FrancophonIA/ELRC3.0 huggingface dataset:
English: Entecavir Accord belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver.
Croatian: Entekavir Accord pripada klasi lijekova koji mogu prouzročiti laktacidozu (suvišak mliječne kiseline u krvi) i povećanje jetre.
English: During Year 2, genotypic resistance to ETV was detected in 2 patients (1.1% cumulative probability of resistance through Year 2).
Croatian: Tijekom 2. godine, genotipska rezistencija na entekavir utvrđena je u 2 bolesnika (kumulativna vjerojatnost rezistencije tijekom 2. godine: 1,1%).
English: Contents of the pack and other information What Entecavir Accord contains
Croatian: Sadržaj pakiranja i druge informacije Što Entekavir Accord sadrži
English: virus (HBV) infection in adults.
Croatian: (dugotrajne) infekcije virusom hepatitisa B (HBV) u odraslih.
English: These 14 patients had a lower rate of genotypic entecavir resistance (cumulative probability 18.8% through 5 years of follow-up) than the overall study population (see table).
Croatian: Tih 14 bolesnika imalo je nižu stopu genotipske rezistencije na entekavir (kumulativna vjerojatnost od 18,8% kroz 5 godina praćenja) nego ukupna populacija u ispitivanju (vidjeti tablicu).
English: In the clinical trials entecavir treatment was discontinued if patients achieved a prespecified response.
Croatian: U kliničkim se ispitivanjima liječenje entekavirom prekidalo ukoliko su bolesnici postigli unaprijed određeni odgovor.
English: Frequency is defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000).
Croatian: (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000).
English: When your treatment with Entecavir Accord is stopped, your doctor will continue to monitor you and take blood tests for several months.
Croatian: Entekavir Accord, liječnik će Vas tijekom nekoliko mjeseci nastaviti pratiti i raditi krvne pretrage.
English: the condition of your liver.
Croatian: Vaše jetre.
English: Duration of therapy
Croatian: Trajanje terapije
English: Entecavir Accord tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years.
Croatian: Entekavir Accord tablete primjenjuju se i za liječenje kronične (dugotrajne) HBV infekcije u djece i adolescenata u dobi od 2 godine do manje od 18 godina.
English: Tumour development was preceded by pneumocyte proliferation in the lung which was not observed in rats, dogs, or monkeys, indicating that a key event in lung tumour development observed in mice likely was species-specific.
Croatian: Razvoju tumora prethodila je proliferacija pneumocita u plućima, koja se nije opazila u štakora, pasa ili majmuna, što ukazuje na to da je ključni događaj u razvoju tumora pluća u miša vjerojatno specifičan za vrstu.
English: General: patients should be advised that therapy with entecavir has not been proven to reduce the risk of transmission of HBV and therefore appropriate precautions should still be taken.
Croatian: Općenito: Bolesnicima treba objasniti kako nije dokazano da terapija entekavirom smanjuje rizik od prijenosa HBV-a i da je stoga i dalje nužno primjenjivati odgovarajuće mjere opreza.
English: Entecavir Accord is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.
Croatian: To je važno zato što se Entekavir Accord uklanja iz tijela putem bubrega i možda će Vam trebati prilagoditi dozu ili raspored doziranja.
English: Pregnancy: there are no adequate data from the use of entecavir in pregnant women.
Croatian: Trudnoća: Nema odgovarajućih podataka o primjeni entekavira u trudnica.
English: Absorption: entecavir is rapidly absorbed with peak plasma concentrations occurring between 0.51.5 hours.
Croatian: Apsorpcija: Entekavir se brzo apsorbira s vršnim koncentracijama u plazmi između 0,5-1,5 sati.
English: Treatment with nucleoside analogues should be discontinued when rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/lactic acidosis of unknown aetiology occur.
Croatian: Liječenje analozima nukleozida treba prekinuti kad nastupi brzo povišenje razina aminotransferaza, progresivna hepatomegalija ili metabolička acidoza/laktacidoza nepoznatog uzroka.
