FrancophonIA/ELRC3.0 huggingface dataset:
English: Read all of this leaflet carefully before you start using this medicine - because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Use with other medicines
Slovenian: Uporaba z drugimi zdravili
English: • abnormal thoughts or feelings, losing contact with reality
Slovenian: • nenormalne misli in občutja, izguba stika z resničnostjo
English: If such contact occurs, wash thoroughly with soap and water, rinse eyes thoroughly with plain water.
Slovenian: Če pride do takšnega stika, kožo temeljito umijte z milom in vodo; oko temeljito izperite s čisto vodo.
English: Tests and checks
Slovenian: Preiskave in kontrole
English: This medicinal product is authorised in the Member States of the EEA under the following names: <{Name of the Member State}> <{Name of the medicinal product}> <{Name of the Member State}> <{Name of the medicinal product}>
Slovenian: To zdravilo je odobreno v državah članicah EGP pod naslednjimi imeni: {Ime države članice}{Ime zdravila}
English: • blood in urine
Slovenian: • kri v urinu
English: Alanine aminotransferase increased
Slovenian: zvišanje alanin-aminotransferaze
English: The recommended dosage, frequency and infusion rates should not be exceeded.
Slovenian: Priporočenega odmerjanja, pogostnosti uporabe in hitrosti infundiranja se ne sme preseči.
English: Dosage reduction is required (see sections 4.2 and 5.2).
Slovenian: Potrebno je zmanjšanje odmerka (glejte poglavji 4.2 in 5.2).
English: (72) x (0.011 x serum creatinine [micromol/L])
Slovenian: (72) x (0,011 x kreatinin v serumu [mikromoli/l])
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.
Slovenian: Če ni uporabljena takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če sta priprava in razredčenje opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
English: Ganciclovir is a potential carcinogen.
Slovenian: Ganciklovir je potencialen kancerogen.
English: It should not be used after the expiry date which is stated on the carton.
Slovenian: Zdravila ne smete uporabljati po datumu izteku roka uporabnosti, ki je naveden na škatli.
English: Cymevene will be given to you by a doctor or nurse.
Slovenian: Zdravilo Cymevene vam bo dal zdravnik ali medicinska sestra.
English: There was no clinically significant effect on ganciclovir concentrations.
Slovenian: Klinično pomembnega vpliva na koncentracijo ganciklovirja ni bilo.
English: The infusion should be given into a vein with adequate blood flow, preferably via a plastic cannula.
Slovenian: Infuzijo je treba dati v veno, ki ima zadosten pretok krvi, po možnosti skozi plastično kanilo.
English: • you are having radiotherapy.
Slovenian: • če imate obsevanje (radioterapijo).
English: A total of 38.5% of subjects were spared antiviral medications beyond their initial postoperative prophylaxis.
Slovenian: Skupno 38,5 % bolnikov ni prejemalo protivirusnih zdravil zunaj uvodne profilakse po operaciji.
English: A weak immune system may be caused by other diseases (such as AIDS) or by medicines (such as chemotherapy or immunosuppressants).
Slovenian: Oslabelost imunskega sistema lahko povzročijo druge bolezni (npr. AIDS) ali zdravila (npr. zdravila za kemoterapijo ali imunosupresivna zdravila).
English: • infertility in men - see ‘Fertility' section
Slovenian: • neplodnost pri moških - glejte poglavje Plodnost
English: Forty-three patients were considered high-risk for CMV and 79 were routine-risk.
Slovenian: Triinštirideset bolnikov je bilo ocenjenih kot bolnikov z velikim tveganjem za CMV, 79 pa kot bolnikov z rutinskim tveganjem.
English: It is also used to prevent CMV infection after an organ transplant or during chemotherapy.
Slovenian: Uporabljamo ga tudi za preprečevanje okužbe s CMV po presaditvi organa ali med kemoterapijo.
English: Neutropenia usually occurs during the first or second week of induction therapy and following administration of a cumulative dose of ≤ 200 mg / kg.
Slovenian: Nevtropenija se po navadi pojavi v prvem ali drugem tednu indukcijskega zdravljenja in po uporabi kumulativnega odmerka ≤ 200 mg/kg.
English: Time to onset of CMV infection was comparable in both groups.
Slovenian: Čas do začetka okužbe s CMV je bil med skupinama podoben.
