FrancophonIA/ELRC3.0 huggingface dataset:
English: The upper particle size limits for SLN detection procedures used in Europe has been established and the acceptance criterion of at least 95% of particles having a diameter ≤ 80 nm was shown to be met by all batches of Nanotop.
Croatian: Utvrđeno je gornje ograničenje veličine čestica za postupke detekcije SLN-a korištene u Europi, a dokazano je da su sve serije lijeka Nanotop udovoljile kriteriju prihvatljivosti prema kojem najmanje 95% čestica treba biti promjera ≤ 80 nm.
English: Due to different views in the interpretation of the data related to particle size distribution within the defined limits relevant for efficacy, this referral was triggered to assess the importance of the batch to batch variability for the distribution and uptake of Nanotop in lymph nodes, and whether this could have an impact on efficacy.
Croatian: Uslijed različitih tumačenja podataka povezanih s distribucijom veličine čestica unutar definiranih ograničenja relevantnih za djelotvornost, ovaj je postupak upućivanje pokrenut sa ciljem ocjenjivanja važnosti varijabilnosti serija za distribuciju i aktivni unos lijeka Nanotop u limfnim čvorovima, te može li ovo imati utjecaja na djelotvornost.
English: The particle range of Nanotop corresponds to that of Nanocoll.
Croatian: Raspon čestica lijeka Nanotop odgovara rasponu čestica lijeka Nanocoll.
English: Technetium (99mTc) Nanocolloid is used for characterisation of the properties of the lymphatic system and in particular sentinel lymph node (SLN) detection in breast cancer and malignant melanoma.
Croatian: Tehnecij (99mTc) koloid nano veličine koristi se za karakterizaciju svojstva limfnog sustav, a posebice u detekciji limfnog čvora „stražara” (engl. sentinel lymph node - SLN) u slučaju raka dojke ili malignog melanoma.
English: This additional supportive data was considered acceptable by the CHMP to demonstrate that the particles size distribution for the studied size ranges as well as the batch variability is in the same range as for Nanocoll, the product referred to in the submitted literature.
Croatian: CHMP je smatrao ove dodatne potkrjepljujuće podatke prihvatljivima za dokazivanje činjenice da je distribucija veličine čestica za ispitane raspone veličina kao i za varijabilnost serija u istom rasponu kao i za lijek Nanocoll, lijek koji je naveden u dostavljenoj literaturi.
English: The HSA nanocolloid has the prerogative to be made up of particles smaller than other colloidal agents for SLN detection.
Croatian: Koloid nano veličine za HSA ima prednost za stvaranje od manjih čestica u odnosu na koloidalna sredstava za detekciju SLN-a.
English: The qualitative and quantitative composition of the medicinal product Nanotop was shown to be the same in comparison to the comparator product Nanocoll.
Croatian: Utvrđeno je da je kvalitativan i kvantitativan sastav lijeka Nanotop jednak onom uspoređenog lijeka Nanocoll.
English: As mentioned previously, the efficacy of a Tc-99m albumin colloid is the ability to identify the first draining SLN. Once the Tc-99m albumin colloid is administered, the passage of the tracer through the lymphatic system is recorded by imaging.
Croatian: Kako je prethodno navedeno, djelotvornost Tc-99m koloida za albumin jest sposobnost identifikacije prvog dreniranog SLN-a.
English: The efficacy of a Tc-99m albumin colloid is the ability to identify the first draining SLN. Once the Tc99m albumin colloid is administered, the passage of the tracer through the lymphatic system is recorded by imaging.
Croatian: Nakon primjene Tc-99m koloida za albumin, oslikavanjem se bilježi prolaz obilježivača kroz limfni sustav.
English: Nanocoll.
Croatian: Chakera et al.
English: You can usually carry on taking the drops, unless the effects are serious.
Croatian: Obično možete nastaviti primjenjivati kapi, osim ako su nuspojave ozbiljne.
English: The half-life of timolol in plasma is about 4 to 6 hours.
Croatian: Poluvrijeme timolola u plazmi je otprilike 4 do 6 sati.
English: Use at the same time each day.
Croatian: Primijenite svakoga dana u isto vrijeme.
English: Frequency cannot be estimated from available data
Croatian: Učestalost se ne može procijeniti iz dostupnih podataka
English: Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.
Croatian: 2 godine Dokazana kemijska i fizikalna stabilnost u primjeni je 28 dana na 25 °C.
English: The plasma protein binding of bimatoprost is approximately 88%.
Croatian: Vezivanje bimatoprosta na proteine plazme iznosi otprilike 88%.
