qanastek/EMEA-V3 huggingface dataset:
8 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.
Fi studji kliniċi, il- livelli ta ’ IgE ħieles fis- serum kienu mnaqqsa b’ mod marbut mad- doża fi żmien siegħa wara li ngħatat l- ewwel doża u dawn il- livelli nżammu baxxi bejn doża u oħra.
One year after discontinuation of Xolair dosing, the IgE levels had returned to pre-treatment levels with no observed rebound in IgE levels after drug washout.
Sena wara li twaqqaf id- dożaġġ b’ Xolair, il- livelli ta ’ IgE reġgħu lura għal livelli ta ’ qabel ma kienet bdiet l- kura mingħajr ma dehru effetti rebound fil- livelli ta ’ IgE wara li l- mediċina kienet tneħħiet għall- kollox mill- ġisem.
Clinical experience 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.
8 Esperjenza klinika L- effikaċja 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 ażżma 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- ażżma avolja kienu qed jirċievu dożi għoljin ta ’ kortikosterojdi li jittieħdu man- nifs u agonist tal- beta2 li jaħdem fit- tul.
Eligible patients had experienced multiple asthma exacerbations requiring systemic corticosteroid treatment or had been hospitalised or attended an emergency room due to a severe asthma exacerbation in the past year despite continuous treatment with high-dose inhaled corticosteroids and a long-acting beta2-agonist.
Il- pazjenti eliġibbli kellhom għadd ta ’ attakki ta ’ ażżma li kienu qed jaggravaw u li kienu jinħtieġu kura b’ kortikosterojdi b’ mod sistemiku jew iddaħħlu l- isptar jew kellhom imorru fil- kamra ta ’ l- emerġenza minħabba s- severità ta ’ l- attakki ta ’ l- ażżma u l- mod kif kienu aggravaw fl- aħħar sena minkejja kura kontinwa b’ doża għolja ta ’ kortikosterojdi li jittieħdu man- nifs u agonist tal- beta2 li jaħdem fit- tul.
Subcutaneous Xolair or placebo were administered as add-on therapy to > 1,000 micrograms beclomethasone dipropionate (or equivalent) plus a long-acting beta2-agonist.
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.
Oral corticosteroid, theophylline and leukotriene- modifier maintenance therapies were allowed (22%, 27%, and 35% of patients, respectively).
Terapiji ta ’ manteniment b’ kortikosterojdi li jittieħdu mill- ħalq, theophylline u modifikaturi ta 'leukotriene tħallew (22%, 27% u 35% tal- pazjenti rispettivament).
The rate of asthma exacerbations requiring treatment with bursts of systemic corticosteroids was the primary endpoint.
L- endpoint ewlieni kien meqjuż bħala r- rata ta ’ aggravar ta ’ l- attakki ta ’ l- ażżma li kellhom bżonn kura b’ dożi qawwija u iżolati ta ’ kortikosterojdi sistemiċi.
Omalizumab reduced the rate of asthma exacerbations by 19% (p = 0.153).
Omalizumab naqqas ir- rata ta ’ aggravar ta’ l- attakki ta ’ l- ażżma b’ 19% (p = 0. 153).
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.
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 tal- pazjenti 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- ażżma (imklużi dħul l- isptar, kamra ta ’ l- emerġenza, u żjajjar bla ħsieb għand it- tabib), u titjib fl- istima ġenerali tat- tabib dwar l - effikaċja tal- kura, Il- Kwalità tal- Ħajja relatata ma ’ l- Ażżma (AQL), sintomi ta ’ l- ażżma u funzjoni tal - pulmun.
In a subgroup analysis, patients with pre-treatment total IgE ≥ 76 IU/ ml were more likely to experience clinically meaningful benefit to Xolair.
F’ analiżi ta ’ sottogrupp, pazjenti li kellhom livelli ta ’ IgE ≥76 IU/ ml kellhom aktar ċans li jiksbu benefiċju ta ’ valur kliniku b’ Xolair.
In these patients in study 1 Xolair reduced the rate of asthma exacerbations by 40% (p = 0.002).
F’ dawn il- pazjenti f’ studju 1, Xolair naqqas ir- rata ta ’ l- aggravar ta ’ l- attakki ta ’ l- ażżma b’ 40% (p = 0. 002).
In addition more patients had clinically meaningful responses in the total IgE ≥ 76 IU/ ml population across the Xolair severe asthma programme.
Minbarra hekk, fil- popolazzjoni ta ’ pazjenti li kellhom livell ta ’ IgE ≥76 IU/ ml aktar pazjenti kellhom respons ta ’ valur kliniku b’ Xolair fil- programm ta ’ ażżma qawwija.
Table 5 includes results in the study 1 population.
Tabella 5 tinkludi riżultati fil- popolazzjoni ta ’ studju 1.
Table 5:
9 Tabella 5:
Results of study 1
Riżultati ta ’ studju 1
Whole study 1 population Asthma exacerbations
Popolazzjoni sħiħa ta ’ studju 1 Aggravar ta ’ l- attakki ta ’ l - Ażżma
Placebo N=210
Plaċebo N=210
Rate per 28-week period
Rata għal kull perijodu ta ’ 28 - ġimgħa
% reduction, p-value for rate ratio Severe asthma exacerbations
Tnaqqis%, valur- p għall - proporzjon tar- rata Aggravar qawwi ta ’ l- attakki ta ’ l- ażżma
19.4%, p = 0.153
19. 4%, p = 0. 153
Rate per 28-week period
Rata għal kull perijodu ta ’ 28 – ġimgħa
% reduction, p-value for rate ratio Emergency visits
Tnaqqis%, valur- p għall - proporzjon tar- rata Żjajjar ta ’ emerġenza
50.1%, p = 0.002
50. 1%, p = 0. 002
% reduction, p-value for rate ratio Physician’ s overall assessment
Tnaqqis%, valur- p għall - proporzjon tar- rata Stima ġenerali tat- tabib
43.9%, p = 0.038
43. 9%, p = 0. 038
% responders* p-value** AQL improvement
% li wrew rispons * Valur- p ** Titjib fl- AQL
60.5%
60. 5%
9 Whole study 1 population% of patients ≥ 0.5 improvement p-value
% ta ’ pazjenti b’ titjib ta ’ ≥0. 5 Valur- p
60.8%
60. 8%
47.8%
47. 8%
* marked improvement or complete control ** p-value for overall distribution of assessment
* titjib konsiderevoli jew kontroll komplet ** valur- p għad- distribuzzjoni totali ta ’ l- istima.
