FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10/09/2002
Croatian: Datum prvog odobrenja: 10/-09/-2002
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Each dose (0.2 ml) of reconstituted suspension contains:
Croatian: 3. NAVOĐENJE DJELATNE TVARI I DRUGIH SASTOJAKA Svaka doza (0.2 ml) rekonstituirane suspenzije sadrži:
English: Allow the solvent to reach room temperature.
Croatian: Zagrijati na sobnu temperaturu ().
English: After administration, occasionally sneezing, coughing, mild and transient discharge from the eyes or nose may occur.
Croatian: Nakon primjene može doći do povremenog kihanja, kašljanja, blagog i prolaznog iscjetka iz nosa i očiju.
English: SPECIAL STORAGE CONDITIONS Store at 2 - 8°C.
Croatian: Čuvati na temperaturi od 2 - 8 ºC.
English: The vaccine is administered directly from the tip of the syringe onto the opening of the nostril and enters the nasal cavity during inhalation.
Croatian: Cjepivo izlazi direktno iz vrha šprice u otvor nosnice i ulazi u nosnu šupljinu tijekom udisanja.
English: 4.7 Use during pregnancy, lactation or lay
Croatian: 4.7 Primjena tijekom graviditeta, laktacije ili nesenja Ne preporuča se primjena tijekom graviditeta i laktacije.
English: In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog samo iniciranja, odmah potražiti pomoć liječnika i pokazati mu uputu o VMP ili etiketu.
English: Excipients: For a full list of excipients, see section 6.1.
Croatian: Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 1 dose
Croatian: 2. KOLIČINA DJELATNE(IH) TVARI 1 doza
English: CONTRAINDICATIONS Do not use in pregnant or lactating queens.
Croatian: 5. KONTRAINDIKACIJE Ne upotrebljavati kod mačaka u graviditetu i laktaciji.
English: Onset of immunity: Onset of immunity was established in 8 week old cats as early as 72 hours after vaccination.
Croatian: Početak imunosti: Početak imunosti nastupa u 8 tjedana starih mačaka, najkasnije 72 sata nakon cijepljenja.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/02/034/001-002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/02/034/001-002
English: Vaccinated animals can spread the Bordetella bronchiseptica vaccine strain for six weeks; in individual cases for at least one year.
Croatian: Cijepljene životinje mogu širiti vakcinalni soj Bordetella bronchispetica još 6 tjedana, u posebnim slučajevima i godinu dana.
English: Store at 2 - 8C.
Croatian: Čuvati na temperaturi od 2-8ºC.
English: Although the risk that immunocompromised humans become infected with Bordetella bronchiseptica is extremely low, such individuals should be aware that cats can shed the organism for up to 1 year after vaccination.
Croatian: Iako je rizik za imunokomprimirane ljude da se zaraze Bordetellom bronchisepticom vrlo nizak, takvi ljudi bi trebali biti svjesni da mačke mogu izlučivati bakterije i do 1 godinu poslije cijepljenja.
English: The onset of immunity was established in 8 week old cats as early as 72 hours after vaccination.
Croatian: Početak imunosti u 8 tjedana starih mačaka nastupa najranije 72 sata nakon cijepljenja.
English: EXPIRY DATE EXP {month/year}
Croatian: ROK VALJANOSTI Exp {mjesec, godina}
English: BATCH NUMBER Lot {number}
Croatian: 6. BROJ PROIZVODNE SERIJE Lot {broj}
English: MARKETING AUTHORISATION NUMBER(S) EU/2/02/034/001
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/02/034/001
English: 106.3-108.3 colony forming units (CFU) of live Bordetella bronchiseptica strain B-C2 Solvent:
Croatian: 106,3 108,3 kolonija formiranih jedinica (KFJ) živih Bordetella bronchiseptica bakterija soj B-C2, Otapalo:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (0.2 ml) of reconstituted suspension contains: Lyophilisate:
Croatian: 2. KVALITATIVNI I KVANTITATIVNI SASTAV Svaka doza (0.2ml) rekonstituirane suspenzije sadrži:
English: Do not mix with any other veterinary medicinal product except the solvent supplied for use with the product.
Croatian: Ne miješati s drugim veterinarsko medicinskim proizvodima, osim s otapalom isporučenim za primjenu s proizvodom.
English: For active immunisation of cats, of 1 month of age or older, to reduce clinical signs of Bordetella bronchiseptica associated upper respiratory tract disease.
