FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: o Eliglustat je kontraindiciran pri bolnikih, ki so srednje dobri (IM) ali dobri presnavljalci (EM) z encimom CYP2D6 in jemljejo kakšen močan ali zmeren zaviralec CYP2D6 hkrati z močnim ali zmernim zaviralcem CYP3A.
English: o Caution should be used with moderate CYP2D6 inhibitors in intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Slovenian: Pri uporabi zmernih zaviralcev encima CYP2D6 je potrebna previdnost pri srednje dobrih (IM) in dobrih presnavljalcih (EM).
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).
Slovenian: Pri dobrih presnavljalcih (EM) s CYP2D6 z blago okvaro jeter, ki jemljejo šibek zaviralec CYP2D6 ali močan, zmeren ali šibek zaviralec CYP3A, je treba razmisliti o odmerku 84 mg eliglustata enkrat na dan (glejte poglavji 4.2 in
English: Cerdelga is indicated in patients who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).
Slovenian: Zdravilo Cerdelga je indicirano pri bolnikih, ki so slabi presnavljalci (PM), srednje dobri presnavljalci (IM) ali dobri presnavljalci (EM) encima CYP2D6.
English: Eliglustat is an inhibitor of P-gp and CYP2D6 in vitro; concomitant administration of eliglustat with P-gp or CYP2D6 substrate substances may increase the plasma concentration of those substances.
Slovenian: Sočasno jemanje eliglustata s substrati P-glikoproteina ali encima CYP2D6 lahko vodi v povečanje njihovih plazemskih koncentracij.
English: Each capsule contains 84 mg of eliglustat (as tartrate)
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 84 mg eliglustata (v obliki tartrata).
English: In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with any degree of hepatic impairment, eliglustat is not recommended (see sections 4.4 and 5.2).
Slovenian: Pri srednje dobrih presnavljalcih (IM) ali pri slabih presnavljalcih (PM) s CYP2D6 s katerokoli stopnjo jetrne okvare uporaba eliglustata ni priporočljiva (glejte poglavji 4.4 in 5.2).
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).
Slovenian: Pri dobrih presnavljalcih (EM) s CYP2D6, ki imajo blago okvaro jeter in hkrati jemljejo šibek zaviralec CYP2D6 ali močan, zmeren ali blag zaviralec CYP3A, je treba razmisliti o uporabi odmerka 84 mg eliglustata enkrat na dan (glejte poglavji 4.4 in 5.2).
English: N Baseline Value (Mean)
Slovenian: N Izhodiščna vrednost (povprečna)
English: The recommended dose is 84 mg eliglustat twice daily in CYP2D6 intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Slovenian: Priporočeni odmerek je 84 mg eliglustata dvakrat dnevno pri srednje dobrih (IM) ali dobrih presnavljalcih (EM) encima CYP2D6.
English: Cerdelga is contraindicated in patients who are CYP2D6 intermediate metabolisers (IMs) or extensive metabolisers (EMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, and in patients who are CYP2D6 poor metabolisers (PMs) taking a strong CYP3A inhibitor (see section 4.3).
Slovenian: Zdravilo Cerdelga je kontraindicirano pri bolnikih, ki so srednje dobri presnavljalci (IM) ali dobri presnavljalci (EM) encima CYP2D6 in jemljejo močan ali zmeren zaviralec encima CYP2D6 sočasno z močnim ali zmernim zaviralcem encima CYP3A in pri bolnikih, ki so slabi presnavljalci (PM) encima CYP2D6 in jemljejo močan zaviralec encima CYP3A (glejte poglavje 4.3).
English: Limited data are available in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment.
Slovenian: Podatkov o dobrih presnavljalcih (EM) s CYP2D6, ki imajo zmerno okvaro jeter, je malo.
English: Study 304 was a single-arm, open-label, multicenter study of Cerdelga in 26 patients.
Slovenian: Dolgotrajni klinični rezultati pri bolnikih z GD1, ki predhodno niso bili zdravljeni - študija 304 Študija 304 je bila enoskupinska, odprta, multicentrična študija zdravila Cerdelga pri 26 bolnikih.
English: In CYP2D6 extensive metabolisers (EMs) with severe (Child-Pugh class C) hepatic impairment, eliglustat is contraindicated (see sections 4.3 and 5.2).
Slovenian: Eliglustat je kontraindiciranpri dobrih presnavljalcih (EM) s CYP2D6, ki imajo hudo okvaro jeter (Child-Pugh razred C) (glejte poglavji 4.3 in 5.2).
