natgillin/translations-raw huggingface dataset:
If entacapone treatment is discontinued, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms.
V primeru prekinitve zdravljenja z entakaponom je treba za doseganje zadostne ravni nadzora nad parkinsonskimi simptomi prilagoditi odmerjanje drugih antiparkinsonskih zdravil, zlasti levodope.
Due to its affinity to cytochrome P450 2C9 in vitro (see section 5.2), entacapone may potentially interfere with medicinal products with metabolism dependent on this isoenzyme, such as S-warfarin.
Zaradi svoje afinitete do citokroma P450 2C9 in vitro (glejte poglavje 5.2) lahko entakapon potencialno ovira presnovo zdravil, ki je odvisna od tega izoencima, na primer presnovo S-varfarina.
The maximum recommended dose is 200 mg ten times daily, i.e. 2,000 mg of entacapone.
Največji priporočeni odmerek je 200 mg desetkrat na dan, tj. 2.000 mg entakapona.
The (Z)-isomer and traces of other metabolites account for the remaining 5%.
Izomera (Z) in drugi presnovki v sledovih predstavljajo preostalih
Entacapone should be given cautiously to patients who are taking other medicinal products which may cause orthostatic hypotension.
Pri dajanju entakapona bolnikom, ki jemljejo druga zdravila, ki lahko povzročajo ortostatsko hipotenzijo, je potrebna previdnost.
Urine may be discoloured reddish-brown by entacapone, but this is a harmless phenomenon.
Entakapon lahko obarva urin rdečkastorjavo, vendar je ta pojav neškodljiv.
As Entacapone Teva tablets will be taken together with other levodopa medicines, please also read the package leaflets of these medicines carefully.
Ker boste tablete Entakapon Teva jemali skupaj z drugimi zdravili z levodopo, skrbno preberite tudi njihova navodila za uporabo.
In human plasma the unbound fraction is about 2.0% in the therapeutic concentration range.
V obsegu terapevtskih koncentracij je nevezana frakcija v človeški plazmi okrog 2,0 %.
Entacapone may, together with levodopa, cause dizziness and symptomatic orthostatism.
Entakapon lahko skupaj z levodopo povzroča omotičnost in simptomatski ortostatizem.
Some of the side effects are often caused by the increased effects of levodopa therapy and are most common at the start of treatment.
Nekatere neželene učinke pogosto povzročijo povečani učinki zdravljenja z levodopo in do njih najbolj pogosto pride na začetku zdravljenja.
Other medicines and Entacapone Teva
Druga zdravila in zdravilo Entakapon Teva
Entacapone Teva tablets contain entacapone and are used together with levodopa to treat Parkinson's disease.
Tablete Entakapon Teva vsebujejo entakapon in jih uporabljamo skupaj z levodopo za zdravljenje Parkinsonove bolezni.
NAME OF THE MEDICINAL PRODUCT AND ROUTE (S) OF ADMINISTRATION
IME ZDRAVILA IN POT(I) UPORABE
Do not use this medicine after the expiry date which is stated on the carton and tablet container label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na vsebniku tablet poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
In repeated dose toxicity studies, anaemia most likely due to iron chelating properties of entacapone was observed.
V študijah toksičnosti pri ponavljajočih se odmerkih je bila opažena anemija, ki je najverjetneje posledica lastnosti entakapona, da z železom tvori kelate.
However, for patients who are receiving dialysis therapy, a longer dosing interval may be considered (see section 5.2).
Vendar je pri bolnikih, zdravljenih z dializo, včasih treba podaljšati časovni razmik med posameznimi odmerki (glejte poglavje 5.2).
- Concomitant use of a selective MAO-A inhibitor plus a selective MAO-B inhibitor and entacapone (see section 4.5).
- Sočasna uporaba selektivnega zaviralca MAO-A in selektivnega zaviralca MAO-B ter entakapona (glejte poglavje 4.5).
Agitation
agitacija
The most frequent adverse reactions caused by entacapone relate to the increased dopaminergic activity and occur most commonly at the beginning of the treatment.
