FrancophonIA/ELRC3.0 huggingface dataset:
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).
Croatian: Druge rijetke ozbiljne nuspojave (koje se mogu javiti u do 1 na 10 000 osoba) uključuju poremećaj u kojemu koštana srž više ne proizvodi krvne stanice, poremećaje živaca, lupus i poremećaje slične lupusu (pri čemu imunosni sustav napada tkiva u vlastitom organizmu, uzrokujući upalu i oštećenja organa) i Stevens-Johnsonov sindrom (reakciju opasnu po život sa simptomima sličnima gripi i bolnim osipom na koži, ustima, očima i spolnim organima).
English: Humira can only be obtained with a prescription.
Croatian: Humira se izdaje samo na liječnički recept.
English: How does Humira work?
Croatian: Kako djeluje Humira?
English: Fewer patients receiving Humira with methotrexate developed antibodies against Humira (which can reduce its effects), so the results found that the use of Humira with methotrexate was more effective than Humira used alone.
Croatian: Manje bolesnika koji su primali lijek Humira u kombinaciji s metotreksatom razvilo je protutijela protiv lijeka Humira (što može smanjiti njegove učinke), pa su rezultati pokazali da je primjena lijeka Humira s metotreksatom djelotvornija od primjene lijeka Humira kao monoterapije.
English: The studies included adult patients for the most part, but included children in studies for Crohn's disease, plaque psoriasis, polyarticular juvenile idiopathic arthritis, non-infectious anterior uveitis and enthesitis-related arthritis.
Croatian: Ispitivanja su većinom obuhvaćala odrasle osobe, dok su djeca bila uključena u ispitivanja za Crohnovu bolest, plak-psorijazu, poliartikularni juvenilni idiopatski artritis, neinfektivni prednji uveitis i artritis povezan s entezitisom.
English: • In hidradenitis suppurativa, 59% of patients receiving Humira in one main study and 42% of patients in another achieved at least a 50% reduction in abscesses and nodules after 12 weeks, without any increase in abscess count or fistulas.
Croatian: • U slučaju hidradenitisa suppurative, u 59 % bolesnika koji su primali lijek Humira u jednom glavnom ispitivanju i u 42 % bolesnika u drugom ispitivanju nakon 12 tjedana došlo je do najmanje 50 %-tnog smanjenja čvorića i kvržica, bez povećanja broja apscesa ili fistula.
English: • axial spondyloarthritis (inflammation of spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation
Croatian: • aksijalnog spondiloartritisa (upale kralježnice koja uzrokuje bolove u leđima), kao i ankilozantnog spondilitisa te kad rendgenska snimka ne pokazuje bolest, no postoje jasni znaci upale
English: In the third study in children aged 2 to 18 years with non-infectious anterior uveitis, in whom methotrexate alone did not work, treatment failed in about 60% of patients receiving placebo with methotrexate compared with about 27% of patients given Humira with methotrexate.
Croatian: U trećem ispitivanju kojim su obuhvaćena djeca u dobi od 2 do 18 godina s neinfektivnim prednjim uveitisom, kod kojih nije djelovala monoterapija metotreksatom, liječenje nije bilo uspješno u oko 60 % bolesnika koji su primali placebo s metotreksatom u usporedbi s oko 27 % bolesnika koji su primali lijek Humira s metotreksatom.
English: For enthesitis-related arthritis, treatment with Humira resulted in fewer swollen and tender joints compared with placebo.
Croatian: Za artritis povezan s entezitisom terapija lijekom Humira rezultirala je manje otečenim i osjetljivim zglobova u usporedbi s placebom.
English: Doctors treating uveitis should also take advice from doctors who have experience of using Humira.
Croatian: Liječnici koji liječe uveitis trebali bi također poslušati savjete liječnika s iskustvom u primjeni lijeka Humira.
English: This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Humira is used to treat.
