FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 150 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz GmbH 150 mg
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 150 mg hard capsules pregabalin
Croatian: Pregabalin Sandoz GmbH 150 mg tvrde kapsule pregabalin
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 200 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz GmbH 200 mg
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 75 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz GmbH 75 mg
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 300 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz GmbH 300 mg
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 225 mg hard capsules
Croatian: Pregabalin Sandoz GmbH 225 mg tvrde kapsule
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/069-073
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/069-073
English: Very rare: may affect up to 1 in 10,000 people
Croatian: Vrlo rijetke: mogu se javiti u manje odo 1 na 10 000 osoba zatajenje jetre hepatitis (upala jetre)
English: INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz GmbH 300 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vanjsko pakiranje: Pregabalin Sandoz GmbH 300 mg
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 100 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz GmbH 100 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/084
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/084
English: INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz GmbH 150 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vanjsko pakiranje: Pregabalin Sandoz GmbH 150 mg
English: Dose regimen
Croatian: Nuspojava spazam
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 200 mg hard capsules
Croatian: Pregabalin Sandoz GmbH 200 mg tvrde kapsule
English: INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz GmbH 75 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vanjsko pakiranje: Pregabalin Sandoz GmbH 75 mg
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 200 mg hard capsules pregabalin
Croatian: Pregabalin Sandoz GmbH 200 mg tvrde kapsule pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 150 mg hard capsules
Croatian: Pregabalin Sandoz GmbH 150 mg tvrde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 300 mg hard capsules
Croatian: Pregabalin Sandoz GmbH 300 mg tvrde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 300 mg hard capsules pregabalin
Croatian: Pregabalin Sandoz GmbH 300 mg tvrde kapsule pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 75 mg hard capsules
Croatian: Pregabalin Sandoz GmbH 75 mg tvrde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 100 mg hard capsules
Croatian: Pregabalin Sandoz GmbH 100 mg tvrde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 75 mg hard capsules pregabalin
Croatian: Pregabalin Sandoz GmbH 75 mg tvrde kapsule pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 100 mg hard capsules pregabalin
Croatian: Pregabalin Sandoz GmbH 100 mg tvrde kapsule pregabalin
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 25 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz GmbH 25 mg
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 50 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz GmbH 50 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/030
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/030
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 25 mg hard capsules
Croatian: Pregabalin Sandoz GmbH 25 mg tvrde kapsule
English: Blister packs: 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules Blister packs (unit dose): 56 x 1, 84 x 1, 100 x 1 or 210 x 1 (3 x 70) hard capsules Container packs: 100, 200 or 250 hard capsules Not all pack sizes may be marketed.
Croatian: Blister pakiranja: 14, 28, 56, 70, 84, 100 ili 120 tvrdih kapsula Blister pakiranja (djeljiva na jedinične doze): 56 x 1, 84 x 1 ili 100 x 1 tvrda kapsula.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 25 mg hard capsules pregabalin
Croatian: Pregabalin Sandoz GmbH 25 mg tvrde kapsule pregabalin
English: MARKETING AUTHORISATION HOLDER Sandoz GmbH
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sandoz GmbH
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 50 mg hard capsules
Croatian: Pregabalin Sandoz GmbH 50 mg tvrde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 50 mg hard capsules pregabalin
Croatian: Pregabalin Sandoz GmbH 50 mg tvrde kapsule pregabalin
English: EU/1/15/1012/084
Croatian: EU/1/15/1012/001-010 EU/1/15/1012/084
English: Blister packs: 14, 28, 56, 70, 84, 100 or 120 hard capsules.
Croatian: Blister pakiranja: 14, 21, 28, 56, 70, 84, 100 ili 120 tvrdih kapsula.
English: 1 year open label safety study in 54 paediatric patients from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory infections were observed more frequently than in adult studies of patients with epilepsy (see sections 4.2, 4.8 and 5.2).
Croatian: Rezultati 12tjednog placebom kontroliranog istraživanja koje je porovedeno u 295 pedijatrijskih bolesnika u dobi od 4 do 16 godina radi procjene djelotvornosti i sigurnosti pregabalina kao dodatne terapije za liječenje parcijalnih napadaja i jednogodišnjeg otvorenog ispitivanja sigurnosti u 54 pedijatrijska bolesnika u dobi od 3 mjeseca do 16 godina starosti s epilepsijom ukazuju da su štetni događaji pireksije i infekcija gornjih dišnih putova zabilježeni češće nego u ispitivanjima u odraslih bolesnika s epilepsijom (vidjeti dijelove 4.2, 4.8 i 5.2).
