FrancophonIA/ELRC3.0 huggingface dataset:
English: The beneficial effect on keratitis was maintained in the open phase of the study, from Month 6 and up to Month 12.
Croatian: Povoljan učinak na keratitis održao se u otvorenoj fazi od 6. do 12. mjeseca ispitivanja.
English: In both studies, no significant improvement of symptoms was observed for IKERVIS compared to vehicle after 6 months of treatment, whether using a visual analogue scale or the OSDI.
Croatian: U oba ispitivanja nije zabilježeno značajno poboljšanje simptoma nakon 6 mjeseci liječenja IKERVISOM u usporedbi s vehikulumom, bez obzira je li korištena vizualno analogna ljestvica ili OSDI.
English: After 6 months of ocular instillation of IKERVIS once per day, 327 patients had values below the lower limit of detection (0.050 ng/mL) and 35 patients were below the lower limit of quantification (0.100 ng/mL).
Croatian: Nakon 6 mjeseci ukapavanja IKERVISA u oko jednom dnevno, u 327 bolesnika vrijednosti su bile ispod donje granice detekcije (0,050 ng/ml) i u 35 bolesnika bile su ispod donje granice kvantifikacije (0,100 ng/ml).
English: IKERVIS treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology.
Croatian: Liječenje IKERVISOM mora započeti oftalmolog ili zdravstveni radnik kvalificiran za područje oftalmologije.
English: There is insufficient information on the effects of ciclosporin in newborns/infants.
Croatian: Nema dovoljno podataka o učincima ciklosporina na novorođenčad/dojenčad.
English: This medicinal product may induce temporary blurred vision or other visual disturbances which may affect the ability to drive or use machines (see section 4.8).
Croatian: Ovaj lijek može izazvati privremeno zamagljen vid ili druge poremećaje vida što može utjecati na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8).
English: What you need to know before you use IKERVIS 3.
Croatian: Što morate znati prije nego počnete primjenjivati IKERVIS
English: 5 single-dose containers.
Croatian: 5 jednodoznih spremnika.
English: If you stop using IKERVIS without speaking to your doctor, the inflammation of the transparent front part of your eye (known as keratitis) will not be controlled and could lead to impaired vision.
Croatian: Ako prestanete primjenjivati IKERVIS bez savjetovanja sa svojim liječnikom, upala prozirnog prednjeg dijela Vašeg oka (poznata kao keratitis) više se neće kontrolirati i može doći do oštećenja vida.
English: Discomfort, itching or irritation in or around the eye including feeling that there is something in the eye.
Croatian: Nelagoda, svrbež ili nadraženost oka ili oko oka, uključujući osjećaj da imate nešto u oku.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
Croatian: Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje navedene serije u promet
English: The European Medicines Agency has waived the obligation to submit the results of studies with IKERVIS in all subsets of the paediatric population for dry eye disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka IKERVIS u svim podskupinama pedijatrijske populacije za sindrom suhog oka (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Slijedom navedenog, nositelj odobrenja će ta izvješća podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Measurable values not exceeding 0.206 ng/mL were measured in eight patients, values considered to be negligible.
Croatian: Mjerljive vrijednosti koje nisu prelazile 0,206 ng/ml izmjerene su u 8 bolesnika i smatraju se zanemarivima.
English: Any opened individual single-dose container with any remaining emulsion should be discarded immediately after use.
Croatian: Svaki otvoreni pojedinačni jednodozni spremnik s preostalom emulzijom treba baciti odmah nakon primjene.
English: Three patients had values above the upper limit of quantification (5 ng/mL) however they were already taking oral ciclosporin at a stable dose, which was allowed by the studies' protocol.
Croatian: Tri bolesnika imala su vrijednosti iznad gornje granice kvantifikacije (5 ng/ml) no oni su već uzimali stabilnu dozu ciklosporina oralno, što je bilo dopušteno protokolom ispitivanja.
