FrancophonIA/ELRC3.0 huggingface dataset:
English: 10 mL of concentrate in a clear type I glass vial closed by a poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on aluminium ring and a blue plastic flip-off cap.
Croatian: I zatvorenoj čepom od butilne gume obložene poli(etilen-ko-tetrafluoroetilenom) pokrivenim aluminijskim prstenom i plavim plastičnim zatvaračem.
English: 1 vial of 2.5 mL 2 vials of 2.5 mL 1 vial of 10 mL 2 vials of 10 mL
Croatian: 1 bočica od 2,5 ml 2 bočice od 2,5 ml 1 bočica od 10 ml 2 bočice od 10 ml
English: The medicinal product should be inspected visually before use.
Croatian: Prije primjene treba pregledati izgled lijeka.
English: 2.5 mL of concentrate in a clear type I glass vial closed by a poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on aluminium ring and a white plastic flip-off cap.
Croatian: I zatvorenoj čepom od butilne gume obložene poli(etilen-ko-tetrafluoroetilenom) pokrivenim aluminijskim prstenom i bijelim plastičnim zatvaračem.
English: Tell your doctor or nurse straight away if you have any of the symptoms of an allergic reaction (e.g. itching, trouble breathing, wheezing, fever, shivering, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness or swelling).
Croatian: Odmah obavijestite liječnika ili medicinsku sestru ako imate bilo kakve simptome alergijske reakcije (npr. svrbež, otežano disanje, piskanje pri disanju,
English: An infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 0.2 µm) should be used for infusion.
Croatian: Za infuziju treba upotrijebiti infuzijski set s ugrađenim sterilnim, nepirogenim, infuzijskim filtrom s niskim afinitetom vezanja proteina (pora veličine 0,2 µm).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Croatian: Sadržaj natrija Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: In Studies I and II, patients receiving reslizumab 3 mg/kg had significant reductions in asthma exacerbations (50% and 59%, respectively) compared to placebo (see Table 4).
Croatian: I i II, bolesnici koji su primali reslizumab u dozi od 3 mg/kg imali su značajno smanjenje egzacerbacija astme (50 % odnosno 59 %) u usporedbi s placebom (vidjeti tablicu 4).
English: No noteworthy differences in the pharmacokinetics of reslizumab were observed across these renal function groups.
Croatian: Nisu bile opažene nikakve znatnije razlike u farmakokinetici reslizumaba između ovih skupina s različitom funkcijom bubrega.
English: Data by study Study I
Croatian: Podaci po pojedinom ispitivanju Ispitivanje
English: In integrated Studies I and II, patients receiving reslizumab 3 mg/kg had significant reductions in asthma exacerbations (56% for subgroup GINA 4 and 5) compared to placebo.
Croatian: I i II, a primarni ishod djelotvornosti prikazan je u tablici 4. U integriranim Ispitivanjima I i II, bolesnici koji su primali reslizumab u dozi od 3 mg/kg imali su značajno smanjenje egzacerbacija astme (56% u podskupini GINA 4 i 5) u usporedbi s onima koji su primali placebo.
English: Effect on sputum eosinophils
Croatian: Učinak na eozinofile u sputumu
English: Sodium acetate trihydrate Acetic acid glacial Sucrose
Croatian: 6.1 Popis pomoćnih tvari natrijev acetat trihidrat ledena acetatna kiselina saharoza voda za injekcije
English: Patients with severe eosinophilic asthma
Croatian: Bolesnici s teškom eozinofilnom astmom
English: Baseline mean blood eosinophil count, µL-1
Croatian: Početna srednja vrijednost broja eozinofila u krvi, µl-1
English: One vial of 2.5 mL contains 25 mg reslizumab.
Croatian: Jedna bočica od 2,5 ml sadrži 25 mg reslizumaba.
English: One vial of 10 mL contains 100 mg reslizumab.
