FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 vial of powder
Croatian: 1 bočica praška
English: PK exposures had a slight correlation with body weight in the study with medical treatment naïve patients, but not in the study with inadequately controlled patients.
Croatian: PK izloženosti imale su malu korelaciju s tjelesnom težinom u ispitivanju s bolesnicima koji nisu ranije primali terapiju lijekovima, ali ne u ispitivanju s neodgovarajuće kontroliranim bolesnicima.
English: Packs containing 6 ampoules or multipacks containing 18 (3 x 6), 30 (5 x 6) or 60 (10 x 6) ampoules.
Croatian: Pakiranja koja sadrže 6 ampula ili višestruka pakiranja koja sadrže 18 (3 x 6), 30 (5 x 6) ili 60 (10 x 6) ampula.
English: Very common (may affect more than 1 in 10 people) - High level of sugar in the blood.
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba) - Visoka razina šećera u krvi.
English: In a clinical study in subjects with impaired hepatic function (Child-Pugh A, B and C), statistically significant differences were found in subjects with moderate and severe hepatic impairment (Child-Pugh B and C).
Croatian: U kliničkom ispitivanju u ispitanika s oštećenom funkcijom jetre (Child-Pugh A, B i C) pronađene su statistički značajne razlike u ispitanika s umjerenim i teškim oštećenjem jetre (Child-Pugh B i C).
English: The data described below reflect exposure of 162 Cushing's disease patients to Signifor in the phase III study.
Croatian: Podaci opisani u nastavku odnose se na izloženost lijeku Signifor u 162 bolesnika s Cushingovom bolešću u ispitivanju faze III.
English: In study C2402, the only notable outlier was a QTcF value >480 ms in 1 patient in the pasireotide intramuscular use 40 mg group.
Croatian: U ispitivanju C2402, jedina zamjetna stršeća vrijednost bila je vrijednost QTcF-a >480 ms u 1 bolesnika u skupini koja je primala 40 mg pasireotida intramuskularno.
English: Patients with baseline HbA1c ≥7% or who were taking antidiabetic medicinal products prior to randomisation tended to have higher mean changes in fasting plasma glucose and HbA1c relative to other patients.
Croatian: Bolesnici s početnim HbA1c ≥7% ili oni koji su uzimali antidijabetike prije randomizacije obično su imali više srednje promjene u glukozi u plazmi natašte i HbA1c u usporedbi s ostalim bolesnicima.
English: Signifor must be given only by deep intramuscular injection.
Croatian: Signifor se smije primijeniti samo dubokom intramuskularnom injekcijom.
English: In the Cushing's disease study G2304, a QTcF value >480 ms was reported for 2 patients.
Croatian: U ispitivanju u bolesnika s Cushingovom bolešću G2304, vrijednost QTcF-a >480 ms bila je prijavljena za 2 bolesnika.
English: Elevated glucose was the most frequently reported Grade 3 laboratory abnormality (23.2% of patients) in the phase III study in Cushing's disease patients.
Croatian: Povišena glukoza bila je najčešće prijavljena laboratorijska abnormalnost 3. stupnja (23,2% bolesnika) u ispitivanju faze III na bolesnicima s Cushingovom bolešću.
English: Episodes of torsade de pointes were not observed in any clinical study with pasireotide.
Croatian: Epizode torsade de pointes nisu bile uočene ni u jednom kliničkom ispitivanju pasireotida.
English: For further details on handling, see section 6.6.
Croatian: Za više pojedinosti o rukovanju lijekom, vidjeti dio 6.6.
English: Pull the protective cover straight off the needle.
Croatian: Uklonite zaštitni poklopac ravno s igle.
English: 30 ampoules (5x6)
Croatian: 30 ampula (5x6)
English: In a randomised double-blinded mechanism study conducted in healthy volunteers, the development of hyperglycaemia with pasireotide administered as pasireotide subcutaneous use at doses of 0.6 and 0.9 mg twice a day was related to significant decreases in insulin secretion as well as incretin hormones (i.e. glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]).
Croatian: U randomiziranom, dvostruko slijepom ispitivanju mehanizma djelovanja provedenom na zdravim dobrovoljcima, razvoj hiperglikemije s pasireotidom primijenjenim supkutano u dozama od 0,6 i 0,9 mg dvaput na dan bio je povezan sa značajnim smanjenjima u izlučivanju inzulina kao i inkretinskih hormona (tj. glukagonu nalik peptida-1 [GLP-1] i inzulinotropnog polipeptida ovisnog o glukozi [GIP]).
