FrancophonIA/ELRC3.0 huggingface dataset:
English: Certain laboratory tests may change, such as the number of white or red blood cells (including leukocytes and lymphocytes) as well as alkaline phosphatase and ALT values (blood laboratory values).
Slovenian: Določene laboratorijske preiskave so lahko spremenjene, kot je število belih ali rdečih krvnih celic (vključno z levkociti in limfociti), kakor tudi vrednosti alkalne fosfataze in alaninaminotransferaze (ALT) (laboratorijske vrednosti v krvi).
English: It may be necessary to discontinue Raptiva treatment 8 weeks before a vaccination.
Slovenian: Morda bo potrebno da prekinete zdravljenje z zdravilom Raptiva 8 tednov pred cepljenjem.
English: These symptoms are uncommon.
Slovenian: Ti simptomi so občasni.
English: No teratogenic effects were seen in mice during organogenesis.
Slovenian: Nobenih teratogenih učinkov niso opazili pri miših med organogenezo.
English: Doses up to 4 mg/kg/week subcutaneously for 10 weeks have been administered without any toxic effect.
Slovenian: Odmerke do 4 mg/kg/teden subkutano, 10 tednov, so uporabljali brez vsakih toksičnih učinkov.
English: The expected degradation products are small peptides and individual amino acids which are eliminated by glomerular filtration.
Slovenian: Pričakovani produkti razgradnje so majhni peptidi in posamezne aminokisline, ki se izločijo z glomerularno filtracijo.
English: 12 EasyMIX adapters for reconstitution.
Slovenian: 12 adapterjev EasyMIX za rekonstitucijo.
English: - If you have forms of psoriasis other than plaque psoriasis (for instance other more severe forms of psoriasis, as diagnosed by your doctor).
Slovenian: - Če imate druge oblike psoriaze kot je psoriaza s plaki (na primer druge težje oblike psoriaze, ki jih je ugotovil vaš zdravnik).
English: A higher rate of malignancies has been associated with therapies affecting the immune system.
Slovenian: Večji delež malignih obolenj povezujejo z zdravljenji, ki vplivajo na imunski sistem.
English: The full effect was seen 24 to 48 hours after the first dose, and was maintained between weekly doses.
Slovenian: Popolni učinek je bil dosežen 24 do 48 ur po prvem odmerku in se je ohranjal med tedenskimi odmerki.
English: The use of Raptiva may be associated with an increased risk of Progressive Multifocal Leukoencephalopathy (PML).
Slovenian: Uporaba zdravila Raptiva je lahko povezana z večjim tveganjem za pojav progresivne multifokalne levkoencefalopatije (PML).
English: As there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.
Slovenian: Ker je pri starejših bolnikih na splošno večja incidenca okužb, je pri zdravljenju starejših potrebna previdnost.
English: Elevation of ALT:
Slovenian: Dvig ravni ALT:
English: In this small number of patients no differences were observed in either pharmacodynamic or pharmacokinetic parameters.
Slovenian: Pri tem majhnem številu bolnikov niso opazili nobenih razlik bodisi v farmakodinamičnih ali farmakokinetičnih parametrih.
English: Therefore, if you are pregnant, consult with your doctor
Slovenian: Zato se, če ste noseči, takoj posvetujte z zdravnikom.
English: From a microbiological point of view, the product should be used immediately after first opening and reconstitution.
Slovenian: Z mikrobiološkega stališča morate zdravilo uporabiti takoj po prvem odprtju ovojnine in rekonstituciji.
English: Raptiva should be used with caution in this patient population.
Slovenian: Raptivo je treba uporabljati previdno pri tej skupini bolnikov.
English: Systemic therapies are medicines taken orally or administered by injection and thus will be present in and affect the whole body.
Slovenian: Zdravila za sistemsko zdravljenje se jemljejo peroralno ali dajejo v obliki injekcij in so zato prisotna v celem telesu in vplivajo na celo telo.
English: Seventeen of these events occurred after discontinuation of Raptiva, while 22 occurred during treatment.
Slovenian: Sedemanjst od teh dogodkov se je pojavilo po prekinitvi uporabe Raptive, medtem ko jih je 22 nastopilo med samim zdravljenjem.
