FrancophonIA/ELRC3.0 huggingface dataset:
English: ASA group, a 20% relative risk reduction (RRR) (95% CI of 10%-28%; p=0.00009) for the clopidogrel plus ASA group [17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)].
Slovenian: Delež bolnikov s primarnim opazovanim dogodkom [srčnožilna (SŽ) smrt, miokardni infarkt (MI) ali kap] je bil 582 (9,3 %) v skupini, zdravljeni s klopidogrelom in ASA, in 719 (11,4 %) v skupini, ki je prejemala ASA, to je 20 % zmanjšanje relativnega tveganja (95 % IZ od 10 % - 28 %; p = 0,00009) v skupini, zdravljeni s klopidogrelom in ASA (17 % zmanjšanje relativnega tveganja, če so bili bolniki zdravljeni konzervativno, 29 % kadar je bila izvedena perkutana transluminalna koronarna angioplastika z ali brez stenta in 10 %, če je bila izvedena premostitvena operacija koronarnih arterij CABG).
English: • Alcohol may increase the risk of gastrointestinal injury when taken with ASA.
Slovenian: • Alkohol lahko ob sočasnem zaužitju ASA poveča nevarnost za gastrointestinalno poškodbo.
English: The concomitant administration of Clopidogrel/Acetylsalicylic acid Mylan with oral anticoagulants is not recommended since it may increase the intensity of bleeding (see section 4.4).
Slovenian: Sočasna uporaba zdravila Klopidogrel/acetilsalicilna kislina Mylan s peroralnimi antikoagulanti ni priporočljiva, ker lahko poveča intenzivnost krvavitev (glejte poglavje 4.4).
English: In particular, in a post-hoc analysis in 2,172 patients (17% of the total CURE population) who underwent stent placement (Stent-CURE), the data showed that clopidogrel compared to placebo, demonstrated a significant RRR of 26.2% favouring clopidogrel for the co-primary endpoint (CV death, MI, stroke) and also a significant RRR of 23.9% for the second co-primary endpoint (CV death, MI, stroke or refractory ischaemia).
Slovenian: Pri 2.172 bolnikih (17 % vseh bolnikov, vključenih v študijo CURE) katerim je bil vstavljen stent (Stent-CURE) so podatki post-hoc analize še posebej pokazali, da je klopidogrel v primerjavi s placebom pri sestavljenem primarnem opazovanem dogodku (SŽ smrt, MI, kap) pomembno zmanjšal RT za 26,2 %.
English: oral anticoagulants, medicines used to reduce blood clotting, ASA or another non-steroidal anti-inflammatory medicine usually used to treat painful and/or inflammatory conditions of muscle or joints, heparin or any other injectable medicine used to reduce blood clotting, ticlopidine, other antiplatelet agents, a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,
Slovenian: • zdravila, ki lahko povečajo tveganje za krvavitve, kot so: - peroralne antikoagulanse, zdravila proti strjevanju krvi, - ASA ali kakšno drugo nesteroidno protivnetno zdravilo, ki jih ponavadi uporabljamo za zdravljenje bolečin in/ali vnetja mišic ali sklepov, - heparin ali drugo zdravilo v obliki injekcij proti strjevanju krvi, - tiklopidin, drugo antiagregacijsko zdravilo, - selektivni zaviralci privzema serotonina (vključno a ne omejeno na fluoksetin ali fluvoksamin), zdravila, ki se običajno uporabljajo za zdravljenje depresije,
English: Aluminium perforated unit dose blisters with desiccant layer containing 28 or 30 film-coated tablets.
Slovenian: Aluminijasti perforirani deljivi pretisni omoti s posameznimi odmerki s sušilno plastjo, ki vsebujejo 28 ali 30 filmsko obloženih tablet.
English: Anti-retroviral therapies (ART)
Slovenian: Protiretrovirusna zdravljenja
English: The plasma concentrations of the active metabolite was 20% reduced (loading dose) and 14% reduced (maintenance dose) during concomitant treatment with pantoprazole 80 mg once daily.
