FrancophonIA/ELRC3.0 huggingface dataset:
English: Lymphoma**, solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma**
Slovenian: pogosti karcinom kože, ki ne vključuje malignega melanoma (vključno z bazalnoceličnim karcinomom in ploščatoceličnim karcinomom), benigni tumor občasni limfom**, tumorji parenhimskih organov (vključno s tumorjem dojk, tumorjem pljuč in tumorjem ščitnice) maligni melanom**,
English: Initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
Slovenian: Začetni odmerek 80 mg (dve 40 mg injekciji v enem dnevu), čemur sledi 40 mg vsaka dva tedna z začetkom en teden kasneje.
English: In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160/80 mg or 80/40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg.
Slovenian: Pediatrični bolniki z zmerno do hudo Crohnovo boleznijo so odvisno od njihove telesne mase (več ali manj od 40 kg) dobivali odprt začetni odmerek adalimumaba 160/80 mg v 0. tednu in 80/40 mg v 2. tednu.
English: • Keep the Idacio pre-filled pen out of the reach of children.
Slovenian: • Zdravilo Idacio napolnjen injekcijski peresnik shranjujte nedosegljivo otrokom.
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome) 1)
Slovenian: zelo pogosti glavobol pogosti parestezije (vključno s hipoastezijo), migrena, stisnjenje živčnih korenin občasni možgansko-žilni dogodki1), tremor, nevropatija redki multipla skleroza, demielinizirajoče bolezni (npr. optični nevritis, sindrom Guillain-Barré)1)
English: Adolescents from 12 to 17 years of age weighing 30 kg or more
Slovenian: Mladostniki s hidradenitis suppurativa stari od 12 do 17 let, ki tehtajo 30 kg ali več
English: Alcohol pads
Slovenian: Zloženec prepojen z alkoholom
English: 79 (73.1) a, b a p<0.001 adalimumab vs. placebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. placebo d p<0.05 adalimumab vs. methotrexate
Slovenian: 79 (73,1) a, b a p < 0,001 adalimumab v primerjavi s placebom b p < 0,001 adalimumab v primerjavi z metotreksatom c p < 0,01 adalimumab v primerjavi s placebom d p < 0,05 adalimumab v primerjavi z metotreksatom V študiji pri psoriazi I so 33. teden "izgubo ustreznega odziva" zabeležili pri 28 % bolnikov, ki so dosegli odziv PASI 75 in so bili ob ponovni randomizaciji razvrščeni na placebo, in pri 5 % bolnikov,
English: Table 13: Paediatric plaque psoriasis efficacy results at 16 weeks MTXa
Slovenian: Preglednica 13: Rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
English: Talk to your child's doctor or pharmacist before using Idacio
Slovenian: Pred začetkom uporabe zdravila Idacio se posvetujte z otrokovim zdravnikom ali farmacevtom.
English: HRa
Slovenian: Bat
English: If these medicines do not work well enough, your child will be given Idacio to reduce the signs and symptoms of his/her disease.
Slovenian: Če ta zdravila ne delujejo dovolj dobro, bo vaš otrok dobil zdravilo Idacio za zmanjšanje znakov in simptomov Crohnove bolezni.
English: Adalimumab 40 mg weekly Placebo
Slovenian: Adalimumab placebo metotreksat
English: If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Slovenian: Če ta odmerek ne bo deloval dovolj dobro, lahko zdravnik poveča odmerek na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: • adolescent hidradenitis suppurativa
Slovenian: • hidradenitis suppurativa pri mladostnikih
English: Step 3 Check the Pre-filled Syringe
Slovenian: 3. korak Preglejte injekcijsko brizgo
English: Idacio therapy should not be continued in patients failing to respond within this time period.
Slovenian: Pri bolnikih, ki se v tem času ne odzovejo na zdravljenje z zdravilom Idacio, zdravljenja ni priporočljivo nadaljevati.
