natgillin/translations-raw huggingface dataset:
At steady state, the concentration of miglustat in cerebrospinal fluid of six type 3 Gaucher disease patients was 31.4-67.2% of that in plasma.
V stanju dinamičnega ravnovesja je koncentracija miglustata v cerebrospinalni tekočini šestih bolnikov z Gaucherjevo bolezijo tipa 3 predstavljala 31,4-67,2 % koncentracije v plazmi.
No patient showed rapid deterioration of type 1 Gaucher disease following the switch to Zavesca monotherapy.
Noben od bolnikov ni kazal hitrega poslabšanja stanja Gaucherjeve bolezni vrste 1 po prehodu na monoterapijo z zdravilom Zavesca.
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.
Pri nekaterih bolnikih je prišlo do zmanjšanja koncentracije trombocitov in povečanja aktivnosti hitotriozidaze, kar kaže, da monoterapija z zdravilom Zavesca morebiti ne zadostuje za vzdrževanje enakega nadzora nad boleznijo pri vseh bolnikih.
- if you suffer from liver disease
- če imate ledvično bolezen - če imate jetrno bolezen
In the first 6 months in patients who were switched to Zavesca, liver and spleen organ volumes and haemoglobin levels were unchanged.
Pri bolnikih, ki so prešli na zdravilo Zavesca, se prvih 6 mesecev volumna jeter in vranice ter ravni hemoglobina niso spremenili.
Data in severe renal impairment are limited to two patients with creatinine clearance in the range 18 - 29 ml/min and cannot be extrapolated below this range.
Podatki za hudo okvarjeno delovanje ledvic so omejeni na dva bolnika, ki sta imela očistek kreatinina v območju 1829 ml/min in podatkov ne moremo ekstrapolirati pod to območje.
Blood and lymphatic system disorders Common
Bolezni krvi in limfatičnega sistema
In addition, inhibitory action on a non-lysosomal glycosylceramidase has been demonstrated experimentally in vitro.
Poleg tega je bilo zaviralno delovanje na ne-lizosomalni glikozilceramidazi dokazana eksperimentalno in vitro.
Zavesca has negligible influence on the ability to drive and use machines.
Zdravilo Zavesca ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Limited data suggest that co-administration of Zavesca 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).
Malo podatkov kaže, da lahko sočasna uporaba zdravil Zavesca in nadomestka encima z imiglucerazo pri bolnikih z Gaucherjevo boleznijo tipa 1 povzroči znižanje izpostavljenosti miglustatu (v majhni študiji s paralelnimi skupinami so opažali približna znižanja 22 % Cmax in 14 % AUC).
Contents of the pack and other information What Zavesca contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Zavesca
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.
V drugi odprti kontrolirani študiji so v tri skupine zdravljenja naključno razporedili 36 bolnikov, ki so se že vsaj 2 leti zdravili z ERT: nadaljevanje zdravljenja z imiglucerazo, kombinacija imigluceraze in zdravila Zavesca ali prehod na zdravilo Zavesca.
These effects occurred at exposure levels similar to those in patients, but showed reversibility.
podobnih tistim pri bolnikih, a so bili reverzibilni.
The survey included a case series of 66 patients treated with Zavesca outside of the clinical trial for a mean duration of 1.5 years.
Študija je vključevala klinično serijo 66 bolnikov, zdravljenih z zdravilom Zavesca, izven kliničnega preskušanja s povprečnim trajanjem 1,5 let.
Peripheral neuropathy seems to be more common in patients with type 1 Gaucher disease compared to the general population.
Kaže, da je periferna nevropatija pogostejša pri bolnikih z Gaucherjevo boleznijo tipa 1 v primerjavi s splošno populacijo.
When compared to the measurements at 6 months, disease control was unchanged after 18 and 24 months of Zavesca monotherapy (20 and 6 patients, respectively).
V primerjavi z meritvami pri 6 mesecih je bil nadzor bolezni po 18 in 24 mesecih monoterapije z zdravilom Zavesca nespremenjen (20 oz. 6 bolnikov).
If you do lose some weight when you start treatment with Zavesca don't worry.
Če po začetku zdravljenja z zdravilom Zavesca izgubite nekaj telesne mase, to ni razlog za zaskrbljenost.
These data suggest a decrease in CL/F by at least 70% in patients with severe renal impairment.
CL/F za vsaj 70 % pri bolnikih s hudo okvarjenim delovanjem ledvic.
