qanastek/EMEA-V3 huggingface dataset:
If you forget to take Xiliarx If you forget to take a dose of this medicine, take it as soon as you remember.
Jekk tinsa tieħu Xiliarx Jekk tinsa tieħu doża ta ’ din il- mediċina, ħudha malli tiftakar.
Like all medicines, Xiliarx can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Xiliarx jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
You should stop taking Xiliarx and see your doctor immediately if you experience the following side effects:  Angioedema (rare):
Għandek tieqaf tieħu Xiliarx u tara t- tabib tiegħek immedjatament jekk qed tħoss l- effetti sekondarji li ġejjin:  Anġjoedema (rari):
Other side effects Some patients have had the following side effects while taking Xiliarx and metformin:  Common:
Effetti sekondarji oħrajn Xi pazjenti kellhom dawn l- effetti sekondarji waqt li kienu qed jieħdu Xiliarx u metformin:  Komuni:
Some patients have had the following side effects while taking Xiliarx and a sulphonylurea:  Common:
Xi pazjenti kellhom dawn l- effetti sekondarji waqt li kienu qed jieħdu Xiliarx u sulphonylurea:  Komuni:
27 Some patients have had the following side effects while taking Xiliarx and a glitazone:  Common:
Grieżem misluħin, imnieħer inixxi
Some patients have had the following side effects while taking Xiliarx alone:  Common:
Xi pazjenti kellhom l- effetti sekondarji li ġejjin meta ħadu Xiliarx waħdu:  Komuni:
HOW TO STORE XILIARX
KIF TAĦŻEN XILIARX
 Keep out of the reach and sight of children.  Do not use Xiliarx after the expiry date which is stated on the blister and the carton.
 Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal.  Tużax Xiliarx wara d- data ta ’ skadenza li tidher fuq il- folja u l- kartuna.
The expiry date refers to the last day of that month.  Store in the original package in order to protect from moisture.  Do not use any Xiliarx pack that is damaged or shows signs of tampering.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.  Aħzen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.  Tuża l- ebda pakkett ta ’ Xiliarx li jkun danneġġjat jew li juri sinjali ta ’ tbabis.
What Xiliarx contains  The active substance is vildagliptin.
X’ fih Xiliarx  Is- sustanza attiva hi vldagliptin.
What Xiliarx looks like and contents of the pack Xiliarx 50 mg tablets are round, white to light yellowish and flat, with “ NVR ” on one side and “ FB” on the other.
Id- Dehra ta ’ Xiliarx u l- kontenuti tal- pakkett Xiliarx 50 mg pilloli huma tondi, bojod jagħtu fl- isfar ċar u ċatti, b ’ “ NVR ” fuq naħa u “ FB ” fuq l - oħra.
Xiliarx 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks containing 336 (3x112) tablets.
Xiliarx 50 mg pilloli jiġu f’ pakketti li jkun fihom 7, 14, 28, 30, 56, 60, 90, 112, 180 jew 336 pillola u f’ pakketti b’ hafna li jkollhom 336 (3x112) pilloli.
29 Κύπρος Δημητριάδης και Παπαέλληνας Λτδ Τηλ: +357 22 690 690
Sverige Κύπρος Novartis Sverige AB Δημητριάδης και Παπαέλληνας Λτδ Tel: +46 8 732 32 00 Τηλ: +357 22 690 690
What is Xolair?
X’ inhu Xolair?
Xolair is a powder and solvent, which are made up into a solution for injection.
Xolair hu magħmul minn trab u solvent li jitħalltu biex jiffurmaw soluzzjoni għall- injezzjoni.
Each vial contains 75 or 150 mg of the active substance omalizumab.
Kull fjala jkun fiha 75 jew 150 mg tas- sustanza attiva omalizumab.
What is Xolair used for?
Għal x’ hiex jintuża Xolair?
Xolair is used to improve the control of severe persistent asthma that is caused by an allergy.
Xolair jintuża fil- kontroll ta ’ ażżma severa persistenti kkawżata minn allerġija.
It is used as an add-on to existing asthma treatment in adults and adolescents over the age of 12 years, who must: • have had a positive skin test result for an allergy caused by an allergen (a stimulus that causes an allergy) in the air, such as house dust mites, pollen or mould, • have reduced lung function (less than 80% of normal), as well as frequent symptoms during the day or waking up during the night, and, • have had many severe ‘ exacerbations ’ of asthma (where asthma got worse, requiring rescue treatment with other medicines) despite treatment with high doses of inhaled corticosteroids plus a long-acting inhaled beta2-agonist.
Jintuża bħala żieda mat- trattament ta ’ l- ażżma eżistenti għall- adulti u l- adoloxxenti li jkollhom iktar minn 12- il sena, li jrid: • ikollhom riżultat pożittiv tat- test tal- ġilda għall- allerġija kkawżata minn allerġen (stimulu li jikkawża allerġija) fl- arja, bħal moffa, polline u trabijiet fid- dar, • ikollhom tnaqqis fil- funzjoni tal- pulmun (inqas minn 80% tan- normal), kif ukoll sintomi frekwenti matul il- jum jew li jkollhom iqumu bil- lejl minħabba fih, u, • ikollhom ħafna ‘ tqanqiliet ’ severi ta ’ l- ażżma (li fihom l- ażżma ssir agħar, u jkunu jeħtieġu trattament ta ’ salvataġġ b’ mediċini oħra) minkejja trattament b’ dożi għoljin ta ’ sterojdi fil- pajp tan- nifs flimkien ma ’ beta2- agonist li jaħdem iktar fit- tul fil- pajp tan- nifs ukoll.
