FrancophonIA/ELRC3.0 huggingface dataset:
English: If the date of the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Croatian: Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s nadopunama Plana (RMP), dokumenti mogu biti podneseni istodobno.
English: Animal studies have shown toxicity to the developing embryo and foetus in rats, but not in rabbits (see section 5.3).
Croatian: Ispitivanja na životinjama ukazala su na toksičnost za razvoj embrija i fetusa u štakora, ali ne i u kunića (vidjeti dio 5.3).
English: Abacavir-resistant isolates of HIV-1 have been selected in vitro and are associated with specific genotypic changes in the reverse transcriptase (RT) codon region (codons M184V, K65R, L74V and Y115F).
Croatian: In vitro su izdvojeni HIV-1 izolati rezistentni na abakavir koji su povezani sa specifičnim promjenama na genotipu kodne regije reverzne transkriptaze (kodoni M184V, K65R, L74V i Y115F).
English: Adults, adolescents and children (weighing at least 25 kg):
Croatian: Odrasli, adolescenti i djeca (tjelesne težine najmanje 25 kg):
English: Therefore, there is little potential for interactions with antiretroviral PIs and other medicinal products metabolised by major P450 enzymes.
Croatian: Stoga postoji mala mogućnost za interakcije lijeka s antiretrovirusnim inhibitorima proteaze, te drugim lijekovima koji se metaboliziraju pomoću glavnih P450 enzima.
English: HLA-B*5701 screening for risk of ABC hypersensitivity should never be substituted for appropriate clinical vigilance and patient management in individuals receiving ABC.
Croatian: HLA-B*5701 probir na rizik za ABC preosjetljivost nikad ne smije biti zamjena za odgovarajuće kliničko praćenje i zbrinjavanje osoba koje uzimaju ABC.
English: Do not take this medicine after the expiry date which is stated on the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake EXP.
English: When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation.
Croatian: Kada takve osobe započinju liječenje, može doći do ponovne aktivacije starije, do tada skrivene infekcije, koja može uzrokovati znakove i simptome upale.
English: Abacavir increases the rate at which methadone is removed from the body.
Croatian: Abakavir povisuje stopu po kojoj se metadon eliminira iz organizma.
English: In pregnant women, more than 800 outcomes after first trimester exposure and more than 1000 outcomes after second and third trimester exposure indicate no malformative and foetal/neonatal effect of abacavir.
Croatian: Više od 800 ishoda nakon izloženosti trudnica u prvom tromjesečju i više od 1000 ishoda nakon izloženosti trudnica u drugom i trećem tromjesečju pokazuju da abakavir ne uzrokuje malformacije i nema učinka na fetus/novorođenče.
English: However, as there were only moderately experienced patients included in this study with an imbalance in baseline viral load between the arms, these results should be interpreted with caution.
Croatian: Međutim, budući da su u studiju bili uključeni bolesnici koji su prethodno samo umjereno liječeni, te da početno virusno opterećenje u dvije ispitivane skupine nije bilo uravnoteženo, pri interpretaciji ovih rezultata potreban je oprez.
English: However, both analyses were compatible with a conclusion of non-inferiority between both treatment arms.
Croatian: Međutim, obje analize su sukladne zaključku da su oba režima liječenja jednako vrijedna.
English: There are insufficient safety data to recommend the use of Ziagen in infants less than three months old.
Croatian: Nema dovoljno podataka o sigurnosti primjene da bi se mogla preporučiti uporaba lijeka Ziagen u dojenčadi mlađe od tri mjeseca.
English: If you are hypersensitive to Ziagen, return all your unused Ziagen oral solution for safe disposal.
Croatian: Ako ste preosjetljivi na Ziagen, vratite svu neiskorištenu Ziagen oralnu otopinu na sigurno odlaganje.
English: Ziagen oral solution is supplied in high density polyethylene bottles with child-resistant closures, containing 240 ml of oral solution.
