FrancophonIA/ELRC3.0 huggingface dataset:
English: Look out for signs of allergic reactions and other serious side effects Xolair can potentially cause serious side effects.
Slovenian: Bodite pozorni na znake alergijskih reakcij in drugih resnih neželenih učinkov Zdravilo Xolair lahko povzroči resne neželene učinke.
English: Omalizumab binds to IgE and lowers free IgE levels.
Slovenian: Omalizumab se veže na IgE in zniža koncentracijo prostega IgE.
English: Xolair must not be administered by the intravenous or intramuscular route.
Slovenian: Zdravila Xolair se ne sme dajati intravensko ali intramuskularno.
English: Xolair treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma.
Slovenian: Zdravljenje z zdravilom Xolair morajo uvajati zdravniki, izkušeni v diagnostiki in zdravljenju težke trdovratne astme.
English: Solution for injection in pre-filled syringe (injection).
Slovenian: raztopina za injiciranje v napolnjeni injekcijski brizgi (injekcija)
English: There are no human fertility data for omalizumab.
Slovenian: Za omalizumab ni na voljo podatkov o vplivu na plodnost pri ljudeh.
English: How to use Xolair
Slovenian: Kako uporabljati zdravilo Xolair
English: Physician's overall assessment % responders* p-value**
Slovenian: Zdravnikova celotna ocena % bolnikov z odzivom*
English: In addition, a population pharmacokinetic analysis showed no relevant effect of H2 antihistamines and LTRAs on omalizumab pharmacokinetics (see section 5.2).
Slovenian: Poleg tega rezultati analize populacijske farmakokinetike ne kažejo, da bi zaviralci histaminskih receptorjev H2 ali antagonisti levkotrienskih receptorjev lahko pomembno vplivali na farmakokinetiko omalizumaba (glejte poglavje 5.2).
English: The safety of omalizumab has been studied in the cynomolgus monkey, since omalizumab binds to cynomolgus and human IgE with similar affinity.
Slovenian: Varnost omalizumaba so proučevali pri opicah cinomolgus, ker se omalizumab pri teh opicah veže na IgE s podobno afiniteto kot pri človeku.
English: BOCF (Baseline Observation Carried Forward) was used to impute missing data.
Slovenian: Za nadomeščanje manjkajočih vrednosti so uporabili metodo uporabe izhodiščne vrednosti BOCF (angl. Baseline Observation Carried Forward).
English: Omalizumab at 300 mg reduced the weekly itch severity score by 8.55 to 9.77 (p <0.0001) compared to a reduction of 3.63 to 5.14 for placebo (see Table 7).
Slovenian: Omalizumab je v odmerku 300 mg zmanjšal oceno izraženosti srbenja v enem tednu za 8,55 do 9,77 (p <0,0001) v primerjavi z zmanjšanjem ocene za 3,63 do 5,14 pri uporabi placeba (glejte preglednico 7).
English: If clinically needed, the use of Xolair may be considered during pregnancy.
Slovenian: O uporabi zdravila Xolair med nosečnostjo se lahko razmisli, če je to klinično potrebno.
English: Solvent for Xolair Water for injections
Slovenian: Vehikel za zdravilo Xolair voda za injekcije
English: Angioedema
Slovenian: Anafilaksija
English: Xolair doses (milligrams per dose) administered by subcutaneous injection every 2 weeks
Slovenian: Odmerki zdravila Xolair (miligrami na odmerek), aplicirani s subkutano injekcijo vsaka 2 tedna
English: However, no apparent toxicity, such as immune complex-mediated disease or complement-dependent cytotoxicity, was seen.
Slovenian: Vendar niso opazili nikakršne očitne toksičnosti, na primer bolezni, v katero je vpleten imunski kompleks, ali od komplementa odvisne citotoksičnosti.
English: Patients in safety study 3 had a mean weekly itch severity score of 13.8 and a mean UAS7 score of 31.2 at baseline.
Slovenian: Bolniki v študiji 3 za oceno varnosti zdravila so imeli ob izhodišču povprečno oceno srbenja v enem tednu 13,8 in povprečno oceno na lestvici UAS7 31,2.
English: Description of selected adverse reactions pertinent to allergic asthma and CSU indications
Slovenian: Opis izbranih neželenih učinkov v povezavi z indikacijama alergijske astme in kronične spontane urtikarije
English: Leave the syringe in the box to protect it from light.
