FrancophonIA/ELRC3.0 huggingface dataset:
English: Aclasta must not be mixed or given intravenously with any other medicinal product and must be given through a separate vented infusion line at a constant infusion rate.
Slovenian: Zdravila Aclasta ne smete mešati ali dajati intravensko z drugim zdravilom, dajati ga morate po ločenem prezračevanem infuzijskem sistemu s stalno hitrostjo infundiranja.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Aclasta in all subsets of the paediatric population in Paget's disease of the bone, osteoporosis in post-menopausal women at an increased risk of fracture, osteoporosis in men at increased risk of fracture and prevention of clinical fractures after a hip fracture in men and women (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Aclasta za vse podskupine pediatrične populacije s Pagetovo boleznijo kosti, za osteoporozo pri postmenopavzalnih ženskah s povečanim tveganjem za zlome, za osteoporozo pri moških s povečanim tveganjem za zlome in za preprečevanje kliničnih zlomov po zlomu kolka pri ženskah in moških (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: In clinical trials in osteoporosis, approximately 0.2% of patients had notable declines of serum calcium levels (less than 1.87 mmol/l) following Aclasta administration.
Slovenian: V kliničnih preskušanjih pri osteoporozi je pri 0,2 % bolnikov prišlo do opaznega znižanja koncentracij kalcija v serumu (manj kot 1,87 mmol/l) po aplikaciji zdravila Aclasta.
English: Temporary interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Slovenian: Razmisliti je treba o začasni prekinitvi zdravljenja z zoledronsko kislino, dokler se stanje ne izboljša in dokler se ne zmanjša vpliv vpletenih dejavnikov tveganja, če je to mogoče doseči.
English: Five of the 6 patients had SAP within the normal range at month 6 (Last Observation Carried Forward, LOCF).
Slovenian: Pri petih od teh šestih bolnikov je bila koncentracija alkalne fosfataze v serumu po 6 mesecih v okviru normalnih vrednosti (po principu zadnje izmerjene vrednosti prenesene naprej (Last Observation Carried Forward, LOCF)).
English: During this entire time period bone turnover markers were within the pre-menopausal range at the end of each year.
Slovenian: V celotnem obdobju so bile ob koncu vsakega leta koncentracije označevalcev pregradnje kosti v okviru premenopavzalnih vrednosti.
English: Thereafter bone markers stabilised within the pre-menopausal range.
Slovenian: Po tem so se koncentracije kostnih označevalcev stabilizirale v premenopavzalnem okviru.
English: Of the 153 Aclasta-treated patients and 115 risedronate-treated patients who entered an extended observation study, after a mean duration of follow-up of 3.8 years from time of dosing, the proportion of patients ending the Extended Observation Period due to the need for re-treatment (clinical judgment) was higher for risedronate (48 patients, or 41.7%) compared with zoledronic acid (11 patients, or 7.2%).
Slovenian: Od 153 bolnikov, zdravljenih z zdravilom Aclasta, in 115 bolnikov, zdravljenih z risedronatom, ki so bili vključeni v študijo podaljšanega opazovanja, je bil po povprečnem trajanju spremljanja 3,8 let od časa odmerjanja delež bolnikov, ki so zaključili svoje sodelovanje v podaljšanem obdobju opazovanja, ker so potrebovali ponovno zdravljenje (po presoji zdravnika), večji v skupini bolnikov, ki so prejemali risedronat, (48 bolnikov oziroma 41,7 %) kot v skupini bolnikov, ki so prejemali zoledronsko kislino (11 bolnikov oziroma 7,2 %).
English: 1 bottle of 100 ml Component of a multipack.
Slovenian: 1 steklenica s 100 ml Del skupnega pakiranja.
English: The patient population randomised in this study (ITT population) included patients with several sub-types of rheumatic conditions, inflammatory bowel disease, or Duchenne muscular dystrophy.