Najpogostejši neželeni učinki, ki jih povzroča entakapon, so povezani s povečano dopaminergično aktivnostjo in se pojavijo najpogosteje na začetku zdravljenja.
Entacapone Teva in association with levodopa may have major influence on the ability to drive and use machines.
Zdravilo Entakapon Teva ima skupaj z levodopo pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
- Concomitant use of entacapone and non-selective monoamine oxidase (MAO-A and MAO-B)
- Sočasna uporaba entakapona in neselektivnih zaviralcev monoaminooksidaze (MAO-A in
Only traces of entacapone are found unchanged in urine.
V urinu je nespremenjen entakapon samo v sledovih.
The metabolism of the medicinal product is slowed in patients with mild to moderate liver insufficiency (Child-Pugh Class A and B), which leads to an increased plasma concentration of entacapone in both the absorption and elimination phases (see section 4.3).
Pri bolnikih z blago do zmerno insuficienco jeter (skupini A in B po Child-Pughovi lestvici), je presnova zdravila upočasnjena, kar povzroči zvišanje koncentracije entakapona v plazmi tako v fazi absorpcije kot v fazi odstranjevanja iz telesa (glejte poglavje 4.3).
Insomnia, hallucinations, confusion, paroniria
nespečnost, halucinacije, zmedenost, paronirija (nočne more)
Women should not breast-feed during treatment with entacapone.
Ženske med zdravljenjem z entakaponom ne smejo dojiti.
If this happens, you should not drive or use any tools or machines (see Driving and using machines).
Če se vam to dogaja, ne smete voziti ali uporabljati naprav ali strojev
What Entacapone Teva is and what it is used for What you need to know before you take Entacapone Teva How to take Entacapone Teva Possible side effects
Kaj je zdravilo Entakapon Teva in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Entakapon Teva Kako jemati zdravilo Entakapon Teva
To reduce levodopa-related dopaminergic adverse reactions, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment, according to the clinical condition of the patient (see sections 4.2 and 4.8).
Za zmanjšanje dopaminergičnih neželenih učinkov, povezanih z levodopo, je v prvih dnevih ali prvih tednih po uvedbi zdravljenja z entakaponom glede na bolnikovo klinično stanje pogosto potrebno prilagoditi odmerjanje levodope (glejte poglavji 4.2 in 4.8).
Renal impairment does not affect the pharmacokinetics of entacapone.
Okvara ledvic ne vpliva na farmakokinetiko entakapona.
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Ischemic heart disease events other than myocardial infarction (e.g. angina pectoris)
dogodki v zvezi z ishemično boleznijo srca, razen miokardnega infarkta (na primer angina pektoris)
Entacapone enhances the effects of levodopa.
Entakapon povečuje učinke levodope.
In clinical studies, adverse dopaminergic reactions, e.g. dyskinesia, were more common in patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination.
V kliničnih študijah so bili neželeni dopaminergični učinki, na primer diskinezija, pogostejši pri bolnikih, ki so dobivali entakapon in agoniste dopamina (na primer bromokriptin), selegilin ali amantadin, kot pri tistih, ki so skupaj s to kombinacijo dobivali placebo.
In clinical studies the most common adverse reactions leading to discontinuation of entacapone treatment have been gastrointestinal symptoms (e.g. diarrhoea, 2.5%) and increased dopaminergic adverse reactions of levodopa (e.g. dyskinesias, 1.7%).
V kliničnih študijah so bili najpogostejši neželeni učinki, ki so povzročili prekinitev zdravljenja z entakaponom, simptomi s strani prebavil (na primer diareja v 2,5 %) in zvečani dopaminergični neželeni učinki levodope (na primer diskinezije v 1,7 %).
The bioavailability of entacapone is about 35% after an oral dose.
Biološka uporabnost entakapona po peroralnem odmerku je okrog 35 %.