Study 2 assessed the efficacy and safety of Xolair in a population of 312 severe allergic asthmatics which matched the population in study 1.
Fi Studju 2 kienu stmati l- effikaċja u s- sigurtà ta ’ Xolair f’ popolazzjoni ta ’ 312 ażmatiċi li jsofru minn allerġija qawwija li kienet taqbel mal- popolazzjoni fi studju 1.
Treatment with Xolair in this open label study led to a 61% reduction in clinically significant asthma exacerbation rate compared to current asthma therapy alone.
Kura b’ Xolair f’ dan l- istudju open - label wassal għal tnaqqis ta ’ 61% fl- aggravar ta ’ l- attakki ta ’ l- ażżma b’ valur kliniku sinifkanti meta mqabbel mat- terapija għall- ażżma li kienet qed tingħata waħidha.
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.
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- effikaċja u s- sigurtà ta ’ Xolair f’ pazjenti b’ ażżma qawwija persistenti.
Most patients were inadequately controlled but were receiving less concomitant asthma therapy than patients in studies 1 or 2.
Il- parti l- kbira tal- pazjenti ma ’ kienux kontrollati b’ mod xieraq iżda kienu qed jieħdu numru anqas ta ’ terapiji oħrajn għall- ażżma mill- pazjenti fi studju 1 jew 2.
Studies 3-5 used exacerbation as primary endpoint, whereas study 6 primarily evaluated inhaled corticosteroid sparing.
Bħala endpoint ewlieni, studji 3- 5 użaw l- aggravar filwaqt li fi studju 6 kien meqjus l- aktar it- tnaqqis fl- użu tal - kortikosterojdi li jittieħdu man- nifs.
In studies 3, 4 and 5 patients treated with Xolair had respective reductions in asthma exacerbation rates of 37.5% (p=0.027), 40.3% (p < 0.001) and 57.6% (p < 0.001) compared to placebo.
Fi studji 3, 4 u 5 pazjenti ittrattati b’ Xolair kellhom tnaqqis rispettiv fir- rati ta ’ l- aggravar ta ’ l- attakki ta ’ l- ażżma ta ’ 37. 5% (p=0. 027), 40. 3% (p < 0. 001) u 57. 6% (p < 0. 001) imqabbla mal- plaċebo.
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).
Fi studju 6, numru akbar sinifikanti ta ’ pazjenti b’ ażżma allerġika qawwija li kienu fuq Xolair setgħu jnaqqsu d- doża ta ’ fluticasone għal ≤500 mikrogrammi/ jum mingħajr ma naqas il- kontroll ta ’ l- ażżma (60. 3%) imqabbel mal- grupp tal- plaċebo (45. 8%, p < 0. 05).
For all six studies there was a statistically significant improvement from baseline in quality of life scores for Xolair patients versus the placebo or control group.
10 Il- punteġġi tal- kwalità tal- ħajja kienu mkejjla bil- kwestjonarju magħruf bħala “ Juniper Asthma - related Quality of Life Questionnaire. ” Għas- sitt studji kollha, kien hemm titjib statistikament sinifikanti mill- linja bażika fil- punteġġi tal- kwalità tal- ħajja għall- pazjenti fuq Xolair kontra l- plaċebo jew il- grupp ta ’ kontroll.
Physician’ s overall assessment of treatment effectiveness:
L- istima ġenerali tat- tabib dwar l- effikaċja tal- kura:
Physician’ s overall assessment was performed in five of the above studies as a broad measure of asthma control performed by the treating physician.
L- istima ġenerali tat- tabib saret f’ ħamsa mill- istudji ta ’ hawn fuq bħala miżura wiesa ’ tal- kontroll ta ’ l- ażżma li saret mit- tabib li jkun qed jagħti l- kura.
The physician was able to take into account PEF, day and night time symptoms, rescue medication use, spirometry and exacerbations.
It- tabib seta ’ jikkonsidra l- PEF, s- sintomi ta ’ bil- lejl u bi nhar, mediċini li jintużaw f’ każ ta ’ emerġenza, spirometrija u aggravar ta ’ l- attakki.
In all five studies a significantly greater proportion of Xolair treated patients were judged to have achieved either a marked improvement or complete control of their asthma compared to placebo patients.
Fil- ħames studji kollha, proporzjon akbar sinifikanti tal- pazjenti kurati b’ Xolair kienu ġudikati li kisbu jew titjib konsiderevoli jew kontroll komplet ta ’ l- ażżma meta mqabbla mal- pazjenti li kienu fuq plaċebo.
The pharmacokinetics of omalizumab have been studied in patients with allergic asthma.
Il- farmakokinetiċi ta ’ omalizumab kienu studjati f’ pazjenti b’ ażżma allerġika.
Absorption After subcutaneous administration, omalizumab is absorbed with an average absolute bioavailability of 62%.
Assorbiment Wara li jingħata taħt il- ġilda, omalizumab jiġi assorbit b’ bijodisponibilità assoluta medja ta ’ 62%.
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.
Wara doża waħda li tingħata taħt il- ġilda f’ pazjenti adulti u adolexxenti li jsofru bl- ażżma, omalizumab kien assorbit bil- mod, u laħaq l- ogħla konċentrazzjoni fis- serum wara medja ta ’ 7- 8 ijiem.
The pharmacokinetics of omalizumab are linear at doses greater than 0.5 mg/ kg.
Il- farmakokinetiċi ta ’ omalizumab issegwi linja dritta f’ dożi akbar minn 0. 5 mg/ kg.
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.
Wara numru ta ’ dożi ta ’ omalizumab, l- erjas taħt il- kurva tal- konċentrazzjoni fis- serum mal- ħin minn Jum 0 sa Jum 14 fi stat fiss kienu sa ’ 6- darbiet dawk ta ’ wara l- ewwel doża.
Distribution In vitro, omalizumab forms complexes of limited size with IgE.
Distribuzzjoni In vitro, omalizumab jifforma kumplessi ta ’ daqs limitat ma ’ IgE.
Precipitating complexes and complexes larger than one million Daltons in molecular weight are not observed in vitro or in vivo.
Kumplessi li jippreċipitaw jew kumplessi akbar minn miljun Daltons fil- piż molekolari ma dehrux in vitro jew in vivo.
