FrancophonIA/ELRC3.0 huggingface dataset:
English: In CYP2D6 extensive metabolisers (EMs) with severe (Child-Pugh class C) hepatic impairment, eliglustat is contraindicated (see sections 4.3 and 5.2).
Croatian: Eliglustat je kontraindiciran u ekstenzivnih metabolizatora (EM) CYP2D6 s teškim (Child-Pugh stupanj C) oštećenjem funkcije jetre (vidjeti dijelove 4.3 i 5.2).
English: • Difficulty swallowing (dysphagia)
Croatian: • Otežano gutanje (disfagija)
English: o In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment taking a weak CYP2D6 inhibitor or a strong, moderate or weak CYP3A inhibitor, a dose of 84 mg eliglustat once daily should be considered.
Croatian: U ekstenzivnih metabolizatora (EM) CYP2D6 s blagim oštećenjem funkcije jetre koji uzimaju slab inhibitor CYP2D6 ili jak, umjeren ili slab inhibitor CYP3A, potrebno je razmotriti dozu od 84 mg eliglustata jednom dnevno.
English: After repeated 84 mg once daily doses of Cerdelga, Cmax and AUC0-24 are predicted to be 3.1- and 3.2fold higher in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment compared to healthy CYP2D6 extensive metabolisers (EMs ) receiving Cerdelga 84 mg twice daily (see sections 4.2 and 4.4).
Croatian: biti 3,1 odnosno 3,2 puta viši u ekstenzivnih metabolizatora (EM) CYP2D6 s umjerenim oštećenjem funkcije jetre u usporedbi sa zdravim ekstenzivnim metabolizatorima (EM) CYP2D6 koji primaju 84 mg lijeka Cerdelga dva puta dnevno (vidjeti dijelove 4.2 i 4.4).
English: b Estimates and p-values are based on an ANCOVA model * All patients transitioned to Cerdelga treatment after Month 9.
Croatian: *Svi bolesnici prešli su na liječenje lijekom Cerdelga nakon 9. mjeseca
English: • Dizziness
Croatian: • Mučnina
English: In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment taking a weak CYP2D6 inhibitor or a strong, moderate or weak CYP3A inhibitor, a dose of 84 mg eliglustat once daily should be considered (see sections 4.4 and 5.2).
Croatian: U ekstenzivnih metabolizatora (EM) CYP2D6 s blagim oštećenjem funkcije jetre koji uzimaju slab inhibitor CYP2D6 ili jak, umjeren ili slab inhibitor CYP3A potrebno je razmotriti dozu od 84 mg eliglustata jednom dnevno (vidjeti dijelove 4.4 i 5.2).
English: In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment taking a weak CYP2D6 inhibitor or strong, moderate or weak CYP3A inhibitor, a dose of 84 mg eliglustat mg once daily should be considered (see sections 4.2 and 5.2).
Croatian: U ekstenzivnih metabolizatora (EM) CYP2D6 s blagim oštećenjem funkcije jetre koji uzimaju slab inhibitor CYP2D6 ili jak, umjeren ili slab inhibitor CYP3A potrebno je razmotriti dozu od 84 mg eliglustata jednom dnevno (vidjeti dijelove 4.2 i 5.2).
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Iritacija grla
English: In extensive metabolisers (EMs) with mild hepatic impairment: see sections 4.2 and 4.4.
Croatian: U ekstenzivnih metabolizatora (EM) s blagim oštećenjem funkcije jetre: vidjeti dijelove 4.2 i 4.4.
English: Caution should be used with strong CYP3A inhibitors in IMs and EMs.
Croatian: Kod primjene s jakim inhibitorima CYP3A potreban je oprez kod IM-a i EM-a.
English: • atomoxetine - used to treat attention deficit hyperactivity disorder (ADHD) • pravastatin - used to lower cholesterol and prevent heart disease
Croatian: • atomoksetin - primjenjuje se za liječenje poremećaja hiperaktivnosti i deficita pažnje (engl.