English: Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Croatian: Prijavljivanje sumnji na nuspojavu: Nakon dobivanja odobrenja lijeka važno je prijavljivanje sumnji na njegove nuspojave.
English: Entecavir has not been studied as a treatment for HIV infection and is not recommended for this use.
Croatian: Entekavir se nije ispitivao za liječenje HIV-infekcije i ne preporučuje se za tu primjenu.
English: Entecavir Accord should not be used during pregnancy unless clearly necessary.
Croatian: Entekavir Accord se ne smije primjenjivati tijekom trudnoće, osim ako to stvarno nije neophodno.
English: Result for the main efficacy endpoints at Week 48 and Week 96 are presented below.
Croatian: Rezultati za glavne mjere ishoda za djelotvornost u 48. tjednu i 96. tjednu prikazane ispod.
English: Race: the population pharmacokinetic analysis did not identify race as significantly influencing entecavir pharmacokinetics.
Croatian: Rasa: Analiza populacijske farmakokinetike nije utvrdila da rasa značajno utječe na farmakokinetiku entekavira.
English: If appropriate, resumption of hepatitis B therapy may be warranted.
Croatian: Ukoliko je prikladno, možda bude potrebno ponovno nastaviti s terapijom hepatitisa B.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: How to store Entecavir Accord Contents of the pack and other information
Croatian: Kako čuvati Entekavir Accord Sadržaj pakiranja i druge informacije
English: HAART regimens did not include emtricitabine or tenofovir disoproxil fumarate.
Croatian: HAART režimi nisu uključivali emtricitabin ili tenofovir dizoproksil fumarat.
English: Biotransformation: entecavir is not a substrate, inhibitor or inducer of the CYP450 enzyme system.
Croatian: Biotransformacija: Entekavir nije supstrat, inhibitor niti induktor enzimskog sustava CYP450.
English: The benefits of long-term virologic suppression with continued therapy must be weighed against the risk of prolonged treatment, including the emergence of resistant hepatitis B virus.
Croatian: Koristi dugoročne virološke supresije tijekom kontinuirane terapije moraju se odvagnuti u odnosu na rizik dugotrajnog liječenja, uključujući pojavu rezistentnog virusa hepatitisa B.
English: Dose adjustment is recommended for patients with creatinine clearance < 50 ml/min, including those on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Croatian: Preporučuje se prilagoditi dozu bolesnicima s klirensom kreatinina < 50 ml/min, uključujući bolesnike na hemodijalizi ili kontinuiranoj ambulantnoj peritonejskoj dijalizi (KAPD).
English: Entecavir was clastogenic to human lymphocyte cultures at concentrations substantially higher than those achieved clinically.
Croatian: Entekavir se pokazao klastogenim u kulturama ljudskih limfocita pri koncentracijama znatno višima od onih koje se postižu u kliničkim uvjetima.
English: * for doses < 0.5 mg entecavir oral solution is recommended.
Croatian: * Za doze < 0,5 mg preporučuje se oralna otopina entekavira.
English: In reproductive toxicology studies in which animals were administered entecavir for up to 4 weeks, no evidence of impaired fertility was seen in male or female rats at high exposures.
Croatian: U ispitivanjima reproduktivne toksičnosti u kojima se životinjama primjenjivao entekavir u razdoblju do 4 tjedna nije se dokazalo oštećenje plodnosti u mužjaka ili ženki štakora pri visokim izloženostima.
English: The pharmacokinetics of entecavir following a single 1 mg dose in patients (without chronic hepatitis B infection) are shown in the table below:
Croatian: Farmakokinetika entekavira nakon jednokratne doze od 1 mg u bolesnika (bez kronične infekcije hepatitisom B) prikazana je u sljedećoj tablici:
English: If your doctor instructs you to take Entecavir Accord on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.
Croatian: Ako Vam liječnik da uputu da uzimate Entekavir Accord na prazan želudac, to znači da ga morate uzeti najmanje 2 sata nakon obroka i najmanje 2 sata prije sljedećeg obroka.