Croatian: Jedna bočica od 10 ml sadrži 100 mg reslizumaba.
English: GINA step 4 patients received medium- to high-dose ICS plus another controller.
Croatian: Global Initiative for Asthma - GINA): Bolesnici u koraku 4 prema klasifikaciji GINA primali su srednje do visoke doze inhalacijskih kortikosteroida plus drugi lijek za kontrolu bolesti.
English: A suitable injection syringe should be used to withdraw the needed amount of concentrate from the vial(s) (see section 4.2 of Summary of Product Characteristics).
Croatian: Za izvlačenje potrebne količine koncentrata iz bočice(a), potrebno je upotrijebiti prikladnu štrcaljku za injekcije (vidjeti dio 4.2 Sažetka opisa svojstava lijeka).
English: Hepatic impairment No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Croatian: U bolesnika s oštećenjem funkcije bubrega nije potrebna prilagodba doze (vidjeti dio 5.2).
English: The serious adverse reaction of anaphylactic reaction was reported and considered related to reslizumab in 3 patients (0.19%) during placebo-controlled and open-label asthma studies.
Croatian: Tijekom placebom kontroliranih i otvorenih ispitivanja astme zabilježena je ozbiljna nuspojava anafilaktičke reakcije a smatrala se povezanom s reslizumabom u 3 bolesnika (0,19 %).
English: [ATS]/European Respiratory Society [ERS] 2000 workshop definition for refractory asthma) from Studies I and II was analysed post hoc.
Croatian: European Respiratory Society - ERS] 2000. godine) u Ispitivanjima
English: CINQAERO 10 mg/mL concentrate for solution for infusion
Croatian: CINQAERO 10 mg/ml koncentrat za otopinu za infuziju
English: FEV1 (mL) Mean diff (95% CIb) (p-value)
Croatian: Srednja vrijednost razlike (95 % CIb) (p-vrijednost)
English: CINQAERO 10 mg/mL concentrate for solution for infusion reslizumab
Croatian: CINQAERO 10 mg/ml koncentrat za otopinu za infuziju reslizumab
English: Asthma exacerbations were evaluated only in the exacerbation studies (Studies I and II: reslizumab
Croatian: Egzacerbacija astme bila je procijenjena samo u ispitivanjima egzacerbacije (Ispitivanja I i II: reslizumab u dozi od 3 mg/kg [n=14] i placebo [n=11]).
English: A suitable injection syringe should be used to withdraw the needed amount of the concentrate from the vial(s) (see section 4.2).
Croatian: Za izvlačenje potrebne količine koncentrata iz bočice(a), potrebno je upotrijebiti prikladnu štrcaljku za injekcije (vidjeti dio 4.2).
English: No treatment effect on asthma exacerbations was observed for this age group (asthma exacerbation rate ratio [reslizumab/placebo] of 2.09).
Croatian: Nije bio opažen terapijski učinak na egzacerbacije astme u ovoj dobnoj skupini (omjer stopa egzacerbacije astme
English: Table 4: Frequency of asthma exacerbations during the 52-week treatment period - Studies I and II, integrated data (Studies I and II) for the overall population and subgroup GINA 4 and 5 Treatment arms (n)
Croatian: integrirani podaci (Ispitivanja I i II) za ukupnu populaciju i podskupinu GINA 4 i 5 Terapijske skupine (n)
English: Each mL of concentrate contains 10 mg of reslizumab.
Croatian: Jedan ml koncentrata sadrži 10 mg reslizumaba.
English: Overall population Reslizumab 3 mg/kg (n=477)
Croatian: Ukupna populacija Reslizumab 3 mg/kg (n=477)
English: Most patients in the population pharmacokinetic analysis had normal renal function (estimated glomerular filtration rate [eGFR]) greater than or equal to 90 mL/min/1.73 m2; n=294, approximately 37%), mild renal impairment (eGFR 60-89 mL/min/1.73 m2; n=446, approximately 56%), or moderate renal impairment (eGFR 30-59 mL/min/1.73 m2; n=63, approximately 8%).