English: There was no accumulation of bimatoprost in the blood over time and the safety profile was similar in elderly and young patients.
Croatian: Nije došlo do akumulacije bimatoprosta u krvi tijekom vremena, a sigurnosni profil bio je sličan u starijih i mlađih bolesnika.
English: In fact, the upper limit of the 95% CI did not exceed 0.14 mm Hg at week 12.
Croatian: Zapravo, gornja granica za 95% CI nije prelazila 0,14 mm Hg u 12. tjednu.
English: The response of these patients should be closely observed.
Croatian: Treba pažljivo motriti odgovor tih bolesnika.
English: Hallucination:
Croatian: Halucinacije:
English: • An increase in blood test results that show how your liver is working
Croatian: • Povišeni rezultati krvnih pretraga koje pokazuju kako radi
English: Other beta-blocking agents
Croatian: Ostali beta-blokatori
English: This high pressure can lead to glaucoma.
Croatian: Taj visoki tlak može rezultirati glaukomom.
English: No functional or microscopic changes related to the periocular effects have been observed, and the mechanism of action for the periocular changes is unknown.
Croatian: Nisu primijećene nikakve funkcionalne niti mikroskopske promjene povezane uz periokularne učinke, a sam mehanizam djelovanja kod periokularnih promjena nije poznat.
English: Do not use the drops while your contact lenses are in your eyes.
Croatian: Nemojte primjenjivati kapi dok su Vam kontaktne leće u očima.
English: Characteristics in older people
Croatian: Osobitosti u osoba starije životne dobi
English: If one dose is missed, treatment should continue with the next dose as planned.
Croatian: Ako se preskoči jedna doza, terapiju treba nastaviti sljedećom planiranom dozom.
English: If overdose occurs treatment should be symptomatic and supportive.
Croatian: Ako dođe do predoziranja, liječenje treba biti simptomatsko i suportivno.
English: Timolol belongs to a group of medicines called beta-blockers.
Croatian: Timolol pripada skupini lijekova koji se nazivaju beta-blokatori.
English: From a microbiological point of view, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 28 days at 25°C.
Croatian: S mikrobiološkog gledišta, rok i uvjeti čuvanja tijekom primjene odgovornost su korisnika i ne bi trebali biti duži od 28 dana na 25 °C.
English: Whilst keeping the eye closed, press your finger against the corner of the closed eye (the site where the eye meets the nose) and hold for 2 minutes.
Croatian: Držeći oko zatvoreno, prstom pritisnite ugao zatvorenog oka (na strani prema nosu) i držite ga tako u trajanju od 2 minute.
English: Timolol is not extensively bound to plasma.
Croatian: Timolol nije u većoj mjeri vezan za plazmu.
English: The ocular and systemic safety profile of the individual components is well established.
Croatian: Dobro su utvrđeni okularni i sistemski sigurnosni profili pojedinih komponenti.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}
Croatian: Ova uputa je zadnji puta revidirana u <{MM/GGGG}> <{mjesec GGGG}
English: Contact with soft contact lenses must be avoided.
Croatian: Treba izbjegavati doticaj s mekim kontaktnim lećama.
English: Ask your doctor for advice before taking any medicine during breast-feeding.
Croatian: Obratite se svom liječniku za savjet prije nego uzmete bilo koji lijek tijekom dojenja.
English: Not known bronchospasm (predominantly in patients with pre-existing bronchospastic disease) 2, asthma
Croatian: Nepoznato bronhospazam (pretežno u bolesnika s već postojećom bronhospastičnom bolešću) 2, astma
English: The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml.
Croatian: Dostupne su sljedeće veličine pakiranja: kutije koje sadrže 1 ili 3 bočice od 3 ml.
English: Do not drive or use machines until the symptoms have cleared.
Croatian: Nemojte upravljati vozilima ili strojevima dok taj učinak ne prođe.
English: Timolol may get into your breast milk.
Croatian: Timolol može dospjeti u majčino mlijeko.
English: Therefore caution should be used in treating such patients.
Croatian: Stoga je potreban oprez prilikom liječenja tih bolesnika.
English: It is a synthetic prostamide, structurally related to prostaglandin F2α (PGF2α) that does not act through any known prostaglandin receptors.
Croatian: Radi se o sintetskom prostamidu, strukturno srodnom prostaglandinu F2α (PGF2α) koji ne djeluje kroz poznate prostaglandinske receptore.
English: The use of two topical beta-adrenergic blocking agents is not recommended (see section 4.5).
Croatian: Ne preporučuje se primjena dvaju topikalnih beta-adrenergičkih blokatora (vidjeti dio 4.5).
English: Therefore, you must throw away the bottle 4 weeks after you first opened it, even if some solution is left.
Croatian: Stoga, morate baciti bočicu 4 tjedna od prvog otvaranja, čak i ako je u njoj ostalo još otopine.
English: This dose expressed as mg/m2 is at least 70-times higher than the accidental dose of one bottle of GANFORT in a 10 kg child.
Croatian: Ta doza, izražena kao mg/m2, najmanje je 70 puta veća od slučajno progutane doze jedne bočice GANFORT-a u djeteta od 10 kg.
English: The anaesthesiologist should be informed when the patient is receiving timolol.
Croatian: Anesteziolog mora biti obaviješten kada bolesnik uzima timolol.
English: However, this finding is not clinically relevant as systemic exposure for both elderly and young subjects remained very low from ocular dosing.
Croatian: Međutim, ti rezultati nisu klinički relevantni jer je sistemska ekspozicija i kod starijih i kod mlađih ispitanika ostala vrlo nisko nakon okularne primjene.
English: The chance of having side effects after using eye drops is lower than when medicines are for example, taken by mouth or injected.
Croatian: Mogućnost pojave nuspojava nakon primjene kapi za oko niža je nego kad se lijekovi uzimaju, na primjer, kroz usta ili ubrizgavanjem.
English: Affecting other parts of the body shortness of breath.
Croatian: Zahvaćaju druge dijelove tijela nedostatak zraka.
English: • Red scaly patches on skin; skin rash
Croatian: • Crvene ljuskave mrlje na koži; osip kože
English: This may result in a decrease in systemic side effects and an increase in local activity.
Croatian: Na taj se način mogu smanjiti sistemske nuspojave i može se povećati lokalna aktivnost.
English: The single-dose container is for single use only; one container is sufficient to treat both eyes.
Croatian: Jednodozni spremnik samo je za jednokratnu primjenu; jedan spremnik dovoljan je za oba oka.
English: Systemic absorption of the individual components was minimal and not affected by co-administration in a single formulation.
Croatian: Sistemska apsorpcija pojedinih komponenti bila je minimalna i nije na nju utjecala zajednička primjena u jedinstvenom pripravku.
English: When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced.
Croatian: Nazolakrimalnom okluzijom ili zatvaranjem vjeđa u trajanju od 2 minute smanjuje se sistemska apsorpcija.
English: Date of first authorisation 19 May 2006 Date of latest renewal 23 June 2011
Croatian: Datum prvog odobrenja: 19. svibnja 2006.
English: However, at therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant.
Croatian: Međutim, pri terapijskoj dozi timolola u kapima za oko nije vjerojatno da će u majčinom mlijeku biti prisutna dovoljna količina da proizvede kliničke simptome beta-blokade u dojenčadi.
English: • Severe allergic reactions with swelling and difficulty breathing which could be life-threatening
Croatian: • Teške alergijske reakcije s oticanjem i otežanim disanjem koje mogu biti opasne po život
English: The elimination half-life, determined after intravenous administration, was approximately 45 minutes; the total blood clearance was 1.5 1/hr/kg.
Croatian: Poluvrijeme eliminacije, utvrđeno nakon intravenske primjene, bilo je otprilike 45 minuta; ukupni krvni klirens bio je 1,5 l/h/kg.
English: It is acknowledged that in more than half of cases timolol eye drops were the only suspect drug, although additional risk factors such as elderly age, underlying disease or concomitant drugs may have contributed.
Croatian: Potvrđeno je da su u više od polovice slučajeva kapi za oči koje sadrže timolol bile jedini lijek na koji se sumnjalo, no nuspojavama su mogli doprinijeti i dodatni faktori rizika poput starije životne dobi, osnovne bolesti ili lijekova koji se istodobno uzimaju.
English: Liquid is constantly being drained out of the eye and new liquid is made to replace this.
Croatian: Ta tekućina čitavo vrijeme istječe iz oka i nastaje nova tekućina koja ju nadomješta.
English: To reduce the systemic absorption, see section 4.2.
Croatian: Za smanjenje sistemske apsorpcije, vidjeti dio 4.2.
English: After ocular administration, the systemic exposure of bimatoprost is very low with no accumulation over time.
Croatian: Nakon primjene u oko, sistemska ekspozicija bimatoprostu je vrlo niska bez akumulacije tijekom vremena.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for bimatoprost / timolol, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za bimatoprost/timolol, znanstveni zaključci CHMP-a su sljedeći:
English: Part of the dose is absorbed systemically where it is extensively metabolised in the liver.
Croatian: Dio doze je apsorbiran sistemski, gdje je u velikoj mjeri metaboliziran u jetri.
English: Always use GANFORT exactly as your doctor or pharmacist has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik ili ljekarnik.
English: This risk may increase with elderly age, and the psychiatric medical history appears to be a risk factor rather than confounding for development of hallucinations following timolol containing eye drops administration
Croatian: Taj se rizik može povećati u starijoj životnoj dobi te se čini da je povijest psihijatrijskih bolesti faktor rizika a ne zbunjujući faktor za pojavu halucinacija nakon primjene kapi za oči koje sadrže timolol.
English: Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost pri visokim dozama toksičnim za majku (vidjeti dio 5.3).
English: The long term effects of increased iridial pigmentation are not known.
Croatian: Dugotrajne posljedice pojačane pigmentacije šarenice nisu poznate.
English: A total of 56 cases have been derived from EudraVigilance for ophthalmic timolol products including 5 for the bimatoprost/timolol combination product which have given rise to various “Perception disturbances” like: Hallucination; Derealisation; Hallucination, auditory; Hallucination, visual.
Croatian: Ukupno 56 slučajeva preuzeto je iz sustava EudraVigilance za oftalmološke lijekove koji sadrže timolol, uključujući 5 slučajeva za lijek koji sadrži kombinaciju bimatoprosta/timolola, koji su doveli do raznih „Poremećaja percepcije” kao što su: halucinacije; derealizacija; halucinacije, slušne; halucinacije, vizualne.
English: Once opened, solutions may become contaminated, which can cause eye infections.
Croatian: Nakon otvaranja, otopina se može zagaditi, što može prouzročiti infekcije oka.
English: Not known hypersensitivity reactions including signs or symptoms of allergic dermatitis, angioedema, eye allergy
Croatian: Nepoznato reakcije preosjetljivosti uključujući znakove ili simptome alergijskog dermatitisa, angioedema, očne alergije
English: The precise mechanism of action is not clearly established, but inhibition of the increased cyclic AMP synthesis caused by endogenous beta-adrenergic stimulation is probable.
Croatian: Precizni mehanizam djelovanja nije jasno utvrđen, no vjerojatno se radi o inhibiciji povećane sinteze cikličnog AMP prouzročene endogenom beta-adrenergičkom stimulacijom.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V*.
English: No specific interaction studies have been performed with the bimatoprost / timolol fixed combination.
Croatian: Nisu provedena specifična ispitivanja interakcija s fiksnom kombinacijom bimatoprost/timolol.
English: EU/1/06/340/003 5 single-dose containers EU/1/06/340/004 30 single-dose containers EU/1/06/340/005 90 single-dose containers
Croatian: EU/1/06/340/003 5 jednodoznih spremnika EU/1/06/340/004 30 jednodoznih spremnika EU/1/06/340/005 90 jednodoznih spremnika
English: Bimatoprost is eliminated primarily by renal excretion, up to 67% of an intravenous dose administered to healthy volunteers was excreted in the urine, 25% of the dose was excreted via the faeces.
Croatian: Bimatoprost se primarno eliminira bubrežnim izlučivanjem, do 67% intravenske doze primijenjene na zdravim dobrovoljcima izlučilo se u mokraći, a 25% doze izlučilo se u fecesu.
English: Like other medicines applied into eyes, timolol is absorbed into the blood.
Croatian: Kao i ostali lijekovi koji se primjenjuju u oko, timolol se apsorbira u krv.
English: These two components decrease elevated intraocular pressure (IOP) by complementary mechanisms of action and the combined effect results in additional IOP reduction compared to either compound administered alone.
Croatian: Te dvije komponente snižavaju povišeni intraokularni tlak (IOT) komplementarnim mehanizmima djelovanja, a njihov kombinirani učinak rezultira dodatnim smanjenjem intraokularnog tlaka u usporedbi s primjenom samo jedne od komponenti.
English: If the liquid cannot drain out quickly enough, the pressure inside the eye builds up and could eventually damage your sight (an illness called glaucoma).
Croatian: Ako tekućina ne istječe dovoljno brzo, dolazi do porasta tlaka u oku, što bi moglo dovesti do oštećenja vida (bolest koja se naziva glaukom).
English: Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions.
Croatian: Bolesnike s kardiovaskularnim bolestima treba pratiti radi znakova pogoršanja tih bolesti ili nuspojava.
English: Contents of the pack and other information What GANFORT contains
Croatian: Sadržaj pakiranja i druge informacije Što GANFORT sadrži
English: These doses are at least 7.5 times higher than the amount of bimatoprost in an accidental dose of the entire contents of a carton of GANFORT single-dose (90 single-dose containers x 0.4 mL; 36 mL) in a 10 kg child [(36 mL*0.3 mg/mL bimatoprost)/10 kg; 1.08 mg/kg].