At therapeutic concentrations, entacapone does not displace other extensively bound substances (e.g. warfarin, salicylic acid, phenylbutazone, or diazepam), nor is it displaced to any significant extent by any of these substances at therapeutic or higher concentrations.
Entakapon v terapevtskih koncentracijah ne izriva drugih učinkovin, ki se v veliki meri vežejo na beljakovine (na primer varfarin, salicilna kislina, fenilbutazon ali diazepam), pa tudi nobena od teh učinkovin v terapevtskih ali višjih koncentracijah ne izriva entakapona v velikem obsegu.
Food does not affect the absorption of entacapone to any significant extent.
Hrana na absorpcijo entakapona nima pomembnega vpliva.
Entacapone Teva taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy.
Zdravilo Entakapon Teva, ki ga jemljete skupaj z levodopo, vam lahko zniža krvni tlak, zaradi česar se vam lahko stemni pred očmi ali postanete omotični.
Regarding reproduction toxicity, decreased foetal weight and a slightly delayed bone development were noticed in rabbits at systemic exposure levels in the therapeutic range.
V zvezi z vplivom na sposobnost razmnoževanja je bilo v poskusih na kuncih pri ravni sistemske izpostavljenosti v terapevtskem območju opaženo zmanjšanje plodove mase in malce upočasnjen razvoj kosti.
Skin, hair, beard and nail discolorations
sprememba barve kože, las, brade in nohtov
Study II: Proportion of daily On time (%) Entacapone (n=103) Placebo (n=102)
Študija II: Delež dnevnega obdobja ‘ON' (%) entakapon (n=103)
The % change from baseline in OFF time was -24% in the entacapone group and 0% in the placebo group in study I. The corresponding figures in study II were -18% and -5%.
Sprememba časa ‘OFF' v odstotkih od izhodišča v študiji I je bila v skupini z entakaponom -24 %, v skupini s placebom pa 0 %.
Since the introduction into the market, isolated cases of NMS have been reported, especially following abrupt reduction or discontinuation of entacapone and other concomitant dopaminergic medicinal products.
Od uvedbe zdravila na trg so poročali o posameznih primerih NMS, posebej po nenadnem zmanjšanju odmerka ali prekinitvi zdravljenja z entakaponom in drugimi sočasno uporabljanimi dopaminergičnimi zdravili.
Entacapone increases the bioavailability of levodopa from standard levodopa/benserazide preparations 5-10% more than from standard levodopa/carbidopa preparations.
Entakapon poveča biološko uporabnost levodope v standardnih pripravkih levodope/benserazida za 5-10 % bolj kot v standardnih pripravkih levodope/karbidope.
Suddenly stopping Entacapone Teva and other medicines to treat Parkinson´s disease may result in unwanted side effects.
Nenadna prekinitev zdravljenja z zdravilom Entakapon Teva in drugimi zdravili za Parkinsonovo bolezen lahko povzroči neželene učinke.
305, 74770 Opava-Komarov, Czech Republic
74770 Opava-Komarov
Hence, the precautions valid for levodopa treatment should also be taken into account for entacapone treatment.
Zato je treba pri zdravljenju z entakaponom upoštevati tudi previdnostne ukrepe, ki veljajo za zdravljenje z levodopo.
Patients being treated with entacapone in association with levodopa and presenting with somnolence and/or sudden sleep onset episodes must be instructed 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 have resolved (see also section 4.4).
Bolnikom, ki se zdravijo z entakaponom v povezavi z levodopo in ki poročajo o zaspanosti in/ali nenadnih napadih spanja, je treba naročiti, naj ne upravljajo motornih vozil in naj se ne ukvarjajo z dejavnostmi, pri katerih lahko zaradi zmanjšane pazljivosti sebe ali druge spravijo v nevarnost resne poškodbe ali smrti (na primer uporaba strojev), dokler takšni ponavljajoči se napadi ne izginejo
Elderly patients No dosage adjustment of entacapone is required for elderly patients.
Za starejše bolnike ni potrebno prilagajanje odmerjanja entakapona.