The apparent volume of distribution in patients following subcutaneous administration was 78 ± 32 ml/ kg.
Il- volum ta ’ distribuzzjoni apparenti f’ pazjenti wara li ngħataw doża taħt il- ġilda kien ta ’ 78 ± 32 ml/ kg.
10 Elimination Clearance of omalizumab involves IgG clearance processes as well as clearance via specific binding and complex formation with its target ligand, IgE.
Eliminazzjoni It- tneħħija ta ’ omalizumab tinvolvi proċessi ta ’ tneħħija ta’ IgG kif ukoll tneħħija permezz ta ’ twaħħil u formazzjoni speċifiċi ta ’ kumplessi mal- ligand immirat, IgE.
Liver elimination of IgG includes degradation in the reticuloendothelial system and endothelial cells.
Eliminazzjoni ta ’ IgG mill- fwied tinkludi degradazzjoni fis- sistema retikulo- endotiljali u fiċ- ċelloli endotiljali.
Intact IgG is also excreted in bile.
IgG intatt jiġi eskretat ukoll fil- bile.
In asthma patients the omalizumab serum elimination half-life averaged 26 days, with apparent clearance averaging 2.4 ± 1.1 ml/ kg/ day.
F’ pazjenti li jsofru bl- ażżma, 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.
In addition, doubling of body weight approximately doubled apparent clearance.
Minbarra hekk, meta l- piż tal- ġisem irdoppja, it- tneħħija apparenti kważi rduppjat.
Characteristics in patient populations Age, Race/ Ethnicity, Gender The population pharmacokinetics of Xolair were analysed to evaluate the effects of demographic characteristics.
Karatteristiċi f’ popolazzjonijiet ta ’ pazjenti Età, Razza/ Etniċità, Sess Il- farmakokinetiċi tal- popolazzjoni fuq Xolair kienet analizzata sabiex jiġu evalwati l- effetti tal - karatteristiċi demografiċi.
Analyses of these limited data suggest that no dose adjustments are necessary for age (12-76 years), race, ethnicity or gender.
Analiżi ta ’ dan it- tagħrif limitat jissuġġerixxi li m’ hemmx bżonn isir tibdil fid- dożi għall- età (12- 76 sena), razza, etniċità jew sess.
Renal and hepatic impairment There are no pharmacokinetic or pharmacodynamic data in patients with renal or hepatic impairment (see section 4.4).
Indeboliment renali u epatiku M’ hemmx tagħrif farmakokinetiku jew farmakodinamiku f’ pazjenti li jsofru b’ indeboliment renali jew epatiku (ara sezzjoni 4. 4).
The safety of omalizumab has been studied in the cynomolgus monkey, since omalizumab binds to cynomolgus and human IgE with similar affinity.
Is- sigurtà ta ’ omalizumab kienet studjata f’ xadini cynomolgus, peress li omalizumab jintrabat ma ’ l - IgE tal- bniedem u ta 'cynomolgus b’ affinità simili.
Antibodies to omalizumab were detected in some monkeys following repeated subcutaneous or intravenous administration.
Antikorpi għal omalizumab instabu f’ xi xadini wara l- għoti ta 'dożi ripetuti taħt il- ġilda jew għal ġol- vini.
However, no apparent toxicity, such as immune complex-mediated disease or complement-dependent cytotoxicity, was seen.
Ma kienx
There was no evidence of an anaphylactic response due to mast-cell degranulation in cynomolgus monkeys.
11 hemm evidenza ta ’ rispons anafilattiku permezz ta ’ degranulazzjoni ta ’ ċelluli tat- tip mast fix- xadini cynomolgus.
Chronic administration of omalizumab was well tolerated in non-human primates, with the exception of a dose-related and age-dependent decrease in blood platelets, with a greater sensitivity in juvenile animals.
Għotja kronika ta ’ omalizumab kienet tollerata sew f’ primati li ma jinkludux il- bniedem, bl- eċċezzjoni ta ’ nuqqas ta ’ plejtlets tad- demm relatata mad- doża u marbuta ma ’ l- età, b’ sensitività akbar f’ bhejjem ta ’ età żgħira.
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.
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.
In addition, acute haemorrhage and inflammation were observed at injection sites in cynomolgus monkeys.
Minbarra hekk, kien hemm emorraġġija akuta u infjammazzjoni fil- post ta 'l- injezzjoni f’ xadini cynomolgus.
Formal carcinogenicity studies have not been conducted with omalizumab.
Ma sarux sudji formali dwar kemm l- użu ta ’ omalizumab jista ’ jikkawża mard tal- kanċer.
In reproduction studies in cynomolgus monkeys subcutaneous doses up to 75 mg/ kg (about 12-fold exposure ratio based on 28-day AUC values at 75 mg/ kg versus the clinical maximum dose) 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.
Fi studji dwar ir- riproduzzjoni f’ xadini cynomolgus, dożi mogħtija taħt il- ġilda sa ’ 75 mg/ kg (madwar 12- il darba il- proporzjon ta ’ espożizzjoni ta ’ 75 mg/ kg bażati fuq valuri ta ’ l- AUC ta ’ 28- jum kontra l - ogħla doża klinika) ma kkawżawx tossiċità fl- omm, fl- embriju jew teratoġeniċità meta ngħataw waqt l- iżvilupp ta ’ l- organi u ma kellhomx effetti avversi fuq l- iżvilupp tal- fetu jew tal- wild li kien għadu kif twieled meta ngħata fl- aħħar żmien tat- tqala, ħlas u treddigħ.
Omalizumb is excreted in milk in cynomolgus monkeys.
Omalizumab joħroġ mal- ħalib tax- xadini cynomolgus.
Milk levels of omalizumab were 1.5% of the maternal blood concentration.
Il- livelli ta ’ omalizumab fil- ħalib kienu ta ’ 1. 5% il- livelli tal- konċentrazzjoni fid- demm ta ’ l- omm.
Sucrose Histidine Histidine hydrochloride monohydrate Polysorbate 20
Sucrose Histidine Histidine hydrochloride monohydrate Polysorbate 20
4 years
4 snin.
The chemical and physical stability of the reconstituted product have been demonstrated for 8 hours at 2°C to 8°C and for 4 hours at 30°C.
L- istabilità kimika u fiżika tal- prodott imħallat żammet għal 8 sigħat f’ temperatura ta ’ 2°C sa 8°C u għal 4 sigħat f ’ 30°C.