English: Vial Kit
Slovenian: NALEPKA NA VIALI
English: What you need to know before your child uses Idacio Do not use Idacio - if your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če je vaš otrok alergičen na adalimumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome
Slovenian: Bolezni prebavil zelo pogosti bolečine v trebuhu, navzeja in bruhanje pogosti gastrointestinalna krvavitev, dispepsija, bolezen gastroezofagealnega refluksa, Sjögrenov sindrom občasni pankreatitis, disfagija, edem obraza redki intestinalna perforacija1)
English: Response RA study Ia**
Slovenian: Študija revmatoidnega artritisa Ia**
English: Ear and labyrinth disorders Common
Slovenian: Motnje reprodukcije in dojk občasni erektilna disfunkcija
English: Syringe plunger
Slovenian: Zapora tankega črevesa
English: Hepatitis, reactivation of hepatitis B1), autoimmune hepatitis1)
Slovenian: zelo pogosti zvišani jetrni encimi občasni vnetje žolčnika in holelitiaza, jetrna steatoza, zvišana vrednost bilirubina v krvi redki hepatitis, reaktivacija hepatitisa B1), avtoimunski hepatitis1)
English: pruritus
Slovenian: Konica
English: 0.8 mL solution in pre-filled PhysiojectTM pen containing a pre-filled syringe (type I glass) with a 29G
Slovenian: 0,8 ml raztopina v napolnjenem PhysiojectTM peresniku vsebuje napolnjeno injekcijsko brizgo (steklo tipa I), z iglo (29G s tanko steno, 12,7 mm) s pokrovčkom za iglo, ki ne vsebuje lateksa, in z batno zaporko (sintetična guma).
English: Initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Slovenian: Začetni odmerek 80 mg (dve 40 mg injekciji v enem dnevu), čemur sledi 40 mg vsaka dva tedna z začetkom en teden po začetnem odmerku.
English: • Your child might get infections more easily while receiving Idacio treatment.
Slovenian: • Med zdravljenjem z zdravilom Idacio se lahko poveča dovzetnost za okužbe.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One 0.8 mL pre-filled syringe contains 40 mg adalimumab
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena 0,8 ml napolnjena injekcijska brizga vsebuje 40 mg adalimumaba.
English: 3.1 Check the syringe to make sure that: • The syringe, the clear needle guard, and the needle cap are not cracked or damaged (Figure G).
Slovenian: • je injekcijska brizga, varovalo za injekcijsko iglo ali pokrovček na igli počen ali poškodovan (Slika G).
English: NAME OF THE MEDICINAL PRODUCT Idacio 40 mg solution for injection in pre-filled syringe adalimumab
Slovenian: Navodilo za uporabo Idacio 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi adalimumab
English: 6 months 13.3% 65.1% 19.1% 12 months NA
Slovenian: 12. teden 1 % 24. teden 1 %
English: Step 7 Record injection and dispose components
Slovenian: Zabeležite injiciranje in zavrzite pripomočke
English: Adalimumab 40 mg weekly
Slovenian: Adalimumab 40 mg vsak teden
English: Single use pre-filled pen (adalimumab) for subcutaneous injection 40mg
Slovenian: Napolnjen injekcijski peresnik (adalimumab) za subkutano injiciranje 40 mg usposobljena odrasla oseba.
English: Idiopathic thrombocytopenic purpura
Slovenian: Neželeni učinki pogosti levkocitoza, trombocitopenija občasni idiopatska trombocitopenična purpura redki pancitopenija
English: Mean steady-state trough levels of approximately 7 µg/mL were observed in Crohn's disease patients who received a maintenance dose of 40 mg adalimumab every other week.
Slovenian: Pri bolnikih s Crohnovo boleznijo, ki so dobivali vzdrževalni odmerek 40 mg adalimumaba vsak drugi teden, so ugotovili najnižjo koncentracijo pred naslednjim odmerkom v stanju dinamičnega ravnovesja približno 7 µg/ml.
English: Do not remove the needle from the skin when the plunger reaches the end.
Slovenian: Ko bat potisnete do konca, ne izvlecite injekcijske igle iz kože.
