FrancophonIA/ELRC3.0 huggingface dataset:
English: In the reported cases, these reactions were generally reversible on discontinuation of treatment (see section 4.8).
Slovenian: V opisanih primerih so bile te reakcije po prenehanju zdravljenja praviloma reverzibilne (glejte poglavje 4.8).
English: These events are generally reversible and usually seen in patients with renal impairment or with other predisposing factors (see section 4.4).
Slovenian: Ti učinki so na splošno reverzibilni in se po navadi pojavijo pri bolnikih z okvaro ledvic ali drugimi predispozicijskimi faktorji (glejte poglavje 4.4).
English: The CHMP recommended a cut-off at 10 ml/min in this case (resulting in an estimated exposure of 39-63 at <10 ml/min and 43-77 at CLcr 10-30 ml/min).
Slovenian: CHMP je v tem primeru priporočil mejno vrednost pri 10 ml/min (tako da je ocenjena izpostavljenost 39-63 pri CLcr <10 ml/min in 43-77 pri CLcr 10-30 ml/min).
English: The prevalence of aciclovir-resistant HSV has remained low and stable despite increasing clinical use of antiviral agents directed at herpes viruses for nearly three decades.
Slovenian: Pogostnost proti aciklovirju odpornih virusov HSV je ostala nizka in stabilna kljub naraščajoči klinični rabi protivirusnih sredstev, usmerjenih proti herpesvirusom v zadnjih skoraj tridesetih letih.
English: Valtrex Tablets 500 mg are supplied in cartons containing 10, 30, 42, 90 or 112 film-coated tablets.
Slovenian: Tablete Valtrex 500 mg so na voljo v škatlah, ki vsebujejo 10, 30, 42, 90 ali 112 filmsko obloženih tableta.
English: The sample size of the clinical trial database is based on pooled data from valaciclovir pivotal studies for 4 different indications.
Slovenian: Velikost vzorca v zbirki podatkov kliničnega preskušanja temelji na združenih podatkih ključnih študij valaciklovirja za 4 različne indikacije.
English: Subcutaneous administration of aciclovir in internationally accepted tests did not produce teratogenic effects in rats or rabbits.
Slovenian: Subkutana uporaba aciklovirja v mednarodno sprejetih testih ni povzročila teratogenih učinkov pri podganah ali kuncih.
English: The CHMP agreed the removal of several more specific indication statements (i.e., herpes labialis, ocular HSV infections, reduction of transmission).
Slovenian: CHMP se je strinjal z odstranitvijo več specifičnih izjav glede indikacij (tj. labialni herpes, očesne okužbe s HSV, zmanjšanje prenosa).
English: However, at therapeutic doses of valaciclovir, no effects on the breastfed newborns/infants are anticipated since the dose ingested by the child is less than 2% of the therapeutic dose of intravenous aciclovir for treatment of neonatal herpes (see Section 5.2).
Slovenian: Vendar pri terapevtskih odmerkih valaciklovirja ni pričakovati učinkov na dojene novorojenčke/dojenčke, ker je odmerek, ki ga zaužije otrok, manj kot 2 % terapevtskega odmerka intravenskega aciklovirja za zdravljenje neonatalnega herpesa (glejte poglavje 5.2).
English: 2605 Broendby,
Slovenian: 2605 Broendby, Danska
English: Table 1: DOSAGE ADJUSTMENT FOR RENAL IMPAIRMENT Therapeutic Indication
Slovenian: Preglednica 1: PRILAGODITEV ODMERJANJA PRI OKVARI LEDVIC Terapevtska indikacija
English: This dose should be reduced according to creatinine clearance (see Renal impairment below).
Slovenian: Ta odmerek je treba zmanjšati glede na očistek kreatinina (glejte Okvara ledvic, spodaj).
English: The IDSA (Infectious disease society of America) recommends valaciclovir 1000 mg TID [Dworkin, 2007] and the European Conference on Infections in Leukemia recommends the same valaciclovir dosage for at least 7 days [Styczynski, 2009].
Slovenian: Organizacija IDSA (Ameriško združenje za infekcijske bolezniInfectious disease society of America) priporoča odmerek valaciklovirja 1000 mg 3-krat dnevno [Dworkin, 2007], Evropska konferenca za infekcije pri levkemiji (European Conference on Infections in Leukemia) pa priporoča enak odmerek valaciklovirja vsaj 7 dni [Styczynski, 2009].
