FrancophonIA/ELRC3.0 huggingface dataset:
English: The medicine works in exactly the same way as the immunoglobulins naturally present in your blood.
Slovenian: Zdravilo učinkuje na povsem enak način kot imunoglobulini, ki so naravno prisotni v vaši krvi.
English: Please refer to section 4.4 for details on risk factors and monitoring recommendations.
Slovenian: Za podrobnosti o dejavnikih tveganja in priporočila o spremljanju glejte poglavje 4.4.
English: • lack of certain immunoglobulin G subclasses causing recurrent infections.
Slovenian: •pomanjkanje nekaterih podrazredov imunoglobulina G, kar povzroča ponavljajoče se okužbe.
English: • Chills, including low body temperature
Slovenian: • mrzlica, vključno z znižano telesno temperaturo
English: If you are breast-feeding and receive Hizentra, the immunoglobulins of the medicine can also be found in the breast milk.
Slovenian: Če dojite in prejemate zdravilo Hizentra, je mogoče imunoglobuline najti tudi v materinem mleku.
English: However, medicines that contain immunoglobulins have been used in pregnant or breast-feeding women for years, and no harmful effects on the course of pregnancy or on the baby have been observed.
Slovenian: Vendar so zdravila, ki vsebujejo imunoglobuline, že leta v uporabi pri nosečnicah ali doječih materah in niso opazili nobenih škodljivih učinkov na potek nosečnosti ali dojenčka.
English: After receiving Hizentra, the results of certain blood tests (serological tests) may be impaired for a certain time.
Slovenian: Po prejemu zdravila Hizentra so lahko rezultati nekaterih krvnih (seroloških) preiskav za določen čas slabši.
English: Your doctor will decide if further tests are necessary and whether Hizentra should be continued.
Slovenian: Zdravnik se bo odločil, ali so potrebni dodatni testi, in ali naj nadaljujete s prejemanjem zdravila Hizentra.
English: Subjects received in total 1,831 weekly Hizentra infusions.
Slovenian: Preiskovanci so skupno prejeli 1.831 tedenskih infuzij zdravila Hizentra.
English: Treatment of patients who are born with a reduced ability or inability to produce immunoglobulins (primary immunodeficiencies).
Slovenian: Zdravljenje bolnikov, ki so rojeni z zmanjšano sposobnostjo ali nesposobnostjo proizvajanja imunoglobulinov (primarna imunska pomanjkljivost).
English: Finally, withdraw the desired volume of Hizentra.
Slovenian: Nato povlecite iz viale želeno količino zdravila Hizentra.
English: After infusion of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Slovenian: Po infundiranju imunoglobulina lahko prehodno povečanje različnih pasivno prenesenih protiteles v bolnikovi krvi povzroči lažno pozitivne rezultate pri seroloških preiskavah.
English: Each single dose may need to be injected at different anatomic sites.
Slovenian: Vsak posamezni odmerek bo morda potrebno injicirati v različna mesta na telesu.
English: Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D may interfere with some serological tests for red cell allo-antibodies (Coombs' test).
Slovenian: Pasivni prenos protiteles na eritrocitne antigene, na primer A, B, D, lahko vpliva na nekatere serološke preiskave za eritrocitna aloprotitelesa (Coombsov test).
English: Your doctor will initiate therapy with Hizentra 1 week after your last intravenous immunoglobulin infusion by administrating under the skin (subcutaneously) with a weekly dose of 1.0 to 2.0 ml/kg of body weight.
Slovenian: Zdravnik bo uvedel zdravljenje z zdravilom Hizentra 1 teden po vaši zadnji intravenski infuziji imunoglobulinov z dajanjem pod kožo (subkutano), s tedenskim odmerkom 1,0 do 2,0 ml/kg telesne mase.
English: Hizentra contains immunoglobulins that have been prepared from the blood of healthy people.
Slovenian: Zdravilo Hizentra vsebuje imunoglobuline, pripravljene iz krvi zdravih ljudi.
