FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant use of probenecid is essential for reducing the pronounced nephrotoxicity of cidofovir to an extent that results in an acceptable benefit/risk balance of cidofovir therapy.
Slovenian: Sočasna uporaba probenecida je za zmanjševanje izrazite nefrotoksičnosti cidofovira bistvena, saj omogoča sprejemljivo razmerje med koristjo in tveganji za zdravljenje s cidofovirom.
English: At the end of a one-hour infusion of cidofovir 5 mg/kg administered with concomitant oral probenecid, the mean (± SD) serum concentration of cidofovir was 19.6 (± 7.18) µg/ml.
Slovenian: Na koncu enourne infuzije 5 mg/kg cidofovira, uporabljene sočasno s peroralnim probenecidom, je bila povprečna (± SD) koncentracija cidofovira v serumu 19,6 (± 7,18) µg/ml.
English: There is a risk that concomitant treatment of Vistide with products containing tenofovir disoproxil fumarate may give rise to a pharmacodynamic interaction and increase the risk of Fanconi syndrome (see section 4.4).
Slovenian: Obstaja tveganje, da bi lahko sočasno zdravljenje z zdravilom Vistide in zdravili, ki vsebujejo tenofovirdizoproksil fumarat, povzročilo farmakodinamične interakcije in zvišanje tveganja za Fanconijev sindrom (glejte poglavje 4.4).
English: Renal insufficiency:
Slovenian: Jetrna insuficienca:
English: (See sub-sections “How to take probenecid with Vistide” and “How IV fluids are given before Vistide” below.)
Slovenian: (Glejte spodnji podpoglavji »Kako jemati probenecid z zdravilom Vistide« in »Kako se dajejo i.v.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, nemudoma obvestite svojega zdravnika ali farmacevta.
English: • headache, weakness/fatigue, chills and allergic reactions.
Slovenian: • vključujejo glavobol, šibkost/utrujenost, mrzlico in alergijske reakcije.
English: Possible side effects of taking probenecid
Slovenian: Možni neželeni učinki jemanja probenecida
English: Skin and subcutaneous tissue disorders Very common
Slovenian: Bolezni kože in podkožja Zelo pogosti
English: • adefovir (for HBV infection)
Slovenian: • adefovir (za okužbe z virusom HBV)
English: A probenecid desensitisation program is not recommended for use.
Slovenian: Postopek desenzibilizacije na probenecid ni priporočljiv.
English: Cidofovir-selected mutants had a mutation in the DNA polymerase gene and were cross-resistant to ganciclovir, but susceptible to foscarnet.
Slovenian: S cidofovirom selekcionirani mutanti so imeli mutacijo v genu za DNA polimerazo in so bili navzkrižno odporni proti gancikloviru, a občutljivi za foskarnet.
English: Vistide is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila Vistide ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: Although not observed in human studies of Vistide, such changes may occur in humans and cause infertility.
Slovenian: Tega v študijah zdravila Vistide pri ljudeh sicer niso opazili, vendar se takšne spremembe lahko pojavijo tudi pri človeku in povzročijo neplodnost.
English: Following in vitro selection of ganciclovir-resistant HCMV isolates, cross-resistance between ganciclovir and cidofovir was seen with ganciclovir-selected mutations in the HCMV DNA polymerase gene but not with mutations in the UL97 gene.
Slovenian: Po in vitro-selekciji izolatov HCMV, odpornih proti gancikloviru, so ugotovili navzkrižno odpornost med ganciklovirom in cidofovirom pri z ganciklovirom selekcioniranih mutacijah v genu DNA polimeraze HCMV, ne pa pri mutacijah v genu UL97.
English: Two grams of probenecid should be administered 3 hours prior to the cidofovir dose and one gram administered at 2 and again at 8 hours after completion of the 1 hour cidofovir infusion (for a total of 4 grams).
Slovenian: Dva grama probenecida je treba dati 3 ure pred odmerkom cidofovira, en gram 2 uri in še en gram 8 ur po koncu enourne infuzije cidofovira (skupaj 4 grame).
English: There have been reports of leukopenia, hepatic necrosis, nephrotic syndrome, and aplastic anaemia.
