FrancophonIA/ELRC3.0 huggingface dataset:
English: During arthroscopy, the medicine is placed into the damaged area of the patient's cartilage.
Croatian: Tijekom artroskopije lijek se stavi u oštećeno područje
English: Spherox contains spheroids made from the patient's own healthy cartilage cells.
Croatian: Spherox sadrži sferoide proizvedene od zdravih stanica hrskavice samog bolesnika.
English: Spherox contains spheroids (spherical aggregates) of chondrocytes, cells found in healthy cartilage.
Croatian: Spherox sadrži sferoide (nakupine sferičnog oblika) hondrocita, stanica koje se nalaze u zdravoj hrskavici.
English: What benefits of Spherox have been shown in studies?
Croatian: Koje su koristi lijeka Spherox dokazane u ispitivanjima?
English: For practical information about using Spherox, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Spherox bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: How does Spherox work?
Croatian: Kako djeluje Spherox?
English: How is Spherox used?
Croatian: Kako se Spherox koristi?
English: To prepare the medicine, a small sample is taken by arthroscopy (a type of keyhole surgery) from the patient's cartilage in the knee.
Croatian: Da bi se pripremio lijek, iz bolesnikova se koljena artroskopijom (vrsta kirurškog postupka koja uključuje mali rez) uzme mali uzorak hrskavice.
English: For the full list of all side effects reported with Spherox, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Spherox potražite u uputi o lijeku.
English: Spherox has been shown to improve patients' symptoms and knee function in two studies in adults between 18 and 50 years of age.
Croatian: U dva ispitivanja provedena u odraslih u dobi između 18 i 50 godina, pokazalo se da Spherox poboljšava bolesnikove simptome i funkciju koljena.
English: It was to be available as tablets (5, 10, 25 and 50 mg).
Croatian: Trebao je biti dostupan u obliku tableta (5, 10, 25 i 50 mg).
English: The company provided the results of studies on the quality, safety and effectiveness of the medicine, including information from the literature.
Croatian: Tvrtka je dostavila rezultate istraživanje o kvaliteti, sigurnosti i djelotvornosti lijeka, uključujući podatke iz literature.
English: What is Elmisol?
Croatian: Što je Elmisol?
English: The study looked at the ability of the medicine to prevent the disease coming back.
Croatian: Istraživanje je bilo usmjereno na sposobnost lijeka da spriječi povratak bolesti.
English: Withdrawal of the marketing authorisation application for Elmisol (levamisole)
Croatian: Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Elmisol (levamisol)
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because there were concerns about the main study which would prevent its use to support the application.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da povlači svoj zahtjev jer postoje razlozi za zabrinutost u vezi s glavnim istraživanjem zbog kojih se ono ne može upotrijebiti u prilog zahtjevu.
English: The Committee was concerned about some elements of the way the main study was carried out and whether these were in accordance with the requirements of good clinical practice (GCP).
Croatian: Odbor je izrazio zabrinutost zbog nekih elemenata u načinu provedbe glavnog istraživanja te ga je brinulo jesu li ti elementi u skladu sa zahtjevima dobre kliničke prakse.
English: On 29 May 2017, ACE Pharmaceuticals BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Elmisol, for the treatment of nephrotic syndrome.
Croatian: Dana 29. svibnja 2017. tvrtka ACE Pharmaceuticals BV službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Elmisol za liječenje nefrotskog sindroma.
English: Elmisol is a medicine containing the active substance levamisole hydrochloride.
Croatian: Elmisol je lijek koji sadržava djelatnu tvar levamisol hidroklorid.
English: Other concerns included the possibility of dosing errors because the different strengths of tablet might get confused, the way the stability of the active substance in the tablets had been tested, and inadequate information on the medicine's actions, distribution in the body and risks of interactions with other medicines.
Croatian: Ostali razlozi za zabrinutost uključivali su mogućnost pogrešaka u doziranju jer se mogu pomiješati različite jačine tableta, način na koji se ispitala stabilnost djelatne tvari u tabletama te nedovoljni podatci o djelovanju lijeka, njegovoj distribuciji u tijelu i rizicima od interakcije s drugim lijekovima.
English: It is not completely understood how levamisole works in nephrotic syndrome, but it is known to affect the immune system (the body's natural defences).
Croatian: Nije u cijelosti poznato na koji način levamisol djeluje na nefrotski sindrom, ali poznato je da djeluje na imunosni sustav (prirodni obrambeni sustav tijela).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Elmisol.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se koristi lijek Elmisol.