English: There are no data on treatment started more than 72 hours after onset of the zoster rash.
Slovenian: O zdravljenju, ki se začne več kot 72 ur po pojavu zostrovega izpuščaja, ni podatkov.
English: The success of chemotherapy or transplantation is often compromise by infection during the period of immunosuppression after treatment or surgery reactivation of latent viruses is particularly common (Bustamante, 1991: Houglund, 2001).
Slovenian: Uspeh kemoterapije ali presaditve pogosto ogrozi okužba v obdobju imunske supresije po zdravljenju ali kirurškem posegu; posebej pogosta je reaktivacija latentnih virusov (Bustamante, 1991: Houglund,
English: Values for Cmax and AUC denote mean ± standard deviation.
Slovenian: Vrednosti Cmax in AUC pomenijo povprečje ± standardni odklon.
English: The CHMP endorsed the wording and considered acceptable the posology 1000 mg three times daily.
Slovenian: CHMP je potrdil besedilo in za sprejemljivo štel odmerjanje 1000 mg trikrat dnevno.
English: Netherlands GlaxoSmithKline BV Huis ter Heideweg 62
Slovenian: Nizozemska GlaxoSmithKline BV Huis ter Heideweg 62
English: Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-Roi cedex, France
Slovenian: Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-Roi cedex, Francija
English: The CHMP noted that, the studies supporting the safe and efficacy use of valaciclovir were performed in HIV-patients only, and for the most in patients without severe CD4 depletion.
Slovenian: CHMP je ugotovil, da so bile študije, ki podpirajo varno in učinkovito uporabo valaciklovirja, opravljene le pri bolnikih s HIV in večinoma pri bolnikih brez hudega zmanjšanja števila CD4.
English: HSV Treatment
Slovenian: Zdravljenje HSV
English: Additionally, the model results chosen for predictions of Cmax and AUC were conservative by their provision of higher estimates for subjects with severe renal impairment.
Slovenian: Poleg tega so bili rezultati modela za napovedi vrednosti Cmax in AUC konzervativni z vidika podajanja visokih ocen za osebe s hudo okvarjenim delovanjem ledvic.
English: Studies 123-007 and HS230018 were conducted to evaluate the safety and efficacy of valaciclovir in the suppression of recurrent ano-genital HSV episodes in HIV-infected subjects (Conant, 2002).
Slovenian: Študiji 123-007 in HS230018 sta bili opravljeni za presojo varnosti in učinkovitosti valaciklovirja za supresijo ponovitev anogenitalnih epizod HSV pri preiskovancih, okuženih s HIV (Conant, 2002).
English: The conclusion summarises that the prevalence of aciclovir resistant HSV has not changed significantly during the last three decades.
Slovenian: Zaključek povzema, da se pogostnost proti aciklovirju odpornih virusov HSV v zadnjih tridesetih letih ni bistveno spremenila.
English: The MAH was requested to consider adverse events irrespective of statistical significance
Slovenian: Imetnik dovoljenja za promet z zdravilom je bil naprošen, da obravnava neželene pojave ne glede na statistični pomen.
English: The most common adverse reactions (ARs) reported in at least one indication by patients treated with Valtrex in clinical trials were headache and nausea.
Slovenian: Najpogostejša neželena učinka (NU), ki so ju pri vsaj eni indikaciji navajali bolniki, zdravljeni z zdravilom Valtrex v kliničnih raziskavah, sta glavobol in navzea.
English: The criteria varied among studies, but excluded subjects with either serum creatinine greater than the upper limit of normal (Scr > ULN), Scr > 1.5 mg/dL (~133 uM), or with creatinine clearance less than 35 mL/min.
Slovenian: Merila so se med študijami razlikovala, vendar so izključila preiskovance, če so imeli raven kreatinina v serumu večjo, kot je zgornja normalna meja (Scr > ULN), Scr >1,5 mg/dL (~133 uM), ali če je bil očistek kreatinina manjši od 35 mL/min.
English: Adequate fluid intake should be ensured during treatment (see section 4.4).
Slovenian: Med zdravljenjem je treba zagotoviti ustrezen vnos tekočine (glejte poglavje 4.4).
English: The efficacy of valaciclovir for the treatment of other HSV skin infections has been documented.
