FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Tijekom kliničkih ispitivanja u odraslih bolesnika i adolescenata 12 godina starosti i više, najčešće zabilježene nuspojave bile su glavobolje i reakcije na mjestu injiciranja, uključujući bol na mjestu injiciranja, oteklinu, eritem i svrbež.
English: Xolair contains the active substance omalizumab.
Croatian: Xolair sadrži djelatnu tvar omalizumab.
English: ADMINISTRATION EVERY 2 WEEKS SEE TABLE 3
Croatian: PRIMJENA SVAKA 2 TJEDNA VIDJETI TABLICU 3
English: Omalizumab binds to IgE and prevents binding of IgE to FcRI (high-affinity IgE receptor) on basophils and mast cells, thereby reducing the amount of free IgE that is available to trigger the allergic cascade.
Croatian: Omalizumab se veže na IgE i sprječava vezanje IgE na FcεRI (IgE receptor visokog afiniteta) na bazofilima i mastocitima, smanjujući pri tome količinu slobodnog IgE koji je na raspolaganju za pokretanje alergijske kaskade.
English: The apparent volume of distribution in patients with asthma following subcutaneous administration was 78 ± 32 ml/kg.
Croatian: Prividni volumen distribucije u bolesnika s astmom nakon supkutane primjene iznosio je 78 ± 32 ml/kg.
English: What you need to know before you use Xolair
Croatian: Što morate znati prije nego primite Xolair
English: There are no pharmacokinetic or pharmacodynamic data in patients with renal or hepatic impairment (see sections 4.2 and 4.4).
Croatian: Nema podataka o farmakokinetici i farmakodinamici u bolesnika s bubrežnim ili jetrenim oštećenjem (vidjeti dijelove 4.2 i 4.4).
English: Xolair treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma or chronic spontaneous urticaria.
Croatian: Liječenje Xolairom treba započeti liječnik s iskustvom u dijagnosticiranju i liječenju teške perzistentne astme ili kronične spontane urtikarije.
English: In studies 1 and 2, patients had a mean weekly itch severity score of between 13.7 and 14.5 at baseline and a mean UAS7 score of 29.5 and 31.7 respectively.
Croatian: U ispitivanjima 1 i 2 bolesnici su imali srednji tjedni rezultat za težinu svrbeža između 13,7 i 14,5 na početku te srednji UAS7 rezultat od 29,5 odnosno 31,7.
English: In allergic asthma, the safety and efficacy of Xolair in paediatric patients below the age of 6 years have not been established.
Croatian: Kod alergijske astme, sigurnost i djelotvornost Xolaira u pedijatrijskih bolesnika ispod 6 godina nije ustanovljena.
English: Following a single subcutaneous dose in adult and adolescent patients with asthma, omalizumab was absorbed slowly, reaching peak serum concentrations after an average of 7-8 days.
Croatian: Nakon pojedinačne supkutane doze u odraslih bolesnika i adolescenata s astmom omalizumab se apsorbirao polako, postižući vršne koncentracije u serumu nakon prosječno 7-8 dana.
English: OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)
Croatian: VANJSKA KUTIJA VIŠESTRUKIH PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: There have been no studies on the effect of impaired renal or hepatic function on the pharmacokinetics of Xolair.
Croatian: Nisu provedena ispitivanja učinka oštećenja funkcije bubrega ili jetre na farmakokinetiku Xolaira.
English: • Sharps disposal container.
Croatian: • Spremnik za odlaganje oštrih predmeta.
English: Consequently, if clinically needed, the use of Xolair may be considered during breast-feeding.
Croatian: Zbog toga, ako je klinički potrebno, može se razmotriti primjena Xolaira tijekom dojenja.
English: Intact IgG is also excreted in bile.
Croatian: Nerazgrađeni IgG se isto tako izlučuje putem žuči.
English: Symptoms may include rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (voice box), windpipe or other parts of the body, fast heartbeat, dizziness and light-headedness, confusion, shortness of breath, wheezing or trouble breathing, blue skin or lips, collapsing and losing consciousness.
Croatian: Simptomi mogu uključivati osip, svrbež kože ili koprivnjaču, oticanje lica, usana, jezika, grkljana (glasnica), dušnika ili drugih dijelova tijela, ubrzane otkucaje srca, omaglicu i ošamućenost, smetenost, nedostatak zraka, piskanje u prsima ili smetnje disanja, plavilo kože ili usana, kolaps i gubitak svijesti.