Growth should be monitored in paediatric and adolescent patients during treatment with Zavesca; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy.
Med zdravljenjem z zdravilom Zavesca je treba spremljati rast pediatričnih bolnikov in mladostnikov; razmerje med koristmi in tveganji je treba ponovno oceniti posamično za vsakega bolnika pred nadaljevanjem zdravljenja.
LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
SEZNAM POMOŽNIH SNOVI FARMACEVTSKA OBLIKA IN VSEBINA
After 3 years of continuous Zavesca treatment, mean reductions in liver and spleen organ volume were 17.5% and 29.6%, respectively.
Po treh letih stalnega jemanja zdravila Zavesca je bilo povprečno zmanjšanje volumna jeter 17,5 % in vranice 29,6 %.
The most common serious adverse reaction reported with Zavesca treatment in clinical studies was peripheral neuropathy (see section 4.4).
Najpogostejši resni neželeni učinek, o katerem so poročali pri zdravljenju z zdravilom Zavesca v kliničnih študijah, je bila periferna nevropatija (glejte poglavje section 4.4).
Do not drive or use any tools or machines if you feel dizzy.
Če ste omotični, ne vozite in ne upravljajte z nobenim orodjem ali stroji.
Gelatin, Titanium dioxide (E171).
Ovoj kapsule želatina, titanov dioksid (E171).
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 Zavesca between meals, and/or to anti-diarrhoeal medicinal products such as loperamide.
V klinični praksi so opažali prebavne dogodke, ki jih je izzval miglustat, in ki so ustrezali individualni spremembi prehrane (na primer zmanjšanju vnosa saharoze, laktoze in drugih ogljikovih hidratov), jemanju zdravila Zavesca med obroki ali jemanju zdravil proti diareji, na primer loperamida, ali obojega.
Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).
Zdravilo Zavesca smemo uporabljati samo za zdravljenje bolnikov, za katere encimsko nadomestno zdravljenje ni primerno (glejte poglavji 4.4 in 5.1).
Your doctor will perform some tests before and during treatment with Zavesca to assess this (see section 2).
Vaš zdravnik bo to ocenil z nekaj preskusi pred zdravljenjem z zdravilom Zavesca in med zdravljenjem (glejte poglavje 2).
Ask your pharmacist how to throw away medicines you no longer take.
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
Box of 4 blister strips, each blister strip containing 21 capsules providing a total of 84 capsules.
Škatla s 4 pretisnimi omoti, vsak pretisni omot vsebuje 21 kapsul, skupaj torej 84 kapsul.
They could be signs of peripheral neuropathy, due to side effects of Zavesca or they could be due to existing conditions.
To so morda znaki periferne nevropatije, ki nastanejo zaradi neželenih učinkov zdravila Zavesca, morda pa so vzrok zanje obstoječe bolezni.
Zavesca 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).
Zdravilo Zavesca je indicirano za zdravljenje progresivne nevrološke manifestacije pri odraslih bolnikih in pediatričnih bolnikih z Niemann-Pickovo boleznijo vrste C (glejte poglavji 4.4, in 5.1).
Zavesca should not be taken during breast-feeding.
Zdravila Zavesca se ne sme jemati v času dojenja.
If your diarrhoea does not respond to these measures, or if you have any other abdominal complaint, consult your doctor.
Če driska po teh ukrepih ne bo izzvenela ali če imate še druge prebavne težave, se o tem posvetujte s svojim zdravnikom.
Take the next capsule at the usual time.
Če ste pozabili vzeti zdravilo Zavesca Kapsulo vzemite ob običajnem času.
• Zavesca is also used to treat progressive neurological symptoms in Niemann-Pick type C disease in adults and in children.
• Zdravilo Zavesca se uporablja tudi za zdravljenje progresivnih nevroloških simptomov pri Niemann-Pickovi bolezni tipa C pri odraslih in otrocih.
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, -30.7)] were observed between baseline and end of study.
Med izhodiščem in koncem študije so opazili majhno povprečno zmanjšanje hemoglobina [-0,95 g/dl (95-odstotni IZ: -1,38, -0,53)] in število trombocitov [-44,1 × 109/l (95-odstotni IZ: -57,6, -30,7)].
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,
Poleg tega so tu še učinki, zabeleženi pri živalih pri odmerkih, ki povzročijo ravni izpostavljenosti, ki so podobne ali malo višje kot klinične ravni izpostavljenosti: spremembe v limfoidnih organih pri vseh testiranih vrstah, spremembe vrednosti transaminaz, vakuolizacija ščitnice in trebušne slinavke, katarakte, nefropatija ter spremembe miokarda pri podganah.
