natgillin/translations-raw huggingface dataset:
The first dose of the day of Tasmar should be taken together the first dose of the day of a levodopa preparation, and the subsequent doses should be given approximately 6 and 12 hours later.
Prvi odmerek zdravila Tasmar je potrebno vzeti skupaj s prvim odmerkom preparata levodope in približno 6 do 12 ur kasneje je potrebno vzeti naslednji odmerek.
Symptoms have usually onset during Tasmar treatment or shortly after Tasmar has been discontinued.
Simptomi se običajno pojavijo med zdravljenjem ali kmalu po prekinitvi zdravljenja z zdravilom Tasmar.
To improve efficacy, your doctor should only increase the dose to the higher dose (200 mg three times a day) if the increase in how your Parkinson's disease symptoms are controlled outweighs the expected increase in side effects.
Za izboljšanje učinkovitosti lahko vaš zdravnik odmerek poveča na višji odmerek (na 200 mg trikrat na dan) le, če povečan nadzor nad simptomi vaše Parkinsonove bolezni odtehta pričakovano povečanje neželenih učinkov.
The combination of MAO-A and MAO-B inhibitors is equivalent to non-selective MAO-inhibition, therefore they should not both be given concomitantly with Tasmar and levodopa preparations (see also section 4.5).
Kombinacija zaviralcev MAO-A in MAO-B je enakovredna neselektivnemu zaviranju MAO in se zato skupaj z zdravilom Tasmar in pripravki levodope ne sme jemati (glejte tudi poglavje 4.5).
Tasmar used with your other Parkinson medicines can cause excessive drowsiness (somnolence) and sudden sleep onset episodes (you may suddenly fall asleep).
Zdravilo Tasmar lahko z uporabo ostalih vaših zdravil za zdravljenje Parkinsonove bolezni povzroči povečano zaspanost (somnolenco) in obdobja nenadnega uspavanja (nenadoma lahko zaspite).
For oral use.
Peroralna uporaba.
Tolcapone is an orally active, selective and reversible catechol-O-methyltransferase (COMT) inhibitor.
Tolkapon je peroralno aktivni, selektivni in reverzibilni zaviralec katehol-O-metiltransferaze (COMT).
The prescriber should be observant of adverse reactions caused by putative increased plasma levels of these drugs when combined with Tasmar.
Predpisovalec mora biti pozoren na neželene učinke, povzročene z domnevno zvišanimi plazemskimi ravnmi teh učinkovin, kadar se kombinirajo z zdravilom Tasmar.
Marketing Authorisation Holder: Meda AB
Imetnik dovoljenja za promet z zdravilom: Meda AB
Uncommon: liver injury, in rare cases with fatal outcome
Občasni: - poškodbe jeter, v redkih primerih s smrtnim izidom.
Patients receiving multiple medications with effects on different central nervous system (CNS) pathways (e.g. antidepressants, neuroleptics, anticholinergics) may be at greater risk of developing NMS.
Bolniki, ki jemljejo več zdravil z učinki na različne poti v centralnem živčnem sistemu (CŽS) (npr. antidepresive, nevroleptike, antiholinergike), so verjetno izpostavljeni večjemu tveganju za razvoj MNS.
Patients being treated with Levodopa and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved (see also section
Bolnike, ki se zdravijo z levodopo in so občutili zaspanost in/ali doživeli obdobja nenadnega uspavanja moramo obvestiti, da opustijo vožnjo ali vključevanje v dejavnosti, kjer bi zaradi zmanjšane pozornosti sebe ali druge izpostavili tveganju za resne poškodbe ali smrt (npr. upravljanje strojev), dokler taka ponavljajoča se obdobja in zaspanost ne minejo (glejte tudi poglavje 4.4).
1 Primary and Secondary Outcome of double-blind Trial Entacapone
Primarni in sekundarni izidi dvojno slepega preskušanja entakapon n = 75
The administration of Tasmar is restricted to prescription and supervision by physicians experienced in the management of advanced Parkinson's disease.
Uporaba zdravila Tasmar je omejena na predpisovanje in nadzorovanje zdravljenja s strani zdravnikov z izkušnjami pri zdravljenju napredovale Parkinsonove bolezni.
