natgillin/translations-raw huggingface dataset:
Prompt medical care is needed since serious allergic reactions may be potentially life-threatening.
Takoj je potrebna nujna zdravniška pomoč, ker so lahko hude alergijske reakcije potencialno življenje ogrožajoče.
Some foam or bubbles may remain in the vial.
Nekaj pene in mehurčkov lahko ostane v viali.
Gradual reduction of dose or frequency does not appear to be beneficial.
Postopno zmanjševanje odmerka ali pogostnosti odmerkov ni kazalo koristi.
Additional Information
DODATNE INFORMACIJE
Data from extended treatment (more than 12 weeks) have been obtained from 4311 patients in open label uncontrolled studies.
Podatke o dolgotrajnem zdravljenju (več kot 12 tednov) so pridobili na 4311 bolnikih iz odprtih nekontroliranih študij.
After reconstitution, an immediate use is recommended (see also section 6.4).
Po rekonstituciji priporočamo takojšnjo uporabo (glejte tudi poglavje 6.4).
b) Vaccinations
b) Cepljenje
Therefore, conventional non-clinical safety data with the medicinal product are limited and do not allow for a comprehensive safety assessment.
Zato so običajni predklinični podatki o varnosti z zdravilom omejeni in ne omogočajo obsežne ocene varnosti.
These symptoms are very common and occur most often after the first two doses and decrease with continued use.
Ti simptomi so zelo pogosti in se najpogosteje pojavijo po prvih dveh odmerkih ter se zmanjšajo z nadaljno uporabo.
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.
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.
Do not inject but withdraw the needle and repeat the injection procedure.
Ne injicirajte, ampak izvlecite iglo in ponovite postopek injiciranja.
(See section 4.4).
(Glejte poglavje 4.4).
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- You might get infections more easily.
Lahko boste bolj dovzetni za okužbe.
Therapy may be continued only in patients who responded to treatment (PGA good or better).
Zdravljenje se lahko nadaljuje samo pri bolnikih, ki so se odzvali na zdravljenje (PGA dober ali boljši).
Please contact your doctor if you forget to take 2 or more doses of Raptiva.
Prosimo posvetujte se z zdravnikom, če ste pozabili vzeti 2 ali več odmerkov zdravila Raptiva.
If you notice that any of these reactions do not vanish after the second injection, tell your doctor.
Če opazite, da katerakoli od teh reakcij ne izgine po drugi injekciji, o tem obvestite svojega
- Some patients had reactions including headache, fever, nausea and vomiting within two days of each of the first two injections.
- Nekateri bolniki so imeli reakcije, vključno z glavobolom, vročino, slabostjo in bruhanjem v roku dveh dni, po vsaki od prvih dveh injekcij.
- If you have active tuberculosis or other severe infections.
- Če imate aktivno tuberkulozo ali druge hude okužbe.
Therapy may be continued only in patients who responded to treatment, your doctor will discuss with you the extent of your response to treatment.
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.
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.
Ni znano ali lahko zdravilo Raptiva škoduje otroku, če ste noseči in ali lahko vpliva na vašo zmožnost zanositve.
Raptiva is a medicine containing efalizumab, made by means of biotechnology.
Raptiva je zdravilo, ki vsebuje efalizumab, izdelan s pomočjo biotehnologije.
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.
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.
It is recommended that you are monitored for any signs or symptoms of adverse effects and that you are given appropriate symptomatic treatment immediately.
Priporočljivo je, da vas opazujejo na kakršnekoli znake ali simptome neželenih učinkov in vas takoj ustrezno simptomatsko zdravijo.
Four of these patients had clinical signs of thrombocytopenia.
Štirje izmed teh bolnikov so imeli klinične znake trombocitopenije.
If you eject too much Raptiva back into the vial, simply repeat the drawing up process and continue.
Če izstisnete preveč raztopine Raptiva nazaj v vialo, preprosto ponovno povlecite raztopino nazaj in nadaljujte.
