natgillin/translations-raw huggingface dataset:
These include loss of co-ordination, problems with ‘ saccadic’ (rapid) eye movements that can lead to impaired vision, delayed development, difficulty swallowing, increased muscle tone, fits and learning difficulties.
Med njimi so izguba koordinacije, težave s hitrim, sunkovitim premikanjem oči, ki lahko vodi do okvare vida, zaostalost v razvoju, težave pri požiranju, povečan tonus mišic, krči in težave pri učenju.
Because the number of patients with these diseases is low, they are considered ‘ rare’, and Zavesca was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 18 October 2000 for type 1 Gaucher disease and on 16 February 2006 for Niemann Pick type C disease.
Bolnikov s tema boleznima je malo, bolezni veljata za redki, zato je bilo zdravilo Zavesca dne 18. oktobra 2000 določeno kot „ zdravilo sirota “ (zdravilo za zdravljenje redkih bolezni) za zdravljenje Gaucherjeve bolezni tipa 1 in dne 16. februarja 2006 za zdravljenje Niemann- Pickove bolezni tipa C.
Treatment with Zavesca should be started and monitored by doctors who are experienced in the management of Gaucher or Niemann-Pick type C disease.
Zdravljenje z zdravilom Zavesca mora uvesti in nadzirati zdravnik z izkušnjami z zdravljenjem Gaucherjeve ali Niemann- Pickove bolezni.
The recommended starting dose for type 1 Gaucher disease is one capsule by mouth three times a day.
Priporočeni začetni odmerek pri Gaucherjevi bolezni tipa 1 je ena kapsula peroralno trikrat na dan.
For Niemann-Pick type C disease, the recommended dose is two capsules three times a day for adults and adolescents.
Pri Niemann- Pickovi bolezni je priporočeni odmerek dve kapsuli trikrat na dan za odrasle in mladostnike.
The dose depends on weight and height in children below 12 years.
Pri otrocih, mlajših od 12 let, je odmerek odvisen od telesne mase in višine.
Zavesca can be taken with or without food.
Zdravilo Zavesca se lahko jemlje skupaj s hrano ali brez nje.
It is intended for long-term use.
Namenjeno je dolgoročni uporabi.
The dose should be reduced in patients with kidney problems and, on a temporary basis, in patients who develop diarrhoea.
Reproduction is authorised provided the source is acknowledged Odmerek je treba zmanjšati pri bolnikih, ki imajo težave z ledvicami, ter začasno pri bolnikih, pri katerih se pojavi driska.
Zavesca has not been studied in patients with liver problems.
Zdravila Zavesca niso proučevali pri bolnikih, ki imajo težave z jetri.
For further information, see the Summary of Product Characteristics (also part of the EPAR).
Za nadaljnje informacije glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
By preventing the enzyme from working, miglustat can reduce the production of glycosphingolipids in cells.
S preprečevanjem delovanja encima miglustat zmanjša izdelovanje glikosfingolipidov v celicah.
This is expected to slow down or prevent the development of the symptoms of type 1 Gaucher disease and to reduce the symptoms of Niemann-Pick type C disease.
S tem naj bi bil razvoj siptomov Gaucherjeve bolezni tipa 1 upočasnjen ali preprečen, simptomi Niemann- Pickove bolezni pa zmanjšani.
For mild to moderate type 1 Gaucher disease, the effectiveness of Zavesca was investigated in one main study involving 28 patients who were unable or unwilling to receive ERT.
Učinkovitost zdravila Zavesca pri zdravljenju blage ali zmerne Gaucherjeve bolezni tipa 1 so proučevali v eni glavni študiji z 28 bolniki, ki se niso mogli ali hoteli zdraviti z ERT.
The study measured if Zavesca had an effect on the size of the liver and spleen, and if it improved blood counts, such as the levels of haemoglobin (a protein found in red blood cells that carries oxygen around the body) and platelet counts (components that help the blood to clot).
