natgillin/translations-raw huggingface dataset:
Studies have shown that cidofovir is clastogenic in vitro at 100 µg/ml and is embryotoxic in rats and rabbits.
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.
Take special care with Vistide
Bodite posebno pozorni pri uporabi zdravila Vistide
The following table lists adverse reactions possibly or probably related to probenecid based on clinical trial experience:
Spodnja tabela navaja neželene učinke, zabeležene v kliničnih preskušanjih, ki so morda ali verjetno povezani s probenecidom:
Total
Splošno
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.
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.
In a 26-week intravenous toxicity study, a significant increase in incidence of mammary adenocarcinomas was seen in female rats and of Zymbal's gland carcinomas in male and female rats at subtherapeutic plasma levels of cidofovir.
V 26-tedenski študiji intravenske toksičnosti so pri subterapevtskih koncentracijah cidofovira v plazmi opažali značilno zvečanje pogostnosti mamarnih adenokarcinomov pri podganjih samicah ter karcinomov Zymbalove žleze pri podganjih samcih in samicah.
Breast-feeding should be discontinued during treatment with cidofovir.
Med zdravljenjem s cidofovirom je treba prenehati z dojenjem.
Nausea, vomiting Diarrhoea Pancreatitis
Navzea, bruhanje Diareja
To lower the risk of kidney damage, probenecid tablets and intravenous fluids (saline solution) must be given on the day of each Vistide infusion.
Da bi zmanjšali tveganje za okvaro ledvic, morate dobiti tablete probenecida in intravensko tekočino (fiziološko raztopino) na isti dan kot infuzijo z zdravilom Vistide.
You are not to be given Vistide.
Ne smete dobiti zdravila Vistidine.
Therefore, when co-prescribing cidofovir/probenecid with other agents, it is important for prescribers to consult the current probenecid SmPC (or an appropriate drug reference source) and the respective prescribing information of the other co-administered products for full information regarding drug interactions and other features of that product.
Zato je pomembno, da zdravniki, ki cidofovir/probenecid predpišejo skupaj z drugimi zdravili, preverijo veljavni povzetek glavnih značilnosti probenecida (oz. ustrezen referenčni vir o zdravilu) ter navodila za predpisovanje drugih sočasno uporabljenih zdravil, da bi dobili celotne informacije o interakcijah zdravil in drugih lastnostih posameznega zdravila.
Additional reactions reported from post-marketing experience include kidney failure, damage to kidney tubule cells, inflammation of the pancreas and hearing impairment.
Dodatni neželeni učinki, o katerih so poročali po prihodu zdravila na trg, vključujejo odpoved ledvic, okvaro tubulnih celic ledvic, vnetje trebušne slinavke in motnje sluha.
In addition probenecid may also cause other adverse reactions including anorexia, gingival pain, flushing, alopecia, dizziness, anaemia, and pollakiuria.
Poleg tega lahko probenecid povzroči tudi druge neželene učinke, med drugim anoreksijo, bolečine v dlesnih, zardevanje, alopecijo, omotico, anemijo in polakisurijo.
Compatibility of Vistide with Ringer's Solution, Lactated Ringer's Solution or bacteriostatic infusion fluids has not been evaluated.
Združljivost zdravila Vistide z Ringerjevo raztopino, Ringerjevo laktatno raztopino in bakteriostatskimi infuzijskimi tekočinami ni raziskana.
General disorders and administration site conditions Very common
Splošne težave in spremembe na mestu aplikacije Zelo pogosti
Concomitant administration of Vistide and other potentially nephrotoxic agents is contraindicated (see section 4.4).
Sočasna uporaba zdravila Vistide in drugih potencialno nefrotoksičnih sredstev je kontraindicirana (glejte poglavje 4.4).
Evidence for a nephroprotective effect for probenecid was shown in a 52-week study conducted in cynomolgus monkeys administered cidofovir 2.5 mg/kg once weekly intravenously with 1 g of probenecid given orally.
Nefroprotektivni učinek probenecida je pokazala 52-tedenska študija na opicah cynomolgus, ki so enkrat na teden dobile 2,5 mg/kg cidofovira intravensko in 1 g probenecida peroralno.