English: Remove the Signifor injection kit from refrigerated storage.
Croatian: Izvadite Signifor set za primjenu injekcije iz hladnjaka.
English: Pasireotide binds with high affinity to four of the five hssts.
Croatian: Pasireotid se visokim afinitetom veže za četiri od pet hsst-a.
English: Remove the injection kit from the fridge and let the kit stand at room temperature for a minimum of 30 minutes before reconstitution, but do not exceed 24 hours.
Croatian: Izvadite set za primjenu injekcije iz hladnjaka i ostavite ga na sobnoj temperature najmanje 30 minuta prije rekonstitucije, ali ne dulje od 24 sata.
English: At therapeutic dose levels pasireotide is also not an inhibitor of UGT1A1, OATP1B1 or 1B3, OAT1 or OAT3, OCT1 or OCT2, P-gp, BCRP, MRP2 and BSEP.
Croatian: Pri terapijskim dozama pasireotid također ne inhibira UGT1A1, OATP1B1 ili 1B3, OAT1 ili OAT3, OCT1 ili OCT2, P-gp, BCRP, MRP2 i BSEP.
English: Tap the syringe with your fingers to get rid of air bubbles.
Croatian: Lagano kucnite štrcaljku prstima kako biste izbacili mjehuriće zraka.
English: Table 3 Percentage change in mean and median UFC levels per randomised dose group at month 6 and month 12 compared to baseline values
Croatian: Tablica 3 Postotak promjene srednjih razina i medijana razina UFC-a po skupinama randomiziranim po dozama u 6. i 12. mjesecu u usporedbi s početnim vrijednostima
English: Pasireotide has been shown to prolong the QT interval on the ECG in two dedicated healthy volunteer studies.
Croatian: Dokazano je da pasireotid produžuje QT interval na EKG-u u dva posebna ispitivanja na zdravim dobrovoljcima.
English: Recommended procedure: hold the ampoule in an upright position with the coloured dot facing away from you.
Croatian: Preporučeni postupak: držite ampulu uspravno tako da je obojana točka okrenuta od Vas.
English: Somatostatin receptors are expressed in many tissues, especially in neuroendocrine tumours in which hormones are excessively secreted, including GH in acromegaly and ACTH in Cushing's disease.
Croatian: Somatostatinski receptori izraženi su u mnogim tkivima, osobito u neuroendokrinim tumorima u kojima se prekomjerno izlučuju hormoni, uključujući GH kod akromegalije i ACTH kod Cushingove bolesti.
English: The primary efficacy end-point was the proportion of patients in each arm who achieved normalisation of mean 24-hour UFC levels (UFC ≤ULN) after 6 months of treatment and who did not have a dose increase (relative to randomised dose) during this period.
Croatian: Primarna mjera ishoda djelotvornosti bila je udio bolesnika u svakoj skupini koji su postigli normalizaciju srednjih 24-satnih razina UFC-a (UFC ≤GGN) nakon 6 mjeseci liječenja i kojima nije povećana doza (u odnosu na randomiziranu dozu) tijekom ovog razdoblja.
English: Included in the injection kit:
Croatian: Uključeno u set za primjenu injekcije:
English: The primary efficacy endpoint was to compare the proportion of patients achieving biochemical control (defined as mean GH levels <2.5 μg/l and normalisation of sex- and age-adjusted IGF-1) at week 24 with pasireotide intramuscular use 40 mg or 60 mg versus continued treatment with active control (octreotide intramuscular use 30 mg or lanreotide deep subcutaneous injection 120 mg), separately.
Croatian: Mjera primarnog ishoda djelotvornosti bila je usporediti udio bolesnika koji postignu biokemijsku kontrolu (definiranu kao srednje razine GH-a <2,5 μg/l i normalizacija IGF-1 prilagođenog za spol i dob) u 24. tjednu uz pasireotid 40 mg ili 60 mg primijenjen intramuskularno naspram kontinuiranog liječenja aktivnom kontrolom (oktreotid 30 mg primijenjen intramuskularno ili duboka supkutana injekcija 120 mg lanreotida), odvojeno.
