natgillin/translations-raw huggingface dataset:
74770 Opava-Komarov Czech Republic 
305 74770 Opava-Komarov Češka
Therefore, such addition should be undertaken with caution outside of clinical situations where the combination has proven to be beneficial. 
Zato je potrebna previdnost pri tovrstni uporabi izven kliničnih stanj, pri katerih se je kombinacija izkazala za učinkovito.
If you have had a heart attack, it should be prescribed for at least four weeks. 
Če ste imeli srčno kap morate zdravilo jemati najmanj štiri tedne.
An occasional use of ASA (no more than 1,000 mg in any 24-hour period) should generally not cause a problem, but prolonged use of ASA in other circumstances should be discussed with your doctor or pharmacist. 
Občasna uporaba ASA (ne več kot 1.000 mg v 24 urah) praviloma ne bi smela povzročati težav, toda o dolgotrajnejši uporabi ASA v drugih okoliščinah se morate posvetovati z zdravnikom ali farmacevtom.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/.
Given that children, infants and toddlers are often only seen at a late stage of intoxication, they will usually have already reached the acidosis stage. 
glede na to, da dojenčki in mali otroci pogosto do zdravnika pridejo šele v pozni fazi zastrupitve, so običajno že v fazi acidoze.
It is preferable not to take this product during first and second trimesters of pregnancy. 
Bolje je, da tega zdravila ne jemljete v prvem in drugem tromesečju nosečnosti.
Bleeding is the most common reaction reported both in clinical studies as well as in the post-marketing experience where it was mostly reported during the first month of treatment. 
Krvavitev je najpogostejši učinek o katerih so poročali v kliničnih študijah, kot tudi v obdobju postmarketinške uporabe, kjer so o tem poročali predvsem v prvem mesecu zdravljenja.
In addition, your doctor may identify changes in your blood or urine tests. 
Poleg tega lahko zdravnik ugotovi tudi spremembe v izvidih preiskav krvi ali urina.
Side effects with unknown frequency (frequency cannot be estimated from the available data): 
Možni neželeni učinki, katerih pogostnost ni znana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
• decrease in blood pressure 
• znižanje krvnega tlaka,
This was associated with a reduction of the mean inhibition of platelet aggregation by 15% and 11%, respectively. 
To je bilo povezano z zmanjšanjem zavrtja agregacije trombocitov za 15 % in 11 %.
A patient with poor metaboliser status will possess two loss-of-function alleles as defined above. 
Bolnik, ki ima slab presnovni status, bo imel dva hipofunkcijska alela, kot je pojasnjeno zgoraj.
Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery. 
Bolnike je treba skrbno spremljati zaradi znakov krvavitve, vključno z okultno krvavitvijo, zlasti med prvimi tedni zdravljenja in/ali po invazivnih kardioloških postopkih ali kirurških posegih.
• You should tell your doctor if a surgery (including dental) is planned. 
• obvestite svojega zdravnika: če imate predvideno kakšno operacijo (vključno z zobozdravstvenim posegom).
Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be excluded. 
Posledično ni mogoče izključiti neposrednega učinka (blaga toksičnost) ali posrednega učinka (neprijeten okus).
TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis. 
TTP je lahko usodna in zahteva takojšnje zdravljenje vključno s plazmaferezo.
In addition, due to the presence of ASA, its use is also contraindicated in: 
Poleg tega je zaradi vsebnosti ASA uporaba kontraindicirana tudi:
From literature, limited data in Asian populations are available to assess the clinical implication of genotyping of this CYP on clinical outcome events. 
V literaturi je za azijske populacije na voljo omejena količina podatkov, da bi lahko ocenili klinične posledice genotipizacije tega CYP za dogodke kliničnega izida.
Interactions with the following medicinal products have been reported with ASA: 
Poročali so o interakcijah med ASA in sledečimi zdravili:
The results obtained in populations with different characteristics (e.g. unstable angina or non-Q-wave MI, low to high risk levels, diabetes, need for revascularisation, age, gender, etc.) were consistent with the results of the primary analysis. 
Rezultati, pridobljeni pri populacijah z različnimi karakteristikami (npr. nestabilna angina, MI brez Q zobca, visoka do nizka raven tveganja, diabetes, potreba po revaskularizaciji, spol, starost, itd), so bili skladni z rezultati primarne analize.
Although no formal carcinogenicity studies have been performed with ASA, it has been shown that it is not a tumour promoter. 
Čeprav formalnih študij kancerogenosti z ASA ni bilo, je dokazano, da snov ni promotor tumorjev.