From a microbiological point of view, the product should be used immediately after reconstitution.
Mill- lat mikrobijoloġiku, il- prodott għandu jintuża malli jitħallat.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 8 hours at 2°C to 8°C or 4 hours at 30°C.
Jekk ma jintużax mill- ewwel, il - ħinijiet tal- ħażna waqt l- użu u l- kundizzjonijiet ta ’ l- użu huma r- responsabbiltà ta ’ min qed jużah u normalment ma jaqbżux 8 sigħat f’ 2°C sa 8°C jew 4 sigħat f’ 30°C.
Powder vial:
Trab tal- kunjett: b’ saba ’.
Clear, colourless type I glass vial with a butyl rubber stopper and grey flip-off seal.
Ċar, kunjett tal- ħġieg tat- tip I bla kulur b’ tapp tal- gomma butyl griż u siġill li ttajru
Solvent ampoule:
Solvent ampulla:
Clear, colourless type I glass ampoule containing 2 ml water for injections.
Ċar, ampulla tal- ħġieġ tat- tip I bla kulur li fiha 2 ml ta ’ ilma għall- injezzjonijiet.
Package of one vial of powder for solution for injection and one ampoule of water for injections.
Pakkett ta 'kunjett wieħed ta ’ trab għal soluzzjoni għall- injezzjoni u ampulla waħda għall- ilma għall - injezzjonijiet.
The lyophilised product takes 15-20 minutes to dissolve, although in some cases it may take longer.
Il- prodott lajofilizzat jieħu 15- 20 minuta biex jinħall, għalkemm f’ xi każijiet jista ’ jieħu aktar.
The fully reconstituted product will appear clear or slightly opaque and may have a few small bubbles or foam around the edge of the vial.
Il - prodott imħallat bil- lest ikun jidher ċar jew ftit opak u jista ’ jkollu ftit bżieżaq żgħar jew rawgħa mad - dawra tax- xifer tal- kunjett.
Because of the viscosity of the reconstituted product care must be taken to WITHDRAW ALL OF THE PRODUCT from the vial before expelling any air or excess solution from the syringe in order to obtain the 0.6 ml.
Minħabba li l- prodott fil- kunjett ikun daqsxejn magħqud, għandha tingħata attenzjoni sabiex il- PRODOTT KOLLU JINĠIBED mill- kunjett qabel ma tneħħi xi arja jew soluzzjoni żejda mis- siringa sabiex tikseb 0. 6 ml.
12 To prepare Xolair 75 mg vials for subcutaneous administration, please adhere to the following instructions:
Biex tipprepara kunjetti ta ’ 75 mg Xolair biex jingħata taħt il- ġilda, jekk jogħġbok żomm ma ’ dawn l - istruzzjonijiet:
Draw 0.9 ml of water for injections from the ampoule into a syringe equipped with a large-bore 18-gauge needle.
Iġbed 0. 9 ml ta ’ ilma għall- injezzjonijiet mill- ampulla fis- siringa li għandha labra b’ kalibru wiesa ’ tal- 18 gejġ.
With the vial placed upright on a flat surface, insert the needle and transfer the water for injections into the vial containing the lyophilised powder using standard aseptic techniques, directing the water for injections directly onto the powder.
Bil- kunjett wieqaf fuq superfiċje ċatta, daħħal il- labra u aqleb l- ilma għall- injezzjonijiet fil - kunjett li fih it- trab lajofilizzat bil- ħarsien tal- metodi asettiċi, u immira l- ilma għall - injezzjonijiet direttament fuq it- trab.
Keeping the vial in an upright position, vigorously swirl it (do not shake) for approximately 1 minute to evenly wet the powder.
Waqt li żżomm il- kunjett wieqaf, dawwar bil- qawwa (imma tħawwadx) għal madwar minuta sabiex it- trab jixxarrab kollu.
To aid in dissolution after completing step 3, gently swirl the vial for 5-10 seconds approximately every 5 minutes in order to dissolve any remaining solids.
Biex tiffaċilita li jinħall, f’ punt 3, bil- galbu dawwar il- kunjett għal 5- 10 sekondi madwar kull 5 minuti sabiex tħoll xi solidi li jkun għad fadal.
Note that in some cases it may take longer than 20 minutes for the powder to dissolve completely.
Innota li f’ xi każijiet tista ’ ddum aktar minn 20 minuta biex jinħall it- trab għal kollox.
If this is the case, repeat step 4 until there are no visible gel-like particles in the solution.
Jekk jiġri hekk, erġa ’ irrepeti punt 4 sakemm ma jibqgħux jidhru biċċiet qieshom ġell fis- soluzzjoni.
When the product is fully dissolved, there should be no visible gel-like particles in the solution.
Meta l- prodott jinħall għal kollox, m’ għandux ikun hemm biċċiet qieshom ġell fis- soluzzjoni.
Small bubbles or foam around the edge of the vial are common.
Bżiezaq żgħar jew rawgħa max- xifer tal- kunjett huma komuni.
The reconstituted product will appear clear or slightly opaque.
Il- prodott imħallat ikun jidher ċar jew ftit opak.
Do not use if solid particles are present.
Tużahx jekk ikun hemm xi frak.
Invert the vial for at least 15 seconds in order to allow the solution to drain towards the stopper.
Aqleb il- kunjett għal madwar 15- il sekonda sabiex tħalli s- soluzzjoni tinżel lejn it- tapp.
Using a new 3-ml syringe equipped with a large-bore, 18-gauge needle, insert the needle into the inverted vial.
B’ siringa ġdida ta ’ 3- ml mgħammra b’ labra b’ kalibru wiesa ’ gejġ- 18, daħħal il- labra fil- kunjett rasu l- isfel.
Keeping the vial inverted position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe.
Bil- kunjett rasu l- isfel, qiegħed il- ponta tal- labra fil- qiegħ nett tas- soluzzjoni fil - kunjett meta tkun qed tiġbed is- soluzzjoni fis- siringa.
Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.
Qabel tneħħi l- labra mill- kunjett, iġbed il - planġer lura għal kollox sat- tarf tal- bettija tas- siringa sabiex tneħħi s- soluzzjoni kollha mill - kunjett maqlub rasu l- isfel.
Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
Ibdel il- labra tal- 18- gejġ b’ labra tal- 25- gejġ għal injezzjonijiet taħt il- ġilda.
Expel air, large bubbles, and any excess solution in order to obtain the required 0.6 ml dose.
