FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have any kidney or blood problems your doctor might suggest a smaller dose of Cymevene and check your blood cell counts more often during treatment.
Slovenian: Če imate kakršne koli težave z ledvicami ali krvjo, vam bo zdravnik morda predlagal manjši odmerek zdravila Cymevene in vam bo med zdravljenjem pogosteje kontroliral krvno sliko.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Slovenian: Navodilo je bilo nazadnje revidirano {mesec LLLL}.
English: Caution:
Slovenian: Opozorilo:
English: The steady state volume of distribution has a range of 0.54−0.87 L/kg.
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja je od 0,54 do 0,87 l/kg.
English: Do not use bacteriostatic water for injection containing parabens (para-hydroxybenzoates), since these are incompatible with Cymevene.
Slovenian: Ne uporabljajte bakteriostatske vode za injekcije, ki vsebuje parabene (parahidroksibenzoate), ker ti niso kompatibilni z zdravilom Cymevene.
English: Alopecia Urticaria Dry skin
Slovenian: alopecija urtikarija suhost kože
English: Pharmacokinetics of intravenous ganciclovir were also studied in infants and children with normal renal function and aged 9 months−12 years.
Slovenian: Farmakokinetiko intravenskega ganciklovirja so raziskali tudi pri dojenčkih in otrocih z normalnim delovanjem ledvic, starih od 9 mesecev do 12 let.
English: Caution should be exercised in the handling of Cymevene.
Slovenian: Pri ravnanju z zdravilom Cymevene je potrebna previdnost.
English: Patients with low baseline platelet counts (< 100,000 /mL) have an increased risk of developing thrombocytopenia.
Slovenian: Bolniki z majhnim izhodiščnim številom trombocitov (< 100.000/ml) imajo večje tveganje za pojav trombocitopenije.
English: • vincristine, vinblastine, doxorubicin - used for cancer,
Slovenian: • vinkristin, vinblastin, doksorubicin - uporabljajo se za zdravljenje raka,
English: Probenecid given with oral ganciclovir resulted in statistically decreased renal clearance of ganciclovir, and led to clinically significant increased exposure.
Slovenian: Probenecid, uporabljen s peroralnim ganciklovirjem, je statistično zmanjšal ledvični očistek ganciklovirja in klinično pomembno povečal izpostavljenost.
English: From a microbiological point of view, the Cymevene infusion solution should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba raztopino zdravila Cymevene za infundiranje uporabiti takoj.
English: The fraction of ganciclovir removed during a single dialysis session varied from 50% to 63%.
Slovenian: Delež ganciklovirja, ki se je odstranil med eno dializo, je bil od 50 do 63 %.
English: Injection site reactions occur commonly in patients receiving ganciclovir.
Slovenian: Reakcije na mestu injiciranja so pri bolnikih, ki prejemajo ganciklovir, pogoste.
English: In animal studies ganciclovir was found to be mutagenic, teratogenic, aspermatogenic, carcinogenic and to impair fertility.
Slovenian: V študijah na živalih se je ganciklovir izkazal za mutagenega, teratogenega, aspermatogenega, kancerogenega in je okvaril plodnost.
English: Sensitive human viruses include human cytomegalovirus (HCMV), herpes-simplex virus-1 and -2 (HSV-1 and HSV-2), human herpes virus -6, -7 and -8 (HHV-6, HHV-7, HHV-8), Epstein-Barr virus (EBV), varicella-zoster virus (VZV), and hepatitis B virus.
Slovenian: Med občutljivimi humanimi virusi so humani citomegalovirus (HCMV), herpes-simpleks virus-1 in -2 (HSV-1 in HSV-2), humani herpesvirus -6, -7 in -8 (HHV-6, HHV-7, HHV-8), Epstein-Barrov virus (EBV), virus varicella-zoster (VZV) in virus hepatitisa B. Klinične študije so bile omejene na oceno učinkovitosti pri bolnikih s citomegalovirusno okužbo.
English: • low white blood cell counts.
Slovenian: • majhno število belih krvnih celic.
English: The duration of maintenance treatment should be determined on an individual basis, local treatment guidelines should be consulted.
Slovenian: Trajanje vzdrževalnega zdravljenja je treba določiti individualno in upoštevati je treba lokalne smernice za zdravljenje.