English: - If you experience a worsening of your psoriasis or you develop arthritis, please inform your doctor.
Slovenian: - Če nastopi poslabšanje psoriaze ali razvijete artritis, se prosimo posvetujte s svojim zdravnikom.
English: The increase included CD4 T-lymphocytes, CD8 T-lymphocytes, B-lymphocytes, and natural killer (NK) cells, although NK cells and CD4 cells increased less relative to other cell types.
Slovenian: Povečanje je vključevalo CD4 limfocite T, CD8 limfocite T, limfocite B in naravne celice ubijalke (NK), čeprav se je število celic naravnih ubijalk in celic CD4 relativno manj zvečalo glede na ostale vrste celic.
English: Patients with active tuberculosis and other severe infections.
Slovenian: Bolniki z aktivno tuberkulozo ali drugimi hudimi okužbami.
English: The most frequent serious infections were pneumonia, cellulitis, infections not otherwise specified and sepsis.
Slovenian: Najpogostejše hude okužbe so bile pljučnica, celulitis, druge sicer nespecificirane okužbe in sepsa.
English: Efalizumab is a monoclonal antibody.
Slovenian: Efalizumab je monoklonalno protitelo.
English: Pharmacotherapeutic group: selective immunosuppressive agents, ATC code: L04AA21
Slovenian: Farmakoterapevtska skupina: zdravila za selektivno zaviranje imunske odzivnosti, Oznaka ATC: L04AA21
English: Tend at steady state is 25 days (range 13-35 days).
Slovenian: Tkon v stanju dinamičnega ravnovesja je 25 dni (razpon 13-35 dni).
English: He/she will calculate the correct dosage based on your new weight.
Slovenian: Zdravnik bo izračunal pravilen odmerek zdravila na podlagi vaše nove telesne mase.
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Ne uporabite dvojnega odmerka, da bi nadomestili izpuščeni odmerek.
English: Aseptic meningitis*, Severe infections*, JC virus infection resulting in progressive multifocal leukoencephalopathy*
Slovenian: Aseptični meningitis* Hude okužbe* JC virusna okužba, ki se kaže kot progresivna multifokalna levkoencefalopatija*
English: Therefore, combination therapies with these products are not recommended (see section 4.5).
Slovenian: Zato sočasno zdravljenje s temi zdravili ni priporočljivo (glejte poglavje 4.5).
English: In the cases occurring during treatment, most of these events (16/22) occurred in patients presenting no response to Raptiva.
Slovenian: V primerih pojava med zdravljenjem, je večina teh dogodkov (16/22) nastopila pri bolnikih, ki niso pokazali odziva na zdravljenje z Raptivo.
English: No differences in safety or efficacy were observed between elderly (≥ 65 years) patients and younger patients.
Slovenian: Posebne skupine bolnikov Med starejšimi (≥ 65 let) bolniki in mlajšimi bolniki niso opazili nobenih razlik v varnosti in učinkovitosti.
English: The same results were confirmed in patients that were unsuitable for other systemic therapies (see Table 1 below).
Slovenian: Isti rezultat je bil potrjen pri bolnikih, ki so bili neprimerni za druge sistemske terapije (glejte spodaj
English: After initiation of therapy, these reactions were generally less frequent and occurred at similar rates to that seen in the placebo group from the third and subsequent weekly injections.
Slovenian: Po začetku zdravljenja, so bile te reakcije na splošno manj pogoste in so se pojavljale v podobnem deležu kot pri skupini, ki je prejemala placebo, po tretji in nadaljnih tedenskih injekcijah.
English: • Dispose of all used items: Once you have finished your injection, immediately discard all needles and empty glass containers in a sharps container.
Slovenian: • Odstranite vse uporabljene predmete: Ko ste zaključili z injiciranjem, takoj odstranite vse igle in prazne steklene vsebnike v posodo za ostre predmete.
English: Hypersensitivity and allergic disorders:
Slovenian: Preobčutljivost in alergijske bolezni:
English: After proper training in the reconstitution and injection technique, patients may self-inject with Raptiva, if their physician determines that this is appropriate.
Slovenian: Po ustreznem šolanju o pripravi raztopine in tehniki injiciranja, si lahko bolniki sami injicirajo Raptivo, če njihov zdravnik določi, da je to primerno.
