natgillin/translations-raw huggingface dataset:
Da vildagliptin har været forbundet med leverproblemer, skal patienterne have foretaget tests for at kontrollere deres lever, før behandling med Xiliarx påbegyndes og med jævne mellemrum under behandlingen.
Because vildagliptin has been associated with liver problems, patients should have tests to check their liver before treatment with Xiliarx and at regular intervals during treatment.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Xiliarx er større end risiciene ved Xiliarx til behandling af type 2- diabetes mellitus, når det anvendes som oral tostofbehandling i kombination med metformin, et sulfonylurinstofeller et thiazolidindion stof.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Xiliarx’ s benefits in the treatment of type 2 diabetes mellitus are greater than its risks when used as dual oral therapy in combination with metformin, a sulphonylurea or a thiazolidinedione.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Xiliarx.
The Committee recommended that Xiliarx be given marketing authorisation.
2/ 3 Andre oplysninger om Xiliarx:
Other information about Xiliarx:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xiliarx til Novartis Europharm Limited den 19. november 2008.
The European Commission granted a marketing authorisation valid throughout the EU for Xiliarx to Novartis Europharm Limited on 19 November 2008.
Den fuldstændige EPAR for Xiliarx findes her.
The full EPAR for Xiliarx can be found here.
EU- nummer EU/ 1/ 08/ 486/ 001 EU/ 1/ 08/ 486/ 002 EU/ 1/ 08/ 486/ 003 EU/ 1/ 08/ 486/ 004 EU/ 1/ 08/ 486/ 005 EU/ 1/ 08/ 486/ 006 EU/ 1/ 08/ 486/ 007 EU/ 1/ 08/ 486/ 008 EU/ 1/ 08/ 486/ 009 EU/ 1/ 08/ 486/ 010 EU/ 1/ 08/ 486/ 011
EU/ 1/ 08/ 486/ 001 EU/ 1/ 08/ 486/ 002 EU/ 1/ 08/ 486/ 003 EU/ 1/ 08/ 486/ 004 EU/ 1/ 08/ 486/ 005 EU/ 1/ 08/ 486/ 006 EU/ 1/ 08/ 486/ 007 EU/ 1/ 08/ 486/ 008 EU/ 1/ 08/ 486/ 009 EU/ 1/ 08/ 486/ 010 EU/ 1/ 08/ 486/ 011
Særnavn Xiliarx Xiliarx Xiliarx Xiliarx Xiliarx Xiliarx Xiliarx Xiliarx Xiliarx Xiliarx Xiliarx
Xiliarx Xiliarx Xiliarx Xiliarx Xiliarx Xiliarx Xiliarx Xiliarx Xiliarx Xiliarx Xiliarx
Voksne Når Xiliarx anvendes i kombination med metformin eller et glitazon, er den anbefalede daglige dosis af vildagliptin 100 mg, administreret som én dosis på 50 mg om morgenen og én dosis på 50 mg om aftenen.
Adults When used in dual combination with metformin or a thiazolidinedione, the recommended daily dose of vildagliptin is 100 mg, administered as one dose of 50 mg in the morning and one dose of 50 mg in the evening.
Når Xiliarx kombineres med et sulfonylurea, er den anbefalede dosis af vildagliptin 50 mg én gang daglig om morgenen.
When used in dual combination with a sulphonylurea, the recommended dose of vildagliptin is 50 mg once daily administered in the morning.
5. 2).
Xiliarx can be administered with or without a meal (see also section 5.2).
4. 4 og 5. 2).
The use of Xiliarx is not recommended in patients with moderate or severe renal impairment or in haemodialysis patients with end-stage renal disease (ESRD) (see also sections 4.4 and 5.2).
4. 4 og 5. 2).
Hepatic impairment Xiliarx should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN) (see also sections 4.4 and 5.2).
Børn og unge (< 18 år) Xiliarx bør ikke anvendes til børn og unge p. g. a. manglende dokumentation for sikkerhed og virkning.
Paediatric population (< 18 years) Xiliarx is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Generelt Xiliarx kan ikke erstatte insulin hos insulinkrævende patienter.
General Xiliarx is not a substitute for insulin in insulin-requiring patients.
Xiliarx bør ikke anvendes til patienter med type 1- diabetes eller til behandling af diabetisk ketoacidose.
Xiliarx should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Derfor frarådes Xiliarx til disse patienter.
Therefore, the use of Xiliarx is not recommended in these patients.
Nedsat leverfunktion Xiliarx må ikke anvendes til patienter med nedsat leverfunktion, inklusive patienter der før behandlingstidspunktet har ALAT eller ASAT > 3x ULN.