Tasmar 100 mg (only applicable for the outer carton)
Tasmar 100 mg (le na zunanji ovojnini)
Hypokinesia Syncope
pogosti hipokinezija sinkopa
Drugs that increase catecholamines: Since tolcapone interferes with the metabolism of catecholamines, interactions with other drugs affecting catecholamine levels are theoretically possible.
Zdravila, ki povišajo kateholamine: ker tolkapon vpliva na presnovo kateholaminov, so interakcije z ostalimi zdravili, ki vplivajo na kateholamine, teoretično možne.
Therefore, caution should be exercised when potent noradrenaline uptake inhibitors such as desipramine, maprotiline, or venlafaxine are administered to Parkinson's disease patients being treated with Tasmar and levodopa preparations.
Zato je potrebna previdnost kadar močne zaviralce ponovnega privzema noradrenalina, kot so dezipramin, maprotilin ali venlafaksin, dajemo bolnikom s Parkinsonovo boleznijo, zdravljenim z zdravilom Tasmar in pripravki levodope.
Since your ability to drive a car or operate machinery may be affected by Parkinson's disease, you should discuss this with your doctor.
Ker ima Parkinsonova bolezen lahko vpliv na vašo sposobnost vožnje avtomobila ali upravljanja orodij ali strojev, se o tem pogovorite z zdravnikom.
You should not start taking Tasmar until your doctor - has described the risks of treatment with Tasmar, - has explained the measures necessary to minimise those risks, - has answered any questions you may have.
Zdravila Tasmar ne smete začeti jemati, dokler vam vaš zdravnik - ne opiše tveganj zdravljenja z zdravilom Tasmar, - ne opiše ukrepov, potrebnih za zmanjšanje teh tveganj na najnižjo možno raven,
30 film-coated tablets 60 film-coated tablets 100 film-coated tablets 200 film-coated tablets
30 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet 200 filmsko obloženih tablet
Phaeochromocytoma.
• feokromocitom,
In animal studies, tolcapone was excreted into maternal milk.
Tolkapon se je v študijah na živalih izločal v materino mleko.
Carcinogenesis, mutagenesis: 3 % and 5 % of rats in the mid- and high- dose groups, respectively, of the 24-month carcinogenicity study were shown to have renal epithelial tumours (adenomas or carcinomas).
Kancerogenost, mutageneza: v 24-mesečni študiji kancerogenega potenciala se je izkazalo, da je 3 % podgan v skupini s srednje velikimi odmerki in 5 % podgan v skupini z velikimi odmerki, imelo ledvične epitelijske tumorje (adenome ali karcinome).
If you do not get better at the higher dose after a total of 3 weeks, your doctor should stop your treatment with Tasmar.
Če se vaše stanje ob jemanju večjega odmerka ne izboljša po skupno 3 tednih, mora zdravnik vaše zdravljenje z zdravilom Tasmar prekiniti.
For the remainder, when treatment was discontinued, transaminase levels returned to pre-treatment levels.
Ostalim so se vrednosti transaminaze po prekinitvi zdravljenja vrnile na vrednosti pred zdravljenjem.
If you forget to take Tasmar
Če ste pozabili vzeti zdravilo Tasmar
The most commonly observed adverse reactions associated with the use of Tasmar, occurring more frequently than in placebo-treated patients are listed in the table below.
Najpogosteje opaženi neželeni učinki, povezani z uporabo zdravila Tasmar, ki so se pojavili pogosteje kot pri s placebom zdravljenih bolnikih, so našteti v spodnji preglednici.
If treatment is discontinued: Patients who show evidence of acute liver injury while on Tasmar and are withdrawn from the medicinal product may be at increased risk for liver injury if Tasmar is reintroduced.
Če zdravljenje prekinemo: bolniki, ki med zdravljenjem z zdravilom Tasmar kažejo znake akutne poškodbe jeter in jim zdravilo ukinemo, so verjetno izpostavljeni večjemu tveganju za poškodbo jeter, če zdravilo Tasmar ponovno uvedemo.
If you have forgotten several doses, please inform your doctor and follow the advice given to you.
Če ste izpustili več odmerkov, prosimo obvestite svojega zdravnika in upoštevajte njegova navodila.
The NMS consists of some or all of the following: severe muscle stiffness, jerking movements of muscles, arms or legs, and soreness of muscles.
