FrancophonIA/ELRC3.0 huggingface dataset:
English: • In the case, you will use the manual push infusion technique with a syringe, you may use only one infusion site per syringe.
Croatian: • U slučaju primjene infuzije ručnim potiskivanjem štrcaljke, može se koristiti samo jedno mjesto infuzije po štrcaljki.
English: 9 Infuse Hizentra
Croatian: 9 Infuzija Hizentre
English: Select the infusion site(s) - The number and location of infusion sites depends on the volume of the total dose.
Croatian: 7 Priprema mjesta za infuziju Odaberite mjesto(a) za infuziju - Broj i lokacija mjesta za infuziju ovise o volumenu ukupne doze.
English: What Hizentra is and what it is used for
Croatian: Što je Hizentra i za što se koristi
English: Elderly population The same warnings and precautions apply to the elderly population.
Croatian: Starija populacija Ista se upozorenja i mjere opreza odnose i na stariju populaciju.
English: Adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Croatian: Povremeno se mogu pojaviti nuspojave kao što su zimica, glavobolja, vrućica, povraćanje, alergijske reakcije, mučnina, artralgija, nizak krvni tlak i umjerena bol u donjem dijelu leđa.
English: How Hizentra works
Croatian: Kako Hizentra djeluje
English: The extension study investigated the long-term safety and efficacy of Hizentra maintenance therapy in the two weekly doses, 0.2 g/kg and 0.4 g/kg bw.
Croatian: Nastavak ispitivanja istraživao je sigurnost dugotrajne primjene i djelotvornost terapije održavanja Hizentre u dvije tjedne doze od 0,2 g/kg i 0,4 g/kg tt.
English: Solutions that are cloudy or have deposits should not be used.
Croatian: Otopine koje su mutne ili sadrže taloge ne smiju se koristiti.
English: Sustained IgG trough levels with a mean concentration of 12.53 g/l were thereby achieved throughout the treatment period.
Croatian: Time su postignute održane najniže razine IgG sa srednjom koncentracijom od 12,53 g/l tijekom liječenja.
English: • combination of low immunoglobulin levels, frequent infections and inability to produce adequate amounts of antibodiesafter vaccination (common variable immunodeficiency)
Croatian: • kombinacija niske razine imunoglobulina, čestih infekcija i nemogućnosti stvaranja dovoljne količine protutijela nakon cijepljenja (zajednička varijabla imunodeficijencije)
English: Patients who completed the PATH study without relapse on 0.2 g/kg bw dose and initially received this dose in the extension study had a relapse rate of 50 % (3/6 patients).
Croatian: Bolesnici koji su završili PATH ispitivanje bez relapsa na dozi od 0,2 g/kg tt i početno su primili ovu dozu u nastavku ispitivanja imali su relaps stopu od 50% (3/6 bolesnika).
English: The mean dose administered each week was 0.23 g/kg bw.
Croatian: Srednja doza primijenjena svakog tjedna bila je 0,23 g/kg tt.
English: The solution should be clear and pale-yellow or light-brown.
Croatian: Otopina treba biti bistra i blijedo žute ili svijetlo smeđe boje.
English: In a clinical phase III trial with Hizentra (n = 46), the subjects achieved sustained trough levels (median 8.1 g/l) over a period of 29 weeks when receiving median weekly doses of 0.06 to 0.24 g/kgbw.
Croatian: U fazi III kliničkog ispitivanja lijeka Hizentra (n = 46), održane najniže razine (medijan 8,1 g/l) u ispitanika postignute su u razdoblju od 29 tjedana tijekom primanja tjedne doze s medijanom 0,06 do 0,24 g/kg tt.
English: Human normal immunoglobulin (SCIg)
Croatian: Ljudski normalni imunoglobulin (s.c.Ig)
English: Time to CIDP relapse (Figure 1) was evaluated, and the corresponding probabilities for CIDP relapse based on Kaplan-Meier estimates were: placebo, 58.8 %; 0.2 /kg bw Hizentra, 35.0 %; and 0.4 g/kg bw Hizentra, 22.4 %.