English: • Involuntary shaking movements in one or more parts of the body (tremor, including psychomotor hyperactivity)
Slovenian: •nehotni tresoči gibi v enem ali več delih telesa(tremor, vključno s psihomotorično hiperaktivnostjo)
English: If using a transfer device (vented spike), follow the instructions provided by the device manufacturer.
Slovenian: Če uporabljate pripomoček za prenos (prezračevano konico), sledite navodilom, ki jih je priložil izdelovalec naprave.
English: Hizentra has an approximate osmolality of 380 mOsmol/kg.
Slovenian: Približna osmolalnost zdravila Hizentra je 380 mOsmol/kg.
English: It is strongly recommended that every time you receive a dose of Hizentra the name and batch number of the product are recorded in order to maintain a record of the batches used (see section 3 “How to use Hizentra”).
Slovenian: Priporočamo, da se ob vsaki uporabi zdravila Hizentra zapišeta ime in številka serije zdravila, s čimer vodimo evidenco uporabljenih serij zdravila (glejte poglavje 3 »Kako uporabljati zdravilo Hinzentra«).
English: Vial(s)
Slovenian: Viala(e)
English: In these rare cases allergic reactions, such as a sudden fall in blood pressure or shock may occur (see also section 4 “Possible side effects”).
Slovenian: V teh redkih primerih se lahko pojavijo alergijske reakcije kot sta nenadni padec krvnega tlaka ali šok (glejte tudi poglavje 4 »Možni neželeni učinki«).
English: Do NOT infuse Hizentra ► if you are allergic to human immunoglobulins, polysorbate 80 or L-proline.
Slovenian: NE infundirajte zdravila Hizentra: ► če ste alergični na humane imunoglobuline, polisorbat 80 ali L-prolin.
English: • Administer Hizentra under the skin only.
Slovenian: • Zdravilo Hizentra dajajte samo pod kožo.
English: Immunoglobulins are also known as antibodies and are blood proteins that help your body to fight infections.
Slovenian: Imunoglobulini so poznani tudi kot protitelesa in so krvne beljakovine, ki pomagajo telesu pri boju proti okužbam.
English: Trough levels should be measured and assessed in conjunction with the patient's clinical response.
Slovenian: Ravni pred naslednjim odmerkom je treba meriti in oceniti hkrati s kliničnim odzivom bolnika.
English: The safety, efficacy and tolerability of Hizentra in patients with CIDP has been assessed in a multicentre, double-blind, randomised, placebo-controlled, parallel-group phase III PATH [Polyneuropathy and Treatment with Hizentra] study.
Slovenian: Varnost, učinkovitost in prenosljivost zdravila Hizentra pri bolnikih s CIDP so ocenjevali v multicentrični, dvojno slepi, randomizirani, s placebom nadzorovani študiji vzporednih skupin faze III PATH [Polyneuropathy and Treatment with Hizentra].
English: The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome in replacement therapy indications.
Slovenian: Odmerjanje pri otrocih in mladostnikih (0-18 let) se ne razlikuje od odmerjanja pri odraslih, saj je odmerjanje za vsako indikacijo podano glede na telesno maso in prilagojeno kliničnemu izidu pri indikacijah nadomestnega zdravljenja.
English: By replacing the missed doses when daily dosing was resumed, the median concentration profile recovered within 2 to 3 days.
Slovenian: Z nadomestitvijo izpuščenih odmerkov in ponovnim vsakodnevnim odmerjanjem se je mediani profil koncentracije izboljšal v 2 do 3 dneh.
English: Depending on the clinical response (e.g. infection rate), adjustment of the dose and/or the dose interval may be considered in order to aim for higher trough levels.
Slovenian: Glede na klinični odziv (npr. stopnjo okužbe) je za doseganje višjih ravni potrebno premisliti o prilagoditvi odmerjanja in/ali odmernega intervala.
English: Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.
Slovenian: Imunoglobulini se izločajo v materino mleko in lahko prispevajo k prenosu zaščitnih protiteles na novorojenčka.
