FrancophonIA/ELRC3.0 huggingface dataset:
English: Each dose of 0.5 ml vaccine contains:
Slovenian: En odmerek z 0,5 ml cepiva vsebuje:
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Slovenian: KOLIČINA UČINKOVIN(E) VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
English: Re-vaccination scheme:
Slovenian: Shema revakcinacije:
English: Per dose of 0.5 ml: Recombinant Protein Q from Leishmania infantum MON-1 ≥ 36.7 EU
Slovenian: Na 0,5 ml odmerek: rekombinantni protein Q iz Leishmania infantum MON-1 ≥ 36,7 EU.
English: It is essential that measures to reduce exposure to sand-flies are employed in vaccinated animals.
Slovenian: Pri cepljenih živalih je bistvenega pomena upoštevati ukrepe za zmanjšanje izpostavljenosti peščenim muham.
English: For active immunisation of non-infected dogs from 6 months of age to reduce the risk of developing an active infection and/or clinical disease after exposure to Leishmania infantum.
Slovenian: Za aktivno imunizacijo neokuženih psov od 6 meseca starosti za zmanjšanje tveganja razvoja aktivne okužbe in/ali klinične bolezni po izpostavljenosti parazitu Leishmania infantum.
English: WITHDRAWAL PERIOD(S) SPECIAL WARNING(S), IF NECESSARY
Slovenian: POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A)
English: De-worming of infested dogs prior to vaccination is recommended.
Slovenian: Pred cepljenjem se priporoča razglistenje infestiranega psa.
English: 4.2 Indications for use, specifying the target species For active immunisation of non-infected dogs from 6 months of age to reduce the risk of developing an active infection and/or clinical disease after exposure to Leishmania infantum.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Za aktivno imunizacijo neokuženih psov od 6 meseca starosti za zmanjšanje tveganja razvoja aktivne okužbe in/ali klinične bolezni po izpostavljenosti parazitu Leishmania infantum.
English: White lyophilisate.
Slovenian: Bel liofilizat.
English: Do not mix with any other veterinary medicinal product, except solvent supplied for use with the medicinal product.
Slovenian: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen z vehiklom, ki je priložen za uporabo s tem zdravilom.
English: Type I glass vials containing 1 dose of vaccine;
Slovenian: Viale iz stekla tipa I, ki vsebujejo 1 odmerek cepiva.
English: Lyophilisate (white lyophilisate)
Slovenian: Liofilizat (bel liofilizat)
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.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki po EXP.
English: Sodium chloride Arginine hydrochloride Boric acid.
Slovenian: Liofilizat: natrijev klorid argininijev klorid borova kislina
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.
Slovenian: Učinkovitost cepiva je bila dokazana v terenski študiji, kjer so bili seronegativni psi različnih pasem dve leti naravno izpostavljeni parazitu Leishmania infantum na območjih z veliko jakostjo okužbe.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Subcutaneous use.
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
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.
Slovenian: Učinkovitost cepiva je bila dokazana v terenski študiji, kjer so bili psi dve leti naravno izpostavljeni parazitu Leishmania infantum na območjih z veliko jakostjo okužbe.
English: BATCH NUMBER Lot {number} EXPIRY DATE EXP {mm/yyyy} THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Slovenian: ŠTEVILKA SERIJE Lot {številka} DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mm/llll} BESEDILO »SAMO ZA ŽIVALI« Samo za živali.
English: A test for the detection of Leishmania infection is recommended prior to vaccination.
Slovenian: Pred cepljenjem je priporočljivo opraviti test za ugotavljanje okužbe s parazitom Leishmania.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Slovenian: PRILOGA II A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
English: Laboratorios LETI, S.L.unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos
Slovenian: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos
English: Following administration of a double dose, reactions are similar in nature to those observed following the administration of a single dose (see section 4.6).
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju dvojega odmerka so opazili reakcije, podobne po naravi, kot po dajanju enega odmerka (glejte poglavje 4.6).
English: Shelf life of the solvent: 5 years.
Slovenian: Rok uporabnosti v vehikel: 5 leti.
English: Primary vaccination scheme: A single dose of the vaccine (0.5 ml) to be administered to dogs from 6 months of age.
Slovenian: Shema primarne vakcinacije: En odmerek cepiva (0,5 ml) se da psom od starosti 6 mesecev.
