natgillin/translations-raw huggingface dataset:
Although embryo-foetal development was not negatively influenced in rabbits, the study is not considered predictive for human risk assessment.
Iako opikapon nije negativno utjecao na embrionalni i fetalni razvoj kunića, rezultati ispitivanja ne smatraju se prediktivnima za ocjenu rizika u ljudi.
Opicapone may, together with levodopa, cause dizziness, symptomatic orthostatism and somnolence.
Opikapon, zajedno s levodopom, može uzrokovati omaglicu, simptomatsku ortostazu i somnolenciju.
History of neuroleptic malignant syndrome and/or non-traumatic rhabdomyolysis.
Neuroleptički maligni sindrom i/ili netraumatska rabdomioliza u anamnezi.
Medicinal products metabolised by COMT
Lijekovi koji se metaboliziraju pomoću COMT-a
Table 3 - OFF-time responder rates at endpoint Response type
Tablica 3 - omjeri respondera s obzirom na OFF-vrijeme u mjernoj točki ishoda Tip odgovora
There is no relationship between exposure of opicapone and body weight over the range of 40-100 kg.
Izloženost opikaponu i tjelesna težina u rasponu od 40 do 100 kg međusobno nisu povezane.
Table 1 - Frequency of adverse reactions (MedDRA) in placebo-controlled Phase 3 studies System Organ Class
Tablica 1 - Učestalost nuspojava (MedDRA) u placebom kontroliranim ispitivanjima faze 3 Klasifikacija organskih sustava
Opicapone in association with levodopa may have major influence on the ability to drive and use machines.
Opikapon udružen s levodopom može značajno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
Study 1 Change in OFF-time
Ispitivanje 1 Promjena u OFF-vremenu
Removal of opicapone by gastric lavage and/or inactivation by administering activated charcoal should be considered.
Mora se razmotriti potreba uklanjanja opikapona ispiranjem želuca i/ili njegova inaktivacija primjenom aktivnog ugljena.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OPA/Al/PVC//Al
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER OPA/Al/PVC//Al
The results of the open-label (OL) extension studies of 1 year duration in 862 patients who continued treatment from the double-blind studies (Study 1-OL and Study 2-OL) indicated maintenance of the effect achieved during DB study periods.
Rezultati nastavka otvorenih ispitivanja u trajanju od 1 godine na 862 bolesnika koji su nastavili liječenjem iz dvostruko slijepih ispitivanja (Otvoreno ispitivanje 1 i Otvoreno ispitivanje 2) pokazali su održavanje učinka postignutog tijekom perioda dvostruko slijepih ispitivanja.
Change in total ON-time without troublesome dyskinesiasa
Promjena u ukupnom ON-vremenu bez problematičnih diskinezijaa
Your doctor may need to adjust your treatment; - medicines to treat asthma such as rimiterole or isoprenaline.
Vaš će liječnik možda morati prilagoditi Vašu terapiju; - lijekove za liječenje astme poput rimiterola ili izoprenalina.
- The active substance is opicapone.
- Djelatna tvar je opikapon.
A single dose study with opicapone 25 mg showed an average increase of 30 % in the rate, but not the extent, of exposure to repaglinide (a CYP2C8 substrate), when the two drugs were co-administered.
Ispitivanje primjene jednokratne doze od 25 mg opikapona pokazalo je prosječni porast stope za 30% ali ne i opsega izloženosti repaglinidu, supstratu za CYP2C8, kada su se oba lijeka primjenjivala istodobno.
10 hard capsules 30 hard capsules
10 tvrdih kapsula 30 tvrdih kapsula
If end-of-dose motor fluctuations were not sufficiently controlled and tolerability allowed, the opicapone dose could be increased to 50 mg.
Ako motoričke fluktuacije na kraju doze nisu bile dovoljno kontrolirane, a podnošenje lijeka je to dopuštalo, doza opikapona mogla se je povećati na
Ongentys is for use in adults who are already taking medicines containing levodopa and DOPA decarboxylase inhibitors.
Ongentys se primjenjuje u odraslih koji već uzimaju lijekove koji sadrže levodopu i inhibitore DOPA dekarboksilaze.
Opicapone is a weak in vitro inhibitor of CYP2C8 and OATP1B1, whereas repaglinide is a sensitive CYP2C8 and OATP1B1 substrate.
