FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 5 includes results in the study 1 population.
Maltese: Tabella 5 tinkludi riżultati fil-popolazzjoni ta' studju 1.
English: Precipitating complexes and complexes larger than one million Daltons in molecular weight are not observed in vitro or in vivo.
Maltese: Kumplessi li jippreċipitaw jew kumplessi akbar minn miljun Daltons fil-piż molekolari ma dehrux in vitro jew in vivo.
English: Draw 1.4 ml of water for injections from the ampoule into a syringe equipped with a large-bore 18-gauge needle.
Maltese: Iġbed 1.4 ml ta' ilma għall-injezzjonijiet mill-ampulla fis-siringa mgħammra b'labra 18-gejġ b'kalibru wiesa'.
English: In controlled clinical trials and during interim analyses of an observational study, a numerical imbalance of ATE was observed.
Maltese: Waqt provi kliniċi kkontrollati u waqt analiżi interim ta' studju ta' osservazzjoni, kien osservat żbilanċ numeriku fl-ATE.
English: Latex-sensitive individuals
Maltese: Individwi sensittivi għal-latex
English: The strata were baseline weekly itch severity score (<13 vs. ≥13) and baseline weight (<80 kg vs. ≥80 kg).
Maltese: ≥13) u l-piż fil-linja bażi (<80 kg vs.
English: c or use 0.6 ml from a 150 mg vial.
Maltese: c jew uża 0.6 ml minn kunjett ta' 150 mg.
English: 525 mg 1 blue (75 mg)
Maltese: 525 mg 1 blu (75 mg)
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.
Maltese: Xolair hu indikat bħala terapija kumplimentari fit-trattament ta' urtikarja spontanja kronika f'pazjenti adulti u adolexxenti (minn 12-il sena 'l fuq) b'rispons inadegwat għat-trattament bl-antiistamina H1.
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).
Maltese: 77 (p<0.0001) imqabbel mat-tnaqqis ta' 3.63 sa 5.14 għall-plaċebo (ara Tabella 7).
English: Plunger head
Maltese: Ras il-planġer head
English: In a subgroup analysis, patients with pre-treatment total IgE ≥76 IU/ml were more likely to experience clinically meaningful benefit to Xolair.
Maltese: F'analiżi ta' sottogrupp, pazjenti li kellhom livelli ta' IgE ≥76 IU/ml kellhom aktar ċans li jiksbu benefiċju ta' valur kliniku bi Xolair.
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.
Maltese: Il-pazjenti fl-istudju 3 dwar is-sigurtà kellhom skor medju dwar is-severità ta' 13.8 u skor medju ta' UAS7 ta' 31.2 fil-linja bażi.
English: A prospective pregnancy registry study (EXPECT) in 250 pregnant women with asthma exposed to Xolair showed the prevalence of major congenital anomalies was similar (8.1% vs. 8.9%) between EXPECT and disease-matched (moderate and severe asthma) patients.
Maltese: Studju prospettiv tar-reġistru tat-tqala (EXPECT) fuq 250 mara tqila bl-ażżma esposti għal Xolair wera li l-prevalenza ta' anomaliji konġenitali maġġuri kienet simili (8.1% vs. 8.9%) bejn EXPECT u pazjenti b'marda simili (ażżma moderata u gravi). Linterpretazzjoni tad-data tista' tiġi affettwata minħabba limitazzjonijiet metodoloġiċi tal-istudju, inklużi daqs żgħir tal-kampjun u disinn mhux randomised.
English: Further evaluations which did show statistical significance (p<0.05) in favour of Xolair included reductions in severe exacerbations (where patient's lung function was reduced to below 60% of personal best and requiring systemic corticosteroids) and asthma-related emergency visits (comprised of hospitalisations, emergency room, and unscheduled doctor visits), and improvements in Physician's overall assessment of treatment effectiveness, Asthma-related Quality of Life (AQL), asthma symptoms and lung function.
Maltese: Omalizumab naqqas ir-rata ta' aggravar ta'lattakki ta' l-ażma b'19% (p = 0.153). Kalkoli oħra li wrew titjib statistikament sinifikanti (p<0.05) favur Xolair kienu jinkludu tnaqqis fl-aggravar qawwi ta' l-attakki (fejn il-funzjoni tal-pulmun talpazjenti kienet imnaqqsa għal taħt 60% ta' l-aħjar valur personali u li kellhom bżonn kortikosterojdi b'mod sistemiku) u żjajjar ta' emergenza relatati ma' l-ażma (imklużi dħul l-isptar, kamra ta' lemerġenza, u żjajjar bla ħsieb għand it-tabib), u titjib fl-istima ġenerali tat-tabib dwar l-effett tal-kura, Il-Kwalità tal-Ħajja relatata ma' l-Ażma (AQL), sintomi ta' l-ażma u funzjoni tal-pulmun.
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.
Maltese: Xolair 150 mg trab u solvent għal soluzzjoni għall-injezzjoni huwa disponibbli f'pakketti li fihom kunjett 1 ta' trab u ampulla 1 ta' ilma għall-injezzjonijiet, u f'pakketti multipli li jkun fihom 4 (4 x 1) ampulli ta' ilma għall-injezzjoni jew 10 (10 x 1) kunjetti ta' trab u 10 (10 x 1) ampulli ta' ilma għall-injezzjonijiet.
English: 225 mg 1 blue (75 mg)
Maltese: 225 mg 1 blu (75 mg)
English: Headache*
Maltese: Deni**
English: Omalizumab is a man-made protein that is similar to natural proteins produced by the body.
Maltese: Omalizumab huwa proteina magħmula mill-bniedem li tixbah lill-proteini naturali prodotti mill-ġisem.
English: Table 1 Conversion from dose to number of syringes, number of injections and total injection volume for each administration
Maltese: Tabella 1 Konverżjoni minn doża għan-numru ta' siringi, numru ta' injezzjonijiet u t-total tal-volum tal-injezzjoni għal kull għotja ta' doża
English: Mean change from baseline in weekly itch severity score showed a reduction of 8.25 at week 12 and of 8.95 at week 24.
Maltese: Il-bidla medja mil-linja bażi fl-iskor dwar is-severità tal-ħakk ta' kull ġimgħa wriet tnaqqis ta' 8.25 fit-12-il ġimgħa u ta' 8.95 fl-24 ġimgħa.
English: In rare cases, patients on therapy with anti-asthma medicinal products, including omalizumab, may present or develop systemic eosinophilia and vasculitis.
Maltese: F'każijiet rari, pazjenti fuq terapija bi prodotti mediċinali kontra l-ażma, inkluż omalizumab, jista' jaqbadhom jew jiżviluppaw eżinofilja sistemika u vaskulite.
English: Following doses of 75 mg, 150 mg or 300 mg every 4 weeks in patients with CSU, trough serum concentrations of omalizumab increased proportionally with the dose level.
Maltese: Wara dożi ta' 75 mg, 150 mg jew 300 mg kull 4 ġimgħat f'pazjenti b'CSU, l-inqas livell ta' konċentrazzjonijiet ta' omalizumab fis-serum żdied proporzjonalment skont il-livell tad-doża.
English: The vial delivers 0.6 ml (75 mg) of Xolair.
Maltese: Il-kunjett ikun fih 0.6 ml (75 mg) ta' Xolair.
English: Xolair is also available in vials with 150 mg omalizumab.
Maltese: Xolair huwa disponibbli wkoll f'kunjetti b'150 mg omalizumab.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: One syringe of 0.5 ml solution contains 75 mg omalizumab.
Maltese: Siringa waħda b'0.5 ml ta' soluzzjoni fiha 75 mg omalizumab.
English: There are no pharmacokinetic or pharmacodynamic data in patients with renal or hepatic impairment (see sections 4.2 and 4.4).
Maltese: M'hemmx tagħrif farmakokinetiku jew farmakodinamiku f'pazjenti li jsofru b'indeboliment renali jew epatiku (ara sezzjonijiet 4.2 u 4.4).
English: Patients in the 300 mg treatment groups achieved the highest mean proportion of angioedema-free days from week 4 to week 12, (91.0-96.1%; p<0.001) compared to the placebo groups (88.1-89.2%).