The side effects in this section are given with an estimation of the frequency with which they may occur.
Neželeni učinki v tem poglavju so navedeni skupaj z oceno pogostnosti s katero se lahko pojavijo.
There are no adequate data from the use of efalizumab in pregnant women.
Ni zadostnih podatkov o uporabi efalizumaba pri nosečnicah.
Physico-chemical stability of the reconstituted product has been shown for 24 hours at 2°C to 8°C.
Potrjena fizikalnokemijska stabilnost rekonstituiranega zdravila je 24 ur pri temperaturi med 2°C in 8°C.
Your doctor or nurse will have already advised you where to inject.
Vaš zdravnik ali medicinska sestra sta vas že poučila, kam si injicirati zdravilo.
Monoclonal antibodies are proteins that recognise and bind to other specific proteins of the human body.
Monoklonalna protitelesa so beljakovine, ki prepoznajo in se vežejo za druge specifične beljakovine v človeškem telesu.
The percentage of patients reporting flu-like symptoms was greatest with the first injection and decreased by more than 50% with the second injection.
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.
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.
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.
• Shortness of breath or any persistent respiratory difficulties.
- Kratko sapo ali kakršne koli vztrajne težave z dihanjem.
Detailed instructions for use are provided in the package leaflet.
Natančna navodila za uporabo so v priloženem navodilu za uporabo.
Do not use if you notice that the solution is not clear or contains particles.
Ne uporabljajte zdravila, če ste opazili, da raztopina ni bistra ali vsebuje delce.
The pH of the reconstituted solution is 5.9 - 6.5.
pH rekonstituirane raztopine je 5,9 do 6,5.
- If you have been diagnosed as having a disorder of your immune system.
- Če so ugotovili, da imate motnje imunskega sistema.
• Fever or if you think that you have an infection.
- Zvišano telesno temperaturo ali, če menite, da imate okužbo.
Women of childbearing potential have to use appropriate contraception during treatment.
Ženske v rodni dobi morajo med zdravljenjem uporabljati ustrezno kontracepcijo.
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).
Pogostejše določanje je priporočljivo na začetku zdravljenja (npr. enkrat mesečno) in je lahko v nadaljevanju zdravljenja manj pogosto (npr. vsake 3 mesece).
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.
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.
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).
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).
It may be necessary to discontinue Raptiva treatment 8 weeks before a vaccination.
Morda bo potrebno da prekinete zdravljenje z zdravilom Raptiva 8 tednov pred cepljenjem.
These symptoms are uncommon.
Ti simptomi so občasni.
No teratogenic effects were seen in mice during organogenesis.
Nobenih teratogenih učinkov niso opazili pri miših med organogenezo.
Doses up to 4 mg/kg/week subcutaneously for 10 weeks have been administered without any toxic effect.
Odmerke do 4 mg/kg/teden subkutano, 10 tednov, so uporabljali brez vsakih toksičnih učinkov.
The expected degradation products are small peptides and individual amino acids which are eliminated by glomerular filtration.
Pričakovani produkti razgradnje so majhni peptidi in posamezne aminokisline, ki se izločijo z glomerularno filtracijo.
12 EasyMIX adapters for reconstitution.
12 adapterjev EasyMIX za rekonstitucijo.
- If you have forms of psoriasis other than plaque psoriasis (for instance other more severe forms of psoriasis, as diagnosed by your doctor).
- Če imate druge oblike psoriaze kot je psoriaza s plaki (na primer druge težje oblike psoriaze, ki jih je ugotovil vaš zdravnik).
A higher rate of malignancies has been associated with therapies affecting the immune system.
Večji delež malignih obolenj povezujejo z zdravljenji, ki vplivajo na imunski sistem.
The full effect was seen 24 to 48 hours after the first dose, and was maintained between weekly doses.
Popolni učinek je bil dosežen 24 do 48 ur po prvem odmerku in se je ohranjal med tedenskimi odmerki.
