FrancophonIA/ELRC3.0 huggingface dataset:
English: In extensive post-registration observational studies with Helixate NexGen, involving more than 1000 patients the following was observed: Less than 0.2% PTP developed de-novo inhibitors.
Croatian: U opsežnim opservacijskim ispitivanjima lijeka Helixate NexGen nakon registracije koja su obuhvaćala više od 1000 bolesnika zabilježeni su sljedeći rezultati: u manje od 0,2% prethodno liječenih bolesnika razvili su se de-novo inhibitori.
English: In one observational study, the incidence of inhibitor development in previously untreated patients with severe haemophilia A was 64/183 (37.7%) with Helixate NexGen (followed up to 75 exposure days).
Croatian: U jednom opservacijskom ispitivanju, incidencija razvoja inhibitora u prethodno neliječenih bolesnika s teškom hemofilijom A bila je 64/183 (37,7%) uz Helixate NexGen (praćenih do 75 dana izloženosti).
English: If you are using Helixate NexGen to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Croatian: Ako Helixate NexGen uzimate za prevenciju (profilaksu) krvarenja, liječnik će Vam izračunati potrebnu dozu.
English: • If you have previously developed a factor VIII inhibitor and you switch factor VIII products, you may be at risk of your inhibitor coming back.
Croatian: • Ako ste prethodno već razvili inhibitor faktora VIII te počnete uzimati neki drugi lijek s faktorom VIII, postoji rizik da se inhibitor vrati.
English: Determination of activated partial thromboplastin time (aPTT) is a conventional in vitro assay method for biological activity of factor VIII.
Croatian: Farmakodinamički učinci Određivanje aktiviranog parcijalnog tromboplastinskog vremena (APTV) uobičajena je metoda in vitro određivanja biološke aktivnosti faktora VIII.
English: Helixate NexGen is used for treatment and prophylaxis of bleeding adults, adolescents and children of all ages with haemophilia A (congenital factor VIII deficiency).
Croatian: Helixate NexGen se koristi za liječenje i prevenciju krvarenja u odraslih, adolescenata i djece bilo koje dobi s hemofilijom A (nasljedni nedostatak faktora VIII).
English: Therefore, Helixate NexGen should be used during pregnancy and breast-feeding only if clearly indicated.
Croatian: Helixate NexGen stoga se u trudnoći i tijekom dojenja smije koristiti samo ako za to postoje jasne indikacije.
English: • If you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing a rare severe sudden allergic reaction (a socalled anaphylactic reaction) to this medicine.
Croatian: • Ako osjetite stezanje u prsima, omaglicu, mučninu ili nesvjesticu ili pak omaglicu prilikom ustajanja jer to mogu biti znakovi rijetke, ali teške i iznenadne alergijske reakcije (takozvane anafilaktičke reakcije) na ovaj lijek.
English: Rare: may affect up to 1 in 1,000 users
Croatian: Rijetko: mogu se javiti u do 1 na 1000 korisnika
English: Cases of recurrence of inhibitors (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development.
Croatian: Zabilježeni su slučajevi ponovnog razvoja inhibitora (niskog titra) nakon promjene terapije s jednog lijeka koji sadrži faktor VIII na drugi u prethodno liječenih bolesnika u kojih je izloženost dulja od 100 dana i u kojih su se već razvijali inhibitori.
English: Keep the vials in the outer carton in order to protect from light.
Croatian: Bočice držite u vanjskom pakovanju radi zaštite od svjetla.
English: The safety and efficacy of Helixate NexGen in children of all ages have been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost lijeka Helixate NexGen ustanovljena je u djece svih dobi.
English: Required IU = body weight (kg) × desired factor VIII rise (% of normal) × 0.5
Croatian: Potreban broj IU = tjelesna težina (kg) × željeni porast faktora VIII (% od normalne vrijednosti) × 0,5 II.
English: Only the provided administration sets can be used because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Croatian: Smiju se koristiti samo kompleti za primjenu koji se isporučuju uz lijek jer zbog adsorpcije ljudskog rekombinantnog koagulacijskog faktora VIII u unutrašnje površine određene infuzijske opreme liječenje može biti neuspješno.
English: If a further dose needs to be administered, use a new syringe with product reconstituted as described above.
Croatian: Ako je potrebno primijeniti drugu dozu, uzmite novu štrcaljku s lijekom razrijeđenim prema gore navedenom postupku.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: LIJEKA Plan upravljanja rizikom (RMP) Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2.