Slovenian: Populacija bolnikov, ki so bili randomizirani v tej študiji (populacija z namenom zdravljenja, populacija ITT (ITT- intention to treat)), je vključevala bolnike z več podvrstami revmatičnih bolezni, bolnike z vnetno boleznijo črevesa ali z Duchennovo mišično distrofijo.
English: You must not be given Aclasta if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, ne smete dobiti zdravila Aclasta.
English: Aclasta is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
Slovenian: Zdravilo Aclasta je kontraindicirano pri bolnikih z očistkom kreatinina < 35 ml/min (glejte poglavji 4.3 in 4.4).
English: Incidence of individual adverse reactions following the first infusion was: pyrexia (17.1%), myalgia (7.8%), influenza-like illness (6.7%), arthralgia (4.8%) and headache (5.1%).
Slovenian: Po prvi infuziji so bile incidence posameznih neželenih učinkov naslednje: zvišana telesna temperatura (17,1 %), mialgija (7,8 %), gripi podobna bolezen (6,7 %), artralgija (4,8 %) in glavobol (5,1 %).
English: • Reminder card with the following key messages: o Need to calculate creatinine clearance based on actual body weight using the Cockcroft-Gault formula before each treatment with Aclasta o Contraindication in patients with creatinine clearance < 35 ml/min o Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity o Need to ensure appropriate hydration of the patient especially those at an advanced age and those receiving diuretic therapy o Need to infuse Aclasta slowly over a period of no less than 15 minutes o Once-yearly dosing regime o Adequate calcium and vitamin D intake are recommended in association with Aclasta administration o Need for appropriate physical activity, non-smoking and healthy diet
Slovenian: • Opomnik z naslednjimi ključnimi sporočili: o potreba izračuna očistka kreatinina glede na dejansko telesno maso po CockcroftGaultovi formuli pred vsakim zdravljenjem z zdravilom Aclasta, o kontraindikacija pri bolnikih z očistkom kreatinina < 35 ml/min, o kontraindikacije med nosečnostjo in dojenjem zaradi možne teratogenosti, o potrebo po zagotovitvi primerne hidriranosti bolnika, zlasti v primeru starejših bolnikov in bolnikov, ki prejemajo diuretično terapijo, o potrebnost počasnega infundiranja zdravila Aclasta v času, ki ni krajši od 15 minut, o shemo odmerjanja enkrat letno, o priporočilo o zadostnem vnosu kalcija in vitamina D v zvezi z uporabo zdravila Aclasta, o potrebnost ustrezne telesne dejavnosti in zdrave prehrane ter odsotnosti kajenja;
English: The incidence of clinical fractures, including vertebral, non-vertebral and hip fractures, was evaluated in 2,127 men and women aged 50-95 years (mean age 74.5 years) with a recent (within 90 days) low-trauma hip fracture who were followed for an average of 2 years on study treatment (Aclasta).
Slovenian: Incidenco kliničnih zlomov, vključno z zlomi vretenc, nevretenčnimi zlomi in zlomi kolka, so vrednotili pri 2.127 moških in ženskah, starih 50-95 let (povprečna starost 74,5 let) z nedavnim (v okviru 90 dni) zlomom kolka po lažji poškodbi, ki so jih opazovali povprečno 2 leti med zdravljenjem s študijskim zdravilom Aclasta.
English: All patients were required to receive background therapy of vitamin D and calcium.
Slovenian: Vsi bolniki so morali kot osnovno zdravljenje jemati vitamin D in kalcij.
English: In patients treated with Aclasta, no osteomalacia, marrow fibrosis or woven bone formation was detected.
Slovenian: Pri bolnicah, ki so se zdravile z zdravilom Aclasta, niso odkrili osteomalacije, fibroze kostnega mozga ali tvorbe retikularne kostnine.
English: Approximately 42% of patients had a femoral neck BMD T-score below -2.5 and approximately 45% of the patients had a femoral neck BMD T-score above -2.5.
