FrancophonIA/ELRC3.0 huggingface dataset:
English: Apply a tourniquet and prepare the injection site by wiping the skin well with an alcohol swab provided in the kit.
Croatian: Stavite podvezu i pripremite mjesto za injekciju tako što ćete kožu dobro obrisati vaticom natopljenom alkoholom koja je priložena u kompletu.
English: ReFacto AF contains sodium
Croatian: ReFacto AF sadrži natrij
English: In the PUPs, the mean recovery was stable over time (5 visits during a 2-year period) and ranged from 1.5 to 1.8 IU/dl per IU/kg.
Croatian: U prethodno neliječenih bolesnika, srednja vrijednost povrata bila je stabilna tijekom vremena (5 kontrola u razdoblju od 2 godine) i kretao se u rasponu od 1,5 do 1,8 IU/dl po IU/kg.
English: Please dispose of all unused solution, the empty vial(s) and the used needles and syringes in an appropriate container for throwing away of medical waste as these materials may hurt others if not disposed of properly.
Croatian: Molimo bacite svu neiskorištenu otopinu, prazne bočice i uporabljene igle i štrcaljke u odgovarajući spremnik za odlaganje otpada da se druge osobe zbog neispravnog rukovanja materijalom ne bi ozlijedile.
English: The need for an increased dose relative to that used for adults and older children should be anticipated when treating younger children (less than 6 years of age) with ReFacto AF (see section 5.2)..
Croatian: Kad se lijekom ReFacto AF liječe mlađa djeca (u dobi do 6 godina), može se očekivati da će biti potrebna viša doza od one koja se primjenjuje kod odraslih i starije djece (vidjeti dio 5.2).
English: t1/2 (h)
Croatian: AUCt (IU·h/ml) t1/2 (h)
English: Neuropathy peripheral; somnolence; dysgeusia
Croatian: Poremećaji živčanog sustava glavobolja omaglica periferna neuropatija; pospanost; disgeuzija
English: How to use ReFacto AF
Croatian: Kako primjenjivati ReFacto AF
English: Remove any air in the infusion set tubing by drawing back on the syringe.
Croatian: Uklonite sav zrak iz cjevčice pribora za infuziju povlačenjem unatrag klipa štrcaljke.
English: Reconstitution:
Croatian: Priprema:
English: Ελλάδα PFIZER ΕΛΛΑΣ Α.Ε.Τηλ: +30 210 678
Croatian: PFIZER ΕΛΛΑΣ Α.Ε Τηλ: +30 210 678 5800
English: The pre-filled syringe should be gently rotated until all of the powder is dissolved.
Croatian: Napunjenu štrcaljku treba nježno okretati dok se sav prašak ne otopi.
English: The procedures below are provided as guidelines for the reconstitution and administration of ReFacto AF.
Croatian: Postupci niže ponuđeni su kao smjernice za pripremu i primjenu lijeka ReFacto AF.
English: Pharmacokinetic parameter estimates for ReFacto in previously treated patients with haemophilia A
Croatian: Procjene farmakokinetičkih parametara za ReFacto u prethodno liječenih bolesnika s hemofilijom A PK parametar
English: Each pre-filled syringe of ReFacto AF contains nominally 250, 500, 1000, 2000, or 3000 IU of moroctocog alfa.
Croatian: Jedna napunjena štrcaljka lijeka ReFacto AF nominalno sadrži 250, 500, 1000, 2000 ili 3000 IU moroktokoga alfa.
English: • muscular pain
Croatian: • bol u mišićima
English: 1 vial with 250 IU moroctocog alfa 1 vial with 500 IU moroctocog alfa 1 vial with 1000 IU moroctocog alfa 1 vial with 2000 IU moroctocog alfa
Croatian: 1 bočica s 250 IU moroktokoga alfa 1 bočica s 500 IU moroktokoga alfa 1 bočica s 1000 IU moroktokoga alfa 1 bočica s 2000 IU moroktokoga alfa
English: • general feeling of being unwell
Croatian: • opće loše osjećanje
English: The instructions below are for the use of multiple ReFacto AF pre-filled syringe kits with a 10 cc or larger luer lock syringe.