Xolair treatment should only be considered for patients whose asthma is caused by IgE (immunoglobulin E, an antibody).
It- trattament b’ Xolair għandu jkun ikkunsidrat għal pazjenti li l- ażżma tagħhom tkun ikkawżata minn IgE (immunoglobulin E, antikorp).
How is Xolair used?
Kif jintuża Xolair?
Xolair treatment should be initiated by a doctor who has experience in the treatment of severe persistent asthma.
It- trattament b’ Xolair għandu jinbeda minn tabib li jkollu esperjenza fit- trattament ta ’ l- ażżma severa persistenti.
Before giving Xolair, the doctor must measure the level of IgE in the patient ’ s blood.
Qabel ma ’ jagħti Xolair, it- tabib għandu jkejjel il- livell ta ’ IgE fid- demm tal- pazjent.
Patients whose IgE level is below 76 IU/ ml are less likely to benefit from the medicine.
Il - pazjenti li jkollhom livell ta ’ IgE inqas minn 76 IU/ ml għandhom inqas probabilità li jibbenefikaw mill- mediċina.
Xolair is given by a healthcare worker (such as a doctor or nurse) as a subcutaneous injection (under the skin) at the top of the arm or in the thigh, every two or four weeks.
Xolair jingħata minn professjonista tas- saħħa (bħal tabib jew ners) bħala injezzjoni taħt il- ġilda) fil- parti ta ’ fuq tad- driegħ jew tal- koxxa, kull ġimagħtejn jew kull erba ’ ġimgħat.
The dose and dosing frequency of Xolair depend on the level of IgE in the blood and body weight.
Id- doża u l - frekwenza tad- doża ta ’ Xolair jiddependu fuq il- livell ta ’ l- IgE fid- demm u fuq il- piż tal- pazjent.
The usual dose range is between 75 and 375 mg in one to three injections, and the maximum recommended dose is 375 mg every two weeks.
Id - doża normali tvarja bejn 75 u 375 mg f’ bejn injezzjoni waħda u tlieta, u d- doża massima rakkomandata hi 375 mg kull ġimagħtejn.
See the Summary of Product Characteristics (which is also part of the EPAR) for further information.
Għal iktar tagħrif ara s- Sommarju tal- Karatteristiċi tal - Prodott (li wkoll hi parti mill- EPAR).
How does Xolair work?
Kif jaħdem Xolair?
The active substance in Xolair, omalizumab, is a monoclonal antibody.
Is- sustanza attiva f’ Xolair, omalizumab, hu antikorp monoklonali.
Omalizumab has been designed to bind to human IgE, which is 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Antikorp monoklonali hu antikorp (tip ta ’ proteina) li jkun ġie ddisinjat biex jagħraf u jeħel ma ’ struttura speċifika (magħrufa bħala 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged produced in large quantities in patients with allergies and triggers an allergic reaction in response to an allergen.
Omalizumab ġie ddisinjat biex jeħel ma ’ l- IgE uman li jiġi prodott fi kwantitajiet kbar fil- pazjenti li jkollhom allerġiji u jqanqlu reazzjoni allerġika b’ rispons għall- allerġen.
By binding to IgE, omalizumab ‘ mops up’ the free IgE circulating in the blood.
Billi jeħel ma ’ l- IgE, omalizumab ‘ jixrob ’ l- IgE ħieles li jkun qed jiċċirkula fid- demm.
This means that when the body encounters an allergen, there is less IgE available to trigger an allergic reaction.
Dan ifisser li meta l- ġisem jiltaqa ’ ma ’ allerġen, ikun hemm inqas IgE ħieles li jkun jista ’ jqanqal reazzjoni allerġika.
This helps to reduce the symptoms of allergy, such as asthma attacks.
Dan jgħin biex inaqqas is- sintomi ta ’ l- allerġija bħal attakki ta ’ l- ażżma.
How has Xolair been studied?
Kif ġie studjat Xolair?
The effects of Xolair were first tested in experimental models before being studied in humans.
L- effetti ta ’ Xolair ġew ittestjati għall- ewwel darba b’ mudelli esperimentali qabel ma ’ ġew studjati fuq il- bniedem.
Xolair has been studied in patients with allergic asthma in five main studies involving 2,299 patients, including one study of 482 patients with severe allergic asthma that was not controlled by conventional treatments.
Xolair ġie studjat f’ pazjenti b’ ażżma allerġika f’ ħames studji ewlenin li fihom ħadu sehem 2, 299 pazjent, inkluż wieħed li fih ħadu sehem 482 pazjent b’ ażżma allerġika severa li ma kinitx ikkontrollata bit- trattamenti konvenzjonali.
The effects of Xolair were compared with those of placebo (a dummy treatment), when added to the patients’ existing treatment.
L- effetti ta ’ Xolair tqabblu ma ’ dawk ta ’ plaċebo (trattament finta), meta żdiedu mat- trattament eżistenti.
The main measures of effectiveness were the number of exacerbations and number of patients with exacerbations of asthma, the patients’ quality of life (assessed using standard questionnaires), and the reduction in the amount of inhaled corticosteroid that the patients needed to take.