Before each administration of Vistide, serum creatinine and urine protein levels should be investigated.
Pred vsako aplikacijo zdravila Vistide je treba izmeriti kreatinin v serumu in koncentracijo beljakovin v urinu.
If any of these apply to you, talk to your doctor.
Če za vas velja karkoli od zgoraj navedenega, se posvetujte z zdravnikom.
Very common side effects possibly related to probenecid (These can affect more than 1 user in 10)
Zelo pogosti neželeni učinki, ki so morda povezani s probenecidom (Pojavijo se lahko pri več kot 1 od 10 bolnikov)
Dose-dependent nephrotoxicity is the major dose-limiting toxicity related to administration of cidofovir (see section 4.8).
Od odmerka odvisni nefrotoksični učinki so med uporabo cidofovira glavni toksični pojavi, ki omejujejo odmerek (glejte poglavje 4.8).
The safety and efficacy of Vistide have not been established for the treatment of CMV disease in patients over 60 years of age.
Varnost in učinkovitost zdravljenja citomegalovirusne bolezni z zdravilom Vistide pri bolnikih, starejših od 60 let, nista bili dokazani.
Therefore, when coprescribing probenecid with cidofovir, it is important for prescribers to consult the current probenecid SmPC (or an appropriate drug reference source) for full information on the safety profile and other features of that product.
Zato je pomembno, da zdravniki, ki skupaj predpišejo probenecid in cidofovir, preverijo veljavni povzetek glavnih značilnosti probenecida (oz. ustrezen referenčni vir o zdravilu) za celotne informacije o varnosti in drugih značilnostih tega zdravila.
Adverse reactions identified from post-marketing experience are included in italics.
Med pomarketinškim obdobjem zabeleženi neželeni učinki so napisani v ležeči pisavi.
Daily intravenous administration of cidofovir during the period of organogenesis led to reduced fetal body weights when administered to pregnant rats at 1.5 mg/kg/day and to pregnant rabbits at 1.0 mg/kg/day.
Vsakodnevna intravenska uporaba cidofovira med organogenezo je povzročila manjšo telesno težo plodov tako pri brejih podganah (1,5 mg/kg/dan) kot brejih samicah kunca (1,0 mg/kg/dan).
The doctor or nurse will transfer the appropriate dose of Vistide from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution.
Zdravnik ali medicinska sestra bo ustrezen odmerek zdravila Vistide prenesel iz viale v infuzijsko vrečko, v kateri je 100 ml 0,9-odstotne (normalne) fiziološke raztopine.
In vivo activity against HCMV was confirmed with controlled clinical studies of cidofovir for the treatment of CMV retinitis in patients with AIDS, which demonstrated statistically significant delays in time to CMV retinitis progression for patients on cidofovir when compared to control patients.
In vivo je bilo delovanje proti HCMV potrjeno s kontroliranimi kliničnimi študijami cidofovira za zdravljenje citomegalovirusnega retinitisa pri bolnikih z AIDS-om.
The safety and efficacy of Vistide has not been demonstrated in diseases other than CMV retinitis in adults with AIDS.
Varnost in učinkovitost zdravila Vistide pri drugih boleznih, razen pri CMV retinitisu in pri odraslih z AIDS-om, nista bili dokazani.
Respiratory, thoracic and mediastinal disorders Common
Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti
Patients who can tolerate the additional fluid load may receive up to a total of 2 litres of 0.9% saline intravenously with each dose of cidofovir.
Bolniki, ki prenesejo dodatno obremenitev s tekočino, lahko z vsakim odmerkom cidofovira dobijo skupno do 2 litra 0,9-odstotne (normalne) fiziološke raztopine.
No metabolites of cidofovir have been detected in serum or urine of patients.
V serumu in urinu bolnikov niso odkrili presnovkov cidofovira.
Men should be advised to practice barrier contraceptive methods during and for 3 months after treatment with cidofovir (see section 4.4).
Moškim je treba svetovati, naj uporabljajo pregradno kontracepcijsko zaščito med zdravljenjem s cidofovirom in do 3 mesece po njem (glejte poglavje 4.4).