Slovenian: Pri sočasni uporabi 80 mg pantoprazola enkrat dnevno, so se zmanjšale plazemske koncentracije akivnega presnovka za 20 % (začetni odmerek) in 14 % (vzdrževalni odmerek), z zmanjšanjem zavrtja agregacije trombocitov za 15°% in 11°%.
English: In patients concomitantly receiving nicorandil and NSAIDs including ASA and LAS, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and haemorrhage (see section 4.4).
Slovenian: Pri bolnikih, ki sočasno jemljejo nikorandil in nesteroidna protivnetna zdravila (NSAID), vključno z ASA in lizin acetilsalicilatom (LAS), obstaja povečano tveganje za hude zaplete, kot so gastrointestinalne razjede, perforacija in krvavitve (glejte poglavje 4.4).
English: How to store Clopidogrel/Acetylsalicylic acid Mylan Contents of the pack and other information
Slovenian: Shranjevanje zdravila Klopidogrel/acetilsalicilna kislina Mylan Vsebina pakiranja in dodatne informacije
English: In patients concomitantly receiving nicorandil and NSAIDs including ASA and LAS, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and haemorrhage (see section 4.5).
Slovenian: Pri bolnikih, ki sočasno jemljejo nikorandil in nesteroidna protivnetna zdravila (NSAID), vključno z ASA in lizin acetilsalicilatom (LAS), obstaja povečano tveganje za hude zaplete, kot so gastrointestinalne razjede, perforacija in krvavitve (glejte poglavje 4.5).
English: The ASA in Clopidogrel/Acetylsalicylic acid Mylan is rapidly hydrolysed in plasma to salicylic acid, with a half-life of 0.3 to 0.4 hours for ASA doses from 75 to 100 mg. Salicylic acid is primarily conjugated in the liver to form salicyluric acid, a phenolic glucuronide, an acyl glucuronide, and a number of minor metabolites.
Slovenian: ASA iz zdravila Klopidogrel/acetilsalicilna kislina Mylan v plazmi hitro hidrolizira v salicilno kislino z razpolovnim časom 0,3 do 0,4 ur pri odmerkih od 75 mg do 100 mg ASA.
English: Although the administration of clopidogrel 75 mg/day did not modify the pharmacokinetics of S-warfarin or International Normalised Ratio (INR) in patients receiving long-term warfarin therapy, coadministration of clopidogrel with warfarin increases the risk of bleeding because of independent effects on haemostasis.
Slovenian: Uporaba 75 mg klopidogrela na dan ni spremenila farmakokinetike S-varfarina ali internacionalnega normaliziranega razmerja (INR) pri bolnikih, ki so dolgotrajno prejemali varfarin.
English: No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation (IPA) were observed between ultra-rapid, extensive and intermediate metabolisers.
Slovenian: Med ultrahitrimi, dobrimi in srednjimi metabolizatorji niso ugotovili bistvenih razlik v izpostavljenosti aktivnemu presnovku in povprečnem zavrtju agregacije trombocitov (IPA).
English: What you need to know before you take Clopidogrel/Acetylsalicylic acid Mylan Do not take Clopidogrel/Acetylsalicylic acid Mylan
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Klopidogrel/acetilsalicilna kislina Mylan
English: Alcohol may increase the risk of gastrointestinal injury when taken with ASA.
Slovenian: Alkohol lahko ob sočasnem zaužitju ASA poveča nevarnost za gastrointestinalno poškodbo.
English: Pharmacotherapeutic group: group: ATC code: Antithrombotic agents, platelet aggregation inhibitors excl. Heparin, ATC Code: B01AC30.
Slovenian: Farmakoterapevtska skupina: oznaka ATC: Zaviralci agregacije trombocitov brez heparina.
English: Clopidogrel/Acetylsalicylic acid Mylan must not be used in patients with severe renal impairment (see section 4.3).