Croatian: Niže su navedene upute za pripremu više kompleta ReFacto AF napunjenih štrcaljki sa štrcaljkom od 10 cc ili većom štrcaljkom s luer lock-om.
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 pro-coagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.
Croatian: Ti su inhibitori obično IgG imunoglobulini usmjereni protiv prokoagulacijske aktivnosti faktora VIII, a njihova količinase određuje u Bethesda jedinicama (BU) po ml plazme pomoću modificiranog testa.
English: This is done by bending the cap up and down until the perforation is broken.
Croatian: To ćete napraviti tako da savijate zatvarač gore dolje sve dok ne pukne duž perforacije.
English: • chills, catheter site reaction
Croatian: • zimica, reakcija na mjestu ulaza katetera
English: Holding the ReFacto AF pre-filled syringe in an upright position, slowly advance the plunger rod until most, but not all, of the air is removed from the drug product chamber.
Croatian: Držeći ReFacto AF napunjenu štrcaljku u uspravnom položaju, polako potiskujte klip dok ne istisnete veći dio, ali ne i sav zrak iz komore s lijekom.
English: Multiple ReFacto AF in Pre-filled Syringe Reconstitution to a 10 cc or Larger Luer Lock Syringe (10 cc or larger luer lock syringes not provided)
Croatian: Priprema više ReFacto AF napunjenih štrcaljki u štrcaljki od 10 cc ili većoj štrcaljki s luer lockom (štrcaljke od 10 cc ili veće štrcaljke s luer lock-om nisu priložene)
English: Appropriate training is recommended for non-healthcare professionals administering the product.
Croatian: Za osobe koje nisu zdravstveni radnici, a primjenjuju lijek, preporučuje se odgovarajuća obuka.
English: ReFacto AF should be infused within 3 hours after either reconstitution or removal of the grey tip cap from the pre-filled syringe.
Croatian: ReFacto AF treba primijeniti infuzijom u roku od 3 sata nakon pripreme ili uklanjanja sivog zatvarača s vrška napunjene štrcaljke.
English: The dose and frequency of ReFacto AF prescribed throughout the study were at the investigator's discretion as per local standard of care.
Croatian: Tijekom trajanja ispitivanja doza i učestalost primjene lijeka ReFacto AF bile su propisane po nahođenju ispitivača prema lokalnom standardnom liječenju.
English: The solution is to be discarded if visible particulate matter or discolouration is observed.
Croatian: Otopinu treba baciti ako se opaze vidljive čestice ili promjena boje.
English: IV use, after reconstitution.
Croatian: i.v. primjena, nakon pripreme otopine.
English: Continuing to hold the ReFacto AF pre-filled syringe in an upright position, slowly advance the plunger rod until most, but not all, of the air is removed from the (top) chamber.
Croatian: Dok i dalje držite ReFacto AF napunjenu štrcaljku uspravno, polako potiskujte klip dok ne istisnete veći dio zraka, iako ne sav zrak, iz (gornje) komore.
English: Discuss your intravenous infusion procedure with your doctor or other healthcare professional.
Croatian: Razgovarajte s liječnikom ili drugim zdravstvenim radnikom o postupku intravenske infuzije.
English: 1 vented sterile cap
Croatian: 1 propusni sterilni zatvarač
English: Life-threatening haemorrhages
Croatian: Životno opasna krvarenja
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane smanjen apetit
English: If your or your child's bleeding is not being controlled with ReFacto AF, tell your doctor immediately.
Croatian: Vašeg djeteta ne može kontrolirati pomoću lijeka ReFacto AF, odmah se obratite liječniku.
English: The lyophilised powder in the top chamber of the pre-filled syringe must be reconstituted with the solvent [sodium chloride 9 mg/mL (0.9%) solution] in the bottom chamber of the pre-filled syringe.
Croatian: Liofilizirani prašak u gornjoj komori napunjene štrcaljke mora se rekonstituirati s priloženim otapalom [otopina natrijevog klorida od 9 mg/ml (0,9%)] u donjoj komori napunjene štrcaljke.
English: In PUPs, pharmacokinetic parameters of ReFacto were evaluated using the chromogenic assay.
Croatian: U prethodno neliječenih bolesnika farmakokinetički parametri lijeka ReFacto bili su procijenjeni pomoću kromogenog testa.