Croatian: Ziagen oralna otopina se isporučuje u bocama od polietilena visoke gustoće sa sigurnosnim zatvaračima za djecu, koje sadrže 240 ml oralne otopine.
English: Pharmacotherapeutic group: nucleoside reverse transcriptase inhibitors, ATC Code: J05AF06
Croatian: Farmakoterapijska skupina: nukleozidni inhibitori reverzne transkriptaze, ATK oznaka: J05AF06.
English: One randomised, double blind, placebo controlled clinical study in adults has compared the combination of abacavir, lamivudine and zidovudine to the combination of indinavir, lamivudine and zidovudine.
Croatian: U jednom randomiziranom, dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju u odraslih, uspoređivala se kombinacija abakavira, lamivudina i zidovudina s kombinacijom indinavira, lamivudina i zidovudina.
English: The calorific value of sorbitol is 2.6 kcal/g.
Croatian: Kalorijska vrijednost sorbitola je 2,6 kcal/g sorbitola.
English: ABC Hypersensitivity (including risk of reduced clinical vigilance for ABC HSR following HLA-B*5701 screening).
Croatian: Preosjetljivost na abakavir (uključujući rizik smanjene kliničke vigilancije za reakciju preosjetljivosti na abakavir (ABC HSR) nakon HLA-B*5701 probira).
English: 60 film-coated, scored tablets
Croatian: 60 filmom obložene, tablete s razdjelnom crtom
English: Ziagen also contains preservatives (parahydroxybenzoates) which may cause allergic reactions (possibly delayed).
Croatian: Ziagen također sadrži konzervanse (parahidroksibenzoate) koji mogu izazvati alergijske reakcije (koje mogu biti odgođene).
English: -2.3% (95% CI -9.3% to +4.7%), p=0.52
Croatian: -2,3% (95% CI -9,3% do +4,7%), p=0,52
English: There are no data available on the safety of abacavir when administered to babies less than three months old.
Croatian: Ne postoje podaci o sigurnosti primjene abakavira kada se daje djeci mlađoj od tri mjeseca života.
English: In patients with moderate or severe hepatic impairment, no clinical data are available, therefore the use of abacavir is not recommended unless judged necessary.
Croatian: Nema kliničkih podataka za bolesnike s umjerenim ili teškim oštećenjem jetre, stoga se primjena abakavira ne preporučuje osim ako se procijeni da je neophodna.
English: Your doctor may need to monitor you while you are taking Ziagen.
Croatian: Liječnik bi Vas trebao nadzirati dok uzimate Ziagen.
English: If the doctor thinks they may have been related, you will be told never again to take Ziagen, or any other medicine containing abacavir
Croatian: Ako liječnik misli da bi mogli biti povezani, bit će Vam rečeno da više nikad ne uzimate Ziagen ili bilo koji drugi lijek koji sadržava abakavir
English: Pull out the syringe plunger until the syringe contains the first part of your full dose Turn the bottle the right way up.
Croatian: Izvucite klip štrcaljke dok štrcaljka ne sadrži prvu polovicu pune doze.
English: Abacavir belongs to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Croatian: Abakavir pripada skupini antiretrovirusnih lijekova, nazvanih nukleozidnim analozima - inhibitorima reverzne transkriptaze (NRTI).
English: Once daily (600 mg) administration:
Croatian: Primjena jedanput na dan (600 mg):
English: Children from three months to one year of age: The recommended dose is 8 mg/kg twice daily.
Croatian: Djeca u dobi od tri mjeseca do godinu dana: Preporučena doza je 8 mg/kg dvaput na dan.
English: Alternatively, for patients who are unable to swallow tablets, the tablet(s) may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2).
Croatian: Alternativno, za bolesnike koji nisu u mogućnosti progutati tabletu cijelu, tableta (tablete) se mogu zdrobiti i dodati maloj količini kašaste hrane ili tekućine, te se sva količina mora odmah progutati
English: In adults moderately exposed to antiretroviral therapy the addition of abacavir to combination antiretroviral therapy provided modest benefits in reducing viral load (median change 0.44 log10 copies/ml at 16 weeks).