Croatian: 56 %) ili umjereno oštećenu funkciju bubrega (eGFR 30-59 ml/min/1,73 m2; n=63, približno 8 %).
English: The effect of reslizumab 3 mg/kg administered once every 4 weeks on secondary endpoints, including FEV1, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ) and Asthma Symptom Utility Index (ASUI), further supports the efficacy of reslizumab 3 mg/kg compared to placebo.
Croatian: Učinak reslizumaba, primijenjenog u dozi od 3 mg/kg jedanput svaka 4 tjedna, na sekundarne mjere ishoda, uključujući FEV1, Upitnik o kvaliteti života s astmom (engl.
English: The patients received either four doses of placebo or reslizumab 0.3 mg/kg or 3 mg/kg administered once every 4 weeks.
Croatian: 0,3 mg/kg ili 3 mg/kg koje su se davale jedanput svaka 4 tjedna.
English: Based on the similar reslizumab exposure observed in patients older than 65 years of age as compared to patients 18 to <65 years of age, no dose adjustment is recommended (see section 5.2).
Croatian: Na temelju slične izloženosti reslizumabu u bolesnika starijih od 65 godina u usporedbi s bolesnicima u dobi od
English: Package leaflet: Information for the patient CINQAERO 10 mg/mL concentrate for solution for infusion reslizumab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika CINQAERO 10 mg/ml koncentrat za otopinu za infuziju reslizumab
English: The primary efficacy measure for both Studies I and II was the frequency of asthma exacerbations for each patient during the 52-week treatment period.
Croatian: I i II bila je učestalost egzacerbacija astme u svakog bolesnika tijekom razdoblja liječenja od 52 tjedna.
English: Studies I and II
Croatian: I i II
English: Merckle GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Croatian: 3 89079 Ulm
English: CINQAERO should be prescribed by physicians experienced in the diagnosis and treatment of the above-mentioned indication (see section 4.1).
Croatian: 4.2 Doziranje i način primjene CINQAERO trebaju propisivati liječnici s iskustvom u dijagnozi i liječenju gore navedene indikacije
English: Reslizumab has not been studied in patients with hepatic impairment.
Croatian: Reslizumab nije ispitan u bolesnika s oštećenjem funkcije jetre.
English: What are the benefits of using CINQAERO
Croatian: Koje su koristi primjene lijeka CINQAERO
English: The concentrate is clear to slightly hazy opalescent, colourless to slightly yellow.
Croatian: opalescentan, bezbojan do blago žut.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva manje često mijalgija*
English: Maintenance OCS was not allowed.
Croatian: Nije bila dopuštena terapija održavanja peroralnim kortikosteroidima.
English: In Study III, patients receiving reslizumab 3 mg/kg had significantly larger increases in FEV1 from baseline compared to placebo (treatment difference: 160 mL, p=0.0018).
Croatian: Ispitivanju III, bolesnici koji su primali reslizumab u dozi od 3 mg/kg imali su značajno veće povećanje FEV1 u odnosu na početnu vrijednost u usporedbi s onima koji su primali placebo
English: In Studies I and II, severe eosinophilic asthma is defined as any patients falling into GINA steps 4 and 5 (medium- to high-dose ICS [≥ 440 µg fluticasone propionate] plus another controller, with or without maintenance OCS) with a blood eosinophil count of ≥400 µL-1 at start of treatment.
Croatian: I i II, teška eozinofilna astma definirana je kao astma kod svakog bolesnika u koracima 4 i 5 prema klasifikaciji GINA (srednje do visoke doze inhalacijskih kortikosteroida [≥
English: Preparation of solution for infusion
Croatian: Priprema otopine za infuziju
English: Asthma exacerbation ratea
Croatian: Stopa egzacerbacije astmea
English: CINQAERO is a medicine containing the active substance reslizumab, a monoclonal antibody, a type of protein that recognises and binds to a specific target substance in the body.
