FrancophonIA/ELRC3.0 huggingface dataset:
English: Some Member States have revised the dose recommendations in patients with renal impairment in treatment of herpes zoster based on safety signals.
Slovenian: Nekatere države članice so na osnovi varnostnih signalov popravile priporočila za odmerjanje za zdravljenje herpesa zostra pri bolnikih z okvaro ledvic.
English: Valtrex Tablets 1000 mg are supplied in cartons containing 21 film-coated tablets.
Slovenian: Tablete Valtrex 1000 mg so na voljo v škatlah, ki vsebujejo 21 filmsko obloženih tablet.
English: 6.6 Special precautions for disposal No special requirements
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje
English: Immunocompetent Adults and Adolescents (≥12 years) The dose is 500 mg of Valtrex to be taken twice daily (1000 mg total daily dose).
Slovenian: Imunokompetentni odrasli in mladostniki (≥ 12 let) Odmerek zdravila Valtrex je 500 mg dvakrat na dan (celotni dnevni odmerek 1.000 mg).
English: The CHMP concluded that the MAH has provided a comprehensive account for the frequency of resistance in immunocompetent and immunocompromised individuals across the clinical trials.
Slovenian: CHMP je menil, da je imetnik dovoljenja za promet z zdravilom predložil celovit pregled pogostnosti odpornosti pri imunsko kompetentnih in imunsko kompromitiranih osebah v kliničnih preskušanjih.
English: Nervous system side effects might include feeling confused or agitated, or feeling unusually sleepy or drowsy.
Slovenian: Med neželenimi učinki, ki prizadenejo živčevje, so lahko občutek zmedenosti ali vznemirjenost oz. nenavadna zaspanost ali dremavost.
English: 82104 Bratislava
Slovenian: Galvaniho 7/A, 82104 Bratislava Slovaška
English: Indication 1 Varicella zoster virus (VZV) infections - herpes zoster The following indication was agreed: “Valtrex is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults.
Slovenian: Indikacija 1 - okužbe z virusom varicella zoster (VZV) - herpes zoster Potrjena je bila naslednja indikacija: „Zdravilo Valtrex je indicirano za zdravljenje herpesa zostra (pasovca) in očesnega zostra pri imunsko kompetentnih odraslih bolnikih.
English: Therapy should be initiated at the earliest symptom of a cold sore (e.g. tingling, itching or burning).
Slovenian: Zdravljenje je treba začeti ob prvem simptomu ocvirkov (npr. mravljinčenju, srbenju ali pekočem občutku).
English: Aciclovir inhibits herpes virus DNA polymerase.
Slovenian: Aciklovir zavira polimerazo DNA herpesvirusov.
English: • The usual dose is one 500 mg tablet once a day.
Slovenian: • Običajen odmerek je ena 500 mg tableta enkrat na dan.
English: Moreover, immunocompromised patients with ophthalmic zoster or those with a high risk for disease dissemination and visceral organ involvement should be treated with intravenous antiviral therapy.
Slovenian: Poleg tega je treba imunsko oslabele bolnike z oftalmičnim zostrom in bolnike z zelo velikim tveganjem razsoja bolezni in zajetja visceralnih organov zdraviti z intravenskimi protivirusnimi zdravili.
English: CSF penetration, determined by CSF/plasma AUC ratio, is independent of renal function and was about 25% for aciclovir and the metabolite 8-OH-ACV, and about 2.5% for the metabolite CMMG.
Slovenian: Prodiranje v cerebrospinalno tekočino, določeno kot razmerje AUC v cerebrospinalni tekočini/plazmi, ni odvisno od delovanja ledvic; za aciklovir in njegov presnovek 8-OH-ACV je približno 25 % in za presnovek CMMG približno 2,5 %.
English: Polysorbate 80 (500 and 1000 mg tablets only) Blue printing ink FT203 containing brilliant blue (E133) (250 mg and 1000 mg tablets only) Carnauba wax
Slovenian: Polisorbat 80 (samo 500 mg in 1000 mg tablete) Modro črnilo FT203, ki vsebuje modro FCF (E133) (samo 250 mg in 1000 mg tablete) Karnauba vosek
English: Slovak Republic GlaxoSmithKline Slovakia s.r.o.,
Slovenian: GlaxoSmithKline Slovakia s.r.o.,
English: These include: aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine and probenecid.
