FrancophonIA/ELRC3.0 huggingface dataset:
English: The adjusted mean dietary phenylalanine tolerance in the Kuvan in conjunction with a phenylalanine-restricted diet group was 80.6 mg/kg/day and was statistically significantly greater (p<0.001) than the adjusted mean dietary phenylalanine tolerance in dietary phenylalanine therapy alone group (50.1 mg/kg/day).
Croatian: Prilagođena srednja vrijednost tolerancije na fenilalanin u prehrani u skupini koja je primala Kuvan uz prehranu siromašnu fenilalaninom iznosila je 80,6 mg/kg na dan i bila je statistički značajno veća (p<0,001) od prilagođene srednje vrijednosti tolerancije na fenilalanin u prehrani u skupini čija je terapija bila samo prehrana siromašna fenilalaninom (50,1 mg/kg/dan).
English: Be sure whether you should use Kuvan 500 mg powder for oral solution alone or both medicines to prepare your dose.
Croatian: Morate znati trebate li uzimati samo Kuvan 500 mg prašak za oralnu otopinu ili oba lijeka kako biste pripremili svoju dozu.Vrećice otvorite tek kada ste ih spremni upotrijebiti.
English: Use in patients above 20 kg body weight Place the tablets in a glass or cup (120 to 240 ml) of water and stir until dissolved.
Croatian: Primjena kod bolesnika tjelesne težine iznad 20 kg Tablete stavite u čašu ili šalicu s vodom (120 do 240 ml) i miješajte dok se tablete ne otope.
English: The mean ± SD increase in dietary phenylalanine tolerance was 17.5 ±13.3 mg/kg/day for the group treated with sapropterin dihydrochloride 20 mg/kg/day, compared to 3.3 ± 5.3 mg/kg/day for the placebo group (p=0.006).
Croatian: Srednja vrijednost ± SD povećanja tolerancije fenilalanina u prehrani je bilo 17,5 ± 13,3 mg/kg/dnevno za skupinu liječenu dozom sapropterindiklorida od 20 mg/kg/dnevno, u odnosu na 3,3 ± 5,3 mg/kg/dnevno za placebo skupinu (p=0,006).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET 100 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE VREĆICA 100 mg
English: The starting dose of Kuvan in adult and paediatric patients with PKU is 10 mg/kg body weight once daily.
Croatian: Početna doza lijeka Kuvan kod odraslih i pedijatrijskih bolesnika s PKU je 10 mg/kg tjelesne težine, jednom dnevno.
English: Kuvan tablets should be administered with a meal to increase the absorption.
Croatian: Tablete Kuvana se uzimaju za vrijeme jela kako bi se povećala apsorpcija lijeka.
English: Number of sachets to be dissolved (100 mg strength only)
Croatian: Broj vrećica koje treba otopiti (samo jačina od 100 mg)
English: Potassium content
Croatian: Sadržaj kalija
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET 500 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE VREĆICA 500 mg
English: If inadequate control of blood phenylalanine levels is observed during treatment with Kuvan, the patient's adherence to the prescribed treatment, and diet, should be reviewed before considering an adjustment of the dose of sapropterin.
Croatian: Ako se tijekom liječenja lijekom Kuvan uoči neodgovarajuća kontrola koncentracija fenilalanina u krvi, prije razmatranja prilagodbe doze treba ispitati pridržava li se bolesnik propisane terapije i načina ishrane.
English: Pour the amount of water into the cup, as instructed by your doctor (e.g. your doctor told you to use 20 ml for dissolving one Kuvan sachet).
Croatian: Natočite određenu količinu vode u čašicu za lijek, prema uputama Vašeg liječnika (npr. liječnik Vam je rekao da uporabite 20 ml za otapanje jedne vrećice Kuvana).
English: Caution is recommended during concomitant use of Kuvan with all medicinal products that cause vasodilation, including those administered topically, by affecting nitric oxide (NO) metabolism or action including classical NO donors (e.g. glyceryl trinitrate
Croatian: Preporučuje se oprez tijekom istodobne primjene lijeka Kuvan i svih lijekova koji uzrokuju vazodilataciju, uključujući i one koji se primjenjuju topikalno, djelovanjem na metabolizam ili aktivnost dušičnog oksida (NO).
