qanastek/EMEA-V3 huggingface dataset:
In clinical studies Xolair was commonly used in conjunction with inhaled and oral corticosteroids, inhaled short-acting and long-acting beta agonists, leukotriene modifiers, theophyllines and oral antihistamines.
33 Waqt provi kliniċi, ħafna drabi Xolair intuża ma ’ kortikosterojdi li jittieħdu man- nifs jew mill- ħalq, ma ’ agonisti- beta li jittieħdu man- nifs li għandhom azzjoni qasira jew fit- tul, modifikaturi tal - leukotriene, theophyllines u anti- istaminiċi li jittieħdu mill- ħalq.
There was no indication that the safety of Xolair was altered with these other commonly used asthma medications.
Ma ’ kienx hemm indikazzjoni li s - sigurtà ta ’ Xolair kienet mibdula b’ dawn il- medikamenti li jintużaw ta ’ spiss għall- kura tal- ażma.
Limited data are available on the use of Xolair in combination with specific immunotherapy (hypo-sensitisation therapy).
Hemm tgħarif limitat dwar l- użu ta ’ Xolair ma ’ immunoterapija speċifika (terapija ta ’ iposensitazzjoni).
32 Xolair may indirectly reduce the efficacy of medicinal products for the treatment of helminthic or other parasitic infections (see section 4.4).
Xolair jista ’ b’ mod indirett inaqqas l- effikaċja ta ’ prodotti mediċinali għall- kura ta ’ infezzjonijiet ikkawżati minn elminti jew parassiti oħra (ara sezzjoni 4. 4).
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala, fuq l- iżvilupp tal- embriju/ fetu, ħlas jew żvilupp wara t - twelid (ara sezzjoni 5. 3).
Omalizumab is excreted into non-human primate breast milk and risk to the suckling child cannot be excluded.
Omalizumab joħroġ fil- ħalib tas - sider ta ’ primati li ma jinkludux il- bniedem u ma jistax jiġi eskluż li jkun hemm riskju għat- tarbija li tkun qed titredda ’.
Breast-feeding women should not breast-feed during Xolair therapy.
Nisa li qed ireddgħu m’ għandhomx ireddgħu waqt terapija b’ Xolair.
Over 4,400 allergic asthma patients were randomised in controlled efficacy trials with Xolair.
Aktar minn 4, 400 pazjent b’ ażma allerġika kienu randomised fi provi kkontrollati tal- effikaċja b’ Xolair.
Based on clinical experience, about 16% of patients treated with Xolair are expected to experience adverse events.
Fuq bażi ta ’ esperjenza klinika, madwar 16% tal- pazjenti kkurati b’ Xolair huma mistennija li jesperjenzaw każijiet avversi.
During clinical trials the most commonly reported adverse reactions were injection site reactions, including injection site pain, swelling, erythema and pruritus, and headaches.
Waqt provi kliniċi, l- aktar reazzjonijiet avversi li kienu rapurtati ta ’ spiss kienu reazzjonijiet fil- post tal- injezzjoni, inklużi uġigħ fil- post tal- injezzjoni, nefħa, ħmura u ħakk u attakki ta ’ uġigħ ta ’ ras.
Most of the reactions were mild or moderate in severity.
Fil - parti l- kbira tagħhom dawn ir- reazzjonijiet kienu ħfief jew moderati fil- qawwa tagħhom.
Table 4 lists the adverse reactions recorded in clinical studies in the total safety population treated with Xolair by system organ class and by frequency.
It- tabella 4 telenka r- reazzjonijiet avversi li kienu reġistrati waqt provi kliniċi fil- popolazzjoni sigura kollha tal- pazjenti kurati b’ Xolair, skont is- sistema tal- klassifika tal- organi u skont il- frekwenza.
Frequencies are defined as: common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100) and rare (< 1/ 1,000).
Il- frekwenzi huma definiti bħala: komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥1/ 1, 000 sa < 1/ 100) u rari (< 1/ 1, 000).
Events reported in the post-marketing setting are listed with frequency not known (cannot be estimated from the available data).
Każijiet rappurtati wara t- tqegħid fis- suq qegħdin elenkati bil - frekwenza mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
Table 4:
34 Tabella 4:
Headache Syncope, paraesthesia, somnolence, dizziness
Uġigħ ta ’ ras Sinkope, paresteżija, ngħas, sturdament
Churg-Strauss syndrome)
Bronkospażmu allerġiku, farinġite, sogħla Larinġoedema Vaskulite granulomatuża allerġika (i. e. sindrome Churg- Strauss)
Dyspeptic signs and symptoms, diarrhoea, nausea
Sinjali u sintomi dispeptiċidijarea, dardir
33 Skin and subcutaneous tissue disorders Uncommon Rare Not known
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni Rari Mhux magħruf
Photosensitivity, urticaria, rash, pruritus Angioedema Alopecia
Fotosensittività, urtikarja, raxx, ħakk Angjoedema Alopeċja
Postural hypotension, flushing
Pressjoni baxxa skont il- qagħda, fwawar
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
Injection site reactions such as swelling, erythema, pain, pruritus Influenza-like illness, swelling arms, weight increase, fatigue
Reazzjonijiet fil- post tal- injezzjoni bħal nefħa, ħmura, uġigħ, ħakk Mard li jixbaħ l- influwenza, driegħ minfuħa, żieda fil- piż, għeja
Anaphylactic reaction, other serious allergic conditions Serum sickness, may include fever and lymphadenopathy
Reazzjoni anafilattika, kundizzjonijiet allerġiċi serji oħrajn Marda tas- serum, tista ’ tinkludi deni u limfadenopatija
Malignancies The overall observed incidence rate of malignancy in the Xolair clinical trial programme was comparable to that reported in the general population (see section 4.4).