English: In extensive metabolisers (EMs) with mild or moderate hepatic impairment: see sections 4.2, 4.3 and
Croatian: U ekstenzivnih metabolizatora (EM) s blagim ili umjerenim oštećenjem funkcije jetre: vidjeti dijelove 4.2, 4.3 i 4.4.
English: Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).
Croatian: Gaucher disease type 1, GD1) koji su spori metabolizatori (SM), intermedijarni metabolizatori (IM) ili ekstenzivni metabolizatori (EM) CYP2D6.
English: Caution should be used with moderate CYP3A inhibitors in IMs and EMs.
Croatian: Kod primjene s umjerenim inhibitorima CYP3A potreban je oprez kod IM-a i EM-a.
English: o Eliglustat is contraindicated in patients who are CYP2D6 intermediate metabolisers (IMs) or extensive metabolisers (EMs) who are taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor.
Croatian: o Eliglustat je kontraindiciran u bolesnika koji su intermedijarni metabolizatori (IM) ili ekstenzivni metabolizatori (EM) CYP2D6, a koji uzimaju jak ili umjeren inhibitor CYP2D6
English: Hepatic impairment:
Croatian: Oštećenje funkcije bubrega:
English: In CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment (Child-Pugh class B), eliglustat is not recommended (see sections 4.4 and 5.2).
Croatian: Eliglustat se ne preporučuje u ekstenzivnih metabolizatora (EM) CYP2D6 s umjerenim (Child-Pugh stupanj B) oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
English: o In CYP2D6 extensive metabolisers (EMs) with severe hepatic impairment, Cerdelga is contraindicated.
Croatian: o Cerdelga je kontraindicirana u ekstenzivnih metabolizatora (EM) CYP2D6 s teškim oštećenjem funkcije jetre.
English: • Hives (urticaria)
Croatian: • Koprivnjača (urtikarija)
English: Limited or no data are available in CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with any degree of hepatic impairment.
Croatian: o Cerdelga se ne preporučuje u intermedijarnih metabolizatora (IM) ili sporih metabolizatora (SM) CYP2D6 s bilo kojim stupnjem oštećenja funkcije jetre.
English: • Heartburn (dyspepsia)
Croatian: • Iritacija grla • Žgaravica (dispepsija)
English: Percentage Change in Spleen Volume MN (%) (primary endpoint) Absolute Change in Haemoglobin Level (g/dL) (secondary endpoint) Percentage Change in Liver Volume MN (%) (secondary endpoint) Percentage Change in Platelet Count (%) (secondary endpoint) MN = Multiples of Normal, CI = confidence interval a At baseline, mean spleen volumes were 12.5 and 13.9 MN in the placebo and Cerdelga groups, respectively, and mean liver volumes were 1.4 MN for both groups.
Croatian: Postotak promjene u volumenu slezene MN (%) (primarna mjera ishoda) Apsolutna promjena u razini hemoglobina (g/dl) (sekundarna mjera ishoda) Postotak promjene u volumenu jetre MN (%) (sekundarna mjera ishoda) Postotak promjene broja trombocita
English: In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with mild, moderate or severe renal impairment or ESRD, eliglustat is not recommended (see sections 4.4 and 5.2).
Croatian: Eliglustat se ne preporučuje u intermedijarnih metabolizatora (IM) ili sporih metabolizatora (SM) CYP2D6 s blagim, umjerenim ili teškim oštećenjem funkcije bubrega ili ESRD-om (vidjeti dijelove 4.4 i 5.2)
English: At 84 mg twice daily dosing with eliglustat in non-PMs, it is predicted that concomitant use of moderate CYP3A inhibitors (e.g. erythromycin, ciprofloxacin, fluconazole, diltiazem, verapamil, aprepitant, atazanavir, darunavir, fosamprenavir, imatinib, cimetidine) would increase eliglustat exposure approximately up to 3-fold.
Croatian: Pri dozi eliglustata od 84 mg jednom dnevno kod SM-a, predviđa se da će istovremena primjena umjerenih inhibitora CYP3A (npr. eritromicin, ciprofloksacin, flukonazol, diltiazem, verapamil,
English: Limited data are available in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment.
Croatian: U ekstenzivnih metabolizatora (EM) CYP2D6 s umjerenim oštećenjem funkcije jetre dostupni podaci su ograničeni.