Slovenian: Približno 42 % bolnikov je imelo vrednost T mineralne gostote kosti vratu stegnenice pod -2,5 in približno 45 % bolnikov je imelo vrednost T mineralne gostote kosti vratu stegnenice nad -2,5.
English: Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/l) occurred in 2.3% of Aclasta-treated patients in a large clinical trial compared to 21% of Aclasta-treated patients in the Paget's disease trials.
Slovenian: Na podlagi laboratorijskih preiskav so ugotovili, da je do prehodnega asimptomatskega znižanja koncentracij kalcija pod okvir normalnih referenčnih vrednosti (pod 2,10 mmol/l) prišlo pri 2,3 % bolnikov, ki so prejemali zdravilo Aclasta v obsežnem kliničnem preskušanju, v primerjavi z 21 % pri bolnikih, ki so prejemali zdravilo Aclasta v preskušanjih zdravljenja Pagetove bolezni.
English: The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75  33% of the creatinine clearance, which showed a mean of 84  29 ml/min (range 22 to 143 ml/min) in the 64 patients studied.
Slovenian: Ledvični očistek je znašal 75  33 % očistka kreatinina, ki je pri 64 proučevanih bolnikih pokazal srednjo vrednost 84  29 ml/min (obseg 22 do 143 ml/min).
English: In clinical trials in osteoporosis, the change in creatinine clearance (measured annually prior to dosing) and the incidence of renal failure and impairment was comparable for both the Aclasta and placebo treatment groups over three years.
Slovenian: V kliničnih preskušanjih pri osteoporozi sta bili v treh letih sprememba očistka kreatinina (ki so jo merili enkrat letno pred odmerjanjem) in incidenca odpovedi ter okvare ledvic primerljivi med skupinama z zdravilom Aclasta in s placebom.
English: • Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of Aclasta.
Slovenian: • Pred odmerjanjem zdravila Aclasta morajo biti bolniki, zlasti starejši in tisti, ki jemljejo diuretike, primerno hidrirani.
English: Aclasta is not recommended in women of childbearing potential.
Slovenian: Uporaba zdravila Aclasta ni priporočena pri ženskah v rodni dobi.
English: If you are considering stopping Aclasta treatment, please go to your next appointment and discuss this with your doctor.
Slovenian: Če nameravate prenehati z zdravljenjem z zdravilom Aclasta, se pri naslednjem pregledu o tem pogovorite z zdravnikom.
English: Before stopping Aclasta therapy
Slovenian: Preden prenehate prejemati zdravilo Aclasta
English: Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given Aclasta.
Slovenian: Skrbno se ravnajte po vseh navodilih zdravnika, farmacevta ali medicinske sestre, preden vam dajo zdravilo Aclasta.
English: Microcomputed tomography (μCT) analysis demonstrated increased trabecular bone volume and preservation of trabecular bone architecture in patients treated with Aclasta compared to placebo.
Slovenian: Analiza s pomočjo mikroračunalniške tomografije (μCT) je pokazala povečan volumen trabekularne kostnine in ohranjeno trabekularno strukturo kosti pri bolnicah, ki so se zdravile z zdravilom Aclasta, v primerjavi s tistimi, ki so prejemale placebo.
English: Clinical efficacy in the treatment of post-menopausal osteoporosis (PFT)
Slovenian: Klinična učinkovitost pri zdravljenju postmenopavzalne osteoporoze (PFT)
English: The efficacy and safety of Aclasta in the treatment and prevention of osteoporosis associated with long-term systemic glucocorticoid therapy were assessed in a randomised, multicentre, double-blind, stratified, active-controlled study of 833 men and women aged 18-85 years (mean age for men 56.4 years; for women 53.5 years) treated with > 7.5 mg/day oral prednisone (or equivalent).