English: A 10 ml oral syringe should be used for administration of volumes of ≤10 ml and a 20 ml oral syringe for administration of volumes of >10 ml.
Croatian: Za primjenu volumena ≤10 ml treba koristiti oralnu štrcaljku od 10 ml, a za primjenu volumena >10 ml treba koristiti oralnu štrcaljku za doziranje od 20 ml.
English: Mannitol (E421) Potassium citrate (E332) Sucralose (E955) Ascorbic acid (E300)
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari manitol (E421) kalijev citrat (E332) sukraloza (E955) askorbatna kiselina (E300)
English: Patients above 20 kg body weight
Croatian: Bolesnici tjelesne težine iznad 20 kg
English: • Small spoon or clean utensil for stirring
Croatian: • mala žlica ili čisti pribor za miješanje
English: Respiratory, thoracic and mediastinal disorders Very common:
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često: rinoreja
English: Safety and efficacy of Kuvan in patients with renal or hepatic insufficiency have not been established.
Croatian: Bolesnici s oštećenjem funkcije bubrega i jetre Sigurnost i djelotvornost lijeka Kuvan kod bolesnika s insuficijencijom bubrega ili jetre nisu ustanovljene.
English: • the amount of water needed to mix one dose of Kuvan
Croatian: • koja je količina vode potrebna za pripremu jedne doze Kuvana
English: Calcium hydrogen phosphate, anhydrous Crospovidone type A Ascorbic acid (E300) Sodium stearyl fumarate Riboflavin (E101)
Croatian: A askorbatna kiselina (E300) natrijev stearilfumarat riboflavin (E101)
English: However, sapropterin has not been shown to be genotoxic in the in vitro test with human lymphocytes as well as in in vivo micronucleus mouse tests.
Croatian: Međutim, kod in vitro testiranja na humanim limfocitima, kao i kod in vivo mikronukleusnih testiranja na miševima, sapropterin nije pokazao genotoksičnost.
English: Powder for oral solution Off-white to light yellow powder
Croatian: Prašak za oralnu otopinu Gotovo bijeli do svijetložuti prašak.
English: The powder is filled in unit dose sachets containing 500 mg sapropterin dihydrochloride.
Croatian: Prašak je pakiran u vrećice s jediničnom dozom od 500 mg sapropterindiklorida.
English: • The number of Kuvan tablets needed for one dose
Croatian: • količina tableta Kuvana potrebnih za jednu dozu
English: Pharyngolaryngeal pain, nasal congestion, cough Gastrointestinal disorders Common:
Croatian: bolovi u farinksu i larinksu, kongestija nosa, kašalj Poremećaji probavnog sustava Često:
English: This medicine contains 0.3 mmol (12.6 mg) potassium per sachet.
Croatian: Ovaj lijek sadrži 0,3 mmol (12,6 mg) kalija po vrećici.
English: Discard unused solution within 30 minutes for powder solution.
Croatian: Baciti neiskorištenu otopinu praška u roku od 30 minuta.
English: Children up to 20 kg body weight
Croatian: Djeca tjelesne težine do 20 kg
English: Active management of dietary phenylalanine and overall protein intake while taking this medicinal product is required to ensure adequate control of blood phenylalanine levels and nutritional balance.
Croatian: Kako bi se tijekom uzimanja lijeka Kuvan osigurala adekvatna kontrola koncentracije fenilalanina i tirozina u krvi te nutritivna ravnoteža, potrebna je aktivna kontrola unosa fenilalanina i sveukupnog unosa proteina hranom.
English: This medicine contains 1.6 mmol (62.7 mg) potassium per sachet.
Croatian: Ovaj lijek sadrži 1,6 mmol (62,7 mg) kalija po vrećici.
English: Use in children up to 20 kg body weight Only use the 100 mg sachets to prepare Kuvan for children weighing up to 20 kg body weight.
Croatian: Za djecu tjelesne težine do 20 kg upotrebljavajte samo vrećice od 100 mg za pripremu lijeka Kuvan.
English: Upon dissolving Kuvan powder for oral solution in water, the solution has a clear, colourless to yellow appearance.
