natgillin/translations-raw huggingface dataset:
No clastogenic or mutagenic effects of natalizumab were observed in the Ames or human chromosomal aberration assays.
Klastogeni ali mutageni učinek natalizumaba pri Amesovem preskusu ali v metodi človeške kromosomske aberacije ni bil ugotovljen.
Physicians must evaluate each individual case to determine whether there is evidence of an immunocompromised state prior to commencing treatment with TYSABRI (see section 4.3).
Zdravnik mora oceniti vsak posamični primer, da ugotovi znake poslabšanja imunske odzivnosti, preden se začne zdravljenje z zdravilom TYSABRI (glejte poglavje 4.3).
The Marketing Authorisation Holder must, following discussions and agreement with the National Competent Authorities in each Member State where TYSABRI is marketed, ensure that all physicians who intend to prescribe TYSABRI are provided with a physician pack containing the following elements:
Imetnik dovoljenja za promet z zdravilom mora, po dogovoru in soglasju s pristojnimi organi v vsaki državi članici, v kateri se trži zdravilo TYSABRI, zagotoviti, da bodo vsi zdravniki, ki bodo predpisovali zdravilo TYSABRI, dobili informacije, ki bodo vključevale naslednje elemente: • Povzetek glavnih značilnosti zdravila in Navodilo za uporabo
If an opportunistic infection is suspected, dosing with TYSABRI is to be suspended until such infections can be excluded through further evaluations.
Pri sumu na oportunistično okužbo je treba zdravljenje z zdravilom TYSABRI prekiniti, dokler okužbe ni mogoče dejansko izključiti z nadaljnjim vrednotenjem.
Hypersensitivity reactions usually occurred during the infusion or within the 1-hour period after the completion of the infusion (See section 4.4).
Preobčutljivostne reakcije so se običajno pojavile med infundiranjem ali do 1 uro po zaključenem infundiranju (glejte poglavje 4.4).
Age yrs, median (range) MS-history yrs, median (range) Time since diagnosis, yrs median (range)
Starost v letih, mediana (razpon) Zgodovina obolelosti za MS v letih, mediana (razpon)
A further mechanism of action of natalizumab may be to suppress ongoing inflammatory reactions in diseased tissues by inhibiting the interaction of α4-expressing leukocytes with their ligands in the extracellular matrix and on parenchymal cells.
Nadaljnji mehanizem delovanja natalizumaba je lahko zaviranje tekoče vnetne reakcije v obolelem tkivu s preprečevanjem interakcije levkocitov z izraženimi α4 integrini, z njihovimi ligandi v ekstracelularnem prostoru in na parenhimskih celicah.
If not used immediately, the diluted solution must be stored at 2˚C - 8˚C and infused within 8 hours of dilution.
Razredčeno raztopino, ki je ne porabite takoj, morate hraniti na 2 ˚C do 8 ˚C in infundirati v roku 8 ur po razredčitvi.
Proportion progressed1(12-week confirmation; primary outcome)
12 tednih; primarni izid)
Patients who are anti-JCV antibody positive are at an increased risk of developing PML compared to patients who are anti-JCV antibody negative.
Pri bolnikih, ki so pozitivni na protitelesa proti JCV, je tveganje za razvoj PML večje v primerjavi z bolniki, ki so negativni za protitelesa proti JCV.
Anti-JCV antibody negative patients may still be at risk of PML for reasons such as a new JCV infection, fluctuating antibody status or a false negative test result.
Pri bolnikih, ki so negativni na protitelesa proti JCV, še vedno obstaja tveganje za PML zaradi nove okužbe z JCV, stanja nihanja protiteles ali lažno negativnega rezultata testa.
Natalizumab is a recombinant humanised anti-α4-integrin antibody produced in a murine cell line by recombinant DNA technology.
Natalizumab je rekombinantno humanizirano anti-α4-integrin protitelo, proizvedeno na celični liniji miši in podgan z uporabo tehnologije rekombinantne DNA.
In patients with PML a reaction known as IRIS (Immune Reconstitution Inflammatory Syndrome) is likely to occur after treatment for PML, as TYSABRI is removed from your body.
