FrancophonIA/ELRC3.0 huggingface dataset:
English: X-ray changes from baseline were then rated using the Radiographic Global Impression of Change rating scale as follows: -3=severe worsening, -2=moderate worsening, -1=minimal worsening, 0=no change, +1=minimal healing, +2=substantial healing, +3= near-complete or complete healing.
Slovenian: Radiološke spremembe od izhodišča so ocenjevali s pomočjo Lestvice radiografskega globalnega vtisa sprememb RGI-C (Radiographic Global Impression of Change), kot sledi: -3=resno poslabšanje, -2=zmerno poslabšanje, -1=minimalno poslabšanje, 0=ni spremembe, +1=minimalno celjenje, +2=znatno celjenje, +3=skoraj popolno ali popolno celjenje.
English: • Each vial is for single use and should only be punctured once.
Slovenian: • Ena viala je samo za enkratno uporabo in jo je dovoljeno le enkrat prebosti.
English: Injections sites should be rotated and carefully monitored for signs of potential reactions (see section 4.4).
Slovenian: Mesta injiciranja je treba menjavati in skrbno spremljati znake možnih reakcij (glejte poglavje 4.4).
English: cellulitis, scar, mass, extravasation, exfoliation and vesicles) are the most common adverse reactions observed in about 74% of the patients in clinical studies.
Slovenian: celulitisom, brazgotino, tvorbo, ekstravazacijo, eksfoliacijo in mehurčki na mestu injiciranja) so najpogostejši neželeni učinki, ki so jih v kliničnih študijah opazili pri približno 74 % bolnikov.
English: Your doctor, pharmacist or nurse will advise you on how you can obtain a sharps container.
Slovenian: Zdravnik, farmacevt ali medicinska sestra vam bodo svetovali, kje dobiti vsebnik za ostre odpadke.
English: This will help seal the punctured tissue and prevent any leakage.
Slovenian: To bo zatesnilo preluknjano tkivo in preprečilo izcejanje.
English: The impact of immunogenicity on asfotase alfa pharmacokinetic varied over time due to the time varying nature of immunogenicity and overall was estimated to decrease pharmacokinetic exposures by less than 20%.
Slovenian: Vpliv imunogenosti na farmakokinetiko asfotaze alfa je s časom nihal, ker tudi imunogenost s časom niha, celokupno pa je bilo ocenjeno, da farmakokinetično izpostavljenost zmanjša za manj kot 20 %.
English: Study ENB-010-10 was a controlled open-label study in 69 patients, aged 1 day to 72 months, with perinatal/infantile-onset HPP.
Slovenian: Študija ENB-010-10 je bila kontrolirana odprta študija pri 69 bolnikih, starih od 1 dan do 72 mesecev, s perinatalnim/infantilnim začetkom HPP.
English: Vial type used for injection
Slovenian: Vrsta viale, ki se uporablja za injekcijo
English: • Information on cold chain management for Strensiq during storage and travel
Slovenian: • informacije o zagotavljanju nepretrgane hladne verige za zdravilo Strensiq med shranjevanjem in potovanjem,
English: Most injection site reactions were mild and selflimiting, and the majority (> 99%) were reported as non-serious.
Slovenian: Največ reakcij na mestu injiciranja je bilo blagih in so izzvenele brez zdravljenja, o večini reakcij na mestu injiciranja (> 99 %) pa so poročali kot o neresnih.
English: Most of these reactions were non-serious, mild to moderate in intensity.
Slovenian: Reakcije so bile večinoma neresne in blage do zmerne po intenzivnosti.
English: Patients with hypophosphatasia have low levels of an enzyme called alkaline phosphatase that is important for various body functions, including the proper hardening of bones and teeth.
Slovenian: Bolniki s hipofosfatazijo imajo nizke ravni encima, imenovanega alkalna fosfataza, ki je pomemben za različne telesne funkcije, vključno s pravilno trdoto kosti in zob.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Strensiq in one or more subsets of the paediatric population in hypophosphatasia (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Strensiq za eno ali več podskupin pediatrične populacije za hipofosfatazijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The improvement in rickets severity was maintained for at least 72 months of follow-up treatment (including at least 84 months in 4 patients), as measured by the RGI C.
