FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP considered that ChondroCelect was shown to be effective at treating defects in the knee cartilage between 1 and 5 cm2 in size, and that the safety profile was considered acceptable.
Croatian: CHMP je zaključio da je lijek ChondroCelect dokazao svoju djelotvornost u liječenju oštećenja hrskavice koljena veličine između 1 i 5 cm2, te je zaključeno da su profili sigurne primjene prihvatljivi.
English: In addition, the company that makes ChondroCelect will ensure that all surgeons and other healthcare professionals involved in the handling or use of ChondroCelect receive training materials on how to use the product.
Croatian: Nadalje, tvrtka koja proizvodi lijek ChondroCelect osigurat će da kirurzi i drugi zdravstveni djelatnici koji su uključeni u rukovanje ili primjenu lijeka ChondroCelect zaprime materijale za obuku o načinu primjene lijeka.
English: A risk management plan has been developed to ensure that ChondroCelect is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka ChondroCelect.
English: ChondroCelect is used in adults to repair damage to the cartilage in the knee.
Croatian: ChondroCelect se koristi u odraslih bolesnika za liječenje oštećenja hrskavice u koljenu.
English: Based on the assessment performed by the CAT, the CHMP decided that ChondroCelect's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Na temelju procjene koju je proveo CAT, CHMP je odlučio da koristi lijeka ChondroCelect nadamašuju njegove rizike i preporučio je izdavanje odobrenja za stavljanje lijeka u promet.
English: ChondroCelect characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Croatian: ChondroCelect karakterizirane viabilne autologne stanice hrskavice razvijene ex vivo koje imaju specifične markerske proteine
English: The materials for other healthcare professionals will include information on how to handle the collected biopsy and prepare ChondroCelect for implantation, and how to follow patients up and plan the recommended physiotherapy.
Croatian: Materijali za druge zdravstvene djelatnike uključivati će informacije o načinu rukovanja prikupljenom biopsijom i pripremi lijeka ChondroCelect za ugradnju, te kako pratiti bolesnike i planirati preporučenu fizioterapiju.
English: It is used when there is a single defect in the cartilage of the femoral condyle (the bottom end of the thighbone) that is causing symptoms.
Croatian: Koristi se kada postoji pojedinačno simptomatično oštećenje hrskavice femoralnog kondila koljena (donji završetak bedrene kosti) koji uzrokuje simptome.
English: It must also not be used in patients with advanced osteoarthritis of the knee (a disease causing swelling and pain in the knee) and those with the femoral growth plate (the end part of the thighbone) that is not fully closed.
Croatian: Ne smije se koristiti u bolesnika s teškim osteoartritisom (oticanje i bol) koljena i u bolesnika s nepotpuno zatvorenom femoralnom epifiznom pločom rasta (završetak bedrene kosti).
English: The training materials for surgeons will include information on how to collect the cartilage biopsy from patients, perform the operation and follow patients up.
Croatian: Materijali za obuku kirurga uključuju informacije o načinu uzimanja biopsije hrskavice iz bolesnika, provođenje kirurškog zahvata i praćenje bolesnika.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for ChondroCelect, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek ChondroCelect uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: ChondroCelect must be administered by a qualified surgeon in a hospital.
Croatian: ChondroCelect smije primjenjivati samo obučeni kirurg u bolnici.
English: What is the risk associated with ChondroCelect?
Croatian: Koji su rizici povezani s lijekom ChondroCelect?
English: ChondroCelect was more effective than microfracture at healing the defects in the cartilage.
Croatian: ChondroCelect je bio djelotvorniji od mikrofraktura u zacijeljivanju nedostataka u hrskavici.
English: What benefit has ChondroCelect shown during the studies?
Croatian: Koje su koristi lijeka ChondroCelect dokazane u ispitivanjima?
English: What is ChondroCelect?
Croatian: Što je ChondroCelect?
English: The active substance in ChondroCelect is the patient's own cartilage cells.
Croatian: Djelatna tvar lijeka ChondroCelect su bolesnikove vlastite stanice hrskavice.
English: Why has ChondroCelect been approved?
Croatian: Zašto je lijek ChondroCelect odobren?
English: What is ChondroCelect used for?
Croatian: Za što se ChondroCelect koristi?
