FrancophonIA/ELRC3.0 huggingface dataset:
English: This includes the retina at the back of the eye - this means the virus can cause problems with eye sight.
Croatian: To uključuje i mrežnicu u očnoj pozadini, što znači da ovaj virus može uzrokovati tegobe s vidom.
English: There were 9 deaths during the study, 3 in the ganciclovir group and 6 in the control group.
Croatian: Zabilježeno je 9 smrtnih slučajeva tijekom ispitivanja, 3 u skupini liječenoj ganciklovirom i 6 u kontrolnoj skupini.
English: • infertility in men - see ‘Fertility' section
Croatian: • neplodnost u muškaraca - pogledajte odlomak „Plodnost“
English: The study included 21 infants with normal hearing at birth who developed late-onset hearing loss.
Croatian: U ispitivanje je uključeno 21 dojenče s normalnim sluhom po rođenju koji su razvili kasni gubitak sluha.
English: The risk of neutropenia is not predictable on the basis of the number of neutrophils before treatment.
Croatian: Rizik od neutropenije nije moguće predvidjeti na temelju broja neutrofila prije početka liječenja.
English: It is also used to prevent CMV infection after an organ transplant or during chemotherapy.
Croatian: Također se koristi za sprječavanje CMV infekcije nakon presađivanja organa ili tijekom kemoterapije.
English: If such contact occurs, wash thoroughly with soap and water, rinse eyes thoroughly with plain water.
Croatian: Ako ipak dođe do kontakta, kožu temeljito operite sapunom i vodom, a oči dobro isperite običnom vodom.
English: Ganciclovir was effective with a toxicity profile similar to that seen in adults.
Croatian: Ganciklovir je bio učinkovit, uz profil toksičnosti sličan onome u odraslih.
English: It is used in adults and adolescents 12 years and older.
Croatian: Primjenjuje se u odraslih i adolescenata u dobi od 12 ili više godina.
English: What you need to know before you use Cymevene
Croatian: Što morate znati prije nego počnete primjenjivati Cymevene
English: Neutropenia also occurs more often in paediatric patients, but there is no correlation between neutropenia and infectious adverse reactions in the paediatric population.
Croatian: Neutropenija se također javlja češće u pedijatrijskih bolesnika, ali ne postoji korelacija između neutropenije i infektivnih nuspojava u pedijatrijskoj populaciji.
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.
Croatian: Iako su primatelji ganciklovira imali manje zastoja i normalnije neurološke ishode, većina ih je i dalje zaostajala za onim što se smatra normalnim razvojem u dobi od 6 tjedana, 6 mjeseci i 12 mjeseci.
English: • If you have two infusions a day, this will continue for up to 21 days.
Croatian: • Ako primate 2 infuzije na dan, liječenje će trajati najviše 21 dan.
English: Cymevene should be administered as recommended in section 4.2 to reduce the risk of local tissue irritation.
Croatian: Cymevene se mora primjenjivati sukladno preporukama u dijelu 4.2 kako bi se smanjio rizik od lokalne iritacije tkiva.
English: There was no clinically significant effect on ganciclovir concentrations.
Croatian: Nije bilo klinički značajnog učinka na koncentracije ganciklovira.
English: Of the 100 patients enrolled, 42 met all study criteria and had both baseline and 6-month follow up audiometric evaluations.
Croatian: Od 100 uključenih bolesnika, njih 42 su ispunjavala sve kriterije za ispitivanje i kod njih su provedene i početna i kontrolna audiometrijska procjena nakon 6 mjeseci.
English: Alanine aminotransferase increased
Croatian: povišena razina alanin aminotransferaze
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Croatian: Ovaj Sažetak opisa svojstava lijeka, označavanje i uputa o lijeku ishod su arbitražnog postupka na koji se odnosi ova Odluka Komisije.
English: The benefits of treatment should be carefully considered in each case and should clearly outweigh the risks (see section 4.2).
Croatian: Koristi liječenja moraju se pomno razmotriti u svakom pojedinom slučaju i moraju jasno nadmašiti rizike (vidjeti dio 4.2).
English: Patients with impaired renal function are at increased risk of toxicity (especially haematological toxicity).
Croatian: Bolesnici s oštećenjem bubrežne funkcije izloženi su povećanom riziku od toksičnosti (osobito hematološke toksičnosti).
English: INSTRUCTIONS FOR USE AND HANDLING
Croatian: UPUTE ZA UPORABU I RUKOVANJE
English: INFORMATION IN BRAILLE Justification for not including Braille accepted [To be completed nationally]
Croatian: Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma [Ispunjava država članica]
English: Infusion concentrations greater than 10mg/mL are not recommended.
Croatian: Ne preporučuju se infuzije u koncentraciji većoj od 10 mg/ml.
English: The range of exposures was comparable to those observed in adults.
Croatian: Raspon izloženosti bio je usporediv s onim primijećenim u odraslih.
English: Do not use Cymevene if any of the above apply to you.
Croatian: Nemojte primjenjivati Cymevene ako se nešto od navedenog odnosi na Vas.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Croatian: Osobito obavijestite liječnika ili ljekarnika ako uzimate neki od sljedećih lijekova:
English: The use of ganciclovir warrants extreme caution, especially in the paediatric population due to the potential for long-term carcinogenicity and reproductive toxicity.
Croatian: Primjena ganciklovira zahtijeva izuzetan oprez, osobito u pedijatrijskoj populaciji, zbog moguće dugoročne kancerogenosti i reproduktivne toksičnosti.
English: • pancreatitis - signs are severe stomach pain which spreads into your back.
Croatian: • upala gušterače - znakovi su jaka bol u trbuhu koja se širi u leđa
English: Clinical studies have been limited to evaluation of efficacy in patients with CMV infection.
Croatian: Klinička ispitivanja bila su ograničena na ocjenjivanje djelotvornosti u bolesnika s CMV infekcijom.
English: treatment of cytomegalovirus (CMV) disease in immunocompromised patients;
Croatian: liječenje citomegalovirusne (CMV) bolesti u imunokompromitiranih bolesnika;
English: A weak immune system may be caused by other diseases (such as AIDS) or by medicines (such as chemotherapy or immunosuppressants).
Croatian: Imunosni sustav može biti oslabljen zbog drugih bolesti (poput AIDS-a) ili lijekova (npr. kemoterapije ili imunosupresivnih lijekova).
English: Dermatitis Night sweats Pruritus
Croatian: dermatitis noćno znojenje pruritus
English: Neutropenia usually occurs during the first or second week of induction therapy and following administration of a cumulative dose of ≤ 200 mg / kg.
Croatian: Neutropenija obično nastupa tijekom prvog ili drugog tjedna uvodnog liječenja i nakon primjene kumulativne doze od ≤ 200 mg/kg.
English: There were no deaths secondary to CMV.
Croatian: Nije bilo smrtnih slučajeva koji bi bili posljedica CMV-a.
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).
Croatian: Podaci o sigurnosti i djelotvornosti ganciklovira u djece mlađe od 12 godina, uključujući novorođenčad, su ograničeni (vidjeti dijelove 4.4, 4.8 i 5.1).
English: No studies on the efficacy or safety of ganciclovir in the elderly have been conducted.
Croatian: Nisu provedena ispitivanja djelotvornosti ni sigurnosti ganciklovira u starijih osoba.
English: Agitation Psychotic disorder
Croatian: agitacija psihotični poremećaj
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležna tijela država članica mogu naknadno ažurirati informacije o lijeku, gdje je prikladno u suradnji s referentnom državom članicom, sukladno postupcima navedenima u Poglavlju 4 Glave III Direktive
English: What Cymevene is and what it is used for
Croatian: Što je Cymevene i za što se koristi
English: • fever, chills or night sweats
Croatian: • vrućica, zimica ili noćno znojenje
English: Do not use Cymevene if:
Croatian: Nemojte primjenjivati Cymevene:
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.
Croatian: Zbog sličnosti kemijske strukture ganciklovira sa strukturom aciklovira i penciklovira, moguća je križna reakcija preosjetljivosti između tih lijekova.
English: Infants who received ganciclovir had improved neurodevelopmental outcomes at 6 and 12 months compared with those who did not receive antiviral treatment.
Croatian: Dojenčad koja je primala ganciklovir imala je poboljšane neurorazvojne ishode nakon 6 i 12 mjeseci u usporedbi s onom koja nije primala antivirusno liječenje.
English: Other antiretrovirals
Croatian: Drugi antiretrovirusni lijekovi
English: - Maintenance treatment: For immunocompromised patients at risk of relapse maintenance therapy may be given.
Croatian: Terapija održavanja: U imunokompromitiranih bolesnika izloženih riziku od relapsa može se primijeniti terapija održavanja.
English: Ganciclovir penetrates the cerebrospinal fluid, where concentrations observed reach 24%−67% of the plasma concentrations.
Croatian: Ganciklovir prodire u cerebrospinalnu tekućinu, gdje opažene koncentracije dosežu 24% - 67% koncentracije u plazmi.
English: 4.5 Interaction with other medicinal products and other forms of interaction Pharmacokinetic interactions
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija
English: Alopecia Urticaria Dry skin
Croatian: alopecija urtikarija suha koža
English: Twelve subjects (9.8%) developed CMV disease (8 high-risk vs. 4 routine-risk, p = 0.03).
Croatian: U 12 ispitanika (9,8%) razvila se CMV bolest (8 visokorizičnih naspram 4 s rutinskim rizikom, p = 0,03).
English: Ganciclovir must be administered by intravenous infusion over 1 hour at a concentration not exceeding 10 mg/mL.
Croatian: Ganciklovir se mora primjenjivati intravenskom infuzijom u trajanju od jednog sata, u koncentraciji koja ne prelazi 10 mg/ml.
English: If your doctor wants you to start using Cymevene you must stop breast-feeding before you start using the medicine.
Croatian: Ako Vaš liječnik želi da se počnete liječiti lijekom Cymevene, morate prestati dojiti prije nego što počnete primjenjivati lijek.
English: Plasma protein binding was 1%−2% over ganciclovir concentrations of 0.5 and 51 µg/mL.
Croatian: Vezivanje za proteine plazme iznosilo je 1 - 2% u koncentracijama ganciklovira od 0,5 i 51 µg/ml.
English: Sensitive human viruses include human cytomegalovirus (HCMV), herpes-simplex virus-1 and -2 (HSV-1 and HSV-2), human herpes virus -6, -7 and -8 (HHV-6, HHV-7, HHV-8), Epstein-Barr virus (EBV), varicella-zoster virus (VZV), and hepatitis B virus.
Croatian: Osjetljivi ljudski virusi uključuju ljudski citomegalovirus (HCMV), herpes simpleks virus tip 1 i tip 2 (HSV-1 i HSV-2), ljudske herpes viruse 6, 7 i 8 (HHV-6, HHV-7, HHV-8), Epstein-Barrov virus (EBV),
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.
Croatian: Liječenje kod progresije bolesti: Svaki bolesnik u kojega dođe do progresije CMV bolesti, bilo tijekom terapije održavanja ili zbog prekida liječenja ganciklovirom, može se ponovno liječiti primjenom uvodnog režima liječenja.
English: • your age
Croatian: • Vašoj dobi
English: The fraction of ganciclovir removed during a single dialysis session varied from 50% to 63%.
Croatian: Udio ganciklovira koji se ukloni tijekom jedne dijalize varira od 50% do 63%.
English: If you think you have been given too much Cymevene talk to your doctor or go to hospital straight away.
Croatian: Ako mislite da ste primili preveliku dozu lijeka Cymevene, odmah se obratite svom liječniku ili otiđite u bolnicu.
English: Forty-three patients were considered high-risk for CMV and 79 were routine-risk.
Croatian: Za 43 bolesnika smatralo se da imaju visok rizik za CMV infekciju, dok ih je 79 imalo rutinski rizik.
English: It is considered likely that ganciclovir causes temporary or permanent inhibition of spermatogenesis (see sections 4.6, 4.8 and 5.3).
Croatian: Smatra se da ganciklovir vjerojatno uzrokuje privremenu ili trajnu inhibiciju spermatogeneze (vidjeti dijelove 4.6, 4.8 i 5.3).
English: Neutropenia was the only severe adverse drug reaction observed during the study and although none of the children required treatment cessation, 4 required granulocyte colony-stimulating factor (G-CSF) treatment to maintain absolute neutrophil counts > 400 cells/mm3.
Croatian: Jedina teška nuspojava primijećena tijekom ispitivanja bila je neutropenija; iako nijedno dijete nije moralo prekinuti liječenje, u 4 je djeteta bilo potrebno liječenje faktorom stimulacije kolonije granulocita (G-CSF) kako bi se apsolutni broj neutrofila održao na > 400 stanica/mm3.
English: Antiviral Activity
Croatian: Antivirusna aktivnost
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}>
Croatian: Ovaj lijek je odobren u državama članicama Europskog gospodarskog prostora (EGP) pod sljedećim nazivima:
English: The duration of maintenance treatment should be determined on an individual basis, local treatment guidelines should be consulted.
Croatian: Trajanje terapije održavanja treba odrediti individualno; potrebno je slijediti lokalne smjernice za liječenje.
English: Tell your doctor straight away if you notice any of the following serious side effects - your doctor may tell you to stop taking Cymevene and you may need urgent medical treatment:
Croatian: Odmah obavijestite svog liječnika ako primijetite sljedeće ozbiljne nuspojave - liječnik će Vam možda reći da prestanete primjenjivati Cymevene, a možda će Vam biti potrebno hitno liječenje:
English: • you have had problems with your blood cell counts caused by medicines in the past
Croatian: • ako ste ranije već imali poremećaje broja krvnih stanica uzrokovane lijekovima
English: The recommended dosage, frequency and infusion rates should not be exceeded.
Croatian: Preporučena doza, učestalost i brzina infuzije ne smiju se premašiti.
English: • loss of appetite, anorexia or weight loss
Croatian: • gubitak teka, anoreksija ili gubitak tjelesne težine
English: Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, nucleosides and nucleotides excluding reverse transcriptase inhibitors, ATC code: J05AB06.
Croatian: Farmakoterapijska skupina: Pripravci za liječenje sustavnih virusnih infekcija, antivirotici koji djeluju direktno, nukleozidi i nukleotidi, isključujući inhibitore reverzne transkriptaze, ATK oznaka: J05AB06.
English: If you stop using Cymevene Do not stop using Cymevene without talking to your doctor.
Croatian: Ako prestanete primjenjivati Cymevene Nemojte prestati primjenjivati Cymevene bez prethodnog razgovora sa svojim liječnikom.
English: • hands or feet feeling weak or numb, which may affect your balance
Croatian: • slabost ili utrnulost u šakama ili stopalima, što može utjecati na ravnotežu
English: The infusion should be given into a vein with adequate blood flow, preferably via a plastic cannula.
Croatian: Infuzija se mora primijeniti u venu s dovoljnim protokom krvi, po mogućnosti putem plastične kanile.
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.
Croatian: Nisu provedena formalna ispitivanja sigurnosti primjene ganciklovira u djece mlađe od 12 godina, ali na temelju iskustva s valganciklovirom, predlijekom ganciklovira, ukupan sigurnosni profil aktivnog lijeka sličan je u pedijatrijskih i u odraslih bolesnika.
English: The safety of ganciclovir for use in pregnant women has not been established.
Croatian: Sigurnost primjene ganciklovira u trudnica nije utvrđena.
English: Cymevene may affect fertility.
Croatian: Cymevene može utjecati na plodnost.
English: Ganciclovir is predominantly eliminated by renal excretion via glomerular filtration and active tubular secretion of unchanged ganciclovir.
Croatian: Ganciklovir se pretežno uklanja izlučivanjem kroz bubrege glomerularnom filtracijom i aktivnom tubularnom sekrecijom nepromijenjenog lijeka.
English: • swollen stomach
Croatian: • oticanje trbuha
English: From a microbiological point of view, the Cymevene infusion solution should be used immediately.
Croatian: S mikrobiološkog gledišta, Cymevene otopinu za infuziju treba odmah primijeniti.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 - 8°C (do not freeze).
Croatian: Dokazana je kemijska i fizikalna stabilnost tijekom 24 sata na temperaturi od 2 do 8°C (ne zamrzavati).
English: From a microbiological point of view, the reconstituted solution should be used immediately.
Croatian: S mikrobiološkog gledišta, rekonstituiranu otopinu treba odmah primijeniti.
English: None of the children required a cochlear implant and hearing loss improved in 83% of ears affected by hearing loss at baseline.
Croatian: Niti jednom djetetu nije bila potrebna ugradnja umjetne pužnice, a gubitak sluha popravio se u 83% ušiju zahvaćenih gubitkom sluha na početku ispitivanja.
English: It will be given through a tube into your vein.
Croatian: Primat ćete ga putem cjevčice u venu.
English: As a consequence, pharmacokinetic interactions with protease inhibitors and non-nucleoside reverse transcriptase inhibitors are not anticipated.
Croatian: Kao rezultat toga, ne očekuju se farmakokinetičke interakcije s inhibitorima proteaze i nenukleozidnim inhibitorima reverzne transkriptaze.
English: • how well your kidneys are working
Croatian: • tome koliko Vam dobro rade bubrezi
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).
Croatian: Antivirusna aktivnost in vitro, mjerena kao IC50 ganciklovira u djelovanju protiv CMV-a, kreće se u rasponu od 0,08 µM (0,02 µg/ml) do 14 µM (3,57 µg/ml).
English: Neutropenia was the only side effect reported and it was not necessary to discontinue treatment in any patient.
Croatian: Jedina prijavljena nuspojava bila je neutropenija, a prekid liječenja nije bio potreban niti u u jednog bolesnika.
English: If you are a woman who could get pregnant - use contraception while you are using Cymevene.
Croatian: Ako ste žena koja može zatrudnjeti - koristite kontracepciju dok se liječite lijekom Cymevene.