English: Attach the syringe to the luer end of the infusion set tubing.
Croatian: Spojite štrcaljku na luer-kraj infuzijske cjevčice.
English: Each vial of ReFacto AF contains nominally 250, 500, 1000, or 2000 IU of moroctocog alfa.
Croatian: Jedna bočica lijeka ReFacto AF nominalno sadrži 250, 500, 1000 ili 2000 IU moroktokoga alfa.
English: Aseptic technique (meaning clean and germ-free) should be used during the reconstitution procedure.
Croatian: 2. Tijekom postupka pripreme treba primjenjivati aseptičku tehniku (što znači čisto i bez mikroba).
English: Use the reconstituted solution within 3 hours of reconstitution.
Croatian: Primijenite pripremljenu otopinu u roku od 3 sata nakon pripreme.
English: Pfizer Oy Puh/Tel: +358 (0)9 43 00 40
Croatian: Puh/Tel: +358 (0)9 43 00 40
English: Do not use this medicine after the expiry date which is stated on the outer carton and pre-filled syringe label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza “Rok valjanosti”.
English: Record on the outer carton the date ReFacto AF pre-filled syringe is removed from the refrigerator and set at room temperature (up to 25oC).
Croatian: Zabilježite na vanjskom pakiranju datum kad ste ReFacto AF napunjenu štrcaljku uklonili iz hladnjaka i ostavili na sobnoj temperaturi (do 25°C).
English: The final solution must be inspected visually for particulate matter before administration.
Croatian: 12. Konačnu otopinu treba vizualno pregledati prije primjene da ne sadrži sitne čestice.
English: Insert the needle on the infusion set tubing into the vein as instructed by your doctor, and remove the tourniquet.
Croatian: Uvedite iglu cjevčice pribora za infuziju u venu prema uputama liječnika i otpustite podvezu.
English: 1 pre filled syringe (250 IU powder in top chamber and 4 ml solvent in bottom chamber) 1 pre filled syringe (500 IU powder in top chamber and 4 ml solvent in bottom chamber) 1 pre filled syringe (1000 IU powder in top chamber and 4 ml solvent in bottom chamber) 1 pre filled syringe (2000 IU powder in top chamber and 4 ml solvent in bottom chamber) 1 pre filled syringe (3000 IU powder in top chamber and 4 ml solvent in bottom chamber)
Croatian: 1 napunjena štrcaljka (250 IU praška u gornjoj komori i 4 ml otapala u donjoj komori)) 1 napunjena štrcaljka (500 IU praška u gornjoj komori i 4 ml otapala u donjoj komori) 1 napunjena štrcaljka (1000 IU praška u gornjoj komori i 4 ml otapala u donjoj komori) 1 napunjena štrcaljka (2000 IU praška u gornjoj komori i 4 ml otapala u donjoj komori) 1 napunjena štrcaljka (3000 IU praška u gornjoj komori i 4 ml otapala u donjoj komori)
English: Clear, colourless solvent
Croatian: Bistro, bezbojno otapalo
English: Uncommon ≥ 1/1,000 to
Croatian: Manje često ≥ 1/1000 i < 1/100
English: MARKETING AUTHORISATION NUMBER
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: EU/1/99/103/001 EU/1/99/103/002 EU/1/99/103/003 EU/1/99/103/004
Croatian: EU/1/99/103/001 EU/1/99/103/002
English: The product may be removed from refrigerated storage for one single period of maximum 3 months at room temperature (up to 25°C).
Croatian: Lijek se može izvaditi iz hladnjaka i čuvati u jednom razdoblju od najviše 3 mjeseca na sobnoj temperaturi (do 25°C).
English: System Organ Class
Croatian: MedDRA klasifikacija organskih sustava
English: b Subjects in the PUP study were not required to follow a regular continuous prophylaxis treatment; however, with the exception of one subject (with only on demand (OD) treatment) the majority of subjects took regular prophylaxis infusions.
Croatian: Međutim, uz iznimku jednog ispitanika (koji je liječen samo prema potrebi), većina ispitanika redovno je primala profilaktičke infuzije.