English: CYP2D6 phenotype
Slovenian: Fenotip encima CYP2D 6
English: b Estimates and p-values are based on an ANCOVA model * All patients transitioned to Cerdelga treatment after Month 9.
Slovenian: b Predvidene vrednosti in vrednosti p temeljijo na modelu ANCOVA
English: Limited or no data were available in patients with ESRD and in CYP2D6 intermediate metabolisers (IMs) or poor metabolisers(PMs) with severe renal impairment (see sections 4.2 and 4.4).
Slovenian: Pri bolnikih z ESRD in pri srednje dobrih presnavljalcih (IM) ali slabih presnavljalcih (PM) s hudo okvaro ledvic je podatkov malo ali jih ni (glejte poglavji 4.2 in 4.4).
English: o In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with any degree of hepatic impairment, Cerdelga is not recommended.
Slovenian: o Uporaba zdravila Cerdelga ni priporočljiva pri srednje dobrih (IM) ali slabih presnavljalcih (PM) s kakršnokoli stopnjo okvare jeter.
English: CYP2D6 inhibitors used simultaneously with CYP3A inhibitors In intermediate (IMs) and extensive metabolisers (EMs):
Slovenian: Zaviralci CYP2D6, uporabljeni sočasno z zaviralci CYP3A
English: Contents of the pack and other information What Cerdelga contains
Slovenian: Shranjevanje zdravila Cerdelga Vsebina pakiranja in dodatne informacije
English: What you need to know before you take Cerdelga 3.
Slovenian: Kaj je zdravilo Cerdelga in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Cerdelga Kako jemati zdravilo Cerdelga Možni neželeni učinki
English: In extensive metabolisers (EMs) with mild or moderate hepatic impairment: see sections 4.2, 4.3 and
Slovenian: Pri dobrih presnavljalcih (EM) z blago ali zmerno okvaro jeter: glejte poglavja 4.2., 4.3 in 4.4.
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 14 trdih kapsul
English: Use of a moderate CYP3A inhibitor with eliglustat is not recommended in PMs.
Slovenian: Pri PM hkrati z eliglustatom ni priporočljivo uporabljati zmernih zaviralcev CYP3A.
English: Long-term clinical outcomes in treatment-naïve GD1 patients - study 304
Slovenian: Ključna študija zdravila Cerdelga pri bolnikih z GD1, ki predhodno niso bili zdravljeni - študija 02507 (ENGAGE)
English: In extensive metabolisers (EMs) with mild hepatic impairment: see sections 4.2 and 4.4.
Slovenian: Pri dobrih presnavljalcih (EM) z blago okvaro jeter: glejte poglavji 4.2. in 4.4.
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).
Slovenian: Podatkov o dobrih presnavljalcih (EM), srednje dobrih presnavljalcih (IM) ali slabih presnavljalcih (PM) s CYP2D6, z ESRD ter o srednje dobrih presnavljalcih (IM) ali slabih presnavljalcih (PM) s CYP2D6, z blago, zmerno ali hudo okvaro ledvic, je malo ali jih ni.
English: o In CYP2D6 extensive metabolisers (EMs) with severe hepatic impairment, Cerdelga is contraindicated.
Slovenian: o Zdravilo Cerdelga je kontraindicirano pri dobrih presnavljalcih (EM) s CYP2D6 s hudo okvaro jeter.
English: Caution should be used with moderate CYP3A inhibitors in IMs and EMs.
Slovenian: Pri uporabi zmernih zaviralcev encima CYP3A je potrebna previdnost pri srednje dobrih (IM) in dobrih presnavljalcih (EM).
English: In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment (Child-Pugh class A), no dosage adjustment is required and the recommended dose is 84 mg eliglustat twice daily.
Slovenian: o Priporočeni odmerek eliglustata pri srednje dobrih (IM) in dobrih presnavljalcih (EM) encima CYP2D6 je 84 mg dvakrat na dan. Priporočeni odmerek eliglustata pri slabih presnavljalcih (PM) z encimom CYP2D6 je 84 mg enkrat na dan.
English: Caution should be used with strong CYP3A inhibitors in IMs and EMs.
Slovenian: Pri uporabi močnih zaviralcev encima CYP3A je potrebna previdnost pri srednje dobrih (IM) in dobrih presnavljalcih (EM).
English: Limited or no data are available in CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with any degree of hepatic impairment.
Slovenian: Podatkov o srednje dobrih presnavljalcih (IM) ali slabih presnavljalcih (PM) s kakršno koli stopnjo okvare jeter, je malo ali jih ni.
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).
