FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be exercised when treating such patients (see section 4.8, heading ‘Product-class-related adverse reactions').
Croatian: Potreban je oprez pri liječenju takvih bolesnika (vidjeti dio 4.8, naslov 'Nuspojave povezane sa skupinom lijeka').
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Single dose: 0.3 mg/90 µl
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA Jedna doza: 0,3 mg/90 µl
English: If you have an active or suspected infection in or around the eye.
Croatian: Ako imate aktivnu ili sumnjate na infekciju oka ili područja oko oka.
English: At one year, pegaptanib 0.3 mg exhibited a statistically significant treatment benefit for the primary efficacy endpoint; proportion of patients losing less than 15 letters of visual acuity (prespecified pooled analysis, pegaptanib 0.3 mg 70% versus Sham 55%, p = 0.0001; EOP1003 pegaptanib 0.3 mg 73% versus Sham 59%, p = 0.0105; EOP1004 pegaptanib 0.3 mg 67% versus Sham 52%, p = 0.0031).
Croatian: Nakon godine dana je liječenje pegaptanibom u dozi od 0,3 mg imalo statistički značajne pozitivne učinke na primarnu mjeru ishoda djelotvornosti; udio bolesnika u kojih se oštrina vida smanjila za manje od 15 slova (prethodno utvrđena analiza objedinjenih podataka: pegaptanib 0,3 mg 70% naspram placebo postupka 55%, p = 0,0001; EOP1003: pegaptanib 0,3 mg 73% naspram placebo postupka 59%, p = 0,0105; EOP1004: pegaptanib 0,3 mg 67% naspram placebo postupka 52%, p =
English: A direct relationship to Macugen or any of the various treatments administered as part of the injection preparation procedure, or to other factors has not been established in these cases.
Croatian: U tim slučajevima nije utvrđena neposredna veza s lijekom Macugen ili bilo kojim drugim lijekom primijenjenim u sklopu pripreme za injekciju, kao ni s drugim faktorima.
English: Nevertheless, Macugen should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
Croatian: Međutim, Macugen se tijekom trudnoće smije primjenjivati samo ako moguća korist liječenja za majku opravdava mogući rizik za plod.
English: To prevent contamination, the syringe should not be removed from the pouch until the patient has been prepared for injection.
Croatian: Kako bi se spriječila kontaminacija, štrcaljka se ne smije vaditi iz vrećice dok bolesnik nije pripremljen za injekciju.
English: The pouch must not be opened until the patient has been prepared for injection.
Croatian: Vrećica se ne smije otvarati dok bolesnik nije pripremljen za injekciju.
English: Pharmacotherapeutic group: Ophthalmologicals, Ocular vascular disorder agents, ATC Code S01LA03.
Croatian: Farmakoterapijska skupina: Oftalmici, Lijekovi za vaskularne poremećaje oka, ATK oznaka S01LA03.
English: The mean area under the plasma concentration-time curve (AUC) is about 25 g·hr/ml at this dose.
Croatian: Kod te doze srednje površina ispod krivulje koncentracija-vrijeme u plazmi (AUC) iznosi približno 25 g·hr/ml.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedene u dijelu 6.1.
English: The medicine must be discarded if kept at room temperature for more than two weeks.
Croatian: Lijek se mora zbrinuti ako se čuvao na sobnoj temperaturi dulje od dva tjedna.
English: See section 6.6 for instructions to expel the excess volume before injection.
Croatian: Vidjeti dio 6.6 za upute o izbacivanju viška volumena prije injekcije.
English: Pegaptanib was studied in two controlled, double-masked, and identically designed randomised studies (EOP1003; EOP1004) in patients with neovascular AMD.
Croatian: Pegaptanib je ispitivan u dva kontrolirana, dvostruko maskirana, identično dizajnirana randomizirana ispitivanja (EOP1003; EOP1004) u kojima su sudjelovali bolesnici s neovaskularnom senilnom makularnom degeneracijom.