English: Immune mediated haemolytic anaemia*
Slovenian: Imunsko posredovana hemolitična anemija*
English: Other studies: p-values compared each efalizumab group with placebo using Fisher's exact test within each study.
Slovenian: Druge študije: p-vrednosti primerjave vsake skupine z efalizumabom s placebom z uporabo Fisherjevega testa natančnosti znotraj vsake študije.
English: All values were between 2.5 fold and 3.5 fold the ULN (Upper Limit of Normal).
Slovenian: Vse vrednosti so bile med 2,5 kratnimi do 3,5 kratnimi vrednostmi zgornje normalne meje (ULN - »Upper Limit of Normal«).
English: Headache was the most frequent of the flu-like symptoms.
Slovenian: Glavobol je bil najpogostejši med gripi podobnimi simptomi.
English: If any of these symptoms are severe or persist, you should contact your doctor.
Slovenian: Če je katerikoli od teh simptomov hud in vztrajen, se morate posvetovati z zdravnikom.
English: It is not yet known whether or not Raptiva can increase the risk of lymphoproliferative disorders or other malignancies in psoriasis patients.
Slovenian: Ni še znano ali lahko Raptiva poveča ali ne tveganje za limfoproliferativne bolezni ali druge maligne bolezni pri bolnikih s psoriazo.
English: In the same population two cases of severe thrombocytopenia (0.6%) of rapid onset were observed (See section 4.4).
Slovenian: V isti populaciji so opazili dva primera hude nenadne trombocitopenije (0,6 %) (glejte poglavje 4.4).
English: Failure on prior systemic therapies is defined as insufficient response (PASI < 50 or PGA less than good), or worsening of disease in patients while on treatment, and who were adequately dosed for a sufficiently long duration to assess response with at least each of the 3 major systemic therapies as
Slovenian: Neuspeh predhodnih sistemskih terapij je opredeljen kot nezadosten odziv (PASI<50 ali PGA manj kot dobro), ali poslabšanje bolezni med zdravljenjem pri bolnikih, ki so prejemali zadostne odmerke v zadosti dolgem časovnem obdobju za oceno odziva z najmanj vsakim od 3 glavnih sistemskih zdravil,
English: Another subject who received 10 mg/kg intravenous dose experienced severe vomiting following administration of efalizumab, which also required hospitalization.
Slovenian: Druga oseba, ki je prejela odmerek 10 mg/kg intravensko, je doživela hudo bruhanje po aplikaciji efalizumaba, kar je prav tako zahtevalo hospitalizacijo.
English: Both occurrences fully resolved without any sequelae.
Slovenian: Oba pojava sta bila razrešena brez vsakih posledic.
English: Another pharmacodynamic marker, consistent with the mechanism of action of efalizumab, was the increase in the absolute counts of circulating leukocytes observed during efalizumab treatment.
Slovenian: Naslednji farmakodinamični marker, konsistenten z mehanizmom delovanja efalizumaba, je bilo povečanje absolutnega števila cirkulirajočih levkocitov, ki so ga opazili med zdravljenjem z efalizumabom.
English: The safety and efficacy of Raptiva in moderate to severe plaque psoriasis patients has been demonstrated in five randomized, double-blind, placebo-controlled trials at the recommended dose (n=1742).
Slovenian: Varnost in učinkovitost Raptive pri bolnikih z zmerno do hudo psoriazo s plaki je bila dokazana v petih naključnih, dvojno slepih, s placebom kontroliranih preskušanjih s priporočenim odmerkom (n=1742).
English: Any unused solution must be
Slovenian: Vso neuporabljeno raztopino morate
English: In case of overdose, it is recommended that the patient be monitored under close medical care and appropriate symptomatic treatment instituted immediately.
Slovenian: V primeru prevelikega odmerjanja je priporočljivo spremljati bolnika pod strogim zdravniškim nadzorom in takoj uvesti ustrezno simptomatsko zdravljenje.
English: Anaphylaxis is a more serious allergic reaction that may involve dizziness, vomiting, low blood pressure, and difficulty with breathing.
Slovenian: Anafilaksija je nevarnejša alergijska reakcija, ki lahko vključuje omotico, bruhanje, nizek krvni tlak in težave z dihanjem.