English: In case of clinical deterioration the dose may be increased to the recommended maximum of 0.4g/kg weekly dose.
Slovenian: V primeru kliničnega poslabšanja se lahko odmerek poveča na priporočeni največji tedenski odmerek 0,4 g/kg.
English: Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection.
Slovenian: Sum na alergijsko ali anafilaktično reakcijo zahteva takojšnjo prekinitev injiciranja.
English: The patient or a caregiver must be instructed in the use of infusion devices, the keeping of treatment diary, recognition of and measures to be taken in case of severe adverse reactions.
Slovenian: Bolnik ali skrbnik naj bosta poučena o uporabi infuzijskih črpalk, vodenju dnevnika zdravljenja, prepoznavanju resnih neželenih učinkov in ukrepih, ki naj se izvedejo v primeru le-teh.
English: Grasp the skin between 2 fingers and insert the needle into the subcutaneous tissue.
Slovenian: Z dvema prstoma oblikujte kožno gubo in vbodite iglo v podkožno tkivo.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte poglavje
English: Hizentra is used to raise abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy).
Slovenian: Zdravilo Hizentra se uporablja za dvig nenormalno nizke ravni imunoglobulina v vaši krvi na normalne ravni (nadomestno zdravljenje).
English: • Reactions at the infusion site
Slovenian: • reakcije na mestu infundiranja
English: An infusion was considered valid, if ≥95 % of the planned flow rate/volume per ≥1 infusion site was achieved.
Slovenian: Infundiranje se je štelo za veljavno, če je bilo doseženih ≥ 95 % načrtovane hitrosti infundiranja/količino na ≥ 1 mesto infundiranja.
English: Simulation of 2-3 missed daily doses resulted in a median serum IgG level decrease of ≤ 4% compared to consistent daily dosing.
Slovenian: Simulacija z izpuščenimi 2-3 dnevnimi odmerki je povzročila mediano zmanjšanje ravni IgG v serumu za ≤ 4 % v primerjavi z doslednim vsakodnevnim odmerjanjem.
English: Certain adverse reactions may occur more frequently in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when treatment has been stopped for more than eight weeks.
Slovenian: Nekateri neželeni učinki se lahko pogosteje pojavijo pri bolnikih, ki prvič prejmejo humani polispecifični imunoglobulin, ali v redkih primerih, kadar se zdravilo s humanim polispecifičnim imunoglobulinom zamenja ali kadar se zdravljenje prekine za več kot osem tednov.
English: If you think you should receive Hizentra more or less frequently, please speak to your doctor.
Slovenian: Če menite, da bi morali zdravilo Hizentra prejemati pogosteje ali redkeje, se pogovorite z zdravnikom.
English: Direct comparative data for Hizentra versus IVIG are not available.
Slovenian: Neposredni primerjalni podatki za zdravilo Hizentra v primerjavi z i.v.Ig niso na voljo.
English: Patients exhibiting signs and symptoms of AMS should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis.
Slovenian: Bolnike, ki kažejo znake in simptome AMS, je treba temeljito nevrološko pregledati, vključno s študijami cerebrospinalne tekočine, da se izključijo drugi razlogi za meningitis.
English: Select the infusion site(s) - The number and location of infusion sites depends on the volume of the total dose.
Slovenian: Izberite mesto(a) infundiranja - Število in položaj mest infundiranja sta odvisna od količine celokupnega odmerka.
English: A phase III, multicentre, 48-week open-label extension study enrolled 82 CIDP patients from the PATH study.
Slovenian: V podaljšano multicentrično, 48-tedensko odprto študijo faze III je bilo vključenih 82 bolnikov s CIDP iz študije PATH.
English: It is believed that the body's defense attack underlines such inflammation, and the immunoglobulins present in Hizentra help to protect the nerves from being attacked (immunomodulatory therapy).
Slovenian: Domnevajo, da telesni obrambni sistem poudari takšno vnetje, imunoglobulini, prisotni v zdravilu Hizentra, pa pomagajo varovati živce pred napadom (imunomodulacijsko zdravljenje).
