FrancophonIA/ELRC3.0 huggingface dataset:
English: Increases to more than three times the upper limit of normal (ULN) in alanine aminotransferase (ALT) occurred in 1 % of patients receiving Tasmar 100 mg three times daily, and 3 % of patients at 200 mg three times daily.
Slovenian: Povišanje alanin-aminotransferaze (ALT) do več kot trikratne zgornje referenčne vrednosti (ULN), se je pojavilo pri 1 % bolnikov, ki so prejemali zdravilo Tasmar 100 mg trikrat na dan in pri 3 % bolnikov, ki so prejemali zdravilo Tasmar 200 mg trikrat na dan. Povišanja so bila približno dvakrat verjetnejša pri ženskah.
English: NMS (Neuroleptic Malignant Syndrome): Symptoms of Neuroleptic Malignant Syndrome (NMS) may occur during Tasmar treatment.
Slovenian: Med zdravljenjem z zdravilom Tasmar se lahko pojavijo simptomi malignega nevroleptičnega sindroma (MNS).
English: may affect more than 1 in 10 people
Slovenian: pojavijo se lahko pri več kot 1 od 10 bolnikov pogosti:
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Tasmar in association with levodopa.
Slovenian: Bolniki in negovalci morajo vedeti, da se pri bolnikih, zdravljenih z dopaminskimi agonisti in/ali drugimi dopaminergičnimi zdravili, kot je zdravilo Tasmar v povezavi z levodopo, lahko pojavijo vedenjski simptomi motenj nadzora impulzov, vključno s patološkim igranjem iger na srečo, povečanim libidom, hiperseksualnostjo, kompulzivnim nakupovanjem, prenajedanjem in kompulzivnim hranjenjem.
English: The following suggestions are based on pharmacological considerations and have not been evaluated in clinical trials.
Slovenian: Prilagajanje odmerka levodope ob prekinitvi zdravljenja z zdravilom Tasmar Naslednji predlogi so osnovani glede na farmakologijo in niso bili vrednoteni v kliničnih preskušanjih.
English: The maximum therapeutic dose of 200 mg three times daily should not be exceeded, as there is no evidence of additional efficacy at higher doses.
Slovenian: Ker ni podatkov o dodatni učinkovitosti pri večjih odmerkih, največjega terapevtskega odmerka 200 mg trikrat na dan ne smemo preseči.
English: Transient elevation above pretreatment levels of erythrocyte COMT activity was observed after withdrawal of tolcapone.
Slovenian: Po ukinitvi tolkapona so opazili prehodno povečanje eritrocitne aktivnosti COMT nad vrednosti pred zdravljenjem.
English: Very common: involuntary movement (dyskinesia), nausea, decreased appetite, diarrhoea, headache, dizziness sleep problems, somnolence, feeling lightheaded while you stand, (orthostatic complaints),mental confusion and hallucinations, movement disorder with involuntary muscle spasms or malpositions (dystonia), dreaming excessive.
Slovenian: Zelo pogosti: - nehoteno gibanje (diskinezija), - slabost, izguba apetita, driska, - glavobol, omotica, - težave s spanjem, somnolenca, - občutek vrtoglavice, ko stojite (ortostatske težave), zmedenost in halucinacije, - motnje gibanja z neželenimi mišičnimi krči (distonija), - prekomerne sanje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton and bottle label, 100 film-coated tablets
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN STIČNI OVOJNINI Škatla in nalepka na steklenici, 100 filmsko obloženih tablet
English: Calcium hydrogen phosphate Microcrystalline cellulose Povidone K30
Slovenian: Jedro tablete: kalcijev hidrogenfosfat mikrokristalna celuloza povidon K30 natrijev karboksimetilškrob laktoza smukec magnezijev stearat
English: Talk to your doctor or pharmacist before taking Tasmar.
Slovenian: Pred začetkom jemanja zdravila Tasmar se posvetujte z zdravnikom ali farmacevtom.