English: Whenever you'll experience vision disturbances, eye discomfort/pain, eye redness or nausea and vomiting, immediately refer to your doctor and tell about your symptoms.
Croatian: Kad god iskusite smetnje vida, nelagodu/bol oka, crvenilo oka ili mučninu i povraćanje, odmah o tim simptomima obavijestite Vašeg liječnika.
English: The safety and efficacy of Macugen in children under 18 years has not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Macugen u djece mlađe od 18 godina nisu ustanovljene.
English: Patients received a mean of between 8.4-8.6 treatments out of possible 9 total across all treatment arms in the first year.
Croatian: Bolesnici su tijekom prve godine u svim ispitivanim skupinama u prosjeku primili 8,4-8,6 od ukupno mogućih 9 doza.
English: The injection is given into the vitreous of the eye, which is the jelly-like substance inside the eye.
Croatian: Injekcija se daje u staklovinu oka, tvar nalik želatini koja se nalazi u unutrašnjosti oka.
English: Overdose with Macugen has not been reported in clinical trials.
Croatian: Predoziranje lijekom Macugen nije prijavljeno u kliničkim ispitivanjima.
English: The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required).
Croatian: Postupak injiciranja mora se provesti u aseptičkim uvjetima, što uključuje kiruršku dezinfekciju ruku, uporabu sterilnih rukavica, sterilnog pokrova i sterilnog spekuluma za vjeđe (ili drugog instrumenta za istu namjenu) te dostupnost sterilne paracenteze (u slučaju potrebe).
English: OTHER SPECIAL WARNING(S), IF NECESSARY CAUTION: Expel excess volume before injecting.
Croatian: DRUGA POSEBNA UPOZORENJA, AKO JE POTREBNO OPREZ: Izbaciti višak volumena prije injiciranja.
English: Each carton contains one pre-filled syringe in a pouch (single dose pack).
Croatian: Svaka kutija sadrži jednu napunjenu štrcaljku u vrećici (pakiranje od jedne doze)
English: Increased intraocular pressure
Croatian: Povišeni intraokularni tlak
English: VEGF165 is the VEGF isoform preferentially involved in pathological ocular neovascularisation.
Croatian: VEGF165 je izooblik VEGF-a prvenstveno uključen u patološku neovaskularizaciju oka.
English: However, no special considerations are needed in this population (see section 5.2)
Croatian: Međutim, u toj skupini bolesnika nisu potrebne posebne mjere opreza (vidjeti dio 5.2).
English: Reduced body weight (5%) and minimal delayed ossification in forepaw phalanges were observed, only at exposure levels based on AUC of over 300 fold greater than that expected in humans.
Croatian: Primijećena je smanjena tjelesna težina (5%) i minimalno usporeno okoštavanje članaka prednjih šapa, ali samo kod razina izloženosti 300 puta većih od očekivane izloženosti u ljudi, na temelju AUC-a.
English: There are limited data on safety in patients with prior history of stroke or transient ischaemic attacks.
Croatian: Postoje ograničeni podaci o sigurnosti primjene u bolesnika s prethodnom anamnezom moždanog udara ili tranzitornih ishemijskih ataka.
English: There are no reproductive toxicity studies in rabbits.
Croatian: Nisu provedena istraživanja reproduktivne toksičnosti u kunića.
English: Patients should be instructed to report any symptoms suggestive of these conditions without delay (see section 4.4).
Croatian: Bolesnike treba uputiti da bez odlaganja prijave sve simptome koji bi mogli upućivativati na navedena stanja (vidjeti dio 4.4).
English: This medicinal product should be discarded if kept at room temperature for more than two weeks.
Croatian: Ovaj lijek treba zbrinuti ako se čuva na sobnoj temperaturi više od dva tjedna.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Macugen in all subsets of the paediatric population in age-related macular degeneration.
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Macugen u svim podskupinama pedijatrijske populacije u indikaciji senilne makularne degeneracije.