MNS sestavlja nekaj ali vse od naštetega: - huda mišična togost, trzajoči premiki mišic, rok ali nog in bolečina v mišicah.
A double-blind trial compared Tasmar with entacapone in Parkinson's disease patients who had at least three hours of OFF time per day while receiving optimised levodopa therapy.
Dvojno slepo preskušanje je primerjalo zdravilo Tasmar z entakaponom pri bolnikih s Parkinsonovo boleznijo, ki so imeli najmanj triurno obdobje »izklopa« (OFF) na dan, medtem ko so prejemali optimizirano terapijo z levodopo.
The only adverse reaction commonly leading to discontinuation of Tasmar in clinical trials was diarrhoea (see section 4.4).
Edini neželeni učinek, ki je pogosto vodil k prekinitvi jemanja zdravila Tasmar v kliničnih preskušanjih, je bil diareja (glejte poglavje 4.4).
In Parkinson`s patients, NMS tends to occur when discontinuing or stopping dopaminergic-enhancing medications.
Pri bolnikih s Parkinsonovo boleznijo se MNS pojavi predvsem takrat, ko prekinjamo ali ukinjamo dopaminergike.
No effects were seen on the pharmacokinetics of the COMT substrate carbidopa.
Na farmakokinetiko COMT substrata karbidope učinkov niso opazili.
Patients with hepatic impairment (see section 4.3) Tasmar is contraindicated for patients with liver disease or increased liver enzymes.
Bolniki z okvaro jeter (glejte poglavje 4.3) Zdravilo Tasmar je kontraindicirano pri bolnikih z boleznijo jeter ali povišano raven jetrnih encimov.
Liver injury:
Poškodbe jeter:
In clinical trials, patients receiving Tasmar/levodopa preparations reported a similar adverse reaction profile independent of whether or not they were also concomitantly administered selegiline (a MAO-B inhibitor).
V kliničnih preskušanjih so bolniki, ki so prejemali zdravilo Tasmar in pripravke z levodopo, poročali o podobnem profilu neželenih učinkov neodvisno od tega, ali so sočasno jemali selegilin (zaviralec MAO-B).
Liver function should be checked before starting treatment with Tasmar and then monitored every 2 weeks for the first year of therapy, every 4 weeks for the next 6 months and every 8 weeks thereafter.
Jetrno funkcijo je treba preveriti pred začetkom zdravljenja z zdravilom Tasmar in potem spremljati vsaka 2 tedna v prvem letu zdravljenja, vsake 4 tedne naslednjih 6 mesecev in potem vsakih 8 tednov.
Excipients with known effect: Each tablet contains 7.5 mg lactose For the full list of excipients, see section 6.1.
Pomožne snovi z znanim učinkom: Ena tableta vsebuje 7,5 mg laktoze Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Number (proportion) with moderate or marked improvement
Sekundarni izidi število (delež) z zmernim do izrazitim izboljšanjem
Patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
Bolniki z redko dedno obliko galaktozne intolerance, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze-galaktoze, tega zdravila ne smejo jemati.
A natural protein (enzyme) in your body, the (COMT) Catechol-O-methyltransferase in your body breaks down levodopa.
Naravni protein (encim) katehol-O-metiltransferaza (COMT) v vašem telesu razgrajuje zdravilo levodopo.
Hepatic impairment: Because of the risk of liver injury observed during post-marketing use, Tasmar is contraindicated in patients with liver disease or increased liver enzymes.
Okvara jeter: zaradi tveganja za poškodbo jeter, opaženega med uporabo v času trženja, je zdravilo Tasmar kontraindicirano pri bolnikih z boleznijo jeter ali povišanimi ravnmi jetrnih encimov.
Do not reduce or stop taking your medicine unless your doctor tells you.
Ne zmanjšajte odmerka in ne prenehajte jemati zdravila Tasmar, razen če vam to naroči zdravnik.
Treatment should be immediately discontinued if ALT and/or AST exceed the upper limit of normal or if symptoms or signs suggesting the onset of hepatic failure (persistent nausea, fatigue, lethargy, anorexia, jaundice, dark urine, pruritus, right upper quadrant tenderness) develop.
