FrancophonIA/ELRC3.0 huggingface dataset:
English: No relevant data was obtained in clinical studies in CSU that would require a modification of the sections below.
Slovenian: V kliničnih študijah kronične spontane urtikarije niso odkrili nobenih posebnih podatkov, zaradi katerih bi bilo treba spreminjati poglavja v nadaljevanju besedila.
English: - The needle cap of the syringe may contain dry rubber (latex).
Slovenian: - Pokrovček igle pri injekcijski brizgi lahko vsebuje suho gumo (lateks).
English: If you are breast-feeding or plan to breast-feed, ask your doctor for advice before using this medicine.
Slovenian: Če dojite ali nameravate dojiti, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Gripping the middle of the blue syringe guard, lift the syringe out of the tray.
Slovenian: Injekcijsko brizgo primite za srednji del modrega zapirala brizge in jo dvignite iz ovitka.
English: Draw 0.9 ml of water for injections from the ampoule into a syringe equipped with a large-bore 18-gauge needle.
Slovenian: Potegnite 0,9 ml vode za injekcije iz ampule v injekcijsko brizgo, na katero je nataknjena igla velikega premera, št. 18.
English: Powder vial: Clear, colourless type I glass vial with a butyl rubber stopper and blue flip-off seal.
Slovenian: Viala s praškom: viala iz prozornega, brezbarvnega stekla tipa I z zamaškom iz butilne gume in modro zaporko.
English: The reconstituted medicinal product will appear clear to slightly opalescent, colourless to pale brownish-yellow.
Slovenian: Rekonstituirano zdravilo bo videti bistro do rahlo opalescentno in brezbarvno do bledo rjavorumeno obarvano.
English: Consequently, if clinically needed, the use of Xolair may be considered during breast-feeding.
Slovenian: Zato se lahko razmisli o uporabi zdravila Xolair med dojenjem, če je to klinično potrebno.
English: The vial delivers 0.6 ml (75 mg) of Xolair.
Slovenian: Viala vsebuje 0,6 ml raztopine (75 mg) zdravila Xolair.
English: The highest cumulative dose administered to patients was 44,000 mg over a 20-week period and this dose did not result in any untoward acute effects.
Slovenian: Največji kumulativni odmerek, dan bolnikom v obdobju 20 tednov, je bil 44.000 mg.
English: In clinical studies in CSU, Xolair was used in conjunction with antihistamines (anti-H1, anti-H2) and leukotriene receptor antagonists (LTRAs).
Slovenian: V kliničnih študijah kronične spontane urtikarije so zdravilo Xolair uporabljali skupaj z antihistaminiki (zaviralci histaminskih receptorjev H1 oziroma H2) in z antagonisti levkotrienskih receptorjev.
English: Clinical studies in CSU included some patients aged 12 to 17 years taking Xolair in conjunction with antihistamines (anti-H1, anti-H2) and LTRAs.
Slovenian: V klinične študije kronične spontane urtikarije je bilo vključenih nekaj bolnikov v starosti od 12 do 17 let,ki so prejemali zdravilo Xolair skupaj z antihistaminiki (zaviralci histaminskih receptorjev H1 oziroma H2) in z antagonisti levkotrienskih receptorjev.
English: You may cover the injection site with a small adhesive bandage, if needed.
Slovenian: Če je treba, ga lahko pokrijete z majhnim obližem.
English: The pharmacokinetics of omalizumab have been studied in adult and adolescent patients with allergic asthma as well as in adult and adolescent patients with CSU.
Slovenian: Farmakokinetiko omalizumaba so proučevali pri odraslih in adolescentnih bolnikih z alergijsko astmo ter pri odraslih in adolescentnih bolnikih s kronično spontano urtikarijo.
English: Xolair 150 mg powder and solvent for solution for injection is supplied as a white to off-white powder in a small glass vial together with an ampoule containing 2 ml of water for injections.
Slovenian: Zdravilo Xolair 150 mg prašek in vehikel za raztopino za injiciranje je na voljo v obliki belega do skoraj belega praška v majhni stekleni viali skupaj z ampulo, ki vsebuje 2 ml vode za injekcije.