English: Caution should be exercised when prescribing nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease.
Croatian: Nužan je oprez kad se analozi nukleozida propisuju bolesnicima (osobito pretilim ženama) s hepatomegalijom, hepatitisom ili drugim poznatim faktorom rizika za bolest jetre.
English: There is limited experience of entecavir overdose reported in patients.
Croatian: Postoji ograničeno iskustvo s prijavljenim predoziranjem entekavirom u bolesnika.
English: Increased incidences of other tumours including brain gliomas in male and female rats, liver carcinomas in male mice, benign vascular tumours in female mice, and liver adenomas and carcinomas in female rats were seen only at high lifetime exposures.
Croatian: Povećane incidencije drugih tumora, uključujući gliome mozga u mužjaka i ženki štakora, karcinome jetre u mužjaka miša, benigne vaskularne tumore u ženki miša i adenome i karcinome jetra u ženki štakora, vidjele su se samo pri visokim izloženostima tijekom cijelog života.
English: Following administration of 14C-entecavir, no oxidative or acetylated metabolites and minor amounts of the phase II metabolites, glucuronide and sulfate conjugates, were observed.
Croatian: Nakon primjene 14C-entekavira nisu opaženi ni oksidirani ili acetilirani metaboliti niti manje količine metabolita faze II, glukuronidni i sulfatni konjugati.
English: The recommended dose for adult patients with decompensated liver disease is 1 mg once daily, which must be taken on an empty stomach (more than 2 hours before and more than 2 hours after a meal) (see section 5.2).
Croatian: Preporučena doza za odrasle bolesnike s dekompenziranom bolešću jetre je 1 mg jednom dnevno, a mora se uzeti na prazan želudac (više od 2 sata prije i više od 2 sata poslije obroka) (vidjeti dio 5.2).
English: Elderly: no dosage adjustment based on age is required.
Croatian: Stariji: Nije potrebna prilagodba doze na temelju dobi.
English: All 61 patients had HBsAg loss post-transplantation, and 2 of these later became HBsAg positive despite maintaining undetectable HBV DNA (<6 IU/ml).
Croatian: U svih 61 bolesnika nastupio je nestanak HBsAg nakon transplantacije, dok su 2 od tih bolesnika kasnije postali HBsAg pozitivni usprkos tome što su i dalje imali nemjerljiv HBV DNK (<6 IU/ml).
English: The decision to treat paediatric patients should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information.
Croatian: Odluku o liječenju pedijatrijskih bolesnika treba donijeti nakon što se pažljivo razmotre individualne potrebe bolesnika i uzimajući u obzir važeće smjernice za liječenje pedijatrijskih bolesnika, uključujući vrijednosti početnih histoloških parametara.
English: Entecavir is not a substrate, an inducer or an inhibitor of cytochrome P450 (CYP450) enzymes (see section 5.2).
Croatian: Entekavir nije supstrat, induktor niti inhibitor enzima citokroma P450 (CYP450) (vidjeti dio 5.2).
English: The median EC50 value for entecavir against LVDr HBV (rtL180M and rtM204V) was 0.026 µM (range 0.010-0.059 µM).
Croatian: Medijan vrijednosti EC50 za entekavir protiv LVDr HBV (rtL180M i rtM204V) bio je 0,026 µM (raspon 0,010-0,059 µM).
English: To differentiate between elevations in aminotransferases due to response to treatment and increases potentially related to lactic acidosis, physicians should ensure that changes in ALT are associated with improvements in other laboratory markers of chronic hepatitis B.
Croatian: Da bi se povišenja aminotransferaza koja su odgovor na liječenje razlikovala od povišenja koja bi mogla biti povezana s laktacidozom, liječnici moraju potvrditi da su promjene ALT-a povezane s poboljšanjem drugih laboratorijskih pokazatelja kroničnog hepatitisa B.