The recommended dose of Vistide in patients with normal kidney function is 5 mg per kg of body weight given once weekly for two consecutive weeks.
Priporočeni odmerek zdravila Vistide pri bolnikih z normalnim delovanjem ledvic je 5 mg na kg telesne mase enkrat na teden, dva tedna zapored.
No tumours were observed in cynomolgus monkeys administered cidofovir intravenously once weekly for 52 weeks at doses up to 2.5 mg/kg/week.
Tumorjev pa niso opazili pri opicah cynomolgus, ki so 52 tednov dobivale cidofovir intravensko enkrat na teden v odmerkih od 2,5 mg/kg/teden.
The chemical stability of Vistide mixed in saline solution has been demonstrated in glass bottles, in infusion bags composed of either polyvinyl chloride (PVC) composition or ethylene/propylene copolymer, and in PVC based vented IV administration sets.
Kemična stabilnost zdravila Vistide, zmešanega s fiziološko raztopino, je dokazana v steklenih steklenicah, infuzijskih vrečkah iz polivinilklorida (PVC) ali etilen/propilenskega kopolimera ter v ventiliranih kompletih za intravensko apliciranje, izdelanih na podlagi PVC.
Common side effects possibly related to probenecid (These can affect 1 to 10 users in 100)
Pogosti neželeni učinki, ki so morda povezani s probenecidom (Pojavijo se lahko pri 1 do 10 od 100 bolnikov)
• amphotericin B (for fungal infection)
• amfotericin B (za glivične okužbe)
4 g probenecid
4 g probenecida
1 g probenecid
1 g probenecida
Prevention of nephrotoxicity
Preprečevanje nefrotoksičnosti
Hepatic insufficiency:
Ledvična insuficienca:
2 g probenecid
2 g probenecida
The chemical and physical stability of Vistide admixed with saline has been demonstrated in glass bottles, in infusion bags composed of either polyvinyl chloride (PVC) or ethylene/propylene copolymer, and in PVC based vented IV administration sets.
Kemična in fizikalna stabilnost zdravila Vistide, zmešanega s fiziološko raztopino, je dokazana v steklenicah, infuzijskih vrečkah iz polivinilklorida (PVC) ali etilen/propilenskega kopolimera ter v ventiliranih kompletih za intravensko (i.v.)
• Kidney damage is the major side effect of Vistide treatment.
• Glavni neželeni učinek zdravljenja z zdravilom Vistide je okvara ledvic.
Beginning two weeks after completion of induction treatment, the recommended maintenance dose of Vistide in patients with normal kidney function is 5 mg per kg of body weight given once every two weeks.
Vzdrževalno zdravljenje se začne dva tedna po koncu začetnega; priporočeni vzdrževalni odmerek zdravila Vistide pri bolnikih z normalnim delovanjem ledvic je 5 mg na kg telesne mase enkrat na dva tedna.
Method of preparation and administration
Postopek priprave in apliciranja
Pharmacotherapeutic group: Antivirals for systemic use, nucleosides and nucleotides excluding reverse transcriptase inhibitors, ATC code: J05AB12
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, nukleozidi in nukleotidi razen zaviralcev reverzne transkriptaze.
The active substance of Vistide 75 mg/ml is cidofovir.
Zdravilna učinkovina v zdravilu Vistide 75 mg/ml je cidofovir.
Vistide must be administered with oral probenecid and intravenous saline as described below (see section 4.4 for appropriate recommendations, and under section 6.6 for information on obtaining probenecid).
Z vsako infuzijo zdravila Vistide je treba uporabiti peroralni probenecid in intravensko fiziološko raztopino (za ustrezna priporočila glejte poglavje 4.4, za informacije, kako dobiti probenecid, pa poglavje 6.6).
In addition to probenecid, patients must receive a total of one litre of 0.9% (normal) saline solution intravenously immediately prior to each infusion of cidofovir.
Poleg probenecida morajo bolniki tik pred vsako infuzijo cidofovira intravensko dobiti skupno en liter 0,9-odstotne fiziološke raztopine.
