FrancophonIA/ELRC3.0 huggingface dataset:
English: For subcutaneous use only.
Slovenian: Samo za subkutano uporabo.
English: However, if your antibody levels are sufficient and you have a fixed dose regimen, you or your caregiver may be trained to carry out the injection at home (see below).
Slovenian: Če pa je raven vaših protiteles zadostna in imate ustaljeno odmerno shemo, se lahko vi ali vaše negovalno osebje naučite dajati injekcijo doma (glejte spodaj).
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Slovenian: V skladu s členom 114 Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
English: This can be an allergic reaction or a serious allergic reaction (anaphylactic shock).
Slovenian: To je lahko alergijska reakcija ali resna alergijska reakcija (anafilaktični šok).
English: Interference with serological testing
Slovenian: Vpliv na serološko testiranje
English: Carefully push the plunger in until the air bubbles have disappeared.
Slovenian: Previdno potiskajte bat, dokler vsi zračni mehurčki ne izginejo.
English: This medicine must not be mixed with other medicines.
Slovenian: Zdravila ne smete mešati z drugimi zdravili.
English: Dispose of all used items
Slovenian: Zavrzite vse uporabljene stvari
English: All patients included in this study had to run through a training period of at least 29 days and home self-administration could start on day 36 at the earliest.
Slovenian: Vsi bolniki, vključeni v študijo, so morali opraviti obdobje usposabljanja, ki je trajalo vsaj 29 dni, samoinjiciranje pa se je lahko najprej začelo šele
English: This also applies to unknown or emerging viruses and other pathogens.
Slovenian: To velja tudi za neznane ali pojavljajoče se viruse in druge povzročitelje bolezni.
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Slovenian: Če predložitev PSUR in posodobitev RMP sovpadata, se lahko predložita sočasno.
English: Consequences of an overdose are not known.
Slovenian: Posledice prevelikega odmerjanja niso znane.
English: The doctor or his/her assistant will teach you the process of administration.
Slovenian: Zdravnik ali njegov asistent vas bo naučil izpeljati postopek injiciranja.
English: There is no data about efficacy in post-exposure prophylaxis.
Slovenian: O učinkovitosti zdravila pri postekspozicijski profilaksi ni podatkov.
English: You may have to wait at least 3 months after the last injection of Zutectra before you can have live attenuated vaccines.
Slovenian: Morda boste morali počakati najmanj 3 mesece po zadnji injekciji zdravila Zutectra, preden boste lahko opravili cepljenja z živim oslabljenimi cepivi.
English: The mean anti-HBs serum level before switching was 393 ± 139 IU/l.
Slovenian: Srednja raven anti-HB v serumu pred zamenjavo je bila 393±139 i.e./l.
English: 59 % IgG1, 35 % IgG2, 3 % IgG3, 3 % IgG4 IgA content ≤ 6,000 micrograms/ml
Slovenian: 59 % IgG1, 35 % IgG2, 3 % IgG3, 3 % IgG4
English: It should be clear and contain no particles.
Slovenian: Biti mora bistra in brez delcev.
English: Tell your doctor or healthcare professional if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali zdravstvenega delavca, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The effects were grouped by system organ classes under relevant medical headings.
Slovenian: Učinki so bili razporejeni po skupinah glede na organske sisteme pod ustreznimi medicinskimi nazivi.
English: Do not attempt to inject Zutectra until you are sure that you understand how to prepare the injection solution and give the injection.
Slovenian: Ne poskušajte injicirati, dokler niste prepričani, da ste razumeli, kako pripraviti injekcijsko raztopino in kako dati injekcijo.
English: SPCare Especialidades Farmacêuticas, Lda Rua Luciano Cordeiro, nº 123, 1º dto.
Slovenian: Rua Luciano Cordeiro, nº 123, 1º dto.
English: If the solution is discoloured, cloudy or contains particles, discard it and start again with a new syringe.
Slovenian: Če je raztopina razbarvana, motna ali vsebuje delce, jo zavrzite in ponovno začnite z novo injekcijsko brizgo.
English: The physician must therefore weigh the benefit of treatment with Zutectra against the potential risk of hypersensitivity reactions.
Slovenian: Zdravnik mora zato pretehtati korist zdravljenja z zdravilom Zutectra v primerjavi z možnim tveganjem za pojav preobčutljivostnih reakcij.
English: After injection 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 injiciranju imunoglobulinov lahko prehodno zvišanje različnih pasivno prenesenih protiteles v bolnikovi krvi vodi v zavajajoče pozitivne rezultate serološkega testiranja.