Maltese: 1%; p<0.001) imqabbel mal-gruppi mogħtija plaċebo (88.1-89.2%).
English: Infections and infestations Sinusitis
Maltese: Infezzjonijiet u infestazzjonijiet Sinużite
English: Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2).
Maltese: Kura bi Xolair għandha titqies biss f'każ ta' pazjenti b'evidenza konvinċenti li l-ażma tkun medjata b'IgE (immunoglobulina E) (ara sezzjoni 4.2).
English: Limited data are available on the use of Xolair in combination with specific immunotherapy (hypo-sensitisation therapy).
Maltese: Hemm tagħrif limitat dwar l-użu ta' Xolair ma' immunoterapija speċifika (terapija ta' iposensitazzjoni).
English: Angioedema
Maltese: Angjoedima
English: Anaphylactic reaction, other serious allergic conditions, antiomalizumab antibody development
Maltese: Reazzjoni anafilattika, kundizzjonijiet allerġiċi serji oħra, żvilupp ta' antikorp anti-omalizumab
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).
Maltese: M'hemmx tagħrif farmakokinetiku jew farmakodinamiku f'pazjenti b'ażma allerġika jew CSU li jsofru b'indeboliment renali jew epatiku (ara sezzjonijiet 4.2 u 4.4).
English: Component of a multipack.
Maltese: Jagħmel parti minn pakkett multiplu.
English: For a 75 mg dose, draw up 0.6 ml into the syringe and discard the remaining solution.
Maltese: Għal doża ta' 75 mg, iġbed 0.6 ml fis-siringa u armi s-soluzzjoni li jibqa'.
English: Omalizumab studies 1, 2 and 3 Pooled Frequency category Placebo N=242
Maltese: Ġabra ta' studji 1, 2 u 3 b'Omalizumab
English: Since IgE may be involved in the immunological response to some helminth infections, Xolair may indirectly reduce the efficacy of medicinal products for the treatment of helminthic or other parasitic infections (see section 4.4).
Maltese: Peress li IgE jista' jkun involut fir-rispons immunoloġiku għal xi infezzjonijiet ikkawżati minn elminti, Xolair b'mod indirett jista' jnaqqas l-effikaċja ta' prodotti mediċinali għall-kura ta' infezzjonijiet ikkawżati minn elminti jew parassiti oħra (ara sezzjoni 4.4).
English: Draw 0.9 ml of water for injections from the ampoule into a syringe equipped with a large-bore 18-gauge needle.
Maltese: Iġbed 0.9 ml ta' ilma għall-injezzjonijiet mill-ampulla fis-siringa mgħammra b'labra 18-gejġ b'kalibru wiesa'.
English: Xolair is indicated in adults, adolescents and children (6 to <12 years of age).
Maltese: Xolair huwa indikat fl-adulti, fl-adoloxxenti u fit-tfal (minn 6 snin sa <12-il sena).
English: The apparent volume of distribution in patients following subcutaneous administration was 78 ± 32 ml/kg.
Maltese: Il-volum ta' distribuzzjoni apparenti f'pazjenti b'ażma wara li ngħataw doża taħt il-ġilda kien ta' 78 ± 32 ml/kg.
English: Number of injections
Maltese: Numru ta' injezzjonijiet
English: In asthma patients the omalizumab serum elimination half-life averaged 26 days, with apparent clearance averaging 2.4  1.1 ml/kg/day.
Maltese: F'pazjenti li jsofru bl-ażma, il-medja tal-half life ta' eliminazzjoni mis-serum ta' omalizumab kienet ta' 26 jum, b'medja tat-tneħħija apparenti ta' 2.4  1.1 ml/kg/jum.
English: Xolair works by blocking a substance called immunoglobulin E (IgE), which is produced by the body.
Maltese: Xolair jaħdem billi jimblokka sustanza msejjħa immunoglobulina E (IgE), li tiġi magħmula millġisem.
English: Week 12 Primary Endpoint
Maltese: Endpoint primarju fit12-il ġimgħa
English: p-value is derived from ANCOVA t-test.