Pri bolnikih s PML obstaja možnost, da se po zdravljenju PML pojavi reakcija, imenovana IRIS (vnetni sindrom imunske obnove), ker se zdravilo TYSABRI odstrani iz telesa.
PML should be considered as a differential diagnosis in any MS patient taking TYSABRI presenting with neurological symptoms and/or new brain lesions in MRI.
Pri diferencialni diagnozi je treba na PML pomisliti pri vseh bolnikih z MS, ki jemljejo zdravilo TYSABRI in pri katerih so prisotni nevrološki simptomi in/ali nove lezije na možganih na MRS.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
The duration of treatment with TYSABRI prior to onset ranged from a few months to several years (see section 4.4).
TYSABRI pred začetkom bolezni je trajalo od nekaj mesecev do več let (glejte poglavje 4.4).
The safety and efficacy of TYSABRI in combination with other immunosuppressive and antineoplastic therapies have not been fully established.
Sočasno ali predhodno zdravljenje z zaviralci imunskega odziva Varnost in učinkovitost zdravila TYSABRI v kombinaciji z drugimi zaviralci imunskega odziva in antineoplastičnimi zdravili ni bila povsem ugotovljena.
A study in pregnant cynomolgus monkeys demonstrated natalizumab-related changes in the foetus that included mild anaemia, reduced platelet counts, increased spleen weights and reduced liver and thymus weights.
Študija na brejih opicah cynomolgus je na plodu pokazala spremembe, povezane z natalizumabom, ki so vključevale blago anemijo, zmanjšano število trombocitov, povečano maso vranice in zmanjšano maso jeter in priželjca.
Symptoms of JCV GCN are similar to symptoms of PML (i.e. cerebellar syndrome).
Simptomi JCV GCN so podobni simptomom PML (tj. cerebelarni sindrom).
The highest incidence of adverse reactions identified from placebo-controlled trials in multiple sclerosis patients with natalizumab given at the recommended dose, are reported as dizziness, nausea, urticaria and rigors associated with infusions.
Neželeni učinki, ki so jo ugotovili v preskušanjih, kontroliranih s placebom, pri bolnikih z multiplo sklerozo, ki so prejemali priporočeni odmerek natalizumaba, o katerih so poročali z največjo incidenco, so bili omotica, navzea, urtikarija in rigor, povezan z infuzijami.
However, in the presence of pro-inflammatory cytokines, VCAM-1 is upregulated on endothelial cells and possibly on glial cells near the sites of inflammation.
Vendar pa se lahko v prisotnosti provnetnih citokinov poveča število VCAM-1 molekul na endotelijskih celicah, morda pa tudi na celicah glie blizu vnetnih žarišč.
Immunosuppressant treatment prior to the use of TYSABRI
Zdravljenje z imunosupresivi pred začetkom uporabe zdravila TYSABRI
Re-testing of anti-JCV antibody negative patients every 6 months is recommended.
Vsakih 6 mesecev se priporoča ponovno testiranje bolnikov, ki so negativni na protitelesa proti JCV.
For medicinal products such as interferon and glatiramer acetate, concomitant exposure of this duration was not associated with safety risks in clinical trials.
V kliničnih preskušanjih sočasna izpostavljenost zdravilom, kot sta interferon in glatiramer acetat, v tem času ni pokazala povezave s tveganjem za varnost.
PML has been reported following discontinuation of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation.
Po prekinitvi uporabe zdravila TYSABRI so pri bolnikih, ki niso imeli izvidov, ki bi ob času prekinitve kazali na PML, poročali o PML.
Instructions for use:
NAVODILA ZA UPORABO
TYSABRI stops the cells that cause inflammation from going into your brain.
Zdravilo TYSABRI celicam, ki povzročajo vnetje, preprečuje vstop v možgane.
• Yellowing of your skin or the whites of your eyes
• porumenelost kože ali beločnice
During treatment with TYSABRI, small reductions in haemoglobin (mean decrease 0.6 g/dl), haematocrit (mean decrease 2%) and red blood cell counts (mean decrease 0.1 x 106/l) were seen.
