FrancophonIA/ELRC3.0 huggingface dataset:
English: In laboratory studies including experimental challenge with Leishmania infantum, the vaccine reduced the severity of the disease, including clinical signs and parasite burden in spleen and lymph nodes.
Croatian: U laboratorijskim ispitivanjima u kojima su životinje bile izložene Leishmania infantum, cjepivo je umanjilo simptome oboljenja, uključujući i kliničku sliku i količinu parazita u slezeni i limfnim čvorovima.
English: Water for injections.
Croatian: Otapalo: voda za injekcije.
English: Shelf life of the solvent: 5 years.
Croatian: Rok valjanosti otapalo: 5 godine.
English: Primary vaccination scheme: A single dose of the vaccine (0.5 ml) to be administered to dogs from 6 months of age.
Croatian: Primarna shema cijepljenja: Jedna doza cjepiva (0,5 ml) primjenjuje se psima starijim od 6 mjeseci.
English: Method of administration:
Croatian: Metoda primjene:
English: A test for the detection of Leishmania infection is recommended prior to vaccination.
Croatian: Prije cijepljenja preporučuje se test za otkrivanje infekcije parazitom Leishmania.
English: 6.5 Nature and composition of immediate packaging Lyophilisate vial
Croatian: 6.5 Osobine i sastav unutarnjeg pakovanja
English: BATCH NUMBER Lot {number} EXPIRY DATE EXP {mm/yyyy} THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Croatian: BROJ PROIZVODNE SERIJE Lot {broj} ROK VALJANOSTI EXP {mm/gggg} RIJEČI „SAMO ZA PRIMJENU NA ŽIVOTINJAMA“
English: Solvent Water for injections: q.s.
Croatian: Otapalo voda za injekcije q.s. 0,5 ml.
English: Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim otapalom priloženim za primjenu s veterinarsko-medicinskim proizvodom.
English: After vaccination, scratching at the injection site has been observed very commonly in dogs.
Croatian: Poslije cijepljenja kod pasa je vrlo često primijećeno češanje mjesta uboda.
English: The efficacy of the vaccine was demonstrated in a field study where seronegative dogs from a variety of breeds were naturally exposed to Leishmania infantum in zones with high infection pressure over a two year period.
Croatian: Učinkovitost cjepiva dokazana je ispitivanjem na terenu gdje su seronegativni psi različitih pasmina, u razdoblju od dvije godine, bili prirodno izloženi uzročniku Leishmania infantum u područjima gdje postoji velika mogućnost zaraze.
English: De-worming of infested dogs prior to vaccination is recommended.
Croatian: Prije cijepljenja preporuča se dehelmintizacija zaraženih pasa.
English: The efficacy of the vaccine was demonstrated in a field study where dogs were naturally exposed to Leishmania infantum in zones with high infection pressure over a two year period.
Croatian: Učinkovitost cjepiva dokazana je ispitivanjem na terenu gdje su psi, u razdoblju od dvije godine, bili prirodno izloženi uzročniku Leishmania infantum u područjima gdje postoji velika mogućnost zaraze.
English: Re-vaccination scheme: A single dose of the vaccine (0.5 ml) to be given annually thereafter.
Croatian: Ponovno cijepljenje: Jedna doza cjepiva (0,5 ml) godišnje za ponovno cijepljenje.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial of lyophilisate
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: Laboratorios LETI, S.L.unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol, 5, Poligono Industrial Norte, Tres Cantos
English: Shelf life after reconstitution according to directions: use immediately Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi poslije EXP.
English: Lyohilisate:
Croatian: Liofilizat:
English: 20 doses
Croatian: 20 doza
English: Reconstitute one vial of the white lyophilisate using 0.5 ml of the solvent.
Croatian: Rekonstituirati jednu bočicu bijelog liofilizata s 0,5 ml otapala.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance
Croatian: Naziv i adresa proizvođača biološki djelatne tvari
English: It is essential that measures to reduce exposure to sand-flies are employed in vaccinated animals.