Croatian: Ocijenjeno je vrijeme do relapsa KUDP-a (Slika 1), dok su odgovarajuće vjerojatnosti za relaps KUDP-a na temelju Kaplan-Meierovih procjena bile: 58,8% za placebo; 35,0% za Hizentru 0,2 g/kg tt; 22,4% za Hizentru 0,4 g/kg po tt.
English: Pre-filled syringes 5, or 10 ml of solution in a pre-filled syringe (cyclo-olefin-copolymer (COC)).
Croatian: 5 ili 10 ml otopine u napunjenoj štrcaljki (cikloolefin kopolimer (COC)).
English: Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contraindicated.
Croatian: − Hipogamaglobulinemije i rekurentnih bakterijskih infekcija kod bolesnika s kroničnom limfocitnom leukemijom (KLL), kod kojih profilaktički antibiotici nisu djelovali ili su kontraindicirani.
English: The weekly dose can be divided into smaller doses and administered by desired number of times per week.
Croatian: Tjedna doza se može podijeliti na manje doze kako bi se primijenila u željenom broju primjena kroz tjedan.
English: When only considering relapse, the CIDP relapse rates were 19.0 % for 0.4 g/kg bw Hizentra and 33.3 % for 0.2 g/kg bw Hizentra compared with 56.1 % for placebo (p < 0.001 or p = 0.012, respectively).
Croatian: Kada se razmatra samo relaps, stope relapsa KUDP-a bile su 19,0% za ispitanike liječene Hizentrom u dozi od 0,4 g/kg tt i 33,3% za dozu od 0,2 g/kg tt u usporedbi s 56,1% za placebo (p <0,001 odnosno p = 0,012).
English: In the US prospective open label, single arm and multicentre study, a total of 49 subjects with primary immunodeficiency syndromes aged between 5 and 72 years old were treated with Hizentra for up to 15 months.
Croatian: U američkom prospektivno otvorenom, multicentričnom ispitivanju s jednom skupinom, ukupno 49 ispitanika sa sindromom primarne imunodeficijencije u dobi između 5 i 72 godine bilo je liječeno Hizentrom do 15 mjeseci.
English: Hypogammaglobulinaemia and recurrent infections in multiple myeloma (MM) patients.
Croatian: − Hipogamaglobulinemije i rekurentnih infekcija kod bolesnika s multiplim mijelomom (MM).
English: A 24 or larger (i.e. lower gauge number) needle gauge may be required to allow patients to infuse at higher flow rates.
Croatian: Možda će biti potrebna igla veličine 24G ili većeg promjera (odnosno manji G broj (engl. „gauge“)) kako bi bolesnici mogli infundirati pri većim brzinama.
English: Sustained IgG trough levels with mean concentrations of 7.99 - 8.25 g/l were thereby achieved throughout the treatment period.
Croatian: Time su postignute održane najniže razine IgG sa srednjim koncentracijama od 7,99 do 8,25 g/l tijekom liječenja.
English: No differences were seen in the pharmacokinetic parameters between adult and paediatric PID study patients.
Croatian: Nisu uočene razlike u farmakokinetičkim parametrima između odraslih i pedijatrijskih PID bolesnika u ispitivanju.
English: If Hizentra is accidentally administered into a blood vessel, patients could develop shock.
Croatian: U slučaju nehotične primjene Hizentre u krvnu žilu, bolesnici mogu pasti u šok.
English: Each vial of 5 ml solution contains: 1 g of human normal immunoglobulin Each vial of 10 ml solution contains: 2 g of human normal immunoglobulin Each vial of 20 ml solution contains: 4 g of human normal immunoglobulin Each vial of 50 ml solution contains: 10 g of human normal immunoglobulin
Croatian: Jedna bočica od 5 ml otopine sadrži: 1 g ljudskog normalnog imunoglobulina Jedna bočica od 10 ml otopine sadrži: 2 g ljudskog normalnog imunoglobulina Jedna bočica od 20 ml otopine sadrži: 4 g ljudskog normalnog imunoglobulina Jedna bočica od 50 ml otopine sadrži: 10 g ljudskog normalnog imunoglobulina
English: The recommended initial infusion rate should not exceed 0.5 ml/min/site (30 ml/hour/site).
