FrancophonIA/ELRC3.0 huggingface dataset:
English: Each orodispersible tablet contains 50 mg of sildenafil (as the citrate salt).
Slovenian: Ena orodisperzibilna tableta vsebuje 50 mg sildenafila (v obliki soli sildenafilijevega citrata).
English: VIAGRA 50 mg tablets Sildenafil
Slovenian: VIAGRA 50 mg tablete sildenafil
English: VIAGRA 50 mg tablets Blue, rounded, diamond-shaped tablets, marked “PFIZER” on one side and “VGR 50” on the other.
Slovenian: Tablete so modre barve, v obliki romba z zaobljenimi robovi ter oznako "PFIZER" na eni in "VGR 50" na drugi strani.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite katerikoli neželeni učinek, se posvetujte zzdravnikom, farmacevtom ali medicinsko sestro.
English: Non-arteritic anterior ischaemic optic neuropathy (NAION) Retinal vascular occlusion*, Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma, Visual field defect, Diplopia, Visual acuity reduced, Myopia, Asthenopia, Vitreous floaters, Iris disorder, Mydriasis, Halo vision, Eye oedema, Eye swelling, Eye disorder, Conjunctival hyperaemia, Eye irritation, Abnormal sensation in eye, Eyelid oedema, Scleral discoloration
Slovenian: Očesne bolezni motnje zaznavanja barv**, motnje vida, zamegljen vid motnje solzenja***, bolečine v očeh, fotofobija, fotopsija, očesna hiperemija, občutek svetlosti pri gledanju, konjunktivitis nearteritična anteriorna ishemična optična nevropatija (NAION)*, zapora mrežnične vene*, krvavitev mrežnice, arteriosklerotična retinopatija, motnje mrežnice, glavkom, izpad vidnega polja, diplopija, zmanjšanje ostrine vida, miopija, astenopija, motnjave v steklovini, motnje šarenice, midriaza, videnje svetlobnih krogov, očesni edem, oteklost oči, očesna bolezen, hiperemija veznice, draženje oči, nenormalen občutek v očeh, edem vek, obarvanje beločnice
English: Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction, ATC Code: G04B E03.
Slovenian: Farmakoterapevtska skupina: zdravila za bolezni sečil, zdravila za zdravljenje erektilne disfunkcije.
English: VIAGRA 25 mg film-coated tablets Sildenafil
Slovenian: VIAGRA 25 mg filmsko obložene tablete sildenafil
English: EU/1/98/077/015 (2 film-coated tablets) EU/1/98/077/010 (4 film-coated tablets) EU/1/98/077/011 (8 film-coated tablets) EU/1/98/077/012 (12 film-coated tablets) EU/1/98/077/025 (24 film-coated tablets)
Slovenian: EU/1/98/077/015 (2 filmsko obloženi tableti) EU/1/98/077/010 (4 filmsko obložene tablete) EU/1/98/077/011 (8 filmsko obloženih tablet) EU/1/98/077/012 (12 filmsko obloženih tablet) EU/1/98/077/025 (24 filmsko obloženih tablet)
English: You should be aware of how you react to VIAGRA before you drive or use machinery.
Slovenian: Zdravilo VIAGRA lahko povzroči omotico in lahko neugodno vpliva na vid. Preden vozite ali upravljate s stroji, morate vedeti, kako se odzivate na zdravilo VIAGRA.
English: EU/1/98/077/016 (2 film-coated tablets) EU/1/98/077/017 (4 film-coated tablets) EU/1/98/077/018 (8 film-coated tablets) EU/1/98/077/019 (12 film-coated tablets)
Slovenian: EU/1/98/077/016 (2 filmsko obloženi tableti) EU/1/98/077/017 (4 filmsko obložene tablete) EU/1/98/077/018 (8 filmsko obloženih tablet) EU/1/98/077/019 (12 filmsko obloženih tablet)
English: VIAGRA 50 mg orodispersible tablets Sildenafil
Slovenian: VIAGRA 50 mg orodisperzibilne tablete sildenafil
English: VIAGRA 100 mg film-coated tablets Sildenafil
Slovenian: VIAGRA 100 mg filmsko obložene tablete sildenafil
English: Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 mL/min) a 25 mg dose should be considered.