Il- mezzi ewlenin tal- kejl ta ’ l- effettikaċja kienu n- numru ta ’ tqanqiliet u n- numru ta ’ pazjenti bi tqanqiliet ta ’ l- ażżma, il- kwalità tal- ħajja tal - pazjenti (valutata bl- użu ta ’ kwestjonarji standard), u t- tnaqqis fl- ammont ta ’ sterojdi li l- pazjent kellu jieħu fil- pajp tan- nifs.
What benefit has Xolair shown during the studies?
X’ inhu l- benefiċċju ta ’ Xolair li ntwera f’ dawn l- istudji?
The first three studies showed that patients receiving Xolair had around half as many exacerbations of asthma over the first 28 or 52 weeks of treatment, with around 0.5 exacerbations per year in the Xolair group and around one per year in the placebo group.
L- ewwel tliet studji wrew li l- pazjenti li kienu qed jieħdu Xolair kellhom madwar nofs l- ammont ta ’ tqanqiliet fl- ewwel 28 jew 52 ġimgħa ta ’ trattament, b’ madwar 0. 5 tqanqiliet fis- sena fil- grupp ta ’ Xolair u madwar waħda kull sena fil- grupp tal- plaċebo.
Fewer of the patients being given Xolair had exacerbations than those being given placebo.
Kien hemm inqas pazjenti mill- grupp li ngħata Xolair li kellhom tqanqiliet meta imqabbla ma ’ dawk li ngħataw il- plaċebo.
Patients taking Xolair also reported a greater improvement in their quality of life than those taking placebo.
Il- pazjenti li kienu qed jieħdu Xolair irrappurtaw ukoll titjib ikbar fil- kwalità tal- ħajja minn dawk li kienu ngħataw plaċebo.
In the fourth study, there was a greater reduction in use of fluticasone (a corticosteroid) in the patients taking Xolair than in those taking placebo.
Fir- raba ’ studju, kien hemm tnaqqis ikbar fl- użu ta ’ fluticasone (sterojde) fil- pazjenti li kienu qed jieħdu Xolair milli f’ dawk li kienu qed jieħdu l- plaċebo.
Across these studies, the effects of Xolair were greater in patients with severe asthma.
Fl- istudji kollha flimkien, l- effetti ta ’ Xolair kienu ikbar f’ pazjenti b’ ażżma severa.
In the study of patients with severe allergic asthma, although there was no difference in the rate of asthma exacerbations between Xolair- and placebo-treated patients, Xolair led to a reduction in the number of exacerbations that was consistent with previous studies.
Fl- istudju ta ’ pazjenti b’ ażżma allerġika severa, għalkemm ma kienx hemm differenza fir- rata ta ’ tqanqiliet ta ’ l- ażżma bejn il- pazjenti ttrattati b’ Xolair u dawk trattati bil- plaċebo, Xolair wassal għal tnaqqis fin- numru ta ’ tqanqiliet li kien konsistenti ma ’ l- istudji preċedenti.
What is the risk associated with Xolair?
X’ inhu r- riskju assoċjat ma ’ Xolair?
The most common side effects with Xolair (seen in between 1 and 10 patients in 100) are headache, and injection site reactions, including pain, swelling, erythema (redness) and pruritus (itching).
L- iktar effetti sekondarji komuni b’ Xolair (li dehru f’ bejn pazjent 1 u 10 minn kull 100) kienu l- uġigħ ta ’ ras, u r- reazzjonijiet fis- sit ta ’ l- injezzjoni, inkluż uġigħ, nefħa, ħmura u ħakk.
For the full list of all side effects reported with Xolair, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrappurtati b’ Xolair, ara l- Fuljett ta ’ Tagħrif.
Xolair should not be given to people who may be hypersensitive (allergic) to omalizumab or any of the other ingredients.
Xolair m’ għandux jingħata lil persuni allerġiċi għal omalizumab jew għal xi sustanza oħra tiegħu.
Why has Xolair been approved?
Għaliex ġie approvat Xolair?
The Committee for Medicinal products for Human Use (CHMP) concluded that, overall, there was a pattern of results in the studies of Xolair that show that it is effective in treating severe allergic asthma, despite the results of the final main study.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li, globalment, kien hemm tendenza fir- riżultati dwar Xolair li turi li hu effettiv fit- trattament ta ’ l- ażżma allerġika severa minkejja r- riżultati fl- istudju ewlieni aħħari.
Therefore, the Committee decided that Xolair’ s benefits are greater than its risks as an additional treatment for adults and adolescents over 12 years who have severe persistent allergic asthma.
Għalhekk, il- Kumitat iddeċieda li l- benefiċċji ta ’ Xolair huma ikbar mir- riskji bħala trattament addizzjonali għal adulti u adoloxxenti ta ’ iktar minn 12- il sena li jkollhom ażżma allerġika persistenti.
It recommended that Xolair be given marketing authorisation.
Il- Kumitat irrakkomanda li Xolair jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Xolair:
Tagħrif ieħor dwar Xolair:
The European Commission granted a marketing authorisation valid throughout the European Union for Xolair to Novartis Europharm Limited on 25 October 2005.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Xolair valida madwar l- Unjoni Ewropea kollha lil Novartis Europharm Limited fil- 25 ta ’ Ottubru 2005.
The full EPAR for Xolair can be found here.
L- EPAR sħiħ għal Xolair jista ’ jinstab hawn.