English: 4 doses
Slovenian: 4 odmerki
English: A single dose of the vaccine (0.5 ml) to be given annually thereafter.
Slovenian: En odmerek cepiva (0,5 ml) je treba dati enkrat letno.
English: Re-vaccination scheme: A single dose of the vaccine (0.5 ml) to be given annually thereafter.
Slovenian: Shema revakcinacije: En odmerek cepiva (0,5 ml) je treba dati enkrat letno.
English: A single dose of the vaccine (0.5 ml) to be administered to dogs from 6 months of age.
Slovenian: En odmerek cepiva (0,5 ml) se da psom od starosti 6 mesecev.
English: 20 doses
Slovenian: 20 odmerkov
English: Lyohilisate:
Slovenian: Liofilizat:
English: After vaccination, scratching at the injection site has been observed very commonly in dogs.
Slovenian: Po cepljenju so zelo pogosto opazili, da se psi praskajo na mestu injiciranja.
English: Type I glass vials containing 0.8 ml of solvent.
Slovenian: Viale iz stekla tipa I, ki vsebujejo 0,8 ml vehikla.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial of lyophilisate
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Reconstitute one vial of the white lyophilisate using 0.5 ml of solvent.
Slovenian: Rekonstituirajte eno vialo belega liofilizata z 0,5 ml vehikla.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Recombinant Protein Q from L. infantum MON-1
Slovenian: Rekombinantni protein Q iz L. infantum MON-1
English: Overdose (symptoms, emergency procedures, antidotes) if necessary:
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno: Po dajanju dvojega odmerka so opazili reakcije, podobne po naravi kot po dajanju enega odmerka.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Jih ni.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT LETIFEND, lyophilisate and solvent for solution for injection for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI LETIFEND, liofilizat in vehikel za raztopino za injiciranje za pse
English: Laboratorios LETI, S.L.unipersonal C/ Del Sol, 5, Poligono Industrial Norte, Tres Cantos, 28760, Madrid SPAIN
Slovenian: unipersonal C/ Del Sol, 5, Poligono Industrial Norte, Tres Cantos, 28760, Madrid ŠPANIJA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT LETIFEND lyophilisate for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI LETIFEND liofilizat za pse
English: Name and address of the manufacturer responsible for batch release:
Slovenian: Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega za sproščanje serij
English: 6.5 Nature and composition of immediate packaging Lyophilisate vial
Slovenian: 6.5 Vrsta ovojnine in vsebina
English: Lyophilisate and solvent for solution for injection.
Slovenian: Liofilizat in vehikel za raztopino za injiciranje.
English: LETIFEND, lyophilisate and solvent for solution for injection for dogs.
Slovenian: LETIFEND, liofilizat in vehikel za raztopino za injiciranje za pse.
English: LETIFEND, lyophilisate and solvent for solution for injection for dogs
Slovenian: LETIFEND, liofilizat in vehikel za raztopino za injiciranje za pse
English: Plastic box containing 25 vials of 1 dose of lyophilisate and 25 vials of 0.8 ml of solvent.
Slovenian: Plastična škatla, ki vsebuje 25 vial z 1 odmerkom liofilizata in 25 vial z 0,8 ml vehikla.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT LETIFEND solvent for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI LETIFEND vehikel za pse
English: Plastic box containing 4 vials of 1 dose of lyophilisate and 4 vials of 0.8 ml of solvent.
Slovenian: Plastična škatla, ki vsebuje 4 viale z 1 odmerkom liofilizata in 4 viale z 0,8 ml vehikla.
English: Plastic box containing 20 vials of 1 dose of lyophilisate and 20 vials of 0.8 ml of solvent.
Slovenian: Plastična škatla, ki vsebuje 20 vial z 1 odmerkom liofilizata in 20 vial z 0,8 ml vehikla.
English: Plastic box containing 100 vials of 1 dose of lyophilisate and 100 vials of 0.8 ml of solvent.
Slovenian: Plastična škatla, ki vsebuje 100 vial z 1 odmerkom liofilizata in 100 vial z 0,8 ml vehikla.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Slovenian: Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin)
English: Plastic box containing 50 vials of 1 dose of lyophilisate and 50 vials of 0.8 ml of solvent.
Slovenian: Plastična škatla, ki vsebuje 50 vial z 1 odmerkom liofilizata in 50 vial z 0,8 ml vehikla.