Slovenian: Pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) je očistek sildenafila zmanjšan, zato je priporočljivi začetni odmerek 25 mg. Glede na učinkovitost in prenašanje se odmerek lahko postopoma zveča na 50 mg do 100 mg, če je to potrebno.
English: VIAGRA 50 mg film-coated tablets Sildenafil
Slovenian: VIAGRA 50 mg filmsko obložene tablete sildenafil
English: EU/1/98/077/013 (2 film-coated tablets) EU/1/98/077/002 (4 film-coated tablets) EU/1/98/077/003 (8 film-coated tablets) EU/1/98/077/004 (12 film-coated tablets)
Slovenian: EU/1/98/077/013 (2 filmsko obloženi tableti) EU/1/98/077/002 (4 filmsko obložene tablete) EU/1/98/077/003 (8 filmsko obloženih tablet) EU/1/98/077/004 (12 filmsko obloženih tablet)
English: EU/1/98/077/014 (2 film-coated tablets) EU/1/98/077/006 (4 film-coated tablets) EU/1/98/077/007 (8 film-coated tablets) EU/1/98/077/008 (12 film-coated tablets) EU/1/98/077/024 (24 film-coated tablets)
Slovenian: EU/1/98/077/014 (2 filmsko obloženi tableti) EU/1/98/077/006 (4 filmsko obložene tablete) EU/1/98/077/007 (8 filmsko obloženih tablet) EU/1/98/077/008 (12 filmsko obloženih tablet) EU/1/98/077/024 (24 filmsko obloženih tablet)
English: Vertigo, Tinnitus Deafness
Slovenian: Bolezni sečil hematurija
English: Contact your doctor if you take more tablets than you should.
Slovenian: Če vzamete več tablet, kot vam je bilo naročeno, se posvetujte z zdravnikom.
English: EU Number Invented Name Strength Pharmaceutical Form
Slovenian: EU številka Izmišljeno ime
English: London, 22 March 2007 Doc.
Slovenian: London, 22. marec 2007 Sklic dok.
English: International non-proprietary name (INN): ruboxistaurin
Slovenian: Mednarodno nelastniško ime (INN): ruboksistavrin
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Slovenian: Če pa ste vključeni v klinično preizkušanje in potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: The main measure of effectiveness was the proportion of patients in each group who experienced a loss of vision at the end of the study.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov v vsaki skupini, pri katerih je prišlo do izgube vida do konca študije.
English: ‘Non-proliferative' means that the disease is an early stage, during which the patient may not notice any change in vision.
Slovenian: „Neproliferativna“ pomeni, da je bolezen v zgodnji stopnji, ko bolnik morda sploh ne opazi sprememb vida.
English: Ref. EMEA/117441/2007
Slovenian: EMEA/44534/2008
English: The committee also had concerns over the medicine's side effects, particularly disturbances of the heart rhythm.
Slovenian: Odbor je imel zadržke tudi glede neželenih učinkov zdravila, zlasti motenj srčnega ritma.
English: Retinopathy can eventually lead to a loss of vision and even blindness.
Slovenian: Retinopatija lahko sčasoma povzroči poslabšanje vida in celo slepoto.
English: This was assessed by measuring the number of letters they could see on a standard vision chart: a fall of 15 letters or more over six months was considered to be a loss of vision.
Slovenian: Slednje se je ocenjevalo na podlagi štetja črk, ki jih je preiskovanec lahko videl na standardni okulistični tabli: zmanjšanje rezultata za 15 črk ali več v šestih mesecih se je štelo za izgubo vida.
English: The CHMP had formulated a list of questions to be answered by the company, but the company had not yet responded to them.
Slovenian: CHMP je pripravil seznam vprašanj, na katera naj bi družba odgovorila, vendar tega doslej še ni storila.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for ARXXANT
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom ARXXANT
English: The effects of ARXXANT were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila ARXXANT so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: How far into the evaluation was the application when it was withdrawn?
