natgillin/translations-raw huggingface dataset:
Zavesca 100 mg capsules Miglustat
Zavesca 100 mg kapsule miglustat
Dosage in type 1 Gaucher disease
Doziranje kod Gaucherove bolesti tipa 1
There are no pharmacokinetic data available in patients with liver impairment or in the elderly (> 70 years).
Nema dostupnih farmakokinetičkih podataka za bolesnike s oštećenjem funkcije jetre ili za starije bolesnike
Do not breastfeed while you are taking Zavesca.
Nemojte dojiti tijekom uzimanja Zavesce.
Pharmacokinetic parameters of miglustat were assessed in healthy subjects, in a small number of patients with type 1 Gaucher disease, Fabry disease, HIV-infected patients, and in adults, adolescents and children with Niemann-Pick type C disease or type 3 Gaucher disease.
Gaucherovom bolesti tipa 1, Fabrijevom bolesti, kod bolesnika zaraženih HIV-om, te kod odraslih, adolescenata i djece s Niemann-Pickovom bolesti tipa C ili Gaucherovom bolesti tipa
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.
Kod bolesnika s prilagođenim klirensom kreatinina od 50-70 ml/min/1,73 m2, primjenu treba početi s dozom od 100 mg dvaput dnevno u bolesnika s Gaucherovom bolesti tipa 1, te dozom od 200 mg dvaput dnevno (prilagođeno površini tijela u bolesnika mlađih od 12 godina) u bolesnika s
The benefit of treatment with Zavesca for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be re-appraised after at least 1 year of treatment with Zavesca, (see section 4.4).
C treba redovito ocjenjivati, npr. svakih 6 mjeseci; nastavak liječenja treba ponovo procijeniti nakon najmanje 1 godine liječenja Zavescom (vidjeti dio 4.4).
Zavesca is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.
Zavesca je indicirana za peroralno liječenje odraslih bolesnika s blagom do umjerenom Gaucherovom bolesti tip 1.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
D UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU
An open-label, non comparative, 2-year study enrolled 42 patients with type 1 Gaucher disease, who had received a minimum of 3 years of ERT and who fulfilled criteria of stable disease for at least 2 years.
koji su najmanje 3 godine primali ERT a koji su zadovoljavali kriterij stabilne bolesti od najmanje 2 godine.
Zavesca has been administered at doses of up to 3000 mg/day for up to six months in HIV positive patients during clinical trials.
Zavesca je u kliničkim ispitivanjima kod HIV pozitivnih bolesnika primjenjivana u dozama do 3000 mg/dan tijekom šest mjeseci.
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.
420 i 840/500 mg/kg/dan (smanjenje doze nakon pola godine) za rezultat je imala povećanu incidenciju upalnih i hiperplastičnih lezija u debelom crijevu kod oba spola.
Musculoskeletal and connective tissue disorders Common
dispepsija Poremećaji mišićno-koštanog sustava i vezivnog tkiva
Due to limited experience, Zavesca should be used with caution in patients with renal or hepatic impairment.
Zbog ograničenog iskustva, kod bolesnika s poremećajem funkcije bubrega ili jetre, Zavescu treba koristiti oprezno.
The recommended dose for the treatment of adolescent patients (12 years of age and above) with Niemann-Pick type C disease is 200 mg three times a day.
Pedijatrijska populacija Preporučena doza za liječenje adolescentnih bolesnika (12 godina i starijih) s Niemann-Pickovom bolesti tipa C je 200 mg triput dnevno.
How to store Zavesca
Kako čuvati Zavescu
Other possible side effects are muscular spasms or weakness, fatigue chills and malaise, depression, difficulty sleeping, forgetfulness, and less libido.
Ostale moguće nuspojave su grčevi u mišićima ili slabost, umor, zimica ili malaksalost, depresija,
• For type 1 Gaucher disease: For adults, the usual dose is one capsule (100 mg) three times a day (morning, afternoon and evening).