Slovenian: Zdravilo Klopidogrel/acetilsalicilna kislina Mylan se ne sme uporabljati pri bolnikih s hudo okvaro ledvic (glejte poglavje 4.3).
English: Tablet coating: hypromellose, triacetin, talc, poly (vinyl alcohol) (partially hydrolysed), titanium dioxide (E171), glycerol monocaprylocaprate (E422), sodium lauril sulfate, iron oxide yellow (E172)
Slovenian: - Obloga tablete: hipromeloza, triacetin, smukec, polivinilalkohol (delno hidroliziran), titanov dioksid (E171), glicerilmonokaprilokaprat (E422), natrijev lavrilsulfat, rumeni železov oksid (E172)
English: Hypoglycaemia*, gout* (see section 4.4)
Slovenian: *, protin (glejte poglavje 4.4)
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the group taking ASA alone.
Slovenian: V študiji CLARITY je v skupini s klopidogrelom in ASA prišlo do splošnega povečanja krvavitev v primerjavi s skupino s placebom in ASA.
English: It is unknown whether ASA dose in Clopidogrel/Acetylsalicylic acid Mylan alters fertility.
Slovenian: Ni znano, ali ASA v zdravilu Klopidogrel/acetilsalicilna kislina Mylan vpliva na plodnost.
English: The concomitant administration of Clopidogrel/Acetylsalicylic acid Mylan with oral anticoagulants is not recommended since it may increase the intensity of bleeding (see section 4.5).
Slovenian: Sočasna uporaba zdravila Klopidogrel/acetilsalicilna kislina Mylan in peroralnih antikoagulantov ni priporočljiva, ker lahko poveča jakost krvavitev (glejte poglavje 4.5).
English: Bottles 100 film-coated tablets
Slovenian: Plastenke 100 filmsko obloženih tablet
English: th month of pregnancy), the dose should be kept as low and duration of treatment as short as possible.
Slovenian: Če acetilsalicilno kislino uporablja ženska, ki poskuša zanositi, ali do 24. tedna amenoreje (5. meseca nosečnosti), mora biti odmerek čim manjši, zdravljenje pa čim kratkotrajnejše.
English: Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis, noncardiogenic pulmonary oedema with chronic use and in the context of a hypersensitivity reaction due to acetylsalicylic acid*, eosinophilic pneumonia.
Slovenian: Bolezni dihal, prsnega koša in mediastinalneg a prostora epistaksa krvavitve v dihalih (hemoptiza, pljučna krvavitev), bronhospazem, intersticijski pnevmonitis, nekardiogeni pljučni edem zaradi kronične uporabe in v zvezi s preobčutljivostno reakcijo zaradi acetilsalicilne kisline eozinofilna pljučnica.
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema, druginduced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus, fixed eruption*
Slovenian: Hypersensitivity Syndrome), kožni izpuščaj z eozinofilijo in sistemskimi simptomi, kot posledica zdravljenja z zdravilom (sindrom DRESS, Drug Rash with Eosinophilia and Systemic Symptoms), eritematozen ali eksfoliativen izpuščaj, urtikarija, ekcem, lihen planus, fiksen izpuščaj
English: Clopidogrel/Acetylsalicylic acid Mylan must not be used in patients with severe hepatic impairment (see section 4.3).
Slovenian: Zdravilo Klopidogrel/acetilsalicilna kislina Mylan se ne sme uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets contain Allura Red AC which may cause allergic reactions.
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/100 mg filmsko obložene tablete vsebujejo barvilo rdeče AC, ki lahko povzroči alergijske reakcije.
English: In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.
Slovenian: Poleg tega so med uporabo zaviralcev sinteze prostaglandinov v obdobju organogeneze ugotovili večjo incidenco različnih malformacij, vključno z malformacijami srca in ožilja.