Croatian: U odraslih bolesnika umjereno izloženih antiretrovirusnim lijekovima dodavanje abakavira u kombinaciju za antiretrovirusnu terapiju pruža umjerenu korist u smanjenju virusnog opterećenja (medijan promjene 0,44 log10 kopija/ml u 16. tjednu).
English: Film-coated tablet (tablets)
Croatian: Filmom obložena tableta (tablete).
English: In controlled clinical studies laboratory abnormalities related to Ziagen treatment were uncommon, with no differences in incidence observed between Ziagen treated patients and the control arms.
Croatian: U kontroliranim kliničkim ispitivanjima, odstupanja laboratorijskih testova povezana sa lijekom Ziagen bila su manje česta, te nije bilo razlika između bolesnika liječenih lijekom Ziagen i kontrolne skupine.
English: Tell your doctor if you are taking phenytoin.
Croatian: Obavijestite liječnika ako uzimate fenitoin.
English: No studies on the effects on ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja učinka abakavira na sposobnost upravljanja vozilima i rada sa strojevima.
English: Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take the recomended once daily dose (as described above) approximately 12 hours after the last twice daily dose, and then continue to take the recomended once daily dose (as described above) approximately every 24 hours.
Croatian: Bolesnici koji prelaze s režima doziranja dvaput na dan na režim doziranja jedanput na dan trebaju uzeti preporučenu dozu za primjenu jedanput na dan (kako je prethodno opisano) približno 12 sati nakon posljednje doze koja se primjenjuje dvaput na dan, a zatim nastaviti uzimati preporučenu dozu za primjenu jedanput na dan (kako je prethodno opisano) približno svaka 24 sata.
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Croatian: U bolesnika koji već boluju od poremećaja jetrene funkcije, uključujući kronični aktivni hepatitis, češće su zabilježene abnormalnosti funkcije jetre tijekom kombiniranog antiretrovirusnog liječenja, te takve bolesnike treba pratiti prema uobičajenoj praksi.
English: The scored tablets are yellow, biconvex, capsule shaped and are engraved with ‘GX 623' on both sides.
Croatian: Žute, bikonveksne tablete u obliku kapsule, s razdjelnom crtom i s utisnutom oznakom “GX 623” na obje strane.
English: No additional safety issues have been identified in paediatric subjects receiving either once or twice daily dosing compared to adults.
Croatian: U pedijatrijskih ispitanika koji su primali terapiju jedanput ili dvaput na dan nisu primijećeni dodatni sigurnosni problemi u odnosu na odrasle.
English: When changing back to a twice daily regimen, patients should take the recommended twice daily dose approximately 24 hours after the last once daily dose.
Croatian: Pri povratku na režim doziranja dvaput na dan, bolesnik treba uzeti preporučenu dozu za primjenu dvaput na dan približno 24 sata nakon posljednje doze koja se primjenjuje jedanput na dan.
English: -1.6% (95% CI -8.4% to +5.2%), p=0.65
Croatian: -1,6% (95% CI -8,4% do +5,2%), p=0,65
English: Elimination of abacavir is via hepatic metabolism with subsequent excretion of metabolites primarily in the urine.
Croatian: Eliminacija abakavira ide putem metabolizma u jetri s kasnijom ekskrecijom metabolita primarno putem urina.
English: The once daily regimen of abacavir is supported by a 48 weeks multi-centre, double-blind, controlled study (CNA30021) of 770 HIV-infected, therapy-naïve adults.
Croatian: Režim doziranja abakavira jedanput na dan podupire multicentrična, dvostruko slijepa, kontrolirana studija (CNA30021), provedena na 770 prethodno neliječenih odraslih bolesnika zaraženih virusom
English: After 36 weeks on a regimen including twice daily abacavir and lamivudine, 669 eligible subjects were randomised to either continue twice daily dosing or switch to once daily abacavir and lamivudine for at least 96 weeks.
