natgillin/translations-raw huggingface dataset:
VISTIDE should not be used during pregnancy.
Zdravila VISTIDE se med nosečnostjo ne sme uporabljati.
Women of childbearing potential should be advised to use effective contraception during and after treatment with cidofovir.
Ženske v rodni dobi morajo med zdravljenjem s cidofovirom in po njem uporabljati učinkovito kontracepcijo.
Lactation It is not known whether cidofovir is excreted in human milk.
Dojenje Ni znano, ali se cidofovir izloča v materino mleko.
Because many substances are excreted in human milk, nursing mothers should be instructed to discontinue cidofovir or discontinue nursing if they continue to receive cidofovir.
Ker se v materino mleko izločajo številne snovi, je treba doječim materam naročiti, naj nehajo uporabljati cidofovir oz. naj nehajo dojiti, če nadaljujejo z uporabo cidofovira.
Passage of the placenta barrier of cidofovir-related compound was observed in pregnant rats.
Pri brejih podganah so opažali prehajanje cidofoviru sorodne snovi skozi placentno pregrado.
Excretion of cidofovir-related material into milk of lactating animals was not examined.
Izločanje cidofoviru sorodnih snovi v mleku doječih živali ni raziskano.
Refer to section 4.4 for further information
Za nadaljnje informacije glejte poglavje 4. 4.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1000 to < 1/ 100) or not known (cannot be estimated from the available data).
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10), občasni (≥ 1/ 1000 do < 1/ 100) ali ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
Adverse reactions possibly or probably related to cidofovir based on clinical trial experience and post-marketing surveillance
5 Neželeni učinki, morda ali verjetno povezani s cidofovirjem na podlagi kliničnih preskušanj in pomarketinškega spremljanja
System Organ Class Blood and lymphatic system disorders
Organski sistem Bolezni krvi in limfatičnega sistema
Very common Nervous system disorders
Zelo pogosti Bolezni živčevja
Very common Eye disorders
Zelo pogosti Očesne bolezni
Common Ear and labyrinth disorders
Pogosti Ušesne bolezni, vključno z motnjami labirinta
Iritis, uveitis, hypotony of the eye (see Section 4.4)
Iritis, uveitis, hipotonija očesa (glejte poglavje 4. 4)
Not known Respiratory, thoracic and mediastinal disorders
Ni znano
Common Gastrointestinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti Bolezni prebavil
Very common Not known Skin and subcutaneous tissue disorders
Zelo pogosti Ni znano Bolezni kože in podkožja
Nausea, Vomiting Pancreatitis
Navzea, bruhanje Pankreatitis
Very common Renal and urinary disorders
Zelo pogosti Bolezni sečil
Proteinuria, blood creatinine increased (see Section 4.4)
Proteinurija, zvišanje kreatinina v krvi (glejte poglavje 4. 4)
Common Uncommon
Pogosti Občasni Splošne težave in spremembe na mestu aplikacije
Renal failure Fanconi syndrome acquired
Odpoved ledvic Pridobljeni Fanconijev sindrom
General disorders and administration site conditions Very common Common
Zelo pogosti Pogosti
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.
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.
The finding of any glycosuria, proteinuria/ aminoaciduria, hypouricemia, hypophosphatemia and/ or hypokalemia, should prompt for the consideration of cidofovir-related Fanconi syndrome.
Pojav glikozurije, proteinurije/ aminacidurije, hipourikemije, hipofosfatemije in/ ali hipokaliemije mora zbuditi sum na Fanconijev sindrom, povezan s cidofovirjem.
6 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:
System Organ Class Nervous system disorders
Organski sistem Bolezni živčevja
Common Gastrointestinal disorders
Pogosti Bolezni prebavil
Very common Skin and subcutaneous tissue disorders
Zelo pogosti Bolezni kože in podkožja
General disorders and administration site conditions Very common Common
Zelo pogosti Splošne težave in spremembe na mestu aplikacije
Fever Asthenia, chills
Izpuščaj
In addition probenecid may also cause other adverse
Zelo pogosti Pogosti
reactions including anorexia, gingival pain,
Zvišana telesna temperatura Astenija, mrzlica
flushing, alopecia, dizziness, anaemia, and pollakiuria.
6 Poleg tega lahko probenecid povzroči tudi druge neželene učinke, med drugim anoreksijo, bolečine v dlesnih, zardevanje, alopecijo, omotico, anemijo in polakisurijo.
Hypersensitivity reactions, with dermatitis, pruritus, urticaria and, rarely, anaphylaxis, and Stevens-Johnson syndrome have occurred.
