FrancophonIA/ELRC3.0 huggingface dataset:
English: The area under the concentration-time curve (AUC) to minimum inhibitory concentration (MIC) ratio of oritavancin for the infecting organism has been shown to be the parameter that best correlates with efficacy.
Slovenian: Farmakokinetično/farmakodinamično (FK/FD) razmerje Pokazalo se je, da je parameter, ki najboljše korelira z učinkovitostjo, razmerje med površino pod krivuljo koncentracija-čas (AUC-area under the concentration-time curve) in minimalno inhibitorno koncentracijo (MIC-minimum inhibitory concentration) oritavancina za povzročitelje okužbe.
English: Aseptic procedures should be used for the preparation of Orbactiv.
Slovenian: Priprava zdravila Orbactiv mora potekati po aseptičnih postopkih.
English: No dosage adjustment is required for patients with mild to moderate hepatic impairment (Child-Pugh Class B) (see section 5.2).
Slovenian: Prilagajanje odmerka pri bolnikih z blago ali zmerno okvaro jeter (razred B po Child-Pughu) ni potrebno (glejte poglavje 5.2).
English: Serious hypersensitivity reactions, including anaphylactic reactions and anaphylactic shock have been reported with the use of oritavancin.
Slovenian: Pri uporabi oritavancina so poročali o resnih preobčutljivostnih reakcijah, vključno z anafilaktičnimi reakcijami in anafilaktičnim šokom.
English: How you will be given Orbactiv
Slovenian: Kako boste dobili zdravilo Orbactiv
English: Interference with assay for coagulation tests
Slovenian: Vplivi na koagulacijske teste
English: After reconstitution and dilution, 1 ml solution for infusion contains 1.2 mg oritavancin.
Slovenian: Po rekonstituciji in redčenju vsebuje 1 ml raztopine za infundiranje 1,2 mg oritavancina.
English: The Chromogenic Factor Xa Assay, the Thrombin Time (TT) assay and the assays used for the diagnosis of Heparin Induced Thrombocytopenia (HIT) are not affected by oritavancin.
Slovenian: Oritavancin ne vpliva na kromogeni preizkus določanja aktivnosti faktorja Xa, določanje trombinskega časa (TT-thrombin Time) in preizkus trombocitopenije, izzvane s heparinom (HITheparin induced thrombocytopenia).
English: Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after oritavancin administration because the activated partial thromboplastin time (aPTT) test results may remain falsely elevated for up to 120 hours after oritavancin administration (see sections 4.4 and 4.5).
Slovenian: Uporaba intravenskega nefrakcioniranega natrijevega heparinata je kontraindicirana 120 ur (5 dni) po dajanju oritavancina, saj so lahko rezultati testov aktiviranega delnega tromboplastinskega časa
English: If you get any side effects, talk to your doctor or nurse.
Slovenian: Če opazite kateregakoli izmed neželenih učinovk, se posvetujte z zdravnikom ali medicinsko sestro.
English: Nausea, vomiting, diarrhoea, constipation
Slovenian: Bolezni prebavil pogosti navzea, bruhanje, driska, zaprtje
English: After reconstitution
Slovenian: 3 leta Po rekonstituciji
English: • More enzymes produced by your liver (as shown in blood tests);
Slovenian: • povišane vrednosti jetrnih encimov (spremenjene vrednosti jetrnih testov)
English: • Muscle pain;
Slovenian: • bolečina v mišicah
English: How to store Orbactiv
Slovenian: Shranjevanje zdravila Orbactiv
English: • Headache;
Slovenian: • glavobol
English: Cellulitis, abscess (limb and subcutaneous)
Slovenian: Infekcijske in parazitske bolezni pogosti celulitis, abscesi (okončine in podkožni)
English: • Feeling sick (nausea) or being sick (vomiting);
Slovenian: • siljenje na bruhanje (navzea) ali bruhanje
English: • Beta-haemolytic streptococci of Group G
Slovenian: • Betahemolitični streptokoki skupine G
English: It is particularly important to tell your doctor if you are using medicines that prevent blood from clotting (oral anticoagulants, e.g.coumarin anticoagulants ).