English: OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)
Slovenian: ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČNO Z “BLUE BOX” PODATKI)
English: Mean change from baseline to week 12 in the overall DLQI for the 300 mg treatment groups was greater (p<0.001) than for placebo showing an improvement ranging from 9.7-10.3 points compared to 5.1-6.1 points for the corresponding placebo groups.
Slovenian: Povprečna sprememba skupne ocene dermatološkega indeksa kakovosti življenja (DLQI) od izhodišča do 12. tedna je bila v skupinah z odmerkom 300 mg večja (p<0,001) kot v skupinah s placebom, in sicer je prišlo do izboljšanja za 9,7 do 10,3 točke v primerjavi z izboljšanjem za 5,1 do 6,1 točke v ustreznih skupinah s placebom.
English: Push the needle all the way in to ensure that the medicine can be fully administered.
Slovenian: Iglo potisnite do konca, da boste zagotovo vbrizgali celoten odmerek zdravila.
English: Dispose of the used syringe immediately in a sharps container.
Slovenian: Uporabljeno injekcijsko brizgo takoj zavrzite v zbiralnik za ostre predmete.
English: Powder vial: Clear, colourless type I glass vial with a butyl rubber stopper and grey flip-off seal.
Slovenian: Viala s praškom: viala iz prozornega, brezbarvnega stekla tipa I z zamaškom iz butilne gume in sivo zaporko.
English: The needle cap of the syringe may contain dry rubber (latex).
Slovenian: Pokrovček igle pri injekcijski brizgi lahko vsebuje suho gumo (lateks).
English: If a dose of Xolair is missed
Slovenian: Če ste pozabili na odmerek zdravila Xolair
English: AMPOULE LABEL
Slovenian: NALEPKA NA AMPULI
English: This medicine is used to treat chronic spontaneous urticaria in adults and adolescents (12 years of age and older) who are already receiving antihistamines but whose CSU symptoms are not well controlled by these medicines.
Slovenian: To zdravilo se uporablja za zdravljenje kronične spontane urtikarije pri odraslih in mladostnikih (starih 12 let in več), ki že prejemajo antihistaminike, vendar njihovi simptomi kronične spontane urtikarije s temi zdravili niso dobro urejeni.
English: 1 pre-filled syringe.
Slovenian: 1 napolnjena injecijska brizga.
English: However, animal studies do not indicate either direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Slovenian: Omalizumab prehaja placentarno bariero, študije na živalih pa ne kažejo niti neposrednih niti posrednih škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Chronic spontaneous urticaria (CSU) You will be given two 150 mg injections at a time every four weeks.
Slovenian: Kronična spontana urtikarija Vsake štiri tedne boste skupaj prejeli po dve injekciji s 150 mg učinkovine.
English: Not known (frequency cannot be estimated from the available data) - muscle pain and joint swelling - hair loss
Slovenian: Pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov) - bolečine v mišicah ter otekanje sklepov - izpadanje las
English: 0.5 ml solution in a pre-filled syringe barrel (type I glass) with staked needle (stainless steel), (type I) plunger stopper and needle cap.
Slovenian: 0,5 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I), na katero je pritrjena igla (nerjaveče jeklo (tipa I), batni zamašek in pokrovček igle.
English: Infections and infestations Sinusitis
Slovenian: Infekcijske in parazitske bolezni sinusitis pogosti
English: One vial contains 75 mg omalizumab.
Slovenian: Ena viala vsebuje 75 mg omalizumaba.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtoma ali medicinsko sestro.
English: Because of the viscosity of the reconstituted medicinal product care must be taken to withdraw all of the medicinal product from the vial before expelling any air or excess solution from the syringe in order to obtain the 1.2 ml.
Slovenian: Zaradi viskoznosti rekonstituiranega zdravila morate paziti, da boste zdravilo v celoti odvzeli iz viale, preden boste iz brizge odstranili zrak ali odvečno raztopino, da boste dobili potrebnih 1,2 ml.
English: In the specific subgroup of patients on high dose inhaled corticosteroids, the omalizumab group had a statistically significantly lower rate of clinically significant asthma exacerbations than the placebo group.