Croatian: Nakon 36 tjedana liječenja režimom koji je uključivao primjenu abakavira i lamivudina dvaput na dan, 669 za to prikladnih ispitanika bilo je randomizirano ili za nastavak liječenja uz doziranje dvaput na dan ili za prelazak na liječenje abakavirom i lamivudinom jedanput na dan tijekom najmanje 96 tjedana.
English: A plastic adapter and oral dosing syringe are provided for accurate measurement of the prescribed dose of oral solution.
Croatian: Plastični nastavak i štrcaljka za oralno doziranje su priloženi za precizno određivanje doze oralne otopine.
English: -4.8% (95% CI -11.5% to +1.9%), p=0.16
Croatian: -4,8% (95% CI -11,5% do +1,9%), p=0,16
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Croatian: Relevantni primjeri uključuju citomegalovirusom izazvani retinitis, generalizirane i/ili fokalne infekcije mikobakterijama i pneumoniju izazvanu uzročnikom Pneumocystis jiroveci (carinii).
English: The metabolites and unchanged abacavir account for about 83% of the administered abacavir dose in the urine.
Croatian: Metaboliti i nepromijenjeni abakavir čine oko 83% primijenjene doze abakavira koja se izlučuje urinom.
English: • Therapy experienced adults
Croatian: • Prethodno liječene odrasle osobe
English: Overall the available data from observational cohorts and from randomised trials show some inconsistency so can neither confirm nor refute a causal relationship between abacavir treatment and the risk of myocardial infarction.
Croatian: Sveukupni dostupni podaci iz opservacijskih kohorti, kao i kroz randomizirana ispitivanja pokazala su određenu nedosljednost, koja u tom slučaju niti može dokraja isključiti ili povezati uzrokovani razvoj infarkta miokarda s uporabom abakavira.
English: The tablet coating contains triacetin, methylhydroxypropylcellulose, titanium dioxide, polysorbate 80 and iron oxide yellow.
Croatian: Ovojnica tablete sadrži triacetin, metilhidroksipropilcelulozu, titanijev dioksid, polisorbat 80 i žuti željezov oksid.
English: Following intravenous administration, the apparent volume of distribution was about 0.8 l/kg, indicating that abacavir penetrates freely into body tissues.
Croatian: Nakon intravenske primjene, prividni volumen raspodjele bio je oko 0,8 l/kg, što pokazuje da abakavir slobodno ulazi u tjelesna tkiva.
English: These may affect up to 1 in 10 people:
Croatian: Mogu se pojaviti u manje od 1 na 10 osoba:
English: Even patients who don't have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction).
Croatian: Čak i u bolesnika koji nemaju gen HLA-B*5701 može se razviti reakcija preosjetljivosti (ozbiljna alergijska reakcija).
English: Therefore patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases.
Croatian: Stoga te bolesnike treba pažljivo nadzirati liječnik koji ima iskustva u liječenju HIV infekcija.
English: In a meta-analysis of five clinical trials where abacavir was added to intensify therapy, of 166 subjects, 123 (74%) had M184V/I, 50 (30%) had T215Y/F, 45 (27%) had M41L, 30 (18%) had K70R and 25 (15%) had D67N.
Croatian: U metaanalizi 5 kliničkih ispitivanja u kojima je abakavir dodan kako bi se pojačala terapija, od 166 ispitanika, 123 (74%) je imalo M184V/I, 50 (30%) je imalo T215Y/F, 45 (27%) je imalo M41L, 30 (18%) je imalo K70R, a 25 (15%) je imalo D67N.
English: Long term data with abacavir used as a once daily regimen (beyond 48 weeks) are currently limited.
Croatian: Zasad nema dovoljno podataka o dugoročnoj primjeni abakavira u doziranju jedanput na dan (dulje od 48 tjedana).