English: Tablet coating: hypromellose, triacetin, talc, poly (vinyl alcohol) (partially hydrolysed), titanium dioxide (E171), glycerol monocaprylocaprate (E422), sodium lauril sulfate, Allura Red AC (E129) (see section 2 ‘Clopidogrel/Acetylsalicylic acid Mylan contains Allura Red AC')
Slovenian: - Obloga tablete: hipromeloza, triacetin, smukec, polivinilalkohol (delno hidroliziran), titanov dioksid (E171), glicerilmonokaprilokaprat (E422), natrijev lavrilsulfat, barvilo rdeče AC (E129) (glejte poglavje 2 »Zdravilo Klopidogrel/acetilsalicilna kislina Mylan vsebuje barvilo rdeče AC«).
English: If you take more Clopidogrel/Acetylsalicylic acid Mylan than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Slovenian: Zaradi povečanega tveganja za krvavitve se posvetujte s svojim zdravnikom ali najbližjo ambulanto za nujno zdravniško pomoč.
English: Cases of Reye's syndrome have occurred following the use of salicylates during varicella infections (see section 4.4).
Slovenian: Po uporabi salicilatov med okužbo z noricami so poročali o pojavu Reyevega sindroma (glejte poglavje 4.4)
English: Tablet core: microcrystalline cellulose, lactose (see section 2 ‘Clopidogrel/Acetylsalicylic acid Mylan contains lactose'), croscarmellose sodium, hydroxypropylcellulose, colloidal anhydrous silica, talc, hydrogenated castor oil, pregelatinized starch, stearic acid, iron oxide yellow (E172).
Slovenian: - Jedro tablete: mikrokristalna celuloza, laktoza (glejte poglavje 2 »Zdravilo Klopidogrel/acetilsalicilna kislina Mylan vsebuje laktozo«), premreženi natrijev karmelozat, hidroksipropilceluloza, brezvodni koloidni silicijev dioksid, smukec, hidrogenirano ricinusovo olje, predgelirani škrob, stearinska kislina, rumeni železov oksid (E172).
English: Patients should be counselled about the risks of gastrointestinal injury and bleeding while taking clopidogrel plus ASA with alcohol, especially if alcohol consumption is chronic or heavy.
Slovenian: Bolnike je treba opozoriti o povečani nevarnosti gastrointestinalnih poškodb in krvavitev pri sočasnem zaužitju klopidogrela in ASA z alkoholom, še posebej, če gre za veliko ali kronično rabo alkohola (glejte poglavje 4.5.
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), bone marrow failure*, aplastic anaemia, pancytopenia, bicytopenia*, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia, haemolytic anaemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency* (see section
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija, levkopenija, eozinofilija nevtropenija, vključno s hudo nevtropenijo trombotična trombocitopenična purpura (TTP) (glejte poglavje 4.4), odpoved kostnega mozga aplastična anemija, pancitopenija, bicitopenija agranulocitoza, huda trombocitopenija, pridobljena hemofilija A, granulocitopenija, anemija, hemolitična anemija pri bolnikih s pomanjkanjem glukoza-6-fosfatdehidrogenaze (G6PD) (glejte poglavje 4.4)
English: Acute liver failure, liver injury, mainly hepatocellular*, hepatitis, elevation of hepatic enzymes*, abnormal liver function test, chronic hepatitis*
Slovenian: Bolezni jeter, žolčnika in žolčevodov akutna odpoved jeter, poškodba jeter, predvsem hepatocelularna hepatitis, zvišane vrednosti jetrnih encimov
English: - For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose.
Slovenian: - če je zamuda več kot 12 ur: bolnik naj naslednji odmerek vzame ob pravem času;
English: Repeat-dose toxicity studies have shown that levels up to 200 mg/kg/day are well tolerated in rats; dogs appear to be more sensitive, probably due to the high sensitivity of canines to the ulcerogenic effects of NSAIDs.
Slovenian: Študije toksičnosti pri ponavljajočih se odmerkih so pokazale, da podgane dobro prenesejo količino do 200 mg/kg/dan.
English: No genotoxicity or clastogenicity issues of concern have been found with ASA.
Slovenian: Z ASA niso ugotovili skrb zbujajočih genotoksičnih ali klastogenih učinkov.