English: Ciclosporin has been shown to inhibit the production and/or release of pro-inflammatory cytokines, including interleukin 2 (IL-2) or T-cell growth factor (TCGF).
Croatian: Dokazano je da ciklosporin inhibira proizvodnju i/ili otpuštanje proupalnih citokina, uključujući interleukin 2 (IL-2) ili faktor rasta T stanica (TCGF).
English: The primary objective of the study was to assess the duration of the improvement following IKERVIS treatment discontinuation once the patient was improved with respect to the baseline of the SANSIKA study (i.e. at least 2 grade improvement on the modified Oxford scale).
Croatian: Primarni cilj ispitivanja bila je procjena trajanja poboljšanja nakon prekida liječenja IKERVISOM nakon što je u bolesnika došlo do poboljšanja u odnosu na početno stanje u ispitivanju SANSIKA (tj. poboljšanje za najmanje 2 stupnja mjereno modificiranom Oksfordskom skalom).
English: This may result in a decrease in systemic undesirable effects and an increase in local activity (see section 4.4).
Croatian: To može uzrokovati smanjenje sustavnih nuspojava i pojačati lokalno djelovanje (vidjeti dio 4.4).
English: IKERVIS has moderate influence on the ability to drive and use machines.
Croatian: IKERVIS umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • If you wear contact lenses, take them out at bedtime before using the drops; you can reinsert them when you wake up.
Croatian: • Ako nosite kontaktne leće, izvadite ih prije spavanja i prije primjene kapi; možete ih ponovo staviti kada se probudite.
English: After opening of the aluminium pouches, the single-dose containers should be kept in the pouches in order to protect from light and avoid evaporation.
Croatian: Nakon otvaranja aluminijske vrećice, jednodozne spremnike treba i dalje čuvati u vrećici radi zaštite od svjetlosti i izbjegavanja isparavanja.
English: Patients receiving immunosuppressive therapies, including ciclosporin, are at increased risk of infections.
Croatian: Bolesnici na imunosupresivnom liječenju, uključujući i liječenje ciklosporinom, imaju povećan rizik od infekcija.
English: Talk to your doctor or pharmacist before using IKERVIS - if you have previously had an eye infection by the herpes virus that might have damaged the transparent front part of the eye (cornea).
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite IKERVIS - ako ste prethodno imali infekciju oka virusom herpesa koji je mogao oštetiti prozirni prednji dio oka (rožnicu).
English: If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 15 minutes apart.
Croatian: Ako se primjenjuje više oftalmoloških lijekova za topikalnu primjenu, svaki se lijek mora primijeniti u razmaku od najmanje 15 minuta.
English: • Open the aluminium pouch, which contains 5 single-dose containers.
Croatian: • Otvorite aluminijsku vrećicu koja sadrži pet jednodoznih spremnika.
English: CLINICAL PARTICULARS 4.1 Therapeutic indication
Croatian: 4.1 Terapijske indikacije
English: The most common adverse reactions were eye pain (19.2%), eye irritation (17.8%), lacrimation (6.4%), ocular hyperaemia (5.5%) and eyelid erythema (1.7%) which were usually transitory and occurred during instillation.
Croatian: Najčešće nuspojave bile su bol u oku (19,2%), iritacija oka (17,8%), suzenje (6,4%), hiperemija očiju (5,5%) te eritem vjeđe (1,7%); obično su bile prolazne i javljale se tijekom ukapavanja.
English: Pharmacotherapeutic group: Ophthalmologicals, other ophthalmologicals, ATC code: S01XA18.
Croatian: Farmakoterapijska skupina: oftalmologici, ostali oftalmologici, ATK oznaka: S01XA18.
English: SANTEN Oy Niittyhaankatu 20 33720 Tampere Finland
Croatian: SANTEN Oy Niittyhaankatu 20 33720 Tampere
English: Santen Tél: +33 (0) 1 70 75 26 84
Croatian: Tél: +33 (0) 1 70 75 26 84
English: There is no data on the effects of IKERVIS on human fertility.