English: Congestive heart failure
Croatian: Oštećenje bubrega
English: Εθνική Οδός No 1 (12ο km) Μεταμόρφωση GR-144 51 Αθήνα Τηλ: +30 210 2811712
Croatian: National Road No 1 (12th klm) GR-144 51, Metamorphosis, Αthens Greece
English: Elimination
Croatian: Režim doziranja
English: Blister packs: 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) or 120 (2 x 60) hard capsules Blister packs (unit dose): 56 x 1, 84 x 1 (2 x 42), 100 x 1 (2 x 50) or 210 x 1 (3 x 70) hard capsules Container packs: 100, 200 or 250 hard capsules
Croatian: Blister pakiranja: 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) ili 120 (2 x 60) tvrdih kapsula.
English: EU/1/15/1012/085
Croatian: EU/1/15/1012/011-017 EU/1/15/1012/085
English: Pregabalin Sandoz GmbH is available in the following presentations: PVC/PVDC//Alu blisters packed in carton.
Croatian: Pregabalin Sandoz GmbH je dostupan u sljedećim oblicima pakiranja:
English: 00351 Helsinki, Finland
Croatian: 00351 Helsinki, Finska
English: 00 Praha 6, Czech
Croatian: 00 Prag 6, Češka
English: Budapest, Hungary
Croatian: Budimpešta, Mađarska
English: 1831 Diegem, Belgium
Croatian: 1831 Diegem, Belgija
English: 167 14 Bromma, Sweden
Croatian: 167 14 Bromma, Švedska
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Croatian: Dodatak I Popis zaštićenih imena, farmaceutskih oblika, doza lijekova, putova primjene, nositelja odobrenja za stavljanje lijeka u promet u državama članicama
English: Tatoiou Street 14671 Nea Erythrea, Greece
Croatian: Tatoiou Street 14671 Nea Erythrea, Grčka
English: Slotsmarken 13, 2970 Hoersholm, Denmark
Croatian: Slotsmarken 13, 2970 Hoersholm, Danska
English: Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands
Croatian: Kampenringweg 45 D-E, 2803 PE Gouda,
English: France sanofi-aventis France 1-13 Bd Romain Rolland 75014 Paris, France
Croatian: Francuska sanofi-aventis France 1-13 Bd Romain Rolland 75014 Pariz, Francuska
English: Denmark sanofi-aventis Denmark A/S
Croatian: Danska sanofi-aventis Denmark A/S
English: Finland sanofi-aventis Oy Huopalahdentie 24 PL 22
Croatian: Finska sanofi-aventis Oy Huopalahdentie 24 PL 22
English: Republic
Croatian: Republika
English: Slovak Republic sanofi-aventis Pharma Slovakia s.r.o Einsteinova 24, 85101 Bratislava, Slovak Republic
Croatian: Slovačka Republika sanofi-aventis Pharma Slovakia s.r.o Einsteinova 24, 85101 Bratislava, Slovačka Republika
English: Austria sanofi-aventis GmbH, Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria
Croatian: Austrija sanofi-aventis GmbH, Leonard-Bernstein-Straße 10, A-1220 Beč, Austrija
English: Bulgaria sanofi-aventis Bulgaria EOOD
Croatian: Bugarska sanofi-aventis Bulgaria EOOD
English: Netherlands sanofi-aventis Netherlands BV.
Croatian: Nizozemska sanofi-aventis Netherlands BV.
English: One Onslow Street, Guildford Surrey, GU1 4YS, United Kingdom
Croatian: One Onslow Street, Guildford Surrey, GU1 4YS, Ujedinjeno Kraljevstvo
English: Norway sanofi-aventis Norge AS, Strandveien 15, PO Box 133, 1325
Croatian: Norveška sanofi-aventis Norge AS, Strandveien 15, PO Box 133, 1325 Lysaker, Norveška
English: Hungary sanofi-aventis Zrt.
Croatian: Mađarska sanofi-aventis Zrt.