Slovenian: Poročali so o levkopeniji, nekrozi jeter, nefrotskem sindromu in aplastični anemiji.
English: Male patients should be advised that cidofovir caused reduced testes weight and hypospermia in animals.
Slovenian: Moškim bolnikom je treba povedati, da je cidofovir pri živalih povzročil zmanjšanje teže mod in hipospermijo.
English: It is not known whether Vistide is passed on to the baby in human milk.
Slovenian: Ni znano, ali se zdravilo Vistide iz materinega mleka prenaša na otroka.
English: • In general, women with HIV should not breast-feed in order to avoid passing HIV to their
Slovenian: • Na splošno je priporočljivo, da ženske, okužene s HIV, ne dojijo svojih otrok, ker se virus lahko prenese na dojenčka z materinim mlekom.
English: Vistide is contraindicated in patients with renal insufficiency (see section 4.2).
Slovenian: Zdravilo Vistide je kontraindicirano pri bolnikih z insuficienco ledvic (glejte poglavje 4.2).
English: The first litre of saline solution should be infused over a 1 hour period immediately before the cidofovir infusion, and the second litre, if given, infused over a 1-3 hour period beginning simultaneously with the cidofovir infusion or starting immediately after the infusion of cidofovir.
Slovenian: Prvi liter fiziološke raztopine je treba infundirati v teku 1 ure tik pred infuzijo cidofovira, drugi liter (če se uporabi) pa v obdobju od 1 do 3 ur, ki se začne hkrati z infuzijo cidofovira ali takoj po njej.
English: Alopecia, rash
Slovenian: Alopecija, izpuščaj
English: Differential white blood cell counts should also be performed prior to each dose of cidofovir (see section 4.8).
Slovenian: Prav tako je treba pred vsakim odmerkom cidofovira pregledati diferencialno krvno sliko (glejte poglavje 4.8).
English: Cidofovir administration is contraindicated in patients unable to receive probenecid or other sulfacontaining medication (see section 4.4 Prevention of nephrotoxicity).
Slovenian: Uporaba cidofovira je kontraindicirana pri bolnikih, ki ne morejo dobivati probenecida ali drugih zdravil, ki vsebujejo žveplo (glejte poglavje 4.4, Preprečevanje nefrotoksičnosti).
English: In order to reduce the potential for nausea and/or vomiting associated with administration of probenecid, patients should be encouraged to eat food prior to each dose of probenecid.
Slovenian: Za zmanjšanje verjetnosti za navzeo in/ali bruhanje, povezanih z uporabo probenecida, je treba bolnike spodbuditi, naj pred vsakim odmerkom probenecida zaužijejo hrano.
English: You should also read the probenecid package leaflet.
Slovenian: Preberite tudi navodilo za uporabo probenecida.
English: Biochemical data support selective inhibition of HSV-1, HSV-2 and HCMV DNA polymerases by cidofovir diphosphate, the active intracellular metabolite of cidofovir.
Slovenian: Biokemični podatki potrjujejo selektivno zavrtje DNA polimeraz HSV-1, HSV-2 in HCMV s cidofovirdifosfatom, aktivnim znotrajceličnim presnovkom cidofovira.
English: 8 hours after end of Vistide infusion
Slovenian: 8 ur po koncu infundiranja zdravila Vistide
English: • inflammation of the eye, reduced pressure in the eyes, difficult or laboured breathing, shortness of breath, diarrhoea and chills.
Slovenian: • vnetje oči, znižan očesni tlak, oteženo ali naporno dihanje, kratka sapa, driska in mrzlica.
English: Precautions to be taken before handling or administering the medicinal product: Adequate precautions including the use of appropriate safety equipment are recommended for the preparation, administration and disposal of Vistide.
Slovenian: Previdnostni ukrepi potrebni pred ravnanjem z zdravilom ali uporabo zdravila: Pri pripravi, uporabi in odstranjevanju zdravila Vistide je treba upoštevati ustrezne previdnostne ukrepe, vključno z uporabo primerne varnostne opreme.
English: The median times to retinitis progression in the two efficacy studies (GS-93-106 and GS-93-105), were 120 days and not reached for the treatment arms vs. 22 days and 21 days for the untreated (deferred treatment) arms, respectively.