Mard malinn Ir- rata globali tal- inċidenza tal- mard malinn fil- programm tal- provi kliniċi bi Xolair dehret li kienet kumparabbli ma ’ dik rappurtata fil- popolazzjoni ġenerali (ara sezzjoni 4. 4).
No pattern of persistent decrease in platelet counts, as observed in non-human primates (see section 5.3), has been reported in humans even though isolated cases of idiopathic thrombocytopenia have been reported in the post-marketing setting.
Fil- bnedmin ma kienx rapurtat xempju ta ’ tnaqqis persisitenti tal- għadd tal- plejtlets bħal ma ġie osservat fil- primati mhux bnedmin (ara sezzjoni 5. 3) anki jekk każijiet iżolati ta ’ tromboċitopenija idjopatika kienu rrappurtati wara t- tqegħid fis- suq.
Parasitic infections In patients at chronic high risk of helminth infection, a placebo-controlled trial showed a slight numerical increase in infection rate with omalizumab that was not statistically significant.
Infezzjonijiet bil- parassiti F’ pazjenti li kellhom riskju kroniku għoli ta ’ infezzjoni b’ mard tal- elminti, prova kontrollata bi plaċebo wriet żieda żgħira fir- rata tal- infezzjoni b’ omalizumab li ma kienitx statistikament sinifikanti.
The course, severity, and response to treatment of infections was unaltered (see section 4.4).
L- iżvilupp, severità u rispons għall- kura tal- infezzjonijiet ma nbidlux (ara sezzjoni 4. 4).
4.9 Overdose
35 4. 9 Doża eċċessiva
The highest cumulative dose administered to patients was 44,000 mg over a 20-week period and this dose did not result in any untoward acute effects.
L- ogħla doża kumulattiva li ngħatat lil pazjenti kienet 44, 000 mg f’ perijodu ta ’ 20 ġimgħa u din ma wasslitx għal xi effetti ħżiena akuti.
34 Omalizumab is a recombinant DNA-derived humanised monoclonal antibody that selectively binds to human immunoglobulin E (IgE).
Omalizumab huwa antikorp monoklonali modifikat għal wieħed uman derivat mit- teknoloġija ta ’ DNA rikombinat li jeħel b’ mod selettiv mal- immunoglobulina E (IgE).
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.
L- antikorp huwa IgG1 kappa li fih reġjuni ta ’ qafas uman b 'reġjuni kumplimentari determinanti ta ’ antikorp murine parent li jeħel mal- IgE.
Omalizumab binds to IgE and prevents binding of IgE to FCε RI (high-affinity IgE receptor), thereby reducing the amount of free IgE that is available to trigger the allergic cascade.
Omalizumab jeħel mal- IgE u ma jħallix l- IgE jeħel mal- FCεRI (riċettur b’ affinità kbira għall- IgE), b’ hekk inaqqas l- ammont ta ’ IgE ħieles li jkun jista ’ jibda kaskata ta ’ reazzjonijiet allerġiċi.
Furthermore, the in vitro histamine release from basophils isolated from Xolair-treated subjects was reduced by approximately 90% following stimulation with an allergen compared to pre-treatment values.
Minbarra hekk, il- ħelsien in vitro ta ’ istamina minn bażofili ta ’ persuni li ngħataw Xolair naqset b’ madwar 90% wara stimulazzjoni b’ allerġen meta mqabbla mal- valuri li nkisbu qabel il- kura.
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 washout of the medicinal product.
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- prodott mediċinali kien tneħħa 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.
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 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 tal- ażma 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 ’ ażma li kienu qed jaggravaw u li kienu jinħtieġu kura b’ kortikosterojdi b’ mod sistemiku jew iddaħħlu l- isptar jew kellhom imorru fil- kamra tal- emerġenza minħabba s- severità tal- attakki tal- ażma 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.
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 tal- attakki tal- ażma 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 tal- ażma 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 tal- attakki (fejn il- funzjoni tal- pulmun tal- pazjenti kienet imnaqqsa għal taħt 60% tal- aħjar valur personali u li kellhom bżonn kortikosterojdi b’ mod sistemiku) u żjajjar ta 'emergenza relatati mal- ażma (imklużi dħul l- isptar, kamra tal- 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 mal- Ażma (AQL), sintomi tal- ażma 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.