• Za Gaucherovu bolest tipa 1: za odrasle je uobičajena doza jedna kapsula (100 mg) tri puta dnevno
How to take Zavesca
Kako uzimati Zavescu
The benefit of treatment with Zavesca for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be re-appraised after at least 1 year of treatment with Zavesca.
C treba redovito ocjenjivati, npr. svakih 6 mjeseci; nastavak liječenja treba ponovo procijeniti nakon najmanje 1 godine liječenja Zavescom.
Marketing Authorisation Holder:
Nositelj odobrenja za stavljanje lijeka u promet:
Dosage in Niemann-Pick type C disease
Doziranje kod Niemann-Pickove bolesti tipa C
A second open, controlled study randomised 36 patients who had received a minimum of 2 years of treatment with ERT, into three treatment groups: continuation with imiglucerase, imiglucerase in combination with Zavesca, or switch to Zavesca.
godine bili liječeni ERT-om, u tri skupine liječenja: nastavak liječenja imiglucerazom, imiglucerazom u kombinaciji sa Zavescom, ili prelazak na Zavescu.
Twenty-eight patients with mild to moderate type 1 Gaucher disease were enrolled in this 12-month non-comparative study, and 22 patients completed the study.
12-mjesečno nekomparativno ispitivanje, a 22 bolesnika su završila ispitivanje.
A total daily dose of 300 mg Zavesca administered in three divided doses was used in the above two studies.
U gornja dva ispitivanja primijenjena je ukupna dnevna doza Zavesce od 300 mg u tri pojedinačne doze.
1.Separate at perforations 2.Peel back paper at arrows 3.Push product through foil
Ogulite crni papir kod strelica 3. Gurnite lijek kroz foliju
Each capsule contains 100 mg miglustat.
Jedna kapsula sadržava 100 mg miglustata.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PRILOG II. A. PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
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 Gaucherove bolesti tipa 1 na kosti ocjenjivane su u 3 otvorena klinička ispitivanja u bolesnika liječenih miglustatom 100 mg triput dnevno u trajanju do 2 godine (n = 72).
If you take more capsules than you were told to, consult your doctor immediately.
Smjesta se obratite svom liječniku ako ste uzeli više kapsula nego
Miglustat affected embryo/foetal survival in rats and rabbits, dystocia was reported, post-implantation losses were increased, and an increased incidence of vascular anomalies occurred in rabbits.
primijećena je distocija, porasli su gubitci nakon implantacije i došlo je do povećane incidencije vaskularnih anomalija kod kunića.
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.
Kod bolesnika s Gaucherovom bolesti tipa 1 primijećena su mala smanjenja broja trombocita, a koja nisu povezana s krvarenjem, u bolesnika koji su s ERT prešli na Zavescu.
Each capsule contains 100 mg miglustat
Jedna kapsula sadržava 100 mg miglustata
Until further information is available, it is advised that before seeking to conceive, male patients should cease Zavesca and maintain reliable contraceptive methods for 3 months thereafter.
savjetuje se muškim bolesnicima da prije pokušaja začeća djeteta prekinu uzimanje Zavesce i primjenjuju pouzdane metode kontracepcije daljnja 3 mjeseca.
In some patients there were reductions in platelet count and increases in chitotriosidase activity indicating that Zavesca monotherapy may not maintain the same control of disease activity in all patients.
U nekih je bolesnika došlo do smanjenja broja trombocita i do povećanja aktivnosti hitotriozidaze što ukazuje na to da monoterapija
You must use effective birth control while taking Zavesca.
Dok uzimate Zavescu morate primjenjivati učinkovitu kontracepciju.
The pharmacokinetics of miglustat is similar in adult type 1 Gaucher disease patients and Niemann-Pick type C disease patients when compared to healthy subjects.
Farmakokinetika miglustata slična je onoj u odraslih bolesnika s Gaucherovom bolesti tipa 1 i Niemann
LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
OBLIK I SADRŽAJ
ANNEX II
PRILOG III.