Croatian: Nema podataka o učincima IKERVISA na plodnost u ljudi.
English: IKERVIS should be administered last (see section 4.4).
Croatian: IKERVIS treba primijeniti posljednji (vidjeti dio 4.4).
English: The co-primary endpoints were the change in CFS score, and the change in global score of ocular discomfort unrelated to study medication instillation, both measured at Month 6.
Croatian: Dodatne primarne ciljne točke bile su promjena bodova CFS-a i promjena ukupnog rezultata procjene očne nelagode nepovezano s primjenom lijeka, oboje mjereno u 6. mjesecu.
English: Ikervis should not be used if you are pregnant.
Croatian: Nemojte primjenjivati IKERVIS ako ste trudni.
English: Patients spent more time on CFS grade 2 (Median 12.7 weeks/year) and grade 1 (Median 6.6 weeks/year) than CFS grade 3 (Median 2.4 weeks/year), CFS grades 4 and 5 (Median time 0 week/year).
Croatian: Bolesnici su dulje vrijeme imali 2. stupanj CFS-a (medijan 12,7 tjedana/godina) i 1. stupanj (medijan 6,6 tjedana/godina) nego 3. stupanj (medijan 2,4 tjedana/godina) te 4. i 5. stupanj (medijan 0 tjedana/godina).
English: Luxembourg/Luxemburg
Croatian: Luxembourg/Luxemburg Santen Oy
English: Formal pharmacokinetic studies have not been conducted in humans with IKERVIS.
Croatian: Nisu provedena formalna farmakokinetička ispitivanja s IKERVISOM u ljudi.
English: Patients randomised to the vehicle group were switched to IKERVIS after 6 months.
Croatian: Bolesnici randomizirani u skupinu koja je primala vehikulum nakon 6 mjeseci su prebačeni na IKERVIS.
English: No significant changes have been observed in the other secondary endpoints (TBUT, lissamine green staining and Schirmer test, NEI-VFQ and EQ-5D) over the course of the extension study.
Croatian: Nisu uočene značajne promjene u drugim sekundarnim ciljnim točkama (TBUT, lissamin green bojenje, Schirmerov test, procjena kvalitete života pomoću upitnika NEI-VFQ i EQ-5D) tijekom trajanja produžetka ispitivanja.
English: Excipient IKERVIS contains cetalkonium chloride which may cause eye irritation.
Croatian: Pomoćna tvar IKERVIS sadrži cetalkonijev klorid koji može uzrokovati iritaciju oka.
English: Pack sizes: 30 and 90 single-dose containers.
Croatian: Veličine pakiranja: 30 i 90 jednodoznih spremnika.
English: In five clinical studies including 532 patients who received IKERVIS and 398 who received IKERVIS vehicle (control), IKERVIS was administered at least once a day in both eyes, for up to one year.
Croatian: U 5 kliničkih ispitivanja koja su uključila 532 bolesnika koji su primali IKERVIS i 398 bolesnika koji su primali vehikulum IKERVISA (kontrola), IKERVIS je davan najmanje jednom dnevno u oba oka tijekom jedne godine.
English: Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defences against local infections and malignancies.
Croatian: Oftalmički lijekovi koji utječu na imunološki sustav, uključujući ciklosporin, mogu utjecati na obranu domaćina od lokalnih infekcija i maligniteta.
English: IKERVIS has not been studied in patients with a history of ocular herpes and should therefore be used with caution in such patients.
Croatian: IKERVIS nije ispitan u bolesnika s anamnezom očnog herpesa te se stoga kod takvih bolesnika mora primjenjivati oprezno.
English: Ciclosporin-induced inactivation of calcineurin inhibits the dephosphorylation of the transcription factor NF-AT and prevents NF-AT translocation into the nucleus, thus blocking the release of proinflammatory cytokines such as IL-2.