English: ReFacto AF is provided as a powder and solvent for solution for injection in a pre-filled syringe that contains the ReFacto AF powder in the top chamber and the solvent [sodium chloride 9 mg/ml (0.9%) solution] in the bottom chamber.
Croatian: ReFacto AF se isporučuje kao prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki koja sadrži ReFacto AF prašak u gornjoj komori i otapalo [otopinu natrijevog klorida od 9 mg/ml (0,9%)] u donjoj komori.
English: Patients can affix one of the peel-off labels found on the vial or pre-filled syringe to document the batch number in their diary or for reporting any side effects.
Croatian: Bolesnici mogu zalijepiti jednu od samoljepivih naljepnica koje se nalaze na bočici ili napunjenoj štrcaljki da bi zabilježili broj serije u svoj dnevnik ili za prijavu bilo kakvih nuspojava.
English: With the syringe still connected to the adapter, gently rotate the vial until the powder is dissolved.
Croatian: Dok je štrcaljka još spojena s nastavkom, nježno okrećite bočicu sve dok se prašak ne otopi.
English: In a ReFacto AF study of 19 PUPs, the recovery at the beginning of the study in the 17 children aged 28 days to less than 2 years was 1.32 ± 0.65 IU/dl per IU/kg and in the 2 children aged 2 to <6 years were 1.7 and 1.8 IU/dl per IU/kg.
Croatian: U ispitivanju lijeka ReFacto AF provedenom na 19 prethodno neliječenih bolesnika, povrat u 17 djece u dobi od 28 dana do manje od 2 godine iznosio je 1,32 ± 0,65 IU/dl po IU/kg na početku ispitivanja,
English: The vial should be gently rotated until all of the powder is dissolved.
Croatian: Bočicu treba nježno okretati dok se sav prašak ne otopi.
English: - The active substance is moroctocog alfa (recombinant coagulation factor VIII).
Croatian: - Djelatna tvar je moroktokog alfa (rekombinantni koagulacijski faktor VIII).
English: - The other ingredients are sucrose, calcium chloride dihydrate, L-histidine, polysorbate 80 and sodium chloride.
Croatian: Drugi sastojci su saharoza, kalcijev klorid dihidrat, L-histidin, polisorbat 80 i natrijev klorid.
English: ReFacto AF contains B-domain deleted recombinant coagulation factor VIII (moroctocog alfa).
Croatian: ReFacto AF sadrži rekombinantni koagulacijski faktor VIII bez B-domene (moroktokog alfa).
English: Record on the outer carton the date ReFacto AF is removed from the refrigerator and set at room temperature (up to 25oC).
Croatian: Zabilježite na vanjskom pakiranju datum kada ste ReFacto AF uklonili iz hladnjaka i ostavili na sobnoj temperaturi (do 25°C).
English: Administration (Intravenous Infusion): ReFacto AF should be administered using the infusion set provided in this kit and the pre-filled solvent syringe provided or a single sterile disposable plastic luer lock syringe.
Croatian: ReFacto AF treba primijeniti pomoću pribora za infuziju priloženog u ovom kompletu i priložene napunjene štrcaljke s otapalom ili sterilnom plastičnom štrcaljkom s luer lock-om za jednokratnu uporabu.
English: The contents of the pack are: - one pre-filled syringe containing moroctocog alfa 250, 500, 1000, 2000, or 3000 IU powder and solvent, 4 ml sterile sodium chloride 9 mg/ml (0.9 %) solution for injection for reconstitution - one plunger rod - one protective blue vented sterile cap - one sterile infusion set - two alcohol swabs - one plaster - one gauze pad
Croatian: Sadržaj pakiranja je sljedeći: - jedna napunjena štrcaljka koja sadrži moroktokog alfa 250, 500, 1000, 2000 ili 3000 IU prašak i otapalo, 4 ml sterilne otopine za injekciju natrijevog klorida od 9 mg/ml (0.9 %) za pripremu - jedan potisnik klipa - jedan zaštitni plavi propusni sterilni zatvarač - jedan sterilni set za infuziju - dvije vatice natopljene alkoholom
English: ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection The product does not contain a preservative, and the reconstituted product should be used immediately, or within 3 hours after reconstitution.
Croatian: ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU prašak i otapalo za otopinu za injekciju Ovaj lijek ne sadrži konzervanse te se rekonstituirani lijek treba primijeniti odmah ili u roku od 3 sata od rekonstitucije.
English: Κύπρος PFIZER ΕΛΛΑΣ Α.Ε.
Croatian: PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH)
English: ReFacto AF is administered by intravenous infusion over several minutes after reconstitution of the lyophilised powder for injection with sodium chloride 9 mg/mL (0.9%) solution for injection (provided).
Croatian: ReFacto AF se primjenjuje intravenskom infuzijom tijekom nekoliko minuta nakon rekonstitucije liofiliziranog praška za injekciju s otopinom za injekciju natrijevog klorida od 9 mg/ml (0,9%) (priložena).
English: Slowly depress the plunger rod to inject all the solvent into the ReFacto AF vial.
Croatian: Sporim pritiskom na klip ubrizgajte cijelu količinu otapala u bočicu ReFacto AF.
English: 1 plunger rod 1 sterile infusion set 2 alcohol swabs 1 plaster
Croatian: 1 napunjena štrcaljka s 4 ml otapala 1 nastavak za bočicu 1 sterilni set za infuziju 2 vatice natopljene alkoholom 1 flaster
English: Attach the plunger rod to the solvent syringe by inserting the rod into the opening in the syringe stopper and pushing and turning the rod firmly until it is securely seated in the stopper.
Croatian: Spojite klip na štrcaljku s otapalom tako što ćete uvesti klip u otvor čepa štrcaljke te ga potisnuti i čvrsto zakrenuti sve dok čvrsto ne sjedne u čep.
English: Sucrose, calcium chloride dihydrate, L-histidine, polysorbate 80, sodium chloride
Croatian: saharoza, kalcijev klorid dihidrat, L-histidin, polisorbat 80, natrijev klorid
English: ReFacto AF is administered by intravenous (IV) infusion after reconstitution of the powder with the solvent (0.9% sodium chloride).
Croatian: ReFacto AF primjenjuje se intravenskom (i.v.) infuzijom nakon pripreme praška s otapalom (0,9% natrijev klorid).
English: Allow the vial of lyophilised ReFacto AF and the pre-filled solvent syringe to reach room temperature.
Croatian: Ostavite bočicu liofiliziranog ReFacto AF i napunjene štrcaljke s otapalom da dosegnu sobnu temperaturu.
English: België /Belgique / Belgien
Croatian: België /Belgique / Belgien Pfizer S.A./N.V.
English: ReFacto AF contains 1.23 mmol (or 29 mg) sodium per pre-filled syringe of reconstituted powder.
Croatian: ReFacto AF sadrži 1,23 mmola (ili 29 mg) natrija po napunjenoj štrcaljki pripremljenog praška.
English: ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection The vial of lyophilised product powder for injection must be reconstituted with the supplied solvent [sodium chloride 9 mg/mL (0.9%) solution] from the pre-filled syringe using the sterile vial adapter reconstitution device.
Croatian: ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU prašak i otapalo za otopinu za injekciju Bočica s liofiliziranim praškom za injekciju lijeka mora se rekonstituirati s priloženim otapalom [otopina natrijevog klorida od 9 mg/ml (0,9%)] iz napunjene štrcaljke pomoću sterilnog nastavka za bočicu za rekonstituciju.
English: Hypotension; thrombophlebitis; flushing
Croatian: Krvožilni poremećaji krvarenje: hematomi hipotenzija; tromboflebitis; navale crvenila
English: The solvent syringe should be removed, leaving the vial adapter in place, and a single large luer lock syringe may be used to draw back the reconstituted contents of each of the individual vials.
Croatian: Štrcaljku s otapalom treba ukloniti, ostavljajući nastavak za bočicu na mjestu, a za izvlačenje pripremljenog sadržaja iz pojedine bočice može se uporabiti zasebna velika štrcaljka s luer lock-om (napravom koja spaja štrcaljku s bočicom).
English: For your convenience, the medicine can be removed from such storage for one single period of maximum 3 months at room temperature (up to 25°C).
Croatian: Kako bi Vam bilo lakše, lijek možete izvaditi iz hladnjaka i čuvati ga jednokratno u razdoblju od najviše 3 mjeseca na sobnoj temperaturi (do 25°C).