Common effects - may affect up to 1 in 10 people Common side effects of treatment include headache, dizziness, paraesthesia (tingling or numbness), abnormal coordination, hypoaesthesia (reduced sensation to touch), dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, swelling or discomfort in the abdomen (stomach) and thrombocytopenia (reduced levels of blood platelets).The neurological symptoms and thrombocytopenia could be due to the underlying disease.
Česte nuspojave liječenja uključuju glavobolju, omaglicu, paresteziju (trnci ili obamrlost), nenormalnu koordinaciju, hipoesteziju (oslabljen osjet na dodir), dispepsiju (žgaravica), mučninu, zatvor i povraćanje,
Very common effects - may affect more than 1 in 10 people The most common side effects are diarrhoea, flatulence (wind), abdominal (stomach) pain, weight loss and decreased appetite.
Najčešće nuspojave su proljev, flatulencija (vjetrovi), bol u trbuhu, gubitak težine i smanjen tek.
Therapy should be directed by physicians who are knowledgeable in the management of Gaucher disease or Niemann-Pick type C disease, as appropriate.
4.2 Doziranje i način primjene Liječenje trebaju voditi liječnici s odgovarajućim iskustvom u liječenju Gaucherove bolesti ili Niemann
Name and address of the manufacturer responsible for batch release Actelion Manufacturing GmbH
Nazivi i adresa proizvođača odgovornog za puštanje serije lijeka u promet
Mild reductions in platelet counts without association to bleeding were observed in some patients with Niemann-Pick type C disease treated with Zavesca.
Kod nekih bolesnika s Niemann-Pickovom bolesti tipa C liječenih Zavescom primijećena su mala smanjenja broja trombocita, a koja nisu povezana s krvarenjem.
SPECIAL STORAGE CONDITIONS
POPIS POMOĆNIH TVARI
Your doctor will perform the following tests before treatment and during treatment with Zavesca: - an examination to check the nerves in your arms and legs - measurement of vitamin B12 levels - monitoring growth if you are a child or adolescent with Niemann-Pick type C disease - monitoring of blood platelet counts
pregled za provjeru živaca Vaših ruku i nogu mjerenje razine vitamina B12
Miglustat
Dojenje
GENERAL CLASSIFICATION FOR SUPPLY 15.
14. NAČIN IZDAVANJA LIJEKA 15. UPUTE ZA UPORABU
Zavesca may make you feel dizzy.
Zavesca može uzrokovati omaglicu.
Zavesca has not been evaluated in patients with hepatic impairment.
Zavesca nije procjenjivana kod bolesnika s oštećenjem funkcije jetre.
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).
Therapy - ERT) u liječenju bolesnika s Gaucherovom bolesti tipa 1, nema dokaza da je Zavesca djelotvornija ili sigurnija od ERT.
- If you get any side effects,talk to your doctor or pharmacist.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
• Zavesca is also used to treat progressive neurological symptoms in Niemann-Pick type C disease in adults and in children.
• Zavesca se također primjenjuje za liječenje progresivnih neuroloških simptoma kod
Posology
Postupanje
for up to 2 years (n = 72).
(> 70 godina).
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.
Ključno ispitivanje Zavesce bilo je provedeno na bolesnicima koji nisu mogli ili nisu željeli primati ERT.
Janssen-Cilag Ltd. Tel: +44 1 494 567 444
Tel: +44 1 494 567 444
Muscle spasms, muscle weakness General disorders and administration site reactions Common:
Opći poremećaji i reakcije na mjestu primjene Često:
INSTRUCTIONS ON USE 16.
Odvojite po perforaciji 2.
- if you suffer from liver disease
Oštećenje funkcije jetre
Pregnancy
Doziranje
Hepatic impairment
Oštećenje funkcije bubrega
Investigations Common
KLINIČKI PODACI
There were no events of bone crisis, avascular necrosis or fracture during the treatment period.