Slovenian: Dokumentirana je učinkovitost valaciklovirja za zdravljenje drugih okužb kože s HSV.
English: Film-coated tablets 10 tablets
Slovenian: filmsko obložene tablete 10 tablet
English: The CHMP considering the above trials results endorsed the use of valaciclovir for the prophylaxis of CMV infection.
Slovenian: CHMP je ob upoštevanju rezultatov zgoraj omenjenih preskušanj potrdil uporabo valaciklovirja za profilakso okužbe s CMV.
English: Valtrex can cause side effects that affect your ability to drive.
Slovenian: Zdravilo Valtrex lahko povzroči neželene učinke, ki vplivajo na sposobnost vožnje.
English: GlaxoSmithKline S.p.A. - Via A. Fleming, 237135 Verona,
Slovenian: - Via A. Fleming, 237135 Verona,
English: Valaciclovir is eliminated in the urine principally as aciclovir (greater than 80% of the recovered dose) and the aciclovir metabolite CMMG (about 14% of the recovered dose).
Slovenian: Valaciklovir se izloči v urinu predvsem kot aciklovir (več kot 80 % odmerka, ki se pojavi v urinu) in kot presnovek aciklovirja CMMG (približno 14 % odmerka, ki se pojavi v urinu).
English: • altered brain function (encephalopathy)
Slovenian: • spremenjeno delovanje možganov (encefalopatija),
English: The reported adverse events (AEs) were listed events and no new and significant safety signals could be identified.
Slovenian: Zabeleženi neželeni učinki so bili že navedeni učinki, novih pomembnih varnostnih signalov pa ni bilo odkritih.
English: Aciclovir is converted to a small extent to the metabolites 9(carboxymethoxy)methylguanine (CMMG) by alcohol and aldehyde dehydrogenase and to 8-hydroxy-aciclovir (8-OH-ACV) by aldehyde oxidase.
Slovenian: Aciklovir se z alkoholno in aldehidno dehidrogenazo v majhni meri pretvori v presnovek 9(karboksimetoksi)metilgvanin (CMMG) in z aldehidno oksidazo v 8-hidroksi-aciklovir (8OH-ACV).
English: The CHMP considered that herpes labialis should not be a specific treatment indication, however the dosage for herpes labialis could be mentioned under this section.
Slovenian: CHMP je menil, da labialni herpes ne sme biti specifična indikacija za zdravljenje, vendar je odmerjanje za labialni herpes mogoče omeniti v tem poglavju.
English: Reduced sensitivity to aciclovir has been described as a result of subtle alterations in either the virus thymidine kinase or DNA polymerase.
Slovenian: Manjša občutljivost za aciklovir je bila opisana kot posledica majhnih sprememb v virusni timidin-kinazi ali DNA-polimerazi.
English: Rashes including photosensitivity, pruritus.
Slovenian: izpuščaji, vključno s fotosenzibilnostjo, srbenje
English: Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV-infection (see section 5.1).
Slovenian: Klinične študije niso bile izvedene pri bolnikih, okuženih s HSV, ki so bili imunsko oslabeli zaradi drugih vzrokov, ne zaradi okužbe s HIV (glejte poglavje 5.1).
English: The phosphorylation process is completed (conversion from mono- to triphosphate) by cellular kinases.
Slovenian: Fosforilacijo dokončajo (pretvorba iz monofosfata v trifosfat) celične kinaze.
English: Your doctor may adjust the dose of Valtrex if:
Slovenian: Zdravnik vam bo morda prilagodil odmerek zdravila Valtrex:
English: Clinical response should be closely monitored, particularly in immunocompromised patients.
Slovenian: Klinični odziv je treba natančno spremljati, zlasti pri imunsko oslabelih bolnikih.
English: Valtrex (and associated names) has been included in the list of products for Summary of Product Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Slovenian: Zdravilo Valtrex (in z njim povezana imena) je bilo dano na seznam za usklajevanje povzetkov glavnih značilnosti zdravila, ki ga je pripravila usklajevalna skupina za postopek medsebojnega priznavanja in decentralizirane postopke za zdravila za uporabo v humani medicini (CMD(h)) v skladu s členom 30(2) Direktive 2001/83/ES, kakor je bila spremenjena.
English: During suppressive treatment with antiviral agents, the frequency of viral shedding is significantly reduced.