The use of Raptiva may be associated with an increased risk of Progressive Multifocal Leukoencephalopathy (PML).
Uporaba zdravila Raptiva je lahko povezana z večjim tveganjem za pojav progresivne multifokalne levkoencefalopatije (PML).
As there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.
Ker je pri starejših bolnikih na splošno večja incidenca okužb, je pri zdravljenju starejših potrebna previdnost.
Elevation of ALT:
Dvig ravni ALT:
In this small number of patients no differences were observed in either pharmacodynamic or pharmacokinetic parameters.
Pri tem majhnem številu bolnikov niso opazili nobenih razlik bodisi v farmakodinamičnih ali farmakokinetičnih parametrih.
Therefore, if you are pregnant, consult with your doctor
Zato se, če ste noseči, takoj posvetujte z zdravnikom.
From a microbiological point of view, the product should be used immediately after first opening and reconstitution.
Z mikrobiološkega stališča morate zdravilo uporabiti takoj po prvem odprtju ovojnine in rekonstituciji.
Raptiva should be used with caution in this patient population.
Raptivo je treba uporabljati previdno pri tej skupini bolnikov.
Systemic therapies are medicines taken orally or administered by injection and thus will be present in and affect the whole body.
Zdravila za sistemsko zdravljenje se jemljejo peroralno ali dajejo v obliki injekcij in so zato prisotna v celem telesu in vplivajo na celo telo.
Seventeen of these events occurred after discontinuation of Raptiva, while 22 occurred during treatment.
Sedemanjst od teh dogodkov se je pojavilo po prekinitvi uporabe Raptive, medtem ko jih je 22 nastopilo med samim zdravljenjem.
- If you experience a worsening of your psoriasis or you develop arthritis, please inform your doctor.
- Če nastopi poslabšanje psoriaze ali razvijete artritis, se prosimo posvetujte s svojim zdravnikom.
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.
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.
Patients with active tuberculosis and other severe infections.
Bolniki z aktivno tuberkulozo ali drugimi hudimi okužbami.
The most frequent serious infections were pneumonia, cellulitis, infections not otherwise specified and sepsis.
Najpogostejše hude okužbe so bile pljučnica, celulitis, druge sicer nespecificirane okužbe in sepsa.
Efalizumab is a monoclonal antibody.
Efalizumab je monoklonalno protitelo.
Pharmacotherapeutic group: selective immunosuppressive agents, ATC code: L04AA21
Farmakoterapevtska skupina: zdravila za selektivno zaviranje imunske odzivnosti, Oznaka ATC: L04AA21
Tend at steady state is 25 days (range 13-35 days).
Tkon v stanju dinamičnega ravnovesja je 25 dni (razpon 13-35 dni).
He/she will calculate the correct dosage based on your new weight.
Zdravnik bo izračunal pravilen odmerek zdravila na podlagi vaše nove telesne mase.
Do not take a double dose to make up for a forgotten dose.
Ne uporabite dvojnega odmerka, da bi nadomestili izpuščeni odmerek.
Aseptic meningitis*, Severe infections*, JC virus infection resulting in progressive multifocal leukoencephalopathy*
Aseptični meningitis* Hude okužbe* JC virusna okužba, ki se kaže kot progresivna multifokalna levkoencefalopatija*
Therefore, combination therapies with these products are not recommended (see section 4.5).
Zato sočasno zdravljenje s temi zdravili ni priporočljivo (glejte poglavje 4.5).
In the cases occurring during treatment, most of these events (16/22) occurred in patients presenting no response to Raptiva.
V primerih pojava med zdravljenjem, je večina teh dogodkov (16/22) nastopila pri bolnikih, ki niso pokazali odziva na zdravljenje z Raptivo.
No differences in safety or efficacy were observed between elderly (≥ 65 years) patients and younger patients.