Imbotta l- arja, bżieżaq kbar jew soluzzjoni żejda ‘ l barra sabiex tikseb id- doża ta ’ 0. 6 ml meħtieġa.
A thin layer of small bubbles may remain at the top of the solution in the syringe.
Saff irqieq ta ’ bżieżaq żgħar jistgħu jibqgħu fil- wiċċ tas- soluzzjoni tas- siringa.
Because the solution is slightly viscous, it may take take 5-10 seconds to administer the solution by subcutaneous injection.
Minħabba li s- soluzzjoni tkun daqsxejn magħquda, tista ’ tieħu 5- 10 sekondi biex tagħti s - soluzzjoni b’ injezzjoni taħt il- ġilda.
The vial delivers 0.6 ml (75 mg) of Xolair.
Il- kunjett ikun fih 0. 6 ml (75 mg) ta ’ Xolair.
The injections are administered subcutaneously in the deltoid region of the arm or the thigh.
L- injezzjonijiet jingħataw taħt il- ġilda fir- reġjun tad- deltojd tad- driegħ jew fil- koxxa.
Xolair 75 mg powder for solution for injection is supplied in a single-use vial and contains no antibacterial preservatives.
Xolair 75 mg trab għal soluzzjoni għall- injezzjoni issibu f’ kunjett li jintuża darba u ma fihx preservativi għal kontra l- batteri.
From a microbiological point of view, the product should be used immediately after reconstitution (see section 6.3).
Mill- lat mikrobijoloġiku, il- prodott għandu jintuża mill- ewwel wara li jitħallat (ara sezzjoni 6. 3).
Xolair 150 mg powder and solvent for solution for injection
Xolair 150 mg trab u solvent għal soluzzjoni għall- injezzjoni
One vial contains 150 mg of omalizumab.
Kunjett wieħed fih 150 mg omalizumab.
After reconstitution the vial contains 125 mg/ ml of omalizumab (150 mg in 1.2 ml).
Wara r- rikostituzzjoni l- kunjett ikun fih 125 mg/ ml ta ’ omalizumab (150 mg f ’ 1. 2 ml)
See Table 1 for a conversion chart and Tables 2 and 3 for the dose determination charts.
Ara Tabella 1 għaċ- ċart ta ’ konverżjoni u Tabelli 2 u 3 għaċ- ċarts biex tistabilixxi d- doża.
Patients whose baseline IgE levels or body weight in kilograms are outside the limits of the dosing table should not be given Xolair.
15 Pazjenti li jkollhom il- linja bażika tal- livelli ta ’ IgE jew il- piż tal- ġisem f’ kilogrammi jaqaw barra mill- limiti tat- tabella tad- dożaġġ m’ għandhomx jingħataw Xolair.
15 For subcutaneous administration only.
Użu għal taħt il- ġilda biss.
16 Table 3:
16 Tabella 3:
17 4.4 Special warnings and precautions for use
17 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Patients with diabetes mellitus, the glucose-galactose malabsorption syndrome, fructose intolerance or sucrase-isomaltase deficiency should be warned that one 150 mg Xolair dose contains 108 mg of sucrose.
Pazjenti li jsofru bid- dijabete mellitus, sindrome ta ’ malassorbiment ta 'glucose- galactose, intolleranza għall- fructose jew defiċjenza ta ’ sucrase- isomaltase għandhom jiġu avżati li doża waħda ta ’ 150 mg Xolair fiha 108 mg ta ’ sucrose.
In rare cases, patients on therapy with anti-asthma agents, including omalizumab, may present or develop systemic eosinophilia and vasculitis.
18 F’ każijiet rari, pazjenti fuq terapija b’ sustanzi kontra l- ażma, inkluż omalizumab, jista ’ jaqbadhom jew jiżviluppaw eżinofilja sistemika u vaskulite.
Omalizumab has been associated with age-dependent decreases in blood platelets in non-human primates, with a greater relative sensitivity in juvenile animals (see section 5.3).
Omalizumab kien assoċjat ma ’ tnaqqis dipendenti fuq l- età fin- numru ta ’ plejtlets
It is not known whether omalizumab is excreted in human breast milk.
Mhux mgħaruf jekk omalizumab joħroġx fil- ħalib tas- sider tal- mara.
20 General disorders and administration site conditions Common Uncommon Immune system disorders
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Komuni Mhux komuni Disturbi fis- sistema immuni
For further information, see section 4.4.
Għal aktar informazzjoni, ara sezzjoni 4. 4.
4.9 Overdose
21 4. 9 Doża eċċessiva
21 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.
Fi studji kliniċi, il- livelli ta ’ IgE ħieles fis- serum kienu mnaqqsa b’ mod marbut mad- doża fi żmien siegħa wara li ngħatat l- ewwel doża u dawn il- livelli nżammu baxxi bejn doża u oħra.
Clinical experience 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.
22 Esperjenza klinika L- effikaċja 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 ażżma 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- ażżma avolja kienu qed jirċievu dożi għoljin ta ’ kortikosterojdi li jittieħdu man- nifs u agonist tal- beta2 li jaħdem fit- tul.
In a subgroup analysis patients with pre-treatment total IgE ≥ 76 IU/ ml were more likely to experience clinically meaningful benefit to Xolair.
F’ analiżi ta ’ sottogrupp, pazjenti li kellhom livelli ta ’ IgE ≥76 IU/ ml kellhom aktar ċans li jiksbu benefiċju ta ’ valur kliniku b’ Xolair.
Table 5:
23 Tabella 5:
Rate per 28-week period% reduction, p-value for rate ratio Emergency visits
Rata għal kull perijodu ta ’ 28 – ġimgħa
0.24 50.1%, p =
0. 24
0.48 0.002
50. 1%, p = 0. 002
Rate per 28-week period% reduction, p-value for rate ratio Physician’ s overall assessment
Rata għal kull perijodu ta ’ 28 - ġimgħa
0.24 43.9%, p =
0. 24
0.43 0.038
0. 43
% responders*
Tnaqqis%, valur- p għall - proporzjon tar- rata Stima ġenerali tat- tabib
42.8%
43. 9%, p = 0. 038
p-value** AQL improvement
% li wrew rispons * Valur- p ** Titjib fl- AQL
22
42. 8%
Whole study 1 population% of patients ≥ 0.5 improvement
% ta ’ pazjenti b’ titjib ta ’ ≥0. 5 Valur- p
p-value * marked improvement or complete control ** p-value for overall distribution of assessment
* titjib konsiderevoli jew kontroll komplet ** valur- p għad- distribuzzjoni totali ta ’ l- istima.