English: In patients with poor glycaemic control, diabetes management and monitoring should be intensified prior to initiation and during pasireotide therapy.
Croatian: U bolesnika sa slabom glikemijskom kontrolom, zbrinjavanje i praćenje šećerne bolesti treba intenzivirati prije započinjanja terapije pasireotidom te za njenog trajanja.
English: Mean FPG levels commonly increased within the first month of treatment with decreases and stabilisation observed in subsequent months.
Croatian: Srednje razine FPG-a obično su se povisile unutar prvih mjesec dana liječenja, a smanjenja i stabilizacija opaženi su u narednim mjesecima.
English: Uncommon (may affect up to 1 in 100 people) - Low level of red blood cells (anaemia)
Croatian: Manje često (mogu se javiti u manje od 1 na 100 osoba) - Niska razina crvenih krvnih stanica (anemija)
English: Your doctor or nurse will instruct you on how to inject yourself with Signifor.
Croatian: Vaš liječnik ili medicinska sestra uputit će Vas kako da si sami ubrizgate Signifor.
English: The most common adverse reactions (incidence ≥1/10) from the pooled safety data from the phase III studies C2305 and C2402 were (in decreasing order): diarrhoea (most common in study C2305), cholelithiasis, hyperglycaemia (most common in study C2402) and diabetes mellitus.
Croatian: Najčešće nuspojave (incidencija ≥1/10) iz objedinjenih sigurnosnih podataka iz ispitivanja faze III, C2305 i C2402, bile su (počevši od najčešćih): proljev (najčešći u ispitivanju C2305), kolelitijaza, hiperglikemija (najčešća u ispitivanju C2402) i šećerna bolest.
English: Mean fasting plasma glucose levels commonly increased within the first month of treatment, with decreases and stabilisation observed in subsequent months.
Croatian: Srednje razine glukoze u plazmi natašte obično su se povećavale unutar prvih mjeseca dana liječenja, pri čemu su u narednim mjesecima bila uočena smanjenja i stabilizacija.
English: Slowly pull back the plunger to check that no blood vessel has been penetrated (reposition if a blood vessel has been penetrated).
Croatian: Polako povucite klip kako biste provjerili da niste probili krvnu žilu (ubodite u drugo mjesto ako ste probili krvnu žilu).
English: At therapeutic dose levels pasireotide is also not an inhibitor of UGT1A1, OATP, 1B1 or 1B3, P-gp, BCRP, MRP2 and BSEP.
Croatian: Pri terapijskim dozama pasireotid također ne inhibira UGT1A1, OATP, 1B1 ili 1B3, P-gp, BCRP, MRP2 i BSEP.
English: Maximum allowed dose was 60 mg for pasireotide intramuscular use and 30 mg for octreotide intramuscular use.
Croatian: Najveća dopuštena doza bila je 60 mg za pasireotid primijenjen intramuskularno i 30 mg za oktreotid primijenjen intramuskularno.
English: Renal impairment No dose adjustment is required in patients with impaired renal function (see section 5.2).
Croatian: Nije potrebno prilagođavanje doze u bolesnika s oštećenom funkcijom bubrega (vidjeti dio 5.2).
English: The elevations of fasting plasma glucose and HbA1c observed with pasireotide intramuscular use treatment are reversible after discontinuation.
Croatian: Povišenja glukoze u plazmi natašte i HbA1c uočena uz liječenje pasireotidom primijenjenim intramuskularno reverzibilna su nakon prekida liječenja.
English: Gamma glutamyltransferase increased, alanine aminotransferase increased, aspartate aminotransferase increased, lipase increased, blood glucose increased, blood amylase increased, prothrombin time prolonged
Croatian: Povišena gama glutamiltransferaza, povišena alanin aminotransferaza, povišena aspartat aminotransferaza, povišena lipaza, povišena glukoza u krvi, povišena amilaza u krvi, produženo protrombinsko vrijeme
English: Adverse reactions of hyperglycaemia and diabetes mellitus led to study discontinuation in 5 (3.1%) and 4 (2.5%) patients, respectively.
Croatian: Nuspojave hiperglikemije i šećerne bolesti dovele su do prekida ispitivanja u 5 (3,1%) odnosno 4 (2,5%) bolesnika.
English: Patients who develop increased transaminase levels should be monitored frequently until values return to pre-treatment levels.