English: It is unknown if ganciclovir is excreted in human breast milk, but the possibility of ganciclovir being excreted in breast milk and causing serious adverse reactions in the breastfed infant cannot be excluded.
Slovenian: Ni znano, ali se ganciklovir pri človeku izloča v materino mleko, vendar možnosti izločanja ganciklovirja v materino mleko in povzročitve resnih neželenih učinkov pri dojenem otroku ni mogoče izključiti.
English: From a microbiological point of view, the reconstituted solution should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba rekonstituirano raztopino uporabiti takoj.
English: In patients with normal renal function, more than 90% of the intravenously administered ganciclovir dose is recovered unchanged in the urine within 24 hours.
Slovenian: Pri bolnikih z normalnim delovanjem ledvic se več kot 90 % intravensko uporabljenega odmerka ganciklovirja v 24 urah pojavi nespremenjenega v urinu.
English: Of the 100 patients enrolled, 42 met all study criteria and had both baseline and 6-month follow up audiometric evaluations.
Slovenian: Od 100 vključenih bolnikov jih je 42 izpolnjevalo vsa merila študije in so imeli avdiometrično oceno opravljeno izhodiščno in po 6
English: • how well your kidneys are working
Slovenian: • tega, kako dobro vam delujejo ledvice,
English: Such an effect is also anticipated during concomitant administration of intravenous ganciclovir and probenecid.
Slovenian: Takšen učinek je treba pričakovati tudi med sočasno uporabo intravenskega ganciklovirja in probenecida.
English: Infusion concentrations greater than 10mg/mL are not recommended.
Slovenian: Koncentracija infuzije nad 10 mg/ml ni priporočljiva.
English: Neutropenia also occurs more often in paediatric patients, but there is no correlation between neutropenia and infectious adverse reactions in the paediatric population.
Slovenian: Tudi nevtropenija je pri pediatričnih bolnikih pogostejša, vendar v pediatrični populaciji ni korelacije med nevtropenijo in infekcijskimi neželenimi učinki.
English: • feeling short of breath.
Slovenian: • občutek kratke sape.
English: Serum creatinine (µmol/L)
Slovenian: Kreatinin v serumu (µmol/l)
English: difficulty swallowing or breathing.
Slovenian: težave s požiranjem ali dihanjem.
English: Chemical and physical in-use stability has been demonstrated for the reconstituted product for 12 hours at 25°C after dissolving with water for injections.
Slovenian: Kemijska in fizikalna stabilnost rekonstituiranega zdravila med uporabo sta dokazani za 12 ur pri temperaturi 25 °C po raztapljanju z vodo za injekcije.
English: While you are using Cymevene your doctor will do regular blood tests.
Slovenian: Med uporabo zdravila Cymevene vam bo zdravnik redno opravljal preiskave krvi.
English: There were no deaths secondary to CMV.
Slovenian: Smrti zaradi CMV ni bilo.
English: Information on the safety and efficacy of ganciclovir in children under 12 years of age, including neonates, is limited (see sections 4.4, 4.8 and 5.1).
Slovenian: Podatkov o varnosti in učinkovitosti ganciklovirja pri otrocih, mlajših od 12 let (vključno z novorojenčki), je malo (glejte poglavja 4.4, 4.8 in 5.1).
English: Three subjects developed acute rejection within 6 months of detection of CMV, but CMV was preceded by rejection in 13 subjects.
Slovenian: Pri treh bolnikih se je akutna zavrnitev razvila v 6 mesecih po odkritju CMV, a pri 13 bolnikih je do zavrnitve prišlo pred odkritjem CMV.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 - 8°C (do not freeze).
Slovenian: Kemijska in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi od 2 do 8 °C (ne zamrzujte).
English: Antiviral treatment consisted of either:
Slovenian: Protivirusno zdravljenje je obsegalo bodisi:
English: 4.5 Interaction with other medicinal products and other forms of interaction Pharmacokinetic interactions
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: Cymevene may temporarily or permanently stop men from producing sperm.
Slovenian: Pri moških lahko začasno ali trajno prekine nastajanje semenčic.
English: It will be given through a tube into your vein.
Slovenian: Dobili ga boste po cevki v veno.
English: - Treatment of disease progression: Any patient, in whom CMV disease progresses, either while on maintenance treatment or because treatment with ganciclovir has been withdrawn, may be re-treated using the induction treatment regimen.