Slovenian: Učinkovitost in varnost zdravila pri zdravljenju in preprečevanju osteoporoze, do katere pride zaradi dolgotrajnega zdravljenja s sistemskimi glukokortikoidi, so ocenjevali v randomizirani, multicentrični, dvojno slepi, stratificirani, aktivno kontrolirani študiji z 833 moškimi in ženskami, starimi od 18 do 85 let (s povprečno starostjo 56,4 leta pri moških in 53,5 let pri ženskah), ki so peroralno jemali več kot 7,5 mg prednizona na dan (ali ekvivalent).
English: It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Aclasta, as directed by your healthcare provider.
Slovenian: Pomembno je, da v nekaj urah pred prejemom zdravila Aclasta popijete vsaj 2 kozarca tekočine (na primer vode), kakor vam naroči zdravstveni delavec, s katerim sodelujete.
English: You must not be given Aclasta: - if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Zdravila Aclasta ne smete dobiti - če ste alergični na zoledronsko kislino, druge difosfonate ali katero koli sestavino tega zdravila
English: It comes in 100 ml plastic bottles as a ready-to-use solution for infusion.
Slovenian: Pakirana je v 100-mililitrskih plastičnih steklenicah v obliki raztopine za infundiranje, pripravljene za uporabo.
English: The incidence of these reactions decreased markedly with subsequent annual doses of Aclasta.
Slovenian: Incidenca teh učinkov je izrazito upadla pri naslednjih letnih odmerjanjih zdravila Aclasta.
English: Uncommon (may affect up to 1 in 100 people) Swelling, redness, pain and itching to the eyes or eye sensitivity to light.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) otekanje, rdečina, bolečina in srbenje v očeh ali povečana občutljivost oči za svetlobo
English: Patients being treated with Aclasta should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Slovenian: Bolniki, ki prejemajo zdravilo Aclasta, ne smejo sočasno prejemati omenjenih zdravil oziroma katerega od drugih difosfonatov, saj ni znano, kako navedena zdravila delujejo v kombinaciji.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml vial of Aclasta, i.e., essentially “sodium free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100-mililitrsko vialo zdravila Aclasta, kar v bistvu pomeni “brez natrija”.
English: Aclasta treatment rapidly reduced the rate of bone turnover from elevated post-menopausal levels with the nadir for resorption markers observed at 7 days, and for formation markers at 12 weeks.
Slovenian: Zdravljenje z zdravilom Aclasta je hitro znižalo stopnjo pregradnje kosti z zvišanih postmenopavzalnih vrednosti; koncentracije označevalcev resorpcije so bile najnižje po 7 dneh, koncentracije označevalcev nastajanja kosti pa po 12 tednih.
English: At 24 months a similar significant increase of 3.6% in total hip BMD was observed for patients treated with Aclasta as compared to the effects observed in post-menopausal women in the HORIZON-PFT study.
Slovenian: Po 24 mesecih so pri bolnikih, ki so prejemali zdravilo Aclasta, opažali pomembno 3,6-odstotno povečanje mineralne gostote kosti celotnega kolka, kar je podobno učinkom, ki so jih opažali pri postmenopavzalnih ženskah v študiji HORIZON-PFT.
English: A randomised, double-blind, placebo-controlled study was conducted in paediatric patients aged 5 to 17 years treated with glucocorticoids who had decreased bone mineral density (lumbar spine BMD Zscore of -0.5 or less) and a low impact/fragility fracture.
Slovenian: Randomizirano, dvojno slepo in s placebom kontrolirano študijo so izvedli pri pediatričnih bolnikih v starosti od 5 do 17 let, ki so prejemali glukokortikoide in so imeli zmanjšano mineralno gostoto kosti (vrednost Z mineralne gostote kosti ledvene hrbtenice -0,5 ali manj) in zlom ob majhni poškodbi oziroma zaradi krhkosti kosti.
English: Women who were evaluated for the incidence of vertebral fractures did not receive concomitant osteoporosis therapy, which was allowed for women contributing to the hip and all clinical fracture evaluations.