Croatian: Preporučena početna brzina infuzije ne smije prelaziti 0.5 ml/min/mjestu (30 ml/sat/mjestu).
English: Therapy should be initiated and monitored under the supervision of a healthcare professional experienced in the treatment of immunodeficiency/CIDP with SCIg.
Croatian: Nadomjesnu terapiju treba započeti i nadzirati zdravstveni radnik s iskustvom u liječenju imunodeficijencije/KUDP-a sa s.c.Ig.
English: • Muscular weakness
Croatian: • Mišićna slabost
English: For dosing every two weeks, double the weekly Hizentra dose.
Croatian: Za doziranje svaka dva tjedna udvostruči se tjedna doza Hizentre.
English: ► In isolated cases, you may experience pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body, sudden confusion, or trouble speaking or understanding could be signs of a blood clot.
Croatian: ► U izoliranim slučajevima, možete osjetiti bol i/ili oticanje ruke ili noge s toplinom na zahvaćenom području, promjena boje ruke ili noge, neobjašnjivi nedostatak zraka, bol u prsnom košu ili nelagoda koja se pogoršava dubokim disanjem, neobjašnjiv ubrzani puls, obamrlost ili slabost na jednoj strani tijela, iznenadna smetenost, ili poteškoće u govoru i razumijevanju mogu biti znakovi za krvni ugrušak.
English: If administration with an additional Hizentra syringe is required, a new sterile injection needle should be used and the infusion site changed.
Croatian: Ako je potrebna dodatna štrcaljka lijeka Hizentra, treba koristiti novu sterilnu iglu i promijeniti mjesto infuzije.
English: Only one infusion site per syringe can be infused.
Croatian: Samo se jedno mjesto može infundirati po štrcaljki.
English: The following side effects are very common (affects more than 1 patient in 10):
Croatian: Sljedeće nuspojave su vrlo česte (javljaju se u više od 1 na 10 bolesnika):
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Croatian: Unatoč tim mjerama, kod primjene lijekova dobivenih iz ljudske krvi ili plazme, mogućnost prijenosa infekcije ne može biti potpuno isključena.
English: In case of home treatment, this will be initiated by a healthcare professional experienced in the treatment of immunodeficiency/CIDP with SCIg and in the guidance of patients for home treatment.
Croatian: U slučaju kućnog liječenja, liječenje će započeti i nadzirati zdravstveni radnik s iskustvom u liječenju imunodeficijencije/KUDP-a sa s.c.Ig i u vođenju bolesnika na kućnom liječenju.
English: Immunoglobulins are produced by human body's immune system.
Croatian: Imunoglobuline stvara ljudski imunološki sustav.
English: Subjects in the high dose Hizentra group remained stable in the Rasch-built Overall Disability Scale (R-ODS) centile score.
Croatian: Ispitanici u skupini s visokom dozom Hizentre ostali su stabilni prema centilnom skoru na ljestvici R-ODS (engl.
English: For all patients who received 0.2 g/kg bw in the extension study, 47.9 % (35/73 patients) had a relapse.
Croatian: Svi bolesnici koji su primili 0,2 g/kg tt u nastavku ispitivanja, njih 47,9% (35/73 bolesnika) je imalo relaps.
English: The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 5 to 6 g/l and aim to be within the reference interval of serum IgG for age.
Croatian: Doznim režimom treba se postići najniža razina IgG (mjerena prije iduće infuzije) od najmanje 5 do 6
English: • Fast heartbeat (tachycardia)
Croatian: • Brzi otkucaji srca (tahikardija)
English: In the case of measles, this impairment may persist for up to 1 year.
Croatian: U slučaju morbila, umanjena učinkovitost može potrajati i do godinu dana.
English: The following side effects are common (affects 1 to 10 patients in 100):
Croatian: Sljedeće nuspojave su česte (javljaju se u 1 do 10 na 100 bolesnika):
English: The mean duration of exposure was 118.9 days in the 0.2 g/kg bw and 129 days in the 0.4 g/kg bw Hizentra group (maximum exposure up to 167 and 166 days in each group, respectively).