Croatian: Bolesnike kod kojih se razviju povišene razine transaminaze treba pratiti učestalo dok se vrijednosti ne vrate na razine od prije liječenja.
English: Pull slightly on the plunger to check that a blood vessel has not been punctured.
Croatian: Lagano povucite klip kako biste provjerili da nije probodena krvna žila.
English: Baseline characteristics were balanced between the two randomised dose groups, except for marked differences in the mean value of baseline 24-hour UFC (1156 nmol/24 h for the 0.6 mg twice daily group and 782 nmol/24 h for the 0.9 mg twice daily group; normal range 30-145 nmol/24 h).
Croatian: Početne karakteristike bile su dobro uravnotežene između dviju skupina randomiziranih po dozama, osim kada je riječ o izraženim razlikama u srednjoj vrijednosti početnog 24-satnog UFC-a (1156 nmol/24 h za skupinu koja je primala 0,6 mg dvaput na dan i 782 nmol/24 h za skupinu koja je primala 0,9 mg dvaput na dan; normalni raspon 30-145 nmol/24 h).
English: At month 6, normalisation of mean UFC levels was observed in 14.6% (95% CI 7.0-22.3) and 26.3% (95% CI 16.6-35.9) of patients randomised to pasireotide 0.6 mg and 0.9 mg twice daily, respectively.
Croatian: U 6. mjesecu normalizacija srednjih razina UFC-a bila je uočena u 14,6% (95%-tni CI 7,0-22,3) odnosno 26,3% (95%-tni CI 16,6-35,9) bolesnika randomiziranih na primanje pasireotida u dozi od 0,6 mg odnosno 0,9 mg dvaput na dan.
English: Put the needle into the ampoule and pull the plunger to draw up the entire contents of the ampoule into the syringe.
Croatian: Stavite iglu u ampulu i povucite klip kako biste izvukli cjelokupni sadržaj ampule u štrcaljku.
English: Dose adjustment is not required in patients with mildly impaired hepatic function (Child Pugh A).
Croatian: Nije potrebno prilagođavanje doze u bolesnika s blago oštećenom funkcijom jetre (Child Pugh A).
English: Mean change in UFC (% from baseline)
Croatian: Srednja promjena UFC-a (% od početne vrijednosti)
English: Always keeping your skin pinched, slowly press the plunger down as far as it will go until all the solution is injected.
Croatian: Držeći kožu cijelo vrijeme, polako pritisnite klip do kraja dok cjelokupna otopina nije ubrizgana.
English: Baseline mean GH was 17.6 µg/l, 12.1 µg/l and 9.5 µg/l, in the 40 mg, 60 mg and active control groups, respectively.
Croatian: Početni srednji GH bio je redom 17,6 μg/l, 12,1 μg/l i 9,5 μg/l u skupinama koje su primale 40 mg, 60 mg, odnosno aktivnu kontrolu.
English: Monitoring of pituitary function (e.g. TSH/free T4, GH/IGF-1) before and periodically during Signifor therapy should therefore be considered, as clinically appropriate.
Croatian: Stoga treba razmotriti praćenje funkcije hipofize (npr. TSH/slobodni T4, GH/IGF-1) prije i periodički tijekom terapije Signiforom, kako je klinički potrebno.
English: Body weight has been found to be a covariate in the population pharmacokinetic analysis of Cushing's disease patients.
Croatian: Otkriveno je da je tjelesna težina kovarijabla u farmakokinetičkoj analizi populacije bolesnika s Cushingovom bolešću.
English: Very common (may affect more than 1 in 10 people) - Changed level of sugar in the blood.
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba) - Promjene u razini šećera u krvi.
English: Powder: brownish vial (glass) with rubber stopper (chlorobutyl rubber), containing the active substance (pasireotide).
Croatian: Prašak: smećkasta bočica (staklo) s gumenim čepom (klorobutil guma), sadrži djelatnu tvar (pasireotid).
English: The solution should be free of visible particles, clear and colourless.
Croatian: Otopina mora biti bez vidljivih čestica, bistra i bezbojna.
English: Do not use Signifor if you notice the solution is not clear or contains particles.
Croatian: Nemojte primjenjivati Signifor ako primijetite da otopina nije bistra ili da sadrži čestice.
English: Keeping your thumbs together above and below the neck, break off the top of the ampoule at the breaking point.
