FrancophonIA/ELRC3.0 huggingface dataset:
English: These studies did not reveal any safety concerns for humans.
Slovenian: Te študije niso pokazale pomislekov glede varnosti pri ljudeh.
English: Date of first authorisation: 22 November 2018
Slovenian: Datum prve odobritve: 22.november 2018
English: This study has been performed in compliance with the agreed Paediatric Investigation Plan.
Slovenian: Ta študija je bila izvedena v skladu z dogovorjenim načrtom pediatričnih raziskav.
English: Final study protocol should be submitted within 3 months after CHMP Opinion.
Slovenian: Končni protokol študije je treba predložiti v 3 mesecih po CHMP mnenju.
English: • heart disease or you are at risk of heart disease.
Slovenian: • imate bolezen srca ali pri vas obstaja tveganje za bolezen srca.
English: An extension study included patients completing the main study.
Slovenian: V podaljšanje študije so bili vključeni bolniki, ki so zaključili glavno študijo.
English: The following symptoms could be an early warning of these reactions:
Slovenian: Naslednji simptomi so lahko zgodnje opozorilo za te reakcije:
English: Ninety nine of 110 patients (90%) remained on the assigned regimen.
Slovenian: 99 od 110 bolnikov (90 %) je ostalo na dodeljenem režimu.
English: Parameters (units)
Slovenian: Parameter (enota)
English: The effect on fertility in humans is unknown.
Slovenian: Vpliv na plodnost pri ljudeh ni znan.
English: From a microbiological point of view the product should be used immediately after reconstitution.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po rekonstituciji.
English: Therefore, factor VIII should be used during pregnancy and breast-feeding only if clearly indicated.
Slovenian: Faktor VIII se sme med nosečnostjo in dojenjem uporabljati le, če je to jasno indicirano.
English: • local infections
Slovenian: • lokalnimi okužbami,
English: These may be signs of a rare severe sudden allergic reaction to this medicine.
Slovenian: To so lahko znaki redke, hude nenadne alergijske reakcije na to zdravilo.
English: Rarely, inhibitors may develop after the first 50 exposure days.
Slovenian: Inhibitorji le redko nastanejo šele po prvih 50 dneh izpostavitve.
English: The primary efficacy variable was annualized bleed rate (ABR).
Slovenian: Primarna spremenljivka učinkovitosti je bila letna stopnja krvavitve (ABR - annualized bleed rate).
English: Frequency of doses (hours) / Duration of therapy (days)
Slovenian: Pogostnost odmerjanja (ure)/ trajanje zdravljenja (dnevi)
English: At the end of this period the product should not be put back in the refrigerator, but should be used or discarded.
Slovenian: Ob koncu tega obdobja zdravila ne smete dati nazaj v hladilnik, ampak ga uporabite ali zavrzite.
English: The most serious side effects are allergic reactions or severe allergic reaction.
Slovenian: Najbolj resni neželeni učinki so alergijske reakcije ali huda alergijska reakcija.
English: The clinical effect of factor VIII is the most important element in evaluating the effectiveness of treatment.
Slovenian: Klinična učinkovitost faktorja VIII je najpomembnejša za oceno učinkovitosti zdravljenja.
English: The molecular weight of the protein is approximately 234 kDa.
Slovenian: Molekulska masa beljakovine je približno 234 kDa.
English: • The product must be used within 3 hours.
Slovenian: • Zdravilo je treba uporabiti v 3 urah.
English: Frequencies have been evaluated according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Pogostnosti so opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100).
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: PRILOGA II A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: Determine the point of injection and clean the skin.
Slovenian: Določite mesto injiciranja in kožo očistite.
English: • Store in a refrigerator.
Slovenian: • Shranjujte v hladilniku.
English: Inject your next dose immediately and continue at regular intervals as advised by your doctor.
Slovenian: Takoj si injicirajte naslednji odmerek in zdravljenje nadaljujte v rednih presledkih, kot vam je predpisal zdravnik.
