FrancophonIA/ELRC3.0 huggingface dataset:
English: The responder rates were: 33% at week 12 and 67% at week 24 for UAS7=0, and 56% at week 12 and 67% at week 24 for UAS7≤6.
Maltese: Irrati tal-parteċipanti kienu: 33% fit-12-il ġimgħa u 67% fl-24 ġimgħa għal UAS7=0, u 56% fit-12il ġimgħa u 67% fl-24 ġimgħa għal UAS7≤6.
English: - Serum sickness.
Maltese: - Mard tas-serum.
English: CARTON CONTAINING 1 VIAL AND 1 AMPOULE AS UNIT PACK (INCLUDING BLUE BOX)
Maltese: KARTUNA B'KUNJETT 1 U AMPULLA 1 BĦALA PAKKETT GĦALIH (INKLUŻA LKAXXA ĊELESTI)
English: *Omalizumab is a humanised monoclonal antibody manufactured by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell line.
Maltese: *Omalizumab huwa antikorp monoklonali umanizzat manifatturat permezz ta' teknoloġija tat-tfassil tad-DNA f'razza ta' ċelluli mammiferi tal-ovarju tal-ħamster Ċiniż (CHO - Chinese hamster ovary).
English: Musculoskeletal and connective tissue disorders Rare
Maltese: Disturbi muskoluskelettriċi u tat-tessuti konnettivi Rari
English: Dose (mg) Number of vials
Maltese: Doża (mg) Numru ta' siringi
English: In clinical studies in CSU, Xolair was used in conjunction with antihistamines (anti-H1, anti-H2) and leukotriene receptor antagonists (LTRAs).
Maltese: Fi studji kliniċi f'pazjenti b'CSU, Xolair intuża flimkien ma' antiistamini (anti-H1, anti-H2) u ma' antagonisti ta' reċettur tal-lewċotrijeni (LTRAs).
English: The safety and tolerability of omalizumab were investigated with doses of 75 mg, 150 mg and 300 mg every four weeks in 975 CSU patients, 242 of whom received placebo.
Maltese: Is-sigurtà u t-tollerabbiltà ta' omalizumab kienu investigati b'dożi ta' 75 mg, 150 mg u 300 mg kull erba' ġimgħat f'975 pazjent b'CSU, fejn 242 minnhom ingħataw plaċebo.
English: In vitro, omalizumab forms complexes of limited size with IgE.
Maltese: In vitro, omalizumab jifforma kumplessi ta' daqs limitat ma' IgE.
English: Clinical efficacy and safety in allergic asthma
Maltese: Effikaċja klinika u sigurtà f'ażma allerġika
English: The three studies enrolled 975 patients aged between 12 and 75 years (mean age 42.3 years; 39 patients 12-17 years, 54 patients ≥65 years; 259 males and 716 females).
Maltese: It-tliet studji sieħbu 975 pazjent ta' bejn 12-il sena u 75 sena (età medja ta' 42.3 snin; 39 pazjent ta' bejn 12 u 17-il sena, 54 pazjent li għandhom ≥65;
English: Use 0.9 ml and discard the rest.
Maltese: Uża 0.9 ml u armi li jibqa'.
English: The antibody is an IgG1 kappa that contains human framework regions with the complementary-determining regions of a murine parent antibody that binds to IgE.
Maltese: L-antikorp huwa IgG1 kappa li fih reġjuni ta' qafas uman b' reġjuni kumplimentari determinanti ta' antikorp murine parent li jeħel ma' l-IgE.
English: Polysorbate 20 and water for injections.
Maltese: Polysorbate 20 u ilma għall-injezzjonijiet.
English: Allergic asthma
Maltese: Ażma allerġika
English: It belongs to a class of medicines called monoclonal antibodies.
Maltese: Tappartjeni għal klassi ta' mediċini msejħa antikorpi monoklonali.