Med zdravljenjem z zdravilom TYSABRI je bilo opaženo majhno zmanjšanje hemoglobina (povprečno zmanjšanje 0,6 g/dl), hematokrita (povprečno zmanjšanje 2 %) in števila eritrocitov (povprečno zmanjšanje 0,1 x 106/l).
Reductions in female guinea pig fertility were observed in one study at doses in excess of the human dose; natalizumab did not affect male fertility.
Zmanjšanje plodnosti pri samicah budre so opazili v eni študiji z odmerki, ki so presegali odmerek pri človeku; natalizumab ni vplival na plodnost pri samcih.
In Phase 3 MS clinical trials, concomitant treatment of relapses with a short course of corticosteroids was not associated with an increased rate of infection.
V fazi 3 kliničnih preskušanj MS ni bila ugotovljena povečana stopnja okužb pri sočasnem zdravljenju recidivov s kratkoročnim dajanjem kortikosteroidov s povečano stopnjo okužb.
See package leaflet for further information.
Glejte navodilo za uporabo za več informacij.
Short courses of corticosteroids can be used in combination with TYSABRI.
Kratkoročno dajanje kortikosteroidov v kombinaciji z zdravilom TYSABRI je dovoljeno.
No data are available in MS patients regarding concomitant exposure with immunosuppressant medication.
bolnike ni podatkov v zvezi s sočasno izpostavljenostjo zdravilom, ki zavirajo imunski odziv.
Monitoring for development of IRIS, which has occurred within days to several weeks after plasma exchange in TYSABRI treated patients with PML, and appropriate treatment of the associated inflammation during recovery from PML should be undertaken (see the Physician Information and Management Guidelines for further information).
Pri bolnikih s PML, ki so se zdravili z zdravilom TYSABRI, je treba uvesti nadzor za razvoj IRIS (pojavi se v nekaj dneh do nekaj tednih po zamenjavi plazme) ter ustrezno zdravljenje s tem povezane vnetne reakcije v času okrevanja od PML (za nadaljnje informacije glejte Informacije za zdravnike in smernice za zdravljenje bolezni).
Progressive Multifocal Leukoencephalopathy (PML) Use of TYSABRI has been associated with an increased risk of PML, an opportunistic infection caused by JC virus, which may be fatal or result in severe disability.
Z jemanjem zdravila TYSABRI je povezano povečanje tveganja za PML, oportunistično okužbo, ki jo povzroča JCV, ki lahko povzroči smrt ali hudo prizadetost.
Patients and physicians should continue to follow the same monitoring protocol and be alert for any new signs or symptoms that may be suggestive of PML for approximately 6 months following discontinuation of TYSABRI.
Bolniki in zdravniki naj nadaljujejo s spremljanjem po istem protokolu in naj bodo še približno 6 mesecev po prekinitvi zdravljenja z zdravilom TYSABRI pozorni na morebiten pojav novih znakov ali simptomov, ki bi lahko kazali na PML.
In some instances, the reaction reoccurred when TYSABRI was reintroduced.
V nekaterih primerih so se težave pojavile pri ponovnem odmerjanju zdravila TYSABRI.
Short courses of steroids used to treat relapses were not associated with increased infections in clinical trials.
Pri kratkoročnem dajanju steroidov za zdravljenje recidivov ni bila ugotovljena povezava s povečanjem okužb pri kliničnih preskušanjih.
No studies on the effects on the ability to drive and use machines have been performed with TYSABRI.
Študij vpliva na sposobnost vožnje in upravljanja s stroji za zdravilo TYSABRI niso izvedli.
Mean number of T1-hypointense lesions
Povprečno število hipointenzivnih lezij T1
Natalizumab showed no effects on in vitro assays of α4-integrin-positive tumour line proliferation or cytotoxicity.
