natgillin/translations-raw huggingface dataset:
The in vitro antiviral activity, measured as IC50 of ganciclovir against CMV, is in the range of 0.08 µM (0.02 µg/ml) to 14 µM (3.57 µg/ml).
Protivirusno delovanje in vitro, merjeno kot IC50 ganciklovirja proti citomegalovirusom, je v območju od 0,08 µM (0,02 µg/ml) do 14 µM (3,57 µg/ml).
Ganciclovir is not metabolised to a significant extent.
Ganciklovir se ne presnovi v pomembni meri.
- Maintenance treatment: For immunocompromised patients at risk of relapse maintenance therapy may be given.
- Vzdrževalno zdravljenje: Imunsko oslabeli bolniki s tveganjem za recidiv lahko prejemajo vzdrževalno zdravljenje.
Although ganciclovir recipients had fewer delays and more normal neurological outcomes, most were still behind what would be considered normal development at 6 weeks, 6 months, or 12 months of age.
Čeprav so imeli prejemniki ganciklovirja manj zamud in več normalnih nevroloških izidov, pa jih je bila večina pri 6 tednih, 6 mesecih in 12 mesecih starosti še vedno v zaostanku v primerjavi s tistim, kar velja za normalen razvoj.
Ganciclovir is predominantly eliminated by renal excretion via glomerular filtration and active tubular secretion of unchanged ganciclovir.
Izločanje Ganciklovir se pretežno odstrani z izločanjem skozi ledvice z glomerularno filtracijo in aktivno tubularno sekrecijo nespremenjenega ganciklovirja.
Estimates of ganciclovir clearance for continuous dialysis were lower (4.0−29.6 mL/min) but resulted in greater removal of ganciclovir over a dose interval.
Ocene očistka ganciklovirja pri kontinuirani dializi so bile nižje (4,0−29,6 ml/min), a so povzročile večjo odstranitev ganciklovirja v odmernem intervalu.
As a result of the potential for reproductive toxicity and teratogenicity, women of childbearing potential must be advised to use effective contraception during and for at least 30 days after treatment.
Zaradi možnih reproduktivnih toksičnih učinkov in teratogenosti je treba ženskam v rodni dobi naročiti, da morajo med zdravljenjem in vsaj še 30 dni po zdravljenju uporabljati učinkovito kontracepcijo.
Half-lives in subjects without renal impairment ranged from 2.73 ± 1.29 (N = 6) to 3.98 ± 1.78 hours (N = 8).
Razpolovni časi pri bolnikih brez okvare ledvic so segali od 2,73 ± 1,29 (n = 6) do 3,98 ± 1,78 (n = 8).
Draw 10 mL of water for injection into a syringe, then slowly inject through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.
10 ml vode za injekcije v brizgo, nato počasi injicirajte skozi osrednji del gumijastega zamaška v vialo; igla naj bo pri tem usmerjena v steno viale.
• tremor, shaking
• tremor, tresenje
Cymevene should not be used by pregnant women unless the benefits to the mother outweigh the possible risks to the unborn baby.
Zdravila Cymevene se pri nosečnicah ne sme uporabljati, razen če koristi za mater odtehtajo možna tveganja za nerojenega otroka.
Infants who received ganciclovir had improved neurodevelopmental outcomes at 6 and 12 months compared with those who did not receive antiviral treatment.
Pri dojenčkih, ki so prejemali ganciklovir, so po 6 in 12 mesecih ugotavljali boljše nevrorazvojne izide kot pri tistih, ki niso prejemali protivirusnega zdravljenja.
Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, which inhibits replication of herpes viruses both in vitro and in vivo.
Ganciklovir je sintezen analog 2'-deoksigvanozina, ki zavre replikacijo herpesvirusov in vitro in in vivo.
• low red blood cell counts shown in tests
• majhno število rdečih krvnih celic, ki se pokaže na preiskavah
The benefits of treatment should be carefully considered in each case and should clearly outweigh the risks (see section 4.2).