There is insufficient clinical experience regarding the use of doses above 100 mg/day up to 500 mg/day. 
Ni zadostnih kliničnih izkušenj z uporabo odmerkov nad 100 mg/dan in do 500 mg/dan.
After first opening bottle: 30 days 
Po prvem odprtju plastenke: 30 dni.
In addition to clinical studies experience, adverse reactions have been spontaneously reported. 
Poleg kliničnih študij, so o neželenih učinkih poročali tudi spontano.
If you have been told by your doctor to stop treatment temporarily, ask your doctor when to restart the treatment. 
Če vam je zdravnik naročil, da zdravilo nehajte jemati začasno, ga vprašajte, kdaj naj z zdravljenjem ponovno nadaljujete.
These may be due to rare decrease of some blood 
To so lahko znaki redkega zmanjšanja števila določenih krvnih celic.
In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups. 
V študiji COMMIT je bil celokupni delež večjih necerebralnih krvavitev ali cerebralnih krvavitev nizek in podoben v obeh skupinah.
Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe. 
Klinične študije kažejo, da so odmerki do 100 mg/dan pri restriktivni obstetrični rabi, ki zahteva poseben nadzor, varni.
Their frequency is defined using the following conventions: 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). 
Njihova pogostnost je navedena upoštevaje naslednji dogovor: pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
- In patients with ST segment elevation acute myocardial infarction: Therapy should be started as early as possible after symptoms start and continued for at least four weeks. 
- Pri bolnikih z akutnim miokardnim infarktom z elevacijo ST spojnice: zdravljenje je potrebno začeti čim prej po nastopu simptomov in z njim nadaljevati vsaj štiri tedne.
• If you are allergic to clopidogrel, acetylsalicylic acid (ASA) or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na klopidogrel, acetilsalicilno kislino (ASA) ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
With severe intoxication, serious disturbances of the acid-base equilibrium occur. 
Pri hudi zastrupitvi se pojavijo resne motnje acido-baznega ravnotežja.
• severe abdominal pain with or without back pain 
• huda bolečina v trebuhu z ali brez bolečine v hrbtu,
The incidence of severe cases was similar for clopidogrel and ASA. 
Incidenca hujših primerov je bila podobna za klopidogrel in ASA.
If acetylsalicylic acid is used by a woman attempting to conceive, or until the 24th amenorrhea week (5th month of pregnancy), the dose should be kept as low and duration of treatment as short as possible. 
Če acetilsalicilno kislino uporablja ženska, ki poskuša zanositi, ali do 24. tedna amenoreje (5. mesec nosečnosti), mora biti odmerek čim manjši, zdravljenje pa čim krajše.
Uricosurics (benzbromarone, probenecid, sulfinpyrazone) 
Urikozuriki (benzbromaron, probenecid, sulfinpirazon)
It is unknown whether ASA alters fertility. 
Ni znano, če ASA vpliva na plodnost.
• generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting) 
• splošne alergijske reakcije (na primer, splošni občutek toplote z nenadnim nelagodjem do nezavesti),
The influence of CYP2C19 genotype on clinical outcomes in patients treated with clopidogrel has not been evaluated in prospective, randomised, controlled trials. 
Vpliv genotipa CYP2C19 na klinične izide pri bolnikih, zdravljenih s klopidogrelom, ni bil ocenjen v prospektivnih, randomiziranih, kontroliranih raziskavah.
Haemodialysis is the preferred treatment for severe intoxication. 
Hemodializa je izbrani način zdravljenja hude zastrupitve.
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary 
- kardiopulmonalnim toksičnim učinkom (s prezgodnjim zaprtjem arterioznega duktusa in
The European Medicines Agency has waived the obligation to submit the results of studies with the combination of clopidogrel/acetylsalicylic acid in all subsets of the paediatric population in the treatment of coronary atherosclerosis (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od obveznosti po predložitvi rezultatov študij kombinacije klopidogrela/acetilsalicilne kisline pri vseh podskupinah pediatrične populacije za zdravljenje koronarne ateroskleroze (glejte poglavje 4.2 za informacije o pediatrični uporabi).
Thus, the results from this subset are in line with the overall trial results. 
Pri tej podskupini bolnikov so rezultati v skladu s celotnimi rezultati študije.
In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers. 
Pri slabih metabolizatorjih je bila izpostavljenost aktivnemu presnovku za 63 do 71 % manjša kot pri obsežnih metabolizatorjih.