Croatian: vrsta proteina koja prepoznaje određenu ciljnu tvar u tijelu i veže se za nju.
English: cohort of 763 patients within Studies I and II met this criterion; the primary efficacy outcome is presented in Table 4.
Croatian: Ovaj je kriterij zadovoljila kohorta od 763 bolesnika u Ispitivanjima
English: Patients with severe refractory eosinophilic asthma Reslizumab produced significant reductions in asthma exacerbations relative to placebo in the refractory population (59%) and non-refractory population (49%).
Croatian: U populaciji s refraktornom (59 %) i onoj s nerefraktornom (49 %) bolešću reslizumab je značajno smanjio egzacerbacije astme u odnosu na placebo.
English: The effect of reslizumab in patients with asthma and elevated sputum eosinophil counts (at least 3%) was evaluated in a 15-week, phase 2, randomised, double-blind, placebo-controlled clinical study with reslizumab 3 mg/kg.
Croatian: bio je procijenjen u 15-tjednom, randomiziranom, dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju faze 2 u kojem se davao u dozi od 3 mg/kg.
English: Of these subjects, 1,006 asthma patients were exposed for at least 6 months, 759 exposed for at least 1 year and 237 exposed for longer than 2 years (up to 3 years).The following adverse reactions have been reported with reslizumab during placebo-controlled asthma studies for up to 52 weeks of treatment with a 3 mg/kg dose given intravenously (1,028 patients).
Croatian: 1006 bolesnika s astmom bilo izloženo lijeku najmanje 6 mjeseci, 759 najmanje 1 godinu, a 237 dulje od 2 godine (do 3 godine).
English: CINQAERO is used to treat severe eosinophilic asthma in adult patients (18 years of age and over) when the condition is not well controlled despite treatment with high-dose inhaled corticosteroids together with another asthma medicine.
Croatian: 18 godina i više) kada bolest nije dobro kontrolirana unatoč liječenju visokim dozama inhalacijskih kortikosteroida zajedno s drugim lijekom za astmu.
English: Eosinophils began to return towards baseline in those reslizumab patients completing a 90-day follow-up assessment (394 µL-1, n=36).
Croatian: Broj eozinofila počeo se vraćati prema početnim vrijednostima u bolesnika liječenih reslizumabom u kojih je završena procjena nakon
English: Description of selected adverse reactions
Croatian: Reakcije preosjetljivosti i reakcije povezane s primjenom
English: How CINQAERO is given
Croatian: Kako primjenjivati CINQAERO
English: Batch
Croatian: ACQ
English: Exacerbation history
Croatian: Prijavljivanje nuspojava
English: Eosinophil counts
Croatian: Broj eozinofila
English: Pliva Hrvatska d.o.o.
Croatian: Merckle GmbH Graf-Arco-Str.
English: PC:
Croatian: PC SN NN
English: Placebo (n=380)
Croatian: Placebo (n=380) 95 % CI
English: The significance of these changes is unknown.
Croatian: Važnost ovih promjena nije poznata.
English: It is therefore difficult to recommend an optimum method.
Croatian: Stoga je teško preporučiti optimalnu metodu.
English: • are planning to have a baby.
Croatian: • planirate imati dijete.
English: • think you may be pregnant; or
Croatian: • mislite da biste mogli biti trudni; ili
English: Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Croatian: Iako ova interakcija nije formalno ispitana, ne postoji dokaz da je takva interakcija štetna.
English: The usual dose varies depending on your illness and weight.
Croatian: Uobičajena doza varira ovisno o Vašoj bolesti i težini.
English: These can be taken from you or from a donor.
Croatian: One se mogu prikupiti od Vas ili davatelja.