Tijekom razdoblja liječenja nije bilo koštanih kriza,
• or that the product (potentially modified or not) does not undergo significant dechelation and does not lead to retention of gadolinium in tissues.
• ili o tome da lijek (potencijalno izmijenjen ili ne) ne prolazi značajno dekeliranje i ne uzrokuje zadržavanje gadolinija u tkivima.
• 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 klinički važnim koristima koje trenutačno nisu ustanovljene za određenu skupinu bolesnika ili indikaciju i koje nadmašuju rizike povezane s lijekom.
For the suspensions of intravenous gadodiamide, gadopentetic acid, and gadoversetamide containing medicinal products to be lifted, the Marketing Authorisation Holder(s) shall provide evidence
Kako bi se ukinula obustava odobrenja za lijekove koji sadržavaju gadodiamid, gadopentetičnu kiselinu i gadoversetamid, nositelji odobrenja za stavljanje u promet trebaju podnijeti dokaze
Annex IV Conditions for lifting the suspension of the marketing authorisations
Prilog IV. Uvjeti za ukidanje obustave odobrenja za stavljanje lijeka u promet
Conditions for lifting the suspension of the marketing authorisation(s)
Uvjeti za ukidanje obustave odobrenja za stavljanje lijeka u promet
• they must have frequent symptoms during the day or waking up during the night;
• moraju imati česte simptome tijekom dana ili buđenje tijekom noći;
The effects were maintained after 6 months of treatment.
Djelovanje je održano nakon 6 mjeseci liječenja.
It has also been studied in 627 children aged between six and 12 years.
Lijek je također ispitan u 627 djece u dobi između šest i 12 godina.
This summary was last updated in 02-2014.
Sažetak je posljednji put ažuriran u 02.2014.
All patients receiving Xolair must meet the following criteria:
Svi bolesnici koji primaju Xolair moraju udovoljiti sljedećim kriterijima:
The full EPAR for Xolair can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Xolair nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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.
Uobičajen raspon doze iznosi između 75 i 600 mg u jednoj do četiri injekcije, a maksimalna preporučena doza iznosi 600 mg svaka dva tjedna.
Other information about Xolair:
Ostale informacije o lijeku Xolair:
Patients aged 12 years or over must also have reduced lung function (less than 80% of normal).
Bolesnici u dobi od 12 godina i stariji moraju imati smanjenu funkciju pluća (manje od 80% normalnog).
This helps to reduce the symptoms of allergy, such as asthma attacks.
Ovo pomaže pri smanjivanju simptoma alergije, poput napadaja astme.
The doctor will periodically re-assess the need to continue treatment with Xolair.
Liječnik periodički ponovno procjenjuje potrebu za nastavak liječenja lijekom Xolair.
Each vial and syringe contains 75 or 150 mg of omalizumab.
Svaka bočica i šprica sadrže 75 ili 150 mg omalizumaba.
The European Commission granted a marketing authorisation valid throughout the European Union for Xolair on 25 October 2005.
Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Xolair vrijedi na prostoru Europske unije od 25. listopada 2005.
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.
Iako je uloga IgE u kroničnoj spontanoj urtikariji manje jasna, smanjivanje njegove dostupnosti omalizumabom dokazano poboljšava simptome ovog stanja.
• 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;
• morali su imati pozitivan rezultat kožnog testa na alergiju koju uzrokuje alergen (podražaj koji uzrokuje alergiju) u zraku, poput grinja kućne prašine, peludi ili plijesni;
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.
Dostupan je u dva oblika: kao bočica koja sadrži prašak i otopina koja je pripremljena kao otopina za injekciju; i kao napunjena šprica koja sadrži otopinu za injekciju.
This means that when the body encounters an allergen, there is less IgE available to trigger an allergic reaction.
Ovo znači da u trenutku kada je tijelo izloženo alergenu, prisutno je manje IgE raspoloživog za poticanje alergijske reakcije.
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).