English: It is recommended that every time that you use Helixate NexGen, the name and batch number of the product are documented.
Croatian: Dokumentiranje Preporučuje se da se svaki put kad primijenite Helixate NexGen zabilježe naziv i broj serije lijeka.
English: No studies were performed on the mutagenic potential of Helixate NexGen, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of Helixate NexGen.
Croatian: Nisu provedena ni ispitivanja mutagenog potencijala lijeka Helixate NexGen budući da za lijek koji mu je prethodio nije uočen mutageni potencijal u in vitro i in vivo ispitivanjima.
English: Concentrations of rFVIII solution 100 IU/ml 200 IU/ml 400 IU/ml
Croatian: Koncentracija otopine rFVIII 100 IU/ml 200 IU/ml 400 IU/ml
English: Each package of Helixate NexGen contains:
Croatian: Pakiranje lijeka Helixate NexGen sadrži sljedeće:
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
Croatian: Čuvati u hladnjaku (2 °C - 8 °C).
English: b) By continuous infusion Raise factor VIII activity presurgery with an initial bolus infusion and immediately follow with continuous infusion (in IU/kg/h) adjusting according to patient's daily clearance and desired factor VIII levels for at least 7 days.
Croatian: Povećati aktivnost faktora VIII prije operacije početnom infuzijom u obliku bolusa, a zatim odmah nastaviti s kontinuiranom infuzijom (u IU/kg/h) tijekom najmanje 7 dana uz prilagodbu prema dnevnoj dozvoljenoj dozi za bolesnika i željenoj razini faktora VIII.
English: Fertility There are no fertility data available.
Croatian: Nema podataka o utjecaju na plodnost.
English: In clinical studies, Helixate NexGen has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated paediatric patients (MTPs, defined as having ≤4 exposure days) with residual FVIII:C < 2 IU/dl.
Croatian: U kliničkim ispitivanjima, Helixate NexGen se upotrebljavao za liječenje krvarenja u 37 prethodno neliječenih bolesnika (PNB) te 23 minimalno liječena pedijatrijska bolesnika (MLB, definirani kao izloženi lijeku ≤4 dana) s rezidualnim FVIII C < 2 IU/dl.
English: A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE
English: Example: for a 75 kg patient with a clearance of 3 ml/h/kg, the initial infusion rate would be 3 IU/h/kg to achieve a FVIII level of 100%.
Croatian: Primjer: početna brzina infuzije za bolesnika težine 75 kg i klirensa od 3 ml/h/kg iznosila bi 3 IU/h/kg ako se želi postići razina faktora VIII od 100%.
English: Helixate NexGen is provided as a powder and solvent for solution for injection and is a dry white to slightly yellow powder or cake.
Croatian: Helixate NexGen sastoji se od praška i otapala za otopinu za injekciju, a dostupan je u obliku suhog bijelog do žućkastog praška ili kolačića.
English: Patients with haemophilia A may develop neutralising antibodies (inhibitors) to factor VIII.
Croatian: Bolesnici s hemofilijom A mogu razviti neutralizirajuća protutijela (inhibitore) na faktor VIII.
English: • formation of neutralising antibodies to factor VIII (inhibitors) in previously untreated patients
Croatian: • stvaranje neutralizirajućih protutijela na faktor VIII (inhibitora) u prethodno neliječenih bolesnika
English: Even doses several fold higher than the recommended clinical dose (related to body weight) failed to demonstrate any acute or subacute toxic effects for Helixate NexGen in laboratory animals (mouse, rat, rabbit, and dog).
Croatian: Čak i pri primjeni višestruko veće doze lijeka Helixate NexGen od preporučene kliničke doze (koja je povezana s tjelesnom težinom) u laboratorijskih se životinja (miša, štakora, kunića i psa) nisu očitovali nikakvi akutni ni subakutni toksični učinci.
English: PUPs = previously untreated patients PTPs = previously treated patients MTPs = minimally treated patients * see section below
Croatian: PNB = prethodno neliječeni bolesnici PLB = prethodno liječeni bolesnici MLB = minimalno liječeni bolesnici
English: • This medicine is intended for intravenous administration only and should be administered within 3 hours after reconstitution.
Croatian: Ovaj lijek namijenjen je isključivo za primjenu u venu te se mora primijeniti u roku od 3 sata nakon pripreme za primjenu.