English: • development of 1 or more symptom from at least 2 of the following groups: - Fever - Shortness of breath, sore throat or cough - Nausea or vomiting or diarrhoea or abdominal pain - Extreme tiredness or achiness or general ill feeling
Croatian: • razvoja 1 ili više simptoma iz najmanje 2 od sljedećih grupa: - vrućica - kratkoća daha, grlobolja ili kašalj
English: Clinical relevance in human of these data is unknown.
Croatian: Klinički značaj tih podataka za ljude nije poznat.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Croatian: Zabilježeno je da se autoimuni poremećaji (kao što je Gravesova bolest i autoimuni hepatitis) javljaju kod imunološke reaktivacije, međutim, zabilježeno vrijeme početka je varijabilno i ovi se događaji mogu javiti mnogo mjeseci nakon početka liječenja (vidjeti dio 4.4).
English: If you cannot swallow the tablet(s), you may crush and combine them with a small amount of food or drink, and take all the dose immediately.
Croatian: Ako ne možete progutati tabletu, možete je izdrobiti i pomiješati s malom količinom hrane ili pića, te uzeti odmah cijelu dozu.
English: Children receiving abacavir oral tablets according to the recommended dosage regimen achieve higher plasma abacavir exposure than children receiving oral solution because higher mg/kg doses are administered with the tablet formulation.
Croatian: Djeca koja primaju tablete abakavira za peroralnu primjenu sukladno preporučenom režimu doziranja postižu više razine izloženosti abakaviru u plazmi nego djeca koja primaju oralnu otopinu jer se tabletama primjenuju veće doze u mg/kg.
English: These findings included decreased foetal body weight, foetal oedema, and an increase in skeletal variations/malformations, early intra-uterine deaths and still births.
Croatian: Ovi nalazi uključuju smanjenu fetalnu tjelesnu težinu, fetalni edem i porast varijacija/malformacija kostura, rane intrauterine smrti i mrtvorođenčad.
English: If you have any further questions ask your doctor or pharmacist.
Croatian: Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: The bottle contains 240 ml (20 mg abacavir/ml) of solution.
Croatian: Boca sadrži 240 ml (20 mg abakavira/ml) otopine.
English: Isolates from most patients experiencing virological failure with a regimen containing abacavir in pivotal clinical trials showed either no NRTI-related changes from baseline (45%) or only M184V or M184I selection (45%).
Croatian: Izolati većine bolesnika iz ključnih kliničkih ispitivanja, u kojih je uz terapiju koja sadržava abakavir izostao virološki odgovor, pokazali su ili nikakav pomak od početnih vrijednosti povezan s NRTI (45%) ili samo selekciju M184V ili M184I (45%).
English: The recommended dose is 8 mg/kg twice a day or 16 mg/kg once a day, up to a maximum total daily dose of 600 mg daily.
Croatian: Preporučena doza je 8 mg/kg dvaput na dan ili 16 mg/kg jedanput na dan, do maksimalne ukupne doze od 600 mg na dan.
English: In a crossover study in 27 HIV-infected patients, intracellular carbovir-TP exposures were higher for the abacavir 600 mg once daily regimen (AUC24,ss + 32 %, Cmax24,ss + 99 % and Ctrough + 18 %) compared to the 300 mg twice daily regimen.
Croatian: U križnoj studiji 27 bolesnika zaraženih virusom HIV unutarstanična izloženost karbovir-TP-u bila je veća pri doziranju od 600 mg abakavira jedanput na dan (AUC24,ss + 32%, Cmax24,ss + 99% i Ctrough + 18%) u usporedbi s 300 mg dvaput na dan.
English: Medicinal product subject to restricted medical prescription (See Annex I Summary of Product Characteristics, 4.2).
Croatian: Lijek se izdaje na ograničeni recept (Vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: There was a low, similar overall incidence of virologic failure (viral load >50 copies/ml) in both the once and twice daily treatment groups (10% and 8% respectively).