Croatian: dana za Hizentra skupinu liječenu s 0,2 g/kg tt i 129 dana za 0,4 g/kg tt (maksimalna izloženost do 167 odnosno 166 dana u svakoj grupi).
English: In the second patient group receiving Hizentra via pump-assisted administration (n=18), weekly Hizentra infusions were administered with 25, 50, 75 and 100 ml/hour/site flow rate.
Croatian: U drugoj skupini bolesnika koja su primali lijek Hizentra pomoću pumpe (n = 18) primjenjivane su tjedne infuzije lijeka Hizentra s brzinom protoka od 25, 50, 75 i 100 ml/sat/mjestu.
English: When using multiple vials to achieve the desired dose, repeat this step.
Croatian: Ako upotrebljavate nekoliko bočica kako biste postigli željenu dozu,
English: The solution is clear and pale-yellow or light-brown.
Croatian: Otopina je bistra, blijedo žute ili svijetlo smeđe boje.
English: Data from prospective clinical trials on the use of human normal immunoglobulin in breast feeding women is limited.
Croatian: Podaci iz prospektivnih kliničkih ispitivanja o primjeni ljudskog normalnog imunoglobulina u dojilja su ograničeni.
English: Replacement therapy The medicinal product should be administered via the subcutaneous route.
Croatian: Lijek se treba primjenjivati supkutanim putem.
English: Caution should be exercised in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilization, severely hypovolemic patients, patients with diseases which increase blood viscosity).
Croatian: hipertenzije, dijabetesa mellitusa i anamneze vaskularnih bolesti ili trombotskih epizoda, bolesnika sa stečenim ili naslijeđenim trombofilijskim poremećajima, bolesnici s produljenim razdobljima imobilizacije, bolesnika s teškom hipovolemijom, bolesnika s bolestima koje povećavaju viskoznost krvi).
English: • The active substance is human normal immunoglobulin.
Croatian: • Djelatna tvar je ljudski normalni imunoglobulin.
English: The initial subcutaneous dose may be a 1:1 conversion from the previous IVIG dose (calculated as weekly dose).
Croatian: Početna supkutana doza može se izračunati na temelju prethodne i.v.Ig doze uz omjer 1: 1 (ali je potrebno izračunati tjednu dozu).
English: Because the solution contains no preservative, Hizentra should be used/infused as soon as possible after opening the vial or blistered pre-filled syringe.
Croatian: Budući da otopina ne sadrži konzervans, Hizentra se treba upotrijebiti/ubrizgati što je prije moguće nakon otvaranja bočice ili napunjene štrcaljke u blisteru.
English: 1 x 5 ml 1 x 10 ml 1 x 20 ml 1 x 50 ml 10 x 5 ml 10 x 10 ml 10 x 20 ml 10 x 50 ml 20 x 5 ml 20 x 10 ml 20 x 20 ml
Croatian: 1 x 5 ml 1 x 10 ml 1 x 20 ml 1 x 50 ml 10 x 5 ml 10 x 10 ml 10 x 20 ml 10 x 50 ml 20 x 5 ml 20 x 10 ml
English: The recommended initial infusion rate is up to 0.5 ml/min/site (30 ml/hour/site).
Croatian: Preporučena početna brzina infuzije je do 0,5 ml/min/mjestu (30 ml/sat/mjestu).
English: Marketing Authorisation Holder and Manufacturer CSL Behring GmbH
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač CSL Behring GmbH
English: For all patients who received 0.4 g/kg bw in the PATH extension study, 9.7 % (7/72 patients) had a relapse.
Croatian: Svi bolesnici koji su primili 0,4 g/kg tt u nastavku PATH ispitivanja, njih 9,7% (7/72 bolesnika) je imalo relaps.
English: Immunomodulatory therapy
Croatian: Imunomodulacijska terapija
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Croatian: Unatoč tome, kod primjene lijekova dobivenih iz ljudske krvi ili plazme, mogućnost prijenosa infektivnih bolesti ne može biti potpuno isključena.