Natalizumab ni kazal učinkov v metodi in vitro α4-integrinpozitivne proliferacije ali citotoksičnosti tumorske linije.
o Description of MRI protocols for baseline, routine screening and in case of PML suspicion o Anti-JCV antibody testing, frequency of testing, interpretation of qualitative and quantitative results, seroprevalence of JCV-antibodies and seroconversion rate over time o Monitoring strategy after discontinuation of TYSABRI treatment o The need to inform patients about the benefits and risk of TYSABRI and provide them with:
o Testiranje za protitelesa proti JCV, pogostnost testiranja, interpretacija kvalitativnih in kvantitativnih rezultatov, stopnja seroprevalence protiteles proti JCV in serokonverzije glede na čas o Strategija spremljanja po prekinitvi zdravljenja z zdravilom TYSABRI o Zahtevo, da se bolnike obvesti o koristih in tveganjih zdravljenja z zdravilom TYSABRI in se jim da: kopijo obrazca za uvedbo zdravljenja opozorilno kartico za bolnike, vključno z osnovnim besedilom, s katerim soglaša
Physicians must discuss the benefits and risks of TYSABRI therapy with the patient and provide them with a Patient Alert Card.
Zdravnik se mora o koristih in tveganjih zdravljenja z zdravilom TYSABRI posvetovati z bolnikom in bolniku izročiti kartico s posebnimi opozorili.
Persistent anti-natalizumab antibodies (one positive test reproducible on retesting at least 6 weeks later) developed in approximately 6% of patients.
Pri približno 6 % bolnikov so se razvila obstojna proti-natalizumabna protitelesa (en pozitivni test, potrjen pri ponovnem testiranju vsaj 6 tednov kasneje).
• TYSABRI must not be mixed with other medicinal products or diluents.
• Zdravilo TYSABRI se ne sme mešati z drugimi zdravili ali topili.
TYSABRI contains the active substance (natalizumab).
Zdravilo TYSABRI vsebuje zdravilno učinkovino (natalizumab).
• Information about any registry or other monitoring system set up in the Member State and how to enter patients
o reakcijah na infuzijo o preobčutljivostnih reakcijah o nastajanju protiteles • Informacije o kakršnemkoli registru ali drugem nadzornem sistemu, ki je bil uveden v državi članici in o načinu vključevanja bolnikov.
Within 3 months prior to starting TYSABRI Annually during treatment with TYSABRI More frequent MRIs (e.g. on a 3 to 6 monthly basis) for patients at high risk for PML.
enkrat letno med zdravljenjem z zdravilom TYSABRI Pogostejša MRS (npr. vsake 3 do 6 mesecev) za bolnike z veliki tveganjem za PML.
• Information that atypical/opportunistic infections, in particular PML, may occur with TYSABRI and include: o That the risk of PML increases with increasing duration of treatment and that treatment beyond 24 months carries additional risk and other factors associated with an increased risk for the development of PML
• Informacijo, da se lahko pri uporabi zdravila TYSABRI pojavijo atipične/oportunistične okužbe, zlasti PML, vključno z: o Da tveganje PML narašča s trajanjem zdravljenja in da zdravljenje, ki traja dlje kot
Only body weight and the presence of anti-natalizumab antibodies were found to influence natalizumab disposition.
Ugotovili so, da na izločevanje natalizumaba vpliva le telesna masa in prisotnost proti-natalizumabnih protiteles.
Following the repeat intravenous administration of a 300 mg dose of natalizumab to MS patients, the mean maximum observed serum concentration was 110 ± 52 μg/ml.
Ugotovljena srednja najvišja koncentracija v serumu pri bolnikih z MS po ponavljajočem intravenskem dajanju 300 mg odmerka natalizumaba je bila 110 ± 52 μg/ml.
If PML or JCV GCN is suspected, further dosing must be suspended until PML has been excluded.
Pri sumu na progresivno multifokalno levkoencefalopatijo (PML) ali JCV GCN morate s terapijo prenehati, dokler se PML ne izključi.
The nature of the infections was generally similar in natalizumab- and placebo-treated patients.
Narava okužb bolnikov, zdravljenih z natalizumabom in tistih, zdravljenih s placebom, je bila na splošno podobna.
Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy) have a significantly higher risk of PML.