Croatian: Zabilježena je mala ukupna incidencija izostanka virološkog odgovora (virusno opterećenje > 50 kopija/ml), slična u obje skupine (10% u skupini liječenoj jedanput na dan i 8% u skupini liječenoj dvaput na dan).
English: How to take Ziagen
Croatian: Kako uzimati Ziagen
English: • In order to avoid restarting abacavir, patients who have experienced a suspected HSR should be instructed to dispose of their remaining Ziagen tablets
Croatian: • Kako bi se izbjeglo ponovno uzimanje abakavira, bolesnike koji su imali suspektnu reakciju preosjetljivosti mora se uputiti da zbrinu preostale Ziagen tablete.
English: It is important to take Ziagen regularly, because if you take it at irregular intervals, you may be more likely to have a hypersensitivity reaction.
Croatian: Važno je da Ziagen uzimate redovito jer neredovito uzimanje može povećati rizik od reakcije preosjetljivosti.
English: For example, if your dose is 30 ml, you need to take 3 syringe-fulls of medicine Take the syringe out of the bottle and wash it thoroughly in clean water.
Croatian: Na primjer, ako doza iznosi 30 ml, morate uzeti 3 pune štrcaljke lijeka.
English: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands
Croatian: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Nizozemska
English: In a pharmacokinetic study (PENTA 15), four virologically controlled subjects less than 12 months of age switched from abacavir plus lamivudine oral solution twice daily to a once daily regimen.
Croatian: U jednom je farmakokinetičkom ispitivanju (PENTA 15) četvero ispitanika mlađih od 12 mjeseci s kontroliranim virusnim opterećenjem bilo prebačeno s oralne otopine abakavir plus lamivudin dvaput na dan na režim doziranja jedanput na dan.
English: Changes in laboratory chemistries
Croatian: Promjene u laboratorijskim nalazima biokemijskih parametara
English: The results are summarised in the table below:
Croatian: Rezultati su sažeto prikazani u sljedećoj tablici:
English: Importantly, such symptoms may lead to misdiagnosis of HSR as respiratory disease (pneumonia, bronchitis, pharyngitis), or gastroenteritis .
Croatian: Važno je napomenuti da takvi simptomi mogu dovesti do pogrešne dijagnoze reakcije preosjetljivosti kao bolesti dišnog sustava (pneumonije, bronhitisa, faringitisa) ili gastroenteritisa.
English: • a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
Croatian: • široko rasprostranjen osip sa žuljevima i ljuštenjima kože, posebice oko usta, nosa, očiju i genitalija (Stevens-Johnsonov sindrom) i u težim oblicima koji uzrokuju ljuštenje kože u više od
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
Croatian: Bolesnici koji su kronični nositelji virusa hepatitisa B ili C i koji su na kombinacijskoj antiretrovirusnoj terapiji imaju povećan rizik od nastupa ozbiljnih i potencijalno fatalnih jetrenih nuspojava.
English: Children from one year of age: The recommended dose is 8 mg/kg twice daily or 16 mg/kg once daily, up to a maximum total daily dose of 600 mg (30 ml).
Croatian: Djeca od navršenih godinu dana: Preporučena doza je 8 mg/kg dvaput na dan ili 16 mg/kg jedanput na dan, do maksimalne ukupne dnevne doze od 600 mg (30 ml).
English: As well as the side effects listed below for Ziagen, other conditions can develop during combination therapy for HIV.
Croatian: Kao i niže navedene nuspojave za Ziagen, za vrijeme kombinirane terapije za HIV mogu se razviti i druga stanja.
English: According to clinical trials performed in children abacavir is rapidly and well absorbed from oral solution and tablet formulations administered to children.
Croatian: Klinička ispitivanja provedena s djecom pokazala su da se abakavir brzo i dobro apsorbira nakon primjene oralne otopine i tablete u djece.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KARTONSKA KUTIJA - TABLETE