What Vistide is and what it is used for
Kaj je zdravilo Vistide in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Vistide
The recommended dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once weekly for two consecutive weeks.
Priporočeni odmerek cidofovira je 5 mg/kg telesne teže (v enourni intravenski infuziji s stalno hitrostjo) enkrat na teden, dva tedna zapored.
Each ml contains 75 mg cidofovir anhydrous.
En ml vsebuje 75 mg brezvodnega cidofovira.
The entire volume of the bag will be infused into your vein at a constant rate over a period of 1 hour using a standard infusion pump.
Celotno vsebino vrečke vam bodo s standardno infuzijsko črpalko v teku ene ure s stalno hitrostjo infundirali v veno.
Proteinuria, blood creatinine increased (see section 4.4) Renal failure Fanconi syndrome acquired General disorders and administration site conditions Very common Common
Proteinurija, zvišanje kreatinina v krvi (glejte poglavje 4.4) Odpoved ledvic
Obtaining probenecid
Kako dobiti probenecid
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA,
Therapy must be accompanied by administration of oral probenecid and adequate intravenous saline prehydration (see section 6.6 for information on obtaining probenecid) with each cidofovir dose.
Vsak odmerek cidofovira mora spremljati uporaba peroralnega probenecida in primerna intravenska predhidracija s fiziološko raztopino (za informacije, kako dobiti probenecid, glejte poglavje 6.6).
HCMV strains resistant to ganciclovir may still be susceptible to cidofovir.
Na cidofovir so lahko občutljivi sevi HCMV, ki so odporni proti gancikloviru.
The other ingredients are
Pomožne snovi so:
The safety and efficacy of Vistide has not been demonstrated in diseases other than CMV retinitis in patients with AIDS.
Varnost in učinkovitost zdravila Vistide pri drugih boleznih, razen pri citomegalovirusnem retinitisu in pri bolnikih z AIDS-om, nista bili dokazani.
Induction treatment.
Začetno zdravljenje.
The entire volume should be infused intravenously into the patient at a constant rate over a period of 1 hour by use of a standard infusion pump.
Celotno količino je treba bolniku infundirati intravensko s standardno infuzijsko črpalko in stalno hitrostjo v obdobju ene ure.
Vistide has not been studied in children.
Zdravilo Vistide pri otrocih ni raziskano.
Cidofovir is a cytidine analogue with in vitro and in vivo activity against human cytomegalovirus (HCMV).
Cidofovir je citidinski analog, ki deluje proti humanemu citomegalovirusu (HCMV) in vitro in in vivo.
No cross-resistance between foscarnet and cidofovir was seen with foscarnet-selected mutants.
Pri mutantih, selekcioniranih s foskarnetom, niso ugotovili navzkrižne odpornosti med foskarnetom in cidofovirom.
With a syringe, transfer under aseptic conditions the appropriate dose of Vistide from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution, and mix thoroughly.
Ustrezni odmerek zdravila Vistide v aseptičnih pogojih z brizgo prenesite iz viale v infuzijsko vrečko, v kateri je 100 ml 0,9-odstotne (normalne) fiziološke raztopine, in dobro premešajte.
Cidofovir suppresses HCMV replication by selective inhibition of viral DNA synthesis.
Cidofovir s selektivno inhibicijo sinteze virusne DNA zavre replikacijo humanega citomegalovirusa.
The appropriate dose of Vistide should be transferred from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution.
Ustrezen odmerek zdravila Vistide je treba prenesti iz viale v infuzijsko vrečko, ki vsebuje 100 mililitrov 0,9-odstotne (normalne) fiziološke raztopine.
Cidofovir induced chromosomal aberrations in human peripheral blood lymphocytes in vitro without metabolic activation (S-9 fraction).
In vitro je cidofovir brez presnovne aktivacije (frakcija S-9) induciral kromosomske aberacije v človeških limfocitih v periferni krvi.
No mutagenic response was elicited by cidofovir at dose levels up to 5 mg/plate, in the presence and absence of metabolic activation by rat liver S-9 fraction, in microbial assays involving Salmonella typhimurium for base pair substitutions or frameshift mutations (Ames) and Escherichia coli for reverse mutations.