English: Of the 61 patients who were evaluable for efficacy (received entecavir for at least 1 month), 60 also received hepatitis B immune globulin (HBIg) as part of the post-transplant prophylaxis regimen.
Croatian: Od 61 bolesnika u kojih se mogla napraviti procjena djelotvornosti (primali su entekavir najmanje 1 mjesec), 60 ih je također primilo imunoglobulin protiv hepatitisa B (HBIg) u sklopu profilaktičkog režima nakon transplantacije.
English: What Entecavir Accord looks like and contents of the pack
Croatian: Kako Entekavir Accord izgleda i sadržaj pakiranja
English: whether you have kidney problems.
Croatian: tome imate li tegobe s bubrezima.
English: At 24 weeks the reduction in HBV viral load was significantly greater with entecavir (-3.65 vs an increase of 0.11 log10 copies/ml).
Croatian: U 24. tjednu, smanjenje virusnog opterećenja HBV-om bilo je značajno veće kod bolesnika liječenih entekavirom (-3,65 naspram povećanju od 0,11 log10 kopija/ml).
English: Cases of lactic acidosis have been reported, often in association with hepatic decompensation, other serious medical conditions or drug exposures (see section 4.4).
Croatian: Prijavljeni su slučajevi laktacidoze, često povezani s dekompenzacijom jetre, drugim ozbiljnim zdravstvenim stanjima ili izlaganjem nekom lijeku (vidjeti dio 4.4).
English: Responses for patients with baseline Knodell Fibrosis Scores of 4 (cirrhosis) were comparable to overall responses on all efficacy outcome measures (all patients had compensated liver disease).
Croatian: Knodellovom indeksu fibroze (ciroza) mogli su se usporediti s ukupnim odgovorima u svim mjerama ishoda djelotvornosti (svi su bolesnici imali kompenziranu bolest jetre).
English: Pharmacotherapeutic group: antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors
Croatian: Farmakoterapijska skupina: antivirusni lijekovi za sustavnu primjenu, nukleozidni i nukleotidni inhibitori reverzne transkriptaze
English: After opening the bottle use within 90 days.
Croatian: Bočicu upotrijebiti u roku od 90 dana nakon otvaranja.
English: Entecavir Accord are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablet (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Croatian: Entekavir Accord se isporučuje u kutijama koje sadrže 30 x 1 ili 90 x 1 filmom obloženu tabletu (u blisterima s jediničnim dozama) i u bocama koje sadrže 30 filmom obloženih tableta.
English: Baseline demographics and HBV disease characteristics were comparable between the 2 treatment arms and across age cohorts.
Croatian: Početna demografska i obilježja HBV bolesti bila su usporediva između 2 liječene skupine i u različitim dobnim kohortama.
English: Blister pack:
Croatian: Blister pakiranje:
English: In HIV antiviral assays, entecavir at micromolar concentrations was not antagonistic to the anti-HIV activity in cell culture of these six NRTIs or emtricitabine.
Croatian: U antivirusnim testovima HIV-a, entekavir u mikromolarnim koncentracijama nije imao antagonističku aktivnost na anti-HIV aktivnost u kulturi stanica ovih šest NRTI ili emtricitabina.
English: All dosing will be taken once daily orally (by mouth).
Croatian: Doza se uvijek uzima jednom dnevno kroz usta.
English: Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park Paola, PLA 3000
Croatian: KW20A Kordin Industrial Park Paola, PLA 3000
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU TEKST VANJSKE KUTIJE (ZA BOCU I BLISTERE)
English: This finding was not observed in repeat-dose studies in other species, including monkeys administered entecavir daily for 1 year at exposures ≥ 100 times those in humans.
Croatian: Ovaj se nalaz nije opazio u ispitivanjima toksičnosti ponovljenih doza u drugih vrsta, uključujući majmune kojima se entekavir primjenjivao svakodnevno tijekom 1 godine uz izloženosti koje su bile ≥ 100 puta veće od onih u ljudi.