Slovenian: V dveh študijah učinkovitosti (GS-93-106 in GS-93-105) je bil mediani čas do napredovanja retinitisa v zdravljenem kraku 120 dni in v nezdravljenem (odloženo zdravljenje) 22 dni (študija GS-93-106); v študiji GS-93-105 ta čas v zdravljenem kraku ni bil dosežen, v nezdravljenem (odloženo zdravljenje) pa je znašal 21 dni.
English: Vistide is given by intravenous infusion (a drip into a vein).
Slovenian: Zdravilo Vistide se daje v obliki intravenske infuzije (vkapljanja v veno).
English: Vistide should not be administered concurrently with medicinal products containing tenofovir disoproxil fumarate due to the risk of Fanconi syndrome (see section 4.5).
Slovenian: Zdravila Vistide se ne sme dajati sočasno z zdravili, ki vsebujejo tenofovirdizoproksil fumarat zaradi tveganja Fanconijevega sindroma (glejte poglavje 4.5).
English: Samples of your urine and/or blood will be taken before each infusion of Vistide and used for testing kidney function.
Slovenian: Pred vsako infuzijo zdravila Vistide vam bodo vzeli vzorec urina in/ali krvi za oceno delovanja ledvic.
English: • foscarnet (for viral infection)
Slovenian: • foskarnet (za virusne okužbe)
English: • Sodium hydroxide
Slovenian: • natrijev hidroksid
English: 3 hours before start of Vistide infusion
Slovenian: 3 ure pred začetkom infundiranja zdravila Vistide
English: Reports of renal failure (plus events possibly caused by renal failure, e.g. blood creatinine increased, proteinuria, glycosuria) received during post-marketing surveillance include some which were fatal.
Slovenian: Med primeri odpovedi ledvic (in spremembami, katerih vzrok je lahko odpoved ledvic, npr. zvišanje kreatinina v krvi, proteinurija, glikozurija), opisanimi v pomarketinškem obdobju, je bilo tudi nekaj takšnih s smrtnim izidom.
English: CMV retinitis is an eye infection caused by a virus named cytomegalovirus (CMV).
Slovenian: Citomegalovirusni retinitis je okužba oči, ki jo povzroča poseben virus, citomegalovirus (CMV).
English: Although not observed in clinical studies of cidofovir, such changes may occur in humans and cause infertility.
Slovenian: Tega v kliničnih študijah cidofovira sicer niso opazili, vendar se takšne spremembe lahko pojavijo tudi pri človeku in povzročijo neplodnost.
English: Patients treated at 3.0 mg/kg, 5.0 mg/kg or 10 mg/kg without concomitant probenecid developed evidence of proximal tubular cell injury, including glycosuria, and decreases in serum phosphate, uric acid and bicarbonate, and elevations in serum creatinine.
Slovenian: Pri bolnikih, ki so prejemali odmerke 3,0 mg/kg, 5,0 mg/kg ali 10,0 mg/kg brez sočasne uporabe probenecida, so se pojavili znaki okvare celic proksimalnih tubulov, vključno z glikozurijo, znižanjem fosfata v serumu, sečne kisline in bikarbonata v serumu ter zvišanjem kreatinina v serumu.
English: Interactions of cidofovir/probenecid and anti-HIV drugs or drugs used to treat common chronic viral infections in this population, such as HCV- and HBV-related hepatitis, have not been investigated in clinical trials.
Slovenian: V kliničnih preizkušanjih niso proučili interakcij cidofovira/probenecida in drugih zdravil proti HIV, ali zdravil, ki se uporabljajo za zdravljenje običajnih kroničnih virusnih okužb v tej populaciji, kot je s HCV in HBV povezan hepatitis.
English: Patients with AIDS are at high risk of developing CMV retinitis or other forms of CMV disease such as colitis (an inflammatory bowel disease).
Slovenian: Bolnike z AIDS-omzelo ogrožajo tako citomegalovirusni retinitis kot druge oblike bolezni zaradi CMV, npr. kolitis (vnetna bolezen črevesja).
English: Cidofovir administration is contraindicated in patients unable to receive probenecid because of a clinically significant hypersensitivity to the active substance or medicinal product or to other sulfacontaining medicines.