English: You should not be given Xolair: - if you are allergic to omalizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ne smijete primati Xolair - ako ste alergični na omalizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Table 3 ADMINSTRATION EVERY 2 WEEKS.
Croatian: Tablica 3 PRIMJENA SVAKA 2 TJEDNA.
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.
Croatian: Bolesnici u ispitivanju sigurnosti 3 imali su srednji tjedni rezultat za težinu svrbeža od 13,8 te srednji UAS7 rezultat od 31,2 na početku.
English: It is also important that you do not inject Xolair yourself until you have been trained by your doctor or nurse on: - how to recognise the early signs and symptoms of serious allergic reactions - what to do if the symptoms occur.
Croatian: Poduka za prepoznavanje ozbiljnih alergijskih reakcija Isto tako je važno da si ne ubrizgavate Xolair sami dok Vas liječnik ili medicinska sestra nisu podučili: - kako prepoznati rane znakove i simptome ozbiljnih alergijskih reakcija. - što učiniti ako se pojave simptomi.
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.
Croatian: Klinička ispitivanja KSU-a uključivala su neke bolesnike u dobi od 12 do 17 godina koji su uzimali Xolair zajedno s antihistaminicima (anti-H1, anti-H2) i antagonistima leukotrijenskih receptora.
English: The adverse reactions are listed by MedDRA system organ class.
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava po MedDRA-i.
English: If a dose of Xolair is missed Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Croatian: Ako ste zaboravili primijeniti Xolair Javite se svom liječniku ili u bolnicu čim prije, kako biste ponovno dogovorili termin.
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).
Croatian: Omalizumab u dozi od 300 mg smanjio je tjedni rezultat za težinu svrbeža za 8,55,do 9,77 (p<0,0001) u usporedbi sa smanjenjem od 3,63, do 5,14, za placebo (vidjeti Tablicu 7).
English: Xolair is given to you by a doctor or nurse as an injection just under the skin (subcutaneously).
Croatian: Liječnik ili medicinska sestra će Vam Xolair dati injekcijom neposredno ispod kože (supkutano).
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).
Croatian: Za 300 mg, u ispitivanjima 1 i 3, srednje smanjenje u odnosu na početnu vrijednost tjednog rezultata za težinu svrbeža bilo je 9,8 odnosno 8,6, udio bolesnika s UAS7≤6 bio je 61,7% odnosno 55,6%, a udio bolesnika s kompletnim odgovorom (UAS7=0) bio je 48,1% odnosno 42,5%, (za sve p<0,0001, u usporedbi s placebom).
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.
Croatian: Farmakokinetika omalizumaba ispitivana je u odraslih bolesnika i adolescenata s alergijskom astmom, kao i u odraslih bolesnika i adolescenata s KSU-om.
English: Serum sickness
Croatian: Serumska bolest
English: For subcutaneous administration only.
Croatian: Samo za supkutanu primjenu.
English: Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss, and fatigue.
Croatian: Simptomi mogu uključivati bol u mišićima, bol i oticanje zglobova, osip, vrućicu, gubitak težine i umor.
English: Angioedema
Croatian: Anafilaksija
English: The primary endpoint was the change from baseline to week 12 in weekly itch severity score.
Croatian: Primarna mjera ishoda bila je promjena od početne vrijednosti do 12. tjedna u tjednom rezultatu za težinu svrbeža.
English: The majority of anaphylactic reactions occurred within the first 3 doses of Xolair.
Croatian: Većina anafilaktičkih reakcija pojavila se uz prve 3 doze Xolaira.
English: Clinical trial and post-marketing cases of systemic lupus erythematosus (SLE) have been reported in patients with moderate to severe asthma and CSU.
Croatian: Slučajevi sistemskog eritemskog lupusa (SLE) iz kliničkog ispitivanja i nakon stavljanja lijeka na tržište bili su prijavljeni u bolesnika s umjerenom do teškom astmom i kroničnom spontanom urtikarijom (KSU).
English: 1.2 ml = maximum delivered volume per vial (Xolair 150 mg).
Croatian: 1,2 ml = maksimalno dobiven volumen po bočici (Xolair 150 mg).
English: Xolair therapy has not been studied in patients with autoimmune diseases, immune complex-mediated conditions, or pre-existing renal or hepatic impairment (see section 4.2).