English: Xolair 75 mg injection omalizumab SC
Maltese: Xolair 75 mg injezzjoni omalizumab SC
English: Multipack comprising 4 packs
Maltese: Pakkett multiplu li fih 4 pakketti
English: See Table 1 for a conversion chart and Tables 2 and 3 for the dose determination charts in adults, adolescents and children (6 to <12 years of age).
Maltese: Ara Tabella 1 għaċ-ċart ta' konverżjoni u Tabelli 2 u 3 għaċ-ċarts biex tistabilixxi d-doża f'adulti, adoloxxenti u tfal (minn 6 snin sa <12-il sena).
English: Adults and adolescents ≥12 years of age
Maltese: Adulti u adoloxxenti età ta' ≥12-il sena
English: 1.2 ml = maximum delivered volume per vial (Xolair 150 mg).
Maltese: 1.2 ml = Volum massimu mwassal għal kull kunjett (Xolair 150 mg).
English: 0.6 ml = maximum delivered volume per vial (Xolair 75 mg).
Maltese: 0.6 ml = Volum massimu mwassal għal kull kunjett (Xolair 75 mg).
English: The clinical relevance of anti-Xolair antibodies is not well understood.
Maltese: Irrelevanza klinika ta' l-antikorpi kontra Xolair mhijiex mifhuma biżżejjed.
English: Clinical efficacy and safety in chronic spontaneous urticaria (CSU)
Maltese: Effikaċja klinika u sigurtà f'urtikarja spontanja kronika (CSU)
English: After subcutaneous administration, omalizumab is absorbed with an average absolute bioavailability of 62%.
Maltese: Wara li jingħata taħt il-ġilda, omalizumab jiġi assorbit b'bijodisponibilità assoluta medja ta' 62%.
English: The pharmacokinetics of omalizumab are linear at doses greater than 0.5 mg/kg.
Maltese: Ilfarmakokinetiċi ta' omalizumab issegwi linja dritta f'dożi akbar minn 0.5 mg/kg.
English: The pharmacokinetics of omalizumab have been studied in adult and adolescent patients with allergic asthma.
Maltese: Il-farmakokinetiċi ta' omalizumab kienu studjati f'pazjenti adulti u adoloxxenti b'ażma allerġika.
English: However, animal studies do not indicate either direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Madankollu studji f'annimali ma wrewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Powder: sucrose, L-histidine, L-histidine hydrochloride monohydrate and polysorbate 20.
Maltese: Trab: sucrose, L-histidine, L-histidine hydrochloride monohydrate u polysorbate 20.
English: What Xolair contains - The active substance is omalizumab.
Maltese: X'fih Xolair - Is-sustanza attiva hi omalizumab.
English: Table 5 Adverse reactions from the pooled CSU safety database (day 1 to week 24) at 300 mg omalizumab
Maltese: Reazzjonijiet avversi skont databażi miġmugħa dwar is-sigurtà fost pazjenti b'CSU (jum 1 sa ġimgħa 24) 300 mg omalizumab
English: Xolair contains the active substance omalizumab.
Maltese: Xolair fih is-sustanza attiva omalizumab.
English: In CSU patients, based on population pharmacokinetic simulations, omalizumab serum elimination half-life at steady state averaged 24 days and apparent clearance at steady state for a patient of 80 kg weight was 3.0 ml/kg/day.
Maltese: F'pazjenti b'CSU, skont is-simulazzjonijiet farmakokinetiċi tal-popolazzjoni, il-half-life tal-eliminazzjoni ta' omalizumab fis-serum fi stadju stabbli damet medja ta' 24 jum u t-tneħħija apparenti fi stadju stabbli għal pazjent li jiżen 80 kg kienet ta' 3.0 ml/kg/kuljum.
English: - The other ingredients are L-arginine hydrochloride, L-histidine hydrochloride, L-histidine,
Maltese: - Is-sustanzi l-oħra huma L-arginine hydrochloride, L-histidine hydrochloride, L-histidine,
English: Children (6 to 11 years of age) are not expected to self-administer Xolair.