Croatian: Držeći jedan palac iznad a drugi ispod vrata ampule, otkinite vrh ampule na mjestu loma.
English: How much Signifor to use
Croatian: Koliko Signifora primijeniti
English: Dispose of syringe immediately in a sharps container.
Croatian: Štrcaljku odmah odložite u spremnik za oštre predmete.
English: The primary efficacy end point was the proportion of patients in each arm who achieved mean 24-hour UFC levels ≤ULN after 7 months of treatment, regardless of prior dose increase.
Croatian: Mjera primarnog ishoda djelotvornosti bila je udio bolesnika u svakoj skupini koji su postigli srednje 24-satne razine UFC-a ≤GGN nakon 7 mjeseci liječenja, bez obzira na prethodno povećanje doze.
English: The proportion of patients achieving biochemical control was 15.4% (p-value = 0.0006) and 20.0% (p-value <0.0001) for pasireotide intramuscular use 40 mg and 60 mg, respectively at 24 weeks compared with zero in the active control arm (Table 3).
Croatian: Udio bolesnika koji su postigli biokemijsku kontrolu bio je 15,4% (p-vrijednost = 0,0006) odnosno 20,0% (p-vrijednost <0,0001) za pasireotid 40 mg odnosno 60 mg intramuskularno u 24. tjednu, u usporedbi s nula u skupini s aktivnom kontrolom (Tablica 3).
English: In both dose groups, Signifor resulted in a decrease in mean UFC after 1 month of treatment, and this was maintained over time.
Croatian: U obje dozne skupine Signifor je rezultirao smanjenjem srednjeg UFC-a nakon 1 mjeseca liječenja i to se održalo tijekom vremena.
English: Important information about some of the ingredients of Signifor Signifor contains less than 1 mmol sodium (23 mg) per dose, which means it is essentially “sodium-free”.
Croatian: Važne informacije o nekim sastojcima Signifora Signifor sadrži manje od 1 mmol (23 mg) natrija po dozi, što znači da ima zanemarive količine natrija.
English: Sinus bradycardia, QT prolongation
Croatian: Sinusna bradikardija, produženje QT intervala
English: The starting dose was 40 mg for pasireotide intramuscular use and 20 mg for octreotide intramuscular use.
Croatian: Početna je doza bila 40 mg za pasireotid primijenjen intramuskularno i 20 mg za oktreotid primijenjen intramuskularno.
English: Studies in rats have shown effects on female reproductive parameters (see section 5.3).
Croatian: Ispitivanja na štakorima pokazala su učinke na ženske reproduktivne parametre (vidjeti dio 5.3).
English: Monitoring for an effect on the QTc interval is advisable and ECG should be performed prior to the start of Signifor therapy, one week after the beginning of the treatment and as clinically indicated thereafter.
Croatian: Savjetuje se praćenje učinka na QTc interval te obavljanje EKG-a prije početka terapije Signiforom, tjedan dana nakon početka liječenja, te nakon toga u skladu s kliničkim indikacijama.
English: The most common adverse reactions (incidence ≥10%) were diarrhoea, nausea, abdominal pain, cholelithiasis, injection site reactions, hyperglycaemia, diabetes mellitus, fatigue and glycosylated haemoglobin increased.
Croatian: Najčešće nuspojave (incidencija ≥10%) bile su proljev, mučnina, bolovi u abdomenu, kolelitijaza, reakcije na mjestu primjene, hiperglikemija, šećerna bolest, umor i povišenje razine glikiranog hemoglobina.
English: The total proportion of patients with either full or partial mean UFC control at month 6 was 34% and 41% of the randomised patients to the 0.6 mg and 0.9 mg dose, respectively.
Croatian: Ukupni udio bolesnika s potpunom ili djelomičnom kontrolom srednjeg UFC-a u 6. mjesecu bio je 34% odnosno 41% bolesnika randomiziranih na primanje doze od 0,6 mg odnosno 0,9 mg.
English: INSTRUCTIONS FOR USE OF SIGNIFOR SOLUTION FOR INJECTION
Croatian: UPUTE ZA PRIMJENU SIGNIFOR OTOPINE ZA INJEKCIJU
English: The therapeutic benefits of a reduction in growth hormone (GH) levels and normalisation of insulin-like growth factor 1 (IGF-1) concentration in female acromegalic patients and of a reduction or normalisation of serum cortisol levels in female patients with Cushing's disease could potentially restore fertility.