Croatian: Za aktivnu imunizaciju mačaka, primjenjuje se u dobi od 1 mjeseca starosti ili starijih, za smanjenje kliničkih znakova bolesti gornjih dišnih putova uzrokovanih s Bordetella bronchiseptica.
English: Manufacturers of the biological active substance
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATNE TVARI I ZA PROIZVOĐAČ
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Ne pojavljuju se druge nuspojave osim onih navedenih u odjeljku 4.6. gdje se spominje prekomjerno doziranje cjepiva.
English: Aseptically reconstitute the lyophilisate with 0.3 ml of the sterile solvent provided.
Croatian: Aseptički rekonstituirati liofizilizat s 0,3 ml sterilnog otapala.
English: Gelatin
Croatian: KARENCIJA
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.
Croatian: 15. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Intervet International B.V.
English: Not all presentations may be marketed.
Croatian: Ne moraju sve veličine pakovanja biti u prometu.
English: Vaccinated animals can spread the vaccine strain of Bordetella bronchiseptica for six weeks, and there may be intermittent shedding for at least one year.
Croatian: Cijepljene životinje mogu širiti vakcinalni soj Bordetella bronchispetica još 6 tjedana, mogući su slučajevi povremenog širenja i do godinu dana.
English: Although the risk of immunocompromised humans becoming infected with Bordetella bronchiseptica is extremely low, it is advised that cats that are in close contact with immunocompromised humans are not vaccinated with this vaccine.
Croatian: Iako je rizik za imunokomprimirane ljude da se zaraze Bordetellom bronchisepticom vrlo nizak, savjetuje se, da se mačke koje su u bliskom kontaktu sa imunokomprimiranim ljudima ne cijepe tim cjepivom.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for the solvent vial:
Croatian: OSNOVNI DJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA Naljepnica za otapalo:
English: INDICATION Live vaccine against feline upper respiratory tract disease caused by Bordetella bronchiseptica.
Croatian: 6. INDIKACIJA(E) Živo cjepivo protiv bolesti gornjih dišnih putova mačke, uzrokovane s Bordetella bronchiseptica.
English: IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Immunologicals for felidae - cat - live bacterial vaccines.
Croatian: Farmakoterapijska grupa: Imunološki pripravak za felidae - mačke - živo bakterijsko cjepivo ATCvet kod: QI 06AE02.
English: Vaccination scheme: One dose, of 0.2 ml of reconstituted vaccine at least 72 hours prior to period of anticipated risk.
Croatian: Jedna doza od 0,2 ml rekonstituiranog cjepiva najkasnije 72 sata prije rizika od kontakta sa uzročnikom.
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension..
Croatian: OBLIK Liofilizat i otapalo za suspenziju
English: For animal treatment only - to be supplied only on veterinary prescription.
Croatian: Može se izdavati samo na veterinarski recept.
English: Although the risk of immunocompromised humans becoming infected with Bordetella bronchiseptica is extremely low, it is advised that cats, which are in close contact with immunocompromised humans are not vaccinated with this vaccine.
Croatian: Postoji rizik za imunokomprimirane ljude da se zaraze Bordetellom bronchisepticom, ali je vrlo nizak, i zato savjetujemo da se mačke, koje su u bliskom kontaktu sa imunokomprimiranim ljudima, ne cijepe tim cjepivom.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATNE TVARI I ZA PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: TARGET SPECIES Cats
Croatian: 5. CILJNE VRSTE ŽIVOTINJA Mačke
English: Box label:
Croatian: Naljepnica na kutiji
English: colony forming units (CFU) of live Bordetella bronchiseptica bacteria strain B-C2
Croatian: kolonijalno formiranih jedinica CFU živih Bordatella bronchiseptica bakterija, soj B-C2,.
English: PACKAGE LEAFLET FOR Nobivac Bb lyophilisate and solvent for suspension for cats
Croatian: UPUTA O VMP ZA Nobivac Bb liofilizat i otapalo za suspenziju za mačke
English: Active substance:
Croatian: Nazalna primjena:
English: Lyophilisate: Off-white or cream-coloured pellet Solvent: clear colourless solution
Croatian: OBLIK Liofilizat i otapalo za suspenziju Liofilizat: bezbojna do bjelkasta peleta Otapalo: bistra bezboja otopina
English: SPECIAL STORAGE PRECAUTIONS Keep out of the reach and sight of children Store at 2 - 8C.