English: Luxembourg sanofi-aventis Belgium Culliganlaan 1C
Croatian: Luksemburg sanofi-aventis Belgium Culliganlaan 1C
English: Marion Merrell S.A. Martínez Villergas, 52 28027 Madrid Spain
Croatian: Španjolska Marion Merrell S.A. Martínez Villergas, 52
English: Dunajska cesta 151 1000 Ljubljana Slovenia
Croatian: Slovenija sanofi-aventis d.o.o. Dunajska cesta 151 1000 Ljubljana Slovenija
English: United Kingdom Aventis Pharma Ltd. (or trading as Marion Merrell or Aventis Pharma)
Croatian: Aventis Pharma Ltd. (or trading as Marion Merrell or Aventis Pharma) One Onslow Street Guildford
English: Italy sanofi-aventis SPA Viale L. Bodio, 37/B20158 Milano, Italy
Croatian: Bodio, 37/B20158 Milano, Italija
English: Sanofi-Aventis Malta Ltd. Triq Kan. K. Pirotta, Birkirkara BKR1114, Malta
Croatian: K. Pirotta, Birkirkara BKR1114, Malta
English: Aventis Pharma Ltd. Trading as sanofi-aventis or Sanofi
Croatian: Trading as sanofi-aventis or Sanofi
English: 400 mg powder for injectable preparations
Croatian: 400 mg prašak za pripravke za injekciju
English: Belgium sanofi-aventis Belgium Culliganlaan 1C
Croatian: Belgija sanofi-aventis Belgium Culliganlaan 1C 1831 Diegem, Belgija
English: Ireland sanofi-aventis Ireland Ltd., T/A Sanofi 18 Riverwalk Citywest Business Campus, Dublin 24, Ireland
Croatian: Irska sanofi-aventis Ireland Ltd., T/A Sanofi
English: TARGOCID® 400 400 mg powder for solution for injection
Croatian: TARGOCID® 400 400 mg prašak za otopinu za injekciju
English: 200 mg Powder for injection/infusion, solution
Croatian: 200 mg prašak za injekciju/infuziju, otopina
English: TARGOCID® 200 200 mg powder for solution for injection
Croatian: TARGOCID® 200 200 mg prašak za otopinu za injekciju
English: 400 mg Powder for injection/infusion, solution
Croatian: 400 mg prašak za injekciju/infuziju, otopina
English: 200 mg Powder and solvent for injection or infusion
Croatian: 200 mg prašak i otapalo za injekciju ili infuziju
English: Slovenia sanofi-aventis d.o.o.
Croatian: Italija sanofi-aventis SPA Viale L.
English: Targocid® 200 mg 200 mg powder and solvent for solution for infusion/injection or oral solution
Croatian: Targocid® 200 mg 200 mg prašak i otapalo za otopinu za infuziju/injekciju ili oralnu otopinu
English: 200 mg powder for solution for injection/ infusion
Croatian: 200 mg prašak za otopinu za injekciju /infuziju
English: 200 mg powder and solvent for injection
Croatian: 200 mg prašak i otapalo za injekciju
English: Targocid® 100 mg 100 mg powder and solvent for solution for infusion/injection or oral solution
Croatian: Targocid® 100 mg 100 mg prašak i otapalo za otopinu za infuziju/injekciju ili oralnu otopinu
English: 200 mg powder for solution for injection
Croatian: 200 mg prašak za otopinu za injekciju
English: Targocid® 400 mg 400 mg powder and solvent for solution for infusion/injection or oral solution
Croatian: Targocid® 400 mg 400 mg prašak i otapalo za otopinu za infuziju/injekciju ili oralnu otopinu
English: 400 mg powder for solution for injection
Croatian: 400 mg prašak za otopinu za injekciju
English: 100 mg powder for solution for injection
Croatian: 100 mg prašak za otopinu za injekciju
English: Alexander Stamboliiski Blvd.