Slovenian: Uporaba cidofovira je kontraindicirana pri bolnikih, ki probenecida ne morejo dobivati zaradi klinično pomembne preobčutljivosti zanj ali za druga zdravila, ki vsebujejo žveplo.
English: In case of uveitis/iritis cidofovir should be discontinued if there is no response to treatment with a topical corticosteroid or the condition worsens, or if iritis/uveitis reoccurs after successful treatment.
Slovenian: Če v primeru uveitisa/iritisa ni odziva na zdravljenje z lokalnim kortikosteroidom ali če se stanje poslabša oziroma če se iritis/uveitis po uspešnem zdravljenju ponovi, je treba uporabo cidofovira prekiniti.
English: Vistide is indicated for the treatment of CMV retinitis in adults with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction.
Slovenian: Zdravilo Vistide je indicirano za zdravljenje citomegalovirusnega (CMV) retinitisa pri odraslih s sindromom pridobljene imunske pomanjkljivosti (AIDS-om), ki nimajo motenega delovanja ledvic.
English: Vistide should be administered by health care professionals adequately experienced in the care of AIDS patients.
Slovenian: Zdravilo Vistide morajo aplicirati zdravstveni delavci, ki imajo ustrezne izkušnje z oskrbo bolnikov z AIDS-om.
English: The most common side effect observed with Vistide is damage to the kidneys.
Slovenian: Najpogostejši neželeni učinek, opažen med uporabo zdravila Vistide, je okvara ledvic.
English: The finding of any glycosuria, proteinuria/aminoaciduria, hypouricemia, hypophosphatemia and/or hypokalemia, should prompt for the consideration of cidofovir-related Fanconi syndrome.
Slovenian: Pojav glikozurije, proteinurije/aminacidurije, hipourikemije, hipofosfatemije in/ali hipokaliemije mora zbuditi sum na Fanconijev sindrom, povezan s cidofovirjem.
English: If administered, the second litre of saline should be given either at the start of the Vistide infusion or immediately afterwards, and infused over a 1 to 3 hour period.
Slovenian: V tem primeru je treba drugi liter fiziološke raztopine nastaviti bodisi na začetku infundiranja zdravila Vistide ali takoj po njegovem koncu in mora teči v obdobju od 1 do 3 ur.
English: • Hydrochloric acid
Slovenian: • klorovodikova kislina
English: The physician is advised to discuss this issue with the patient, and based upon the condition of the disease and the tolerance of medication, give his recommendation in the individual case.
Slovenian: Zdravnik se mora o tem pogovoriti z bolnikom in priporočila oblikovati individualno, glede na stanje bolezni in prenašanje zdravila.
English: Your doctor may instruct you to drink plenty of fluids before receiving Vistide.
Slovenian: Zdravnik vam bo morda svetoval, da pred uporabo zdravila Vistide zaužijete veliko tekočine.
English: Vistide is supplied as a sterile concentrate for solution for infusion in clear, glass vials containing 375 mg of the active ingredient, anhydrous cidofovir, formulated in 5 ml water for injections at a concentration of 75 mg/ml.
Slovenian: Zdravilo Vistide je na voljo kot sterilen koncentrat za raztopino za infundiranje v prozornih steklenih vialah, ki vsebujejo 375 mg zdravilne učinkovine, brezvodnega cidofovira, v 5 ml vode za injekcije, tako da je koncentracija 75 mg/ml.
English: Incorporation of cidofovir into viral DNA results in reductions in the rate of viral DNA synthesis.
Slovenian: Vgraditev cidofovira v virusno DNA povzroči upočasnitev sinteze virusne DNA.
English: If following hydration, a ≥ 2+ proteinuria is still observed, cidofovir therapy should be discontinued.
Slovenian: Če je proteinurija ≥ 2+ prisotna tudi po hidraciji, je treba zdravljenje s cidofovirom prekiniti.
English: Men should be advised to practice barrier contraceptive methods during and for 3 months after treatment with cidofovir (see sections 4.6 and 5.3).
Slovenian: Moškim je treba svetovati, naj uporabljajo pregradno kontracepcijsko zaščito med zdravljenjem s cidofovirom in do 3 mesece po njem (glejte poglavji 4.6 in 5.3).
