FrancophonIA/ELRC3.0 huggingface dataset:
English: • hydroxyurea - used for a problem called polycythemia, sickle cell disease and cancer,
Croatian: • hidroksiureju - koristi se za liječenje stanja koje se zove „policitemija“, bolesti srpastih stanica i raka
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).
Croatian: Stoga je potreban oprez kada se Cymevene propisuje bolesnicima s poznatom preosjetljivošću na na aciklovir ili penciklovir (ili njihove predlijekove:
English: Ganciclovir should therefore be considered a potential teratogen and carcinogen in humans with the potential to cause birth defects and cancers.
Croatian: Stoga ganciklovir treba smatrati potencijalno teratogenim i kancerogenim za ljude te lijekom koji može uzrokovati prirođene mane i karcinome.
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).
Croatian: Izloženost izražena kao srednja vrijednost AUC0-∞ iznosila je 19,4 ± 7,1 µg.h/ml 1. dana te 24,1 ± 14,6 µg.h/ml 14. dana, dok su odgovarajuće vrijednosti Cmax iznosile 7,59 ± 3,21 µg/ml (1. dan) i 8.31 ± 4.9 µg/ml (14. dan).
English: The pharmacokinetic characteristics of ganciclovir were the same after single and multiple (q12h) 5 mg/kg intravenous doses.
Croatian: Farmakokinetičke značajke ganciklovira iste su nakon jednokratne i višekratnih (svakih 12 sati) intravenskih doza od 5 mg/kg.
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.
Croatian: Ako imate tegoba s bubrezima ili krvnom slikom, liječnik će Vam možda preporučiti manju dozu lijeka Cymevene i češće provoditi krvne pretrage tijekom liječenja.
English: After dilution in infusion solutions (sodium chloride 0.9%, dextrose 5%, Ringer's or lactated Ringer's solution for injection) :
Croatian: Nakon razrjeđivanja u infuzijskim otopinama (natrijev klorid 0,9%, glukoza 5%, Ringerova otopina ili
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).
Croatian: Muškarcima se mora savjetovati da tijekom liječenja i najmanje 90 dana nakon završetka liječenja koriste mehaničku kontracepciju, osim ako je sigurno da žena ne može zatrudnjeti (vidjeti dijelove 4.6, 4.8 i 5.3).
English: [See Annex I - To be completed nationally]
Croatian: [Vidjeti Prilog I. - ispunjava država članica]
English: This adverse reaction has only been reported in studies in AIDS patients treated with Cymevene for CMV retinitis.
Croatian: Ova je nuspojava prijavljena samo u ispitivanjima provedenima u bolesnika oboljelih od AIDS-a liječenih lijekom Cymevene zbog citomegalovirusnog retinitisa.
English: People with kidney or blood problems
Croatian: Bolesnici s bubrežnim tegobama ili problemima s krvnom slikom
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).
Croatian: Stoga istodobnu primjenu tih lijekova s ganciklovirom treba razmotriti samo ako moguća korist nadilazi moguće rizike (vidjeti dio 4.4).
English: The mean systemic clearance ranged from 2.64 ± 0.38 mL/min/kg (N = 15) to 4.52 ± 2.79 mL/min/kg (N = 6) and renal clearance ranged from 2.57 ± 0.69 mL/min/kg (N = 15) to 3.48 ± 0.68 mL/min/kg (N = 20), corresponding to 90%−101% of administered ganciclovir.
Croatian: Srednja vrijednost sistemskog klirensa kretala se u rasponu od 2,64 ± 0,38 ml/min/kg (N = 15) do 4,52 ± 2,79 ml/min/kg (N = 6), a bubrežni klirens u rasponu od 2,57 ± 0,69 ml/min/kg (N = 15) do 3,48 ± 0,68 ml/min/kg (N = 20), što odgovara 90% - 101% primijenjenog ganciklovira.
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.
Croatian: - intravenski ganciklovir u dozi od 5 mg/kg na dan tijekom 6 tjedana, a nakon toga peroralni valganciklovir u dozi od 17 mg/kg dvaput na dan tijekom 6 tjedana, a zatim jedanput na dan do navršene 1. godine života, ili - peroralni valganciklovir u dozi od 17 mg/kg dvaput na dan tijekom 12 tjedana, a zatim jedanput na dan tijekom 9 mjeseci
English: This is because Cymevene may pass into breast milk.
Croatian: Naime, Cymevene može prijeći u majčino mlijeko.
English: In patients with mild, moderate, and severe renal impairment, mean systemic clearances of 2.1, 1 and 0.3 mL/min/kg were observed.
Croatian: U bolesnika s blagim, umjerenim i teškim oštećenjem bubrežne funkcije zabilježene su srednje vrijednosti sistemskog klirensa od 2,1 ml/min/kg, 1 ml/min/kg odnosno 0,3 ml/min/kg.
English: Ganciclovir causes impaired fertility and teratogenicity in animals.
Croatian: Ganciklovir uzrokuje poremećaje plodnosti i teratogen je u životinja.
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).
Croatian: Bolesnici s jatrogenom imunosupresijom izazvanom liječenjem imunosupresivima izloženi su većem riziku od trobocitopenije nego bolesnici oboljeli od AIDS-a (vidjeti dio 4.4).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 500 mg
English: Based on the occurrence of aspermatogenesis at ganciclovir exposures below therapeutic levels in animal studies, it is considered likely that ganciclovir may cause temporary or permanent inhibition of human spermatogenesis (see section 4.4).
Croatian: S obzirom da se u ispitivanjima na životinjama javila aspermatogeneza pri razinama izloženosti gancikloviru nižima od terapijskih razina, smatra se da bi ganciklovir vjerojatno mogao uzrokovati privremenu ili trajnu inhibiciju spermatogeneze u ljudi (vidjeti dio 4.4).
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).
Croatian: U jednom retrospektivnom ispitivanju istraživao se učinak antivirusnog liječenja na kasni gubitak sluha u dojenčadi s kongenitalnom CMV infekcijom (dob: 4 do 34 mjeseca, srednja vrijednost dobi:
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).
Croatian: Muškarcima se mora savjetovati da tijekom liječenja i najmanje 90 dana nakon završetka liječenja ganciklovirom koriste mehaničku kontracepciju, osim ako je sigurno da žena ne može zatrudnjeti (vidjeti dijelove 4.4 i 5.3).
English: • allergic reaction - the signs may include, red itchy skin, swelling of the throat, face, lips or mouth, difficulty swallowing or breathing.
Croatian: • alergijska reakcija - znakovi mogu uključivati crvenilo i svrbež kože, oticanje grla, lica, usana ili usta, otežano gutanje ili disanje.
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
Croatian: • nizak broj krvnih pločica - znakovi uključuju krvarenje ili nastanak modrica lakše nego obično, krv u mokraći ili stolici ili krvarenje iz desni; krvarenje može biti teško
English: If you are planning to have a baby, talk to your doctor or pharmacist before using Cymevene.
Croatian: Ako planirate imati dijete, obratite se svom liječniku ili ljekarniku prije nego primijenite Cymevene.
English: • flucytosine, amphotericin B - used for fungal infections,
Croatian: • flucitozin, amfotericin B - koriste se za liječenje gljivičnih infekcija
English: • allergic reaction - the signs may include red itchy skin, swelling of the throat, face, lips or mouth,
Croatian: • alergijska reakcija - znakovi mogu uključivati crvenilo i svrbež kože, oticanje grla, lica, usana ili usta,
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.
Croatian: S obzirom da se u ispitivanjima na životinjama javila aspermatogeneza pri sistemskim razinama izloženosti gancikloviru nižima od terapijskih razina, smatra se vjerojatnim da bi ganciklovir mogao uzrokovati inhibiciju spermatogeneze u ljudi.
English: Talk to your doctor, pharmacist or nurse before using Cymevene if:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Cymevene:
English: Powder for concentrate for solution for infusion (powder for concentrate).
Croatian: OBLIK Prašak za koncentrat za otopinu za infuziju (prašak za koncentrat).
English: After reconstitution Cymevene is a colourless to slightly yellowish solution, practically free from visible particles.
Croatian: Nakon rekonstitucije, Cymevene je bezbojna do blago žućkasta otopina koja gotovo da ne sadrži vidljive čestice.
English: Convulsions have been reported in patients taking imipenem-cilastatin and ganciclovir (see sections 4.4 and 4.5).
Croatian: Konvulzije su prijavljene u bolesnika koji su uzimali imipenem/cilastatin zajedno s ganciklovirom (vidjeti dijelove 4.4 i 4.5).
English: Since Cymevene is considered a potential teratogen and carcinogen in humans, caution should be observed in its handling.
Croatian: Budući da se Cymevene smatra potencijalno teratogenim i kancerogenim za ljude, pri rukovanju lijekom potreban je oprez.
English: - Pre-emptive therapy:
Croatian: Preemptivna terapija:
English: Ganciclovir was mutagenic in mouse lymphoma cells and clastogenic in mammalian cells.
Croatian: Ganciklovir se pokazao mutagenim u stanicama limfoma miševa i klastogenim u stanicama sisavaca.
English: (72) x (0.011 x serum creatinine [micromol/L])
Croatian: Za muškarce = (140 - dob [godine]) x (tjelesna težina [kg]) (72) x (0,011 x serumski kreatinin [mikromol/l])
English: In animal studies ganciclovir was found to be mutagenic, teratogenic, aspermatogenic, carcinogenic and to impair fertility.
Croatian: U ispitivanjima na životinjama ganciklovir je pokazao mutagena, teratogena, aspermatogena i kancerogena svojstva te štetan utjecaj na plodnost.
English: Cymevene solutions are alkaline (pH ~11).
Croatian: Otopine lijeka Cymevene su lužnate (pH ~11).
English: Mean Ganciclovir systemic plasma clearance (mL/min)
Croatian: Srednja vrijednost sistemskog klirensa ganciklovira iz plazme (ml/min)
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).
Croatian: Ostale moguće interakcije s lijekovima Toksičnost se može povećati kada se ganciklovir daje istodobno s drugim lijekovima za koje se zna da su mijelosupresivni ili remete bubrežnu funkciju (kao što su dapson, pentamidin, flucitozin, vinkristin, vinblastin, doksorubicin, amfotericin B, mofetilmikofenolat, trimetoprim/sulfametoksazol i hidroksiurea)
English: In animal studies ganciclovir impaired fertility in male and female mice.
Croatian: U ispitivanjima na životinjama ganciklovir je štetno djelovao na plodnost mužjaka i ženki miševa.
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.
Croatian: Dokazana je kemijska i fizikalna stabilnost rekonstituiranog lijeka tijekom 12 sati na temperaturi od 25°C
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).
Croatian: Liječenje Budući da se ganciklovir uklanja hemodijalizom, ona bi mogla biti korisna za smanjenje izloženosti lijeku u bolesnika koji prime preveliku dozu ganciklovira (vidjeti dio 5.2).
English: • tremor, shaking
Croatian: • nevoljno drhtanje, tresavica
English: • a skin reaction where the medicine was injected - such as inflammation, pain and swelling.
Croatian: • kožna reakcija na mjestu primjene injekcije - primjerice upala, bol i oticanje
English: Ganciclovir IV
Croatian: ganciklovir i.v.
English: Intravenous ganciclovir exhibits linear pharmacokinetics over the range of 1.6−5.0 mg/kg.
Croatian: Linearnost/nelinearnost Intravenski primijenjen ganciklovir ima linearnu farmakokinetiku u rasponu doza od 1,6 - 5,0 mg/kg.
English: In patients treated with ganciclovir the most serious and common adverse drug reactions are haematological reactions and include neutropenia, anaemia and thrombocytopenia.
Croatian: U bolesnika liječenih ganciklovirom najozbiljnije i najčešće nuspojave su hematološke nuspojave, koje obuhvaćaju neutropeniju, anemiju i trombocitopeniju.
English: Following reconstitution of the powder, 1ml solution contains 50 mg ganciclovir.
Croatian: Nakon rekonstitucije praška, 1 ml otopine sadrži 50 mg ganciklovira.
English: For storage conditions of the reconstituted concentrate, see sections 6.3.
Croatian: Uvjete čuvanja rekonstituiranog koncentrata vidjeti u dijelu 6.3.
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).
Croatian: U bolesnika s oštećenjem bubrežne funkcije doza ganciklovira mora se prilagoditi sukladno klirensu kreatinina (CrCl), kao što je prikazano u sljedećoj tablici (vidjeti dijelove 4.4 i 5.2).
English: • serious kidney problems shown in tests
Croatian: • ozbiljne tegobe s bubrezima otkrivene u nalazima pretraga
English: The vial should be gently rotated/ swirled for some minutes to obtain a clear reconstituted solution.
Croatian: Bočicu treba lagano vrtjeti nekoliko minuta da dobijete bistru rekonstituiranu otopinu.
English: 10-24 mL/min 1.25mg/kg/day
Croatian: 10-24 ml/min 1,25 mg/kg/dan
English: • muscle pain or spasms
Croatian: • bolovi ili grčevi u mišićima
English: In a prospective study, 36 severely immunocompromised paediatric patients (6 months - 16 years of age) with HIV and CMV infection received intravenous ganciclovir at a dose of 5 mg/kg per day for 2 days followed by oral ganciclovir for a median of 32 weeks.
Croatian: U prospektivnom je ispitivanju 36 teško imunokompromitiranih pedijatrijskih bolesnika (u dobi od 6 mjeseci do 16 godina) s HIV i CMV infekcijom primalo intravenski oblik ganciklovira u dozi od 5 mg/kg na dan tijekom 2 dana, a zatim peroralni ganciklovir tijekom medijana od 32 tjedna.
English: Three subjects developed acute rejection within 6 months of detection of CMV, but CMV was preceded by rejection in 13 subjects.
Croatian: CMV-a, ali je odbacivanje nastupilo prije CMV-a u 13 ispitanika.
English: Other adverse drugs reactions are presented in the table below.
Croatian: Ostale nuspojave na lijek prikazane su u tablici u nastavku.
English: Ganciclovir may have a major influence on the ability to drive and use machines (see section 4.8).
Croatian: Ganciklovir može značajno utjecati na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio
English: In a retrospective study, 122 paediatric liver transplantation recipients (16 days - 18 years of age, median age 2.5 years) received a minimum of 14 days of intravenous ganciclovir 5 mg/kg twice a day followed by pre-emptive CMV PCR monitoring.
Croatian: U retrospektivnom su ispitivanju 122 primatelja presatka jetre pedijatrijske dobi (16 dana do 18 godina, medijan dobi 2,5 godina) primala intravenski ganciklovir u dozi od 5 mg/kg dvaput na dan tijekom najmanje 14 dana, nakon čega je uslijedila preemptivna kontrola CMV-a putem testova lančane reakcije polimerazom (PCR).
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).
Croatian: Oštećenje funkcije bubrega: Očekuje se da bi predoziranje ganciklovirom moglo dovesti do povećane bubrežne toksičnosti u bolesnika s oštećenom funkcijom bubrega (vidjeti dio 4.4).
English: Mean Cmax was 5.5 ± 6 µg/mL at 4 mg/kg and 7.0 ± 1.6 µg/mL at 6 mg/kg.
Croatian: Srednja vrijednost Cmax bila je 5,5 ± 6 µg/ml nakon primjene doze od 4 mg/kg, odnosno 7,0 ± 1,6 µg/ml nakon primjene doze od 6 mg/kg.
English: For storage conditions after reconstitution and after dilution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon rekonstitucije i razrjeđivanja lijeka vidjeti u dijelu 6.3.
English: Candida infections including oral candidiasis.
Croatian: sepsa celulitis infekcija mokraćnog sustava infekcije čiji je uzročnik Candida, uključujući oralnu kandidijazu
English: If you are not sure, talk to your doctor, pharmacist or nurse before using Cymevene.
Croatian: Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Cymevene.
English: Cardiac arrhythmias
Croatian: Srčani poremećaji:
English: The total plasma clearance of ganciclovir is linearly correlated with creatinine clearance.
Croatian: Ukupan klirens ganciklovira iz plazme u linearnoj je korelaciji s klirensom kreatinina.
English: Anaphylactic reaction
Croatian: anafilaktička reakcija
English: LIST OF EXCIPIENTS This medicinal product contains sodium.
Croatian: POPIS POMOĆNIH TVARI Lijek sadrži natrij.
English: Cymevene contains sodium
Croatian: Cymevene sadrži natrij
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.
Croatian: Dokazano je da poluvijek trifosfata u stanicama zaraženima HSV-om iznosi 18 sati, a u stanicama zaraženima HCMV-om od 6 do 24 sata nakon uklanjanja izvanstaničnog ganciklovira.
English: • your blood counts
Croatian: • Vašoj krvnoj slici
English: By one year after baseline, 5/24 ganciclovir recipients and 13/19 control patients had worsening hearing (p < 0.01).
Croatian: Godinu dana nakon početka ispitivanja pogoršanje sluha razvilo se u 5/24 primatelja ganciklovira i 13/19 kontrolnih bolesnika (p < 0,01).
English: Dysgeusia (taste disturbance) Hypoaesthesia
Croatian: glavobolja nesanica disgeuzija (poremećaj okusa)
English: Add a volume of 100ml of diluent to the reconstituted solution.
Croatian: Rekonstituiranoj otopini dodajte volumen od 100 ml sredstva za razrjeđivanje.
English: • liver and kidney problems shown in tests
Croatian: • jetrene i bubrežne tegobe otkrivene u nalazima pretraga
English: These drugs should not be used concomitantly unless the potential benefits outweigh the potential risks (see section 4.4).
Croatian: Ovi se lijekovi ne smiju primjenjivati istodobno, osim ako moguća korist ne nadilazi moguće rizike (vidjeti dio
English: How to store Cymevene
Croatian: Kako čuvati Cymevene
English: • low white blood cell counts - with signs of infection such as sore throat, mouth ulcers or a fever
Croatian: • nizak broj bijelih krvnih stanica - uz znakove infekcije poput grlobolje, vrijedova u ustima ili vrućice
English: Macular oedema Retinal detachment Vitreous floaters Eye pain
Croatian: makularni edem odvajanje mrežnice plutajuće mutnine staklovine bol u oku
English: None of the ganciclovir recipients had worsening hearing from baseline to 6 months, compared with 7 control patients (p < 0.01).
