FrancophonIA/ELRC3.0 huggingface dataset:
English: - Intravenous ganciclovir 5 mg/kg daily for 6 weeks followed by oral valganciclovir 17 mg/kg twice daily for 6 weeks then daily until 1 year of age, or - Oral valganciclovir 17 mg/kg twice daily for 12 weeks then daily for 9 months.
Slovenian: - intravenski ganciklovir 5 mg/kg na dan 6 tednov, nato peroralni valganciklovir 17 mg/kg dvakrat na dan 6 tednov in potem enkrat na dan do 1 leta starosti, ali - peroralni valganciklovir 17 mg/kg dvakrat na dan 12 tednov, nato enkrat na dan 9 mesecev.
English: If you are planning to have a baby, talk to your doctor or pharmacist before using Cymevene.
Slovenian: Če načrtujete, da bi imeli otroka, se posvetujte z zdravnikom ali farmacevtom, preden začnete uporabljati zdravilo Cymevene.
English: This medicinal product contains 2 mmol (43mg) sodium per 500 mg dose.
Slovenian: To zdravilo vsebuje 2 mmola (43 mg) natrija na 500-mg odmerek.
English: Ganciclovir should therefore be considered a potential teratogen and carcinogen in humans with the potential to cause birth defects and cancers.
Slovenian: Zato je treba ganciklovir pri človeku obravnavati kot potencialno teratogeno in kancerogeno snov, ki lahko povzroči prirojene hibe in raka.
English: Refer to treatment guidelines.
Slovenian: Glejte smernice za zdravljenje.
English: Treatment of CMV disease in adults and adolescents from 12 years of age with normal renal function
Slovenian: Zdravljenje citomegalovirusne bolezni pri odraslih in mladostnikih, starejših od 12 let, z normalnim delovanjem ledvic
English: • serious kidney problems shown in tests
Slovenian: • resne težave z ledvicami, ki se pokažejo na preiskavah
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {DD month YYYY} Date of latest renewal: {DD month YYYY}
Slovenian: Datum prve odobritve: {DD. mesec LLLL}
English: The flip-off cap should be removed to expose the central portions of the rubber stopper.
Slovenian: Snemno zaporko je treba odstraniti, da se izpostavi osrednji del gumijastega zamaška.
English: • liver and kidney problems shown in tests
Slovenian: • težave z jetri in ledvicami, ki se pokažejo na preiskavah
English: • trimethoprim, trimethoprim/sulfamethoxazole, dapsone - used for bacterial infections,
Slovenian: • trimetoprim, trimetoprim/sulfametoksazol, dapson - uporabljajo se za zdravljenje bakterijskih okužb,
English: • changes in blood cell counts.
Slovenian: • spremembe krvne slike.
English: Due to the similarity of the chemical structure of ganciclovir and that of aciclovir and penciclovir, a cross-hypersensitivity reaction between these drugs is possible.
Slovenian: Kemijska zgradba ganciklovirja je podobna kemijski zgradbi aciklovirja in penciklovirja, zato je med temi zdravili možna navzkrižna preobčutljivost.
English: Twelve subjects (9.8%) developed CMV disease (8 high-risk vs. 4 routine-risk, p = 0.03).
Slovenian: Citomegalovirusna bolezen se je razvila pri 12 bolnikih (9,8 %; pri 8 z velikim in 4 z rutinskim tveganjem, p = 0,03).
English: As a consequence, pharmacokinetic interactions with protease inhibitors and non-nucleoside reverse transcriptase inhibitors are not anticipated.
Slovenian: Glede na to ni pričakovati farmakokinetičnih medsebojnih delovanj z zaviralci proteaz in zaviralci nenukleozidne reverzne transkriptaze.
English: treatment of cytomegalovirus (CMV) disease in immunocompromised patients;
Slovenian: zdravljenje citomegalovirusne (CMV) bolezni pri imunsko oslabelih bolnikih;
English: Intravenous ganciclovir exhibits linear pharmacokinetics over the range of 1.6−5.0 mg/kg.
Slovenian: Intravenski ganciklovir ima v območju od 1,6 do 5,0 mg/kg linearno farmakokinetiko.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila o rekonstituciji zdravila pred dajanjem glejte poglavje 6.6.
