FrancophonIA/ELRC3.0 huggingface dataset:
English: ► In isolated cases, you may be allergic (hypersensitive) to immunoglobulins and allergic reactions such as a sudden fall in blood pressure or shock may occur (e.g. you may feel lightheaded, dizzy, faint on standing, cold in the hands and feet, sense an abnormal heart beat or chest pain, or have blurred vision).
Slovenian: ► V posamičnih primerih ste lahko alergični (preobčutljivi) na imunoglobuline, pri čemer se lahko pojavijo alergijske reakcije, kot je nenadno znižanje krvnega tlaka ali šok (počutite se lahko na primer omotično, vrtoglavo, čutite omedlevico, ko stojite, imate hladne roke in noge, čutite nenormalni srčni utrip ali bolečino v prsih ali imate zamegljen vid).
English: Postmarketing experience with Hizentra in patients ≥ 65 years of age shows an overall similar safety profile in this age group as in younger patients.
Slovenian: Izkušnje po trženju zdravila Hizentra kažejo na splošno podoben varnostni profil pri bolnikih ≥ 65 let kot pri mlajših bolnikih.
English: Sodium content Hizentra is essentially sodium free.
Slovenian: Vsebnost natrija Zdravilo Hizentra je v bistvu brez natrija.
English: Only one infusion site per syringe can be infused.
Slovenian: Z eno injekcijsko brizgo se lahko infundira samo na enem mestu.
English: There is no limit to the number of infusion sites.
Slovenian: Število mest infundiranja ni omejeno.
English: The following side effects are uncommon (affects 1 to 10 patients in 1,000):
Slovenian: Spodaj navedeni neželeni učinki so občasni (pojavijo se pri 1 do 10 od 1.000 bolnikov):
English: Non-clinical data reveal no special risk for humans based on safety pharmacology and toxicity studies.
Slovenian: Predklinični podatki na osnovi študij farmakološke varnosti in toksičnosti niso pokazali nobenega posebnega tveganja za človeka.
English: • Hives (urticaria)
Slovenian: • izpuščaji (koprivnica)
English: For all patients who received 0.2 g/kg bw in the extension study, 47.9 % (35/73 patients) had a relapse.
Slovenian: Med vsemi bolniki, ki so prejemali odmerek 0,2 g/kg telesne mase v podaljšani študiji, jih je imelo relaps 47,9 % (35/73 bolnikov).
English: 7 Prepare infusion site(s)
Slovenian: 7 Pripravite mesto(a) infundiranja
English: In the clinical studies with CIDP patients, 61 subjects >65 years of age were treated with Hizentra.
Slovenian: V kliničnih študijah z bolniki s CIDP je bilo 61 preiskovancev, zdravljenih z zdravilom Hizentra, starih >65 let.
English: 4.2Posology and method of administration
Slovenian: 4.2 Odmerjanje in način uporabe
English: Hizentra comes as a ready-to-use solution in single-use vials or single-use pre-filled syringes.
Slovenian: Zdravilo Hizentra se dobavlja v obliki raztopine, pripravljene za uporabo, v vialah za enkratno uporabo ali napolnjenih injekcijskih brizgah za enkratno uporabo.
English: Clean the infusion site(s) using an antiseptic skin preparation, Allow each site to dry before proceeding.
Slovenian: Očistite mesto(a) infundiranja z antiseptično raztopino za kožo in počakajte, da se koža posuši, preden nadaljujete.
English: OUTER BOX (pre-filled syringe)
Slovenian: ŠKATLA (napolnjena injekcijska brizga)
English: Hizentra is also available in packs of 1, 10 or 20 vials.
Slovenian: Zdravilo Hizentra je na voljo tudi v pakiranju po 1, 10 ali 20 vial.
English: Hizentra is made from human blood plasma (this is the liquid part of the blood).