English: The starting material or what Zutectra is made from is human blood plasma (this is the liquid part of the blood).
Slovenian: Izhodiščni material za izdelavo zdravila Zutectra je človeška krvna plazma (to je tekoči del krvi).
English: If you have an allergic reaction to Zutectra, the injection will be stopped immediately.
Slovenian: Če boste imeli alergijsko reakcijo na zdravilo Zutectra, bodo injiciranje takoj ustavili.
English: Zutectra contains a small quantity of IgA.
Slovenian: Zdravilo Zutectra vsebuje majhno količino IgA.
English: Information on the starting material of Zutectra and the possibility of transmission of infectious agents:
Slovenian: Informacija o izhodiščnem materialu za zdravilo Zutectra in možnosti prenosa povzročiteljev nalezljivih bolezni:
English: No patient prematurely discontinued the study due to lack of feasibility of home self-treatment.
Slovenian: Noben od bolnikov ni predčasno prenehal sodelovati v študiji, ker samoinjiciranje doma ne bi bilo mogoče.
English: Choose the area where you will make the injection and make a note of it in the diary.
Slovenian: Izberite predel, kamor boste injicirali zdravilo, in ga zabeležite v dnevnik.
English: A failure rate of 0 % was also found for the facultative extension phase (week 24) (95 % CI: [0, 20.6 %])
Slovenian: Stopnja osipa je tudi v fakultativni podaljšani fazi (teden 24) (95-% IZ: [0; 20,6 %]) znašala 0 %.
English: With the exception of 6 patients who withdrew prior to day 36, all patients achieved complete hospital and home self-administration.
Slovenian: 36. dan. Z izjemo 6 bolnikov, ki so pred 36. dnem prenehali sodelovati, so vsi bolniki končali uporabo v bolnišnici in samoinjiciranje doma.
English: This recommendation applies also for documentation in the treatment diary during self-administration of the medicinal product in a home treatment.
Slovenian: Ta priporočila veljajo tudi za dokumentiranje v dnevniku zdravljenja ob samoinjiciranju zdravila pri zdravljenju na domu.
English: Patients must be monitored for serum anti-HBs antibody levels regularly.
Slovenian: Pri bolnikih je treba redno spremljati serumske ravni protiteles proti HBs.
English: Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
Slovenian: Klinične izkušnje z imunoglobulini nakazujejo, da ni pričakovati škodljivih vplivov na potek nosečnosti, na plod in na novorojenčka.
English: The contents of one syringe are intended for use once only.
Slovenian: Vsebina ene injekcijske brizge je namenjena samo za enkratno uporabo.
English: The administration in thighs is shown as an example in the following pictures:
Slovenian: Dajanje zdravila v stegno je kot primer prikazano z naslednjimi sličicami:
English: You should inject Zutectra into the fatty layer between the skin and muscle (about 8 to 12 mm under the skin).
Slovenian: Zdravilo Zutectra morate injicirati v maščobni sloj med kožo in mišico (približno od 8 do 12 mm pod površino kože).
English: The following instructions are intended to explain how to inject Zutectra.
Slovenian: Naslednja navodila so namenjena razlagi, kako injicirate zdravilo Zutectra.
English: Zutectra has a half-life of about 3-4 weeks.
Slovenian: Izločanje Razpolovni čas zdravila Zutectra je približno 3-4 tedne.
English: Patients should be HBsAg negative before treatment start.
Slovenian: Bolniki morajo biti pred začetkom zdravljenja HBsAg-negativni.
English: No hepatitis B reinfection was reported and no patient was tested HBsAg positive during the treatment period of 48 weeks.
Slovenian: Niso poročali o ponovni okužbi s hepatitisom B in noben bolnik ni imel pozitivnih testov na HBsAg med 48-tedenskim obdobjem zdravljenja.
English: Open each syringe only when you are ready for an injection.
Slovenian: Vsako injekcijsko brizgo odprite šele, ko ste pripravljeni za injiciranje.
English: You may be allergic to immunoglobulins (antibodies) without knowing it, even if you have tolerated previous treatments with human immunoglobulins.
Slovenian: Možno je, da ste alergični na imunoglobuline (protitelesa), ne da bi to vedeli, celo če ste predhodna zdravljenja s humanimi imunoglobulini dobro prenašali.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to human immunoglobulins.
Slovenian: Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali na humane imunoglobuline.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or healthcare professional for advice before taking this medicine.