Slovenian: Zlasti pomembno je, da zdravniku poveste, če jemljete zdravila za preprečevanje strjevanja krvi
English: - Orbactiv is a powder for concentrate for solution for infusion - Orbactiv is a white to off white powder, supplied in a 50 ml glass vial.
Slovenian: - Zdravilo Orbactiv je bel do umazano bel prašek v 50 ml stekleni viali.
English: Lifetime studies in animals have not been conducted to evaluate the carcinogenic potential of oritavancin.
Slovenian: Študij za ugotavljanje kancerogenega potenciala oritavancina, pri katerih bi živali spremljali vse življenje, niso izvedli.
English: The reconstituted solution should be further diluted in glucose 5% intravenous infusion bag immediately.
Slovenian: Rekonstituirano raztopino nadalje takoj razredčite v vreči za intravensko infuzijo z glukozo (5-%).
English: Bronchospasm, wheezing
Slovenian: multiformni eritem, oblivanje
English: Three Orbactiv 400 mg vials need to be reconstituted and diluted to prepare a single once-only 1,200 mg IV dose.
Slovenian: Rekonstituirati in razredčiti je treba tri viale zdravila Orbactiv 400 mg, da pripravite en i.v.
English: • Withdraw and discard 120 mL from a 1,000 mL D5W intravenous bag.
Slovenian: Redčenje: • Iz 1.000 ml vreče za intravensko infuzijo D5W izvlecite 120 ml tekočine in jo zavrzite.
English: Orbactiv 400 mg powder for concentrate oritavancin
Slovenian: Orbactiv 400 mg prašek za koncentrat oritavancin
English: The reconstituted solution should be further diluted in glucose 50 mg/ml (5%) intravenous infusion bag immediately.
Slovenian: Rekonstituirano raztopino nadalje takoj razredčite v vreči za intravensko infuzijo z glukozo 50 mg/ml
English: A study to assess the drug-drug interaction effect of a single 1,200mg dose of oritavancin on the pharmacokinetics of S-warfarin following a single dose was conducted in 36 healthy subjects.
Slovenian: Pri 36 zdravih osebah so izvedli študijo za oceno, kako pri medsebojnem delovanju med zdravili posamezen 1200 mg odmerek oritavancina učinkuje na farmakokinetiko S-varfarina.
English: If not used immediately storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at 25°C and 24 hours at 2-8°C following dilution in a glucose 5% intravenous infusion bag, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Običajno naj bi čas shranjevanja ne bil daljši od 12 ur pri 25 ºC in 24 ur pri 2 do 8 ºC po razredčitvi v vreči za intravensko infuzijo s 5
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA
English: Myalgia
Slovenian: odmerek
English: Each vial contains oritavancin diphosphate equivalent to 400 mg oritavancin.
Slovenian: Ena viala vsebuje 400 mg oritavancina v obliki oritavancin difosfata.
English: Clinical efficacy has not been established against the following pathogens although in vitro studies suggest that they would be susceptible to oritavancin in the absence of acquired mechanisms of resistance:
Slovenian: Klinične učinkovitosti proti naslednjim patogenom niso ugotovili, čeprav študije in vitro nakazujejo,
English: After dilution, 1 ml of the solution for infusion contains 1.2 mg oritavancin.
Slovenian: Po redčenju vsebuje 1 ml raztopine za infundiranje 1,2 mg oritavancina.
English: Your doctor will treat you as necessary.
Slovenian: Zdravnik vas bo po potrebi zdravil.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti mialgija občasni tenosinovitis
English: No effect of oritavancin on the in vivo coagulation system was observed in nonclinical and clinical studies.
Slovenian: V nekliničnih in kliničnih študijah ni bilo opaziti vpliva oritavancina na sistem strjevanja krvi in vivo.
English: Extramedullary haematopoiesis in the spleen was observed in rats.
Slovenian: Pri podganah so opazili ekstramedularno hematopoezo vranice.