English: 80-100 (pre- and post-operative)
Slovenian: 80 - 100 (pred in po posegu)
English: • allergic to damoctocog alfa pegol or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • alergični na damoktokog alfa pegol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The listed warnings and precautions apply both to adults and adolescents.
Slovenian: Navedena opozorila in previdnostni ukrepi veljajo za odrasle in otroke.
English: It is produced by recombinant technology without addition of any human- or animal-derived components in the manufacturing process.
Slovenian: Zdravilo je pridobljeno z rekombinantno tehnologijo brez dodane kakršne koli sestavine humanega ali živalskega izvora v postopku izdelave.
English: • one vial adapter (with integrated filter)
Slovenian: • 1 adapter za vialo (z vgrajenim filtrom)
English: Sixty one subjects (83.6%) completed the main study and 59 patients continued in the optional extension study.
Slovenian: 61 preiskovancev (83,6 %) je zaključilo glavno študijo in 59 bolnikov je sodelovalo v neobveznem podaljšanju študije.
English: Repeat injection every 24-48 hours.
Slovenian: Ponavljajte injiciranje vsakih 24 do 48 ur.
English: *AUC calculated for a dose of 60 IU/kg
Slovenian: *AUC izračunana za odmerek 60 i.e./kg
English: These make Jivi less effective at preventing and controlling bleeding.
Slovenian: Zaradi njih je zdravilo Jivi manj učinkovito pri preprečevanju in obvladovanju krvavitev.
English: The medicinal product must be prepared for injection under aseptic conditions.
Slovenian: Za injiciranje je treba zdravilo pripraviti v aseptičnih pogojih.
English: The powder is dry, and white to slightly yellow.
Slovenian: Prašek je suh, bel do rahlo rumen.
English: Uncommon (PTPs)*
Slovenian: občasni (PTP)*
English: The protein in damoctocog alfa pegol has been modified (pegylated) to prolong its action in the body.
Slovenian: Beljakovina v damoktokogu alfa pegol je bila modificirana (pegilirana), da se podaljša njeno delovanje v telesu.
English: The required dose of Jivi is determined using the following formula:
Slovenian: Potrebni odmerek zdravila Jivi se izračuna z uporabo naslednje formule:
English: What you need to know before you use Jivi
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Jivi
English: Always use this medicine exactly as described in this leaflet and as your doctor or pharmacist has told you.
Slovenian: Zdravilo vedno uporabljajte tako kot je opisano v navodilu za uporabo oziroma tako kot vam je svetoval zdravnik ali farmacevt.
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Slovenian: Če inhibitorji nastanejo, se to kaže kot nezadosten klinični odziv.
English: Paediatric population < 12 years of age
Slovenian: Pediatrična populacija < 12 let starosti
English: The implications of any potential risk to affected patients with a hypersensitivity reaction to pegylated proteins are unknown.
Slovenian: Posledice morebitnih tveganj za bolnike s preobčutljivostno reakcijo na pegilirane beljakovine niso znane.
English: If you forget to use Jivi
Slovenian: Če ste pozabili uporabiti zdravilo Jivi
English: No triggers or predictors of the immune response to PEG could be identified.
Slovenian: Sprožilcev ali napovedovalcev imunskega odziva na PEG ni bilo mogoče opredeliti.
English: Other medicines and Jivi
Slovenian: Druga zdravila in zdravilo Jivi
English: All patients could be successfully treated with their previous factor VIII products.
Slovenian: Vse bolnike se lahko uspešno zdravi z njihovim prejšnim zdravilom s faktorjem VIII.
English: Table 1: Guide for dosing in bleeding episodes and surgery for adolescents and adults
Slovenian: Preglednica 1: Vodilo za odmerjanje pri krvavitvah in kirurških posegih pri mladostnikih in odraslih
English: A total of 221 patients constituted the safety population from three pivotal Phase I and III studies [PROTECT VIII].
Slovenian: Populacijo za oceno varnosti je sestavljajo 221 bolnikov iz treh ključnih študij faze I. in III. [PROTECT VIII].