English: For the full list of all side effects reported with ChondroCelect, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka ChondroCelect, potražite u uputi o lijeku.
English: How is ChondroCelect used?
Croatian: Kako se ChondroCelect koristi?
English: How has ChondroCelect been studied?
Croatian: Kako je ChondroCelect ispitivan?
English: How does ChondroCelect work?
Croatian: Kako djeluje ChondroCelect?
English: International non-proprietary name (INN): spiramycin
Croatian: Međunarodni nezaštićeni naziv (INN): spiramicin
English: 11 December 2014
Croatian: 11. prosinca 2014.
English: The final opinion was converted into a Decision by the European Commission on 11 December 2014.
Croatian: Europska Komisija usvojila je konačno mišljenje u obliku Odluke 11. prosinca 2014.
English: 1 Article 35 of Directive 2001/82/EC, as amended 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: Direktive 2001/82/EZ, s izmjenama 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information.
Croatian: Na temelju ocjene trenutno dostupnih podataka, CVMP je zaključio da cjelokupan profil koristi i rizika za ove proizvode ostaje pozitivan, što je predmetom izmjena u informacijama o proizvodu.
English: Captalin solution for injection contains 31.25 g spiramycin per 100 ml, corresponding to 1 000 000 IU spiramycin per ml.
Croatian: Captalin otopina za injekciju sadrži 31.25 g spiramicina na 100 ml, što odgovara 1 000 000 IU spiramicina na ml.
English: Written explanations were provided by the applicants and marketing authorisation holders on 10 December 2012, 14 October 2013, 1 April 2014 and 10 June 2014.
Croatian: Podnositelji zahtjeva i nositelji odobrenja za stavljanje VMP-a u promet dostavili su pisana pojašnjenja dana 10. prosinca 2012., 14. listopada 2013., 1. travnja 2014. i 10. lipnja 2014.
English: The referral started on 13 September 2012.
Croatian: Upućivanje je započeto 13. rujna 2012.
English: The CVMP was requested to give its opinion on the indications, dosing regimens and withdrawal periods in cattle and pigs, in order to ensure efficacious treatment and lower the risk of development of antimicrobial resistance to spiramycin taking into account the available data and also to harmonise the withdrawal periods in cattle and pigs for the concerned products.
Croatian: Od CVMP-a je zatraženo da donese svoje mišljenje o indikacijama, režimima doziranja razdobljima ustezanja za goveda i svinje, kako bi se osiguralo djelotvorno liječenje i manji rizik od razvoja antimikrobne rezistencije na spiramicin uzimajući u obzir dostupne podatke kao i harmoniziranje razdoblja karencije u goveda i svinja za odgovarajuće proizvode.
English: The veterinary medicinal products Suanovil 20 solution for injection and its generic product Spirovet are solutions for injection which contain 20 g spiramycin per 100 ml, corresponding to 600 000 IU spiramycin per ml.
Croatian: Veterinarsko-medicinski proizvodi Suanovil 20 otopina za injekciju i njegov generički proizvod Spirovet su otopine za injekcije koje sadrže 20 g spiramicina po 100 ml, što odgovara 600 000 IU spiramicina po ml.
English: The Committee appointed C. Ibrahim as rapporteur and B. Urbain as co-rapporteur.
Croatian: Ibrahim kao izvjestitelja i B.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.
Croatian: Znanstveni zaključci navedeni su u Prilogu II. zajedno s dopunama u sažetcima opisa svojstava proizvoda, etiketama i uputama o lijeku u Prilogu III.
English: Oral explanations were given on 9 September 2014.
Croatian: Usmena pojašnjenja su dana 9. rujna 2014.
English: Therefore, on 9 September 2014 the Committee adopted by majority a positive opinion, recommending variations to the terms of the marketing authorisations for Suanovil 20 and associated names, Captalin and associated names and generic products thereof.
Croatian: Odbor je većinski usvojio pozitivno mišljenje, preporučujući izmjene u uvjetima odobrenja za stavljanje lijeka u promet za Suanovil 20 i povezane nazive, Captalin i povezane nazive te za generičke proizvode istih.
English: Opinion following an Article 351 referral for Suanovil 20 and associated names, Captalin and associated names and generic products thereof
Croatian: Mišljenje po provođenju postupka upućivanja u skladu s člankom 35.1 za Suanovil 20 i povezane nazive, Captalin i povezane nazive te generičke proizvode istih
English: Opinion following an Article 350F referral for Suanovil 20 and associated names, Captalin and associated names and generic products thereof EMA/745255/2014
Croatian: Mišljenje po provođenju postupka upućivanja u skladu s člankom 35.0F za Suanovil 20 i povezane nazive, Captalin i povezane nazive te generičke proizvode istih
English: On 12 September 2012, Gemany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Suanovil 20 and associated names, Captalin and associated names and generic products thereof.
Croatian: Direktive 2011/82/EZ, u vezi s lijekom Suanovil 20 i povezanim nazivima, lijekom Captalin i povezanim nazivima i generičkim proizvodima istih.
English: --1 Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ≥ 5.3 log10 FAID50*/ml Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) ≥ 5.3 log10 FAID50*/ml Clostridium tetani toxoid: ≥ 30 IU**/ml * vCP content checked by global FAID50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP.
Croatian: --1 Virus influence konja A/eq/Ohio/03 [H3N8] rekombiniran s virusom boginja kanarinca (vCP2242) ≥ 5,3 log10 FAID50*/ml Virus influence konja A/eq/Richmond/1/07 [H3N8] rekombiniran s virusom boginja kanarinca (vCP3011) ≥ 5,3 log10 FAID50*/ml Clostridium tetani toksoid ≥ 30 IU**/ml
English: ** antitoxic antibody titre induced after repeated vaccination in guinea pig sera according to Ph. Eur.
Croatian: ID ** titar antitoksičnih protutijela induciran nakon ponovljenog cijepljenja u serumu zamoraca prema Ph.
English: Horses Intramuscular use vial (glass) 1 ml
Croatian: Intramuskularna primjena bočica (staklena)
English: 13 December 2018
Croatian: 13. prosinca 2018.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal was due to a change in the company's strategy.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da je do povlačenja zahtjeva došlo zbog promjene strategije tvrtke.
English: On 5 December 2018, Pfizer Europe MA EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fyzoclad, for the treatment of a number of inflammatory diseases.
Croatian: Dana 5. prosinca 2018., tvrtka Pfizer Europe MA EEIG službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Fyzoclad za liječenje određenog broja upalnih bolesti.
English: It was to be available as a solution for injection.
Croatian: Trebao je biti dostupan u obliku otopine za injekciju.
English: As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations.
Croatian: Budući da je CHMP procjenjivao inicijalnu dokumentaciju koju je dostavila tvrtka, još uvijek nije donio nikakve preporuke.
English: This means that Fyzoclad was intended to be highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: To znači da je Fyzoclad je trebao biti vrlo sličan drugom biološkom lijeku („referentni lijek”) koji je već odobren u EU-u.
English: The company informed the CHMP that there are no ongoing clinical trials with Fyzoclad.
Croatian: Tvrtka je obavijestila CHMP da nema kliničkih ispitivanja lijeka Fyzoclad koja su u tijeku.
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Croatian: Vezivanjem na TNF adalimumab blokira njegovo djelovanje te tako smanjuje upalu i druge simptome bolesti.
English: The application was withdrawn while the CHMP was still evaluating the initial documentation provided by the company.
Croatian: Zahtjev je povučen u trenutku kada je CHMP još uvijek procjenjivao inicijalnu dokumentaciju koju je tvrtka dostavila.
English: Fyzoclad was developed as a ‘biosimilar' medicine.
Croatian: Fyzoclad je razvijen kao „biosličan” lijek.
English: Fyzoclad acts on the immune system and was to be used to treat the following inflammatory conditions:
Croatian: Fyzoclad djeluje na imunološki sustav i trebao se primjenjivati za liječenje sljedećih upalnih bolesti:
English: The reference medicine for Fyzoclad is Humira.
Croatian: Referentni lijek za lijek Fyzoclad je Humira.
English: This substance is involved in causing inflammation associated with the diseases that adalimumab is intended to treat and is found at high levels in patients with these diseases.
Croatian: uključena u nastanak upale povezane s bolestima koje je adalimumab trebao liječiti, a ustanovljena je u visokim koncentracijama u bolesnika s tim bolestima.
English: What is Fyzoclad?
Croatian: Što je Fyzoclad?
English: Fyzoclad is a medicine that contains the active substance adalimumab.