English: Dilution: Three reconstituted vials are needed for dilution for administration of a single 1,200 mg intravenous infusion.
Slovenian: Redčenje: Za eno 1.200 mg intravensko infuzijo je treba razredčiti tri rekonstituirane viale.
English: Beta-haemolytic streptococci Groups A, B, C, G 0.25 Viridans group streptococci (S. anginosus group only)
Slovenian: Beta-hemolitični streptokoki skupin A, B, C, G
English: • Pain or irritation where the injection was given;
Slovenian: • bolečina ali draženje na mestu dajanja injekcije • srbenje, kožni izpuščaj
English: Blood bilirubin increased
Slovenian: občasni povečana raven bilirubina v krvi
English: Powder for concentrate for solution for infusion (powder for concentrate).
Slovenian: prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat) Bel do umazano bel prašek.
English: A screening drug-drug interaction study was conducted in healthy volunteers (n=16) evaluating the concomitant administration of a single 1,200 mg dose of oritavancin with probe substrates for several CYP450 enzymes.
Slovenian: za ocenitev sočasnega dajanja enega odmerka 1.200 mg oritavancina s preiskovalnimi substrati za več encimov CYP450.
English: Dosage adjustment of oritavancin is not needed in patients with mild or moderate renal impairment.
Slovenian: Pri bolnikih z blago ali zmerno ledvično okvaro odmerka oritavancina ni treba prilagajati.
English: Mannitol Phosphoric acid (for pH-adjustment)
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol fosforna kislina (za uravnavanje pH)
English: Headache, dizziness
Slovenian: • hud izpuščaj • vročinski oblivi
English: • Shivering or trembling;
Slovenian: • tresenje ali drgetanje
English: • Reduced blood platelet count below the normal lower limit (known as thrombocytopenia).
Slovenian: • zmanjšano število krvnih ploščic (trombocitopenija)
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora občasni bronhospazem, sopenje
English: • Constipation;
Slovenian: • vrtoglavica
English: Leucocytoclastic vasculitis, angioedema, erythema multiforme, flushing
Slovenian: Bolezni kože in podkožja pogosti urtikarija, izpuščaj, pruritus občasni levkocitoklastični vaskulitis, angioedem,
English: Orbactiv 400 mg powder for concentrate for solution for infusion
Slovenian: Orbactiv 400 mg prašek za koncentrat za raztopino za infundiranje
English: 6.5 Nature and contents of container
Slovenian: 6.5 Vrsta ovojnine in vsebina <ter posebna oprema za uporabo, dajanje ali implantacijo>
English: Infusion site reactions, including the following symptoms infusion site phlebitis, infusion site erythema, extravasation, induration, pruritis, rash, oedema peripheral
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti reakcije na mestu infundiranja, vključno z naslednjimi simptomi: flebitis na mestu infundiranja, eritem na mestu infundiranja,
English: There was no evidence of transplacental transfer of oritavancin in pregnant rats.
Slovenian: Pri brejih podganjih samicah ni bilo znakov prehajanja oritavancina skozi placento.
English: Antibacterial-associated colitis and pseudomembranous colitis have been reported for oritavancin and may range in severity from mild to life threatening diarrhoea.
Slovenian: Pri uporabi oritavancina so poročali o kolitisu in o psevdo-membranskem kolitisu, povezanem s protibakterijskimi zdravili, ki sta lahko blaga do življenjsko nevarna.
English: Hypoglycaemia, hyperuricaemia
Slovenian: Presnovne in prehranske motnje občasni hipoglikemija, hiperurikemija
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema pogosti anemija občasni eozinofilija, trombocitopenija
English: Dosage adjustment of oritavancin is not needed in patients with mild and moderate hepatic impairment.
Slovenian: Pri bolnikih z blago in zmerno jetrno okvaro odmerka oritavancina ni treba prilagajati.
English: Orbactiv 400 mg powder for concentrate for solution for infusion oritavancin
Slovenian: Orbactiv 400 mg prašek za koncentrat za raztopino za infundiranje oritavancin
English: Tachycardia
Slovenian: • driska
English: In Phase 3 ABSSSI clinical trials, more cases of osteomyelitis were reported in the oritavancin-treated arm than in the vancomycin-treated arm (see section 4.8).
