natgillin/translations-raw huggingface dataset:
Fasenra may reduce the number of asthma attacks you are experiencing, help you breathe better and decrease your asthma symptoms.
Zdravilo Fasenra vam lahko zmanjša število napadov astme, olajša dihanje in zmanjša simptome astme.
When considered alone or in combination with baseline blood eosinophils count, these factors may further identify patients who may achieve greater response from benralizumab treatment (Table 4).
Če te dejavnike upoštevamo same ali v kombinaciji z izhodiščnim številom eozinofilcev, lahko dodatno pomagajo odkriti bolnike, ki bi lahko dosegli večji odziv na zdravljenje z benralizumabom (preglednica 4).
Lift the Fasenra Pen straight up.
Dvignite peresnik Fasenra Pen naravnost navzgor.
In a randomized, double-blind parallel-group study of 103 patients aged between 12 and 21 years with severe asthma, the humoral antibody responses induced by seasonal influenza virus vaccination do not appear to be affected by benralizumab treatment.
Randomizirana, dvojno slepa študija vzporednih skupin, ki je zajela 103 bolnike s hudo astmo, stare od 12 do 21 let, ni pokazala, da bi zdravljenje z benralizumabom neugodno vplivalo na odzive humoralnih protiteles, ki jih povzroči cepljenje proti sezonskim virusom influence.
It is unknown if Fasenra may influence a patient's response against helminth infections.
Ni znano, ali lahko zdravilo Fasenra vpliva na bolnikov odziv na okužbe s helminti.
Of these, 46 received placebo, 40 received Fasenra every 4 weeks for 3 doses, followed by every 8 weeks thereafter, and 22 received Fasenra every 4 weeks.
Od teh jih je 46 prejemalo placebo, 40 zdravilo Fasenra na 4 tedne za 3 odmerke in pozneje na 8 tednov ter 22 zdravilo Fasenra na 4 tedne.
Fasenra should not be used to treat acute asthma exacerbations.
Zdravila Fasenra se ne sme uporabljati za zdravljenje akutnih poslabšanj astme.
Reductions in exacerbation rates were observed irrespective of baseline eosinophil count; however, increasing baseline eosinophil counts was identified as a potential predictor of improved treatment response particularly for FEV1.
Zmanjšanje deleža poslabšanj so opažali ne glede na izhodiščno število eozinofilcev, toda naraščajoče izhodiščno število eozinofilcev se je izkazalo kot možen napovednik boljšega odziva na zdravljenje, še zlasti glede FEV1.
Hold the pre-filled syringe in 1 hand as shown.
Napolnjeno iglo držite z eno roko, kot je prikazano.
In the event of a hypersensitivity reaction, Fasenra should be discontinued permanently and appropriate therapy initiated.
V primeru preobčutljivostne reakcije je treba zdravilo Fasenra trajno prenehati uporabljati in uvesti ustrezno zdravljenje.
Gently hold pressure over your skin with a cotton ball or gauze until the bleeding stops.
S kosmom vate ali zložencem gaze nežno pritiskajte na kožo, dokler se krvavitev ne ustavi.
Do not use the syringe if it is dropped without the needle cover in place or if the needle is damaged or dirty.
Ne uporabite brizge, če vam kam pade, ko pokrovček igle ni več nameščen, ali če je igla poškodovana ali umazana.
Do not try to put the cap back on the Fasenra Pen.
Ne poskušajte namestiti pokrovčka nazaj na peresnik Fasenra Pen.
Its colour may vary from colourless to yellow.
Lahko je brezbarvno do rumeno.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
The recommended dose of benralizumab is 30 mg by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks thereafter.
Priporočeni odmerek benralizumaba je 30 mg v subkutani injekciji na 4 tedne prve 3 odmerke, pozneje pa na 8 tednov.
Patients with pre-existing helminth infections should be treated before initiating therapy with Fasenra.
Bolnike z obstoječimi okužbami s helminti je treba zdraviti pred uvedbo zdravljenja z zdravilom Fasenra.
Treatment with benralizumab results in near complete depletion of blood eosinophils within 24 hours following the first dose which is maintained throughout treatment.