English: Clinical experience in CYP2D6 poor metabolisers (PMs) and ultra-rapid metabolisers (URMs)
Croatian: Ultrabrzi metabolizatori (UBM) i neodređeni metabolizatori CYP2D6
English: Limited or no data are available in CYP2D6 extensive metabolisers (EMs), intermediate metabolisers (IMs) or poor metabolisers (PMs) with ESRD and in CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with mild, moderate, or severe renal impairment; use of eliglustat in these patients is not recommended (see sections 4.2 and 5.2).
Croatian: (IM) ili spori metabolizatori (SM) CYP2D6 s blagim, umjerenim ili teškim oštećenjem funkcije bubrega dostupni podaci su ograničeni ili nema dostupnih podataka; primjena eliglustata u tih bolesnika se ne preporučuje (vidjeti dijelove 4.2 i 5.2).
English: In CYP2D6 extensive metabolisers (EMs) with mild or moderate hepatic impairment taking a strong or moderate CYP2D6 inhibitor, Cerdelga is contraindicated (see sections 4.3 and 5.2).
Croatian: Cerdelga je kontraindicirana u ekstenzivnih metabolizatora (EM) CYP2D6 s blagim ili umjerenim oštećenjem funkcije jetre koji uzimaju jak ili umjeren inhibitor CYP2D6 (vidjeti dijelove 4.3 i 5.2).
English: • Joint pain (arthalagia)
Croatian: • Bol u zglobovima (artralgija)
English: o In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with any degree of hepatic impairment, Cerdelga is not recommended.
Croatian: U intermedijarnih metabolizatora (IM) ili sporih metabolizatora (SM) CYP2D6 s bilo kojim stupnjem oštećenja funkcije jetre dostupni podaci su ograničeni ili nema dostupnih podataka.
English: A dose of eliglustat 84 mg once daily should be considered when a strong CYP2D6 inhibitor (e.g. paroxetine, fluoxetine, quinidine, bupropion) is used concomitantly in IMs and EMs.
Croatian: Kada se kod IM-a i EM-a istovremeno uzima jaki inhibitor CYP2D6 (npr. paroksetin, fluoksetin, kinidin, bupropion) potrebno je razmotriti dozu od 84 mg eliglustata jednom dnevno.
English: Spleen Volume Patients with stable spleen volume (%)*
Croatian: Volumen slezene Postotak bolesnika sa stabilnim volumenom slezene*a Postotak promjene u volumenu slezene MN
English: You will be instructed in:
Croatian: Bit ćete upućeni u:
English: • there has been a long interval (more than eight weeks) since the previous infusion.
Croatian: • je prošlo dulje razdoblje (više od osam tjedana) od prethodne infuzije.
English: Therefore, your baby may be protected from certain infections.
Croatian: Na taj način i Vaša beba može biti zaštićena od određenih infekcija.
English: Ask your healthcare professional how to throw away medicines you no longer use.
Croatian: Pitajte svog zdravstvenog radnika kako baciti lijekove koje više ne koristite.
English: If this happens, you should not drive or use machines until these effects have disappeared.
Croatian: Ako se to dogodi, ne biste trebali voziti ili upravljati strojevima dok ti učinci ne prođu.
English: Produced from the plasma of human donors.
Croatian: Proizvedeno iz plazme ljudskih donora.
English: Please refer to section 4.4 for details on risk factors and monitoring recommendations.
Croatian: Molimo pogledajte dio 4.4 za detalje o faktorima rizika i preporukama za praćenje.
English: Absorption and Distribution
Croatian: Apsorpcija i distribucija
English: Date of first authorisation: 14 April 2011 Date of first renewal: 18 February 2016
Croatian: Datum prve obnove odobrenja: 18. veljače 2016.
English: If large doses are given (> 50 ml), try to administer them at multiple sites.
Croatian: Ako se primjenjuju velike doze (>50 ml), pokušajte ih rasporediti na više mjesta.
English: Please refer also to section 5.1.
Croatian: Vidjeti također dio 5.1.