English: After reconstitution with 10 mL of water for injections, each mL provides 50 mg of ganciclovir.
Slovenian: Po rekonstituciji z 10 ml vode za injekcije en mililiter vsebuje 50 mg ganciklovirja.
English: Avoid inhalation or direct contact of the powder contained in the vials or direct contact of the reconstituted solution with the skin or mucous membranes.
Slovenian: Izogibajte se vdihavanju praška ali neposrednemu stiku s praškom v viali in neposrednemu stiku rekonstituirane raztopine s kožo ali sluznicami.
English: - Prophylaxis:
Slovenian: - Profilaksa:
English: Cymevene may affect fertility.
Slovenian: Zdravilo Cymevene lahko neugodno vpliva na plodnost.
English: • hydroxyurea - used for a problem called polycythemia, sickle cell disease and cancer,
Slovenian: • hidroksisečnina - uporablja se za zdravljenje policitemije, bolezni srpastih celic in raka,
English: Therefore, breastfeeding must be discontinued during treatment with ganciclovir (see section 4.3).
Slovenian: Zato mora bolnica med zdravljenjem z ganciklovirjem opustiti dojenje (glejte poglavje 4.3).
English: You may get the following symptoms if you have too much:
Slovenian: V primeru prevelikega odmerka se vam lahko pojavijo naslednji simptomi:
English: • changes in blood cell counts
Slovenian: • spremembe v krvni sliki
English: • mycophenolate mofetil - used after an organ transplant,
Slovenian: • mofetilmikofenolat - uporablja se po presaditvah organov,
English: In animal studies ganciclovir impaired fertility in male and female mice.
Slovenian: V študijah na živalih je ganciklovir poslabšal plodnost mišjih samcev in samic.
English: Children and adolescents There is limited information on how safe or effective Cymevene is in children under 12 years.
Slovenian: Podatkov o varnosti in učinkovitosti zdravila Cymevene pri otrocih, mlajših od 12 let, je malo.
English: Agitation Psychotic disorder
Slovenian: agitiranost psihotična motnja
English: Ganciclovir
Slovenian: ganciklovir
English: Antiviral Activity
Slovenian: Protivirusno delovanje
English: Male patients must be advised to practice barrier contraception during and for at least 90 days following treatment with ganciclovir unless it is certain that the female partner is not at risk of pregnancy (see sections 4.4 and 5.3).
Slovenian: Moškim je treba naročiti, naj med zdravljenjem in vsaj še 90 dni po zdravljenju z ganciklovirjem uporabljajo pregradno kontracepcijo, razen če je popolnoma gotovo, da partnerka ne more zanositi (glejte poglavji 4.4 in 5.3).
English: Based on patient weight the appropriate volume should be removed with a syringe from the vial and further diluted into an appropriate infusion solution.
Slovenian: Priprava končne razredčene raztopine za infundiranje Glede na bolnikovo telesno maso je treba z brizgo izvleči ustrezno količino iz viale in dodatno razredčiti za ustrezno raztopino za infundiranje.
English: The possibility of viral resistance should be considered in patients who repeatedly achieve a poor clinical response or experience continuous viral excretion during treatment.
Slovenian: Pri bolnikih, ki ponavljaje dosegajo slab kliničen odziv ali se jim med zdravljenjem stalno izloča virus,
English: The total plasma clearance of ganciclovir is linearly correlated with creatinine clearance.
Slovenian: Celotni plazemski očistek ganciklovirja linearno korelira z očistkom kreatinina.
English: Mean Ganciclovir Plasma half-life (hours)
Slovenian: Povprečni plazemski razpolovni čas ganciklovirja (ure)
English: Oral ganciclovir is no longer available but adverse reactions reported with its use can also be expected to occur in patients receiving intravenous ganciclovir.
Slovenian: Peroralnega ganciklovirja ni več na voljo, vendar je pri bolnikih, ki prejemajo intravenski ganciklovir, mogoče pričakovati tudi neželene učinke, zabeležene med peroralno uporabo.