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Slovenian: Kompleks faktorja VIII in von Willebrandovega faktorja je sestavljen iz dveh molekul (faktor VIII in von Willebrandov faktor) z različnim fiziološkim delovanjem.
English: Duration of treatment Usually Jivi treatment for haemophilia is needed lifelong.
Slovenian: Trajanje zdravljenja Običajno je zdravljenje hemofilije z zdravilom Jivi potrebno celo življenje.
English: Your doctor may carry out tests to confirm this and ensure that your Jivi dose provides adequate factor VIII levels.
Slovenian: Vaš zdravnik bo morda opravil preiskave, s katerimi bo to potrdil in se prepričal, da vaš odmerek zdravila Jivi zagotavlja ustrezne ravni faktorja VIII.
English: Remove the protective cap from the vial (A).
Slovenian: Odstranite zaščitno zaporko na viali (A).
English: Interactions of human coagulation factor VIII (rDNA) products with other medicinal products have not been reported.
Slovenian: Ni poročil o medsebojnem delovanju zdravil s humanim koagulacijskim faktorjem VIII (rDNA) z drugimi zdravili.
English: Jivi was evaluated in pharmacology, single and repeated dose as well as juvenile toxicity studies in rats and rabbits.
Slovenian: Zdravilo Jivi so ocenili v farmakoloških študijah pri enkratnem in ponavljajočih odmerkih in v študijah toksičnosti pri mladičih podgan in kuncev.
English: If a further dose is needed, use a new syringe with product reconstituted as described above.
Slovenian: Če je potreben dodaten odmerek zdravila, uporabite novo injekcijsko brizgo z zdravilom, rekonstituiranim po postopku, ki je opisan zgoraj.
English: Multipack with 30 single packs, each containing:
Slovenian: Skupno pakiranje s 30 posameznimi pakiranji, vsako vsebuje:
English: Jivi is produced without the addition of any human or animal derived protein in the cell culture process, purification, PEGylation or final formulation.
Slovenian: Zdravilo Jivi je pripravljeno brez dodajanja kakršnih koli beljakovin humanega ali živalskega izvora v celično kulturo, v procesu prečiščevanja, PEGilacije ali v končno zdravilo.
English: Do not use Jivi if you are
Slovenian: Ne uporabljajte zdravila Jivi, če ste
English: EU/1/18/1324/001 - 1 x (Jivi 250 IU) EU/1/18/1324/002 - 1 x (Jivi 500 IU) EU/1/18/1324/003 - 1 x (Jivi 1000 IU) EU/1/18/1324/004 - 1 x (Jivi 2000 IU) EU/1/18/1324/005 - 1 x (Jivi 3000 IU) EU/1/18/1324/006 - 30 x (Jivi 250 IU) EU/1/18/1324/007 - 30 x (Jivi 500 IU) EU/1/18/1324/008 - 30 x (Jivi 1000 IU) EU/1/18/1324/009 - 30 x (Jivi 2000 IU) EU/1/18/1324/010 - 30 x (Jivi 3000 IU)
Slovenian: EU/1/18/1324/001 - 1 x (Jivi 250 i.e.) EU/1/18/1324/002 - 1 x (Jivi 500 i.e.) EU/1/18/1324/003 - 1 x (Jivi 1000 i.e.) EU/1/18/1324/004 - 1 x (Jivi 2000 i.e.) EU/1/18/1324/005 - 1 x (Jivi 3000 i.e.) EU/1/18/1324/006 - 30 x (Jivi 250 i.e.) EU/1/18/1324/007 - 30 x (Jivi 500 i.e.) EU/1/18/1324/008 - 30 x (Jivi 1000 i.e.) EU/1/18/1324/009 - 30 x (Jivi 2000 i.e.) EU/1/18/1324/010 - 30 x (Jivi 3000 i.e.)
English: What Jivi is and what it is used for
Slovenian: Kaj je zdravilo Jivi in za kaj ga uporabljamo
English: This medicine must not be mixed with other injections.