Croatian: 11. POSEBNI UVIJETI ČUVANJA Čuvati na temperaturi od 2-8ºC.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Bb lyophilisate and solvent for suspension for cats
Croatian: NAZIV VETERINARSKO MEDICINSKOG PROIZVODA Nobivac Bb liofilizat i otapalo za suspenziju za mačke
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Solvent for Nobivac Bb
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Otapalo za Nobivac Bb
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Bb for cats
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Nobivac Bb za mačke
English: PACKAGE SIZE 5 unit-dose vials of lyophilisate and 5 vials of solvent.
Croatian: 4. VELIČINA PAKOVANJA 5 doza/bočica liofilizata i 5 bočica otapala
English: Lyohpilisate:
Croatian: Shema cijepljenja:
English: Read the package leaflet before use.
Croatian: Prije upotrebe pročitati uputu o VMP
English: 4.5 Special precautions for use
Croatian: 4.5 Posebne mjere predostrožnost za primjenu na životinjama
English: MANUFACTURER'S BATCH NUMBER Lot/Batch {number}
Croatian: 17. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
English: Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of solvent.
Croatian: Plastična kutija koja sadrži 5 bočica od 1 doze liofilizata i 5 bočica otapala.
English: INDICATION(S)
Croatian: DODATAK II
English: Carton box containing 5 vials of 1 dose of lyophilisate and 5 vials of solvent.
Croatian: Kartonske kutije koje sadrže 5 bočica od 1 doze liofilizata i 5 bočica otapala.
English: 6.4 Special precautions for storage
Croatian: 11. POSEBNE MJERE PREDOSTROŽNOSTI ZA ČUVANJE
English: Phosphate buffers.
Croatian: Želatina, Sorbitol, Fosfatni pufer
English: EXPIRY DATE
Croatian: Lot / Serija
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 106.3- 108.3 CFU/dose B. bronchiseptica
Croatian: 2. KOLIČINA DJELATNE(IH) TVARI CFU/doza Bordetella bronchiseptica
English: CFU of live Bordetella bronchiseptica bacteria strain B-C2.
Croatian: 2. NAVOĐENJE DJELATNIH I DRUGIH TVARI 0,2 ml doze sadrži: CFU živih Bordetella bronchiseptica bakterija soj B-C2.
English: ROUTE(S) OF ADMINISTRATION Nasal use.
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: Veterinary medicinal product subject to prescription.
Croatian: Izdaje se samo na veterinarski recept.
English: The final opinion was converted into a Decision by the European Commission on 16 March 2015.
Croatian: Konačno mišljenje pretvoreno je u odluku Europske komisije 16. ožujka 2015.
English: 16 March 2015
Croatian: 16. ožujka 2015.
English: The referral started on 4 June 2014.
Croatian: Postupak upućivanja pokrenut je 4. lipnja 2014.
English: International non-proprietary name (INN): colistin
Croatian: Međunarodni nezaštićeni naziv (INN): gentamicin
English: This group of antibiotics has a polypeptide structure, with mainly bactericidal activity and a medium antibacterial spectrum, which covers Gram-negative microorganisms only.
Croatian: Ova grupa antibiotika ima polipeptidnu strukturu, s uglavnom baktericidnim djelovanjem i srednjim antibakterijskim spektrom koji pokriva samo gram-negativne mikroorganizme.
English: Committee for Medicinal Products for Veterinary Use (CVMP)
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP)
English: The most common target species are pigs followed by chicken and cattle then other poultry species (e.g. turkeys), horses, rabbits, sheep and goats.
Croatian: Najčešće ciljne vrste su svinje nakon čega slijede pilići i goveda te druge vrste peradi (primjerice purani), a zatim konji, zečevi, ovce i koze.
English: Colistin sulfate belongs to the polymyxin group of antibiotics.
Croatian: Kolistin sulfat ubraja se u grupu antibiotika polimiksina.
English: Veterinary medicinal products containing colistin as a sole active substance for oral administration in food producing animals are widely used in almost all EU Member States.
Croatian: Veterinarsko-medicinski proizvodi koji sadrže kolistin kao jedinu djelatnu tvar za primjenu na usta u životinja koje se koriste za proizvodnju hrane imaju široku primjenu u gotovo svim državama članicama EU-a.