English: Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: • Increased blood pressure (hypertension)
Croatian: • Povišen krvni tlak (hipertenzija)
English: It is usually prepared from pooled plasma from not fewer than 1,000 donors.
Croatian: Obično se priprema od udružene plazme od najmanje 1000 donora.
English: In case of shock, standard medical treatment should be administered.
Croatian: U slučaju šoka, potrebno je primijeniti standardni medicinski postupak.
English: Interference with serological testing
Croatian: Interferencija sa serološkim testiranjem
English: The dose or dosing interval should not be changed without consulting your doctor.
Croatian: Doza ili interval između doza se ne smije mjenjati bez savjetovanja s liječnikom.
English: • measures to be taken in case of severe side effects.
Croatian: • mjere koje treba poduzeti u slučaju teških nuspojava.
English: • Involuntary shaking movements in one or more parts of the body (tremor, including psychomotor hyperactivity)
Croatian: • Nevoljno tresenje u jednom ili više dijelova tijela (tremor, uključujući psihomotornu hiperaktivnost)
English: True allergic reactions are rare.
Croatian: Prave alergijske reakcije su rijetke.
English: This may need to be divided over several days.
Croatian: To će se doziranje možda morati rasporediti na nekoliko dana.
English: Subjects generally used 4 infusion sites in parallel (up to 8 sites in parallel).
Croatian: Ispitanici su uglavnom paraleno koristili 4 infuzijska mjesta (do 8 mjesta paralelno).
English: The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Croatian: Mehanizam djelovanja u indikacijama osim zamjenske terapije nije potpuno razjašnjen, ali uključuje imunomodulacijske efekte.
English: However, true allergic reactions are rare.
Croatian: Ipak, prave alergijske reakcije su rijetke.
English: The dose may need to be adapted to achieve the desired clinical response.
Croatian: Doza će se možda morati prilagoditi kako bi se postigao željeni klinički odgovor.
English: ► that you are carefully monitored for any symptoms throughout the infusion period, especially if:
Croatian: ► pažljivo praćenje bilo kakvih simptoma tijekom razdoblja primjene infuzije, osobito ako:
English: For safety with respect to transmissible agents, see section 4.4.
Croatian: Za sigurnost s obzirom na prenosive agense, vidjeti dio 4.4.
English: You must not mix other medicines with Hizentra.
Croatian: Ne smijete miješati druge lijekove s Hizentrom.
English: The recommended initial infusion rate depends on the individual patient's needs.
Croatian: Preporučena početna brzina infuzije ovisi o individualnim potrebama bolesnika.
English: All other patients should be observed for at least 20 minutes after administration.
Croatian: Sve ostale bolesnike treba nadgledati barem 20 minuta nakon primjene.
English: Non-clinical data reveal no special risk for humans based on safety pharmacology and toxicity studies.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja sigurnosne farmakologije i toksičnosti.
English: This includes conditions such as:
Croatian: Ovo uključuje stanja kao što su:
English: If the points above do not apply for you it is recommended that you are observed for at least 20 minutes after administration.
Croatian: Ako se gore navedeno ne odnosi na Vas, preporučuje se da Vas se nadgleda najmanje 20 minuta nakon primjene lijeka.
English: • Do not store above 25 °C.
Croatian: • Ne čuvati na temperaturi iznad 25° C.
English: In all three groups, each infusion parameter was used for 4 weeks, after which subjects successfully completing required minimal number of valid infusions could switch to the next higher infusion parameter.
Croatian: U sve tri skupine, svaki se infuzijski parametar koristio 4 tjedna, nakon čega su ispitanici koji su uspješno završili potreban minimalni broj valjanih infuzija mogli prijeći na sljedeći veći infuzijski parametar.
English: 11 Clean up
Croatian: 11 Čišćenje
English: The following dose regimens are given as a guideline.
Croatian: Sljedeći režimi doziranja preporučuju se kao smjernica.
English: Elimination IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Croatian: IgG i IgG-kompleksi se razgrađuju u stanicama retikuloendotelnog sustava.
English: The dose and dose regimen are dependent on the indication.
Croatian: Doza i doziranje ovise o indikaciji.