Pojavile so se preobčutljivostne reakcije z dermatitisom, srbenjem, urtikarijo in, redko, anafilaksijo in Stevens- Johnsonovim sindromom.
One patient received a single dose of 16.4 mg/ kg and the other patient received a single dose of 17.3 mg/ kg.
En bolnik je dobil en sam odmerek 16, 4 mg/ kg, drugi bolnik pa en sam odmerek 17, 3 mg/ kg.
One of these patients experienced a minor transient change in renal function, while the other patient had no change in renal function (see section 4.4).
Pri enem od teh bolnikov je prišlo do majhne prehodne spremembe v delovanju ledvic, pri drugem pa se delovanje ledvic ni spremenilo (glejte poglavje 4. 4).
Antiviral for systemic use, ATC Code:
Oznaka ATC:
General Cidofovir is a cytidine analogue with in vitro and in vivo activity against human cytomegalovirus (HCMV).
Splošno Cidofovir je citidinski analog, ki deluje proti humanemu citomegalovirusu (HCMV) in vitro in in vivo.
Mechanism of action Cidofovir suppresses HCMV replication by selective inhibition of viral DNA synthesis.
Mehanizem delovanja Cidofovir s selektivno inhibicijo sinteze virusne DNA zavre replikacijo humanega citomegalovirusa.
Biochemical data support selective inhibition of HSV-1, HSV-2 and HCMV DNA polymerases by cidofovir diphosphate, the active intracellular metabolite of cidofovir.
Biokemični podatki potrjujejo selektivno zavrtje DNA polimeraz HSV- 1, HSV- 2 in HCMV s cidofovirdifosfatom, aktivnim znotrajceličnim presnovkom cidofovira.
Cidofovir diphosphate inhibits these viral polymerases at concentrations that are 8- to 600-fold lower than those needed to inhibit human cellular DNA polymerases alpha, beta, and gamma.
Cidofovirdifosfat zavre te virusne polimeraze v koncentracijah, ki so od 8 - do 600- krat nižje od koncentracij, potrebnih za zavrtje DNA polimeraz alfa, beta in gama v človeških celicah.
Prolonged antiviral effects of cidofovir are related to the half-lives of its metabolites; cidofovir diphosphate persists inside cells with a half-life of 17-65 hours and a cidofovir phosphate-choline adduct has a half-life of 87 hours.
Podaljšano protivirusno učinkovanje cidofovira je povezano z razpolovnimi časi njegovih presnovkov; cidofovirdifosfat ostane v notranjosti celic z razpolovnim časom od 17 do 65 ur; adukt cidofovirfosfat- holin ima razpolovni čas 87 ur.
7 Antiviral activity Cidofovir is active in vitro against HCMV, a member of the herpesviridae family.
Protivirusno delovanje Cidofovir in vitro deluje proti humanemu citomegalovirusu, pripadniku družine herpesvirid.
The in vitro sensitivity to cidofovir is shown in the following table:
Občutljivost za cidofovir in vitro prikazuje naslednja preglednica.
Cidofovir Inhibition of Virus Multiplication in Cell Culture
Zavrtje razmnoževanja virusa s cidofovirom v celični kulturi
Virus wild-type CMV isolates ganciclovir-resistant CMV isolates foscarnet-resistant CMV isolates
virus divji tip izolatov CMV proti gancikloviru odporni izolati CMV proti foskarnetu odporni izolati CMV
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 aidsom.
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.
Čas do napredovanja citomegalovirusnega retinitisa pri bolnikih, ki so dobivali cidofovir, je bil v teh študijah statistično pomembno daljši kot pri kontrolnih bolnikih.
22 days and 21 days for the untreated (deferred treatment) arms, respectively.
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.
In study GS-93-107 conducted in patients who had relapsed after treatment with other agents, the median time to retinitis progression was 115 days.
V študiji GS- 93- 107, opravljeni pri bolnikih z relapsom po zdravljenju z drugimi zdravili, je bil mediani čas do napredovanja retinitisa 115 dni.
Viral resistance 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.
Odpornost virusov 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.
Cidofovir-selected mutants had a mutation in the DNA polymerase gene and were cross-resistant to ganciclovir, but susceptible to foscarnet.
S cidofoviroim selekcionirani mutanti so imeli mutacijo v genu za DNA polimerazo in so bili navzkrižno odporni proti gancikloviru, a občutljivi za foskarnet.