English: Cymevene can cause some serious side effects that you need to tell your doctor about straight away.
Slovenian: Bodite pozorni na neželene učinke Zdravilo Cymevene lahko povzroči nekatere resne neželene učinke, o katerih morate nemudoma obvestiti zdravnika.
English: How to use Cymevene
Slovenian: Kako uporabljati zdravilo Cymevene
English: If you think you have been given too much Cymevene talk to your doctor or go to hospital straight away.
Slovenian: Če ste uporabili večji odmerek zdravila Cymevene, kot bi smeli Če menite, da ste dobili preveč zdravila Cymevene, se nemudoma posvetujte z zdravnikom ali pojdite v bolnišnico.
English: • allergic reaction - the signs may include, red itchy skin, swelling of the throat, face, lips or mouth, difficulty swallowing or breathing.
Slovenian: • alergijska reakcija - med znaki so lahko rdeča, srbeča koža, oteklost žrela, obraza, ustnic ali ust, težave s požiranjem ali dihanjem.
English: Cymevene is a powder for solution for infusion.
Slovenian: Zdravilo Cymevene je prašek za raztopino za infundiranje.
English: • swollen stomach
Slovenian: • bolečine v trebuhu
English: Single-dose glass vials of 10 mL with fluoro-resin laminated rubber stopper and aluminum closure with flip-off cap.
Slovenian: 10-ml steklene viale z enim odmerkom, ki imajo gumijast zamašek, laminiran s fluorosmolo, in aluminijsko zaporo s snemno zaporko.
English: Do not administer by rapid or bolus intravenous injection because the resulting excessive plasma levels may increase the toxicity of ganciclovir.
Slovenian: Ganciklovirja ne dajajte v hitri intravenski injekciji ali v bolusu, ker lahko tako nastala prekomerna koncentracija zdravila v plazmi poveča njegovo toksičnost.
English: If the blood cell counts are significantly reduced during therapy with ganciclovir, treatment with haematopoietic growth factors and/or discontinuation of treatment should be considered (see sections 4.4 and 4.8).
Slovenian: Če se med zdravljenjem z ganciklovirjem število krvnih celic bistveno zmanjša, pride v poštev zdravljenje s hematopoetskimi rastnimi faktorji in/ali prenehanje zdravljenja (glejte poglavji 4.4 in
English: The following information is intended for healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: NAVODILA ZA UPORABO IN RAVNANJE Z ZDRAVILOM
English: Men must be advised to practice barrier contraception during treatment, and for at least 90 days thereafter, unless it is certain that the female partner is not at risk of pregnancy (see sections 4.6, 4.8 and 5.3).
Slovenian: Moškim je treba naročiti, da morajo med zdravljenjem in vsaj še 90 dni po zdravljenju uporabljati pregradno kontracepcijo, razen če je popolnoma gotovo, da partnerka ne more zanositi (glejte poglavja 4.6, 4.8 in
English: Also do this for at least 90 days after Cymevene has been stopped.
Slovenian: Kontracepcijo morate uporabljati tudi še vsaj 90 dni po koncu zdravljenja z zdravilom Cymevene.
English: Please refer to the Summary of Product Characteristics for full prescribing information.
Slovenian: Za celotne informacije za predpisovanje zdravila, prosimo, glejte povzetek glavnih značilnosti zdravila.
English: INSTRUCTIONS FOR USE AND HANDLING
Slovenian: NAVODILA ZA UPORABO
English: • eczema, skin problems, itching
Slovenian: • ekcem, težave s kožo, srbenje
English: These drugs should not be used concomitantly unless the potential benefits outweigh the potential risks (see section 4.4).
Slovenian: Teh zdravil se ne sme uporabljati hkrati, razen če možne koristi odtehtajo možna tveganja (glejte poglavje 4.4).
English: Also do this for at least 30 days after Cymevene has been stopped.
Slovenian: Kontracepcijo morate uporabljati tudi še vsaj 30 dni po koncu zdravljenja z zdravilom Cymevene.