Croatian: Terapija Xolairom nije ispitivana u bolesnika s autoimunim bolestima, stanjima koja su posredovana imunokompleksom, kao ni u bolesnika s prethodno postojećim oštećenjem funkcije bubrega ili jetre (vidjeti dio 4.2).
English: There have been no studies on the effect of impaired renal or hepatic function on the pharmacokinetics of omalizumab.
Croatian: Nisu provedena ispitivanja učinka oštećenja funkcije bubrega ili jetre na farmakokinetiku omalizumaba.
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.
Croatian: U kliničkim ispitivanjima razine slobodnog IgE u serumu su se smanjile, u ovisnosti o dozi, unutar jednog sata nakon primjene prve doze te su se održavale između doza.
English: Following a single subcutaneous dose in adult and adolescent patients with asthma or CSU, omalizumab was absorbed slowly, reaching peak serum concentrations after an average of 6-8 days.
Croatian: Nakon pojedinačne supkutane doze u odraslih bolesnika i adolescenata s astmom ili KSU-om omalizumab se apsorbirao polako, postižući vršne koncentracije u serumu nakon prosječno 6-8 dana.
English: 0.6 ml = maximum delivered volume per vial (Xolair 75 mg).
Croatian: 0,6 ml = maksimalno dobiven volumen po bočici (Xolair 75 mg).
English: Xolair is available in packs containing one vial of powder for solution for injection and one ampoule of 2 ml water for injections.
Croatian: Xolair je dostupan u pakiranju koje sadrži jednu bočicu s praškom za otopinu za injekciju i jednu ampulu s 2 ml vode za injekcije.
English: Therefore medicinal products for the treatment of anaphylactic reactions should always be available for immediate use following administration of Xolair.
Croatian: Stoga lijekovi za liječenje anafilaktičkih reakcija trebaju uvijek biti dostupni za slučaj da je potrebna njihova hitna primjena nakon davanja Xolaira.
English: A history of anaphylaxis unrelated to omalizumab may be a risk factor for anaphylaxis following Xolair administration.
Croatian: Anamneza anafilaksije koja nije bila povezana s omalizumabom može biti čimbenik rizika za pojavu anafilaksije nakon primjene Xolaira.
English: Medicinal product or vaccine interaction studies have not been performed with Xolair.
Croatian: Ispitivanja interakcija Xolaira s lijekovima ili cjepivima nisu provedena.
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).
Croatian: Nema podataka o farmakokinetici i farmakodinamici u bolesnika s alergijskom astmom ili KSU-om i bubrežnim ili jetrenim oštećenjem (vidjeti dijelove 4.2 i 4.4).
English: Expel air, large bubbles, and any excess solution in order to obtain the required 0.6 ml dose.
Croatian: Istisnuti zrak, velike mjehuriće i suvišak otopine, da se dobije potrebna doza od 0,6 ml.
English: Xolair should not be used in children under 12 years of age.
Croatian: Xolair se ne smije primjenjivati u djece mlađe od 12 godina.
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.
Croatian: U kliničkim ispitivanjima u bolesnika s alergijskom astmom razine slobodnog IgE u serumu su se smanjile, u ovisnosti o dozi, unutar jednog sata nakon primjene prve doze te su se održavale između doza.
English: ADMINISTRATION EVERY 4 WEEKS SEE TABLE 2
Croatian: PRIMJENA SVAKA 4 TJEDNA VIDJETI TABLICU 2
English: Driving and using machines It is unlikely that Xolair will affect your ability to drive and use machines.
Croatian: Mala je vjerojatnost da će Xolair utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: Symptoms may include one or more of the following: joint pain with or without swelling or stiffness, rash, fever, swollen lymph nodes, muscle pain.
Croatian: Simptomi mogu uključivati jedno ili više od sljedećeg: bolovi u zglobovima sa ili bez oticanja ili ukočenosti, osip, vrućica, oticanje limfnih čvorova, bolovi u mišićima.
English: The pharmacokinetics of omalizumab have been studied in adult and adolescent patients with allergic asthma.
Croatian: Farmakokinetika omalizumaba ispitivana je u odraslih bolesnika i adolescenata s alergijskom astmom.
English: Pack containing one vial of powder for solution for injection and one ampoule of water for injections.
Croatian: Pakiranje sadrži jednu bočicu s praškom za otopinu za injekciju i jednu ampulu s vodom za injekcije.
English: - Do not use this medicine after the expiry date which is stated on the label.
Croatian: - Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake EXP.
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.