English: Following absorption, the ASA in Clopidogrel/Acetylsalicylic acid Mylan is hydrolysed to salicylic acid with peak plasma levels of salicylic acid occurring within 1 hour of dosing, such that plasma levels of ASA are essentially undetectable 1.5-3 hours after dosing.
Slovenian: Salicilna kislina doseže največjo koncentracijo v plazmi v 1 uri po uporabi zdravila, tako da je koncentracija ASA v plazmi po 1,5 do 3 urah po uporabi praktično nezaznavna.
English: 28 x 1 film-coated tablets 30 x 1 film-coated tablets
Slovenian: 30 × 1 filmsko obložena tableta
English: Acetylsalicylic acid inhibits platelet aggregation by irreversible inhibition of prostaglandin cyclooxygenase and thus inhibits the generation of thromboxane A2, an inducer of platelet aggregation and vasoconstriction.
Slovenian: Acetilsalicilna kislina zavira agregacijo trombocitov z ireverzibilnim zavrtjem prostaglandinske ciklooksigenaze.
English: The bottles contain a desiccant.
Slovenian: Plastenke vsebujejo sušilno sredstvo.
English: Excipients with known effect Each film-coated tablet contains 48 mg of lactose and 0.81 mg Allura Red AC.
Slovenian: Ena filmsko obložena tableta vsebuje 48 mg laktoze in 0,81 mg barvila rdeče AC. Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: You should not breast-feed while using this medicine.
Slovenian: Tega zdravila po možnosti ne jemljite med obdobjem dojenja.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets EU/1/19/1395/001 - Cartons of 28 film coated tablets in aluminium blister packs EU/1/19/1395/002 - Cartons of 30 film coated tablets in aluminium blister packs EU/1/19/1395/003 - Cartons of 28 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/004 - Cartons of 30 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/005 - Cartons of 100 film coated tablets in HDPE bottle packs
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/75 mg filmsko obložene tablete EU/1/19/1395/001 - škatle z 28 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/19/1395/002 - - škatle s 30 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/19/1395/003 - škatle z 28 x 1 (pakiranje s posameznimi odmerki) filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/19/1395/004 - škatle s 30 x 1 (pakiranje s posameznimi odmerki) filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/19/1395/005 - škatle s 100 filmsko obloženimi tabletami v HDPE plastenki
English: What Clopidogrel/Acetylsalicylic acid Mylan looks like and contents of the pack
Slovenian: Izgled zdravila Klopidogrel/acetilsalicilna kislina Mylan in vsebina pakiranja
English: Patients should also be told that it might take longer than usual to stop bleeding when they take Clopidogrel/Acetylsalicylic acid Mylan, and that they should report any unusual bleeding (site or duration) to their physician.
Slovenian: Bolnikom morate povedati, da se jim lahko med jemanjem zdravila Klopidogrel/acetilsalicilna kislina Mylan krvavitve ustavijo počasneje kot ponavadi.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI), ODGOVORNEN
English: • Severe hepatic impairment.
Slovenian: • hude jetrne okvare,
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid (ASA).
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v obliki hidrogensulfata) in 100 mg acetilsalicilne kisline (ASA).
English: A significantly lower exposure to clopidogrel active metabolite and reduced platelet inhibition have been demonstrated in HIV-infected patients treated with ritonavir- or cobicistat-boosted anti-retroviral therapies.
Slovenian: Pri bolnikih, okuženih z virusom HIV, ki se zdravijo s protiretrovirusnim zdravljenjem, okrepljenim z ritonavirjem ali kobicistatom, so dokazali pomembno zmanjšano izpostavljenost aktivnemu presnovku klopidogrela in zmanjšano zaviranje trombocitov.
English: Haematuria
Slovenian: Obloga
English: Repeated doses of clopidogrel 75 mg per day produced substantial inhibition of ADP-induced platelet aggregation from the first day; this increased progressively and reached steady state between Day 3 and Day 7.