Slovenian: Tega zdravila ne smete mešati z drugimi raztopinami za injiciranje.
English: EXP (End of the 6 month period, if stored up to 25 °C): ................ Do not use after this date.
Slovenian: EXP (konec 6-mesečnega obdobja, če je zdravilo shranjeno pri temperaturi do 25 °C): ................ Ne uporabljajte po tem datumu.
English: No de novo or confirmed cases of inhibitor against factor VIII occurred.
Slovenian: Primeri de novo ali potrjeni primeri inhibitorjev faktorja VIII se niso pojavili.
English: Repeat injection every 8 to 24 hours until threat is resolved.
Slovenian: Ponavljajte injiciranje vsakih 8 do 24 ur, dokler ogroženost ne mine.
English: Additional 34 minor surgeries were performed in 19 patients.
Slovenian: Poleg tega je bilo pri 19 bolnikih izvedeno 34 manjših kirurških posegov.
English: During the extension study, 24 patients were treated 2x/week, 37 patients every 5-days, 29 patients every 7 days and 17 patients changed treatment regimen.
Slovenian: V podaljšanju študije je bilo 24 bolnikov zdravljenih dvakrat na teden, 37 bolnikov vsakih 5 dni, 29 bolnikov vsakih 7 dni in 17 bolnikov, pri katerih je bil spremenjen režim zdravljenja.
English: Adolescent population
Slovenian: Populacija mladostnikov
English: Incremental recovery was determined in 131 patients at several time points.
Slovenian: Pri 131 bolnikih so v več časovnih točkah določili dejanski dvig aktivnosti.
English: In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Slovenian: Pri bolnikih s prisotnimi srčnožilnimi dejavniki tveganja nadomestno zdravljenje z zdravili s faktorjem VIII lahko poveča tveganje za srčnožilne bolezni.
English: Repeated PK measurements did not indicate any relevant changes in PK characteristics after long-term treatment.
Slovenian: Ponovljene farmakokinetične meritve niso pokazale pomembnih sprememb farmakokinetičnih značilnosti po dolgotrajnem zdravljenju.
English: Specifically, no residual radioactivity was detected in the brain, indicating that the radio-labelled compound did not cross the blood brain barrier.
Slovenian: Radioaktivnost v možganih ni bila ugotovljena, kar kaže, da radioaktivno označena spojina ne prehaja skozi krvnomožgansko pregrado.
English: Wipe the rubber stopper on the vial with an alcohol swab and allow the stopper to air dry before use.
Slovenian: Gumijasti zamašek na viali obrišite z alkoholnim zložencem ter ga pustite, da se pred uporabo osuši na zraku.
English: Repeat injection every 24-48 hours for 3 to 4 days or more until pain and acute disability are resolved.
Slovenian: Ponavljajte injiciranje vsakih 24 do 48 ur, 3 do 4 dni ali več, dokler ne mineta bolečina in akutna onesposobljenost.
English: A total of 121 subjects received treatment during the extension study with a median duration of 464 days.
Slovenian: Skupno 121 preiskovancev je bilo zdravljenih v podaljšanju študije z mediano trajanja zdravljenja 464 dni.
English: Prophylactic treatment in subjects ≥12 years
Slovenian: Profilaktično zdravljenje pri preiskovancih ≥ 12 let
English: Jivi Patients ≥12 years n=22
Slovenian: Zdravilo Jivi bolniki ≥ 12 let n = 22
English: Laboratories intending to measure Jivi activity should check their procedures for accuracy.
Slovenian: Laboratoriji, v katerih bodo merili aktivnost zdravila Jivi, morajo preveriti natančnost svojega postopka.
English: • a reduction in blood pressure, which may make you feel faint upon standing
Slovenian: • znižanje krvnega tlaka, zaradi česar se vam lahko vrti, kadar vstanete,
English: This is of importance when monitoring the factor VIII activity of Jivi, and when changing laboratory and/or reagents used in the assay.