Slovenian: - Zdravljenje napredovale bolezni: Vsakega bolnika, pri katerem citomegalovirusna bolezen napreduje (bodisi med vzdrževalnim zdravljenjem bodisi ker je bilo zdravljenje z ganciklovirjem ukinjeno), je mogoče znova zdraviti z uporabo sheme za indukcijsko zdravljenje.
English: The use of ganciclovir warrants extreme caution, especially in the paediatric population due to the potential for long-term carcinogenicity and reproductive toxicity.
Slovenian: Ganciklovir je treba uporabljati skrajno previdno zlasti v pediatrični populaciji, ker obstaja možnost dolgoročne kancerogenosti in reproduktivnih toksičnih učinkov.
English: • you have had problems with your blood cell counts caused by medicines in the past
Slovenian: • če ste imeli težave s številom krvnih celic med zdravljenjem z zdravili v preteklosti.
English: However, ganciclovir readily diffuses across the human placenta.
Slovenian: Vendar pa ganciklovir zlahka difundira skozi človeško placento.
English: Cymevene solutions are alkaline (pH ~11).
Slovenian: Raztopine zdravila Cymevene so alkalne (pH ~11).
English: The safety of ganciclovir for use in pregnant women has not been established.
Slovenian: Varnost ganciklovirja pri nosečnicah ni ugotovljena.
English: Candida infections including oral candidiasis.
Slovenian: okužba sečil okužbe s Candido, vključno z oralno kandidozo
English: Such results are consistent with the positive mouse carcinogenicity study with ganciclovir.
Slovenian: Ti rezultati se skladajo s pozitivno študijo kancerogenosti ganciklovirja pri miših.
English: The range of exposures was comparable to those observed in adults.
Slovenian: Razpon izpostavljenosti je bil podoben kot pri odraslih.
English: You should not become pregnant while using this medicine.
Slovenian: Med uporabo tega zdravila ne smete zanositi.
English: However, the rates of certain adverse reactions, such as pyrexia and abdominal pain, which may be characteristic of the paediatric population, occur more often in paediatric than in adult patients.
Slovenian: Toda določeni neželeni učinki, npr. zvišana telesna temperatura in bolečine v trebuhu, ki so morda značilni za pediatrično populacijo, se pri pediatričnih bolnikih pojavljajo pogosteje kot pri odraslih.
English: Ganciclovir was associated with a decrease in the detection of CMV by culture or polymerase chain reaction.
Slovenian: Ganciklovir je bil povezan z zmanjšanjem detekcije CMV s kulturo ali z verižno reakcijo s polimerazo.
English: This is because Cymevene may pass into breast milk.
Slovenian: Zdravilo Cymevene namreč lahko prehaja v materino mleko.
English: • didanosine, stavudine, zidovudine or any other medicines used for HIV.
Slovenian: • didanozin, stavudin, zidovudin ali katero koli drugo zdravilo proti HIV.
English: The dose of Cymevene varies from one patient to another.
Slovenian: Odmerek zdravila Cymevene se od bolnika do bolnika razlikuje.
English: The diluted solution should then be infused intravenously over 1 hour as directed in section 4.2.
Slovenian: Razredčeno raztopino je nato treba infundirati intravensko v teku 1 ure, kot je navedeno v poglavju 4.2.
English: Patients with impaired renal function are at increased risk of toxicity (especially haematological toxicity).
Slovenian: Bolniki z okvarjenim delovanjem ledvic imajo večje tveganje za toksične učinke (zlasti za hematološko toksične učinke).
English: A retrospective study investigated the effect of antiviral treatment on late-onset hearing loss in infants with congenital CMV infection (4-34 months of age, mean age 10.3±7.8 months, median age 8 months).
Slovenian: Retrospektivna študija je raziskovala vpliv protivirusnega zdravljenja na pozno nastalo poslabšanje sluha pri dojenčkih s kongenitalno okužbo s CMV (starost od 4 do 34 mesecev, povprečna starost 10,3 ± 7,8 meseca, mediana starost 8 mesecev).
English: • you have low white blood cell, red blood cell or platelet counts - your doctor will do blood tests before you start and during your treatment
Slovenian: • če imate majhno število belih krvnih celic, rdečih krvnih celic ali krvnih ploščic - zdravnik bo opravljal preiskave krvi pred začetkom zdravljenja in med zdravljenjem.
English: Prior to initiation of ganciclovir treatment, patients should be advised of the potential risks to the foetus.