English: 6 Prepare the tubing
Croatian: 6 Priprema cijevi
English: • Do not use this medicine after the expiry date which is stated on the outer carton and the pre filled syringe label after EXP.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i naljepnici na napunjenoj štrcaljki nakon oznake „Rok valjanosti“.
English: If you have any further questions on the use of this medicine, please ask your doctor or healthcare professional.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili zdravstvenom radniku.
English: Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus or the neonate are to be expected.
Croatian: Kliničko iskustvo s imunoglobulinima upućuje na to da nema očekivanih štetnih učinaka na tijek trudnoće, ili na fetus i novorođenče.
English: Paediatric population The same interactions may occur in the paediatric population.
Croatian: Jednake interakcije mogu se javiti i u pedijatrijskoj populaciji.
English: If well-tolerated, you may increase the infusion rate up to 2.0 ml/min/site (120 ml/hour/site) for subsequent infusions.
Croatian: Ako se dobro podnosi, možete povećati brzinu infuzije do 2,0 ml/min/mjestu (120 ml/sat/mjestu) za sljedeće infuzije.
English: Treatmentof low immunoglobulin levels and recurrent bacterial infections in patients with chronic lymphocytic leukaemia(CLL), a certain kind of blood cancer, where prophylactic antibiotics have failed or are contra-indicated.
Croatian: Liječenje niskih razina imunoglubulina i opetovanih bakterijskih infekcija kod bolesnika s kroničnom limfocitnom leukemijom (KLL), jednom vrstom raka krvi, gdje profilaktički antibiotici ne djeluju ili su kontraindicirani.
English: Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
Croatian: Kliničko iskustvo s imunoglobulinima upućuje na to da nema očekivanih štetnih učinaka na plodnost.
English: Once a vial or the blistered pre-filled syringe has been opened, the solution should be used immediately.
Croatian: Nakon što se bočica ili napunjena štrcaljka u blisteru otvore, otopinu treba primijeniti odmah.
English: Hizentra may be infused into sites such as abdomen, thigh, upper arm, and / or lateral hip.
Croatian: Hizentra može biti infundirana na mjesta kao što su abdomen, bedro, nadlaktica i lateralna strana kuka.
English: In clinical studies Hizentra was evaluated in 61 subjects with CIDP >65 years of age and no specific dose adjustments were necessary to achieve the desired clinical outcome.
Croatian: Hizentra je ocijenjena u kliničkim ispitivanjima kod 61 ispitanika s KUDP-om u dobi od > 65 godina starosti i bez potrebe prilagodbe specifične doze za postizanje željenog kliničkog ishoda.
English: The initial infusion rate should not exceed 20 ml/hour/site.
Croatian: Početna brzina infuzije ne smije prelaziti 20 ml/sat/mjestu.
English: If well-tolerated, you may gradually increase the infusion rate to 35 ml/hour/site for the subsequent two infusions.
Croatian: U slučaju dobrog podnošenja, brzina infuzije postupno se može povećati na 35 ml/sat/mjestu za dvije sljedeće infuzije.
English: Frequency of Adverse Drug Reactions (ADR) associated with Hizentra obtained from clinical studies and post-marketing surveillance, reporting rate per patient or per infusion
Croatian: Učestalost nuspojava povezanih s Hizentrom dobivena iz kliničkih ispitivanja i praćenja nakon stavljanja lijeka u promet, stopa prijava po bolesniku ili po infuziji.
English: In infants and children, infusion site may be changed every 5-15 ml.
Croatian: Kod dojenčadi i djece, mjesto infuzije može se mijenjati svakih
English: There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
Croatian: A ili parvovirusa B19V putem imunoglobulina, a također se pretpostavlja da sadržaj protutijela čini važan doprinos virusnoj sigurnosti.
English: The weekly maintenance doses may be divided into smaller doses and administered as often as required during the week.
Croatian: Tjedna doza održavanja može biti podijeljena na manje doze koje se primjenjuju u željenom rasporedu primjena tijekom tjedna.
English: Hizentra may impair the effect of some live virus vaccines such as measles, rubella, mumps and chicken pox.