Slovenian: V posebni podskupini bolnikov, ki so se zdravili z visokimi odmerki kortikosteroidov za inhaliranje, so bile pri bolnikih, ki so prejemali omalizumab, klinično pomembne eksacerbacije astme statistično značilno manj pogoste kot pri bolnikih s placebom.
English: - Store in a refrigerator (2°C - 8°C).
Slovenian: - Shranjujte v hladilniku (2 C - 8 C).
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) - upper respiratory tract infection, such as inflammation of the pharynx and common cold - feeling of pressure or pain in the cheeks and forehead (sinusitis, sinus headache) - pain in joints (arthralgia)
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) - okužba zgornjih dihal, na primer vnetje žrela in nahod - občutek pritiska ali bolečine v predelu lic ali čela (sinusitis, sinusni glavobol) - bolečine v sklepih (artralgija)
English: What Xolair looks like and contents of the pack Xolair 75 mg powder and solvent for solution for injection is supplied as a white to off-white powder in a small glass vial together with an ampoule containing 2 ml of water for injections.
Slovenian: Zdravilo Xolair 75 mg prašek in vehikel za raztopino za injiciranje je na voljo v obliki belega do skoraj belega praška v majhni stekleni viali skupaj z ampulo, ki vsebuje 2 ml vode za injekcije.
English: You may also use the lower abdomen, but not the area 5 centimetres around the navel (belly button).
Slovenian: Zdravilo lahko injicirate tudi na spodnjem delu trebuha, vendar ne v oddaljenosti 5 centimetrov ali manj od popka.
English: After reconstitution one vial contains 125 mg/ml of omalizumab (75 mg in 0.6 ml).
Slovenian: Po rekonstituciji ena viala vsebuje 125 mg/ml omalizumaba (75 mg v 0,6 ml).
English: Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.
Slovenian: Zdravilo Xolair je indicirano kot dodatno zdravilo za zdravljenje odraslih in mladostnikov (starih 12 let ali več), ki imajo kronično spontano urtikarijo, njihov odziv na zdravljenje z zaviralci histaminskih receptorjev H1 pa ni zadosten.
English: Xolair is also available in vials with 150 mg omalizumab.
Slovenian: Zdravilo Xolair je na voljo tudi v vialah, ki vsebujejo 150 mg omalizumaba.
English: For 300 mg, in studies 1 and 3, the mean decrease from baseline in weekly itch severity score was 9.8 and 8.6, the proportion of patients with UAS7≤6 was 61.7% and 55.6%, and the proportion of patients with complete response (UAS7=0) was 48.1% and 42.5%, respectively, (all p<0.0001, when compared to placebo).
Slovenian: Rezultati glede učinkovitosti so bili po 24 tednih podobni kot po 12 tednih zdravljenja: V študijah 1 in 3 je pri uporabi odmerka 300 mg povprečno zmanjšanje ocene izraženosti srbenja v enem tednu znašalo 9,8 oziroma 8,6 točke, delež bolnikov z oceno UAS7≤ 6 je znašal 61,7 % oziroma 55,6 %, delež bolnikov s popolnim odzivom (z oceno 0 na lestvici UAS7) pa je znašal 48,1 % oziroma 42,5 % (za vse z vrednostjo p<0,0001 v primerjavi s placebom).
English: In addition, acute haemorrhage and inflammation were observed at injection sites in cynomolgus monkeys.
Slovenian: Poleg tega so pri opicah cinomolgus na mestih injiciranja opazili akutno krvavitev in vnetje.
English: Because of the viscosity of the reconstituted medicinal product care must be taken to withdraw all of the medicinal product from the vial before expelling any air or excess solution from the syringe in order to obtain the 0.6 ml.
Slovenian: Zaradi viskoznosti rekonstituiranega zdravila morate paziti, da boste zdravilo v celoti odvzeli iz viale, preden boste iz brizge odstranili zrak ali odvečno raztopino, da boste dobili potrebnih 0,6 ml.
English: Type I local or systemic allergic reactions, including anaphylaxis and anaphylactic shock, may occur when taking omalizumab, even after a long duration of treatment.