Zdravljenje z benralizumabom povzroči skoraj popolno izgubo eozinofilcev v krvi, ki se pojavi v 24 urah po prvem odmerku in se ohrani med celotnim zdravljenjem.
There are limited data available in subjects with creatinine clearance values less than 30 mL/min; however, benralizumab is not cleared renally.
Podatkov za bolnike z očistkom kreatinina manj kot 30 ml/min je malo, vendar se benralizumab ne odstranjuje skozi ledvica.
Fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists (see section 5.1).
Zdravilo Fasenra je indicirano kot dodatno vzdrževalno zdravljenje za odrasle bolnike s hudo eozinofilno astmo, ki ni ustrezno urejena kljub velikim odmerkom inhalacijskih kortikosteroidov in dolgodelujočih agonistov β (glejte poglavje 5.1).
Slowly ease up on the plunger until the needle guard covers the needle.
Počasi sprostite bat, dokler ščitnik igle ne prekrije igle.
Placebo patients in Trials 1 and 2 are included up to the end of the predecessor trial (Week 48 in Trial 1, Week 56 in Trial 2).
Bolniki, ki so v preskušanjih 1 in 2 prejemali placebo, so vključeni do konca predhodnega preskušanja (48. teden v preskušanju 1, 56. teden v preskušanju 2).
Anti-benralizumab antibodies were associated with increased clearance of benralizumab and increased blood eosinophil levels in patients with high anti-drug antibody titres compared to antibody negative patients; in rare cases, blood eosinophil levels returned to pre-treatment levels.
Protitelesa proti benralizumabu so bila pri bolnikih z visokimi titri protiteles povezana z večjim očistkom benralizumaba in povečanjem števila eozinofilcev v krvi v primerjavi z bolniki, ki niso imeli takšnih protiteles; v redkih primerih se je število eozinofilcev v krvi vrnilo na raven pred zdravljenjem.
Adolescent patients aged 12 to 17 (n=86) from Trials 1 and 2 continued treatment with Fasenra in Trial 4 for up to 108 weeks.
Mladostniki, stari od 12 do 17 let (n=86), iz preskušanj 1 in 2 so v preskušanju 4 nadaljevali zdravljenje z zdravilom Fasenra do 108 tednov.
Anaphylactic reactions have been reported.
Poročali so o anafilaktičnih reakcijah.
The two exacerbation trials, SIROCCO (Trial 1) and CALIMA (Trial 2), enrolled a total of 2,510 patients with severe uncontrolled asthma, 64% females, with a mean age of 49 years.
V dveh preskušanjih poslabšanj SIROCCO (preskušanje 1) in CALIMA (preskušanje 2) je bilo vključenih 2510 bolnikov s hudo, neurejeno astmo; 64 % je bilo žensk in povprečna starost je bila 49 let.
It should not be injected into areas where the skin is tender, bruised, erythematous, or hardened.
Zdravila se ne sme injicirati v predele, kjer je koža občutljiva, podpluta, pordela ali zatrdela.
Intravenous and subcutaneous administration to cynomolgus monkeys was associated with reductions in peripheral blood and bone marrow eosinophil counts, with no toxicological findings.
Intravenska in subkutana uporaba pri opicah cynomolgus sta bili povezani z zmanjšanjem števila eozinofilcev v periferni krvi in kostnem mozgu, brez toksikoloških ugotovitev.
The European Medicines Agency has waived the obligation to submit the results of studies with Fasenra in paediatric population aged from birth to less than 6 years in asthma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Fasenra za pediatrično populacijo v starosti od rojstva do manj kot 6 let pri astmi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
In these studies, Fasenra was administered at a dose of 30 mg once every 4 weeks for the first 3 doses, and then every 4 or 8 weeks thereafter as add-on to background treatment and was evaluated in comparison with placebo.
V teh študijah so zdravilo Fasenra uporabili v odmerku 30 mg enkrat na 4 tedne za prve 3 odmerke, pozneje pa na 4 ali 8 tednov; zdravilo je bilo uporabljeno kot dodatek osnovnemu zdravljenju in so ga ocenjevali v primerjavi s placebom.