According to in vitro studies, significant displacement is not anticipated at therapeutic concentrations of the medicinal products.
Glede na opravljene študije in vitro pri terapevtskih koncentracijah zdravil ni predvideno pomembno izrinjanje.
Entacapone Teva is taken together with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations).
Zdravilo Entakapon Teva se jemlje skupaj z zdravili, ki vsebujejo levodopo (bodisi pripravki levodope/karbidope bodisi pripravki levodope/benserazida).
Entacapone Teva has no effect on relieving the symptoms of Parkinson´s disease unless taken with levodopa.
Zdravilo Entakapon Teva ne lajša simptomov Parkinsonove bolezni, če ga bolnik ne vzame skupaj z levodopo.
The recommended dose of Entacapone Teva is one 200 mg tablet with each levodopa dose.
Priporočeni odmerek zdravila Entakapon Teva je ena 200-miligramska tableta z vsakim odmerkom levodope.
30 film-coated tablets 60 film-coated tablets 100 film-coated tablets 175 film-coated tablets
30 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet 175 filmsko obloženih tablet
Hepatitis with mainly cholestatic features (see section 4.4.)
hepatitis s prevladujočimi znaki holestaze (glejte poglavje
Entacapone in association with levodopa has been associated with somnolence and episodes of sudden sleep onset in patients with Parkinson's disease and caution should therefore be exercised when driving or operating machines (see also section 4.7).
Pri bolnikih s Parkinsonovo boleznijo je entakapon v povezavi z levodopo povezan s somnolenco in epizodami nenadnih napadov spanja, zato je pri upravljanju motornih vozil in strojev potrebna previdnost (glejte tudi poglavje 4.7).
The daily dose of levodopa should be reduced by about 10-30% by extending the dosing intervals and/or by reducing the amount of levodopa per dose, according to the clinical condition of the patient.
Glede na bolnikovo klinično stanje je treba dnevni odmerek levodope zmanjšati za približno 1030 %, in sicer s podaljšanjem časovnega presledka med posameznimi odmerki in/ali z zmanjšanjem količine levodope na odmerek.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov, navedeno v poglavju
How to store Entacapone Teva Contents of the pack and other information
Shranjevanje zdravila Entakapon Teva Vsebina pakiranja in dodatne informacije
Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has been observed rarely in patients with Parkinson's disease.
Redko so opažali rabdomiolizo, ki nastane sekundarno pri težkih diskinezijah ali nevroleptičnem malignem sindromu (NMS) pri bolnikih s Parkinsonovo boleznijo.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
POGOJI ALI OMEJTIVE GLEDE OSKRBE IN UPORABE
Entacapone Teva film-coated tablets are light brown, biconvex ellipse-shaped with approximately 18 mm length and 10 mm width, embossed with “E200” on one side and plain on the other side.
Entakapon Teva 200 mg filmsko obložene tablete so svetlorjave, bikonveksne tablete v obliki elipse, dolge približno 18 mm in široke 10 mm, z vtisom »E200« na eni strani, na drugi strani pa brez vtisa.
Contents of the pack and other information What Entacapone Teva contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Entakapon Teva
Isolated cases of NMS have been reported following abrupt reduction or discontinuation of entacapone and other dopaminergic treatments.
Poročali so o posameznih primerih NMS, ki so sledili nenadnemu zmanjšanju odmerka ali prekinitvi zdravljenja z entakaponom in drugimi dopaminergičnimi zdravili.
One 200 mg tablet is taken with each levodopa/dopa decarboxylase inhibitor dose.
Ena tableta po 200 mg se vzame z vsakim odmerkom levodope/zaviralca dopa-dekarboksilaze.
60 film-coated tablets 100 film-coated tablets 175 film-coated tablets
60 filmsko obloženih tablet 100 filmsko obloženih tablet 175 filmsko obloženih tablet
The other major class of adverse reactions are gastrointestinal symptoms, including nausea, vomiting, abdominal pain, constipation and diarrhoea.