English: At Week 72 post-transplant, none of 55 observed cases had virologic recurrence of HBV [defined as HBV DNA ≥50 IU/ml (approximately 300 copies/ml)], and there was no reported virologic recurrence at time of censoring for the remaining 6 patients.
Croatian: U 72. tjednu nakon transplantacije, niti jedan od 55 promatranih slučajeva nije prijavio virološki povrat HBV-a [definiran kao HBV DNK ≥50 IU/ml (približno 300 kopija/ml)] i nije bilo prijavljenog virološkog povrata u vrijeme cenzuriranja podataka za preostalih 6 bolesnika.
English: Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV.
Croatian: Stoga je potrebno poduzeti odgovarajuće postupke kako bi se spriječio neonatalni prijenos HBV-a.
English: By 48 weeks of post-treatment follow-up, a substantial number of HBeAg negative patients lost response.
Croatian: Odgovor je do kraja 48. tjedna praćenja nakon liječenja izgubio znatan broj HBeAg negativnih bolesnika.
English: In patients with a suboptimal virological response after 24 weeks of treatment with entecavir, a modification of treatment should be considered (see sections 4.5 and 5.1).
Croatian: U bolesnika sa suboptimalnim virološkim odgovorom nakon 24 tjedna liječenja entekavirom potrebno je razmotriti modifikaciju liječenja (vidjeti dijelove 4.5 i 5.1).
English: Take Entecavir Accord as long as your doctor has told you.
Croatian: Uzimajte Entekavir Accord onoliko dugo koliko Vam je rekao liječnik.
English: decompensated liver disease (see section 4.4)
Croatian: dekompenziranom bolešću jetre (vidjeti dio 4.4)
English: The study population was 82% male, 39% Caucasian, and 37% Asian, with a mean age of 49 years; 89% of patients had HBeAg-negative disease at the time of transplant.
Croatian: U ispitnoj populaciji bilo je 82% muškaraca, 39% bijelaca i 37% azijata, prosječne dobi od 49 godina; 89% bolesnika imalo je HBeAg-negativnu bolest u vrijeme transplantacije.
English: Testicular changes (seminiferous tubular degeneration) were evident in repeat-dose toxicology studies in rodents and dogs at exposures ≥ 26 times those in humans.
Croatian: Promjene na testisima (degeneracija sjemenih kanalića) bile su očite u ispitivanjima toksičnosti ponovljenih doza u glodavaca i pasa pri izloženostima koja su bile ≥ 26 puta veće od onih u ljudi.
English: How to store Entecavir Accord
Croatian: Kako čuvati Entekavir Accord
English: discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Entecavir Accord treatment may be.
Croatian: upitajte liječnika radi li Vam jetra ispravno i, ukoliko to nije slučaj, kako bi to moglo utjecati na Vaše liječenje lijekom Entekavir Accord.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su navedene padajućim slijedom prema ozbiljnosti.
English: Resistance is mediated by reduced inhibitor binding to the altered HBV reverse transcriptase, and resistant HBV exhibits reduced replication capacity in cell culture.
Croatian: Rezistencija je posredovana smanjenim vezanjem inhibitora za promijenjenu HBV reverznu transkriptazu, a rezistentni HBV pokazuje smanjeni kapacitet umnažanja u staničnoj kulturi.
English: Patients should be monitored closely for adverse reactions when entecavir is coadministered with such medicinal products.
Croatian: Bolesnike treba pomno pratiti zbog nuspojava kad se entekavir istodobno primjenjuje s takvim lijekovima.
English: Also, patients with decompensated liver disease may be at higher risk for lactic acidosis and for specific renal adverse events such as hepatorenal syndrome.
Croatian: Također, bolesnici s dekompenziranom bolešću jetre mogu imati viši rizik od laktacidoze i specifičnih bubrežnih štetnih događaja, kao što je hepatorenalni sindrom.
English: The frequency and nature of adverse events in this study were consistent with those expected in patients who have received a liver transplant and the known safety profile of entecavir.