Slovenian: Pred začetkom zdravljenja z ganciklovirjem je treba bolnike seznaniti z možnimi tveganji za plod.
English: Cymevene is indicated in adults and adolescents from 12 years of age for the:
Slovenian: Zdravilo Cymevene je indicirano pri odraslih in mladostnikih, starejših od 12 let, za:
English: • The other ingredients are sodium hydroxide and hydrochloric acid.
Slovenian: • Drugi sestavini zdravila sta natrijev klorid in klorovodikova kislina.
English: If your doctor wants you to start using Cymevene you must stop breast-feeding before you start using the medicine.
Slovenian: Če zdravnik želi, da začnete uporabljati zdravilo Cymevene, morate nehati dojiti, preden začnete uporabljati to zdravilo.
English: This belongs to a group called anti-viral medicines.
Slovenian: Ta učinkovina spada v skupino protivirusnih zdravil.
English: • sight problems or eye pain
Slovenian: • težave z vidom ali bolečine v očeh
English: The reconstituted solution should be checked carefully to ensure that the product is in solution and practically free from visible particles prior to dilution with compatible solvent.
Slovenian: Rekonstituirano raztopino je treba skrbno pregledati za zagotovitev, da je zdravilo raztopljeno in praktično brez vidnih delcev pred razredčenjem s kompatibilnim vehiklom.
English: Neutropenia was the only side effect reported and it was not necessary to discontinue treatment in any patient.
Slovenian: Edini zabeleženi neželeni učinek je bila nevtropenija in zdravljenja ni bilo treba prenehati pri nobenem bolniku.
English: Ganciclovir penetrates the cerebrospinal fluid, where concentrations observed reach 24%−67% of the plasma concentrations.
Slovenian: Ganciklovir prodira v cerebrospinalno tekočino, v kateri opažena koncentracija dosega od 24 do 67 % koncentracije v plazmi.
English: Vials of Cymevene are supplied in packs of 1 or 5.
Slovenian: Viale zdravila Cymevene so na voljo v pakiranjih z 1 ali 5 vialami.
English: Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, nucleosides and nucleotides excluding reverse transcriptase inhibitors, ATC code: J05AB06.
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, zdravila z direktnim delovanjem na viruse, nukleozidi in nukleotidi (razen zaviralcev reverzne transkriptaze), oznaka ATC: J05AB06.
English: What Cymevene is and what it is used for What you need to know before you use Cymevene How to use Cymevene
Slovenian: Kaj je zdravilo Cymevene in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Cymevene Kako uporabljati zdravilo Cymevene
English: Asymptomatic CMV infection was detected by PCR in 34.4% of subjects and was more likely in high-risk than in routine-risk recipients (58.1% vs. 21.8%, p = 0.0001).
Slovenian: PCR je odkrila asimptomatsko citomegalovirusno okužbo pri 34,4 % bolnikov; ta je bila pri prejemnikih z velikim tveganjem verjetnejša kot pri prejemnikih z rutinskim tveganjem (58,1 % v primerjavi z 21,8 %, p = 0,0001).
English: No studies on the efficacy or safety of ganciclovir in the elderly have been conducted.
Slovenian: Študij o učinkovitosti ali varnosti ganciklovirja pri starejših bolnikih niso izvedli.
English: The study included 21 infants with normal hearing at birth who developed late-onset hearing loss.
Slovenian: Študija je zajela 21 dojenčkov, ki so imeli ob rojstvu normalen sluh in se jim je pojavilo pozno poslabšanje sluha.
English: The virustatic activity of ganciclovir is a result of the inhibition of viral DNA synthesis by: (1) competitive inhibition of incorporation of deoxyguanosine triphosphate into DNA by DNA polymerase, and (2) incorporation of ganciclovir triphosphate into viral DNA, causing termination of, or very limited, viral DNA elongation.
Slovenian: Virustatično delovanje ganciklovirja je posledica zavrtja sinteze virusne DNA s: (1) kompetitivnim zavrtjem vgradnje deoksigvanozin-trifosfata v DNA z virusno DNA-polimerazo in (2) vgradnjo ganciklovir-trifosfata v virusno DNA, kar povzroči zaključek ali le še zelo majhno podaljšanje virusne
English: In animals studies ganciclovir was associated with reproductive toxicity and teratogenicity (see sections 4.4 and 5.3).
Slovenian: V študijah na živalih je bil ganciklovir povezan z reproduktivnimi toksičnimi učinki in teratogenostjo (glejte poglavji 4.4 in 5.3).