English: Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Croatian: Oprezno uklonite blister pakiranje s kompleta uređaja Mix2Vial držeći ga za obod i povlačeći okomito prema gore.
English: The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 ml/min).
Croatian: Brzina primjene određuje se prema stupnju tolerancije bolesnika (maksimalna je brzina infuzije 2 ml/min).
English: • If you are allergic to mouse or hamster protein.
Croatian: • ako ste alergični na bjelančevine miša ili hrčka.
English: With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew the set carefully into two pieces.
Croatian: Jednom rukom primite komplet uređaja Mix2Vial za onu stranu na kojoj je lijek, a drugom za stranu na kojoj je otapalo te oprezno odvijte komplet u dva komada.
English: Finally, apply a small pressure dressing to the wound.
Croatian: Na kraju lagano stisnite ranu previjanjem.
English: In clinical studies with 73 previously treated patients (PTP, defined as having ≥100 exposure days), followed over 4 years, no de-novo inhibitors were observed.
Croatian: U kliničkim ispitivanjima 73 prethodno liječena bolesnika (PLB, definirani kao oni s ≥100 dana izloženosti) praćenih tijekom 4 godine nije zabilježena pojava de-novo inhibitora.
English: It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that Helixate NexGen can be used for continuous infusion in surgeries (pre-, during and postoperative).
Croatian: Kliničko ispitivanje provedenu u odraslih bolesnika s hemofilijom A u kojih se radi veliki kirurški zahvat pokazalo je da se Helixate NexGen može koristiti za kontinuiranu infuziju kod operacije (prije,
English: 1 vial with 5.0 ml water for injections.
Croatian: 1 bočica s 5,0 ml vode za injekcije
English: 1 vial with 2.5 ml water for injections.
Croatian: 1 bočica s 2,5 ml vode za injekcije
English: • If for the administration of Helixate NexGen you will require a central venous access device (CVAD), the risk of CVAD-related complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted should be considered by your doctor.
Croatian: • Ako Vam je zbog primjene lijeka Helixate NexGen potrebno postaviti centralni venski kateter, Vaš liječnik treba uzeti u obzir rizik od komplikacija povezanih s centralnim venskim kateterom, kao što su lokalne infekcije, bakterije u krvi (bakterijemija) i stvaranje krvnog ugruška u krvnoj žili (tromboza) u koju je uveden kateter.
English: • formation of neutralising antibodies to factor VIII (inhibitors) in previously treated patients
Croatian: • stvaranje neutralizirajućih protutijela na faktor VIII (inhibitora) u prethodno liječenih bolesnika
English: • an additional package with: - 1 filter transfer device 20/20 [Mix2Vial] - 1 venipuncture set - 1 disposable 5 ml syringe - 2 alcohol swabs for single use
Croatian: • dodatno pakovanje koje sadrži sljedeće: - 1 uređaj za prijenos s filtrom 20/20 [Mix2Vial]
English: Inhibitor development in previously untreated and treated patients (PUPs / PTPs) has been reported (see section 4.4).
Croatian: Razvoj inhibitora zabilježen je u prethodno neliječenih i liječenih bolesnika (PNB / PLB) (vidjeti dio
English: It is strongly recommended that every time that Helixate NexGen is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Croatian: Dokumentiranje Snažno se preporučuje da se pri svakoj primjeni lijeka Helixate NexGen zabilježi naziv i serijski broj lijeka kako bi se održala veza između bolesnika i serije lijeka..
English: Usually, the substitution therapy with Helixate NexGen is a life-time treatment.
Croatian: Nadomjesno liječenje lijekom Helixate NexGen najčešće traje tijekom cijelog života.
English: Helixate NexGen contains low level of polysorbate-80 as an excipient, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC) materials.
Croatian: Helixate NexGen kao pomoćnu tvar sadrži malu količinu polisorbata 80, za koji je poznato da povećava brzinu ekstrakcije di-(2-etilheksil)ftalata (DEHP) iz polivinilkloridnih
English: Helixate NexGen should be injected intravenously over several minutes.
Croatian: Helixate NexGen injicira se intravenski tijekom nekoliko minuta.
English: Do not use Helixate NexGen if you notice visible particulate matter or turbidity.
Croatian: Helixate NexGen nemojte koristiti ako zamijetite vidljive čestice ili zamućenje.