Koristi zdravljenja je treba pri vsakem posameznem bolniku skrbno pretehtati in morajo jasno odtehtati tveganja (glejte poglavje 4.2).
Excipient(s) with known effect: approximately 43 mg (2 mEq) sodium.
Pomožne snovi z znanim učinkom: približno 43 mg (2 mEq) natrija.
Consideration should be given to official guidance on the appropriate use of antiviral agents.
Za ustrezno uporabo protivirusnih učinkovin je treba upoštevati uradne smernice.
This is because it may affect the unborn baby.
To zdravilo namreč lahko škoduje nerojenemu otroku.
Therapy should not be initiated if the absolute neutrophil count is less than 500 cells/µL or the platelet count is less than 25,000 cells/µL or the haemoglobin is less than 8 g/dL (see sections 4.2 and 4.8).
Zdravljenja se ne sme začeti, če je absolutno število nevtrofilcev manj kot 500 celic/µl, če je število trombocitov manj kot 25.000 celic/µl ali če je koncentracija hemoglobina pod 8 g/dl (glejte poglavji 4.2 in 4.8).
If this happens, do not drive or use any tools or machines.
Če se vam to zgodi, ne upravljajte vozil,
Children treated before 2004 then received oral ganciclovir 30 mg/kg/dose up to 1 g/dose three times daily (n = 41), while children treated after 2004 received valganciclovir up to 900 mg once daily (n = 51).
Otroci, zdravljeni pred letom 2004, so potem prejemali peroralni ganciklovir 30 mg/kg/odmerek do 1 g/odmerek trikrat na dan (n = 41), otroci, zdravljeni po letu 2004, pa so prejemali valganciklovir do 900 mg enkrat na dan (n = 51).
Patients should be closely monitored for didanosine toxicity (see section 4.4).
Bolnike je treba skrbno spremljati glede toksičnih učinkov didanozina (glejte poglavje 4.4).
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.
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.
This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Navodilo je bilo nazadnje revidirano {mesec LLLL}.
Caution:
Opozorilo:
The steady state volume of distribution has a range of 0.54−0.87 L/kg.
Volumen porazdelitve v stanju dinamičnega ravnovesja je od 0,54 do 0,87 l/kg.
Do not use bacteriostatic water for injection containing parabens (para-hydroxybenzoates), since these are incompatible with Cymevene.
Ne uporabljajte bakteriostatske vode za injekcije, ki vsebuje parabene (parahidroksibenzoate), ker ti niso kompatibilni z zdravilom Cymevene.
Alopecia Urticaria Dry skin
alopecija urtikarija suhost kože
Pharmacokinetics of intravenous ganciclovir were also studied in infants and children with normal renal function and aged 9 months−12 years.
Farmakokinetiko intravenskega ganciklovirja so raziskali tudi pri dojenčkih in otrocih z normalnim delovanjem ledvic, starih od 9 mesecev do 12 let.
Caution should be exercised in the handling of Cymevene.
Pri ravnanju z zdravilom Cymevene je potrebna previdnost.
Patients with low baseline platelet counts (< 100,000 /mL) have an increased risk of developing thrombocytopenia.
Bolniki z majhnim izhodiščnim številom trombocitov (< 100.000/ml) imajo večje tveganje za pojav trombocitopenije.
• vincristine, vinblastine, doxorubicin - used for cancer,
• vinkristin, vinblastin, doksorubicin - uporabljajo se za zdravljenje raka,
Probenecid given with oral ganciclovir resulted in statistically decreased renal clearance of ganciclovir, and led to clinically significant increased exposure.
Probenecid, uporabljen s peroralnim ganciklovirjem, je statistično zmanjšal ledvični očistek ganciklovirja in klinično pomembno povečal izpostavljenost.
From a microbiological point of view, the Cymevene infusion solution should be used immediately.
Z mikrobiološkega stališča je treba raztopino zdravila Cymevene za infundiranje uporabiti takoj.