The European Medicines Agency has deferred the obligation to submit the results of studies with Fasenra in one or more subsets of the paediatric population in asthma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Fasenra za eno ali več podskupin pediatrične populacije za astmo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The depletion of blood eosinophils is accompanied by a reduction in serum eosinophil granule proteins eosinophil derived neurotoxin (EDN) and eosinophil cationic protein (ECP) and a reduction in blood basophils.
Izguba eozinofilcev v krvi spremlja znižanje dveh beljakovin eozinofilnih granul (v eozinofilcih nastalega nevrotoksina (EDN - eosinophil derived neurotoxin) in eozinofilne kationske beljakovine (ECP - eosinophil cationic protein)) v serumu in zmanjšanje števila bazofilcev v krvi.
In placebo-controlled studies, injection site reactions (e.g. pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with the recommended benralizumab dose compared with 1.9% in patients treated with placebo.
V študijah, kontroliranih s placebom, so se reakcije na mestu injiciranja (npr. bolečina, pordelost, srbenje, papule) pojavile pri 2,2 % bolnikov, ki so prejemali priporočeni odmerek benralizumaba, in pri 1,9 % bolnikov, ki so prejemali placebo.
• injection site reaction (for example pain, redness, itching, swelling near where the injection was given)
• reakcija na mestu injiciranja (na primer bolečina, pordelost, srbenje, oteklina v bližini mesta,
If you have forgotten to inject a dose of Fasenra, talk to your doctor, pharmacist or nurse as soon as possible.
Če ste pozabili injicirati odmerek zdravila Fasenra, se čim prej posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
What Fasenra is and what it is used for What you need to know before you use Fasenra How to use Fasenra Pen Possible side effects
Kaj je zdravilo Fasenra in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Fasenra Kako uporabljati zdravilo Fasenra Možni neželeni učinki
After removal from the refrigerator, Fasenra must be used within 14 days or discarded.
Ko zdravilo Fasenra vzamete iz hladilnika, ga je treba uporabiti v 14 dneh ali ga zavreči.
Do not remove the needle cover until you have reached Step 6 of these instructions and are ready to inject Fasenra.
Ne odstranite pokrovčka igle, dokler ne pridete do 6. koraka teh navodil in ste pripravljeni na injiciranje zdravila Fasenra.
Eosinophilic asthma is a type of asthma where patients have too many eosinophils in the blood or lungs.
Eozinofilna astma je vrsta astme, pri kateri imajo bolniki v krvi ali pljučih preveliko število eozinofilcev.
Across Trials 1 and 2 combined, there was a numerically greater exacerbation rate reduction and greater improvements in FEV1 with increasing baseline blood eosinophils.
V preskušanjih 1 in 2 skupaj so ugotovili številčno večje zmanjšanje deleža poslabšanj in večje izboljšanje FEV1 z naraščajočim izhodiščnim številom eozinofilcev.
Before using your Fasenra Pen, your healthcare provider should show you or your caregiver how to use it correctly.
Preden uporabite peresnik Fasenra Pen, mora zdravnik vam ali vašemu skrbniku pokazati, kako ga pravilno uporabite.
Fasenra is a medicine containing the active substance benralizumab, which is a monoclonal antibody, a type of protein that recognises and attaches to a specific target substance in the body.
Zdravilo Fasenra vsebuje učinkovino benralizumab, ki je monoklonsko protitelo, tj. vrsta beljakovine, ki v telesu prepozna posebne ciljne snovi in se nanje veže.
Overall, treatment-emergent anti-drug antibody response developed in 107 out of 809 (13%) patients treated with Fasenra at the recommended dosing regimen during the 48 to 56 week treatment period of the phase 3 placebo controlled exacerbation trials.
V celoti se je odziv s protitelesi proti zdravilu med zdravljenjem pojavil pri 107 od 809 (13 %) bolnikov, ki so prejemali zdravilo Fasenra v priporočeni odmerni shemi v obdobju od 48 do 56 tednov zdravljenja v preskušanju poslabšanj faze III, nadzorovanega s placebom.
What Fasenra is and what it is used for
Kaj je zdravilo Fasenra in za kaj ga uporabljamo
IgG monoclonal antibodies are not primarily cleared via hepatic pathway; change in hepatic function is not expected to influence benralizumab clearance.
Monoklonska protitelesa IgG se ne odstranjujejo v prvi vrsti po jetrni poti in ni pričakovati, da bi spremenjeno delovanje jeter vplivalo na očistek benralizumaba.
Additional information and instructions for the preparation and administration of Fasenra using the pre-filled syringe or pre-filled pen (Fasenra Pen) are given in the package leaflet and ‘Instructions for Use'.
Dodatne informacije in navodila za pripravo in dajanje zdravila Fasenra z napolnjeno injekcijsko brizgo ali napolnjenim injekcijskim peresnikom (Fasenra Pen) so podane v priloženem navodilu za uporabo in "Navodilih za uporabo zdravila".
e. Baseline is prior to Fasenra treatment in Trial 1 and 2.
e. "Izhodiščno" pomeni pred zdravljenjem z zdravilom Fasenra v preskušanjih 1 in 2.
While 2 dosing regimens were studied in Trials 1, 2, and 3, the recommended dosing regimen is Fasenra administered every 4 weeks for the first 3 doses, then every 8 weeks thereafter (see section 4.2) as no additional benefit was observed by more frequent dosing.
V preskušanjih 1, 2 in 3 so uporabljali 2 odmerni shemi, toda priporočeno odmerjanje zdravila Fasenra je na 4 tedne za prve 3 odmerke, pozneje pa na 8 tednov (glejte poglavje 4.2), ker s pogostejšo uporabo niso ugotovili dodatne koristi.
Grasp the syringe body (not the plunger) to remove the pre-filled syringe from its tray.
Primite telo injekcijske brizge (ne njenega bata), da boste napolnjeno injekcijsko brizgo vzeli iz podloge.
Benralizumab is a humanised IgG1 monoclonal antibody that is degraded by proteolytic enzymes widely distributed in the body and not restricted to hepatic tissue.
Benralizumab je humanizirano monoklonsko protitelo IgG1 in ga razgradijo proteolitični encimi, ki so v telesu široko porazdeljeni in niso omejeni na jetrno tkivo.
Effect on blood eosinophils
Vpliv na eozinofilce v krvi
Driving and using machines It is unlikely that Fasenra will affect your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Fasenra vplivalo na vašo sposobnost upravljanja vozil in strojev.
Other medicines and Fasenra
Druga zdravila in zdravilo Fasenra
(See Step 9 - Dispose the used pre-filled syringe)
(glejte 9. korak - Kako zavreči uporabljeno napolnjeno injekcijsko brizgo)
Dispose of the full container as instructed by your healthcare provider or pharmacist.
Celotni vsebnik zavrzite, kot vam je naročil zdravnik ali farmacevt.
Step 2 - Prepare to use your Fasenra Pen
2. korak - Pripravite se za uporabo peresnika Fasenra Pen
Trial 4 assessed the long-term effect of Fasenra on annual exacerbation rate, lung function, ACQ-6, AQLQ(S)+12 and maintenance of OCS reduction at the 2 dosing regimens studied in the predecessor studies.
Preskušanje 4 je ocenjevalo dolgoročni učinek zdravila Fasenra na letni delež poslabšanj, pljučno funkcijo, ACQ-6, AQLQ(S)+12 in ohranitev zmanjšanja OCS med uporabo 2 shem odmerjanja, proučevanih v predhodnih študijah.
Use a quick, dart-like motion to insert the needle into the pinched skin.
S hitrim, rahlo sunkovitim gibom zabodite iglo v stisnjeno kožo.
What Fasenra looks like and contents of the pack Fasenra is a solution which is colourless to yellow.
Izgled zdravila Fasenra in vsebina pakiranja Zdravilo Fasenra je raztopina, ki je brezbarvna do rumena.
• if your asthma remains uncontrolled or worsens during treatment with this medicine.
• če ostane astma med zdravljenjem s tem zdravilom neurejena ali se poslabša.