English: The analysis of all recorded in vivo recoveries in previously treated patients demonstrated a mean rise of 2 % per IU/kg body weight for Helixate NexGen.
Croatian: Analiza svih oporavaka in vivo zabilježenih u prethodno liječenih bolesnika pokazala je da prilikom korištenja lijeka Helixate NexGen dolazi do srednje vrijednosti porasta razine faktora od 2% po IU/kg tjelesne mase.
English: Duration of treatment Your doctor will tell you, how often and at what intervals this medicine is to be administered.
Croatian: Trajanje liječenja Liječnik će Vam reći potrebnu učestalost i vremenske razmake primjene ovog lijeka.
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of Helixate NexGen during pregnancy and breast-feeding is not available.
Croatian: Zbog rijetke pojave hemofilije A u žena nisu dostupni podaci o primjeni lijeka Helixate NexGen tijekom trudnoće i dojenja.
English: Detailed instructions for preparation and administration are contained in the package leaflet provided with Helixate NexGen.
Croatian: Detaljne upute za pripremu i primjenu lijeka navedene su u Uputi o lijeku koja se isporučuje uz Helixate NexGen.
English: Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved.
Croatian: Polako okrećite bočicu s lijekom i prozirnim adapterom dok se sadržaj potpuno ne rastopi.
English: Animal reproduction studies have not been conducted with Helixate NexGen.
Croatian: Nisu provedena reproduktivna ispitivanja lijeka Helixate NexGen na životinjama.
English: • one vial with powder (10 ml clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper and aluminium seal)
Croatian: • jednu bočicu s praškom (10-mililitarska bočica od prozirnog stakla tipa 1 sa sivim gumenim čepom od halogenobutila bez lateksa i aluminijskim prstenom)
English: Place the solvent vial on an even, clean surface and hold the vial tight.
Croatian: Postavite bočicu otapala na ravnu i čistu površinu te je čvrsto držite.
English: MARKETING AUTHORISATION HOLDER Bayer Pharma AG 13342 Berlin Germany
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet Bayer Pharma AG 13342 Berlin
English: Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Croatian: Liječenje takvih bolesnika moraju voditi liječnici s iskustvom u liječenju hemofilije i inhibitora faktora VIII.
English: • one vial with solvent (6 ml clear glass type 1 vial with latex-free grey chlorobutyl rubber blend stopper and aluminium seal)
Croatian: • jednu bočicu s otapalom (60-mililitarska bočica od prozirnog stakla tipa 1 sa sivim gumenim čepom klorobutila bez lateksa i aluminijskim prstenom)
English: The reconstituted product must be filtered prior to administration to remove potential particulate matter in the solution.
Croatian: Pripremljeni lijek se prije primjene mora filtrirati kako bi se iz otopine uklonile moguće čestice.
English: Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.
Croatian: Primite Mix2Vial zajedno s blister pakiranjem te šiljak plavog kraja adaptera ugurajte ravno prema dolje kroz čep bočice otapala.
English: Expected factor VIII rise (% of normal) = 2 × administered IU body weight (kg)
Croatian: Očekivani porast faktora VIII (% od normalne vrijednosti) = 2 × primijenjeni broj IU
English: Helixate NexGen should be reconstituted and administered with the components provided with each package.
Croatian: Helixate NexGen treba pripremiti i primijeniti pomoću pribora priloženog u pakiranju.
English: • You must use aseptic conditions (meaning clean and germ free) during reconstitution and administration.
Croatian: Tijekom pripreme i primjene moraju se koristiti aseptični uvjeti (što znači da okruženje mora biti čisto i bez mikroorganizma).
English: Method of administration Intravenous use.
Croatian: Za intravensku primjenu.
English: What Helixate NexGen 1000 IU is and what it is used for
Croatian: Što je Helixate NexGen 1000 IU i za što se koristi
English: Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe.
Croatian: 12. Kada je otopina prenesena u štrcaljku, čvrsto primite cilindar štrcaljke (s klipom okrenutim prema dolje) te odvojite prozirni adapter uređaja Mix2Vial od štrcaljke.
English: If this dose does not control your bleeding your doctor may consider giving you an additional product, factor VIIa concentrate or (activated) prothrombin complex concentrate.
Croatian: liječnik će Vam možda dati dodatni lijek - koncentrat faktora VIIa ili (aktivirani) koncentrat protrombinskog kompleksa.
English: After reconstitution, the solution is drawn through the Mix2Vial filter transfer device into the sterile disposable syringe (both supplied).
Croatian: Otopina se nakon pripreme za primjenu navlači u sterilnu jednokratnu štrcaljku kroz uređaj za prijenos s filtrom Mix2Vial (oba se pribora isporučuju uz lijek).
English: Additional pharmacokinetic parameters for Helixate NexGen for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 ml/h.Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 ml/h corresponding to 3.0 ml/h/kg (range 1.6-4.6 ml/h/kg).
Croatian: Srednji ishodni klirens 14 odraslih bolesnika podvrgnutih opsežnim kirurškim zahvatima uz kontinuiranu infuziju iznosio je 188 ml/h, što odgovara 3,0 ml/h/kg (raspon od 1,6 do 4,6 ml/h/kg).
English: Helixate NexGen powder should only be reconstituted with the supplied solvent (5.0 ml water for injections) using the supplied sterile Mix2Vial filter transfer device.
Croatian: Prašak Helixate NexGen smije se pripremati samo otapalom (5,0 ml vode za injekcije) priloženim u sterilnom uređaju za prijenos s filtrom Mix2Vial.
English: 16 Let blood flow back to the open end of the venipuncture set and then attach the syringe with the solution.
Croatian: 16 Pustite da krv poteče u otvoreni kraj kompleta za venepunkciju te priključite štrcaljku s otopinom.
English: LIST OF EXCIPIENTS Glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, sucrose.
Croatian: Glicin, natrijev klorid, kalcijev klorid, histidin, polisorbat 80, saharoza.
English: The solvent will automatically flow into the product vial.
Croatian: Otapalo će automatski poteći u bočicu s lijekom.
English: Helixate NexGen powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) using the supplied sterile Mix2Vial filter transfer device.
Croatian: Prašak Helixate NexGen smije se pripremati samo otapalom (2,5 ml vode za injekcije) priloženim u sterilnom uređaju za prijenos s filtrom Mix2Vial.
English: Discard the solvent vial with the blue Mix2Vial adapter attached.
Croatian: Bacite bočicu s otapalom zajedno s plavim adapterom uređaja Mix2Vial.
English: After administration of Helixate NexGen, peak factor VIII activity decreased by a two-phase exponential decay with a mean terminal half-life of about 15 hours.
Croatian: Vršna vrijednost aktivnosti faktora VIII nakon primjene lijeka Helixate NexGen opada tijekom njegove dvofazne razgradnje, a prosječni terminalni poluvijek iznosi oko 15 sati.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH 2.5 ML WATER FOR INJECTIONS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA S 2,5 ML VODE ZA INJEKCIJE
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay.
Croatian: Ti su inhibitori najčešće IgG imunoglobulini usmjereni na prokoagulacijsku aktivnost faktora VIII i izražavaju se u Bethesda jedinicama (BU) na ml plazme primjenom izmijenjenog testa.
English: Experience regarding fertility or the use of Helixate NexGen during pregnancy and breast-feeding is not available.
Croatian: Nisu dostupni podaci o uzimanju lijeka Helixate NexGen tijekom trudnoće i dojenja, kao niti iskustvo u pogledu plodnosti.
English: While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly.
Croatian: Klip štrcaljke držite potisnutim, a zatim preokrenite sustav te povucite otopinu u štrcaljku polaganim povlačenjem klipa.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH 5.0 ML WATER FOR INJECTIONS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA S 5,0 ML VODE ZA INJEKCIJE
English: If bleeding is not controlled
Croatian: Ako se krvarenje ne zaustavi ni većom dozom,
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for the presence of factor VIII inhibitor should be performed.
Croatian: Ako se ne postignu očekivane razine aktivnosti faktora VIII u plazmi ili ako se krvarenje ne može kontrolirati odgovarajućom dozom, potrebno je provesti pretragu na prisutnost inhitora faktora VIII.
English: In this case, the product expires at the end of this 12-month period or the expiration date on the product vial, whichever is earlier.
Croatian: Rok valjanosti ovog lijeka u tom slučaju ističe nakon 12-mjesečnog razdoblja ili datuma isteka roka valjanosti na bočici, ovisno o tome koji nastupi ranije.
English: • You must filter the reconstituted product before administration to remove potential particulate matter in the solution.
Croatian: Pripremljeni lijek prije primjene morate filtrirati kako biste uklonili moguće čestice iz otopine.