Druga pomembna skupina neželenih učinkov so simptomi s strani prebavil, ki obsegajo navzeo, bruhanje, bolečine v trebuhu, zapeko in drisko.
Approximately 10-20% is excreted in urine.
Približno 10-20 %
Entacapone may form chelates with iron in the gastrointestinal tract.
Entakapon lahko v prebavilih tvori kelate z železom.
The following adverse reactions, listed below in Table 1, have been accumulated both from clinical studies with entacapone and since the introduction of entacapone into the market.
Tabelarični pregled neželenih učinkov Neželeni učinki, ki so navedeni spodaj v preglednici 1, so bili opaženi v kliničnih študijah z entakaponom in po prihodu entakapona na trg.
In addition, Entacapone Teva taken with levodopa may make you feel very drowsy, or cause you to sometimes find yourself suddenly fall asleep.
Poleg tega lahko zdravilo Entakapon Teva, ki ga vzamete skupaj z levodopo, povzroči hudo zaspanost ali povzroči, da včasih ugotovite, da ste nenadoma zaspali.
Light brown, biconvex, ellipse-shaped film-coated tablets with approximately 18 mm length and 10 mm width, embossed ‘E200' on one side, plain on the other side.
Svetlorjave, bikonveksne filmsko obložene tablete v obliki elipse, dolge približno 18 mm in široke 10 mm, z vtisom »E200« na eni strani, na drugi strani pa brez vtisa.
Entacapone decreases the metabolic loss of levodopa to 3O-methyldopa (3-OMD) by inhibiting the COMT enzyme.
Entakapon z zaviranjem encima COMT zmanjšuje izgubo levodope zaradi presnavljanja v 3-O-metildopo (3-OMD).
The prescribing information for these levodopa preparations is applicable to their concomitant use with entacapone.
Informacije za predpisovanje teh pripravkov levodope veljajo tudi, če jih bolnik jemlje sočasno z entakaponom.
Entacapone Teva may make it harder for you to digest iron.
Zdravilo Entakapon Teva lahko oteži prebavljanje železa.
Iron oxide yellow (E172) Lecithin (soya) Iron oxide red (E172)
rdeči železov oksid (E172)
- If you have any further questions, ask your doctor or pharmacist.
− Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
When stopping your doctor may need to re-adjust the dosage of your other medicines to treat Parkinson´s disease.
Pri prekinitvi jemanja vam bo zdravnik mogoče prilagodil odmerjanje drugih vaših zdravil za zdravljenje Parkinsonove bolezni.
Entacapone should only be used in combination with levodopa/benserazide or levodopa/carbidopa.
Entakapon se uporablja samo v kombinaciji z levodopo/benserazidom ali levodopo/karbidopo.
If you forget to take Entacapone Teva
Če ste pozabili vzeti zdravilo Entakapon Teva
Fatigue, sweating increased, fall
utrujenost, povečano znojenje, padci zelo redki:
Be particularly careful when you drive or when you use tools or machinery.
Bodite še posebno previdni, kadar vozite,
If you stop taking Entacapone Teva
Če ste prenehali jemati zdravilo Entakapon Teva
Pharmacotherapeutic group: other dopaminergic agents, ATC code: N04BX02.
Farmakoterapevtska skupina: drugi dopaminergiki, oznaka ATC: N04BX02 Entakapon pripada novi skupini zdravil, zaviralcem katehol-O-metiltransferaze (COMT).
Thus, control of INR is recommended when entacapone treatment is initiated for patients receiving warfarin.
Zato je pri uvajanju zdravljenja z entakaponom bolnikom, ki dobivajo varfarin, priporočljivo kontroliranje INR.
However, the experience of the clinical use of entacapone with several medicinal products, including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine, and medicinal products that are metabolised by COMT (e.g. catecholstructured compounds: rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, apomorphine, and paroxetine) is still limited.