The major route of elimination of cidofovir was by renal excretion of unchanged drug by a combination of glomerular filtration and tubular secretion.
Glavna pot izločanja cidofovira je ledvično izločanje nespremenjenega zdravila s kombinacijo glomerulne filtracije in tubulne sekrecije.
In patients with normal renal function, 80 to 100% of the intravenous dose was recovered in the urine over 24 hours as unchanged cidofovir.
Pri bolnikih z normalnim delovanjem ledvic se je v 24 urah od 80 do 100% intravenskega odmerka izločilo v urinu kot nespremenjeni cidofovir.
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) mcg/ ml.
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) mcg/ ml.
The mean values of total serum clearance, volume of distribution at steady-state and terminal elimination half-life were 138 (± 36) ml/ hr/ kg, 388 (± 125) ml/ kg and 2.2 (±0.5) hour, respectively.
Povprečni celotni serumski očistek je bil 138 (± 36) ml/ uro/ kg, volumen porazdelitve v stanju dinamičnega ravnovesja 388 (± 125) ml/ kg in terminalni razpolovni čas izločanja 2, 2 (± 0, 5) ure.
Dose-independent kinetics were demonstrated with single doses of cidofovir given over the dose range 3 to 7.5 mg/ kg.
S posamičnimi odmerki cidofovira v odmernem območju od 3 do 7, 5 mg/ kg so dokazali od odmerka neodvisno kinetiko.
In vitro protein binding In vitro protein binding of cidofovir to plasma or serum protein was 10% or less over the cidofovir concentration range 0.25 to 25 mcg/ ml.
Vezava na beljakovine in vitro Vezava cidofovira na beljakovine v plazmi ali serumu in vitro je bila v koncentracijskem območju od 0, 25 do 25 mcg/ ml cidofovira 10% ali manj.
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.
Carcinogenesis 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.
Kancerogeneza 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.
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.
V drugi študiji je subkutano injiciranje cidofovira 19 tednov zapored pri podganjih samicah povzročilo mamarne adenokarcinome že v odmerkih 0, 6 mg/ kg/ teden.
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.
Mutagenicity and reproductive toxicology Studies have shown that cidofovir is clastogenic in vitro at 100 µg/ ml and is embryotoxic in rats and rabbits.
8 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.
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.
An increase in formation of micronucleated polychromatic erythrocytes was observed in vivo in mice receiving a high, toxic intraperitoneal dose of cidofovir (≥ 2000 mg/ kg).
Pri miših, ki so dobile velik, toksičen intraperitonealen odmerek cidofovira (≥ 2000 mg/ kg), so in vivo opažali zvečano tvorbo mikronukleusnih polikromatičnih eritrocitov.
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.
At the 4 cidofovir levels (12.5 to 100 µg/ ml) tested, the percentage of damaged metaphases and number of aberrations per cell increased in a concentration-dependent manner.
Pri 4 raziskanih koncentracijah cidofovira (od 12, 5 do 100 µg/ ml) sta odstotek okvarjenih metafaz in število aberacij na celico naraščala od koncentracije odvisno.
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.
Female rats dosed intravenously once weekly at 1.2 mg/ kg/ week or higher for up to 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.
Peri- and post-natal development studies in which female rats received subcutaneous injections of cidofovir once daily at doses up to 1.0 mg/ kg/ day from day 7 of gestation through day 21 postpartum (approximately 5 weeks) resulted in no adverse effects on viability, growth, behaviour, sexual maturation or reproductive capacity in the offspring.
Peri - in postnatalne razvojne študije, v katerih so podganje samice enkrat na dan dobivale subkutane injekcije cidofovira v odmerkih do 1, 0 mg/ kg/ dan, in sicer od 7. dne gestacije do 21. postpartalnega dneva (približno 5 tednov), niso pokazale nobenih neželenih učinkov na sposobnost za življenje mladičev, njihovo rast, vedenje, spolno dozorevanje ali reprodukcijsko zmožnost.
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 no- observable-effect dosages for embryotoxicity was 0.5 mg/ kg/ day in rats and 0.25 mg/ kg/ day in rabbits.
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.
Sodium Hydroxide Hydrochloric Acid Water for Injection
natrijev hidroksid klorovodikova kislina voda za injekcije
This medicinal product must not be mixed with other medicinal products or diluents except those mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili ali topili razen s tistimi, ki so omenjena v poglavju 6. 6.
Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2 – 8ºC when dilution is performed under controlled and validated aseptic conditions.
Kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi od 2 - 8 °C, če je bilo redčenje izvedeno pod kontroliranimi in validiranimi aseptičnimi pogoji.