Croatian: Neophodno je kod cijepljenih životinja primijeniti mjere za smanjenje izloženosti papataču.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT LETIFEND lyophilisate for dogs
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA LETIFEND liofilizat za pse
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT LETIFEND, lyophilisate and solvent for solution for injection for dogs
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA LETIFEND, liofilizat i otapalo za otopinu za injekciju za pse
English: Lyophilisate and solvent for solution for injection.
Croatian: Liofilizat i otapalo za otopinu za injekciju.
English: ≥ 36.7 ELISA Units (EU)* * Antigen content determined in an ELISA against an internal standard.
Croatian: ≥ 36,7 ELISA jedinica (EU)*
English: LETIFEND, lyophilisate and solvent for solution for injection for dogs.
Croatian: LETIFEND, liofilizat i otapalo za otopinu za injekciju za pse.
English: PHARMACEUTICAL FORM Lyophilisate and solvent for solution for injection.
Croatian: OBLIK Liofilizat i otapalo za otopinu za injekciju.
English: Laboratorios LETI, S.L.unipersonal C/ Del Sol, 5, Poligono Industrial Norte, Tres Cantos, 28760, Madrid SPAIN
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol, 5, Poligono Industrial Norte, Tres Cantos, 28760, Madrid ŠPANJOLSKA
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Recombinant Protein Q from L. infantum MON-1
Croatian: KOLIČINA DJELATNE(IH) TVARI Rekombinirana bjelančevina Q iz L. infantum MON-1 SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA 1 doza
English: Type I glass vials containing 0.8 ml of solvent.
Croatian: I koja sadrži 0,8 ml otapala.
English: LETIFEND, lyophilisate and solvent for solution for injection for dogs
Croatian: LETIFEND, liofilizat i otapalo za otopinu za injekciju za pse
English: Plastic box containing 4 vials of 1 dose of lyophilisate and 4 vials of 0.8 ml of solvent.
Croatian: Plastična kutija s 4 bočice s 1 dozom liofilizata i 4 bočice s 0,8 ml otapala.
English: Plastic box containing 25 vials of 1 dose of lyophilisate and 25 vials of 0.8 ml of solvent.
Croatian: Plastična kutija s 25 bočica s 1 dozom liofilizata i 25 bočica s 0,8 ml otapala.
English: Plastic box containing 20 vials of 1 dose of lyophilisate and 20 vials of 0.8 ml of solvent.
Croatian: Plastična kutija s 20 bočica s 1 dozom liofilizata i 20 bočica s 0,8 ml otapala.
English: Plastic box containing 100 vials of 1 dose of lyophilisate and 100 vials of 0.8 ml of solvent.
Croatian: Plastična kutija sa 100 bočica s 1 dozom liofilizata i 100 bočica s 0,8 ml otapala.
English: PACKAGE LEAFLET: LETIFEND, lyophilisate and solvent for solution for injection for dogs
Croatian: UPUTA O VMP: LETIFEND, liofilizat i otapalo za otopinu za injekciju za pse
English: Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of 0.8 ml of solvent.
Croatian: Plastična kutija s 5 bočica s 1 dozom liofilizata i 5 bočica s 0,8 ml otapala.
English: Plastic box containing 50 vials of 1 dose of lyophilisate and 50 vials of 0.8 ml of solvent.
Croatian: Plastična kutija s 50 bočica s 1 dozom liofilizata i 50 bočica s 0,8 ml otapala.
English: Plastic box containing 10 vials of 1 dose of lyophilisate and 10 vials of 0.8 ml of solvent.
Croatian: Plastična kutija s 10 bočica s 1 dozom liofilizata i 10 bočica s 0,8 ml otapala.
English: 4 doses
Croatian: 4 doze
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANIEN)
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANYOLORSZÁG)
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANJE)
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ŠPANIELSKO)
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Μαδρίτη (ΙΣΠΑΝΙΑ) Τηλ: + 34 91 771 17 90
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Μαδρίτη (ΙΣΠΑΝΙΑ) Τηλ: + 34 91 771 17 90
English: Plastic box containing 1 vial of 1 dose of lyophilisate and 1 vial of 0.8 ml of solvent.
Croatian: Plastična kutija s 1 bočicom s 1 dozom liofilizata i 1 bočicom s 0,8 ml otapala.
