FrancophonIA/ELRC3.0 huggingface dataset:
English: EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan) was a long-term outcome, double-blind, controlled clinical trial in patients hospitalised with worsening HF and signs and symptoms of volume overload.
Croatian: je bilo dvostruko slijepo, kontrolirano kliničko ispitivanje dugoročnih ishoda kod bolesnika hospitaliziranih radi pogoršanja zatajenja srca te znakova i simptoma volumnog preopterećenja.
English: Samsca 7.5 mg tablets Samsca 15 mg tablets Samsca 30 mg tablets
Croatian: Samsca 7,5 mg tablete Samsca 15 mg tablete Samsca 30 mg tablete
English: Clearance of tolvaptan is not significantly affected by age.
Croatian: Dob Životna dob ne utječe značajno na klirens tolvaptana.
English: Samsca 7.5 mg tablets Each tablet contains 7.5 mg tolvaptan.
Croatian: Samsca 7,5 mg tablete Svaka tableta sadrži 7,5 mg tolvaptana.
English: Package leaflet: Information for the user Samsca 7.5 mg tablets Samsca 15 mg tablets Samsca 30 mg tablets tolvaptan
Croatian: Uputa o lijeku: Informacije za korisnika Samsca 7,5 mg tablete Samsca 15 mg tablete Samsca 30 mg tablete tolvaptan
English: Samsca 15 mg and Samsca 30 mg tablets are available as 10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters
Croatian: Samsca 15 mg i Samsca 30 mg tablete dostupne su kao 10 × 1 tableta u PVC/Al perforirani blister s jediničnim dozama
English: Excipient with known effect 70 mg lactose (as monohydrate) per tablet
Croatian: 70 mg laktoze (u obliku hidrata) po tableti
English: In healthy subjects, tolvaptan, a CYP3A4 substrate, had no effect on the plasma concentrations of some other CYP3A4 substrates (e.g. warfarin or amiodarone).
Croatian: Kod zdravih ispitanika, tolvaptan, supstrat CYP3A4 ne djeluje na koncentraciju nekih drugih supstrata
English: • barbiturates (used to treat epilepsy/seizures and some sleep disorders),
Croatian: Sljedeći lijekovi mogu smanjiti učinak ovog lijeka: • barbiturati (primjenjuju se za liječenje epilepsije/napadaja i nekih poremećaja spavanja),
English: Samsca is not recommended in the paediatric age group.
Croatian: Samsca se ne preporučuje za primjenu kod djece.
English: 10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters
Croatian: 10 × 1 tableta u PVC/Al perforirani blister s jediničnim dozama 30 × 1 tableta u PVC/Al perforirani blister s jediničnim dozama
English: Samsca 7.5 mg tablets EU/1/09/539/005 (10 tablets) EU/1/09/539/006 (30 tablets) EU/1/09/539/007 (10 × 1 tablet) EU/1/09/539/008 (30 × 1 tablet)
Croatian: Samsca 7,5 mg tablete EU/1/09/539/005 (10 tablete) EU/1/09/539/006 (30 tablete) EU/1/09/539/007 (10 × 1 tableta) EU/1/09/539/008 (30 × 1 tableta)
English: Samsca 7.5 mg tablets tolvaptan
Croatian: Samsca 7,5 mg tablete tolvaptan
English: Samsca 30 mg: Blue, round, shallow-convex tablets with dimensions of Ø8 × 3.0 mm, debossed with “OTSUKA” and “30” on one side.
Croatian: Samsca 30 mg: plave, okrugle, blago konveksne tablete dimenzija Ø8 × 3,0 mm, s utisnutim „OTSUKA“ i „30“ s jedne strane.
English: • other products which increase the salt in your blood or which contain large amounts of salt.
Croatian: • diltiazem (za liječenje visokog krvnog tlaka i bola u prsnom košu), • drugi lijekovi koji povećavaju količinu soli u krvi ili koji sadrže velike količine soli.
English: Samsca 15 mg and Samsca 30 mg tablets
Croatian: Samsca 15 mg i Samsca 30 mg tablete
English: • Anuria
Croatian: • Anurija
English: In a pilot, randomized (1:1:1), double-blind trial in 30 patients with hyponatremia secondary to SIADH, the pharmacodynamics of tolvaptan following single doses of 3.75, 7.5 and 15 mg were assessed.
Croatian: Farmakodinamika tolvaptana nakon jednokratnih doza od 3,75, 7,5 i 15 mg procijenjena je u randomiziranom (1:1:1), dvostruko slijepom, pilot-ispitivanju u 30 bolesnika s hiponatremijom zbog
English: Otsuka Pharmaceutical Italy S.r.l.
Croatian: Otsuka Pharmaceutical Netherlands B.V.
English: • find it difficult to urinate
Croatian: • imate poteškoće s mokrenjem
English: Blue, round, shallow-convex tablets with dimensions of Ø8 × 3.0 mm, debossed with “OTSUKA” and “30” on one side.
Croatian: Plave, okrugle, blago konveksne tablete dimenzija Ø8 × 3,0 mm, s utisnutim oznakama „OTSUKA“ i „30“ na jednoj strani.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS AND PERFORATED UNIT DOSE BLISTERS
Croatian: BLISTERI I PERFORIRANI BLISTERI S JEDINIČNIM DOZAMA
English: Samsca 7.5 mg tablets
Croatian: Samsca 7,5 mg tablete
English: In a post-authorisation safety study of tolvaptan in hyponatremia secondary to SIADH, several cases of hepatic disorders and elevated transaminases were observed (see section 4.8).
Croatian: U ispitivanju sigurnosti primjene tolvaptana kod hiponatremije zbog SIADH-a provedenom nakon stavljanja lijeka u promet opaženo je nekoliko slučajeva poremećaja jetre i povišenih transaminaza
English: Samsca 7.5 mg tablets 5 years
Croatian: Samsca 7,5 mg tablete 5 godina
English: Samsca 15 mg tablets tolvaptan
Croatian: Samsca 15 mg tablete tolvaptan
English: Syncope1, Headache1, Dizziness1
Croatian: Poremećaji živčanog sustava sinkopa1, glavobolja1, omaglica1
English: Tolvaptan affinity for the human V2-receptor is 1.8 times that of native AVP.
Croatian: receptor je 1,8 puta veći nego afinitet prirodnog AVP-a.
English: Samsca 30 mg tablets tolvaptan
Croatian: Samsca 30 mg tablete tolvaptan
English: Samsca 30 mg tablets
Croatian: Samsca 30 mg tablete
English: Asthenia, Pyrexia, Malaise1
Croatian: Opći poremećaji i reakcije na mjestu primjene žeđ astenija, pireksija, malaksalost1
English: Each Samsca 30 mg tablet contains 30 mg tolvaptan.
Croatian: Jedna tableta Samsce od 30 mg sadrži 30 mg tolvaptana.
English: Samsca 15 mg tablets and Samsca 30 mg tablets 4 years
Croatian: Samsca 15 mg tablete i Samsca 30 mg tablete 4 godine
English: Samsca 15 mg: Blue, triangular, shallow-convex tablets with dimensions of 6.58 × 6.2 × 2.7 mm, debossed with “OTSUKA” and “15” on one side.
Croatian: Samsca 15 mg: plave, trokutaste, blago konveksne tablete dimenzija 6,58 × 6,2 × 2,7 mm, s utisnutim „OTSUKA“ i „15“ s jedne strane.
English: Samsca 15 mg tablets
Croatian: Samsca 15 mg tablete
English: Blue, triangular, shallow-convex tablets with dimensions of 6.58 × 6.2 × 2.7 mm, debossed with “OTSUKA” and “15” on one side.
Croatian: Plave, trokutaste, blago konveksne tablete dimenzija 6,58 × 6,2 × 2,7 mm, s utisnutim oznakama „OTSUKA“ i „15“ na jednoj strani.
English: Samsca 7.5 mg: Blue, rectangular, shallow-convex tablets with dimensions of 7.7 × 4.35 × 2.5 mm, debossed with “OTSUKA” and “7.5” on one side.