Slovenian: zdravljenih z oritavancinom, kot v kraku bolnikov, zdravljenih z vankomicinom (glejte poglavje 4.8).
English: Susceptibility testing break points
Slovenian: Mejne vrednosti testiranja dovzetnosti
English: Orbactiv is intended for intravenous (IV) administration, only after reconstitution and dilution.
Slovenian: Zdravilo Orbactiv je namenjeno intravenskemu (i.v.)
English: It is important that your hands and items you use be as clean as possible.
Slovenian: Pomembno je, da so vaše roke in predmeti, ki jih uporabljate, čim bolj čisti.
English: Children and adolescents (< 18 years)
Slovenian: Otroci in adolescenti (<18 let)
English: None of those events was serious and less than 5% were considered severe.
Slovenian: Nobeden od teh dogodkov ni bil resen in manj kot 5 % so ocenili kot hude.
English: It is for single use only.
Slovenian: Je samo za enkratno uporabo.
English: Generally reconstitution takes less than 5 minutes.
Slovenian: Na splošno traja rekonstitucija manj kot 5 minut.
English: The duration of therapy is 12 weeks.
Slovenian: Trajanje zdravljenja je 12 tednov.
English: This may occur rarely in particular at
Slovenian: To se lahko redko pojavi, zlasti na začetku
English: These reactions were largely mild to moderate.
Slovenian: Te reakcije so bile večinoma blage do zmerne.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2004
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 20. september 2004
English: It is important that you tell your doctor if you have had or you have any of the above.
Slovenian: Pomembno je, da poveste zdravniku, če ste imeli ali imate karkoli od zgoraj navedenega.
English: These changes, which may be associated with the use of Raptiva, can usually only be detected with blood tests.
Slovenian: Te spremembe, ki so lahko povezane z uporabo zdravila Raptiva, se običajno lahko ugotovi le s krvnimi preiskavami.
English: Only at 25 weeks of age was this decrease no longer significant.
Slovenian: Šele pri 25 tednih starosti, ni bilo zmanjšanje več klinično pomembno.
English: Steady state was achieved at week 4.
Slovenian: Stanje dinamičnega ravnovesja je bilo doseženo v 4 tednu.
English: Your doctor will tell you how much you should inject.
Slovenian: Vaš zdravnik vam bo povedal koliko zdravila si morate injicirati.
English: EXP Use immediately after reconstitution.
Slovenian: EXP Uporabite takoj po rekonstituciji.
English: Elevation of alkaline phosphatase:
Slovenian: Dvig ravni alkaline fosfataze:
English: Over 600 patients have been treated for more than 1 year including 166 patients treated for more than 2 years and up to 3 years.
Slovenian: Več kot 600 bolnikov se je zdravilo več kot 1 leto, vključno s 166 bolniki, ki so se zdravili več kot 2 leti in do 3 let.
English: The injection can be self-administered or given by another person, for example a family member or your doctor.
Slovenian: Injekcijo si lahko dajete sami ali vam jo da kdo drug, na primer družinski član ali vaš zdravnik.
English: In such cases, it is recommended to
Slovenian: V teh primerih je priporočljivo prekiniti
English: Prompt medical care is needed since serious allergic reactions may be potentially life-threatening.
Slovenian: Takoj je potrebna nujna zdravniška pomoč, ker so lahko hude alergijske reakcije potencialno življenje ogrožajoče.
English: Some foam or bubbles may remain in the vial.
Slovenian: Nekaj pene in mehurčkov lahko ostane v viali.
English: Gradual reduction of dose or frequency does not appear to be beneficial.
Slovenian: Postopno zmanjševanje odmerka ali pogostnosti odmerkov ni kazalo koristi.
English: Additional Information
Slovenian: DODATNE INFORMACIJE
English: Data from extended treatment (more than 12 weeks) have been obtained from 4311 patients in open label uncontrolled studies.