English: You must not take it if you suffer from hyperprolinaemia (see also section 2 “What you need to know before you use Hizentra”).
Croatian: Ne smijete primati Hizentru ako patite od hiperprolinemije (vidjeti također dio 2 "Što morate znati prije nego počnete primjenjivati Hizentru").
English: The syndrome usually begins within several hours to 2 days following immune globulin treatment.
Croatian: Sindrom obično počinje unutar nekoliko sati do 2 dana nakon liječenja imunoglobulinima.
English: Continued treatment of the pregnant woman ensures a passive immunity for the neonate.
Croatian: Kontinuirano liječenje trudnica osigurava pasivan imunitet novorođenčetu.
English: Embolic and thrombotic events
Croatian: Embolijski i trombotički događaji
English: In these cases, it is recommended that you are monitored during the first infusion and for an hour afterwards.
Croatian: U tim slučajevima, preporučuje se da Vas se pomno nadzire tijekom prve infuzije i najmanje 1
English: You may use an unlimited number of sites simultaneously.
Croatian: Istovremeno možete koristiti neograničeni broj mjesta.
English: They can particularly occur in patients with anti-IgA antibodies who should be treated with particular caution.
Croatian: Mogu se osobito pojaviti u bolesnika s anti-IgA protutijelima, koje treba liječiti s posebnim oprezom.
English: Do not use solutions that have been frozen.
Croatian: Nemojte upotrebljavati otopine koje su bile smrznute.
English: Patient`s individual clinical response should be the primary consideration in dose adjustment.
Croatian: Individualni klinički odgovor bolesnika treba biti primarni razlog za prilagodbu doze.
English: They help your body to fight infections caused by bacteria and viruses or maintain the balance in your immune system (referred to as immunomodulation).
Croatian: Oni pomažu Vašem tijelu u borbi s infekcijama uzrokovanim bakterijama i virusima ili održavaju ravnotežu u Vašem imunološkom sustavu (u daljenjem tekstu imunomodulacija).
English: If using an infusion pump, follow the manufacturer's instructions.
Croatian: Ako upotrebljavate pumpu za infuziju, slijedite upute proizvođača.
English: Please also refer to section 2 “What you need to know before you use Hizentra” for additional details on circumstances which increase the risk of side effect.
Croatian: Proučite dio 2 “Što morate znati prije nego počnete primati Hizentru” za dodatne pojedinosti o okolnostima koje povećavaju rizik od nuspojava.
English: • you receive human normal immunoglobulin for the first time
Croatian: • primate ljudski normalni imunoglobulin po prvi puta
English: ► into a blood vessel.
Croatian: ► u krvne žile.
English: • the keeping of a treatment diary, and
Croatian: • vođenje dnevnika liječenja, i
English: • an infusion device, or
Croatian: • uređaja za infuziju, ili
English: Do not use solutions that are cloudy or contain particles.
Croatian: Nemojte upotrebljavati otopine koje su mutne ili sadrže čestice.
English: L-proline is a physiological, nonessential amino acid.
Croatian: L-prolin je fiziološka, neesencijalna aminokiselina.
English: In adults doses may be given up to 50 ml/site.
Croatian: Kod odraslih mogu se dati doze do 50 ml/mjestu.
English: Hizentra contains immunoglobulins that have been prepared from the blood of healthy people.
Croatian: Hizentra sadrži imunoglobuline koji su pripremljeni od krvi zdravih ljudi.
English: The colour can vary from pale-yellow to light-brown.
Croatian: Boja može varirati od blijedo žute do svijetlo smeđe.
English: • you have switched from a different medicine
Croatian: • ste na terapiju prešli s drugog lijeka
English: • aseptic infusion techniques
Croatian: • tehnike aseptične infuzije
English: Other important information about Hizentra
Croatian: Druge važne informacije o Hizentri
English: There is no limit to the number of infusion sites.
Croatian: Nema ograničenja vezano uz broj mjesta primjene infuzije.
English: Also tell your doctor what drugs you are using, as some drugs, such as those that contain the hormone estrogen (for example, birth control pills), may increase your risk of developing a blood clot.