The fraction of ganciclovir removed during a single dialysis session varied from 50% to 63%.
Delež ganciklovirja, ki se je odstranil med eno dializo, je bil od 50 do 63 %.
Injection site reactions occur commonly in patients receiving ganciclovir.
Reakcije na mestu injiciranja so pri bolnikih, ki prejemajo ganciklovir, pogoste.
In animal studies ganciclovir was found to be mutagenic, teratogenic, aspermatogenic, carcinogenic and to impair fertility.
V študijah na živalih se je ganciklovir izkazal za mutagenega, teratogenega, aspermatogenega, kancerogenega in je okvaril plodnost.
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.
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.
• low white blood cell counts.
• majhno število belih krvnih celic.
The duration of maintenance treatment should be determined on an individual basis, local treatment guidelines should be consulted.
Trajanje vzdrževalnega zdravljenja je treba določiti individualno in upoštevati je treba lokalne smernice za zdravljenje.
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.
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.
• you are allergic to aciclovir, valaciclovir, penciclovir or famciclovir - these are other medicines used for viral infections
• če ste alergični na aciklovir, valaciklovir, penciklovir ali famciklovir - to so druga zdravila, ki se uporabljajo za zdravljenje virusnih okužb.
Hepatic function abnormal Blood alkaline phosphatase increased Aspartate aminotransferase increased
nenormalno delovanje jeter zvišanje alkalne fosfataze v krvi zvišanje aspartat-aminotransferaze
Patients with iatrogenic immunosuppression due to treatment with immunosuppressive drugs are at greater risk of thrombocytopenia than patients with AIDS (see section 4.4).
Bolniki z iatrogeno imunosupresijo zaradi zdravljenja z imunosupresivnimi zdravili imajo večje tveganje za trombocitopenijo kot bolniki z AIDSom (glejte poglavje 4.4).
It is considered likely that ganciclovir causes temporary or permanent inhibition of spermatogenesis (see sections 4.6, 4.8 and 5.3).
Verjetno je, da ganciklovir prehodno ali trajno zavre spermatogenezo (glejte poglavja 4.6, 4.8 in 5.3).
As dosage modifications are recommended in patients with renal impairment, serum creatinine or estimated creatinine-clearance levels should be monitored.
Ker je za bolnike z okvaro ledvic priporočena prilagoditev odmerjanja, jim je treba kontrolirati kreatinin v serumu ali ocenjeno vrednost očistka kreatinina.
Cymevene is used to treat diseases caused by a virus called cytomegalovirus (CMV) in patients who have a weak immune system.
Zdravilo Cymevene uporabljamo za zdravljenje bolezni, ki jo povzroča virus, imenovan citomegalovirus (CMV), pri bolnikih z oslabljenim imunskim sistemom.
Further phosphorylation occurs by several cellular kinases to produce ganciclovir triphosphate, which is then slowly metabolised intracellularly.
Nadaljnja fosforilacija poteka z več celičnimi kinazami, tako da nastane ganciklovir-trifosfat, ki se nato počasi presnovi znotraj celice.
This adverse reaction has only been reported in studies in AIDS patients treated with Cymevene for CMV retinitis.
O tem neželenem učinku so poročali le v študijah pri bolnikih z AIDSom, ki so zdravilo Cymevene prejemali za zdravljenje citomegalovirusnega retinitisa.
Therefore, patients taking probenecid and Cymevene should be closely monitored for ganciclovir toxicity.
Zato je treba bolnike, ki sočasno dobivajo probenecid in zdravilo Cymevene, skrbno spremljati glede toksičnih učinkov ganciklovirja.
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).
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).
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.
Zato se ga ne sme uporabljati pri nosečnicah, razen če klinična potreba po zdravljenju bolnice odtehta možna teratogena tveganja za plod.
The volume of distribution of intravenously administered ganciclovir is correlated to body weight.
Porazdelitev Volumen porazdelitve intravensko uporabljenega ganciklovirja korelira s telesno maso.