English: Mean Ganciclovir systemic plasma clearance (mL/min)
Slovenian: Povprečni sistemski plazemski očistek ganciklovirja (ml/min)
English: • kidney or liver problems
Slovenian: • težave z ledvicami ali jetri
English: • fever, chills or night sweats
Slovenian: • zvišana telesna temperatura, mrzlica ali nočno znojenje
English: For storage conditions of the reconstituted concentrate, see sections 6.3.
Slovenian: Za pogoje shranjevanja rekonstituiranega koncentrata glejte poglavje 6.3.
English: The pharmacokinetics of intravenous ganciclovir in infants and children were consistent with those observed in neonates and adults.
Slovenian: Farmakokinetika intravenskega ganciklovirja se je pri dojenčkih in otrocih skladala s farmakokinetiko, ugotovljeno pri novorojenčkih in odraslih.
English: What Cymevene looks like and contents of the pack Cymevene is a white to off white powder for concentrate for solution for infusion, supplied in a singledose glass vial, with a rubber stopper and aluminium closure with flip-off cap.
Slovenian: Zdravilo Cymevene je bel ali skoraj bel prašek za koncentrat za raztopino za infundiranje, ki je na voljo v stekleni viali z enim odmerkom; viala ima gumijast zamašek in aluminijsko zaporo s snemno zaporko.
English: Renal impairment: It is expected that an overdose of ganciclovir could result in increased renal toxicity in patients with renal impairment (see section 4.4).
Slovenian: Okvara ledvic: Pričakovati je, da lahko preveliko odmerjanje ganciklovirja pri bolnikih z okvaro ledvic poveča toksičnost za ledvice (glejte poglavje 4.4).
English: Ganciclovir IV
Slovenian: ganciklovir i.v.
English: • allergic reaction - the signs may include red itchy skin, swelling of the throat, face, lips or mouth,
Slovenian: • alergijska reakcija - med znaki so lahko rdeča, srbeča koža, oteklost žrela, obraza, ustnic ali ust,
English: After reconstitution:
Slovenian: Po pripravi:
English: Powder for concentrate for solution for infusion (powder for concentrate).
Slovenian: FARMACEVTSKA OBLIKA Prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat).
English: If you or your partner becomes pregnant while using Cymevene, talk to your doctor straight away.
Slovenian: Če bolnica ali partnerka bolnika med zdravljenjem z zdravilom Cymevene zanosi, se morate takoj posvetovati z zdravnikom.
English: Ganciclovir should not be used concomitantly with imipenem-cilastatin unless the potential benefits outweigh the potential risks (see section 4.5).
Slovenian: Ganciklovirja se ne sme uporabljati hkrati z imipenem-cilastatinom, razen če možne koristi odtehtajo možna tveganja (glejte poglavje 4.5).
English: Based upon animal studies where aspermatogenesis was induced at ganciclovir systemic exposures below therapeutic levels, it is considered likely that ganciclovir causes inhibition of human spermatogenesis.
Slovenian: Glede na študije na živalih, v katerih se je aspermatogeneza pojavila ob sistemski izpostavljenosti ganciklovirju, nižji od terapevtske, je verjetno,
English: It is recommended that complete blood counts including platelet counts be monitored during therapy.
Slovenian: Med zdravljenjem je priporočljivo spremljati celotno krvno sliko, vključno s številom trombocitov.
English: 10-24 mL/min 1.25mg/kg/day
Slovenian: 10-24 ml/min 1,25 mg/kg/dan
English: The duration of prophylaxis is based on the risk of CMV disease, local treatment guidelines should be consulted.
Slovenian: Trajanje profilakse je odvisno od tveganja za citomegalovirusno bolezen in upoštevati je treba lokalne smernice za zdravljenje.
English: In CMV-infected cells, ganciclovir is initially phosphorylated to ganciclovir monophosphate by the viral protein kinase, UL97.
Slovenian: V celicah, okuženih s CMV, virusna proteinska kinaza UL97 najprej fosoforilira ganciklovir v ganciklovir-monofosfat.
English: After reconstitution Cymevene is a colourless to slightly yellowish solution, practically free from visible particles.
Slovenian: Po rekonstituciji je zdravilo Cymevene brezbarvna do rumenkasta raztopina, ki je skoraj brez vidnih delcev.
English: The duration of maintenance therapy is based on the risk of CMV disease, local treatment guidelines should be consulted.
Slovenian: Trajanje vzdrževalnega zdravljenja je odvisno od tveganja za citomegalovirusno bolezen in upoštevati je treba lokalne smernice za zdravljenje.
English: Creatinine clearance (mL/min)
Slovenian: (ml/min)
English: Therefore, these drugs should be considered for concomitant use with ganciclovir only if the potential benefits outweigh the potential risks (see section 4.4).
Slovenian: Zato pridejo ta zdravila v poštev za sočasno uporabo z ganciklovirjem le v primeru, da možne koristi odtehtajo možna tveganja (glejte poglavje 4.4).
English: • probenecid - used for gout,
Slovenian: • probenecid - uporablja se za zdravljenje protina,
English: Cardiac arrhythmias
Slovenian: motnje srčnega ritma
English: Caution should therefore be used when prescribing Cymevene to patients with known hypersensitivity to aciclovir or penciclovir (or to their prodrugs, valaciclovir or famciclovir respectively).
Slovenian: Pri predpisovanju zdravila Cymevene bolnikom z znano preobčutljivostjo na aciklovir ali penciklovir (ali na njuni predzdravili valaciklovir oz.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 500 mg
English: For storage conditions after reconstitution and after dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po rekonstituciji in razredčenju zdravila glejte poglavje 6.3.
English: The majority of the reports were either not associated with any adverse reactions, or included one or more of the adverse reactions listed below: - Haematological toxicity: myelosuppression including pancytopenia, medullary aplasia, leucopenia, neutropenia, granulocytopenia - Hepatotoxicity: hepatitis, liver function disorder - Renal toxicity: worsening of haematuria in a patient with pre-existing renal impairment, acute renal failure, elevated creatinine.
Slovenian: Večina poročil bodisi ni navajala nobenih neželenih učinkov bodisi so zajela enega ali več od spodaj naštetih neželenih učinkov: - Hematološka toksičnost: mielosupresija vključno s pancitopenijo, medularno aplazijo, levkopenijo,
English: Pharmacodynamic interactions
Slovenian: Farmakokinetično medsebojno delovanje
English: • urine infection - signs include fever, passing urine more often, pain when passing urine
Slovenian: • okužba sečil - med znaki so zvišana telesna temperatura, pogostejše odvajanje urina,
English: <10 mL/min 1.25 mg/kg 3x/wk after haemodialysis
Slovenian: < 10 ml/min 1,25 mg/kg 3x/teden po hemodializi
English: Since renal function decreases with age, ganciclovir should be administered to the elderly with special consideration for their renal status (see section 4.2).
Slovenian: Ker se delovanje ledvic s starostjo zmanjšuje, je treba med uporabo ganciklovirja pri starejših bolnikih posebej upoštevati stanje njihovih ledvic (glejte poglavje 4.2).
English: Following reconstitution of the powder, 1ml solution contains 50 mg ganciclovir.
Slovenian: Po rekonstituciji praška vsebuje 1 ml raztopine 50 mg ganciklovirja.
English: Precaution to be taken before handling or administering the medicinal product: Since ganciclovir is considered a potential teratogen and carcinogen in humans, caution should be taken in its handling (see section 6.6).
Slovenian: Ganciklovir velja pri človeku za potencialni teratogen in kancerogen, zato je pri ravnanju z njim potrebna previdnost (glejte poglavje 6.6).
English: • you are allergic to ganciclovir, valganciclovir or any of the other ingredients of this medicine
Slovenian: • če ste alergični na ganciklovir, valganciklovir ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
English: Didanosine plasma concentrations were found to be consistently raised when given with ganciclovir.
Slovenian: Ugotovili so, da je bila med sočasno uporabo didanozina z ganciklovirjem koncentracija didanozina v plazmi dosledno zvišana.
English: Cymevene contains sodium
Slovenian: Zdravilo Cymevene vsebuje natrij
English: Macular oedema Retinal detachment Vitreous floaters Eye pain
Slovenian: edem makule odstop mrežnice delci v steklovini bolečine v očeh
English: This should be taken into consideration by patients on a controlled sodium diet.