English: • increased sweating;
Slovenian: • zardevanje;
English: Mean steady-state trough levels of approximately 8 µg/mL were observed in ulcerative colitis patients who received a maintenance dose of 40 mg adalimumab every other week.
Slovenian: Pri bolnikih z ulceroznim kolitisom, ki so dobivali vzdrževalni odmerek 40 mg adalimumaba vsak drugi teden, so ugotovili povprečno najmanjšo koncentracijo v stanju dinamičnega ravnovesja približno 8 µg/ml.
English: Clinical response (CR-100) Patients in steroid-free remission for >=90 daysa
Slovenian: Placebo klinični odziv pri hidradenitis N = 154
English: Needle cap Liquid-filled syringe Barrel (inside)
Slovenian: Valj injekcijske brizge, napolnjen s tekočino (znotraj)
English: The joint survey drug utilisation final study report submitted by the MAHs, together with the joint database drug utilisation final study report submitted by the MAHs as a separate procedure (EMEA/H/N/PSR/J/0003), complies with their obligation to conduct a drug utilisation study to characterise prescribing practices for the medicinal product during typical and clinical use in representative groups of prescribers and to assess the main reason for prescription as imposed during the Article 107i procedure EMA/H/A-107i/1357 for cyproterone/ethinylestradiol containing products.
Slovenian: Končno poročilo študije skupne raziskave o uporabi zdravila, ki so jo predložili imetniki dovoljenj za promet, skupaj s končnim poročilom študije skupne zbirke podatkov o uporabi zdravila, ki so jo predložili imetniki dovoljenj za promet v ločenem postopku (EMEA/H/N/PSR/J/0003), je v skladu z obveznostjo izvajanja študije o uporabi zdravila za ugotavljanje značilnosti predpisovalnih praks zdravila v okviru običajne in klinične uporabe pri reprezentativnih skupinah predpisovalcev in za ocenitev glavnih razlogov za predpisovanje, naloženih v okviru postopka člena 107i EMA/H/A107i/1357 za zdravila, ki vsebujejo ciproteron/etinilestradiol.
English: Therefore, in view of available data regarding the joint survey drug utilisation final study report, together with the joint database drug utilisation final study report submitted as a separate procedure (EMEA/H/N/PSR/J/0003), the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Slovenian: Zato na podlagi razpoložljivih podatkov glede končnega poročila študije skupne raziskave o uporabi zdravila, skupaj s končnim poročilom študije skupne zbirke podatkov o uporabi zdravila, predložene v okviru ločenega postopka (EMEA/H/N/PSR/J/0003), odbor PRAC meni, da so potrebne spremembe pogojev dovoljenj za promet z zdravili.
English: Do not touch the syringe tip with your hand or any surface.
Slovenian: Ne dotikajte se konca brizge z roko ali katero koli površino.
English: Set the syringe aside for further use.
Slovenian: Odložite brizgo za nadaljnjo uporabo.
English: Now remove and discard the adapter housing (E).
Slovenian: Sedaj odstranite in zavrzite ohišje adapterja (E).
English: Each package of KOGENATE Bayer contains:
Slovenian: Vsako pakiranje zdravila KOGENATE Bayer vsebuje:
English: The pre-filled syringe contains water for injections to be used to reconstitute the contents of the vial.
Slovenian: Napolnjena injekcijska brizga vsebuje vodo za injekcije, ki se uporablja za rekonstitucijo vsebine viale.
English: Remove the cap from the powder vial by gently moving it from side to side several times, whilst at the same time pulling upwards.
Slovenian: Zaporko na viali s praškom odstranite tako, da jo večkrat rahlo premaknete z ene na drugo stran, medtem pa jo sočasno vlečete navzgor.
English: • mild hypotension (mildly reduced blood pressure, which may make you feel faint upon standing)
Slovenian: • blaga hipotenzija (blago znižanje krvnega tlaka, zaradi česar se vam lahko vrti, kadar stojite)
English: Be sure that the powder is completely dissolved.
Slovenian: Prepričajte se, da je prašek popolnoma raztopljen.