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.
Zelo pogosti neželeni učinki - pojavijo se lahko pri več kot 1 od 10 bolnikov Najbolj pogosti neželeni učinki so driska, flatulenca (vetrovi), bolečine v trebuhu, izguba telesne mase in zmanjšanje apetita.
If you do get any of these effects, please seek medical advice from your doctor as soon as possible.
Če opazite katerega koli od teh učinkov, čim prej obvestite zdravnika.
What you need to know before you take Zavesca Do not take Zavesca
Kaj morate vedeti, preden boste vzeli zdravilo Zavesca Ne jemljite zdravila Zavesca:
Use of Zavesca in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended.
Uporabe Zavesce pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/min/1,73 m2) ne priporočamo.
The most common adverse reactions reported in clinical studies with Zavesca were diarrhoea, flatulence, abdominal pain, weight loss and tremor (see section 4.4).
Najpogostejši neželeni učinki, o katerih so poročali v kliničnih študijah z zdravilom Zavesca, so bili driska, flatulenca, bolečina v trebuhu, izguba telesne mase in tremor (glejte poglavje 4.4).
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.
Koristi zdravljenja z zdravilom Zavesca pri nevroloških manifestacijah pri bolnikih z NiemannPickovo boleznijo tipa C je treba redno preverjati, npr. vsakih 6 mesecev; za nadaljevanje terapije se je treba ponovno odločiti po vsaj 1-letnem zdravljenju z zdravilom Zavesca.
Sometimes your doctor will need to reduce the dose or stop Zavesca treatment to stop the tremor.
Lahko se zgodi, da bo moral vaš zdravnik, da bi odpravil tremor, znižati vaš odmerek zdravila Zavesca ali prekiniti zdravljenje z njim.
ACLAR/ALU blister strips supplied as a box of 4 blister strips, each blister strip containing 21 capsules providing a total of 84 capsules.
ACLAR/ALU pretisni omoti, štirje pretisni omoti na škatlo, vsak pretisni omot vsebuje 21 kapsul, skupaj 84 kapsul.
In 11 clinical trials in different indications 247 patients were treated with Zavesca at dosages of 50200 mg t.i.d.
V 11 kliničnih preskušanjih z različnimi indikacijami so 247 bolnikov zdravili z zdravilom Zavesca z odmerki 50-200 mg trikrat dnevno.
The recommended starting dose for the treatment of adult patients with type 1 Gaucher disease is 100 mg three times a day.
Priporočeni začetni odmerek za zdravljenje odraslih bolnikov z Gaucherjevo boleznijo tipa 1 je 100 mg trikrat dnevno.
Zavesca is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.
Zavesca se jemlje le, kadar bolnik za encimsko nadomestno zdravljenje ni primeren.
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.
Dokler ne bo na voljo več informacij, je treba moškim svetovati, da pred zaploditvijo prenehajo uporabljati zdravilo Zavesca in še 3 mesece potem uporabljajo zanesljivo metodo kontracepcije.
Zavesca 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.
Zdravilo Zavesca so preučevali v zvezi z indikacijami, pri katerih bi bili lahko nekateri neželeni učinki, kot so nevrološki in nevropsihološki simptomi/znaki, kognitivna disfunkcija in trombocitopenija tudi posledica bolezni, zaradi katere se bolnik zdravi.
Capsule, hard White capsules with “OGT 918” printed in black on the cap and “100” printed in black on the body.
Bele kapsule, ki imajo v črni barvi na pokrovčku natisnjeno "OGT 918", na ovoju pa "100".
Studies in animals have shown reproductive toxicity, including dystocia (see section 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja, vključno z distocijo (glejte 5.3).
Male patients should maintain reliable contraceptive methods while taking Zavesca.
Bolniki moškega spola naj v času jemanja zdravila Zavesca uporabljajo zanesljive kontracepcijske metode.
The inhibitory action on glucosylceramide synthase forms the rationale for substrate reduction therapy in Gaucher disease.
Zaviralno delovanje na glukozilceramid-sintazo je podlaga za zdravljenje z zmanjšanjem substrata pri Gaucherjevi bolezni.
If you get a slight tremor, usually trembling hands, seek medical advice from your doctor as soon as possible.