English: The vial should be gently rotated/ swirled for some minutes to obtain a clear reconstituted solution.
Slovenian: Vialo je treba nekaj minut previdno vrteti/sukati, da nastane bistra rekonstituirana raztopina.
English: Read the leaflet for further information.
Slovenian: Za nadaljnje informacije glejte navodilo za uporabo.
English: All children received intravenous ganciclovir 5 mg/kg twice daily for 2 weeks following transplantation.
Slovenian: Vsi otroci so prejemali intravenski ganciklovir 5 mg/kg dvakrat na dan 2 tedna po presaditvi.
English: 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).
Slovenian: 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).
English: Ganciclovir is not metabolised to a significant extent.
Slovenian: Ganciklovir se ne presnovi v pomembni meri.
English: - Maintenance treatment: For immunocompromised patients at risk of relapse maintenance therapy may be given.
Slovenian: - Vzdrževalno zdravljenje: Imunsko oslabeli bolniki s tveganjem za recidiv lahko prejemajo vzdrževalno zdravljenje.
English: 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.
Slovenian: 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.
English: Ganciclovir is predominantly eliminated by renal excretion via glomerular filtration and active tubular secretion of unchanged ganciclovir.
Slovenian: Izločanje Ganciklovir se pretežno odstrani z izločanjem skozi ledvice z glomerularno filtracijo in aktivno tubularno sekrecijo nespremenjenega ganciklovirja.
English: 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.
Slovenian: Ocene očistka ganciklovirja pri kontinuirani dializi so bile nižje (4,0−29,6 ml/min), a so povzročile večjo odstranitev ganciklovirja v odmernem intervalu.
English: 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.
Slovenian: 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.
English: Half-lives in subjects without renal impairment ranged from 2.73 ± 1.29 (N = 6) to 3.98 ± 1.78 hours (N = 8).
Slovenian: Razpolovni časi pri bolnikih brez okvare ledvic so segali od 2,73 ± 1,29 (n = 6) do 3,98 ± 1,78 (n = 8).
English: 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.
Slovenian: 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.
English: • tremor, shaking
Slovenian: • tremor, tresenje
English: Cymevene should not be used by pregnant women unless the benefits to the mother outweigh the possible risks to the unborn baby.
Slovenian: Zdravila Cymevene se pri nosečnicah ne sme uporabljati, razen če koristi za mater odtehtajo možna tveganja za nerojenega otroka.
English: Infants who received ganciclovir had improved neurodevelopmental outcomes at 6 and 12 months compared with those who did not receive antiviral treatment.
Slovenian: Pri dojenčkih, ki so prejemali ganciklovir, so po 6 in 12 mesecih ugotavljali boljše nevrorazvojne izide kot pri tistih, ki niso prejemali protivirusnega zdravljenja.
English: Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, which inhibits replication of herpes viruses both in vitro and in vivo.
Slovenian: Ganciklovir je sintezen analog 2'-deoksigvanozina, ki zavre replikacijo herpesvirusov in vitro in in vivo.
English: • low red blood cell counts shown in tests
Slovenian: • majhno število rdečih krvnih celic, ki se pokaže na preiskavah
English: The benefits of treatment should be carefully considered in each case and should clearly outweigh the risks (see section 4.2).
Slovenian: Koristi zdravljenja je treba pri vsakem posameznem bolniku skrbno pretehtati in morajo jasno odtehtati tveganja (glejte poglavje 4.2).
English: Excipient(s) with known effect: approximately 43 mg (2 mEq) sodium.
Slovenian: Pomožne snovi z znanim učinkom: približno 43 mg (2 mEq) natrija.
English: Consideration should be given to official guidance on the appropriate use of antiviral agents.
Slovenian: Za ustrezno uporabo protivirusnih učinkovin je treba upoštevati uradne smernice.
English: This is because it may affect the unborn baby.
Slovenian: To zdravilo namreč lahko škoduje nerojenemu otroku.
English: 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).
Slovenian: 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).
English: If this happens, do not drive or use any tools or machines.
Slovenian: Če se vam to zgodi, ne upravljajte vozil,
English: 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).
Slovenian: 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).
English: Patients should be closely monitored for didanosine toxicity (see section 4.4).
Slovenian: Bolnike je treba skrbno spremljati glede toksičnih učinkov didanozina (glejte poglavje 4.4).