English: If you get any side effects talk to you doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Impulse control disorders* (Libido increased, hypersexuality, pathological gambling, compulsive spending or buying, binge eating, compulsive eating (see section 4.4))
Slovenian: Psihiatrične motnje zelo pogosti motnje spanja prekomerne sanje somnolenca zmedenost halucinacija redki motnje nadzora impulzov* (povečan libido, hiperseksualnost, patološko igranje iger na srečo, kompulzivno nakupovanje, prenajedanje in kompulzivno hranjenje (glejte poglavje 4.4))
English: Common: chest pain, constipation, dyspepsia, stomach ache, vomiting, dry mouth, fainting increased sweating, influenza-like symptoms reduced voluntary and involuntary movement (hypokinesia) upper respiratory tract infection increase of specific liver enzymes, urine discoloration
Slovenian: Pogosti: - bolečine v prsih, - zaprtje, dispepsija, bolečine v želodcu, bruhanje, suha usta, - omedlevanje, - povečano potenje, - gripi podobni simptomi, - zmanjšano prostovoljno in neprostovolno gibanje (hipokinezija), - okužba zgornjih dihal, - povišanje specifičnih jetrnih encimov, - sprememba barve urina.
English: Tolcapone does not accumulate with three times daily dosing of 100 or 200 mg. At these doses, Cmax is approximately 3 and 6 µg/ml, respectively.
Slovenian: Tolkapon se ne kopiči pri odmerjanju 100 ali 200 mg trikrat na dan.
English: What do you need to know before you take Tasmar Do not take Tasmar: if you have liver disease or increased liver enzymes if you have severe involuntary movement (dyskinesia) if you have a previous history of severe symptoms of muscle stiffening, fever or mental confusion (Neuroleptic Malignant Syndrome (NMS) Symptom Complex) and /or if you have damage of skeletal muscle tissue (non-traumatic Rhabdomyolysis) if you are hypersensitive (allergic) to the active substance tolcapone or to any of the other ingredients of Tasmar.
Slovenian: Ne jemljite zdravila Tasmar: - če imate bolezen jeter ali povečane jetrne encime; - če imate hudo nehoteno gibanje (diskinezijo); - če ste v preteklosti imeli hude simptome mišične togosti, vročine ali zmedenosti (kompleks simptomov malignega nevroleptičnega sindroma (MNS)) in/ali če imate poškodbe skeletno mišičnega tkiva (netravmatsko rabdomiolizo); - če ste preobčutljivi (alergični) na zdravilno učinkovino tolkapon ali katerokoli sestavino zdravila Tasmar; - če imate posebni tip tumorja nadledvične žleze (feokromocitom); - če jemljete določena zdravila proti depresiji in anksioznosti imenovana neselektivni inhibitorji monoaminooksidaze (MAO).
English: 100 film-coated tablets
Slovenian: 30 filmsko obloženih tablet
English: Always take Tasmar exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Tasmar vedno natančno upoštevajte navodila zdravnika.
English: How to store Tasmar
Slovenian: Shranjevanje zdravila Tasmar
English: may affect up to 1 in 100 people
Slovenian: pojavijo se lahko pri največ 1 od 100 bolnikov redki:
English: What Tasmar looks like and contents of the pack Tasmar is a pale to light yellow, oval shaped, film-coated tablet.
Slovenian: Zdravilo Tasmar je svetla do rahlo rumena, ovalna, filmsko obložena tableta.
English: Review of treatment is recommended if such symptoms develop.
Slovenian: Če se pojavijo taki simptomi, je treba znova oceniti zdravljenje.
English: Each film-coated tablet contains 100 mg tolcapone.
Slovenian: Ena filmsko obložena tableta vsebuje 100 mg tolkapona.
English: Each film-coated tablet contains 200 mg tolcapone.
Slovenian: Ena filmsko obložena tableta vsebuje 200 mg tolkapona.
English: may affect up to 1 in 1,000 people
Slovenian: pojavijo se lahko pri največ 1 od 1.000 bolnikov zelo redki:
English: Also contains lactose See leaflet for further information.
Slovenian: Za več informacij preberite priloženo navodilo.
English: EU/1/97/044/004 30 tablets EU/1/97/044/005 60 tablets
Slovenian: EU/1/97/044/004 30 tablet EU/1/97/044/005 60 tablet
English: Nausea, vomiting and dizziness were observed, particularly in combination with levodopa.
Slovenian: Posebno v kombinaciji z levodopo so opazili slabost, bruhanje in vrtoglavost.
