FrancophonIA/ELRC3.0 huggingface dataset:
English: This summary was last updated in 01-2016.
Croatian: Ovaj sažetak je posljednji put ažuriran u 01.2016.
English: The maximum recommended dosing frequency is once a day.
Croatian: Najveća preporučena učestalost doziranja je jednom na dan.
English: The full EPAR for Viagra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Viagra nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This was recorded in a special questionnaire completed at home using a scoring system on a five-point scale, where a score of 5 represents the best result.
Croatian: Bilježilo je se u posebnom upitniku koji se popunjava kod kuće upotrebom sustava bodovanja na temelju ljestvice od pet bodova, pri čemu broj 5 predstavlja najbolji rezultat.
English: Viagra was significantly more effective than placebo in all studies.
Croatian: Viagra je bila znatno djelotvornija od placeba tijekom svih ispitivanja.
English: For Viagra to be effective, sexual stimulation is required.
Croatian: Kako bi Viagra bila djelotvorna, potrebna je seksualna stimulacija.
English: Sexual stimulation is still needed to produce an erection.
Croatian: Seksualna stimulacija još je uvijek potrebna za postizanje erekcije.
English: The recommended dose of Viagra is 50 mg taken as needed about one hour before sexual activity.
Croatian: Preporučena doza lijeka Viagra je 50 mg uzeta prema potrebi otprilike sat vremena prije seksualne aktivnosti.
English: Orodispersible tablets are tablets that dissolve in the mouth.
Croatian: Raspadljive tablete za usta su tablete koje se otapaju u ustima.
English: The orodispersible tablets should be placed on the tongue and left to disintegrate before swallowing.
Croatian: Raspadljive tablete za usta treba staviti na jezik i ostaviti da se raspadnu prije gutanja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Viagra on 14 September 1998.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Viagra na snazi u Europskoj uniji od 14. rujna 1998.
English: The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects.
Croatian: Doza se može povećati na najviše 100 mg ili smanjiti na 25 mg, ovisno o učinkovitosti i nuspojavama.
English: Viagra has been studied in four main studies including 1,690 men aged 19 to 87 years, where it was compared with placebo (a dummy treatment) for between 12 and 26 weeks.
Croatian: Viagra je ispitivana u četiri glavna ispitivanja s 1 690 muškaraca u dobi od 19 do 87 godina, u kojima je uspoređivana s placebom (prividnim liječenjem) između 12 i 26 tjedana.
English: The main measure of effectiveness was based on the ability of the men to get and maintain an erection.
Croatian: Glavno mjerilo djelotvornosti bila je mogućnost postizanja i održavanja erekcije kod muškaraca.
English: Patients with liver problems or severe kidney problems should start treatment with the 25 mg dose.
Croatian: Bolesnici koji imaju probleme s jetrom ili teške probleme s bubrezima trebaju započeti liječenje dozom od 25 mg.
English: If Viagra is taken with food, the onset of activity may be delayed compared with taking it without food.
Croatian: Ako se Viagra uzima s hranom, nastup aktivnosti može biti odgođen u usporedbi s uzimanjem lijeka natašte.
English: By blocking the breakdown of cGMP, Viagra restores erectile function.
Croatian: Blokadom razgradnje cGMP-a Viagra ponovno uspostavlja erektilnu funkciju.
English: Viagra is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a sufficiently hard penis (erection) for satisfactory sexual activity.
Croatian: Viagra se koristi za liječenje odraslih muškaraca s erektilnom disfunkcijom (koja se ponekad naziva impotencija), kada ne mogu postići ili održati ukrućeni penis (erekciju) dostatan za zadovoljavajuću seksualnu aktivnost.
English: This is a summary of the European public assessment report (EPAR) for Viagra.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Viagra.
English: What measures are being taken to ensure the safe and effective use of Viagra?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Viagra?
English: For more information about treatment with Viagra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Viagra pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Viagra is a medicine that contains the active substance sildenafil.
Croatian: Viagra je lijek koji sadrži djelatnu tvar sildenafil.
English: Other information about Viagra
Croatian: Ostale informacije o lijeku Viagra
English: In the fixed-dose studies, the proportions of patients reporting that treatment improved their erections were 62% (25 mg), 74% (50 mg) and 82% (100 mg), compared with 25% on placebo.