36 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 tal- aggravar tal- attakki tal- ażma 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 ’ ażma qawwija.
Whole study 1 population Asthma exacerbations
Popolazzjoni sħiħa ta ’ studju 1 Aggravar tal- attakki tal- Ażma
% reduction, p-value for rate ratio
Tnaqqis%, valur- p għall - proporzjon tar- rata Aggravar qawwi tal- attakki tal - ażma
35 Severe asthma exacerbations Rate per 28-week period
Rata għal kull perijodu ta ’ 28 – ġimgħa
% of patients ≥ 0.5 improvement p-value
% ta ’ pazjenti b’ titjib ta ’ ≥0. 5 Valur- p
* marked improvement or complete control ** p-value for overall distribution of assessment
* titjib konsiderevoli jew kontroll komplet ** valur- p għad- distribuzzjoni totali tal- istima.
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 tal- attakki tal- ażma b’ valur kliniku sinifkanti meta mqabbel mat- terapija għall- ażma 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’ ażma 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- ażma mill- pazjenti fi studju 1 jew 2.
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 tal- aggravar tal- attakki tal - ażma 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).
37 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 tal- ażma (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.
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 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 tal - ażma li saret mit- tabib li jkun qed jagħti l- kura.
The physician was able to take into account PEF (peak expiratory flow), day and night time symptoms, rescue medication use, spirometry and exacerbations.
It- tabib seta ’ jikkonsidra l- PEF (l- ogħla punt tat- tfigħ ’ il barra tan- nifs), is- sintomi ta ’ bil- lejl u bi nhar, mediċini li jintużaw f’ każ ta ’ emerġenza, spirometrija u aggravar tal- 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 tal- ażma 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’ ażma allerġika.
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- ażma, omalizumab kien assorbit bil- mod, u laħaq l- ogħla konċentrazzjoni fis- serum wara medja ta ’ 7- 8 ijiem.
Following multiple
Il - farmakokinetiċi ta ’ omalizumab issegwi linja dritta f’ dożi akbar minn 0. 5 mg/ kg.
36 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.
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 retikuloendotiljali u fiċ- ċelloli endotiljali.
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- 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.
Analyses of these limited data suggest that no dose adjustments are necessary for age (12-76 years), race, ethnicity or gender (see section 4.2).
Analiżi ta ’ dan it- tagħrif limitat jissuġġerixxi li m’ hemmx bżonn isir tibdil fid- dożi għall- età (12- 76 sena), razza, etniċità jew sess (ara sezzjoni 4. 2).
Renal and hepatic impairment There are no pharmacokinetic or pharmacodynamic data in patients with renal or hepatic impairment (see sections 4.2 and 4.4).
Indeboliment renali u epatiku M’ hemmx tagħrif farmakokinetiku jew farmakodinamiku f’ pazjenti li jsofru b’ indeboliment renali jew epatiku (ara sezzjonijiet 4. 2 u 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 mal- 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.
Chronic administration of high dose levels (up to 250 mg/ kg) of omalizumab did not induce toxicologically-significant adverse reactions 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 ’ livelli ta ’ doża għolja (sa 250 mg/ kg) ta ’ omalizumab ma kkaġunawx reazzjonijiet avversi sinifikanti b’ mod tossikoloġiku f’ primati li ma jinkludux il- bniedem, bl- eċċezzjoni ta ’ nuqqas ta ’ plejtlets tad- demm relatata mad- doża u marbuta mal- 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 tal- injezzjoni f’ xadini cynomolgus.
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 tal- AUC ta ’ 28- jum kontra l - ogħla doża klinika) ma kkawżawx tossiċità fl- omm, fl- embriju jew teratoġeniċità meta ngħataw waqt l- iżvilupp tal- 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 breast milk in cynomolgus monkeys.
Omalizumab joħroġ mal- ħalib tas- sider 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 tal- omm.
L-arginine hydrochloride L-histidine hydrochloride L-histidine Polysorbate 20 Water for injections
L- arginine hydrochloride L- histidine hydrochloride L- histidine Polysorbate 20 Ilma għall- injezzjonijiet
6.5 Nature and contents of container
39 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
0.5 ml solution in a pre-filled syringe barrel (type I glass) with staked needle (stainless steel), (type I) plunger stopper (latex-free rubber) and needle shield (latex-free).
0. 5 ml ta ’ soluzzjoni f’ siringa mimlija għal- lest f’ tubu ċilindriku tas- siringa (ħġieġ tat- tip I) b’ labra (tal- azzar li ma jissaddadx) imwaħħla miegħu, tapp tal- planġer (tat- tip I) (lastku li ma fihx latex), u protezzjoni għal- labra (li ma fihiex latex).
Pack sizes of 1, 4 or 10.
Pakketti b’ 1, b’ 4 jew b’ 10.
Prior to completion of the injection, avoid contact with the device activation clips to keep from prematurely covering the needle with the needle guard.
Qabel ma titlesta l- injezzjoni, evita l- kuntatt mal- klipps ta ’ attivazzjoni tal- istrument biex tevita li tgħatti l- labra bil- protezzjoni tal- labra qabel il- waqt.