Xolair 75 mg powder and solvent for solution for injection
Xolair 75 mg trab u solvent għal soluzzjoni għall- injezzjoni
One vial contains 75 mg of omalizumab.
Kunjett wieħed fih 75 mg 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’ razza ta ’ ċelluli mammarji ta ’ l- ovarju tal- ħamster Ċiniż (CHO).
After reconstitution the vial contains 125 mg/ ml of omalizumab (75 mg in 0.6 ml).
Wara r- rikostituzzjoni l- kunjett ikun fih 125 mg/ ml ta ’ omalizumab (75 mg f ’ 0. 6 ml)
Xolair is an off-white lyophilised powder.
Xolair huwa trab lajofilizzat offwajt.
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 ta ’ l- ażżma ta ’ pazjenti adulti u adolexxenti (minn 12- il sena ‘ l fuq) li jsofru b’ ażżma 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 ta ’ l- ażżma 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 mediated asthma (see section 4.2).
Kura b’ Xolair għandha titqies biss f’ każijiet fejn ikun hemm evidenza konvinċenti li l- ażżma tkun medjata b’ IgE (ara sezzjoni 4. 2).
Use in adolescents and adults (12 years of age and older) Xolair treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma.
Użu f’ adolexxenti u adulti (minn 12- il sena ‘ l fuq) Kura b’ Xolair għandha tkun mibdija minn tobba li għandhom esperjenza fid- dijanjożi u l- kura ta ’ ażżma qawwija u persistenti.
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).
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).
Prior to initial dosing, patients should have their IgE level determined by any commercial serum total IgE assay for their dose assignment.
Qabel ma jingħata l- ewwel dożaġġ, lill- pazjenti għandu jitkejlilhom il- livell ta ’ IgE totali fis- serum permezz ta’ assay kummerċjali liema jkun sabiex jiġi stabilit kemm għandha tkun d- doża tagħhom.
Based on these measurements 75-375 mg of Xolair in 1 to 3 injections may be needed for each administration.
Skond dawn il- qisien 75- 375 mg ta ’ Xolair b’ minn 1 sa 3 injezzjonijiet kull darba jistgħu jkunu meħtieġa.
Patients with IgE lower than 76 IU/ ml were less likely to experience benefit (see section 5.1).
Pazjenti li kellhom IgE aktar baxx minn 76 IU/ ml kellhom anqas ċans li jħossu xi benefiċju (ara sezzjoni 5. 1).
Prescribing physicians should ensure that patients with IgE below 76 IU/ ml have unequivocal in vitro reactivity (RAST) to a perennial allergen before starting therapy.
It- tobba li jordnaw din il- mediċina għandhom jiżguraw ruħhom li pazjenti li għandhom IgE taħt 76 IU/ ml jkollhom reazzjoni in vitro (RAST) għal allerġen perenni li ma jħalli ebda dubju qabel ma tibda ’ t- terapija.
See Table 1 for a conversion chart and Tables 2 and 3 for the dose determination charts.
2 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.
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.
The maximum recommended dose is 375 mg omalizumab every two weeks.
L- aktar doża għolja rakkomandata hija 375 mg ta ’ omalizumab kull ġimgħatejn.
2 For subcutaneous administration only.
Użu għal taħt il- ġilda biss.
Do not administer by the intravenous or intramuscular route.
M’ għandekx tagħtih għal ġol- vini jew għal ġol- muskoli.
The injections are administered subcutaneously in the deltoid region of the arm.
L- injezzjonijiet jingħataw taħt il- ġilda fil- parti tad- deltojd fuq id- driegħ.
Alternatively, the injections can be administered in the thigh if there is any reason precluding administration in the deltoid region.
Jew inkella, l- injezzjonijiet jistgħu jingħataw fil- koxxa jekk hemm xi raġuni li teskludi l- għotja fid- deltojd.
There is limited experience with self-administration of Xolair.
It- tagħrif fuq meta l- pazjent jagħti Xolair lilu nnifsu huwa limitat.
Therefore treatment is intended to be administered by a healthcare provider.
Għaldaqstant, il- kura għandha tingħata minn xi ħadd li jieħu ħsieb il- kura tas- saħħa.
For information on reconstitution of Xolair, see section 6.6.
Għal tagħrif dwar ir- rikostituzzjoni ta ’ Xolair, ara sezzjoni 6. 6.
Conversion from dose to number of vials, number of injections and total injection volume for each administration
Konverżjoni minn doża għan- numru ta ’ kunjetti, numru ta ’ injezzjonijiet u t- total tal- volum ta ’ l- injezzjoni għal kull għotja ta ’ doża
Number of vials
Numru ta ’ kunjetti 75 mg a 150 mg b 1c
Number of injections
Numru ta ’ injezzjonijiet Volum totali ta ’ l- injezzjoni (ml)
Total injection volume (ml)
1 0. 6 1 1. 2
0.6 1.2 1.8 2.4 3.0
2 1. 8 2 2. 4
delivered
3 3. 0
or use 0.6 ml from a 150 mg vial.
0. 6 ml = Volum massimu mwassal għal kull kunjett (Xolair 75 mg). b 1. 2 ml = Volum massimu mwassal għal kull kunjett (Xolair 150 mg). c jew uża 0. 6 ml minn kunjett ta ’ 150 mg.
ADMINISTRATION EVERY 4 WEEKS.