Croatian: Ciklosporinom inducirana inaktivacija kalcineurina inhibira defosforilaciju transkripcijskog faktora NFAT i sprječava njegovu translokaciju u jezgru te na taj način blokira otpuštanje proupalnih citokina kao što je IL-2.
English: Mechanism of action and pharmacodynamic effects Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide immunomodulator with immunosuppressant properties.
Croatian: Ciklosporin (također poznat i kao ciklosporin A) je ciklički polipeptidni imunomodulator s imunosupresivnim svojstvima.
English: IKERVIS is used to treat adults with severe keratitis (inflammation of the cornea, the transparent layer in the front part of the eye).
Croatian: IKERVIS se primjenjuje za liječenje odraslih s teškim keratitisom (upala rožnice, prozirnog sloja na prednjem dijelu oka).
English: Assessment of DED symptoms by VAS showed a worsening of patient's discomfort from the time treatment was first stopped to the time it was restarted except pain which remained relatively low and stable.
Croatian: Procjena simptoma sindroma suhog oka pomoću vizualno-analogne skale pokazala je pogoršanje nelagode u bolesnika u razdoblju od prvog prekida liječenja do ponovnog uvođenja liječenja, osim po pitanju boli koja je ostala relativno slaba i nije se pogoršavala.
English: Talk to your doctor if you are using eye drops containing steroids with IKERVIS as these might increase the risk of side effects.
Croatian: Obavijestite svog liječnika ako primjenjujete kapi za oči koje sadrže steroide uz IKERVIS jer one mogu povećati rizik od nuspojava.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS POUCH LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NALJEPNICA ZA VREĆICU
English: The proportion of IKERVIS-treated patients with a 3-grade improvement in CFS score at Month 6 (from 4 to 1) was 28.8%, compared to 9.6% of vehicle-treated subjects, but this was a post-hoc analysis, which limits the robustness of this outcome.
Croatian: Udio bolesnika liječenih IKERVISOM s poboljšanjem od 3 stupnja (s 4 na 1) mjereno bodovima CFS-a u 6. mjesecu bio je 28,8% u usporedbi s 9,6% ispitanika liječenih vehikulumom, ali to je bila post hoc analiza, što ograničava robusnost ovog rezultata.
English: One mL of emulsion contains 0.05 mg cetalkonium chloride (see section 4.4).
Croatian: Pomoćna tvar s poznatim učinkom Jedan ml emulzije sadrži 0,05 mg cetalkonijevog klorida (vidjeti dio 4.4).
English: It is supplied in single-dose containers made of a low-density polyethylene (LDPE).
Croatian: Isporučuje se u jednodoznim spremnicima načinjenim od polietilena niske gustoće (LDPE).
English: In 374 patients from the two efficacy studies, plasma concentrations of ciclosporin were measured before administration and after 6 months (SICCANOVE study and SANSIKA study) and 12 months of treatment (SANSIKA study).
Croatian: U 374 bolesnika iz dva ispitivanja djelotvornosti, mjerene su koncentracije ciklosporina u plazmi prije primjene te nakon 6 (SICCANOVE i SANSIKA ispitivanje) i 12 mjeseci liječenja (SANSIKA ispitivanje).
English: Uncommon Keratitis bacterial, herpes zoster ophthalmic.
Croatian: Bakterijski keratitis, očni herpes zoster.
English: In Post SANSIKA study patients alternatively received IKERVIS treatment or no treatment depending on CFS score (patients received IKERVIS when there was a worsening of keratitis).
Croatian: U ispitivanju Post SANSIKA bolesnici su bili liječeni IKERVISOM ili nisu bili liječeni, ovisno o bodovima CFS-a (bolesnici su primali IKERVIS kada je došlo do pogoršanja keratitisa).
English: If you are breast feeding talk to your doctor before using this medicine.
Croatian: Ako dojite, razgovarajte sa svojim liječnikom prije primjene ovog lijeka.
English: Pregnancy There is no data from the use of IKERVIS in pregnant women.
Croatian: Trudnoća Nema podataka o primjeni IKERVISA u trudnica.
English: Elderly patients The elderly population has been studied in clinical studies.
Croatian: Starija populacija je ispitivana u kliničkim ispitivanjima.
English: poloxamer 188, sodium hydroxide (to adjust pH) and water for injections.
Croatian: 188, natrijev hidroksid (za podešavanje pH) i voda za injekcije.
English: 30 single-dose containers 90 single-dose containers
Croatian: 30 jednodoznih spremnika 90 jednodoznih spremnika
English: Instillation site pain was a frequently reported local adverse reaction associated with the use of IKERVIS during clinical trials.
Croatian: Bol na mjestu ukapavanja bila je često zabilježena lokalna nuspojava povezana s primjenom IKERVISA tijekom kliničkih ispitivanja.
English: No interaction studies have been performed with IKERVIS.
Croatian: Nisu provedena ispitivanja interakcija s IKERVISOM.
English: The efficacy and safety of IKERVIS were evaluated in two randomised, double-masked, vehiclecontrolled clinical studies in adult patients with dry eye disease (keratoconjunctivitis sicca) who met the International Dry Eye Workshop (DEWS) criteria.
Croatian: Djelotvornost i sigurnost IKERVISA procijenjene su u dva randomizirana, dvostruko slijepa, vehikulumom kontrolirana klinička ispitivanja u odraslih bolesnika s dijagnozom sindroma suhog oka (keratokonjunktivitis sicca) koji su ispunili kriterije DEWS (International Dry Eye Workshop).
English: Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes (see section 5.1).
Croatian: Liječenje teškog keratitisa u odraslih bolesnika sa sindromom suhog oka koji se ne poboljšava unatoč liječenju umjetnim suzama (vidjeti dio 5.1).
English: Prior to administration, the single-dose container should be gently shaken.
Croatian: Prije primjene, jednodozni spremnik treba nježno protresti.
English: Combination with other medicinal products that affect the immune system Co-administration of IKERVIS with eye drops containing corticosteroids could potentiate the effects of ciclosporin on the immune system (see section 4.4).
Croatian: Kombinacija s drugim lijekovima koji utječu na imunološki sustav Istodobna primjena IKERVISA s kapima za oči koje sadrže kortikosteroide može pojačati učinke ciklosporina na imunološki sustav (vidjeti dio 4.4).
English: The proportion of responders in the IKERVIS group was 28.6%, compared to 23.1% in the vehicle group.
Croatian: Udio bolesnika koji su odgovorili na terapiju u skupini koja je primala IKERVIS bio je 28,6% u usporedbi s 23,1% u skupini koja je primala vehikulum.
English: In addition, no improvement was observed for IKERVIS compared to vehicle at Month 6 for other secondary endpoints, including ocular discomfort score, Schirmer test, use of concomitant artificial tears, investigator's global evaluation of efficacy, tear break-up time, lissamine green staining, quality of life score, and tear osmolarity.
Croatian: Dodatno, nije uočeno poboljšanje uz IKERVIS u usporedbi s vehikulumom u 6. mjesecu za druge sekundarne ciljne točke uključujući rezultat procjene očne nelagode, Schirmerov test, istodobnu primjenu umjetnih suza, opću procjenu djelotvornosti od strane ispitivača, vrijeme prekida suznog filma, lissamin green bojenje, procjenu kvalitete života i osmolarnost suza.
English: Two patients had values above the upper limit of quantification, however they were also on oral ciclosporin at a stable dose since their inclusion in the study.
Croatian: Dva bolesnika imala su vrijednosti iznad gornje granice kvantifikacije no oni su također uzimali stabilnu dozu ciklosporina oralno od uključenja u ispitivanje.
English: Do not use this medicine after the expiry date which is stated on the outer carton, the aluminium pouch and on the single-dose containers after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskoj kutiji, aluminijskoj vrećici i na jednodoznom spremniku iza oznake “Rok valjanosti”.