English: It is important to tell your doctor if you:
Croatian: Važno je da kažete svom liječniku ako:
English: These changes all reversed after discontinuation of treatment.
Croatian: Sve te promjene povukle su se nakon prekida liječenja.
English: You, or people caring for you, can be taught how to give subcutaneous injections so that you can continue your treatment at home.
Croatian: Vi, ili osobe koje Vas njeguju, možete naučiti kako davati potkožne injekcije tako da možete nastaviti s terapijom kod kuće.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine.
Croatian: Čimbenici rasta su proteini koji se prirodno proizvode u tijelu, ali se mogu proizvesti i pomoću biotehnologije za primjenu kao lijek.
English: When the response has been obtained, the minimal effective dose to maintain this level should be established.
Croatian: Kad se postigne odgovor, treba odrediti minimalnu učinkovitu dozu za održavanje te razine.
English: This medicine may cause dizziness.
Croatian: Ovaj lijek može prouzročiti omaglicu.
English: Instructions on how to inject yourself
Croatian: Upute kako da sami sebi date injekciju
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Croatian: Imunogenost Kao i kod svih terapijskih proteina, postoji potencijal za imunogenost.
English: Date of first authorisation: 06 February 2009 Date of latest renewal: 13 November 2013
Croatian: Datum posljednje obnove: 13. studenog 2013.
English: Do not take a double dose to make up for any missed doses.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili propuštene doze.
English: • trouble sleeping (insomnia)
Croatian: • problemi sa spavanjem (nesanica)
English: Your doctor may want to monitor you closely, see section 4 of the package leaflet.
Croatian: Vaš liječnik će Vas možda htjeti pažljivo nadzirati, pogledajte dio 4 upute o lijeku.
English: However, you should not attempt this unless you have been properly trained first by your health care provider.
Croatian: Međutim, ne smijete to pokušati osim ako Vas prvo nije ispravno u tome obučio
English: Do not increase the dose your doctor has given you.
Croatian: Nemojte povećavati dozu koju Vam je liječnik propisao.
English: - if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na filgrastim ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Regular blood tests will be taken to monitor the number of white blood cells in your body.
Croatian: Redovne krvne pretrage će biti potrebne kako bi se pratio broj bijelih krvnih stanica u Vašem tijelu.
English: The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
Croatian: Izbor metode mobilizacije treba razmotriti u odnosu na ukupne ciljeve liječenja pojedinog bolesnika.
English: Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Croatian: Vezanje protutijela događa se u skladu s očekivanim za sve biološke lijekove; međutim, za sada nije povezano s neutralizirajućom aktivnosti.
English: After 1 - 2 weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Croatian: Nakon 1 - 2 tjedna terapije, početna doza se može udvostručiti ili prepoloviti ovisno o odgovoru bolesnika.
English: Please tell your doctor immediately during treatment:
Croatian: Odmah obavijestite svog liječnika tijekom liječenja:
English: The volume of distribution in blood is approximately 150 ml/kg.
Croatian: Volumen raspodjele u krvi iznosi približno 150 ml/kg.
English: The incidence of fever and documented infections were not reduced in either setting.
Croatian: Incidencija vrućice i dokumentiranih infekcija nije bila smanjena niti u jednoj od te dvije situacije.
English: The only consistently reported adverse event was musculoskeletal pain‚ which is no different from the experience in the adult population.
Croatian: Jedini dosljedno prijavljeni štetni događaj bila je mišićno-koštana bol, što se ne razlikuje od iskustva odrasle populacije.
English: At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
Croatian: Na kraju tog razdoblja, lijek se ne smije vratiti u hladnjak, nego ga treba zbrinuti.
English: This section contains information on how to give yourself an injection of Filgrastim HEXAL.
Croatian: Ovaj dio sadrži informacije o tome kako da sami sebi date injekciju lijeka Filgrastim HEXAL.
English: No undesirable effects directly attributable to this degree of leukocytosis have been reported.