Opikapon je slabi in vitro inhibitor CYP2C8 i OATP1B1, dok je repaglinid osjetljiv supstrat za CYP2C8 i OATP1B1.
If not sufficient to manage the adverse events, the opicapone dose could then be down titrated.
Ako to nije bilo dovoljno za kontrolu štetnih događaja, doza opikapona mogla je postepeno biti smanjivana.
Therefore, it can be presumed that opicapone and its metabolites are mainly excreted in the faeces.
Stoga se može pretpostaviti da se opikapon i njegovi metaboliti uglavnom izlučuju stolicom.
10 hard capsules 30 hard capsules 90 hard capsules
10 tvrdih kapsula 30 tvrdih kapsula 90 tvrdih kapsula
Careful monitoring of patients being treated with these medicinal products is advised when opicapone is used.
Savjetuje se pažljivi nadzor bolesnika liječenih opikaponom kada primaju ove lijekove.
It is unknown whether opicapone or its metabolites are excreted in human milk.
Nije poznato izlučuju li se opikapon ili njegovi metaboliti u majčino mlijeko.
At clinically relevant concentrations, opicapone is not expected to inhibit OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, BCRP, P-gp/MDR1, BSEP, MATE1 and MATE2-K transporters as suggested by in vitro and in vivo studies.
U klinički relevantnim koncentracijama ne očekuje se da opikapon inhibira OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, BCRP, P-gp/MDR1, BSEP, MATE1 i MATE2-K, kako sugeriraju in vitro i in vivo ispitivanja.
How to take Ongentys
Kako uzimati Ongentys
White high density polyethylene (HDPE) bottles with polypropylene (PP) child resistant closures containing 10, 30 or 90 capsules.
Bijele boce od polietilena visoke gustoće (HDPE) sa zatvaračem od polipropilena (PP) sigurnim za djecu, koje sadrže 10, 30 ili 90 kapsula.
Following once-daily multiple oral doses of opicapone in the dose range of 5 to 50 mg, opicapone sulphate presented a long terminal phase with elimination half-life values ranging from 94 h to 122 h and, as a consequence of this long terminal elimination half-life, opicapone sulphate presented a high accumulation ratio in plasma, with values close of up to 6.6.
Nakon višekratne peroralne primjene opikapona, uz doziranjem jedanput na dan u rasponu od 5 do 50 mg, opikaponsulfat je imao dugu terminalnu fazu s vrijednostima poluvijeka eliminacije u rasponu od 94 do 122 h te je, kao posljedicu ovog dugog poluvijeka eliminacije, imao visok omjer akumulacije u plazmi s vrijednostima gotovo do 6,6.
In Study 1, 122 patients were treated with opicapone 5 mg and 122 patients were treated with entacapone 200 mg (active comparator).
U Ispitivanju1 liječeno je 122 bolesnika opikaponom od 5 mg i 122 bolesnika entakaponom od 200 mg (aktivni komparator).
Caution must be exercised in these patients and dose adjustment may be necessary (see section
Kod primjene u tih bolesnika potreban je oprez i može biti potrebno prilagođavanje doze (vidjeti dio 5.2).
It is used to treat Parkinson's disease and associated movement problems.
Primjenjuje se za liječenje Parkinsonove bolesti i s njom povezanih teškoća s pokretima.
Ongentys is a medicine that contains the active substance opicapone.
Ongentys je lijek koji sadrži djelatnu tvar opikapon.
There is no experience with opicapone when used concomitantly with the MAO-B inhibitor safinamide.
Nema iskustva s istodobnom primjenom opikapona i MAO-B inhibitora safinamida.
In the table below (Table 1) all adverse reactions are presented by System Organ Class and frequency.
U tablici u nastavku (Tablica 1) prikazane su sve nuspojave prema klasifikaciji organskih sustava i učestalosti.
Each hard capsule contains 148.2 mg of lactose (as monohydrate).
Jedna tvrda kapsula sadrži 148,2 mg laktoze (u obliku hidrata).
The most abundant peaks in plasma after a single-dose of 100 mg 14C-opicapone are metabolites BIA 9-1103 (sulphate) and BIA 9-1104 (methylated), 67.1 and 20.5% of radioactive AUC respectively.
Nakon primjene jednokratne doze od 100 mg 14C-opikapona najveće vršne koncentracije u plazmi imali su metaboliti BIA 9-1103 (sulfat) i BIA 9-1104 (metilirani), 67,1 odnosno 20,5% AUC radioaktivnosti.