V mikrobnih preizkusih, v katerih so raziskovali substitucijo baznih parov pri Salmonella typhimurium ali mutacije okvirnega položaja (frameshift mutation; Ames) in reverzne mutacije pri Escherichia coli, cidofovir ni bil mutagen v odmerkih do 5 mg/ploščico, s presnovno aktivacijo s frakcijo S-9 podganjih jeter ali brez takšne aktivacije.
Viral resistance
Odpornost virusov
The saline solution should be infused over a 1 hour period immediately before the Vistide infusion.
Fiziološko raztopino vam morajo infundirati v enournem obdobju tik pred infuzijo zdravila Vistide.
Very common side effects (These can affect more than 1 user in 10)
Zelo pogosti neželeni učinki (Pojavijo se lahko pri več kot 1 od 10 bolnikov)
If you could get pregnant, you must use an effective method of contraception to stop you getting pregnant during treatment with Vistide
Če lahko zanosite, morate med zdravljenjem z zdravilom Vistide in 1 mesec po njem uporabljati učinkovito kontracepcijsko zaščito.
Normal saline is given to lower the risk of kidney damage.
Normalna fiziološka raztopina se uporablja za zmanjšanje tveganja okvare ledvic.
You should receive a total of one litre of 0.9% (normal) saline solution intravenously (as a drip into a vein) before each Vistide dose.
Pred vsakim odmerkom zdravila Vistide morate dobiti skupno en liter 0,9-odstotne (normalne) fiziološke raztopine intravensko (vkapljanja v veno).
Vistide 75 mg/ml concentrate for solution for infusion Cidofovir
Vistide 75 mg/ml koncentrat za raztopino za infundiranje cidofovir
Vistide should be used with caution in diabetic patients due to the potential increased risk of developing low pressure in the eye (ocular hypotony).
Pri bolnikih z diabetesom je treba zdravilo Vistide uporabljati previdno, ker ga spremlja zvečano tveganje za nizek očesni
The entire volume of the bag should be infused into the patient's vein at a constant rate over a period of 1 hour using a standard infusion pump.
Celotno količino infuzijske vrečke je treba bolniku infundirati intravensko s standardno infuzijsko črpalko in stalno hitrostjo v obdobju ene ure.
Vistide vials should be visually inspected for particulate matter and discolouration prior to administration.
Viale zdravila Vistide je treba pred uporabo pregledati in preveriti, da v vsebini ni delcev in da ni obarvana.
Vistide must be diluted in 100 millilitres 0.9% (normal) saline prior to administration.
Zdravilo Vistide je treba pred uporabo raztopiti s 100 mililitri 0,9-odstotne (normalne) fiziološke raztopine.
Each vial contains 375 mg/5 ml cidofovir anhydrous.
Ena viala vsebuje 375 mg/5 ml brezvodnega cidofovira.
Adequate precautions including the use of appropriate safety equipment are recommended for the preparation, administration and disposal of Vistide.
Pri pripravi, uporabi in odstranjevanju zdravila Vistide je treba upoštevati ustrezne previdnostne ukrepe, vključno z uporabo primerne varnostne opreme.
An increase in formation of micronucleated polychromatic erythrocytes was observed in vivo in mice receiving a high, toxic intraperitoneal dose of cidofovir (≥ 2,000 mg/kg).
Pri miših, ki so dobile velik, toksičen intraperitonealen odmerek cidofovira (≥ 2.000 mg/kg), so in vivo opažali zvečano tvorbo mikronukleusnih polikromatičnih eritrocitov.
NAME OF THE MEDICINAL PRODUCT Vistide 75 mg/ml concentrate for solution for infusion
IME ZDRAVILA Vistide 75 mg/ml koncentrat za raztopino za infundiranje
Cidofovir therapy should be discontinued and intravenous hydration is advised if serum creatinine increases by ≥ 44 µmol/l (≥ 0.5 mg/dl), or if persistent proteinuria ≥ 2+ develops.
Če kreatinin v serumu naraste na ≥ 44 µmol/l (≥ 0,5 mg/dl) ali se pojavi trajna proteinurija ≥ 2+, je treba zdravljenje s cidofovirom prekiniti in priporočljiva je intravenska hidracija.