English: They may occur even if you received human immunoglobulins previously and tolerated them well.
Slovenian: Pojavijo se lahko celo, če ste humane imunoglobuline že prejeli in ste jih dobro prenašali.
English: Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Slovenian: Bolniki, ki imajo neželene učinke med zdravljenjem, naj počakajo, da le-ti minejo, preden spet vozijo ali upravljajo stroje.
English: The therapy with Hizentra is initiated 1 week after the last IVIg infusion.
Slovenian: Zdravljenje z zdravilom Hizentra se začne 1 teden po zadnjem infundiranju i.v.Ig.
English: Tell your doctor or healthcare professional prior to treatment if you have an immunoglobulin type A (IgA) deficiency.
Slovenian: Pred zdravljenjem zdravniku ali zdravstvenemu delavcu povejte, če imate pomanjkanje imunoglobulina vrste A (IgA).
English: If the pre-filled syringe can be placed directly on the pump, then go to Step 6.
Slovenian: Če je mogoče napolnjeno injekcijsko brizgo namestiti neposredno na črpalko, nadaljujete s korakom 6.
English: Following this, maintenance doses may be given at repeated intervals, from daily to once every two weeks, to reach a cumulative monthly dose of about 2 to 4 ml/kg of body weight.
Slovenian: Potem se lahko uporabljajo vzdrževalni odmerki v ponavljajočih intervalih, od vsakodnevnega do enkrat v dveh tednih, da se doseže kumulativni mesečni odmerek približno od 2 do 4 ml/kg telesne mase.
English: The recommended subcutaneous dose is 0.2 to 0.4 g/kg body weight per week administered in 1 or 2 sessions over 1 or 2 consecutive days.
Slovenian: Priporočeni subkutani odmerek je 0,2 do 0,4 g/kg telesne mase na teden, ki se ga da v 1 ali 2 intervalih v 1 ali 2 zaporednih dneh.
English: • the date of administration,
Slovenian: • datum infundiranja,
English: You may reduce possible side effects if you infuse Hizentra slowly.
Slovenian: Morebitne neželene učinke lahko zmanjšate, če zdravilo Hizentra infundirate počasi.
English: Please tell your doctor prior to treatment.
Slovenian: Zdravniku to pred zdravljenjem povejte.
English: 5 Preparation of Hizentra for infusion The 5 ml and 10 ml pre-filled syringes are supplied fully assembled and ready to use.
Slovenian: 5 Priprava zdravila Hizentra za infundiranje 5 ml in 10 ml napolnjene injekcijske brizge so na voljo v celoti sestavljene in pripravljene za uporabo.
English: Information on safety with respect to transmissible agents Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Slovenian: Standardni ukrepi za preprečevanje okužb, ki jih povzroča uporaba zdravil, pripravljenih iz človeške krvi ali plazme, vključujejo izbiro krvodajalcev, presejanje posameznih donacij krvi in zbirov plazme za posebne označevalce okužbe in vključevanje učinkovitih proizvodnih korakov za inaktivacijo/odstranjevanje virusov.
English: • the batch number of the medicine, and
Slovenian: • številko serije zdravila in
English: more than one infusion device can be used simultaneously.
Slovenian: Hkrati se lahko uporabi več kot ena naprava za infundiranje.
English: The recommended infusion rate given under section 4.2 should be adhered to.
Slovenian: Upošteva naj se priporočeno hitrost infundiranja, navedena v poglavju 4.2.
English: The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 5 to 6 g/l and aim to be within the reference interval of serum IgG for age.
Slovenian: Z režimom odmerjanja je treba doseči raven protiteles IgG, merjeno pred naslednjo infuzijo, ki je najmanj 5 do 6 g/l, in jo poskušati obdržati znotraj mej referenčnega intervala serumskih IgG glede na starost.
English: Other medicines and Hizentra
Slovenian: Druga zdravila in zdravilo Hizentra
English: The dose or dosing interval should not be changed without consulting your doctor.