Slovenian: Med supresivnim zdravljenjem s protivirusnimi zdravili se pogostnost izločanja virusov bistveno zmanjša.
English: At high parenteral doses of aciclovir testicular atrophy and aspermatogenesis have been observed in rats and dogs.
Slovenian: Pri velikih parenteralnih odmerkih aciklovirja so pri podganah in psih opažali atrofijo testisov in aspermatogenezo.
English: Both elderly patients and patients with renal impairment are at increased risk of developing neurological side-effects and should be closely monitored for evidence of these effects.
Slovenian: Tako starejši bolniki kot bolniki z okvaro ledvic imajo tudi večje tveganje nevroloških neželenih učinkov in jih je treba natančno nadzirati glede znakov teh učinkov.
English: The 5855 subjects are comprised as follows: herpes zoster treatment (n=967); genital herpes treatment (n=1160 high dose and n=1203 low dose); genital herpes suppression (n=1009 high dose and n=269 low dose); cold-sore treatment (n=609 high dose and n=638 low dose).
Slovenian: Teh 5855 preiskovancev je vključevalo: zdravljenje pasovca (n=967); zdravljenje genitalnega herpesa (n=1160 z velikim odmerkom in n=1203 z majhnim odmerkom); supresija genitalnega herpesa (n=1009 z velikim odmerkom in n=269 z majhnim odmerkom); zdravljenje herpesa na ustnici (n=609 z velikim odmerkom in n=638 z majhnim odmerkom).
English: A limited amount of data on the use of valaciclovir and a moderate amount of data on the use of aciclovir in pregnancy is available from pregnancy registries (which have documented the pregnancy outcomes in women exposed to valaciclovir or to oral or intravenous aciclovir (the active metabolite of valaciclovir); 111 and 1246 outcomes (29 and 756 exposed during the first trimester of pregnancy, respectively) and postmarketing experience indicate no malformative or foeto/neonatal toxicity.
Slovenian: Maloštevilni podatki o uporabi valaciklovirja in srednje številni podatki o uporabi aciklovirja med nosečnostjo so na voljo iz registrov nosečnosti (ki imajo zajete izide nosečnosti žensk, izpostavljenih valaciklovirju ali peroralnemu ali intravenskemu aciklovirju (aktivnemu presnovku valaciklovirja); 111 oz. 1246 izidov (29 oz. 756 izpostavljenih v prvem trimesečju nosečnosti) in postmarketinške izkušnje ne kažejo na pojav malformacij ali toksičnih učinkov za plod ali novorojenčka.
English: Among subjects participating in a viral shedding sub-study, valaciclovir significantly reduced shedding by 73 % compared to placebo (see section 4.4 for additional information on transmission reduction).
Slovenian: Med osebami, ki so sodelovale v podštudiji izločanja virusov, je valaciklovir značilno zmanjšal izločanje za 73 % v primerjavi s placebom (glejte poglavje 4.4 za dodatne informacije o zmanjšanju prenosa).
English: The dose is 500 mg of Valtrex twice daily.
Slovenian: Odmerek je 500 mg zdravila Valtrex dvakrat na dan.
English: Patients should be closely monitored for changes in renal function, and doses adjusted accordingly (see section 4.2).
Slovenian: Bolnike je treba natančno nadzirati glede sprememb delovanja ledvic in odmerek ustrezno prilagoditi (glejte poglavje 4.2).
English: Haemodialysis significantly enhances the removal of aciclovir from the blood and may, therefore, be considered a management option in the event of symptomatic overdose.
Slovenian: Hemodializa bistveno pospeši odstranjevanje aciklovirja iz krvi in je zato lahko ena od možnosti zdravljenja, če je preveliko odmerjanje simptomatsko.
English: Two randomized, double-blind, placebo-controlled safety and efficacy studies were described to support the use of valaciclovir in the treatment of cold sores (herpes labialis).
Slovenian: Opisani sta bili dve randomizirani, dvojno zaslepljeni, s placebom kontrolirani študiji varnosti in učinkovitosti za podporo uporabi valaciklovirja za zdravljenje herpesa na ustnici (labialnega herpesa).
English: For HSV suppression in immunocompetent subjects with a history of ≥10 recurrences/year, better results may be obtained with 250 mg twice daily.