English: Viruses containing mutations in the UL97 gene are resistant to ganciclovir alone, whereas viruses with mutations in the UL54 gene are resistant to ganciclovir but may show cross-resistance to other antivirals that also target viral polymerase.
Slovenian: Virusi z mutacijami v genu UL97 so odporni samo proti ganciklovirju, medtem ko so virusi z mutacijami v genu UL54 odporni proti ganciklovirju, navzkrižno pa so lahko odporni tudi proti drugim protivirusnim zdravilom, ki so prav tako usmerjena na virusno polimerazo.
English: • you are allergic to aciclovir, valaciclovir, penciclovir or famciclovir - these are other medicines used for viral infections
Slovenian: • če ste alergični na aciklovir, valaciklovir, penciklovir ali famciklovir - to so druga zdravila, ki se uporabljajo za zdravljenje virusnih okužb.
English: Hepatic function abnormal Blood alkaline phosphatase increased Aspartate aminotransferase increased
Slovenian: nenormalno delovanje jeter zvišanje alkalne fosfataze v krvi zvišanje aspartat-aminotransferaze
English: Patients with iatrogenic immunosuppression due to treatment with immunosuppressive drugs are at greater risk of thrombocytopenia than patients with AIDS (see section 4.4).
Slovenian: Bolniki z iatrogeno imunosupresijo zaradi zdravljenja z imunosupresivnimi zdravili imajo večje tveganje za trombocitopenijo kot bolniki z AIDSom (glejte poglavje 4.4).
English: It is considered likely that ganciclovir causes temporary or permanent inhibition of spermatogenesis (see sections 4.6, 4.8 and 5.3).
Slovenian: Verjetno je, da ganciklovir prehodno ali trajno zavre spermatogenezo (glejte poglavja 4.6, 4.8 in 5.3).
English: As dosage modifications are recommended in patients with renal impairment, serum creatinine or estimated creatinine-clearance levels should be monitored.
Slovenian: Ker je za bolnike z okvaro ledvic priporočena prilagoditev odmerjanja, jim je treba kontrolirati kreatinin v serumu ali ocenjeno vrednost očistka kreatinina.
English: Cymevene is used to treat diseases caused by a virus called cytomegalovirus (CMV) in patients who have a weak immune system.
Slovenian: Zdravilo Cymevene uporabljamo za zdravljenje bolezni, ki jo povzroča virus, imenovan citomegalovirus (CMV), pri bolnikih z oslabljenim imunskim sistemom.
English: Further phosphorylation occurs by several cellular kinases to produce ganciclovir triphosphate, which is then slowly metabolised intracellularly.
Slovenian: Nadaljnja fosforilacija poteka z več celičnimi kinazami, tako da nastane ganciklovir-trifosfat, ki se nato počasi presnovi znotraj celice.
English: This adverse reaction has only been reported in studies in AIDS patients treated with Cymevene for CMV retinitis.
Slovenian: O tem neželenem učinku so poročali le v študijah pri bolnikih z AIDSom, ki so zdravilo Cymevene prejemali za zdravljenje citomegalovirusnega retinitisa.
English: Therefore, patients taking probenecid and Cymevene should be closely monitored for ganciclovir toxicity.
Slovenian: Zato je treba bolnike, ki sočasno dobivajo probenecid in zdravilo Cymevene, skrbno spremljati glede toksičnih učinkov ganciklovirja.
English: Toxicity may be enhanced when ganciclovir is co-administered with other drugs known to be myelosuppressive or associated with renal impairment (such as dapsone, pentamidine, flucytosine, vincristine, vinblastine, doxorubicin, amphotericin B, mycophenolate mofetil, trimethoprim/sulphamethoxazole, and hydroxyurea) as well as nucleoside analogues (including zidovudine).
Slovenian: Toksičnost se lahko poveča, če je ganciklovir uporabljen sočasno z drugimi zdravili, za katera je znano, da so mielosupresivna ali so povezana z okvaro ledvic (npr. dapson, pentamidin, flucitozin, vinkristin, vinblastin, doksorubicin, amfotericin B, mofetilmikofenolat, trimetoprim/sulfametoksazol in hidroksisečnina), ter z nukleozidnimi analogi (vključno z zidovudinom).
English: Therefore, ganciclovir should not be used in pregnant women unless the clinical need for treatment of the woman outweighs the potential teratogenic risk to the foetus.