Slovenian: Izboljšanje izraženosti rahitisa je trajalo vsaj 72 mesecev nadaljevalnega zdravljenja (vključno z vsaj 84 meseci pri 4 bolnikih), izmerjeno z RGI C.
English: No animal studies have been conducted to evaluate the genotoxic and carcinogenic potential of asfotase alfa.
Slovenian: Študij na živalih za ocenitev genotoksičnosti in kancerogenega potenciala asfotaze alfa niso izvedli.
English: Preclinical fertility studies were conducted and showed no evidence of effect on fertility and embryo-fetal development.
Slovenian: Izvedli so predklinične študije plodnosti, ki niso pokazale dokazov o vplivu na plodnost in razvoj zarodka in plodu.
English: Age at inclusion was from 13 to 66 years and was between 17 and 72 years at study completion.
Slovenian: Starost ob vključitvi je bila od 13 do 66 let, ob zaključku študije pa od 17 do 72 let.
English: • Detailed description on how Strensiq is injected using aseptic techniques
Slovenian: • natančen opis načina injiciranja zdravila Strensiq z uporabo aseptične tehnike,
English: Patients received STRENSIQ at 6 mg/kg per week for the first 4 weeks.
Slovenian: Bolniki so prejemali zdravilo STRENSIQ v odmerku 6 mg/kg na teden prve 4 tedne.
English: After removing the bubbles, check the dose of medication in the syringe to be sure you have drawn up the correct amount.
Slovenian: Potem, ko odstranite mehurčke, preverite odmerek zdravila v brizgi in se prepričajte, da je v brizgi pravilna količina zdravila.
English: Improvements in median RGI-C were maintained over the course of treatment, which ranged from 0.9 to 302.3 weeks, even if fewer patients were followed after Week 96 (a total of 29 patients were followed after Week 96 and ≤8 patients after Week 192).
Slovenian: Izboljšanja medianega RGIC so trajala ves čas zdravljenja z razponom od 0,9 do 302,3 tedna, tudi če so po 96. tednu sledili manj bolnikom (po 96. tednu so sledili skupaj 29 bolnikom, po 192. tednu pa ≤ 8 bolnikom).
English: The absolute bioavailability after the first and third subcutaneous administration ranged from 45.8 to 98.4%, with median Tmax ranging between 24.2 to 48.1 hours.
Slovenian: Absolutna biološka razpoložljivost po prvem in tretjem subkutanem dajanju je bila v območju od 45,8 do 98,4 %, mediani Tmax pa v območju od 24,2 do 48,1 ure.
English: The majority of the patients who received asfotase alfa moved to scores of +2 and +3 over the first 6 months of exposure and this was sustained with on-going treatment.
Slovenian: Večina bolnikov, ki so prejemali asfotazo alfa, se je premaknila na oceni +2 in +3 v prvih 6 mesecih izpostavljenosti, kar se je ohranilo med trajanjem zdravljenja.
English: Remove the plastic cap covering the syringe needle.
Slovenian: Odstranite plastični pokrovček, ki pokriva iglo brizge.
English: 11 patients were enrolled in the initial study and 10 patients entered the extension study, with 9 patients completing the extension study.
Slovenian: Enajst bolnikov je bilo vključenih v začetno študijo, 10 bolnikov pa v podaljšano študijo, od katerih je 9 bolnikov dokončalo podaljšano študijo.
English: Pull the cap straight off the needle.
Slovenian: Pokrovček potegnite naravnost dol z igle.
English: Body Weight (kg)
Slovenian: Telesna masa (kg)
English: If the decision is made to re-administer the product, the re-challenge should be made under medical supervision and consideration may be given to use of appropriate pre-medication.
Slovenian: Ob odločitvi za ponovno uporabo zdravila je treba ponovno uporabo izvesti pod zdravniškim nadzorom in razmisliti je treba o ustreznem predzdravljenju.