English: Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of 0.8 ml of solvent.
Slovenian: Plastična škatla, ki vsebuje 5 vial z 1 odmerkom liofilizata in 5 vial z 0,8 ml vehikla.
English: Plastic box containing 10 vials of 1 dose of lyophilisate and 10 vials of 0.8 ml of solvent.
Slovenian: Plastična škatla, ki vsebuje 10 vial z 1 odmerkom liofilizata in 10 vial z 0,8 ml vehikla.
English: Plastic box containing 1 vial of 1 dose of lyophilisate and 1 vial of 0.8 ml of solvent.
Slovenian: Plastična škatla, ki vsebuje 1 vialo z 1 odmerkom liofilizata in 1 vialo z 0,8 ml vehikla.
English: PACKAGE LEAFLET: LETIFEND, lyophilisate and solvent for solution for injection for dogs
Slovenian: NAVODILO ZA UPORABO LETIFEND, liofilizat in vehikel za raztopino za injiciranje za pse
English: Wash your hands
Slovenian: Umijte si roke.
English: In Period 2, analyses demonstrated stability of improvements achieved during Period 1 for both doses regimen.
Slovenian: V obdobju 2 so analize pokazale stabilnost izboljšanj, doseženih v obdobju 1 za oba režima odmerjanja.
English: Tilt your head back and look up at the ceiling 8.
Slovenian: Glavo nagnite nazaj in poglejte v strop.
English: EXCELVISION 27 rue de la Lombardière ZI la Lombardière 07100 Annonay France
Slovenian: EXCELVISION 27 rue de la Lombardière ZI la Lombardière 07100 Annonay Francija
English: If this happens, wait until your vision clears before you drive or use machines.
Slovenian: Če se to zgodi, počakajte, da se vam vid zbistri, preden vozite ali upravljate stroje.
English: Do not exceed the treatment period prescribed by your doctor.
Slovenian: Ne presezite obdobja zdravljenja, ki ga je predpisal zdravnik.
English: Mean age was 9.2 years (SD: 3.3, age range: 4-17 years).
Slovenian: Povprečna starost je bila 9,2 leti (SD: 3,3, starostni razpon: 4 do 17 let).
English: However, no special dose adjustment is needed in these populations.
Slovenian: Vendar pa odmerka pri teh populacijah ni treba posebej prilagajati.
English: What you need to know before you use Verkazia 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Verkazia 3.
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.
Slovenian: Če znaki in simptomi VKC vztrajajo tudi po koncu sezone, se lahko zdravljenje vzdržuje s priporočenim odmerkom ali pa se zmanjša na eno kapljico dvakrat na dan, ko je dosežen ustrezen nadzor znakov in simptomov.
English: Only use Verkazia in your eye as described under section 3.
Slovenian: Zdravilo Verkazia uporabljajte v očesu le, kot je opisano v poglavju 3.
English: (see section 4.4).
Slovenian: (Glejte poglavje 4.4).
English: If you use drops in both eyes, repeat the steps 6 to 9 for your other eye. 12.
Slovenian: Če kapljice uporabljate za obe očesi, ponovite korake 6-9 še za drugo oko.
English: This helps to stop Verkazia getting into the rest of the body.
Slovenian: To pomaga preprečiti, da bi zdravilo Verkazia prešlo v preostali del telesa.
English: They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Slovenian: Navedeni so po organskih sistemih in razvrščeni po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Clinical relevance of the primary efficacy endpoint was however difficult to address.
Slovenian: Klinični pomen primarnega opazovanega dogodka učinkovitosti je bilo težko oceniti.
English: Children below 4 years
Slovenian: Otroci, stari manj kot 4 let
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.
Slovenian: Če ste prenehali uporabljati zdravilo Verkazia, ne da bi se pogovorili z zdravnikom, vaša alergija ni pod nadzorom in lahko povzroči dolgotrajne težave z vidom.
English: 168 patients [127 children (75.6%) and 41 adolescents (24.4%)] were included in the efficacy analyses.
Slovenian: 168 bolnikov [127 otrok (75,6 %) in 41 mladoletnikov (24,4 %)] je bilo vključeno v analize učinkovitosti.
English: If you forget to use Verkazia, continue with the next dose as planned.
Slovenian: Če ste pozabili uporabiti zdravilo Verkazia, nadaljujte z naslednjim odmerkom, kot je načrtovano.