Vendar so izkušnje s klinično uporabo entakapona z več zdravili, med drugim z zaviralci MAO-A, tricikličnimi antidepresivi, zaviralci ponovnega privzema noradrenalina, kot so desipramin, maprotilin in venlafaksin, in zdravili, ki jih presnavlja COMT (na primer spojine s kateholno skupino: rimiterol, izoprenalin, adrenalin,
When Entacapone Teva is given at higher doses:
Pri uporabi višjih odmerkov zdravila Entakapon Teva:
Urine discoloration
sprememba barve urina
Hepatic function tests abnormal
• nenormalni izvidi testov jetrne funkcije.
Entacapone is administered orally and simultaneously with each levodopa/carbidopa or levodopa/benserazide dose.
Način uporabe Entakapon se uporablja peroralno in sočasno z vsakim odmerkom levodope/karbidope ali levodope/benserazida.
Usually the adverse reactions caused by entacapone are mild to moderate.
Neželeni učinki, ki jih povzroča entakapon, so navadno blagi do zmerni.
Entacapone increases the bioavailability of levodopa from standard levodopa/benserazide preparations slightly (5-10%) more than from standard levodopa/carbidopa preparations.
Entakapon nekoliko bolj (za 5-10 %) poveča biološko uporabnost levodope iz standardnih pripravkov levodope/benserazida kot iz standardnih pripravkov levodope/karbidope.
Usually side effects caused by Entacapone Teva are mild to moderate.
Neželeni učinki, ki jih povzroča zdravilo Entakapon Teva, so navadno blagi do zmerni.
Entacapone may aggravate levodopa-induced orthostatic hypotension.
Entakapon lahko poslabša ortostatsko hipotenzijo, ki jo povzroči levodopa.
Starch, pregelatinised Magnesium stearate
Jedro tablete mikrokristalna celuloza povidon predgelirani škrob magnezijev stearat
vivid dreams, and confusion; - heart or artery disease events (e.g. chest pain).
• dogodki pri boleznih srca oziroma arterijskih boleznih (na primer bolečina v prsih).
Uncommon (may affect up to 1 in 100 people): - Heart attack.
Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov):
In doses of 1,400 to 2,000 mg per day, the following side effects are more common: - Uncontrollable movements; - nausea; - abdominal pain.
Pri odmerkih 1.400 do 2.000 mg na dan so bolj pogosti naslednji neželeni učinki:
Entacapone Teva taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep.
Zdravilo Entakapon Teva, ki ga vzamete skupaj z levodopo, lahko povzroča zaspanost ali povzroči, da včasih nenadoma zaspite.
Mogilska 80, 31-546, Krakow, Poland
31-546, Krakow
Entacapone in association with levodopa has been associated with isolated cases of excessive daytime somnolence and sudden sleep onset episodes.
Opis izbranih neželenih učinkov Entakapon v povezavi z levodopo povezujejo s posameznimi primeri čezmerne zaspanosti podnevi in napadov nenadnega spanja.
What Entacapone Teva looks like and contents of the pack
Izgled zdravila Entakapon Teva in vsebina pakiranja
inhibitors (e.g. phenelzine, tranylcypromine).
MAO-B) (na primer fenelzina in tranilcipromina).
How to take Entacapone Teva
Kako jemati zdravilo Entakapon Teva
The elimination of entacapone occurs mainly by non-renal metabolic routes.
Entakapon se odstranjuje iz telesa v glavnem po presnovnih poteh, ki vodijo mimo ledvic.
Entacapone is always given as an adjunct to levodopa treatment.
Entakapon vedno predpisujemo kot dodatek k levodopi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (30, 60, 100 or 175 film-coated tablets)
PODATKI NA ZUNANJI OVOJNINI OVOJNINI ŠKATLA (30, 60, 100 ali 175 filmsko obloženih tablet)
No overt teratogenic or primary foetotoxic effects were observed in animal studies in which the exposure levels of entacapone were markedly higher than the therapeutic exposure levels.
V študijah na živalih, kjer je bila izpostavljenost entakaponu znatno večja kot med zdravljenjem ljudi, niso bili opaženi očitni teratogeni ali primarni toksični učinki na plod.