English: Morning
Slovenian: Opomba jutro
English: Mylan Healthcare B.V Krijgsman 20
Slovenian: Mylan Healthcare B.V.
English: EU/1/97/044/001 30 tablets EU/1/97/044/002 60 tablets
Slovenian: EU/1/97/044/001 30 tablet EU/1/97/044/002 60 tablet
English: Tasmar is supplied as film-coated tablets containing 200 mg tolcapone.
Slovenian: Zdravilo Tasmar je v obliki filmsko obložene tablete, ki vsebuje 200 mg tolkapona.
English: Tolcapone's effect on levodopa pharmacokinetics is similar with all pharmaceutical formulations of levodopa/benserazide and levodopa/carbidopa; it is independent of levodopa dose, levodopa/AADC-I (benserazide or carbidopa) ratio and the use of sustained-release formulations.
Slovenian: Tolkaponov učinek na farmakokinetiko levodope je podoben za vse farmacevtske formulacije levodope/benserazida in levodope/karbidope.
English: Tasmar is supplied as film-coated tablets containing 100 mg tolcapone.
Slovenian: Zdravilo Tasmar je v obliki filmsko obložene tablete, ki vsebuje 100 mg tolkapona.
English: Upper respiratory tract infection
Slovenian: Infekcijske in parazitske bolezni pogosti infekcije zgornjih dihal
English: Therefore, you should contact your doctor immediately if you experience symptoms such as nausea, vomiting, pain in your stomach (particulary over the liver in the right upper area), loss of appetite, weakness, fever, darkening of urine, jaundice (yellow skin or eyes) or if you tire more easily.
Slovenian: Če imate simptome, kot so slabost, bruhanje, bolečina v trebuhu (še posebno v zgornjem desnem delu trebuha, v predelu jeter), izguba apetita, šibkost, visoka vročina, temnenje urina ali zlatenica (rumenkasta koža ali beločnica) ali se hitreje utrudite, takoj obvestite svojega zdravnika.
English: Before beginning treatment: To reduce the risk of liver injury you should not use Tasmar if you have a liver disease in case of elevated liver function tests in the blood test done before starting treatment (tests of alanine amino transferase (ALT) and aspartate amino transferase (AST)).
Slovenian: Da bi zmanjšali tveganje za poškodbo jeter, zdravila Tasmar ne smete jemati če imate bolezen jeter, - če krvne preiskave, narejene pred zdravljenjem, kažejo kakršno koli nepravilnost delovanja jeter
English: 30 film-coated tablets 60 film-coated tablets
Slovenian: 60 filmsko obloženih tablet
English: Vomiting Constipation Xerostomia Abdominal pain Dyspepsia
Slovenian: Bolezni prebavil zelo pogosti slabost driska pogosti bruhanje zaprtje kserostomija bolečine v trebuhu dispepsija
English: Tasmar 100 mg film-coated tablets
Slovenian: Tasmar 100 mg filmsko obložena tableta
English: The active substance is tolcapone (100 mg in each film- coated tablet) The other ingredients are:
Slovenian: Kaj vsebuje zdravilo Tasmar - Zdravilna učinkovina je tolkapon (100 mg v eni filmsko obloženi tableti).
English: Tasmar 200 mg film coated tablets
Slovenian: Tasmar 200 mg filmsko obložena tableta
English: if you develop persistent or severe diarrhoea
Slovenian: - če se pojavi driska, ki ne preneha ali huda driska.
English: Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than needed to satisfy your hunger).
Slovenian: Vključuje lahko: o močan impulz za patološko igranje iger na srečo kljub resnim posledicam za vas same ali vašo družino; o spremenjeno ali povečano zanimanje za spolnost ali z njo povezano neobvladljivo vedenje, ki zadeva vas in druge, na primer povečano spolno poželenje; o neobvladljivo prekomerno nakupovanje ali trošenje; o prenajedanje (uživanje velikih količin hrane v kratkem času) ali kompulzivno uživanje hrane (uživanje večje količine hrane kot običajno in več kot je potrebno za potešitev lakote).