Maltese: Il-valur-p qed jinkiseb mit-t-test ANCOVA.
English: Table 7 Change from baseline to week 12 in weekly itch severity score, studies 1, 2 and 3 (mITT population*)
Maltese: Tabella 7 Bidla mil-linja bażi fit-12-il ġimgħa fl-iskor dwar is-severità tal-ħakk ta' kull ġimgħa, studji 1, 2 u 3 (popolazzjoni mITT*)
English: In these patients in study 1 Xolair reduced the rate of asthma exacerbations by 40% (p = 0.002).
Maltese: F'dawn il-pazjenti f'studju 1, Xolair naqqas ir-rata ta' l-aggravar ta' l-attakki ta' l-ażma b'40% (p = 0.002).
English: One vial contains 75 mg omalizumab.
Maltese: Kunjett wieħed fih 75 mg omalizumab.
English: In addition, a population pharmacokinetic analysis showed no relevant effect of H2 antihistamines and LTRAs on omalizumab pharmacokinetics (see section 5.2).
Maltese: H2 u LTRAs fuq il-farmakokinetiċi ta' omalizumab (ara sezzjoni 5.2).
English: Reactions reported in the post-marketing setting are listed with frequency not known (cannot be estimated from the available data).
Maltese: Reazzjonijiet rappurtati wara t-tqegħid fis-suq qegħdin elenkati bil-frekwenza mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomised design.
Maltese: L-interpretazzjoni tad-data tista' tiġi affettwata minħabba limitazzjonijiet metodoloġiċi tal-istudju, inklużi daqs żgħir tal-kampjun u disinn mhux randomised.
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.
Maltese: Pakkett li jkun fih kunjett wieħed ta' trab u ampulla waħda ta' ilma għall-injezzjonijiet, u pakketti multipli li jkun fihom 4 (4 x 1) kunjetti ta' trab u 4 (4 x 1) ampulli ta' ilma għall-injezzjonijiet jew 10 (10 x 1) kunjetti ta' trab u 10 (10 x 1) ampulli ta' ilma għall-injezzjonijiet.
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
Maltese: (ipotensjoni skont il-qagħda), issir ruxxan - uġigħ fil-grieżem, sogħla, problemi akuti biex tieħu n-nifs. - tħossok ħażin (tqallih), diarrea, indiġestjoni - ħakk, infafet, raxx, il-ġilda ssir aktar sensittiva għax-xemx - żieda fil-piż - sintomi li jixbhu l-influwenza - dirgħajn jintefħu
English: Take the box containing the syringe out of the refrigerator and leave it unopened for about 20 minutes so that it reaches room temperature (leave the syringe in the box to protect it from light).
Maltese: Oħroġ il-kaxxa li fiha s-siringa mill-friġġ u ħalliha magħluqa għal madwar 20 minuta sa kemm tilħaq it-temperatura tal-kamra (ħalli s-siringa fil-kaxxa biex tipproteġiha mid-dawl).
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.
Maltese: Waqt il-perjodu ta' 52 ġimgħa ta' kura double-blind (li tinkludi l-fażi ta' 24 ġimgħa fejn ingħatat doża fissa ta' sterojd u l-fażi ta' 28 ġimgħa ta' aġġustament tal-isterjod) id-differenza fir-rati bejn iż-żewġ gruppi ta' kura kienet tirrapreżenta tnaqqis relattiv ta' 50% (rata ta' proporzjon 0.504, p<0.001) fittaħrix tal-ażma fil-pazjenti li kienu qed jieħdu omalizumab.
English: - The needle cap of the syringe may contain dry rubber (latex).
Maltese: - L-għatu tal-labra tas-siringa jista' jkollu lastku xott (latex).
English: Four additional large placebo-controlled supportive studies of 28 to 52 weeks duration in 1,722 adults and adolescents (studies 3, 4, 5, 6) assessed the efficacy and safety of Xolair in patients with severe persistent asthma.
Maltese: Ma' dawn, erba' studji ta' support kbar kontrollati bi plaċebo, li damu minn 28 sa 52 ġimgħa f'1,722 adulti u adolexxenti (studji 3,4,5,6) stmaw l-effett u s-sigurtà ta' Xolair f'pazjenti b'ażma qawwija persistenti.
English: The removable needle cap of this pre-filled syringe contains a derivative of natural rubber latex.
Maltese: L-għatu li jitneħħa tal-labra ta' din is-siringa mimlija għal-lest fiha derivat tal-lastku naturali latex.
English: INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
Maltese: KARTUNA GĦALL-PAKKETT INTERMEDJU (MINGĦAJR IL-KAXXA Ċ-ĊELESTI)
English: Xolair 150 mg injection omalizumab SC
Maltese: Xolair 150 mg injezzjoni omalizumab
English: One vial contains 150 mg of omalizumab*.
Maltese: U KWANTITATTIVA Kunjett wieħed fih 150 mg omalizumab*.
English: 1 purple (150 mg)
Maltese: 1 vjola (150 mg)
English: One vial contains 75 mg of omalizumab*.
Maltese: U KWANTITATTIVA Kunjett wieħed fih 75 mg omalizumab*.
English: 2 purple (150 mg)
Maltese: 2 vjola (150 mg)
English: CARTON FOR UNIT PACK
Maltese: KARTUA INTERMEDJA TAL-PAKKETTI
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.
Maltese: Waqt provi kliniċi f'pazjenti adulti u adoloxxenti ta' età minn 12-il sena 'l fuq l-aktar reazzjonijiet avversi li kienu rapurtati ta' spiss kienu uġigħ ta' ras u reazzjonijiet fil-post ta' l-injezzjoni, inklużi uġigħ fil-post ta' l-injezzjoni, nefħa, ħmura, ħakk.
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.
Maltese: Xolair 150 mg trab u solvent għal soluzzjoni għall-injezzjoni huwa fornut bħala trab abjad jagħti floffwajt f'kunjett żgħir tal-ħġieġ flimkien m'ampulla li fiha 2 ml ta' ilma għall-injezzjonijiet.
English: Emergency visits Rate per 28-week period % reduction, p-value for rate ratio
Maltese: Żjajjar ta' emerġenza Rata għal kull perijodu ta' 28ġimgħa
English: Chronic administration of omalizumab at dose levels of up to 250 mg/kg (at least 14 times the highest recommended clinical dose in mg/kg according to the recommended dosing table) was well tolerated in non-human primates (both adult and juvenile animals), with the exception of a dose-related and agedependent decrease in blood platelets, with a greater sensitivity in juvenile animals.
Maltese: Għotja kronika ta' omalizumab f'livelli ta' doża ta' mhux aktar minn 250 mg/kg (mill-inqas 14-il darba l-ogħla doża klinika rakkomandata f'mg/kg skont it-tabella ta' dożaġġ rakkomandata) kienet ittollerata sew f'primati li ma jinkludux il-bniedem (kemm f'annimali adulti kif ukoll f'annimali żgħażagħ), bl-eċċezzjoni ta' nuqqas ta' plejtlets tad-demm relatata mad-doża u marbuta ma' l-età, b'sensitività akbar f'bhejjem ta' età żgħira.
English: Xolair is not indicated for the treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus.
Maltese: Xolair mhux indikat għal-kura ta' attakki ta' l-ażma akuti li jkunu qed jaggravaw, attakki ta' bronkospażmu akuti jew status asthmaticus.
English: 4 purple (150 mg)
Maltese: 4 vjola (150 mg)
English: Look out for signs of allergic reactions and other serious side effects Xolair can potentially cause serious side effects.
Maltese: Attent għal sinjali ta' reazzjonijiet allerġiċi u effetti sekondarji oħrajn serji Xolair jista' jikkawża effetti sekondarji serji.
English: Chronic spontaneous urticaria (CSU) You will be given two 150 mg injections at a time every four weeks.
Maltese: Urtikarja spontanja kronika (CSU) Se jkollok bżonn żewġ injezzjonijiet ta' 150 mg kull darba kull erba' ġimgħat.
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.
