FrancophonIA/ELRC3.0 huggingface dataset:
English: Letermovir inhibits CYP2C8 in vitro but may also induce CYP2C8 based on its induction potential.
Croatian: Letermovir inhibira CYP2C8 in vitro, ali zbog svog indukcijskog potencijala također može inducirati CYP2C8.
English: In order to optimise the sterility assurance level (SAL) of the manufacturing process, the marketing authorisation holder should implement the measures outlined in the Post Approval Change Management Protocol (PACMP) agreed with the CHMP concerning development, validation and introduction of terminal sterilisation.
Croatian: Radi optimiziranja razine osiguranja sterilnosti (engl. sterility assurance level, SAL) proizvodnog procesa, nositelj odobrenja mora implementirati mjere koje se odnose na razvoj, validaciju i uvođenje završne sterilizacije navedene u Protokolu upravljanja izmjenama nakon dobivanja odobrenja za stavljanje u promet (engl.
English: The most commonly reported adverse reactions occurring in at least 1% of subjects in the PREVYMIS group and at a frequency greater than placebo were: nausea (7.2%), diarrhoea (2.4%), and vomiting
Croatian: Najčešće prijavljene nuspojave, koje su se javile u najmanje 1% ispitanika u skupini liječenoj lijekom PREVYMIS i čija je učestalost bila veća uz PREVYMIS nego uz placebo, bile su mučnina (7,2%), proljev (2,4%) i povraćanje (1,9%).
English: • PREVYMIS should not be co-administered through the same intravenous line (or cannula) with other medicinal products and diluent combinations except those listed below.
Croatian: • PREVYMIS se ne smije primjenjivati istodobno kroz istu intravensku liniju (ili kanilu) s drugim lijekovima ni u kombinaciji s drugim sredstvima za razrjeđivanje osim onih navedenih u nastavku.
English: Week 0
Croatian: 0. tjedan
English: Based on population pharmacokinetic analyses, there is no effect of age on letermovir pharmacokinetics.
Croatian: Prema populacijskim farmakokinetičkim analizama, dob ne utječe na farmakokinetiku letermovira.
English: One subject (who received 60 mg/day) had a letermovir resistant genotypic variant (GV) (V236M).
Croatian: Jedan ispitanik (koji je primao dozu od 60 mg na dan) imao je genotipsku varijantu (GV) koja uzrokuje rezistenciju na letermovir (V236M).
English: This is equivalent to 1.15% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 1,15% maksimalnog preporučenog dnevnog unosa soli za odraslu osobu.
English: Compatible intravenous bags and infusion set materials
Croatian: Kompatibilne infuzijske vrećice i infuzijski setovi
English: See list under “Do not take PREVYMIS if you take either of these medicines.”
Croatian: Popis tih lijekova možete pronaći u dijelu 'Nemojte uzimati PREVYMIS ako uzimate bilo koji od ovih lijekova'.
English: • If you miss your appointment to get PREVYMIS, call your doctor straight away to reschedule your appointment.
Croatian: • Ako propustite termin za primjenu lijeka PREVYMIS, odmah nazovite svog liječnika i dogovorite novi termin.
English: After dilution, PREVYMIS should be administered by intravenous infusion via peripheral or central venous catheter using a total time of approximately 60 minutes.
Croatian: Nakon razrjeđivanja PREVYMIS treba primijeniti intravenskom infuzijom putem perifernog ili centralnog venskog katetera tijekom ukupnog razdoblja od približno 60 minuta.
English: If a dose is missed, it should be given to the patient as soon as possible.
Croatian: Ako bolesnik propusti primiti dozu lijeka, treba mu je dati što je prije moguće.
English: Subjects were monitored through Week 24 post-transplant for the primary efficacy endpoint with continued follow-up through Week 48 post-transplant.
Croatian: Ispitanike se pratilo 24 tjedna nakon transplantacije kako bi se utvrdila primarna mjera ishoda za djelotvornost, te ih se nastavilo pratiti do 48. tjedna nakon transplantacije.
English: • cyclosporine, tacrolimus, sirolimus - used to prevent transplant rejection
Croatian: • ciklosporin, takrolimus, sirolimus - koriste se za sprječavanje odbacivanja presatka
English: • glyburide, repaglinide - for high blood sugar
Croatian: • gliburid, repaglinid - koriste se za liječenje visokih vrijednosti šećera u krvi
English: Comparing letermovir regimen administered without cyclosporine, the effect is more marked after iv than oral letermovir.