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ESPANJA) Puh/Tel: + 34 91 771 17 90
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ESPANJA) Puh/Tel: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANJE/ESPAGNE/SPANIEN) Tél/Tel: + 34 91 771 17 90
Croatian: Luxembourg/Luxemburg Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ESPAGNE/SPANIEN) Tél/Tel: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANIA) Tlf: + 34 91 771 17 90
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANIA) Tlf: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANIEN) Tlf: + 34 91 771 17 90
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANIEN) Tlf: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPÁNN) Sími: + 34 91 771 17 90
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPÁNN) Sími: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madride (SPĀNIJA) Tel: + 34 91 771 17 90
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madride (SPĀNIJA) Tel: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madridas (ISPANIJA) Tel: +34 91 771 17 90
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madridas (ISPANIJA) Tel: +34 91 771 17 90
English: Solvent vial
Croatian: Bočica otapala
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ESPAÑA) Tel: + 34 91 771 17 90
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ESPAÑA) Tel: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ŠPANĚLSKO) Tel: + 34 91 771 17 90
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ŠPANIJA) Tel: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANIA) Tel: + 34 91 771 17 90
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANIA) Tel: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ŠPANJOLSKA) Tel: + 34 91 771 17 90
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ŠPANJOLSKA) Tel: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (HISPAANIA) Tel: + 34 91 771 17 90
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (HISPAANIA) Tel: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPAIN) Tel: + 34 91 771 17 90
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPAIN) Tel: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANIEN) Tel: + 34 91 771 17 90
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANJE) Tel: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ESPANHA) Tel: + 34 91 771 17 90
Croatian: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ESPANHA) Tel: + 34 91 771 17 90
English: Swelling and redness of eyelid.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI
English: However, no special dose adjustment is needed in these populations.
Croatian: Ipak, nisu potrebne posebne prilagodbe doze u ovim populacijama.
English: In Period 2, analyses demonstrated stability of improvements achieved during Period 1 for both doses regimen.
Croatian: U Razdoblju 2 analize su pokazale stabilnost poboljšanja postignutih u Razdoblju 1 za oba režima doziranja.
English: Tilt your head back and look up at the ceiling 8.
Croatian: Nagnite glavu natrag i gledajte u strop
English: Do not take a double dose to make up for the forgotten dose.
Croatian: Nemojte primijeniti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Only use Verkazia in your eye as described under section 3.
Croatian: Primjenjujte Verkaziu u oko samo kako je opisano u dijelu 3.
English: Effects on the immune system
Croatian: Učinci na imunosni sustav
English: Mean age was 9.2 years (SD: 3.3, age range: 4-17 years).
Croatian: Srednja vrijednost dobi bila je 9,2 godine (SD: 3,3; raspon dobi: 4-17 godina).
English: Verkazia is likely to be present in breast milk in very small amounts.
Croatian: Verkazia će vjerojatno biti prisutna u majčinom mlijeku u vrlo malim količinama.
English: What Verkazia is and what it is used for 2.
Croatian: Što je Verkazia i za što se koristi 2.
English: By pressing at this point, you close down the opening of this drainage duct.
Croatian: Pritiskom na to mjesto zatvarate otvor tog odvodnog kanala.
English: If you use drops in both eyes, repeat the steps 6 to 9 for your other eye. 12.
Croatian: Ako primjenjujete kapi u oba oka, ponovite korake 6 do 9 za drugo oko.
English: Efficacy and safety of Verkazia have not been studied beyond 12 months.
Croatian: Djelotvornost i sigurnost Verkazie nisu ispitivane dulje od 12 mjeseci.
English: A caregiver should help a child starting Verkazia treatment, particularly if the child is aged under 10 years, and should continue to supervise the child until the child is able to use Verkazia properly without help.
Croatian: Djetetu koje počinje primjenjivati Verkaziu treba pomoći njegovatelj, naročito ako je dijete mlađe od 10 godina, te treba nastaviti nadgledati dijete sve dok ono ne bude sposobno pravilno primijeniti Verkaziu bez pomoći.
English: If signs and symptoms of VKC persist after the end of the season, the treatment can be maintained at the recommended dose or decreased to one drop twice daily once adequate control of signs and symptoms is achieved.