Croatian: Također recite svim liječniku koje lijekove uzimate, jer neki lijekovi, poput onih koji sadrže hormon estrogen (na primjer, pilule za kontracepciju), mogu kod Vas povećati rizik za stvaranje krvnih ugrušaka.
English: You may be allergic (hypersensitive) to immunoglobulins without knowing it.
Croatian: Možda ste alergični (preosjetljivi) na imunoglobuline ne znajući to.
English: Other medicines and Hizentra
Croatian: Drugi lijekovi i Hizentra
English: • Chills, including low body temperature
Croatian: • Zimica, uključujući nisku tjelesnu temperaturu
English: This medicine contains trace amounts of IgA (not more than 50 micrograms /ml).
Croatian: Ovaj lijek sadrži količine IgA u tragovima (ne više od 50 mikrograma/ml).
English: Start infusion.
Croatian: Započnite s infuzijom.
English: Finally, withdraw the desired volume of Hizentra.
Croatian: Konačno, povucite željenu količinu Hizentre.
English: Tell your doctor or healthcare professional if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili zdravstvenog radnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Hizentra can be infused using:
Croatian: Hizentra se može infundirati upotrebom:
English: Excipients with known effects Hizentra contains approximately 250 mmol/L (range: 210 to 290) of L-proline.
Croatian: Pomoćne tvari s poznatim učinkom Hizentra sadrži približno 250 mmol/l (raspon od: 210 do 290) L-prolina.
English: Hizentra has an approximate osmolality of 380 mOsmol/kg.
Croatian: Približna osmolalnost Hizentre iznosi 380 mOsmol/kg.
English: Both Hizentra doses demonstrated superiority over placebo for the primary endpoint.
Croatian: Obje ispitivane doze Hizentre pokazale su superiornost nad placebom u primarnoj mjeri ishoda.
English: Manufacturers of these medicines also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Croatian: Proizvođači tih lijekova također provode korake prilikom obrade krvi ili plazme, a koji mogu inaktivirati ili ukloniti viruse.
English: The medicine is used in adults and children (0-18 years) in the following situations:
Croatian: Lijek se koristi u odraslih i djece (0-18 godina) u sljedećim situacijama:
English: By replacing the missed doses when daily dosing was resumed, the median concentration profile recovered within 2 to 3 days.
Croatian: Nadoknadom propuštenih doza nakon što je dnevno doziranje ponovno uspostavljeno, medijan profila koncentracije ponovno je dosegnut u roku od 2 do 3 dana.
English: Chest pain, Influenza like illness, Pain
Croatian: Bol u prsištu, bolest nalik gripi, bol
English: An infusion was considered valid, if ≥95 % of the planned flow rate/volume per ≥1 infusion site was achieved.
Croatian: Infuzija se smatra valjanom ako je postignuto ≥95% planiranog protoka/volumena po ≥1 mjestu infuzije.
English: Your doctor will determine whether you need a loading dose (for adults and children) of at least 1 to 2.5 ml/kg of body weight divided over several days.
Croatian: Vaš liječnik će odrediti je li Vam potrebna udarna doza (za odrasle i djecu) od najmanje 1 do 2,5 ml/kg tjelesne težine podijeljena u nekoliko dana.
English: • the date of administration,
Croatian: • datum primjene,
English: Record the following data in your treatment diary:
Croatian: 10 Evidencija infuzije Zabilježite sljedeće podatke u svoj dnevnik liječenja:
English: Infusion parameter and responder rate (%)
Croatian: Infuzijski parametar i stopa ispitanika s uspjehom (%)
English: Please see also section 2 of this leaflet about the risk of allergic reactions, blood clots and AMS.
Croatian: Pogledajte i dio 2. ove upute o riziku od alergijskih reakcija, krvnih ugrušaka i AMS-a.
English: The medicine works in exactly the same way as the immunoglobulins naturally present in your blood.
Croatian: Lijek djeluje na isti način kao i imunoglobulini prirodno prisutni u Vašoj krvi.
English: Fatigue (including Malaise), Pyrexia
Croatian: Umor (uključujući malaksalost), pireksija