Croatian: Ta je tvar uključena u nastajanje upale i pronađena je u velikim koncentracijama u bolesnika s bolestima koje se liječe lijekom Humira.
English: • In studies in adults and children with plaque psoriasis, including psoriasis of the nail, a higher proportion of patients receiving Humira had improvements in symptoms compared with patients receiving methotrexate or placebo (a dummy treatment).
Croatian: • U ispitivanjima provedenim među djecom s plak-psorijazom, uključujući psorijazu noktiju, u većem postotku bolesnika koji su primali lijek Humira simptomi su se ublažili u usporedbi s bolesnicima koji su primali metotreksat ili placebo (prividno liječenje).
English: • In rheumatoid arthritis, the greatest reductions in symptoms were seen in the studies on Humira as an add-on to methotrexate: around two-thirds of the patients adding Humira had at least a 20% reduction in symptoms after six months, compared with a quarter of those adding placebo.
Croatian: • Kod reumatoidnog artritisa najveće ublažavanje simptoma zabilježeno je tijekom ispitivanja lijeka Humira kao dodatka metotreksatu: kod oko dvije trećine bolesnika koji su dodavali lijek Humira simptomi su ublaženi za barem 20 % nakon šest tjedana, u usporedbi s jednom četvrtinom kod bolesnika koji su dodavali placebo.
English: • plaque psoriasis, a disease causing red, scaly patches on the skin
Croatian: • plak-psorijaze, bolesti koja uzrokuje crvene ljuskave lezije na koži
English: • In polyarticular juvenile idiopathic arthritis, around 40% of patients aged between 4 and 17 years receiving Humira, either alone or in combination with methotrexate, had a flare-up of arthritis, compared with around 69% of those receiving placebo.
Croatian: • Kod poliartikularnog juvenilnog idiopatskog artritisa oko 40 % bolesnika u dobi od 4 do 17 godina koji su primali lijek Humira kao monoterapiju ili u kombinaciji s metotreksatom, osjetilo je pogoršanje artritisa u usporedbi s oko 69 % bolesnika koji su primali placebo.
English: For more information about using Humira, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Humira pročitajte u uputi o lijeku odnosno obratite se liječniku ili ljekarniku.
English: Humira has been studied extensively and has been shown to be effective at reducing symptoms in patients with inflammatory conditions.
Croatian: Provedena su opsežna ispitivanja lijeka Humira te se on pokazao djelotvornim u smanjivanju simptoma u bolesnika s upalnim stanjima.
English: In this study, treatment failure occurred in about 55% of patients receiving placebo compared with 39% receiving Humira.
Croatian: U tom ispitivanju liječenje nije djelovalo u otprilike 55 % bolesnika koji su primili placebo u usporedbi s 39 % bolesnika koji su primili lijek Humira.
English: • Humira also produced a greater improvement in symptoms than placebo in studies of psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis without evidence in the X-ray of ankylosing spondylitis but with clear signs of inflammation, and induction and maintenance phases of treatment for Crohn's disease, psoriasis and ulcerative colitis.
Croatian: • Kod bolesnika koji su uzimali lijek Humira također je došlo do većeg ublažavanja simptoma nego kod bolesnika koji su primali placebo u ispitivanjima psorijatičnog artritisa, ankilozantnog spondilitisa, aksijalnog spondiloartritisa bez dokazanog ankilozantnog spondilitisa na rendgenskim snimkama, ali s jasnim znakovima upale, te faze indukcije i održavanja terapije Crohnove bolesti, psorijaze i ulceroznog kolitisa.
English: In this study treatment failed in about 79% of patients receiving placebo compared with about 55% given Humira.
Croatian: U tom ispitivanju liječenje nije djelovalo u otprilike 79 % bolesnika koji su primili placebo u usporedbi s 55 % bolesnika koji su primili lijek Humira.
English: • psoriatic arthritis (red, scaly patches on the skin with inflammation of the joints)
Croatian: • psorijatičnog artritisa (crvenih ljuskavih lezija na koži i upale zglobova)
English: For the full list of restrictions with Humira, see the package leaflet.