English: Treatment for CMV retinitis is necessary to reduce the potential for blindness.
Slovenian: Takšen retinitis je treba zdraviti, da bi zmanjšali možnost oslepitve.
English: To reduce the risk of nausea and/or vomiting associated with taking probenecid, you should eat food before each dose.
Slovenian: Za zmanjšanje tveganja za slabost in/ali bruhanje, ki sta povezana z jemanjem probenecida, morate pred vsakim odmerkom probenecida zaužiti hrano.
English: A significantly increased foetal incidence of external, soft tissue and skeletal anomalies occurred in rabbits at 1.0 mg/kg/day, which was also maternally toxic.
Slovenian: Pri kuncih se je pogostnost zunanjih anomalij, anomalij mehkih tkiv in okostja pri odmerku 1,0 mg/kg/dan, ki je bil toksičen tudi za samice matere, pomembno zvečala.
English: Each vial contains approximately 2.5 mmol (or 57 mg) sodium per vial (5 ml) as a constituent of the excipients.
Slovenian: Ena viala vsebuje približno 2,5 mmol (ali 57 mg) natrija na vialo (5 ml) kot sestavino pomožnih snovi.
English: 2 hours after end of Vistide infusion
Slovenian: 2 uri po koncu infundiranja zdravila Vistide
English: Marketing Authorisation Holder Gilead Sciences International Limited Cambridge
Slovenian: Imetnik dovoljenja za promet z zdravilom Gilead Sciences International Limited Cambridge
English: • Vistide caused reduced testes weight and low sperm count (hypospermia) in animals.
Slovenian: • V študijah na živalih je zdravilo Vistide zmanjšalo težo mod in povzročilo majhno število semenčic (hipospermijo).
English: • You should not be given Vistide if you are pregnant.
Slovenian: • Če ste noseči, ne smete dobiti zdravila Vistide.
English: Continued administration of cidofovir to patients with persistent ≥ 2+ proteinuria following intravenous hydration may result in further evidence of proximal tubular injury, including glycosuria, decreases in serum phosphate, uric acid and bicarbonate, and elevations in serum creatinine.
Slovenian: Nadaljnja uporaba cidofovira pri bolnikih s stalno proteinurijo ≥ 2+ po intravenski hidraciji lahko povzroči dodatne znake okvare proksimalnih tubulov, vključno z glikozurijo, znižanjem fosfata v serumu, sečne kisline in bikarbonata v serumu ter zvišanjem kreatinina v serumu.
English: For patients with evidence of decreased kidney function, your Vistide dose may be interrupted or stopped depending on your individual case.
Slovenian: Če se izkaže, da je delovanje ledvic zmanjšano, lahko zdravnik uporabo zdravila Vistide prekine ali ustavi odvisno od vašega individualnega stanja.
English: The mean values of total serum clearance, volume of distribution at steady-state and terminal elimination halflife were 138 (± 36) ml/h/kg, 388 (± 125) ml/kg and 2.2 (± 0.5) h, respectively.
Slovenian: Povprečni celotni serumski očistek je bil 138 (± 36) ml/h/kg, volumen porazdelitve v stanju dinamičnega ravnovesja 388 (± 125) ml/kg in terminalni razpolovni čas izločanja 2,2 (± 0,5) h. S posamičnimi odmerki cidofovira v odmernem območju od 3 do 7,5 mg/kg so dokazali od odmerka neodvisno kinetiko.
English: Common side effects (These can affect 1 to 10 users in 100)
Slovenian: Pogosti stranski učinki (Pojavijo se lahko pri 1 do 10 od 100 bolnikov)
English: The container/closure components include: Type I clear borosilicate glass vials, Teflon faced grey butyl plug stoppers, and aluminium crimp seals with a flip off plastic tab.
Slovenian: Komponente vsebnika/zapore so: viala iz prozornega borosilikatnega stekla tipa I, s teflonom prevlečen siv butilni vtični zamašek in stisnjeno aluminijsko tesnilo s plastičnim odtržnim nastavkom.
English: This medicine contains 2.5 mmol (or 57 mg) sodium per vial which should be taken into consideration if you are on a controlled sodium diet.