Hepatic impairment Xiliarx should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST > 3x ULN.
Leverfunktionstest skal udføres før initiering af behandling med Xiliarx for at kende patientens baselineværdi.
Liver function tests should be performed prior to the initiation of treatment with Xiliarx in order to know the patient ’ s baseline value.
På grund af de manglende data for mennesker bør Xiliarx ikke anvendes under graviditet.
Due to lack of human data, Xiliarx should not be used during pregnancy.
Xiliarx må ikke anvendes under amning.
Xiliarx should not be used during lactation.
De bivirkninger, der blev rapporteret hos patienter, der modtog Xiliarx som monoterapi i dobbeltblindede studier og tillægsbehandlinger er opført nedenfor for hver indikation efter organsystemklasse og absolut hyppighed.
Adverse reactions reported in patients who received Xiliarx in double-blind studies as monotherapy and add-on therapies are listed below for each indication by system organ class and absolute frequency.
Bivirkninger rapporteret hos patienter, der modtog Xiliarx 100 mg daglig i kombination med metformin i dobbeltblindede studier (N=208)
Adverse reactions reported in patients who received Xiliarx 100 mg daily in combination with metformin in double-blind studies (N=208)
Bivirkninger rapporteret hos patienter, der modtog Xiliarx 50 mg daglig i kombination med et sulfonylurea i dobbeltblindede studier (N=170)
Adverse reactions reported in patients who received Xiliarx 50 mg in combination with a sulphonylurea in double-blind studies (N=170)
I pioglitazon- tillægsstudiet var den absolutte vægtstigning 1, 4 for placebo og 2, 7 kg for Xiliarx 100 mg daglig.
In the pioglitazone add-on study, the absolute weight increases with placebo, Xiliarx 100 mg daily were 1.4 and 2.7 kg, respectively.
6 Forekomsten af perifert ødem, når vildagliptin 100 mg daglig blev anvendt i tillæg til maksimal dosis af baggrunds- pioglitazon (45 mg én gang daglig), var 7, 0%, sammenlignet med 2, 5% for baggrunds - pioglitazon alene.
The incidence of peripheral oedema when vildagliptin 100 mg daily was added to a maximum dose of background pioglitazone (45 mg once daily) was 7.0%, compared to 2.5% for background pioglitazone alone.
Bivirkninger rapporteret hos patienter, der modtog Xiliarx 100 mg daglig i kombination med et glitazon i dobbeltblindede studier (N=158)
Adverse reactions reported in patients who received Xiliarx 100 mg daily in combination with a thiazolidinedione in double-blind studies (N=158)
Bivirkninger rapporteret hos patienter, der modtog Xiliarx 100 mg daglig som monoterapi i dobbeltblindede studier (N=1. 855)
Adverse reactions reported in patients who received Xiliarx 100 mg daily as monotherapy in double-blind studies (N=1,855)
Alle
Management
7 symptomer og laboratorieabnormaliteter blev afhjulpet uden behandling efter seponering af forsøgsmedicinen.
7 In the event of an overdose, supportive management is recommended.
Behandling med vildagliptin 50- 100 mg daglig hos patienter med type 2- diabetes forbedrede markørerne for betacellefunktionen signifikant, herunder HOMA-  (Homeostasis Model Assessment- ), forholdet mellem proinsulin og insulin og målinger af betacellereaktionsevnen fra den hyppigst anvendte måltidstolerancetest.
Treatment with vildagliptin 50-100 mg daily in patients with type 2 diabetes significantly improved markers of beta cell function including HOMA-  (Homeostasis Model Assessment–), proinsulin to insulin ratio and measures of beta cell responsiveness from the frequently-sampled meal tolerance test.
I et 52- ugers dobbeltblindet kontrolleret forsøg reducerede vildagliptin (50 mg to gange daglig) baseline- HbA 1c med - 1% sammenlignet med - 1, 6% for metformin (titreret til 2 g/ dag) blev statistisk
In a 52-week double-blind controlled trial, vildagliptin (50 mg twice daily) reduced baseline HbA 1c by -1% compared to -1.6% for metformin (titrated to 2 g/ day) statistical non-inferiority was not achieved.
I et 24- ugers dobbeltblindet kontrolleret forsøg blev vildagliptin (50 mg to gange daglig) sammenlignet med rosiglitazon (8 mg én gang daglig).
