English: Why is Halagon approved?
Croatian: Zašto je Halagon odobren?
English: The active substance in Halagon, halofuginone, prevents the growth of Cryptosporidium parvum.
Croatian: Djelatna tvar u VMP-u Halagon, halofuginon, sprječava rast parazita Cryptosporidium parvum.
English: This means that Halagon is similar to a ‘reference medicine' already authorised in the EU called Halocur.
Croatian: To znači da je Halagon sličan „referentnom VMP-u” koji je već odobren u Europskoj uniji (EU) pod nazivom Halocur.
English: Therefore, the CVMP's view was that, as for Halocur, the benefits outweigh the identified risks.
Croatian: Stoga je stav CVMP-a da u slučaju VMP-a Halocur koristi nadmašuju utvrđene rizike.
English: The exact way halofuginone works is unknown.
Croatian: Nije poznat točan način na koji halofuginon djeluje.
English: This is a parasite belonging to the ‘protozoa' family that invades the digestive system, causing diarrhoea.
Croatian: Riječ je parazitu iz porodice protozoa koji napada probavni sustav i izaziva proljev.
English: This is a summary of the European public assessment report (EPAR) for Halagon.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o veterinarsko-medicinskom proizvodu Halagon.
English: Because Halagon is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Halagon generički VMP, smatra se da su njegove koristi i rizici isti kao i oni referentnog VMP-a.
English: It also limits the spread of the disease by preventing the formation of oocysts, which are a stage in the lifecycle of the parasite that are passed in the faeces.
Croatian: Također ograničava širenje bolesti sprječavanjem stvaranjem oocista, faze u životnom ciklusu parazita kada
English: Halagon EMA/664633/2016
Croatian: EMA/848945/2016 Halagon
English: Halagon is a medicine used to treat newborn calves to prevent or reduce diarrhoea caused by an organism called Cryptosporidium parvum.
Croatian: Halagon je VMP koji se koristi za prevenciju ili smanjenje proljeva izazvanog organizmom Cryptosporidium parvum u novorođene teladi.
English: The medicine contains the active substance halofuginone.
Croatian: VMP sadrži djelatnu tvar halofuginon.
English: Because Halagon is a generic medicine and is bioequivalent to the reference medicine the precautions are the same as for the reference medicine.
Croatian: Budući da je Halagon generički VMP te je bioekvivalentan referentnom VMP-u, mjere opreza iste su kao i kod referentnog VMP-a.
English: The Committee recommended that Halagon be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet VMP-a Halagon u EU-u.
English: How does Halagon work?
Croatian: Kako djeluje Halagon?
English: For practical information about using Halagon, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Halagon vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Other information about Halagon?
Croatian: Ostale informacije o VMP-u Halagon
English: For more information about treatment with Halagon, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Halagon vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Halagon, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers when using Halagon.
Croatian: U sažetku opisa svojstava VMP-a kao i u uputi o VMP-u Halagon nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: How is Halagon used?
Croatian: Kako se Halagon koristi?
English: How has Halagon been studied?
Croatian: Kako je Halagon ispitivan?
English: Protect other people
Croatian: Zaštitite druge ljude
English: You need to be aware of the extra risks:
Croatian: Stoga morate biti svjesni dodatnih rizika:
English: Do not drive or operate machines unless you are feeling well.
Croatian: Nemojte voziti ili koristiti strojeve ako se ne osjećate dobro.
English: • if you are seriously overweight (especially if you're a woman).
Croatian: • ako ste ozbiljno pretili (posebice ako ste žena)
English: No fatalities occurred, and all patients recovered.
Croatian: Niti jedan slučaj nije završio smrću i svi su se bolesnici oporavili.
English: See Section 4 for more information.
Croatian: Pogledajte dio 4 za više informacija.
English: If you notice any of these symptoms:
Croatian: Ako ste primijetili neki od ovih simptoma:
English: Combination not recommended.
Croatian: Kombinacija se ne preporučuje.
English: Look out for important symptoms
Croatian: Obratite pozornost na važne simptome
English: You may have problems with your bones
Croatian: Možete imati problema s kostima
English: Patients at increased risk should be followed closely.
Croatian: Bolesnike s povećanim rizikom treba pažljivo pratiti.
English: Interaction studies have only been performed in adults.
Croatian: Studije interakcija provedene su samo kod odraslih.
English: You need to keep taking it every day to stop your illness getting worse.
Croatian: Terapiju trebate uzimati svakodnevno, kako bi spriječili da se bolest pogorša.
English: • deep, rapid, difficult breathing
Croatian: • duboko, ubrzano, otežano disanje
English: 31-546 Krakow
Croatian: 31-546 Krakow Poljska
English: • difficulty moving.
Croatian: • otežano kretanje.
English: • if they drink alcohol
Croatian: • ako konzumiraju alkohol
English: You may need extra check-ups, including blood tests, while you are taking your medicine.
Croatian: Možda ćete trebati dodatne pretrage, uključujući krvne pretrage, dok uzimate ovaj lijek.
English: So it is very important to talk to your doctor about any changes in your health.
Croatian: Zato je vrlo važno da svog liječnika obavijestite o svim promjenama Vašeg zdravstvenog stanja.
English: ANTIHISTAMINES (HISTAMINE H1 RECEPTOR ANTAGONISTS)
Croatian: ANTIHISTAMINICI (ANTAGONISTI HISTAMIN H1 RECEPTORA)
English: • if they have been taking combination therapy for a long time
Croatian: • ako su uzimali kombiniranu terapiju kroz dulje razdoblje
English: Date of first authorisation: 02 March 2011 Date of latest renewal: 19 November 2015
Croatian: Datum posljednje obnove: 19. studenog 2015
English: However, absolute bioavailability (approximately 55-65 %) was reduced in paediatric patients below 12 years of age.
Croatian: Međutim, apsolutna bioraspoloživost (otprilike 55-65%) je smanjena u pedijatrijskih bolesnika mlađih od 12 godina.
English: See your doctor as soon as possible.
Croatian: Posjetite Vašeg liječnika čim prije je moguće.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Croatian: Ovakve reakcije su tipično zabilježene u prvih nekoliko tjedana ili mjeseci po uvođenju CART-a.
English: Take the tablets at regular times, leaving approximately 12 hours between each tablet.
Croatian: Uzmite tablete u redovito vrijeme, s razmakom od otprilike 12 sati između svake tablete.
English: EU/1/10/663/001 EU/1/10/663/002
Croatian: EU/1/10/663/002
English: Your doctor will monitor the effectiveness of your treatment.
Croatian: Vaš liječnik će nadzirati učinkovitost liječenja.
English: There are no data available on the safety of lamivudine when administered to babies less than three months old.
Croatian: Nema raspoloživih podataka o sigurnosti lamivudina kad se primjenjuje bebama mlađim od tri mjeseca.
English: The observed lamivudine half-life of elimination is 5 to 7 hours.
Croatian: Opaženo poluvrijeme eliminacije lamivudina iznosi 5-7 sati.
English: • difficulty in sleeping (insomnia)
Croatian: • teškoće pri spavanju (insomnija)