English: Oral colistin formulations including powder, solution, premix, tablets and paste have been authorised, mainly for group and flock treatment for the treatment and prevention of different specified gastrointestinal diseases caused by sensitive Enterobacteriacea species (e.g. Salmonella and Escherichia coli), but marketing authorisations without more specific indications do also exist.
Croatian: Formulacije kolistina za primjenu na usta, uključujući prašak, otopinu, smjesu, tablete i pastu, odobrene su uglavnom za terapiju grupa i jata te prevenciju raznih specificiranih gastrointestinalnih bolesti uzrokovanih vrstama Enterobacteriacea (primjerice Salmonella i Escherichia coli) osjetljivima na lijek, no postoje i odobrenja za stavljanje lijeka u promet bez specifičnijih indikacija.
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 ukupan profil omjera koristi i rizika ovih VMP-ova ostaje pozitivan, no predmetom je izmjena u informacijama o VMP-u.
English: On 12 May 2014, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing colistin to be administered orally.
Croatian: Europska komisija dostavila je Agenciji obavijest o postupku upućivanja u skladu s člankom 35. Direktive 2001/82/EZ za veterinarsko-medicinske proizvode koji sadrže kolistin, a koji se primjenjuju na usta.
English: No written comments on the recommendations and proposed changes in the product information were provided by the applicants and marketing authorisation holders.
Croatian: Podnositelji zahtjeva i nositelji odobrenja za stavljanje lijeka u promet nisu dostavili pisane komentare na preporuke i predložene izmjene informacija o proizvodu.
English: The CVMP was requested to give its opinion on the measures that need to be taken in order to ensure the prudent use of colistin in food-producing animals across the EU and to minimise potential risks with the use of the identified products; inter alia whether there is a need to include adequate indications and warnings on prudent use in the product information and/or restrict indications for the identified products taking into account the CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005) 2.
Croatian: Od CVMP-a je zatraženo da donese mišljenje o mjerama koje su potrebne kako bi se osigurala razumna uporaba kolistina u životinja koje se koriste u proizvodnji hrane diljem EU-a te kako bi se smanjili potencijalni rizici povezani s uporabom identificiranih proizvoda; između ostalog, je li potrebno uvrstiti primjerene indikacije i upozorenja o razumnoj primjeni u informacije o proizvodu i/ili ograničiti indikacije za utvrđene proizvode, uzimajući pritom u obzir
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 relevantnih dijelova Sažetka opisa svojstava VMP-a, a označivanje i upute o VMPu u Prilogu III.
English: Therefore, on 11 December 2014 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing colistin to be administered orally.
Croatian: Odbor većinom glasova usvojio pozitivno mišljenje kojim se preporuča izmjena uvjeta za izdavanje odobrenja za stavljanje u promet veterinarsko-medicinskih proizvoda koji sadrže kolistin za primjenu na usta.
English: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/02/WC500070670.pdf
Croatian: 2 Smjernice koje je revidirao CVMP, a koje se odnose na SPC za antimikrobike (EMEA/CVMP/SAGAM/383441/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/02/WC500070670.pdf
English: The Committee appointed C. Ibrahim as rapporteur and M. Holzhauser-Alberti as co-rapporteur.
Croatian: Holzhauser-Albertija suizvjestiteljem.
English: Opinion following an Article 351 referral for veterinary medicinal products containing colistin to be administered orally
Croatian: Mišljenje nakon postupka upućivanja provedenog u skladu s člankom 35.1 za veterinarsko-medicinske proizvode koji sadrže kolistin za primjenu na usta
English: 1 Article 35 of Directive 2001/82/EC, as amended 2 CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom smjernice koje je revidirao CVMP, a koje se odnose na sažetak opisa svojstava proizvoda (SPC) za antimikrobike (EMEA/CVMP/SAGAM/383441/2005) 2.
English: Immediate Packaging Pack size
Croatian: Doza Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Croatian: Broj (EU) odobrenja
English: Cufence must be stored in a refrigerator (between 2ºC and 8ºC).
Croatian: Cufence se mora čuvati u hladnjaku (između 2 °C i 8 °C).
English: Cufence should be taken on an empty stomach, at least one hour before or two hours after meals.
Croatian: Cufence treba uzimati na prazan želudac, najmanje jedan sat prije obroka ili dva sata poslije obroka.