8 In a 24-week double-blind controlled trial, vildagliptin (50 mg twice daily) was compared to rosiglitazone (8 mg once daily).
ved uge 24
HbA 1c (%) at week 24
Derfor vil vildagliptin 9 sandsynligvis ikke påvirke den metaboliske clearance af samtidigt administrerede præparater, som metaboliseres af CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 eller CYP 3A4/ 5.
Therefore, vildagliptin is not likely to affect metabolic clearance of co-medications metabolised by CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 or CYP 3A4/ 5.
85% af dosis udskilt i ruinen, og 15% af dosis genfindes i fæces.
9 Elimination Following oral administration of [14C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose is recovered in the faeces.
10 Vildagliptin var ikke mutagent i konventionelle in vitro - og in vivo- test for genotoksicitet.
Vildagliptin was not mutagenic in conventional in vitro and in vivo tests for genotoxicity.
Et studie af fertilitet og tidlig fosterudvikling hos rotter viste ingen dokumentation for nedsat fertilitet, nedsat reproduktionsevne eller forsinket tidlig fosterudvikling på grund af vildagliptin.
10 A fertility and early embryonic development study in rats revealed no evidence of impaired fertility, reproductive performance or early embryonic development due to vildagliptin.
PSUR PSUR- cyklussen af Xiliarx vil stemme overens med den, der gælder for kryds- reference - produktet, Galvus, indtil andet specificeres.
PSURs The PSUR cycle of Xiliarx will correspond to the one attributed to the cross-referred product, Galvus, until otherwise specified.
Xiliarx 50 mg tabletter Vildagliptin
Xiliarx 50 mg tablets Vildagliptin
- Lægen har ordineret Xiliarx til dig personligt.
- This medicine has been prescribed for you.
Virkning og anvendelse 2.
What Xiliarx is and what it is used for 2.
Det skal du vide, før du begynder at tage Xiliarx 3.
Before you take Xiliarx 3.
Sådan skal du tage Xiliarx 4.
How to take Xiliarx 4.
Opbevaring 6.
How to store Xiliarx 6.
VIRKNING OG ANVENDELSE
WHAT XILIARX IS AND WHAT IT IS USED FOR
Xiliarx tilhører en gruppe af lægemidler, der hedder ” orale antidiabetika ”.
Xiliarx belongs to a group of medicines called “ oral antidiabetics”.
Xiliarx bruges til at behandle patienter med type 2- diabetes (sukkersyge).
Xiliarx is used to treat patients with type 2 diabetes.
Din læge kan ordinere Xiliarx sammen med visse andre typer medicin mod sukkersyge, som du allerede tager for at kontrollere sukkersygen, hvis én slags medicin ikke er nok til at kontrollere blodsukkeret alene.
Your doctor will prescribe Xiliarx together with certain other antidiabetic medicines which you will already be taking to control diabetes, if one medicine alone is not enough to control your blood sugar level.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE XILIARX
BEFORE YOU TAKE XILIARX
6:
Do not take Xiliarx:  if you are allergic (hypersensitive) to vildagliptin or any of the other ingredients of Xiliarx (see section 6:
25 Vær ekstra forsigtig med at tage Xiliarx:
Take special care with Xiliarx:
Hvis noget at dette gælder for dig, skal du fortælle det til lægen, før du tager Xiliarx:  hvis du har type 1- diabetes (sukkersyge, hvor din krop ikke producerer insulin).  hvis du har en moderat eller alvorlig nyresygdom.  hvis du er i dialyse.  hvis du har en leversygdom.  hvis du lider af hjertesvigt.
25  if you have type 1 diabetes (i. e. your body does not produce insulin).  if you have moderate or severe kidney disease.  if you are on dialysis.  if you have liver disease.  if you suffer from heart failure.
Du skal ikke tage Xiliarx igen, hvis du tidligere har taget Xiliarx, men blev nødt til at stoppe på grund af bivirkninger (leversygdom).
If you have previously taken Xiliarx but had to stop taking it because of side effects (liver disease), you should not take Xiliarx again.
Xiliarx anbefales ikke til børn og unge.
The use of Xiliarx in children and adolescents is not recommended.
Din læge vil muligvis ønske at ændre din Xiliarx- dosis, hvis du tager anden medicin (såsom medicin kaldet thiazider, kortikosteroider, skjoldbrusk- medicin og visse typer medicin, der påvirker nervesystemet).
Your doctor may wish to alter your dose of Xiliarx if you are taking other medicines (such as medicines so called thiazides, corticosteroids, thyroid products and certain products affecting the nervous system).
Brug af Xiliarx sammen med mad og drikke Du kan tage Xiliarx sammen med mad eller uden mad.
Taking Xiliarx with food and drink You can take Xiliarx with or without food.
Graviditet og amning Kvinder, der er gravide eller planlægger at blive gravide, skal kontakte deres læge før de tager Xiliarx.
Pregnancy and breast-feeding Women who are pregnant or plan to become pregnant should consult their doctor before taking Xiliarx.
Trafik - og arbejdssikkerhed Hvis du føler dig svimmel, når du tager Xiliarx, må du ikke køre bil eller betjene maskiner.
Driving and using machines If you feel dizzy while taking Xiliarx, do not drive or use machines.
Vigtig information om nogle af de øvrige indholdsstoffer i Xiliarx Xiliarx indeholder lactose (mælkesukker).
Important information about some of the ingredients of Xiliarx Xiliarx contains lactose (milk sugar).
SÅDAN SKAL DU TAGE XILIARX
HOW TO TAKE XILIARX
Tag altid Xiliarx nøjagtigt efter lægens anvisning.
Always take Xiliarx exactly as your doctor has told you.
Så meget Xiliarx skal du tage Den mængde Xiliarx, du skal tage, afhænger af din sygdomstilstand.
How much to take The amount of Xiliarx people have to take varies depending on their condition.
Din læge vil fortælle dig helt nøjagtigt, hvor mange Xiliarxtabletter du skal tage.
Your doctor will tell you exactly how many tablets of Xiliarx to take.
Den normale dosis Xiliarx er enten:  50 mg daglig, som du tager på én gang om morgenen, hvis du tager Xiliarx sammen med anden medicin, kaldet sulfonylurea, eller  100 mg daglig, som 50 mg om morgenen og 50 mg om aftenen, hvis du tager Xiliarx sammen med anden medicin, kaldet metformin eller et glitazon.
The usual dose of Xiliarx is either:  50 mg daily taken as one dose in the morning if you are taking Xiliarx with another medicine called a sulphonylurea, or  100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Xiliarx with another medicine called metformin or a glitazone.
26 Din læge vil ordinere Xiliarx sammen med anden medicin for at kontrollere dit blodsukker.
26 Your doctor will prescribe Xiliarx together with another medicine to control your blood sugar level.
Hvornår og hvordan du skal tage Xiliarx  Tag medicinen om morgenen eller om morgenen og om aftenen.  Synk tabletterne hele med lidt vand.
When and how to take Xiliarx  Take this medicine in the morning or in the morning and evening.  Swallow the tablets whole with some water.
Så længe skal du tage Xiliarx  Tag Xiliarx hver dag, så længe din læge siger, at du skal gøre det.
How long to take Xiliarx  Take Xiliarx every day for as long as your doctor tells you.
Det kan være nødvendigt med behandling i lang tid.  Din læge holder øje med din sygdomstilstand for at kontrollere, at behandlingen virker, som den skal.  Hold ikke op med at tage Xiliarx, medmindre lægen siger det.
You may have to take this treatment over a long period of time.  Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.  Do not stop taking Xiliarx unless your doctor tells you to.
Hvis du har taget for mange Xiliarx tabletter Hvis du tager for mange Xiliarx tabletter, eller hvis en anden har taget din medicin, skal du straks kontakte din læge.
If you take more Xiliarx than you should If you take too many Xiliarx tablets, or if someone else has taken your medicine, talk to your doctor straight away.
Hvis du har glemt at tage Xiliarx Hvis du glemmer at tage en dosis af medicinen, skal du tage den, så snart du husker det.
If you forget to take Xiliarx If you forget to take a dose of this medicine, take it as soon as you remember.
Xiliarx kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Xiliarx can cause side effects, although not everybody gets them.
Du bør stoppe med at tage Xiliarx og straks kontakte din læge, hvis du oplever nogle af følgende bivirkninger:  Angioødem (sjælden):
You should stop taking Xiliarx and see your doctor immediately if you experience the following side effects:  Angioedema (rare):
Andre bivirkninger Nogle patienter har oplevet følgende bivirkninger, mens de tog Xiliarx og metformin:  Almindelige:
Other side effects Some patients have had the following side effects while taking Xiliarx and metformin:  Common:
Nogle patienter har oplevet følgende bivirkninger, mens de tog Xiliarx og et sulfonylurea:  Almindelige:
Some patients have had the following side effects while taking Xiliarx and a sulphonylurea:  Common:
Ondt i halsen, løbende næse 27 Nogle patienter har oplevet følgende bivirkninger, mens de tog Xiliarx og et glitazon:  Almindelige:
27 Some patients have had the following side effects while taking Xiliarx and a glitazone:  Common:
Nogle patienter har oplevet følgende bivirkninger, mens de tog Xiliarx alene:  Almindelig:
Some patients have had the following side effects while taking Xiliarx alone:  Common:
OPBEVARING
HOW TO STORE XILIARX
 Opbevares utilgængeligt for børn.  Brug ikke Xiliarx efter den udløbsdato, der står på blisterkortet og pakningen.