Croatian: Fyzoclad je lijek koji sadrži djelatnu tvar adalimumab.
English: How does Fyzoclad work?
Croatian: Kako djeluje Fyzoclad?
English: The company presented laboratory studies comparing Fyzoclad to its reference medicine Humira in terms of structure, purity and biological activity.
Croatian: Tvrtka je dostavila rezultate laboratorijskih ispitivanja u kojima je Fyzoclad uspoređen s referentnim lijekom Humira u pogledu kemijske strukture, čistoće i biološkog djelovanja.
English: • psoriasis and paediatric plaque psoriasis (both are diseases causing red, scaly patches on the skin).
Croatian: • psorijaze i pedijatrijske plak psorijaze (obje bolesti uzrokuju crvene, ljuskave mrlje na koži);
English: • uveitis (inflammation of the layer beneath the white of the eyeball) and paediatric uveitis.
Croatian: • uveitisa (upale sloja ispod bjeloočnice) i pedijatrijskog uveitisa.
English: Fyzoclad was expected to work in the same way as the reference medicine, Humira.
Croatian: Očekivalo se da će Fyzoclad djelovati na jednak način kao i referentni lijek Humira.
English: What was Fyzoclad expected to be used for?
Croatian: Za što se Fyzoclad trebao primjenjivati?
English: In addition, a study in patients with rheumatoid arthritis compared Fyzoclad with Humira.
Croatian: Osim toga, Fyzoclad je uspoređen s lijekom Humira u ispitivanju provedenom u bolesnika s reumatoidnim artritisom.
English: The active substance in Fyzoclad and Humira, adalimumab, is a monoclonal antibody (a type of protein) that has
Croatian: Djelatna tvar u lijekovima Fyzoclad i Humira, adalimumab, monoklonsko je protutijelo (vrsta bjelančevine) namijenjeno prepoznavanju i vezivanju za tvar u tijelu zvanu faktor nekroze tumora (TNF).
English: • juvenile idiopathic arthritis (disease causing inflammation in the joints);
Croatian: • juvenilnog idiopatskog artritisa (bolest koja uzrokuje upalu zglobova);
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
Croatian: • psorijatičnog artritisa (bolesti koja uzrokuje crvene, ljuskave mrlje na koži i upalu zglobova);
English: • axial spondyloarthritis (inflammation of the spine causing back pain);
Croatian: • aksijalnog spondiloartritisa (upala kralježnice koja uzrokuje bol u leđima);
English: In this way Procoralan helps to control and reduce the number of angina attacks.
Croatian: Na taj način, Procoralan pomaže u kontroliranju i smanjenju broja napadaja angine.
English: Procoralan should be taken during meals.
Croatian: Procoralan treba uzimati tijekom obroka.
English: If you forget to take a dose of Procoralan, take the next dose at the usual time.
Croatian: Ako zaboravite uzeti jednu dozu Procoralana, uzmite sljedeću dozu u uobičajeno vrijeme.
English: Children Procoralan is not intended for use in children and adolescents younger than 18 years.
Croatian: Djeca Procoralan nije namijenjen djeci ni mladeži mlađoj od 18 godina.
English: What Procoralan is and what it is used for
Croatian: Što je Procoralan i za što se koristi
English: If you take more Procoralan than you should:
Croatian: Ako uzmete više Procoralana nego što ste trebali:
English: The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Procoralan.
Croatian: Kalendar otisnut na blister pakovanju koje sadržava tablete, trebao bi Vam pomoći da zapamtite, kada ste zadnji put uzeli tabletu Procoralana.
English: If you are pregnant and have taken Procoralan, talk to your doctor.
Croatian: Ako ste trudni, a uzeli ste Procoralan, obratite se liječniku.
English: Other medicines and Procoralan
Croatian: Drugi lijekovi i Procoralan
English: Do not take Procoralan - if you are allergic to ivabradine or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte uzimati Procoralan - ako ste alergični na ivabradin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6);
English: Procoralan contains lactose
Croatian: Procoralan sadrži laktozu
English: If you think that the effect of Procoralan is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako mislite da je učinak Procoralana prejak ili preslab, razgovarajte s liječnikom ili ljekarnikom.