Croatian: Nisu prijavljeni neželjeni učinci koji su se mogli izravno pripisati ovom stupnju leukocitoze.
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Croatian: Stoga veličinu slezene treba pažljivo pratiti (npr. kliničkim pregledima, ultrazvukom).
English: Thereafter, it is recommended that the ANC is measured at least twice per week for the first 2 weeks and subsequently once per week or once every other week during maintenance therapy.
Croatian: Nakon toga se preporučuje mjeriti apsolutni broj neutrofila najmanje dvaput tjedno tijekom prva 2 tjedna, a potom jedanput tjedno ili jedanput svakog drugog tjedna za vrijeme terapije održavanja.
English: Transfusion reactione a See section c (Description of selected adverse reactions)
Croatian: Transfuzijska reakcijae a Vidjeti dio c (Opis odabranih nuspojava)
English: Haematuria was common and proteinuria occurred in a small number of patients.
Croatian: Hematurija je bila česta, a proteinurija je nastupila u malog broja bolesnika.
English: In other circumstances, additional leukaphereses may be necessary.
Croatian: U drugim situacijama mogu biti potrebne dodatne leukafereze.
English: You should talk to your doctor about your risks of developing cancers of the blood and what testing should be done.
Croatian: Trebate razgovarati sa svojim liječnikom o rizicima razvoja zloćudne bolesti krvi i pretragama koje trebate obaviti.
English: If yields are inadequate, as measured by the criteria above, alternative forms of treatment not requiring progenitor support should be considered.
Croatian: Ako prinosi stanica nisu odgovarajući, mjereno prema gore navedenim kriterijima, treba razmotriti alternativne oblike liječenja za koje nije potrebna progenitorska potpora.
English: Idiopathic or cyclic neutropenia
Croatian: Idiopatska ili ciklička neutropenija:
English: Pack sizes of 1, 3, 5 or 10 pre-filled syringes.
Croatian: Veličine pakiranja od 1, 3, 5 ili 10 napunjenih štrcaljki.
English: Talk to your doctor, pharmacist or nurse before using Filgrastim HEXAL.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Filgrastim HEXAL.
English: • lungs do not function as they should, causing breathlessness (respiratory failure)
Croatian: • pluća ne funkcioniraju kako bi trebala, što uzrokuje nedostatak zraka (respiratorno zatajenje)
English: > 1.0 x 109/l for 3 consecutive days
Croatian: > 1,0 x 109/l tijekom 3 uzastopna dana
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove (EMA): http://www.ema.europa.eu.
English: Dose adjustment is not required in these circumstances.
Croatian: U takvim situacijama nije potrebna prilagodba doze.
English: • increase of certain enzymes in the blood
Croatian: • povišene vrijednosti određenih enzima u krvi
English: European Retrospective Study (2004)
Croatian: Europsko retrospektivno ispitivanje (2004) 1992 - 2002b
English: If you have missed an injection, or injected too little, contact your doctor as soon as possible.
Croatian: Ako ste propustili injekciju ili ste injektirali premalo lijeka, obratite se svom liječniku što je prije moguće.
English: In pregnant rats, no maternal or foetal toxicity was observed at doses up to 575 µg/kg/day.
Croatian: Kod gravidnih štakorica nije uočena maternalna ili fetalna toksičnost pri dozama do 575 µg/kg/dan.
English: There are no prospectively randomised comparisons of the two recommended mobilisation methods (Filgrastim alone, or in combination with myelosuppressive chemotherapy) within the same patient population.
Croatian: Nisu provedene prospektivne randomizirane usporedbe dvije preporučene metode mobilizacije (samo filgrastimom ili u kombinaciji s mijelosupresivnom kemoterapijom) u istoj populaciji bolesnika.
English: Use each syringe only for one injection.
Croatian: Koristite svaku štrcaljku samo za jednu injekciju.