Slovenian: Injekcijsko brizgo pustite v škatli, da ostane zaščitena pred svetlobo.
English: DO NOT USE if the product has expired.
Slovenian: ZDRAVILA NE UPORABITE, če mu je potekel rok uporabe.
English: In specifically-designed non-clinical fertility studies in non-human primates, including mating studies, no impairment of male or female fertility was observed following repeated dosing with omalizumab at dose levels up to 75 mg/kg.
Slovenian: V specifično zasnovanih nekliničnih študijah plodnosti pri nečloveških primatih, med katere sodijo tudi študije parjenja, po ponavljajočem odmerjanju omalizumaba v odmerkih do 75 mg/kg niso opažali vpliva na plodnost niti pri samcih niti pri samicah.
English: During the 52-week double-blind treatment period (including the 24-week fixed-dose steroid phase and the 28-week steroid adjustment phase) the difference in rates between treatment groups represented a 50% (rate ratio 0.504, p<0.001) relative decrease in exacerbations for omalizumab patients.
Slovenian: V 52-tedenskem obdobju dvojno slepega zdravljenja (ki je obsegalo 24-tedensko obdobje s stalnim odmerkom steroidnih zdravil in 28-tedensko obdobje prilagajanja odmerkov steroidnih zdravil) je razlika v pogostnosti eksacerbacij med obema skupinama predstavljala 50 % (razmerje pogostnosti 0,504, p<0,001) manjšo pogostnost pri bolnikih z omalizumabom v primerjavi z bolniki, ki so prejemali placebo.
English: What Xolair is and what it is used for What you need to know before you use Xolair How to use Xolair
Slovenian: Kaj je zdravilo Xolair in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Xolair Kako uporabljati zdravilo Xolair Možni neželeni učinki
English: Because omalizumab clearance at clinical doses is dominated by the reticular endothelial system (RES) it is unlikely to be altered by renal or hepatic impairment.
Slovenian: Ker ob uporabi kliničnih odmerkov odstranjevanje omalizumaba poteka večinoma z retikuloendotelijskim sistemom, ni veliko možnosti, da bi nanj vplivala okvara ledvic ali jeter.
English: Common (may affect up to 1 in 10 people) - reactions at the injection site including pain, swelling, itching and redness - pain in the upper part of the tummy (in children) - headache (very common in children)
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov) - reakcije na mestu injiciranja, ki obsegajo bolečino, oteklino, srbenje in rdečino - bolečine v zgornjem delu trebuha (pri otrocih) - glavobol (zelo pogost pri otrocih)
English: The safety and efficacy of Xolair in children below age 6 have not been established.
Slovenian: Varnost in učinkovitost zdravila Xolair pri otrocih, starih manj kot 6 let, nista bili dokazani.
English: Clinical trial and post-marketing cases of systemic lupus erythematosus (SLE) have been reported in patients with moderate to severe asthma and CSU.
Slovenian: V kliničnih študijah in obdobju trženja zdravila so poročali o primerih sistemskega eritematoznega lupusa (SLE) pri bolnikih z zmerno do hudo astmo in tistih s kronično spontano urtikarijo.
English: In clinical trials in children 6 to <12 years of age, the most commonly reported adverse reactions were headache, pyrexia and upper abdominal pain.
Slovenian: Med kliničnimi preskušanji pri otrocih, starih 6 do <12 let, so bile neželene reakcije, o katerih so najpogosteje poročali, glavobol, zvišana telesna temperatura in bolečine v zgornjem delu trebuha.
English: Figure 1 shows the mean weekly itch severity score over time in study 1.
Slovenian: Na sliki 1 je prikazan časovni potek povprečne ocene izraženosti srbenja v enem tednu v študiji 1.
English: Xolair treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma or chronic spontaneous urticaria.
Slovenian: Zdravljenje z zdravilom Xolair morajo uvajati zdravniki, izkušeni v diagnostiki in zdravljenju težke trdovratne astme ali kronične spontane urtikarije.
English: Chronic spontaneous urticaria (CSU) You will need two 150 mg injections at a time every four weeks.
Slovenian: Kronična spontana urtikarija Vsake štiri tedne boste skupaj potrebovali po dve injekciji s 150 mg učinkovine.