Posebne skupine bolnikov Med starejšimi (≥ 65 let) bolniki in mlajšimi bolniki niso opazili nobenih razlik v varnosti in učinkovitosti.
The same results were confirmed in patients that were unsuitable for other systemic therapies (see Table 1 below).
Isti rezultat je bil potrjen pri bolnikih, ki so bili neprimerni za druge sistemske terapije (glejte spodaj
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.
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.
• Dispose of all used items: Once you have finished your injection, immediately discard all needles and empty glass containers in a sharps container.
• Odstranite vse uporabljene predmete: Ko ste zaključili z injiciranjem, takoj odstranite vse igle in prazne steklene vsebnike v posodo za ostre predmete.
Hypersensitivity and allergic disorders:
Preobčutljivost in alergijske bolezni:
After proper training in the reconstitution and injection technique, patients may self-inject with Raptiva, if their physician determines that this is appropriate.
Po ustreznem šolanju o pripravi raztopine in tehniki injiciranja, si lahko bolniki sami injicirajo Raptivo, če njihov zdravnik določi, da je to primerno.
Immune mediated haemolytic anaemia*
Imunsko posredovana hemolitična anemija*
Other studies: p-values compared each efalizumab group with placebo using Fisher's exact test within each study.
Druge študije: p-vrednosti primerjave vsake skupine z efalizumabom s placebom z uporabo Fisherjevega testa natančnosti znotraj vsake študije.
All values were between 2.5 fold and 3.5 fold the ULN (Upper Limit of Normal).
Vse vrednosti so bile med 2,5 kratnimi do 3,5 kratnimi vrednostmi zgornje normalne meje (ULN - »Upper Limit of Normal«).
Headache was the most frequent of the flu-like symptoms.
Glavobol je bil najpogostejši med gripi podobnimi simptomi.
If any of these symptoms are severe or persist, you should contact your doctor.
Če je katerikoli od teh simptomov hud in vztrajen, se morate posvetovati z zdravnikom.
It is not yet known whether or not Raptiva can increase the risk of lymphoproliferative disorders or other malignancies in psoriasis patients.
Ni še znano ali lahko Raptiva poveča ali ne tveganje za limfoproliferativne bolezni ali druge maligne bolezni pri bolnikih s psoriazo.
In the same population two cases of severe thrombocytopenia (0.6%) of rapid onset were observed (See section 4.4).
V isti populaciji so opazili dva primera hude nenadne trombocitopenije (0,6 %) (glejte poglavje 4.4).
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
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,
Another subject who received 10 mg/kg intravenous dose experienced severe vomiting following administration of efalizumab, which also required hospitalization.
Druga oseba, ki je prejela odmerek 10 mg/kg intravensko, je doživela hudo bruhanje po aplikaciji efalizumaba, kar je prav tako zahtevalo hospitalizacijo.
Both occurrences fully resolved without any sequelae.
Oba pojava sta bila razrešena brez vsakih posledic.
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.
Naslednji farmakodinamični marker, konsistenten z mehanizmom delovanja efalizumaba, je bilo povečanje absolutnega števila cirkulirajočih levkocitov, ki so ga opazili med zdravljenjem z efalizumabom.
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).
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).
Any unused solution must be
Vso neuporabljeno raztopino morate
In case of overdose, it is recommended that the patient be monitored under close medical care and appropriate symptomatic treatment instituted immediately.
V primeru prevelikega odmerjanja je priporočljivo spremljati bolnika pod strogim zdravniškim nadzorom in takoj uvesti ustrezno simptomatsko zdravljenje.
Anaphylaxis is a more serious allergic reaction that may involve dizziness, vomiting, low blood pressure, and difficulty with breathing.
Anafilaksija je nevarnejša alergijska reakcija, ki lahko vključuje omotico, bruhanje, nizek krvni tlak in težave z dihanjem.
Approximately half of the patients treated for more than 1 year were PASI 75 responders (when all dropouts were considered as non-responders).