Slovenian: Podatke o dolgotrajnem zdravljenju (več kot 12 tednov) so pridobili na 4311 bolnikih iz odprtih nekontroliranih študij.
English: After reconstitution, an immediate use is recommended (see also section 6.4).
Slovenian: Po rekonstituciji priporočamo takojšnjo uporabo (glejte tudi poglavje 6.4).
English: b) Vaccinations
Slovenian: b) Cepljenje
English: Therefore, conventional non-clinical safety data with the medicinal product are limited and do not allow for a comprehensive safety assessment.
Slovenian: Zato so običajni predklinični podatki o varnosti z zdravilom omejeni in ne omogočajo obsežne ocene varnosti.
English: These symptoms are very common and occur most often after the first two doses and decrease with continued use.
Slovenian: Ti simptomi so zelo pogosti in se najpogosteje pojavijo po prvih dveh odmerkih ter se zmanjšajo z nadaljno uporabo.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Slovenian: Če zdravila ne uporabite takoj, so čas in pogoji shranjevanja pripravljene raztopine pred uporabo odgovornost uporabnika in običajno niso daljši od 24 ur pri temperaturi med 2°C in 8°C, razen, če je bila raztopina rekonstituirana v nadzorovanih in validiranih aseptičnih pogojih.
English: Do not inject but withdraw the needle and repeat the injection procedure.
Slovenian: Ne injicirajte, ampak izvlecite iglo in ponovite postopek injiciranja.
English: (See section 4.4).
Slovenian: (Glejte poglavje 4.4).
English: 1 DNA Way, South San Francisco, CA 94080-4990
Slovenian: 1 DNA Way, South San Francisco, CA 94080-4990 ZDA
English: - You might get infections more easily.
Slovenian: Lahko boste bolj dovzetni za okužbe.
English: Therapy may be continued only in patients who responded to treatment (PGA good or better).
Slovenian: Zdravljenje se lahko nadaljuje samo pri bolnikih, ki so se odzvali na zdravljenje (PGA dober ali boljši).
English: Please contact your doctor if you forget to take 2 or more doses of Raptiva.
Slovenian: Prosimo posvetujte se z zdravnikom, če ste pozabili vzeti 2 ali več odmerkov zdravila Raptiva.
English: If you notice that any of these reactions do not vanish after the second injection, tell your doctor.
Slovenian: Če opazite, da katerakoli od teh reakcij ne izgine po drugi injekciji, o tem obvestite svojega
English: - Some patients had reactions including headache, fever, nausea and vomiting within two days of each of the first two injections.
Slovenian: - Nekateri bolniki so imeli reakcije, vključno z glavobolom, vročino, slabostjo in bruhanjem v roku dveh dni, po vsaki od prvih dveh injekcij.
English: - If you have active tuberculosis or other severe infections.
Slovenian: - Če imate aktivno tuberkulozo ali druge hude okužbe.
English: Therapy may be continued only in patients who responded to treatment, your doctor will discuss with you the extent of your response to treatment.
Slovenian: Zdravljenje se lahko nadaljuje samo pri bolnikih, ki so se odzvali na zdravljenje, vaš zdravnik se bo pogovoril z vami o obsegu vašega odziva na zdravljenje.
English: It is not known whether Raptiva can cause harm to your baby if you are pregnant or whether it can affect your ability to become pregnant.
Slovenian: Ni znano ali lahko zdravilo Raptiva škoduje otroku, če ste noseči in ali lahko vpliva na vašo zmožnost zanositve.
English: Raptiva is a medicine containing efalizumab, made by means of biotechnology.
Slovenian: Raptiva je zdravilo, ki vsebuje efalizumab, izdelan s pomočjo biotehnologije.
English: Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Slovenian: Bolnikom svetujte, naj obvestijo svojega partnerja ali skrbnika o zdravljenju s tem zdravilom, saj bodo ti morda opazili simptome, ki se jih sam bolnik morda ne bo zavedal.
English: It is recommended that you are monitored for any signs or symptoms of adverse effects and that you are given appropriate symptomatic treatment immediately.