Slovenian: To morajo upoštevati bolniki na dieti z omejitvijo natrija.
English: White to off-white solid cake.
Slovenian: Bela ali skoraj bela čvrsta pogača.
English: If you stop using Cymevene Do not stop using Cymevene without talking to your doctor.
Slovenian: Ne prenehajte uporabljati zdravila Cymevene, ne da bi se prej posvetovali z zdravnikom.
English: Cymevene contains the active substance ganciclovir.
Slovenian: Zdravilo Cymevene vsebuje zdravilno učinkovino ganciklovir.
English: Patients with Renal Impairment Undergoing Haemodialysis
Slovenian: Bolniki z okvaro ledvic, zdravljeni s hemodializo
English: Aseptic technique should be used throughout to reconstitute lyophilised Cymevene.
Slovenian: Priprava rekonstituiranega koncentrata Med celotnim postopkom rekonstitucije liofiliziranega zdravila Cymevene je treba uporabljati aseptično tehniko.
English: What Cymevene is and what it is used for
Slovenian: Kaj je zdravilo Cymevene in za kaj ga uporabljamo Kaj je zdravilo Cymevene
English: • low level of platelets - signs include bleeding or bruising more easily than usual, blood in urine or stools or bleeding from gums, the bleeding could be severe.
Slovenian: • majhno število trombocitov (krvnih ploščic) - med znaki so večja nagnjenost h krvavitvam ali podplutbam kot po navadi, kri v urinu ali blatu ali krvavitev iz dlesni; krvavitev je lahko huda.
English: 25-49 mL/min 2.5 mg/kg/day
Slovenian: 25-49 ml/min 2,5 mg/kg/dan
English: • changes to your sense of touch, tingling, tickling, pricking or burning feeling
Slovenian: • spremembe v zaznavanju dotika, mravljinčenje, draženje, zbadanje ali pekoč občutek • napadi krčev
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Cymevene Vsebina pakiranja in dodatne informacije
English: • low level of platelets - signs include bleeding or bruising more easily than usual, blood in urine or stools or bleeding from gums, the bleeding could be severe
Slovenian: • majhno število trombocitov (krvnih ploščic) - med znaki so večja nagnjenost h krvavitvam ali podplutbam kot po navadi, kri v urinu ali blatu ali krvavitev iz dlesni; krvavitev je lahko huda,
English: Convulsions have been reported in patients taking ganciclovir and imipenem−cilastatin concomitantly.
Slovenian: Pri bolnikih, ki so sočasno uporabljali ganciklovir in imipenem−cilastatin, so poročali o konvulzijah.
English: Confusional state Thinking abnormal
Slovenian: depresija anksioznost stanje zmedenosti nenormalno mišljenje
English: 5 mg/kg given as an intravenous infusion over one hour, once daily on 7 days per week or 6 mg/kg once daily on 5 days per week.
Slovenian: 5 mg/kg v intravenski infuziji v teku ene ure enkrat na dan 7 dni na teden ali 6 mg/kg enkrat na dan 5 dni na teden.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Cymevene.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se pred začetkom uporabe zdravila Cymevene posvetujte z zdravnikom ali farmacevtom.
English: - Induction treatment: 5 mg/kg given as an intravenous infusion over one hour, every 12 hours for 1421 days.
Slovenian: - Indukcijsko zdravljenje: 5 mg/kg v intravenski infuziji v teku ene ure, vsakih 12 ur od 14 do 21 dni.
English: Formal safety studies with ganciclovir have not been conducted in children under 12 years of age but based on experience with valganciclovir, a pro-drug of ganciclovir, the overall safety profile of the active drug is similar in paediatric and adult patients.
Slovenian: Toda na podlagi izkušenj z valganciklovirjem, predzdravilom ganciklovirja, so splošne varnostne značilnosti aktivnega zdravila pri pediatričnih in odraslih bolnikih podobne.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and dilution.
Slovenian: za intravensko uporabo po rekonstituciji in razredčenju
English: Ganciclovir causes impaired fertility and teratogenicity in animals.
Slovenian: Ganciklovir pri živalih poslabša plodnost in je teratogen.