GĦOTJA KULL 4 ĠIMGĦAT.
Xolair doses (milligrams per dose) administered by subcutaneous injection every 4 weeks
Dożi ta ’ Xolair (milligrammi għal kull doża) mogħtija b’ injezzjoni taħt il- ġilda kull 4 ġimgħat
Body weight (kg) Baseline IgE
Piż tal- ġisem (kg) Linja Bażika IgE
> 100-200
> 100– 200
> 200-
> 200 –
> 300-400
> 300– 400
> 400-500
> 400– 500
ADMINISTRATION EVERY 2 WEEKS SEE TABLE 3
GĦOTJA KULL ĠIMGĦATEJN ARA TABELLA 3
> 500-600
> 500– 600
> 600-700
> 600– 700
ADMINSTRATION EVERY 2 WEEKS.
GĦOTJA KULL ĠIMGĦATEJN.
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 ġimgħatejn
≥ 30-100
≥30– 100
ADMINISTRATION EVERY 4 WEEKS SEE TABLE 2
GĦOTJA KULL 4 ĠIMGĦAT ARA TABELLA 2
> 200-300
> 200– 300
300-400
300– 400
DO NOT ADMINISTER – data is unavailable for dose
M’ GĦANDEKX TAGĦTIH – M’ hemmx tagħrif biex tkun
recommendation
rakkommandata din id- doża
Treatment duration, monitoring and dose adjustments Discontinuation of Xolair treatment generally results in a return to elevated free IgE levels and associated symptoms.
Tul tal- kura, monitoraġġ u tibdil fid- dożi Meta titwaqqaf il- kura b’ Xolair normalment twassal għal livelli ta ’ IgE ħieles għoljin mill- ġdid, flimkien mas- sintomi marbuta magħhom.
At 16 weeks after commencing Xolair therapy patients should be assessed by their physician for treatment effectiveness before further injections are administered.
Meta jkunu għaddew 16- il ġimgħa minn meta tkun bdiet il- kura b’ Xolair, il- pazjenti għandhom jiġu eżaminati mit- tabib tagħhom sabiex tkun stabilita l- effikaċja tal- kura qabel jingħataw aktar injezzjonijiet.
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 ta ’ l- ażżma (ara sezzjoni 5. 1; L- istima ġenerali tat- tabib dwar l - effikaċja tal- kura).
Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment.
Il- livelli totali ta ’ IgE jkunu għoljin waqt il- kura, u jibqgħu għoljin sa sena wara li titwaqqaf il- kura.
Therefore, re-testing of IgE levels during Xolair treatment cannot be used as a guide for dose determination.
Għaldaqstant il- kejl tal- livelli ta ’ IgE ma jistgħux jintużaw bħala gwida sabiex tkun deċiża d- doża li għandha tingħata.
Dose determination after treatment interruptions lasting less than one year should be based on serum IgE levels obtained at the initial dose determination.
Id- dożi li għandhom jingħataw wara li tkun twaqqfet il- kura għal anqas minn sena, għandhom ikunu bażati fuq il- livelli ta ’ IgE fis- serum li jkunu inkisbu fil- bidu meta tkun ġiet deċiża d - doża.
Total serum IgE levels may be re-tested for dose determination if treatment with Xolair has been interrupted for one year or more.
Il- livelli totali ta ’ IgE fis- serum jistgħu jiġu eżaminati mill- ġdid sabiex tiġi deċiża d- doża jekk il - kura b’ Xolair tkun ilha li twaqqfet għal sena jew aktar.
Doses should be adjusted for significant changes in body weight (see Tables 2 and 3).
Id- dożi għandhom ikunu mibdula biex jgħamlu tajjeb għat- tibdil sinifikanti fil- piż tal- ġisem (ara Tabelli 2 u 3).
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.
Children (age below 12 years) Safety and efficacy in paediatric patients below the age of 12 years have not been established and use of Xolair in such patients is therefore not recommended.
Tfal (età taħt it- 12- il sena) Is- sigurtà u l- effikaċja f’ pazjenti pedjatriċi taħt it- 12- il sena ma ġewx stabiliti u għaldaqstant l- użu ta ’ Xolair f’ dawn il- pazjenti mhuwiex rakkomandat.
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 ta ’ l- ażżma 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 ta 'l- ikel.
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 awto- immunitarju, kundizzjonijiet immunitarji medjati b’ kumpless, jew indeboliment tal- kliewi jew tal- fwied li jkun hemm minn qabel.
Caution should be exercised when administering Xolair in these patient populations.
Għandu jkun hemm attenzjoni meta jingħata Xolair f’ dawn il- gruppi ta ’ pazjenti.
Abrupt discontinuation of systemic or inhaled corticosteroids after initiation of Xolair therapy is not recommended.
Mhux rakkomandat li jitwaqqaf f’ daqqa l- użu ta ’ kortikosterojdi li jittieħdu b’ mod sistemiku jew li jittieħdu man- nifs wara li tinbeda t- terapija b’ Xolair.
Decreases in corticosteroids should be performed under the direct supervision of a physician and may need to be performed gradually.
It- tnaqqis fl- użu ta ’ kortikosterojdi għandu jsir taħt superviżjoni diretta ta ’ tabib u jista ’ jkun li jkollha ssir b’ mod gradwali.
Patients with diabetes mellitus, the glucose-galactose malabsorption syndrome, fructose intolerance or sucrase-isomaltase deficiency should be warned that one 75 mg Xolair dose contains 54 mg of sucrose.
Pazjenti li jsofru bid- dijabete mellitus, sindrome ta ’ malassorbiment ta 'glucose- galactose, intolleranza għal fructose jew defiċjenza ta ’ sucrase- isomaltase għandhom jiġu avżati li doża waħda ta ’ 75 mg Xolair fiha 54 mg ta ’ sucrose.
Immune system disorders a.
Disturbi fis- sistema immuni a.
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.
Reazzjonijiet allerġiċi tat- tip I Reazzjonijiet allerġiċi tat- tip I lokali jew sistemiċi, inkluż anafilassi u xokk anafilattiku, jistgħu jseħħu meta jkun qed jittieħed omalizumab, li jistgħu jibdew anki wara żmien twil ta ’ kura.
Most of these reactions occurred within 2 hours after the first and subsequent injections of Xolair but some started beyond 2 hours and even beyond 24 hours after the injection.
Il- biċċa l- kbira ta ’ dawn ir- reazzjonijiet seħħew fi żmien sagħtejn wara l- ewwel injezzjoni ta ’ Xolair u injezzjonijiet sussegwenti iżda xi wħud bdew wara sagħtejn u anki wara aktar minn 24 siegħa wara l- injezzjoni.
Therefore medications 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.
Patients should be informed that such reactions are possible and prompt medical attention should be sought if allergic reactions occur.
Il- pazjenti għandhom ikunu mgħarrfa li dawn it- tip ta ’ reazzjonijiet jistgħu jseħħu u l- pazjent għandu jfittex attenzjoni medika immedjata jekk ikun hemm reazzjonijiet allerġiċi.
Anaphylactic reactions were rare in clinical trials (see section 4.8).
Fi provi kliniċi, reazzjonijiet anafilattiċi kienu rari (ara sezzjoni 4. 8).
As with all recombinant DNA derived humanised monoclonal antibodies, patients may in rare cases develop antibodies to omalizumab.
Bħal ma jiġri b’ kull antikorpi monoklonali modifikati għal wieħed uman li jkunu ġejjin minn DNA rikombinat, f’ każijiet rari l- pazjenti jistgħu jiżviluppaw antikorpi għal omalizumab.
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 suggested pathophysiologic mechanism includes immune-complex formation and deposition due to development of antibodies against omalizumab.
Il- mekkaniżmu patofiżjoloġiku ssuġġerit jinkludi l- formazzjoni u d - depożizzjoni ta ’ kumpless immuni minħabba l- iżvilupp ta ’ antikorpi kontra omalizumab.
The onset has typically been 1-5 days after administration of the first or subsequent injections, also after long duration of treatment.
Dan il- mard ġeneralment seħħ minn ġurnata sa ħamest ijiem wara l- għoti tal- ewwel injezzjoni jew xi waħda mill - injezzjonijiet sussegwenti, anke wara tul ta ’ żmien ta ’ kura.
Symptoms suggestive of serum sickness include arthritis/ arthralgias, rash (urticaria or other forms), fever and lymphadenopathy.
Sintomi li jissuġġerixxu marda tas- serum jinkludu artrite/ artralġji, raxx (urtikarja jew forom oħra), deni u limfadenopatija.
Antihistamines and corticosteroids may be useful for preventing or treating this disorder, and patients should be advised to report any suspected symptoms.
Antistamini u kortikoserojdi jistgħu jkunu ta ’ użu billi jilqgħu kontra jew jikkuraw dan id- disturb, u l- pazjenti għandhom jingħataw parir biex jirrappurtaw kwalunkwe sintomi li jisusspettaw li għandhom.
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.
5 F’ każijiet rari, pazjenti fuq terapija b’ sustanzi kontra l- ażma, inkluż omalizumab, jista ’ jaqbadhom jew jiżviluppaw eżinofilja sistemika u vaskulite.
These events are commonly associated with the reduction of oral corticosteroid therapy.
Dawn il- każijiet ħafna drabi huma assoċjati mat- tnaqqis tat- terapija tal- kortikosterojdi orali.
In these patients, physicians should be alert to the development of marked eosinophilia, vasculitic rash, worsening pulmonary symptoms, paranasal sinus abnormalities, cardiac complications, and/ or neuropathy.
F’ dawn il- pazjenti, it- tobba għandhom joqgħodu attenti biex jaraw jekk tiżviluppax eżinofilja qawwija, raxx vaskulitiku jew aggravar tas- sintomi pulmonari, anormalitajiet tas- sinus paranażali kumpikazzjonijiet kardijaċi, u/ jew newropatija.
Discontinuation of omalizumab should be considered in all severe cases with the above mentioned immune system disorders.
It- twaqqif ta ’ omalizumab għandu jiġi kkunsidrat fil- każijiet qawwija kollha tad- disturbi fis- sistema immuni msemmija hawn fuq.
Parasitic (helminth) infections IgE may be involved in the immunological response to some helminth infections.
Infezzjonijiet ta ’ parassiti (elminti) IgE jista ’ jkun involut fir- rispons immunoloġiku għal xi infezzjonijiet ta ’ xi elminti.
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 ta ’ l- infezzjoni għal - kura ma nbidlux.
The helminth infection rate in the overall clinical programme, which was not designed to detect such infections, was less than 1 in 1,000 patients.
Ir- rata ta ’ infezzjoni b’ elminti fil- programm kliniku ġenerali, li ma kienx diżenjat sabiex isib dawn it- tip ta ’ infezzjonijiet, kienet anqas minn 1 f’ 1, 000 pazjent.
However, caution may be warranted in patients at high risk of helminth infection, in particular when travelling to areas where helminthic infections are endemic.
Madankollu, f’ pazjenti b’ riskju għoli ta ’ infezzjonijiet b’ elminti. jista ’ jkun hemm bżonn attenzjoni kbira, l- aktar meta jkun hemm bżonn ta ’ vjaġġar lejn żoni fejn infezzjonijiet b’ elminti huma endemiċi.
If patients do not respond to recommended anti-helminth treatment, discontinuation of Xolair should be considered.
Jekk ma jkunx hemm rispons mill- pazjenti għall- kura rakkomandata kontra l- elminti, għandu jitqies il- waqfien ta ’ Xolair.
Malignancies During clinical trials, there was a numerical imbalance in cancers arising in the Xolair treatment group compared with the control group.
Mard malinn Waqt provi kliniċi kien hemm żbilanċ numeriku fil- mard tal- kanċer li kien hemm fil- grupp ta ’ pazjenti li kienu qed jiġu kurati b’ Xolair, mal- grupp ta ’ kontroll.
The frequency of observed cases was uncommon (< 1/ 100) in both the active and the control group, i. e.
Il- frekwenza tal- każijiet li dehru ma ’ kienetx komuni (< 1/ 100) kemm fil- grupp attiv kif ukoll fil- grupp ta ’ kontroll, i. e.
25 cancers in 5,015 patients treated with Xolair (0.5%) and 5 cancers in 2,854 patients in the control group (0.18%).
25 każ ta ’ kanċer f’ 5, 015 pazjent li kienu qed jieħdu Xolair (0. 5%) u 5 każijiet ta ’ kanċer f’ 2, 854 pazjent fil- grupp ta ’ kontroll (0. 18%).
The diversity in the type of cancers observed, the relatively short duration of exposure and the clinical features of the individual cases render a causal relationship unlikely.
Id- diversità fit- tipi ta ’ każijiet ta ’ kanċer li dehru, l- espożizzjoni relattivament qasira u l- karatteristiċi kliniċi tal- każijiet individwali ma jindikawx li dawn setgħu kienu kkawżati mill- kura.
The overall observed incidence rate of malignancy in the Xolair clinical trial programme was comparable to that reported in the general population.
Ir- rata ġenerali ta ’ mard malinn li deher fil- programm tal- prova klinika b’ Xolair kien kumparabbli ma ’ dak li kien rappurtat fil- popolazzjoni ġenerali.
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 ta ’ l- effluss u mekkaniżmi li jinvolvu t- twaħħil ma ’ proteini, għalhekk mhux probabli li jkun hemm nuqqas ta ’ qbil ma ’ prodotti mediċinali oħrajn.
No formal medicinal product or vaccine interaction studies have been performed with Xolair.
Ma sarux studji formali dwar l- effetti ta ’ Xolair ma ’ mediċini oħra jew ma ’ tilqim.
There is no pharmacological reason to expect that commonly prescribed medications 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 ta ’ l- ażżma u omalizumab.
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.
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 ta ’ l- ażżma.
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 ’ ipo - sensitazzjoni).
Efficacy of Xolair treatment in combination with specific immunotherapy has not been established.
Ma ġietx stabilita l- effikaċja tal- kura b’ Xolair kombinata ma ’ immunoterapija speċifika.
Current data suggest that no dose adjustments of Xolair are needed in patients on established hypo-sensitisation therapy.
It- tgħarif li hemm bħalissa juri li m’ hemmx għalfejn li tinbidel id- doża ta ’ Xolair f’ pazjenti li jkunu ġew stabiliti fuq terapija ta ’ ipo- sensitazzjoni.
There are no adequate data from the use of omalizumab in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ omalizumab waqt it- tqala.
Omalizumab crosses the placental barrier and the potential for harm to the foetus is unknown.
Omalizumab jaqsam mill- barriera tal- plaċenta u l- ħsara li tista ’ ssir fuq il - fetu mhix magħrufa.
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 tad- demm fi primati li ma jinkludux il- bniedem, b’ sensitività relattiva akbar f’ annimali ta ’ età żgħira (ara sezzjoni 5. 3).
Xolair should not be used during pregnancy unless clearly necessary.
Xolair m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
It is not known whether omalizumab is excreted in human breast milk.
6 Mhux mgħaruf jekk omalizumab joħroġx fil- ħalib tas- sider tal- mara.
Omalizumab is excreted into non-human primate breast milk and an effect on 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 xi effett fuq it- tarbija li tkun qed titredda.
Nursing mothers should not breast-feed during Xolair therapy.
Ommijiet li jistgħu jreddgħu m’ għandhomx ireddgħu waqt terapija b’ Xolair.
Patients receiving Xolair should be warned that if they experience dizziness, fatigue, faintness or drowsiness they should not drive or use machinery.
Pazjenti li qed jirċievu Xolair għandhom ikunu mgħarrfa li jekk iħossu sturdament, għejja, telf mis - sensi jew ħedla, m’ għandhomx isuqu jew iħaddmu magni.
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 ta ’ l- injezzjoni, inklużi uġigħ fil- post ta 'l- 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.
Tabella 4 tniżżel r- reazzjonijiet avversi li kienu reġistrati waqt provi kliniċi fil- popolazzjoni sigura kollha tal- pazjenti kurati b’ Xolair, skond il- klassi tas- sistema ta ’ l- organi u skond 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).
Blood and lymphatic system disorders Not known Nervous system disorders
Disturbi tad- demm u tas- sistema limfatika Mhux magħruf Disturbi fis- sistema nervuża
Idiopathic severe thrombocytopenia
Tromboċitopenja idjopatika severa
Headache Dizziness, somnolence, paraesthesia, syncope
Uġigħ ta ’ ras Sturdament, ngħas, parasteżija, sinkope
Respiratory, thoracic and mediastinal disorders Uncommon Rare Not known Gastrointestinal disorders
Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni Rari Mhux magħruf Disturbi gastro- intestinali
Churg-Strauss syndrome)
Farinġite, sogħla, bronkospażmu allerġiku Larinġoedima Vaskulite granulomatuża allerġika (i. e. sindrome ta ’ Churg - Strauss)
Nausea, diarrhoea, dyspeptic signs and symptoms
Dardir, dijarea, sinjali u sintomi dispeptiċi
Skin and subcutaneous tissue disorders Uncommon Rare Not known
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni Rari Mhux magħruf
Urticaria, rash, pruritus, photosensitivity Angioedema Alopecia
Urtikarja, raxx, ħakk, fotosensittività Angjoedima Alopeċja
Musculoskeletal and connective tissue disorders Not known Infections and infestations
Disturbi muskolu- skeltrali u tal- connective tissue Mhux magħruf Infezzjonijiet u infestazzjonijiet
Arthralgia, myalgia, joint swelling
Uġigħ fil- ġogi, uġigħ fil- muskoli, nefħa fil- ġogi
Rare Vascular disorders
Rari Disturbi vaskulari
Parasitic infection
Infezzjoni ta ’ parassiti
Postural hypotension, flushing
Pressjoni baxxa skond il- qagħda, fwawar
7 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 pain, erythema, pruritus, swelling Weight increase, fatigue, swelling arms, influenza-like illness
Reazzjonijiet fis- sit ta ’ l- injezzjoni bħal uġigħ, ħmura, ħakk, nefħa Żieda fil- piż, għeja, driegħ minfuħa, mard li jixbaħ l- influwenza
Rare Not known
Rari Mhux magħruf
Anaphylactic reaction, other serious allergic conditions Serum sickness, may include fever and lymphadenopathy
Reazzjoni anafilattika, kundizzjonijiet allerġiċi serji oħra Marda tas- serum, tista ’ tinkludi deni u limfadenopatija
Immune system disorders
7 Disturbi fis- sistema immuni Għal aktar informazzjoni, ara sezzjoni 4. 4.
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 ta ’ l- 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).
Platelets In clinical trials few patients had platelet counts below the lower limit of the normal laboratory range.
Plejtlets Fi provi kliniċi, kienu ftit dawk il- pazjenti li kellhom għadd tal- plejtlets taħt il- limitu baxx tal- medda normali tal- laboratorju.
None of these changes were associated with bleeding episodes or a decrease in haemoglobin.
L- ebda wieħed minn dawn il- bidliet ma kienu assoċjati ma ’ każijiet ta ’ fsada jew tnaqqis fl- emoglobulina.
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 ta ’ l- 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 ta ’ l- elminti, prova kontrollata bi plaċebo wriet żieda żgħira fir- rata ta ’ l- 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 ta ’ l- infezzjonijiet ma nbidlux (ara sezzjoni 4. 4).
A maximum tolerated dose of Xolair has not been determined.
Ma kienetx determinata l- ogħla doża ta ’ Xolair li tista ’ tkun tollerata.
Single intravenous doses up to 4,000 mg have been administered to patients without evidence of dose- limiting toxicities.
Dożi sa 4, 000 mg waħidhom li jingħataw għal ġol- vina ingħataw f’ pazjenti mingħajr ma dehru effetti tossiċi li llimitaw id- doża.
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.
Pharmacotherapeutic group: other systemic drugs for obstructive airway diseases, ATC code:
Kategorija farmakoterapewtika: mediċini sistemiċi oħrajn għal mard li jfixkel il- passaġġi tan- nifs, Kodiċi ATC:
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 ma ’ l- 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 ma ’ l- IgE.
Omalizumab binds to IgE and prevents binding of IgE to the high-affinity FCε RI receptor, thereby reducing the amount of free IgE that is available to trigger the allergic cascade.
Omalizumab jeħel ma ’ IgE u ma jħallix l- IgE jeħel mar- riċettur FCεRI li għandu affinità kbira, b’ hekk inaqqas l- ammont ta ’ IgE ħieles li jkun jista ’ jibda kaskata ta ’ reazzjonijiet allerġiċi.
Treatment of atopic subjects with omalizumab resulted in a marked down-regulation of FCε RI receptors on basophils.
Kura ta ’ persuni atopiċi b’ omalizumab wasslet għal tnaqqis sostanzjali ta ’ riċetturi FCεRI fuq bażofili.
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 ’ istamin minn bażofili ta ’ persuni li ngħataw Xolair naqset b’ madwar 90% wara stimulazzjoni b’ allerġen meta mqabbla mal- valuri li nkisbu qabel il- kura.