Slovenian: Med takšna spadajo: aminoglikozidi, organske spojine platine, kontrastna sredstva z jodom, metotreksat, pentamidin, foskarnet, ciklosporin, takrolimus, cimetidin in probenecid.
English: Clinical Trial Data Nervous system disorders Very common:
Slovenian: Podatki kliničnih raziskav Bolezni živčevja Zelo pogosti:
English: Aciclovir PK Parameter
Slovenian: Farmakokinetični parameter aciklovirja
English: This applies to concomitant administration with aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, and tacrolimus.
Slovenian: To velja za sočasno uporabo z aminoglikozidi, organskimi spojinami platine, kontrastnimi sredstvi z jodom, metotreksatom, pentamidinom, foskarnetom, ciklosporinom in takrolimusom.
English: Valaciclovir is almost completely metabolised to aciclovir.
Slovenian: Valaciklovir se skoraj popolnoma presnovi v aciklovir.
English: • if you are allergic (hypersensitive) to valaciclovir or aciclovir or any of the other ingredients
Slovenian: • če ste alergični (preobčutljivi) na valaciklovir, aciklovir ali katerokoli sestavino zdravila (ki so naštete v poglavju 6).
English: Don't take Valtrex
Slovenian: Ne vzemite zdravila Valtrex
English: Unchanged valaciclovir was not detected in maternal serum, breast milk, or infant urine.
Slovenian: V materinem serumu, mleku ali dojenčkovem urinu niso odkrili nespremenjenega valaciklovirja.
English: Rare (affects up to 1 in 1,000 people)
Slovenian: Redki (pojavijo se pri največ 1 od 1.000 oseb):
English: Valtrex is not usually harmful, unless you take too much over several days.
Slovenian: Če ste vzeli večji odmerek zdravila Valtrex, kot bi smeli Zdravilo Valtrex običajno ne škoduje, če prevelikega odmerka ne jemljete več dni zapored.
English: Cytomegalovirus (CMV) infections:
Slovenian: Okužbe s citomegalovirusom (CMV):
English: If cutaneous lesions are extensive or if visceral involvement is suspected, IV aciclovir should be initiated and continued until clinical improvement is evident [Balfour, 1983].
Slovenian: aciklovir in nadaljevati do očitnega kliničnega izboljšanja [Balfour, 1983].
English: Your doctor will weigh up the benefit to you against the risk to your baby of taking Valtrex while you're pregnant or breastfeeding.
Slovenian: Zdravnik bo pretehtal koristi, ki jih jemanje zdravila Valtrex med nosečnostjo ali dojenjem pomeni za vas, v primerjavi s tveganjem za otroka.
English: The CHMP endorsed the MAH's proposal to delete “Valtrex accelerates the resolution of pain….and postherpetic neuralgia” and the information was moved under section 5.1.
Slovenian: CHMP je potrdil predlog imetnika dovoljenja za promet z zdravilom, da se izbriše „Valtrex skrajša trajanje bolečine … in postherpetično nevralgijo“ in ta podatek premakne v poglavje 5.1.
English: Aciclovir triphosphate competitively inhibits the virus DNA polymerase and incorporation of this nucleoside analogue results in obligate chain termination, halting virus DNA synthesis and thus blocking virus replication.
Slovenian: Aciklovir trifosfat kompetitivno zavira virusno DNA-polimerazo, posledica vgradnje tega nukleozidnega analoga pa je dokončna zaključitev verige.
English: The CHMP asked the MAH to evaluate all other sections of the nationally approved EU SPCs and suggest appropriate changes in the text where divergences exist.
Slovenian: Druga poglavja povzetka glavnih značilnosti zdravila CHMP je prosil imetnika dovoljenja za promet z zdravilom, da pregleda vsa druga poglavja nacionalno odobrenih povzetkov glavnih značilnosti zdravila v EU ter predlaga ustrezne spremembe besedila, kjer so razlike.
English: Several indications were not approved in all Member States, in particular for immunocompromised patients.
Slovenian: Nekatere indikacije niso bile odobrene v vseh državah članicah.
English: Severo Ochoa, 2 ,28760, Tres Cantos Madrid Spain
Slovenian: Severo Ochoa, 2 ,28760, Tres Cantos Madrid Španija
English: The MAH retained an appropriate cautionary statement in the Pregnancy and Lactation Section 4.6 in the harmonised EU SPC.