Maltese: It-tfal (minn 6 sa 11-il sena) mhux mistennija jamministraw Xolair huma stess.
English: In a separate analysis of pooled clinical trials, which included all randomised double-blind, placebo-controlled clinical trials lasting 8 or more weeks, the rate of ATE per 1,000 patient years was 2.69 (5/1,856 patient years) for Xolair-treated patients and 2.38 (4/1,680 patient years) for placebo patients (rate ratio 1.13, 95% confidence interval 0.24-5.71).
Maltese: F'analiżi separata ta' provi kliniċi meħuda flimkien, li kienet tinkludi lprovi kliniċi kollha randomizzati, double-blind u kkontrollati bi plaċebo u li damu għaddejjin 8 ġimgħat jew aktar, ir-rata ta' ATE għal kull 1,000 sena ta' pazjent kienet ta' 2.69 (5/1,856 snin ta' pazjent) għall-pazjenti ttrattati b'Xolair u ta' 2.38 (4/1,680 snin ta' pazjent) għall-pazjenti kkontrollati bi plaċebo (il-proporzjon tar-rata ta' 1.13, 95% intervall ta' kunfidenza 0.24-5.71).
English: Physician's overall assessment % responders* p-value**
Maltese: Stima ġenerali tat-tabib % li wrew rispons*
English: Tabulated list of adverse reactions
Maltese: Tabella ta' reazzjonijiet avversi
English: Omalizumab crosses the placental barrier.
Maltese: Omalizumab jaqsam il-barriera tal-plaċenta.
English: Milk levels of omalizumab were 0.15% of the maternal serum concentration.
Maltese: Il-livelli ta' omalizumab fil-ħalib kienu ta' 0.15% il-livelli tal-konċentrazzjoni fis-serum ta' l-omm.
English: Laryngoedema
Maltese: Pożoloġija
English: In the final analysis of the observational study, the rate of ATE per 1,000 patient years was 7.52 (115/15,286 patient years) for Xolair-treated patients and 5.12 (51/9,963 patient years) for control patients.
Maltese: Fl-analiżi finali tal-istudju ta' osservazzjoni, ir-rata ta' ATE għal kull 1,000 sena ta' pazjent kienet ta' 7.52 (115/15,286 snin ta' pazjent) għall-pazjenti ttrattati b'Xolair u ta' 5.12 (51/9,963 snin ta' pazjent) għal pazjenti ta' kontroll.
English: Other medicines and Xolair
Maltese: Mediċini oħra u Xolair
English: Patients with CSU
Maltese: Pazjenti b'CSU
English: PRE-FILLED SYRINGE LABEL
Maltese: Ġwienaħ protettivi tas-siringa
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.
Maltese: Il-farmakokinetiċi ta' omalizumab kienu studjati f'pazjenti adulti u adoloxxenti b'ażma allerġika kif ukoll f'pazjenti adulti u adolexxenti b'CSU.
English: Statistically significant results were further observed in the responder rates for UAS7≤6 (at week 12) which were higher for the 300 mg treatment groups, ranging from 52-66% (p<0.0001) compared to 11-19% for the placebo groups, and complete response (UAS7=0) was achieved by 34-44% (p<0.0001) of patients treated with 300 mg compared to 5-9% of patients in the placebo groups.
Maltese: Riżultati statistikament sinjifikanti kienu osservati aktar skont ir-rati tal-parteċipanti għal UAS7≤6 (fit-12il ġimgħa) li kienu ogħla għall-grupp mogħti trattament ta' 300 mg, mifruxa fuq medda ta' 52-66% (p<0.0001) imqabbel mal-medda ta' 11-19% għall-grupp mogħti plaċebo, u r-rispons sħiħ (UAS7=0) inkiseb minn 34-44% (p<0.0001) tal-pazjenti ttrattati bi 300 mg mqabbel ma' 5-9% tal-pazjenti filgrupp mogħti l-plaċebo.