The combination of clopidogrel/acetylsalicylic acid should not be used during the first two trimesters of pregnancy unless the clinical condition of the woman requires treatment with clopidogrel/ASA. 
Kombinacije klopidogrela/acetilsalicilne kisline se ne sme uporabljati v prvih dveh tromesečjih nosečnosti, razen če klinično stanje nosečnice ne zahteva terapije s klopidogrelom/ASA.
Patients should be told about the signs and symptoms of GI undesirable effects and what steps to take if they occur (see section 4.8). 
Bolnike je treba seznaniti z znaki in simptomi neželenih gastrointestinalnih učinkov ter kako naj ukrepajo, če se le-ti pojavijo (glejte poglavje 4.8).
Patients should inform physicians and dentists that they are taking the combination of clopidogrel/acetylsalicylic acid before any surgery is scheduled and before any new medicinal product is taken. 
Bolniki morajo obvestiti zdravnika in zobozdravnika, da jemljejo kombinacijo klopidogrela/ acetilsalicilne kisline, pred vsakim načrtovanim kirurškim posegom in preden vzamejo katerokoli novo zdravilo.
Alkalising of the urine (250 mmol sodium bicarbonate for 3 hours) while monitoring the urine pH is indicated. 
Indicirana je alkalizacija urina (250 mmol natrijevega bikarbonata, in sicer 3 ure) ob nadzorovanju pH urina.
Reye's Syndrome is a very rare disease which can be fatal. 
Reyev sindrom je zelo redka bolezen, ki je lahko smrtna.
Less pronounced reductions of metabolite exposure has been observed with pantoprazole or lansoprazole. 
Manj izrazita zmanjšana izpostavljenost presnovkov je bila opažena pri pantoprazolu ali lanzoprazolu.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 
Datum prve odobritve:
• Hypersensitivity to the active substances or to any of the excipients listed in section 2 or section 
• preobčutljivosti na zdravilni učinkovini ali katero koli pomožno snov, navedeno v poglavju 2 ali
Other medicinal products: A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic (PK) interactions. 
Druga zdravila: Številne druge klinične študije so izvedli s klopidogrelom in drugimi sočasno danimi zdravili, da bi preučili potencial za farmakodinamične in farmakokinetične interakcije.
The safety and efficacy of clopidogrel/acetylsalicylic acid in children and adolescents under 18 years old have not been established. 
Varnost in učinkovitost zdravila Klopidogrel/acetilsalicilna kislina Teva pri otrocih in mladostnikih mlajših od 18 let nista bili ugotovljeni.
• if you have a history of asthma or allergic reactions including allergy to any medicine used to 
• če ste v imeli v preteklosti astmo ali alergijske reakcije, vključno z alergijo na katerokoli
This is linked to the way your medicine works as it prevents the ability of blood clots to form. 
To je povezano z načinom delovanja zdravila, saj le-to preprečuje strjevanje krvi.
The elimination half-life of the main circulating (inactive) metabolite was 8 hours after single and repeated administration. 
Razpolovni čas izločanja glavnega (neaktivnega) krožečega presnovka je bil 8 ur po enkratnem in večkratnem dajanju.
Caution is required because ASA may inhibit the effect of uricosuric agents through competitive elimination of uric acid. 
Potrebna je previdnost, saj ASA lahko zavre učinek urikozuričnih zdravil s kompetitivno eliminacijo sečne kisline.
Where elective surgery is being considered, the need for dual antiplatelet therapy should be reviewed and consideration given to the use of a single antiplatelet agent. 
Če je predvidena elektivna operacija, je treba potrebo po dvotirnem antiagregacijskem zdravljenju ponovno pretehtati ter razmisliti o uporabi samo enega antiagregacijskega zdravila.
Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese. 
Objavljene pogostnosti genotipa slabega metabolizatorja s CYP2C19 so približno 2% pri belcih, 4% pri črncih in 14% pri Kitajcih.
This benefit was mostly driven by the statistically significant reduction in the incidence of MI [287 (4.6%) in the clopidogrel plus ASA group and 363 (5.8%) in the ASA group]. 
Ta korist je bila v prisotna predvsem zaradi statistično pomembnega zmanjšanja incidence MI [287 (4,6 %) v skupini, zdravljeni s klopidogrelom in z ASA ter 363 (5,8 %) v skupini z ASA].
By preventing this clumping in some types of blood vessels (called arteries), antiplatelet medicinal products reduce the chances of blood clots forming (a process called atherothrombosis). 
S preprečevanjem tega zlepljanja v nekaterih vrstah krvnih žil (imenovane arterije), zaviralci agregacije trombocitov zmanjšajo možnost nastanka krvnih strdkov (proces se imenuje aterotromboza).
For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. 
Morda vam je zdravnik za zdravljenje vaše bolezni v zamašeno ali zoženo arterijo namestil žilno opornico, da se obnovi ustrezen pretok krvi.
Following therapeutic doses, approximately 10% is found excreted in the urine as salicylic acid, 75% as salicyluric acid, 10% phenolic- and 5% acyl-glucuronides of salicylic acid. 
Po terapevtskih odmerkih se približno 10 % izloči v urinu kot salicilna kislina, 75 % kot salicilurična kislina, 10 % kot fenolni glukuronid in 5 % kot acilglukuronid salicilne kisline.
Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively). 
Klopidogrel in glavni krožeči (neaktivni) presnovek se in vitro reverzibilno vežeta na humane plazemske proteine (98 % oziroma 94 %).
The population included 27.8% women, 58.4% patients ≥60 years (26% ≥70 years) and 54.5% patients who received fibrinolytics. 
Populacijo bolnikov je sestavljalo 27,8 % žensk, 58,4 % bolnikov starosti ≥ 60 let (26 % ≥ 70 let ) in 54,5 % bolnikov, ki so dobivali fibrinolitike.
You should specifically tell your doctor if you take 
Obvestite svojega zdravnika, zlasti, če jemljete:
Apart from the specific medicinal product interaction information described above, interaction studies with the combination of clopidogrel/acetylsalicylic acid and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed. 
Razen zgoraj navedenih informacij o specifičnih interakcijah z zdravili, študije o interakcijah kombinacije klopidogrela/acetilsalicilne kisline in nekaterih zdravil, ki jih pogosto uporabljajo bolniki z aterotrombotično boleznijo niso bile izvedene.
In cases of confirmed isolated activated Partial Thromboplastin Time (aPTT) prolongation with or without bleeding, acquired haemophilia should be considered. 
V primeru podaljšanega potrjenega izoliranega aktiviranega parcialnega tromboplastinskega časa (aPTT), s krvavitvijo ali brez nje, je treba razmisliti o možnosti pojava pridobljene hemofilije.
Patients who have had developed a previous allergic reaction and/or haematological reaction to one thienopyridine may have an increased risk of developing the same or another reaction to another thienopyridine. 
Bolniki, ki so kdaj imeli alergijsko in/ali hematološko reakcijo na enega od tienopiridinov, imajo lahko večje tveganje za pojav enake ali druge reakcije na drug tienopiridin.
Patients were required to have either ECG changes compatible with new ischaemia or elevated cardiac enzymes or troponin I or T to at least twice the upper limit of normal. 
Bolniki so morali imeti bodisi spremembe elektrokardiograma (EKG), združljive z novo ishemijo ali povišane srčne encime ali troponin I ali T, in sicer najmanj dvakrat nad zgornjo mejo normalnega.
Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites. 
Absorpcija je najmanj 50 %, na podlagi presnovkov klopidrogela, izločenih z urinom.
TEVA UK Limited BRAMPTON ROAD HAMPDEN PARK EASTBOURNE, EAST SUSSEX,BN22 9AG, United Kingdom 
TEVA UK Limited BRAMPTON ROAD HAMPDEN PARK EASTBOURNE, EAST SUSSEX,BN22 9AG, Velika Britanija
A pharmacodynamic interaction between the combination of clopidogrel/acetylsalicylic acid and heparin is possible, leading to increased risk of bleeding. 
Farmakodinamična interakcija med kombinacijo klopidogrela/acetilsalicilne kisline in heparinom je možna in vodi do povečanega tveganja za krvavitev.
There have been a number of retrospective analyses, however, to evaluate this effect in patients treated with clopidogrel for whom there are genotyping results: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477), and ACTIVE-A (n=601), as well as a number of published cohort studies. 
Vendar pa so bile opravljene številne retrospektivne analize za oceno tega učinka pri bolnikih, zdravljenih s klopidogrelom, za katere so na voljo rezultati genotipizacije: CURE (n=2.721), CHARISMA (n=2.428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1.477) in ACTIVE-A (n=601), poleg tega pa tudi številne objavljene kohortne študije.
The following symptoms can also arise: hyperthermia and perspiration, leading to dehydration, restlessness, convulsions, hallucinations and hypoglycaemia. 
