natgillin/translations-raw huggingface dataset:
Data from two multicentre phase II clinical trials support the use of capecitabine monotherapy for treatment of patients after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Monoterapija kapecitabinom nakon neuspješne kemoterapije taksanima i antraciklinima te u bolesnika u kojih antraciklinska terapija nije indicirana Podaci iz faze II dvaju multicentričnih kliničkih ispitivanja opravdavaju monoterapiju kapecitabinom u liječenju bolesnika nakon neuspjeha liječenja taksanima i antraciklinskim kemoterapijskim protokolom ili u slučaju kada nije indicirana daljnja antraciklinska terapija.
Each film-coated tablet contains 150 mg capecitabine
Jedna filmom obložena tableta sadrži 150 mg kapecitabina.
Each film-coated tablet contains 300 mg capecitabine
Jedna filmom obložena tableta sadrži 300 mg kapecitabina.
Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leukopenia, Haemolytic anaemia, International Normalised Ratio (INR) increased/Prothrombin time prolonged
leukopenija, hemolitička anemija, povišen INR/produljeno protrombinsko vrijeme
Hepatic impairment
• bol u živcima
Colon, colorectal and breast cancer
Monoterapija Karcinom debelog crijeva, kolorektalni karcinom i karcinom dojke
Table 5 lists ADRs associated with the use of capecitabine monotherapy based on a pooled analysis of safety data from three major studies including over 1900 patients (studies M66001, SO14695, and SO14796).
Tablici 5 nalazi se popis nuspojava povezanih s primjenom kapecitabina u monoterapiji koji se temelji na združenoj analizi sigurnosnih podataka iz tri glavna ispitivanja na više od 1900 bolesnika
PVC/PVdC/Aluminium blisters Do not store above 30°C.
PVC/PVdC/aluminij blisteri
• inflammation of the skin causing red scaly patches due to an immune system illness
• upala kože koja uzrokuje crvene ljuskave mrlje, a posljedica je bolesti imunološkog sustava Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba):
Capecitabine Accord 500 mg film-coated tablets Each film-coated tablet contains 500 mg of capecitabine.
Kapecitabin Accord 500 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 25 mg laktoze, bezvodne.
In combination with docetaxel, the recommended starting dose of capecitabine in the treatment of metastatic breast cancer is 1250 mg/m2 twice daily for 14 days followed by a 7-day rest period,
U kombinaciji s docetakselom preporučena početna doza kapecitabina u liječenju metastatskog karcinoma dojke je 1250 mg/m² i uzima se dvaput dnevno tijekom 14 dana nakon čega slijedi 7 dana pauze, dok je doza docetaksela 75 mg/m² i primjenjuje se svaka 3 tjedna u jednosatnoj intravenskoj infuziji.
Capecitabine Accord 500 mg film-coated tablets capecitabine
Kapecitabin Accord 500 mg filmom obložene tablete kapecitabin
Capecitabine can induce the occurrence of diarrhoea, which has been observed in up to 50% of patients.
Proljev (vidjeti dio 4.4) U do 50% bolesnika je uočeno da kapecitabin može inducirati pojavu proljeva.
Premedication to maintain adequate hydration and anti-emesis according to the cisplatin summary of product characteristics should be started prior to cisplatin administration for patients receiving the capecitabine plus cisplatin combination.
U bolesnika koji uzimaju kapecitabin u kombinaciji s cisplatinom potrebno je prije primjene cisplatina provesti premedikaciju kako bi se održala primjerena hidracija i spriječilo povraćanje, kao što je opisano u sažetku opisa svojstava lijeka za cisplatin.
Content of the pack and other information
Sadržaj pakiranja i dodatne informacije Što Kapecitabin
Capecitabine Accord 300 mg film-coated tablets Each film-coated tablet contains 300 mg of capecitabine.
Kapecitabin Accord 300 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 15 mg laktoze, bezvodne.