Slovenian: To je pomembno pri spremljanju aktivnosti faktorja VIII zdravila Jivi in pri zamenjavi laboratorija in/ali reagentov, ki se uporabljajo v metodi.
English: The specific activity of Jivi is approximately 10000 IU/mg protein.
Slovenian: Specifična aktivnost zdravila Jivi je približno 10.000 i.e./mg beljakovine.
English: The speed of injection should be based on your comfort, but should not be faster than 2.5 mL per minute.
Slovenian: Hitrost injiciranja naj bo prilagojena vašemu počutju, vendar ne injicirajte hitreje kot 2,5 ml na minuto.
English: This applies also for modified long acting factor VIII products.
Slovenian: To velja tudi za modificirana dolgodelujoča zdravila, ki vsebujejo faktor VIII.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness required in the individual case.
Slovenian: Število danih enot in pogostnost odmerjanja je treba vedno določiti glede na klinično učinkovitost, potrebno pri posameznem bolniku.
English: Pharmacotherapeutic group: antihaemorrhagics: blood coagulation factor VIII, ATC code: B02BD02.
Slovenian: Farmakoterapevtska skupina: antihemoragiki, koagulacijski faktor VIII, oznaka ATC: B02BD02.
English: 12-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain factor VIII activity of 30-60% (IU/dL).
Slovenian: Ponavljajte odmerjanje vsakih 12 do 24 ur, dokler se rana ustrezno ne zaceli; nato nadaljujte zdravljenje vsaj še naslednjih 7 dni za vzdrževanje aktivnosti faktorja VIII na 30 do 60 % (i.e./dl).
English: The use of Jivi in children below 12 years is not indicated (see section 4.2, for information on paediatric use).
Slovenian: Zdravilo Jivi ni namenjeno za uporabo pri otrocih, mlajših od 12 let (za informacije o pediatrični uporabi glejte poglavje 4.2).
English: Very common (may affect more than 1 in 10 people): • headache
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): • glavobol
English: AUC (IU.h/dL)*
Slovenian: AUC (i.e.*h/dl)*
English: In case of anaphylaxis or shock, the current medical standards for treatment should be implemented.
Slovenian: V primeru anafilakse ali šoka je treba začeti s standardnimi ukrepi za zdravljenje.
English: To prevent bleeding your doctor will select an appropriate dose and frequency depending on your need:
Slovenian: Za preprečevanje krvavitev bo zdravnik izbral ustrezen odmerek zdravila in določil pogostnost dajanja glede na vaše potrebe:
English: ≥ 18 years N=133
Slovenian: ≥ 18 let n = 133
English: 11 patients in the age group < 6 years dropped out due to an immune response to PEG associated with loss of efficacy and/or hypersensitivity reaction during the first four ED.
Slovenian: 11 bolnikov v starostni skupini < 6 let je sodelovanje prekinilo zaradi imunskega odziva na PEG, povezanega z izgubo učinkovitosti in/ali preobčutljivostno reakcijo v prvih štirih dneh izpostavitve zdravilu.
English: The end date of the 6 month storage period at a temperature up to 25 °C should be recorded on the product carton.
Slovenian: Končni datum 6-mesečnega obdobja shranjevanja pri temperaturi do 25 °C je treba zabeležiti na škatlo zdravila.
English: You may be at risk of device-related complications where the catheter is inserted including:
Slovenian: Obstaja lahko tveganje za zaplete, povezane s pripomočkom, na mestu vstavitve katetra, vključno z
English: Post Authorisation Safety Study (PASS): In order to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues/organs, the MAH should conduct and submit the results of a noninterventional post-authorisation safety study according to an agreed protocol.
Slovenian: Študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Z namenom preučevati potencialne učinke kopičenja PEG v horioidnem pleksusu možganov in drugih tkivih/organih, mora imetnik dovoljenja za promet po pridobitvi dovoljenja za promet opraviti in predložiti rezultate neintervencijske študije o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom v skladu z dogovorjenim protokolom.