English: The primary support for safety and efficacy of Xolair in the group aged 6 to <12 years comes from one randomised, double-blind, placebo-controlled, multi-centre trial (study 7).
Maltese: Is-sapport primarju għas-sigurtà u l-effett ta' Xolair fil-grupp ta' dawk li għandhom minn 6 snin sa <12-il sena ġej minn studju wieħed, randomised, double-blind, ikkontrollat bi plaċebo, multiċentriku (studju 7).
English: Children (6 to <12 years of age)
Maltese: Tfal (età minn 6 snin sa <12 -il sena)
English: Clinical trial data on adolescents (12 to 17 years) included a total of 39 patients, of whom 11 received the 300 mg dose.
Maltese: Dejta minn prova klinika fuq adolexxenti (minn 12 sa 17-il sena) kienet tinkludi total ta' 39 pazjent, li minnhom 11 ingħataw doża ta' 300 mg.
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.
Maltese: Studji kliniċi fost pazjenti b'CSU inkluda xi pazjenti li kellhom bejn 12 u 17-il sena li jieħdu Xolair flimkien ma' antiistamini (anti-H1, anti-H2) u LTRAs.
English: Churg-Strauss syndrome and hypereosinophilic syndrome Patients with severe asthma may rarely present systemic hypereosinophilic syndrome or allergic eosinophilic granulomatous vasculitis (Churg-Strauss syndrome), both of which are usually treated with systemic corticosteroids.
Maltese: Sindrome Churg-Strauss u sindrome ipereżinofiliku Pazjenti b'ażma severa f'xi każijiet rari jista' jkollhom sindrome ipereżinofiliku sistemiku jew vaskulite granulomatuża eżinofilika allerġika (Sindrome Churg-Strauss), li t-tnejn li huma s-soltu jkunu kkurati b'kortikosterojdi sistemiċi.
English: The population pharmacokinetics of omalizumab were analysed to evaluate the effects of demographic characteristics.
Maltese: Il-farmakokinetiċi tal-popolazzjoni ta' omalizumab kienet analizzata sabiex jiġu evalwati l-effetti talkaratteristiċi demografiċi.
English: Xolair is used for the treatment of: - allergic asthma - chronic spontaneous urticaria (CSU)
Maltese: Xolair jintuża għat-trattament ta': - ażma allerġika - urtikarja spontanja kronika (CSU)
English: Table 4 lists the adverse reactions recorded in clinical studies in the total safety population treated with Xolair by MedDRA system organ class and frequency.
Maltese: Tabella 4 telenka r-reazzjonijiet avversi li kienu reġistrati waqt provi kliniċi fil-popolazzjoni sigura kollha tal-pazjenti kurati bi Xolair, skont il-klassi tas-sistema ta' l-organi u l-frekwenza ta' MedDRA.
English: The corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-kategorija bil-frekwenza korrispondenti għal kull reazzjoni avversa tissejjes skont il-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1000); rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: The chemical and physical stability of the reconstituted medicinal product have been demonstrated for 8 hours at 2°C to 8°C and for 4 hours at 30°C.
Maltese: L-istabilità kimika u fiżika tal-prodott mediċinali mħallat żammet għal 8 sigħat f'temperatura ta' 2C sa 8C u għal 4 sigħat f' 30C.
English: Frequency category
Maltese: TALPAKKETTI MULTIPLI
English: Children 6 to <12 years of age
Maltese: Tfal ta' età minn 6 snin sa <12-il sena
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.
Maltese: Fit-tieni perjodu ta' 28-ġimgħa ta' kura double blind id-differenza fir-rati bejn il-gruppi ta' kura kienet tirrapreżenta tnaqqis ta' 63% (rata ta' proporzjon 0.37, p<0.001) meta mqabbla mal-plaċebo fil-pazjenti li ħadu omalizumab.
