natgillin/translations-raw huggingface dataset:
There is no experience with eptifibatide and low molecular weight heparins. 
Izkušenj s sočasno uporabo nizkomolekularnih heparinov in eptifibatida ni.
Reproduction studies in animal species where eptifibatide shows a similar pharmacologic activity as in humans are not available. 
Reprodukcijskih študij pri živalskih vrstah, pri katerih ima eptifibatid podobno farmakološko delovanje kot pri ljudeh, ni bilo, zato te niso primerne za oceno toksičnosti eptifibatida za razmnoževanje (glejte poglavje 4.6).
Eptifibatide Accord 2 mg/ml solution for injection 
Eptifibatide Accord 2 mg/ml, raztopina za injiciranje
Eptifibatide appeared to increase the risk of bleeding when administered with streptokinase in an acute myocardial infarction study. 
V raziskavi akutnega miokardnega infarkta je kazalo, da eptifibatid poveča tveganje za krvavitve pri sočasni uporabi s streptokinazo.
It is not known whether eptifibatide is excreted in human milk. 
Ni znano, ali se pri človeku eptifibatid izloča v materino mleko, zato priporočamo prekinitev dojenja v času zdravljenja.
There was no consistent evidence that eptifibatide increased the risk of major or minor bleeding associated with tissue plasminogen activator in either a PCI or an acute myocardial infarction study. 
Niti v raziskavi perkutanih koronarnih posegov niti v raziskavi akutnega miokardnega infarkta ni bilo enotnih dokazov, da bi eptifibatid povečal tveganje za pojav večjih ali manjših krvavitev v povezavi z uporabo aktivatorja tkivnega plazminogena.
Citric acid monohydrate Sodium hydroxide Water for injections 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi citronska kislina monohidrat natrijev hidroksid voda za injekcije
Eptifibatide Accord must not be used to treat patients with: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - evidence of gastrointestinal bleeding, gross genitourinary bleeding or other active abnormal bleeding within the previous 30 days of treatment - history of stroke within 30 days or any history of haemorrhagic stroke - known history of intracranial disease (neoplasm, arteriovenous malformation, aneurysm) - major surgery or severe trauma within past 6 weeks - a history of bleeding diathesis - thrombocytopenia (< 100,000 cells/mm3) 
- preobčutljivostjo na zdravilno učinkovino ali katerokoli pomožno snov navedeno v poglavju - znaki krvavitve v prebavilih, obilno krvavitvijo v sečilih ali spolnih organih ali kako drugo aktivno nenormalno krvavitvijo, ki nastopi v zadnjih 30 dneh pred zdravljenjem; - anamnezo možganske kapi v zadnjih 30 dneh ali anamnezo hemoragične kapi kadarkoli; - znano anamnezo intrakranialne bolezni (neoplazme, arteriovenske malformacije, anevrizme);
Solution for infusion 1 vial of 100 ml 
raztopina za infundiranje 1 viala 100 ml
Thrombocytopenia, including acute profound thrombocytopenia, has been observed with eptifibatide administration post-marketing (see section 4.8) 
Pri uporabi eptifibatida v obdobju trženja so opažali trombocitopenijo, vključno z akutno hudo trombocitopenijo (glejte poglavje 4.8).
- If you have any further questions, ask your doctor or hospital pharmacist or nurse. 
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, bolnišničnim farmacevtom ali medicinsko sestro.
The reduction in the incidence of endpoint events in patients receiving eptifibatide appeared early during treatment. 
Zmanjšanje incidence pojavov končnega cilja pri bolnikih, ki so prejeli eptifibatid, je nastopilo zgodaj med zdravljenjem, kasneje (v času do 1 leta) pa več niso opažali povečanih koristi zdravljenja za bolnike.
Platelet inhibition was readily reversed, with a return of platelet function towards baseline (> 50 % platelet aggregation) 4 hours after stopping a continuous infusion of 2.0 microgram/kg/min. 
Zaviranje trombocitov je hitro reverzibilno; 4 ure po prekinitvi kontinuirane infuzije 2,0 mikrograma/kg/min se funkcija trombocitov povrne proti izhodiščni vrednosti (> 50 % agregacija trombocitov).
4.8 Undesirable effects 
Občasni neželeni učinki
Each ml of solution for infusion contains 0.75 mg of eptifibatide. 
En ml raztopine za infundiranje vsebuje 0,75 mg eptifibatida.
The pharmacokinetics of eptifibatide are linear and dose proportional for bolus doses ranging from 90 to 250 microgram/kg and infusion rates from 0.5 to 3.0 microgram/kg/min. 
Za bolusne odmerke od 90 do 250 mikrogramov/kg in za hitrosti infundiranja od 0,5 do 3,0 mikrograme/kg/min je farmakokinetika eptifibatida linearna in sorazmerna odmerku.
How to store Eptifibatide Accord 
Shranjevanje zdravila Eptifibatide Accord
Eptifibatide Accord 0.75 mg/ml solution for infusion eptifibatide 
Eptifibatide Accord 0,75 mg/ml raztopina za infundiranje eptifibatid
Cerebral ischaemia. 
Bolezni živčevja Občasni možganska ishemija;
Eptifibatide Accord 2 mg/ml solution for injection eptifibatide 
Eptifibatide Accord 2 mg/ml raztopina za injiciranje eptifibatid
Talk to your doctor or hospital pharmacist or nurse before using Eptifibatide Accord. 
Pred uporabo zdravila Eptifibatide Accord se posvetujte s svojim zdravnikom, bolnišničnim farmacevtom ali medicinsko sestro.
Eptifibatide did not appear to increase the risk of major and minor bleeding associated with concomitant use of warfarin and dipyridamole. 
Pri sočasni uporabi z varfarinom in dipiridamolom ni bilo videti, da bi eptifibatid povečal tveganje za pojav večjih ali manjših krvavitev.
Particularly: blood thinners (oral anticoagulants) or medicines that prevent blood clots, including warfarin, dipyridamole, ticlopidine, aspirin (except those that you may be given as part of Eptifibatide Accord treatment). 
- zdravila za redčenje krvi (peroralne antikoagulante) ali, - zdravila, ki preprečujejo nastajanje krvnih strdkov, vključno z varfarinom, dipiridamolom,
Arterial procedures 
Posegi na arterijah
Eptifibatide Accord is an antithrombotic agent that acts by inhibition of platelet aggregation; therefore the patient must be observed carefully for indications of bleeding during treatment (see section 4.8). 
Bolnika morate torej med zdravljenjem skrbno spremljati, da odkrijete znake krvavitve (glejte poglavje 4.8).
No statistically significant benefit of early routine eptifibatide strategy was demonstrated in the subgroup of patients who were managed medically or during the medical management periods prior to PCI or CABG. 
V podskupini bolnikov, vodenih konzervativno ali v konzervativno vodenih obdobjih pred perkutanim koronarnim posegom ali CABG, niso ugotovili statistično značilne koristi zgodnje rutinske uporabe eptifibatida.
Distrobution 
Porazdelitev
− medicines that prevent blood clots, including warfarin, dipyridamole, ticlopidine, aspirin (except those that you may be given as part of Eptifibatide Accord treatment). 
tiklopidinom in acetilsalicilno kislino (razen tistih, ki jih boste morda dobili v okviru zdravljenja z zdravilom Eptifibatide Accord).
With delayed provisional eptifibatide administration, the TIMI major events were 1.4 % vs 2.0 % in patients who received reduced dose and standard dose respectively (p=0.54).There were no notable differences observed with GUSTO severe bleeding rates. 
V primeru odložene pomožne uporabe eptifibatida je bil delež večjih dogodkov po TIMI med prejemniki nižjega odmerka 1,4 % in med prejemniki standardnega odmerka 2 % (p = 0,54).
Eptifibatide p-Value 
Vrednost p
One vial of 100 ml of solution for infusion contains 75 mg of eptifibatide. 
Ena 100 ml viala raztopine za infundiranje vsebuje 75 mg eptifibatida.
UA/NQMI: For a patient who weighs ≥ 70 kg, it is recommended that a bolus dose of 5,000 units is given, followed by a constant intravenous infusion of 1,000 units/hr. 
Bolniki z nestabilno angino pektoris ali miokardnim infarktom brez zobca Q v EKG: Za bolnike, s telesno maso ≥ 70 kg, je priporočen bolusni odmerek 5.000 enot, ki naj mu sledi stalna intravenska infuzija 1.000 enot/h.
Eptifibatide Accord is an inhibitor of platelet aggregation. 
Zdravilo Eptifibatide Accord je antitrombotično zdravilo, ki deluje tako, da zavira agregacijo trombocitov.
One vial of 10 ml solution for injection contains 20 mg of eptifibatide. 
Ena 10 ml viala raztopine za injiciranje vsebuje 20 mg eptifibatida.
One vial of 10 ml of solution for injection contains 20 mg of eptifibatide. 
Ena 10 ml viala z raztopino za injiciranje vsebuje 20 mg eptifibatida.
Particularly: 
Še posebej pozorni bodite na:
PURSUIT trial The pivotal clinical trial for Unstable Angina (UA)/Non-Q Wave Myocardial Infarction (NQMI) was PURSUIT. 
Osrednja klinična študija nestabilne angine pektoris ali miokardnega infarkta brez zobca Q v EKG je bila študija PURSUIT.
All patients received routine standard of care and were randomised to either placebo or eptifibatide (2 bolus doses of 180 microgram/kg and a continuous infusion until discharge from hospital or a maximum of 18-24 hours). 
Vsi bolniki so bili deležni rutinske zdravstvene oskrbe in so bili naključno razporejeni bodisi v skupino, ki bo prejemala placebo, ali v skupino, ki bo prejemala eptifibatid (2 bolusna odmerka po
- if you had a major operation or severe injury during the past 6 weeks. 
- večjo operacijo ali hujšo poškodbo v zadnjih 6 tednih; - hemoragično diatezo v anamnezi;
Bleeding (major and minor bleeding including femoral artery access, CABG-related, gastrointestinal, genitourinary, retroperitoneal, intracranial, haematemesis, haematuria, oral/oropharyngeal, haemoglobin/haematocrit decreased and other). 
intrakranialno, hematemezo, hematurijo, oralno ali orofaringealno, zmanjšane vrednosti hemoglobina in hematokrita in druge);
In patients with previous immune-mediated thrombocytopenia from other parenteral GP IIb/IIIa inhibitors, there are no data with the use of eptifibatide. 
Trombocitopenija in imunogenost, povezani z zaviralci GP IIb/IIIa Zdravilo Eptifibatide Accord zavira agregacijo trombocitov, ni pa videti, da bi vplival na njihovo življenjsko dobo.
If you get any side effects, talk to your doctor or hospital pharmacist or nurse. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, bolnišničnim farmacevtom ali medicinsko sestro.
Package leaflet: Information for the patient Eptifibatide Accord 0.75 mg/ml solution for infusion eptifibatide 
NAVODILO ZA UPORABO Eptifibatide Accord 0,75 mg/ml raztopina za infundiranje eptifibatid
Package leaflet: Information for the patient Eptifibatide Accord 2 mg/ml solution for injection eptifibatide 
NAVODILO ZA UPORABO Eptifibatide Accord 2 mg/ml raztopina za injiciranje eptifibatid
- If you get any side effects talk to your doctor or hospital pharmacist or nurse. 
- Če opazite katerikoli neželeni učinek se posvetujte s svojim zdravnikom, bolnišničnim farmacevtom ali medicinsko sestro.
PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS LABEL for 100 ml vial 
OVOJNINAH NALEPKA za 100 ml vialo
Eptifibatide Accord inhibits platelet aggregation, but does not appear to affect the viability of platelets. 
Zdravilo Eptifibatide Accord zavira agregacijo trombocitov, kar pomeni, da pomaga preprečevati nastajanje krvnih strdkov.
Do not use if particulate matter or discolouration is present. 
Če so v njej vidni delci ali je vsebina obarvana, je ne smete uporabiti.
According to epidemiological findings, a higher incidence of cardiovascular events has been associated with certain indicators, for instance: - age - elevated heart rate or blood pressure - persistent or recurrent ischemic cardiac pain - marked ECG changes (in particular ST-segment abnormalities) - raised cardiac enzymes or markers (e.g. CK-MB, troponins) and - heart failure 
Po epidemioloških izsledkih je večja incidenca kardiovaskularnih pojavov povezana z določenimi pokazatelji, npr.: - starostjo,
The infusion was continued until hospital discharge, until the time of coronary artery bypass grafting (CABG) or for up to 72 hours, whichever occurred first. 
Infuzijo so prejemali do odpusta iz bolnišnice, do koronarnega premostitvenega posega ali do preteka
> 110 mm Hg on antihypertensive therapy) - severe renal impairment (creatinine clearance < 30 ml/min) or dependency on renal dialysis - clinically significant hepatic impairment - concomitant or planned administration of another parenteral glycoprotein (GP) IIb/IIIa inhibitor 
- klinično pomembno jetrno okvaro; - sočasno ali predvideno uporabo kakega drugega parenteralnega zaviralca glikoproteina (GP)
Thrombocytopenia. 
Občasni trombocitopenija;
EXPIRY DATE 
Študija PURSUIT
This may happen during school holidays. 
To se lahko zgodi med šolskimi počitnicami.
This commitment will be reviewed after 5 years. 
Ta zaveza se pregleda po 5 letih.
Remember that some foods and medicines contain alcohol. 
Ne pozabite, da nekatera živila in zdravila vsebujejo alkohol.
However, these findings were not consistent across all the reviewed studies. 
Vendar ta odkritja niso dosledna v vseh pregledanih študijah.
It may harm other people, even if they have the same symptoms as your child 
Drugim ljudem lahko škodi, kljub temu, da imajo enake simptome kot vaš otrok.
You should closely follow the advise of your doctor. 
Skrbno upoštevajte nasvete svojega zdravnika.
Aggressive or hostile behaviour 
Nasilno ali sovražno vedenje
The significance of this finding to humans is unknown. 
Pomen teh ugotovitev za ljudi ni znan.
• severe changes in mood or personality 
• hude spremembe razpoloženja ali osebnosti;
• whether there is a family history of sudden unexplained death in the family. 
• o družinski anamnezi nenadne nerazložljive smrti v družini;
The reviews of the published literature and epidemiological data reached the same conclusion. 
Pregled objavljene literature in epidemioloških podatkov je dal enak zaključek.
Risk Management Plans 
Načrti obvladovanja tveganja
A risk to the suckling child cannot be excluded. 
Tveganje za dojenčka ne moremo izključiti.
It must only be prescribed by a doctor and must therefore not be passed on to anyone else. 
Predpiše ga lahko le zdravnik, zato ga ne smete dajati drugim.
This medicine is intended solely for you or for your child. 
To zdravilo je namenjeno izključno vam ali vašemu otroku.
Some patients may require long-term follow up. 
Pri nekaterih bolnikih je lahko potrebno dolgotrajno spremljanje.
ADHD can also have a severe effect on a child's education. 
ADHD lahko slabo vpliva tudi na otrokovo izobraževanje.
Tablets should not be chewed, divided, or crushed. 
Tablet ne sme žvečiti, razdeliti ali zdrobiti.
Within the 5-year follow-up, particular emphasis will be placed on assessing the effects of a cumulative exposure of at least 18 months. 
V petletnem obdobju sledenja bo posebno poudarjeno vrednotenje učinkov kumulativne izpostavitve v najmanj 18 mesecih.
EL - Greece UCB A.E. 
EL - Grčija UCB A.E.
Suicidal tendency 
Samomorilne težnje
Adequate diagnosis requires the use of medical and specialised psychological, educational, and social resources. 
Ustrezna diagnoza zahteva uporabo medicinskih in posebnih psiholoških, izobraževalnih in socialnih virov.
In general there are no signs of teratogenicity in animals. 
Na splošno pri živalih ni znakov teratogenosti.
Methyphenidate should be used together with other forms of treatment, as part of a comprehensive treatment programme. 
Metilfenidat je treba uporabljati skupaj z drugimi oblikami zdravljenja kot del celovitega programa zdravljenja.
“Effects of stimulant medication on growth in the MTA (Multimodal Treatment Study of ADHD)” follow-up, carried out by the MTA Cooperative Group. 
„Učinki stimulacijskih zdravil na rast v MTA (Študija multimodalnega zdravljenja ADHD)“, ki ga je opravila MTA Cooperative Group.
In addition, clinical studies investigating the issues are currently ongoing and the final reports will be submitted to the regulatory authorities. 
Poleg tega trenutno potekajo klinične študije, v katerih raziskujejo omenjena vprašanja, končna poročila pa bodo predložena regulativnim organom.
In addition more data is needed to assess the psychiatric outcome as well as the effect on growth and development of the children. 
Poleg tega je potrebnih več podatkov za ovrednotenje psihiatričnih izidov ter učinka na rast in razvoj otrok.
The preferred design would be a prospective, cohort study. 
Prednostna zasnova bo prospektivna, kohortna študija.
Overall Safety Discussion and Conclusion 
Splošna razprava varnosti in zaključek
Use with alcohol 
Uporaba skupaj z alkoholom
These concerns are individually discussed in the following sections. 
Posamezni zadržki so obravnavani v spodnjih poglavjih.
The submitted data suggested that events occurred within the recommended doses. 
Predloženi podatki kažejo, da je do dogodkov prišlo pri priporočenih odmerkih.
Never take a double dose to make up for a forgotten <tablet> <dose> <…>.> 
Nikoli ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo <tableto> <prejšnji odmerek> <…>.>
Very rare: sudden cardiac death* 
Zelo redki: nenadna srčna smrt*
National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders: 
Nacionalni pristojni organi, katerih delo usklajuje referenčna država članica, kadar je smiselno, zagotovijo, da imetniki dovoljenj za promet z zdravilom izpolnjujejo naslednje pogoje:
2.1.d Cyanosis 
2.1.d Cianoza
Benefit/risk 
Koristni učinki/tveganja
The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. 