Croatian: U bolesnica s akromegalijom terapijske koristi sniženja razine hormona rasta (GH) i normalizacije koncentracije inzulinu sličnog faktora rasta-1 (IGF-1) te smanjenja ili normalizacije razina kortizola u serumu u bolesnica s Cushingovom bolešću mogu se očitovati ponovnom uspostavom plodnosti.
English: Patients with poor glycaemic control (as defined by HbA1c values >8% while receiving antidiabetic therapy) may be at higher risk of developing severe hyperglycaemia and associated complications (e.g. ketoacidosis).
Croatian: Bolesnici sa slabom glikemijskom kontrolom (definiranom vrijednostima HbA1c >8% dok primaju antidijabetičku terapiju) mogli bi imati veći rizik od razvoja teške hiperglikemije i povezanih komplikacija (npr. ketoacidoza).
English: 6 ampoules
Croatian: 6 ampula
English: Insulin and antidiabetic medicinal products
Croatian: Inzulin i antidijabetici
English: Common (may affect up to 1 in 10 people) - Tiredness, fatigue, pale skin (signs of low level of red blood cells) - Loss of appetite - Headache - Bloating - Vomiting - Dizziness - Pain, discomfort, pruritis and swelling at the injection site - Change in liver function test results
Croatian: Često (mogu se javiti u manje od 1 na 10 osoba) - Zamor, umor, blijeda koža (znakovi niske razine crvenih krvnih stanica) - Gubitak apetita - Glavobolja - Nadutost - Povraćanje - Omaglica - Bol, nelagoda, svrbež i oticanje na mjestu primjene injekcije - Promjena u rezultatima testova funkcije jetre
English: QTcF >480 ms was reported for 3 versus 2 patients in the pasireotide intramuscular use and octreotide intramuscular use groups, respectively, and QTcF >60 ms prolonged from baseline was reported for 2 versus 1 patients in the respective groups.
Croatian: QTcF >480 ms bio je prijavljen za 3 bolesnika u skupini koja je primala pasireotid intramuskularno, odnosno za 2 bolesnika u skupini koja je primala oktreotid intramuskularno, te je QTcF >60 ms produžen u odnosu na početnu vrijednost bio prijavljen za 2, odnosno 1 bolesnika u dotičnim skupinama.
English: Doses up to 2.1 mg twice a day have been used in healthy volunteers, with the adverse reaction diarrhoea being observed at a high frequency.
Croatian: Kod zdravih dobrovoljaca korištene su doze jačine do 2,1 mg dvaput na dan, pri čemu je vrlo često uočen proljev kao nuspojava.
English: Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products, such as beta blockers (e.g. metoprolol, carteolol, propranolol, sotalol), acetylcholinesterase inhibitors (e.g. rivastigmine, physostigmine), certain calcium channel blockers (e.g. verapamil, diltiazem, bepridil), certain antiarrhythmics (see also section 4.4).
Croatian: Kliničko praćenje srčane frekvencije, naročito na početku liječenja, preporučuje se u bolesnika koji primaju pasireotid istodobno s lijekovima protiv bradikardije, kao što su beta blokatori (npr. metoprolol, karteolol, propranolol, sotalol), inhibitori acetilkolinesteraze (npr. rivastigmin, fizostigmin), određenim blokatorima kalcijevih kanala (npr. verapamil, diltiazem, bepridil), određenim antiaritmicima (vidjeti također dio 4.4).
English: Solvent: colourless pre-filled syringe (glass) with front and plunger stopper (chlorobutyl rubber), containing 2 ml solvent.
Croatian: Otapalo: bezbojna napunjena štrcaljka (staklo) s prednjim čepom i čepom klipa (klorobutil guma), sadrži 2 ml otapala.
English: In both dose groups, Signifor resulted in a decrease in mean UFC after 1 month of treatment which was maintained over time.
Croatian: U obje dozne skupine Signifor je rezultirao smanjenjem u srednjem UFC-u nakon jednog mjeseca liječenja koje se održalo tijekom vremena.
English: Withdraw the needle from the injection site and activate the safety guard.
Croatian: Izvucite iglu s mjesta primjene i aktivirajte štitnik.