Slovenian: Imetnik dovoljenja za promet z zdravilom je v povzetku glavnih značilnosti zdravila, usklajenem za EU, ohranil ustrezno previdnostno izjavo v poglavju 4.6 Nosečnost in dojenje.
English: • treat and prevent HSV infections of the eye
Slovenian: • zdravljenje in preprečevanje očesnih okužb s HSV.
English: It should be kept in mind that the modelling is based on some not very strong relationships, e.g. Cmax as a function of creatinine clearance.
Slovenian: Upoštevati je treba, da modeliranje temelji na nekaterih manj močnih povezavah, npr.
English: Aciclovir is a potent and selective inhibitor of a number of herpes viruses, including the human pathogens herpes simplex virus (HSV), varicella zoster virus (VZV), and cytomegalovirus (CMV).
Slovenian: Aciklovir je močen in selektiven zaviralec številnih herpesvirusov, vključno s povzročitelji bolezni pri človeku: virusom herpes simpleks (HSV), virusom varicella zoster (VZV) in citomegalovirusom (CMV).
English: In patients receiving higher aciclovir exposures from valaciclovir (e.g., at doses for zoster treatment or CMV prophylaxis), caution is required during concurrent administration with drugs which inhibit active renal tubular secretion.
Slovenian: Pri bolnikih, pri katerih je izpostavljenost aciklovirju iz valaciklovirja večja (npr. v odmerkih za zdravljenje zostra ali profilakso CMV), je potrebna previdnost med sočasno uporabo zdravil, ki zavirajo aktivno tubularno sekrecijo.
English: 4.4 Special warnings and precautions for use Hydration status
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi
English: For ARs identified as associated with valaciclovir from post-marketing experience, and observed in clinical trials, study incidence has been used to assign the AR frequency category.
Slovenian: Za neželene učinke, za katere je bilo med postmarketinško uporabo ugotovljeno, da so povezani z valaciklovirjem in so bili zabeleženi v kliničnih raziskavah, je bila za dodelitev kategorije pogostnosti neželenega učinka uporabljena incidenca v študijah.
English: The dose of Valtrex should be reduced in patients with impaired renal function as shown in Table 1 below.
Slovenian: Bolnikom z okvarjenim delovanjem ledvic je treba odmerek zdravila Valtrex zmanjšati, kot prikazuje preglednica 1, spodaj.
English: The second dose should be taken about 12 h (no sooner than 6 h) after the first dose.
Slovenian: Drugi odmerek je treba vzeti približno 12 ur (in ne prej kot 6 ur) po prvem odmerku.
English: The CHMP asked the MAH to give an estimate of the frequency of resistance in immunocompetent and immunocompromised across clinical trials to be put in perspective to post marketing data.
Slovenian: CHMP je prosil imetnika dovoljenja za promet z zdravilom, da oceno pogostnosti odpornosti pri imunsko kompetentnih in kompromitiranih osebah v kliničnih preskušanjih poda glede na podatke iz obdobja trženja zdravila.
English: In plasma as well as CSF, concentrations of aciclovir, CMMG and 8-OH-ACV were on average 2, 4 and 5-6 times higher, respectively, at severe renal impairment compared with normal renal function.
Slovenian: Pri bolnikih s hudo okvaro ledvic je bila koncentracija aciklovirja, CMMG oziroma 8-OHACV v plazmi in cerebrospinalni tekočini v povprečju 2-krat, 4-krat oziroma 5- do 6-krat večja kot pri bolnikih z normalnim delovanjem ledvic.
English: • confused or disturbed thoughts
Slovenian: • nezavest (koma), • zmedene ali motene misli.
English: This information is included in section 4.4 of the SPC.
Slovenian: Ta podatek je vključen v poglavju 4.4 povzetka glavnih značilnosti zdravila.
English: Valtrex is indicated for the prophylaxis of CMV infection and disease following solid organ transplantation in adults and adolescents (see section 4.4)
Slovenian: Zdravilo Valtrex je indicirano za profilakso okužbe s CMV in CMV- bolezni po presaditvi parenhimskega organa pri odraslih in mladostnikih (glejte poglavje 4.4).
English: Valtrex is indicated for the treatment of herpes zoster in adult patients with mild or moderate immunosuppression”.