Using the syringe 1.
L- użu tas- siringa 1.
Pull off the needle cap from the syringe and discard it.
Neħħi l- għatu tal- labra minn mas- siringa u armih.
Do not touch the exposed needle.
Tmissx il- labra mikxufa.
Gently pinch the skin at the injection site and insert the needle.
Oqros b’ mod ġentili il- ġilda fis- sit tal- injezzjoni u daħħal il- labra.
Holding onto the finger flange, slowly depress the plunger as far as it will go.
Filwaqt li żżomm mal- flanġ tas- saba ’, bil- mod imbotta l- planġer l- isfel sa fejn jista ’ jasal.
Keep the plunger fully depressed until after you have withdrawn the needle from the injection site.
Żomm il- planġer magħfus s’ isfel nett sa wara li tkun neħħejt il- labra minn ġos- sit tal- injezzjoni.
If any solution leaks from the injection site, insert the needle further.
Jekk tnixxi xi soluzzjoni mis- sit tal- injezzjoni, daħħal il- labra aktar il- ġewwa.
Keeping the plunger fully depressed, carefully lift the needle straight out from the injection site.
Filwaqt li żżomm il- planġer magħfus s’ isfel nett, b’ attenzjoni oħroġ il- labra kollha minn ġos- sit tal- injezzjoni.
Slowly release the plunger and allow the needle guard to automatically cover the exposed needle.
Bil- mod erħi l- planġer u ħalli l- protezzjoni tal- labra tgħatti l- labra mikxufa b’ mod awtomatiku.
Disposal instructions Dispose of the used syringe immediately in a sharps container.
Istruzzjonijiet għar- rimi Armi s- siringa wżata immedjatament f’ kontenitur apposta għal oġġetti bix- xifer jew bil- ponta.
Xolair 150 mg solution for injection Omalizumab
Xolair 150 mg soluzzjoni għall- injezzjoni Omalizumab
Each pre-filled syringe of 1 ml solution contains 150 mg of omalizumab.
Kull siringa milija għal- lest b’ 1 ml ta ’ soluzzjoni fiha 150 mg ta ’ omalizumab
See Table 1 for a conversion chart and Tables 2 and 3 for the dose determination charts.
41 Ara Tabella 1 għaċ- ċart ta ’ konverżjoni u Tabelli 2 u 3 għaċ- ċarts biex tistabilixxi d- doża.
40 The maximum recommended dose is 375 mg omalizumab every two weeks.
L- aktar doża għolja rakkomandata hija 375 mg ta ’ omalizumab kull ġimgħatejn.
41 Table 3:
42 Tabella 3:
42 Children (age below 12 years) Xolair is not recommended for use in children below age 12 due to insufficient data on safety and efficacy.
43 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.
• 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.
• 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.
The onset has typically been 1-5 days after administration of the first or subsequent injections, also after long duration of treatment.
44 injezzjonijiet sussegwenti, anke wara tul ta ’ żmien ta ’ kura.
44 Xolair may indirectly reduce the efficacy of medicinal products for the treatment of helminthic or other parasitic infections (see section 4.4).
45 Xolair jista ’ b’ mod indirett inaqqas l- effikaċja ta ’ prodotti mediċinali għall- kura ta ’ infezzjonijiet ikkawżati minn elminti jew parassiti oħra (ara sezzjoni 4. 4).
Table 4:
46 Tabella 4:
45 Skin and subcutaneous tissue disorders Uncommon Rare Not known
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni Rari Mhux magħruf
4.9 Overdose
47 4. 9 Doża eċċessiva
46 Omalizumab is a recombinant DNA-derived humanised monoclonal antibody that selectively binds to human immunoglobulin E (IgE).
Omalizumab huwa antikorp monoklonali modifikat għal wieħed uman derivat mit- teknoloġija ta ’ DNA rikombinat li jeħel b’ mod selettiv mal- immunoglobulina E (IgE).
In a subgroup analysis, patients with pre-treatment total IgE ≥ 76 IU/ ml were more likely to experience clinically meaningful benefit to Xolair.
48 F’ analiżi ta ’ sottogrupp, pazjenti li kellhom livelli ta ’ IgE ≥76 IU/ ml kellhom aktar ċans li jiksbu benefiċju ta ’ valur kliniku b’ Xolair.
47 Severe asthma exacerbations Rate per 28-week period
Rata għal kull perijodu ta ’ 28 – ġimgħa
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).
49 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 tal- ażma (60. 3%) imqabbel mal- grupp tal- plaċebo (45. 8%, p < 0. 05).
48 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.
5.3 Preclinical safety data
50 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
1 ml solution in a pre-filled syringe barrel (type I glass) with staked needle (stainless steel), (type I) plunger stopper (latex-free rubber), and needle shield (latex-free).
1 ml ta ’ soluzzjoni f’ siringa mimlija għal- lest f’ tubu ċilindriku tas- siringa (ħġieġ tat- tip I) b’ labra (tal - azzar li ma jissaddadx) imwaħħla miegħu, tapp tal- planġer (tat- tip I) (lastku li ma fihx latex), u protezzjoni għal- labra (li ma fihiex latex).