Slovenian: Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali zdravstvenim delavcem, preden vzamete to zdravilo.
English: Talk to the doctor or healthcare professional about these or any other unusual conditions you may find.
Slovenian: Z zdravnikom ali strokovnim zdravstvenim delavcem se pogovorite o vsakem neobičajnem stanju, ki ga opazite.
English: At the time of transplantation 21 patients (42.9%) were tested positive for HDV, patients with a positive HIV or HCV test were excluded from study participation.
Slovenian: Ob času presaditve je imelo 21 bolnikov (42,9 %) pozitiven rezultat testa za HDV, medtem ko so bolnike s pozitivnim rezultatom testa za HIV ali HCV izključili iz študije.
English: Gently pinch the skin together around the disinfected injection site (to raise it up a little) and push the needle into the skin with a rapid, confident movement at an angle of 45 to 90 degrees.
Slovenian: Nežno stisnite kožo okrog dezinficiranega mesta (in jo nekoliko privzdignite) ter iglo potisnite v kožo s hitrim, odločnim gibom pod kotom od 45 do 90 stopinj.
English: Distribution of IgG subclasses: IgG1:
Slovenian: Porazdelitev podrazredov IgG: IgG1:
English: Injection into a vein or a blood vessel may result in allergic shock.
Slovenian: Injiciranje v veno ali krvno žilo lahko povzroči alergijski šok.
English: If the recipient is a carrier of HBsAg, there is no benefit in administering this medicinal product.
Slovenian: Če je prejemnik zdravila nosilec HBsAg, od dajanja tega zdravila ne bo nobene koristi.
English: Abdomen (stomach): Do not use the area within one inch around the navel.
Slovenian: Abdomen (trebuh): Ne uporabljajte predela v širini enega palca (2,5 cm) okrog popka.
English: The patient or caregiver will be instructed in injection techniques, the keeping of a treatment diary and measures to be taken in case of severe adverse events.
Slovenian: Bolnik ali negovalno osebje bo poučeno o tehnikah injiciranja, vodenju dnevnika zdravljenja in ukrepih v primeru hudih neželenih učinkov.
English: You are likely to have more fatty tissue the closer you are to the hip and the further you are from the knee.
Slovenian: Verjetno je več maščobnega tkiva čim bližje kolku in čim dlje od kolena.
English: Thighs: Use middle and outer areas where you can pinch up tissue.
Slovenian: Stegno: Uporabite srednja in zunanja področja, kjer lahko tkivo stisnete in dvignete.
English: If you do choose to inject your arm yourself, try to pinch up the tissue by placing your upper arm over the back of a chair or brace it against a wall.
Slovenian: Če se odločite, da si boste zdravilo sami injicirali v roko, poskusite tkivo stisniti in dvigniti tako, da roko naslonite na naslonjalo stola ali jo uprete v steno.
English: Any unused medicine or waste material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: Paediatric population There is no relevant indication for use of Zutectra in children under the age of 18.
Slovenian: Ustrezne indikacije za uporabo zdravila Zutectra pri otrocih, starih manj kot 18 let, ni.
English: The other ingredients are glycine and water for injections.
Slovenian: Drugi sestavini zdravila sta glicin in voda za injekcije.
English: No serious adverse reaction was reported.
Slovenian: O resnih neželenih učinkih niso poročali.
English: Palpitations, cardiac discomfort Rare*
Slovenian: Bolezni srca palpitacije, srčno nelagodje redki*
English: No serious adverse events were reported to be related to study medication.
Slovenian: O resnih neželenih učinkih, povezanih s študijskim zdravilom, niso poročali.
English: If you are HBs antigen positive you will not receive Zutectra since there is no benefit in administering this medicine to you.
Slovenian: Če ste HBs antigen pozitivni, zdravila Zutectra ne boste prejeli, ker od dajanja tega zdravila ne bi imeli nobene koristi.
English: Other medicines and Zutectra
Slovenian: Druga zdravila in zdravilo Zutectra
English: Before preparing the injection, decide where you are going to inject.
Slovenian: Pred pripravo injekcije se odločite, kam boste injicirali zdravilo.
English: - Take the syringe out of the pack.
Slovenian: - Injekcijsko brizgo vzemite iz pakiranja.
English: SN: {number} [serial number]
Slovenian: PC: {številka} [koda zdravila] SN: {številka} [serijska številka]
English: For the documentation of your injections of Zutectra it is strongly recommended to use the treatment diary.