English: Patients should be instructed not to drive or use machines until this has resolved.
Croatian: Bolesnike treba uputiti da ne upravljaju vozilima niti da rukuju strojevima dok se te nuspojave ne povuku.
English: Macugen is administered as a single injection (0.3 mg) into your eye at intervals of 6 weeks (i.e. 9 times per year).
Croatian: Macugen se primijenjuje u obliku jedne injekcije (0,3 mg) u oko u razmacima od 6 tjedana (tj. 9 puta godišnje).
English: Ask your doctor or pharmacist for advice before starting Macugen treatment.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet prije nego počnete liječenje lijekom Macugen.
English: Each pre-filled syringe contains approximately 0.25-0.27 ml of solution.
Croatian: Svaka napunjena štrcaljka sadrži približno 0,25-0,27 ml otopine.
English: Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults (see section 5.1).
Croatian: Macugen je indiciran za liječenje neovaskularne (vlažne) senilne makularne degeneracije u odraslih (vidjeti dio 5.1).
English: As expected with intravitreal injections, transient increases in intraocular pressure may be seen.
Croatian: Kao što se i očekuje kod intravitrealnih injekcija, može doći do prolaznih povišenja intraokularnog tlaka.
English: Please tell your doctor immediately if you notice any of the following symptoms: eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, increased sensitivity to light, increased number of small particles in your vision.
Croatian: Molimo odmah obavijestite liječnika ako primijetite neki od sljedećih simptoma: bol ili pojačanu nelagodu u oku, pogoršanje crvenila oka, zamagljen ili oslabljen vid, pojačanu osjetljivost na svjetlost, povećan broj malih čestica u vidnom polju.
English: The medicine is used for the treatment of all types of abnormal blood vessels growth in adult AMD patients.
Croatian: Lijek se primjenjuje u liječenju svih vrsta rasta abnormalnih krvnih žila u odraslih bolesnika s makularnom degeneracijom.
English: Sustained small increases in intraocular pressure (IOP) have also been reported after repeated intravitreal dosing in a post marketing observational study.
Croatian: Održana, mala povišenja intraokularnog tlaka (IOP) također su zabilježena nakon opetovanog intravitrealnog doziranja u postmarketinškom opservacijskom ispitivanju.
English: Patients had up to one prior PDT and baseline visual acuity in the study eye between 20/40 and 20/320.
Croatian: Bolesnici su prethodno primili najviše jednu fotodinamsku terapiju, a početna oštrina vida ispitivanog oka kretala se u rasponu od 20/40 do 20/320.
English: Uncommonly, an infection in the internal portion of the eye can occur after two weeks following Macugen treatment.
Croatian: Manje često može doći do infekcije unutarnjeg dijela oka unutar dva tjedna nakon liječenja lijekom Macugen.
English: In mice, rats, rabbits, dogs and monkeys, pegaptanib distributes primarily into plasma volume and is not extensively distributed to peripheral tissues after intravenous administration.
Croatian: U miševa, štakora, kunića, pasa i majmuna pegaptanib se nakon intravenske primjene raspodjeljuje prvenstveno u volumen plazme, a ne raspodjeljuje se u velikoj mjeri u periferna tkiva.
English: This disease leads to vision loss resulting from damage to the central part of the retina (called the macula), at the back of the eye.
Croatian: Ta bolest dovodi do gubitka vida zbog oštećenja središnjeg dijela mrežnice (koji se naziva makula ili žuta pjega) u stražnjem dijelu oka.
English: If the solution appears cloudy, particles are observed or if there is evidence of damage to the syringe, or if the plastic clip is missing or not attached to the syringe, that Macugen dose should not be used.
Croatian: Ako je otopina zamućena ili sadrži čestice, ako je štrcaljka oštećena ili ako plastični zatvarač vrha nedostaje ili nije pričvršćen za štrcaljku, ta se doza lijeka Macugen ne smije upotrijebiti.