Slovenian: bZa supresijo HSV pri imunokompetentnih osebah z anamnezo ≥ 10 ponovitev na leto je mogoče boljše rezultate doseči z 250 mg dvakrat na dan.
English: Valtrex is not usually recommended for use during pregnancy.
Slovenian: Uporaba zdravila Valtrex med nosečnostjo po navadi ni priporočljiva.
English: Indication 3 Cytomegalovirus (CMV) infections The prophylaxis of cytomegalovirus was not approved in some Member States.
Slovenian: Indikacija 3 - okužbe s citomegalovirusom (CMV) Profilaksa citomegalovirusa ni bila odobrena v nekaterih državah članicah.
English: Tell your doctor or pharmacist if you are taking any other medicines that affect the kidneys.
Slovenian: Svojemu zdravniku ali farmacevtu povejte, če jemljete kakšna druga zdravila, ki vplivajo na ledvice.
English: These nervous system side effects usually occur in people with kidney problems, the elderly or in organ transplant patients taking high doses of 8 grams or more of Valtrex a day.
Slovenian: Ti neželeni učinki na živčevju se po navadi pojavijo bolnikom, ki imajo težave z ledvicami, starejšim bolnikom ali bolnikom po presaditvi organa, ki jemljejo velike odmerke osmih gramov zdravila Valtrex ali več na dan.
English: The MAH, to show the safety and efficacy of valaciclovir for the prophylaxis of CMV disease in transplant recipients, presented four randomized, controlled clinical trials: Lowance, 1999; Egan, 2002; Ljungman, 2002; Winston, 2003.
Slovenian: Imetnik dovoljenja za promet z zdravilom je v dokaz varnosti in učinkovitosti valaciklovirja za profilakso bolezni CMV po presaditvah predložil štiri randomizirana, kontrolirana klinična preskušanja: Lowance, 1999; Egan, 2002; Ljungman, 2002; Winston, 2003.
English: The bioavailability of aciclovir from valaciclovir is about 3.3 to 5.5-fold greater than that historically observed for oral aciclovir.
Slovenian: Biološka uporabnost aciklovirja iz valaciklovirja je približno 3,3- do 5,5-krat večja od tiste, ki je bila v preteklosti ugotovljena s peroralnim aciklovirjem.
English: • You should take Valtrex for around 90 days after your surgery, until your doctor tells you to stop.
Slovenian: • Zdravilo Valtrex morate jemati približno 90 dni po operaciji, dokler vam zdravnik ne naroči, da z jemanjem prenehajte.
English: Section 4.2 Posology and method of administration There were differences in Section 4.2 between Member States.
Slovenian: V poglavju 4.2 so razlike med državami članicami.
English: The clinical trial safety database is based on 5855 subjects exposed to valaciclovir in clinical trials covering multiple indications (treatment of herpes zoster, treatment/suppression of genital herpes & treatment of cold sores).
Slovenian: Podatkovna baza o varnosti kliničnih raziskav temelji na podatkih o 5855 posameznikih, ki so bili v kliničnih preskušanjih izpostavljeni valaciklovirju za različne indikacije (zdravljenje herpesa zostra, zdravljenje/supresija genitalnega herpesa in zdravljenje labialnega herpesa ["ocvirkov"]).
English: The safety and efficacy of valaciclovir for the treatment of HSV in immunocompromised patients was evaluated in Study 123-008 but there are limited data available to demonstrate the efficacy and the optimal dosage of VACV for treating HSV in immunocompromised patients.
Slovenian: Varnost in učinkovitost valaciklovirja za zdravljenje HSV pri imunsko kompromitiranih bolnikih sta bili ovrednoteni v študiji 123-008, vendar je za dokaz učinkovitosti in optimalnega odmerjanja VACV za zdravljenje HSV pri imunsko kompromitiranih bolnikih na voljo malo podatkov.
English: The MAH provided several key documents describing Study HS230027 and Study HS230028, and data analysis supporting short-course, high-dose therapy in immunocompetent adolescents and adults.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil več ključnih dokumentov, ki opisujejo študiji HS230027 in HS230028, ter analizo podatkov, ki podpira kratkotrajno visookodmerno zdravljenje imunsko kompetentnih mladostnikov in odraslih bolnikov.
English: For other indications where the normal dose is in the lower range, dose reductions in renal impairment are not made until CLcrea is below 30 ml/min, since at these exposure levels, the expected increase in exposure at CLcrea 30-49 ml/min is not considered a great safety risk.