For all six studies there was a statistically significant improvement from baseline in quality of life scores for Xolair patients versus the placebo or control group.
24 Il- punteġġi tal- kwalità tal- ħajja kienu mkejjla bil- kwestjonarju magħruf bħala “ Juniper Asthma - related Quality of Life Questionnaire. ” Għas- sitt studji kollha, kien hemm titjib statistikament sinifikanti mill- linja bażika fil- punteġġi tal- kwalità tal- ħajja għall- pazjenti fuq Xolair kontra l- plaċebo jew il- grupp ta ’ kontroll.
Physicians overall assessment of treatment effectiveness:
L- istima ġenerali tat- tabib dwar l- effikaċja tal- kura:
23 Elimination Clearance of omalizumab involves IgG clearance processes as well as clearance via specific binding and complex formation with its target ligand, IgE.
Eliminazzjoni It- tneħħija ta ’ omalizumab tinvolvi proċessi ta ’ tneħħija ta’ IgG kif ukoll tneħħija permezz ta ’ twaħħil u formazzjoni speċifiċi ta ’ kumplessi mal- ligand immirat, IgE.
However, no apparent toxicity, such as immune complex-mediated disease or complement-dependent cytotoxicity, was seen.
Madankollu ma deherx li kien hemm xi tossiċità, bħal mard immunitarju medjat b’ kumplessi jew ċitotossiċità dipendenti mill- kompliment.
There was no evidence of an anaphylactic response due to mast-cell degranulation in cynomolgus monkeys.
Ma kienx hemm evidenza ta ’ rispons anafilattiku permezz ta ’ degranulazzjoni ta ’ ċelluli tat- tip mast fix- xadini cynomolgus.
Chronic administration of omalizumab was well tolerated in non-human primates, with the exception of a dose-related and age-dependent decrease in blood platelets, with a greater sensitivity in juvenile animals.
25 Għotja kronika ta ’ omalizumab kienet tollerata sew f’ primati li ma jinkludux il- bniedem, bl- eċċezzjoni ta ’ nuqqas ta ’ plejtlets tad- demm relatata mad- doża u marbuta ma ’ l- età, b’ sensitività akbar f’ bhejjem ta ’ età żgħira.
Powder vial:
Trab tal- kunjett: ttajru b’ saba ’.
Clear, colourless type I glass vial with a butyl rubber stopper and blue flip-off seal.
Ċar, kunjett tal- ħġieg tat- tip I bla kulur b’ tapp tal- gomma butyl ċelesti u siġill li
Xolair 150 mg powder and solvent for solution for injection is supplied as packs containing 1, 4 or 10 vials of powder and 1, 4 or 10 ampoules of water for injections, respectively.
Xolair 150 mg trab u solvent għall- injezzjonijiet issibu f’ pakketti li jkun fihom 1, 4 jew 10 kunjetti ta ’ trab u 1, 4 jew 10 ampulli ta ’ ilma għall- injezzjonijiet, rispettivament.
Because of the viscosity of the reconstituted product care must be taken to WITHDRAW ALL OF THE PRODUCT from the vial before expelling any air or excess solution from the syringe in order to obtain the 1.2 ml.
Minħabba li l- prodott fil- kunjett ikun daqsxejn magħqud, għandha tingħata attenzjoni sabiex il- PRODOTT KOLLU JINĠIBED mill- kunjett qabel ma tneħħi xi arja jew soluzzjoni żejda mis- siringa sabiex tikseb 1. 2 ml.
25 To prepare Xolair 150 mg vials for subcutaneous administration, please adhere to the following instructions:
Biex tipprepara kunjetti ta ’ 150 mg Xolair biex jingħata taħt il- ġilda, jekk jogħġbok żomm ma ’ dawn l- istruzzjonijiet:
Draw 1.4 ml of water for injections from the ampoule into a syringe equipped with a large-bore 18-gauge needle.
Iġbed 1. 4 ml ta ’ ilma għall- injezzjonijiet mill- ampulla fis- siringa li għandha labra b’ kalibru wiesa ’ tal- 18 gejġ.
Expel air, large bubbles, and any excess solution in order to obtain the required 1.2 ml dose.
Imbotta l- arja, bżieżaq kbar jew soluzzjoni żejda ‘ l barra sabiex tikseb id- doża ta ’ 1. 2 ml meħtieġa.
Because the solution is slightly viscous, it may take 5-10 seconds to administer the solution by subcutaneous injection.
Minħabba li s- soluzzjoni tkun daqsxejn magħquda, tista ’ tieħu 5- 10 sekondi biex tagħti s - soluzzjoni b’ injezzjoni taħt il- ġilda.
The vial delivers 1.2 ml (150 mg) of Xolair.
Il- kunjett ikun fih 1. 2 ml (150 mg) ta ’ Xolair.
For a 75 mg dose, draw up 0.6 ml into the syringe and discard the remaining solution.
Għal doża ta ’ 75 mg, iġbed 0. 6 ml fis- siringa u armi s- soluzzjoni li jibqa ’.
Xolair 150 mg powder for solution for injection is supplied in a single-use vial and contains no antibacterial preservatives.
Xolair 150 mg trab għal soluzzjoni għall- injezzjoni issibu f’ kunjett li jintuża darba u ma fihx preservativi għal kontra l- batteri.
Xolair 75 mg solution for injection Omalizumab
Xolair 75 mg soluzzjoni għall- injezzjoni Omalizumab
Each pre-filled syringe of 0.5 ml solution contains 75 mg of omalizumab.
Kull siringa milija għal- lest b’ 0. 5 ml ta ’ soluzzjoni fiha 75 mg ta ’ omalizumab.
Omalizumab is a humanised monoclonal antibody manufactured by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell line.
Omalizumab huwa antikorp monoklonali modifikat għal wieħed uman manifatturat bit- teknoloġija ta ’ DNA rikombinata f’ linja ta ’ ċelluli mammarji tal- ovarju tal- ħamster Ċiniż (CHO).
Clear to opalescent, slightly yellow to brown solution.
Soluzzjoni trasparenti sa tkanġi, minn safra sa kemmxejn kannella.
Xolair is indicated as add-on therapy to improve asthma control in adult and adolescent patients (12 years of age and above) 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 high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
Xolair huwa indikat bħala terapija kumplimentari sabiex jitjieb il- kontroll tal- ażma ta ’ pazjenti adulti u adolexxenti (minn 12- il sena ‘ l fuq) li jsofru b’ ażma allerġika persistenti u qawwija li jkollhom test tal - ġilda posittiv jew reazzjoni in vitro għal xi allerġen perenni fl- arja u li jkollhom tnaqqis fil- funzjoni tal- pulmun (FEV1 < 80%), kif ukoll sintomi frekwenti matul il- jum jew qawmien bil- lejl u li jkollhom numru ta ’ attakki ħorox tal- ażma u li jkunu qed jaggravaw għalkemm ikunu qed jieħdu dożi għoljin ta ’ kortikosterojdi li jittieħdu man- nifs kuljum, flimkien ma ’ agonist- beta2 li jaħdem fit- tul u li jittieħed man- nifs.
Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2).
Kura b’ Xolair għandha titqies biss f’ każijiet fejn ikun hemm evidenza konvinċenti li l- ażma tkun medjata b’ IgE (immunoglobulina E) (ara sezzjoni 4. 2).
Xolair treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma.
Kura b’ Xolair għandha tkun mibdija minn tobba li għandhom esperjenza fid- dijanjożi u l- kura ta ’ ażma qawwija u persistenti.
Use in adolescents and adults (12 years of age and older) The appropriate dose and dosing frequency of Xolair is determined by baseline IgE (IU/ ml), measured before the start of treatment, and body weight (kg).
Użu f’ adolexxenti u adulti (minn 12- il sena ‘ l fuq) Id- doża xierqa u l- frekwenza ta ’ dożaġġ ta ’ Xolair li għandhom jingħataw għandhom jiġu stabiliti mill- linja bażika ta ’ IgE (IU/ ml), imkejla qabel ma tibda l- kura, kif ukoll mill- piż tal- ġisem (kg).
Based on these measurements 75-375 mg of Xolair in 1 to 3 injections may be needed for each administration.
Skont dawn il- qisien 75- 375 mg ta ’ Xolair b’ minn 1 sa 3 injezzjonijiet kull darba jistgħu jkunu meħtieġa.
See Table 1 for a conversion chart and Tables 2 and 3 for the dose determination charts.
29 Ara Tabella 1 għaċ- ċart ta ’ konverżjoni u Tabelli 2 u 3 għaċ- ċarts biex tistabilixxi d- doża.
28 The maximum recommended dose is 375 mg omalizumab every two weeks.
L- aktar doża għolja rakkomandata hija 375 mg ta ’ omalizumab kull ġimgħatejn.
Conversion from dose to number of syringes, number of injections and total injection volume for each administration
Konverżjoni minn doża għan- numru ta ’ siringi, numru ta ’ injezzjonijiet u t- total tal - volum tal- injezzjoni għal kull għotja ta ’ doża
Number of syringes 75 mg 150 mg
Numru ta ’ 75 mg
Number of injections
Numru ta ’ injezzjonijiet
Total injection volume (ml)
Volum totali tal- injezzjoni (ml)
Body weight (kg) Baseline IgE
Piż tal- ġisem (kg) Ig E fil - linja bażika
ADMINISTRATION EVERY 2 WEEKS SEE TABLE 3
GĦOTJA KULL ĠIMAGĦTEJN ARA TABELLA 3
29 Table 3:
30 Tabella 3:
ADMINSTRATION EVERY 2 WEEKS.
GĦOTJA KULL ĠIMAGĦTEJN.
Xolair doses (milligrams per dose) administered by subcutaneous injection every 2 weeks
Dożi ta ’ Xolair (milligrammi għal kull doża) mogħtija b’ injezzjoni taħt il- ġilda kull ġimagħtejn
DO NOT ADMINISTER – data is unavailable for dose
M’ GĦANDEKX TAGĦTIH –
> 600-700
m’ hemmx tagħrif disponibbli biex > 600- 700
recommendation
tkun rakkomandata din id- doża
For subcutaneous administration only.
Biex jingħata taħt il- ġilda biss.
Do not administer by the intravenous or intramuscular route.
Tagħtihx minn ġol- vina jew ġol- muskolu.
The injections are administered subcutaneously in the deltoid region of the arm.
L- injezzjonijiet jingħataw taħt il- ġilda fil- parti deltoid tad- driegħ.
Alternatively, the injections can be administered in the thigh if there is any reason precluding administration in the deltoid region.
B’ mod alternattiv, l- injezzjonijiet jistgħu jingħataw fil- koxxa jekk hemm xi raġuni għalfejn ma jistawx jingħataw fil- parti deltoid.
There is limited experience with self-administration of Xolair.
Hemm esperjenza limitata dwar t- teħid ta ’ Xolair mill- pazjent nnifsu.
Therefore treatment is intended to be administered by a healthcare provider (see section 6.6).
Għalhekk il- kura hija maħsuba biex tingħata minn persuni li jipprovdu kura tas- saħħa (ara sezzjoni 6. 6).
The decision to continue Xolair should be based on whether a marked improvement in overall asthma control is seen (see section 5.1; Physician’ s overall assessment of treatment effectiveness).
Id- deċiżjoni jekk għandux jitkompla Xolair trid tkun bażata fuq jekk kienx hemm titjib ġenerali sostanzjali fil- kontroll tal- ażma (ara sezzjoni 5. 1; L- istima ġenerali tat- tabib dwar l- effikaċja tal- kura).
Elderly (65 years of age and older) There are limited data available on the use of Xolair in patients older than 65 years but there is no evidence that elderly patients require a different dosage from younger adult patients.
Anzjani (minn 65 sena ’ l fuq) It- tagħrif dwar l- użu ta ’ Xolair f’ pazjenti li għandhom minn 65 sena ’ l fuq huwa limitat iżda m’ hemm xejn li juri li pazjenti anzjani jista ’ jkollhom bżonn dożaġġ differenti minn pazjenti adulti li jkunu iżgħar.
30 Children (age below 12 years) Xolair is not recommended for use in children below age 12 due to insufficient data on safety and efficacy.
31 Tfal (età taħt it- 12- il sena) Xolair mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 12- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Patients with renal or hepatic impairment There have been no studies on the effect of impaired renal or hepatic function on the pharmacokinetics of Xolair.