English: No statistical difference was found in the incidence of increased IOP between patients with a history of increased IOP or glaucoma versus patients without.
Croatian: Nije uočena statistički značajna razlika u incidenciji povišenog IOP-a između bolesnika s anamnezom povišenog IOP-a ili glaukoma u usporedbi s bolesnicima bez tih poremećaja.
English: The rate of absorption from the eye is the rate-limiting step in the disposition of pegaptanib in animals and is likely to be in humans.
Croatian: Brzina apsorpcije iz oka faktor je koji ograničava raspoloživost pegaptaniba u životinja; a vjerojatno je tako i u ljudi.
English: Overfill volume
Croatian: Prepunjeni volumen
English: A post marketing observational study has also reported on a small risk of slow sustained increase in intraocular pressure (see section 4.8).
Croatian: U postmarketinškim opservacijskim studijama također je zabilježen mali rizik od sporog, održanog povišenja intraokularnog tlaka (vidjeti dio 4.8)..
English: A decrease in creatinine clearance down to 20 ml/min may be associated with up to a 2.3-fold increase in pegaptanib AUC.
Croatian: Smanjenje klirensa kreatinina na 20 ml/min može biti povezano s povećanjem AUC-a pegaptaniba do 2,3 puta.
English: Special populations:
Croatian: Posebne populacije bolesnika:
English: After expelling air bubble and excess drug
Croatian: Nakon izbacivanja mjehurića zraka i viška lijeka
English: • decreased pressure inside the eye
Croatian: • snižen tlak u unutrašnjosti oka
English: MedDRA system organ class
Croatian: MedDRA organski sustav
English: After 2 consecutive injections of Macugen, if a patient does not demonstrate a treatment benefit (loss of less than 15 letters of visual acuity) at the 12-week visit, consideration should be given to stopping or withholding Macugen therapy.
Croatian: Ako se nakon 2 uzastopne injekcije lijeka Macugen na kontrolnom pregledu u 12. tjednu ne primijete dobrobiti liječenja (slabljenje oštrine vida za manje od 15 slova), treba razmotriti privremen ili trajan prekid liječenja lijekom Macugen.
English: These side effects are most probably caused by the injection procedure rather than the medicine, and include:
Croatian: Te nuspojave najvjerojatnije izaziva postupak injiciranja, a ne lijek; među njih se ubrajaju:
English: In humans, the average ± standard deviation apparent plasma half-life of pegaptanib after a 3 mg (10-times the recommended dose) monocular dose is 10 ± 4 days.
Croatian: U ljudi prosječni ± standardna devijacija prividni poluvijek pegaptaniba u plazmi nakon primjene monokularne doze od 3 mg (10 puta više od preporučene doze) iznosi 10 ± 4 dana.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31/01/2006
Croatian: Datum prvog odobrenja: 31. siječnja 2006.
English: Warnings and precautions Talk to your doctor before you are given Macugen.
Croatian: Upozorenja i mjere opreza Razgovarajte s liječnikom prije nego Vam primijeni Macugen.
English: Before expelling air bubble and excess drug
Croatian: Prije izbacivanja mjehurića zraka i viška lijeka
English: Therefore, the perfusion of the optic nerve head and intraocular pressure should be monitored.
Croatian: Stoga treba kontrolirati perfuziju glave vidnog živca i intraokularni tlak.
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Croatian: Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju nadopunama Plana (RMP), dokumenti mogu biti podneseni istodobno.
English: A mean maximum plasma concentration of about 80 ng/ml occurs within 1 to 4 days after a 3 mg monocular dose in humans.
Croatian: U ljudi se srednja maksimalna koncentracija u plazmi od oko 80 ng/ml postiže unutar 1 do 4 dana nakon primjene monokularne doze od 3 mg.
English: Macugen works by inhibiting the growth of these abnormal blood vessels and by stemming the bleeding and leakage.