52 A.
52 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT B.
Name and address of the manufacturer of the biological active substance
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Novartis Pharma S. A. S.
Isem u indirizz tal- manifattur tas- sustanza bijoloġika attiva Novartis Pharma S. A. S.
Centre de Biotechnologie 8, rue de l’ Industrie F-68330 Huningue FRANCE
Centre de Biotechnologie 8, rue de l’ Industrie F- 68330 Huningue FRANZA
Novartis Pharma S. A. S.
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott Novartis Pharma S. A. S.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 dated 22 July 2008 and presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Il- MAH għandu jaċċerta ruħu li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 2. 0 bid- data tat- 22 ta ’ Lulju 2008 ppreżentata f’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat - Tqegħid fis- Suq, tkun f’ lokha u taħdem qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2 dated 13 February 2008, of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ l- Immaniġġar tar- Riskju Il- MAH jintrabat li jwettaq l- istudji u l- attivitajiet l- oħra dwar il- farmakoviġilanza dettaljati fil- Pjan ta ’ Farmakoviġilanza, hekk kif miftiehem fil- verżjoni 2 bid- data tat- 13 ta ’ Frar 2008 tal- Pjan ta ’ l - Immaniġġjar tar- Riskju (RMP) ippreżentat f’ modulu 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġornamenti ta ’ l- RMP sussegwenti kif miftiehem mis- CHMP.
In addition, an updated RMP should be submitted:
Minbarra hekk, RMP aġġornat għandu jkun sottomess
- when new information is received that may impact on the current Safety Specification,
- meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni kurrenti dwar is -
Pharmacovigilance Plan or risk minimisation activities,
Sigurtà, Pjan ta ’ Farmakoviġilanza jew attivitajiet sabiex ikun imnaqqas għall- minimu r- riskju.
- within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
- fi żmien 60 jum minn meta jintlaħaq avveniment importanti (farmakoviġilanza jew tnaqqis tar -
- at the request of the EMEA.
riskju għall- minimu).
54 ANNEX III
54
LABELLING AND PACKAGE LEAFLET
- fuq talba ta ’ l- EMEA
55 A.
55 ANNESS III
56 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
Xolair 75 mg powder and solvent for solution for injection Omalizumab
Xolair 75 mg trab u solvent għal soluzzjoni għall- injezzjoni Omalizumab
One vial contains 75 mg omalizumab.
Kunjett wieħed fih 75 mg omalizumab.
Powder: sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.
Trab: sucrose, histidine, histidine hydrochloride monohydrate u polysorbate 20.
Solvent: water for injections.
Solvent: ilma għall- injezzjonijiet.
1 x 75 mg vial 1 x 2 ml solvent ampoule
Kunjett 1 x 75 mg Ampulla 1 x 2 ml solvent
EXP Use immediately after reconstitution (may be stored at 2°C - 8°C for up to 8 hours or at 30°C for 4 hours).
JIS Uża mill- ewwel wara li tħalltu (jista ’ jinżamm bejn 2°C – 8°C sa 8 sigħat jew f’ 30°C għal 4 sigħat).
58 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
59 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Xolair 75 mg powder for solution for injection Omalizumab Subcutaneous use
Xolair 75 mg trab għal soluzzjoni għall- injezzjoni Omalizumab Użu għal taħt il- ġilda
Store in a refrigerator (2°C - 8°C)
Aħżen fi friġġ (2°C – 8°C)
Solvent for Xolair Water for injections
Solvent għal Xolair Ilma għall- injezzjonijiet
Use 0.9 ml and discard the rest
Uża 0. 9 ml u armi li jibqa ’.
60 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
61 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON CONTAINING 1 VIAL AND 1 AMPOULE AS UNIT PACK (INCLUDING BLUE BOX)
KARTUNA B’ KUNJETT 1 U AMPULLA 1 BĦALA PAKKETT GĦALIH (INKLUŻA L - KAXXA ĊELESTI)
Xolair 150 mg powder and solvent for solution for injection Omalizumab
Xolair 150 mg trab u solvent għal soluzzjoni għall- injezzjoni Omalizumab
One vial contains 150 mg omalizumab.
Kunjett wieħed fih 150 mg omalizumab.
1 x 150 mg vial 1 x 2 ml solvent ampoule
Kunjett 1 x 150 mg Ampulla 1 x 2 ml solvent
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
63 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR INTERMEDIATE PACK (WITHOUT BLUE BOX) OF MULTIPACKS
KARTUNA GĦALL- PAKKETT INTERMEDJU (MINGĦAJR IL- KAXXA Ċ- ĊELESTI) TAL - PAKKETTI MULTIPLI
1 x 150 mg vial 1 x 2 ml solvent ampoule Component of a multipack comprising 4 packs, each containing 1 vial and 1 ampoule.