Nervous system disorders Common
Bolezni živčevja Pogosti
6 weeks prior to mating and for 2 weeks post mating had decreased litter sizes and live births per litter and increased early resorptions per litter.
Podganje samice, ki so dobivale cidofovir intravensko v odmerkih 1,2 mg/kg/teden ali več enkrat na teden do 6 tednov pred parjenjem in 2 tedna po njem, so imele manjšo velikost legla in manj živorojenih mladičev na leglo ter več zgodnjih resorpcij na leglo.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vistide 75 mg/ml concentrate for solution for infusion Cidofovir
IME ZDRAVILA IN POT(I) UPORABE Vistide 75 mg/ml koncentrat za raztopino za infundiranje cidofovir
Your treatment with Vistide may be stopped by your doctor if changes in kidney function occur.
Če se vam delovanje ledvic spremeni, lahko zdravnik zdravljenje z zdravilom Vistide prekine.
Dyspnea
Odmerek
The table below lists the adverse reactions identified through clinical trials or post-marketing surveillance by system organ class (SOC) and frequency.
Spodnja tabela po organskih sistemih in pogostnosti navaja neželene učinke, ugotovljene v kliničnih preskušanjih ali med pomarketinškim spremljanjem.
Vistide is used to treat an eye infection called CMV retinitis in patients with AIDS (Acquired Immunodeficiency Syndrome).
Kaj je zdravilo Vistide in za kaj ga uporabljamo Zdravilo Vistide se uporablja za zdravljenje okužbe oči, imenovane citomegalovirusni retinitis, pri bolnikih z AIDS-om (sindromom pridobljene imunske pomanjkljivosti).
Clear solution.
Bistra raztopina.
Caution should be applied when considering cidofovir treatment of patients with diabetes mellitus due to the potential increased risk of developing ocular hypotony.
Zaradi potencialno zvečanega tveganja za očesno hipotonijo je treba zdravljenje s cidofovirom previdno pretehtati pri bolnikih z diabetesom mellitusom.
Date of last renewal
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Beginning two weeks after the completion of induction treatment, the recommended maintenance dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once every two weeks.
Priporočeni vzdrževalni odmerek cidofovira je 5 mg/kg telesne teže (v enourni intravenski infuziji s stalno hitrostjo) enkrat na dva tedna.
• nausea, vomiting, rash and fever.
• slabost s siljenjem na bruhanje, bruhanje, izpuščaj in vročina.
• low white blood cell counts, headache, nausea, vomiting, protein in the urine, increase in blood creatinine (a measure of kidney function), hair loss, rash, weakness/fatigue and fever.
• znižano število belih krvnih celic, glavobol, slabost s siljenjem na bruhanje, bruhanje,
Adverse reactions such as asthenia may occur during cidofovir therapy.
Med zdravljenjem s cidofovirom se lahko pojavijo neželeni učinki, npr. astenija.
The following information is intended for medical or healthcare professionals only: Vistide vials should be inspected visually prior to use.
Viale zdravila Vistide je treba pred uporabo pregledati.
No adverse effects on fertility or general reproduction were seen following once weekly intravenous injections of cidofovir in male rats for 13 consecutive weeks at doses up to 15 mg/kg/week.
Po intravenskem injiciranju cidofovira podganjim samcem enkrat na teden 13 tednov zapored v odmerkih do 15 mg/kg/teden niso ugotovili neželenih učinkov na plodnost ali splošno reprodukcijsko sposobnost.
Eye disorders Common
Očesne bolezni Pogosti
Each vial contains 375 mg/5 ml cidofovir anhydrous as the active substance.
Ena viala kot zdravilno učinkovino vsebuje 375 mg/5 ml brezvodnega cidofovira.
Food should be taken before you are given Vistide.
Pred uporabo zdravila Vistide morate zaužiti hrano.
23 April 2007
Datum zadnjega podaljšanja dovoljenja za promet: 23.4.2007
Elderly population:
Starejši:
• You should not be given Vistide if you are breast-feeding.
• Če dojite, ne smete dobiti zdravila Vistide.