Animal studies with opicapone do not indicate harmful effects with respect to fertility (see section 5.3).
Ispitivanja opikapona na životinjama ne ukazuju na štetne učinke na plodnost (vidjeti dio 5.3).
Ongentys contains lactose
Ongentys sadrži laktozu
Ongentys contains lactose.
Ongentys sadrži laktozu.
Sulphation of opicapone appears to be the major metabolic pathway in humans, yielding the inactive opicapone sulphate metabolite.
Čini se da je sulfatacija opikapona glavni metabolički put u ljudi, kojim nastaje nedjelatni metabolit opikaponsulfat.
The effects of opicapone on fertility in humans have not been studied.
Učinci opikapona na plodnost u ljudi nisu ispitivani.
An in vitro study showed opicapone inhibited CYP2C8 activity.
In vitro ispitivanje pokazalo je da opikapon inhibira aktivnost CYP2C8.
Following administration of a single oral dose of 14C-opicapone, the main excretion route of opicapone and its metabolites was faeces, accounting for 58.5% to 76.8% of the administered radioactivity (mean 67.2%).
Nakon primjene jedne peroralne doze 14C-opikapona, glavni put izlučivanja opikapona i njegovih metabolita bio je putem stolice, na što se odnosilo 58,5% do 76,8% primijenjene radioaktivnosti (srednja vrijednost
A study conducted in healthy subjects showed that there were no changes in repaglinide's exposure when repaglinide was administered following multiple once-daily administration of opicapone 50 mg.
Ispitivanje provedeno na zdravim ispitanicima pokazalo je da nije bilo promjene u izloženosti repaglinidu kada se repaglinid primjenjivao nakon višekratne primjene 50 mg opikapona jedanput dnevno.
Ongentys may increase their effect; - medicines used to treat allergic reactions such as adrenaline.
Ongentys može pojačati njihov učinak; - lijekove koji se primjenjuju za liječenje alergijskih reakcija poput adrenalina.
Behaviours such as these have been reported in patients using other medicines for Parkinsons´s disease.
Ovakvo ponašanje zabilježeno je i u bolesnika koji su uzimali druge lijekove za liječenje Parkinsonove bolesti.
A second study conducted showed that, at steady state, opicapone 50 mg had no effect on repaglinide systemic exposure.
Drugo provedeno ispitivanje pokazalo je da u stanju dinamičke ravnoteže opikapon u dozi od 50 mg nije imao utjecaja na sistemsku izloženost repaglinidu.
Study 2 Change in OFF-time
Ispitivanje 2 Promjena u OFF-vremenu
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh Class C), therefore, Ongentys is not recommended in these patients (see section 5.2).
Nema kliničkog iskustva s primjenom u bolesnika s teškim oštećenjem jetre (stupanj C prema ChildPughovoj klasifikaciji), stoga se Ongentys ne preporučuje u tih bolesnika (vidjeti dio 5.2).
No dose adjustment is needed for elderly patients (see section 5.2).
Nije potrebno prilagođavanje doze u bolesnika starije dobi (vidjeti dio 5.2).
Your doctor may need to reconsider your treatment.
Vaš liječnik će možda trebati razmotriti promjenu u liječenju.
However, an evaluation with 50 mg opicapone was performed in subjects included in both phase 3 studies with GFR/1.73 m2 <60 mL/min (i.e. moderately decreased renal elimination capacity), and using pooled BIA 9-1103 data (major metabolite of opicapone).
Međutim, napravljena je procijena primjene 50 mg opikapona u ispitanika uključenih u oba ispitivanja faze 3 s brzinom glomerularne filtracije od < 60 ml/min/1,73 m2 (tj. umjereno oslabljene sposobnosti bubrežne eliminacije), korištenjem objedinjenih podataka za BIA 9-1103 (glavni metabolit opikapona).
At steady state, opicapone 50 mg significantly increased the extent of levodopa systemic exposure approximately 2 fold compared to placebo following a single oral administration of either 100/25 mg levodopa/carbidopa or 100/25 mg levodopa/benserazide administered 12 h after the opicapone dose.
otprilike za 2 puta u usporedbi s placebom nakon jednokratne peroralne primjene 100/25 mg levodope/karbidope ili 100/25 mg levodope/benzerazida primijenjenih 12 sati nakon doze opikapona.
Breast-feeding should be discontinued during treatment with Ongentys.
Dojenje treba prekinuti za vrijeme liječenja lijekom Ongentys.
The pharmacokinetics of opicapone was evaluated in healthy subjects and moderate chronic hepatic impaired patients after administration of a single-dose of 50 mg.
Farmakokinetika opikapona procjenjivana je u zdravih ispitanika i u bolesnika s umjerenim kroničnim oštećenjem funkcije jetre nakon primjene jedne doze od 50 mg.
The difference in LS mean change in OFF-time of opicapone 50 mg to entacapone was -24.8 minutes and non-inferiority of opicapone 50 mg to entacapone was demonstrated (95% confidence interval: -61.4, 11.8).
Razlika u LS srednjoj vrijednosti promjene OFFvremena između skupine koja je primala opikapon 50 mg i skupine koja je primala entakapon iznosila je24,8 minuta, te je pokazana neinferiornost opikapona 50 mg prema entakaponu (95% CI: -61,4; 11,8).
Effect of opicapone on transporters
Učinak opikapona na transportere
BIA 9-1103 plasma levels were not affected in patients with chronic renal impairment, and as such, no dose adjustment needs to be considered.
1103 u plazmi nisu bile promijenjene u bolesnika s kroničnim oštećenjem funkcije bubrega te stoga nema potrebe prilagođavati dozu.
The LS mean reduction in absolute OFF-time from baseline to endpoint in the entacapone group was -78.7 minutes.
dobivena metodom najmanjih kvadrata (LS mean), u skupini entakapona iznosila je -78,7 minuta.
ongentys 50 mg (only on the outer packaging)
ongentys 50 mg (samo na vanjskom pakiranju)
ongentys 25 mg (only on the outer packaging)
ongentys 25 mg (samo na vanjskom pakiranju)
Pharmacokinetic results showed that opicapone is rapidly absorbed, with a tmax of 1.0 h to 2.5 h following once-daily multiple-dose administration up to 50 mg opicapone.
Rezultati farmakokinetičkog ispitivanja pokazali su da se opikapon brzo apsorbira uz tmax od 1,0 h do 2,5 h nakon višekratnih primjena opikapona u dozi do 50 mg jedanput na dan.
After oral administration, the apparent volume of distribution of opicapone at a dose of 50 mg was 29 L with an inter-subject variability of 36%.
Nakon peroralne primjene, prividni volumen distribucije opikapona pri dozi od 50 mg iznosio je 29 l, s varijabilnošću među ispitanicima od 36%.
Opicapone may interfere with the metabolism of medicinal products containing a catechol group that are metabolised by COMT, e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dopexamine or dobutamine, leading to potentiated effects of these medicinal products.
Opikapon može interferirati s metabolizmom lijekova koji sadrže katekolnu skupinu a metaboliziraju se pomoću COMT-a, npr. rimiterolom, izoprenalinom, adrenalinom, noradrenalinom, dopaminom,
Concomitant use of opicapone and MAO inhibitors for the treatment of Parkinson's disease, e.g. rasagiline (up to 1 mg/day) and selegiline (up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation), is permissible (see section 4.3).
npr. razagilina (do 1 mg/dan) i selegilina (do 10 mg/dan u formulaciji za peroralnu primjenu ili 1,25 mg/dan u formulaciji za bukalnu apsorpciju) (vidjeti dio 4.3).
Shellac, propylene glycol, ammonia, indigo carmine aluminium (E132)
Tinta za označivanje šelak, propilenglikol, amonijak, boja indigo carmine aluminium (E132)
HDPE bottles: Keep the bottle tightly closed in order to protect from moisture.
Boce od HDPE: Bocu čuvati čvrsto zatvorenu radi zaštite od vlage.
Lactose monohydrate Sodium starch glycolate, Type A Maize starch, pregelatinized Magnesium stearate
Sadržaj kapsule laktoza hidrat natrijev škroboglikolat, vrsta A kukuruzni škrob, prethodno geliran magnezijev stearat
Abdominal distention, Abdominal pain, Abdominal pain upper, Dyspepsia
povraćanje distenzija abdomena, bol u abdomenu, bol u gornjem abdomenu, dispepsija
Many of the side effects can be managed by your doctor adjusting your levodopa medicine.
Mnoge nuspojave mogu se ukloniti tako da Vam liječnik prilagodi dozu lijeka koji sadrži levodopu.
Indigo carmine aluminium lake (E132) Erythrosine (E127)
Ovojnica kapsule želatina boja indigo carmine aluminium lake (E132) eritrozin (E127) titanijev dioksid (E171)
CI = confidence interval; LS mean = least square mean; N = number of non-missing values; OPC = opicapone.
CI = interval pouzdanosti; LS srednja vrijednost = srednja vrijednost dobivena metodom najmanjeg kvadrata; N = broj postojećih vrijednosti; OPC = opikapon; a.
The bioavailability of opicapone was significantly higher in patients with moderate chronic hepatic impairment and no safety concerns were observed.
Bioraspoloživost opikapona bila je značajno viša u bolesnika s umjerenim kroničnim oštećenjem funkcije jetre, ali pojave koje bi mogle utjecati na sigurnost primjene nisu primjećene.
Shellac, titanium dioxide (E171), propylene glycol, ammonia, simethicone
Tinta za označivanje šelak, titanijev dioksid (E171), propilenglikol, amonijak, simetikon
The pharmacokinetics of opicapone was not directly evaluated in subjects with chronic renal impairment.
Farmakokinetika opikapona nije izravno procjenjivana u ispitanika s kroničnim oštećenjem funkcije bubrega.
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 90 e-mail: info@bial.com
Mamede do Coronado Portugal tel: +351 22 986 61 00 faks: +351 22 986 61 90 e-mail: info@bial.com
No dose adjustment is necessary in patients with renal impairment, as opicapone is not excreted by the kidney (see section 5.2).
Nije potrebno prilagođavanje doze u bolesnika s oštećenjem funkcije bubrega, jer se opikapon ne izlučuje bubrezima (vidjeti dio 5.2).
Responders, n (%) 65 (47.8)
Responderi, n (%)
BIA 9-1103, its major metabolite, was transported by OATP1B1 and OATP1B3, and efflux transported by BCRP, but is not a substrate for the P-gp/MDR1 efflux transporter.
BIA 9-1103, njegov glavni metabolit, transportiran je pomoću OATP1B1 i OATP1B3, a efluks transporter mu je bio BCRP.
Intolerance to excipients
Intolerancija na pomoćne tvari
- The other ingredients are: o capsule content: lactose monohydrate, sodium starch glycolate (Type A), pregelatinized maize starch and magnesium stearate o capsule shell: gelatine, indigo carmine aluminium lake (E132), erythrosine (E127) and titanium dioxide (E171) o printing ink: shellac, titanium dioxide (E171), propylene glycol, ammonia, simethicone
- Drugi sastojci su: o sadržaj kapsule: laktoza hidrat, natrijev škroboglikolat (vrsta A), prethodno gelirani kukuruzni škrob i magnezijev stearat o ovojnica kapsule: želatina, boja indigo carmine aluminium lake (E132), eritrozin (E127) i titanijev dioksid (E171) o tinta za označivanje: šelak, titanijev dioksid (E171), propilenglikol, amonijak, simetikon
Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
dekarboksilaze (DDCI) u odraslih bolesnika s Parkinsonovom bolešću i motoričkim fluktuacijama pri kraju doze koji se ne mogu stabilizirati primjenom te kombinacije.
Blood creatine phosphokinase increased
Pretrage povišena razina kreatin-fosfokinaze u krvi smanjenje tjelesne težine
After oral administration, the apparent total body clearance of opicapone at a dose of 50 mg was 22 L/h, with an inter-subject variability of 45%.
Nakon peroralne primjene, prividni ukupni klirens opikapona iz tijela pri dozi od 50 mg iznosio je 22 l/h, s varijabilnošću među ispitanicima od 45%.
Ongentys may increase its effect; - medicines containing quinidine, a medicine used to treat abnormal heart rhythms or malaria.
Ongentys može pojačati njihov učinak; - lijekove koji sadrže kinidin, lijek koji se koristi za liječenje nenormalnih srčanih ritmova ili malarije.
Ongentys should be taken preferably at bedtime.
Ongentys je najbolje uzeti prije spavanja.
Talk to your doctor or pharmacist before taking Ongentys: - if you have severe liver problems and suffered from loss of appetite, weight loss, weakness, or exhaustion within a short period of time.
- ako imate teške probleme s jetrom i izgubili ste apetit, tjelesnu težinu, pojavila Vam se slabosti ili iscrpljenosti unutar kratkog vremena.
Ongentys taken with levodopa may make you feel light-headed, dizzy, or sleepy.
Ongentys, kad se uzima s levodopom, može uzrokovati da osjećate ošamućenost, omaglicu, ili pospanost.
Keep the bottle tightly closed in order to protect from moisture
Bocu čuvati čvrsto zatvorenu radi zaštite od vlage.
There is limited experience with opicapone when used concomitantly with tricyclic antidepressants and noradrenaline re-uptake inhibitors (e.g. venlafaxine, maprotiline and desipramine).
Triciklički antidepresivi i inhibitori ponovne pohrane noradrenalina Iskustva s opikaponom kada se on istodobno primjenjuje s tricikličkim antidepresivima i inhibitorima ponovne pohrane noradrenalina (npr. venlafaksinom, maprotilinom i dezipraminom) su ograničena.
In healthy subjects, the opicapone elimination half-life (t1/2) was 0.7 h to 3.2 h following once-daily multiple-dose administration up to 50 mg opicapone.
U zdravih ispitanika poluvijek eliminacije (t1/2) opikapona, nakon njegove višekratne primjene u dozi do 50 mg jedanput na dan, iznosio je 0,7 h do 3,2 h.
Your doctor may need to review your treatments.
Vaš će liječnik možda trebati preispitati je li Vaše liječenje odgovarajuće.
Because of this, concomitant use of opicapone with MAO inhibitors (e.g. phenelzine, tranylcypromine and moclobemide) other than those for the treatment of Parkinson's disease is contraindicated.
Zbog toga je kontraindicirana istodobna primjena opikapona i inhibitora MAO (npr. fenelzina, tranilcipromina i moklobemida), osim onih namijenjenih liječenju Parkinsonove bolesti.
The difference in LS mean change in OFF-time of entacapone to placebo in Study 1 was -30.5 minutes.
Razlika u LS srednjoj vrijednosti promjene OFF-vremena između skupine koja je primala entakapon i skupine koja je primala placebo u Ispitivanju 1 iznosila je -30,5 minuta.
Ear and labyrinth disorders
Poremećaji uha i labirinta kongestija uha
Ongentys is to be administered as an adjunct to levodopa treatment.
Ongentys se primjenjuje kao dodatak liječenju levodopom.
Blisters: Store in the original blister in order to protect from moisture.
Blisteri: Čuvati u originalnom blisteru radi zaštite od vlage.
Anxiety, Depression, Hallucination auditory, Nightmare, Sleep disorder.,
halucinacije, vidne halucinacije, nesanica anksioznost, depresija, slušne halucinacije,
Bottles: Keep the bottle tightly closed in order to protect from moisture.
Boce: Bocu čuvati čvrsto zatvorenu radi zaštite od vlage.
Ongentys may increase their effects; - medicines for high cholesterol such as rosuvastatin, simvastatin, atorvastatin or pravastatin Ongentys may increase their effects; - medicines that affect the immune system such as methotrexate.
Ongentys može pojačati njihov učinak; - lijekove koji se primjenjuju za liječenje zatajivanja srca poput dobutamina, dopamina ili dopeksamina; Ongentys može pojačati njihov učinak; - lijekove za liječenje povišene razine kolesterola poput rosuvastatina, simvastatina, atorvastatina ili pravastatina.
Increases in liver enzymes were reported in studies with nitrocatechol inhibitors of catechol-Omethyltransferase (COMT).
U ispitivanjima s nitrokatekolskim inhibitorima katekol-O-metiltransferaze (COMT) zabilježen je porast razine jetrenih enzima.
Blisters: 10, 30 or 90 capsules.
Blisteri: 10, 30 ili 90 kapsula.
- The other ingredients are: o capsule content: lactose monohydrate, sodium starch glycolate (Type A), pregelatinized maize starch and magnesium stearate o capsule shell: gelatine, indigo carmine aluminium lake (E132), erythrosine (E127) and titanium dioxide (E171) o printing ink: shellac, propylene glycol, ammonia, indigo carmine aluminium (E132)
o sadržaj kapsule: laktoza hidrat, natrijev škroboglikolat (vrsta A), prethodno gelirani kukuruzni škrob i magnezijev stearat o ovojnica kapsule: želatina, boja indigo carmine aluminium lake (E132), eritrozin (E127) i titanijev dioksid (E171) o tinta za označivanje: šelak, propilenglikol, amonijak, boja indigo carmine aluminium (E132)