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).
What Raptiva is and what it is used for
KAJ JE ZDRAVILO RAPTIVA IN ZA KAJ GA UPORABLJAMO
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).
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).
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).
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).
Over long term treatment up to 3 years, a small and gradual decrease in mean platelet counts within the normal range was observed.
Pri dolgotrajnem zdravljenju do 3 let, so opazili majhno in postopno zmanjšanje srednjega števila trombocitov znotraj normalnih vrednosti.
Treatment with Raptiva should be initiated by a physician specialised in dermatology.
Zdravljenje z Raptivo mora začeti zdravnik specialist dermatolog.
Over long term treatment, the frequency of hypersensitivity-related adverse events did not increase.
Pri dolgotrajnem zdravljenju se pogostnost neželenih dogodkov, povezanih s preobčutljivostjo, ni povečala.
Excretion of efalizumab in human milk has not been investigated, however immunoglobulins are expected to be excreted in human milk.
Izločanja efalizumaba v mleko pri človeku niso proučevali, vendar se izločanje imunoglobulinov v mleko pri človeku pričakuje.
Inflammatory polyradiculoneuropathy*
Vnetna poliradikulonevropatija*
Tell your doctor if you have renal or hepatic impairment.
Povejte zdravniku, če imate okvare ledvic ali jeter.
For instructions for use see section 6.6.
Za navodila za uporabo glejte poglavje 6.6.
To maintain sterility, Raptiva must be used immediately after first opening and reconstitution.
Za vzdrževanje sterilnosti morate zdravilo Raptiva uporabiti takoj po prvem odprtju ovojnine in rekonstituciji.
Placebo 1.0 mg/kg/wk Treatment Effect [95% CI]
Placebo 1,0 mg/kg/teden Učinek zdravljenja [95 % IZ]
- If you are allergic (hypersensitive) to efalizumab or any of the other ingredients of Raptiva.
- Če ste alergični na (preobčutljivi za) efalizumab ali katerokoli sestavino zdravila Raptiva.
Please check with your doctor if you are planning to receive any vaccine (see “Take special care with
Posvetujte se z zdravnikom, če načrtujete cepljenje (glejte »Bodite posebno pozorni pri uporabi
Generally patients with facial paralysis recover within a few weeks without any specific treatment.
Bolniki s paralizo obraznega živca pa običajno okrevajo v nekaj tednih in brez posebnega
Limited data are available on the effects of vaccination.
Podatki o vplivu na cepljenje so omejeni.
Tell your doctor and discuss with him your general health if you notice any of the following:
Obvestite svojega zdravnika in se pogovorite z njim o vašem splošnem zdravstvenem stanju, če
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.
Na podlagi farmakološkega mehanizma delovanja efalizumaba, ni pričakovati, da bi uporaba Raptive vplivala na bolnikovo sposobnost vožnje in upravljanja s stroji.
A pneumococcal vaccine administered 6 weeks after discontinuation of Raptiva yielded normal results.
Cepljenje proti pnevmokokom, 6 tednov po prekinitvi uporabe Raptive, je dalo normalne rezultate.
You are now ready to select and prepare your injection site.
Sedaj lahko izberete in pripravite mesto, kamor si boste injicirali zdravilo.
Re-treatment may be associated with lower or inadequate response to Raptiva than in the earlier treatment periods.
Ponovno zdravljenje je lahko povezano z manjšim ali nezadostnim odzivom na zdravilo Raptiva glede na predhodna obdobja zdravljenja.
Efalizumab does not cross-react with CD11a from species other than humans and chimpanzees.
Efalizumab ne reagira navzkrižno s CD11 drugih živalskih vrst, razen s humanimi in šimpanzovimi.
In case re-treatment with Raptiva is needed you should follow the guidance of your doctor.
Če je potrebno ponovno zdravljenje z zdravilom Raptiva, morate upoštevati navodila svojega zdravnika.