Croatian: Kada se uspoređuje režim primjene letermovira bez ciklosporina, učinak je izraženiji nakon intravenske nego nakon peroralne primjene letermovira.
English: Medicinal products metabolised by CYP2C9 and/or CYP2C19
Croatian: Lijekovi koji se metaboliziraju putem CYP2C9 i/ili CYP2C19
English: • Tigecycline *Refer to the prescribing information to confirm compatibility of simultaneous co-administration.
Croatian: • ganciklovirnatrij tigeciklin *Vidjeti informacije o lijeku za potvrdu kompatibilnosti za istodobnu primjenu.
English: Table 4: Letermovir AUC (ng•hr/mL) values in HSCT Recipients Treatment Regimen
Croatian: Tablica 4: Vrijednosti AUC-a (ng•h/ml) letermovira u primatelja HSCT-a Režim liječenja
English: Concomitant administration with St. John's wort (Hypericum perforatum) (see section 4.5).
Croatian: Istodobna primjena s gospinom travom (Hypericum perforatum) (vidjeti dio 4.5).
English: The other ingredients are: hydroxypropylbetadex (cyclodextrin), sodium chloride, sodium hydroxide (E524), water for injections.
Croatian: Drugi sastojci su: hidroksipropilbetadeks (ciklodekstrin), natrijev klorid, natrijev hidroksid (E524), voda za injekcije.
English: If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego što uzmete ovaj lijek.
English: Letermovir is a moderate inducer of enzymes and transporters.
Croatian: Letermovir je umjeren induktor enzima i prijenosnika.
English: Some saturation was observed at lower concentrations.
Croatian: Pri nižim je koncentracijama opažen određen stupanj zasićenja.
English: - Examples of medicinal products transported by BCRP include rosuvastatin and sulfasalazine.
Croatian: - Primjeri lijekova koje prenosi BCRP uključuju rosuvastatin i sulfasalazin.
English: In cases of clinically significant CMV DNAemia or disease, letermovir prophylaxis was stopped and standard-of-care pre-emptive therapy (PET) or treatment was initiated.
Croatian: U slučajevima klinički značajne razine CMV DNK u krvi ili CMV bolesti prekinuta je profilaksa letermovirom i uvedena standardna preemptivna terapija (PET) ili liječenje.
English: Intravenous use after dilution Single use only
Croatian: Intravenska primjena nakon razrjeđivanja Samo za jednokratnu primjenu
English: FAS=Full analysis set; FAS includes randomised subjects who received at least one dose of study medicine, and excludes subjects with detectable CMV DNA at baseline.
Croatian: = potpuni skup podataka za analizu; FAS populacija uključuje randomizirane ispitanike koji su primili najmanje jednu dozu ispitivanog lijeka, a ne uključuje ispitanike s mjerljivom razinom CMV DNK na početku ispitivanja.
English: Expected: ↓ warfarin
Croatian: Očekivano: ↓ varfarin
English: Concomitant administration with pimozide (see sections 4.4 and 4.5).
Croatian: Istodobna primjena s pimozidom (vidjeti dijelove 4.4 i 4.5).
English: Stratum-adjusted treatment difference (Letermovir
Croatian: Razlika između liječenja prilagođena za stratum (letermovir - placebo)
English: Note: The proportion of subjects with detectable CMV viral DNA on Day 1 that developed clinically significant CMV infection in the letermovir group was 64.6% (31/48) compared to 90.9% (20/22) in the placebo group through Week 24 post-transplant.
Croatian: Napomena: Udio ispitanika koji su 1. dana imali mjerljivu razinu CMV DNK i u kojih se do 24. tjedna nakon transplantacije razvila klinički značajna CMV infekcija iznosio je 64,6% (31/48) u skupini liječenoj letermovirom u usporedbi s 90,9% (20/22) u skupini koja je primala placebo.
English: Administration of PREVYMIS may result in a clinically relevant decrease in plasma concentrations of co-administered medicinal products that are significantly transported by P-gp in the intestine such as dabigatran and sofosbuvir.