Pojavijo se lahko tudi sledeči simptomi: hipertermija in znojenje, ki povzroči dehidracijo, nemir, konvulzije, halucinacije in hipoglikemija.
In CHARISMA and one cohort study (Simon), an increased event rate was observed only in poor metabolisers when compared to extensive metabolisers. 
V študiji CHARISMA in eni kohortni študiji (Simon) so večji delež dogodkov ugotovili samo pri slabih metabolizatorjih v primerjavi z obsežnimi.
• signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots, and/or confusion (see section 2 ‘Warnings and precautions'). 
• znaki jetrnih težav, kot je porumenelost kože in/ali oči (zlatenica), ki so lahko, ali pa ne, povezani s krvavitvijo, ki se pojavi pod kožo kot drobne rdeče pike in/ali zmedenostjo (glejte poglavje 2 »Opozorila in previdnostni ukrepi«).
There is a possible association between acetylsalicylic acid (ASA) and Reye's Syndrome when products containing ASA are given to children or adolescents with a viral infection. 
Obstaja možna povezava med acetilsalicilno kislino (ASA) in Reyevim sindromom, če otroci ali mladostniki prejemajo zdravila z ASA pri virusni okužbi.
• sudden life-threatening allergic reactions 
• nenadne smrtno nevarne alergijske reakcije,
The decrease was associated with a 39% (loading dose) and 21% (maintenance dose) reduction of inhibition of platelet aggregation. 
Zmanjšanje je bilo povezano z 39 % (začetni odmerek) oz. 21 % (vzdrževalni odmerek) zmanjšanjem zaviranja agregacije trombocitov.
If patients must temporarily stop antiplatelet therapy, the combination of clopidogrel/acetylsalicylic acid should be discontinued 7 days prior to surgery. 
Če mora bolnik začasno prekiniti zdravljenje z antiagregacijskimi zdravili, je treba kombinacijo klopidogrela/acetilsalicilne kisline prenehati jemati 7 dni pred kirurškim posegom.
Platelet aggregation and bleeding time gradually returned to baseline values, generally within 5 days after treatment was discontinued. 
Agregacija trombocitov in čas krvavitve sta se postopoma vrnila na izhodiščno vrednost, običajno v 5 dneh po ukinitvi zdravljenja.
The clinical relevance of this interaction is uncertain. 
Klinični pomen te interakcije ni popolnoma znan.
Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of clopidogrel, sometimes after a short exposure. 
Zelo redko so poročali o trombotični trombocitopenični purpuri (TTP) po uporabi klopidogrela, ki se je včasih pojavila že po kratki izpostavljenosti.
5.2 Pharmacokinetic properties Clopidogrel: 
5.2 Farmakokinetične lastnosti Klopidogrel:
The safety of the concomitant administration of clopidogrel, fibrin or non-fibrin specific thrombolytic agents and heparins was assessed in patients with acute myocardial infarction. 
Varnost sočasne uporabe klopidogrela, fibrinsko specifičnih ali fibrinsko nespecifičnih trombolitikov in heparinov je bila ocenjena pri bolnikih z akutnim miokardnim infarktom.
a planned surgery (including dental) in the next seven days. 
nedaven kirurški poseg (vključno z zobozdravstvenimi posegi), načrtovan kirurški poseg (vključno z zobozdravstvenimi posegi) v naslednjih sedmih
• skin allergy 
• kožna alergija,
Acetylsalicylic Acid: Single-dose studies have shown that the oral toxicity of ASA is low. 
Acetilsalicilna kislina: Študije enkratnih odmerkov so pokazale, da je peroralna toksičnost ASA majhna.
Other medicines and Clopidogrel/Acetylsalicylic acid Teva Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. 
Druga zdravila in zdravilo Klopidogrel/acetilsalicilna kislina Teva Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno s tistimi, ki ste jih dobili brez recepta.
Adverse reactions that occurred with clopidogrel alone, with ASA alone* or with clopidogrel in combination with ASA either during clinical studies or that were spontaneously reported are presented in the table below. 
Neželeni učinki, zabeleženi samo s klopidogrelom, samo z ASA ali s klopidogrelom v kombinaciji z ASA v kliničnih študijah ali opisani spontano, so navedeni v spodnji tabeli.
Specific pharmacokinetic studies performed with radiolabelled clopidogrel have shown that the parent compound or its metabolites are excreted in the milk. 
Specifične farmakokinetične študije, izvedene z radioaktivno označenim klopidogrelom, so pokazale, da se matična spojina ali njeni presnovki izločajo v mleko.