English: The specific activity of KOGENATE Bayer is approximately 4000 IU/mg protein.
Slovenian: Specifična aktivnost zdravila KOGENATE Bayer je približno 4000 i.e./mg proteina.
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), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do <1/100), redki (≥ 1/10.000 do <1/1.000), zelo redki
English: If a further dose needs to be administered, use a new syringe with product reconstituted as described above.
Slovenian: Če je potreben dodaten odmerek zdravila uporabite novo brizgo in rekonstituirajte zdravilo kot je opisano zgoraj.
English: • two alcohol swabs for single use
Slovenian: • dva alkoholna tampona za enkratno uporabo
English: Determine the point of injection, clean the skin with an alcohol swab, and prepare site of injection antiseptically as advised by your doctor.
Slovenian: Določite točko injiciranja, kožo očistite in razkužite mesto injiciranja z alkoholnim tamponom kot vam je svetoval zdravnik.
English: If you notice any of the following symptoms during injection/infusion:
Slovenian: • disgevzija Če opazite katerega od naslednjih simptomov med injiciranjem/infundiranjem:
English: Warm the unopened powder vial and the solvent syringe in your hands until they feel as warm as your hands.
Slovenian: Z rokami segrejte neodprto vialo s praškom in injekcijsko brizgo z vehiklom dokler nista tako topli kot vaše roke.
English: Filtering can be achieved by following the reconstitution and/or administration steps as described below.
Slovenian: Pri filtriranju upoštevajte postopek za rekonstitucijo in/ali uporabo, kot je opisano spodaj.
English: In situations where the venipuncture set provided cannot be used (e.g. when infusing into a peripheral or central line), a separate filter compatible with KOGENATE Bayer should be used.
Slovenian: V primerih, ko priloženega pribora za vensko punkcijo ni mogoče uporabiti (npr. pri infundiranju v periferno ali centralno veno) je treba uporabiti ločen filter, ki je združljiv z zdravilom KOGENATE
English: Dissolve the powder by gently swirling the vial.
Slovenian: Prašek raztopite z nežnim obračanjem viale.
English: KOGENATE Bayer should be injected intravenously over several minutes.
Slovenian: KOGENATE Bayer je treba injicirati intravensko nekaj minut.
English: If a further dose is required, remove the empty syringe by turning it anti-clockwise.
Slovenian: Če je potreben dodaten odmerek zdravila, odstranite prazno brizgo tako, da jo obrnete v nasprotni smeri urnega kazalca.
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to the International Standard for factor VIII in plasma).
Slovenian: Aktivnost faktorja VIII v plazmi je izražena v odstotkih (glede na normalno človeško plazmo) ali v mednarodnih enotah (glede na mednarodni standard za faktor VIII v plazmi).
English: Experience regarding fertility or the use of KOGENATE Bayer during pregnancy and breast-feeding is not available.
Slovenian: Izkušenj o plodnosti ali uporabi zdravila KOGENATE Bayer med nosečnostjo in dojenjem ni.
English: Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 ml/h corresponding to 3.0 ml/h/kg (range 1.6-4.6 ml/h/kg).
Slovenian: Povprečni začetni očistek pri 14-ih odraslih bolnikih pri katerih je bil narejen večji kirurški poseg in so dobili kontinuirano infuzijo, je 188 ml/h, kar ustreza 3,0 ml/h/kg (območje 1,6 - 4,6 ml/h/kg).
English: Additional pharmacokinetic parameters for KOGENATE Bayer for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 ml/h.
Slovenian: Dodatni farmakokinetični parametri za bolusno injekcijo zdravila KOGENATE Bayer so: povprečni čas zadrževanja [PČZ (0 - 48)] je približno 22 ur, očistek pa je približno 160 ml/h.
English: The vial contains a dry white to slightly yellow powder or cake.
Slovenian: Viala vsebuje suh bel do rahlo rumen prašek ali pogačo.
English: Hold the vial on end above the vial adapter and syringe (I).
Slovenian: Vialo držite za konec nad adapterjem za vialo in brizgo (I).
English: If these components cannot be used, please contact your doctor.