English: Tell your doctor or a pharmacist as soon as possible: if you do not feel well while you are taking Tasmar if you experience symptoms such as nausea, vomiting, abdominal pain, loss of appetite, weakness, fever, darkening of urine or jaundice since uncommonly disturbances in the way the liver works, sometimes severe hepatitis was observed, if you notice a darkening of your urine since this could be a sign of a muscular or liver injury.
Slovenian: Čimprej povejte svojemu zdravniku ali farmacevtu: - če se med jemanjem zdravila Tasmar ne počutite dobro - če dobite simptome, kot so slabost, bruhanje, bolečina v trebuhu, izguba apetita, šibkost,
English: Neuroleptic Malignant Syndrome Symptom Complex
Slovenian: MNS (maligni nevroleptični sindrom)
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja pogosti povečano potenje
English: Adverse Events
Slovenian: Neželeni učinki
English: Patients with severe renal impairment (creatinine clearance <30 ml/min) should be treated with caution.
Slovenian: Previdnost je potrebna pri bolnikih s hudo okvaro ledvic (očistek kreatinina <30 ml/min).
English: Dyskinesia Dystonia Headache Dizziness
Slovenian: pvrednost interval zaupanja
English: Therefore you must refrain from driving or operating machines until such recurrent episodes and excessive drowsiness have resolved.
Slovenian: Dokler taka ponavljajoča se obdobja uspavanja in zaspanost ne minejo, opustite vožnjo ali upravljanje strojev.
English: may affect up to 1 in 10 people
Slovenian: pojavijo se lahko pri največ 1 od 10 bolnikov občasni:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: Izgled zdravila Tasmar in vsebina pakiranja
English: Yellow iron oxide Ethylcellulose
Slovenian: Filmska obloga: hipromeloza smukec rumeni železov oksid etilceluloza titanov dioksid triacetin natrijev lavrilsulfat
English: Primary Outcome
Slovenian: DRUGI PODATKI
English: How to take the medication:
Slovenian: NAČIN IZDAJANJA ZDRAVILA
English: Renal and urinary disorders Common
Slovenian: Presnovne in prehranske motnje zelo pogosti anoreksija
English: may affect up to 1 in 10,000 people
Slovenian: pojavijo se lahko pri največ 1 od 10.000 bolnikov neznana pogostnost:
English: The side effects at the higher dose can often be severe and affect your liver, If you do not get better at the higher dose after a total of 3 weeks, your doctor should stop your treatment with Tasmar.
Slovenian: Neželeni učinki pri večjem odmerku so pogosto lahko hudi in prizadenejo vaša jetra.
English: Tasmar 200 mg film-coated tablets Tolcapone
Slovenian: Tasmar 200 mg filmsko obložene tablete tolkapon
English: Renal and urinary disorders
Slovenian: • huda diskinezija,
English: Tasmar 100 mg film-coated tablets Tolcapone
Slovenian: Tasmar 100 mg filmsko obložene tablete tolkapon
English: Nervous system disorders
Slovenian: Bolezni živčevja zelo pogosti diskinezija distonija glavobol
English: This will help to protect against the diseases.
Slovenian: To mu bo pomagalo pri obrambi pred boleznimi.
English: This summary was last updated on 7 September 2011.
Slovenian: Povzetek je bil nazadnje posodobljen dne 07/09/2011.
English: A temporary increase in body temperature of 1-2°C can occur.
Slovenian: Lahko pride do prehodnega povišanja temperature za 1-2 °C.
English: In the future, if the rabbits are exposed to any of the viruses, the immune system will be able to respond more quickly.
Slovenian: Ob ponovni izpostavitvi kuncev kateremu koli virusu se bo v prihodnje imunski sistem lahko hitreje odzval.
English: There may also be a small, painless swelling at the injection site within the first two weeks after vaccination.
Slovenian: Na mestu injiciranja se lahko v obdobju prvih dveh tednov po cepljenju pojavi tudi majhna, neboleča oteklina.
English: It contains a weakened strain of the myxoma virus which has been genetically modified so that it can produce a protein of the RHD virus.
Slovenian: Vsebuje oslabljen sev virusa miksoma, ki je bil gensko spremenjen, tako da lahko proizvaja beljakovino virusa RHD.
English: It is available as a lyophilisate (freeze-dried substance) and a solvent that are made up into a suspension for injection.
Slovenian: Na voljo je v obliki liofilizata (snov, posušena z zmrzovanjem) in vehikla za pripravo suspenzije za injiciranje.
English: Nobivac Myxo-RHD, like all vaccines, works by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Slovenian: Zdravilo Nobivac Myxo-RHD podobno kot vsa cepiva deluje tako, da imunski sistem (naravni obrambni mehanizem telesa) „nauči“, kako naj se brani pred boleznijo.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Slovenian: Karenca je časovno obdobje, ki mora preteči po uporabi zdravila in preden se lahko žival zakolje in meso uporabi za prehrano ljudi.
English: The studies showed that Nobivac Myxo-RHD was effective in providing immunity against myxomatosis and RHD three weeks after vaccination and that the immunty was still present after one year.
Slovenian: Študije so pokazale, da je bilo zdravilo Nobivac Myxo-RHD učinkovito pri zagotavljanju imunosti proti miksomatozi in RHD tri tedne po cepljenju ter da je bila imunost prisotna tudi po enem letu.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nobivac Myxo-RHD to Intervet International BV on 7 September 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Nobivac Myxo-RHD, veljavno po vsej Evropski uniji, odobrila družbi Intervet International BV dne 07/09/2011.
English: Fifteen field and laboratory studies were carried out, in which rabbits vaccinated with Nobivac MyxoRHD were compared with unvaccinated rabbits to establish the onset and duration of immunity against myxoma and RHD viruses.
Slovenian: Izvedenih je bilo 15 preskušanj na terenu in v laboratorijih, pri katerih so kunce, cepljene z zdravilom Nobivac Myxo-RHD, primerjali z necepljenimi kunci pri ugotavljanju začetka in trajanja imunosti proti virusom miksoma in RHD.
English: When it is given to rabbits the immune system recognises the myxoma and RHD materials as ‘foreign' and makes antibodies against them.
Slovenian: Pri cepljenju kuncev njihov imunski sistem viruse miksoma in RHD snovi prepozna kot „tujke“ in proti njim razvije protitelesa.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac Myxo-RHD exceed the risks when used to reduce the number of deaths and clinical signs due to myxomatosis and prevent death due to rabbit haemorrhagic disease.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini ( CVMP ) je zaključil, da so koristi zdravila Nobivac Myxo-RHD večje od z njim povezanih tveganj, kadar se zdravilo uporablja za zmanjševanje smrtnosti in kliničnih znakov miksomatoze ter preprečevanje smrtnosti zaradi hemoragične bolezni kuncev.
English: Nobivac Myxo-RHD is used in rabbits aged five weeks or more to reduce number of deaths and clinical signs due to myxomatosis (skin tumours caused by the myxoma virus) and to prevent death due to rabbit haemorrhagic disease (RHD), a disease resulting in blood clot formation caused by the RHD virus.
Slovenian: Zdravilo Nobivac Myxo-RHD se uporablja pri kuncih, starih pet tednov ali več, za zmanjševanje smrtnosti in kliničnih znakov miksomatoze (kožni tumorji, ki jih povzroča virus miksoma) in preprečevanje smrtnosti zaradi hemoragične bolezni kuncev (RHD), bolezni, pri kateri virus RHD povzroča tvorjenje krvnih strdkov.
English: The Committee recommended that Nobivac Myxo-RHD be given a marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Nobivac Myxo-RHD odobri dovoljenje za promet z zdravilom.
English: Live myxoma vectored RHD virus strain 009
Slovenian: Miksoma virus, živi vektorski RHD sev 009
English: Other information about Nobivac Myxo-RHD:
Slovenian: Druge informacije o zdravilu Nobivac Myxo-RHD:
English: Nobivac Myxo-RHD is a vaccine that contains live myxoma vectored RHD virus strain 009.
Slovenian: Zdravilo Nobivac Myxo-RHD je cepivo, ki vsebuje miksoma virus, živi vektorski RHD sev 009.
English: Rabbits that were vaccinated with Nobivac Myxo-RHD had fewer signs of myxomatosis, more antibodies against RHD virus in their blood and a lower death rate than unvaccinated rabbits.
Slovenian: Pri kuncih, cepljenih z zdravilom Nobivac Myxo-RHD, se je pojavljalo manj znakov miksomatoze, v njihovi krvi je bilo več protiteles proti virusu RHD, stopanja umrljivosti pa je bila nižja kot pri necepljenih kuncih.
English: What benefit has Nobivac Myxo-RHD shown during the studies?
Slovenian: Kakšne koristi je zdravilo Nobivac Myxo-RHD izkazalo med študijami?
English: The swelling will resolve completely by the end of the third week.
Slovenian: Oteklina popolnoma izgine v treh tednih po cepljenju.
English: What is the risk associated with Nobivac Myxo-RHD?
Slovenian: Kakšna tveganja so povezana z zdravilom Nobivac Myxo-RHD?
English: Why has Nobivac Myxo-RHD been approved?
Slovenian: Zakaj je bilo zdravilo Nobivac Myxo-RHD odobreno?
English: The withdrawal period for Nobivac Myxo-RHD is zero days.
Slovenian: Karenca pri zdravilu Nobivac Myxo-RHD je nič dni.
English: What is Nobivac Myxo-RHD used for?
Slovenian: Za kaj se zdravilo Nobivac Myxo-RHD uporablja?
English: How has Nobivac Myxo-RHD been studied?
Slovenian: Kako je bilo zdravilo Nobivac Myxo-RHD raziskano?
English: What is Nobivac Myxo-RHD?
Slovenian: Kaj je zdravilo Nobivac Myxo-RHD?
English: How does Nobivac Myxo-RHD work?
Slovenian: Kako zdravilo Nobivac Myxo-RHD deluje?
English: The daily dose should be divided into at least two single doses.
Slovenian: Dnevni odmerek je treba razdeliti na vsaj dva enkratna odmerka.
English: There are limited data on the long term outcomes.
Slovenian: Podatkov o dolgoročnih izidih je malo.
English: Your doctor will discuss this with you but you should also follow the advice in section 2 of this leaflet.
Slovenian: Zdravnik se bo z vami pogovoril o tem, a upoštevati morate tudi nasvete v 2. poglavju tega navodila.
English: Your doctor will stop your treatment and advise you further.
Slovenian: Zdravnik bo končal vaše zdravljenje in vam svetoval, kako naprej.
English: • The need for regular review of treatment.
Slovenian: • Potrebo po rednem ponovnem ocenjevanju zdravljenja.
English: Valproate is excreted in human milk with a concentration ranging from 1% to 10% of maternal serum levels.
Slovenian: Valproat se pri človeku izloča v materinem mleku v koncentraciji, ki sega od 1 do 10 % koncentracije v materinem serumu.
English: What you need to know before you take <invented name>
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo <Izmišljeno ime>
English: This is a greater risk of major malformations than for the general population, for whom the risk is about 2-3%.
Slovenian: To tveganje je večje od tveganja za hujše malformacije v splošni populaciji, ki je približno 2 do 3 %.
English: Afibrinogenemia has also been reported and may be fatal.
Slovenian: Poročali so tudi o afibrinogenemiji, ki je lahko smrtna.
English: The exact gestational period of risk for these effects is uncertain and the possibility of a risk throughout the entire pregnancy cannot be excluded.
Slovenian: Natančno gestacijsko obdobje tveganja za te učinke je negotovo in ni mogoče izključiti, da tveganje obstaja celotno nosečnost.
English: • The nature and the magnitude of the risks of exposure during pregnancy, in particular the teratogenic risks and the risks of developmental disorders.
Slovenian: • Naravo in stopnjo tveganja izpostavljenosti med nosečnostjo, še posebej tveganje za teratogenost in razvojne motnje.
English: • The need to use effective contraception.
Slovenian: • Potrebo po uporabi učinkovite kontracepcije.
English: However, this syndrome must be distinguished from the decrease of the vitamin-K factors induced by phenobarbital and enzymatic inducers.
Slovenian: Ta sindrom pa je treba razločevati od znižanja faktorjev vitamina K, ki ga povzročijo fenobarbital in induktorji encimov.
English: Developmental disorders
Slovenian: Razvojne motnje
English: In particular the prescriber must ensure the patient understands:
Slovenian: Zdravnik, ki predpiše zdravilo, mora še zlasti poskrbeti, da bolnica razume: