natgillin/translations-raw huggingface dataset:
It must not be used in women with unexplained bleeding from the womb and women with signs or symptoms of endometrial cancer (a cancer of the lining of the womb).
Ne smije se upotrebljavati u žena s nerazjašnjenim krvarenjem iz maternice i u žena sa znakovima ili simptomima raka endometrija (rak sluznice maternice).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Conbriza.
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Conbriza.
For more information about treatment with Conbriza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Conbriza pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
After two years, the average bone density remained almost unchanged in women who received Conbriza, but in women who received placebo it was reduced by over 1%.
Nakon dvije godine prosječna gustoća kostiju ostala je gotovo nepromijenjena u žena koje su primale lijek Conbriza, dok se u žena koje su primale placebo smanjila za više od 1 %.
The difference was more relevant in the sub-group of women at higher risk of fractures before the study.
Razlika je bila značajnija u podgrupi žena koje su prije ispitivanja imale povećani rizik od prijeloma.
This is a summary of the European public assessment report (EPAR) for Conbriza.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Conbriza.
What is Conbriza?
Što je Conbriza?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Conbriza, including the appropriate precautions to be followed by healthcare professionals and patients.
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Conbriza nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
A risk management plan has been developed to ensure that Conbriza is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Conbriza.
What is the risk associated with Conbriza?
Koji su rizici povezani s lijekom Conbriza?
In both main studies the effects of Conbriza were similar to the effects of raloxifene.
U oba glavna ispitivanja učinci lijeka Conbriza bili su slični učincima raloksifena.
The main measure of effectiveness was the change in bone density (a measure of how strong the bones are) in the spine after two years of treatment.
Glavni pokazatelj djelotvornosti bila je promjena u gustoći kostiju kralježnice (mjera jačine kostiju) nakon dvije godine liječenja.
Conbriza must not be used in women who have had venous thromboembolism events (problems due to the formation of blood clots in the veins) including deep vein thrombosis (a blood clot in a deep vein, usually in the leg), pulmonary embolism (a blood clot in the lungs) and retinal vein thrombosis (a blood clot at the back of the eye).
Conbriza se ne smije upotrebljavati u žena koje su imale venske tromboembolijske događaje (probleme uslijed stvaranja krvnih ugrušaka u venama), uključujući duboku vensku trombozu (krvni ugrušak u dubokoj veni, najčešće u nozi), plućnu emboliju (krvni ugrušak u plućima) i trombozu mrežnične vene (krvni ugrušak u stražnjem dijelu oka).
Gradually, the bones become thin and fragile, and more likely to break (fracture).
Kosti postupno postaju tanke i lomljive, te je mogućnost loma (frakture) veća.
All of the women in the study were also given calcium and vitamin D supplements.
Sve žene koje su sudjelovale u ispitivanju primale su nadomjeske kalcija i vitamina D.
Bazedoxifene has the same effect as oestrogen in the bone.
Bazedoksifen ima isti učinak na kosti kao estrogen.
The CHMP decided that Conbriza's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je odlučio da koristi lijeka Conbriza nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
The most common side effects with Conbriza (seen in more than 1 patient in 10) are hot flushes, muscle spasms and peripheral oedema (swelling, especially of the ankles and feet).
Najčešće nuspojave lijeka Conbriza (zabilježene u više od 1 na 10 bolesnica) su valunzi, grčevi u mišićima i periferni edem (oticanje, posebno gležnjeva i stopala).
Conbriza is a medicine that contains the active substance bazedoxifene.
Conbriza je lijek koji sadrži djelatnu tvar bazedoksifen.
Conbriza was also compared with raloxifene and placebo in another main study involving 1,583 postmenopausal women who were considered to be at risk of osteoporosis.
Lijek Conbriza također je uspoređivan s raloksifenom i placebom u drugom glavnom ispitivanju koje je uključivalo 1 583 žene u postmenopauzi s rizikom od osteoporoze.
What benefit has Conbriza shown during the studies?
Koje su koristi lijeka Conbriza dokazane u ispitivanjima?
The active substance in Conbriza, bazedoxifene, is a selective oestrogen receptor modulator (SERM).
Djelatna tvar lijeka Conbriza, bazedoksifen, selektivni je modulator estrogenskih receptora (SERM).
Bazedoxifene acts as an ‘agonist' of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Bazedoksifen djeluje kao „agonist” estrogenskih receptora (tvar koja stimulira receptor za estrogen) u pojedinim tkivima tijela.
In the first study, Conbriza was more effective than placebo at reducing the number of new spine fractures.
U prvom ispitivanju lijek Conbriza pokazao se učinkovitijim od placeba u smanjenju broja novih prijeloma kralježnice.
It is used in women who are at risk of fracture (broken bones).
Koristi se u žena s povećanim rizikom od prijeloma (loma kosti).
Conbriza is used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Conbriza se koristi u liječenju osteoporoze (bolesti koja čini kosti lomljivima) u žena u postmenopauzi.
Conbriza has been compared with raloxifene (another medicine used to treat osteoporosis) and placebo (a dummy treatment) in one main study involving about 7,500 women with osteoporosis who had been through the menopause.
Lijek Conbriza uspoređivan je s raloksifenom (drugim lijekom za liječenje osteoporoze) i placebom (prividnim liječenjem) u jednom glavnom ispitivanju koje je uključivalo približno 7 500 žena u postmenopauzi s osteoporozom.
In the other study, Conbriza was also more effective than placebo at maintaining the bone density of the spine.
U drugom ispitivanju lijek Conbriza također se pokazao učinkovitijim od placeba u održavanju gustoće kostiju kralježnice.
Why has Conbriza been approved?
Zašto je lijek Conbriza odobren?
The women were treated for two years and received calcium supplements.
Žene su lijek i nadomjestak kalcija primale tijekom dvije godine.
Conbriza has been shown to significantly reduce fractures in the spine but not in the hip.
Conbriza dokazano značajno smanjuje incidenciju prijeloma kralježnice, no nije utvrđena djelotvornost kod prijeloma kuka.
What is Conbriza used for?
Za što se Conbriza koristi?
How is Conbriza used?
Kako se Conbriza koristi?
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.
Osteoporoza je učestalija u žena nakon menopauze, kada se smanjuju razine ženskog hormona estrogena.
For the full list of all side effects reported with Conbriza, see the package leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Conbriza potražite u uputi o lijeku.
Conbriza is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant.
Kontraindicirana je primjena u žena koje mogu zatrudnjeti
Patients should also receive calcium and vitamin D supplements if they do not get enough from their diet.
D ako unos tih tvari hranom nije dovoljan.
How does Conbriza work?
Kako djeluje Conbriza?
Conbriza was not shown to be effective at reducing the number of fractures outside the spine.
Nije dokazana djelotvornost lijeka Conbriza u smanjenju broja nevertebralnih prijeloma
They are packed in bottles.
Pakirane su u bočicama.
wait at least 2 to 3 hours before taking the other.
Poslije uzimanja jednog od njih pričekajte najmanje 2 do 3 sata prije uzimanja drugog.
In individual cases, only some of these symptoms and/or findings may be evident.
U pojedinačnim slučajevima mogu se javiti samo neki od tih simptoma i/ili nalaza.
• Inability to resist the impulse to perform an action that could be harmful, which may include:
• Nemogućnost odupiranja porivu da napravite nešto što bi moglo biti štetno, a moglo bi uključivati:
• if you have ever had a heart attack or any other diseases of the heart;
• ako ste ikada imali srčani udar ili druge bolesti srca;
• uncontrollable excessive shopping or spending;
• nekontrolirano pretjerano kupovanje ili trošenje.
In particular please tell your doctor if you are taking any of the following:
Osobito obavijestite svog liječnika ako uzimate nešto od sljedećeg:
Approximately 92 % of the dose is eliminated during ß-phase with a short elimination half-life of 30 minutes.
Približno 92% doze eliminira se tijekom ß-faze s kratkim poluvremenom eliminacije od 30 minuta.
See Section 2 Warnings and precautions.
Vidjeti dio 2 Upozorenja i mjere opreza.
• warfarin used to thin the blood;
• varfarin korišten za razrjeđivanje krvi;
EU/1/11/708/001 30 film-coated tablets EU/1/11/708/002 60 film-coated tablets EU/1/11/708/003 100 film-coated tablets EU/1/11/708/004 175 film-coated tablets
EU/1/11/708/001 30 filmom obloženih tableta EU/1/11/708/002 60 filmom obloženih tableta EU/1/11/708/003 100 filmom obloženih tableta EU/1/11/708/004 175 filmom obloženih tableta
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
• if you have liver disease;
• ako imate bolest jetre;
The pharmacokinetic properties of entacapone are similar in both young people and elderly.
Farmakokinetička svojstva entakapona slična su i u mladih i u starijih osoba.
10-20% is excreted in urine.
Približno 10-20% izlučuje se mokraćom.
• Uncontrollable movements;
• nekontrolirani pokreti;
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web portal.
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenim na europskom internetskom portalu za lijekove.
• strong impulse to gamble excessively despite serious personal or family consequences;
• snažan poriv za pretjeranim kockanjem, usprkos ozbiljnim posljedicama za Vas osobno ili za Vašu obitelj.
Weight decrease * Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data, since no valid estimate can be derived from clinical trials or epidemiological studies).
* Nuspojave su poredane prema učestalosti, pri čemu se na početku navode najčešće, koristeći sljedeće izraze: vrlo često (≥1/10); često (≥1/100, <1/10); manje često (≥1/1000, <1/100); rijetko (≥1/10 000, <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka, budući da se iz kliničkih ili epidemioloških ispitivanja ne može izvući valjana procjena).
• Uncontrollable movements with difficulty in performing voluntary movements (dyskinesias);
• nekontrolirani pokreti sa teškoćama u izvođenju voljnih pokreta (diskinezije);
• decreased appetite, weight loss;
• smanjeni apetit, gubitak tjelesne težine;
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenosti.
However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 11-26%].
Međutim, u jednom ispitivanju interakcija na zdravim dobrovoljcima, entakapon nije promijenio razine S-varfarina u plazmi, dok je AUC R-varfarina porastao prosječno za 18% [CI90 11-26%].
It is estimated that 8090% of the dose is excreted in faeces, although this has not been confirmed in man.
Procjenjuje se da se 80-90% doze izlučuje stolicom, premda to nije potvrđeno na ljudima.
• Agitation;
• uznemirenost;
Date of first authorisation: 18 August 2011 Date of latest renewal: 8 April 2016
Datum posljednje obnove: 8. travnja 2016.
You may experience the following side effects:
Mogli biste osjetiti sljedeće nuspojave:
There are four different pack sizes (bottles containing 30, 60, 100 or 175 tablets).
Postoje četiri različite veličine pakiranja (bočice koje sadrže 30, 60, 100 ili 175 tableta).
Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
Obavijestite svog liječnika ako doživite nešto od gore navedenoga; liječnik će s Vama razgovarati o načinima za kontroliranje ili umanjivanje simptoma.
Entacapone binds to human albumin binding site II which also binds several other medicinal products, including diazepam and ibuprofen.
Entakapon se veže na II. vezno mjesto ljudskog albumina, na koje se također veže nekoliko drugih lijekova, uključujući diazepam i ibuprofen.
• hallucinations (seeing/hearing/feeling/smelling things that are not really there), sleeplessness,
• halucinacije (vidjeti/čuti/osjećati/mirisati stvari koje stvarno nisu prisutne), nesanica, živopisni snovi i smetenost;
Follow the instructions that your doctor has given you.
Pažljivo slijedite upute svog liječnika.
Do not use this medicine after the expiry date which is stated on the carton and on the bottle label.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju i na naljepnici za bočicu.
If you are allergic to peanut or soya, do not use this medicine.
Ako ste alergični na kikiriki ili soju, nemojte uzimati ovaj lijek.
CI95% 45 min, 1 h 56 min Study II: Proportion of daily On time (%) Entacapone (n=103) Placebo (n=102)
CI95% 45 min, 1 h 56 min Ispitivanje II: udio dnevnog trajanja „ON“ faze (%) Entakapon (n=103) Placebo (n=102)
The peak concentration (Cmax) in plasma is usually reached about one hour after ingestion of a 200 mg entacapone tablet.
Vršna koncentracija (Cmax) u plazmi postiže se obično oko jedan sat nakon uzimanja tablete od 200 mg entakapona.
Marketing Authorisation Holder and Manufacturer: Orion Corporation
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač: Orion Corporation
Skin and subcutaneous tissue disorders Rare:
Poremećaji kože i potkožnog tkiva Rijetko:
Absorption There are large intra- and interindividual variations in the absorption of entacapone.
Postoje velike intra- i interindividualne razlike u apsorpciji entakapona.
• if you are allergic to entacapone or to peanut or soya or any of the other ingredients of this medicine (listed in section 6);
• ako ste alergični na entakapon ili kikiriki ili soju ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.);
• if you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the risk of severe high blood pressure);
• ako imate tumor nadbubrežne žlijezde (poznat pod nazivom feokromocitom; to može povećati rizik od izrazitog povišenja krvnog tlaka);
• iron supplements.
• preparati željeza.
Do not drive or operate machinery if you experience these side effects.
Nemojte voziti ili upravljati strojevima ako primijetite ove nuspojave.
• if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Entacapone Orion);
• ako uzimate određene lijekove protiv depresije (upitajte svog liječnika ili ljekarnika može li se Vaš lijek protiv depresije uzimati zajedno s Entacapone
Experience with Entacapone Orion in patients under 18 years is limited.
Orionom u bolesnika mlađih od 18 godina je ograničeno.
In human plasma the unbound fraction is about 2.0% in the therapeutic concentration range.
Udio nevezanog lijeka u ljudskoj plazmi iznosi oko 2,0% u rasponu terapijskih koncentracija.
2D barcode carrying the unique identifier included [carton only]
Sadrži 2D barkod s jedinstvenim identifikatorom [samo na kutiji]
Hepatic impairment See section 4.3.
Oštećenje jetre Vidjeti dio 4.3.
After absorption from the gastrointestinal tract, entacapone is rapidly distributed to the peripheral tissues with a distribution volume of 20 litres at steady state (Vdss).
Nakon apsorpcije iz probavnog sustava entakapon se brzo raspodjeljuje u periferna tkiva s volumenom distribucije od 20 litara u stanju ravnoteže (Vdss).
• if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic malignant syndrome (NMS).
• ako ste bilo kada imali rijetku reakciju na antipsihotike zvanu neuroleptički maligni sindrom (NMS).
Baseline Week 8-24 66.8±14.5
Tjedan 8-24 66,8±14,5
• altered or increased sexual interest and behaviour of significant concern to you or to others,
• promijenjeno ili povećano zanimanje za spolnost i spolne odnose te ponašanje koje u značajnoj mjeri zabrinjava Vas ili druge, primjerice, pojačani seksualni nagon.
30 tablets 60 tablets 100 tablets 175 tablets
30 tableta 60 tableta 100 tableta 175 tableta
If you experience such effects at the start of treatment with Entacapone Orion you should contact your doctor who may decide to adjust your dosage of levodopa.
Ako osjetite te nuspojave na početku liječenja Entacapone Orionom, trebate se obratiti svom liječniku, koji može odlučiti o prilagođavanju doziranja levodope.
• abnormal results in liver function test.
• abnormalni rezultati pretraga jetrene funkcije.
Patients who are hypersensitive to peanut or soya, should not use this medicinal product.
Bolesnici osjetljivi na kikiriki ili soju ne bi trebali uzimati ovaj lijek.
The safety and efficacy of Entacapone Orion in children below age 18 have not been established.
Sigurnost i djelotvornost Entacapone Oriona u djece u dobi do 18 godina nisu ustanovljene.
• if you experience increasing loss of appetite, weakness, exhaustion and weight loss within a relatively short period of time, a general medical evaluation including liver function should be considered.
• ako imate povećani gubitak apetita, slabost, iscrpljenost i gubitak tjelesne težine unutar relativno kratkog vremenskog perioda, potrebno je razmisliti o općem liječničkom pregledu, uključujući pretragu jetrene funkcije.
soya lecithin.
sojin lecitin.
Dyskinesias (27%), nausea (11%), diarrhoea (8%), abdominal pain (7%) and dry mouth (4.2%) were reported significantly more often with entacapone than with placebo in pooled data from clinical studies involving 406 patients taking the medicinal product and 296 patients taking placebo.
Diskinezije (27%), mučnina (11%), proljev (8%), bol u abdomenu (7%) i suha usta (4,2%) zabilježene su značajno češće s entakaponom nego s placebom u objedinjenim podacima iz kliničkih ispitivanja koja su uključivala 406 bolesnika koji su uzimali lijek i 296 bolesnika koji su uzimali placebo.
yellow iron oxide (E 172), red iron oxide (E 172) and titanium dioxide (E 171).
žuti željezov oksid (E172), crveni željezov oksid (E172) i titanijev dioksid (E171).
For the characteristics of NMS see Section 4 Possible side effects.
Za karakteristike NMS-a vidjeti dio 4 Moguće nuspojave.
Data from in vitro studies using human liver microsomal preparations indicate that entacapone inhibits cytochrome P450 2C9 (IC50 4 µM).
Podaci iz in vitro ispitivanja uz korištenje humanih jetrenih mikrosomalnih preparata pokazuju da entakapon inhibira citokrom P450 2C9 (IC50 ~ 4 μM).
** The incidence rates of myocardial infarction and other ischaemic heart disease events (0.43% and 1.54%, respectively) are derived from an analysis of 13 double-blind studies involving 2,082 patients with end-of-dose motor fluctuations receiving entacapone.
** Stope incidencije infarkta miokarda i drugih događaja vezanih uz ishemijsku srčanu bolest (0,43%, odnosno, 1,54%) su izvedene iz analize 13 dvostruko slijepih ispitivanja u koja su bila uključena 2082 bolesnika s motoričkim fluktuacijama pri kraju doze, a koji su primali entakapon.
- The film-coating contains partly hydrolysed polyvinyl alcohol, talc, macrogol, soya lecithin,
- Ovojnica tablete sadrži polivinilni alkohol, djelomično hidroliziran, talk, makrogol, sojin lecitin,
Some of the adverse reactions, such as dyskinesia, nausea, and abdominal pain, may be more common with the higher doses (1,400 to 2,000 mg per day) than with the lower doses of entacapone.
Neke od nuspojava, kao diskinezija, mučnina i bol u abdomenu, mogu biti češće s višim dozama (1400 do 2000 mg na dan) nego s nižim dozama entakapona.
• binge eating (eating large amounts of food in a short time period) or compulsive eating
• nekontrolirano prejedanje (jedenje velikih količina hrane u kratkom razdoblju) ili kompulzivno jedenje (jedenje više hrane nego što je normalno i potrebno za utaživanje gladi).
Clinical interaction studies with diazepam and nonsteroidal anti-inflammatory medicinal products have not been carried out.
Klinička ispitivanja interakcija s diazepamom i nesteroidnim protuupalnim lijekovima nisu provedena.
Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Entakapon je indiciran kao dodatak standardnim preparatima levodope/benzerazida ili levodope/karbidope, za primjenu u odraslih bolesnika s Parkinsonovom bolešću i motoričkim fluktuacijama pri kraju doze, koji se ne mogu stabilizirati tim kombinacijama.
COMT inhibition in red blood cells closely follows the plasma concentrations of entacapone, thus clearly indicating the reversible nature of COMT inhibition.
Inhibicija COMT u eritrocitima vjerno prati koncentracije entakapona u plazmi, što jasno ukazuje na reverzibilnu prirodu inhibicije COMT.
• a rare severe muscle disorder (rhabdomyolysis) which causes pain, tenderness and weakness of the muscles and may lead to kidney problems.
• rijedak, teški mišićni poremećaj (rabdomioliza) koji uzrokuje bol, osjetljivost i slabost mišića i može dovesti do problema s bubrezima.
Baseline Week 8-24 10.7±2.2
Tjedan 8-24 10,7±2,2
• discolouration of skin, hair, beard and nails.
• promjena boje kože, kose, brade i noktiju.
Entacapone should be given cautiously to patients who are taking other medicinal products which may cause orthostatic hypotension.
Entakapon treba davati s oprezom bolesnicima koji uzimaju druge lijekove, a koji mogu izazvati ortostatsku hipotenziju.
In two phase III double-blind studies in a total of 376 patients with Parkinson's disease and end-ofdose motor fluctuations, entacapone or placebo was given with each levodopa/dopa decarboxylase inhibitor dose.
U dva dvostruko slijepa ispitivanja faze III s ukupno 376 bolesnika s Parkinsonovom bolešću i motoričkim fluktuacijama pri kraju doze davani su entakapon ili placebo sa svakom dozom inhibitora levodope/dopa dekarboksilaze.