Slovenian: Zdravilo Cerdelga je kontraindicirano pri dobrih presnavljalcih (EM) s CYP2D6, ki imajo blago okvaro jeter in hkrati jemljejo močan ali zmeren zaviralec CYP2D6 (glejte poglavji 4.3 in 5.2).
English: Date of first authorisation: 14 April 2011 Date of first renewal: 18 February 2016
Slovenian: Datum prve odobritve: 14. april 2011 Datum prvega podaljšanja: 18. februar 2016
English: Therefore, your baby may be protected from certain infections.
Slovenian: Zato je vaš dojenček morda zaščiten pred določenimi okužbami.
English: Produced from the plasma of human donors.
Slovenian: Narejeno iz plazme človeških darovalcev.
English: • there has been a long interval (more than eight weeks) since the previous infusion.
Slovenian: • je od zadnjega infundiranja poteklo dlje časa (več kot osem tednov).
English: Please refer also to section 5.1.
Slovenian: Glejte tudi poglavje 5.1.
English: This includes conditions such as:
Slovenian: To vključuje bolezni, kot so:
English: This may need to be divided over several days.
Slovenian: Ta se lahko porazdeli na več dni.
English: You will be instructed in:
Slovenian: Dobili boste navodila za:
English: If this happens, you should not drive or use machines until these effects have disappeared.
Slovenian: Če se to zgodi, ne smete voziti ali upravljati s stroji, dokler ti učinki ne izzvenijo.
English: • measures to be taken in case of severe side effects.
Slovenian: • ukrepe v primeru resnih neželenih učinkov.
English: Consequences of an overdose are not known.
Slovenian: Posledice prevelikega odmerka niso znane.
English: If large doses are given (> 50 ml), try to administer them at multiple sites.
Slovenian: Če se dajejo veliki odmerki (> 50 ml), jih poskušajte dati na več mestih.
English: Infusion parameter and responder rate (%)
Slovenian: Parameter infundiranja in delež odziva (%)
English: In these cases, it is recommended that you are monitored during the first infusion and for an hour afterwards.
Slovenian: V teh primerih vas morajo spremljati med prvim infundiranjem in še eno uro po njem.
English: Do not use solutions that have been frozen.
Slovenian: Ne uporabljajte raztopin, ki so bile zamrznjene.
English: ► into a blood vessel.
Slovenian: ► v krvno žilo.
English: All other patients should be observed for at least 20 minutes after administration.
Slovenian: Vse druge bolnike je treba opazovati vsaj 20 minut po dajanju zdravila.
English: Please see also section 2 of this leaflet about the risk of allergic reactions, blood clots and AMS.
Slovenian: Glejte tudi poglavje 2 tega navodila o tveganju alergijskih reakcij, krvnih strdkih in AMS.
English: Elimination IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Slovenian: Izločanje IgG in kompleksi IgG se razgradijo v celicah retikuloendotelijskega sistema.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah objavljenih na evropskem spletnem portalu o zdravilih.
English: However, true allergic reactions are rare.
Slovenian: Vendar pa so prave alergijske reakcije redke.
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.
Slovenian: Zdravniku povejte tudi, katera zdravila uporabljate, saj lahko nekatera zdravila, kot tista, ki vsebujejo hormon estrogen (na primer kontracepcijske tabletke), povečajo vaše tveganje za nastanek krvnih strdkov.
English: The dose and dose regimen are dependent on the indication.
Slovenian: Odmerek in režim odmerjanja sta odvisna od indikacije.
English: Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: The recommended initial infusion rate depends on the individual patient's needs.
Slovenian: Priporočena začetna hitrost infundiranja je odvisna od potreb posameznega bolnika.
English: This also applies to any unknown or emerging viruses or other types of infections.
Slovenian: To velja tudi za katere koli neznane ali nove viruse ali druge vrste okužb.
English: If the points above do not apply for you it is recommended that you are observed for at least 20 minutes after administration.
Slovenian: Če zgoraj navedeno za vas ne velja, se priporoča, da vas opazujejo vsaj 20 minut po prejemu zdravila.
English: True allergic reactions are rare.
Slovenian: Prave alergijske reakcije so redke.
English: ► that you are carefully monitored for any symptoms throughout the infusion period, especially if:
Slovenian: ► da vas skrbno spremljajo, če se med infundiranjem pojavi katerikoli simptom, še zlasti, če:
English: The dose may need to be adapted to achieve the desired clinical response.
Slovenian: Odmerek bo morda treba prilagoditi, da dosežemo želeni klinični odziv.
English: It may happen particularly if you do not have enough of the immunoglobulin type A (IgA) in your blood (IgA deficiency).