Croatian: Učestalost i priroda štetnih događaja u ovom ispitivanju bile su sukladne onima koje su se očekivale u bolesnika s transplantatom jetre i poznatom sigurnosnom profilu entekavira.
English: What Entecavir Accord is and what it is used for What you need to know before you take Entecavir Accord How to take Entecavir Accord Possible side effects
Croatian: Što je Entekavir Accord i za što se koristi Što morate znati prije nego počnete uzimati Entekavir Accord Kako uzimati Entekavir Accord
English: Results for selected study endpoints at weeks 24 and 48 are shown in the table.
Croatian: Rezultati za odabrane mjere ishoda ispitivanja u 24. i 48. tjednu prikazane su u sljedećoj tablici.
English: Genotypic evaluations were performed for all patients with available samples who had virologic breakthrough through Week 96 or HBV DNA ≥ 50 IU/ml at Week 48 or
Croatian: Genotipske procjene provedene su za sve bolesnike s dostupnim uzorcima koji su doživjeli virološki proboj do 96. tjedna ili koji su imali HBV DNK ≥ 50 IU/ml u 48. tjednu ili 96. tjednu.
English: The lower Cmax and AUC when taken with food is not considered to be of clinical relevance in nucleoside-naive patients but could affect efficacy in lamivudine-refractory patients (see section 4.2).
Croatian: Cmax i AUC kad se entekavir uzima s hranim ne smatraju se klinički značajnim u bolesnika prethodno neliječenih analozima nukleozida, ali mogle bi utjecati na djelotvornost u bolesnika refrakternih na lamivudin (vidjeti dio 4.2).
English: Subjects were randomized (2:1) to receive blinded treatment with entecavir 0.015 mg/kg up to 0.5 mg/day (N = 120) or placebo (N = 60).
Croatian: Ispitanici su randomizirani (2:1) da primaju slijepo liječenje entekavirom u dozi od 0,015 mg/kg do najviše 0,5 mg/dan (N = 120) ili placebo (N = 60).
English: Week 96 .
Croatian: 96. tjedan
English: Elderly: the effect of age on the pharmacokinetics of entecavir was evaluated comparing elderly subjects in the age range 65-83 years (mean age females 69 years, males 74 years) with young subjects in the age range 20-40 years (mean age females 29 years, males 25 years).
Croatian: Starije osobe: Učinak dobi na farmakokinetiku entekavira procijenio se usporedbom starijih ispitanika u dobi od 65 do 83 godine (prosječna dob žena: 69 godina, muškaraca: 74 godine) s mlađim ispitanicima u dobi od 20 do 40 godina (prosječna dob žena: 29 godina, muškaraca: 25 godina).
English: There are limited data on patients co-infected with HIV who have low CD4 cell counts (< 200 cells/mm3).
Croatian: Postoje samo ograničeni podaci o bolesnicima istodobno inficiranima HIV-om koji imaju nizak broj CD4 stanica (< 200 stanica/mm3).
English: uncommon (at least 1 in 1,000 patients): rash, hair loss.
Croatian: manje često (u najmanje 1 na 1000 bolesnika): osip, ispadanje kose.
English: All (10/10) patients with advanced fibrosis or cirrhosis at baseline (Ishak fibrosis score of 4, 5 or 6) had a ≥ 1 point decrease (median decrease from baseline was 1.5 points).
Croatian: Svi (10/10) bolesnici s uznapredovalom fibrozom ili cirozom na početku ispitivanja (stupanj fibroze 4, 5 ili 6 prema Ishakovom indeksu) imali su smanjenje za ≥ 1 boda (medijan smanjenja u odnosu na početnu vrijednost bio je 1,5 boda).
English: High-density polyethylene (HDPE) bottle contians a silica gel cainster with child resistant polypropylene closure containing 30 film-coated tablets.
Croatian: Boca od polietilena visoke gustoće (HDPE) sadrži spremnik silika-gela s polipropilenskim zatvaračem sigurnim za djecu koja sadrži 30 filmom obloženih tableta.