Croatian: U 24. tjednu razlika u stopama između terapijskih skupina bila je 34%-tno smanjenje (omjer stopa 0,662, p=0,047) kod bolesnika liječenih omalizumabom u odnosu na placebo.
English: Expel air, large bubbles, and any excess solution in order to obtain the required 1.2 ml dose.
Croatian: Istisnuti zrak, velike mjehuriće i suvišak otopine, da se dobije potrebna doza od 1,2 ml.
English: Xolair doses (milligrams per dose) administered by subcutaneous injection every 2 weeks
Croatian: Doze Xolaira (miligrami po dozi) koje se primjenjuju supkutanom injekcijom svaka 2 tjedna
English: General disorder and administration site conditions Injection site reaction*
Croatian: Opći poremećaji i reakcije na mjestu primjene Reakcije na mjestu primjene injekcije*
English: Posology The recommended dose is 300 mg by subcutaneous injection every four weeks.
Croatian: Preporučena doza je 300 mg supkutanom injekcijom svaka četiri tjedna.
English: Also contains: L-arginine hydrochloride, L-histidine hydrochloride, L-histidine, polysorbate 20, water for injections.
Croatian: Također sadrži: L-argininklorid, L-histidinklorid, L-histidin, polisorbat 20, vodu za injekcije.
English: CARTON FOR UNIT PACK
Croatian: KUTIJA JEDINIČNOG PAKIRANJA
English: Xolair has not been studied in patients with hyperimmunoglobulin E syndrome or allergic bronchopulmonary aspergillosis or for the prevention of anaphylactic reactions, including those provoked by food allergy, atopic dermatitis, or allergic rhinitis.
Croatian: E ili alergijskom bronhopulmonalnom aspergilozom, kao ni za prevenciju anafilaktičkih reakcija, uključujući one izazvane alergijom na hranu, atopijskog dermatitisa ili alergijskog rinitisa.
English: Caution should be exercised when administering Xolair in these patient populations.
Croatian: Prilikom primjene Xolaira u ovim populacijama bolesnika potreban je oprez.
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
Croatian: Manje često (mogu se javiti u manje od 1 na 100 ljudi) - omaglicu, pospanost ili umor - žmarce ili utrnulost u rukama ili stopalima - nesvjesticu, sniženi krvni tlak pri sjedanju ili ustajanju (posturalna hipotenzija), navale crvenila - grlobolju, kašalj, akutne probleme s disanjem - mučninu, proljev, probavne smetnje - svrbež, urtikariju, osip, pojačanu osjetljivost kože na sunce - povećanje tjelesne težine - simptome nalik gripi - oticanje ruku
English: The reconstituted medicinal product will appear clear to slightly opalescent, colourless to pale brownish-yellow.
Croatian: Rekonstituirani lijek će biti bistar do lagano opalescentan, bezbojan do blijedo smeđkasto-žute boje.
English: The safety and efficacy of Xolair in children below age 6 have not been established.
Croatian: Sigurnost i djelotvornost Xolaira u djece ispod 6 godina nije ustanovljena.
English: Xolair doses (milligrams per dose) administered by subcutaneous injection every 4 weeks
Croatian: Doze Xolaira (miligrami po dozi) koje se primjenjuju supkutanom injekcijom svaka 4 tjedna
English: Omalizumab is excreted in breast milk in cynomolgus monkeys.
Croatian: Omalizumab se u cynomolgus majmuna izlučuje u mlijeku.
English: DO NOT USE if the product has expired.
Croatian: NE UPOTREBLJAVAJTE ako je lijeku istekao rok valjanosti.
English: Following multiple doses of omalizumab, areas under the serum concentration-time curve from Day 0 to Day 14 at steady state were up to 6-fold of those after the first dose.
Croatian: Nakon višekratnih doza omalizumaba površine ispod krivulje ovisnosti koncentracije u serumu o vremenu, od dana 0 do dana 14, u stanju dinamičke ravnoteže bile su do 6 puta veće od onih nakon prve doze.
English: Xolair is also available in vials with 150 mg omalizumab.
Croatian: Xolair je također dostupan u bočicama sa 150 mg omalizumaba.
English: Table 2 ADMINISTRATION EVERY 4 WEEKS.
Croatian: Tablica 2 PRIMJENA SVAKA 4 TJEDNA.
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.