Če med zdravljenjem z zdravilom Zavesca izkusite blag tremor, običajno tresenje rok, to čim prej sporočite zdravniku.
Sodium starch glycollate, Povidone (K30), Magnesium stearate.
povidon (K30), magnezijev stearat.
Gastrointestinal events, mainly diarrhoea, have been observed in more than 80% of patients, either at the outset of treatment or intermittently during treatment (see section 4.8).
Pri več kot 80 % bolnikov so na začetku zdravljenja ali občasno med zdravljenjem opažali neželene učinke na prebavila, zlasti diarejo (glejte poglavje 4.8).
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).
Koristi zdravljenja z zdravilom Zavesca pri nevroloških manifestacijah pri bolnikih z NiemannPickovo boleznijo tipa C je treba redno preverjati, npr. vsakih 6 mesecev; za nadaljevanje terapije se je treba ponovno odločiti po vsaj 1-letnem zdravljenju z zdravilom Zavesca (glejte poglavje 4.4).
Zavesca has been administered at doses of up to 3000 mg/day for up to six months in HIV positive patients during clinical trials.
Zdravilo Zavesca so v kliničnih preskušanjih uporabljali v odmerkih do 3000 mg/dan do šest mesecev pri bolnikih s HIV.
Male patients should maintain reliable contraceptive methods while taking Zavesca (see sections 4.4 and 5.3).
Moški morajo ves čas uporabe zdravila Zavesca uporabljati zanesljiv način kontracepcije (glejte poglavji 4.4 in 5.3).
Due to limited experience, Zavesca should be used with caution in patients with renal or hepatic impairment.
Posebne populacije Zaradi malo izkušenj moramo zdravilo Zavesca pri bolnikih z okvarjenim delovanjem ledvic ali jeter uporabljati previdno.
Contents of the pack and other information
Shranjevanje zdravila Zavesca Vsebina pakiranja in dodatne informacije
Studies in the rat have shown that miglustat adversely affects sperm parameters (motility and morphology) thereby reducing fertility (see sections 4.4 and 5.3).
Plodnost Študije pri podganah so pokazale, da miglustat negativno vpliva na parametre sperme (gibljivost in obliko), s čimer zmanjša plodnost (glejte poglavji 4.4 in 5.3).
In addition 12 paediatric patients were enrolled in an uncontrolled substudy for an overall average duration of 3.1 years and up to 4.4 years.
nekontrolirano podštudijo je bilo za celokupno povprečno obdobje 3,1 leta in do 4,4 let vključenih 12 pediatričnih bolnikov.
Zavesca works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids.
Zdravilo Zavesca deluje tako, da zavira delovanje encima, ki se imenuje 'glukozilceramid sintaza', ki je odgovoren za prvi korak sinteze večine glikosfingolipidov.
Other possible side effects are muscular spasms or weakness, fatigue chills and malaise, depression, difficulty sleeping, forgetfulness, and less libido.
Drugi možni neželeni učinki so mišični krči ali slabost, utrujenost, mrzlice in splošno slabo počutje,
Peripheral neuropathy, ataxia, amnesia, paraesthesia, hypoaesthesia, headache, dizziness
Pogosto periferna nevropatija, ataksija, amnezija, parestezije, hipoestezija, glavobol,
There is no experience with the use of Zavesca in patients over the age of 70.
Ni izkušenj z zdravljenjem bolnikov, starih več kot 70 let, z zdravilom Zavesca.
Other studies revealed changes in sperm parameters (motility and morphology) consistent with an observed reduction in fertility.
Druge študije so odkrile spremembe v parametrih spermijev (gibljivost in morfologija),
Use in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended (see sections 4.4 and 5.2).
Pickovo boleznijo tipa C. Uporabe pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/min/1,73 m2) ne priporočamo (glejte poglavji 4.4 in 5.2).
Twenty-one patients completed 24 months of miglustat treatment.
24-mesečno zdravljenje z miglustatom.
The usual dose of Zavesca in adult patients was 200 mg t.i.d., and was adjusted according to body surface area in paediatric patients.
Običajni odmerek zdravila Zavesca pri odraslih bolnikih je bil 200 mg trikrat dnevno, ustrezno prilagojen na površino telesa pri pediatričnih bolnikih.
Therapy should be directed by physicians who are knowledgeable in the management of Gaucher disease or Niemann-Pick type C disease, as appropriate.
Zdravljenje naj vodijo zdravniki z izkušnjami zdravljenja Gaucherjeve ali Niemann-Pickove bolezni, kot je ustrezno.