Croatian: Primjena lijeka PREVYMIS može dovesti do klinički značajnog pada koncentracija u plazmi istodobno primijenjenih lijekova koje u značajnoj mjeri prenosi P-gp u crijevima, kao što su dabigatran i sofosbuvir.
English: Nervous system disorders Uncommon dysgeusia, headache
Croatian: Poremećaji živčanog sustava Manje često disgeuzija, glavobolja
English: There were no differences in the incidence of or time to engraftment between the PREVYMIS and placebo groups.
Croatian: Nije bilo razlika u incidenciji ili vremenu do prihvaćenosti presatka između skupine liječene lijekom PREVYMIS i one koja je primala placebo.
English: Favors Placebo
Croatian: U korist placeba
English: The medicinal product interactions described are based on studies conducted with PREVYMIS or are predicted medicinal product interactions that may occur with PREVYMIS (see sections 4.3, 4.4, 5.1, and 5.2).
Croatian: Opisane interakcije s drugim lijekovima temelje se na provedenim ispitivanjima lijeka PREVYMIS ili predstavljaju predviđene interakcije između lijekova koje bi mogle nastupiti kod primjene lijeka PREVYMIS (vidjeti dijelove 4.3, 4.4, 5.1 i 5.2).
English: Efficacy consistently favoured letermovir across subgroups including low and high risk for CMV reactivation, conditioning regimens, and concomitant immunosuppressive regimens (see Figure 2).
Croatian: Podaci o djelotvornosti dosljedno su govorili u prilog letermoviru u svim podskupinama, uključujući one prema visokom ili niskom riziku od reaktivacije CMV-a, režimima kondicioniranja i istodobnim imunosupresivnim režimima (vidjeti Sliku 2).
English: This is because PREVYMIS has not been tested in this age group.
Croatian: Naime, PREVYMIS se nije ispitivao u toj dobnoj skupini.
English: Letermovir was not genotoxic in a battery of in vitro or in vivo assays, including microbial mutagenesis assays, chromosomal aberration in Chinese Hamster Ovary cells, and in an in vivo mouse micronucleus study.
Croatian: Letermovir nije bio genotoksičan u nizu testova in vitro ili in vivo, uključujući test mutagenosti na bakterijama, test kromosomskih aberacija na stanicama jajnika kineskog hrčka te mikronukleusni test na miševima in vivo.
English: PREVYMIS concentrate for solution for infusion requires dilution (see section 6.6) prior to administration.
Croatian: PREVYMIS koncentrat za otopinu za infuziju treba razrijediti (vidjeti dio 6.6) prije primjene.
English: • efavirenz, etravirine, nevirapine, lopinavir, ritonavir - for HIV
Croatian: • efavirenz, etravirin, nevirapin, lopinavir, ritonavir - koriste se za liječenje HIV-a
English: In vivo studies are available investigating the net effect on CYP3A4, P-gp, OATP1B1/3 additionally on CYP2C19.
Croatian: Dostupna su ispitivanja in vivo u kojima se ocjenjivao neto učinak na CYP3A4, P-gp, OATP1B1/3 i dodatno na CYP2C19.
English: In a Phase 2b trial evaluating letermovir doses of 60, 120, or 240 mg/day or placebo for up to 84 days in 131 HSCT recipients, DNA sequence analysis of a select region of UL56 (amino acids 231 to 369) was performed on samples obtained from 12 letermovir-treated subjects who experienced prophylaxis failure and for whom samples were available for analysis.
Croatian: U ispitivanju faze 2b, u kojem se ocjenjivala primjena letermovira u dozama od 60, 120 ili 240 mg na dan ili placeba tijekom do 84 dana u 131 primatelja HSCT-a, provedena je analiza slijeda DNK u izdvojenoj regiji gena UL56 (aminokiseline 231 - 369) na uzorcima prikupljenima u 12 ispitanika liječenih letermovirom u kojih je profilaksa bila neuspješna i čiji su uzorci bili dostupni za analizu.
English: In preclinical distribution studies, letermovir is distributed to organs and tissues with the highest concentrations observed in the gastrointestinal tract, bile duct and liver and low concentrations in the brain.
Croatian: U nekliničkim ispitivanjima distribucije letermovir se raspodjeluje u organe i tkiva, pri čemu su najviše koncentracije zabilježene u probavnom sustavu, žučovodu i jetri, dok su koncentracije u mozgu bile niske.
English: The pharmacokinetics of letermovir have been characterized following oral and IV administration in healthy subjects and HSCT recipients.
Croatian: Farmakokinetika letermovira okarakterizirana je nakon peroralne i i.v. primjene zdravim ispitanicima i primateljima HSCT-a.
English: In a Phase 3 trial (P001), DNA sequence analysis of the entire coding regions of UL56 and UL89 was performed on samples obtained from 22 letermovir-treated subjects, in the FAS population who experienced prophylaxis failure and for whom samples were available for analysis.
Croatian: U ispitivanju faze 3 (P001) provedena je analiza slijeda DNK u cjelokupnim kodirajućim regijama gena UL56 i UL89 na uzorcima prikupljenima u 22 ispitanika liječena letermovirom iz populacije bolesnika za koje je postojao potpuni skup podataka za analizu (engl. full-analysis set, FAS), a u kojih je profilaksa bila neuspješna i čiji su uzorci bili dostupni za analizu.
English: Based on population pharmacokinetic analyses, there is no difference in letermovir pharmacokinetics in females compared to males.
Croatian: Prema populacijskim farmakokinetičkim analizama, nema razlike u farmakokinetici letermovira između žena i muškaraca.
English: Do not use this medicine after the expiry date which is stated on the carton and blister card after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blister kartici iza oznake "EXP".
English: The mechanism is likely saturation/autoinhibition of OATP1B1/3.
Croatian: Mehanizam je vjerojatno zasićenje/autoinhibicija OATP1B1/3.
English: Concomitant use of dabigatran should be avoided due to the risk of reduced dabigatran efficacy.
Croatian: Treba izbjegavati istodobnu primjenu dabigatrana zbog rizika da će njegova djelotvornost biti smanjena.
English: At baseline, 50% of subjects received a myeloablative regimen, 52% were receiving cyclosporine, and 42% were receiving tacrolimus.
Croatian: Na početku ispitivanja 50% ispitanika primalo je mijeloablacijsku terapiju, 52% primalo je ciklosporin, a njih 42% primalo je takrolimus.
English: Letermovir was administered either orally or IV; the dose of letermovir was the same regardless of the route of administration.
Croatian: Letermovir se primjenjivao ili peroralno ili intravenski; doza letermovira bila je ista neovisno u putu primjene.
English: CMV DNA was monitored on a weekly basis until posttransplant Week 14, and subsequently bi-weekly until Week 24.
Croatian: Razina CMV DNK pratila se svaki tjedan do 14. tjedna nakon transplantacije, a nakon toga svaki drugi tjedan do 24. tjedna.
English: In HSCT recipients, letermovir AUC was estimated using population pharmacokinetic analyses using Phase 3 data (see Table 4).
Croatian: AUC letermovira u primatelja HSCT-a procijenjen je u populacijskim farmakokinetičkim analizama na temelju podataka iz ispitivanja faze 3 (vidjeti Tablicu 4).
English: You should not be given PREVYMIS if:
Croatian: Ne smijete primiti PREVYMIS:
English: Do not break, crush, or chew the tablet.
Croatian: Tabletu nemojte lomiti, drobiti ni žvakati.
English: Concomitant use of repaglinide and letermovir with or without cyclosporine is not recommended.
Croatian: Istodobna primjena repaglinida i letermovira, u kombinaciji s ciklosporinom ili bez njega, se ne preporučuje.
English: ↑ or ↓ efavirenz (CYP2B6 inhibition or induction)
Croatian: ↑ ili ↓ efavirenz (inhibicija ili indukcija CYP2B6)
English: The safety and efficacy of letermovir has been established in patients with a negative CMV DNA test result prior to initiation of prophylaxis.
Croatian: Sigurnost i djelotvornost letermovira ustanovljene su u bolesnika koji su prije uvođenja profilakse imali negativan nalaz testa na CMV DNK.
English: • nafcillin - for bacterial infections
Croatian: • nafcilin - koristi se za liječenje bakterijskih infekcija
English: In healthy subjects, oral administration of 480 mg single dose of letermovir with a standard high fat and high calorie meal did not have any effect on the overall exposure (AUC) and resulted in approximately 30% increase in peak levels (Cmax) of letermovir.
Croatian: Peroralna primjena jedne doze letermovira od 480 mg zajedno sa standardnim visokokaloričnim obrokom s visokim udjelom masnoća u zdravih ispitanika nije utjecala na sveukupnu izloženost (AUC), dok je povećala vršne vrijednosti (Cmax) letermovira za približno 30%.
English: -Examples of medicinal products transported by OAT3 includes ciprofloxacin, tenofovir, imipenem, and cilastin.
Croatian: - Primjeri lijekova koje prenosi OAT3 uključuju ciprofloksacin, tenofovir, imipenem i cilastin.
English: - Examples of medicinal products metabolised by UGT1A1 are raltegravir and dolutegravir.
Croatian: - Primjeri lijekova koji se metaboliziraju putem UGT1A1 su raltegravir i dolutegravir.
English: Plasma concentrations of medicinal products transported by OAT3 may be increased.
Croatian: Koncentracije lijekova koje prenosi OAT3 u plazmi mogu biti povišene.
English: Subjects received CMV DNA monitoring weekly until post-transplant week 14 and then bi-weekly until post-transplant week 24, with initiation of standard-of-care CMV pre-emptive therapy if CMV DNAemia was considered clinically significant.
Croatian: Ispitanicima se kontrolirala razina CMV DNK svaki tjedan do 14. tjedna nakon transplantacije, a zatim svaka dva tjedna do 24. tjedna nakon transplantacije, uz uvođenje standardne preemptivne terapije protiv CMV-a ako se razina CMV DNK u krvi smatrala klinički značajnom.
English: Expected: ↓ letermovir (P-gp/UGT induction)
Croatian: Očekivano: ↓ letermovir (indukcija P-gp-a/UGT-a)
English: Amphotericin B (lipid complex) is compatible with PREVYMIS.
Croatian: Amfotericin B (lipidni kompleks) kompatibilan je s lijekom PREVYMIS.
English: Concentrate for solution for infusion (sterile concentrate) Clear, colourless liquid pH between 7 and 8
Croatian: Bistra, bezbojna tekućina pH između 7 i 8
English: The entire contents of the IV bag should be administered.
Croatian: Treba primijeniti cijeli sadržaj infuzijske vrećice.
English: Do not use the vial if the solution is discoloured or contains visible particles.
Croatian: Bočica se ne smije upotrijebiti ako je otopina promijenila boju ili ako sadrži vidljive čestice.
English: How to take PREVYMIS
Croatian: Kako uzimati PREVYMIS
English: Any intravenous bags or infusion set materials not listed below should not be used.
Croatian: Ne smiju se koristiti nijedna infuzijska vrećica ili infuzijski set koji nisu načinjeni od materijala navedenih u nastavku.
English: Medicinal products transported by the renal transporter OAT3
Croatian: Lijekovi koje prenosi bubrežni prijenosnik OAT3
English: When PREVYMIS is co-administered with these statins, a statin dose reduction may be necessary
Croatian: Kada se PREVYMIS primjenjuje istodobno s tim statinima, možda će biti potrebno smanjiti dozu statina
English: PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).
Croatian: PREVYMIS je indiciran za profilaksu reaktivacije citomegalovirusa (CMV) i CMV bolesti u odraslih CMV-seropozitivnih primatelja [R+] alogenih transplantata hematopoetskih matičnih stanica (engl. allogeneic hematopoietic stem cell transplant, HSCT).
English: What PREVYMIS looks like and contents of the pack PREVYMIS 240 mg and 480 mg concentrate for solution for infusion is a clear, colourless liquid.
Croatian: Kako PREVYMIS izgleda i sadržaj pakiranja PREVYMIS 240 mg i 480 mg koncentrat za otopinu za infuziju je bistra i bezbojna tekućina.
English: Rifampicin co-administration resulted in an initial increase in letermovir plasma concentrations (due to OATP1B1/3 and/or P-gp inhibition) that is not clinically relevant, followed by clinically relevant decreases in letermovir plasma concentrations (due to induction of P-gp/UGT) with continued rifampicin co-administration (see Table 1).