Slovenian: Informacije o snoveh, iz katerih je narejeno zdravilo Hizentra Zdravilo Hizentra je narejeno iz humane krvne plazme (tekočega dela krvi).
English: Hizentra must not be given intravascularly.
Slovenian: Zdravilo Hizentra se ne sme dajati intravensko.
English: Hizentra contains proline
Slovenian: Zdravilo Hizentra vsebuje prolin.
English: AMS is characterised by the following signs and symptoms: severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomiting.
Slovenian: Za AMS so značilni naslednji znaki in simptomi: hud glavobol, tog vrat, dremavost, zvišana telesna temperatura, fotofobija, navzea in bruhanje.
English: Accordingly, over the treatment period for up to 24 weeks Hizentra prevented relapse in 81 % and 67 % of subjects in the 0.4 g/kg bw and 0.2 g/kg bw group, respectively, while in the placebo group 44 % of subjects remained relapse-free.
Slovenian: V skladu s tem je v obdobju zdravljenja do 24 tednov zdravilo Hizentra preprečilo relapse pri 81 % preiskovancev, ki so dobivali odmerek 0,4 g/kg TM, in 67 % preiskovancev, ki so dobivali odmerek 0,2 g/kg TM, medtem ko se v skupini s placebom pri 44 % preiskovancev relaps ni pojavil.
English: 10 Record the infusion
Slovenian: 10 Zabeležite infuzijo
English: The following side effects are common (affects 1 to 10 patients in 100):
Slovenian: Spodaj navedeni neželeni učinki so pogosti (pojavijo se pri 1 do 10 od 100 bolnikov):
English: Patients who completed the pivotal PATH study without relapse on 0.4 g/kg bw dose and initially received this dose in the extension study had a relapse rate of 5.6 % (1/18 patients).
Slovenian: Pri bolnikih, ki so po prejemanju odmerka 0,4 g/kg telesne mase zaključili osrednjo študijo PATH brez relapsa in so na začetku prejeli ta odmerek tudi v podaljšani študiji, je bila stopnja ponovitve 5,6 % (1/18 bolnikov).
English: The recommended initial infusion rate is up to 20 ml/hour/site.
Slovenian: Priporočena začetna hitrost infundiranja je do 20 ml/uro/mesto.
English: Once a vial has been opened, use the solution immediately.
Slovenian: Po odprtju viale je treba raztopino uporabiti takoj.
English: EU/1/11/687/004 EU/1/11/687/005 EU/1/11/687/006 EU/1/11/687/010 EU/1/11/687/011 EU/1/11/687/012 EU/1/11/687/013 EU/1/11/687/014
Slovenian: EU/1/11/687/001 EU/1/11/687/002 EU/1/11/687/003 EU/1/11/687/004 EU/1/11/687/005 EU/1/11/687/006 EU/1/11/687/010 EU/1/11/687/011 EU/1/11/687/012 EU/1/11/687/013 EU/1/11/687/014
English: If well-tolerated, you may gradually increase the infusion rate to 35 ml/hour/site for the subsequent two infusions.
Slovenian: Če dobro prenašate infundiranje, se lahko hitrost postopoma poveča na 35 ml/uro/mesto za naslednji dve infundiranji.
English: Thereafter, the infusion rate can be increased further as per your tolerability.
Slovenian: Po tem lahko hitrost infundiranja še povečate glede na to, kako prenašate infundiranje.
English: Patients who completed the PATH study without relapse on 0.2 g/kg bw dose and initially received this dose in the extension study had a relapse rate of 50 % (3/6 patients).
Slovenian: Pri bolnikih, ki so po prejemanju odmerka 0,2 g/kg telesne mase zaključili študijo PATH brez relapsa in so na začetku prejemali ta odmerek tudi v podaljšani študiji, je bila stopnja relapsa 50 % (3/6 bolnikov).
English: How to use Hizentra
Slovenian: Kako uporabljati zdravilo Hizentra
English: Pack sizes Packs of 1, 10 or 20 vials
Slovenian: Vsebina pakiranja Pakiranje po 1, 10 ali 20 vial.
English: Hizentra may be infused into sites such as abdomen, thigh, upper arm, and / or lateral hip.
Slovenian: Zdravilo Hizentra se lahko infundira na mestih, kot so trebuh, stegna, nadlaket in/ali lateralni del kolka.
English: Excipients: L-proline, polysorbate 80, water for injections.
Slovenian: Pomožne snovi: L-prolin, polisorbat 80, voda za injekcije Za nadaljnje informacije glejte navodilo za uporabo.
English: For all patients who received 0.4 g/kg bw in the PATH extension study, 9.7 % (7/72 patients) had a relapse.
Slovenian: Med vsemi bolniki, ki so prejemali odmerek 0,4 g/kg telesne mase v podaljšani študiji PATH, jih je imelo relaps 9,7 % (7/72 bolnikov).
English: What Hizentra looks like and contents of the pack Hizentra is a solution for subcutaneous injection (200 mg/ml).
Slovenian: Zdravilo Hizentra je raztopina za subkutano injiciranje (200 mg/ml).
English: Human normal immunoglobulin (SCIg)
Slovenian: Humani polispecifični imunoglobulin (s.c.Ig).
English: Immunomodulatory therapy in CIDP
Slovenian: Imunomodulacija pri CIDP
English: • The active substance is human normal immunoglobulin.
Slovenian: • Učinkovina je humani polispecifični imunoglobulin.
English: Pre-filled syringe(s)
Slovenian: Napolnjena(e) injekcijska(e) brizga(e)
English: Hizentra has not been evaluated in clinical studies in paediatric patients with CIDP who are under the age of 18.
Slovenian: Zdravila Hizentra niso ovrednotili v kliničnih študijah pri pediatričnih bolnikih s CIDP, mlajšimi od 18 let.
English: If well-tolerated (see also section 4.4), the infusion rate can be increased up to 2.0 ml/min/site (120 ml/hour/site).
Slovenian: Če bolnik infundiranje dobro prenaša (glejte tudi poglavje 4.4), se lahko hitrost poveča do 2,0 ml/min/mesto (120 ml/uro/mesto).
English: EU/1/11/687/001 1 x 5 ml vial EU/1/11/687/002 10 x 5 ml vials EU/1/11/687/003 20 x 5 ml vials EU/1/11/687/004 1 x 10 ml vial EU/1/11/687/005 10 x 10 ml vials EU/1/11/687/006 20 x 10 ml vials EU/1/11/687/010 1 x 20 ml vial EU/1/11/687/011 10 x 20 ml vials EU/1/11/687/012 20 x 20 ml vials EU/1/11/687/013 1 x 50 ml vial EU/1/11/687/014 10 x 50 ml vials
Slovenian: EU/1/11/687/001 1 x 5 ml viala EU/1/11/687/002 10 x 5 ml viale EU/1/11/687/003 20 x 5 ml viale EU/1/11/687/004 1 x 10 ml viala EU/1/11/687/005 10 x 10 ml viale EU/1/11/687/006 20 x 10 ml viale EU/1/11/687/010 1 x 20 ml viala EU/1/11/687/011 10 x 20 ml viale EU/1/11/687/012 20 x 20 ml viale EU/1/11/687/013 1 x 50 ml viala EU/1/11/687/014 10 x 50 ml viale
English: Subjects in the high dose Hizentra group remained stable in the Rasch-built Overall Disability Scale (R-ODS) centile score.
Slovenian: Pri preiskovancih, ki so dobivali večji odmerek zdravila Hizentra, je stanje glede na oceno centilne vrednosti po lestvici R-ODS (Rasch -built Overall Disability Scale) ostalo stabilno.
English: Therefore, Hizentra should only be given with caution to breast-feeding mothers.