Pri bolnikih, ki imajo vse tri dejavnike tveganja za PML (tj. so pozitivni na protitelesa proti JCV in so se z zdravilom TYSABRI zdravili več kot 2 leti in so pred tem prejemali imunosupresive), je tveganje za PML značilno večje.
Symptoms can include; walking problems, numbness in the face, arms or legs, problems seeing things, tiredness, feeling off-balance or light headed, bladder and bowel problems, difficulty in thinking and concentrating, depression, acute or chronic pain, sexual problems, and stiffness and muscle spasms.
utrujenost, občutek neuravnoteženosti ali slabotnosti, težave z mehurjem ali črevesjem, težave z razmišljanjem in koncentracijo, depresijo, akutne ali kronične bolečine, težave s spolnostjo, otrdelost mišic in mišične krče.
In anti-JCV antibody positive TYSABRI treated patients who have not used prior immunosuppressants the level of anti-JCV antibody response (index) is associated with the level of risk for PML.
Pri bolnikih, zdravljenih z zdravilom TYSABRI, pozitivnih na protitelesa proti JCV, ki pred tem niso prejemali imunosupresivov, je raven odziva na protitelesa proti JCV (indeks) povezana z ravnijo tveganja za PML.
The symptoms of JCV GCN are similar to PML.
Simptomi JCV GCN so podobni kot pri PML.
If there are signs of treatment-related abnormalities these must return to normal before treatment with natalizumab is started.
Pri znakih bolezenskih sprememb, povezanih z zdravljenjem, se mora stanje bolnikov najprej vrniti na normalno raven pred zdravljenjem, preden se lahko daje natalizumab.
Progressive multifocal leukoencephalopathy (PML).
Progresivna multifokalna levkoencefalopatija (PML).
• Severe anaemia (decrease in your red blood cells which can make your skin pale and can make you feel breathless or lacking energy)
• neobičajne okužbe (tako imenovane »oportunistične okužbe«) • huda anemija (zmanjšanje števila rdečih krvnih celic, kar lahko povzroči bledo kožo in zasoplost ali pomanjkanje energije)
• The diluted medicinal product is to be used as soon as possible and within 8 hours of dilution.
• Raztopino uporabite takoj, ko je mogoče in najpozneje 8 ur po razredčitvi.
TYSABRI must not be mixed with other medicinal products or diluents.
Zdravila TYSABRI se ne sme mešati z drugimi zdravili ali topili.
Progressive Multifocal Leukoencephalopathy (PML)
Progresivna multifokalna levkoencefalopatija (PML)
• Physician information about TYSABRI
• Informacije o zdravilu TYSABRI za zdravnike
Hazard ratio for disability progression was 0.36 (95% CI: 0.17, 0.76) p = 0.008.
Razmerje nevarnosti za napredovanje prizadetosti je bilo 0,36 (95-% IZ: 0,17; 0,76) p = 0,008.
LIST OF EXCIPIENTS sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; sodium chloride; polysorbate 80 (E433) and water for injections.
Natrijev dihidrogenfosfat monohidrat; natrijev hidrogenfosfat heptahidrat; natrijev klorid; polisorbat 80 (E433) in voda za injekcije.
Continued therapy must be carefully reconsidered in patients who show no evidence of therapeutic benefit beyond 6 months
Nadaljevanje zdravljenja pri bolnikih, ki po 6 mesecih ne kažejo znakov izboljšanja, je treba skrbno pretehtati.
Readministration
Ponovna uporaba
Serious, life-threatening, and sometimes fatal cases have been reported in the postmarketing setting in multiple sclerosis patients receiving TYSABRI (see section 4.8).
V obdobju po začetku trženja so poročali o resnih, življenjsko nevarnih in včasih smrtnih primerih pri bolnikih z multiplo sklerozo, ki so se zdravili z zdravilom TYSABRI (glejte poglavje 4.8).
• The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 ml/minute.
• Razporejeno na 1 uro infundirajte približno 2 ml razredčene raztopine na minuto.