English: * Frequency calculated from clinical trials for adverse events detected from spontaneous report
Croatian: * Učestalost izračunata iz kliničkih ispitivanja za nuspojave otkrivene iz spontanih prijava
English: What Procoralan is and what it is used for What you need to know before you take Procoralan How to take Procoralan
Croatian: Što je Procoralan i za što se koristi Što morate znati prije nego počnete uzimati Procoralan Kako uzimati Procoralan
English: What you need to know before you take Procoralan
Croatian: Što morate znati prije nego počnete uzimati Procoralan
English: If you forget to take Procoralan:
Croatian: Ako ste zaboravili uzeti Procoralan:
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Kako uzimati Procoralan Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Procoralan in all subsets of the paediatric population in the treatment of angina pectoris.
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Procoralan u svim podskupinama pedijatrijske populacije u liječenju angine pektoris.
English: 5 How to store Procoralan Contents of the pack and other information
Croatian: Kako čuvati Procoralan Sadržaj pakiranja i dodatne informacije
English: Elevated creatinine in blood ECG prolonged QT interval
Croatian: Povišena vrijednost kreatinina u krvi Prolongiran QT interval u EKG-u
English: What Procoralan contains - The active substance is ivabradine (as hydrochloride).
Croatian: Što Procoralan sadrži - Djelatna tvar je ivabradin (u obliku ivabradinklorida).
English: Procoralan mainly works by reducing the heart rate by a few beats per minute.
Croatian: Procoralan poglavito djeluje smanjivanjem srčane frekvencije za nekoliko otkucaja u minuti.
English: If any of the above applies to you, talk straight away to your doctor before or while taking Procoralan.
Croatian: Ako se bilo što od gore navedenog odnosi na Vas, razgovarajte o tome s liječnikom prije nego što počnete uzimati Procoralan, ili kada ga već uzimate.
English: Ivabradine does not influence intracardiac conduction, contractility (no negative inotropic effect) or ventricular repolarisation:
Croatian: Ivabradin ne utječe na intrakardijalno provođenje, kontraktilnost (nema negativnog inotropnog učinka) ili na ventrikulsku repolarizaciju:
English: Marketing Authorisation Holder and Manufacturer:
Croatian: Nositelj odobrenja za stavljanje u promet gotovog lijeka i proizvođač:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Procoralan in one or more subsets of the paediatric population in the treatment of chronic heart failure (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Procoralan u jednoj ili više podskupina pedijatrijske populacije u liječenju kroničnog zatajenja srca (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Talk to your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be discontinued if you take Procoralan.
Croatian: Obavijestite svog liječnika ukoliko dojite ili planirate dojiti budući da se dojenje treba obustaviti ukoliko uzimate Procoralan.
English: Do not take Procoralan if you are pregnant or are planning to have a baby (see “Do not take Procoralan”).
Croatian: Ne uzimajte Procoralan ako ste trudni ili planirate imati dijete (vidjeti “Nemojte uzimati Procoralan”).
English: A large dose of Procoralan could make you feel breathless or tired because your heart slows down too much.
Croatian: Velika doza Procoralana mogla bi djelovati tako da osjećate umor ili nedostatak zraka jer je došlo do usporenja rada srca.
English: Do not take Procoralan if you are able to become pregnant unless you use reliable contraceptive measures (see “Do not take Procoralan”).
Croatian: Nemojte uzimati Procoralan ako možete zatrudnijeti osim ako koristite pouzdanu kontracepciju (vidjeti „Nemojte uzimati Procoralan”).
English: The starting dose should not exceed one tablet of Procoralan 5 mg twice daily.
Croatian: Početna doza ne smije prelaziti jednu tabletu Procoralan 5 mg dva puta na dan.
English: Procoralan (ivabradine) is a heart medicine used to treat: - Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is over or equal to 70 beats per minute.
Croatian: Procoralan (ivabradin) je lijek za srce koji se primjenjuje u liječenju: - Simptomatske stabilne angine pektoris (koja je karakterizirana pojavom bolova u prsima) u odraslih bolesnika koji imaju puls jednak ili veći od 70 otkucaja u minuti.
English: How to take Procoralan
Croatian: Kako čuvati Procoralan
English: Procoralan may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”).
Croatian: Procoralan može uzrokovati privremene vidne poremećaje (prolazna povećana svjetlost u ograničenom dijelu vidnoga polja, (vidjeti dio 4 “Moguće nuspojave”).