Slovenian: Zdravilo Valtrex je indicirano za zdravljenje herpesa zostra pri odraslih bolnikih z blago do zmerno imunosupresijo.“
English: Use in ocular HSV infections
Slovenian: Očesne okužbe s HSV
English: Cytomegalovirus (CMV) Infections CMV prophylaxis in solid organ transplant recipients in adults and adolescents
Slovenian: Okužbe s citomegalovirusom (CMV) Profilaksa CMV pri prejemnikih presajenih parenhimskih organov pri odraslih in mladostnikih
English: Valtrex reduces the risk of ocular complications of ophthalmic zoster.
Slovenian: Zdravilo Valtrex zmanjša tveganje očesnih zapletov oftalmičnega herpesa zostra.
English: Reversible increases in liver function tests (e.g. bilirubin, liver enzymes).
Slovenian: reverzibilno zvišanje jetrnih funkcijskih testov (npr. bilirubina, jetrnih encimov) Bolezni kože in podkožja
English: The second dose should be taken about 12 h (no sooner than 6 h) after the first dose.”
Slovenian: Drugi odmerek je treba vzeti približno 12 ur po prvem odmerku (vendar ne prej kot v 6 urah).“
English: Zemouto - Coina 2830 Barreiro Portugal
Slovenian: 2830 Barreiro
English: “Valtrex reduces the risk of ocular complications of ophthalmic zoster”.
Slovenian: „Zdravilo Valtrex zmanjša tveganje očesnih zapletov očesnega zostra“.
English: Valtrex Tablets 250 mg are supplied to you in cartons containing 60 film-coated tablets.
Slovenian: Tablete Valtrex 250 mg so na voljo v škatlah, ki vsebujejo 60 filmsko obloženih tablet.
English: Tmax hours (h)
Slovenian: Cmax mikrogrami/ml tmax ure (h)
English: The dose in immunocompromised patients is 1000 mg three times daily for at least seven days (3000 mg total daily dose) and for 2 days following crusting of lesions.
Slovenian: Pri imunsko oslabelih bolnikih je odmerek 1.000 mg trikrat na dan vsaj sedem dni (celotni dnevni odmerek 3.000 mg) in 2 dni po nastanku krast na spremembah.
English: Valaciclovir is rapidly and almost completely converted to acyclovir and L-valine via intestinal and hepatic first-pass metabolism.
Slovenian: Valaciklovir se hitro in skoraj popolnoma pretvori v aciklovir in L-valin s črevesno in jetrno presnovo prvega prehoda.
English: • treat cold sores (in adults and adolescents over 12 years old)
Slovenian: • zdravljenje ocvirkov (pri odraslih in mladostnikih, starejših od 12 let);
English: In patients on intermittent haemodialysis, the Valtrex dose should be administered after the haemodialysis has been performed.
Slovenian: Bolniki na intermitentni hemodializi morajo dobiti odmerek zdravila Valtrex po opravljeni hemodializi.
English: Allen Farmacéutica S.A. Severo Ochoa, 2 ,28760, Tres Cantos Madrid Spain
Slovenian: Allen Farmacéutica S.A. Severo Ochoa, 2 ,28760, Tres Cantos Madrid Španija
English: Valtrex is indicated for the treatment of herpes zoster in adult patients with mild or moderate immunosuppression (see section 4.4).
Slovenian: Zdravilo Valtrex je indicirano za zdravljenje herpesa zostra pri odraslih bolnikih z blago ali zmerno imunosupresijo (glejte poglavje 4.4).
English: 2000mg twice in one day 1000 mg twice in one day 500 mg twice in one day 500 mg single dose
Slovenian: 2.000 mg dvakrat v enem dnevu 1.000 mg dvakrat v enem dnevu 500 mg dvakrat v enem dnevu enkraten odmerek 500 mg
English: Care should be taken to ensure adequate fluid intake in patients who are at risk of dehydration, particularly the elderly.
Slovenian: Stanje hidracije Poskrbeti je treba, da bolniki s tveganjem za dehidracijo, zlasti starejši, pijejo dovolj tekočine.
English: • treat shingles (in adults)
Slovenian: • zdravljenje pasovca (pri odraslih);
English: Based on historical aciclovir experience, valaciclovir appears to be as effective as aciclovir for the treatment of erythema multiforme, eczema herpeticum and herpetic whitlow.
Slovenian: Na podlagi preteklih izkušenj z aciklovirjem je valaciklovir verjetno enako učinkovit kot aciklovir za zdravljenje multiformnega eritema, herpetičnega ekcema in herpetične zanohtnice.
English: Aciclovir half-life is not affected.
Slovenian: Razpolovni čas aciklovirja ni spremenjen.
English: Herpes Simplex Virus (HSV) Infections Treatment of HSV infections - immunocompetent adults and adolescents
Slovenian: Okužbe z virusom herpes simpleks (HSV) Zdravljenje okužb s HSV - imunokompetentni odrasli in mladostniki
English: Varicella zoster virus (VZV) infections - herpes zoster and ophthalmic zoster
Slovenian: Okužbe z virusom varicella zoster (VZV) - herpes zoster in oftalmični zoster
English: Clinical trial data have been used to assign frequency categories to ARs if, in the trials, there was evidence of an association with valaciclovir.
Slovenian: Za določitev kategorije pogostnosti neželenih učinkov so bili uporabljeni podatki kliničnih preskušanj, če so obstajali dokazi o povezanosti z valaciklovirjem.
English: Valaciclovir has shown efficacy in the treatment of herpes labialis (cold sores), mucositis due to chemotherapy or radiotherapy, HSV reactivation from facial resurfacing, and herpes gladiatorum.
Slovenian: Valaciklovir se je izkazal za učinkovitega pri zdravljenju herpesa na ustnicah (ocvirkov), mukozitisa zaradi kemoterapije ali radioterapije, reaktivacije HSV zaradi preplastitve ("resurfacing") obraza in herpesa gladiatorum.
English: However, valaciclovir showed efficacy in the treatment of herpes labialis (cold sores), mucositis due to chemotherapy or radiotherapy, HSV reactivation from facial resurfacing, and herpes gladiatorum.
Slovenian: Kljub temu so dokazali učinkovitost valaciklovirja za zdravljenje labialnega herpesa (herpesa na ustnici), mukozitisa zaradi kemoterapije ali radioterapije, reaktivacije HSV po obdelavi obrazne kože in herpesa gladiatoruma.
English: Whereas - the scope of the referral was the harmonisation of the Summary of Products Characteristics, labelling and package leaflet.
Slovenian: - Namen napotitve je bil uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodilo za uporabo.
English: These are rare in people taking Valtrex.
Slovenian: Te so pri bolnikih, ki prejemajo zdravilo Valtrex, redke.
English: How to take Valtrex
Slovenian: Kako jemati zdravilo Valtrex
English: The MAH provided the dosage adjustment rationale for the treatment of herpes labialis in subjects with renal impairment.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil osnovo za prilagoditev odmerka za zdravljenje labialnega herpesa pri osebah z okvarjenim delovanjem ledvic.
English: Aciclovir inhibits herpes virus DNA synthesis once it has been phosphorylated to the active triphosphate form.
Slovenian: Aciklovir po fosforilaciji v aktivno obliko aciklovir trifosfat zavira sintezo herpesvirusne DNA.
English: GlaxoSmithKline, S.A Severo Ochoa, 2 ,28760, Tres Cantos Madrid Spain
Slovenian: GlaxoSmithKline, S.A Severo Ochoa, 2 ,28760, Tres Cantos Madrid Španija
English: The CHMP endorsed the following: “For herpes labialis (cold sores), valaciclovir 2000 mg twice daily for one day is effective treatment in adults and adolescents.
Slovenian: CHMP je potrdil naslednje: „Za labialni herpes (herpes na ustnici) pri odraslih bolnikih in mladostnikih je učinkovito zdravljenje z 2000 mg valaciklovirja dvakrat dnevno en dan.
English: 2000 mg four times daily
Slovenian: 2.000 mg štirikrat na dan
English: Glaxo Wellcome Operations Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom
Slovenian: Glaxo Wellcome Operations Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, Velika Britanija
English: • Treatment and suppression of recurrent ocular HSV infections.
Slovenian: • za zdravljenje in supresijo ponovitev očesnih okužb s HSV.
English: The MAH revised section 4.8 accordingly.
Slovenian: Imetnik dovoljenja za promet z zdravilom je ustrezno popravil poglavje 4.8.
English: Valaciclovir was not teratogenic in rats or rabbits.
Slovenian: Valaciklovir pri podganah in kuncih ni bil teratogen.