Slovenian: Ženske, ki so jih pregledovali glede zlomov vretenc, niso sočasno prejemale zdravil za zdravljenje osteoporoze, ki so jih sicer lahko prejemale tiste ženske, ki so jih pregledovali samo glede zlomov kolka in kliničnih zlomov.
English: Other disturbances of mineral metabolism must also be effectively treated (e.g. diminished parathyroid reserve, intestinal calcium malabsorption).
Slovenian: Učinkovito je treba zdraviti tudi druge motnje presnove elektrolitov (kot sta zmanjšano delovanje obščitnic in okvarjena absorpcija kalcija v črevesju).
English: Re-treatment consists of an additional intravenous infusion of 5 mg Aclasta after an interval of one year or longer from initial treatment in patients who have relapsed.
Slovenian: Ponovno zdravljenje Pagetove bolezni kosti pomeni dodatno intravensko infuzijo zdravila Aclasta 5 mg eno leto ali več po začetnem zdravljenju bolnikov, pri katerih pride do ponovitve bolezni.
English: More patients reported serious adverse events in the zoledronic acid group than in the placebo group (5 [27.8%] patients versus 1 [6.3%] patient).
Slovenian: O resnih neželenih dogodkih je poročalo več bolnikov iz skupine z zoledronsko kislino kot iz skupine s placebom (5 bolnikov [27,8 %] v primerjavi z 1 bolnikom [6,3 %]).
English: Ask your doctor, pharmacist or nurse for advice before taking this medicine.
Slovenian: Posvetujte se z zdravnikom, s farmacevtom ali z medicinsko sestro, preden vzamete to zdravilo.
English: Aclasta 5 mg solution for infusion zoledronic acid
Slovenian: Aclasta 5 mg raztopina za infundiranje zoledronska kislina
English: In patients with a recent low-trauma hip fracture, it is recommended to give the Aclasta infusion at least two weeks after hip fracture repair (see section 5.1).
Slovenian: Pri bolnikih z nedavnim zlomom kolka po lažji poškodbi je pripročeno dati infuzijo zdravila Aclasta najmanj dva tedna po oskrbi zloma kolka (glejte poglavje 5.1).
English: Aclasta-treated patients aged 75 years and older exhibited a 60% reduction in the risk of vertebral fractures compared to placebo patients (p<0.0001).
Slovenian: Pri bolnikih, ki so bili stari 75 let ali starejši in so prejemali zdravilo Aclasta, je bilo tveganje za zlome vretenc za 60 % manjše v primerjavi z bolniki, ki so prejemali placebo (p<0,0001).
English: The efficacy and safety of Aclasta 5 mg once a year for 3 consecutive years were demonstrated in post-menopausal women (7,736 women aged 65-89 years) with either: a femoral neck bone mineral density (BMD) with a T-score ≤ -1.5 and at least two mild or one moderate existing vertebral fracture(s); or a femoral neck BMD T-score ≤ -2.5 with or without evidence of existing vertebral fracture(s).
Slovenian: Učinkovitost in varnost zdravila Aclasta 5 mg na leto 3 leta zapored so dokazali pri postmenopavzalnih ženskah (7.736 ženskah, starih 65-89 let), ki so imele: bodisi vrednost T mineralne gostote kosti vratu stegnenice ≤ -1,5, pri tem pa prisotna vsaj dva manjša zloma ali en srednje hud zlom vretenca, ali pa vrednost T mineralne gostote kosti vratu stegnenice ≤ -2,5 z znaki prisotnega enega ali več zlomov vretenc ali brez njih.
English: Not known (frequency cannot be estimated from the available data) Severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the face and throat, decreased blood pressure, dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea.
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) hude alergijske reakcije, vključno z omotičnostjo in oteženim dihanjem, otekanje predvsem v obraz in grlo oziroma žrelo, znižan krvni tlak, dehidracija zaradi simptomov po odmerjanju, kot so zvišana telesna temperatura, bruhanje in diareja
English: No statistically significant differences in total body bone mineral content were observed between patients treated with zoledronic acid versus placebo at 6 or 12 months.
Slovenian: Po 6 in po 12 mesecih niso opažali statistično značilnih razlik celotne telesne mineralne gostote kosti (total body bone mineral content) med bolniki, ki so prejemali zoledronsko kislino, in tistimi, ki so prejemali placebo.
English: In the trial for the prevention of clinical fractures following a recent hip fracture, vitamin D levels were not routinely measured but the majority of patients received a loading dose of vitamin D prior to Aclasta administration (see section 4.2).
Slovenian: V preskušanju preventive kliničnih zlomov po nedavnem zlomu kolka niso rutinsko merili koncentracij vitamina D, vendar je večina bolnikov pred aplikacijo zdravila Aclasta prejela večji začetni odmerek vitamina D (glejte poglavje 4.2).
English: Aclasta works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.
Slovenian: Zdravilo Aclasta deluje tako, da normalizira proces kostne pregradnje, omogoči tvorbo normalne kostnine in tako kostem povrne čvrstost.
English: Follow carefully all instructions given to you by your doctor or nurse.
Slovenian: Pri uporabi zdravila natančno upoštevajte navodila, ki vam jih da zdravnik ali medicinska sestra.
English: The MAH shall ensure that the educational programme implemented for the authorised indications of treatment of osteoporosis in post-menopausal women and in men at increased risk of fracture, including those with a recent low-trauma hip fracture, and treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture is updated.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo izobraževalni program, ki ga je izvajal za odobrene indikacije zdravljenja osteoporoze pri postmenopavzalnih ženskah in pri moških s povečanim tveganjem za zlome, vključno s tistimi z nedavnim zlomom kolka po lažji poškodbi, in zdravljenja osteoporoze zaradi dolgotrajnega zdravljenja s sistemskimi glukokortikoidi pri postmenopavzalnih ženskah in pri moških, pri katerih obstaja povečano tveganje za zlom, posodobljen.
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, non-healing of sores or discharge during treatment with zoledronic acid.
Slovenian: Vsem bolnikom je treba naročiti, naj v času zdravljenja z zoledronsko kislino skrbijo za dobro ustno higieno in redno hodijo na preglede k zobozdravniku, v primeru simptomov v ustni votlini, kot so majavost zob, bolečine, otekline, slabo celjenje ustnih razjed ali vnetje, pa naj takoj obvestijo zdravnika.
English: Efficacy was demonstrated if non-inferiority to risedronate was shown sequentially with respect to the percentage change in lumbar spine BMD at 12 months relative to baseline in the treatment and prevention subpopulations, respectively.
Slovenian: Učinkovitost je bila dokazana, če se je pokazalo, da zdravilo Aclasta ni bilo slabše od risedronata glede odstotne spremembe mineralne gostote kosti ledvene hrbtenice po 12 mesecih v primerjavi z izhodiščno vrednostjo, in sicer posebej v podskupini za zdravljenje in posebej v podskupini za preprečevanje osteoporoze.
English: Aclasta is supplied in packs containing one bottle as unit pack, or in multipacks comprising five packs, each containing one bottle.
Slovenian: Zdravilo Aclasta je na voljo v škatlah, ki vsebujejo po eno steklenico kot posamično pakiranje ali skupno pakiranje s petimi škatlami po eno steklenico.
English: • Aclasta should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5).
Slovenian: • Pri sočasni uporabi zdravila Aclasta z drugimi zdravili, ki lahko vplivajo na delovanje ledvic, je potrebna previdnost (glejte poglavje 4.5).
English: For osteoporosis, Aclasta works for one year.
Slovenian: Za zdravljenje osteoporoze deluje zdravilo Aclasta eno leto.
English: 2D barcode carrying the unique identifier included.
Slovenian: Vsebuje dvodimenzionalno črtno kodo z edinstvenio oznako.