Slovenian: Za dokumentiranje dajanja injekcij zdravila Zutectra je zelo priporočljivo, da vodite dnevnik zdravljenja.
English: Your doctor will tell you how much and how often you need to use Zutectra.
Slovenian: Zdravnik vam bo povedal, koliko in kako pogosto morate uporabljati zdravilo Zutectra.
English: In a local tolerance trial in rabbits, there was no evidence of irritation attributable to Zutectra.
Slovenian: V preskušanjih lokalnega prenašanja na kuncih ni bilo dokazov o draženju, ki bi ga lahko pripisali zdravilu Zutectra.
English: Keep the container in the outer carton in order to protect from light.
Slovenian: Vsebnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: - Examine the solution carefully.
Slovenian: - Raztopino skrbno preglejte.
English: 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 zaradi uporabe zdravil, pripravljenih iz človeške krvi ali plazme, vključujejo izbiro darovalcev, presejanje posameznih odvzetih enot in združene plazme za specifične označevalce okužbe ter vključevanje učinkovitih proizvodnih stopenj za inaktivacijo/odstranitev virusov.
English: These include - careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and - the testing of each donation and pools of plasma for signs of virus/infections.
Slovenian: Ti ukrepi vključujejo: - skrbno izbiro darovalcev krvi in plazme, da se izključijo osebe s tveganjem prenosa okužbe in - testiranje vsake odvzete enote in združene plazme za znake virusov/okužb.
English: The ADRs reported in four trials are summarised and categorised according to the MedDRA system organ class and frequency below.
Slovenian: Neželeni učinki, o katerih so poročali v teh štirih preskušanjih, so glede na organski sistem in pogostnost povzeti ter razporejeni po MedDRA klasifikaciji.
English: In very rare cases human normal immunoglobulins may cause a serious allergic reaction.
Slovenian: zelo redkih primerih lahko normalni humani imunoglobulini povzročijo resne alergijske reakcije.
English: Nederland Infarama BVBA Stationsstraat 27
Slovenian: Infarama BVBA Stationsstraat 27
English: No other preparations may be added to the Zutectra solution as any change in the electrolyte concentration or the pH may result in precipitation or denaturisation of the proteins.
Slovenian: K raztopini zdravila Zutectra ne smemo dodajati drugih pripravkov, ker bi vsaka sprememba koncentracije elektrolitov ali pH vrednosti lahko vodila v obarjanje ali denaturacijo beljakovin.
English: Your doctor will regularly check your condition and tell you how much and how often you need to use Zutectra.
Slovenian: Vaš zdravnik bo vaše stanje redno preverjal in vam povedal, koliko zdravila Zutectra morate uporabiti in kako pogosto.
English: The safety of this medicinal product for use in breast-feeding has not been established in controlled clinical trials and therefore should only be given with caution to breast-feeding mothers.
Slovenian: Varnosti tega zdravila za uporabo med dojenjem niso dokazali v kontroliranih kliničnih preskušanjih, zato ga je treba doječim materam dajati previdno.
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 stopnje priprave krvi in plazme, kjer se virusi inaktivirajo ali odstranijo.
English: The objectives of the open, prospective, single-arm clinical trial were the investigation of feasibility of home self-administration (including patient compliance), efficacy and safety of subcutaneous application of Zutectra in a population of stable patients during long-term treatment for prophylaxis against re-infection of a transplanted liver in 66 patients.
Slovenian: Cilj odprtega, prospektivnega kliničnega preskušanja z enim krakom je bilo raziskati možnost samoinjiciranja doma (vključno s sodelovanjem bolnika), učinkovitost in varnost subkutane uporabe zdravila Zutectra pri populaciji stabilnih bolnikov med dolgoročnim zdravljenjem za preprečevanje ponovne okužbe presajenih jeter pri 66 bolnikih.
English: During the 48-weeks treatment phase constant serum HBs antibody concentrations ≥ 100 IU/l were measured in all patients at all assessments with mean values of 312.0 ± 103.5 IU/l at the end of the treatment period.
Slovenian: V 48-tedenskem obdobju zdravljenja so izmerili konstantne koncentracije protiteles HBs v serumu ≥ 100 i.e./l pri vseh bolnikih v vseh ocenitvah s srednjimi vrednostmi 312,0 ± 103,5 i.e./l ob koncu obdobja zdravljenja.
English: Important: Do not use on any area where you can feel lumps, bumps, firm knots, pain or on an area that is discoloured, indented, scabbed, or where the skin is broken.
Slovenian: Pomembno: Ne uporabljajte na predelu, kjer čutite zatrdline, bule, trdne vozliče, bolečino ali na predelu, ki je obarvan, vdrt, krastav ali kjer je koža poškodovana.
English: The following adverse reactions have been reported in the context of 4,810 subcutaneous applications of Zutectra during four completed clinical trials and 1,006 applications during a non-interventional post marketing safety study (PASS).
Slovenian: Po 4.810 subkutanih uporabah zdravila Zutectra med štirimi zaključenimi kliničnimi preskušanji in 1.006 uporabah v neinterventnih študijah o varnosti zdravila po pridobitvi dovoljenja za promet
English: What Zutectra is and what it is used for What you need to know before you use Zutectra How to use Zutectra
Slovenian: Kaj je zdravilo Zutectra in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Zutectra Kako uporabljati zdravilo Zutectra
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/600/001
Slovenian: EU/1/09/600/001
English: Do not use solutions that are cloudy or have particles.
Slovenian: Ne uporabljajte raztopine, ki so motne ali imajo delce.
English: Solutions that are cloudy or have deposits should not be used.
Slovenian: Raztopin, ki so motne ali imajo usedline, ne smete uporabiti.
English: Zutectra can reduce the effectiveness of some vaccines (measles, rubella, mumps, chicken pox) for a period of up to 3 months.
Slovenian: Zdravilo Zutectra lahko v obdobju do 3 mesecev zmanjšuje učinkovitost nekaterih cepiv (ošpice, rdečke, mumps, vodene koze).
English: In particular, patients naive to human normal immunoglobulin, patients switched from an alternative product or when there has been a long interval since the previous injection should be monitored during the first injection and for the first hour after the first injection, in order to detect potential adverse signs.
Slovenian: Zlasti bolnike, ki še niso prejemali normalnega humanega imunoglobulina, bolnike, ki so prešli z alternativnega zdravila ali če je od prejšnjega injiciranja preteklo dalj časa, je treba spremljati med prvim injiciranjem in v prvi uri po prvem injiciranju, da se odkrijejo morebitni neželeni znaki.
English: The best places for injections are where the skin is loose and soft for example in the abdomen, arm, thigh or buttocks, and away from joints, nerves, bones.
Slovenian: Najboljša mesta za injiciranje so tam, kjer je koža ohlapna in mehka, na primer na trebuhu, rokah, stegnu ali zadnjici in stran od sklepov, živcev in kosti.
English: If you have any further questions, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: The non-interventional post authorization safety study (PASS 978) enrolled 61 adult patients ≥ 6 months after liver transplantation for hepatitis B induced liver failure.
Slovenian: V neinterventno študijo o varnosti zdravila po pridobitvi dovoljenja za promet (PASS 978) je bilo vključenih 61 odraslih bolnikov ≥ 6 mesecev po presaditvi jeter zaradi s hepatitisom tipa B izzvane odpovedi jeter.
English: Biotest Medical, S.L.U.
Slovenian: España Biotest Medical, S.L.U.
English: Do not use Zutectra - if you are allergic to human immunoglobulin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Zutectra Ne uporabljajte zdravila Zutectra: če ste alergični na humani imunoglobulin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Precautions to be taken before handling or administering the medicinal product Injection of the medicinal product by the patient or by caregiver in a home treatment requires training by a physician experienced in the guidance of patients for home treatment.
Slovenian: Injiciranje zdravila s strani bolnika ali negovalnega osebja ob zdravljenju na domu zahteva usposabljanje, ki naj ga vodi zdravnik z izkušnjami pri vodenju bolnikov, ki se zdravijo doma.
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Slovenian: Pri zdravilih, ki se izdelajo iz človeške krvi ali plazme, se izvajajo določeni ukrepi za preprečevanje prenosa okužb na bolnike.
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine
English: No fatal case was observed during the study.
Slovenian: V času študije ni bilo smrtnih primerov.
English: Most side effects observed with Zutectra were mild to moderate in nature.
Slovenian: Večina neželenih učinkov, ki so jih opazili z zdravilom Zutectra, je bilo blage do zmerne narave.
English: - Hold the syringe with the needle pointing upwards, and tap the syringe gently with your fingers until the air has collected at the tip.
Slovenian: - Injekcijsko brizgo držite z iglo obrnjeno navzgor in s prsti nežno trkajte po brizgi, dokler se ves zrak ne zbere tik pod vrhom.