Croatian: Macugen djeluje tako da sprječava stvaranje tih abnormalnih krvnih žila te zaustavlja krvarenje i istjecanje tekućine.
English: In animal studies no effects on male or female fertility in mice were observed.
Croatian: U ispitivanjima na životinjama nisu uočeni učinci na plodnost kod mužjaka ili ženki miševa.
English: Macugen should only be administered by ophthalmologists experienced in intravitreal injections.
Croatian: Macugen trebaju aplicirati samo oftalmolozi s iskustvom u primjeni intravitrealnih injekcija.
English: Cases of serious increase in intraocular pressure have been reported when the excess volume in the pre-filled syringe was not expelled before injection.
Croatian: Prijavljeni su slučajevi ozbiljnog povišenja intraokularnog tlaka kad prije primjene iz napunjene štrcaljke nije izbačen višak volumena.
English: • elevation of the liver enzymes, abrasion.
Croatian: • povišene vrijednosti jetrenih enzima, abraziju
English: In animals that received doses of pegaptanib up to 0.5 mg/eye to both eyes, plasma concentrations were 0.03% to 0.15% of those in the vitreous humour.
Croatian: U životinja koje su primale pegaptanib u dozi do 0,5 mg po oku u oba oka koncentracije u plazmi iznosile su 0,03% do 0,15% koncentracija u staklovini.
English: In advanced disease the initiation and continuation of Macugen therapy should consider the potential for useful vision in the eye.
Croatian: U slučaju uznapredovale bolesti, pri započinjanju i nastavku liječenja lijekom Macugen treba uzeti u obzir potencijal za postizanje upotrebljivog vida na oku.
English: The majority of adverse reactions reported following administration of Macugen are related to the intravitreal injection procedure.
Croatian: Većina nuspojava prijavljena nakon primjene lijeka Macugen povezana je s postupkom primjene intravitrealne injekcije.
English: What is in this leaflet What Macugen is and what it is used for What you need to know before you are given Macugen How you will be given Macugen Possible side effects How to store Macugen Contents of the pack and other information
Croatian: Što je Macugen i za što se koristi Što morate znati prije nego ćete primiti Macugen Kako će Vam se primijeniti lijek Macugen Moguće nuspojave
English: Injecting the entire volume of the prefilled syringe could result in overdose (see section 4.8 and 4.9).
Croatian: Ubrizgavanjem cijelog volumena napunjene štrcaljke može doći do predoziranja (vidjeti dio 4.8 i 4.9).
English: Patients who were re-randomized to discontinue pegaptanib after one year, lost visual acuity during the second year.
Croatian: Bolesnici koji su nakon godinu dana randomizirani za prekid liječenja pegaptanibom u drugoj su godini izgubili na oštrini vida.
English: • palpitations, high blood pressure, dilatation of the aorta (the main blood vessel)
Croatian: • osjećaj lupanja srca, visok krvni tlak, proširenje aorte (glavne krvne žile)
English: Important information about some of the ingredients of Macugen This medicine contains less than 1 mmol sodium (23 mg) per 90 microlitre dose, i.e. essentially ‘sodium-free' (see section 6).
Croatian: Važne informacije o nekim sastojcima lijeka Macugen Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi od 90 mikrolitara, tj. zanemarive količine natrija (vidjeti dio 6).
English: Cardiac disorders Uncommon palpitations
Croatian: Srčani poremećaji manje često palpitacije
English: Pegaptanib is metabolised by endo- and exonucleases.
Croatian: Pegaptanib se metabolizira pomoću endo- i egzonukleaza.
English: The recommended dose is 0.3 mg pegaptanib, equivalent to 90 microliters, administered once every six weeks (9 injections per year) by intravitreal injection into the affected eye.
Croatian: Preporučena doza je 0,3 mg pegaptaniba, što odgovara 90 mikrolitara, a primjenjuje se jednom svakih šest tjedana (9 injekcija godišnje) intravitrealnom injekcijom u oboljelo oko.