Slovenian: Pri uporabi omalizumaba se lahko pojavijo lokalne ali sistemske alergijske reakcije tipa I, vključno z anafilaksijo in anafilaktičnim šokom.
English: • Be careful not to touch the syringe guard wings before use.
Slovenian: • Pazite, da se pred odmerjanjem ne boste dotikali sponk za aktivacijo mehanizma.
English: Serum sickness and serum sickness-like reactions, which are delayed allergic type III reactions, have been seen in patients treated with humanised monoclonal antibodies including omalizumab.
Slovenian: Pri bolnikih, zdravljenih s humaniziranimi monoklonskimi protitelesi, med katera sodi tudi omalizumab, so opažali serumsko bolezen in njej podobne reakcije, ki so zapoznele alergijske reakcije tipa III. Domnevajo, da gre za patofiziološki mehanizem, ki vključuje tvorbo in odlaganje imunskih kompleksov, do katerih pride zaradi razvoja protiteles proti omalizumabu.
English: Your doctor will work out how much Xolair your child needs and how often it needs to be given.
Slovenian: Vaš zdravnik bo določil, koliko zdravila Xolair potrebuje vaš otrok in kako pogosto ga mora prejemati.
English: Omalizumab studies 1, 2 and 3 Pooled Frequency category Placebo N=242
Slovenian: kategorija pogostnosti placebo N=242
English: • Do not shake the syringe.
Slovenian: • Injekcijske brizge ne stresajte.
English: Uncommon (may affect up to 1 in 100 people) - feeling dizzy, sleepy or tired - tingling or numbness of the hands or feet - fainting, low blood pressure while sitting or standing (postural hypotension), flushing - sore throat, coughing, acute breathing problems - feeling sick (nausea), diarrhoea, indigestion - itching, hives, rash, increased sensitivity of the skin to sun - weight increase - flu-like symptoms - swelling arms
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov) - občutek vrtoglavosti, zaspanosti ali utrujenosti - mravljinčenje ali odrevenelost dlani ali stopal - omedlevica, nizek krvni tlak sede ali stoje (posturalna hipotenzija), rdečica - vneto žrelo, kašelj, akutne težave z dihanjem - slabost s siljenjem na bruhanje (navzea), driska, prebavne motnje - srbenje, koprivnica, izpuščaj, povečana občutljivost kože za sončne žarke - povečanje telesne mase - gripi podobni simptomi - otekanje rok
English: Seek medical help immediately if you notice any signs indicating a severe allergic reaction or other serious side effects.
Slovenian: Če opazite kakršenkoli znak, ki lahko pomeni, da gre za hudo alergijsko reakcijo ali katerega od drugih resnih neželenih učinkov, takoj poiščite zdravniško pomoč.
English: 1 ml solution in a pre-filled syringe barrel (type I glass) with staked needle (stainless steel), (type I) plunger stopper and needle cap.
Slovenian: 1 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I), na katero je pritrjena igla (nerjaveče jeklo (tipa I), batni zamašek in pokrovček igle.
English: One vial contains 150 mg omalizumab.
Slovenian: Ena viala vsebuje 150 mg omalizumaba.
English: INSTRUCTIONS FOR USE OF XOLAIR PRE-FILLED SYRINGE
Slovenian: NAVODILA ZA UPORABO ZDRAVILA XOLAIR V NAPOLNJENI INJEKCIJSKI BRIZGI
English: Omalizumab studies 1 and 3 Pooled
Slovenian: 24-tedenske študije združeni podatki iz študij omalizumaba 1 in 3
English: Dose Syringes needed for the dose 75 mg 1 blue
Slovenian: odmerek injekcijsjke brizge, ki jih potrebujete za odmerek 75 mg 1 modra (75 mg)
English: There are no pharmacokinetic or pharmacodynamic data in allergic asthma or CSU patients with renal or hepatic impairment (see sections 4.2 and 4.4).
Slovenian: Pri bolnikih z alergijsko astmo oziroma s kronično spontano urtikarijo in s sočasnimi okvarami ledvic ali jeter niso pridobili nikakršnih farmakokinetičnih ali farmakodinamičnih podatkov (glejte poglavji 4.2 in 4.4).