Croatian: Potpuni popis ograničenja za lijek Humira potražite u uputi o lijeku.
English: For the full list of side effects of Humira, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih prilikom primjene lijeka Humira potražite u uputi o lijeku.
English: 277,8 j. Ph. Eur.
Croatian: 277,8 j.
English: List of the invented names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Croatian: Popis zaštićenih imena, farmaceutskih oblika, jačina lijekova, puteva primjene i nositelja odobrenja za stavljanje lijeka u promet u zemljama članicama
English: 51368 Leverkusen, Germany
Croatian: 51368 Leverkusen, Njemačka
English: Berkshire RG14 1JA UK
Croatian: Berkshire RG14 1JA Velika Britanija
English: BE-Belgium Belgium Bayer S.A. 14, J.E.
Croatian: BE-Belgija Belgium Bayer S.A. 14, J.E.
English: BAYER SANTE - 220, avenue de la recherche - 59120 LOOS
Croatian: FR-Francuska BAYER SANTE220, avenue de la recherche 59120 LOOS
English: 1103 Budapest, Hungary
Croatian: 1103 Budapest
English: EL - Greece
Croatian: EL-Grčka
English: Richter Gedeon Nyrt.
Croatian: HU-Mađarska Richter Gedeon Nyrt.
English: 555,6 Ph.Eur.u.
Croatian: 555,6 j.
English: Berkshire RG14 1JA United Kingdom trading as Bayer Plc, Pharmaceutical division
Croatian: Berkshire RG14 1JA Velika Britanija poslujući kao Bayer Plc, Pharmaceutical Division
English: Bayer Pharma Aktiengesellschaft registered business address: Müllerstr.
Croatian: DE-Njemačka Bayer Pharma Aktiengesellschaft registered business address: Müllerstr.
English: Bayer Vital GmbH D-51373 Leverkusen
Croatian: DE-Njemačka Bayer Vital GmbH D-51373 Leverkusen
English: Bayer Healthcare AG Kaiser-Wilhelm-Allee, Bldg. E39
Croatian: HU-Mađarska Bayer Healthcare AG Kaiser-Wilhelm-Allee, Bldg.
English: 1111,1 Ph.Eur.u.
Croatian: 1111,1 j.
English: Quinta do Pinheiro 5 2794-003 Carnaxide Portugal
Croatian: Bayer Portugal, S.A. Rua Quinta do Pinheiro 5 2794-003 Carnaxide Portugal
English: Av. Baix Llobregat, 3-5 08970 Sant Joan Despi Barcelona - España
Croatian: 08970 Sant Joan Despi Barcelona
English: CZ - Czech Republic
Croatian: CZ-Republika Češka
English: Aprotinin containing medicinal products with Marketing Authorisation in the European Union
Croatian: Lijekovi koji sadrže aprotinin s odobrenjem za stavljanje lijeka u promet u Europskoj uniji Zemlja članica (EU/EGP)
English: Nordic Pharma Limited, Abbey House, 1650 Arlington Business Park, Theale, Reading, Berkshire RG7 4SA, UK
Croatian: Nordic Pharma Limited, Abbey House, 1650 Arlington Business Park,
English: UK - United Kingdom
Croatian: UK- Velika Britanija
English: Bayer Austria GmbH Herbststraße 6-10 A-1160 Wien Austria
Croatian: AT-Austrija Bayer Austria GmbH Herbststraße 6-10
English: DE-133 42 Berlin Germany
Croatian: DE-133 42 Berlin
English: Rua
Croatian: U venu
English: Bayer Portugal, S.A.
Croatian: Bayer S.A.
English: Bayer Hellas AG 18 - 20 , Sorou Str.