Slovenian: Kako daleč je bil postopek ocenjevanja vloge v času njenega umika?
English: The company presented the results of one main study involving 685 patients with moderately severe to very severe non-proliferative diabetic retinopathy.
Slovenian: Družba je predložila rezultate ene glavne študije, v katero je bilo vključenih 685 bolnikov z zmerno do zelo hudo neproliferativno diabetično retinopatijo.
English: In patients with diabetes, high levels of glucose (sugar) in the blood may cause this enzyme to become overactivated, leading to damage to the blood vessels.
Slovenian: Pri bolnikih s sladkorno boleznijo lahko visoke ravni glukoze (sladkorja) v krvi povzročijo prekomerno aktivacijo tega encima, kar vodi v poškodbe žil.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with ARXXANT?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih zdravila ARXXANT?
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Slovenian: Ko družba pripravi odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja lahko do 180. dne zaprosi družbo še za odgovore na dodatna vprašanja.
English: What documentation did the company present to support its application to the CHMP?
Slovenian: Katero dokumentacijo je podjetje v podporo vlogi predložilo CHMP?
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Slovenian: Na podlagi pregleda začetne dokumentacije CHMP do 120. dne postopka pripravi seznam vprašanj, ki ga pošlje družbi.
English: The study compared the effects of ARXXANT and placebo (a dummy treatment) over three years.
Slovenian: V študiji so učinke zdravila ARXXANT primerjali s placebom (zdravilom brez zdravilne učinkovine) v obdobju treh let.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a licence.
Slovenian: Ko CHMP izda mnenje, Evropska komisija v približno dveh mesecih izda dovoljenje.
English: The CHMP was concerned that the effectiveness of ARXXANT had not been proven adequately in the clinical study.
Slovenian: CHMP je imel zadržke, da učinkovitost zdravila ARXXANT v klinični študiji ni bila zadostno dokazana.
English: Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that ARXXANT could not have been approved for the treatment of diabetic retinopathy in adult patients with moderate to severe non-proliferative retinopathy.
Slovenian: Na podlagi pregleda podatkov v času umika vloge je imel CHMP nekaj zadržkov in bil začasnega mnenja, da zdravila ARXXANT ni mogoče odobriti za zdravljenje diabetične retinopatije pri odraslih bolnikih z zmerno do hudo neproliferativno retinopatijo.
English: Retinopathy is damage to the blood vessels within the retina, the light-sensitive surface at the back of the eye.
Slovenian: Retinopatija je poškodba žil v mrežnici, za svetlobo občutljivi površini na zadnji strani očesa.
English: ARXXANT is a medicine that contains the active substance ruboxistaurin (as 32 mg tablets).
Slovenian: Zdravilo ARXXANT vsebuje zdravilno učinkovino ruboksistavrin (v obliki 32 mg tablet).
English: What was ARXXANT expected to be used for?
Slovenian: Za kaj naj bi se zdravilo ARXXANT uporabljalo?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with ARXXANT.
Slovenian: Družba je obvestila CHMP, da umik nima posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila ARXXANT.
English: By blocking PKC beta, ruboxistaurin is expected to prevent damage to the blood vessels and loss of vision.
Slovenian: Ruboksistavrin naj bi z blokiranjem PKC beta preprečil poškodbe žil in izgubo vida.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of ARXXANT had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Slovenian: Zato je bil v času umika vloge CHMP mnenja, da koristni učinki zdravila ARXXANT niso bili zadostno dokazani in da morebitni koristni učinki ne odtehtajo znanih tveganj.
English: The active substance in ARXXANT, ruboxistaurin, blocks the activity of the enzyme protein kinase C (PKC) beta.
Slovenian: Zdravilna učinkovina zdravila ARXXANT je ruboksistavrin, ki zavira delovanje encima protein-kinaze C (PKC) beta.
English: On 13 March 2007, Eli Lilly Nederland B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for ARXXANT, for the treatment of diabetic retinopathy in adult patients with moderate to severe non-proliferative retinopathy.