Slovenian: To se lahko zgodi zlasti, če nimate dovolj imunoglobulina tipa A (IgA) v svoji krvi (pomanjkanje IgA).
English: When using multiple vials to achieve the desired dose, repeat this step.
Slovenian: Če za želeni odmerek potrebujete več vial, ponovite ta korak.
English: The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Slovenian: Mehanizem delovanja pri indikacijah, z izjemo nadomestnega zdravljenja, še ni popolnoma pojasnjen, vključuje pa imunomodularne učinke.
English: Overall, the number of infusions without severe local reactions versus the total number of infusions (tolerability) was ≥ 0.98 in all groups for all infusion parameters.
Slovenian: Na splošno je bilo število infundiranj brez hudih lokalnih reakcij v primerjavi s celokupnim številom infuzij (prenosljivost) ≥ 0,98 v vseh skupinah za vse parametre infundiranja.
English: You may be allergic (hypersensitive) to immunoglobulins without knowing it.
Slovenian: Morda ste alergični (preobčutljivi) na imunoglobuline, ne da to veste.
English: Record the following data in your treatment diary:
Slovenian: V dnevnik zdravljenja zabeležite naslednje podatke:
English: 11 Clean up
Slovenian: 11 Pospravite
English: • the keeping of a treatment diary, and
Slovenian: • vodenje dnevnika zdravljenja in
English: Kaplan-Meier Plot Time to CIDP Relapse
Slovenian: Kaplan-Meierjeva krivulja časa do relapsa CIDP
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.
Slovenian: Glejte tudi poglavje 2 »Kaj morate vedeti, preden boste uporabili zdravilo Hizentra« za dodatne podrobnosti o okoliščinah, ki lahko povečujejo tveganje neželenih učinkov.
English: In infants and children, infusion site may be changed every 5-15 ml.
Slovenian: Pri dojenčkih in otrocih se lahko mesto infundiranja menja na vsakih 5-15 ml.
English: You must not take it if you suffer from hyperprolinaemia (see also section 2 “What you need to know before you use Hizentra”).
Slovenian: Ne smete ga uporabljati, če imate hiperprolinemijo (glejte tudi poglavje 2 „Kaj morate vedeti, preden boste uporabili zdravilo Hizentra“.
English: The medicine is used in adults and children (0-18 years) in the following situations:
Slovenian: Zdravilo se uporablja pri odraslih in otrocih (0-18 let) v naslednjih primerih:
English: The colour can vary from pale-yellow to light-brown.
Slovenian: Barva lahko variira od bledo rumene do svetlo rjave.
English: Do not use solutions that are cloudy or contain particles.
Slovenian: Ne uporabljajte raztopin, ki so motne ali vsebujejo delce.
English: • Increased blood pressure (hypertension)
Slovenian: • visok krvni tlak (hipertenzija)
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).
Slovenian: Vašemu telesu pomagajo pri boju proti okužbam, ki jih povzročijo bakterije in virusi, ter pri ohranjanju ravnovesja v imunskem sistemu (tako imenovana imunomodulacija).
English: You must not mix other medicines with Hizentra.
Slovenian: Drugih zdravil ne smete mešati z zdravilom Hizentra.
English: Continued treatment of the pregnant woman ensures a passive immunity for the neonate.
Slovenian: Neprekinjeno zdravljenje nosečnic zagotavlja pasivno imunost pri novorojenčku.
English: • careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and
Slovenian: •skrbna izbira darovalcev krvi in plazme, da se zagotovi izključitev tveganj za prenos okužb in
English: It is usually prepared from pooled plasma from not fewer than 1,000 donors.
Slovenian: Navadno se pripravlja iz zbirov plazme od vsaj 1.000 krvodajalcev.
English: The primary endpoint was the percentage of subjects responding to a higher infusion parameter:
Slovenian: Primarni opazovani dogodek je bil odstotek preiskovancev, ki so se odzivali na višji parameter infundiranja:
English: Manufacturers of these medicines also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Slovenian: Izdelovalci teh zdravil vključijo tudi korake pri obdelavi krvi ali plazme, ki lahko deaktivirajo ali odstranijo viruse.
English: As the dose is given by body weight and adjusted to the clinical outcome of the above mentioned conditions, the dose in the elderly population is not considered to be different from that in subjects 18 to 65 years of age.
Slovenian: Ker je odmerjanje podano glede na telesno maso in prilagojeno kliničnemu izidu zgoraj navedenih stanj, odmerjanje pri starejši populaciji ni drugačno od odmerjanja pri osebah starih od 18 do 65 let.