Croatian: Ako znakovi i simptomi VKK-a perzistiraju i nakon sezone, liječenje se može nastaviti u preporučenoj dozi ili smanjiti na jednu kap dva puta na dan kada se postigne odgovarajuća kontrola znakova i simptoma.
English: Children below 4 years
Croatian: Djeca mlađa od 4 godine
English: Do not use Verkazia in children under the age of 4 years.
Croatian: Ne primjenjujte Verkaziu u djece mlađe od 4 godine.
English: Blocking NF-AT also interferes in the allergy process.
Croatian: Blokiranje NFAT-a utječe i na alergijske procese.
English: EXCELVISION 27 rue de la Lombardière ZI la Lombardière 07100 Annonay France
Croatian: EXCELVISION 27 rue de la Lombardière ZI la Lombardière 07100 Annonay
English: What you need to know before you use Verkazia 3.
Croatian: Što morate znati prije nego počnete primjenjivati Verkaziu 3.
English: Talk to your doctor or pharmacist before using Verkazia: - if you have had an eye infection or if you suspect you have an eye infection - if you have any other kind of eye disease - if you wear contact lenses (the use of Verkazia is not recommended with contact lenses).
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Verkaziu: - ako ste imali infekciju oka ili sumnjate da imate infekciju oka - ako imate bilo kakvu drugu vrstu očne bolesti - ako nosite kontaktne leće (ne preporučuje se primjena Verkazie uz kontaktne leće).
English: Keep single-dose containers in the pouch in order to protect from light and avoid evaporation.
Croatian: Jednodozne spremnike čuvati u vrećici radi zaštite od svjetlosti i izbjegavanja isparavanja.
English: Verkazia is not recommended during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.
Croatian: Ne preporučuje se koristiti lijek Verkazia tijekom trudnoće, osim ako moguća korist za majku ne nadmašuje mogući rizik za fetus.
English: If you stop using Verkazia without speaking to your doctor, your eye allergy will not be controlled and could lead to long-term problems with your sight.
Croatian: Ako prestanete primjenjivati Verkaziu bez savjetovanja sa svojim liječnikom, očna alergija više se neće kontrolirati i može doći do dugotrajnih problema s vidom.
English: Ciclosporin reduces the activity of the body's immune (defence) system and in this way it reduces inflammation (body response to harmful stimuli).
Croatian: Ciklosporin smanjuje aktivnost imunosnog (obrambenog) sustava tijela i na taj način smanjuje upalu (odgovor tijela na štetni podražaj).
English: Blink a few times so that the medicine spreads across your eye 10.
Croatian: Trepnite nekoliko puta kako bi se lijek raširio po oku.
English: Contents of the pack and other information What Verkazia contains
Croatian: Sadržaj pakiranja i druge informacije Što Verkazia sadrži
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Verkazia therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Verkazia uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: There were more male [n=132 (78.6%)] than female patients [n=36 (21.4%)].
Croatian: Bilo je više bolesnika [n=132 (78,6 %)] nego bolesnica [n=36 (21,4 %)].
English: If you are using other eye drops, use Verkazia at least 15 minutes after using the other eye drops.
Croatian: Ako koristite druge kapi za oko, Verkaziu primijenite najmanje 15 minuta nakon korištenja drugih kapi za oko.
English: Do not exceed the treatment period prescribed by your doctor.
Croatian: Nemojte produljiti trajanje liječenja koje Vam je propisao liječnik.
English: Treatment should be discontinued after signs and symptoms are resolved, and reinitiated upon their recurrence.
Croatian: Liječenje treba prekinuti kada se znakovi i simptomi povuku, a ponovno uvesti kada se opet jave.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, phototoxicity and photoallergy, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, fototoksičnosti i preosjetljivosti na svjetlo, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
English: This helps to stop Verkazia getting into the rest of the body.
Croatian: To pomaže u smanjenju ulaska Verkazie u ostatak tijela.
English: Twist off the cap (picture 1)
Croatian: Odvijte čep (slika 1)
English: If overdose with Verkazia occurs, treatment should be symptomatic and supportive.
Croatian: U slučaju predoziranja Verkaziom, liječenje treba biti simptomatsko i suportivno.
English: Verkazia should not be used if you are pregnant.
Croatian: Nemojte primjenjivati Verkaziu ako ste trudni.
English: Other medicines and Verkazia
Croatian: Drugi lijekovi i Verkazia
English: What Verkazia is and what it is used for
Croatian: Što je Verkazia i za što se koristi
English: If you are using Verkazia for more than 12 months, you should visit your doctor regularly, e.g. every 3 to 6 months.
Croatian: Ako koristite Verkaziu dulje od 12 mjeseci, trebali biste redovito posjećivati liječnika, npr. svaka 3 do 6 mjeseci.
English: The improvement was clinically relevant as illustrated by the effect size over 4 months (symptoms domain: 0.67 and daily activities domain: 0.44).
Croatian: Poboljšanje je bilo klinički značajno kao što je prikazano veličinom učinka tijekom 4 mjeseca (u domeni simptoma: 0,67 i u domeni dnevnih aktivnosti: 0,44).
English: After using Verkazia, press a finger lightly on the inner corner of your eyelid, next to your nose for 2 minutes (picture 3).
Croatian: Nakon primjene Verkazie prstom lagano pritisnite unutarnji kut vjeđe, odmah pored nosa na 2 minute (slika 3).
English: Clinical relevance of the primary efficacy endpoint was however difficult to address.
Croatian: Bilo je teško procijeniti klinički značaj primarne mjere djelotvornosti.
English: Patient quality of life (Quick questionnaire) improved significantly better in the high dose group compared to vehicle.
Croatian: Kvaliteta života bolesnika (Quick upitnik) značajno se više poboljšala u skupini koja je primala visoku dozu u usporedbi sa skupinom koja je primala vehikulum.
English: The most common adverse reactions in the clinicial trials with Verkazia were eye pain (11%) and eye pruritus (9%) which were usually transitory and occurred during instillation.
Croatian: Najčešće nuspojave u kliničkim ispitivanjima Verkazie bile su bol u oku (11 %) i svrbež oka (9 %) koje su obično bile prolazne i javljale se tijekom ukapavanja.
English: You should continue Verkazia as prescribed by your doctor.
Croatian: Trebate nastaviti koristiti Verkaziu onako kako Vam je propisao liječnik.
English: If you put in more Verkazia than you should, rinse your eye with water.
Croatian: Ako primijenite više Verkazie nego što ste trebali, isperite oko vodom.
English: What Verkazia looks like and contents of the pack
Croatian: Kako Verkazia izgleda i sadržaj pakiranja
English: If you forget to use Verkazia, continue with the next dose as planned.
Croatian: Ako ste zaboravili primijeniti Verkaziu, nastavite sa sljedećom dozom prema planu.
English: 168 patients [127 children (75.6%) and 41 adolescents (24.4%)] were included in the efficacy analyses.
Croatian: U analize djelotvornosti uključeno je 168 bolesnika [127 djece (75,6 %) i 41 adolescent (24,4 %)].
English: Itching, redness, irritation and discomfort in or around the eye including a feeling that there is something in the eye.
Croatian: Svrbež, crvenilo, nadraženost i nelagoda u oku ili oko oka, uključujući osjećaj da imate nešto u oku.
English: Discard the single-dose container as soon as you have used it, even if there is still some medicine left in it
Croatian: 12. Jednodozni spremnik bacite odmah nakon primjene, čak i ako je ostalo nešto lijeka u njemu
English: There is no relevant use of Verkazia in children below 4 years in the treatment of severe vernal keratoconjunctivitis.
Croatian: Nema relevantne primjene Verkazie u djece mlađe od 4 godine za liječenje teškog vernalnog keratokonjunktivitisa.
English: Fertility There are no data on the effects of Verkazia on human fertility.
Croatian: Plodnost Nema podataka o učincima Verkazie na plodnost u ljudi.
English: One mL of emulsion contains 0.05 mg cetalkonium chloride (see section 4.4).
Croatian: Jedan ml emulzije sadrži 0,05 mg cetalkonijevog klorida (vidjeti dio 4.4).