Croatian: Bayer Hellas AG 18 - 20 , Sorou Str. 151 25 , Marousi Athens
English: Bayer House Strawberry Hill Newbury
Croatian: MT-Malta Bayer Plc Bayer House Strawberry Hill Newbury
English: H-1475 Hungary
Croatian: Pf. 27., H-1475
English: ES - Spain
Croatian: - Španjolska
English: Bayer Pharma AG Berlin, D-13342 Germany
Croatian: PL- Poljska Bayer Pharma AG Berlin, D-13342
English: Bayer HealthCare AG, 51368 Leverkusen, Germany solution for injection/infusion intravenous use
Croatian: FI-Finska Bayer HealthCare AG, 51368 Leverkusen, Njemačka
English: SL - Slovenia
Croatian: Slovenija
English: Richter Gedeon Nyrt., Budapest Pf. 27.,
Croatian: SK-Slovačka Richter Gedeon Nyrt Budapest 10
English: Bayer d.o.o., Bravničarjeva 13, Ljubljana, Slovenia solution for injection and infusion intravenous use
Croatian: SI-Slovenija Bayer d.o.o. Bravničarjeva 13, Ljubljana,
English: 1000000 U.I.C/100 ml
Croatian: Trasylol 1.000.000 UIC 1 000 000 U.I.C / 100 ml
English: (500 000 KIU)
Croatian: Ph.Eur. (500 000 KIU)
English: Route of administration
Croatian: Energieweg 1
English: Pharmaceutical form
Croatian: ES-Španjolska QUIMICA FARMACEUTICA
English: Trasylol 2.000.000 UIC
Croatian: Trasylol 2.000.000 UIC 2 000 000 U.I.C / 200 ml
English: Trasylol 500 000 KIE
Croatian: Trasylol 500 000 KIE 10 ku/ml
English: QUIMICA FARMACEUTICA BAYER, S.L
Croatian: BAYER, S.L.
English: Bayer Schering Pharma AG, Müllerstrasse 170-178, DE13342 Berlin, Germany
Croatian: DK-Danska Bayer Schering Pharma AG Müllerstrasse 170-178
English: HU - Hungary
Croatian: Mađarska
English: AT - Austria
Croatian: Austrija
English: 10000 KIE/ml solution for injection/infusion intravenous use
Croatian: Otopina za injekciju / infuziju
English: 20 mg Capsule, hard
Croatian: 20 mg Kapsula, tvrda
English: Oral use bottle (HDPE)
Croatian: Boca (HDPE)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Croatian: Broj EU odobrenja (Zaštićeno) ime Jačina Farmaceutski oblik Put primjene
English: 23 October 2013
Croatian: 23. listopada 2013.
English: 19 December 2013
Croatian: 19. prosinca 2013.
English: Implementation of the agreement by the Member States (submission of the variation by the Marketing Authorisation Holder(s) as applicable):
Croatian: Primjena sporazuma od strane država članica (podnošenje izmjene od strane nositelja odobrenja ako je primjenjivo):
English: Transmission to National Competent Authorities of the translations of the annexes to the agreement: 19 November 2013
Croatian: Dostavljanje prijevoda dodataka sporazumu nacionalnim nadležnim tijelima:
English: Annex V
Croatian: Raspored primjene sporazuma
English: Ask your pharmacist how to throw away medicines you no longer use.
Croatian: Pitajte svog ljekarnika kako baciti ljekove koje više ne koristite.
English: • Risk Management Plan (RMP)
Croatian: Plan upravljanja rizicima (RMP)
English: Your doctor will tell you exactly how many capsules to take.
Croatian: Liječnik će Vam reći koliko točno kapsula da uzimate.
English: Advagraf with food and drink
Croatian: Advagraf s hranom i pićem
English: Advagraf is used in adults.
Croatian: Advagraf se primjenjuje u odraslih.
English: The three studies demonstrated similar survival rates.
Croatian: Ta su tri ispitivanja pokazala slične stope preživljenja.