English: 3 years.
Slovenian: 3 do 6 mesecev.
English: Discard the single-dose container as soon as you have used it, even if there is still some medicine left in it
Slovenian: Enoodmerni vsebnik zavrzite takoj, ko ga uporabite, četudi je v njem še nekaj zdravila.
English: In that context, responder rate's results were considered as more reliable endpoint.
Slovenian: V tem kontekstu je bil rezultat deleža bolnikov, ki se odzivajo, bolj zanesljiv opazovani dogodek.
English: Verkazia is likely to be present in breast milk in very small amounts.
Slovenian: Zdravilo Verkazia je v materinem mleku verjetno prisotno v zelo majhnih količinah.
English: Keep single-dose containers in the pouch in order to protect from light and avoid evaporation.
Slovenian: Enoodmernik vsebnik shranjujte v mošnjičku za zagotovitev zaščite pred svetlobo in preprečitev izhlapevanja.
English: Efficacy and safety of Verkazia have not been studied beyond 12 months.
Slovenian: Učinkovitosti in varnosti zdravila Verkazia niso raziskovali v obdobju, daljšem kot 12 mesecev.
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).
Slovenian: Izboljšanje je bilo klinično pomembno, kot prikazuje velikost učinka v 4-mesečnem obdobju (domena simptomov: 0,67 in domena dnevnih aktivnosti: 0,44).
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).
Slovenian: Pred začetkom uporabe zdravila Verkazia se posvetujte z zdravnikom ali farmacevtom: - če imate okužbo očesa ali sumite, da imate okužbo očesa - če imate katero koli drugo bolezen očesa - če nosite kontaktne leče (uporaba zdravila Verkazia se ne priporoča s kontaktnimi lečami).
English: There were more male [n=132 (78.6%)] than female patients [n=36 (21.4%)].
Slovenian: Bolnikov [n = 132 (78,6 %)] je bilo več kot bolnic [n = 36 (21,4 %)].
English: Therefore, regular examination of the eye(s) is recommended, e.g. every 3 to 6 months, when Verkazia is used for more than 12 months.
Slovenian: Zato so priporočljivi redni pregledi očes(a), npr. vsake 3 do 6 mesecev, če se zdravilo Verkazia uporablja več kot 12 mesecev.
English: Verkazia should not be used if you are pregnant.
Slovenian: Zdravila Verkazia ne smete uporabljati, če ste noseči.
English: If overdose with Verkazia occurs, treatment should be symptomatic and supportive.
Slovenian: V primeru prevelikega odmerjanja zdravila Verkazia naj bo zdravljenje simptomatsko in podporno.
English: Pull down your lower eyelid (picture 2)
Slovenian: Spodnjo veko povlecite navzdol (slika 2).
English: All available evidence suggests that ciclosporinacts specifically and reversibly on lymphocytes and does not depress haematopoiesis or have any effect on the function of phagocytic cells.
Slovenian: Vsi razpoložljivi dokazi kažejo, da deluje ciklosporin specifično in reverzibilno na limfocite in ne zavira hematopoeze in nima vpliva na delovanje fagocitnih celic.
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.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Verkazia, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Other medicines and Verkazia
Slovenian: Druga zdravila in zdravilo Verkazia
English: If you are using other eye drops, use Verkazia at least 15 minutes after using the other eye drops.
Slovenian: Če uporabljate druge kapljice za oko, zdravilo Verkazia uporabite vsaj 15 minut po uporabi drugih kapljic za oko.
English: Patient quality of life (Quick questionnaire) improved significantly better in the high dose group compared to vehicle.
Slovenian: Kakovost življenja bolnika (vprašalnik Quick) se je značilno izboljšala v skupini z velikim odmerkom v primerjavi s skupino z vehiklom.
English: All four symptoms (photophobia, tearing, itching and mucous discharge) improved over time and the difference from baseline at Month 4 for each symptom largely exceeded 10 mm.
Slovenian: Vsi štirje simptomi (fotofobija, solzenje, srbenje in sluzast izloček) so se sčasoma izboljšali in razlika od izhodišča v 4. mesecu za vsak simptom je močno presegla 10 mm.