English: • Pain related to the musculature and bones (musculoskeletal pain)
Slovenian: • bolečina povezana z mišicami in kostmi (mišično-skeletna bolečina)
English: Tell your doctor or healthcare professional if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: Posology Adults and children (0-18 years)
Slovenian: Odmerjanje Odrasli in otroci (0-18 let)
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.
Slovenian: Zdravnik bo določil, ali potrebujete začetni odmerek (za odrasle in otroke) vsaj 1 do 2,5 ml/kg telesne mase, porazdeljen na več dni.
English: Distribution of the IgG subclasses (approx. values): IgG1 ...........69%
Slovenian: Porazdelitev podrazredov IgG (približne vrednosti): IgG1............69 %
English: In case of shock, standard medical treatment should be administered.
Slovenian: Ob šoku je treba uporabiti standardno zdravljenje.
English: Potential complications can often be avoided by ensuring that patients: are not sensitive to human normal immunoglobulin, by initially injecting the product slowly (see section 4.2); are carefully monitored for any symptoms throughout the infusion period.
Slovenian: Morebitnim zapletom se pogosto lahko izognete, če se prepričate, da bolniki: - niso občutljivi za humani polispecifični imunoglobulin tako, da na začetku počasi injicirate zdravilo (glejte poglavje 4.2); - skrbno spremljajo, če se med infundiranjem pojavi katerikoli simptom.
English: Subjects generally used 4 infusion sites in parallel (up to 8 sites in parallel).
Slovenian: Preiskovanci so običajno uporabljali 4 mesta infundiranja hkrati (do 8 mest hkrati).
English: Your healthcare professional will avoid potential complications by ensuring: ►that you are not sensitive to human normal immunoglobulin.
Slovenian: Zdravstveni delavec se bo izognil morebitnim zapletom tako, da zagotovi: ► da niste občutljivi za humani polispecifični imunoglobulin.
English: These things may increase your risk of having a blood clot after using Hizentra.
Slovenian: Ti dejavniki lahko povečajo vaše tveganje krvnih strdkov po uporabi zdravila Hizentra.
English: The ability to drive and operate machines may be impaired by some adverse reactions associated with Hizentra.
Slovenian: Sposobnost vožnje in upravljanja strojev se lahko poslabša zaradi nekaterih neželenih učinkov, povezanih z zdravilom Hizentra.
English: Solutions that are cloudy or have deposits should not be used.
Slovenian: Raztopin, ki so motne ali imajo usedline, se ne sme uporabiti.
English: Your doctor will decide whether you can receive Hizentra during your pregnancy or while you are breast-feeding.
Slovenian: Zdravnik se bo odločil, ali lahko prejemate zdravilo Hizentra med nosečnostjo ali dojenjem.
English: If using an infusion pump, follow the manufacturer's instructions.
Slovenian: Če uporabljate infuzijsko črpalko, upoštevajte navodila izdelovalca.
English: The syndrome usually begins within several hours to 2 days following immune globulin treatment.
Slovenian: Sindrom se običajno pojavi v nekaj urah do 2 dneh po zdravljenju z imunoglobulinom.
English: Hizentra contains residual amounts of IgA which might cause an allergic reaction.
Slovenian: Zdravilo Hizentra vsebuje ostanke protiteles IgA, ki lahko povzročijo alergijsko reakcijo.
English: CIDP is characterised by chronic inflammation of the peripheral nerves that causes muscle weakness and/or numbness mainly in the legs and arms.
Slovenian: Za CIDP je značilno kronično vnetje perifernih živcev, ki povzroča mišično oslabelost in /ali odrevenelost, povečini v nogah in rokah.
English: In adults doses may be given up to 50 ml/site.
Slovenian: Pri odraslih se lahko uporabi odmerke do 50 ml/mesto.
English: The medicine must be infusedslowly at first.
Slovenian: Zdravilo je treba najprej infundirati počasi.
English: Side effects observed in controlled clinical studies are presented in order of decreasing frequency.
Slovenian: Neželeni učinki, ki so bili opaženi v kontroliranih kliničnih študijah, so predstavljeni po padajoči pogostnosti.
English: This medicine contains trace amounts of IgA (not more than 50 micrograms /ml).
Slovenian: Zdravilo vsebuje sledove IgA (ne več kot 50 mikrogramov/ml).
English: Excipients with known effects Hizentra contains approximately 250 mmol/L (range: 210 to 290) of L-proline.
Slovenian: Pomožne snovi z znanim učinkom: Zdravilo Hizentra vsebuje približno 250 mmol/l (razpon: 210 do 290) L-prolina.