FrancophonIA/ELRC3.0 huggingface dataset:
English: Finally, 30 minutes after drinking the solution, the patient collects a further two breath samples.
Slovenian: Nazadnje bolnik 30 minut potem, ko popije raztopino, odvzame še dva vzorca izdihanega zraka.
English: If there is labelled carbon dioxide in the breath sample after 30 minutes (a positive test), this means that the patient is infected with H. pylori.
Slovenian: Če se v vzorcu izdihanega zraka, zajetem po 30 minutah, nahaja označen ogljikov dioksid (pozitiven test), to pomeni, da je bolnik okužen s H. pylori.
English: Helicobacter Test INFAI has been tested in four studies in adult patients involving a total of 561 patients and one study in 335 children and adolescents.
Slovenian: Zdravilo Helicobacter Test INFAI so preučevali v štirih študijah z odraslimi bolniki, ki so vključevale skupno 561 bolnikov, in eni študiji s 335 otroki in mladostniki.
English: To carry out the test, the patient must collect four samples, two before taking Helicobacter Test INFAI and two thereafter.
Slovenian: Za izvedbo testa mora bolnik zbrati štiri vzorce, dva pred jemanjem zdravila Helicobacter Test INFAI in dva potem.
English: The patient then takes a ‘test meal' (either 200 ml of pure orange juice or 1 g of citric acid dissolved in 200 ml water), followed by the solution of Helicobacter Test INFAI dissolved in water.
Slovenian: Bolnik nato vzame „testni obrok“ (200 ml čistega pomarančnega soka ali 1 g citronske kisline, raztopljene v 200 ml vode), za tem pa raztopino zdravila Helicobacter Test INFAI, raztopljenega v vodi.
English: H. pylori contain enzymes called ureases that make it able to break down urea into carbon dioxide, which is then removed in the breath.
Slovenian: H. pylori vsebuje encime, imenovane ureaze, ki omogočajo razgradnjo sečnine v ogljikov dioksid, ki se nato izloči z dihanjem.
English: In all studies, the results of the test done using Helicobacter Test INFAI agreed with the results obtained with the endoscopy and histology in over 95% of cases.
Slovenian: V vseh študijah so se rezultati testa, izvedenega z uporabo zdravila Helicobacter Test INFAI, v več kot 95 % primerov ujemali z rezultati, pridobljenimi z endoskopijo in histologijo.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) HELICOBACTER TEST INFAI EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) HELICOBACTER TEST INFAI Povzetek EPAR za javnost
English: It can only be used in children when invasive tests (taking a sample from the stomach using a probe) cannot be carried out or have given questionable results, or to check that H. pylori has been eliminated after a specific treatment to clear up the infection.
Slovenian: Pri otrocih se sme uporabiti samo takrat, kadar invazivnih testov (odvzema vzorca iz želodca z instrumentom) ni mogoče izvesti oz. kadar so rezultati teh testov vprašljivi ali da se preveri, ali je bila H. pylori po specifičnem zdravljenju za odstranitev okužbe izkoreninjena.
English: H. pylori is a bacterium that is a factor in diseases such as dyspepsia (heartburn, bloating and nausea), gastritis (inflammation of the stomach), and peptic ulcer disease (ulcers in the stomach or the duodenum).
Slovenian: H. pylori je bakterija, ki je soudeležena pri boleznih, kot so dispepsija (zgaga, napihnjenost in slabost), gastritis (vnetje želodca) in peptični ulkus (razjede želodca ali dvanajstnika).
English: Helicobacter Test INFAI is a breath test: breath samples are collected, which are then sent out for analysis to a specialised laboratory.
Slovenian: Zdravilo Helicobacter Test INFAI je dihalni test: odvzamejo se vzorci izdihanega zraka, ki se nato pošljejo na analizo v specializiran laboratorij.
English: In all studies, patients underwent an endoscopy and histology (when a probe is inserted in the stomach to take a sample and the sample is then analysed) as well as a breath test with Helicobacter Test INFAI, and the results of the two tests were compared.
Slovenian: V vseh študijah so pri bolnikih izvedli endoskopijo in histologijo (pri čemer se v želodec vstavi instrument za odvzem vzorca, vzorec pa se nato analizira) ter dihalni test z zdravilom Helicobacter Test INFAI, nato pa so rezultate testov primerjali med seboj.
English: The active substance in Helicobacter Test INFAI, 13C-urea, is the natural chemical urea that has been labelled with carbon-13 (13C).