English: • disturbance in your eye's reaction to the light (pupillary reflex impaired)
Croatian: • smetnje u načinu na koji oko reagira na svjetlost (poremećen zjenični refleks)
English: • swelling or inflammation of the eyelid, swelling of the area on the inside of the eyelid or the outer surface of the eye (conjunctiva)
Croatian: • oticanje ili upalu vjeđe, oticanje područja unutar vjeđe ili vanjske površine oka (konjunktive)
English: VEGF is a secreted protein that induces angiogenesis, vascular permeability and inflammation, all of which are thought to contribute to the progression of the neovascular (wet) form of AMD.
Croatian: VEGF je izlučeni protein koji potiče angiogenezu, vaskularnu propusnost i upalu, za koje se smatra da pridonose progresiji neovaskularnog (vlažnog) oblika senilne makularne degeneracije.
English: Cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported in patients within several hours after administration of pegaptanib along with various medicinal products administered as part of the injection preparation procedure (see sections 4.2 and 4.4).
Croatian: U bolesnika su prijavljeni slučajevi anafilaksije/anafilaktoidnih reakcija, uključujući angioedem, unutar nekoliko sati nakon primjene pegaptaniba zajedno s drugim lijekovima koji se primjenjuju u sklopu pripreme za injekciju (vidjeti dijelove 4.2 i 4.4).
English: Mean Change in VA from Week 0 (Letters)
Croatian: Srednja vrijednost promjene oštrine vida od 0. tjedna (slova)
English: If you are pregnant discuss this with your doctor before treatment with Macugen.
Croatian: Ako ste trudni razgovarajte sa svojim liječnikom prije nego počnete liječenje Macugenom.
English: Macugen solution for injection is supplied in a single dose pack.
Croatian: Macugen otopina za injekciju dolazi u jednodoznom pakiranju.
English: In animals, pegaptanib is slowly absorbed into the systemic circulation from the eye after intravitreal administration.
Croatian: U životinja se nakon intravitrealne primjene pegaptanib polako apsorbira iz oka u sistemsku cirkulaciju.
English: The pack is supplied without a needle.
Croatian: Pakiranje ne sadrži iglu.
English: No human data on the effect of Macugen on fertility are available.
Croatian: Nema dostupnih podataka o učinku lijeka Macugen na plodnost ljudi.
English: Dose adjustments are not recommended in patients with mild or moderate renal impairment (see section 5.2).
Croatian: Ne preporučuje se prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem bubrežne funkcije (vidjeti dio 5.2).
English: Two early clinical studies conducted in patients who received Macugen alone and in combination with PDT (photodynamic therapy) revealed no apparent difference in the plasma pharmacokinetics of pegaptanib.
Croatian: Dva rana klinička ispitivanja u kojima su sudjelovali bolesnici liječeni lijekom Macugen samostalno ili u kombinaciji s fotodinamskom terapijom (engl. photodynamic therapy, PDT) nisu pokazala na primjetne razlike u farmakokinetici pegaptaniba u plazmi.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza ‘Rok valjanosti'.
English: No special considerations are needed in patients with creatinine clearance above 20 ml/min who are treated with the recommended dose of pegaptanib sodium 0.3 mg.
Croatian: Nisu potrebne posebne mjere opreza u bolesnika s klirensom kreatinina većim od 20 ml/min liječenih preporučenom dozom pegaptanibnatrija od 0,3 mg.
English: A few cases of arterial thromboembolic events were observed in the pegaptanib clinical trials in patients with AMD, DME, and there were no major differences between the groups treated with pegaptanib compared to control.
Croatian: Nekoliko slučajeva arterijskih tromboembolijskih događaja zabilježeno je u kliničkim ispitivanjima pegaptaniba u bolesnika sa senilnom makularnom degeneracijom, dijabetičkim makularnim edemom i nije bilo velikih razlika između skupina liječenih pegaptanibom u usporedbi s kontrolom.