English: Serum creatinine (µmol/L)
Croatian: Serumski kreatinin (µmol/l)
English: The dose of Cymevene varies from one patient to another.
Croatian: Doza lijeka Cymevene razlikuje se od bolesnika do bolesnika.
English: Men If you are a man whose female partner could get pregnant - use a barrier method of contraception (such as condoms) while you are using Cymevene.
Croatian: Ako ste muškarac čija partnerica može zatrudnjeti - koristite kontracepciju metodom barijere (primjerice prezervative) dok se liječite lijekom Cymevene.
English: Half-lives in subjects without renal impairment ranged from 2.73 ± 1.29 (N = 6) to 3.98 ± 1.78 hours (N = 8).
Croatian: Poluvijek u bolesnika bez oštećenja bubrega kretao se u rasponu od 2,73 ± 1,29 (N = 6) do 3,98 ± 1,78 sati (N = 8).
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.
Croatian: Zbog potencijalne reproduktivne toksičnosti i teratogenosti, ženama reproduktivne dobi mora se savjetovati da koriste učinkovitu kontracepciju tijekom liječenja i najmanje 30 dana nakon završetka liječenja.
English: • The active substance is ganciclovir.
Croatian: • Djelatna tvar je ganciklovir.
English: • sight problems or eye pain
Croatian: • problemi s vidom ili bol u očima
English: • changes to your sense of touch, tingling, tickling, pricking or burning feeling
Croatian: • promjene osjeta dodira, trnci, žmarci, bockanje ili žarenje
English: Ganciclovir was associated with a decrease in the detection of CMV by culture or polymerase chain reaction.
Croatian: Primjena ganciklovira bila je povezana sa smanjenom detekcijom CMV-a u kulturi ili lančanoj reakciji polimerazom.
English: Cymevene should not be used by pregnant women unless the benefits to the mother outweigh the possible risks to the unborn baby.
Croatian: Cymevene ne smiju primjenjivati trudnice osim ako korist liječenja za majku ne nadmašuje moguće rizike za nerođeno dijete.
English: Patients with low baseline platelet counts (< 100,000 /mL) have an increased risk of developing thrombocytopenia.
Croatian: Bolesnici s niskim početnim brojem trombocita (< 100 000 stanica/ml) imaju povećan rizik od razvoja trombocitopenije.
English: • hives, dry skin
Croatian: • koprivnjača, suha koža
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).
Croatian: Liječenje se ne smije započeti ako je apsolutni broj neutrofila manji od 500 stanica/µl ili ako je broj trombocita manji od 25 000 stanica/µl ili ako je razina hemoglobina manja od 8 g/dl (vidjeti dijelove 4.2 i 4.8).
English: Creatinine clearance (mL/min)
Croatian: Klirens kreatinina (ml/min)
English: Prior to initiation of ganciclovir treatment, patients should be advised of the potential risks to the foetus.
Croatian: Prije početka liječenja ganciklovirom bolesnike treba upozoriti na moguće rizike za plod.
English: Do not use bacteriostatic water for injection containing parabens (para-hydroxybenzoates), since these are incompatible with Cymevene.
Croatian: Ne koristite bakteriostatsku vodu za injekcije koja sadrži parabene (parahidroksibenzoate) jer oni nisu kompatibilni s lijekom Cymevene.
English: • didanosine, stavudine, zidovudine or any other medicines used for HIV.
Croatian: • didanozin, stavudin, zidovudin ili bilo koje druge lijekove za liječenje HIV-a.
English: If you or your partner becomes pregnant while using Cymevene, talk to your doctor straight away.
Croatian: Ako dođe do trudnoće dok se Vi ili partner liječite lijekom Cymevene, odmah se obratite svom liječniku.
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.
Croatian: Međutim, neke nuspojave koje bi mogle biti karakteristične za pedijatrijsku populaciju, kao što su vrućica i bol u abdomenu, javljaju se češće u pedijatrijskih nego u odraslih bolesnika.
English: * The frequencies of these adverse reactions are derived from post-marketing experience, all other frequency categories are based on the frequency recorded in clinical trials.
Croatian: * Učestalost ovih nuspojava određena je na temelju praćenja nakon stavljanja lijeka u promet, a sve ostale kategorije učestalosti temelje se na učestalosti zabilježenoj u kliničkim ispitivanjima.
English: Cytochrome P450 isoenzymes play no role in ganciclovir pharmacokinetics.
Croatian: Izoenzimi citokroma P450 nemaju ulogu u farmakokinetici ganciklovira.