Croatian: Istodobna primjena rifampicina dovela je do početnog povećanja koncentracija letermovira u plazmi (zbog inihibicije OATP1B1/3 i/ili P-gp-a) koje nije bilo klinički značajno, a zatim je, s daljnjom istodobnom primjenom rifampicina, uslijedilo klinički značajno sniženje koncentracija letermovira u plazmi (zbog indukcije P-gp-a/UGT-a) (vidjeti Tablicu 1).
English: PREVYMIS should be administered as an intravenous (IV) infusion only.
Croatian: PREVYMIS se primjenjuje isključivo kao intravenska (i.v.) infuzija.
English: This is equivalent to 2.30% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 2,30% maksimalnog preporučenog dnevnog unosa soli za odraslu osobu.
English: The magnitude of the OATP1B1/3 inhibition on co-administered medicinal products is likely greater when PREVYMIS is co-administered with cyclosporine (a potent OATP1B1/3 inhibitor).
Croatian: Veličina inhibicijskog učinka OATP1B1/3 na istodobno primijenjene lijekove vjerojatno je veća kada se PREVYMIS primjenjuje istodobno s ciklosporinom (snažnim inhibitorom OATP1B1/3).
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking PREVYMIS.
Croatian: Ako niste sigurni, razgovarajte s liječnikom, ljekarnikom ili medicinskom sestrom prije nego uzmete PREVYMIS.
English: Coadministration of PREVYMIS may result in clinically relevant increases in the plasma concentrations of co-administered CYP3A substrates (see sections 4.3, 4.4, and 5.2).
Croatian: Istodobna primjena lijeka PREVYMIS može dovesti do klinički važnih porasta koncentracija istodobno primijenjenih supstrata CYP3A u plazmi (vidjeti dijelove 4.3, 4.4 i 5.2).
English: Table 3: P001: Efficacy results in HSCT recipients (NC=F Approach, FAS Population) Letermovir
Croatian: Tablica 3: P001: Rezultati za djelotvornost u primatelja HSCT-a (NC=F pristup, FAS populacija)
English: Please note that the interaction potential and clinical consequences may be different depending on whether letermovir is administered orally or IV, and whether cyclosporine is concomitantly used.
Croatian: Imajte na umu da se potencijal za interakcije i kliničke posljedice mogu razlikovati ovisno o tome primjenjuje li se letermovir peroralno ili intravenski, te ovisno o tome primjenjuje li se istodobno i ciklosporin.
English: Conditioning Regimen Myeloablative (n=154, 85)
Croatian: Režim kondicioniranja Mijeloablacijski (n=154, 85)
English: PREVYMIS concentrate for solution for infusion contains hydroxypropylbetadex.
Croatian: PREVYMIS koncentrat za otopinu za infuziju sadrži hidroksipropilbetadeks.
English: Letermovir affects the formation of proper unit length genomes and interferes with virion maturation.
Croatian: Letermovir utječe na stvaranje pravilnih genoma jedinične duljine (engl. unit-length genomes) i ometa sazrijevanje viriona.
English: The effect of letermovir on doses up to 960 mg given IV on the QTc interval was evaluated in a randomised, single-dose, placebo- and active-controlled (moxifloxacin 400 mg oral) 4-period crossover thorough QT trial in 38 healthy subjects.
Croatian: Učinak letermovira u intravenskim (i.v.) dozama do 960 mg na QTc interval ocjenjivao se u randomiziranom, jednodoznom, placebom i aktivnim lijekom (moksifloksacin u peroralnoj dozi od 400 mg) kontroliranom, temeljitom ispitivanju utjecaja na QT interval, ukriženom u 4 razdoblja i provedenom u 38 zdravih ispitanika.
English: PREVYMIS concentrate for solution for infusion is a clear, colourless solution.
Croatian: PREVYMIS koncentrat za otopinu za infuziju je bistra, bezbojna otopina.
English: Type I (30 mL) clear glass vial with a 20 mm fluorocoated chlorobutyl stopper with aluminium flip-off cap containing 12 mL(medium green cap) or 24 mL (dark blue cap) of solution.
Croatian: Prozirna staklena bočica (staklo tipa I) volumena 30 ml s klorobutilnim čepom promjera 20 mm obloženim fluoropolimerom i s aluminijskom flip-off kapicom, koja sadrži 12 ml (zelena kapica) ili 24 ml (tamnoplava kapica) otopine.