Maltese: Għal stima globali tal-effett tal-kura fit-tmiem talperjodu ta' 52 ġimgħa ta' kura double-blind fis-sottogrupp ta' pazjenti severi fuq doża għolja ta' kortikosterojdi li jittieħdu man-nifs flimkien ma' agonisti ta' beta li jaħdmu fit-tul, il-proporzjon ta' pazjenti kklassifikati li kellhom effett ‘eċċellenti' għall-kura kien ogħla u l-proporzjonijiet li kellhom effett ‘moderat' jew ‘dgħajjef' kienu anqas fil-grupp ta' omalizumab meta mqabbel mal-grupp ta' plaċebo: id-differenza bejn il-gruppi kienet statistikament sinifikanti (p<0.
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)
Maltese: Komuni (jista' jaffettwa sa persuna waħda f'kull 10 min-nies) - reazzjonijiet fil-post ta' l-injezzjoni inklużi uġigħ, nefħa, ħakk u ħmura - uġigħ fin-naħa ta' fuq taż-żaqq (fit-tfal) - uġigħ ta' ras (komuni ħafna fit-tfal) - infezzjoni fil-parti ta' fuq tal-passaġġ tan-nifs, bħal infezzjoni tal-farinġi u riħ komuni - tħoss pressjoni jew uġigħ f'ħaddejk u fuq xbinek (sinużite, uġigħ ta' ras minħabba sinus) - uġigħ fil-ġogi (artralġja)
English: One syringe of 1 ml solution contains 150 mg omalizumab.
Maltese: Siringa waħda b'1 ml ta' soluzzjoni fiha 150 mg omalizumab.
English: Figure 1 Mean weekly itch severity score over time, study 1 (mITT population)
Maltese: Figura 1 Il-medja tal-iskor ta' kull ġimgħa dwar is-severità tal-ħakk matul iż-żmien, studju 1 (popolazzjoni mITT)
English: Clinical trial and post-marketing cases of systemic lupus erythematosus (SLE) have been reported in patients with moderate to severe asthma and CSU.
Maltese: Kienu rrappurtati każi ta' lupus eritematożi sistemika (SLE) waqt provi kliniċi u wara li l-prodott tqiegħed fis-suq fost pazjenti b'ażma minn moderata sa gravi u b'CSU.
English: Xolair 150 mg solution for injection is available in packs containing 1 pre-filled syringe and in multipacks containing 4 (4 x 1), 6 (6 x 1) or 10 (10 x 1) pre-filled syringes.
Maltese: Xolair 150 mg soluzzjoni għall-injezzjoni huwa disponibbli f'pakketti li fihom siringa waħda mimlija għal-lest u f'pakketti b'ħafna li fihom 4 (4 x 1), 6 (6 x 1) jew 10 (10 x 1) siringi mimlija għal-lest.
English: Xolair is also available in vials with 75 mg omalizumab.
Maltese: Xolair huwa disponibbli wkoll f'kunjetti b'75 mg omalizumab.
English: One vial contains 150 mg omalizumab.
Maltese: Kunjett wieħed fih 150 mg omalizumab.
English: 3 purple (150 mg)
Maltese: 3 vjola (150 mg)
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.
Maltese: Il-medja tal-bidla mil-linja bażi sat-12-il ġimgħa fid-DLQI sħiħ għall-gruppi ta' trattament mogħtija 300 mg kienet akbar (p<0.001) milli għall-plaċebo li juri titjib ta' bejn 9.7-10.3 punti mqabbel ma' 5.1-6.1 punti għall-gruppi korrispondenti mogħtija lplaċebo.
English: Viewing window Label & expiry date
Maltese: Protezzjoni tallabra Tieqa minn fejn tara Tikketta u data meta tiskadi
English: Pack containing 1 pre-filled syringe, and multipacks containing 4 (4 x 1); 6 (6 x 1) or 10 (10 x 1) prefilled syringes.
Maltese: Pakkett li jkun fih siringa mimlija għal-lest waħda, u pakketti multipli li jkun fihom 4 (4 x 1); 6 (6 x 1) jew 10 (10 x 1) siringi mimlija għal-lest.
English: Solvent for Xolair Water for injections
Maltese: Solvent għal Xolair Ilma għall-injezzjonijiet