English: Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2agonist.
Slovenian: Zdravilo Xolair je indicirano kot dodatno zdravilo za izboljšanje obvladovanja astme pri bolnikih s težko trdovratno alergijsko astmo, ki imajo pozitiven kožni test ali in vitro reaktivnost na trajno prisoten zračni alergen in ki imajo pogoste simptome podnevi ali se pogosto ponoči zbujajo, in so imeli po več dokumentiranih težkih eksacerbacij astme kljub vsakodnevnemu inhaliranju velikih odmerkov kortikosteroidov skupaj z dolgo delujočim agonistom adrenergičnih receptorjev beta2 za inhaliranje.
English: Discontinuation of omalizumab should be considered in all severe cases with the above mentioned immune system disorders.
Slovenian: Pri vseh hudih primerih navedenih bolezni imunskega sistema je treba pretehtati možnost prekinitve zdravljenja z omalizumabom.
English: IgE plays a key role in causing allergic asthma or CSU.
Slovenian: IgE igra ključno vlogo pri povzročanju alergijske astme in kronične spontane urtikarije.
English: Dispose of the used syringe immediately in a sharps container (closable, puncture resistant container).
Slovenian: Uporabljeno injekcijsko brizgo takoj odvrzite v zbiralnik za ostre predmete (ki ga je mogoče zapreti in je narejen iz materiala, ki ga ni mogoče prebosti).
English: Xolair is also available in vials with 75 mg omalizumab.
Slovenian: Zdravilo Xolair je na voljo tudi v vialah, ki vsebujejo 75 mg omalizumaba.
English: In CSU, the safety and efficacy of Xolair in paediatric patients below the age of 12 years have not been established.
Slovenian: Za uporabo pri kronični spontani urtikariji varnost in učinkovitost zdravila Xolair pri pediatričnih bolnikih, starih manj kot 12 let, nista bili dokazani.
English: After reconstitution one vial contains 125 mg/ml of omalizumab (150 mg in 1.2 ml).
Slovenian: Po rekonstituciji viala ena vsebuje 125 mg/ml omalizumaba (150 mg v 1,2 ml).
English: Pack containing 1 vial of powder and 1 ampoule of water for injections, and multipacks containing 4 (4 x 1) vials of powder and 4 (4 x 1) ampoules of water for injections or 10 (10 x 1) vials of powder and 10 (10 x 1) ampoules of water for injections.
Slovenian: Pakiranje vsebuje 1 vialo s praškom za raztopino in 1 ampulo z vodo za injekcije, skupna pakiranja pa vsebujejo 4 (4 x 1) viale s praškom za raztopino in 4 (4 x 1) ampule z vodo za injekcije ali 10 (10 x 1) vial s praškom za raztopino in 10 (10 x 1) ampul z vodo za injekcije.
English: Emergency visits Rate per 28-week period % reduction, p-value for rate ratio
Slovenian: % zmanjšanja, vrednost p za razmerje pogostnosti
English: The rate of asthma exacerbations requiring treatment with bursts of systemic corticosteroids was the primary endpoint.
Slovenian: Primarni cilj opazovanja je bila ocena pogostnosti eksacerbacij astme, pri katerih je bilo potrebno kratkotrajno zdravljenje s sistemskimi kortikosteroidi.
English: 1 x 2 ml solvent ampoule
Slovenian: 1 x 2 ml ampula z vehiklom
English: Xolair does not treat acute asthma symptoms, such as a sudden asthma attack.
Slovenian: Zdravilo Xolair ne zdravi akutnih simptomov astme, na primer nenadnega astmatičnega napada, zato se zdravila Xolair ne sme uporabljati za zdravljenje takih simptomov.
English: Xolair 75 mg solution for injection is available in packs containing 1 pre-filled syringe and in multipacks containing 4 (4 x 1) or 10 (10 x 1) pre-filled syringes.