Croatian: Pogoršanje sluha od početka ispitivanja do 6. mjeseca nije nastupilo niti u jednog primatelja ganciklovira u odnosu na 7 kontrolnih bolesnika (p < 0,01).
English: Look out for side effects
Croatian: Obratite pozornost na nuspojave
English: It is recommended that complete blood counts including platelet counts be monitored during therapy.
Croatian: Tijekom liječenja preporučuje se praćenje kompletne krvne slike, uključujući broj trombocita.
English: Cymevene should be used with caution in patients with pre-existing haematological cytopenia or a history of drug-related haematological cytopenia and in patients receiving radiotherapy.
Croatian: Cymevene se mora primjenjivati uz oprez u bolesnika s postojećom hematološkom citopenijom ili hematološkom citopenijom izazvanom lijekovima u anamnezi te u bolesnika koji primaju terapiju zračenjem.
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.
Croatian: 90% intravenski primijenjene doze ganciklovira izluči se u mokraći u nepromijenjenom obliku tijekom 24
English: Twenty-one of 25 ganciclovir recipients had improved hearing or maintained normal hearing from baseline to 6 months compared with 10/17 control patients (84% and 59%, respectively p = 0.06).
Croatian: Poboljšanje sluha ili održan normalan sluh od početka ispitivanja do 6. mjeseca zabilježeni su u 21/25 primatelja ganciklovira u odnosu na 10/17 kontrolnih bolesnika (84% odnosno 59%, p = 0,06).
English: Blood and lymphatic disorders: Very common (≥ 1/10):
Croatian: Poremećaji krvi i limfnog sustava: Vrlo često (≥ 1/10):
English: Rare: may affect up to 1 in 1,000 people
Croatian: Rijetke: mogu se javiti u do 1 na 1000 osoba • osip
English: • eye infection (conjunctivitis)
Croatian: • uznemirenost ili nervoza • infekcija oka (konjunktivitis)
English: • you are allergic to ganciclovir, valganciclovir or any of the other ingredients of this medicine
Croatian: • ako ste alergični na ganciklovir, valganciklovir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Do not administer by intramuscular or subcutaneous injection because this may result in severe tissue irritation due to the high pH (~11) of ganciclovir solutions (see section 4.8).
Croatian: Ne smije se primijeniti intramuskularnom niti supkutanom injekcijom jer to može dovesti do teške iritacije tkiva zbog visoke pH vrijednosti (~11) otopine ganciklovira (vidjeti dio 4.8).
English: • mycophenolate mofetil - used after an organ transplant,
Croatian: • probenecid - koristi se za liječenje gihta • mofetilmikofenolat - koristi se nakon presađivanja organa
English: 25-49 mL/min 2.5 mg/kg/day
Croatian: 25-49 ml/min 2,5 mg/kg/dan
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.
Croatian: Prije razrjeđivanja s kompatibilnim sredstvom za razrjeđivanje, rekonstituiranu otopinu treba pažljivo pregledati da se uvjerite da se lijek otopio i da gotovo ne sadrži vidljive čestice.
English: Rare (≥ 1/10000, < 1/1000)
Croatian: Rijetko (≥ 1/10 000 i < 1/1000)
English: • low red blood cell counts - signs include feeling short of breath or tired, palpitations or pale skin.
Croatian: • nizak broj crvenih krvnih stanica - znakovi uključuju osjećaj nedostatka zraka ili umor, osjećaj lupanja srca (palpitacije) ili bljedilo kože
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).
Croatian: Budući da bubrežna funkcija slabi sa starijom dobi, kod primjene ganciklovira starijim osobama potrebno je posebno razmotriti njihovu bubrežnu funkciju (vidjeti dio 4.2).
English: Therapeutic guidelines should be consulted.
Croatian: Potrebno je slijediti smjernice za liječenje.
English: Mycophenolate mofetil, stavudine, trimethoprim and zidovudine No significant pharmacokinetic interactions were observed when ganciclovir was administered in combination with either: mycophenolate mofetil, stavudine, trimethoprim or zidovudine.
Croatian: Nisu primijećene klinički značajne farmakokinetičke interakcije kada se ganciklovir primjenjivao u kombinaciji s mofetilmikofenolatom, stavudinom, trimetoprimom ili zidovudinom.