Slovenian: marca 2007 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom ARXXANT, namenjeno zdravljenju diabetične retinopatije pri odraslih bolnikih z zmerno do hudo neproliferativno retinopatijo.
English: ARXXANT was expected to be used to treat adult patients who have moderate to severe non-proliferative retinopathy as a complication of diabetes.
Slovenian: Zdravilo ARXXANT naj bi se uporabljalo za zdravljenje odraslih bolnikov z zmerno do hudo neproliferativno retinopatijo, ki je zaplet sladkorne bolezni.
English: How is ARXXANT expected to work?
Slovenian: Kako naj bi zdravilo ARXXANT delovalo?
English: What is ARXXANT?
Slovenian: Kaj je zdravilo ARXXANT?
English: The application was at day 120 when the company withdrew.
Slovenian: Družba je vlogo umaknila na 120. dan postopka.
English: This damage causes the blood vessels to leak fluid, leading to swelling in the retina.
Slovenian: Zaradi te poškodbe iz žil izteka tekočina, kar povzroči otekanje mrežnice.
English: This is a naturally-occurring enzyme that is responsible for regulating the activity of blood vessels in the retina.
Slovenian: Ta naravno prisotni encim sodeluje pri uravnavanju aktivnosti žil v mrežnici.
English: 49 x 1 tablets (unit dose)
Slovenian: 49 x 1 tableta (za enkratni odmerek)
English: 84 (4 x 21) tablets (multipack)
Slovenian: 84 (4 x 21) tablet (skupno pakiranje)
English: Film-coated tablet Oral use blister (PVC/PE/PCTFE/alu)
Slovenian: 100 mg / 40 mg filmsko obložene tablete peroralna uporaba pretisni omot (PVC/PE/PCTFE/alu)
English: Your doctor will advise you what to do.
Slovenian: Vaš zdravnik vam bo svetoval kaj storiti.
English: Investigator's global assessments of efficacy also showed significant improvement.
Slovenian: Preiskovalčevo celostno vrednotenje učinkovitosti je prav tako pokazalo pomembno izboljšanje.
English: frequency cannot be estimated from the available data
Slovenian: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
English: However clinical circumstances of these cases were so diverse, that no general conclusions can be drawn from the cases.
Slovenian: Klinične okoliščine v teh primerih so bile tako raznolike, da iz njih ne moremo strniti splošnih zaključkov.
English: Your doctor may need to review your treatments.
Slovenian: Vaš zdravnik bo moral morda ponovno oceniti vaše zdravljenje.
English: Take it as soon as you remember, then continue to take it at the usual times.
Slovenian: Vzemite ga takoj, ko se spomnite, potem z jemanjem nadaljujte ob običajnih časih.
English: If this happens notify your doctor.
Slovenian: Če se to zgodi, obvestite svojega zdravnika.
English: Clinical Efficacy and Safety
Slovenian: Klinična Učinkovitost in Varnost:
English: Therefore, the following preventive measures have to be considered.
Slovenian: Zato je potrebno upoštevati naslednje preventivne ukrepe.
English: The following preventive measures have to be considered.
Slovenian: Treba je upoštevati naslednje preventivne ukrepe.
English: Distribution: The volume of distribution (Vss) of tolcapone is small (9 l).
Slovenian: Porazdelitev: volumen porazdelitve (Vss) tolkapona je majhen (9 l).
English: The increases usually appeared within 6 to 12 weeks of starting treatment, and were not associated with any clinical signs or symptoms.
Slovenian: Povišanja so se običajno pojavila med 6 in 12 tednom zdravljenja, in niso bila povezana z nobenimi kliničnimi znaki ali simptomi.
English: These adverse reactions were predictable based on the known adverse reactions to each of the three drugs individually.
Slovenian: Te neželene učinke je bilo mogoče napovedati na osnovi znanih neželenih reakcij vsakega od treh zdravil posamezno.
English: other important symptoms are high fever and mental confusion.