Slovenian: Zato se ga ne sme uporabljati pri nosečnicah, razen če klinična potreba po zdravljenju bolnice odtehta možna teratogena tveganja za plod.
English: The volume of distribution of intravenously administered ganciclovir is correlated to body weight.
Slovenian: Porazdelitev Volumen porazdelitve intravensko uporabljenega ganciklovirja korelira s telesno maso.
English: Ganciclovir was mutagenic in mouse lymphoma cells and clastogenic in mammalian cells.
Slovenian: Ganciklovir je bil mutagen v celicah mišjega limfoma in klastogen v celicah sesalcev.
English: • hives, dry skin
Slovenian: • koprivnica, suha koža
English: Do not use Cymevene if any of the above apply to you.
Slovenian: Ne uporabljajte zdravila Cymevene, če kaj od naštetega velja za vas.
English: Dermatitis Night sweats Pruritus
Slovenian: dermatitis nočno znojenje srbenje
English: None of the children required a cochlear implant and hearing loss improved in 83% of ears affected by hearing loss at baseline.
Slovenian: Nobeden od teh otrok ni potreboval kohlearnega vsadka in poslabšanje sluha se je izboljšalo pri 83 %
English: As the phosphorylation is largely dependent on the viral kinase, phosphorylation of ganciclovir occurs preferentially in virus-infected cells.
Slovenian: Ker je fosforilacija v veliki meri odvisna od virusne kinaze, poteka fosforilacija ganciklovirja predvsem v celicah, okuženih z virusom.
English: Other potential drug interactions
Slovenian: Druga možna medsebojna delovanja z zdravili
English: • hands or feet feeling weak or numb, which may affect your balance
Slovenian: • občutek šibkosti ali omrtvičenosti dlani in stopal; to vam lahko poslabša ravnotežje
English: • feeling agitated or nervous
Slovenian: • vznemirjenost ali živčnost
English: The pharmacokinetic properties of ganciclovir have been evaluated in HIV- and CMV-seropositive patients, patients with AIDS and CMV retinitis, and in solid organ transplant patients.
Slovenian: Farmakokinetične lastnosti ganciklovirja so ocenili pri HIV- in CMV-seropozitivnih bolnikih, bolnikih z AIDSom in citomegalovirusnim retinitisom ter prejemnikih presajenih solidnih organov.
English: Powder: Does not require any special storage conditions.
Slovenian: Prašek: Za shranjevanje zdravila niso potrebna posebna navodila.
English: This is because Cymevene may harm the unborn baby.
Slovenian: Zdravilo Cymevene namreč lahko škoduje nerojenemu otroku.
English: • a skin reaction where the medicine was injected - such as inflammation, pain and swelling.
Slovenian: • kožna reakcija na mestu, kjer je bilo injicirano zdravilo - na primer vnetje, bolečine in oteklost.
English: • you are breast-feeding (see Breast-feeding subsection).
Slovenian: • če dojite (glejte podpoglavje Dojenje).
English: Ganciclovir is removed by haemodialysis, therefore haemodialysis may be of benefit in reducing drug exposure in patients who receive an overdose of ganciclovir (see section 5.2).
Slovenian: Ganciklovir se odstranjuje s hemodializo, zato lahko hemodializa koristi za zmanjšanje izpostavljenosti zdravilu pri bolnikih, ki dobijo prevelik odmerek ganciklovirja (glejte poglavje 5.2).
English: The pharmacokinetics of intravenous ganciclovir were investigated in neonates aged 2−49 days following doses of 4 mg/kg (N = 14) and 6 mg/kg (N = 13).
Slovenian: Pediatrična populacija Farmakokinetiko intravenskega ganciklovirja so raziskali pri novorojenčkih, starih od 2 do 49 dni, po uporabi odmerkov 4 mg/kg (n = 14) in 6 mg/kg (n = 13).
English: Patients with renal impairment have an increased elimination half-life and, depending on renal function, it ranges from about 6 to 17 hours (see section 4.2 for dose modifications required in patients with renal impairment).
Slovenian: Bolniki z okvaro ledvic imajo podaljšan eliminacijski razpolovni čas, ki - odvisno od delovanja ledvic - sega od približno 6 do 17 ur (za prilagoditev odmerka, potrebno pri bolnikih z okvaro ledvic, glejte poglavje 4.2).