Croatian: 1303 Sofija, 103 Alexander Stamboliiski Blvd. fl.8., Bugarska
English: 400 mg powder and solvent for injection
Croatian: 400 mg prašak i otapalo za injekciju
English: 400 mg powder for solution for injection/ infusion
Croatian: 400 mg prašak za otopinu za injekciju/infuziju
English: 400 mg powder for solution for injection/infusion
Croatian: 400 mg prašak za otopinu za injekciju /infuziju
English: 200 mg powder and solvent for solution for infusion/injection or oral solution
Croatian: 200 mg prašak i otapalo za otopinu za infuziju/injekciju ili oralnu otopinu
English: 400 mg powder for injection intramuscular use/intravenous use
Croatian: 400 mg prašak za injekciju primjena u mišić/primjena u venu
English: 400 mg powder and solvent for solution for infusion/injection or oral solution
Croatian: 400 mg prašak i otapalo za otopinu za infuziju/injekciju ili oralnu otopinu
English: 100 mg powder and solvent for solution for infusion/injection or oral solution
Croatian: 100 mg prašak i otapalo za otopinu za infuziju/injekciju ili oralnu otopinu
English: TARGOCID® 400 mg 400 mg powder and solvent for solution for injection
Croatian: TARGOCID® 400 mg 400 mg prašak i otapalo za otopinu za injekciju
English: 100 mg powder and solvent for injection
Croatian: 100 mg prašak i otapalo za injekciju
English: 100 mg powder and solvent for solution for injection/ infusion and oral solution
Croatian: 100 mg prašak i otapalo za otopinu za injekciju/infuziju i oralnu otopinu
English: 200 mg powder and solvent for solution for injection/ infusion and oral solution
Croatian: 200 mg prašak i otapalo za otopinu za injekciju/infuziju i oralnu otopinu
English: Targocid 400 mg 400 mg powder and solvent for solution for injection
Croatian: Targocid 400 mg 400 mg prašak i otapalo za otopinu za injekciju
English: 400 mg powder and solvent for solution for injection/ infusion and oral solution
Croatian: 400 mg prašak i otapalo za otopinu za injekciju/infuziju i oralnu otopinu
English: TARGOCID® 200 mg 200 mg powder and solvent for solution for injection
Croatian: TARGOCID® 200 mg 200 mg prašak i otapalo za otopinu za injekciju
English: Targocid 200 mg 200 mg powder and solvent for solution for injection
Croatian: Targocid 200 mg 200 mg prašak i otapalo za otopinu za injekciju
English: Further information on Lucentis can be found on the Agency's website:ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Više informacija o lijeku Lucentis možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Lucentis received a marketing authorisation valid throughout the EU on 22 January 2007.
Croatian: Lijek Lucentis dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 22. siječnja 2007.
English: All of the patients were over 50 years of age and had not been treated for wet AMD before.
Croatian: Svi su bolesnici bili stariji od 50 godina i nisu prethodno liječeni od vlažnog oblika AMD-a.
English: Treatment with Lucentis should be stopped if the patient is not benefitting from it.
Croatian: Liječenje lijekom Lucentis treba zaustaviti ako bolesnik nema koristi od njega.
English: The most common side effects with Lucentis (seen in more than 1 in 10 patients) are increased intraocular pressure (pressure within the eye), headache, vitritis (inflammation in the eye), vitreous detachment (separation of the vitreous from the back of the eye), retinal haemorrhage (bleeding at the back of the eye), visual disturbance, eye pain, vitreous floaters (spots in the vision), conjunctival haemorrhage (bleeding at the front of the eye), eye irritation, sensation of a foreign body in the eye, increased lacrimation (tear production), blepharitis (inflammation of the eyelids), dry eye, ocular hyperaemia (red eye), eye pruritis (itching), arthralgia (joint pain) and nasopharyngitis (inflammation of the nose and throat).
Croatian: Najčešće nuspojave lijeka Lucentis (uočene u više od 1 na 10 bolesnika) su povišeni intraokularni tlak (tlak unutar oka), glavobolja, vitritis (upala oka), ablacija staklovine (odvajanje staklovine od stražnje strane oka), krvarenje mrežnice (krvarenje stražnje strane oka), poremećaji vida, bol u oku, opaciteti u staklovini (mrlje u vidu), krvarenje konjunktive (krvarenje u prednjem dijelu oka), nadražaj oka, osjećaj stranog tijela u oku, pojačana lakrimacija (stvaranje suza), blefaritis (upala očnih kapaka), suho oko, okularna hiperemija (crveno oko), očni pruritus (svrbež), artralgija (bol u zglobovima) i nazofaringitis (upala nosa i grla).
English: The macula provides the vision needed to see detail for everyday tasks such as driving, reading and recognising faces.
Croatian: Makula osigurava vid koji je potreban za uočavanje detalja tijekom obavljanja svakodnevnih zadataka, poput upravljanja vozilom, čitanja i prepoznavanja lica.
English: The prefilled syringe contains more than the recommended dose, therefore when preparing the injection, the doctor must expel the excess volume and ensure the injection of the correct dose.
Croatian: Napunjena štrcaljka sadržava više od preporučene doze, pa liječnik, pri pripremi injekcije, mora izbaciti višak volumena i osigurati ubrizgavanje pravilne doze.
English: Patients were classified as having experienced no significant worsening of vision if the number of letters that they could see increased, stayed the same, or fell by less than 15.
Croatian: Smatra se da u bolesnika nije došlo do značajnog pogoršanja vida ako se broj slova koje mogu vidjeti povećao, ostao isti ili se smanjio za manje od 15.
English: Other information about Lucentis
Croatian: Ostale informacije o lijeku Lucentis
English: Before each injection, a local anaesthetic is given to reduce or prevent any pain from the injection, and the eye, eyelid and skin around the eye are disinfected.