Slovenian: Za druge indikacije, kjer je normalni odmerek v nižjem območju, se odmerek zmanjšuje šele, ko je CLcrea pod 30 ml/min, saj se pri teh ravneh izpostavitve pričakovano povečanje izpostavljenosti pri ravni CLcrea 30-49 ml/min ne šteje za veliko varnostno tveganje.
English: Other rare side effects: • kidney problems where you pass little or no urine.
Slovenian: Drugi redki neželeni učinki: - težave z ledvicami, tako da izločate zelo malo urina ali sploh nič.
English: The MAH to support this proposed indication presented two randomised, placebo controlled studies (HS230027 and HS0028) [Spruance, 2003] evaluating the efficacy and safety of one dosing regimen of VACV, 2000 mg twice daily for 1 day, compared to placebo.
Slovenian: Imetnik dovoljenja za promet z zdravilom je v podporo tej predlagani indikaciji predložil dve randomizirani, s placebom nadzorovani študiji (HS230027 in HS0028) [Spruance, 2003], v katerih so presojali učinkovitost in varnost enoodmernega režima VACV 2000 mg dvakrat dnevno 1 dan v primerjavi s placebom.
English: • Some people with frequent recurrences may benefit from taking one 250 mg tablet twice a day.
Slovenian: • Nekaterim osebam s pogostimi ponovitvami lahko koristi jemanje ene 250 mg tablete dvakrat na dan.
English: The MAH believed that the use of valaciclovir in pregnancy should not be contraindicated.
Slovenian: Imetnik dovoljenja za promet z zdravilom meni, da se uporaba valaciklovirja v nosečnosti ne bi smela kontraindicirati.
English: For the treatment of HSV in immunocompromised adults, the dosage is 1000 mg twice daily for at least 5 days, following assessment of the severity of the clinical condition and immunological status of the patient.
Slovenian: Za zdravljenje HSV pri imunsko oslabelih odraslih je odmerek 1.000 mg dvakrat na dan vsaj 5 dni, po oceni izrazitosti kliničnega stanja in bolnikovega imunološkega stanja.
English: It is also used to help prevent these infections from returning.
Slovenian: 12 let); uporablja se tudi za preprečevanje ponovitev teh okužb;
English: The dose is reduced by 50% already at CLcrea 30-49 ml/min, while for varicella-zoster infections, which have a normal dose in about the same range as that proposed for herpes labialis, the dose is reduced by 33% at CLcrea 30-49 ml/min.
Slovenian: Odmerek se zmanjša že za 50 % pri CLcrea 30-49 ml/min, pri okužbah z virusom varicella zoster, za katere je običajni odmerek v približno enakem območju, kot je predlagano za labialni herpes, pa se odmerek pri CLcrea 30-49 ml/min zmanjša za 33 %.
English: • you have a weak immune system
Slovenian: • če imate oslabljen imunski sistem.
English: Values for Tmax denote median and range.
Slovenian: Vrednosti tmax pomenijo mediano in razpon.
English: Use for zoster treatment
Slovenian: Uporaba za zdravljenje zostra
English: GlaxoSmithKline (Ireland) Ltd., Stonemasons Way, Rathfarnham, Dublin 16, Ireland
Slovenian: GlaxoSmithKline (Irska) Ltd., Stonemasons Way, Rathfarnham, Dublin 16, Irska
English: The results of the Weller study showed that valaciclovir is comparable to aciclovir in the prevention of herpes keratitis during long term follow-up after surgery.
Slovenian: Rezultati Wellerjeve študije so pokazali, da je valaciklovir primerljiv aciklovirju pri preprečevanju herpetičnega keratitisa med dolgoročnim spremljanjem po kirurškem posegu.
English: The following frequency categories are used for classification of adverse effects: Very common ≥ 1/10,
Slovenian: Za razvrstitev neželenih učinkov so uporabljene naslednje kategorije pogostnosti: Zelo pogosti
English: The CHMP concluded that there was no data to suggest that patients with renal impairment need higher exposure for treatment effect.
Slovenian: CHMP je menil, da ni podatkov, ki bi kazali, da bolniki z okvarjenim delovanjem ledvic potrebujejo večjo izpostavitev za doseganje terapevtskega učinka.