English: Eligible patients had experienced multiple asthma exacerbations requiring systemic corticosteroid treatment or had been hospitalised or attended an emergency room due to a severe asthma exacerbation in the past year despite continuous treatment with high-dose inhaled corticosteroids and a long-acting beta2-agonist.
Slovenian: Bolniki, ki so bili primerni za vključitev v študijo, so imeli po več eksacerbacij astme, pri katerih je bilo potrebno sistemsko zdravljenje s kortikosteroidi, ali so bili hospitalizirani ali opazovani na urgenci zaradi težke eksacerbacije astme v zadnjem letu kljub neprekinjenemu zdravljenju z velikimi odmerki kortikosteroidov za inhalacijo in dolgotrajno delujočim agonistom adrenergičnih receptorjev beta2.
English: In clinical studies in allergic asthma patients, serum free IgE levels were reduced in a dose-dependent manner within one hour following the first dose and maintained between doses.
Slovenian: V kliničnih študijah pri bolnikih z alergijsko astmo so se serumske koncentracije prostega IgE znižale v odvisnosti od odmerka v eni uri po prvem odmerku in ostale takšne v času med zaporednimi odmerki.
English: Solvent ampoule: Clear, colourless type I glass ampoule containing 2 ml water for injections.
Slovenian: Ampula z vehiklom: ampula iz prozornega, brezbarvnega stekla tipa I, ki vsebuje 2 ml vode za injekcije.
English: A third study (study 3) primarily evaluated the safety of Xolair in patients with CSU who remained symptomatic despite treatment with H1 antihistamines at up to four times the approved dose and H2 antihistamine and/or LTRA treatment.
Slovenian: V tretji študiji (v študiji 3) so ocenjevali predvsem varnost uporabe zdravila Xolair pri bolnikih s kronično spontano urtikarijo, pri katerih so simptomi vztrajali kljub zdravljenju z zaviralci histaminskih receptorjev H1 v odmerkih, ki so bili do štirikrat višji od odobrenega, z zaviralci histaminskih receptorjev H2 in/ali z antagonisti levkotrienskih receptorjev.
English: Therefore for patients with a known history of anaphylaxis, Xolair must be administered by a health care professional, who should always have medicinal products for the treatment of anaphylactic reactions available for immediate use following administration of Xolair.
Slovenian: Zato mora bolnikom z ugotovljeno anamnezo anafilaksije zdravilo Xolair aplicirati zdravstveni delavec, ki mora imeti ob aplikaciji zdravila Xolair vedno na voljo zdravila za zdravljenje anafilaktičnih reakcij, pripravljena za takojšnjo uporabo.
English: No pattern of persistent decrease in platelet counts, as observed in non-human primates (see section 5.3), has been reported in humans (patients above 6 years of age), even though isolated cases of idiopathic thrombocytopenia, including severe cases, have been reported in the post-marketing setting.
Slovenian: Pri ljudeh (pri bolnikih, starih 6 let ali več) ne poročajo o vzorcu trdovratnega znižanja koncentracije trombocitov, kakršno so opazili pri drugih primatih (glejte poglavje 5.3), čeprav so v obdobju trženja poročali o posameznih primerih idiopatične trombocitopenije, vključno s hudimi primeri.
English: A history of anaphylaxis unrelated to omalizumab may be a risk factor for anaphylaxis following Xolair administration.
Slovenian: Anafilaksija brez povezave z omalizumabom v anamnezi lahko predstavlja dejavnik tveganja za pojav anafilaksije po odmerjanju zdravila Xolair.
English: Xolair is not recommended for children under 6 years of age.
Slovenian: Zdravilo Xolair ni priporočeno za otroke, ki so stari manj kot 6 let.
English: Of those, 412 patients were treated for up to 12 weeks and 333 patients were treated for up to 24 weeks at the 300 mg dose.
Slovenian: Izmed njih je odmerek 300 mg do 12 tednov prejemalo 412 bolnikov, do 24 tednov pa 333 bolnikov.
English: Figure 1 Mean weekly itch severity score over time, study 1 (mITT population)
Slovenian: Slika 1 Časovni potek povprečne ocene izraženosti srbenja v enem tednu, študija 1 (populacija mITT)
English: Do not stop taking any asthma medicines without talking to your doctor.
Slovenian: Ne prenehajte jemati nobenega zdravila proti astmi, ne da bi se prej pogovorili s svojim zdravnikom.
English: Table 2 ADMINISTRATION EVERY 4 WEEKS.
Slovenian: Preglednica 2 APLIKACIJA VSAKE 4 TEDNE.
English: Omalizumab is excreted in breast milk in cynomolgus monkeys.
Slovenian: Omalizumab se pri opicah cinomolgus izloča v materino mleko.
English: Store in the refrigerator between 2°C and 8°C.
Slovenian: Shranjujte ga v hladilniku pri temperaturi 2 °C - 8 °C.
English: However, most of these reactions occurred within 2 hours after the first and subsequent injections of Xolair but some started beyond 2 hours and even beyond 24 hours after the injection.
Slovenian: Lahko se zgodi, da se pojavijo šele po dolgotrajnem zdravljenju, vendar je večina teh reakcij je nastopila v prvih 2 urah po prvem in po enem od nadaljnih injiciranj zdravila Xolair, nekatere pa so nastopile tudi po več kot 2 urah in celo več kot 24 urah po injiciranju.
English: For the global evaluation of treatment effectiveness at the end of the 52-week double-blind treatment period in the subgroup of severe patients on high-dose inhaled corticosteroids plus long-acting beta agonists, the proportion of patients rated as having ‘excellent' treatment effectiveness was higher, and the proportions having ‘moderate' or ‘poor' treatment effectiveness lower in the omalizumab group compared to the placebo group; the difference between groups was statistically significant (p<0.001), while there were no differences between the omalizumab and placebo groups for patients' subjective Quality of Life ratings.
Slovenian: Ob koncu 52-tedenskega obdobja dvojno slepega zdravljenja podskupine bolnikov z močno izraženo boleznijo, ki so se zdravili z visokimi odmerki kortikosteroidov za inhaliranje in z dolgodelujočimi agonisti adrenergičnih receptorjev beta, je bil v skupini z omalizumabom v okviru celotne ocene učinkovitosti zdravljenja delež tistih, pri katerih so učinkovitost zdravljenja ocenili kot “odlično”, večji, delež tistih, pri katerih so učinkovitost zdravljenja ocenili kot “zmerno” ali “slabo”, pa manjši kot v skupini s placebom; razlika med skupinama je bila statistično značilna (p<0,001).
English: 1.2 ml = maximum delivered volume per vial (Xolair 150 mg).
Slovenian: 1,2 ml = največji injicirani volumen na vialo (Xolair 150 mg).
English: Slowly depress the plunger as far as it will go so that the plunger head is completely between the syringe guard wings.
Slovenian: Počasi potiskajte bat, dokler gre, tako da se na koncu ročaj bata povsem usede med sponke za aktivacijo mehanizma.
English: There is no pharmacological reason to expect that commonly prescribed medicinal products used in the treatment of asthma or CSU will interact with omalizumab.
Slovenian: Ni farmakološkega razloga za pričakovanje, da bi pogosto predpisovana zdravila, ki se uporabljajo pri zdravljenju astme in kronične spontane urtikarije, medsebojno delovala z omalizumabom.
English: All patients were required to have inadequate symptom control, as assessed by a weekly urticaria activity score (UAS7, range 0-42) of ≥16, and a weekly itch severity score (which is a component of the UAS7; range 0-21) of ≥8 for the 7 days prior to randomisation, despite having used an antihistamine for at least 2 weeks beforehand.
Slovenian: Pogoj za vstop v študijo je bila nezadostna urejenost simptomov glede na oceno na lestvici aktivnosti urtikarije v enem tednu (angl. weekly urticaria activity score, UAS7 z oceno od 0 do 42), ki je morala biti najmanj 16, izraženost srbenja v enem tednu (ocena, ki je sestavni del lestvice UAS7 in obsega od 0 do 21 točk) pa je morala biti ocenjena z najmanj 8 v 7 dneh pred randomizacijo, kljub uporabi antihistaminikov najmanj 2 tedna pred tem.
English: Xolair is available in packs containing one vial of powder for solution for injection and one ampoule of 2 ml water for injections.
Slovenian: Zdravilo Xolair je na voljo v pakiranju, ki vsebuje eno vialo s praškom za raztopino za injiciranje in eno ampulo z 2 ml vode za injekcije.
English: During clinical trials in adult and adolescent patients 12 years of age and older, the most commonly reported adverse reactions were headaches and injection site reactions, including injection site pain, swelling, erythema and pruritus.
Slovenian: Med kliničnimi preskušanji pri odraslih in mladostnikih, starih 12 let ali več, so bile neželene reakcije, o katerih so najpogosteje poročali, glavoboli in reakcije na mestu aplikacije, med drugim bolečina, oteklina, eritem in srbenje na mestu injiciranja.
English: There was no evidence of an anaphylactic response due to mast-cell degranulation in cynomolgus monkeys.
Slovenian: Pri opicah cinomolgus ni bilo znakov anafilaktičnega odziva zaradi degranulacije mastocitov.
English: The LS mean was estimated using an ANCOVA model.
Slovenian: Povprečja po metodi najmanjših kvadratov so ocenili s pomočjo modela ANCOVA.
English: Xolair doses (milligrams per dose) administered by subcutaneous injection every 4 weeks
Slovenian: Odmerki zdravila Xolair (miligrami na odmerek), aplicirani s subkutano injekcijo vsake 4 tedne
English: There are no pharmacokinetic or pharmacodynamic data in patients with renal or hepatic impairment (see sections 4.2 and 4.4).
Slovenian: Pri bolnikih z okvarami ledvic ali jeter niso pridobili nikakršnih farmakokinetičnih ali farmakodinamičnih podatkov (glejte poglavji 4.2 in 4.4).
English: CARTON FOR INTERMEDIATE PACK (WITHOUT BLUE BOX) OF MULTIPACKS
Slovenian: ŠKATLA ZA VMESNO PAKIRANJE (BREZ “BLUE BOX” PODATKOV) V SKUPNEM PAKIRANJU
English: There have been no studies on the effect of impaired renal or hepatic function on the pharmacokinetics of omalizumab.
Slovenian: Študij o vplivu okvarjene ledvične ali jetrne funkcije na farmakokinetiko omalizumaba niso izvajali.
English: Xolair should not be used in children under 12 years of age.
Slovenian: Zdravila Xolair se ne sme uporabljati pri otrocih, ki so stari manj kot 12 let.
English: Using a new 3-ml syringe equipped with a large-bore, 18-gauge needle, insert the needle into the inverted vial.
Slovenian: Sedaj uporabite novo 3-mililitrsko brizgo z iglo velikega premera, številka 18, iglo zabodite v preobrnjeno vialo.
English: 0.6 ml = maximum delivered volume per vial (Xolair 75 mg).
Slovenian: 0,6 ml = največji injicirani volumen na vialo (Xolair 75 mg).
English: The omalizumab group showed greater decreases in beta-agonist rescue medication use than the placebo group at the end of the 52-week treatment period, although the difference between treatment groups was not statistically significant.
Slovenian: Ob koncu 52-tedenskega obdobja zdravljenja se je uporaba ustreznejšega zdravljenja z agonisti adrenergičnih receptorjev beta bolj zmanjšala pri skupini bolnikov z omalizumabom kot pri skupini s placebom, a razlika med obema skupinama ni bila statistično značilna.
English: Parasitic infection
Slovenian: Infestacije s paraziti
English: Influenza-like illness, swelling arms, weight increase, fatigue *: Very common in children 6 to <12 years of age **: In children 6 to <12 years of age
Slovenian: pogosti reakcije na mestu injiciranja, na primer oteklina, eritem, bolečina, pruritus občasni gripi podobna bolezen, otekanje zgornjih udov, zvečanje telesne mase, utrujenost *: zelo pogosti pri otrocih, starih 6 do <12 let **: pri otrocih , starih 6 do <12 let
English: At 24 weeks, the difference in rates between treatment groups represented a 34% (rate ratio 0.662, p = 0.047) decrease relative to placebo for omalizumab patients.
Slovenian: Po 24 tednih je razlika v pogostnosti eksacerbacij med obema skupinama predstavljala 34 % (razmerje pogostnosti 0,662, p = 0,047) manjšo pogostnost pri bolnikih z omalizumabom v primerjavi z bolniki, ki so prejemali placebo.
English: Keep taking your current asthma medicine during Xolair treatment.
Slovenian: Med zdravljenjem z zdravilom Xolair nadaljujte z jemanjem svojega dosedanjega zdravila proti astmi.
English: INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
Slovenian: VMESNA ŠKATLA V SKUPNEM PAKIRANJU (BREZ “BLUE BOX” PODATKOV)
English: To prepare Xolair 75 mg vials for subcutaneous administration, please adhere to the following instructions:
Slovenian: Xolair 75 mg viale za subkutano uporabo pripravite po naslednjih navodilih:
English: In clinical studies, serum free IgE levels were reduced in a dose-dependent manner within one hour following the first dose and maintained between doses.
Slovenian: V kliničnih študijah so se serumske koncentracije prostega IgE znižale v odvisnosti od odmerka v eni uri po prvem odmerku in ostale takšne v času med zaporednimi odmerki.
English: Musculoskeletal and connective tissue disorders Arthralgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija pogosti
English: The box contains Xolair pre-filled syringe(s) individually sealed in a plastic tray.
Slovenian: Škatla vsebuje eno ali več napolnjenih injekcijskih brizg z zdravilom Xolair, od katerih je vsaka posebej zaprta v plastičen ovitek.
English: Summary of safety profile
Slovenian: Povzetek varnostnih lastnosti zdravila
English: There have been no studies on the effect of impaired renal or hepatic function on the pharmacokinetics of Xolair.
Slovenian: Študij o vplivu okvarjene ledvične ali jetrne funkcije na farmakokinetiko zdravila Xolair niso izvajali.
English: Dispose of the used syringe immediately after use in a sharps container.
Slovenian: Uporabljeno injekcijsko brizgo takoj po uporabi odvrzite v zbiralnik za ostre predmete.
English: ADMINISTRATION EVERY 4 WEEKS SEE TABLE 2
Slovenian: ZA UPORABO VSAKE 4 TEDNE GLEJTE PREGLEDNICO 2
English: DO NOT FREEZE.
Slovenian: NE ZAMRZUJTE.
English: In the second double-blind 28week treatment period the difference in rates between treatment groups represented a 63% (rate ratio 0.37, p<0.001) decrease relative to placebo for omalizumab patients.
Slovenian: V drugem 28-tedenskem obdobju dvojno slepega zdravljenja je razlika v pogostnosti eksacerbacij med skupinama predstavljala 63 % (razmerje pogostnosti 0,37, p<0,001) manjšo pogostnost pri bolnikih z omalizumabom v primerjavi z bolniki, ki so prejemali placebo.
English: In patients with asthma, following multiple doses of omalizumab, areas under the serum concentrationtime curve from Day 0 to Day 14 at steady state were up to 6-fold of those after the first dose.
Slovenian: Pri bolnikih z astmo so bile po več odmerkih omalizumaba površine pod krivuljo serumske koncentracije od dneva 0 do dneva 14 v stanju dinamičnega ravnovesja do 6-krat večje od tistih po prvem odmerku.
English: Draw 1.4 ml of water for injections from the ampoule into a syringe equipped with a large-bore 18-gauge needle.
Slovenian: Potegnite 1,4 ml vode za injekcije iz ampule v injekcijsko brizgo, na katero je nataknjena igla velikega premera, št. 18.
English: Arterial thromboembolic events (ATE)
Slovenian: Arterijski trombembolični dogodki
English: ADMINISTRATION EVERY 2 WEEKS SEE TABLE 3
Slovenian: ZA UPORABO VSAKA 2 TEDNA GLEJTE PREGLEDNICO 3
English: To prepare Xolair 150 mg vials for subcutaneous administration, please adhere to the following instructions:
Slovenian: Xolair 150 mg viale za subkutano uporabo pripravite po naslednjih navodilih:
English: In addition more patients had clinically meaningful responses in the total IgE ≥76 IU/ml population across the Xolair severe asthma programme.
Slovenian: Poleg tega je v celotnem programu z zdravilom Xolair za težko astmo imelo v podskupini s celotnim IgE ≥76 i.e./ml več bolnikov klinično pomemben odziv.
English: L-histidine hydrochloride monohydrate Polysorbate 20
Slovenian: L-histidinijev klorid hidrat polisorbat 20
English: The vial delivers 1.2 ml (150 mg) of Xolair.
Slovenian: Viala vsebuje 1,2 ml raztopine (150 mg) zdravila Xolair.
English: Also contains: L-arginine hydrochloride, L-histidine hydrochloride, L-histidine, polysorbate 20, water for injections.
Slovenian: Vsebuje tudi L-argininijev klorid, L-histidinijev klorid, L-histidin, polisorbat 20, vodo za injekcije.