Croatian: Samsca 7,5 mg: plave, pravokutne, blago konveksne tablete dimenzija 7,7 × 4,35 × 2,5 mm, s utisnutim „OTSUKA“ i „7.5“ s jedne strane.
English: Blue, rectangular, shallow-convex tablets with dimensions of 7.7 × 4.35 × 2.5 mm, debossed with “OTSUKA” and “7.5” on one side.
Croatian: Plave, pravokutne, blago konveksne tablete dimenzija 7,7 × 4,35 × 2,5 mm, s utisnutim oznakama „OTSUKA“ i „7.5“ na jednoj strani.
English: Each Samsca 15 mg tablet contains 15 mg tolvaptan.
Croatian: Jedna tableta Samsce od 15 mg sadrži 15 mg tolvaptana.
English: EU/1/09/539/001 (10 × 1 tablet) EU/1/09/539/002 (30 × 1 tablet)
Croatian: EU/1/09/539/001 (10 × 1 tableta) EU/1/09/539/002 (30 × 1 tableta)
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva ekhimoza, pruritus osip sa svrbežom1
English: Hyponatremia
Croatian: Anafilaksija
English: EU/1/09/539/003 (10 × 1 tablet) EU/1/09/539/004 (30 × 1 tablet)
Croatian: EU/1/09/539/003 (10 × 1 tableta) EU/1/09/539/004 (30 × 1 tableta)
English: Orthostatic hypotension
Croatian: Krvožilni poremećaji ortostatska hipotenzija
English: EU/1/09/539/005 (10 tablets) EU/1/09/539/006 (30 tablets) EU/1/09/539/007 (10 × 1 tablet) EU/1/09/539/008 (30 × 1 tablet)
Croatian: EU/1/09/539/005 (10 tablete) EU/1/09/539/006 (30 tablete) EU/1/09/539/007 (10 × 1 tableta) EU/1/09/539/008 (30 × 1 tableta)
English: • ketoconazole (against fungal infections),
Croatian: Sljedeći lijekovi mogu pojačati učinak ovog lijeka: • ketokonazol (protiv gljivičnih infekcija),
English: Samsca 30 mg tablets Each tablet contains 30 mg tolvaptan.
Croatian: 35 mg laktoze (u obliku hidrata) po tableti Samsca 30 mg tablete Svaka tableta sadrži 30 mg tolvaptana.
English: Samsca 7.5 mg tablets are available as 10 tablets in PP/Alu blisters 30 tablets in PP/Alu blisters 10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters
Croatian: Samsca 7,5 mg tablete 10 tablete u PP/Al blister 30 tablete u PP/Al blister
English: The dose could be increased to 30 and 60 mg/day depending on response using a 3 day titration scheme.
Croatian: Dozu se moglo povećati na 30 do 60 mg/dan,
English: • thirst
Croatian: • svrbež
English: Otsuka Pharmaceutical Netherlands B.V. Tel/ Tél: +31 (0) 20 85 46 555
Croatian: Tel/ Tél: +31 (0) 20 85 46 555
English: Maize starch
Croatian: EVEREST (engl.
English: Otsuka Pharmaceutical Netherlands B.V. Tél/Tel: +31 (0) 20 85 46 555
Croatian: Tél/Tel: +31 (0) 20 85 46 555
English: • feeling sick
Croatian: • žeđ • mučnina
English: Distribution, biotransformation and elimination:
Croatian: Distribucija, biotransformacija i eliminacija:
English: The potential risk to humans is unknown.
Croatian: Nije poznat potencijalan rizik za ljude.
English: Under these circumstances vision loss may be rapid and severe.
Croatian: U takvim okolnostima gubitak vida može biti brz i težak.
English: Please read section 2.
Croatian: Molimo pročitajte dio 2.
English: Your doctor may monitor this after each injection.
Croatian: Vaš će liječnik to možda kontrolirati nakon svake injekcije.
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su isključivo zdravstvenim djelatnicima:
English: It tells you what to do if you have any of these symptoms.
Croatian: U njemu piše što morate učiniti ako se pojavi neki od navedenih simptoma.