Croatian: Prije svake injekcije daje se lokalni anestetik za smanjenje ili sprječavanje bilo kakvog bola od injekcije, a oko, očni kapak i kožu potrebno je dezinficirati.
English: What measures are being taken to ensure the safe and effective use of Lucentis?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Lucentis?
English: Choroidal neovascularisation
Croatian: Koroidna neovaskularizacija
English: • the ‘wet' form of age-related macular degeneration (AMD).
Croatian: • „vlažnog” oblika starosne makularne degeneracije (AMD).
English: After one year, between 94 and 96% of the AMD patients receiving Lucentis every month experienced no significant worsening of their vision, compared with 62% of those receiving sham injections and 64% of those treated with verteporfin PDT.
Croatian: Nakon godinu dana, između 94 i 96 % bolesnika s AMD-om koji su primali Lucentis svaki mjesec nije doživjelo značajno pogoršanje vida u usporedbi sa 62 % onih koji su primali placebo injekcije te 64 % onih liječenih PDT verteporfinom.
English: • other sight problems associated with choroidal neovascularisation;
Croatian: • drugih problema s vidom koji su povezani s koroidnom neovaskularizacijom.
English: What is Lucentis and what is it used for?
Croatian: Što je Lucentis i za što se primjenjuje?
English: In both studies, the main measure of effectiveness was the change in vision in the affected eye, measured by comparing the number of letters that the patient could see at the end of the treatment period with the number before starting treatment.
Croatian: U oba je ispitivanja glavna mjera učinkovitosti bila promjena vida u zahvaćenom oku mjerena usporedbom broja slova koje je bolesnik mogao vidjeti na kraju razdoblja liječenja s brojem prije početka liječenja.
English: The recommended dose for Lucentis is 0.5 mg given as a single intravitreal injection.
Croatian: Preporučena doza lijeka Lucentis je 0,5 mg u obliku jedne intravitrealne injekcije.
English: In both studies, the improvement in vision was maintained over the course of the study.
Croatian: U oba ispitivanja poboljšanje vida zadržano je tijekom trajanja ispitivanja.
English: Side effects reported with Lucentis are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Lucentis pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What are the risks associated with Lucentis?
Croatian: Koji su rizici povezani s lijekom Lucentis?
English: The European Medicines Agency decided that Lucentis's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Lucentis nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The interval between two injections of Lucentis into the same eye must be at least four weeks.
Croatian: Između dviju injekcija lijeka Lucentis primijenjenih u jedno oko mora proći najmanje četiri tjedna.
English: The company that makes Lucentis will provide information packs to patients to help them prepare for Lucentis treatment, recognise serious side effects and know when to seek urgent attention from their doctor.
Croatian: Tvrtka koja proizvodi lijek Lucentis bolesnicima će proslijediti materijale s informacijama koje će im pomoći da se pripreme za liječenje lijekom Lucentis, da prepoznaju ozbiljne nuspojave te da znaju kada trebaju potražiti hitnu medicinsku pomoć od svojeg liječnika.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific target (called an antigen) that is found in certain cells in the body.
Croatian: Monoklonsko protutijelo je protutijelo (vrsta proteina) namijenjeno prepoznavanju određene ciljane strukture (nazvane antigen) koja se nalazi u određenim stanicama u tijelu i vezivanju na nju.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lucentis 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 Lucentis nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: As for all medicines, data on the use of Lucentis are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Lucentis kontinuirano se prate.
English: The vision of patients receiving Lucentis also remained better than the vision of those receiving sham injections in a study in which injections were given less frequently, with injections every month for the first three months and then every three months.
Croatian: Vid bolesnika koji su primali Lucentis također je ostao bolji od vida onih koji su primali placebo injekcije u ispitivanju u kojem su injekcije primjenjivane rjeđe, uz injekcije svaki mjesec tijekom prva tri mjeseca, a potom svaka tri mjeseca.
English: The conditions Lucentis is used to treat are:
Croatian: Lijek Lucentis primjenjuje se za liječenje:
English: Rarely, endophthalmitis (an infection inside the eye), blindness, serious damage to the retina and cataract (clouding of the lens) can occur.
Croatian: Rijetko se mogu pojaviti endoftalmitis (infekcija unutarnjeg dijela oka), sljepoća, ozbiljno oštećenje mrežnice i katarakta (zamućenje leće).
English: An overview of Lucentis and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Lucentis i zašto je odobren u EU-u
English: Why is Lucentis authorised in the EU?
Croatian: Zašto je lijek Lucentis odobren u EU-u?