Examination of surrogate fertility parameters (including organ weights and histopathology of reproductive tissues) in animals treated with benralizumab suggested no impairment of fertility.
Proučevanje nadomestnih parametrov plodnosti (vključno z maso organov in histopatologijo reproduktivnih tkiv) pri živalih, ki so prejemale benralizumab, ni pokazalo okvare plodnosti.
The green plunger will move down in the viewing window during the injection.
Zeleni bat se bo med injiciranjem pomikal navzdol v okence za ogled.
It binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with high affinity and specificity.
Z veliko afiniteto in specifičnostjo se veže na podenoto alfa humanega receptorja interlevkina - 5 (IL - 5Rα).
Self-administration should only be considered in patients already experienced with Fasenra treatment.
Samoinjiciranje pride v poštev le pri bolnikih, ki že imajo izkušnje z zdravljenjem z zdravilom Fasenra.
Fasenra is used to treat severe eosinophilic asthma in adults.
Zdravilo Fasenra uporabljamo za zdravljenje hude eozinofilne astme pri odraslih bolnikih.
Proportional odds model (sensitivity analysis) Percent reduction in OCS from baseline at Week 28 ≥90% reduction ≥75% reduction ≥50% reduction >0% reduction
Vrednost p Wilcoxonovega testa vsot rangov Model sorazmernih obetov (analiza občutljivosti) Odstotno zmanjšanje OCS od izhodišča do 28. tedna ≥ 90 % zmanjšanje ≥ 75 % zmanjšanje ≥ 50 % zmanjšanje > 0 % zmanjšanje
Based on the population pharmacokinetic analysis, the pharmacokinetics of benralizumab in adolescents aged 12 to 17 years were consistent with adults.
Glede na populacijsko farmakokinetično analizo se je farmakokinetika benralizumaba pri mladostnikih v starosti od 12 do 17 let skladala s farmakokinetiko pri odraslih.
• pharyngitis (sore throat)
• vnetje žrela (faringitis)
In this study there was a median reduction from baseline in airway mucosa eosinophils of 96% in the benralizumab treated group compared to a 47% reduction in the placebo group (p=0.039).
V tej študiji so v skupini, ki je prejemala benralizumab, ugotovili mediano zmanjšanje števila eozinofilcev v sluznici dihal od izhodišča za 96 % in v skupini, ki je prejemala placebo, za 47 % (p = 0,039).
Based on the population pharmacokinetic analysis, commonly co-administered medicinal products (montelukast, paracetamol, proton pump inhibitors, macrolides and theophylline/aminophylline) had no effect on benralizumab clearance in patients with asthma.
Glede na populacijsko farmakokinetično analizo pogosto sočasno uporabljena zdravila (montelukast, paracetamol, zaviralci protonske črpalke, makrolidi in teofilin/aminofilin) pri bolnikih z astmo niso vplivala na očistek benralizumaba.
Throw away the cap and other used supplies in your household waste.
Pokrovček in drug porabljeni pribor zavrzite med gospodinjske odpadke.
Before Use
Pred uporabo
However, in the offspring of monkeys dosed while pregnant, there was a reduction in eosinophils.
Toda potomci opic, ki so zdravilo prejemale med brejostjo, so imeli zmanjšano število eozinofilcev.
A history of anaphylaxis unrelated to benralizumab may be a risk factor for anaphylaxis following Fasenra administration (see section 4.3).
Anamneza anafilaksije, nepovezane z benralizumabom, je lahko dejavnik tveganja za anafilaksijo po uporabi zdravila Fasenra (glejte poglavje 4.3).
In both Trials 1 and 2, patients receiving Fasenra experienced statistically significant reductions in asthma symptoms (Total Asthma Score) compared to patients receiving placebo.
Tako v preskušanju 1 kot v preskušanju 2 so se prejemnikom zdravila Fasenra simptomi astme (celotna ocena astme - Total Asthma Score) zmanjšali statistično značilno bolj kot prejemnikom placeba.
Elderly No dose adjustment is required for elderly patients (see section 5.2).
Starejši Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
Based on population pharmacokinetic analysis, the estimated absolute bioavailability was approximately 59% and there was no clinically relevant difference in relative bioavailability in the administration to the abdomen, thigh, or upper arm.
Na podlagi populacijske farmakokinetične analize je bila ocenjena absolutna biološka uporabnost približno 59 % in relativna biološka uporabnost se ni razlikovala glede na to, ali je bilo zdravilo injicirano v trebuh, stegno ali nadlaket.
The trial included an 8-week run-in period during which the OCS was titrated to the minimum effective dose without losing asthma control.
Preskušanje je obsegalo 8 - tedensko obdobje uvajanja, med katerim so OCS titrirali na najmanjši učinkoviti odmerek, s katerim je bila astma še urejena.
Following a second year of treatment of these patients from the phase 3 placebo-controlled trials, an additional 18 out of 510 (4%) had newly developed treatment-emergent antibodies.
Po drugem letu zdravljenja teh bolnikov iz preskušanj faze III, nadzorovanih s placebom, so se med zdravljenjem nastala protitelesa na novo pojavila pri dodatnih 18 od 510 (4 %) bolnikov.
Fasenra is administered as a subcutaneous injection.
Zdravilo Fasenra se uporablja kot subkutana injekcija.
Solution for injection in pre-filled syringe (injection) Solution for injection in pre-filled pen (injection) (Fasenra Pen)
raztopina za injiciranje v napolnjeni injekcijski brizgi (injekcija) raztopina za injiciranje v napolnjenem injekcijskem peresniku (injekcija) (Fasenra Pen)
Do not remove the cap until you have reached Step 6 of these instructions and are ready to inject Fasenra.
Ne odstranite pokrovčka, dokler ne pridete do 6. koraka teh navodil in ste pripravljeni na injiciranje zdravila Fasenra.
There is no specific treatment for an overdose with benralizumab.
Za preveliko odmerjanje benralizumaba ni specifičnega zdravljenja.
There were 108 adolescents aged 12 to 17 with asthma enrolled in the phase 3 trials (Trial 1: n=53, Trial 2: n=55).
V preskušanja faze III je bilo vključenih 108 mladostnikov z astmo, starih od 12 do 17 let (preskušanje 1: n = 53, preskušanje 2: n = 55).
*Benralizumab is a humanised monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
*Benralizumab je humanizirano monoklonsko protitelo, pridobljeno v celicah jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA.
Clean the injection site with an alcohol wipe in a circular motion.
S krožnim gibom očistite mesto injiciranja z alkoholnim lističem.
Do not recycle your used sharps container.
Porabljenega vsebnika za ostre odpadke ne reciklirajte.
The primary endpoint was percent reduction from baseline of the final OCS dose during Weeks 24 to 28, while maintaining asthma control.
Primarni cilj študije je bil odstotek zmanjšanja končnega odmerka OCS (od 24. do 28. tedna) v primerjavi z izhodiščem ob ohranjeni urejenosti astme.
In patients who received Fasenra in predecessor Trials 1 and 2, 73% were exacerbation-free in the extension Trial 4.
Med bolniki, ki so prejemali zdravilo Fasenra v predhodnih preskušanjih 1 in 2, jih je bilo v podaljšanem preskušanju 4 brez poslabšanj 73 %.
Benralizumab is an anti-eosinophil, humanised afucosylated, monoclonal antibody (IgG1, kappa).
Benralizumab je antieozinofilno humanizirano afukozilirano monoklonsko protitelo (IgG1, kapa).
The active substance is benralizumab.
Učinkovina je benralizumab.
• where the skin is tender, bruised, scaly or hard
• v predele, kjer je koža občutljiva, podpluta, se lušči ali je zatrdela,
In a prenatal and postnatal development study in pregnant cynomolgus monkeys, there were no benralizumab-related maternal, embryo-foetal, or postnatal effects observed.
V študiji prenatalnega in postnatalnega razvoja pri brejih opicah cynomolgus niso opazili z benralizumabom povezanih učinkov na mater, zarodek oz. plod ali postnatalnih učinkov.
Do not touch the cleaned area before injecting.
Očiščenega predela se pred injiciranjem ne dotikajte več.