 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.
Udløbsdatoen er den sidste dag i den nævnte måned.  Opbevares i den originale pakning for at beskytte mod fugt.  Brug ikke Xiliarx, hvis emballagen er beskadiget eller viser tegn på, at nogen har forsøgt at åbne den.
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.
Xiliarx indeholder:  Aktivt stof: vildagliptin.
What Xiliarx contains  The active substance is vildagliptin.
Xiliarxs udseende og pakningsstørrelse Xiliarx 50 mg tabletter er runde, hvide til svagt lysegule og flade præget med ” NVR ” på den ene side og ” FB ” på den anden side.
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.
Xiliarx 50 mg tabletter fås i pakninger med 7, 14, 28, 30, 56, 60, 90, 112, 180 eller 336 tabletter i multipakninger, der indeholder 336 (3x112) tabletter.
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.
Hvis du vil have yderligere oplysninger om Xiliarx, skal du henvende dig til den lokale repræsentant:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Xolair leveres som et pulver og solvens, der blandes til en opløsning til injektion.
Xolair is a powder and solvent, which are made up into a solution for injection.
Hvert hætteglas indeholder 75 eller 150 mg af det aktive stof omalizumab.
Each vial contains 75 or 150 mg of the active substance omalizumab.
Xolair anvendes til at opnå bedre kontrol med svær, vedvarende astma, der skyldes allergi.
Xolair is used to improve the control of severe persistent asthma that is caused by an allergy.
Det anven - des som tillægsbehandling til anden astmamedicin hos voksne og unge over 12 år, når patienterne: • har haft en positiv lappeprøve for et allergen (et stof, der medfører allergi, dvs. overfølsomhed) i luften, f. eks. husstøvmider, pollen eller skimmel, • har nedsat lungefunktion (mindre end 80% af den normale) foruden hyppige symptomer i dag - tiden eller opvågninger om natten, og • har haft mange svære forværringer af deres astma (som kræver akut behandling med anden me - dicin), selv om de er i behandling med høje doser af inhalationskortikosteroider plus en lang - tidsvirkende inhaleret beta2- agonist.
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.
Anvendelse af Xolair bør kun overvejes, når astmaen skyldes IgE (immunoglobulin E, et antistof).
Xolair treatment should only be considered for patients whose asthma is caused by IgE (immunoglobulin E, an antibody).
Behandling med Xolair bør kun påbegyndes af en læge med erfaring i behandling af svær, langvarig astma.
Xolair treatment should be initiated by a doctor who has experience in the treatment of severe persistent asthma.
Før Xolair gives, skal lægen måle indholdet af IgE i patientens blod.
Before giving Xolair, the doctor must measure the level of IgE in the patient ’ s blood.
Patienter, hvis IgE - indhold er under 76 IE/ ml, har mindre sandsynlighed for at få gavn af medicinen.
Patients whose IgE level is below 76 IU/ ml are less likely to benefit from the medicine.
Xolair bør gives af medicinsk personale, f. eks. en læge eller sygeplejerske, ved subkutan injektion (indsprøjtning under huden) i overarmen eller i låret hver anden eller hver fjerde uge.
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.
Dosis og doseringshyppighed for Xolair afhænger af indholdet af IgE i blodet og af legemsvægten.
The dose and dosing frequency of Xolair depend on the level of IgE in the blood and body weight.
Den anbefalede dosis er mellem 75 og 375 mg, der gives som en til tre injektioner, og den maksimale anbefalede dosis er 375 mg hver anden uge.
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.
Yderligere oplysninger herom fremgår af produktresuméet, der ligeledes er en del af EPAR.
See the Summary of Product Characteristics (which is also part of the EPAR) for further information.
Et monoklonalt antistof er en type protein, der er opbygget, så det genkender og binder sig til en bestemt struktur, der kaldes et antigen og findes i organismen.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is in the body.
(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 Ved at bindes til IgE indfanger omalizumab det frie IgE i blodet.
(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.
Det betyder, at når kroppen møder et allergen, er der mindre IgE til at udløse en allergisk reaktion.
By binding to IgE, omalizumab ‘ mops up’ the free IgE circulating in the blood.