English: Approximately half of the patients treated for more than 1 year were PASI 75 responders (when all dropouts were considered as non-responders).
Slovenian: Približno polovica bolnikov, ki so se zdravili več kot 1 leto, je bilo PASI 75 odzivnih (če se vse predčasno izpadle bolnike šteje kot neodzivne).
English: What Raptiva is and what it is used for
Slovenian: KAJ JE ZDRAVILO RAPTIVA IN ZA KAJ GA UPORABLJAMO
English: Given the mechanism of action of efalizumab, its effects on the immune system may be potentiated by systemic immunosuppressives commonly used for the treatment of psoriasis (see section 4.4).
Slovenian: Glede na mehanizem delovanja efalizumaba, lahko njegove učinke na imunski sistem potencirajo sistemski imunosupresivi, ki se običajno uporabljajo za zdravljenje psoriaze (glejte poglavje 4.4).
English: Patients must be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML (such as impaired cognition, visual disturbances, hemiparesis, altered mental state or behavioural changes).
Slovenian: Bolnike je potrebno spremljati v rednih časovnih intervalih, da bi lahko ugotovili kakršnekoli nove nevrološke simptome ali znake ali njihovo poslabšanje, ki bi lahko kazali na možnost, da gre za pojav PML (na primer motnje kognitivnih funkcij, motnje vida, hemiparezo, spremenjeno duševno stanje ali vedenjske spremembe).
English: Over long term treatment up to 3 years, a small and gradual decrease in mean platelet counts within the normal range was observed.
Slovenian: Pri dolgotrajnem zdravljenju do 3 let, so opazili majhno in postopno zmanjšanje srednjega števila trombocitov znotraj normalnih vrednosti.
English: Treatment with Raptiva should be initiated by a physician specialised in dermatology.
Slovenian: Zdravljenje z Raptivo mora začeti zdravnik specialist dermatolog.
English: Over long term treatment, the frequency of hypersensitivity-related adverse events did not increase.
Slovenian: Pri dolgotrajnem zdravljenju se pogostnost neželenih dogodkov, povezanih s preobčutljivostjo, ni povečala.
English: Excretion of efalizumab in human milk has not been investigated, however immunoglobulins are expected to be excreted in human milk.
Slovenian: Izločanja efalizumaba v mleko pri človeku niso proučevali, vendar se izločanje imunoglobulinov v mleko pri človeku pričakuje.
English: Inflammatory polyradiculoneuropathy*
Slovenian: Vnetna poliradikulonevropatija*
English: Tell your doctor if you have renal or hepatic impairment.
Slovenian: Povejte zdravniku, če imate okvare ledvic ali jeter.
English: For instructions for use see section 6.6.
Slovenian: Za navodila za uporabo glejte poglavje 6.6.
English: To maintain sterility, Raptiva must be used immediately after first opening and reconstitution.
Slovenian: Za vzdrževanje sterilnosti morate zdravilo Raptiva uporabiti takoj po prvem odprtju ovojnine in rekonstituciji.
English: Placebo 1.0 mg/kg/wk Treatment Effect [95% CI]
Slovenian: Placebo 1,0 mg/kg/teden Učinek zdravljenja [95 % IZ]
English: - If you are allergic (hypersensitive) to efalizumab or any of the other ingredients of Raptiva.
Slovenian: - Če ste alergični na (preobčutljivi za) efalizumab ali katerokoli sestavino zdravila Raptiva.
English: Please check with your doctor if you are planning to receive any vaccine (see “Take special care with
Slovenian: Posvetujte se z zdravnikom, če načrtujete cepljenje (glejte »Bodite posebno pozorni pri uporabi
English: Generally patients with facial paralysis recover within a few weeks without any specific treatment.
Slovenian: Bolniki s paralizo obraznega živca pa običajno okrevajo v nekaj tednih in brez posebnega
English: Limited data are available on the effects of vaccination.
Slovenian: Podatki o vplivu na cepljenje so omejeni.
English: Tell your doctor and discuss with him your general health if you notice any of the following:
Slovenian: Obvestite svojega zdravnika in se pogovorite z njim o vašem splošnem zdravstvenem stanju, če
English: Based on the pharmacological mechanism of action of efalizumab, the use of Raptiva is not expected to affect patient's ability to drive and use machines.