English: Other adverse drugs reactions are presented in the table below.
Slovenian: Drugi neželeni učinki zdravila so prikazani v spodnji preglednici.
English: For patients with severe leucopenia, neutropenia, anaemia and/or thrombocytopenia it is recommended to consider the use of treatment with haematopoietic growth factors and/or the interruption of ganciclovir therapy (see sections 4.2 and 4.8).
Slovenian: Pri bolnikih s hudo levkopenijo, nevtropenijo, anemijo in/ali trombocitopenijo je priporočljivo razmisliti o zdravljenju s hematopoetskimi rastnimi faktorji in/ali o prekinitvi zdravljenja z ganciklovirjem (glejte poglavji 4.2 in 4.8).
English: LIST OF EXCIPIENTS This medicinal product contains sodium.
Slovenian: SEZNAM POMOŽNIH SNOVI To zdravilo vsebuje natrij.
English: • imipenem/cilastatin - used for bacterial infections,
Slovenian: • imipenem/cilastatin - uporabljata se za zdravljenje bakterijskih okužb,
English: • The active substance is ganciclovir.
Slovenian: • Zdravilna učinkovina je ganciklovir.
English: Cymevene and associated names (see Annex I) 500 mg powder for concentrate for solution for infusion
Slovenian: Cymevene in povezana imena (glejte Prilogo I) 500 mg prašek za koncentrat za raztopino za infundiranje
English: Prevention of CMV disease in adults and adolescents from 12 years of age with normal renal function using prophylaxis or pre-emptive therapy
Slovenian: Preprečevanje citomegalovirusne bolezni pri odraslih in mladostnikih, starejših od 12 let, z normalnim delovanjem ledvic, z uporabo profilakse ali preventivnega zdravljenja
English: Mean Cmax was 5.5 ± 6 µg/mL at 4 mg/kg and 7.0 ± 1.6 µg/mL at 6 mg/kg.
Slovenian: Povprečna Cmax je bila 5,5 ± 6 µg/ml ob odmerku 4 mg/kg in 7,0 ± 1,6 µg/ml ob odmerku 6 mg/kg.
English: Ganciclovir was effective with a toxicity profile similar to that seen in adults.
Slovenian: Ganciklovir je bil učinkovit in toksične značilnosti so bile podobne kot pri odraslih.
English: After dilution in infusion solutions (sodium chloride 0.9%, dextrose 5%, Ringer's or lactated Ringer's solution for injection) :
Slovenian: Po razredčenju z raztopinami za infundiranje (0,9-% natrijevim kloridom, 5-% dekstrozo, Ringerjevo ali Ringer-laktatno raztopino za injekcije):
English: Other medicines and Cymevene Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Therapeutic guidelines should be consulted.
Slovenian: Upoštevati je treba smernice za zdravljenje.
English: Decreased appetite Anorexia
Slovenian: zmanjšan apetit anoreksija zmanjšanje telesne mase
English: Exposure as measured by mean AUC0−∞ on Days 1 and 14 were 19.4 ± 7.1 and 24.1 ± 14.6 µg.h/mL, respectively, and the corresponding Cmax values were 7.59 ± 3.21 µg/mL (Day 1) and 8.31 ± 4.9 µg/mL (Day 14).
Slovenian: Izpostavljenost, merjena s povprečno AUC0−∞ 1. oziroma 14. dan, je bila 19,4 ± 7,1 in 24,1 ± 14,6 µg.h/ml, ustrezni vrednosti Cmax pa sta bili 7,59 ± 3,21 µg/ml (1. dan) in 8,31 ± 4,9 µg/ml (14. dan).
English: During the course of the study, 29/46 ganciclovir-treated patients had neutropenia, compared with 9/43 control patients (p < 0.1).
Slovenian: Med študijo se je nevtropenija pojavila pri 29 od 46 bolnikov, zdravljenih z ganciklovirjem, in pri 9 od 43 kontrolnih bolnikov (p < 0,1).
English: See Serious side effects at the top of section 4 for more information.
Slovenian: Za več informacij glejte Resni neželeni učinki na začetku poglavja 4.
English: This has been shown to occur in HSV- and HCMV-infected cells, with half-lives of 18 and 6−24 hours, respectively, after removal of extracellular ganciclovir.