There was no drug-related increase in tumour incidence in male or female rats in any other organ.
Drugih z zdravilom povezanih povišanj incidenc tumorjev katerega koli drugega organa pri samcih ali samicah podgan ni bilo.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost za učinkovino ali katero koli pomožno snov.
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.
Pogosti neželeni učinki vključujejo glavobol, omotičnost, parestezije (mravljinčenje ali omrtvičenost), nenormalno koordinacijo, hipoestezijo (zmanjšana zmožnost čutenja na dotik), dispepsijo (zgago), navzeo (občutek slabosti), zaprtje in bruhanje, oteklost trebuha ali nelagodje v trebuhu in trombocitopenijo (zmanjšanje števila trombocitov).
Zavesca is a white 100 mg capsule with “OGT 918” printed in black on the cap and “100” printed in black on the body.
Zdravilo Zavesca je bela 100 mg kapsula, ki ima v črni barvi na pokrovčku natisnjeno "OGT 918", na ovoju pa "100".
A total daily dose of 300 mg Zavesca administered in three divided doses was used in the above two studies.
V dveh zgoraj omenjenih študijah so jemali skupni dnevni odmerek 300 mg zdravila Zavesca, razdeljen na tri ločene odmerke.
What Zavesca looks like and contents of the pack
Izgled zdravila Zavesca in vsebina pakiranja
Adverse events observed included granulocytopenia, dizziness and paraesthesia.
Opažani neželeni učinki so bili granulocitopenija, omotičnost in parestezije.
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.
Pediatrična populacija Priporočeni odmerek za zdravljenje mladostnikov (starih 12 let in več) z Niemann-Pickovo boleznijo tipa C je 200 mg trikrat dnevno.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
• Zavesca is used to treat mild to moderate type 1 Gaucher disease in adults.
• Zdravilo Zavesca se uporablja za zdravljenje blage do zmerne Gaucherjeve bolezni tipa 1 pri odraslih.
Male patients should use reliable birth control methods during their treatment with Zavesca, and for 3 months after finishing treatment.
Bolniki moškega spola morajo v času jemanja, ter 3 mesece po prenehanju jemanja zdravila Zavesca, uporabljati zanesljive kontracepcijske metode.
Each capsule contains 100 mg miglustat.
Ena kapsula vsebuje 100 mg miglustata.
Zavesca is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.
Zdravilo Zavesca je indicirano za peroralno zdravljenje odraslih bolnikov z blago do zmerno obliko Gaucherjeve bolezni tipa 1.
There is limited experience with the use of Zavesca in Niemann-Pick type C disease patients under the age of 4 years.
Izkušenj z zdravljenjem z zdravilom Zavesca pri bolnikih z Niemann-Pickovo boleznijo tipa C, starih pod 4 leta, je malo.
Nausea, vomiting, abdominal distension/discomfort, constipation, dyspepsia
Pogosto navzea, bruhanje, trebušna distenzija/nelagodje v trebuhu, zaprtje, dispepsija
Cases of peripheral neuropathy have been reported in patients treated with Zavesca with or without concurrent conditions such as vitamin B12 deficiency and monoclonal gammopathy.
Pri bolnikih, zdravljenih z zdravilom Zavesca, s sočasnim stanjem, kot sta pomanjkanje vitamina B12 in monoklonska gamopatija ali brez teh stanj, so opazili primere periferne nevropatije.
Black iron oxide (E172) Shellac.
Tiskarsko črnilo črn železov oksid (E172),
Zavesca contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Zdravilo Zavesca vsebuje učinkovino miglustat, ki spada v skupino zdravil, ki vplivajo na presnovo.
Capsule shell Gelatin,
Vsebina kapsule natrijev karboksimetilškrob,
Temporary dose reduction to 100 mg once or twice a day may be necessary in some patients because of diarrhoea.
Pri nekaterih bolnikih bo morda zaradi diareje treba začasno znižati odmerek na 100 mg enkrat ali dvakrat dnevno.
Dose reduction may ameliorate the tremor, usually within days, but discontinuation of treatment may sometimes be required.
Običajno lahko znižanje odmerka tremor v nekaj dneh zmanjša,
The benefit to the patient of treatment with Zavesca should be evaluated on a regular basis (see section
Koristi zdravljenja z zdravilom Zavesca je treba pri bolnikih redno preverjati (glejte poglavje 4.4).