Croatian: Nakon otapanja Kuvan praška za oralnu otopinu, otopina je prozirna, bezbojna do žuta.
English: Each sachet contains 1.6 mmol (62.7 mg) potassium.
Croatian: Jedna vrećica sadrži 1,6 mmol (62,7 mg) kalija.
English: • the number of Kuvan 100 mg sachets needed for one dose
Croatian: • broj vrećica od 100 mg Kuvana potrebnih za jednu dozu
English: Use a 10 ml oral syringe for administration of volumes ≤10 ml or a 20 ml oral syringe for administration of volumes >10 ml.
Croatian: Za primjenu volumena ≤10 ml uporabite oralnu štrcaljku od 10 ml, a za primjenu volumena >10 ml uporabite oralnu štrcaljku od 20 ml.
English: Use in children up to 20 kg body weight
Croatian: Primjena kod djece tjelesne težine do 20 kg
English: Each sachet contains 0.3 mmol (12.6 mg) potassium.
Croatian: Jedna vrećica sadrži 0,3 mmol (12,6 mg) kalija.
English: The powder is filled in unit dose sachets containing 100 mg sapropterin dihydrochloride.
Croatian: Prašak je pakiran u vrećice za jediničnu dozu od 100 mg sapropterindiklorida.
English: Take Kuvan with a meal to increase the absorption.
Croatian: Kuvan uzimajte za vrijeme jela, radi povećanja apsorpcije lijeka.
English: Caution is recommended during concomitant use of Kuvan with all medicinal products that cause vasodilation, including those administered topically, by affecting nitric oxide (NO) metabolism or action including classical NO donors (e.g. glyceryl trinitrate (GTN), isosorbide dinitrate (ISDN), sodium nitroprusside (SNP), molsidomin), phosphodiesterase type 5 (PDE-5) inhibitors and minoxidil.
Croatian: Među tim lijekovima su klasični donori dušičnog oksida (npr. gliceriltrinitrat (GTN), izosorbiddinitrat (ISDN), natrijev nitroprusid (SNP), molsidomin), inhibitori fosfodiesteraze tipa 5 (PDE-5) i minoksidil.
English: The use of Kuvan should be considered only if strict dietary management does not adequately reduce blood phenylalanine levels.
Croatian: Liječenje lijekom Kuvan dolazi u obzir samo ako se strogo određenom prehranom ne uspije koncentraciju fenilalanina u krvi sniziti do željenih granica.
English: Use in patients above 20 kg body weight
Croatian: Primjena u bolesnika tjelesne težine iznad 20 kg
English: Adjustment of the Kuvan dose or modification of dietary phenylalanine intake may be required to achieve and maintain blood phenylalanine levels within the desired therapeutic range.
Croatian: Kako bi se postiglo i održalo koncentraciju fenilalanina unutar željenog terapijskog raspona, može biti potrebno prilagođavanje doze Kuvana ili promjena količine fenilalanina koji se unosi hranom.
English: Preparing the sachet(s)
Croatian: Priprema vrećice(a)
English: Point the tip of the oral syringe towards either cheek.
Croatian: Usmjerite vršak oralne štrcaljke prema obrazu djeteta.
English: Drug interactions
Croatian: Interakcije lijeka
English: • the number of Kuvan tablets needed for one dose
Croatian: • koji je broj tableta Kuvana potreban za jednu dozu
English: Each sachet contains 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin).
Croatian: Jedna vrećica sadrži 500 mg sapropterindiklorida (što odgovara 384 mg sapropterina).
English: The solution should be consumed within 30 minutes of initial dissolution.
Croatian: Otopinu je potrebno uzeti unutar 30 minuta od otapanja.
English: Package leaflet: Information for the patient Kuvan 100 mg soluble tablets
Croatian: Uputa o lijeku: Informacije za bolesnika Kuvan 100 mg tablete za oralnu otopinu sapropterindiklorid
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU KUTIJA I NALJEPNICA ZA BOCU
English: Unused solution should be discarded after administration.
Croatian: Nakon primjene, neiskorištenu otopinu potrebno je baciti.
English: Headache and dizziness have been reported after the administration of sapropterin dihydrochloride above the recommended maximum dose of 20 mg/kg/day.
Croatian: Nakon primjene sapropterindiklorida u dozi većoj od preporučene maksimalne doze od 20 mg/kg/dan, zabilježene su pojave glavobolje i omaglica.
English: The powder for oral solution is clear, off-white to light yellow.
Croatian: Prašak za oralnu otopinu je gotovo bijele do svijetložute boje.
English: Your doctor will monitor the restriction of dietary phenylalanine intake prior and during pregnancy.
Croatian: Smanjeni unos fenilalanina hranom bit će pod nadzorom liječnika prije i tijekom trudnoće.
English: Rebound, as defined by an increase in blood phenylalanine levels above pre-treatment levels, may occur upon cessation of treatment.
Croatian: Po prestanku liječenja može doći do povećanja (rebound) koncentracije fenilalanina u krvi na vrijednosti više od onih prije početka liječenja.
English: No increase in total biopterin concentrations in either foetuses or milk was observed in rats after oral administration of 10 mg/kg sapropterin dihydrochloride.
Croatian: Nakon peroralne primjene 10 mg/kg sapropterindiklorida kod štakora, nije zamijećeno povećanje koncentracije ukupnog biopterina niti kod fetusa, niti u mlijeku.
English: Number of 100 mg tablets (dose 20 mg/kg)
Croatian: Broj tableta od 100 mg (doza od 20 mg/kg)
English: To make the tablets dissolve faster you can crush them.
Croatian: Otapanje možete ubrzati ako tablete zdrobite.
English: Kuvan 100 mg powder for oral solution Kuvan 500 mg powder for oral solution Sapropterin dihydrochloride
Croatian: Kuvan 100 mg prašak za oralnu otopinu Kuvan 500 mg prašak za oralnu otopinu sapropterindiklorid
English: Number of 100 mg tablets (dose 10 mg/kg)
Croatian: Broj tableta od 100 mg (doza od 10 mg/kg)
English: Kuvan 500 mg powder for oral solution Sapropterin dihydrochloride
Croatian: Kuvan 500 mg prašak za oralnu otopinu sapropterindiklorid
English: Kuvan 500 mg powder for oral solution
Croatian: Kuvan 500 mg prašak za oralnu otopinu
English: Dietary intake
Croatian: Prijavljivanje nuspojava
English: Dietary modification may be necessary to maintain blood phenylalanine levels within the desired therapeutic range.
Croatian: Kako bi se koncentracija fenilalanina u krvi održala unutar željenog terapijskog raspona, može biti potrebna modifikacija prehrane.
English: Kuvan 100 mg powder for oral solution Kuvan 500 mg powder for oral solution
Croatian: Kuvan 100 mg prašak za oralnu otopinu Kuvan 500 mg prašak za oralnu otopinu
English: An increased incidence of altered renal microscopic morphology (collecting tubule basophilia) was observed in rats following chronic oral administration of sapropterin dihydrochloride at exposures at or slightly above the maximal recommended human dose.
Croatian: Nakon kronične peroralne primjene sapropterindiklorida u maksimalnim dozama preporučenim za ljude ili malo većima, kod štakora je zabilježena povećana incidencija mikroskopskih morfoloških promjena bubrega (bazofilija sabirnih tubula).
English: Kuvan 100 mg powder for oral solution Sapropterin dihydrochloride
Croatian: Kuvan 100 mg prašak za oralnu otopinu sapropterindiklorid
English: More frequent monitoring may be required, as blood phenylalanine levels may increase.
Croatian: Budući da koncentracija fenilalanina u krvi može porasti, mogu biti potrebne učestalije kontrole.
English: Kuvan should be administered with a meal, to increase the absorption.
Croatian: Lijek Kuvan uzima se za vrijeme jela kako bi se povećala apsorpcija.
English: Table 3: 10 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg)
Croatian: Tablica 3: Tablica doziranja za dozu od 10 mg/kg na dan za djecu tjelesne težine do 20 kg Tjelesna težina (kg)
English: Table 2: 5 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg)
Croatian: Tablica 2: Tablica doziranja za dozu od 5 mg/kg na dan za djecu tjelesne težine do 20 kg Tjelesna težina (kg)
English: Kuvan 100 mg powder for oral solution
Croatian: Kuvan 100 mg prašak za oralnu otopinu
English: Table 4: 20 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg)
Croatian: Tablica 4: Tablica doziranja za dozu od 20 mg/kg na dan za djecu tjelesne težine do 20 kg Tjelesna težina (kg)
English: Kuvan 100 mg soluble tablets Sapropterin dihydrochloride
Croatian: Kuvan 100 mg tablete za oralnu otopinu sapropterindiklorid
English: Kuvan 100 mg soluble tablets
Croatian: Kuvan 100 mg tablete za oralnu otopinu
English: Each sachet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
Croatian: Jedna vrećica sadrži 100 mg sapropterindiklorida (sapropterin dihydrochloride) (što odgovara 77 mg sapropterina).
English: Number of 100 mg sachets (dose 10 mg/kg)
Croatian: Broj vrećica od 100 mg (doza od 10 mg/kg)
English: Number of 100 mg sachets (dose 20 mg/kg)
Croatian: Broj vrećica od 100 mg (doza od 20 mg/kg)
English: Each tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
Croatian: Jedna tableta sadrži 100 mg sapropterindiklorida (što odgovara 77 mg sapropterina).
English: Each soluble tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
Croatian: Jedna tableta za oralnu otopinu sadrži 100 mg sapropterindiklorida (što odgovara 77 mg sapropterina).
English: LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
Croatian: POPIS POMOĆNIH TVARI FARMACEUTSKI
English: Table 1: 2 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg) Total dose (mg/day)
Croatian: Tablica 1: Tablica doziranja za dozu od 2 mg/kg na dan za djecu tjelesne težine do 20 kg Tjelesna težina (kg)
English: Powder for dispersion for infusion
Croatian: Prašak za disperziju za infuziju
English: Intravenous use vial (glass)
Croatian: Intravenski bočica (staklo) 100 mg
English: Safety was not assessed in this study.
Croatian: Sigurnost se u ovom ispitivanju nije ocjenjivala.
English: Do not refrigerate or freeze.
Croatian: Ne čuvati u hladnjaku i ne zamrzavati.
English: After that the tests will be done less often.
Croatian: Nakon toga će se provoditi manje često.
English: • hallucinations - hearing or seeing things that are not real.
Croatian: • halucinacije - kada čujete ili vidite stvari koje nisu stvarne
English: No specific information available
Croatian: Nema specifičnih informacija.
English: • The virus can affect any part of the body.
Croatian: • Ovaj virus može zaraziti bilo koji dio tijela.
English: Your doctor will work out how much you need.
Croatian: Liječnik će izračunati koliko lijeka Vam je potrebno.
English: This is called an intravenous infusionand it will usually take one hour.
Croatian: To se zove „intravenska infuzija“ i obično će trajati jedan sat.
English: No studies have been conducted in adults older than 65 years of age.
Croatian: Nisu provedena ispitivanja u odraslih bolesnika starijih od 65 godina.
English: • You will usually start by having one or two infusions every day.
Croatian: • Na početku ćete obično primati jednu ili dvije infuzije svakoga dana.
English: Preparation of the reconstituted concentrate
Croatian: Priprema rekonstituiranog koncentrata
English: The overall incidence of CMV was 16% (15/92 patients).
Croatian: Ukupna incidencija CMV-a bila je 16% (15/92 bolesnika).
English: For females: 0.85 x male value
Croatian: Za žene = 0,85 x vrijednost za muškarce
English: • The virus can affect anyone, but it is a particular problem in people with a weak immune system.
Croatian: • Virusom se može zaraziti svatko, ali on predstavlja osobit problem u osoba s oslabljenim imunosnim sustavom.
English: For the first 2 weeks these blood tests will be done often.
Croatian: Tijekom prva 2 tjedna te će krvne pretrage biti česte.
English: If this happens, do not drive or use any tools or machines.
Croatian: Ako se to dogodi, nemojte voziti ni rukovati alatima ili strojevima.
English: Currently available paediatric data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci o pedijatrijskoj populaciji opisani su u dijelovima 5.1 i 5.2, međutim nije moguće dati preporuku o doziranju.