Zdravljenje se mora takoj prekiniti, če vrednosti ALT in/ali AST presežejo zgornjo referenčno vrednost, ali če se razvijejo simptomi ali znaki, ki kažejo na začetek okvare jeter (nenehna slabost, utrujenost, letargija, anoreksija, zlatenica, temen urin, pruritus, občutljivost zgornjega desnega kvadranta).
Patients with renal impairment (see section 5.2)
Bolniki z okvaro ledvic (glejte poglavje 5.2)
When beginning and during treatment with Tasmar, your dose of Levodopa may need to be changed.
Ko začnete in med zdravljenjem z zdravilom Tasmar bo morda potrebno spremeniti vaš odmerek levodope.
Tasmar treatment should also be discontinued if ALT (alanine amino transferase) and/or AST (aspartate amino transferase) exceed the upper limit of normal or symptoms or signs suggest the onset of hepatic failure (see section 4.4).
Zdravljenje z zdravilom Tasmar moramo prav tako prekiniti, če vrednosti ALT (alaninaminotransferaza) in/ali AST (aspartat-aminotransferaza) presežejo zgornje referenčne vrednosti, ali če simptomi ali znaki kažejo na začetek okvare jeter (glejte poglavje 4.4)
Effect of tolcapone on the metabolism of other drugs: Due to its affinity for cytochrome CYP2C9 in vitro, tolcapone may interfere with drugs whose clearance is dependent on this metabolic pathway, such as tolbutamide and warfarin.
Učinek tolkapona na presnavljanje drugih zdravil: zaradi in vitro afinitete tolkapona za citokrom CYP2C9, lahko med tolkaponom in zdravili, katerih očistek je odvisen od te presnovne poti, kot sta tolbutamid in varfarin, pride do medsebojnega delovanja.
Please inform your doctor about all other medicines you are taking especially: antidepressants, alpha-methyldopa (used to treat increased blood pressure), apomorphine (used for Parkinson's disease), dobutamine (used for the chronic heart disease), adrenaline and isoprenaline (both used for heart attacks) anticoagulants of the warfarin type (that prevent blood clotting).
Prosimo obvestite svojega zdravnika o vseh ostalih zdravilih, ki jih jemljete, posebno o - antidepresivih, - alfa-metildopi (zdravilo za zdravljenje zvišanega krvnega tlaka), - apomorfinu (za zdravljenje Parkinsonove bolezni), - dobutaminu (za zdravljenje kroničnega srčnega popuščanja), - adrenalinu in izoprenalinu (oboje se uporablja pri srčni kapi), - antikoagulantih (preprečujejo strjevanje krvi) varfarinskega tipa.
The consequent increase in dopaminergic stimulation can lead to the dopaminergic adverse reactions observed after treatment with COMT inhibitors.
Posledično povečanje dopaminergične stimulacije lahko vodi do dopaminergičnih neželenih učinkov opaženih po zdravljenju s COMT zaviralci.
1 film-coated tablet Tasmar
1 filmsko obložena tableta zdravila Tasmar
Hypersensitivity to tolcapone or any of its other ingredients listed in section 6.1.
• preobčutljivost na tolkapon ali katero koli pomožno snov navedeno v poglavju 6.1,
If benefits are not seen within 3 weeks of the initiation of the treatment, Tasmar should be discontinued.
Če koristni učinki niso vidni v 3 tednih od začetka zdravljenja, je treba zdravilo Tasmar ukiniti.
An increased incidence of uterine adenocarcinomas was seen in the high-dose group of the rat carcinogenicity study.
V skupini z visokimi odmerki so pri podganah v študijah kancerogenosti opazili povečano incidenco adenokarcinoma maternice.
When beginning Tasmar, all patients should be informed of the symptoms of excessive levodopa dose and what to do if it occurs.
Vse bolnike je ob začetku zdravljenja z zdravilom Tasmar treba seznaniti s simptomi presežka levodope in potrebnimi ukrepi, če do tega pride.
Because of the risk of rare but potentially fatal acute liver injury, Tasmar is only indicated for use in patients with levodopa-responsive idiopathic Parkinson's disease and motor fluctuations, who failed to respond to or are intolerant of other COMT inhibitors.