English: Levamisole has been used for many years to treat a variety of conditions, including worm infections and cancers.
Croatian: Levamisol se godinama upotrebljava za liječenje različitih oboljenja, uključujući zaraze glistama i rak.
English: Suppressing the immune system with corticosteroid medicines can bring the disease under control, but these medicines can have marked side effects and affect growth in young patients.
Croatian: Slabljenjem imunosnog sustava s pomoću kortikosteroida bolest se može staviti pod kontrolu, no ti lijekovi mogu imati zabilježene nuspojave i mogu utjecati na rast u mlađih bolesnika.
English: What was Elmisol expected to be used for?
Croatian: Za što se Elmisol trebao koristiti?
English: Nephrotic syndrome is a kidney disease that is marked by presence of large amounts of protein in the urine and results in fluid build-up in the body, with swelling (oedema), high blood pressure and weight gain.
Croatian: Nefrotski sindrom jest bolest bubrega koja se očituje prisutnošću velikih količina bjelančevina u mokraći, što prouzročuje gomilanje tekućine u tijelu, a to dovodi do oticanja (edema), visokog krvnog tlaka i povećanja tjelesne težine.
English: Levamisole is thought to modify the action of the immune system, helping to control the disease and so reducing the amount of corticosteroids the patient needs.
Croatian: Smatra se da levamisol mijenja djelovanje imunosnog sustava, čime pomaže u kontroliranju bolesti i smanjuje količinu kortikosteroida koja je potrebna bolesniku.
English: Elmisol was to be used in patients in whom symptoms kept coming back after responding to initial treatment with corticosteroid medicines (steroid sensitive nephrotic syndrome).
Croatian: Elmisol se trebao primjenjivati u bolesnika kojima su se vratili simptomi nakon reakcije na početno liječenje kortikosteroidima (nefrotski sindrom osjetljiv na steroide).
English: The main study compared levamisole with placebo (a dummy treatment) in children with nephrotic syndrome that had been brought under control with corticosteroids.
Croatian: U glavnom istraživanju uspoređeno je djelovanje levamisola s djelovanjem placeba (prividnog liječenja) u djece s nefrotskim sindromom koji je stavljen pod kontrolu s pomoću kortikosteroida.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Elmisol could not have been approved for the treatment of nephrotic syndrome.
Croatian: Na temelju pregleda podataka u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Elmisol za liječenje nefrotskog sindroma.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Elmisol in the proposed indication did not outweigh its risks.
Croatian: Sukladno navedenome, CHMP je u vrijeme povlačenja smatrao kako koristi od lijeka Elmisol u predloženoj indikaciji ne nadmašuju s njim povezane rizike.
English: Withdrawal of the marketing authorisation application for Elmisol (levamisole) EMA/CHMP/380586/2017
Croatian: (levamisol) EMA/CHMP/380586/2017
English: How does Elmisol work?
Croatian: Kako djeluje lijek Elmisol?
English: Elmisol was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2005 for nephrotic syndrome.
Croatian: Elmisol je uvršten na popis lijekova za rijetke bolesti dana 28. listopada 2005. za liječenje nefrotskog sindroma.
English: Elmisol was to be used in children from 2 years of age to treat nephrotic syndrome.
Croatian: Elmisol se trebao primjenjivati za liječenje nefrotskog sindroma u djece u dobi od 2 godine i više.
English: In patients with nephrotic syndrome, the immune system is believed to attack the kidney in error, resulting in leakage of proteins out of the kidney into urine.
Croatian: imunosni sustav pogreškom napada bubrege, što prouzročuje ispuštanje bjelančevina iz bubrega u mokraću.
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Croatian: Doza Farmaceutski oblik
English: Immediate Packaging Pack size
Croatian: Veličina pakiranja
English: --1 1 dose (0.5 ml) contains approximately:
Croatian: --1 1 doza (0,5 ml) približno sadrži:
English: ¹ Human Papillomavirus = HPV
Croatian: humani papilomavirus = HPV
English: ² L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology
Croatian: L1 protein u obliku čestica nalik virusu proizvedenih u stanicama kvasca (Saccharomyces cerevisiae CANADE 3C-5 (soj 1895)) tehnologijom rekombinantne DNA.
English: ³ adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (0.5 milligrams Al)
Croatian: adsorbiran na adjuvans amorfni aluminijev hidroksifosfat sulfat (0,5 miligrama Al).
English: 10 syringes
Croatian: 10 štrcaljki
English: 1 syringe + 2 needles
Croatian: 1 štrcaljka + 2 igle
English: Content (concentration)
Croatian: Unutarnje pakiranje Sastav (koncentracija)
English: 10 syringes + 20 needles
Croatian: 10 štrcaljki + 20 igala
English: Pack size vial (glass)
Croatian: Intramuskularno bočica (staklo)
English: Two
Croatian: U
English: 18 December 2018
Croatian: 18. prosinca 2018.
English: What is Perlinring?
Croatian: Što je Perlinring?
English: The Agency concluded that the benefits of Perlinring outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Spain, Finland, France, Germany, Hungary, Ireland, Italy, Lithuania, Latvia, the Netherlands, Poland, Portugal, Romania, Slovenia, Slovakia and Sweden, plus Iceland and Norway.
Croatian: Agencija je zaključila da koristi od lijeka Perlinring nadmašuju s njim povezane rizike te da odobrenje za stavljanje u promet može biti izdano u Ujedinjenoj Kraljevini i državama članicama navedenima u nastavku: Austrija, Belgija, Češka Republika, Danska, Estonija, Finska, Francuska, Hrvatska, Njemačka, Mađarska, Irska, Italija, Litva, Latvija, Nizozemska, Poljska, Portugal, Rumunjska, Slovenija, Slovačka, Španjolska i Švedska, uz Island i Norvešku.
English: Why was Perlinring reviewed?
Croatian: Zašto je Perlinring pregledavan?
English: Perlinring was developed as a generic medicine.
Croatian: Perlinring razvijen je kao generički lijek.
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 7 August 2018.
Croatian: Međutim, države članice nisu mogle postići dogovor pa je regulatorna agencija za lijekove Ujedinjene Kraljevine uputila predmet EMA-i na arbitražni postupak 7. kolovoza 2018.
English: medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Croatian: Dva su lijeka bioekvivalentna ako dovode do iste razine djelatne tvari u organizmu i stoga se očekuje da imaju isti učinak.
English: Each ring contains two hormones, etonogestrel and ethinylestradiol, which are slowly released into the blood circulation and prevent the release of eggs from the ovaries.
Croatian: Prsten sadrži dva hormona, etonogestrel i etinilestradiol, koji se polagano otpuštaju u krvotok i sprječavaju otpuštanje jajašca iz jajnika.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned' Member States, see list above) where the company has applied for a marketing authorisation.
Croatian: To je postupak u kojemu jedna država članica („referentna država članica”, u ovom slučaju Ujedinjena Kraljevina) ocjenjuje lijek radi izdavanja odobrenja za njegovo stavljanje u promet koje će biti valjano u toj državi i u drugim državama članicama („predmetne države članice”, vidjeti prethodni popis).
English: Perlinring is used for 21 days (3 weeks) in a row, followed by a 7-day break, after which a new ring should be used.
Croatian: Perlinring se upotrebljava tijekom 21 dana (tri tjedna) uzastopno, nakon čega slijedi prekid od sedam dana, a nakon toga se može upotrijebiti novi prsten.
English: Perlinring is a contraceptive vaginal ring used to prevent pregnancy.
Croatian: Perlinring je kontracepcijski vaginalni prsten koji se upotrebljava za sprječavanje trudnoće.
English: The European Commission issued an EU-wide legally binding decision on 18 December 2018.
Croatian: Europska komisija objavila je 18. prosinca 2018. odluku koja je zakonski obvezujuća na području cijelog EU-a.
English: On 18 October 2018, the European Medicines Agency completed a review of Perlinring following a disagreement among EU Member States regarding its authorisation.
Croatian: Europska agencija za lijekove je 18. listopada 2018. okončala pregled lijeka Perlinringa nakon neslaganja među državama članicama EU-a u pogledu izdavanja odobrenja za predmetni lijek.
English: Actavis Group PTC EHF submitted Perlinring to the UK medicines agency for a decentralised procedure.
Croatian: Tvrtka Actavis Group PTC EHF podnijela je lijek Perlinring agenciji za lijekove Ujedinjene Kraljevine radi decentraliziranog postupka.
English: This means that Perlinring was developed to contain the same active substance and work in the same way as a ‘reference medicine' already authorised in the EU called Nuvaring.
Croatian: To znači da je Perlinring razvijen da sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Nuvaring.
English: Based on evaluation of the currently available data, the Agency considered that bioequivalence to the reference medicinal product has been shown for the authorised duration of treatment (3 weeks).
Croatian: Na temelju procjene trenutačno dostupnih podataka Agencija je smatrala da je bioekvivalentnost referentnog lijeka dokazana za odobreno trajanje liječenja (tri tjedna).
English: The Agency therefore concluded that the benefits of Perlinring outweigh its risks and recommended that the marketing authorisation be granted in all concerned Member States.
Croatian: Agencija je, stoga, zaključila da koristi lijeka Perlinring nadmašuju s njim povezane rizike te preporučuje izdavanje odobrenja za stavljanje u promet u svim predmetnim državama članicama.
English: Although the bioequivalence data submitted were sufficient to show that Perlinring is bioequivalent to Nuvaring over a period of 3 weeks, they did not cover the additional 4th week during which the contraceptive ring may still be used, even though this use is not recommended.
Croatian: Iako su podneseni podatci o bioekvivalentnosti bili dovoljni kako bi pokazali da je lijek Perlinring bioekvivalentan lijeku Nuvaring tijekom razdoblja od tri tjedna, oni nisu obuhvaćali dodatni četvrti tjedan tijekom kojeg se kontracepcijski prsten i dalje može upotrebljavati, iako se takva upotreba ne preporučuje.
English: The grounds for the referral relate to concerns raised by Germany, France and the Netherlands, that the Nuvaring product information for doctors and patients states that the product continues to be effective if it is used for an additional 4th week.
Croatian: Temelji za arbitražni postupak odnose se na zabrinutosti izražene u Njemačkoj, Francuskoj i Nizozemskoj da informacije o lijeku Nuvaring namijenjene liječnicima i bolesnicama navode da je lijek i dalje djelotvoran ako se upotrebljava tijekom dodatnog četvrtog tjedna.
English: In addition, there is enough evidence to expect that Perlinring continues to be effective for an additional 4th week, as is the case for Nuvaring.
Croatian: Nadalje, postoji dovoljno dokaza koji ukazuju da je moguće očekivati da će Perlinring nastaviti biti djelotvoran tijekom dodatnog četvrtog tjedna, kao što je i lijek Nuvaring.
English: The review of Perlinring was initiated at the request of the United Kingdom, under Article 29 of Directive 2001/83/EC.
Croatian: Pregled lijeka Perlinring pokrenut je na zahtjev Ujedinjene Kraljevine na temelju članka 29.
English: In its application, the company for Perlinring provided data demonstrating that Perlinring is ‘bioequivalent' to Nuvaring over a period of 3 weeks, which is the authorised length of treatment.
Croatian: Tvrtka je u svojem zahtjevu za Perlinring navela podatke koji pokazuju da je Perlinring „bioekvivalentan” lijeku Nuvaring tijekom razdoblja od tri tjedna, što je odobrena duljina liječenja.
English: EMA/720896/2018 Rev 1 EMEA/H/A-29/1473
Croatian: 1 EMEA/H/A-29/1473
English: Bioequivalence data for week 4 were considered necessary by Germany, France and the Netherlands as Perlinring is expected to be used in the same way as Nuvaring.
Croatian: Njemačkoj, Francuskoj i Nizozemskoj smatrali su da su podatci o bioekvivalentnosti za četvrti tjedan nužni jer se očekuje da se Perlinring upotrebljava na isti način kao i lijek Nuvaring.
English: This summary was last updated in September 2017.
Croatian: Sažetak je posljednji put ažuriran u rujnu 2017.
English: These signs usually resolve without treatment.
Croatian: Te pojave obično nestanu bez ikakve terapije.
English: What is Simparica and what is it used for?
Croatian: Što je Simparica i za što se koristi?
English: Sarolaner
Croatian: Simparica sarolaner
English: The full EPAR for Simparica can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Simparica nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This results in uncontrolled activity of the nervous system and the paralysis and death of the parasites.
Croatian: To rezultira nekontroliranim djelovanjem živčanog sustava i paralizom te smrću parazita.
English: The appropriate strength tablet(s) should be used according to the dog's weight.
Croatian: Tabletu(e) odgovarajuće jačine treba koristiti u skladu s tjelesnom težinom psa.
English: As other conditions contribute to demodectic mange, any underlying diseases should also be treated.
Croatian: Budući da druga stanja doprinose demodikozi, sve podležeće bolesti također treba liječiti.
English: The European Commission granted a marketing authorisation valid throughout the EU for Simparica on 6 November 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Simparica na snazi u Europskoj uniji od 6. studenoga 2015.
English: The tablets should be kept in the original package until use in order to prevent children directly accessing the medicine.
Croatian: Tablete treba čuvati u originalnom pakiranju sve do uporabe kako bi se spriječilo da djeca imaju izravan pristup VMP-u.
English: In order to be exposed to the active substance, fleas and ticks must attach to the skin and commence feeding on the dog's blood.
Croatian: Kako bi ih se izložilo aktivnoj tvari, buhe i krpelji moraju se primiti za kožu i započeti hranjenje krvlju psa.
English: Why is Simparica approved?
Croatian: Zašto je VMP Simparica odobren?
English: Sarolaner kills these parasites that have ingested the dog's blood by acting on their nervous system.
Croatian: Sarolaner ubija parazite koji su popili krv psa tako što djeluje na njihov živčani sustav.
English: Because fleas and ticks must start feeding on the dog in order to be killed by the medicine, the risk of transmission of diseases with which they may be infected cannot be excluded.
Croatian: Budući da se buhe i krpelji moraju početi hraniti krvlju psa da bi ih se moglo iskorijeniti VMP-om, ne može se isključiti rizik od prijenosa bolesti kojima oni mogu biti zaraženi.
English: This means that it kills parasites that live on the skin or in the fur of animals, such as fleas, ticks and mites.
Croatian: To znači da ubija parazite koji žive na koži ili u krznu životinja, kao što su buhe, krpelji i grinje.
English: Other information about Simparica
Croatian: Ostale informacije o VMP-u Simparica
English: What are the risks associated with Simparica?
Croatian: Koji su rizici povezani s VMP-om Simparica?
English: It contains the active substance sarolaner.
Croatian: Sadrži djelatnu tvar sarolaner.
English: It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters).
Croatian: Inhibira normalno kretanje nabijenih čestica klorida (iona) u živčanim stanicama i iz njih, posebno onih povezanih s gama-aminobutričnom kiselinom (GABA) i glutamatom, dvjema tvarima koje prenose poruke između živaca (neurotransmiteri).
English: Treatment should be continued until skin scrapings are negative on at least two consecutive occasions one month apart.
Croatian: Liječenje treba nastaviti dok kožne strugotine ne budu negativne barem dva puta uzastopno u razmaku od mjesec dana.
English: Simparica is available as chewable tablets (5, 10, 20, 40, 80 and 120 mg) and can only be obtained with a prescription.
Croatian: VMP Simparica dostupan je u obliku tableta za žvakanje (5, 10, 20, 40, 80 i 120 mg), a izdaje se samo na veterinarski recept.
English: It is not intended to provide practical advice on how to use Simparica.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a Simparica.
English: Sarolaner kills fleas before they can lay eggs and so helps to reduce contamination of the dog's environment.
Croatian: Sarolaner ubija buhe prije nego što uspiju izleći jajašca te tako pomaže pri smanjivanju kontaminacije okruženja psa.
English: For treatment of ear mite infestations a single dose should be given.
Croatian: Za liječenje infestacija ušnim škugarcem, treba dati jednu dozu.
English: Simparica was as effective as moxidectin/imidacloprid and the percentage of Simparica-treated dogs with no live mites was 15%, 69%, 93%, 94%, 100% and 100% on days 30, 60, 90, 120, 150 and 180, respectively.
Croatian: VMP Simparica bio je jednako djelotvoran kao moksidektin/imidakloprid, a postotak pasa liječenih VMP-om Simparica koji nisu imali žive grinje nakon 30, 60, 90, 120, 150 i 180 dana iznosio je 15 %, 69 %, 93 %, 94 %, 100 % i 100 %.
English: However, the following side effects are seen in less than 1 dog in 10,000: mild and short-lived vomiting and diarrhoea as well as tremor (shaking), ataxia (inability to coordinate body movements) or convulsions.
Croatian: Međutim, sljedeće nuspojave zabilježene su u 1 na 10 000 pasa: blago i kratkotrajno povraćanje i proljev, kao i tremor (drhtanje), ataksija (nemogućnost koordiniranja kretanja mišića) ili konvulzije.