Slovenian: Na podlagi farmakološkega mehanizma delovanja efalizumaba, ni pričakovati, da bi uporaba Raptive vplivala na bolnikovo sposobnost vožnje in upravljanja s stroji.
English: A pneumococcal vaccine administered 6 weeks after discontinuation of Raptiva yielded normal results.
Slovenian: Cepljenje proti pnevmokokom, 6 tednov po prekinitvi uporabe Raptive, je dalo normalne rezultate.
English: You are now ready to select and prepare your injection site.
Slovenian: Sedaj lahko izberete in pripravite mesto, kamor si boste injicirali zdravilo.
English: Re-treatment may be associated with lower or inadequate response to Raptiva than in the earlier treatment periods.
Slovenian: Ponovno zdravljenje je lahko povezano z manjšim ali nezadostnim odzivom na zdravilo Raptiva glede na predhodna obdobja zdravljenja.
English: Efalizumab does not cross-react with CD11a from species other than humans and chimpanzees.
Slovenian: Efalizumab ne reagira navzkrižno s CD11 drugih živalskih vrst, razen s humanimi in šimpanzovimi.
English: In case re-treatment with Raptiva is needed you should follow the guidance of your doctor.
Slovenian: Če je potrebno ponovno zdravljenje z zdravilom Raptiva, morate upoštevati navodila svojega zdravnika.
English: The largest study IMP24011 (n=793) included patients (n=526) who were not controlled by, contraindicated to, or intolerant to two or more systemic therapies as judged from the patients' histories of psoriasis treatment.
Slovenian: Največja študija IMP24011 (n=793) je vključevala bolnike (n=526), ki niso bili pod nadzorom z, niso imeli kontraindikacij za ali niso prenašali dveh ali več sistemskih zdravil, po presoji podatkov o bolnikovem zdravljenju psoriaze v preteklosti.
English: Antibody response to an experimental neo-antigen (∅X174) was reduced during Raptiva therapy, but began to normalize 6 weeks after discontinuation of Raptiva therapy and did not demonstrate tolerance induction.
Slovenian: Med zdravljenjem z Raptivo se je zmanjšal odziv protiteles na eksperimentalni neo-antigen (∅X174), vendar se je začel normalizirati 6 tednov po prekinitvi zdravljenja z Raptivo brez znakov razvoja tolerance.
English: Symptoms that might indicate that you have an infection are fever, wounds, feeling tired, dental problems, a bad cough that lasts longer than 2 weeks, pain in the chest or coughing up blood or sputum.
Slovenian: Znaki, ki lahko kažejo, da imate okužbo so zvišana telesna temperatura, rane, občutek utrujenosti, težave z zobmi, hud prehlad, ki traja dlje kot 2 tedna, bolečine v prsnem košu ali izkašljevanje krvi ali sputuma.
English: It has the potential to increase the risk or the severity of infections, e.g. tuberculous pneumonia, and reactivate latent, chronic infections e.g. JC virus infection.
Slovenian: Poveča lahko tveganje za okužbe ali za resnost okužbe, na primer za tuberkulozno pljučnico in reaktivira latentne, kronične okužbe, na primer JC virusne
English: Analysis following long-term use in a cohort of 339 patients with moderate to severe psoriasis receiving Raptiva 1 mg/kg/week, of which 166 patients have been treated for more than 2 years and up to 3 years, did not show any noteworthy differences in frequency of adverse events as compared to 12 weeks of exposure to Raptiva.
Slovenian: Analiza dolgotrajne uporabe v kohortni skupini 339 bolnikov z zmerno do hudo psoriazo, ki so prejemali Raptivo v odmerku 1 mg/kg/teden, od katerih se je 166 bolnikov zdravilo najmanj 2 leti in do 3 let, ni pokazala nobenih omembe vrednih razlik v pogostnosti neželenih dogodkov v primerjavi z 12 tedensko izpostavljenostjo Raptivi.
English: These symptoms diminished thereafter to a percentage comparable to that of patients treated with placebo.
Slovenian: V nadaljevanju so se ti simptomi zmanjšali na delež, ki je primerljiv z deležem pri bolnikih, ki so prejemali placebo.