Ganciclovir was mutagenic in mouse lymphoma cells and clastogenic in mammalian cells.
Ganciklovir je bil mutagen v celicah mišjega limfoma in klastogen v celicah sesalcev.
• hives, dry skin
• koprivnica, suha koža
Do not use Cymevene if any of the above apply to you.
Ne uporabljajte zdravila Cymevene, če kaj od naštetega velja za vas.
Dermatitis Night sweats Pruritus
dermatitis nočno znojenje srbenje
None of the children required a cochlear implant and hearing loss improved in 83% of ears affected by hearing loss at baseline.
Nobeden od teh otrok ni potreboval kohlearnega vsadka in poslabšanje sluha se je izboljšalo pri 83 %
As the phosphorylation is largely dependent on the viral kinase, phosphorylation of ganciclovir occurs preferentially in virus-infected cells.
Ker je fosforilacija v veliki meri odvisna od virusne kinaze, poteka fosforilacija ganciklovirja predvsem v celicah, okuženih z virusom.
Other potential drug interactions
Druga možna medsebojna delovanja z zdravili
• hands or feet feeling weak or numb, which may affect your balance
• občutek šibkosti ali omrtvičenosti dlani in stopal; to vam lahko poslabša ravnotežje
• feeling agitated or nervous
• vznemirjenost ali živčnost
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.
Farmakokinetične lastnosti ganciklovirja so ocenili pri HIV- in CMV-seropozitivnih bolnikih, bolnikih z AIDSom in citomegalovirusnim retinitisom ter prejemnikih presajenih solidnih organov.
Powder: Does not require any special storage conditions.
Prašek: Za shranjevanje zdravila niso potrebna posebna navodila.
This is because Cymevene may harm the unborn baby.
Zdravilo Cymevene namreč lahko škoduje nerojenemu otroku.
• a skin reaction where the medicine was injected - such as inflammation, pain and swelling.
• kožna reakcija na mestu, kjer je bilo injicirano zdravilo - na primer vnetje, bolečine in oteklost.
• you are breast-feeding (see Breast-feeding subsection).
• če dojite (glejte podpoglavje Dojenje).
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).
Ganciklovir se odstranjuje s hemodializo, zato lahko hemodializa koristi za zmanjšanje izpostavljenosti zdravilu pri bolnikih, ki dobijo prevelik odmerek ganciklovirja (glejte poglavje 5.2).
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).
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).
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).
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).
Other adverse drugs reactions are presented in the table below.
Drugi neželeni učinki zdravila so prikazani v spodnji preglednici.
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).
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).
LIST OF EXCIPIENTS This medicinal product contains sodium.
SEZNAM POMOŽNIH SNOVI To zdravilo vsebuje natrij.
• imipenem/cilastatin - used for bacterial infections,
• imipenem/cilastatin - uporabljata se za zdravljenje bakterijskih okužb,
• The active substance is ganciclovir.
• Zdravilna učinkovina je ganciklovir.
Cymevene and associated names (see Annex I) 500 mg powder for concentrate for solution for infusion
Cymevene in povezana imena (glejte Prilogo I) 500 mg prašek za koncentrat za raztopino za infundiranje
Prevention of CMV disease in adults and adolescents from 12 years of age with normal renal function using prophylaxis or pre-emptive therapy
Preprečevanje citomegalovirusne bolezni pri odraslih in mladostnikih, starejših od 12 let, z normalnim delovanjem ledvic, z uporabo profilakse ali preventivnega zdravljenja
Mean Cmax was 5.5 ± 6 µg/mL at 4 mg/kg and 7.0 ± 1.6 µg/mL at 6 mg/kg.
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.
Ganciclovir was effective with a toxicity profile similar to that seen in adults.
Ganciklovir je bil učinkovit in toksične značilnosti so bile podobne kot pri odraslih.