English: Please do not forget to tell your doctor if you are known to be allergic to any substance.
Croatian: Nemojte zaboraviti reći liječniku ako znate da ste alergični na bilo koju tvar.
English: Other possible side effects are as follows:
Croatian: Druge moguće nuspojave su sljedeće:
English: It is important to identify and treat these types of conditions as soon as possible.
Croatian: Važno je što prije prepoznati i liječiti navedena stanja.
English: Your doctor will also give you some local anaesthetic (numbing medicine).
Croatian: Također, Vaš doktor će vam dati malo lokalnog anestetika (lijek koji izaziva utrnulost).
English: This will reduce or prevent any pain you might have with the injection.
Croatian: To će smanjiti ili spriječiti bilo kakvu bol koja bi se mogla javiti injekcijom.
English: Soon after the injection serious allergic reactions may occur.
Croatian: Ubrzo nakon injekcije mogu se pojaviti ozbiljne alergijske reakcije.
English: At the end of the first year (week 54), 1053 patients were re-randomized to either continue or discontinue treatment through week 102.
Croatian: Na kraju prve godine (54. tjedan) 1053 bolesnika ponovno je randomizirano da nastave ili prekinu liječenje do 102. tjedna.
English: Read all of this leaflet carefully before you start your treatment with this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete liječenje ovim lijekom jer sadrži Vama važne podatke.
English: However, there was no consistent pattern among the different haemorrhages.
Croatian: Međutim, nije postojao dosljedan obrazac među različitim hemoragijama.
English: You must not be given Macugen:
Croatian: Ne smije Vam se dati Macugen:
English: Children and adolescents Macugen should not be used in children and adolescents under 18 years old.
Croatian: Djeca i adolescenti Macugen se ne smije koristiti u djece i adolescenata mlađih od 18 godina.
English: At this point, the remaining content of the syringe should be injected.
Croatian: U ovom trenutku treba injicirati preostali sadržaj štrcaljke.
English: Other medicines and Macugen
Croatian: Drugi lijekovi i Macugen
English: The plunger stopper should not be pulled back.
Croatian: Čep klipa ne smije se povući unatrag.
English: The odds of increased IOP was increased by a factor of 1.128 for each additional injection (p= 0.0003).
Croatian: Šanse za povišeni IOP povećale su se za čimbenik 1,128 za svaku dodatnu injekciju (p=0,0003).
English: Frequency of these side effects cannot be estimated from the data available.
Croatian: Učestalost ovih nuspojava ne može se procijeniti iz dostupnih podataka.
English: Data over a two-year period indicate that Macugen treatment should be initiated as early as possible.
Croatian: Podaci prikupljeni tijekom razdoblja od dvije godine upućuju na to da liječenje lijekom Macugen treba započeti što je prije moguće.
English: The symptoms you might experience are described in section 2 of this leaflet ("Warnings and precautions").
Croatian: Simptomi koje možete primijetiti opisani su u dijelu 2. ove upute ("Upozorenja i mjere opreza").
English: The symptoms you might experience and the instruction what to do in such cases are described in section 4 of this leaflet.
Croatian: Simptomi koje možete razviti i upute što učiniti u takvim slučajevima opisani su u dijelu 4 ove upute.
English: If you are allergic to pegaptanib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ako ste alergični na pegaptanib ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6).
English: Your doctor will monitor your condition and recommend how long you should be treated with Macugen.
Croatian: Liječnik će nadzirati Vaše stanje i preporučiti koliko dugo biste se trebali liječiti lijekom Macugen.
English: What Macugen is and what it is used for
Croatian: Što je Macugen i za što se koristi
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije manje često
English: Store in a refrigerator (2ºC to 8ºC).
Croatian: Čuvati u hladnjaku (2°C - 8°C).
English: The adverse reactions are listed by system organ class and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and not known (cannot be estimated from the available data).
Croatian: Nuspojave su razvrstane su prema organskim sustavima i učestalosti pojavljivanja: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100) i nepoznato (ne može se procijeniti iz dostupnih podataka)).