Slovenian: To zdravilo vsebuje 2,5 mmol (ali 57 mg) natrija na vialo, kar morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
English: In a separate study, once weekly subcutaneous injections of cidofovir for 19 consecutive weeks resulted in mammary adenocarcinomas in female rats at doses as low as 0.6 mg/kg/week.
Slovenian: V drugi študiji je subkutano injiciranje cidofovira 19 tednov zapored pri podganjih samicah povzročilo mamarne adenokarcinome že v odmerkih 0,6 mg/kg/teden.
English: Compatibility with Ringer's Solution, Lactated Ringer's Solution or bacteriostatic infusion fluids has not been evaluated.
Slovenian: Združljivost z Ringerjevo raztopino, Ringerjevo laktatno raztopino ali bakteriostatskimi infuzijskimi tekočinami ni raziskana.
English: Vistide is an antiviral medicine which blocks the replication of CMV by interfering with viral DNA production.
Slovenian: Zdravilo Vistide je protivirusno zdravilo, ki zavira razmnoževanje CMV tako, da ovira nastajanje virusne DNA.
English: Vistide is supplied in single-use vials.
Slovenian: Zdravilo Vistide je na voljo v vialah za enkratno uporabo.
English: Concentrate for solution for infusion.
Slovenian: Koncentrat za raztopino za infundiranje.
English: Vistide is for intravenous infusion only.
Slovenian: Zdravilo Vistide je samo za intravensko infundiranje.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation :
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 23.4.1997
English: Your doctor will monitor your kidney function before each dose of Vistide.
Slovenian: Zdravnik bo pred vsakim odmerkom zdravila Vistide preveril delovanje vaših ledvic.
English: Hearing impaired
Slovenian: Okvara sluha
English: Cidofovir is active in vitro against HCMV, a member of the herpesviridae family.
Slovenian: Cidofovir in vitro deluje proti humanemu citomegalovirusu, pripadniku družine herpesviridae.
English: What Vistide contains
Slovenian: Kaj vsebuje zdravilo Vistide
English: The no-observable-effect doses for embryotoxicity were 0.5 mg/kg/day in rats and 0.25 mg/kg/day in rabbits.
Slovenian: Odmerek, pri katerem ni bilo nobenega opaznega embriotoksičnega učinka, je bil pri podganah 0,5 mg/kg/dan in pri kuncih 0,25 mg/kg/dan.
English: To minimise potential nephrotoxicity, oral probenecid and intravenous saline prehydration must be administered with each Vistide infusion (see section 4.4).
Slovenian: Za zmanjšanje morebitne nefrotoksičnosti je treba z vsako infuzijo zdravila Vistide uporabiti peroralni probenecid in intravensko predhidracijo s fiziološko raztopino (glejte poglavje 4.4).
English: For other NRTI drugs administered concomitantly with probenecid, reference should be made to their respective prescribing information for any appropriate recommendations.
Slovenian: Za druge zaviralce nukleozidne reverzne transkriptaze (NRTI), ki se jih uporablja sočasno s probenecidom, je treba za ustrezna priporočila upoštevati njihove povzetke glavnih značilnosti.
English: Vistide is not recommended for use in children below 18 years of age.
Slovenian: Uporaba zdravila Vistide pri otrocih, mlajših od 18 let, ni priporočljiva.
English: Studies have shown that cidofovir is clastogenic in vitro at 100 µg/ml and is embryotoxic in rats and rabbits.
Slovenian: Mutagenost in vpliv na sposobnost razmnoževanja Študije so pokazale, da je cidofovir in vitro klastogen pri 100 µg/ml in je pri podganah in kuncih embriotoksičen.
English: Take special care with Vistide
Slovenian: Bodite posebno pozorni pri uporabi zdravila Vistide
English: The following table lists adverse reactions possibly or probably related to probenecid based on clinical trial experience:
Slovenian: Spodnja tabela navaja neželene učinke, zabeležene v kliničnih preskušanjih, ki so morda ali verjetno povezani s probenecidom:
English: Total
Slovenian: Splošno
English: This medicinal product contains approximately 2.5 mmol (or 57 mg) sodium per vial which should be taken into consideration by patients on a controlled sodium diet.
Slovenian: To zdravilo vsebuje približno 2,5 mmol (ali 57 mg) natrija na vialo, kar morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.