Croatian: U globalnoj procjeni učinkovitosti terapije na kraju 52-tjednog razdoblja dvostruko slijepe terapije u podskupini teških bolesnika na visokim dozama inhalacijskih kortikosteroida s dugo-djelujućim beta-agonistima udio bolesnika kod kojih je učinkovitost liječenja ocijenjena „odličnom“ bio je veći, a udjeli kod kojih je učinkovitost liječenja ocijenjena „umjerenom“ ili „slabom“ bili su manji u skupini liječenoj omalizumabom u usporedbi sa skupinom koja je primala placebo.
English: The vial delivers 1.2 ml (150 mg) of Xolair.
Croatian: Bočica osigurava dozu od 1,2 ml (150 mg) Xolaira.
English: P-value vs. placebo
Croatian: P-vrijednost naspram placeba
English: L-histidine hydrochloride monohydrate Polysorbate 20
Croatian: L-histidinklorid hidrat polisorbat 20
English: Chronic spontaneous urticaria (CSU)
Croatian: Kronična spontana urtikarija (KSU)
English: How to use the Xolair pre-filled syringe
Croatian: Kako upotrijebiti Xolair napunjenu štrcaljku
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.
Croatian: Xolair 150 mg prašak i otapalo za otopinu za injekciju dolazi kao bijeli do bjelkasti prašak u maloj staklenoj bočici zajedno s ampulom koja sadrži 2 ml vode za injekcije.
English: In reproduction studies in cynomolgus monkeys, subcutaneous doses up to 75 mg/kg per week (at least 8 times the highest recommended clinical dose in mg/kg over a 4-week period) did not elicit maternal toxicity, embryotoxicity or teratogenicity when administered throughout organogenesis and did not elicit adverse effects on foetal or neonatal growth when administered throughout late gestation, delivery and nursing.
Croatian: U reprodukcijskim studijama cynomolgus majmuna supkutane doze do 75 mg/kg tjedno (najmanje 8 puta veća od najveće preporučene kliničke doze u mg/kg tijekom 4 tjedna) nisu izazvale toksičnost kod majke, embriotoksičnost ili teratogenost tijekom primjene kroz period organogeneze te nisu izazvale nuspojave vezane uz fetalni i neonatalni rast tijekom primjene kroz period kasne trudnoće, porođaja i dojenja.
English: There is no pharmacological reason to expect that commonly prescribed medicinal products used in the treatment of asthma will interact with omalizumab.
Croatian: Ne postoji farmakološki razlog zbog kojeg bi se mogle očekivati interakcije omalizumaba s lijekovima koji se obično propisuju za liječenje astme.
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)
Croatian: Često (mogu se javiti u manje od 1 na 10 ljudi) - reakcije na mjestu primjene injekcije, uključujući bol, oticanje, svrbež i crvenilo - bol u gornjem dijelu trbuha (u djece) - glavobolju (vrlo često u djece) - infekciju gornjeg dijela dišnog sustava, kao što je upala ždrijela i obična prehlada - osjećaj pritiska ili boli u obrazima i čelu (sinusitis, sinusna glavobolja) - bol u zglobovima (artralgija)
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.
Croatian: Srednja promjena od početne vrijednosti do 12. tjedna u ukupnom rezultatu dermatološkog indeksa kvalitete života (DLQI) za terapijske skupine koje su primale 300 mg bila je veća (p<0,001) nego za placebo, s poboljšanjem u rasponu od 9,7-10,3 bodova u usporedbi s 5,1-6,1 bodova za odgovarajuće placebo skupine.
English: Systemic lupus erythematosus (SLE)
Croatian: • Sistemski eritemski lupus (SLE).
English: If you think you may be allergic to any of the ingredients, tell your doctor as you should not be given Xolair.
Croatian: Ako mislite da biste mogli biti alergični na bilo koji sastojak lijeka Xolair, obavijestite svog liječnika jer u tom slučaju ne smijete primijeniti Xolair.
English: Injection site reactions such as swelling, erythema, pain, pruritus
Croatian: Često reakcije na mjestu injiciranja poput otekline, eritema, boli, svrbeža
English: Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions listed first.
Croatian: Unutar svakog organskog sustava nuspojave su poredane po učestalosti, počevši od najučestalijih.
English: In addition, acute haemorrhage and inflammation were observed at injection sites in cynomolgus monkeys.
Croatian: Osim toga, u cynomolgus majmuna su primijećeni akutno krvarenje i upala na mjestu injekcije.
English: The vial delivers 0.6 ml (75 mg) of Xolair.
Croatian: Bočica osigurava dozu od 0,6 ml (75 mg) Xolaira.