Your doctor can decide whether TYSABRI is not working properly for you by testing your blood and will stop TYSABRI, if necessary.
Zdravnik se lahko na podlagi rezultatov testiranja krvi odloči, ali zdravilo TYSABRI ne deluje pravilno, in po potrebi prekine zdravljenje z zdravilom TYSABRI.
MRI evaluations for T1-weighted gadolinium (Gd)-enhancing lesions and T2-hyperintense lesions were performed annually.
Ocene lezij s slikanjem z magnetno resonance, vidnih z gadolinijem in obteženih s T1, in hiperintenzivnih lezij T2, so se izvajale letno.
Patients with a treatment history of immunosuppressant medicinal products are at increased risk for PML.
Pri bolnikih z zgodovino zdravljenja z zaviralci imunskega odziva je tveganje PML večje.
If the diluted medicinal product is stored at 2°C - 8°C (do not freeze), allow the solution to warm to room temperature prior to infusion.
Raztopina, ki se hrani pri 2 °C - 8 °C (ne zamrzujte), se mora pred infundiranjem segreti na sobno temperaturo.
Patients who have experienced a hypersensitivity reaction must be permanently discontinued from treatment with TYSABRI.
Pri bolnikih, ki so doživeli preobčutljivostno reakcijo, je treba zdravljenje z zdravilom TYSABRI trajno prekiniti.
Patients can switch directly from beta interferon or glatiramer acetate to natalizumab providing there are no signs of relevant treatment-related abnormalities e.g. neutropenia.
Na voljo morajo biti viri za upravljanje s preobčutljivostnimi reakcijami in dostop do MRS. Bolniki lahko direktno preidejo iz interferona beta ali glatiramer acetata na natalizumab, če ne kažejo znakov pomembnih bolezenskih sprememb, povezanih z zdravljenjem, npr. nevtropenije.
• If you have been treated for more than 2 years and you have a lower level of JCV antibodies in your blood.
• nimate protiteles proti virusu JC v krvi ALI • če se zdravite dlje kot 2 leti in imate nižje ravni protiteles proti virusu JC v krvi.
• Swelling of your face, lips or tongue
• oteklina obraza, ustnic ali jezika • težave pri dihanju
Studies have not been conducted to examine the effects of renal or hepatic impairment.
Kliničnih študij, s katerimi bi raziskali učinke okvare ledvic ali jeter, niso izvedli.
6.6 Special precautions for disposal and other handling
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Navodila za uporabo:
• Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy),
To vključuje: • Bolnike, ki imajo vse tri dejavnike tveganja za PML (tj. so pozitivni na protitelesa proti JCV in so se z zdravilom TYSABRI zdravili več kot 2 leti in so pred tem prejemali imunosupresive),
• That TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.
• Opozorilo, da naj zdravljenje z zdravilom TYSABRI uvede in neprestano nadzoruje zdravnik specialist z izkušnjami v diagnosticiranju in zdravljenju nevroloških bolezni, v centrih s hitrim dostopom do MRS.
TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.
Zdravljenje z zdravilom TYSABRI mora uvesti in neprestano nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju nevroloških bolezni, v centrih s pravočasnim dostopom do MRS.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija pogosti
JC virus also causes JCV granule cell neuronopathy (GCN) which has been reported in patients treated with TYSABRI.
JCV nevropatijo zrnatih celic (JCV GCN, granule cell neuronopathy), o kateri so poročali pri bolnikih, zdravljenih z zdravilom TYSABRI.
If a patient develops PML the dosing of TYSABRI must be permanently discontinued.
Če bolnik razvije PML med jemanjem zdravila TYSABRI, je treba zdravljenje trajno prekiniti.
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije
If the diluted medicinal product is stored at 2˚C - 8˚C (do not freeze), allow the solution to warm to room temperature prior to infusion.
Raztopina, ki se hrani pri 2 ˚C - 8 ˚C (ne zamrzujte), se mora pred infundiranjem segreti na sobno temperaturo.
The efficacy of re-administration has not been established, for safety see section 4.4.
Napotke v zvezi z varnostjo najdete v poglavju 4.4.