Študija je proučevala, ali zdravilo Zavesca vpliva na velikost jeter ali vranice ter ali izboljšuje krvne parametre, kot so ravni hemoglobina (protein, ki se nahaja v rdečih krvnih celicah, ki prenašajo kisik po telesu) ter število trombocitov (celice, ki pomagajo pri strjevanju krvi).
For Niemann-Pick type C disease, the effectiveness of Zavesca was studied in one main study involving 31 patients, 12 of whom were less than 12 years old.
Učinkovitost zdravila Zavesca pri Niemann- Pickovi bolezni so proučevali v eni glavni študiji, v katero je bilo vključenih 31 bolnikov, od katerih jih je bilo 12 mlajših od 12 let.
The study compared the effects of adding Zavesca to standard care (measures used to relieve symptoms) with standard care alone.
V študiji so primerjali učinke dodajanja zdravila Zavesca standardnemu zdravljenju (ukrepi za lajšanje simptomov) s standardnim zdravljenjem samim.
The main measure of effectiveness was the change in the speed at which the patients made saccadic horizontal eye movements after a year, but the study also looked at other neurological symptoms such as the patients ’ ability to swallow and their intellectual function.
Glavno merilo učinkovitosti je bila sprememba hitrosti, s katero je bolnik delal sunkovite vodoravne gibe z očmi po enem letu, v študiji pa so opazovali tudi druge nevrološke simptome, kot je bolnikova sposobnost požiranja in njegova intelektualna zmožnost.
A survey of 66 patients treated with Zavesca was also carried out.
Izvedena je bila tudi raziskava pri 66 bolnikih, ki so prejemali zdravilo Zavesca.
In the study of type 1 Gaucher disease, there was a reduction in liver organ size of 12% and a reduction in spleen size of 19% after a year.
V študiji Gaucherjeve bolezni tipa 1 je bila po enem letu velikost jeter manjša za 12%, velikost vranice pa za 19%.
On average, the levels of haemoglobin increased by 0.26 g per decilitre and platelet counts increased by 8.29 million per millilitre.
V povprečju se je raven hemoglobina povečala za 0, 26 grama na deciliter, število trombocitov pa za 8, 29 milijona na mililiter.
In the study of Niemann-Pick type C disease, the improvement in eye movements was similar in patients treated with and without Zavesca.
V študiji Niemann- Pickove bolezni tipa C je bilo izboljšanje sunkovitosti gibov z očmi podobno pri bolnikih, ki so jemali zdravilo Zavesca in tistih, ki ga niso.
The most common side effects with Zavesca (seen in more than 1 patient in 10) are weight loss, tremor (shaking), diarrhoea, flatulence (gas) and abdominal pain (stomach ache).
Najpogostejši neželeni učinki zdravila Zavesca (opaženi pri več kot 1 bolniku od 10) so izguba telesne mase, tresavica, driska, vetrovi in bolečine v trebuhu.
For the full list of all side effects reported with Zavesca, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zavesca, glejte navodilo za uporabo.
Zavesca should not be used in people who may be hypersensitive (allergic) to miglustat or any of the other ingredients.
Zdravila Zavesca ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) miglustat ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that Zavesca’ s benefits are greater than its risks for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease for whom ERT is unsuitable, and of progressive neurological manifestations in adult and paediatric patients with Niemann-Pick type C disease.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Zavesca pri peroralnem zdravljenju bolnikov z blago ali zmerno obliko Gaucherjeve bolezni tipa 1, za katere encimsko nadomestno zdravljenje (ERT) ni primerno, ter pri zdravljenju napredujočih nevroloških sprememb pri odraslih in pediatričnih bolnikih z Niemann- Pickovo boleznijo tipa C, večje od z njim povezanih tveganj.
The Committee recommended that Zavesca be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Zavesca odobri dovoljenje za promet.
Zavesca has been authorised under ‘ Exceptional Circumstances’ because, as the disease is rare, it has not been possible to obtain complete information on the medicine.