Croatian: Ovaj lijek može umanjiti učinak nekih živih virusnih cjepiva, kao što su ona za ospice, rubelu, zaušnjake i vodene kozice.
English: Hizentra comes as a ready-to-use solution in single-use vials or single-use pre-filled syringes.
Croatian: Hizentra je dostupna kao otopina spremna za primjenu u jednokratnim bočicama ili jednokratnim napunjenim štrcaljkama.
English: The mean (SD) IgG trough concentration after Hizentra treatment in the 0.4 g/kg bw group was 20.4 (3.24) g/l and 15.4 (3.06) g/l in the 0.2 g/kg bw group.
Croatian: Srednja vrijednost najniže koncentracije (SD) IgG nakon liječenja Hizentrom u skupini na 0,4 g/kg tt bila je 20,4 (3,24) g/l i 15,4
English: Elderly population The same interactions may occur in the elderly population.
Croatian: Jednake interakcije mogu se javiti i u starijoj populaciji.
English: Pack sizes of 1, 10 or 20 vials: 1 g / 5 ml
Croatian: Pakiranja od 1, 10 ili 20 bočica: 1 g / 5 ml
English: Hizentra was evaluated in 68 paediatric subjects with PID 2 to <12 years of age and in 57 paediatric subjects 12 to <18 years of age.
Croatian: Hizentra je procjenjena kod 68 pedijatrijska ispitanika s PID-om u dobi od 2 do < 12 godina starosti i kod 57 pedijatrijskih ispitanika u dobi od 12 do < 18 godina starosti.
English: Local reactions at infusion sites: swelling, soreness, redness, induration, local heat, itching, bruising and rash.
Croatian: Lokalne reakcije na mjestima primjene: oticanje, bolnost, crvenilo, otvrdnuće, lokalni osjećaj topline,
English: Do not store above 25 °C.
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 25 ° C.
English: Human normal immunoglobulin................................................................................................ 200 mg (purity: at least 98% is immunoglobulin type G (IgG))
Croatian: Ljudski normalni imunoglobulin………………………….................................200 mg (čistoće: najmanje 98% imunoglobulina tipa G (IgG))
English: In clinical studies Hizentra was evaluated in 13 subjects with PID >65 years of age and no specific dose adjustments were necessary to achieve the desired serum IgG levels.
Croatian: Hizentra je ocijenjena u kliničkim ispitivanjima kod 13 ispitanika s PID-om starijih od 65 godina i bez potrebe prilagodbe specifične doze za postizanje željene razine IgG u serumu.
English: Arterial and venous thromboembolic events including myocardial infarction, stroke, deep venous thrombosis and pulmonary embolism have been associated with the use of immunoglobulins.
Croatian: S upotrebom imunoglobulina povezuju se arterijski i venski tromboembolijski događaji uključujući infarkt miokarda, moždani udar, duboku vensku trombozu i plućnu emboliju.
English: AMS is characterised by the following signs and symptoms: severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomiting.
Croatian: AMS obilježavaju slijedeći znakovi i simptomi: jaka glavobolja, ukočenost u vratu, omamljenost, vrućica, fotofobija, mučnina i povraćanje.
English: 4.2Posology and method of administration
Croatian: 4.2 Doziranje i način primjene
English: Side effects observed in controlled clinical studies are presented in order of decreasing frequency.
Croatian: Nuspojave primijećene u kontroliranim kliničkim ispitivanjima navedene su slijedom od najčešćih prema najrjeđim.
English: • Do not use this medicine after the expiry date which is stated on the outer carton and the vial label after EXP.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i naljepnici na bočici nakon oznake „Rok valjanosti“.
English: Home-treatment
Croatian: Kućno liječenje
English: Patients with hyperprolinaemia type I or II.
Croatian: Bolesnici s hiperprolinemijom tipa
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (bočica)
English: Tell your doctor or healthcare professional prior to treatment if you have experienced an intolerance against one of these components earlier.
Croatian: Molimo obavijestite svog liječnika ili zdravstvenog radnika u slučaju ranijeg nepodnošenja bilo kojeg od navedenih sastojaka