English: Date of latest renewal: 19/11/2015
Croatian: Datum posljednje obnove odobrenja: 19. studenog 2015.
English: Active or suspected ocular or periocular infection.
Croatian: Aktivna ili suspektna okularna ili periokularna infekcija.
English: Endophtalmitis
Croatian: Endoftalmitis
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.
Croatian: Prije puštanja u promet u svakoj državi članici, nositelj odobrenja za stavljanje lijeka u promet (MAH) mora se dogovoriti o konačnim edukacijskim materijalima s nadležnim tijelima.
English: The solution to be injected should reach room temperature (below 25°C) before injecting.
Croatian: Temperatura otopine za injekciju bi trebala postići sobnu temperaturu (ispod 25°C) prije injekcije.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Croatian: Neklinički podaci ne upućuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza te genotoksičnosti.
English: Animal studies are insufficient, but have shown reproductive toxicity at high systemic exposure levels (see section 5.3).
Croatian: Istraživanja na životinjama nisu dostatna, ali su pokazala na reproduktivnu toksičnost pri visokim razinama sistemske izloženosti (vidjeti dio 5.3).
English: * Post-marketing experience; see “Description of selected adverse reactions”
Croatian: * Iskustvo nakon stavljanja lijeka u promet: vidjeti „Opis odabranih nuspojava“
English: Investigations Uncommon increased gamma-glutamyltransferase activity
Croatian: Pretrage manje često pojačana aktivnost gama-glutamiltransferaze
English: There are no studies on the carcinogenic potential of pegaptanib.
Croatian: Nisu provedena ispitivanja kancerogenog potencijala pegaptaniba.
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: 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
English: The absolute bioavailability of pegaptanib after intravitreal administration has not been assessed in humans, but is approximately 70-100% in rabbits, dogs and monkeys.
Croatian: Apsolutna bioraspoloživost pegaptaniba nakon intravitrealne primjene nije ocijenjena u ljudi, no iznosi približno 70-100% u kunića, pasa i majmuna.
English: Before the treatment is given your doctor may ask you to use antibiotic eye drops, or to wash your eyes carefully.
Croatian: Prije liječenja liječnik može zatražiti da koristite antibiotske kapi za oči ili da pažljivo isperete oči.
English: These finding are therefore considered to be of limited clinical relevance.
Croatian: Ti se nalazi stoga smatraju klinički manje značajnima.
English: The macula enables the eye to provide the fine central vision that is needed for activities such as driving a car, reading fine print and other similar tasks.
Croatian: Makula oku omogućuje precizan centralni vid potreban za obavljanje aktivnosti poput vožnje automobila, čitanja sitnih slova i drugih sličnih zadataka.
English: These new blood vessels may bleed and leak fluid, causing the macula to bulge or lift up, thus distorting or destroying central vision.
Croatian: Iz tih novih krvnih žila može istjecati krv ili tekućina zbog koje makula nabubri ili se izdigne, čime se iskrivljuje ili uništava centralni vid.
English: Pegaptanib has not been studied in pregnant women.
Croatian: Pegaptanib nije ispitan u trudnica.
English: There is a small risk of a slight lasting increased pressure inside the eye after repeated injection in the eye.
Croatian: Postoji mali rizik od blagog trajno povišenog tlaka unutar oka nakon ponovljene injekcije u oku.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before Macugen treatment.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego počnete liječenje lijekom Macugen.
English: A total of 1190 patients were treated (892 pegaptanib, 298 sham (control)) with a median age of 77 years.
Croatian: Ukupno je liječeno 1190 bolesnika (892 pegaptanibom, a 298 placebo postupkom (kontrola)), čiji je medijan dobi bio 77 godina.
English: After each injection you might be asked to use antibiotic eye drops (or another type of antibiotic treatment) to guard against eye infection.