English: The most frequently reported adverse reactions in clinical trials in PTPs were headache, cough and pyrexia.
Slovenian: Najpogostejši neželeni učinki v kliničnih preskušanjih, o katerih so poročali pri predhodno zdravljenih bolnikih, so bili glavobol, kašelj in pireksija.
English: A clinical immune response associated with anti-PEG antibodies, manifested as symptoms of acute hypersensitivity and/or loss of drug effect has been observed primarily within the first 4 exposure days.
Slovenian: Klinični imunski odziv, povezan s protitelesi proti PEG, ki se kaže kot simptomi akutne preobčutljivosti in/ali izgube učinkovitosti zdravila, so opazili predvsem v prvih 4 dneh izpostavitve.
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breastfeeding is not available.
Slovenian: Ker je hemofilija A pri ženskah redka, izkušenj z uporabo faktorja VIII med nosečnostjo in dojenjem ni na voljo.
English: Based on patient clinical characteristics the dose can also be 60 IU/kg every 7 days or 30-40 IU/kg two times per week (see sections 5.1 and 5.2).
Slovenian: Glede na klinične značilnosti bolnika je lahko odmerek tudi 60 i.e./kg vsakih 7 dni ali 30 - 40 i.e./kg dvakrat na teden (glejte poglavji 5.1 in 5.2).
English: Jivi should be used within 3 hours after reconstitution.
Slovenian: Zdravilo Jivi je treba uporabiti v 3 urah po rekonstituciji.
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Slovenian: Vse bolnike, ki se zdravijo z zdravili s koagulacijskim faktorjem VIII, je treba z ustreznim kliničnim opazovanjem in laboratorijskimi preiskavami skrbno spremljati glede nastanka inhibitorjev.
English: • to use a central venous access device for this medicine.
Slovenian: • je za vnos tega zdravila potreben centralni venski kanal.
English: The maximum rate is 2.5 mL per minute.
Slovenian: Največja hitrost injiciranja je 2,5 ml na minuto.
English: The medicinal product may contain traces of mouse and hamster proteins.
Slovenian: Zdravilo lahko vsebuje sledove beljakovin miši in hrčkov.
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Slovenian: Opozoriti je treba, da vrednost ABR ni primerljiva med različnimi zdravili s faktorjem VIII in različnimi kliničnimi študijami.
English: Immune response to polyethylene glycol (PEG)
Slovenian: Imunski odziv na polietilenglikol (PEG)
English: If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če se zdravila ne uporabi takoj po rekonstituciji, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik.
English: If you stop using Jivi Do not stop using this medicine without checking with your doctor.
Slovenian: Če ste prenehali uporabljati zdravilo Jivi Ne prenehajte uporabljati tega zdravila, ne da bi se prej posvetovali z zdravnikom.
English: Use only the components (vial adapter, pre-filled syringe containing solvent and venipuncture set) provided with each package of this medicine.
Slovenian: Uporabite samo pribor (adapter za vialo, napolnjeno injekcijsko brizgo in pribor za vensko punkcijo), ki je priložen v vsakem pakiranju tega zdravila.
English: All treatment decisions for identifying appropriate prophylactic treatment regimens should be guided by clinical judgement based on individual patient characteristics and treatment response.
Slovenian: Odločitev glede primernega režima profilaktičnega zdravljenja mora temeljiti na klinični presoji značilnosti posameznega bolnika in njegovega odziva na zdravljenje.
English: In distribution and excretion studies in rats, the 60 kDa PEG moiety of Jivi was shown to be widely distributed to and eliminated from organs and tissues, and excreted in urine (68.4% up to day 231 after administration) and faeces (13.8% up to day 168 after administration).
Slovenian: V študijah porazdelitve in izločanja pri podganah so ugotovili, da se 60 kDa PEG, ki je del učinkovine v zdravilu Jivi, obsežno porazdeli in izloči iz organov in tkiv, nato pa se izloči z urinom (68,4 % do 231. dneva po aplikaciji) in blatom (13,8 % do 168. dneva po aplikaciji).