Pazjenti b’ indeboliment tal- kliewi jew tal- fwied Ma kienx hemm studji dwar l- effett tal- funzjoni indebolita tal- kliewi jew tal- fwied fuq il - farmakokinetika ta ’ Xolair.
Because omalizumab clearance at clinical doses is dominated by the reticular endothelial system (RES) it is unlikely to be altered by renal or hepatic impairment.
Minħabba li t- tneħħija ta ’ omalizumab f’ dożi kliniċi hija ddominata mis - sistema endotiljali retikulari (RES) mhuwiex probabbli li jkun hemm tibdil permezz ta ’ indeboliment tal- kliewi jew tal- fwied.
While no particular dose adjustment is recommended for these patients, Xolair should be administered with caution (see section 4.4).
Filwaqt li ma huwa rrakkomandat l- ebda aġġustament tad- doża għal dawn il - pazjenti, Xolair għandu jingħata b’ attenzjoni (ara sezzjoni 4. 4).
General Xolair is not indicated for the treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus.
Ġenerali Xolair mhux indikat għal- kura ta ’ attakki tal- ażma akuti li jkunu qed jaggravaw, attakki ta ’ bronkospażmu akuti jew status asthmaticus.
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.
Xolair ma kienx studjat f’ pazjenti li jsofru b’ sindrome ta ’ iperimmunoglobulina E jew asperġillożi bronkopulmonari allerġika jew għall- użu preventiv ta ’ reazzjonijiet anafilattiċi, inklużi dawk li jkunu kawżati minn allerġija tal- ikel.
Xolair is not indicated for the treatment of these conditions.
Xolair mhuwiex indikat għall- kura ta ’ dawn il- kundizzjonijiet.
Xolair therapy has not been studied in patients with autoimmune diseases, immune complex-mediated conditions, or pre-existing renal or hepatic impairment.
It- terapija b’ Xolair ma ġiex studjat f’ pazjenti li jsofru minn mard awtoimmunitarju, kundizzjonijiet immunitarji medjati b’ kumpless, jew indeboliment tal- kliewi jew tal- fwied li jkun hemm minn qabel.
Immune system disorders • Allergic reactions type I Type I local or systemic allergic reactions, including anaphylaxis and anaphylactic shock, may occur when taking omalizumab, also with onset after a long duration of treatment.
Disturbi fis- sistema immuni • Reazzjonijiet allerġiċi tat- tip I Reazzjonijiet allerġiċi lokali jew sistemiċi tat- tip I, inkluż anafilassi u xokk anafilattiku, jistgħu jseħħu meta jkun qed jittieħed omalizumab, li jistgħu jibdew anki wara żmien twil ta ’ kura.
Therefore medicinal products for the treatment of anaphylactic reactions should always be available for immediate use following administration of Xolair.
Għaldaqstant, mediċini għall- kura ta ’ reazzjonijiet anafilattiċi għandhom ikunu dejjem lesti għall- użu immedjat wara li tingħata doża ta ’ Xolair.
• Serum Sickness Serum sickness and serum sickness-like reactions, which are delayed allergic type III reactions, have rarely been seen in patients treated with humanized monoclonal antibodies including omalizumab.
32 • Marda tas- Serum Marda tas- serum u reazzjonijiet jixbħu l- marda tas- serum, li huma reazzjonijiet allerġiċi tat- tip III li jdumu ma jiġru, dehru b’ mod rari f’ pazjenti kkurati b’ antikorpi monoklonali modifikati għal wieħed uman inkluż omalizumab.
Symptoms suggestive of serum sickness include arthritis/ arthralgias, rash (urticaria or other forms), fever and
Sintomi li jissuġġerixxu marda tas- serum jinkludu artrite/ artralġji, raxx (urtikarja jew forom oħra), deni u limfadenopatija.
• 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.
• 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.
In rare cases, patients on therapy with anti-asthma agents, including omalizumab, may present or develop systemic eosinophilia and vasculitis.
F’ każijiet rari, pazjenti fuq terapija b’ sustanzi kontra l- ażma, inkluż omalizumab, jista ’ jaqbadhom jew jiżviluppaw eżinofilja sistemika u vaskulite.
In patients at chronic high risk of helminth infection, a placebo-controlled trial showed a slight increase in infection rate with omalizumab, although the course, severity, and response to treatment of infection were unaltered.
F’ pazjenti li għandhom riskju għoli kroniku ta ’ infezzjoni b’ elminti, prova kontrollata bi plaċebo wriet żieda żgħira fir- rata ta ’ infezzjonijiet b’ omalizumab, għalkemm l- iżvilupp, severità u rispons tal- infezzjoni għall - kura ma nbidlux.
Malignancies During clinical trials, there was a numerical imbalance in cancers arising in the Xolair (0.5%; 25 cancers in 5,015 patients) treatment group compared with the control (0.18%; 5 cancers in 2,854 patients) group.
Mard malinn Waqt provi kliniċi kien hemm żbilanċ numeriku fil- kankri li kien hemm fil- grupp ta ’ pazjenti li kienu qed jiġu kurati b’ Xolair (0. 5%; 25 kankru f’ 5, 015- il pazjent) meta mqabbla mal- grupp ta ’ kontroll (0. 18%; 5 kankri f ’ 2, 854 pazjent).
Malignancies were uncommon (< 1/ 100) in both the active and the control group.
Mard malinn ma kienx komuni (< 1/ 100) kemm fil- grupp attiv kif ukoll fil- grupp ta ’ kontroll.
Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of omalizumab; thus, there is little potential for drug-drug interactions.
It- tneħħija ta ’ omalizumab ma tinvolvix mekkaniżmi ta ’ enżimi cytochrome P450, pompi tal- effluss u mekkaniżmi li jinvolvu t- twaħħil ma ’ proteini, għalhekk mhux probabli li jkun hemm nuqqas ta ’ qbil ma ’ prodotti mediċinali oħrajn.
Medicinal product or vaccine interaction studies have not been performed with Xolair.
Ma sarux studji dwar l- effetti ta ’ Xolair ma ’ prodotti mediċinali oħra jew ma ’ tilqim.
There is no pharmacological reason to expect that commonly prescribed medicinal products used in the treatment of asthma will interact with omalizumab.
M’ hemmx raġuni farmakoloġika sabiex wieħed jistenna ’ li jkun hemm nuqqas ta ’ qbil bejn mediċini li jingħataw bir- riċetta b’ mod komuni għall- kura tal- ażma u omalizumab.