Zdravilo Zavesca je bilo odobreno „ v izjemnih okoliščinah “, saj zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o zdravilu.
2/ 3 What information is still awaited for Zavesca?
2/ 3 Katere informacije o zdravilu Zavesca še pričakujemo?
The company that makes Zavesca will complete the following studies to address the product’ s effectiveness and safety in type 1 Gaucher disease:  a post-marketing plan to inform doctors on how to use Zavesca and to get patients to report information on the safety of the medicine;  a study to follow up patients already in clinical trials, to continue assessment of the medicine’ s safety and effectiveness and to find out more about the neurological aspects of the disease;  a study to look at the effectiveness and safety of Zavesca in patients who switch from ERT;  a further study of the natural history of the disease, together with the European Working Group for Gaucher Disease (EWGGD).
Družba, ki izdeluje zdravilo Zavesca, bo izvedla naslednje študije, namenjene proučitvi učinkovitosti in varnosti pri zdravljenju Gaucherjeve bolezni tipa 1:  postmarketinški načrt, ki bo zdravnike poučil o pravilni uporabi zdravila Zavesca ter spodbudil bolnike k poročanju o varnosti zdravila;  študijo za nadaljnje spremljanje bolnikov, ki že sodelujejo v kliničnih preskušanjih, v kateri se bo nadaljevalo ocenjevanje varnosti in učinkovitosti zdravila in ki bo prinesla več spoznanj o nevroloških vidikih bolezni;  študijo, ki bo preučila učinkovitost in varnost zdravila Zavesca pri bolnikih, ki so encimsko nadomestno zdravljenje zamenjali z zdravljenjem z zdravilom Zavesca;  nadaljnjo študijo pojava in poteka te bolezni, v sodelovanju z Evropsko delovno skupino za Gaucherjevo bolezen (EWGGD).
The European Commission granted a marketing authorisation valid throughout the European Union for Zavesca on 20 November 2002.
Evropska komisija je dovoljenje za promet z zdravilom Zavesca, veljavno po celotni Evropski uniji, odobrila dne 20. novembra 2002.
The marketing authorisation holder is Actelion Registration Ltd.
Imetnik dovoljenja za promet z zdravilom je družba Actelion Registration Ltd.
The marketing authorisation was renewed on 20 November 2007.
Dovoljenje za promet z zdravilom je bilo obnovljeno 20. novembra 2007.
The records of Zavesca’ s designation as an orphan medicine are available here (type 1 Gaucher disease) and here (Niemann-Pick type C disease).
Zapisa o določitvi zdravila Zavesca kot zdravila sirote sta na voljo tukaj (za Gaucherjevo bolezen tipa 1) in tukaj (za Niemann- Pickovo bolezen tipa C).
The full EPAR for Zavesca can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zavesca je na voljo tukaj.
Zavesca 100 mg hard capsules.
Zavesca 100 mg trde kapsule.
Each capsule contains 100 mg miglustat.
Vsaka kapsula vsebuje 100 mg miglustata.
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".
Zavesca is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.
4. 1 Terapevtske indikacije
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).
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).
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 is no experience with the use of Zavesca in patients with type 1 Gaucher disease under the age of 18.
Izkušenj z uporabo zdravila Zavesca pri bolnikih z Gaucherjevo boleznijo tipa 1, starih manj kot 18 let, ni.
The use of Zavesca is therefore not recommended in children or adolescents with type 1 Gaucher disease.
Uporaba Zavesce pri otrocih ali mladostnikih z Gaucherjevo boleznijo tipa 1 ni priporočljiva.
There is no experience with the use of Zavesca in patients over the age of 70.
Izkušenj z uporabo zdravila Zavesca pri bolnikih, starejših od 70 let, ni.
Dosage in Niemann-Pick type C disease
Odmerjanje pri Niemann- Pickovi bolezni tipa C
The recommended dose for the treatment of adult and adolescent patients with Niemann-Pick type C disease is 200 mg three times a day.
