natgillin/translations-raw huggingface dataset:
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.
Uporablja se kot dodatek obstoječemu zdravljenju astme pri odraslih in mladostnikih, starejših od 12 let, ki: • so imeli pozitiven rezultat kožnega testa za alergijo, ki jo povzroča alergen (dražljaj, ki povzroča alergijo) v zraku, kot na primer pršice hišnega prahu, cvetni prah ali plesen, • imajo zmanjšano funkcijo pljuč (manj kot 80% normalne funkcije) kot tudi pogoste simptome podnevi ali se ponoči zbujajo, in • so imeli po več resnih izbruhov astme (pri čemer se je astma poslabšala, kar je zahtevalo nadomestno zdravljenje z drugimi zdravili) kljub zdravljenju z inhaliranjem velikih odmerkov kortikosteroidov skupaj z dolgo delujočim agonistom adrenergičnih receptorjev beta2 za inhaliranje.
Xolair treatment should only be considered for patients whose asthma is caused by IgE (immunoglobulin E, an antibody).
Zdravilo Xolair je primerno le za bolnike, pri katerih astmo povzroča IgE (imunoglobulin E, protitelo).
Xolair treatment should be initiated by a doctor who has experience in the treatment of severe persistent asthma.
Zdravljenje z zdravilom Xolair mora uvesti zdravnik z izkušnjami z zdravljenjem hude trdovratne astme.
Before giving Xolair, the doctor must measure the level of IgE in the patient ’ s blood.
Pred začetkom dajanja zdravila Xolair mora zdravnik izmeriti raven IgE v bolnikovi krvi.
Patients whose IgE level is below 76 IU/ ml are less likely to benefit from the medicine.
Pri bolnikih, pri katerih je raven IgE nižja od 76 i. e. / ml, je manj verjetno, da bi jim zdravilo koristilo.
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.
Zdravilo Xolair daje zdravstveni delavec (na primer zdravnik ali medicinska sestra) kot subkutano injekcijo (pod kožo) v nadlahet ali stegno vsaka dva ali štiri tedne.
The dose and dosing frequency of Xolair depend on the level of IgE in the blood and body weight.
Odmerek in pogostost odmerjanja zdravila Xolair sta odvisna od ravni IgE v krvi in od telesne mase.
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.
Običajni razpon odmerka je med 75 in 375 mg z eno do tremi injekcijami, največji priporočeni odmerek je 375 mg vsaka dva tedna.
See the Summary of Product Characteristics (which is also part of the EPAR) for further information.
Več informacij najdete v Povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
The active substance in Xolair, omalizumab, is a monoclonal antibody.
Zdravilna učinkovina zdravila Xolair je monoklonsko protitelo omalizumab.
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.
Monoklonsko protitelo je protitelo (tip beljakovine), ki je zasnovano tako, da prepozna in se veže na specifično strukturo (imenovano antigen), ki se nahaja v telesu.
Omalizumab has been designed to bind to human IgE, which is 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Omalizumab je zasnovan tako, da se veže na človeški IgE, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
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By binding to IgE, omalizumab ‘ mops up’ the free IgE circulating in the blood.
Omalizumab z vezavo na IgE „ odstrani “ prosti IgE, ki kroži v krvi.
This means that when the body encounters an allergen, there is less IgE available to trigger an allergic reaction.
To pomeni, da je v trenutku, ko pride telo v stik z alergenom, na voljo manj IgE za sprožanje alergijske reakcije.
The effects of Xolair were first tested in experimental models before being studied in humans.
Učinki zdravila Xolair so bili najprej preizkušeni na preskusnih modelih, nato pa so jih raziskali pri ljudeh.
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.
Zdravilo Xolair so preučevali pri bolnikih z alergijsko astmo v petih glavnih študijah z 2299 bolniki, vključno z eno študijo s 482 bolniki s hudo alergijsko astmo, ki ni bila obvladana z običajnim zdravljenjem.