Croatian: Ove su doze najmanje 7,5 puta veće od ukupne količine bimatoprosta uzetog slučajnim uzimanjem sadržaja čitave kutije jednodoznog GANFORT-a (90 jednodoznih spremnika x 0,4 ml; 36 ml) u djeteta od 10 kg [(36 ml*0,3 mg/ml bimatoprosta)/10 kg; 1,08 mg/kg].
English: 10 single-dose containers.
Croatian: 10 jednodoznih spremnika.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti i kancerogenog potencijala.
English: Studies in rodents produced species-specific abortion at systemic exposure levels 33- to 97-times that achieved in humans after ocular administration.
Croatian: Ispitivanja na glodavcima rezultirala su pobačajima koji su specifični za vrstu pri sistemskim razinama izloženosti 33 do 97 puta većim od onih postignutih u ljudi nakon okularne primjene.
English: Patients with corneal diseases should be treated with caution.
Croatian: Bolesnike s poremećajima rožnice treba liječiti s oprezom.
English: What GANFORT is and what it is used for
Croatian: Što je GANFORT i za što se koristi
English: Animal studies with timolol have shown reproductive toxicity at doses significantly higher than would be used in clinical practice (see section 5.3).
Croatian: Ispitivanja na životinjama s timololom pokazala su reproduktivnu toksičnost pri dozama značajno većim od onih koje se koriste u kliničkoj praksi (vidjeti dio 5.3).
English: Overt cardiac failure, cardiogenic shock.
Croatian: Simptomatsko srčano zatajenje, kardiogeni šok.
English: This helps to stop GANFORT getting into the rest of the body.
Croatian: To pomaže u sprečavanju ulaska GANFORT-a u ostatak tijela.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku, obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Croatian: Benzalkonijev klorid izaziva točkastu keratopatiju i/ili toksičnu ulcerativnu keratopatiju.
English: If you forget to use GANFORT, use a single drop as soon as you remember, and then go back to your regular routine.
Croatian: Ako ste zaboravili primijeniti GANFORT, primijenite jednu kap čim se sjetite, a nakon toga se vratite uobičajenoj rutini.
English: Therefore in view of the data presented in the reviewed PSUR, the PRAC considers that changes to the product information of medical products containing timolol were warranted.
Croatian: U pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su potrebne izmjene informacija o lijeku za lijekove koji sadrže timolol.
English: The usual dose is one drop once a day, either in the morning or in the evening in each eye that needs treatment.
Croatian: Preporučena doza je jedna kap jedanput dnevno, ujutro ili navečer, u svako oko koje treba liječiti.
English: Thus, it is important to apply GANFORT as instructed and avoid it running onto the cheek or other skin areas.
Croatian: Stoga je važno GANFORT primjenjivati prema uputama i pritom izbjegavati njegovo curenje niz obraze ili druge dijelove kože.
English: • Cough, worsening of asthma, worsening of the lung disease called chronic obstructive pulmonary disease (COPD)
Croatian: • Kašalj, pogoršanje astme, pogoršanje plućne bolesti koja se zove kronična opstruktivna plućna bolest (KOPB)
English: Bimatoprost is a potent ocular hypotensive active substance .
Croatian: Bimatoprost je potentna očna hipotenzivna djelatna tvar.
English: This medicine is for single use only and does not contain preservatives.
Croatian: Ovaj lijek namijenjen je za jednokratnu primjenu i ne sadrži konzervanse.
English: Other medicines and GANFORT
Croatian: Drugi lijekovi i GANFORT
English: Table 2 System Organ Class
Croatian: Tablica 2 Klasifikacija organskih sustava
English: The mechanism of action by which bimatoprost reduces intraocular pressure in man is by increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow.
Croatian: Mehanizam djelovanja kojim bimatoprost snižava intraokularni tlak u čovjeka je povećanje istjecanja očne vodice kroz trabekularno tkivo i poboljšanje uveoskleralnog istjecanja.
English: See leaflet for further information.
Croatian: Pogledajte uputu o lijeku za više informacija.
English: Patients with severe peripheral circulatory disturbance/disorders (i.e. severe forms of Raynaud's disease or Raynaud's syndrome) should be treated with caution.
Croatian: Bolesnike s teškim perifernim cirkulacijskim bolestima/poremećajima (npr. teški oblici Raynaudove bolesti ili Raynaudovog sindroma) treba liječiti s oprezom.