English: A responder was defined as a patient 1) with a mean CFS score over the 4 months of treatment ≤ 50% of baseline, 2) who did not withdraw from the study for a reason possibly due to treatment, 3) with no experience of corneal ulceration and 4) no use of rescue medicinal product in the last 4 months of treatment.
Slovenian: Odzivna oseba je bila opredeljena kot bolnik 1) s povprečnim rezultatom CFS v zadnjih 4 mesecih zdravljenja ≤ 50 % od izhodišča, 2) ki ni izstopil iz študije zaradi razloga, ki bi lahko bil posledica zdravljenja, 3) brez izkušnje razjede na roženici in 4) brez uporabe rešilnega zdravila vsaj zadnje 4 mesece zdravljenja.
English: Rescue medicinal product (topical steroids) was used more often in the vehicle than in the high dose regimen: 32.1% in the high dose group and 31.5% in the low dose group received at least one course of rescue medicinal product while they were 53.4% in the vehicle group.
Slovenian: Rešilno zdravilo (topikalne steroide) so pogosteje uporabili v skupini z vehiklom kot pri režimu z velikim odmerkom: 32,1 % v skupini z velikim odmerkom in 31,5 % v skupini z majhnim odmerkom je prejelo vsaj en cikel rešilnega zdravila, medtem ko ga je v skupini z vehiklom prejelo 53,4 %.
English: The excess rate with respect to vehicle was 27.8% for the high dose regimen and 22.4% for the low dose one.
Slovenian: Stopnja najvišje izpostavljenosti glede na vehikel je bila 27,8 % pri režimu z velikim odmerkom in 22,4 % pri režimu z majhnim odmerkom.
English: If you are using Verkazia for more than 12 months, you should visit your doctor regularly, e.g. every 3 to 6 months.
Slovenian: Če uporabljate zdravilo Verkazia več kot 12 mesecev, morate redno obiskovati zdravnika, npr. vsakih
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.
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali iz kliničnih preskušanj z zdravilom Verkazia, so bili očesna bolečina (11 %) in očesni pruritus (9 %), ki sta bila običajno prehodna in sta se pojavila med vkapanjem.
English: What Verkazia is and what it is used for
Slovenian: Kaj je zdravilo Verkazia in za kaj ga uporabljamo
English: Adults The effect of Verkazia has not been studied in patients above 18 years of age.
Slovenian: Učinka zdravila Verkazia niso raziskovali pri bolnikih, starejših od 18 let.
English: Common side effects which are not related to the eye: Upper respiratory tract infection, cough, headache.
Slovenian: Pogosti neželeni učinki, ki niso povezani z očesom: okužbe zgornjih dihal, kašelj, glavobol.
English: No impairment of fertility has been reported in animals receiving intravenous ciclosporin (see section 5.3).
Slovenian: Pri živalih, ki so jim intravensko dajali ciklosporin, niso poročali o vplivu na plodnost (glejte poglavje 5.3).
English: Patients should be advised not to instill more than one drop for each instillation in the affected eye(s).
Slovenian: Bolniku je treba svetovati, naj si v prizadeto oko (očesi) ne nakapa več kot ene kapljice pri posameznem vkapanju.
English: Both differences were statistically significant with p=0.007 for the high dose and p=0.010 for the low dose group.
Slovenian: Obe razliki sta bili statistično značilni s p = 0,007 za skupino z velikim odmerkom in p = 0,010 za skupino z majhnim odmerkom.
English: The recommended dose is one drop of Verkazia 4 times a day (morning, noon, afternoon and evening) to be applied to each affected eye during the VKC season.
Slovenian: Priporočeni odmerek je ena kapljica zdravila Verkazia štirikrat na dan (zjutraj, opoldan, popoldan in zvečer) v vsako prizadeto oko v obdobju sezone VKC.
English: Verkazia has not been studied in patients with an active orofacial herpes simplex infection, a history of ocular herpes, varicella-zoster, or vaccinia virus infection and should therefore be used with caution in such patients.
Slovenian: Zdravila Verkazia niso preučili pri bolnikih z aktivno okužbo z orofacialnim herpesom simpleksom, očesnim herpesom v anamnezi, virusom varicella ali okužbo z virusom vakcinija, zato ga je treba pri takih bolnikih uporabljati previdno.
English: Therefore, the use of Verkazia with contact lenses is not recommended.
Slovenian: Zato se uporaba zdravila Verkazia s kontaktnimi lečami ne priporoča.