Slovenian: - ostala pomembna simptoma sta visoka vročina in duševna zmedenost.
English: - Impulse control disorders (inability to resist the impulse of an action that could be harmful).
Slovenian: - Motnje nadzora impulzov (nezmožnost upreti se impulzu, da izvedete dejanje, ki je lahko škodljivo).
English: Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely.
Slovenian: Nenadno uspavanje med dnevnimi dejavnostmi, v nekaterih primerih brez zavedanja ali opozorilnih znakov, je bilo redko.
English: 35-959 Rzeszów Poland
Slovenian: 35-959 Rzeszów Poljska
English: Management of overdose: Hospitalisation is advised.
Slovenian: Ukrepi pri prevelikem odmerjanju: priporoča se hospitalizacija.
English: Overall, the frequency of adverse reactions increased slightly.
Slovenian: Skupno se je pogostnost neželenih učinkov rahlo povečala.
English: There is no relevant indication for use in children and adolescents.
Slovenian: Ne obstaja relevantna indikacija za uporabo pri otrocih in mladostnikih.
English: Any other yellow urine discolouring is usually harmless.
Slovenian: Vsa ostala rumena obarvanja urina so navadno neškodljiva.
English: Tolcapon e N=75
Slovenian: tolkapon n = 75
English: Tolcapone does not distribute widely into tissues due to its high plasma protein binding (>99.9 %).
Slovenian: Tolkapon se v tkiva ne porazdeli v velikem obsegu zaradi njegove visoke vezave na plazemske proteine (> 99,9 %).
English: Studies in healthy volunteers and parkinsonian patients have confirmed that the maximum effect occurs with 100 - 200 mg tolcapone.
Slovenian: Študije pri zdravih prostovoljcih in Parkinsonovih bolnikih so potrdile, da največji učinek nastane s 100 - 200 mg tolkapona.
English: Accordingly, such patients should not be considered for re-treatment.
Slovenian: Taki bolniki niso primerni za ponovno zdravljenje.
English: The magnitude of the effect was dependent on the dose of benserazide.
Slovenian: Velikost učinka je bila odvisna od odmerka benserazida.
English: General supportive care is indicated.
Slovenian: Indicirana je splošna podporna oskrba.
English: In this case your doctor may perform regular blood tests to monitor how easily your blood clots.
Slovenian: V tem primeru lahko vaš zdravnik predpiše redne krvne preiskave za spremljanje strjevanja krvi.
English: However, it is generally believed that early detection of medicine-induced hepatic injury along with immediate withdrawal of the suspect medication enhances the likelihood for recovery.
Slovenian: Toda, v splošnem smatramo, da zgodnje odkritje z zdravili povzročene poškodbe jeter skupaj s takojšnjo ukinitvijo osumljenega zdravila, poveča možnost okrevanja.
English: Therefore, clinically relevant interactions involving cytochrome CYP2C9 appear unlikely.
Slovenian: Zatorej klinično pomembne interakcije, povezane s citokromom CYP2C9, niso verjetne.
English: Reducing the dose of levodopa (see section 4.2) may often mitigate these adverse reactions.
Slovenian: Zmanjšanje odmerka levodope (glejte poglavje 4.2) lahko velikokrat ublaži neželene učinke.
English: Muscle injury can sometimes cause dark urine.
Slovenian: Poškodba mišic lahko včasih povzroči temen urin.
English: In about half the cases, transaminase levels returned spontaneously to baseline values whilst patients continued Tasmar treatment.
Slovenian: Pri približno polovici primerov so se vrednosti transaminaze spontano vrnile na osnovne vrednosti, medtem ko so bolniki nadaljevali zdravljenje z zdravilom Tasmar.
English: Absorption: Tolcapone is rapidly absorbed with a tmax of approximately 2 hours.
Slovenian: Absorpcija: tolkapon se hitro absorbira s tmax približno 2 uri.
English: You must tell your doctor if you are pregnant or intend to become pregnant.
Slovenian: Zdravniku morate povedati, če ste noseči ali nameravate zanositi.