Croatian: Nakon svake injekcije možda ćete trebati koristiti antibiotske kapi za oči (ili neku drugu vrstu antibiotika) kako bi se spriječila infekcija oka.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Macugen is marketed, at launch and after launch all ophthalmological clinics where Macugen is expected to be used are provided with an updated physician information pack containing the following elements:
Croatian: Nositelj odobrenja će se pobrinuti da nakon rasprava i dogovora s državnim nadležnim tijelima u svakoj državi članici gdje se Macugen nalazi na tržištu, prilikom puštanja u promet i nakon puštanja u promet da sve oftalmološke klinike za koje se očekuje da će se Macugen koristiti dobiju ažurirane paket informacija za liječnika koji sadrži sljedeće elemente:
English: If there are bubbles, the syringe should be gently tapped with a finger until the bubbles rise to the top of the syringe.
Croatian: Ako ima mjehurića, štrcaljku treba nježno lupkati prstom dok se mjehurići ne skupe na vrhu štrcaljke.
English: Pegaptanib pharmacokinetics is similar in female and male patients and within the age range 50 to 90 years.
Croatian: Farmakokinetika pegaptaniba podjednaka je u žena i muškaraca te unutar dobnog raspona od 50 do 90 godina.
English: Macugen should not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child.
Croatian: Macugen se ne smije koristiti tijekom trudnoće, osim ako potencijalna korist nadmašuje potencijalni rizik za plod.
English: Macugen is for single use only.
Croatian: Macugen je namijenjen isključivo za jednokratnu uporabu.
English: Immune system disorders Not known anaphylactic reaction*
Croatian: Poremećaji imunološkog sustava nepoznato anafilaktička reakcija*
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/325/002
Croatian: 12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/325/002
English: Elderly No special considerations are needed.
Croatian: Nisu potrebne posebne mjere opreza.
English: (Actual air bubble formation may vary)
Croatian: (Stvaran oblik mjehurića zraka može se razlikovati)
English: What you need to know before you are given Macugen
Croatian: Što morate znati prije nego počnete primati Macugen
English: (vitreous detachment)
Croatian: (odvajanje staklovine)
English: See section 4.2 for information on paediatric use.
Croatian: Vidjeti dio 4.2 za informacije o primjeni lijeka u pedijatrijskoj populaciji.
English: • There is no experience of using Macugen in pregnant women.
Croatian: • Nema iskustva s primjenom lijeka Macugen u trudnica.
English: If your doctor cannot be reached for any reason, an alternate doctor should be contacted immediately.
Croatian: Ako iz bilo kojeg razloga ne možete stupiti u kontakt sa svojim liječnikom, odmah se obratite nekom drugom liječniku.
English: All injections of Macugen will be administered by your doctor.
Croatian: Sve injekcije lijeka Macugen dat će Vam liječnik.
English: • Macugen is not recommended during breastfeeding as it is not known whether Macugen passes into human milk.
Croatian: • Ne preporuča se liječenje Macugenom tijekom dojenja s obzirom na to da se ne zna da li Macugen prolazi u majčino mlijeko.
English: How to store Macugen
Croatian: Kako čuvati Macugen
English: Overdosing with increased injection volume (e.g. when the excess volume in the pre-filled syringe is not expelled before injection) may elevate intraocular pressure (see section 4.8).
Croatian: Predoziranje s povećanim volumenom injekcije (primjerice kada višak volumena u napunjenoj štrcaljki nije potisnut prije ubrizgavanja) može povisiti intraokularni tlak (vidjeti dio 4.8).
English: Intravitreal injection procedures are associated with a risk of endophthalmitis; in Macugen clinical trials, the incidence of endophthalmitis was 0.1% per injection (see section 4.2).
Croatian: Postupci primjene intravitrealnih injekcija povezani su s rizikom od endoftalmitisa; u kliničkim ispitivanjima lijeka Macugen incidencija endoftalmitisa iznosila je 0,1 % po injekciji (vidjeti dio 4.2).
English: Psychiatric disorders Uncommon nightmare, depression
Croatian: Psihijatrijski poremećaji manje često noćne more, depresija
English: The safety and efficacy of Macugen beyond two years has not been demonstrated.
Croatian: Nije dokazana sigurnost i djelotvornost lijeka Macugen u liječenju duljem od dvije godine.
English: • Physician safety brochure
Croatian: • sigurnosna brošura za liječnika