English: Overall less than 1% of patients discontinued therapy because of acute flu-like symptoms.
Slovenian: Skupno je manj kot 1 % bolnikov prekinil zdravljenje zaradi gripi podobnih
English: This will expose a plastic spiked end that you will use to pierce the vial.
Slovenian: Pokazala se bo plastična konica, s katero prebodete
English: If blood comes into the syringe, the needle has entered a blood vessel.
Slovenian: Če se v injekcijski brizgi pojavi kri, je igla prodrla v krvno žilo.
English: There is no known antidote to Raptiva or any specific treatment for Raptiva overdose other than withholding treatment and patient observation.
Slovenian: Ni znanega antidota za Raptivo ali specifičnega zdravljenja prevelikega odmerjanja Raptive, razen ukinitve terapije in opazovanja bolnika.
English: Long-term exposure:
Slovenian: Dolgotrajna izpostavljenost
English: c) Malignancies and lymphoproliferative disorders
Slovenian: c) Maligne in limfoproliferativne bolezni
English: Wipe the top of the vial with an alcohol swab.
Slovenian: Obrišite vrh viale z alkoholno blazinico.
English: In a clinical study, where subjects were exposed to higher doses of efalizumab (up to 10 mg/kg intravenous), one subject receiving 3 mg/kg intravenous dose experienced hypertension, chills, and fever on the day of study drug dosing, which required hospitalization.
Slovenian: V klinični študiji, kjer so bili posamezniki izpostavljeni višjim odmerkom efalizumaba (do 10 mg/kg intravensko), je ena oseba, ki je prejela 3 mg/kg intravensko, doživela hipertenzijo, mrazenje in vročino na dan odmerjanja preizkušanega zdravila, kar je zahtevalo hospitalizacijo.
English: Among 3291 patients in the combined safety database, 39 patients presented an erythrodermic or pustular psoriasis (1.2%).
Slovenian: Med 3.291 bolniki v skupni podatkovni bazi, je 39 bolnikov razvilo eritrodermično ali pustulozno psoriazo (1,2 %).
English: In this small number of patients no differences were observed in pharmacokinetics, pharmacodynamics, clinically noteworthy adverse events or clinical efficacy.
Slovenian: Pri tem majhnem številu bolnikov niso opazili nobenih razlik v farmakokinetiki, farmakodinamiki, kliničnih omembe vrednih neželenih dogodkih ali klinični učinkovitosti.
English: Therapy should be continued only when adequate response is observed.
Slovenian: Zdravljenje se lahko nadaljuje samo, če je viden zadosten odziv.
English: There was no evidence of an increased risk of any particular malignancy over time with the exception of non-melanoma skin cancer (0.3 vs. 0.9 per 100 patient-years, short term and long term treatment,
Slovenian: Ni bilo dokazov, da se sčasoma poveča tveganje za katerokoli določeno vrsto malignosti, z izjemo nemelanomskega kožnega raka (0,3 proti 0,9 na 100 bolnikov-let, pri kratkotrajnem oziroma dolgotrajnem zdravljenju) (glejte poglavje 4.4).
English: Interstitial pneumonitis*
Slovenian: Intersticijska pljučnica*
English: If you develop a new infection or notice any new or sudden change in thinking, balance, strength, talking, walking or vision, please contact your doctor.
Slovenian: Če razvijete novo okužbo ali opazite novo ali nenadno spremembo mišljenja, ravnotežja, moči, govora, hoje ali vida, se prosimo posvetujte z zdravnikom.
English: Raptiva is a selective immunosuppressor that alters T-lymphocyte function and may affect host defences against infections.
Slovenian: Raptiva je selektivni zaviralec imunske odzivnosti, ki spremeni delovanje limfocitov T in lahko prizadene obrambo gostitelja proti okužbam.
English: - If you discontinue Raptiva treatment (and this applies especially to patients not responding to treatment) your psoriasis may significantly worsen.
Slovenian: - Če prekinete zdravljenje z Raptivo (in to še posebej velja za bolnike, ki se ne odzivajo na zdravljenje), se lahko vaša psoriaza pomembno poslabša.
English: HOW TO USE RAPTIVA
Slovenian: KAKO UPORABLJATI ZDRAVILO RAPTIVA