English: Further information on Cufence can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/cufence
Croatian: Više informacija o lijeku Cufence dostupno je na internetskim stranicama Agencije: www.ema.europa.eu/medicines/human/EPAR/cufence
English: What is Cufence and what is it used for?
Croatian: Što je Cufence i za što se koristi?
English: The recommended daily dose is 4 to 8 capsules in adults, and 2 to 5 capsules in children.
Croatian: Preporučena dnevna doza je između 4 i 8 kapsula u odraslih osoba i 2 do 5 kapsula u djece.
English: improved in 14% of the patients.
Croatian: simptomi poboljšali su se u 14 % bolesnika.
English: What measures are being taken to ensure the safe and effective use of Cufence?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Cufence?
English: What are the risks associated with Cufence?
Croatian: Koji su rizici povezani s lijekom Cufence?
English: Cufence is available as 200 mg capsules.
Croatian: Lijek Cufence dostupan je u obliku kapsula od 200 mg.
English: The safety of Cufence has been shown to be similar to that of other trientine medicines.
Croatian: Sigurnost lijeka Cufence pokazala se sličnom sigurnosti drugih lijekova s trientinom.
English: Other information about Cufence
Croatian: Ostale informacije o lijeku Cufence
English: The European Medicines Agency therefore decided that Cufence's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Cufence nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Side effects reported with Cufence are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Cufence pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Skin rash may affect up to 1 in 100 people.
Croatian: Kožni opis može se javiti u manje od 1 na 100 osoba.
English: The capsules are taken in 2 to 4 divided doses.
Croatian: Tablete se uzimaju podijeljene u 2 do 4 doze.
English: Trientine has been used for over 30 years to treat patients with Wilson's disease.
Croatian: Trientin se primjenjuje već više od 30 godina u liječenju bolesnika s Wilsonovom bolešću.
English: As for all medicines, data on the use of Cufence are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Cufence kontinuirano se prate.
English: Why is Cufence authorised in the EU?
Croatian: Zašto je lijek Cufence odobren u EU-u?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cufence 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 Cufence nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: Cufence (trientine dihydrochloride) EMA/410631/2019
Croatian: Cufence (trientindiklorid) EMA/325626/2019
English: A small proportion of patients had deteriorating symptoms: 5% with worsening liver symptoms and 3% with worsening neurological symptoms.
Croatian: Maleni udio bolesnika doživio je pogoršanje simptoma: 5 % bolesnika doživjelo je pogoršanje simptoma bolesti jetre, a 3 % bolesnika pogoršanje neuroloških simptoma.
English: For more information about using Cufence, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Cufence pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: In some patients, neurological deterioration can occur at the start of the treatment, with symptoms such as dystonia (involuntary muscle contractions), stiffness, tremor (shaking) and dysarthria (difficulty speaking).
Croatian: U pojedinih bolesnika može doći do neuroloških pogoršanja na početku terapije, sa simptomima kao što su distonija (nehotične kontrakcije mišića), ukočenost, tremor (drhtanje) i disartrija (poteškoće u govoru).
English: In a study of medical records of 77 patients treated with trientine for at least six months, symptoms of liver disease improved in almost half (49%) of the patients treated, and neurological symptoms
Croatian: U ispitivanju zdravstvenih kartona 77 bolesnika koji su bili liječeni trientinom najmanje šest mjeseci, simptomi bolesti jetre poboljšali su se kod gotovo polovice liječenih bolesnika (49 %), a neurološki
English: It works by attaching to copper in the body and forming a complex that is then eliminated in the urine and faeces.
Croatian: Djeluje tako da se veže na bakar u tijelu i stvara kompleks koji se zatim izlučuje u mokraći i stolici.
English: An overview of Cufence and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Cufence i zašto je odobren u EU-u
English: Cufence is a medicine used to treat patients aged 5 years and older with Wilson's disease, a genetic condition in which copper absorbed from food builds up in the body, particularly in the liver and the brain, causing damage.
Croatian: Cufence je lijek za liječenje bolesnika u dobi od pet godina i starijih s Wilsonovom bolešću, genetskom bolešću pri kojoj se bakar apsorbiran iz hrane nakuplja u tijelu, posebice u jetri i mozgu, pri čemu uzrokuje oštećenja.
English: Doses are adjusted according to patient response and levels of copper in the body.
Croatian: Doze su prilagođene s obzirom na odgovor bolesnika na lijek i razine bakra u tijelu.