Priporočeni odmerek za zdravljenje odraslih in bolnikov in mladostnikov z Niemann- Pickovo boleznijo tipa C je 200 mg trikrat dnevno.
> 1.25 > 0.88 - 1.25 > 0.73 - 0.88 > 0.47 - 0.73 ≤ 0.47
> 1, 25 > 0, 88 - 1, 25 > 0, 73 - 0, 88 > 0, 47 - 0, 73 ≤ 0, 47
200 mg three times a day 200 mg twice a day 100 mg three times a day 100 mg twice a day 100 mg once a day
200 mg trikrat dnevno 200 mg dvakrat dnevno 100 mg trikrat dnevno 100 mg dvakrat dnevno 100 mg enkrat dnevno
The benefit to the patient of treatment with Zavesca should be evaluated on a regular basis (see section 4.4).
Koristi zdravljenja z zdravilom Zavesca je treba pri bolnikih redno preverjati (glejte poglavje 4. 4).
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.
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.
Pri bolnikih s prilagojenim očistkom kreatinina 50– 70 ml/ min/ 1, 73 m2 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.
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.
Pri bolnikih s prilagojenim očistkom kreatinina 30– 50 ml/ min/ 1, 73 m2 uporabo začnemo z odmerkom 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 - Pickovo boleznijo tipa C.
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).
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).
Hepatic Impairment
Okvarjeno delovanje jeter
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.
Čeprav neposredne primerjave z zdravljenjem z encimskim nadomestnim zdravljenjem (ERT - '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 ERT.
ERT is the standard of care for patients who require treatment for type 1 Gaucher disease (see section 5.1).
ERT je standardna oskrba za bolnike, ki potrebujejo zdravljenje Gaucherjeve bolezni tipa 1 (glejte poglavje 5. 1).
Approximately 38% of patients in clinical trials in type 1 Gaucher disease, and 58% of patients in a clinical trial in Niemann-Pick type C disease reported tremor on treatment.
Približno 38% bolnikov v kliničnih preskušanjih z Gaucherjevo boleznijo tipa 1 in 58% bolnikov v kliničnih preskušanjih z Niemann- Pickovo boleznijo tipa C je poročalo o tremorju med zdravljenjem.
Regular monitoring of vitamin B12 level is recommended because of the high prevalence of vitamin B12 deficiency in patients with type 1 Gaucher disease.
Zaradi visoke prevalence pomanjkanja vitamina B12 pri bolnikih z Gaucherjevo boleznijo tipa 1 priporočamo redno spremljanje ravni vitamina B12.
Peripheral B
3 Pri bolnikih s sočasnimi drugimi obolenji, denimo, pomanjkanjem vitamina B12 ali monoklonsko gamopatijo, ali brez njih, ki so jemali zdravilo Zavesca, so poročali o primerih periferne nevropatije.
neuropathy seems to be more common in patients with type 1 Gaucher disease compared to the general population.
Kot kaže, je periferna nevropatija pogostejša pri bolnikih z Gaucherjevo boleznijo tipa 1 v primerjavi s splošno populacijo.
All patients should undergo baseline and repeat neurological evaluation.
Pri vseh bolnikih bi morali opraviti izhodiščne in kontrolne nevrološke preglede.
Patients who develop symptoms such as numbness and tingling should have a careful re-assessment of risk-benefit.
Pri bolnikih, pri katerih se pojavijo simptomi, denimo, omrtvičenost ali mravljinčenje, je treba ponovno skrbno oceniti razmerje tveganja in koristi.
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 mechanism is probably inhibition of disaccharidases in the gastrointestinal tract.
Mehanizem je verjetno inhibicija disaharidaz v prebavilih.
The majority of cases are mild and are expected to resolve spontaneously on therapy.
Večina primerov je blagih in zanje pričakujemo, da spontano izzvenijo ob nadaljevanju zdravljenja.