English: In patients with dry eye disease, a condition that may be considered to have an inflammatory immunological mechanism, following ocular administration, ciclosporin is passively absorbed into Tlymphocyte infiltrates in the cornea and conjunctiva and inactivates calcineurin phosphatase.
Croatian: U bolesnika sa sindromom suhog oka, stanjem za koje se smatra da nastaje imunološkim upalnim mehanizmom, ciklosporin se, nakon primjene u oko, pasivno apsorbira u T-limfocitne infiltrate u rožnici i konjunktivi i inaktivira kalcineurin fosfatazu.
English: There is limited experience with IKERVIS in the treatment of patients with glaucoma.
Croatian: Iskustvo s primjenom IKERVISA u liječenju bolesnika s glaukomom je ograničeno.
English: • After using IKERVIS, press a finger into the corner of your eye by the nose and close gently the eyelids for 2 minutes (picture 3).
Croatian: • Nakon primjene IKERVISA pritisnite prstom kut oka pored nosa i nježno sklopite vjeđe na
English: • The remaining single-dose containers should be kept in the aluminium pouch.
Croatian: • Preostali jednodozni spremnici trebaju se čuvati u aluminijskoj vrećici.
English: • Conditions or restrictions with regard to the safe and effective use of medicinal product to be implemented by the member states
Croatian: • Uvjeti ili ograničenja vezani uz sigurnu i učinkovitu primjenu lijeka koje trebaju primijeniti zemlje članice
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SINGLE-DOSE CONTAINER LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA JEDNODOZNI SPREMNIK
English: One case of severe epithelial erosion of the cornea identified as corneal decompensation by the investigator resolved without sequeleae was reported.
Croatian: Zabilježen je jedan slučaj teške erozije epitela rožnice koju je ispitivač označio kao dekompenzaciju rožnice, a koja se povukla bez posljedica.
English: There is no relevant use of IKERVIS in children and adolescents aged below 18 in the treatment of severe keratitis in patients with dry eye disease, which has not improved despite treatment with tear substitutes.
Croatian: Nema relevantne primjene IKERVISA u djece i adolescenata u dobi ispod 18 godina u liječenju teškog keratitisa bolesnika sa sindromom suhog oka koji se ne poboljšava unatoč liječenju umjetnim suzama.
English: Each single-dose container contains 0.3 mL eye drops, emulsion.
Croatian: Svaki jednodozni spremnik sadrži 0,3 ml kapi za oko, emulzije.
English: Studies in animals have shown reproductive toxicity following systemic administration of ciclosporin at exposure considered sufficiently in excess of the maximum human exposure indicating little relevance to the clinical use of IKERVIS.
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost nakon sustavne primjene ciklosporina pri izloženosti dozama koje su znatno veće od maksimalne izloženosti u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu IKERVISA.
English: Therefore, caution should be exercised when corticosteroids are administered concomitantly with Ikervis (see section 4.5).
Croatian: Zbog toga je potreban oprez pri istodobnoj primjeni kortikosteroida i IKERVISA (vidjeti dio 4.5).
English: The primary endpoint was the proportion of patients achieving by Month 6 at least a twograde improvement in keratitis (CFS) and a 30% improvement in symptoms, measured with the Ocular Surface Disease Index (OSDI).
Croatian: Primarna ciljna točka bio je udio bolesnika koji su do 6. mjeseca postigli poboljšanje keratitisa (CFS) od najmanje 2 stupnja i poboljšanje simptoma za 30% mjereno indeksom bolesti površine oka (OSDI, engl.
English: Blood concentrations of IKERVIS were measured using a specific high-pressure liquid chromatography-mass spectrometry assay.
Croatian: Koncentracije IKERVISA u krvi mjerene su pomoću visokotlačne tekućinske kromatografije uz masenu spektrometriju.
English: The single-dose containers are wrapped in a sealed aluminium pouch.
Croatian: Jednodozni spremnici uvijeni su u zatvorenu aluminijsku vrećicu.