Bolnik mora biti zavarovan pred samopoškodovanjem in pred zunanjimi dražljaji, ki bi poslabšali že tako prisotno prekomerno stimulacijo.
• how you or your child are feeling e.g. are you feeling emotional, having strange thoughts or if you have had any of these feelings in the past. 
• o vašem počutju ali počutju vašega otroka, ali npr. ste vznemirjeni, imate čudne misli ali ste imeli katerega od teh občutkov v preteklosti;
Furthermore, the Risk Management Plans of these products should also be harmonised. 
Poleg tega je treba uskladiti načrte obvladovanja tveganja omenjenih zdravil.
Drug utilisation studies, including evaluation of Off-Label Use/ Abuse 
Študije uporabe zdravila, vključno z oceno uporabe izven obsega indikacij/zlorabe
Educational tools 
Orodja za izobraževanje
The ongoing Studies on growth, and on sexual maturation should provide valid data on those possible risks. 
Tekoče študije o rasti in spolnem zorenju morajo zagotoviti veljavne podatke o teh možnih tveganjih.
In addition the CHMP requested that new studies on long-term effects on development are carried out. 
Poleg tega je CHMP zahteval, da se opravijo nove študije o dolgoročnih učinkih na razvoj.
Post-marketing reports included cases of central, peripheral and unspecified cyanosis. 
Poročila iz obdobja trženja zdravil so obsegala primere centralne, periferne in neopredeljene cianoze.
2.4 Effects on Growth 
2.4 Učinki na rast
However, a harmonisation exercise between products is deemed one of the main scopes of this procedure to ensure the same level of health protection in all Member States where methylphenidate products are authorised. 
Vendar se usklajevanje zdravil šteje za enega od glavnih ciljev tega postopka, da se zagotovi enaka raven zdravstvenega varstva v vseh državah članicah, kjer so odobrena zdravila z metilfenidatom.
The likelihood of having a side effect is as follows: 
Verjetnost, da se pojavijo neželeni učinki, je naslednja:
The tablet shell is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet. 
Ovojnica tablete se izloči iz telesa; bolnike naj ne skrbi, če v svojem blatu občasno opazijo nekaj, kar je podobno tableti.
2.5 Leukaemia 
2.5 Levkemija
• Checklists for actions before prescribing, and for ongoing monitoring for prescribers and, if possible, carers 
• Kontrolni seznami za ukrepe pred predpisovanjem in kontrolni seznami za stalno spremljanje, namenjeni osebam, ki predpisujejo zdravilo, ter po možnosti skrbnikom
Growth, Development and Sexual Maturation 
Rast, razvoj in spolno zorenje
It may have a moderate influence on the ability to drive and use machines. 
Lahko ima pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
Drug testing This medicine may give a positive result when testing for drug use. 
To zdravilo lahko da pozitivne rezultate pri testiranju na uporabo drog.
Methylphenidate should not be given to children under 6 years of age or the elderly as the safety and benefits of use in these age groups have not been established. 
Metilfenidat se ne sme dajati otrokom, mlajšim od 6 let, ali starejšim osebam, saj varnost in koristi uporabe v teh starostnih skupinah nista bili dokazani.
ADHD is defined by ‘core' signs of lack of attention, hyperactivity and impulsiveness. 
Motnja ADHD je opredeljena z „osnovnimi“ znaki, ki so pomanjkanje pozornosti, hiperaktivnost in impulzivnost.
In conclusion regarding the cardiovascular risks, it is accepted that there is a potential risk. 
V zaključku obravnave tveganja srčno-žilnih obolenj se sprejme, da obstaja potencialno tveganje.
Forms of bipolar disorder 
Oblike bipolarne motnje
Diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10 and should be based on a complete history and evaluation of the patient. 
Diagnoza mora biti postavljena po kriterijih DSM-IV ali po smernicah ICD-10 in mora temeljiti na celotni anamnezi in pregledu bolnika.
The PL will be tested for User readability and the results will be submitted to the regulatory Authorities. 
Navodila za uporabo bodo preskušena za berljivost z vidika uporabnika, rezultati pa bodo predloženi regulativnim organom.
Safety and efficacy in this age group has not been established. 
Varnost in učinkovitost pri tej starostni skupini še ni bila ugotovljena.