English: Idiopathic thrombocytopenia, including severe cases
Maltese: Tromboċitopenja idjopatika, inkluż każijiet gravi
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.
Maltese: Fi studji 1 u 2, il-pazjenti kellhom skor medju dwar is-severità tal-ħakk ta' bejn 13.7 u 14.5 fil-linja bażi u skor medju ta' UAS7 ta' 29.5 u 31.7 rispettivament.
English: Omalizumab is a recombinant DNA-derived humanised monoclonal antibody that selectively binds to human immunoglobulin E (IgE).
Maltese: Omalizumab huwa antikorp monoklonali modifikat għal wieħed uman derivat mit-teknoloġija ta' DNA rikombinat li jeħel b'mod selettiv ma' l-immunoglobulina E (IgE).
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.
Maltese: Fl-24 ġimgħa, id-differenza fir-rati bejn il-gruppi ta' kura kienet tirrapreżenta tnaqqis ta' 34% (rata ta' proporzjon 0.662, p=0.047) meta mqabbla mal-plaċebo filpazjenti li ħadu omalizumab.
English: Subcutaneous Xolair or placebo were administered as add-on therapy to >1,000 micrograms beclomethasone dipropionate (or equivalent) plus a long-acting beta2-agonist.
Maltese: Xolair li jingħata taħt il-ġilda jew plaċebo ngħataw bħala terapija kumplimentari ma' >1,000 mikrogrammi ta' beclomethasone dipropionate (jew ekwivalenti) flimkien ma' agonist tal-beta2 li jaħdem fit-tul.
English: The safety of omalizumab has been studied in the cynomolgus monkey, since omalizumab binds to cynomolgus and human IgE with similar affinity.
Maltese: Is-sigurtà ta' omalizumab kienet studjata f'xadini cynomolgus, peress li omalizumab jintrabat ma' lIgE tal-bniedem u ta' cynomolgus b'affinità simili.
English: Multipack: 4 (4 x 1) vials and 4 (4 x 1) ampoules Multipack: 10 (10 x 1) vials and 10 (10 x 1) ampoules
Maltese: Trab u solvent għal soluzzjoni għal injezzjoni Pakkett multiplu: 4 (4 x 1) kunjetti u 4 (4 x 1) ampulli Pakkett multiplu: 10 (10 x 1) kunjetti u 10 (10 x 1) ampulli
English: Symptoms suggestive of serum sickness include arthritis/arthralgias, rash (urticaria or other forms), fever and lymphadenopathy.
Maltese: Sintomi li jissuġġerixxu marda tas-serum jinkludu artrite/artralġji, raxx (urtikarja jew forom oħra), deni u limfadenopatija.
English: Study 7 was a placebo-controlled trial which included a specific subgroup (n=235) of patients as defined in the present indication, who were treated with high-dose inhaled corticosteroids (≥500 µg/day fluticasone equivalent) plus long-acting beta agonist.
Maltese: L-istudju 7 kien prova kkontrollata bi plaċebo li kienet tinkludi sottogrupp speċifiku (N=235) ta' pazjenti kif iddefinit fl-indikazzjoni preżenti, li kienu kkurati b'doża għolja ta' kortikosterojdi li jittieħdu man-nifs (mediċina ekwivalenti għal ≥500 µg/jum ta' fluticasone) flimkien ma' agonist beta li jaħdem fit-tul.
English: Table 5 lists the adverse reactions (events occurring in ≥1% of patients in any treatment group and ≥2% more frequently in any omalizumab treatment group than with placebo (after medical review)) reported with 300 mg in the three pooled phase III studies.
Maltese: Tabella 5 tinkludi lista ta' reazzjonijiet avversi (l-episodji jseħħu f'≥1% tal-pazjenti fi kwalunkwe grupp ta' trattament u bi frekwenza ta' aktar minn ≥2% fi kwalunkwe grupp mogħti trattament b'omalizumab milli bil-plaċebo (wara konsulta medika)) rrappurtati b'dożi ta' 300 mg waqt tliet studji miġmugħin fi stadju III.
English: These analyses suggest that no dose adjustments are necessary in patients with CSU for age (12-75 years), race/ethnicity, gender, body weight, body mass index, baseline IgE, anti-FcRI autoantibodies or concomitant use of H2 antihistamines or LTRAs.
Maltese: Dawn lanaliżijiet jissuġġerixxu li mhux meħtieġa aġġustamenti tad-doża f'pazjenti b'CSU għall-età (12-75 sena), razza/etniċità, sess, piż, indiċi tal-massa tal-ġisem, linja bażi ta' IgE, awtoantikorpi antiFcRI jew użu konkomitanti ta' antiistamini H2 jew LTRAs.
English: Table 6 Results of study 1
Maltese: Tabella 6 Riżultati ta' studju 1
English: In study 6, significantly more severe allergic asthma patients on Xolair were able to reduce their fluticasone dose to 500 micrograms/day without deterioration of asthma control (60.3%) compared to the placebo group (45.8%, p<0.05).
Maltese: Fi studju 6, numru akbar sinifikanti ta' pazjenti b'ażma allerġika qawwija li kienu fuq Xolair setgħu jnaqqsu d-doża ta' fluticasone għal 500 mikrogrammi/jum mingħajr ma naqas il-kontroll ta' l-ażma (60.3%) imqabbel mal-grupp tal-plaċebo (45.8%, p<0.05).
English: A separate table (Table 5) shows the adverse reactions for the CSU indication resulting from differences in dosages and treatment populations (with significantly different risk factors, comorbidities, co-medications and ages [e.g. asthma trials included children from 6-12 years of age]).
Maltese: Tabella separata (Tabella 5) turi r-reazzjonijiet avversi għall-indikazzjoni CSU li jirriżultaw middifferenzi fid-dożi mogħtija u l-popolazzjonijiet tat-trattament (b'differenza sinifikanti fil-fatturi ta' riskju, komorbiditajiet, komedikazzjonijiet u etajiet [eż. provi fuq l-ażma kienu jinkludu tfal minn 6 snin sa 12-il sena]).
English: After reconstitution one vial contains 125 mg/ml of omalizumab (150 mg in 1.2 ml).
Maltese: Wara r rikostruzzjoni kunjett wieħed fih 125 mg/ml ta' omalizumab (150 mg f'1.2 ml).
English: The product may be kept for a total of 4 hours at 25C.
Maltese: Ilprodott jinsta' jinżamm għal total ta' 4 sigħat f'temperatura ta' 25C.
English: Quality of life scores were measured using the Juniper Asthma-related Quality of Life Questionnaire.
Maltese: Il-punteġġi tal-kwalità tal-ħajja kienu mkejjla bil-kwestjonarju magħruf bħala “Juniper Asthmarelated Quality of Life Questionnaire.”
English: The efficacy and safety of Xolair were demonstrated in a 28-week double-blind placebo-controlled study (study 1) involving 419 severe allergic asthmatics, ages 12-79 years, who had reduced lung function (FEV1 40-80% predicted) and poor asthma symptom control despite receiving high dose inhaled corticosteroids and a long-acting beta2-agonist.
Maltese: L-effett u sigurtà ta' Xolair intweriet fi studju kontrollat bi plaċebo double-blind li dam 28 ġimgħa (studju 1) li fih ħadu sehem 419 pazjent li jsofru minn ażma allerġika qawwija, ta' etajiet bejn 12-79 sena, li kellhom tnaqqis fil-funzjoni tal-pulmun (FEV1 mbassar 40-80%) u nuqqas ta' kontroll tas-sintomi ta' l-ażma avolja kienu qed jirċievu dożi għoljin ta' kortikosterojdi li jittieħdu man-nifs u agonist tal-beta2 li jaħdem fit-tul.