Slovenian: Zdravilna učinkovina v zdravilu Helicobacter Test INFAI, 13C-sečnina, je naravna kemična sečnina, ki je bila označena z ogljikom-13 (13C).
English: Helicobacter Test INFAI can be used to test adults, adolescents who are likely to have peptic ulcer disease, and children aged three to 11 years.
Slovenian: Zdravilo Helicobacter Test INFAI se lahko uporablja za testiranje odraslih, mladostnikov, pri katerih obstaja sum, da imajo peptično razjedo, in otrok, starih od 3 do 11 let.
English: The Committee for Medicinal products for Human Use (CHMP) decided that Helicobacter Test INFAI's benefits are greater than its risks for the in vivo diagnosis of gastroduodenal H. pylori infection in adults, adolescents who are likely to have peptic ulcer disease, and children aged three to 11 years for the evaluation of the success of eradication treatment, or when invasive tests cannot be performed, or when there are discordant results arising from invasive tests.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Helicobacter Test INFAI za in vivo diagnostiko okužb želodca in dvanajstnika s H. pylori pri odraslih, mladostnikih, pri katerih obstaja sum, da imajo peptični ulkus, in otrocih, starih od treh do 11 let, za ocenitev uspešnosti eradikacijske terapije (izkoreninjenja) ali kadar invazivnih testov ni mogoče izvesti oz. kadar so njihovi rezultati protislovni, večje od z njim povezanih tveganj.
English: Helicobacter Test INFAI should not be used in patients who have, or may have gastric (stomach) infection or atrophic gastritis (stomach inflammation that causes the breakdown of the stomach lining), as these might interfere with the breath test.
Slovenian: Zdravila Helicobacter Test INFAI se ne sme uporabljati pri bolnikih, ki imajo ali utegnejo imeti gastrično infekcijo (okužbo želodca) ali atrofični gastritis (vnetje želodca, ki povzroča razgradnjo želodčne sluznice), saj utegneta vplivati na dihalni test.
English: When the patient takes Helicobacter Test INFAI, the 13C-urea contained in the test is broken down by H Pylori into carbon dioxide that also contains 13C.
Slovenian: Ko bolnik vzame zdravilo Helicobacter Test INFAI, H. pylori razgradi 13C-sečnino, ki je v testu, v ogljikov dioksid, ki prav tako vsebuje 13C.
English: Other information about Helicobacter Test INFAI:
Slovenian: Druge informacije o zdravilu Helicobacter Test INFAI:
English: For full information on how the test is carried out, see the Package Leaflet.
Slovenian: Celotne informacije o načinu izvedbe testa so na voljo v Navodilu za uporabo.
English: Helicobacter Test INFAI is used to diagnose Helicobacter pylori infection in the stomach and duodenum (the part of the gut just below the stomach).
Slovenian: Zdravilo Helicobacter Test INFAI se uporablja za diagnosticiranje okužbe s Helicobacter pylori v želodcu in dvanajstniku (delu črevesja neposredno pod želodcem).
English: The Committee recommended that Helicobacter Test INFAI be given marketing authorisation.
Slovenian: Odbor je zato priporočil, da se za zdravilo Helicobacter Test INFAI odobri dovoljenje za promet.
English: The full EPAR for Helicobacter Test INFAI is available here.
Slovenian: Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Helicobacter Test INFAI je na voljo tukaj.
English: What benefit has Helicobacter Test INFAI shown during the studies?
Slovenian: Kakšne koristi je zdravilo Helicobacter Test INFAI izkazalo med raziskavami?
English: What is the risk associated with Helicobacter Test INFAI?
Slovenian: Kakšna tveganja so povezana z zdravilom Helicobacter Test INFAI?
English: Why has Helicobacter Test INFAI been approved?
Slovenian: Zakaj je bilo zdravilo Helicobacter Test INFAI odobreno?
English: What is Helicobacter Test INFAI?
Slovenian: Kaj je zdravilo Helicobacter Test INFAI?
English: The patient should not eat for at least six hours, preferably overnight, before taking the test. Firstly, the patient collects two breath samples, using the tubes or bags supplied with Helicobacter Test INFAI.
Slovenian: Bolnik najprej odvzame dva vzorca izdihanega zraka, pri čemer si pomaga s cevkami ali vrečkami, ki so priložene zdravilu Helicobacter Test INFAI.
English: What is Helicobacter Test INFAI used for?
Slovenian: Za kaj se zdravilo Helicobacter Test INFAI uporablja?
English: How is Helicobacter Test INFAI used?
Slovenian: Kako se zdravilo Helicobacter Test INFAI uporablja?
English: How has Helicobacter Test INFAI been studied?