Zaradi tveganja za nastanek redke, a potencialno življenje ogrožajoče akutne poškodbe jeter, je zdravilo Tasmar indicirano le pri bolnikih z na levodopo odzivno idiopatsko Parkinsonovo boleznijo in motoričnimi fluktuacijami, ki se niso odzvali na zdravljenje z ostalimi zaviralci COMT ali jih ne prenašajo.
Excipients with known effect: Each tablet contains 15 mg lactose For the full list of excipients, see section 6.1.
Pomožne snovi z znanim učinkom: Ena tableta vsebuje 15 mg laktoze Za celoten seznam pomožnih snovi glejte poglavje 6.1.
The tablets should be swallowed whole.
Tablete morate pogoltniti cele.
The recommended dose of Tasmar is 100 mg three times daily, always as an adjunct to levodopa/benserazide or levodopa/carbidopa therapy.
Priporočeni odmerek zdravila Tasmar je 100 mg trikrat na dan, vedno kot dodatek zdravljenja z levodopo/benserazidom ali levodopo/karbidopo.
Administered concomitantly with levodopa and an aromatic amino acid decarboxylase inhibitor (AADC-I), it leads to more stable plasma levels of levodopa by reducing metabolism of levodopa to 3-methoxy-4-hydroxy-L-phenylalanine (3-OMD).
Če je dan sočasno z levodopo in zaviralcem aromatske aminokislinske dekarboksilaze (AADC-I), omogoča bolj stabilne plazemske vrednosti levodope z zmanjšanjem presnove levodope v 3-metoksi4-hidroksil-L-fenilalanin (3-OMD).
Toxicity to reproduction: Tolcapone, when administered alone, was shown to be neither teratogenic nor to have any relevant effects on fertility.
Vplivi na sposobnost za razmnoževanje: tolkapon, dajan samostojno, se ni izkazal za teratogenega, niti da bi neugodno vplival na plodnost.
In an interaction study, tolcapone did not change the pharmacokinetics of tolbutamide.
V študiji medsebojnega delovanja tolkapon ni spremenil farmakokinetike tolbutamida.
If you stop taking Tasmar
Če ste prenehali jemati zdravilo Tasmar
Levodopa dose should not be decreased when Tasmar therapy is being discontinued due to side effects related to too much levodopa.
Odmerkov levodope naj ne bi zmanjševali, kadar zdravljenje z zdravilom Tasmar prekinemo zaradi neželenih učinkov, povezanih s presežkom levodope.
No information on the tolerability of tolcapone in these populations is available (see section 5.2).
Podatkov o prenašanju tolkapona pri tej populaciji ni na voljo (glejte poglavje 5.2).
Neuroleptic Malignant Syndrome Symptom Complex Isolated cases of patients with symptoms suggestive of Neuroleptic Malignant Syndrome Symptom Complex (see sectiom 4.4) have been reported following reduction or discontinuation of Tasmar and following introduction of Tasmar when this was accompanied by a significant reduction in other concomitant dopaminergic medications.
Maligni nevroleptični sindrom s kompleksom simptomov Opisani so bili posamezni primeri bolnikov s simptomi, ki so nakazovali na maligni nevroleptični sindrom s kompleksom simptomov (glejte poglavje 4.4), nastalimi po zmanjšanju odmerka ali prekinitvi zdravila Tasmar, in po uvedbi zdravila Tasmar, kadar so obenem bolniku precej zmanjšali odmerke ostalih sočasno prejetih dopaminergikov.
Adjustments in levodopa are most likely to be required within 1-2 days of Tasmar discontinuation.
Odmerek levodope je najverjetneje treba prilagoditi v 1 do 2 dneh po prekinitvi zdravljenja z zdravilom Tasmar.
There were no similar renal findings in the mouse or dogs carcinogenicity studies.
V študijah kancerogenosti na miših ali psih glede ledvic ni bilo podobnih ugotovitev.
Liver injury has most often occurred between 1 month and 6 months after starting treatment with Tasmar.
Poškodba jeter se je največkrat pojavila med 1. in 6. mesecem zdravljenja z zdravilom Tasmar.
- if you are pregnant or intend to become pregnant.
- Zdravniku morate povedati, če ste noseči ali nameravate zanositi.
Levodopa has been associated with somnolence and episodes of sudden sleep onset.