The effects of Xolair were compared with those of placebo (a dummy treatment), when added to the patients’ existing treatment.
Učinke zdravila Xolair so primerjali z učinki placeba pri dodajanju k bolnikovemu obstoječemu zdravljenju.
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.
Glavna merila učinkovitosti so bila število izbruhov in število bolnikov z izbruhi astme, kakovost življenja bolnika (ovrednotena z uporabo standardnih vprašalnikov) in zmanjšanje količine inhaliranega kortikosteroida, ki so ga bolniki potrebovali.
What benefit has Xolair shown during the studies?
Kakšne koristi je zdravilo Xolair izkazalo med raziskavami?
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.
Prve tri študije so pokazale, da so imeli bolniki, ki so prejemali zdravilo Xolair, približno za polovico manj izbruhov astme v prvih 28 ali 52 tednih zdravljenja: bolniki iz skupine, ki je prejemala zdravilo Xolair, so imeli približno 0, 5 izbruhov na leto, bolniki iz skupine, ki je prejemala placebo, pa približno en izbruh na leto.
Fewer of the patients being given Xolair had exacerbations than those being given placebo.
Izbruhi so bili pri bolnikih, ki so prejemali zdravilo Xolair, manj pogosti kot pri bolnikih, ki so prejemali placebo.
Patients taking Xolair also reported a greater improvement in their quality of life than those taking placebo.
Bolniki, ki so jemali zdravilo Xolair, so poročali tudi o večjem izboljšanju kakovosti življenja kot bolniki, ki so jemali placebo.
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.
V četrti raziskavi je bilo zmanjšanje uporabe flutikazona (kortikosteroida) pri bolnikih, ki so jemali zdravilo Xolair, večje kot pri bolnikih, ki so jemali placebo.
Across these studies, the effects of Xolair were greater in patients with severe asthma.
V vseh raziskavah so bili učinki zdravila Xolair večji pri bolnikih s hudo astmo.
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.
V študiji bolnikov s hudo alergijsko astmo je zdravilo Xolair kljub temu, da ni bilo razlike v pogostosti izbruhov astme med bolniki, ki so prejemali zdravilo Xolar oziroma placebo, privedlo do zmanjšanja števila izbruhov, kar je bilo v skladu s prejšnjimi študijami.
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).
Najpogostejši neželeni učinki zdravila Xolair (opaženi pri 1 do 10 bolnikih izmed 100) so glavobol in reakcije na mestu injiciranja, vključno z bolečino, otekanjem, eritemom (rdečino) in pruritusom (srbenjem).
For the full list of all side effects reported with Xolair, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Xolair, glejte Navodilo za uporabo.
Xolair should not be given to people who may be hypersensitive (allergic) to omalizumab or any of the other ingredients.
Zdravila Xolair ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) omalizumab ali katero koli drugo sestavino.
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da kljub rezultatom končne glavne študije, rezultati drugih študij zdravila Xolair kažejo vzorec, ki kaže na učinkovitost zdravila pri zdravljenju hude alergijske astme.
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.
Zato je Odbor odločil, da so koristi zdravila Xolair kot dopolnilnega zdravljenja odraslih in mladostnikov, starejših od 12 let, s hudo trdovratno alergijsko astmo, večje od z njimi povezanih tveganj.
It recommended that Xolair be given marketing authorisation.
Priporočil je, da se za zdravilo Xolair odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union for Xolair to Novartis Europharm Limited on 25 October 2005.
Evropska komisija je dovoljenje za promet z zdravilom Xolair, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 25. oktobra 2005.
The full EPAR for Xolair can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Xolair je na voljo tukaj.
This summary was last updated in 05-2007.
Ta povzetek je bil nazadnje posodobljen 05- 2007.
75 mg; solvent:
75 mg; vehikel:
150 mg; solvent:
150 mg; vehikel:
Omalizumab is a humanised monoclonal antibody manufactured by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell line.
Omalizumab je humanizirano monoklonsko protitelo, ki ga izdelujejo s tehnologijo rekombinantne DNA v liniji sesalskih celic ovarija kitajskega hrčka (CHO - Chinese hamster ovary).
After reconstitution the vial contains 125 mg/ ml of omalizumab (75 mg in 0.6 ml).
Po rekonstituciji viala vsebuje 125 mg/ ml omalizumaba (75 mg v 0, 6 ml).
Xolair is an off-white lyophilised powder.
Zdravilo Xolair je skoraj bel liofiliziran prašek.
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.
Zdravilo Xolair je indicirano kot dodatno zdravilo za izboljšanje obvladovanja astme pri odraslih in adolescentnih bolnikih (starih 12 let ali več) s težko trdovratno alergijsko astmo, ki imajo pozitiven kožni test ali in vitro reaktivnost na trajno prisoten zračni alergen in ki imajo zmanjšano funkcijo pljuč (FEV1 < 80%), pa tudi pogoste simptome podnevi ali se pogosto ponoči zbujajo, in so imeli po več dokumentiranih težkih eksacerbacij astme kljub vsakodnevnemu inhaliranju velikih odmerkov kortikosteroidov skupaj z dolgo delujočim agonistom adrenergičnih receptorjev beta2 za inhaliranje.
Xolair treatment should only be considered for patients with convincing IgE mediated asthma (see section 4.2).
Zdravljenje z zdravilom Xolair pride v poštev samo za bolnike s prepričljivo astmo, v katero je vpleten IgE (glejte poglavje 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.
Uporaba pri mladostnikih in odraslih (starih 12 let ali več) Zdravljenje z zdravilom Xolair morajo uvajati zdravniki, izkušeni v diagnostiki in zdravljenju težke trdovratne astme.
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).
Ustrezni odmerek in pogostnost odmerjanja zdravila Xolair se določata z izhodiščnim IgE (i. e. / ml), izmerjenim pred začetkom zdravljenja, in s telesno maso (kg).
Prior to initial dosing, patients should have their IgE level determined by any commercial serum total IgE assay for their dose assignment.
Pred prvim odmerkom je treba bolnikom za določitev njihovega odmerka določiti raven IgE z enim od komercialnih kompletov za določanje celotnega IgE v serumu.
Based on these measurements 75-375 mg of Xolair in 1 to 3 injections may be needed for each administration.
Na podlagi teh meritev utegne biti za vsako aplikacijo potrebnih 75- 375 mg zdravila Xolair v 1 do 3 injekcijah.
Patients with IgE lower than 76 IU/ ml were less likely to experience benefit (see section 5.1).
Pri bolnikih, ki so imeli IgE nižji od 76 i. e. / ml, je bilo manj verjetno, da jim bo to zdravilo koristilo (glejte poglavje 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.
Zdravniki, ki predpisujejo zdravilo, se morajo pred začetkom zdravljenja prepričati, da imajo bolniki z IgE pod 76 i. e. / ml nedvoumno in vitro reaktivnost (RAST) na trajno prisoten alergen.
See Table 1 for a conversion chart and Tables 2 and 3 for the dose determination charts.
Glejte preglednico 1 za pretvorbeno shemo in preglednici 2 in 3 za shemi za določanje odmerkov.
Patients whose baseline IgE levels or body weight in kilograms are outside the limits of the dosing table should not be given Xolair.
2 Bolniki, katerih izhodiščna raven IgE ali telesna masa v kilogramih sta zunaj meja sheme za določanje odmerkov, zdravila Xolair ne smejo dobiti.
The maximum recommended dose is 375 mg omalizumab every two weeks.
Največji priporočeni odmerek je 375 mg omalizumaba enkrat na dva tedna.
2 For subcutaneous administration only.
Samo za subkutano uporabo.
Do not administer by the intravenous or intramuscular route.
Ne aplicirajte po intravenski ali intramuskularni poti.
The injections are administered subcutaneously in the deltoid region of the arm.
Injekcije apliciramo subkutano v deltoidni predel nadlakta.
Alternatively, the injections can be administered in the thigh if there is any reason precluding administration in the deltoid region.
Druga možnost je apliciranje injekcij v stegno, če obstaja kak razlog, ki preprečuje aplikacijo v deltoidno regijo.
There is limited experience with self-administration of Xolair.
Izkušnje z aplikacijo zdravila Xolair samemu sebi so omejene.
Therefore treatment is intended to be administered by a healthcare provider.
Zato je zdravilo namenjeno temu, da ga bolniku aplicira zdravstveni delavec.
For information on reconstitution of Xolair, see section 6.6.
Za informacije o rekonstituciji zdravila Xolair glejte poglavje 6. 6.
Conversion from dose to number of vials, number of injections and total injection volume for each administration
Preračunavanje odmerkov v število vial, število injekcij in celotni injicirani volumen za vsako apliciranje zdravila
Body weight (kg) Baseline IgE
Telesna masa (kg) Izhodiščni IgE
(IU/ ml) ≥ 30-100
(i. e. / ml)
ADMINISTRATION EVERY 2 WEEKS SEE TABLE 3
UPORABO VSAKA 2 TEDNA GLEJTE PREGLEDNICO 3
3 Table 3:
3 Preglednica 3:
ADMINSTRATION EVERY 2 WEEKS.
APLIKACIJA VSAKA 2 TEDNA.
(IU/ ml)
(i. e. / ml)
DO NOT ADMINISTER – data is unavailable for dose
NE UPORABLJAJTE – podatki za priporočila za odmerjanje niso na
recommendation
voljo
Treatment duration, monitoring and dose adjustments Discontinuation of Xolair treatment generally results in a return to elevated free IgE levels and associated symptoms.
Trajanje zdravljenja, spremljanje in prilagajanje odmerkov Prekinitev zdravljenja z zdravilom Xolair v glavnem povzroči vrnitev prostega IgE na zvišane vrednosti in z njimi povezane simptome.
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).
Odločitev za nadaljevanje zdravljenja z zdravilom Xolair mora temeljiti na izrazitem izboljšanju celotnega obvladovanja astme (glejte poglavje 5. 1; Zdravnikova celotna ocena učinkovitosti zdravljenja).
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.
Starejši bolniki (stari 65 let ali več) O uporabi zdravila Xolair pri bolnikih, starejših od 65 let, so na voljo omejeni podatki, ni pa dokazov, da bi bilo pri starejših bolnikih potrebno drugačno odmerjanje kot pri mlajših odraslih bolnikih.
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.
Otroci (mlajši od 12 let) Varnosti in učinkovitosti pri pediatričnih bolnikih, mlajših od 12 let, niso ugotavljali, zato pri takih bolnikih uporabe zdravila Xolair ne priporočajo.
General Xolair is not indicated for the treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus.
Splošno Zdravilo Xolair ni indicirano za zdravljenje akutnih eksacerbacij astme, akutnega bronhospazma ali astmatičnega statusa.
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.
Zdravila Xolair niso proučevali pri bolnikih s sindromom hiperimunoglobulina E ali alergijske bronhopulmonalne aspergiloze ali za preprečevanje anafilaktičnih reakcij, vključno s tistimi, ki jih izzove alergija na hrano.
Xolair therapy has not been studied in patients with autoimmune diseases, immune complex-mediated conditions, or pre-existing renal or hepatic impairment.
Zdravljenja z zdravilom Xolair niso proučevali pri bolnikih z avtoimunskimi boleznimi, s stanji, v katere je vpleten imunski kompleks, ali z že obstoječimi okvarami ledvic ali jeter.
Decreases in corticosteroids should be performed under the direct supervision of a physician and may need to be performed gradually.
Možno je, da bo odmerjanje kortikosteroidov treba zmanjševati postopoma.
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.
Bolnike s sladkorno boleznijo, sindromom glukozno- galaktozne malabsorpcije, z intoleranco fruktoze ali s pomanjkanjem saharaze- izomaltaze je treba opozoriti, da en 75- miligramski odmerek zdravila Xolair vsebuje 54 mg saharoze.
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.
Lahko se zgodi, da se te reakcije prvič pojavijo šele po dolgotrajnem zdravljenju.
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.
Večina teh reakcij je nastopila v prvih 2 urah po prvem in po enem od nadaljnih injiciranj zdravila Xolair, nekatere pa so nastopile tudi po več kot 2 urah in celo več kot 24 urah po injiciranju.
Therefore medications for the treatment of anaphylactic reactions should always be available for immediate use following administration of Xolair.
Zato morajo biti ob aplikaciji zdravila Xolair vedno na voljo zdravila za zdravljenje anafilaktičnih reakcij, pripravljena za takojšnjo uporabo.
Anaphylactic reactions were rare in clinical trials (see section 4.8).
V kliničnih preskušanjih so bile anafilaktične reakcije redke (glejte poglavje 4. 8).
As with all recombinant DNA derived humanised monoclonal antibodies, patients may in rare cases develop antibodies to omalizumab.
Podobno kot pri vseh humaniziranih monoklonskih protitelesih, pridobljenih iz rekombinantne DNA, se lahko pri bolnikih v redkih primerih razvijejo protitelesa proti omalizumabu.
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.
b) serumska bolezen Pri bolnikih, zdravljenih s humaniziranimi monoklonskimi protitelesi, med katera sodi tudi omalizumab, so redko opažali serumsko bolezen in njej podobne reakcije, ki so zapoznele alergijske reakcije tipa III.
Symptoms suggestive of serum sickness include arthritis/ arthralgias, rash (urticaria or other forms), fever and lymphadenopathy.
Simptomi, ki nakazujejo možnost serumske bolezni, vključujejo artritis/ artralgije, izpuščaj (urtikarijo ali druge oblike), zvišano telesno temperaturo in limfadenopatijo.
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.
c) Churg- Straussov sindrom in hipereozinofilni sindrom Pri bolnikih s hudo astmo se v redkih primerih izrazi sistemski hipereozinofilni sindrom ali alergijski eozinofilni granulomatozni vaskulitis (Churg- Straussov sindrom); pri obeh sindromih je običajno zdravljenje s sistemskimi kortikosteroidi.
In rare cases, patients on therapy with anti-asthma agents, including omalizumab, may present or develop systemic eosinophilia and vasculitis.
Pri bolnikih, ki uporabljajo zdravila za zdravljenje astme, vključno z omalizumabom, se v redkih
These events are commonly associated with the reduction of oral corticosteroid therapy.
5 primerih izrazita oziroma razvijeta sistemska eozinofilija in vaskulitis, kar se običajno zgodi v povezavi z nižanjem odmerkov peroralnih kortikosteroidov.
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.
Pri teh bolnikih morajo biti zdravniki pozorni na pojavljanje izrazite eozinofilije, izpuščaja v povezavi z vaskulitisom, slabšanja pljučnih simptomov, bolezenskih sprememb v obnosnih votlinah, zapletov na srcu in/ ali nevropatije.
Parasitic (helminth) infections IgE may be involved in the immunological response to some helminth infections.
Infestacije s paraziti (helminti) IgE utegne biti vpleten v imunski odziv na nekatere infestacije s helminti.
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.
Pogostnost infestacije s helminti je bila v celotnem kliničnem programu, ki ni bil zasnovan za odkrivanje takih infestacij, manj od 1 na 1. 000 bolnikov.