After dilution in infusion solutions (sodium chloride 0.9%, dextrose 5%, Ringer's or lactated Ringer's solution for injection) :
Po razredčenju z raztopinami za infundiranje (0,9-% natrijevim kloridom, 5-% dekstrozo, Ringerjevo ali Ringer-laktatno raztopino za injekcije):
Other medicines and Cymevene Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Therapeutic guidelines should be consulted.
Upoštevati je treba smernice za zdravljenje.
Decreased appetite Anorexia
zmanjšan apetit anoreksija zmanjšanje telesne mase
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).
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).
During the course of the study, 29/46 ganciclovir-treated patients had neutropenia, compared with 9/43 control patients (p < 0.1).
Med študijo se je nevtropenija pojavila pri 29 od 46 bolnikov, zdravljenih z ganciklovirjem, in pri 9 od 43 kontrolnih bolnikov (p < 0,1).
See Serious side effects at the top of section 4 for more information.
Za več informacij glejte Resni neželeni učinki na začetku poglavja 4.
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.
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.
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).
Bolnikom z okvaro ledvic je treba odmerek ganciklovirja prilagoditi glede na očistek kreatinina, kot prikazuje spodnja preglednica (glejte poglavji 4.4 in 5.2).
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).
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).
Available in packs of 1 vial or 5 vials.
Zdravilo je na voljo v pakiranjih z 1 ali 5 vialami.
Therefore, women of child bearing potential must be advised to use effective contraception during treatment and for at least 30 days thereafter.
Ženskam v rodni dobi je treba naročiti, da morajo med zdravljenjem in vsaj še 30 dni po zdravljenju porabljati učinkovito kontracepcijo.
It is used in adults and adolescents 12 years and older.
Zdravilo je namenjeno uporabi pri odraslih in otrocih, starih 12 let ali več.
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).
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).
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA
Sodium hydroxide (for pH-adjustment) Hydrochloric acid (for pH-adjustment)
Natrijev hidroksid (za prilagoditev pH)
Severe thrombocytopenia may be associated with potentially life-threatening bleeding.
Hudo trombocitopenijo lahko spremljajo potencialno smrtno nevarne krvavitve.
Haemodialysis reduces plasma concentrations of ganciclovir by about 50% after intravenous administration during a 4-hour haemodialysis session.
Hemodializa zniža koncentracijo ganciklovirja v plazmi za približno 50 % po intravenski uporabi med 4-urno hemodializo.
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:
Med jemanjem zdravila Cymevene bodite pozorni na naslednje - zdravnik vam bo morda naročil, da nehate uporabljati zdravilo Cymevene, in morda boste potrebovali nujno zdravljenje:
The overall incidence of CMV was 16% (15/92 patients).
Celotna incidenca CMV je bila 16 %
Mutagenicity, teratogenicity, carcinogenicity, fertility, and contraception
Mutagenost, teratogenost, kancerogenost, plodnost in kontracepcija
Cytochrome P450 isoenzymes play no role in ganciclovir pharmacokinetics.
Druga protiretrovirusna zdravila Izoencimi citokroma P450 ne igrajo nobene vloge v farmakokinetiki ganciklovirja.
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:
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:
The pharmacokinetic characteristics of ganciclovir were the same after single and multiple (q12h) 5 mg/kg intravenous doses.
Farmakokinetične značilnosti ganciklovirja so bile po enkratnem in večkratnih (na 12 ur) intravenskih odmerkih 5 mg/kg enake.
• feeling tired, dizzy, weak or generally unwell
• utrujenost, omotica, šibkost ali splošno slabo počutje
• low blood pressure, which may make you feel dizzy or faint
• nizek krvni tlak, ki lahko povzroči omotico ali omedlevico
In patients treated with ganciclovir the most serious and common adverse drug reactions are haematological reactions and include neutropenia, anaemia and thrombocytopenia.
Pri bolnikih, zdravljenih z ganciklovirjem, so najresnejši in najpogostejši neželeni učinki hematološke reakcije, ki vključujejo nevtropenijo, anemijo in trombocitopenijo.