Slovenian: Priporočljivo je, da vas opazujejo na kakršnekoli znake ali simptome neželenih učinkov in vas takoj ustrezno simptomatsko zdravijo.
English: Four of these patients had clinical signs of thrombocytopenia.
Slovenian: Štirje izmed teh bolnikov so imeli klinične znake trombocitopenije.
English: If you eject too much Raptiva back into the vial, simply repeat the drawing up process and continue.
Slovenian: Če izstisnete preveč raztopine Raptiva nazaj v vialo, preprosto ponovno povlecite raztopino nazaj in nadaljujte.
English: The side effects in this section are given with an estimation of the frequency with which they may occur.
Slovenian: Neželeni učinki v tem poglavju so navedeni skupaj z oceno pogostnosti s katero se lahko pojavijo.
English: There are no adequate data from the use of efalizumab in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi efalizumaba pri nosečnicah.
English: Physico-chemical stability of the reconstituted product has been shown for 24 hours at 2°C to 8°C.
Slovenian: Potrjena fizikalnokemijska stabilnost rekonstituiranega zdravila je 24 ur pri temperaturi med 2°C in 8°C.
English: Your doctor or nurse will have already advised you where to inject.
Slovenian: Vaš zdravnik ali medicinska sestra sta vas že poučila, kam si injicirati zdravilo.
English: Monoclonal antibodies are proteins that recognise and bind to other specific proteins of the human body.
Slovenian: Monoklonalna protitelesa so beljakovine, ki prepoznajo in se vežejo za druge specifične beljakovine v človeškem telesu.
English: The percentage of patients reporting flu-like symptoms was greatest with the first injection and decreased by more than 50% with the second injection.
Slovenian: Delež bolnikov, ki so poročali o gripi podobnih simptomih, je bil največji po prvi injekciji in se je zmanjšal za več kot 50 % po drugi injekciji.
English: Based on the clinical development data generated (see Table 1) and long-term experience, Raptiva is recommended for use in patients as defined in section 4.1.
Slovenian: Na podlagi pridobljenih podatkov v kliničnem razvoju (glejte tabelo 1) in dolgotrajnih izkušenj, je Raptiva priporočena za uporabo pri bolnikih kot je definirano v poglavju 4.1.
English: • Shortness of breath or any persistent respiratory difficulties.
Slovenian: - Kratko sapo ali kakršne koli vztrajne težave z dihanjem.
English: Detailed instructions for use are provided in the package leaflet.
Slovenian: Natančna navodila za uporabo so v priloženem navodilu za uporabo.
English: Do not use if you notice that the solution is not clear or contains particles.
Slovenian: Ne uporabljajte zdravila, če ste opazili, da raztopina ni bistra ali vsebuje delce.
English: The pH of the reconstituted solution is 5.9 - 6.5.
Slovenian: pH rekonstituirane raztopine je 5,9 do 6,5.
English: - If you have been diagnosed as having a disorder of your immune system.
Slovenian: - Če so ugotovili, da imate motnje imunskega sistema.
English: • Fever or if you think that you have an infection.
Slovenian: - Zvišano telesno temperaturo ali, če menite, da imate okužbo.
English: Women of childbearing potential have to use appropriate contraception during treatment.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem uporabljati ustrezno kontracepcijo.
English: It is recommended that assessments be more frequent when initiating therapy (e.g., monthly) and may decrease in frequency with continued treatment (e.g., every 3 months).
Slovenian: Pogostejše določanje je priporočljivo na začetku zdravljenja (npr. enkrat mesečno) in je lahko v nadaljevanju zdravljenja manj pogosto (npr. vsake 3 mesece).
English: The safety profile in the target population as defined in section 4.1 is similar to the safety profile in the overall population treated during clinical development of Raptiva as presented above.
Slovenian: Varnostni profil ciljne populacije, kot je opredeljena v poglavju 4.1, je podoben varnostnemu profilu celotne populacije zdravljene tekom kliničnega razvoja Raptive, kot zgoraj prikazano.