English: What is hypophosphatasia
Slovenian: Kaj je hipofosfatazija
English: What you need to know before you use Strensiq Do not use Strensiq
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Strensiq Ne uporabljajte zdravila Strensiq
English: For handling of the medicinal product before administration, see section 6.6.
Slovenian: Za informacije o ravnanju z zdravilom pred dajanjem glejte poglavje 6.6.
English: Pharmacokinetic data from all asfotase alfa clinical trials were analysed using population pharmacokinetic methods.
Slovenian: Farmakokinetični podatki iz vseh kliničnih preskušanj z asfotazo alfa so bili analizirani s populacijskimi farmakokinetični metodami.
English: If you need a second injection for your prescribed dose, get another Strensiq vial and repeat steps 1 through 4.
Slovenian: Če za svoj predpisani odmerek potrebujete še eno injekcijo, vzemite še eno vialo zdravila Strensiq in ponovite 1. do 4. korak.
English: Five patients presented with symptoms of hypophosphatasia before 6 months age and 8 patients presented after 6 months age.
Slovenian: Pet bolnikov je imelo simptome hipofosfatazije pred 6 meseci starosti in 8 bolnikov jih je imelo po 6 mesecih starosti.
English: Patients have problems with bone growth and strength, which can lead to broken bones, bone pain, and difficulty walking, as well as difficulties with breathing and a risk of seizures (fits).
Slovenian: Bolniki imajo težave z rastjo in čvrstostjo kosti, kar lahko povzroči kostne zlome, bolečine v kosteh in težave s hojo, pa tudi težave z dihanjem in tveganje za epileptične napade (konvulzije).
English: Take the unopened Strensiq vial(s) out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature.
Slovenian: Iz hladilnika vzemite eno ali več neodprtih vial zdravila Strensiq 15 do 30 minut pred injiciranjem, s čimer boste omogočili tekočini, da se bo segrela na sobno temperaturo.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah,
English: Among 109 hypophosphatasia patients enrolled in the clinical studies and who have post baseline antibody data available, 97/109 (89.0%) tested positive for anti-drug antibodies at some time point after starting Strensiq treatment.
Slovenian: Med 109 bolniki s hipofosfatazijo, vključenimi v klinične študije, pri katerih so na voljo podatki o protitelesih po izhodišču, je pri 97/109 (89,0 %) test pokazal, da so bili v eni časovni točki po začetku zdravljenja z zdravilom Strensiq pozitivni za protitelesa proti zdravilu.
English: The most common adverse reactions observed were injection site reactions and injection-associated adverse reactions.
Slovenian: Najpogostejši neželeni učinki, ki so jih opazili, so bile reakcije na mestu injiciranja in neželene reakcije, povezane z injiciranjem.
English: Pregnancy and breast-feeding Strensiq should not be used during pregnancy or breast-feeding unless medically necessary.
Slovenian: Nosečnost in dojenje Zdravila Strensiq ne smete uporabljati med nosečnostjo ali dojenjem, razen če je to potrebno zaradi zdravstvenih razlogov.
English: The reactions occurred within minutes after taking asfotase alfa, and can occur in patients who were taking asfotase alfa for more than one year.
Slovenian: Do teh reakcij je prišlo v času nekaj minut po jemanju asfotaze alfa, lahko pa se pojavijo tudi pri bolnikih, ki jemljejo asfotazo alfa več kot eno leto.
English: Injection recommendations
Slovenian: Priporočila za injiciranje
English: Store in the original pack in order to protect from light.
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: The onset of hypophosphatasia was under 6 months in 4 patients, between 6 months and 17 years in 14 patients, and over 18 years in one patient.
Slovenian: Pri 4 bolnikih je hipofosfatazija nastopila pri manj kot 6 mesecih, pri 14 bolnikih je nastopila med 6 meseci in 17 leti in pri 1 bolniku pri več kot 18 letih.