Capecitabine Accord 300 mg film-coated tablets capecitabine
Kapecitabin Accord 300 mg filmom obložene tablete kapecitabin
• abdominal pain
• upale vena
Uncommon side effects (may affect up to 1 in 100 people) include:
Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) su:
• skin rash, hair loss (alopecia), skin reddening, dry skin, itching (pruritus), skin discolouration,
• osip na koži, gubitak kose (alopecija), crvenilo kože, suhoća kože, svrbež (pruritus), promjena boje kože, gubitak kože, upala kože, poremećaj noktiju
Intestinal obstruction, Ascites, Enteritis, Gastritis, Dysphagia, Abdominal pain lower, Oesophagitis, Abdominal discomfort,
Poremećaji dišnog sustava, prsišta i sredoprsja grlobolja, disestezija ždrijela štucavica, faringolaringealna bol, disfonija
Herpes viral infection, Nasopharyngitis, Lower respiratory tract infection
Infekcije i infestacije infekcija herpes virusom, nazofaringitis, infekcija donjeg dišnog sustava sepsa, infekcija mokraćnog sustava,
Dihydropyrimidine dehydrogenase (DPD) deficiency Rarely, unexpected, severe toxicity (e.g. stomatitis, diarrhoea, mucosal inflammation, neutropenia and neurotoxicity) associated with 5-FU has been attributed to a deficiency of DPD activity.
neutropenija i neurotoksičnost) povezana s primjenom 5-FU pripisana nedostatnoj aktivnosti DPD-a.
Magnesium stearate
žuči jetre
Diabetes, Hypokalaemia, Appetite disorder, Malnutrition, Hypertriglyceridaemia
Poremećaji metabolizma i prehrane anoreksija dehidracija, gubitak tjelesne težine šećerna bolest, hipokalemija, poremećaj teka, malnutricija, hipertrigliceridemija
Hepatic function abnormal
Poremećaji jetre i poremećena funkcija
Lacrimation increased Visual disorders, Dry eye,
Poremećaji oka pojačano suzenje konjunktivitis,
Sepsis, Urinary tract infection, Cellulitis, Tonsillitis, Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
celulitis, tonzilitis, upala ždrijela, oralna kandidijaza, gripa,
Capecitabine Accord 500 mg film-coated tablets
Kapecitabin Accord 500 mg filmom obložene tablete.
Musculoskeletal stiffness, Muscular weakness
• grčenje mišića
5-fluorouracil intravenous bolus/infusion, each on Days 1 and 2, every 2 weeks
85 mg/m2 intravenski/2 sata oksaliplatin prvog dana, svaka 2 tjedna leukovorin prvog i drugog dana, svaka 2 tjedna intravenski bolus/infuzija 5-fluorouracila prvog i drugog dana, svaka 2 tjedna leukovorin
If no toxicity is observed in patients ≥60 years of age treated with a reduced capecitabine starting dose in combination with docetaxel, the dose of capecitabine may be cautiously escalated to 1250 mg/m2 twice daily.
Ako se u tih bolesnika ne uoče znakovi toksičnosti pri primjeni smanjene početne doze kapecitabina u kombinaciji s docetakselom,
In these trials, 603 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period and given as 3-week cycles).
U tim je ispitivanjima kapecitabinom (1250 mg/m2 dvaput dnevno tijekom 2 tjedna, nakon čega je slijedila jednotjedna pauza) liječeno 236 bolesnika.
• have diarrhoea
• imate proljev
Eye pain, Visual impairment, Vision blurred
Poremećaji oka pojačano suzenje poremećaji vida, suhoća oka, bol u oku, oštećenje vida, zamagljen vid
Dose modifications applied should be applied for the precipitating adverse event as necessary (see section
Ukoliko je potrebno, dozu treba prilagoditi ovisno o nuspojavi (vidjeti dio 4.2).
185 Bureaux de la Colline 92213 Saint Cloud Cedex France
185 Bureaux de la Colline 92213 Saint Cloud Cedex Francuska
Body surface area (m²)
Površina tijela (m2)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 november 2017
Datum prvog odobrenja: 10. studenog 2017.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelju odobrenja za stavljanje lijeka u promet:
Very common effects may affect more than 1 in 10 people.
Vrlo česte nuspojave mogu se javiti u više od 1 na 10 osoba.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1232/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1232/001
You should not take Miglustat Gen.Orph if you are pregnant or thinking of becoming pregnant.
Miglustat Gen.Orph ne smijete uzeti ako ste trudni ili ako namjeravate zatrudniti.
Box of 12 blisters, each blister containing 7 capsules providing a total of 84 capsules.
Kutija s 12 blistera, svaki blister sadrži 7 kapsula što je ukupno 84 kapsule.
Don't stop taking Miglustat Gen.Orph without talking to your doctor.
Nemojte prestati uzimati Miglustat Gen.Orph bez razgovora s liječnikom.
Talk to your doctor or pharmacist before taking Miglustat Gen.Orph if you suffer from kidney disease if you suffer from liver disease
Obratite se svom liječniku ili ljekarniku prije nego uzmete Miglustat Gen.Orph ako patite od bolesti bubrega ako patite od bolesti jetre
In the first 6 months in patients who were switched to miglustat, liver and spleen organ volumes and haemoglobin levels were unchanged.
U prvih 6 mjeseci kod bolesnika koji su prešli na miglustat, volumeni organa jetre i slezene i razine hemoglobina bili su nepromijenjeni.
Miglustat Gen.Orph can be taken with or without food.
Miglustat Gen.Orph se može uzeti s hranom ili bez nje.
Depression, insomnia, libido decreased
Depresija, nesanica, oslabljen libido
When compared to the measurements at 6 months, disease control was unchanged after 18 and 24 months of miglustat monotherapy (20 and 6 patients, respectively).
U usporedbi s mjerenjima provedenim nakon 6 mjeseci, nadzor bolesti bio je nepromijenjen nakon 18 i 24 mjeseca monoterapije miglustatom (20 odnosno 6 bolesnika).
There was no drug-related increase in tumor incidence in male or female rats in any other organ.
Nije bilo povećanja incidencije tumora povezanih s lijekom u muških ili ženskih štakora ni u kojem drugom organu.
Tell your doctor if you are taking medicines containing imiglucerase, which are sometimes used at the same time as Miglustat Gen.Orph.
Obavijestite svog liječnika ako uzimate lijekove koji sadrže imiglucerazu, koji se ponekad uzimaju istovremeno s lijekom Miglustat Gen.Orph.
They may lower the amount of Miglustat Gen.Orph in your body.
To može sniziti količinu lijeka Miglustat Gen.Orph u Vašem tijelu.
After 3 years of continuous miglustat treatment, mean reductions in liver and spleen organ volume were 17.5% and 29.6%, respectively.
Nakon 3 godine neprekidnog liječenja miglustatom, prosječno smanjenje volumena organa jetre i slezene bilo je 17,5% odnosno 29,6%.
Miglustat 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.
Miglustat Gen.Orph je korišten u kliničkim ispitivanjima u deset puta većim dozama od preporučenih: to je uzrokovalo smanjenje broja bijelih krvnih zrnaca i druge nuspojave slične onima opisanim u dijelu 4.
PHARMACEUTICAL FORM Hard capsule.
OBLIK Tvrda kapsula.
Limited data suggest that co-administration of miglustat and enzyme replacement with imiglucerase in patients with type 1 Gaucher disease may result in decreased exposure to miglustat (approximate reductions of 22% in Cmax and 14% in AUC were observed in a small parallel-group study).
Ograničeni podatci ukazuju na to da istovremena primjena miglustata i enzimskog nadomjestka s imiglucerazom u bolesnika s Gaucherovom bolesti tipa 1 može za posljedicu imati smanjenu izloženost miglustatu (približno smanjenje od 22% u Cmax i 14% u AUC zabilježeno u malom ispitivanju s paralelnim skupinama).
If you do lose some weight when you start treatment with Miglustat Gen.Orph don't worry.
Ako izgubite na težini kad počnete liječenje lijekom Miglustat Gen.Orph, ne brinite.
Eighteen patients then continued to receive miglustat under an optional extended treatment protocol.
Osamnaest bolesnika je tada nastavilo primati miglustat u neobaveznom protokolu proširenog liječenja.
Common effects may affect up to 1 in 10 people.
Česte nuspojave mogu se javiti kod 1 na 10 osoba.
Polyamide/aluminium/PVC/Aluminium blister supplied as a box of 12 blisters, each blister containing 7 capsules providing a total of 84 capsules.
Blister od poliamida/aluminija/PVC-a/aluminija pakiran u kutiju s 12 blistera, svaki blister sadrži 7 kapsula što je ukupno 84 kapsule.
The efficacy of Miglustat Gen.Orph in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Djelotvornost lijeka Miglustat Gen.Orph kod djece i adolescenata u dobi od 0 do 17 godina s Gaucherovom bolesti tipa 1 nije ustanovljena.
He or she may reduce the dose of Miglustat Gen.Orph or recommend other medicines to help control side effects.
On ili ona može smanjiti dozu lijeka Miglustat Gen.Orph ili preporučiti drugi lijek koji bi pomogao kontrolirati te nuspojave.
Luxembourg/Luxemburg Gen. Orph
Luxembourg/Luxemburg Gen.
Further effects seen in animals at doses that result in exposure levels similar to or moderately higher than the clinical exposure level were: changes in lymphoid organs in all species tested, transaminase changes, vacuolation of thyroid and pancreas, cataracts, nephropathy and myocardial changes in rats.
Nadalje učinci zabilježeni u životinja pri dozama koje su uzrokovale razine izloženosti slične ili malo više od kliničkih razina izloženosti, bili su: promjene na limfoidnim organima u svih ispitanih vrsta, promjene vrijednosti transaminaza, vakuolizacija štitnjače i gušterače, katarakta, nefropatije i promjene miokarda u štakora.
3 years.
mjeseci.
PHARMACEUTICAL FORM AND CONTENTS Hard capsule.
OBLIK I SADRŽAJ Tvrda kapsula
In clinical practice, miglustat-induced gastrointestinal events have been observed to respond to individualised diet modification (for example reduction of sucrose, lactose and other carbohydrate intake), to taking miglustat between meals, and/or to anti-diarrhoeal medicinal products such as loperamide.
U kliničkoj praksi, primijećene su gastrointestinalne pojave potaknute miglustatom, kao odgovor na individualiziranu prilagodbu prehrane (na primjer smanjeno uzimanje saharoze, laktoze i drugih ugljikohidrata), uzimanje miglustata između obroka, i/ili na lijekove protiv proljeva poput loperamida.
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.
Dvadesetosam bolesnika s blagom ili umjerenom Gaucherovom bolesti tipa 1 uključeni su u ovo 12-mjesečno nekomparativno ispitivanje, a 22 bolesnika su završila ispitivanje.
Use of Miglustat Gen.Orph in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended.
Miglustat Gen.Orph kod bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min/1,73 m2) se ne preporučuje.
Miglustat Gen.Orph has negligible influence on the ability to drive and use machines.
Miglustat Gen.Orph zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
4.4 Special warnings and precautions for use
4.4 Posebna upozorenja i mjere opreza pri uporabi Tremor
If you have diarrhoea, your doctor may ask you to change your diet to reduce your lactose and carbohydrate intake such as sucrose (cane sugar), or not to take Miglustat Gen.Orph together with food, or to temporarily reduce your dose.
Ako imate proljev liječnik može zatražiti prilagodbu prehrane kako biste smanjili uzimanje laktoze i drugih ugljikohidrata kao što je saharoza (šećer iz trske), ili neuzimanje lijeka Miglustat Gen.Orph s hranom ili privremeno smanjenje doze.
Miglustat has been studied in indications where certain events reported as adverse reactions, such as neurological and neuropsychological symptoms/signs, cognitive dysfunction and thrombocytopenia could also be due to the underlying conditions.
Miglustat je ispitivan na indikacijama kod kojih su neki događaji zabilježeni kao nuspojave, poput neuroloških i neurofizioloških simptoma/znakova, kognitivne disfunkcije i trombocitopenije mogli biti posljedica bolesti od koje se bolesnik liječi.
Sometimes your doctor will need to reduce the dose or stop Miglustat Gen.Orph treatment to stop the tremor.
Ponekad će Vam liječnik reći da smanjite dozu ili potpuno prekinete liječenje lijekom Miglustat Gen.Orph kako bi otklonio tremor.
They could be signs of peripheral neuropathy, due to side effects of Miglustat Gen.Orph or they could be due to existing conditions.
To mogu biti znakovi periferne neuropatije, koji se javljaju zbog nuspojava lijeka Miglustat Gen.Orph ili su se javili zbog postojeće bolesti.
This study was conducted over a 6-month randomised comparison period followed by 18 months extension where all patients received miglustat monotherapy.
To je ispitivanje provedeno u 6-mjesečnom randomiziranom komparativnom razdoblju nakon čega je slijedilo 18 mjesečno produljenje u kojem su svi bolesnici primali monoterapiju miglustatom.
In patients included in the clinical trial, 40%-50% of patients had platelet counts below the lower limit of normal at baseline.
Kod bolesnika uključenih u kliničko ispitivanje, 40%- 50% bolesnika broj trombocita na početku bio je ispod donje granice normale.
Miglustat Gen.Orph may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).
Miglustat Gen.Orph se smije koristiti samo u liječenju bolesnika kod kojih enzimska nadomjesna terapija nije prikladna (vidjeti dijelove 4.4 i 5.1).
Miglustat Gen.Orph is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease (see sections 4.4, and 5.1).
Miglusat Gen.Orph je indicirana za liječenje progresivne neurološke manifestacije u odraslih bolesnika i pedijatrijskih bolesnika s Niemann-Pickovom bolesti tipa C (vidjeti dijelove 4.4 i 5.1).
Miglustat has not been evaluated in patients with a history of significant gastrointestinal disease, including inflammatory bowel disease.
Miglustat nije procjenjivan kod bolesnika s težom gastrointestinalnom bolesti u anamnezi, uključujući i upalnu bolest crijeva.
Your doctor will perform some tests before and during treatment with Miglustat Gen.Orph to assess this (see section 2).
Liječnik će provesti neke pretrage prije i za vrijeme liječenja lijekom Miglustat Gen.Orph kako bi to procijenio (vidjeti dio 2).
Male patients should maintain reliable contraceptive methods while taking Miglustat Gen.Orph (see sections 4.4 and 5.3).
Muški bolesnici trebaju primjenjivati pouzdane metode kontracepcije dok uzimaju Miglustat Gen.Orph (vidjeti dijelove 4.4 i 5.3).
There is limited experience with the use of Miglustat Gen.Orph in Niemann-Pick type C disease patients under the age of 4 years.
Postoji ograničeno iskustvo u primjeni Miglustat Gen.Orph kod bolesnika s Niemann-Pickovom bolesti tipa C, mlađih od 4 godine.
What Miglustat Gen.Orph contains - The active substance is miglustat 100 mg. - The other ingredients are sodium starch glycolate (type A), povidone (K30), magnesium stearate, gelatin, titanium dioxide (E171).
Drugi sastojci su: natrijev škroboglikolat (vrsta A), povidon (K30), magnezijev stearat, želatina, titanijev dioksid (E171).
Cases of peripheral neuropathy have been reported in patients treated with miglustat with or without concurrent conditions such as vitamin B12 deficiency and monoclonal gammopathy.
Kod bolesnika liječenih miglustatom zabilježeni su slučajevi periferne neuropatije prisutne samostalno ili praćene stanjima kao što su, pomanjkanje vitamina B12 i monoklonalna gamopatija.
What you need to know before you take Miglustat Gen.Orph 3.
Što morate znati prije nego počnete uzimati Miglustat Gen.Orph
Miglustat Gen.Orph should not be taken during breast-feeding.
Miglustat Gen.Orph se ne smije uzimati tijekom dojenja.
Adverse reactions from clinical trials and spontaneous reporting, occurring in >1% of patients, are listed in the table below by system organ class and frequency (very common: ≥ 1/10, common: ≥ 1/100 < 1/10, uncommon: ≥ 1/1,000 to <1/100, rare: ≥ 1/10,000 to <1/1,000, very rare: <1/10,000).
≥ 1/100 < 1/10, manje često: ≥ 1/1000 do < 1/100, rijetko: ≥ 1/10 000 do < 1/1000, vrlo rijetko:
Small mean reductions in haemoglobin [-0.95 g/dL (95% CI: -1.38, -0.53)] and platelet count [-44.1 × 109/L (95% CI: -57.6,
Između početka i kraja ispitivanja uočeno je malo prosječno smanjenje hemoglobina [-0,95 g/dL (95% CI: -1,38, -0,53)] i broja trombocita [-44,1 × 109/L (95% CI:
Miglustat Gen.Orph is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.
Miglustat Gen.Orph se primjenjuje samo kada se bolesnik smatra nepodobnim za enzimsko nadomjesno liječenje.
The pharmacokinetics of miglustat is similar in adult type 1 Gaucher disease patients and NiemannPick type C disease patients when compared to healthy subjects.
Farmakokinetika miglustata slična je onoj u odraslih bolesnika s Gaucherovom bolesti tipa 1 i NiemannPickovom bolesti tipa C kada se usporedi sa zdravim osobama.
Male patients should maintain reliable contraceptive methods while taking Miglustat Gen.Orph.
Muški bolesnici trebaju primjenjivati pouzdane metode kontracepcije dok uzimaju Miglustat Gen.Orph.
Other medicines and Miglustat Gen.Orph
Drugi lijekovi i Miglustat Gen.Orph
Nausea, vomiting, abdominal distension/discomfort, constipation, dyspepsia
Mučnina, povraćanje, abdominalna distenzija/nelagoda, konstipacija, dispepsija
Elderly There is no experience with the use of Miglustat Gen.Orph in patients over the age of 70.
Nema iskustava s primjenom lijeka Miglustat Gen.Orph u bolesnika starijih od 70 godina.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2)
The reason for these tests is that some patients have had tingling or numbness in the hands and feet, or a decrease in body weight, while taking Miglustat Gen.Orph.
Razlog za te pretrage je taj što što su neki bolesnici, dok su uzimali Miglustat Gen.Orph, osjećali trnce ili obamrlost u šakama i stopalima ili im se smanjila tjelesna težina.
The inhibitory action on glucosylceramide synthase forms the rationale for substrate reduction therapy in Gaucher disease.
Inhibitorsko djelovanje na glukozilceramid sintazu podloga je za liječenje sa smanjenjem supstrata kod Gaucherove bolesti.
The benefit of treatment with Miglustat Gen.Orph 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 Miglustat Gen.Orph.
Korist od liječenja Miglustat Gen.Orph kod neuroloških manifestacija u bolesnika s Niemann-Pickovom bolesti tipa C treba redovito ocjenjivati, npr. svakih 6 mjeseci; nastavak liječenja treba ponovo procijeniti nakon najmanje 1 godine liječenja Miglustat Gen.Orph.
Miglustat Gen.Orph works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids.
Miglustat Gen.Orph djeluje kao inhibitor enzima 'glukozilceramid sintaze', odgovornog za prvi korak u sintezi većine glikosfingolipida.
België/Belgique/Belgien Gen.Orph
België/Belgique/Belgien
Growth should be monitored in paediatric and adolescent patients during treatment with Miglustat Gen.Orph; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy.
U tijeku liječenja Miglustat Gen.Orph treba pratiti rast pedijatrijskih bolesnika i adolescenata; omjer koristi/rizika treba ponovo individualno procjenjivati za nastavak liječenja.
Povidone (K30),
Natrijev škroboglikolat (vrsta A), Povidon (K30),
In 11 clinical trials in different indications 247 patients were treated with miglustat at dosages of 50200 mg t.i.d.
U 11 kliničkih ispitivanja s različitim indikacijama 247 bolesnika je liječeno miglustatom u dozama od 50200 mg triput dnevno, u prosječnom trajanju od 2,1 godine.
Tel: +39 040 899 2219
Biovalley Investments Partner (B.I.P.) Tel: +39 040 899 2219