Slovenian: Ugotovljeno je, da to poteka v celicah, okuženih s HSV oz. HCMV, z razpolovnim časom 18 oz. od 6 do 24 ur po odstranitvi zunajceličnega ganciklovirja.
English: For patients with renal impairment, the dose of ganciclovir should be modified according to creatinine clearance as shown in the table below (see sections 4.4 and 5.2).
Slovenian: Bolnikom z okvaro ledvic je treba odmerek ganciklovirja prilagoditi glede na očistek kreatinina, kot prikazuje spodnja preglednica (glejte poglavji 4.4 in 5.2).
English: Patients treated with ganciclovir and didanosine, medicines known to be myelosuppressive or affecting renal function, should be closely monitored for signs of added toxicity (see section 4.5).
Slovenian: Bolnike, ki dobivajo ganciklovir z didanozinom, znanimi mielosupresivnimi zdravili ali z zdravili, ki vplivajo na delovanje ledvic, je treba skrbno spremljati glede znakov dodatne toksičnosti (glejte poglavje 4.5).
English: Available in packs of 1 vial or 5 vials.
Slovenian: Zdravilo je na voljo v pakiranjih z 1 ali 5 vialami.
English: Therefore, women of child bearing potential must be advised to use effective contraception during treatment and for at least 30 days thereafter.
Slovenian: Ženskam v rodni dobi je treba naročiti, da morajo med zdravljenjem in vsaj še 30 dni po zdravljenju porabljati učinkovito kontracepcijo.
English: It is used in adults and adolescents 12 years and older.
Slovenian: Zdravilo je namenjeno uporabi pri odraslih in otrocih, starih 12 let ali več.
English: Viral resistance to ganciclovir can arise by selection of mutations in the viral kinase gene (UL97) responsible for ganciclovir monophosphorylation and/or the viral polymerase gene (UL54).
Slovenian: Odpornost virusov proti ganciklovirju se lahko pojavi s selekcijo mutacij v genu virusne kinaze (UL97), odgovorne za monofosforilacijo ganciklovirja, in/ali genu virusne polimeraze (UL54).
English: SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA
English: Sodium hydroxide (for pH-adjustment) Hydrochloric acid (for pH-adjustment)
Slovenian: Natrijev hidroksid (za prilagoditev pH)
English: Severe thrombocytopenia may be associated with potentially life-threatening bleeding.
Slovenian: Hudo trombocitopenijo lahko spremljajo potencialno smrtno nevarne krvavitve.
English: Haemodialysis reduces plasma concentrations of ganciclovir by about 50% after intravenous administration during a 4-hour haemodialysis session.
Slovenian: Hemodializa zniža koncentracijo ganciklovirja v plazmi za približno 50 % po intravenski uporabi med 4-urno hemodializo.
English: Look out for these while you are taking Cymevene - your doctor may tell you to stop taking Cymevene and you may need urgent medical treatment:
Slovenian: Med jemanjem zdravila Cymevene bodite pozorni na naslednje - zdravnik vam bo morda naročil, da nehate uporabljati zdravilo Cymevene, in morda boste potrebovali nujno zdravljenje:
English: The overall incidence of CMV was 16% (15/92 patients).
Slovenian: Celotna incidenca CMV je bila 16 %
English: Mutagenicity, teratogenicity, carcinogenicity, fertility, and contraception
Slovenian: Mutagenost, teratogenost, kancerogenost, plodnost in kontracepcija
English: Cytochrome P450 isoenzymes play no role in ganciclovir pharmacokinetics.
Slovenian: Druga protiretrovirusna zdravila Izoencimi citokroma P450 ne igrajo nobene vloge v farmakokinetiki ganciklovirja.
English: Tell your doctor straight away if you notice any of the following serious side effects - your doctor may tell you to stop taking Cymevene and you may need urgent medical treatment:
Slovenian: Zdravnika morate nemudoma obvestiti, če opazite katerega od naslednjih resnih neželenih učinkovzdravnik vam lahko naroči, da prenehate jemati zdravilo Cymevene; morda boste potrebovali nujno zdravljenje:
English: The pharmacokinetic characteristics of ganciclovir were the same after single and multiple (q12h) 5 mg/kg intravenous doses.
Slovenian: Farmakokinetične značilnosti ganciklovirja so bile po enkratnem in večkratnih (na 12 ur) intravenskih odmerkih 5 mg/kg enake.