English: 1 vial of 0.3[0.45; 0.7; 1] ml 12 vials of 0.3[0.45; 0.7; 1] ml
Slovenian: 1 viala z 0,3[0,45; 0,7; 1] ml 12 vial z 0,3[0,45; 0,7; 1] ml
English: What Strensiq is and what it is used for What you need to know before you use Strensiq How to use Strensiq
Slovenian: Kaj je zdravilo Strensiq in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Strensiq Kako uporabljati zdravilo Strensiq
English: The pharmacokinetic variables characterized by population pharmacokinetic analysis represent the overall hypophosphatasia patient population with age range from 1 day to 66 years, subcutaneous doses of up to 28 mg/kg/week and a range of disease onset cohorts.
Slovenian: Farmakokinetične spremenljivke, ki jih karakterizira populacijska farmakokinetična analiza, predstavljajo celokupno populacijo bolnikov s hipofosfatazijo z razponom starosti od 1 dneva do 66 let, subkutanimi odmerki do 28 mg/kg/teden in kohortami območja nastopa bolezni.
English: If more than 1 ml is required, multiple injections may be administered at the same time.
Slovenian: Če je treba dati več kot 1 ml, se lahko sočasno da več injekcij.
English: Disproportionate weight gain Patients may display disproportionate weight increase.
Slovenian: Nesorazmerno povečanje telesne mase Pri bolniku se lahko telesna masa nesorazmerno poveča.
English: At last assessment (n = 10, 9 of whom had at least 72 months of treatment), median Z-score improvements from baseline were 1.93 for length/height and 2.43 for weight.
Slovenian: Ob zadnjem ocenjevanju (N=10, od katerih se jih je 9 zdravilo vsaj 72 mesecev), je bilo mediano izboljšanje vrednosti Z od izhodišča 1,93 za dolžino/višino in 2,43 za telesno maso.
English: In the clinical trial setting, the majority of patients who experienced an injection site reaction had the first occurrence within the first 12 weeks of treatment with asfotase alfa, and some patients continued to experience injection site reactions until 1 or more years after initiating asfotase alfa dosing.
Slovenian: V okviru kliničnega preskušanja se je večini bolnikov, ki so imeli reakcijo na mestu injiciranja, ta prvič pojavila v prvih 12 tednih zdravljenja z asfotazo alfa, nekateri bolniki pa so imeli reakcije na mestu injiciranja eno ali več let po začetku odmerjanja asfotaze alfa.
English: However, in pregnant rabbits administered intravenous doses of up to 50 mg/kg/day asfotase alfa, anti-drug antibodies were detected in up to 75% of animals which could affect the detection of reproductive toxicity.
Slovenian: Vendar pa so pri brejih samicah kuncev, ki so jim dali intravenske odmerke asfotaz alfa do 50 mg/kg/dan, zaznali protitelesa proti zdravilu pri do 75 % živali, kar lahko vpliva na zaznavanje toksičnosti za reprodukcijo.
English: • The correct dose will be calculated by your doctor and consists of a total of 6 mg of asfotase alfa per kg of body weight every week, administered by injection under the skin (subcutaneous), (see the dosing chart below for detailed information on the volume to be injected, and the type of vials to be used, based on your weight).
Slovenian: • Pravilni odmerek bo zdravnik izračunal in vsebuje skupaj 6 mg asfotaze alfa na kg telesne mase vsak teden, dan v obliki podkožne (subkutane) injekcije (glejte razpredelnico odmerjanja v nadaljevanju glede natančnih podatkov o volumnu, ki ga je treba vbrizgati, in vrsti vial, ki jo je treba uporabiti, na podlagi vaše telesne mase).
English: Strensiq is for subcutaneous use only.
Slovenian: Zdravilo Strensiq je samo za subkutano uporabo.
English: Patients are advised to follow proper injection technique and to rotate injection sites (see section 4.2).
Slovenian: Bolnikom se priporoča, da uporabljajo pravilno tehniko injiciranja in da menjujejo mesta injiciranja (glejte poglavje 4.2).
English: Tetracycline for bone-labelling was administered in two 3-day courses (separated by a 14-day interval) prior to acquisition of the bone biopsy.