Slovenian: Večkratni odmerki po 75 mg na dan tvorijo pomembno zaviranje z ADP sprožene agregacije trombocitov od prvega dne.
English: How to take Clopidogrel/Acetylsalicylic acid Mylan
Slovenian: Kako jemati zdravilo Klopidogrel/acetilsalicilna kislina Mylan
English: Tel: + 39 02 612 46921
Slovenian: Mylan Italia S.r.l Tel: + 39 02 612 46921
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets Pink, oval shaped, biconvex, film-coated tablets, approximately 14.8 mm x 7.8 mm debossed with “CA3” on one side of the tablet and “M” on the other side.
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/100 mg filmsko obložene tablete Rožnate, bikonveksne filmsko obložene tablete ovalne oblike in velikosti približno 14,8 mm × 7,8 mm z vtisnjeno oznako »CA3« na eni in »M« na drugi strani tablete.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Mylan should be given as a single daily 75 mg/75 mg dose.
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/75 mg filmsko obložene tablete Zdravilo Klopidogrel/acetilsalicilna kislina Mylan se mora dajati kot enkratni dnevni odmerek 75 mg/75 mg.
English: Varicella vaccine
Slovenian: Cepivo proti noricam
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Yellow, oval shaped, biconvex, film-coated tablets, approximately 14.5 mm x 7.4 mm debossed with “CA2” on one side of the tablet and “M” on the other side.
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/75 mg filmsko obložene tablete Rumene, bikonveksne filmsko obložene tablete ovalne oblike in velikosti približno 14,5 mm × 7,4 mm z vtisnjeno oznako »CA2« na eni in »M« na drugi strani tablete.
English: ASA is known to be excreted in limited amounts in human milk.
Slovenian: Znano pa je, da se pri človeku v materinem mleku izloča ASA.
English: What Clopidogrel/Acetylsalicylic acid Mylan contains
Slovenian: Kaj vsebuje Klopidogrel/acetilsalicilna kislina Mylan
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg
Slovenian: Klopidogrel/acetilsalicilna kislina Mylan 75 mg/100 mg
English: EU/1/19/1395/001 - 28 film coated tablets in aluminium blister packs EU/1/19/1395/002 - 30 film coated tablets in aluminium blister packs EU/1/19/1395/003 - 28 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/004 - 30 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/005 - 100 film coated tablets in HDPE bottle packs
Slovenian: EU/1/19/1395/001 - 28 filmsko obloženih tablet v aluminijastih pretisnih omotih EU/1/19/1395/002 - 30 filmsko obloženih tablet v aluminijastih pretisnih omotih EU/1/19/1395/003 - 28 x 1 (pakiranje s posameznimi odmerki) filmsko obložena tableta v aluminijastih pretisnih omotih
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid (ASA).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Klopidogrel/acetilsalicilna kislina Mylan 75 mg/75 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v obliki hidrogensulfata) in 75 mg acetilsalicilne kisline (ASA).
English: Upper gastrointestinal disorders (oesophagitis, oesophageal ulceration, perforation, erosive gastritis, erosive duodenitis; gastroduodenal ulcer/perforations)*; lower gastrointestinal disorders (small [jejunum and ileum] and large [colon and rectum] intestinal ulcers, colitis and intestinal perforation)*; upper gastro-intestinal symptoms* such as gastralgia (see section 4.4); these ASA related GI reactions may or may not be associated with haemorrhage, and may occur at any dose of acetylsalicylic acid and in patients with or without warning symptoms or a previous history of serious GI events*.
Slovenian: Bolezni zgornjih prebavil (ezophagitis (vnetje sluznice požiralnika), ulkus požiralnika (razjede v požiralniku), perforacija (predrtje), erozivni gastritis, erozivni duodenitis; razjede/perforacije na želodcu/dvanajstniku) bolezni spodnjih prebavil (ulkusi (peptične razjede) tankega [jejunum in ileum] in debelega črevesa [kolon in rektum (danka)], kolitis in perforacije prebavil)