Croatian: U ispitivanjima s fiksnom dozom, udio bolesnika koji su prijavili poboljšanje svoje erekcije uz terapiju iznosio je 62 % (25 mg), 74 % (50 mg) i 82 % (100 mg), u usporedbi s 25 % bolesnika koji su primali placebo.
English: In the questionnaire, scores for the question on how often the patient was able to achieve intercourse went from about 2 without treatment to 3 or 4 with Viagra 50 mg.
Croatian: U upitniku se broj bodova o tome kako je često bolesnik uspio ostvariti spolni odnos kretao između 2 bez terapije i 3 ili 4 s terapijom Viagrom u dozi od 50 mg.
English: The active ingredient in Viagra, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Croatian: Djelatni sastojak lijeka Viagra sildenafil pripada skupini lijekova zvanih inhibitori fosfodiesteraze tipa 5 (PDE5).
English: A risk management plan has been developed to ensure that Viagra is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Viagra.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection.
Croatian: Tijekom normalne seksualne stimulacije, u penisu se stvara cGMP i uzrokuje opuštanje mišića spužvastog tkiva penisa (corpora cavernosa) što omogućava protok krvi u tkivu i tako nastaje erekcija.
English: It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Croatian: Djeluje blokiranjem enzima fosfodiesteraze koji inače razgrađuje tvar poznatu kao ciklički gvanozin monofosfat (cGMP).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Viagra, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Viagra nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati.
English: Viagra must not be taken with nitrates (medicines used to treat angina) or medicines of the class ‘guanylate cyclase stimulators' such as riociguat (used to treat pulmonary hypertension [high blood pressure in the lungs]).
Croatian: Viagra se ne smije uzimati s nitratima (lijekovima koji se koriste za liječenje angine) niti s lijekovima koji pripadaju klasi „stimulatora gvanilat ciklaze”, kao što je riocigvat (koji se koristi za liječenje plućne hipertenzije [visokog krvnog tlaka u plućima]).
English: It is available as tablets (25, 50 or 100 mg) and as orodispersible tablets (50 mg).
Croatian: Lijek je dostupan u obliku tableta (25, 50 ili 100 mg) i u obliku raspadljivih tableta za usta (50 mg).
English: The most common side effects with Viagra are headache, flushing, dyspepsia (indigestion), visual disorders, including visual colour distortion and blurred vision, nasal congestion (blocked nose), dizziness, nausea and hot flushes.
Croatian: Najčešće nuspojave povezane s lijekom Viagra su glavobolja, navala crvenila, dispepsija (loša probava), poremećaji vida, uključujući iskrivljavanje boja kod vida i zamućeni vid, nazalnu kongestiju (začepljen nos), omaglicu, mučninu i navale vrućine.
English: Two of these studies used fixed doses (patients allocated to 25, 50 or 100 mg) and two studies were flexible (patients started on 25 mg and could be moved to 50 or 100 mg depending on their response).
Croatian: U dvama od ovih ispitivanja primjenjivane su fiksne doze (bolesnicima su davane doze od 25, 50 ili 100 mg), a dva su ispitivanja bila fleksibilna (bolesnicima je najprije dana doza od 25 mg koju se moglo povisiti na 50 ili 100 mg, ovisno o njihovom odgovoru).
English: Viagra must not be used where sexual activity is inadvisable (e.g. men with severe heart disease such as unstable angina or severe heart failure).
Croatian: Viagra se ne smije koristiti u slučajevima kada se ne preporučuje seksualna aktivnost (primjerice u muškaraca s teškom bolešću srca poput nestabilne angine ili teškim zatajenjem srca).
English: In addition, there were studies in patients with spinal cord injury and with diabetes.
Croatian: Osim toga, provedena su ispitivanja u bolesnika s ozljedom leđne moždine i dijabetesom.
English: It must also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy or NAION).
Croatian: Lijek također ne smiju uzimati bolesnici koji su doživjeli gubitak vida zbog problema s dotokom krvi u očni živac (nearteritička prednja ishemička neuropatija ili NAION).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Viagra.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek Viagra da bi preporučio njegovo odobrenje za stavljanje u promet te uvjete za njegovu primjenu.
English: Because Viagra has not been studied in patients with severe liver disease, hypotension (low blood pressure), recent stroke or myocardial infarction (heart attack), or a hereditary eye disease, such as retinitis pigmentosa, these patients must not use it. For the full list of restrictions, see the package leaflet.
Croatian: S obzirom na to da Viagra nije ispitivana u bolesnika s teškom bolesti jetre, hipotenzijom (niskim krvnim tlakom), nedavnim moždanim udarom ili infarktom miokarda (srčani udar) ili nasljednom bolešću očiju poput retinitis pigmentose, bolesnici s ovim poremećajima ne smiju je koristiti.
English: What is the risk associated with Viagra?
Croatian: Koji su rizici povezani s lijekom Viagra?
English: What is Viagra?
Croatian: Što je Viagra?
English: The CHMP decided that Viagra's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Viagra nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za stavljanje na tržište.
English: Why has Viagra been approved?
Croatian: Zašto je lijek Viagra odobren?
English: What is Viagra used for?
Croatian: Za što se Viagra koristi?
English: For the full list of all side effects reported with Viagra, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Viagra potražite u uputi o lijeku.
English: What benefit has Viagra shown during the studies?
Croatian: Koje su koristi lijeka Viagra utvrđene u ispitivanjima?
English: How does Viagra work?
Croatian: Kako djeluje Viagra?
English: How is Viagra used?
Croatian: Kako se Viagra koristi?
English: Date of first authorisation: 12/03/2014 Date of last renewal:
Croatian: Datum prvog odobrenja: 12/03/2014 Datum posljednjeg produljenja:
English: Do not use during pregnancy.
Croatian: Ne koristiti tijekom gravidnosti.
English: Treatment may be repeated at 24 hour intervals during 10 consecutive days.
Croatian: Liječenje se može ponoviti u intervalima od 24 sata tijekom 10 uzastopnih dana.
English: Once opened, use within 4 weeks.
Croatian: Jednom otvoren upotrijebiti u roku od 4 tjedna.
English: The correct dose should be mixed into a small amount of food.
Croatian: Ispravnu dozu treba umiješati u malu količinu hrane.
English: ATCvet code: QH02AB06
Croatian: ATCvet kod: QH02AB06
English: Dosage in medium to long term use should therefore generally be kept to the minimum necessary to control symptoms.
Croatian: Stoga je potrebno doziranja pri srednjoj do dugoročnoj primjeni držati na minimumu potrebnom za kontroliranje simptoma.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.emea.europa.eu/.
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije za lijekove http://www.emea.europa.eu/.
English: SACHETS (3, 9 and 18 gram)
Croatian: VREĆICE (3, 9 i 18 grama)
English: A significant increase in triglycerids occurs very commonly.
Croatian: Značajno povećanje triglicerida događa se vrlo često.
English: The active substance in Equisolon is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: Djelatna tvar u Equisolonu je dozvoljena tvar kako je navedeno u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010
English: Sachets of different pack size can be combined to achieve the correct dose, as per the table below:
Croatian: Vrećice različitih veličina mogu se kombinirati kako bi se postigla ispravna doza, kako je navedeno u sljedećoj tablici:
English: Bioavailability after oral administration is about 60%.
Croatian: Biodostupnost nakon peroralne primjene iznosi otprilike 60%.
English: Therefore horses should be monitored frequently during the treatment period.
Croatian: Stoga je potrebno često nadzirati konje tijekom razdoblja liječenja.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required, or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EZ) br. 470/2009 kada se primjenjuju u tim veterinarsko-medicinskim proizvodima.
English: T½ is 3.1 ±2.3 hours but is not meaningful from a therapy standpoint when evaluating systemic corticosteroids.
Croatian: T½ iznosi 3,1 ± 2,3 sati, no nije smislen sa stajališta terapije prilikom ocjene sustavnih kortikosteroida.
English: Bodyweight (kg) of horse
Croatian: Tjelesna težina (kg) konja
English: Excretion of prednisolone is complete within 3 days.
Croatian: Prednizolon je sasvim izlučen u roku od 3 dana.
English: Equal amounts of prednisolone, prednisone, 20βdihydroprednisolone and 20β-dihydroprednisone are found in urine.
Croatian: Podjednake količine prednizolona, prednisona, 20βdihidroprednizolona i 20β-dihidroprednisona pronađene su u urinu.
English: The overall average Tmax is 2.5 ± 3.1 hours, Cmax is 237 ± 154 ng/ml and AUCt is 989 ± 234 ng∙h/ml.
Croatian: Ukupan prosječni Tmax iznosi 2,5 ± 3,1 sati, Cmax iznosi 237 ± 154 ng/ml, a AUCt iznosi 989 ± 234 ng∙h/ml.
English: Where medical treatment of horses with RAO is required, glucocorticoids are effective in controlling clinical signs and decreasing neutrophilia in airways.
Croatian: U slučajevima kada je potrebno liječenje konja s RAO, glukokortikoidi su djelotvorni u kontroliranju kliničkih znakova i snižavanju neutrofilije u zračnim putovima.
English: The treatment should be combined with environmental control.
Croatian: Liječenje treba kombinirati s kontrolom okruženja.
English: In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Croatian: U nedostatku ispitivanja kompatibilnosti ovaj veterinarsko-medicinski proizvod se ne smije miješati s drugim veterinarsko-medicinskim proizvodima.
English: White to off-white powder
Croatian: Bijeli do prljavo bijeli prašak
English: In order to prevent dust formation, do not shake the veterinary medicinal product.
Croatian: Kako bi se spriječilo formiranje prašine, ne tresite veterinarsko-medicinski proizvod.
English: Oral powder.
Croatian: Peroralni prašak.
English: One gram contains:
Croatian: Jedan gram sadrži: Djelatna tvar:
English: Other gastrointestinal symptoms that have been very rarely observed are colic and anorexia.
Croatian: Drugi gastrointestinalni simptomi prijavljeni u vrlo rijetkim slučajevima su kolike i anoreksija.
English: Corticoid administration is to induce an improvement in clinical signs rather than a cure.
Croatian: Primjenom kortikoida inducira se poboljšanje kliničkih znakova, a ne liječenje.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Croatian: Predoziranje (simptomi, hitni postupci, antidoti)
English: This can be a part of possible iatrogenic hyperadrenocorticism (Cushings disease) involving significant alteration of fat, carbohydrate, protein and mineral metabolism, e.g. redistribution of body fat, increase in body weight, muscle weakness and wastage and osteoporosis may result.
Croatian: Ono može biti dio mogućeg jatrogenog hiperadrenokorticizma (Cushingove bolesti) koja uključuje značajnu izmjenu metabolizma masti, ugljikohidrata, proteina i minerala, što može primjerice rezultirati redistribucijom tjelesne masti, povećanjem tjelesne težine, mišićnom slabošću i gubitkom mišića te osteoporozom.
English: Because corticosteroids can reduce the immunoresponse to vaccination, prednisolone should not be used in combination with vaccines or within two weeks after vaccination.
Croatian: Budući da kortikosteroidi mogu smanjiti imunosni odgovor na cijepljenje, prednizolon se ne smije koristiti u kombinaciji s cjepivima ili u roku kraćem od dva tjedna nakon cijepljenja.
English: Following oral administration in horses prednisolone is readily absorbed giving a prompt response which is maintained for approximately 24 hours.
Croatian: Nakon peroralne primjene u konja, prednizolon je odmah apsorbiran što daje brzi odgovor, koji se zadržava tijekom otprilike 24 sata.
English: Very rarely urticaria has been observed.
Croatian: U vrlo rijetkim slučajevima prijavljena je urtikarija.
English: 4 μg/kg 8 μg/kg 6 μg/kg 15 μg/kg
Croatian: 6 μg/kg 15 μg/kg
English: Do not use in viral infections during the viraemic stage or in cases of systemic mycotic infections.
Croatian: Ne koristiti u slučaju virusnih infekcija tijekom viremične faze i u slučajevima sustavnih mikotičkih infekcija.
English: Because of the pharmacological properties of prednisolone, use with caution when the veterinary medicinal product is used in animals with a weakened immune system.
Croatian: Zbog farmakoloških svojstava prednizolona potrebno je biti na oprezu u slučajevima kada se veterinarsko-medicinski proizvod koristi u životinja s oslabljenim imunosnim sustavom.
English: Treatment with prednisolone should only be initiated when satisfactory alleviation of clinical symptoms have not been obtained or are unlikely to be obtained by environmental control alone.
Croatian: Prednizolonom treba liječiti samo kada nije postignuto odgovarajuće uklanjanje kliničkih simptoma ili ako nije izgledno da će se isto postignuti samo kontrolom okruženja.
English: Multiple dosing does not result in plasma accumulation of prednisolone.
Croatian: Višestruko doziranje ne rezultira akumulacijom prednizolona u plazmi.
English: Excessive sweating has been very rarely observed.
Croatian: U vrlo rijetkim slučajevima prijavljeno je prekomjerno znojenje.
English: People with known hypersensitivity to corticosteroids or any of the excipients must not be in contact with the veterinary medicinal product.
Croatian: Osobe za koje je poznato da su preosjetljive na kortikosteroide ili na bilo koju pomoćnu tvar ne smiju doći u kontakt s veterinarskim-medicinskim proizvodom.
English: Each case should be assessed individually by the veterinarian and an appropriate treatment program determined.
Croatian: Veterinar treba individualno procijeniti svaki slučaj, te je potrebno utvrditi odgovarajući program liječenja.
English: 33.3 mg
Croatian: prednizolon 33,3 mg
English: Treatment with prednisolone may not sufficiently restore respiratory function in all cases, and in each individual case the use of medicinal products with more rapid onset of action may need to be considered.
Croatian: Liječenje prednizolonom možda neće biti učinkovito u obnavljanju respiratorne funkcije u svim slučajevima, te se u svakom individualnom slučaju mora uzeti u obzir primjena medicinskih proizvoda s bržim početkom djelovanja.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and the carton after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi i kartonu.
English: Glucocorticoids have an effect on metabolism by increasing gluconeogenesis.
Croatian: Glukokortikoidi djeluju na metabolizam tako što povećavaju glukoneogenezu.
English: Corticosteroids suppress the immunologic response by inhibition of dilatation of capillaries, migration and function of leucocytes and phagocytosis.
Croatian: Kortikosteroidi potiskuju imunološku reakciju tako što inhibiraju dilataciju kapilara, pomicanje i funkciju leukocita i fagocitozu.
English: Following cessation of treatment, signs of adrenal insufficiency extending to adrenocortical atrophy can arise and this may render the animal unable to deal adequately with stressful situations.
Croatian: Nakon prestanka liječenja, mogu se pojaviti znakovi insuficijencije nadbubrežne žlijezde koji se proširuju na adrenokortikalnu atrofiju, te to može učiniti životinju nesposobnom da se primjereno nosi sa stresnim situacijama.
English: A measuring spoon is included.
Croatian: Uključena je mjerna žlica.
English: Partial metabolism of prednisolone to the biologically inert substance prednisone takes place.
Croatian: Odvija se djelomičan metabolizam prednizolona u biološki inertnu tvar prednison.
English: Food mixed with the veterinary medicinal product should be replaced if not consumed within 24 hours.
Croatian: Hrana pomiješana s veterinarsko-medicinskim proizvodom treba se zamijeniti, ako se ne konzumira u roku od 24 sata.
English: Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in horses, in combination with environmental control.
Croatian: Ublažavanje upalnih i kliničkih parametara povezanih s rekurentnom opstrukcijom dišnih putova (RAO) u konja, u kombinaciji s kontrolom okruženja.
English: Pharmacotherapeutic group: corticosteroid for systemic use, glucocorticoid.
Croatian: Farmakoterapijska grupa: kortikosteroid za sustavnu primjenu, glukokortikoid.
English: Meat and offal: 10 days.
Croatian: Meso i jestive iznutrice: 10 dana.
English: Marketing authorisation holder: Le Vet B.V.
Croatian: Nositelj odobrenja za stavljanje u promet: Le Vet B.V.
English: Affected horses are susceptible to inhaled antigens and other pro-inflammatory agents, including fungal spores and dust-derived endotoxin.
Croatian: Oboljeli konji osjetljivi su na inhalirane antigene i druge upalne uzročnike, uključujući i gljivične pore i endotoksin dobiven iz prašine.
English: Very rarely, laminitis has been observed after use of the product.
Croatian: U vrlo rijetkim slučajevima nakon uporabe proizvoda prijavljen je laminitis.