In clinical practice, diarrhoea has been observed to respond to diet modification (reduction of lactose and other carbohydrate intake), to taking Zavesca away from meals, and/ or to anti-diarrhoeal medicinal products such as loperamide.
V klinični praksi so opažali, da diareja izzveni ob spremembi prehrane (zmanjšanju vnosa laktoze in drugih ogljikovih hidratov), jemanju zdravila Zavesca ločeno od obrokov ali jemanju zdravil proti diareji, na primer loperamida, ali obojega.
Studies in the rat have shown that miglustat adversely affects spermatogenesis and sperm parameters, and reduces fertility (see sections 4.6 and 5.3).
Študije na podganah so pokazale, da miglustat neželeno vpliva na spermatogenezo in parametre spermijev ter zmanjšuje plodnost (glejte poglavji 4. 6 in 5. 3).
Until further information is available, before seeking to conceive, male patients should cease Zavesca and maintain reliable contraceptive methods for a further 3 months.
Dokler ne bo na voljo več informacij, svetujemo, da naj moški bolniki, preden bi radi spočeli otroka, nehajo jemati zdravilo Zavesca in naj uporabljajo zanesljivo metodo kontracepcije še nadaljnje 3 mesece po prenehanju jemanja zdravila Zavesca.
There is a close relationship between renal function and clearance of miglustat, and exposure of miglustat is markedly increased in patients with severe renal impairment (see section 5.2).
Delovanje ledvic močno vpliva na očistek miglustata, izpostavljenost miglustatu je opazno višja pri bolnikih s hudo okvarjenim delovanjem ledvic (glejte poglavje 5. 2).
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.
Niemann-Pick type C disease
Niemann- Pickova bolezen tipa C
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 Niemann - Pickovo 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.
Reduced growth has been reported in some paediatric patients with Niemann-Pick type C disease in the early phase of treatment with miglustat where the initial reduced weight gain may be accompanied or followed by reduced height gain.
Pri nekaterih pediatričnih bolnikih z Niemann- Pickovo boleznijo tipa C so poročali o zmanjšani rasti v zgodnji fazi zdravljenja z miglustatom, kjer lahko manjša rast spremlja začetno zmanjšano pridobitev teže ali ji sledi.
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.
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.
In patients included in the clinical trial, 40%-50% of patients had platelet counts below the lower limit of normal at baseline.
Pri bolnikih, vključenih v klinično preskušanje, je 40% - 50% bolnikov imelo število trombocitov pod spodnjo mejo normalnega ob izhodišču.
Limited data suggest that co-administration of Zavesca and Cerezyme 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 Cerezyme 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).
This study also indicated that Zavesca has no or limited effect on the pharmacokinetics of Cerezyme.
Ta študija je tudi pokazala, da zdravilo Zavesca nima ali ima le majhen učinek na farmakokinetiko zdravila Cerezyme.
4 There are no adequate data from the use of miglustat in pregnant women.
Ni zadostnih podatkov o uporabi miglustata pri nosečnicah.
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).
Contraceptive measures should be used by women of childbearing potential.
Ženske v rodni dobi morajo uporabljati kontracepcijo.
Zavesca should not be used during breast-feeding.
Zdravila Zavesca se ne sme uporabljati v času dojenja.
Male patients should maintain reliable contraceptive methods while taking Zavesca and for 3 months after finishing treatment (see sections 4.4 and 5.3)
Moški bolniki morajo med jemanjem zdravila Zavesca in 3 mesece po končanem zdravljenju uporabljati zanesljivo zaščito proti zanositvi (glejte poglavji 4. 4 in 5. 3).
No studies on the effects of Zavesca on the ability to drive or use machines have been performed.
Študij o vplivu Zavesce na sposobnost vožnje in upravljanja s stroji niso izvedli.
However, dizziness has been reported as a very common adverse event, and patients suffering from dizziness should not drive or operate machinery.
So pa poročali o omotičnosti kot o zelo pogostem neželenem učinku, zato bolniki z omotičnostjo ne smejo voziti ali upravljati s stroji.