Kunjett 1 x 150 mg Ampulla 1 x 2 ml solvent Jagħmel parti minn pakkett multiplu li jinkludi 4 pakketti, kull wieħed ikun fih kunjett 1 u ampulla 1.
Component of a multipack comprising 10 packs, each containing 1 vial and 1 ampoule.
Jagħmel parti minn pakkett multiplu li jinkludi 10 pakketti, kull wieħed ikun fih kunjett 1 u ampulla 1.
Multipack comprising 4 packs Multipack comprising 10 packs
Pakkett multiplu li jkun fih 4 pakketti Pakkett multiplu li jkun fih 10 pakketti
WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX)
IT- TIKKETTA TA ’ FUQ IL- KISJA TA ’ BARRA FUQ PAKKETTI MULTIPLI MIKSIJIN FIL- FOJL (INKLUŻA L- KAXXA Ċ- ĊELESTI)
Multipack comprising 4 packs, each containing 1 vial (150 mg) and 1 solvent ampoule (2 ml):
Pakkett multiplu li jinkludi 4 pakketti, kull wieħed ikun fih kunjett 1 (150 mg) u ampulla 1 b’ solvent (2 ml):
Multipack comprising 10 packs, each containing 1 vial (150 mg) and 1 solvent ampoule (2 ml):
Pakkett multiplu li jinkludi 10 pakketti, kull wieħed ikun fih kunjett 1 (150 mg) u ampulla 1 b’ solvent (2 ml):
Multipack comprising 4 packs Multipack comprising 10 packs
Pakkett multiplu li fih 4 pakketti Pakkett multiplu li fih 10 pakketti
66 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
67 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Xolair 150 mg powder for solution for injection Omalizumab Subcutaneous use
Xolair 150 mg trab għal soluzzjoni għall- injezzjoni Omalizumab Użu għal taħt il- ġilda
67 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
68 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Use 1.4 ml and discard the rest.
Uża 1. 4 ml u armi li jibqa ’.
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
69 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR UNIT PACK
KARTUNA GĦAL PAKKETT B’ WIEĦED
0.5 ml solution for injection contains 75 mg omalizumab.
0. 5 ml ta ’ soluzzjoni għall- injezzjoni fih 75 mg omalizumab.
L-arginine hydrochloride, L-histidine hydrochloride, L-histidine, polysorbate 20, water for injections.
L- arginine hydrochloride, L- histidine hydrochloride, L- histidine, polysorbate 20, ilma għall - injezzjonijiet.
One pre-filled syringe containing 0.5 ml solution for injection.
Siringa waħda mimlija għal- lest li fiha 0. 5 ml ta ’ soluzzjoni għall- injezzjoni.
Use only as directed by a doctor.
Uża biss skont kif qallek it- tabib.
Dispose the used syringe immediately in a sharps container.
Armi s- siringa wżata mill- ewwel f’ kontenitur apposta għal oġġetti bix- xifer jew bil- ponta.
75 mg solution for injection
75 mg soluzzjoni għall- injezzjoni
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
71 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)
KARTUNA TA ’ BARRA TAL- PAKKETTI B’ ĦAFNA (INKLUŻ IL- KAXXA L- BLU)
Multipack comprising 4 intermediate packs, each containing 1 pre-filled syringe of 0.5 ml solution for injection.
Pakkett b’ ħafna li fih 4 pakketti iżgħar, li kull wieħed minnhom fih siringa waħda mimlija għal- lest ta ’ 0. 5 ml ta ’ soluzzjoni għall- injezzjoni.
Multipack comprising 10 intermediate packs, each containing 1 pre-filled syringe of 0.5 ml solution for injection.
Pakkett b’ ħafna li fih 10 pakketti iżgħar, li kull wieħed minnhom fih siringa waħda mimlija għal- lest ta ’ 0. 5 ml ta ’ soluzzjoni għall- injezzjoni.
75 mg solution for injection (4) 75 mg solution for injection (10)
75 mg soluzzjoni għall- injezzjoni (4) 75 mg soluzzjoni għall- injezzjoni (10)
72 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
73 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
KARTUA INTERMEDJA TAL- PAKKETTI B’ ĦAFNA (MINGĦAJR IL- KAXXA L- BLU)
Component of a multipack comprising 4 packs, each containing 1 pre-filled syringe of 0.5 ml solution for injection.
Parti minn pakkett b’ ħafna li fih 4 pakketti, li kull wieħed minnhom fih siringa waħda mimlija għal - lest ta ’ 0. 5 ml ta ’ soluzzjoni għall- injezzjoni.
Component of a multipack comprising 10 packs, each containing 1 pre-filled syringe of 0.5 ml solution for injection.
Parti minn pakkett b’ ħafna li fih 10 pakketti, li kull wieħed minnhom fih siringa waħda mimlija għal - lest ta ’ 0. 5 ml ta ’ soluzzjoni għall- injezzjoni.
74 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
75 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER OF PRE-FILLED SYRINGE
FOLJA TAS- SIRINGA MIMLIJA GĦAL- LEST
75 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
76 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PRE-FILLED SYRINGE LABEL
TIKKETTA TAS- SIRINGA MIMLIJA GĦAL- LEST
Xolair 75 mg solution for injection Omalizumab SC use
Xolair 75 mg soluzzjoni għall- injezzjoni Omalizumab Użu għal taħt il- ġilda
1 ml solution for injection contains 150 mg omalizumab.
1 ml ta ’ soluzzjoni għall- injezzjoni fih 150 mg omalizumab.
One pre-filled syringe containing 1 ml solution for injection.
Siringa waħda mimlija għal- lest li fiha 1 ml ta ’ soluzzjoni għall- injezzjoni.
150 mg solution for injection
150 mg soluzzjoni għall- injezzjoni
78 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
79 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Multipack comprising 4 intermediate packs, each containing 1 pre-filled syringe of 1 ml solution for injection.
Pakkett b’ ħafna li fih 4 pakketti iżgħar, li kull wieħed minnhom fih siringa waħda mimlija għal- lest ta ’ 1 ml ta ’ soluzzjoni għall- injezzjoni.
Multipack comprising 10 intermediate packs, each containing 1 pre-filled syringe of 1 ml solution for injection.
Pakkett b’ ħafna li fih 10 pakketti iżgħar, li kull wieħed minnhom fih siringa waħda mimlija għal- lest ta ’ 1 ml ta ’ soluzzjoni għall- injezzjoni.
150 mg solution for injection (4) 150 mg solution for injection (10)
150 mg soluzzjoni għall- injezzjoni (4) 150 mg soluzzjoni għall- injezzjoni (10)
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
81 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Component of a multipack comprising 4 packs, each containing 1 pre-filled syringe of 1 ml solution for injection.
Parti minn pakkett b’ ħafna li fih 4 pakketti, li kull wieħed minnhom fih siringa waħda mimlija għal - lest ta ’ 1 ml ta ’ soluzzjoni għall- injezzjoni.
Component of a multipack comprising 10 packs, each containing 1 pre-filled syringe of 1 ml solution for injection.
Parti minn pakkett b’ ħafna li fih 10 pakketti, li kull wieħed minnhom fih siringa waħda mimlija għal - lest ta ’ 1 ml ta ’ soluzzjoni għall- injezzjoni.
82 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
83 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
83 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
84 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Xolair 150 mg solution for injection Omalizumab SC use
Xolair 150 mg soluzzjoni għall- injezzjoni Omalizumab Użu għal taħt il- ġilda
85 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF
Read all of this leaflet carefully before you start using Xolair.
Aqra sew dan il- fuljett kollu qabel tibda tuża Xolair.
What Xolair is and what it is used for 2.
X’ inhu Xolair u għalxiex jintuża 2.
Before you use Xolair 3.
Qabel ma tuża Xolair 3.
How to use Xolair 4.
Kif għandek tuża Xolair 4.
How to store Xolair 6.
Kif taħżen Xolair 6.
WHAT XOLAIR IS AND WHAT IT IS USED FOR
X’ INHU XOLAIR U GĦALXIEX JINTUŻA
Xolair is used to prevent asthma getting worse and to control asthma symptoms when given in addition to other asthma medication.
Xolair jintuża biex jevita milli taggrava l- ażżma u biex jikkontrolla s- sintomi meta tieħdu flimkien mal- mediċini l- oħrajn għall- ażżma.
Xolair is used to control symptoms of severe allergic asthma in adults or adolescents (12 years of age and older) whose asthma symptoms are not well controlled by high-dose steroid inhalers or beta- agonist inhalers.
Xolair jintuża biex jikkontrolla s- sintomi ta ’ ażżma allerġika qawwija fl- adulti u l- adolexxenti (minn 12- il sena ‘ l fuq) li jkollhom sintomi li ma jkunux kontrollati tajjeb b’ dożi għoljin ta ’ sterojdi li jittieħdu man- nifs jew b’ agonisti- beta li jittieħdu man- nifs.
Xolair works by blocking a substance called immunoglobulin E (IgE), which is produced by the body.
Xolair jaħdem billi jimblokka sustanza msejjħa immunoglobulina E (IgE), li tiġi magħmula mill - ġisem.
IgE plays a key role in causing allergic asthma.
IgE għandu rwol important ħafna bħala fattur li jikkawża l- ażżma allerġika.
Your doctor will measure the amount of IgE in your blood before giving you Xolair injections.
It- tabib tiegħek se jikkalkula l- ammont ta ’ IgE li għandek fid- demm qabel ma jtik l- injezzjonijiet ta ’ Xolair.
BEFORE YOU USE XOLAIR
QABEL MA TUŻA XOLAIR
Do not use Xolair
Tużax Xolair
The
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal omalizumab jew sustanzi oħra ta ’
ingredients are listed in section 6 of this leaflet.
Is- sustanzi qegħdin imniżżlin f’ sezzjoni 6 ta ’ dan il- fuljett.
Talk to your doctor before you have an injection.
Kellem lit- tabib tiegħek qabel tieħu injezzjoni.
Take special care with Xolair Do not use Xolair to treat acute asthma symptoms, such as a sudden asthma attack.
Oqgħod attent ħafna b’ Xolair Tużax Xolair bħala kura għal sintomi akuti ta ’ l- ażżma, bħal attakk f’ daqqa ta ’ l- ażżma.
You will have been given a separate medicine for this.
Kont mogħti mediċini oħra separati għal dan.
Watch out for allergic reactions to Xolair.
Oqgħod attent għal reazzjonijiet allerġiċi għal Xolair.
Xolair contains a protein, and proteins can cause serious allergic reactions in some people.
Xolair fih proteina, u l- proteini jistgħu jikkawżaw reazzjonijiet allerġiċi serji f’ xi persuni.
Signs include rash, difficulty in breathing, swelling or feeling faint.
Sinjali ta ’ dan jinkludu raxx, tbatija biex tieħu n - nifs, nefħa jew tħossok tintilef minn sensik.
If you have an allergic reaction after taking Xolair, contact a doctor as soon as you can.
Jekk ikollok reazzjoni allerġika wara li tieħu Xolair, għamel kuntatt mat- tabib tiegħek malajr kemm jista ’ jkun.
Do not use Xolair to prevent or treat other allergy-type conditions, such as:
Tużax Xolair biex tevita jew tikkura kundizzjonijiet oħra tat- tip allerġiku, bħal:
- sudden allergic reactions
- Reazzjonijiet allerġiċi li jiġu f’ daqqa
- hyperimmunoglobulin E syndrome (an inherited immune disorder)
- Sindrome ta ’ iperimmunoglobulina E (Marda tas- sistema immunitarja li tintiret)
- aspergillosis (a fungus-related lung disease)
- Asperġillożi (Marda tal- pulmun relatata mal- fungu)
- food allergy, allergic skin rash or hay fever.
- Allerġija ġejja minn xi ikel, raxx allerġiku tal- ġilda jew hay fever.
86 Xolair will not harm you but you may need other medicines to treat these conditions.
Xolair mhux ser jgħamillek ħsara iżda jkollok bżonn mediċini oħrajn biex tikkura dawn il - kundizzjonijiet.
Xolair in children Do not give Xolair to children under 12 years of age.
Xolair fi tfal M’ għandekx tagħti Xolair lil tfal taħt it- 12- il sena.
Not enough is known about its effect on younger children.
M’ hemmx tagħrif biżżejjed dwar l- effetti tiegħu fi tfal taħt din l- età.
Xolair and older people Xolair may be given to people aged 65 years and over.
Xolair u persuni anzjani Xolair jista ’ jingħata lil persuni ta ’ 65 sena jew akbar.
There is no evidence to suggest that any special precautions are needed when older people are treated, although experience is still limited.
M’ hemm xejn li jindika li għandhom jittieħdu xi prekawzjonijiet speċjali meta jiġu kkurati nies ta ’ età avvanzata għalkemm l- esperjenza għada limitata.
Patients with kidney or liver problems If you have kidney or liver problems, please talk to your doctor about using Xolair.
Pazjenti bi problemi tal- kliewi jew tal- fwied Jekk għandek problemi tal- kliewi jew tal- fwied, jekk jogħġbok kellem lit- tabib tiegħek dwar l- użu ta ’ Xolair.
Parasite infections If you are living in a region where parasite infections are frequent or travelling to such a region, please tell your doctor.
Infezzjonijiet ta ’ parassiti Jekk qed tgħix f’ reġjun fejn infezzjonijiet ta ’ parassiti huma frekwenti jew jekk sejjer f’ xi reġjun bħal dan, jekk jogħġbok għid lit- tabib tiegħek.
Xolair may weaken your resistance to such infections.
Xolair jista ’ jdgħajjef ir- reżistenza tiegħek għal dawn it- tipi ta ’ infezzjonijiet.
If you are taking a treatment against parasite infection, please tell your doctor.
Jekk qed tieħu trattament għal xi infezzjoni ta ’ parassita, jekk jogħġbok għid lit- tabib tiegħek.
Xolair may reduce the efficacy of your treatment.
Xolair jista ’ jnaqqas l- effikaċja tat- trattament tiegħek.
Taking other medicines Xolair can be used together with inhaled corticosteroids and other medicines for allergic asthma, but it is still important to tell your doctor that you are taking them before you are given Xolair.
Meta tuża mediċini oħra Xolair jista ’ jintuża flimkien ma ’ kortikosterojdi li jittieħdu man- nifs u ma ’ mediċini oħra għall- ażżma allerġika, imma xorta waħda importanti li tgħid lit- tabib tiegħek li qed tieħodhom qabel tingħata Xolair.
You will need to carry on taking your current asthma medicine during Xolair treatment.
Se jkollok bżonn tibqa ’ tieħu l- mediċina għall- ażżma li qed tieħu bħalissa waqt li tieħu l- kura b’ Xolair.
Do not stop taking any asthma medications without talking to your doctor.
M’ għandekx twaqqaf mediċini ta ’ l- ażżma mingħajr ma tkellem lit- tabib tiegħek.