English: If you are not sure, talk to your doctor or pharmacist before taking Valtrex.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom, preden vzamete zdravilo Valtrex.
English: 500 mg once daily b 250 mg once daily
Slovenian: 500 mg enkrat na danb 250 mg enkrat na dan
English: What Valtrex contains
Slovenian: Kaj vsebuje zdravilo Valtrex
English: The clinical status of the patient and the adverse reaction profile of Valtrex should be borne in mind when considering the patient`s ability to drive or operate machinery.
Slovenian: Pri presojanju bolnikove sposobnosti za vožnjo in upravljanje s stroji je treba upoštevati bolnikovo klinično stanje in značilnosti neželenih učinkov zdravila Valtrex.
English: After oral administration, valaciclovir is converted to aciclovir and L-valine by first-pass intestinal and/or hepatic metabolism.
Slovenian: Po peroralni uporabi se valaciklovir med prvim prehodom s presnovo v prebavilih in/ali jetrih pretvori v aciklovir in L-valin.
English: Valtrex can prevent lesion development when taken at the first signs and symptoms of an HSV recurrence.
Slovenian: Če je zdravilo Valtrex uporabljeno ob prvih znakih in simptomih ponovitve HSV, lahko prepreči razvoj sprememb,
English: Germany GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11, 80339 München,
Slovenian: KG, Theresienhöhe 11, 80339 München, Nemčija
English: The CHMP agreed that for herpes labialis, valaciclovir 2000 mg twice daily for one day is effective treatment in adults and adolescents.
Slovenian: CHMP se je strinjal, da je za labialni herpes pri odraslih bolnikih in mladostnikih učinkovito zdravljenje z 2000 mg valaciklovirja dvakrat dnevno en dan.
English: A strict monitoring of the evolution of lesions is advised.
Slovenian: Natančno je treba spremljati razvoj sprememb.
English: If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking Valtrex.
Slovenian: Če niste gotovi, ali kaj od naštetega velja za vas, se posvetujte z zdravnikom ali s farmacevtom, preden vzamete zdravilo Valtrex.
English: 500 mg twice daily 500 mg once daily
Slovenian: 500 mg dvakrat na dan 500 mg enkrat na dan
English: Uncommon ≥ 1/1,000 to < 1/100, Rare
Slovenian: ≥ 1/1.000 do < 1/100
English: Prophylaxis of cytomegalovirus (CMV) infection and disease in adults and adolescents (≥12 years)
Slovenian: Profilaksa okužbe s citomegalovirusom (CMV) in citomegalovirusne bolezni pri odraslih in mladostnikih (≥ 12 let)
English: Varicella zoster virus (VZV) infections - herpes zoster Valtrex is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults (see sections 4.4).
Slovenian: KLINIČNI PODATKI 4.1 Terapevtske indikacije Okužbe z virusom varicella zoster (VZV) - herpes zoster Zdravilo Valtrex je indicirano za zdravljenje herpesa zostra (pasovca) in oftalmičnega zostra pri imunokompetentnih odraslih (glejte poglavje 4.4 ).
English: Middlesex , UB6 0NN, United Kingdom
Slovenian: Middlesex , UB6 0NN, Velika Britanija
English: • low back pain (kidney pain)
Slovenian: • bolečine v ledvenem delu hrbta (ledvične bolečine).
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablets 21 tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložene tablete 21 tablet
English: White, biconvex, elongated tablet with a white to off-white core, with a partial scorebar on both sides and marked “GX CF2” in blue ink on one side.
Slovenian: Bela, bikonveksna podolgovata tablete z belim do skoraj belim jedrom in delno prelomno zarezo na obeh straneh; tableta ima na eni strani oznako “GX CF2”, natisnjeno z modrim črnilom.
English: Vomiting, diarrhoea.
Slovenian: bruhanje, driska
English: • The usual dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice a day.
Slovenian: • Običajen odmerek je 500 mg (ena 500 mg tableta ali dve 250 mg tableti) dvakrat na dan.
English: 1000 mg twice daily 1000 mg once daily
Slovenian: 1.000 mg dvakrat na dan 1.000 mg enkrat na dan
English: They are white and marked with “GX CE7” on one side.
Slovenian: Tablete so bele in imajo na eni strani oznako “GX CE7”.
English: • shortness of breath (dyspnoea)
Slovenian: • kratka sapa (dispneja),