For storage conditions of the diluted medicinal product see section 6.3
Za pogoje shranjevanja razredčenega zdravila glejte poglavje 6. 3.
Type I clear borosilicate glass vials, Teflon faced grey butyl plug stoppers, and aluminium crimp seals with a flip off plastic tab.
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.
VISTIDE is supplied in single-use vials.
Zdravilo VISTIDE je na voljo v vialah za enkratno uporabo.
6.6 Special precautions for disposal and other handling of the product
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Method of preparation and administration VISTIDE vials should be visually inspected for particulate matter and discolouration prior to administration.
Postopek priprave in apliciranja Kot velja za vsa parenteralna zdravila, je treba viale zdravila VISTIDE pred uporabo pregledati in preveriti, da v vsebini ni delcev in da ni obarvana.
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% fiziološke raztopine, in dobro premešajte.
VISTIDE should be administered by health care professionals adequately experienced in the care of AIDS patients.
Zdravilo VISTIDE morajo aplicirati zdravstveni delavci, ki imajo ustrezne izkušnje z oskrbo bolnikov z aidsom.
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 I. V. 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 apliciranje, izdelanih na podlagi PVC.
Other types of I. V. set tubing and infusion bags have not been studied.
Druge vrste intravenskih cevnih kompletov in infuzijskih vrečk niso raziskane.
Compatibility with Ringer’ s Solution, Lactated Ringer’ s Solution or bacteriostatic infusion fluids has not been evaluated.
Združljivost z Ringerjevo raztopino, Ringerjevo laktatno raztopino ali bakteriostatskimi infuzijskimi tekočinami ni raziskana.
Handling and disposal Adequate precautions including the use of appropriate safety equipment are recommended for the preparation, administration and disposal of VISTIDE.
Ravnanje in odstranjevanje Pri pripravi, uporabi in odstranjevanju zdravila VISTIDE je treba upoštevati ustrezne previdnostne ukrepe, vključno z uporabo primerne varnostne opreme.
The preparation of VISTIDE reconstituted solution should be done in a laminar flow biological safety cabinet.
Raztopino zdravila VISTIDE je treba pripraviti v biološkem varnostnem sistemu z laminarnim pretokom.
If VISTIDE contacts the skin, wash membranes and flush thoroughly with water.
Če pride zdravilo VISTIDE v stik s kožo, jo je treba umiti in temeljito splakniti z vodo.
Excess VISTIDE and all other materials used in the admixture preparation and administration
Ostanke zdravila VISTIDE in vseh drugih materialov, ki se uporabljajo za pripravo in apliciranje mešanice, je treba dati v neprepusten, proti vbodom varen vsebnik za odlaganje.
Obtaining probenecid Probenecid is not supplied with VISTIDE and should be obtained via the Marketing Authorisation Holder of probenecid.
Kako dobiti probenecid Probenecid ni dobavljen skupaj z zdravilom VISTIDE in ga je treba dobiti od imetnika dovoljenja za promet s probenecidom.
However, in case of difficulty in obtaining probenecid the local representative of the Marketing Authorisation Holder of VISTIDE should be contacted for information (See also sections 4.2 and 4.4).
V primeru težav z dobavo probenecida pa se je mogoče za informacije obrniti na lokalnega predstavnika imetnika dovoljenja za promet z zdravilom VISTIDE (glejte tudi poglavji 4. 2 in 4. 4).
Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom
Gilead Sciences International Limited Cambridge CB21 6GT 10 Velika Britanija
DATE OF RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
Date of first authorisation Date of last renewal.
Datum pridobitve dovoljenja za promet:
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu
12 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
12 A IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
VISTIDE 75 mg/ ml concentrate for solution for infusion Cidofovir
VISTIDE 75 mg/ ml koncentrat za raztopino za infundiranje cidofovir
Cidofovir Each ml contains 75 mg cidofovir anhydrous.
Cidofovir En ml vsebuje 75 mg brezvodnega cidofovira.
Each vial contains 375 mg/ 5ml cidofovir anhydrous.
Ena viala vsebuje 375 mg/ 5 ml brezvodnega cidofovira.
For intravenous infusion only.
Samo za intravensko uporabo.
17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
17 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVONINAH
VISTIDE 75 mg/ ml concentrate for solution for infusion Cidofovir For intravenous infusion only.
VISTIDE 75 mg/ ml koncentrat za raztopino za infundiranje cidofovir Samo za intravensko infundiranje.
5 ml vial.
5 ml viala