Slovenian: Zdravilo Xolair 75 mg raztopina za injiciranje je na voljo v pakiranjih, ki vsebujejo 1 napolnjeno injekcijsko brizgo in v skupnih pakiranjih, ki vsebujejo 4 (4 x 1) napolnjene injekcijske brizge ali 10 (10 x 1) napolnjenih injekcijskih brizg.
English: Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily highdose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
Slovenian: Zdravilo Xolair je indicirano kot dodatno zdravilo za izboljšanje obvladovanja astme pri bolnikih s težko trdovratno alergijsko astmo, ki imajo pozitiven kožni test ali in vitro reaktivnost na trajno prisoten zračni alergen in ki imajo zmanjšano funkcijo pljuč (FEV1 <80 %), pa tudi pogoste simptome podnevi ali se pogosto ponoči zbujajo, in so imeli po več dokumentiranih težkih eksacerbacij astme kljub vsakodnevnemu inhaliranju velikih odmerkov kortikosteroidov skupaj z dolgo delujočim agonistom adrenergičnih receptorjev beta2 za inhaliranje.
English: This medicine is used to prevent asthma from getting worse by controlling symptoms of severe allergic asthma in adults, adolescents and children (6 years of age and older) who are already receiving asthma medicine, but whose asthma symptoms are not well controlled by medicines such as high-dose steroid inhalers or beta-agonist inhalers.
Slovenian: To zdravilo se uporablja za preprečevanje poslabšanja astme z obvladovanjem simptomov težke alergijske astme pri odraslih, mladostnikih in otrocih (starih 6 let ali več), ki že prejemajo zdravila za astmo, vendar pri njih simptomov astme zdravila, kot so steroidi v velikih odmerkih za inhaliranje ali agonisti adrenergičnih receptorjev beta, ne obvladujejo dobro.
English: Multipack: 4 (4 x 1) pre-filled syringes Multipack: 6 (6 x 1) pre-filled syringes Multipack: 10 (10 x 1) pre-filled syringes
Slovenian: Skupno pakiranje: 4 (4 x 1) napolnjene injekcijske brizge Skupno pakiranje: 6 (6 x 1) napolnjenih injekcijskih brizg Skupno pakiranje: 10 (10 x 1) napolnjenih injekcijskih brizg
English: Based on population pharmacokinetics, distribution of omalizumab was similar in patients with allergic asthma and patients with CSU.
Slovenian: Po podatkih populacijske farmakokinetike je pri bolnikih z alergijsko astmo in pri bolnikih s kronično spontano urtikarijo porazdelitev omalizumaba podobna.
English: Xolair 150 mg powder and solvent for solution for injection is available in packs containing 1 vial of powder and 1 ampoule of water for injections, and in multipacks containing 4 (4 x 1) vials of powder and 4 (4 x 1) ampoules of water for injections or 10 (10 x 1) vials of powder and 10 (10 x 1) ampoules of water for injections.
Slovenian: Zdravilo Xolair 150 mg prašek in vehikel za raztopino za injiciranje je na voljo v pakiranjih, ki vsebujejo 1 vialo s praškom za raztopino za injiciranje in 1 ampulo z vodo za injekcije, in v skupnih pakiranjih, ki vsebujejo 4 (4 x 1) viale s praškom za raztopino za injiciranje in 4 (4 x 1) ampule z vodo za injekcije ali 10 (10 x 1) vial s praškom za raztopino za injiciranje in 10 (10 x 1) ampul z vodo za injekcije.
English: Xolair contains the active substance omalizumab.
Slovenian: Zdravilo Xolair vsebuje učinkovino omalizumab.
English: The injection site
Slovenian: Mesto injiciranja
English: • Cotton ball or gauze.
Slovenian: • kosem vate ali zloženec iz gaze
English: Common * Despite not showing a 2% difference to placebo, injection site reactions were included as all cases were assessed causally related to study treatment.
Slovenian: Infekcijske in parazitske bolezni okužba zgornjih dihal pogosti * Reakcije na mestu injiciranja so vključene v preglednico kljub temu, da do njih ni prišlo za 2 % bolj pogosto kot pri uporabi placeba, vendar je šlo v vseh primerih za vzročno povezanost s študijskim zdravilom.