English: What Advagraf is and what it is used for
Croatian: Što je Advagraf i za što se koristi
English: However, cases of spontaneous abortion have been reported.
Croatian: Međutim, bili su prijavljeni slučajevi spontanih pobačaja.
English: Always take Advagraf exactly as your doctor has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik.
English: Approximately 2% of the radioactivity was eliminated in the urine.
Croatian: Oko 2% radioaktivnosti izlučilo se mokraćom.
English: If you have forgotten to take your Advagraf capsules in the morning, take them as soon as possible on the same day.
Croatian: Ako ste ujutro zaboravili uzeti kapsule Advagrafa, uzmite ih čim prije istog dana.
English: Do not take a double dose the next morning.
Croatian: Nemojte uzeti dvostruku dozu sljedećeg jutra.
English: If you take more Advagraf than you should
Croatian: Ako uzmete više Advagrafa nego što ste trebali
English: To date, no other relevant epidemiological data are available.
Croatian: Drugi relevantni epidemiološki podaci još nisu dostupni.
English: The recommended initial doses presented below are intended to act solely as a guideline.
Croatian: Niže navedene preporučene početne doze služe samo kao smjernice.
English: The capsules should be swallowed whole with a glass of water.
Croatian: Kapsule morate progutati cijele uz čašu vode.
English: A forgotten morning dose should be taken as soon as possible on the same day.
Croatian: Zaboravljena jutarnja doza mora se uzeti čim prije istog dana.
English: Wear appropriate protective clothing and use a sunscreen with a high sun protection factor.
Croatian: Nosite odgovarajuću zaštitnu odjeću i koristite sredstva za sunčanje sa visokim faktorom zaštite.
English: Other medicines and Advagraf
Croatian: Drugi lijekovi i Advagraf
English: Therefore, you may be more prone to infections while you are taking Advagraf.
Croatian: Zbog toga možete postati osjetljiviji na infekcije dok uzimate Advagraf.
English: Like all medicines, Advagraf can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Advagraf može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
English: Advagraf is not recommended for use in children below 18 years due to limited data on safety and/or efficacy.
Croatian: Ne preporučuje se primjena Advagrafa u djece mlađe od 18 godina, zbog ograničenih podataka o sigurnosti i/ili djelotvornosti.
English: Advagraf should generally be administered on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal, to achieve maximal absorption (see section 5.2).
Croatian: Advagraf se općenito primjenjuje na prazan želudac, najmanje 1 sat prije ili 2 do 3 sata nakon obroka, kako bi se postigla maksimalna apsorpcija (vidjeti dio 5.2).
English: Tacrolimus is not compatible with PVC (polyvinylchloride).
Croatian: Takrolimus nije kompatibilan s PVC-om (polivinilkloridom).
English: What Advagraf looks like and contents of the pack
Croatian: Kako Advagraf izgleda i sadržaj pakiranja
English: This is because immunosuppressants could increase the risk of skin cancer.
Croatian: Razlog tome je taj što imunosupresivi povećavaju rizik od raka kože.
English: The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost nuspojava definirana je na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal preparations.
Croatian: Molimo obavijestite liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući lijekove koje ste nabavili bez liječničkog recepta i biljne preparate.
English: Your doctor will usually reduce your Advagraf dose once your condition has stabilised.
Croatian: Liječnik će obično smanjiti dozu Advagrafa kad Vam se stanje stabilizira.
English: Date of first authorisation: 23 April 2007 Date of latest renewal: 13 April 2012
Croatian: Datum posljednje obnove odobrenja: 13. travnja 2012.
English: During treatment, careful monitoring with EBV-PCR is recommended.
Croatian: Tijekom liječenja preporučuje se pažljivo praćenje pomoću PCR-a na EBV.
English: Corresponding data based on whole blood averaged 47.6 l.
Croatian: Odgovarajući podaci iz pune krvi prosječno su bili 47,6 l.