Glavna mjera djelotvornosti bila je promjena u težini svrbeža nakon 12 tjedana liječenja, kako je izmjereno na skali od 0 (bez svrbeža) do 21 (maksimalna težina svrbeža).
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.
Monoklonalno protutijelo je protutijelo (tip proteina) koje je dizajnirano za prepoznavanje i vezanje na specifične strukture u tijelu (naziva antigen).
They also reported a greater improvement in quality of life and used less fluticasone (a corticosteroid).
Ovi su bolesnici također prijavili veća poboljšanja u kvaliteti života i koristili su manje flutikazona (kortikosteroid).
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 mjera djelotvornosti bio je broj eksacerbacija, broj bolesnika koji su imali eksacerbaciju, kvaliteta života (ocijenjeno primjenom standardnog upitnika) i količina udahnutog kortikosteroida koji je bolesnicima bio potreban za liječenje njihove astme.
What measures are being taken to ensure the safe and effective use of Xolair?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka 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.
Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Xolair.
This document is a summary of the European public assessment report (EPAR) for Xolair.
Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Xolair.
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 dizajniran za vezanje na ljudski IgE, koji se proizvodi u velikim količinama u bolesnika s alergijama i aktivira alergijsku reakciju kao odgovor na alergen.
It is used as an addon to existing treatment in patients aged 12 years or over who do not respond to treatment with antihistamines.
Koristi se kao dodatak postojećem liječenju u bolesnika u dobi od 12 godina ili starijih koji nisu odgovorili na liječenje antihistaminima.
• 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.
• moraju imati ozbiljne „eksacerbacije“ astme (kada se astma pogorša mora uslijediti brzodjelujuća terapija drugim lijekovima) usprkos liječenju velikom dozom udahnutih kortikosteroida i dugodjelujućeg inhaliranog beta2 agonista.
For more information about treatment with Xolair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Xolair pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
A risk management plan has been developed to ensure that Xolair is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Xolair.
In the treatment of asthma, Xolair is intended for long-term use.
U liječenju astme, Xolair je predviđen za dugoročnu primjenu.
Before giving Xolair to patients with asthma, the doctor must measure the level of IgE in the patient's blood.
Prije davanja lijeka Xolair bolesnicima koji boluju od astme, liječnik mora izmjeriti razinu IgE u krvi bolesnika.
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.
Xolair se također ispitivao u 3 glavna ispitivanja koja su obuhvatila ukupno 978 bolesnika s kroničnom spontanom urtikarijom koji nisu odgovorili na liječenje temeljeno na antihistaminima.
What is the risk associated with Xolair?
Koji su rizici povezani s lijekom Xolair?
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.
CHMP je također zaključio da je dokazano kako lijek Xolair (300 mg) značajno poboljšava simptome kronične spontane urtikarije prilikom primjene kao dodatni lijek za postojeće liječenje bolesnika, napomenuo je da su podaci ispitivanja o dugoročnoj primjeni duljoj od 6 mjeseci skromni.
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.
Povjerenstvo je zaključilo da načelno postoji uzorak rezultata u ispitivanjima lijeka Xolair za liječenje astme koji dokazuje da je lijek učinkovit u liječenju ozbiljne alergijske astme.
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.
Xolair se ispitivao u više od 2.000 bolesnika u dobi od 12 godina ili starijih oboljelih od alergijske astme u pet glavnih ispitivanja, uključujući jedno ispitivanje koje je obuhvatilo 482 bolesnika s ozbiljnom alergijskom astmom koja nije kontrolirana konvencionalnim liječenjem.
Xolair treatment should only be considered when the asthma is caused by an antibody called immunoglobulin E (IgE).
Liječenje lijekom Xolair treba uzeti u obzir kada je astma uzrokovana protutijelom naziva imunoglobulin E (IgE).
In addition, fewer of the patients receiving Xolair had exacerbations than those receiving placebo.
Nadalje, manji broj bolesnika koji su primali Xolair imalo je eksacerbacije u odnosu na one koju su primali placebo.