English: Not known (frequency cannot be estimated from the available data) - Churg-Strauss syndrome or hypereosinophilic syndrome.
Maltese: Mhux magħruf (ma tistax tittieħed stima tal-frekwenza mid-dejta disponibbli) - Is-sindrome Churg-Strauss jew is-sindrome ipereżinofiliku.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX05
Maltese: Mediċini għal mard li jfixkel il-passaġġi tan-nifs, mediċini sistemiċi oħrajn għal mard li jfixkel il-passaġġi tan-nifs, Kodiċi ATC: R03DX05
English: After reconstitution one vial contains 125 mg/ml of omalizumab (75 mg in 0.6 ml).
Maltese: Wara r rikostruzzjoni kunjett wieħed fih 125 mg/ml ta' omalizumab (75 mg f'0.6 ml).
English: The serum concentration required to attain a 50% drop in platelets from baseline in adult cynomolgus monkeys was roughly 4- to 20-fold higher than anticipated maximum clinical serum concentrations.
Maltese: Il-konċentrazzjoni fis-serum meħtieġa sabiex jintlaħaq tnaqqis ta' 50% fin-numru ta' plejtlets mill-linja bażika f'xadini cynomolgus adulti kienet madwar 4 sa 20 darba ogħla mill-massimu tal-konċentrazzjonijiet fis-serum kliniċi mistennija.
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.
Maltese: Il-pazjenti kollha kienu mitluba li jkollhom kontroll sintomatiku mhux xieraq, skont kif evalwat permezz ta' skor dwar l-attività tal-urtikarja (UAS7, medda ta' 0-42) u ta' ≥16, u skor dwar is-severità tal-ħakk (li hu komponent tal-UAS7; medda 0-21) u ta' ≥8 għas-7t ijiem qabel ir-randomizzazzjoni, minkejja li użaw antiistamin għal mill-inqas ġimagħtejn qabel.
English: The EXPECT study, with 154 infants who had been exposed to Xolair during pregnancy and through breast-feeding did not indicate adverse effects on the breast-fed infant.
Maltese: L-istudju EXPECT, b'154 tarbija li kienu esposti għal Xolair waqt it-tqala u permezz tat-treddigħ, ma indikax effetti avversi fuq trabi li kienu qed jiġu mreddgħa.
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).
Maltese: Għad-doża ta' 300 mg, fl-istudji 1 u 3, it-tnaqqis tal-medja mil-linja bażi fl-iskor dwar is-severità talħakk ta' kull ġimgħa kien ta' 9.8 u 8.6, il-proporzjon ta' pazjenti b'UAS7≤6 kienet ta' 61.7% u 55.6%, u l-proporzjon ta' pazjenti b'rispons sħiħ (UAS7=0) kien ta' 48.1% u 42.5%, rispettivament, (p<0.
English: The vial delivers 1.2 ml (150 mg) of Xolair.
Maltese: Il-kunjett ikun fih 1.2 ml (150 mg) ta' Xolair.
English: Also contains: L-arginine hydrochloride, L-histidine hydrochloride, L-histidine, polysorbate 20, water for injections.
Maltese: Fih ukoll: L-arginine hydrochloride, L-histidine hydrochloride, L-histidine, polysorbate 20, ilma għallinjezzjonijiet.
English: You will need 1 to 4 injections at a time.
Maltese: Se teħtieġ minn injezzjoni 1 sa 4 injezzjonijiet kull darba.
English: AQL improvement % of patients ≥0.5 improvement p-value * marked improvement or complete control ** p-value for overall distribution of assessment
Maltese: Valur-p * titjib konsiderevoli jew kontroll komplet ** valur-p għad-distribuzzjoni totali ta' l-istima.
English: 375 mg 1 blue (75 mg)
Maltese: 375 mg 1 blu (75 mg)