English: Contents of the pack and other information What Advagraf contains
Croatian: Sadržaj pakiranja i druge informacije Što Advagraf sadrži
English: Tubing, syringes and other equipment used to prepare a suspension of Advagraf capsule contents must not contain PVC.
Croatian: Cijevi, štrcaljke i ostali pribor koji se koristi u pripremi suspenzije sadržaja kapsule Advagrafa ne smije sadržavati PVC.
English: nausea or vomiting - if you have an alteration of the electrical activity of your heart called “QT prolongation”.
Croatian: mučnina ili povraćanje - ako imate promjenu električne aktivnosti srca zvane „produljenje QT-a“.
English: febrile neutropenia
Croatian: febrilna neutropenija
English: If you have accidentally taken too much Advagraf, contact your doctor or nearest hospital emergency department immediately.
Croatian: Ako ste slučajno uzeli previše Advagrafa, odmah se javite liječniku ili otiđite u najbližu službu hitne pomoći.
English: Both generalised and localised infections can occur.
Croatian: Mogu nastati kako generalizirane, tako i lokalizirane infekcije.
English: What you need to know before you take Advagraf Do not take Advagraf
Croatian: Što morate znati prije nego počnete uzimati Advagraf Nemojte uzimati Advagraf
English: After opening the aluminium wrapper: 1 year
Croatian: 3 godine Nakon otvaranja aluminijskog omota: 1 godina
English: 0.10 - 0.30 mg per kg body weight per day depending on the transplanted organ.
Croatian: 0,10 - 0,30 mg po kg tjelesne težine na dan ovisno o tome koji je organ presađen.
English: Older peoples There is no evidence currently available to indicate that dosing should be adjusted in older people.
Croatian: Starije osobe Trenutno nema dostupnih dokaza da se u starijih osoba mora prilagoditi doza.
English: As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving Advagraf.
Croatian: Budući da se ne mogu isključiti štetni učinci na novorođenče, žene ne bi smjele dojiti dok uzimaju Advagraf.
English: Your doctor may need to adjust your dose of Advagraf.
Croatian: Liječnik će Vam možda morati prilagoditi dozu Advagrafa.
English: You will need to take Advagraf every day as long as you need immunosuppression to prevent rejection of your transplanted organ.
Croatian: Advagraf ćete morati uzimati svakodnevno, sve dok Vam je potrebna imunosupresija, da bi se spriječilo odbacivanje presađenog organa.
English: very rare:
Croatian: vrlo rijetko:
English: It is not recommended that Advagraf is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).
Croatian: Ne preporučuje se uzimanje Advagrafa zajedno s ciklosporinom (drugi lijek koji se koristi za sprječavanje odbacivanja organa nakon presađivanja).
English: Administration should commence approximately 12-18 hours after the completion of surgery.
Croatian: S primjenom treba započeti oko 12-18 sati nakon završetka operacije.
English: Advagraf reduces your body's defence mechanism (immune system), which will not be as good at fighting infections.
Croatian: Advagraf slabi obrambene mehanizme tijela (imunološki sustav), koji neće biti tako učinkovit u obrani od infekcija kao obično.
English: dermatitis, photosensitivity rare:
Croatian: dermatitis, fotosenzitivnost rijetko:
English: There is no evidence that male and female patients require different doses to achieve similar trough levels.
Croatian: Nema dokaza koji pokazuju da se u muškaraca i žena mora primijeniti različita doza kako bi se postigle slične vrijednosti najniže koncentracije.
English: The safety and efficacy of Advagraf in children under 18 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost primjene Advagrafa u djece mlađe od 18 godina još nije utvrđena.
English: No studies on the effects of tacrolimus (Advagraf) on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja učinaka takrolimusa (Advagrafa) na sposobnost upravljanja vozilima i rada na strojevima.
English: Not known (frequency cannot be estimated from the available data): - Abnormality of the optic nerve (optic neuropathy)
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): - poremećaj vidnog živca (optička neuropatija)
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.