Levodopo povezujejo s somnolenco in obdobji nenadnega uspavanja.
In addition, rhabdomyolysis, secondary to NMS or severe dyskinesia, has been observed.
Poleg tega je bila opažena rabdomioliza, pridružena MNS ali hudi diskineziji.
In all cases, patients should be educated on the symptoms of levodopa under-dose and what to do if it occurs.
V vseh primerih je treba bolnike poučiti o simptomih pomanjkanja levodope in ukrepih ob njegovem morebitnem pojavu.
Tasmar should not be prescribed until there has been a complete informative discussion of the risks with the patient.
Zdravilo Tasmar se ne sme predpisovati, dokler ni ugotovljeno tveganje za bolnika.
NMS is characterised by motor symptoms (rigidity, myoclonus and tremor), mental status changes (agitation, confusion, stupor and coma), elevated temperature, autonomic dysfunction (labile blood pressure, tachycardia) and elevated serum creatine phosphokinase (CPK) which may be a consequence of myolysis.
MNS je opredeljen z motoričnimi simptomi (togost, mioklonus in tremor), spremembami v mentalnem statusu (agitacija, zmedenost, stupor in koma), zvišano telesno temperaturo, avtonomno disfunkcijo (nestabilen krvni tlak, tahikardija) in povišano serumsko kreatin-fosfokinazo (CPK), ki je lahko posledica miolize.
However, when Tasmar therapy is being discontinued for reasons other than too much levodopa, levodopa dose may have to be increased to levels equal to or greater than before initiation of Tasmar therapy, especially if the patient had large decreases in levodopa when starting Tasmar.
Kadar pa terapijo z zdravilom Tasmar prekinemo zaradi razlogov, drugačnih kot je presežek levodope, bo odmerek levodope verjetno treba zvečati na enak ali večji kot pred uvedbo terapije z zdravilom Tasmar, še posebno, če so bolniku odmerek levodope po uvedbi zdravila Tasmar močno zmanjšali.
Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a firstline adjunct therapy to levodopa/benserazide or levodopa/carbidopa (see sections 4.4 and 4.8).
Zaradi tveganja za nastanek potencialno življenje ogrožajoče, akutne poškodbe jeter, zdravila Tasmar ne uporabljamo za dodatno zdravljenje prve izbire pri terapiji z levodopo/benserazidom ali levodopo/karbidopo (glejte poglavje 4.4 in 4.8).
Since Tasmar should be used only in combination with levodopa/benserazide and levodopa/carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with Tasmar.
Ker se zdravilo Tasmar uporablja zgolj v kombinaciji z levodopo/benserazidom in levodopo/karbidopo, so navodila za predpisovanje omenjenih pripravkov z levodopo uporabna tudi za sočasno zdravljenje z zdravilom Tasmar.
The plasma concentrations of benserazide observed after co-administration of tolcapone and benserazide-25 mg/levodopa were still within the range of values observed with levodopa/benserazide alone.
Plazemske koncentracije benserazida, ki so jih opazili po sočasnem dajanju tolkapona in 25 mg benserazida z levodopo, so bile še vedno v mejah vrednosti, opaženih po samostojnem dajanju kombinacije levodopa/benserazid.
On the other hand, after co-administration of tolcapone and benserazide-50 mg/levodopa the benserazide plasma concentrations could be increased above the levels usually observed with levodopa/benserazide alone.
Po drugi strani pa lahko po sočasnem dajanju tolkapona in 50 mg benserazida z levodopo plazemske koncentracije benserazida narastejo prek običajnih ravni, opaženih po dajanju kombinacije levodopa/benserazid.
During treatment: Liver function should be monitored every 2 weeks for the first year of therapy, every 4 weeks for the next 6 months and every 8 weeks thereafter.
Med zdravljenjem: delovanje jeter je treba kontrolirati vsaka 2 tedna v prvem letu zdravljenja, vsake 4 tedne naslednjih 6 mesecev in vsakih 8 tednov za tem.
Very rare (<1/10,000), not known (cannot be estimated from the available data)
zelo pogosti (1/10) pogosti (1/100 do <1/10) občasni (1/1.000 do <1/100) redki (1/10.000 do <1/1.000) zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Other possible side effects:
Ostali neželeni učinki: