natgillin/translations-raw huggingface dataset:
This can result in liver and spleen enlargement, changes in the blood, and bone disease.
spremembe v krvi in kostno bolezen.
Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical studies in patients treated with miglustat 100 mg t.i.d.
Manifestacije Gaucherjeve bolezni vrste 1 na kosteh so bile ocenjene v 3 odprtih kliničnih študijah pri bolnikih, zdravljenih z miglustatom 100 mg trikrat dnevno do 2 leti (n = 72).
Limited data in patients with Fabry disease and impaired renal function showed that CL/F decreases with decreasing renal function.
Malo podatkov za bolnike s Fabryjevo boleznijo in okvarjenim delovanjem ledvic je pokazalo, da se
- If you get any side effects,talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Based on mg/kg/day and corrected for differences in faecal excretion, the doses corresponded to 8, 16 and 33/19 times the highest recommended human dose (200 mg t.i.d.).
Odmerki, ki temeljijo na mg/kg/dan in korekciji zaradi razlik pri izločanju fecesa, ustrezajo 8, 16 in
Depression, insomnia, libido decreased Nervous system disorders Very common
Pogosto depresija, nespečnost, zmanjšan libido
Marketing Authorisation Holder:
Imetnik dovoljenja za promet z zdravilom:
How to store Zavesca
Kako jemati zdravilo Zavesca
Zavesca has not been evaluated in patients with a history of significant gastrointestinal disease, including inflammatory bowel disease.
Zdravila Zavesca pri bolnikih z anamnezo pomembnega obolenja prebavil, vključno z vnetno črevesno boleznijo, niso vrednotili.
Dosage in Niemann-Pick type C disease
Odmerjanje pri Niemann-Pickovi bolezni tipa C Odrasli
Musculoskeletal and connective tissue disorders Common
Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosto mišični krči, oslabelost mišic
Renal impairment
Okvarjeno delovanje ledvic
Diarrhoea, flatulence, abdominal pain
Bolezni prebavil Zelo pogosto diareja, flatulenca, bolečine v trebuhu
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
Administration of miglustat to male and female CD1 mice by oral gavage at dose levels of 210, 420 and 840/500 mg/kg/day (dose reduction after half a year) for 2 years resulted in an increased incidence of inflammatory and hyperplastic lesions in the large intestine in both sexes.
840/500 mg/kg/dan (zmanjšanje odmerka na pol leta) je povzročilo povišano incidenco vnetnih in in hiperplastičnih lezij v debelem črevesu pri obeh spolih..
People usually stop losing weight as treatment goes on.
Z nadaljevanjem zdravljenja z zdravilom Zavesca bolniki običajno prenehajo izgubljati telesno maso.
- Keep this leaflet.
Ločite po perforaciji.
In patients with an adjusted creatinine clearance of 50-70 ml/min/1.73 m2, administration should commence at a dose of 100 mg twice daily in patients with type 1 Gaucher disease and at a dose of 200 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease.
uporabo začnemo z odmerkom 100 mg dvakrat dnevno pri bolnikih z Gaucherjevo boleznijo tipa 1 in z odmerkom 200 mg dvakrat dnevno (prilagojeno na površino telesa pri bolnikih, starih manj kot 12 let) pri bolnikih z Niemann-Pickovo boleznijo tipa C.
Although no direct comparisons with Enzyme Replacement Therapy (ERT) have been performed in treatment-naive patients with type 1 Gaucher disease, there is no evidence of Zavesca having an efficacy or safety advantage over ERT. ERT is the standard of care for patients who require treatment for type 1 Gaucher disease (see section 5.1).
Enzyme Replacement Therapy) pri bolnikih z Gaucherevo boleznijo tipa 1, ki predhodno niso bili zdravljeni, niso bile opravljene, ni dokazov, da bi bilo zdravilo Zavesca učinkovitejše ali varnejše kot
He or she may reduce the dose of Zavesca or recommend other medicines to help control side effects.
Kadar neželeni učinki povzročajo skrbi ali neprijetnosti, se posvetujte s svojim zdravnikom, ki vam bo morda znižal odmerek zdravila Zavesca ali, za nadzor nad neželenimi učinki, priporočil druga zdravila.
Printing ink
PRETISNI OMOT
Mild reductions in platelet counts without association to bleeding were observed in some patients with Niemann-Pick type C disease treated with Zavesca.
Pri nekaterih bolnikih z Niemann-Pickovo boleznijo tipa C, zdravljenih z zdravilom Zavesca, so opazili blago zmanjšanje števila trombocitov, ki ni bilo povezano s krvavitvami.
Administration of miglustat to male and female Sprague-Dawley rats by oral gavage for 2 years at dose levels of 30, 60 and 180 mg/kg/day resulted in an increased incidence of testicular interstitial cell (Leydig cell) hyperplasia and adenomas in male rats at all dose levels.
Dajanje miglustata samcem in samicam podgan Sprague-Dawley po sondi 2 leti v odmerkih 30, 60 in
In patients with an adjusted creatinine clearance of 30-50 ml/min/1.73 m2, administration should commence at a dose of 100 mg once daily in patients with type 1 Gaucher disease and at a dose of 100 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease.
100 mg enkrat dnevno pri bolnikih z Gaucherjevo boleznijo tipa 1 in pri odmerku 100 mg dvakrat dnevno (prilagojeno na površino telesa pri bolnikih, starih manj kot 12 let) pri bolnikih z Niemann
You must use effective birth control while taking Zavesca.
V času jemanja zdravila Zavesca morate uporabljati učinkovite metode preprečitve zanositve.
Zavesca has been used in clinical trials at doses ten times higher than the recommended dose: this caused decreases in white blood cells and other side effects similar to those described in section 4.
To je povzročilo zmanjšanje števila belih krvničk in druge neželene učinke, ki so bili podobni opisanim v poglavju 4.
Mild reductions in platelet counts without association with bleeding were observed in patients with type 1 Gaucher disease who were switched from ERT to Zavesca.
Pri bolnikih z Gaucherjevo boleznijo tipa 1, ki so prešli iz zdravljenja z ERT na zdravilo Zavesca, so opazili blago zmanjšanje števila trombocitov, ki ni bilo povezano s krvavitvami.
Miglustat
omotičnost
Zavesca has not been evaluated in patients with hepatic impairment.
Zdravila Zavesca pri bolnikih z okvarjenim delovanjem jeter niso ovrednotili.
Investigations Common
KLINIČNI PODATKI
You should not take Zavesca if you are pregnant or thinking of becoming pregnant.
Če ste noseči ali nameravate zanositi, zdravila Zavesca ne smete jemati.
The pivotal trial of Zavesca was conducted in patients unable or unwilling to receive ERT. Reasons for not receiving ERT included the burden of intravenous infusions and difficulties in venous access.
Razloga za nezdravljenje z ERT sta bila breme intravenskega infundiranja in težave z venskim pristopom.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
Posology
Ravnanje
Tremor,
Zelo pogosto tremor
The active substance is miglustat 100 mg.
Učinkovina je 100 mg miglustata.
There are also links to other websites about rare diseases and treatments.
Farmakoterapevtska skupina: Druga zdravila za bolezni prebavil in presnove.
Hepatic impairment
Okvarjeno delovanje jeter
Name and address of the manufacturer responsible for batch release Actelion Manufacturing GmbH
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij
Some patients have had tingling or numbness in the hands and feet (seen commonly).
Nekateri bolniki izkusijo mravljinčenje ali otrplost rok ali nog (to so opazili pogosto).
• for clinically important benefits that are currently not established in an identified population or indication and which outweigh the risks related to the product.
• o klinično pomembnih koristih, ki zdaj za opredeljeno populacijo ali indikacijo niso ugotovljene ter prevladajo nad tveganji, povezanimi z izdelkom;
• or that the product (potentially modified or not) does not undergo significant dechelation and does not lead to retention of gadolinium in tissues.
• ali da izdelek (lahko spremenjen ali ne) bistveno ne dekelatira ali ne povzroči zadrževanja gadolinija v tkivih.
For the suspensions of intravenous gadodiamide, gadopentetic acid, and gadoversetamide containing medicinal products to be lifted, the Marketing Authorisation Holder(s) shall provide evidence
Za preklic začasnega umika dovoljenja za promet z zdravili za intravensko uporabo, ki vsebujejo gadodiamid, gadopentetsko kislino in gadoversetamid, imetnik(i) dovoljenja za promet z zdravilom predloži(jo) dokaze:
Annex IV Conditions for lifting the suspension of the marketing authorisations
Priloga IV Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom
Conditions for lifting the suspension of the marketing authorisation(s)
Pogoji za preklic začasnega umika dovoljenj(a) za promet z zdravilom
This summary was last updated in 02-2014.
Povzetek je bil nazadnje posodobljen 02-2014.
• they must have frequent symptoms during the day or waking up during the night;
• imajo pogoste simptome podnevi oziroma se zbujajo ponoči;
The effects were maintained after 6 months of treatment.
Učinki so se ohranili tudi po šestih mesecih zdravljenja.
It has also been studied in 627 children aged between six and 12 years.
Proučevali so ga tudi pri 627 otrocih, starih od šest do 12 let.
The European Commission granted a marketing authorisation valid throughout the European Union for Xolair on 25 October 2005.
Evropska komisija je dovoljenje za promet z zdravilom Xolair, veljavno po vsej Evropski uniji, izdala 25. oktobra 2005.
The doctor will periodically re-assess the need to continue treatment with Xolair.
Zdravnik mora redno ponovno oceniti potrebo po nadaljevanju zdravljenja z zdravilom Xolair.
All patients receiving Xolair must meet the following criteria:
Vsi bolniki, ki prejemajo zdravilo Xolair, morajo izpolnjevati naslednje pogoje:
The full EPAR for Xolair can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Xolair je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Xolair:
Druge informacije o zdravilu Xolair:
Patients aged 12 years or over must also have reduced lung function (less than 80% of normal).
Bolniki, starejši od 12 let, morajo imeti tudi zmanjšano delovanje pljuč (manj od 80 % običajne).
What measures are being taken to ensure the safe and effective use of Xolair?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xolair?
This helps to reduce the symptoms of allergy, such as asthma attacks.
To pomaga lajšati simptome alergije, na primer napade astme.
The usual dose range is between 75 and 600 mg in one to four injections, and the maximum recommended dose is 600 mg every two weeks.
Običajni razpon odmerka je med 75 in 600 mg z eno do štirimi injekcijami, največji priporočeni odmerek pa je 600 mg vsaka dva tedna.
This document is a summary of the European public assessment report (EPAR) for Xolair.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xolair.
It usually takes 12 to 16 weeks for Xolair to show a benefit.
Navadno traja od 12 do 16 tednov, da zdravilo Xolair izkaže korist.
They also reported a greater improvement in quality of life and used less fluticasone (a corticosteroid).
Poročali so tudi o večjem izboljšanju kakovosti življenja in zmanjšanju količine uporabljenega flutikazona (kortikosteroida).
Patients with low IgE levels are less likely to benefit from the medicine.
Pri bolnikih z nizkimi ravnmi IgE je korist zdravila manj verjetna.
• they 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;
• imajo 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;
This means that when the body encounters an allergen, there is less IgE available to trigger an allergic reaction.
To pomeni, da je ob stiku telesa z alergenom na voljo manj IgE za sprožitev alergijske reakcije.
For more information about treatment with Xolair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Xolair preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP decided that Xolair's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Xolair večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
What benefit has Xolair shown during the studies?
Kakšne koristi je zdravilo Xolair izkazalo med študijami?
Although the role of IgE in chronic spontaneous urticaria is less clear, reducing its availability with omalizumab has been shown to improve the symptoms of this condition.
Čeprav je vloga IgE pri kronični spontani urtikariji manj jasna, je zmanjšanje prisotnosti IgE s pomočjo omalizumaba dokazano izboljšalo simptome tega obolenja.
A risk management plan has been developed to ensure that Xolair is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Xolair je bil pripravljen načrt obvladovanja tveganj.
It is available in two forms: as a vial containing a powder and solvent that are made up into a solution for injection; and as a prefilled syringe containing a solution for injection.
Na voljo je v dveh oblikah: kot viala s praškom in vehiklom za pripravo raztopine za injiciranje in kot napolnjena injekcijska brizga, ki vsebuje raztopino za injiciranje.
The effects of Xolair were greater in patients with severe asthma.
Učinki zdravila Xolair so bili večji pri bolnikih s hudo astmo.
It is used as an addon to existing treatment in patients aged 12 years or over who do not respond to treatment with antihistamines.
Uporablja se kot dodatek k obstoječemu zdravljenju pri bolnikih, starejših od 12 let, ki se ne odzivajo na zdravljenje z antihistaminiki.
The main measure of effectiveness was the change in itching severity after 12 weeks of treatment, as measured on a scale ranging from 0 (no itch) to 21 (maximum itch severity).
Glavno merilo učinkovitosti je bila sprememba v stopnji resnosti srbenja po 12 tednih zdravljenja, ki so jo ugotavljali s pomočjo lestvice od 0 (brez srbenja) do 21 (najvišja stopnja srbenja).
The main measures of effectiveness were the number of exacerbations, the number of patients who had an exacerbation, quality of life (assessed using standard questionnaires), and the amount of inhaled corticosteroid that the patients needed to take to treat their asthma.
Glavna merila učinkovitosti so bili število izbruhov, število bolnikov z izbruhi astme, kakovost življenja bolnika (ovrednotena z uporabo standardnih vprašalnikov) in zmanjšanje količine inhaliranega kortikosteroida, ki so ga bolniki potrebovali za nadzor astme.
It is used as an add-on to existing asthma treatment in patients aged six years or over.
Uporablja se kot dodatek k obstoječemu zdravljenju astme pri bolnikih, starejših od šest let.
Before giving Xolair to patients with asthma, the doctor must measure the level of IgE in the patient's blood.
Pred začetkom dajanja zdravila Xolair bolnikom z astmo mora zdravnik izmeriti raven IgE v bolnikovi krvi.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
To je protitelo (vrsta beljakovine), ki je zasnovano tako, da v telesu prepozna posebno strukturo (imenovano antigen) in se veže nanjo.
The CHMP also concluded that Xolair (300 mg) was shown to significantly improve the symptoms of chronic spontaneous urticaria when used as add-on to the patients' existing treatment, but noted that study data on long-term use beyond 6 months are limited.
Poleg tega je menil, da je zdravilo Xolair (300 mg) bistveno izboljšalo simptome kronične spontane urtikarije, kadar se je uporabljalo kot dodatek k bolnikovemu obstoječemu zdravljenju, vendar so podatki iz študij o dolgoročni uporabi tega zdravila dlje kot šest mesecev omejeni.
Omalizumab has been designed to attach to human IgE, which is produced in large quantities in patients with allergies and triggers an allergic reaction in response to an allergen.
Omalizumab je zasnovan tako, da se veže na človeški IgE, ki se pri bolnikih z alergijami tvori v velikih količinah in kot odziv na alergen sproži alergijsko reakcijo.
Xolair treatment should only be considered when the asthma is caused by an antibody called immunoglobulin E (IgE).
Zdravljenje z zdravilom Xolair je smiselno le, če astmo povzroča protitelo, imenovano imunoglobulin E (IgE).
By attaching to IgE, omalizumab ‘mops up' the free IgE circulating in the blood.
Omalizumab si z vezavo na IgE „pripoji“ prosti IgE, ki kroži v krvi.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xolair, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Xolair in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Xolair has also been investigated in 3 main studies involving a total of 978 patients with chronic spontaneous urticaria who did not respond to antihistamine-based treatment.
Zdravilo Xolair so proučevali tudi v treh glavnih študijah, v katerih je sodelovalo 978 bolnikov s kronično spontano urtikarijo, ki se niso odzvali na zdravljenje z antihistaminiki.
• they must have had many severe ‘exacerbations' of asthma (where asthma gets worse, requiring rescue treatment with other medicines) despite treatment with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist.
• imeli so več resnih izbruhov astme (pri katerih se je astma poslabšala, kar je zahtevalo takojšnje zdravljenje z drugimi zdravili) kljub zdravljenju z inhaliranjem velikih odmerkov kortikosteroidov skupaj z dolgo delujočim agonistom receptorjev beta 2 za inhaliranje.
Each vial and syringe contains 75 or 150 mg of omalizumab.
Ena viala oziroma injekcijska brizga vsebuje 75 ali 150 mg zdravilne učinkovine omalizumab.
For the full list of all side effects and restrictions with Xolair, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Xolair glejte navodilo za uporabo.
The active substance in Xolair, omalizumab, is a monoclonal antibody.
Zdravilna učinkovina v zdravilu Xolair, omalizumab, je monoklonsko protitelo.
What is the risk associated with Xolair?
Kakšna tveganja so povezana z zdravilom Xolair?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xolair.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Xolair has been studied in over 2,000 patients aged 12 years or over with allergic asthma in five main studies, including one study involving 482 patients with severe allergic asthma that was not controlled by conventional treatments.
Zdravilo Xolair so proučevali v petih glavnih študijah pri več kot 2 000 bolnikih z alergijsko astmo, starejših od 12 let, vključno z eno študijo s 482 bolniki s hudo alergijsko astmo, ki ni bila nadzorovana z običajnimi zdravljenji.
The Committee concluded that, overall, there was a pattern of results in the studies of Xolair in asthma that show that the medicine is effective in treating severe allergic asthma.
Odbor je menil, da je bil iz rezultatov študij zdravljenja astme z zdravilom Xolair na splošno razviden vzorec, ki kaže na učinkovitost zdravila pri zdravljenju hude alergijske astme.
In addition, fewer of the patients receiving Xolair had exacerbations than those receiving placebo.
Poleg tega je imelo izbruhe manj bolnikov, ki so jemali zdravilo Xolair, kot tistih, ki so jemali placebo.
In the studies in patients with chronic spontaneous urticaria, following 12 weeks of treatment, Xolair 300 mg improved the symptoms of itching by 4.5 to 5.8 points more than placebo.
V študijah z bolniki, ki so imeli kronično spontano urtikarijo, je zdravilo Xolair v odmerku 300 mg po 12 tednih izboljšalo simptome srbenja za od 4,5 do 5,8 točk več kot placebo.
Among the 235 children who were being treated with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist before the start of the study, there was an average of 0.4 exacerbations over the first 24 weeks of treatment in those receiving Xolair, compared with 0.6 in those receiving placebo.
Med 235 otroki, ki so bili pred začetkom študije zdravljeni z visokimi odmerki inhaliranih kortikosteroidov in dolgodelujočimi inhaliranimi agonisti beta 2, so v prvih 24 tednih zdravljenja pri tistih, ki so prejemali zdravilo Xolair, zabeležili povprečno 0,4 izbruha v primerjavi z 0,6 izbruha pri tistih, ki so prejemali placebo.
The dose of Xolair and how often it is given depend on the level of IgE in the blood and body weight.
Odmerek in pogostost dajanja zdravila Xolair sta odvisna od ravni IgE v krvi in telesne mase bolnika.
Xolair treatment should be started by a doctor who has experience in the treatment of severe persistent asthma or chronic spontaneous urticaria.
Zdravljenje z zdravilom Xolair mora uvesti zdravnik, ki ima izkušnje z zdravljenjem hude trdovratne astme ali kronične spontane urtikarije.
Xolair is a medicine that contains the active substance omalizumab.
Xolair je zdravilo, ki vsebuje zdravilno učinkovino omalizumab.
In the study in children with allergic asthma aged between six and 12 years, the number of exacerbations was lower in those receiving Xolair.
V študiji pri otrocih z alergijsko astmo, starih od šest do 12 let, je bilo število izbruhov nižje pri tistih, ki so prejemali zdravilo Xolair.
Xolair is used to improve the control of severe persistent asthma that is caused by an allergy.
Zdravilo Xolair se uporablja za boljše obvladovanje hude trdovratne astme, ki jo povzroča alergija.
Why has Xolair been approved?
Zakaj je bilo zdravilo Xolair odobreno?
In the study of patients with severe allergic asthma, there was no difference in the number of asthma exacerbations between Xolair and placebo, but Xolair led to a similar reduction in the number of exacerbations as in previous studies.
V študiji, v kateri so sodelovali bolniki s hudo alergijsko astmo, ni bilo razlike v številu izbruhov astme med bolniki, ki so prejemali zdravilo Xolair, in bolniki, ki so prejemali placebo, je pa zdravilo Xolair povzročilo podobno zmanjšanje števila izbruhov kot v prejšnjih študijah.
For the treatment of asthma, Xolair is given by a healthcare professional as an injection under the skin of the shoulder or the thigh every two or four weeks.
Pri zdravljenju astme zdravilo Xolair injicira zdravstveni delavec v podkožje ramena ali stegna vsaka dva ali štiri tedne.
For the treatment of chronic spontaneous urticaria, Xolair is given by a healthcare professional by injection under the skin of the shoulder or the thigh, in a dose of 300 mg every four weeks.
Pri zdravljenju kronične spontane urtikarije zdravilo Xolair injicira zdravstveni delavec v podkožje ramena ali stegna, in sicer v odmerku 300 mg vsake štiri tedne.