English: Periodic monitoring of liver enzymes cannot reliably predict the occurrence of fulminant hepatitis.
Slovenian: S periodičnim spremljanjem ravni jetrnih encimov ne moremo zanesljivo napovedati nastanka fulminantnega hepatitisa.
English: There are no adequate data from the use of tolcapone in pregnant women.
Slovenian: Zadostnih podatkov o uporabi tolkapona pri nosečnicah ni.
English: If you go to hospital or if you are prescribed a new medicine, you must tell your doctor that you are taking Tasmar.
Slovenian: Če greste v bolnišnico ali vam je bilo predpisano novo zdravilo, morate zdravniku povedati, da jemljete zdravilo Tasmar.
English: This reduction may increase the average concentration of unbound drug two-fold.
Slovenian: To zmanjšanje lahko dvakratno poveča povprečno koncentracijo nevezane učinkovine.
English: This is due to a decrease in clearance in L-dopa resulting in a prolongation of the terminal elimination half-life (t1/2) of levodopa.
Slovenian: To je zaradi zmanjšanja očistka L-dope, ki se kaže v podaljšanju končne eliminacijske razpolovne dobe (t1/2) levodope.
English: The safety of tolcapone in infants is unknown; therefore, women should not breast-feed during treatment with Tasmar.
Slovenian: Varnost tolkapona pri otrocih ni znana; zato naj ženske med zdravljenjem z zdravilom Tasmar ne dojijo.
English: Tasmar with food and drink and alcohol Tasmar can be taken with or without food.
Slovenian: Zdravilo Tasmar skupaj s hrano, pijačo in alkoholom Zdravilo Tasmar se lahko jemlje s hrano ali brez nje.
English: Hepatocellular injury
Slovenian: Hepatocelularne poškodbe
English: The absolute bioavailability of an oral administration is around 65 %.
Slovenian: Absolutna biološka uporabnost po peroralnem dajanju je okoli 65-%.
English: Additionally late onset hepatitis after approximately 18 months of treatment has been reported rarely.
Slovenian: Redko so poročali o kasnejšem pojavu hepatitisa po približno 18 mesecih zdravljenja.
English: Do not use Tasmar if you notice that the tablets are damaged.
Slovenian: Ne uporabljate zdravila Tasmar, če ste opazili, da so tablete poškodovane.
English: Tasmar should be taken with 1 glass of water.
Slovenian: Zdravilo Tasmar bi morali jemati z 1 kozarcem vode.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na lokalno predstavništvo imetnika dovoljenja za promet z zdravilom.
English: If you develop any symptoms as described above, that you think may be NMS, you should report them to your doctor immediately.
Slovenian: Če se pri vas pojavijo zgoraj opisani simptomi in menite, da bi lahko šlo za MNS, to nemudoma sporočite svojemu zdravniku.
English: After oral administration, 60 % of drug-related material is excreted into urine and 40 % into faeces.
Slovenian: Po peroralnem jemanju se 60 % z zdravilom povezanih substanc izloči v urin in 40 % v blato.
English: Also contains lactose.
Slovenian: Vsebuje laktozo.
English: *: Adverse reactions for which no frequency could be derived from clinical studies (i.e. where a specific adverse reaction was not observed in clinical trials but was reported post-marketing only) are indicated by an asterisk (*), and the frequency category has been calculated according to EU Guideline.
Slovenian: *: Neželeni učinki, za katere ni bilo mogoče oceniti pogostnosti iz razpoložljivih podatkov iz kliničnih študij (tj. če določenega neželenega učinka niso opazili v kliničnem preskušanju, opazili so ga le v obdobju trženja zdravila), so označeni z zvezdico (*) in njihova pogostnost je bila izračunana v skladu z EU smernico.
English: The onset of effect occurs after the first administration.
Slovenian: Učinek nastopi po prvem dajanju.
English: Impulse control disorders: Patients should be regularly monitored for the development of impulse control disorders.
Slovenian: Motnje nadzora impulzov: Pri bolnikih je treba redno nadzirati morebiten pojav motenj nadzora impulzov.