Slovenian: Ne spreminjajte odmerka ali intervala odmerjanja, ne da bi se prej posvetovali z zdravnikom.
English: • The volume of product infused into a particular site may vary.
Slovenian: • Količina zdravila, infundirana v določeno mesto, se lahko razlikuje.
English: Both Hizentra doses demonstrated superiority over placebo for the primary endpoint.
Slovenian: Oba odmerka zdravila Hizentra sta se glede primarnega opazovanega dogodka izkazala za učinkovitejša od placeba.
English: The safety and effectiveness of Hizentra have been established in paediatric subjects 2 to 18 years of age.
Slovenian: Varnost in učinkovitost zdravila Hizentra so ugotavljali pri pediatričnih bolnikih, starih od 2 do 18 let.
English: Patients should be closely monitored and carefully observed for any adverse events throughout the infusion period.
Slovenian: Bolnike je treba skrbno spremljati in opazovati, če se pojavijo kakršnikoli neželeni učinki med infundiranjem.
English: Information available from clinical trials showed no difference in the safety profile of patients ≥ 65 years of age than of younger patients.
Slovenian: Podatki iz kliničnih preskušanj so pokazali, da ni razlik v varnostnem profilu bolnikov ≥ 65 let kot pri mlajših bolnikih.
English: ► if you suffer from hyperprolinaemia (a genetic disorder causing high levels of the amino acid proline in the blood).
Slovenian: ►če imate hiperprolinemijo (genska bolezen, ki povzroča visoke ravni aminokisline prolina v krvi).
English: For spontaneous post-marketing ADRs, the reporting frequency is categorised as unknown.
Slovenian: Za spontane neželene učinke po začetku trženja zdravila je pogostnost poročanja kategorizirana kot neznana.
English: Replacement therapy The medicinal product should be administered via the subcutaneous route.
Slovenian: Nadomestno zdravljenje Zdravilo je treba dajati po subkutani poti.
English: Subjects received in total 2,264 weekly Hizentra infusions.
Slovenian: Preiskovanci so skupaj prejeli 2.264 tedenskih infuzij zdravila Hizentra.
English: Infusion devices appropriate for subcutaneous administration of immunoglobulins can be used.
Slovenian: Uporabijo se lahko infuzijske črpalke, primerne za subkutano uporabo imunoglobulinov.
English: In immunodeficiency, adequate doses of Hizentra may restore abnormally low immunoglobulin G antibody levels to the normal range and thus help against infections.
Slovenian: Pri imunski pomanjkljivosti lahko ustrezni odmerki zdravila Hizentra vrnejo nenormalno nizko raven protiteles imunoglobulina G na normalno vrednost in s tem pomagajo pri zaščiti pred okužbami.
English: What you need to know before you use Hizentra
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Hizentra
English: Frequency of Adverse Drug Reactions (ADR) associated with Hizentra obtained from clinical studies and post-marketing surveillance, reporting rate per patient or per infusion
Slovenian: Pogostnost neželenih učinkov zdravila (NUZ) povezanih z zdravilom Hizentra pridobljenih v kliničnih študijah in spremljanju po začetku trženja, stopnja poročanja na bolnika ali na infuzijo
English: Subcutaneous infusion for home treatment must be initiated and monitored by a healthcare professional experienced in the guidance of patients for home treatment.
Slovenian: Subkutano infundiranje za zdravljenje na domu mora uvesti in nadzirati zdravstveni delavec z izkušnjami pri usposabljanju bolnikov za zdravljenje na domu.
English: • aseptic infusion techniques
Slovenian: • aseptične tehnike infundiranja,
English: In replacement therapy the dose may need to be individualised for each patient dependent on the clinical response and serum IgG trough levels.
Slovenian: Pri nadomestnem zdravljenju bo morda treba odmerek prilagoditi posameznim potrebam bolnika, odvisno od kliničnega odziva in najnižjih ravni protiteles IgG v serumu.
English: CSL Behring AG Wankdorfstrasse 10 CH-3000 Bern 22 Switzerland
Slovenian: CSL Behring AG Wankdorfstrasse 10 CH-3000 Bern 22 Švica
English: • combination of low immunoglobulin levels, frequent infections and inability to produce adequate amounts of antibodiesafter vaccination (common variable immunodeficiency)
Slovenian: • kombinacija nizkih ravni imunoglobulinov, pogostih okužb in nezmožnosti za proizvajanje zadostne količine protiteles po cepljenju (splošna spremenljiva imunska pomanjljivost)
English: Administer solution which is at room or body temperature.
Slovenian: Uporabite raztopino, ki ima sobno ali telesno temperaturo.
English: Patients may experience effects, such as dizziness or nausea, during treatment with Hizentra that might affect the ability to drive and use machines.
Slovenian: Pri bolnikih se lahko med zdravljenjem z zdravilom Hizentra pojavijo neželeni učinki, kot so omotičnost ali siljenje na bruhanje, ki lahko vplivajo na sposobnost vožnje in upravljanja strojev.
English: Replacement therapy in adults, children and adolescents (0-18 years) in: Primary immunodeficiency syndromes with impaired antibody production (see section 4.4).
Slovenian: Nadomestno zdravljenje pri odraslih, otrocih in mladostnikih (0-18 let) pri: - sindromih primarne imunske pomanjkljivosti (PID - primary imunodeficiency) z zmanjšano tvorbo protiteles (glejte poglavje 4.4).
English: Individualize the duration of any treatment beyond 18months based upon the patient's response and demonstrated need for continued therapy.
Slovenian: Zdravljenje, ki traja dlje kot 18 mesecev, je treba prilagoditi vsakemu bolniku posebej, na podlagi njegovega odziva in izkazane potrebe po nadaljnjem zdravljenju.
English: • the infused volume, flow rate, the number and location of infusion sites.
Slovenian: • količino infundiranega zdravila, hitrost pretoka, število in položaj mest infundiranja.
English: Your healthcare professional may adjust the dose based on your response to the treatment.
Slovenian: Zdravstveni delavec lahko prilagodi odmerek glede na vaš odziv na zdravljenje.
English: Discontinuation of immunoglobulin treatment may result in remission of AMS within several days without sequelae.
Slovenian: Prekinitev zdravljenja z imunoglobulinom lahko v nekaj dneh povzroči remisijo AMS brez posledic.
English: The ADRs reported in these clinical studies are summarised and categorised according to the MedDRA System Organ Class (SOC and Preferred Term level) and frequency below.
Slovenian: Neželeni učinki, o katerih so poročali v teh kliničnih študijah, so spodaj povzeti in razvrščeni glede na organske sisteme po MedDRA (specifičen izraz klasifikacije neželenih učinkov) in pogostnosti.
English: The safety of Hizentra has been assessed in several preclinical studies, with particular reference to the excipient L-proline.
Slovenian: Varnost zdravila Hizentra so ocenili v številnih predkliničnih študijah, pri čemer so bili posebno pozorni na pomožno snov L-prolin.
English: Secure the needle to the skin - If necessary, use gauze and tape or transparent dressing to hold the needle in place.
Slovenian: Pritrdite iglo na kožo - Po potrebi uporabite gazo in lepilni trak ali prozorni obliž, da se igla ne premakne.
English: Clinical trials with Hizentra showed a similar overall safety profile in paediatric and adult patients with PID.
Slovenian: Klinična preskušanja z zdravilom Hizentra so pokazala podoben varnostni profil pri pediatričnih in starejših bolnikih s PID.
English: • The other ingredients (excipients) are L-proline, polysorbate 80 and water for injections.
Slovenian: • Druge sestavine zdravila (pomožne snovi) so L-prolin, polisorbat 80 in voda za injekcije.
English: Hizentra maintenance therapy in CIDP has not been studied for periods longer than 18 months.
Slovenian: Vzdrževalnega zdravljenja z zdravilom Hizentra pri CIDP niso preučevali za obdobja, daljša od 18 mesecev.