English: • After that the doctor may prescribe the infusion once a day.
Croatian: • Nakon toga će liječnik možda propisati jednu infuziju dnevno.
English: Cymevene may temporarily or permanently stop men from producing sperm.
Croatian: Cymevene može privremeno ili trajno onemogućiti proizvodnju sperme kod muškaraca.
English: It will depend on:
Croatian: To ovisi o:
English: Read all of this leaflet carefully before you start using this medicine - because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: Time to onset of CMV infection was comparable in both groups.
Croatian: Vrijeme do nastupa CMV infekcije bilo je usporedivo u obje skupine.
English: • blood poisoning (sepsis)
Croatian: • otrovanje krvi (sepsa)
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Croatian: Ova uputa je zadnji puta revidirana u <{MM/GGGG}> <{mjesec GGGG}.>
English: Antiviral treatment consisted of either:
Croatian: Antivirusno liječenje uključivalo je:
English: Consideration should be given to official guidance on the appropriate use of antiviral agents.
Croatian: Potrebno je uzeti u obzir službene smjernice o primjerenoj uporabi antivirusnih lijekova.
English: In these people the CMV virus can lead to a serious disease.
Croatian: U takvih osoba CMV može uzrokovati ozbiljnu bolest.
English: Additional information on special populations
Croatian: Dodatne informacije o posebnim populacijama bolesnika
English: If you use more Cymevene than you should
Croatian: Ako primijenite više lijeka Cymevene nego što ste trebali
English: Powder: Does not require any special storage conditions.
Croatian: Prašak: Ne zahtijeva posebne uvjete čuvanja.
English: Cymevene will be given to you by a doctor or nurse.
Croatian: Cymevene će vam dati liječnik ili medicinska sestra.
English: Of these, 25 received ganciclovir and 17 received no treatment.
Croatian: Od tih je bolesnika njih 25 primalo ganciklovir, a 17 ih nije primalo liječenje.
English: No deaths were related to study medication.
Croatian: Niti jedan smrtni slučaj nije bio povezan s ispitivanim lijekom.
English: Hallucinations*
Croatian: halucinacije*
English: White to off-white solid cake.
Croatian: Bijeli do bjelkasti kompaktni kolačić.
English: • you are having radiotherapy.
Croatian: • ako primate terapiju zračenjem
English: Cymevene can cause some serious side effects that you need to tell your doctor about straight away.
Croatian: Cymevene može uzrokovati neke ozbiljne nuspojave o kojima odmah morate obavijestiti svog liječnika.
English: difficulty swallowing or breathing.
Croatian: otežano gutanje ili disanje.
English: • The other ingredients are sodium hydroxide and hydrochloric acid.
Croatian: • Drugi sastojci su natrijev hidroksid i kloridna kiselina.
English: Ganciclovir is a potential carcinogen.
Croatian: Ganciklovir je potencijalno kancerogen.
English: Dosage reduction is required (see sections 4.2 and 5.2).
Croatian: Potrebno je smanjenje doze (vidjeti dijelove 4.2 i 5.2).
English: If you are pregnant or think you might be pregnant, do not use this medicine unless your doctor tells you to.
Croatian: Ako ste trudni ili mislite da biste mogli biti trudni, nemojte primjenjivati ovaj lijek osim ako Vam to ne preporuči liječnik.
English: Cymevene should not be mixed with other intravenous products.
Croatian: Cymevene se ne smije miješati s drugim intravenskim lijekovima.
English: Ganciclovir is not metabolised to a significant extent.
Croatian: Ganciklovir se ne metabolizira u značajnoj mjeri.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, za vrijeme i uvjete čuvanja prije uporabe odgovoran je korisnik.
English: It should not be used after the expiry date which is stated on the carton.
Croatian: Ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na kutiji.
English: This is because Cymevene may harm the unborn baby.
Croatian: To je zato što bi Cymevene mogao naštetiti nerođenom djetetu.
English: A total of 38.5% of subjects were spared antiviral medications beyond their initial postoperative prophylaxis.
Croatian: Ukupno je 38,5% ispitanika bilo pošteđeno uzimanja antivirusnih lijekova osim inicijalne poslijeoperacijske profilakse.