Slovenian: Če se teh sestavnih delov ne da uporabiti, se posvetujte s svojim zdravnikom.
English: It is recommended that every time that you use KOGENATE Bayer, the name and batch number of the product are documented.
Slovenian: Priporoča se, da vsakič po uporabi zdravila KOGENATE Bayer zabeležite ime in številko serije zdravila.
English: Holding the plunger in place, remove the syringe from the vial adapter (the latter should remain attached to the vial).
Slovenian: Bat držite na mestu in odstranite adapter za vialo (ta naj ostane pritrjen na vialo).
English: In one observational study, the incidence of inhibitor development in previously untreated patients with severe haemophilia A was 64/183 (37.7%) with KOGENATE Bayer (followed up to 75 exposure days).
Slovenian: V eni opazovalni študiji je bila incidenca nastanka inhibitorja pri uporabi zdravila KOGENATE Bayer pri predhodno nezdravljenih bolnikih s hudo hemofilijo A 64/183 (37,7 %) (spremljali so bolnike, ki so bili izpostavljeni do 75 dni).
English: Fill the syringe by drawing the plunger out slowly and smoothly.
Slovenian: Napolnite brizgo tako, da počasi in mirno izvlečete bat brizge.
English: If you cannot use the venipuncture set provided, use a separate filter which is compatible with KOGENATE Bayer.
Slovenian: Če priloženega pribora za vensko punkcijo ne morete uporabiti, uporabite ločen filter, ki je združljiv z zdravilom KOGENATE Bayer.
English: Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with KOGENATE Bayer developed inhibitors within 20 exposure days.
Slovenian: Pri 5 od 37 (14 %) predhodno nezdravljenih bolnikih in pri 4 od 23 (17 %) minimalno zdravljenih bolnikih, ki so se zdravili z zdravilom KOGENATE Bayer, so inhibitorji nastali v 20 dneh izpostavljenosti, Na splošno so pri 9 od 60 (15 %) bolnikov nastali inhibitorji.
English: In extensive post-registration observational studies with KOGENATE Bayer, involving more than 1000 patients the following was observed: Less than 0.2% PTP developed de-novo inhibitors.
Slovenian: V obsežnih poregistracijskih opazovalnih študijah z zdravilom KOGENATE Bayer, v katere je bilo vključenih več kot 1000 bolnikov, so ugotovili naslednje: inhibitorji so de novo nastali pri manj kot 0,2 % predhodno zdravljenih bolnikih.
English: • Do not use the venipuncture set provided for drawing blood because it contains an in-line filter.
Slovenian: • Priloženega pribora za vensko punkcijo ne uporabite za odvzem krvi, ker že vsebuje filter.
English: If the inhibitor is present at levels less than 10 Bethesda Units (BU) per ml, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with KOGENATE Bayer.
Slovenian: Če je vsebnost inhibitorja manjša kot 10 Bethesda enot (BE) na mililiter, ga je možno nevtralizirati z dodatnim odmerkom rekombinantnega koagulacijskega faktorja VIII in nadaljevati klinično učinkovito zdravljenje z zdravilom KOGENATE Bayer.
English: After administration of KOGENATE Bayer, peak factor VIII activity decreased by a two-phase exponential decay with a mean terminal half-life of about 15 hours.
Slovenian: Po dajanju zdravila KOGENATE Bayer se maksimalna aktivnost faktorja VIII zmanjšuje dvofazno eksponentno, razpolovni čas je približno 15 ur.
English: KOGENATE Bayer can be infused by continuous infusion.
Slovenian: KOGENATE Bayer se lahko uporabi kot kontinuirana infuzija.
English: • If for the administration of KOGENATE Bayer you will require a central venous access device (CVAD), the risk of CVAD-related complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted should be considered by your doctor.
Slovenian: • Če je za vnos zdravila KOGENATE Bayer potreben centralni venski kateter (CVK), mora vaš zdravnik upoštevati možnost zapletov, povezanih s CVK, kot so lokalne okužbe, prisotnost bakterij v krvi (bakteriemija) in nastanek krvnih strdkov v krvnih žilah (tromboza) na mestu vstavitve katetra.
English: Determine the point of injection and prepare antiseptically 14.
Slovenian: Določite točko injiciranja in jo pripravite tako da bo aseptična.
English: Peel off the paper cover on the vial adapter plastic housing.
Slovenian: Odstranite papirnat pokrov na plastičnem ohišju adapterja za vialo.
English: These compatible filters are luer adaptor-type of Polyacrylic housing with integrated filter element of a Polyamide screen of 5 - 20 micrometer mesh size.
Slovenian: Filtri, ki so združljivi z luer adapterjem so iz poliakrilnega ohišja z vgrajenim filtrom iz poliamidne mreže z velikostjo luknjic 5 - 20 mikrometrov.
English: Swirl vial gently until all material is dissolved (H).
Slovenian: Vialo nežno obračajte, dokler se ves prašek ne raztopi (H).
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, nausea, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Slovenian: Bolnike je treba opozoriti o zgodnjih opozorilnih znakih preobčutljivosti, ki vključujejo izpuščaj, navzeo, generalizirano urtikarijo, tiščanje v prsih, sopenje, hipotenzijo in anafilakso.
English: Elevation of FVIII levels following administration, in particular with existing cardiovascular risk factors, might put a patient into the same risk for vessel closure or myocardial infarction as for the non-haemophilic population.
Slovenian: Zvečanje aktivnosti faktorja VIII po aplikaciji, zlasti v primeru obstoječih srčnožilnih dejavnikov tveganja, predstavlja pri bolniku najmanj enako tveganje za zaporo žil ali miokardni infarkt kakor pri populaciji, ki nima hemofilije.
English: Therefore, KOGENATE Bayer should be used during pregnancy and breast-feeding only if clearly indicated.
Slovenian: Izkušenj o uporabi zdravila KOGENATE Bayer med nosečnostjo in dojenjem ni, zato ga med nosečnostjo in dojenjem uporabljamo le, če je to jasno indicirano.
English: Ensure that the powder is completely dissolved before use.
Slovenian: Prepričajte se, da je pred uporabo ves prašek popolnoma raztopljen.
English: It is strongly recommended that every time that KOGENATE Bayer is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Slovenian: Priporočljivo je, da se po vsaki uporabi zdravila KOGENATE Bayer zabeležita ime in serijska številka zdravila, da je mogoča povezava med bolnikom in serijo zdravila, ki ga je prejel.
English: Attach the syringe to the venipuncture set and ensure that no blood enters the syringe (J).
Slovenian: Nastavite brizgo na pribor za punkcijo vene in preverite, da vanjo ni prišla kri (J).
English: If you have any questions about KOGENATE Bayer and compatible separate filters contact your doctor.
Slovenian: Če imate kakršna koli vprašanja o zdravilu KOGENATE Bayer in z njim združljivih ločenih filtrih, se posvetujte s svojim zdravnikom.
English: If you have any questions about KOGENATE Bayer and compatible separate filters contact Bayer Pharma AG.
Slovenian: Če imate kakršna koli vprašanja o zdravilu KOGENATE Bayer in z njim združljivih ločenih filtrih, se obrnite na podjetje Bayer Pharma AG.
English: In this case, this medicine expires at the end of this 12-month period or the expiration date on the product vial, whichever is earlier.
Slovenian: V tem primeru rok uporabnosti zdravila poteče ob koncu 12mesečnega obdobja ali z datumom izteka roka uporabnosti navedenega na viali zdravila, odvisno kateri je prej.
English: When you must withdraw blood before an infusion, use an administration set without a filter, then infuse KOGENATE Bayer through an injection filter.
Slovenian: Kadar morate pred infundiranjem odvzeti kri, uporabite pribor brez filtra in nato infundirajte zdravilo KOGENATE Bayer skozi injekcijski filter.
English: After reconstitution, the solution is drawn back into the syringe.
Slovenian: Po rekonstituciji raztopino povlecite nazaj v brizgo.