Slovenian: Tetraciklin za označevanje kosti je bil dan v dveh 3-dnevnih ciklih (med katerima je bil 14-dnevni interval) pred odvzemom biopsije kosti.
English: The need for supervision for subsequent administrations and need for emergency treatment for home care should be at the discretion of the treating physician.
Slovenian: O potrebi po zdravniškem nadzoru ob naslednjih dajanjih zdravila in o zdravljenju v urgentnih primerih pri oskrbi na domu naj presodi lečeči zdravnik.
English: 2 years
Slovenian: 6 mesecih.
English: Consider the risks and benefits of re-administering Strensiq to individual patients following a severe reaction, taking other factors into account that may contribute to the risk of a hypersensitivity reaction, such as concurrent infection and/ or use of antibiotics.
Slovenian: Pred ponovnim dajanjem zdravila Strensiq posameznim bolnikom po resni reakciji pretehtajte razmerje med koristmi in tveganji zdravila, pri čemer upoštevajte tudi druge dejavnike, ki bi lahko prispevali k tveganju za preobčutljivostno reakcijo, kot sta sočasna okužba in/ali uporaba antibiotikov.
English: Step 1: Preparing the Strensiq dose 1.
Slovenian: 1. korak: Priprava odmerka zdravila Strensiq 1.
English: Patients received a median duration of treatment of 27.6 month (range from 1 day to 90 months).
Slovenian: Bolniki so prejeli mediano trajanje zdravljenja 27,6 meseca (razpon od 1 dneva do 90 mesecev).
English: The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
Slovenian: Volumen injekcijske brizge mora biti dovolj majhen, da omogoča natančen odvzem predpisanega odmerka iz viale.
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov proizvajalca biološke učinkovine Lonza Biologics
English: • Increase of parathyroid hormone concentration and low calcium levels have been reported in studies.
Slovenian: • V študijah so poročali o zvišanju koncentracije obščitničnega hormona in nizkih ravneh kalcija.
English: For the time period of observation of historical controls: 1/16 patients displayed apparent catch-up heightgain, 12/16 patients did not display apparent catch-up height-gain and data were inconclusive in 3/16 patients.
Slovenian: Za obdobje opazovanja zgodovinskih kontrolnih podatkov: pri 1 od 16 bolnikov se je pokazalo navidezno dohitevanje v pridobivanju višine, pri 12 od 16 bolnikov se ni pokazalo navidezno dohitevanje v pridobivanju višine in za 3 od 16 bolnikov podatki niso dovoljevali sklepanja.
English: • Instruction on how the injection site is chosen and how the injection is carried out and recorded
Slovenian: • navodila o izbiri injekcijskega mesta in o izvedbi ter beleženju injiciranja,
English: Asfotase alfa is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Uporaba asfotaze alfa ni priporočljiva pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: 69 patients completed the studies, and 11 discontinued.
Slovenian: bolnikov dokončalo študiji, 11 pa ju je prekinilo.
English: How to inject Strensiq:
Slovenian: Kako injicirati zdravilo Strensiq:
English: Holding the syringe like a pencil or a dart, insert the needle into the raised skin so it is at an angle of between 45º and 90º to the skin surface.
Slovenian: Injekcijsko brizgo držite kot svinčnik ali puščico za pikado in iglo vstavite v privzdignjeno kožo tako, da je njen kot na površino kože med 45° in 90°.
English: In adult patients with pediatric-onset HPP, the pharmacokinetics of asfotase alfa at doses of 0.5, 2 and 3 mg/kg administered three times per week was consistent with those observed in pediatric patients with pediatric-onset HPP, and thus supported the approved dose of 6 mg/kg per week in treating adult patients with pediatric-onset HPP.
Slovenian: Pri odraslih bolnikih s pediatričnim nastopom HPP se je farmakokinetika asfotaze alfa v odmerkih po 0,5, 2 in 3 mg/kg, danih trikrat na teden, ujemala s tisto, ki so jo ugotovili pri pediatričnih bolnikih s pediatričnim nastopom HPP, s čimer je podprla odobreni odmerek 6 mg/kg na teden za zdravljenje odraslih bolnikov s pediatričnim nastopom HPP.
English: Strensiq has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Strensiq nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: The treating physician should inform the testing lab that the patient is treated with medication affecting the ALP levels.
Slovenian: Lečeči zdravnik mora obvestiti laboratorij, ki izvaja testiranje, da se bolnik zdravi z zdravilom, ki vpliva na ravni AF.
English: Based on its structure and pharmacokinetics, asfotase alfa is unlikely to affect Cytochrome P-450 related metabolism.
Slovenian: Na podlagi svoje strukture in farmakokinetike ni verjetno, da bi asfotaza alfa vplivala na presnovo, povezano s citokromom P-450.
English: • This total dose can be given either as an injection of 1 mg/kg asfotase alfa 6 times per week or as 2 mg/kg asfotase alfa 3 times per week depending on the recommendation of your doctor.
Slovenian: • Ta skupni odmerek se da kot injekcija 1 mg/kg asfotaze alfa 6-krat na teden ali kot 2 mg/kg asfotaze alfa 3-krat na teden, odvisno od priporočila zdravnika.
English: Do not rub the injection site after injection.
Slovenian: Mesta injiciranja po injiciranju ne drgnite.
English: Table 1: Adverse Reactions Reported in clinical trials in hypophosphatasia patients (age 1 day to 66 years, treatment duration range from 1 day to 391 weeks [7.5 years])
Slovenian: Preglednica 1: Neželeni učinki, o katerih so poročali v kliničnih preskušanjih z bolniki s hipofosfatazijo (starimi 1 dan do 66 let), razpon trajanja zdravljenja od 1 dneva do 391 tednov [7,5
English: Only clear and colourless to slightly yellow aqueous solution without visible signs of deterioration should be used.
Slovenian: Uporabljate lahko le bistro in brezbarvno do rahlo rumenkasto vodno raztopino brez vidnih znakov kvarjenja.
English: Craniosynostosis as a manifestation of hypophosphatasia is documented in published literature and occurred in 61.3% of patients between birth and 5 years of age in a natural history study of untreated infantile-onset hypophosphatasia patients.
Slovenian: Kraniosinostoza kot manifestacija hipofosfatazije je dokumentirana v objavljeni literaturi in se je pojavila pri 61,3 % bolnikov med rojstvom in 5. letom starosti v študiji naravnega poteka bolezni pri bolnikih z nezdravljeno hipofosfatazijo z zgodnjim nastopom.
English: For those patients who received asfotase alfa: 11/13 patients displayed persistent apparent catch-up heightgain as shown by movement over time to a higher percentile on CDC growth charts.
Slovenian: Za bolnike, ki so prejemali asfotazo alfa: 11 od 13 bolnikov je kazalo vztrajno navidezno dohitevanje pridobivanja višine, kot prikazuje gibanje v času, do višjih percentil na tablicah rasti CDC.
English: Push the plunger in completely to inject the air into the vial.
Slovenian: Potisnite bat noter do konca, da boste vbrizgali zrak v vialo.
English: • Instructions on the correct dose to be administered
Slovenian: • navodila o pravilnem odmerku, ki naj ga prejema bolnik,
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: Znotraj vsake skupine pogostnosti so neželeni učinki na zdravilo navedeni po padajoči resnosti.
English: Histological analysis of biopsies used Osteomeasure software (Osteometrics, USA).
Slovenian: Za histološke analize biopsij so uporabili programsko opremo Osteomeasure (Osteometrics, ZDA).
English: Twenty five percent (15 out of 60) of the overall patient population was adult (>18 years) at baseline.
Slovenian: Petindvajset odstotkov (15 od 60) celokupne populacije bolnikov je bilo ob izhodišču odraslih
English: Each vial is intended for single use only and should only be punctured once.
Slovenian: Ena viala je namenjena enkratni uporabi in jo je dovoljeno le enkrat prebosti.