English: The rate of administration should be determined by the patient's comfort level.
Croatian: Brzinu primjene treba podesiti na razinu koja je bolesniku ugodna.
English: 250 IU, 500 IU, 1000 IU, 2000 IU or 3000 IU lyophilised powder in top chamber and 4 mL of solvent in bottom chamber of the pre-filled syringe (type 1 glass) with butyl rubber plungers and closure, one plunger rod for assembly, a polypropylene vented sterile cap, a sterile infusion set, alcohol swabs, a plaster and a gauze pad.
Croatian: 250 IU, 500 IU, 1000 IU, 2000 IU ili 3000 IU liofiliziranog praška u gornjoj komori i 4 ml otapala u donjoj komori napunjene štrcaljke (staklo tipa 1) s klipovima i zatvaračem od butilne gume, jedan potisnik klipa za sklapanje, polipropilenski propusni sterilni zatvarač, sterilni set za infuziju, vatice natopljene alkoholom, flaster i jastučić od gaze.
English: Aspartate aminotransferase increased; alanine aminotransferase increased; blood bilirubin increased; blood creatinine phosphokinase increased * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients
Croatian: povišena aspartat aminotransferaza; povišena alanin aminotransferaza; povišen bilirubin u krvi; povišena kreatinin fosfokinaza u krvi
English: You must contact your doctor immediately if you have any of the following early symptoms of allergic reactions:
Croatian: Ako imate ijedan od sljedećih ranih simptoma alergijskih reakcija (preosjetljivosti), morate se odmah obratiti svom liječniku:
English: ReFacto AF contains 1.23 mmol (or 29 mg) sodium per vial of reconstituted powder.
Croatian: ReFacto AF sadrži 1,23 mmola (ili 29 mg) natrija po bočici pripremljenog praška.
English: The reconstituted ReFacto AF product should be injected intravenously over several minutes.
Croatian: Pripremljeni ReFacto AF treba ubrizgati u venu tijekom nekoliko minuta.
English: Keep in the original package in order to protect from light.
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: • chest pain, rapid heart beat, palpitations
Croatian: • bol u prsnom košu, ubrzani otkucaji srca, osjećaj lupanja srca
English: 1 gauze
Croatian: PRILOG I.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva artralgija mialgija
English: ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection 250 IU, 500 IU, 1000 IU or 2000 IU powder in a 10 mL vial (type 1 glass) with a stopper (butyl) and a flip-off seal (aluminum) and 4 mL of solvent in a pre-filled syringe (type 1 glass) with a plunger stopper (butyl), a tip-cap (butyl) and a sterile vial adapter reconstitution device, a sterile infusion set, alcohol swabs, a plaster and a gauze pad.
Croatian: ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU prašak i otapalo za otopinu za injekciju 250 IU, 500 IU, 1000 IU ili 2000 IU praška u bočici (staklo tipa 1) od 10 ml s čepom (butil) i prstenom (aluminij) i 4 ml otapala u napunjenoj štrcaljki (staklo tipa 1) s čepom klipa (butil), zatvaračem vrha (butil) te sterilni nastavak za bočicu za rekonstituciju, sterilni set za infuziju, vatice natopljene alkoholom, flaster i jastučić od gaze.
English: Total ABR for subjects who reported following an On Demand regimen at Baseline c median (min, max)
Croatian: Ukupni ABR za ispitanike koji su izjavili na početku da slijede režim liječenja prema potrebi medijan (minimum, maksimum)
English: ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU powder and solvent for solution for injection in pre-filled syringe
Croatian: ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki
English: ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU powder and solvent for solution for injection in pre-filled syringe
Croatian: ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU prašak i otapalo za otopinu za injekciju ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki
English: Asthenia; injection site reaction; injection site pain; injection site inflammation
Croatian: Opći poremećaji i reakcije na mjestu primjene pireksija zimica; reakcija povezana s mjestom ulaza katetera astenija; reakcija na mjestu primjene injekcije; bol na mjestu primjene injekcije; upala na mjestu primjene injekcije
English: Anaphylactic reaction
Croatian: Alergijske reakcije
English: Pyrexia
Croatian: Pfizer