English: • feeling tired, dizzy, weak or generally unwell
Slovenian: • utrujenost, omotica, šibkost ali splošno slabo počutje
English: • low blood pressure, which may make you feel dizzy or faint
Slovenian: • nizek krvni tlak, ki lahko povzroči omotico ali omedlevico
English: In patients treated with ganciclovir the most serious and common adverse drug reactions are haematological reactions and include neutropenia, anaemia and thrombocytopenia.
Slovenian: Pri bolnikih, zdravljenih z ganciklovirjem, so najresnejši in najpogostejši neželeni učinki hematološke reakcije, ki vključujejo nevtropenijo, anemijo in trombocitopenijo.
English: Plasma protein binding was 1%−2% over ganciclovir concentrations of 0.5 and 51 µg/mL.
Slovenian: Vezava na beljakovine v plazmi je bila ob koncentracijah ganciklovirja od 0,5 do 51 µg/ml od 1 do 2 %.
English: {(Invented) name and associated names (see Annex I) strength pharmaceutical form} [See Annex I - To be completed nationally]
Slovenian: {(Izmišljeno) ime in povezana imena (glejte Prilogo I) jakost farmacevtska oblika} [Glejte Prilogo I - Izpolni država članica]
English: Ganciclovir must be administered by intravenous infusion over 1 hour at a concentration not exceeding 10 mg/mL.
Slovenian: Ganciklovir je treba dajati v intravenski infuziji v teku ene ure, koncentracija pa ne sme preseči
English: Thrombocytopenia Leucopenia Pancytopenia
Slovenian: trombocitopenija levkopenija pancitopenija
English: • bacterial skin infection - signs include red, painful or swollen skin
Slovenian: • bakterijska okužba kože - med znaki so rdeča, boleča ali otekla koža
English: • you have kidney problems - your doctor will need to give you a lower dose and check your blood cell counts more often during treatment
Slovenian: • če imate težave z ledvicami - zdravnik vam bo moral dati manjši odmerek in med zdravljenjem pogosteje kontrolirati krvno sliko.
English: • feeling depressed, anxious, confused or having abnormal thoughts
Slovenian: • občutek potrtosti, tesnobnost, zmedenost ali nenormalne misli
English: Mean values for the steady state volume of distribution (0.7 L/kg) and systemic clearance (3.15 ± 0.47 mL/min/kg at 4 mg/kg and 3.55 ± 0.35 mL/min/kg at 6 mg/kg) were comparable to those observed in adults with normal renal function.
Slovenian: Povprečne vrednosti volumna porazdelitve v stanju dinamičnega ravnovesja (0,7 l/kg) in sistemskega očistka (3,15 ± 0,47 ml/min/kg ob 4 mg/kg in 3,55 ± 0,35 ml/min/kg ob 6 mg/kg) so bile podobne kot pri odraslih z normalnim delovanjem ledvic.
English: The vial should be gently swirled in order to ensure complete wetting of the product.
Slovenian: Vialo je treba previdno sukati, da je zagotovljeno popolno omočenje zdravila.
English: • muscle pain or spasms
Slovenian: • mišične bolečine ali krči (spazmi)
English: Neutropenia was the only severe adverse drug reaction observed during the study and although none of the children required treatment cessation, 4 required granulocyte colony-stimulating factor (G-CSF) treatment to maintain absolute neutrophil counts > 400 cells/mm3.
Slovenian: Pri nobenem otroku sicer ni bilo treba prenehati zdravljenja, a 4 so potrebovali zdravljenje z granulocitne kolonije stimulirajočim faktorjem (G-CSF) za ohranitev absolutnega števila nevtrofilcev > 400 celic/mm3.
English: During intermittent haemodialysis, estimates for the clearance of ganciclovir ranged from 42−92 mL/min, resulting in intra-dialytic half-lives of 3.3−4.5 hours.
Slovenian: Med intermitentno hemodializo so ocene očistka ganciklovirja segale od 42−92 ml/min, tako da je bil intradializni razpolovni čas 3,3−4,5 ure.
English: Since Cymevene is considered a potential teratogen and carcinogen in humans, caution should be observed in its handling.
Slovenian: Ker velja zdravilo Cymevene pri človeku za potencialno teratogeno in kancerogeno, je pri ravnanju z njim potrebna previdnost.
English: Cross-hypersensitivity
Slovenian: Navzkrižna preobčutljivost