Slovenian: Zato naj se zdravilo Hizentra doječim materam daje samo z največjo previdnostjo.
English: If well-tolerated, you may increase the infusion rate up to 2.0 ml/min/site (120 ml/hour/site) for subsequent infusions.
Slovenian: Če dobro prenašate infundiranje, se lahko hitrost poveča na 2,0 ml/min/mesto (120 ml/uro/mesto) za naslednji dve infundiranji.
English: Device-assisted infusion:
Slovenian: Infundiranje s pomočjo naprave za infundiranje:
English: Hypogammaglobulinaemia in patients, pre- and post-allogeneic haematopoietic stem cell transplantation (HSCT).
Slovenian: - hipogamaglobulinemiji pri bolnikih pred alogensko presaditvijo krvotvornih matičnih celic (HSCT - haematopoietic stem cell transplantation) in po njej.
English: The mean (SD) IgG trough concentration after Hizentra treatment in the 0.4 g/kg bw group was 20.4 (3.24) g/l and 15.4 (3.06) g/l in the 0.2 g/kg bw group.
Slovenian: Srednja vrednost najnižjih koncentracij IgG po zdravljenju z zdravilom Hizentra je bila v skupini, ki je dobivala odmerek 0,4 g/kg TM, 20,4 (3,24) g/l, v skupini, ki je dobivala odmerek 0,2 g/kg TM, pa 15,4 (3,06) g/l.
English: 1 Clean surface Thoroughly clean a table or other flat surface using an antiseptic wipe.
Slovenian: 1 Očistite delovno površino Z antiseptičnim robčkom temeljito očistite mizo ali drugo ravno površino.
English: Adverse Reactions (ARs) have been collected in Hizentra clinical trials from 7 phase III studies in patients with primary immunodeficiency (n = 231), 2 phase IV studies in patients with PID (n=74), 1
Slovenian: Neželeni učinki so bili zbrani v kliničnih preskušanjih zdravila Hizentra v 7 študijah III. faze z bolniki s primarno imunsko pomanjkljivostjo (n = 231), 2 študijah IV. faze z bolniki s PID (n = 74), 1 študiji III. faze (n = 115) in 1 podaljšani študiji (n = 82) z bolniki s CIDP (skupni N = 502 bolnikov; 26.646 infuzij).
English: If you need to administer an additional Hizentra syringe, you must use a new sterile injection needle and change the infusion site.
Slovenian: Če morate aplicirati dodatno injekcijo zdravila Hizentra, morate uporabiti novo sterilno injekcijsko iglo in zamenjati mesto infundiranja.
English: Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
Slovenian: Plodnost Klinične izkušnje z imunoglobulini kažejo, da ni pričakovati škodljivih učinkov na plodnost.
English: If administration with an additional Hizentra syringe is required, a new sterile injection needle should be used and the infusion site changed.
Slovenian: Če je treba aplicirati dodatno injekcijo zdravila Hizentra, je treba uporabiti novo sterilno injekcijsko iglo ter zamenjati mesto infundiranja.
English: These simulations further suggest that a comparable IgG exposure is correspondingly achieved when the weekly maintenance dose of Hizentra is divided in several, more frequent doses (2 to 7 times per week) in the CIDP patients` population.
Slovenian: Te simulacije nadalje kažejo, da je mogoče pri populaciji bolnikov s CIDP doseči primerljivo izpostavljenost IgG, če se tedenske vzdrževalne odmerke zdravila Hizentra ustrezno razdeli na več odmerkov, ki se jih nato daje pogosteje (2- do 7-krat na teden).
English: Hizentra is available in vials of 5, 10, 20 or 50 ml.
Slovenian: Zdravilo Hizentra je na voljo v vialah po 5, 10, 20 ali 50 ml.
English: 50 ml/site
Slovenian: 50 ml/mesto
English: Human normal immunoglobulin................................................................................................ 200 mg (purity: at least 98% is immunoglobulin type G (IgG))
Slovenian: En ml vsebuje: humani polispecifični imunoglobulin ........................................................................................ 200 mg (čistost: vsaj 98 % je imunoglobulina tipa G (IgG))
English: • Because the solution contains no preservative, you must use/infuse it as soon as possible after opening the vial.
Slovenian: • Ker raztopina ne vsebuje konzervansa, morate zdravilo Hizentra po odprtju viale uporabiti/infundirati takoj, ko je mogoče.
English: • In the case, you will use a device-assisted infusion technique (e.g. pump-assisted infusion),
Slovenian: • V primeru, da boste uporabljali tehniko infundiranja s pripomočkom za infundiranje (npr. z infuzijsko črpalko), lahko hkrati uporabite več kot eno napravo za infundiranje.
English: Hizentra is also available in packs of 1 or 10 pre-filled syringes.
Slovenian: Zdravilo Hizentra je na voljo tudi v pakiranju po 1 ali 10 napolnjenih injekcijskih brizg.
English: • You may infuse Hizentra into sites such as abdomen, thigh, upper arm, and lateral hip.
Slovenian: • Zdravilo Hizentra lahko infundirate na mestih, kot so trebuh, stegna, nadlaket in stranski del kolka.
English: EU/1/11/687/015 1 x 5 ml pre-filled syringe EU/1/11/687/016 10 x 5 ml pre-filled syringes EU/1/11/687/017 1 x 10 ml pre-filled syringe EU/1/11/687/018 10 x 10 ml pre-filled syringes
Slovenian: EU/1/11/687/015 1 x 5 ml napolnjena injekcijska brizga EU/1/11/687/016 10 x 5 ml napolnjenih injekcijskih brizg EU/1/11/687/017 1 x 10 ml napolnjena injekcijska brizga EU/1/11/687/018 10 x 10 ml napolnjenih injekcijskih brizg
English: If well-tolerated (see also section 4.4), the infusion rate can then gradually be increased to 35 ml/hour/site for the subsequent two infusions.
Slovenian: Če bolnik infundiranje dobro prenaša (glejte tudi poglavje 4.4), lahko hitrost infundiranja počasi povečujemo do 35 ml/uro/mesto za naslednji dve infundiranji.
English: If you have any further questions, ask your doctor or healthcare professional.
Slovenian: Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Hizentra is also available in vials of 5, 10, 20 and 50 ml.
Slovenian: Zdravilo Hizentra je na voljo tudi v vialah po 5, 10, 20 ali 50 ml.
English: Because the solution contains no preservative, Hizentra should be used/infused as soon as possible after opening the vial or blistered pre-filled syringe.
Slovenian: Ker raztopina ne vsebuje konzervansa, je treba zdravilo Hizentra po odprtju viale ali napolnjene injekcijske brizge v pretisnem omotu uporabiti/infundirati takoj, ko je mogoče.
English: Hizentra was evaluated in 68 paediatric subjects with PID aged 2 to <12 years and in 57 adolescents aged 12 to <18 years.
Slovenian: Zdravilo Hizentra so ocenjevali pri 68 pediatričnih bolnikih s primarno imunsko pomanjkljivostjo (PID-primary immunodeficiency disease), starih od 2 leti do <12 let in pri 57 mladostnikih, starih od 12 do <18 let.
English: No serious bacterial infections were reported during the efficacy period in subjects receiving Hizentra during clinical studies.
Slovenian: V kliničnih študijah pri preiskovancih, ki so prejemali zdravilo Hizentra, pri določanju učinkovitosti niso poročali o resnih bakterijskih okužbah.
English: • Joint pain (arthralgia)
Slovenian: • bolečina v sklepu (artralgija)
English: Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella.
Slovenian: Uporaba imunoglobulina lahko poslabša učinkovitost živih oslabljenih virusnih cepiv, kot so ošpice, rdečke, mumps in norice, za vsaj 6 tednov pa do 3 mesecev.
English: Clinical experience with immunoglobulins suggests however that no harmful effects on the neonate are to be expected.
Slovenian: Klinične izkušnje z imunoglobulini kažejo, da ni pričakovati škodljivih učinkov na novorojenčka.
English: However, if missed doses were not replaced when dosing was resumed, it took up to 5-6 weeks for the IgG trough levels to return to steady-state.
Slovenian: Vendar pa je trajalo do 5-6 tednov, da so se najnižje ravni IgG vrnile na stanje dinamičnega ravnovesja, če izpuščeni odmerki niso bili nadomeščeni, ko se je odmerjanje nadaljevalo.
English: Patient`s individual clinical response should be the primary consideration in dose adjustment.
Slovenian: Primarno vodilo pri prilagajanju odmerka mora biti klinični odziv posameznega bolnika.
English: Packs of 1 or 10 pre-filled syringes.
Slovenian: Vsebina pakiranja Pakiranje po 1 ali 10napolnjenih injekcijskih brizg.
English: Once a vial or the blistered pre-filled syringe has been opened, the solution should be used immediately.
Slovenian: Ko je viala ali napolnjena injekcijska brizga v pretisnem omotu odprta, je treba raztopino porabiti takoj.
English: Hizentra 200 mg/ml solution for subcutaneous injection Hizentra 200 mg/ml solution for subcutaneous injection in pre-filled syringe
Slovenian: Hizentra 200 mg/ml raztopina za subkutano injiciranje Hizentra 200 mg/ml raztopina za subkutano injiciranje v napolnjeni injekcijski brizgi
English: They can particularly occur in patients with anti-IgA antibodies who should be treated with particular caution.
Slovenian: Pojavijo se predvsem pri bolnikih s protitelesi proti IgA.
English: Contact your doctor immediately if you experience signs and symptoms such as shortness of breath, chest pain, pain and swelling of a limb, weakness or numbness on one side of the body after receiving Hizentra.
Slovenian: Takoj se posvetujte z zdravnikom, če po uporabi zdravila Hizentra opazite znake ali simptome, kot so kratka sapa, bolečine v prsnem košu, boleči ali otekli sklepi, šibkost ali omrtvelost po eni strani telesa.
English: Once a blistered pre-filled syringe has been opened, use the solution immediately.
Slovenian: Po odprtju napolnjene injekcijske brizge v pretisnem omotu je treba raztopino uporabiti takoj.
English: • Because the solution contains no preservative, you must use/infuse it as soon as possible after opening the blistered pre-filled syringe.
Slovenian: • Ker raztopina ne vsebuje konzervansa, morate zdravilo Hizentra po odprtju napolnjene injekcijske brizge v pretisnem omotu uporabiti/infundirati takoj, ko je mogoče.
English: If you get any side effects, talk to your doctor or healthcare professional.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali zdravstvenim delavcem.
English: Tell your doctor about your treatment with Hizentra prior to any blood test.
Slovenian: Pred vsako krvno preiskavo zdravnika obvestite o zdravljenju z zdravilom Hizentra.
English: Hizentra is available in pre-filled syringes of 5 or 10 ml.
Slovenian: Zdravilo Hizentra je na voljo v napolnjenih injekcijskih brizgah po 5 ali 10 ml.
English: Keep the vial or the blistered pre-filled syringe in the outer carton in order to protect from light.
Slovenian: Vialo ali napolnjeno injekcijsko brizgo v pretisnem omotu shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: You may use an unlimited number of sites simultaneously.
Slovenian: Istočasno lahko uporabljate poljubno število mest infundiranja.
English: What Hizentra contains
Slovenian: Kaj vsebuje zdravilo Hizentra
English: Treatment of low immunoglobulin levels in patients pre- and post- allogeneic haematopoietic stem cell transplantation (HSCT).
Slovenian: Zdravljenje nizkih ravni imunoglobulinov pri bolnikih pred alogensko presaditvijo krvotvornih matičnih celic in po njej.
English: How Hizentra works
Slovenian: Kako deluje zdravilo Hizentra
English: Hizentra is also available in pre-filled syringes of 5 and 10 ml.
Slovenian: Zdravilo Hizentra je na voljo tudi v napolnjenih injekcijskih brizgah po 5 ali 10 ml.
English: Warnings and precautions Talk to your doctor or healthcare professional before using Hizentra.
Slovenian: Pred začetkom uporabe zdravila Hizentra se posvetujte z zdravnikom ali zdravstvenim delavcem.
English: In total, 57 subjects received 1514 infusions in the placebo group, 57 subjects received 2007 infusions in the 0.2 g/kg bw Hizentra group, and 58 subjects received 2218 infusions in the 0.4 g/kg bw Hizentra group (in total 5739 infusions).
Slovenian: Hizentra 0,2 g/kg TM, 58 preiskovancev pa 2218 infuzij v skupini z odmerkom zdravila Hizentra 0,4 g/kg TM (skupno 5739 infuzij).
English: No paediatric-specific dose adjustments were necessary to achieve the desired serum IgG levels.
Slovenian: Za doseganje želenih ravni IgG v serumu ni bilo potrebno posebno prilagajanje odmerkov za pediatrične bolnike.
English: Start infusion.
Slovenian: Hitrost infundiranja
English: Subjects in both Hizentra dose groups remained stable in electrophysiology parameters.
Slovenian: Glede na elektrofiziološke parametre je stanje preiskovancev v obeh skupinah, ki sta prejemali odmerka zdravila Hizentra, ostalo stabilno.
English: Contact your doctor if you experience the following signs and symptoms: severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomitingafter receiving Hizentra.
Slovenian: Takoj se posvetujte z zdravnikom, če po uporabi zdravila Hizentra opazite naslednje znake ali simptome: hud glavobol, tog vrat, dremavost, zvišala telesna temperatura, fotofobija, siljenje na bruhanjein bruhanje.
English: ► In isolated cases, you may get a bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light, which could be signs of AMS (aseptic meningitis sydrome), which is a temporary reversible non-infectious inflammation of the membranes surrounding the brain and the spinal cord.
Slovenian: ► V posamičnih primerih se lahko pojavi hud glavobol s siljenjem na bruhanje, bruhanje, tog vrat, zvišana telesna temperature in občutljivost na svetlobo, kar so lahko znaki AMS (sindrom aseptičnega meningitisa).
English: • Keep the blistered pre-filled syringe in the outer carton in order to protect from light.
Slovenian: • Napolnjeno injekcijsko brizgo v pretisnem omotu shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Vials
Slovenian: VIALA
English: Tell your doctor or healthcare professional if you are pregnant, plan to become pregnant or are breast-feeding.
Slovenian: Če ste noseči, načrtujete nosečnost ali dojite, o tem obvestite zdravnika ali zdravstvenega delavca.
English: ADRs (MedDRA Preferred Term, PT)
Slovenian: NUZ (specifičen izraz klasifikacije neželenih učinkov po MedDRA)
English: No overall differences in safety or efficacy were observed between CIDP subjects >65 years and CIDP subjects 18 to 65 years of age.
Slovenian: Med preiskovanci s CIDP, starih >65 let, in preiskovanci s CIDP, starih od 18 do 65 let, niso opazili splošnih razlik v varnosti in učinkovitosti.
English: Hypogammaglobulinaemia and recurrent infections in multiple myeloma (MM) patients.
Slovenian: - hipogamaglobulinemiji in ponavljajočih se bakterijskih okužbah pri bolnikih z multiplim mielomom.
English: EU/1/11/687/001 EU/1/11/687/002 EU/1/11/687/003
Slovenian: EU/1/11/687/016