Slovenian: Kako je bilo zdravilo Helicobacter Test INFAI raziskano?
English: How does Helicobacter Test INFAI work?
Slovenian: Kako zdravilo Helicobacter Test INFAI deluje?
English: Date of latest renewal: 8 May 2014
Slovenian: Datum zadnjega podaljšanja: 8. maj 2014
English: • Risk Management Plan (RMP)
Slovenian: • Načrt obvladovanja tveganja (RMP)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 September 2009
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 21. september 2009
English: • Your doctor may order blood tests.
Slovenian: • lahko vaš zdravnik naroči krvne preiskave;
English: Posology • Adults and elderly
Slovenian: Odmerjanje - Odrasli in starostniki
English: 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).
Slovenian: Njihova pogostnost je navedena po naslednjem dogovoru: 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), neznani (ni mogoče oceniti iz razpoložljivih podatkov).
English: • If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na klopidogrel ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: PHARMACEUTICAL FORM Film-coated tablet.
Slovenian: FARMACEVTSKA OBLIKA Filmsko obložena tableta.
English: For the 28x1 tablets pack size, you can check the day on which you last took the tablet by referring to the calendar printed on the blister.
Slovenian: Na pakiranju 28x1 tablet lahko preverite na kateri dan ste zadnjič vzeli tableto, saj so na blistru označeni dnevi.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predstavljen, v Modulu 1.8.1. pridobitve dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo na trg in toliko časa, kolikor bo zdravilo v prometu.
English: Some other medicines may influence the use of Clopidogrel Teva Pharma or vice versa.
Slovenian: Nekatera druga zdravila lahko vplivajo na jemanje zdravila Klopidogrel Teva Pharma in obratno.
English: Other medicines and Clopidogrel Teva Pharma Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Druga zdravila in zdravilo Klopidogrel Teva Pharma Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98 % and 94 % respectively).
Slovenian: Klopidogrel in glavni krožeči (neaktivni) metabolit se in vitro reverzibilno vežeta na humane plazemske proteine (98 % oziroma 94 %).
English: Patients who had developed a previous monitored allergic reaction and/or haematological reaction to one thienopyridine may have an increased risk of developing the same or another reaction to another thienopyridine.
Slovenian: 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.
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Slovenian: KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Nemčija Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska
English: • if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days.
Slovenian: • če ste imeli strdek v možganski arteriji (ishemična kap), ki se je pojavil v zadnjih sedmih dneh,
English: The elimination halflife of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Slovenian: Razpolovni čas izločanja glavnega krožečega presnovka (neaktivnega) je bil 8 ur po enkratnem in večkratnem dajanju.
English: You should take Clopidogrel Teva Pharma for as long as your doctor continues to prescribe it.
Slovenian: Zdravilo Klopidogrel Teva Pharma morate jemati, dokler vam ga vaš zdravnik predpisuje.
English: If you experience prolonged bleeding when taking Clopidogrel Teva Pharma If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.
Slovenian: Če doživite podaljšanje krvavitve v času jemanja zdravila Klopidogrel Teva Pharma Če se urežete ali poškodujete, lahko traja dlje kot običajno, da se krvavitev ustavi.
English: Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
Slovenian: Drugimi aleli, povezanimi z odsotno ali zmanjšano presnovo, so redkejši in vključujejo CYP2C19*4, *5, *6, *7 in
English: The co-primary endpoints were death from any cause and the first occurrence of re-infarction, stroke or death.
Slovenian: Sestavljeni opazovani dogodki so bili smrt zaradi kateregakoli vzroka ali prvi pojav ponovnega infarkta, kap ali smrt.
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Teva Pharma and acetylsalicylic acid for this condition.
Slovenian: Povedati so vam morali, da so "peroralni antikoagulanti" pri tej motnji učinkovitejši kot acetilsalicilna kislina ali kombinirana uporaba zdravila Klopidogrel Teva Pharma in acetilsalicilne kisline.
English: Cross-reactions among thienopyridines
Slovenian: Navzkrižne reackije med tienopiridini
English: • If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
Slovenian: • če imate zdravstveno stanje, ki trenutno povzroča krvavitev, npr. rana na želodcu ali možganska krvavitev.
English: What Clopidogrel Teva Pharma looks like and contents of the pack The film-coated tablets are pink, round and slightly convex.
Slovenian: Izgled zdravila Klopidogrel Teva Pharma in vsebina pakiranja Filmsko obložente tablete so rožnate, okrogle in rahlo izbočene.
English: What Clopidogrel Teva Pharma is and what it is used for What you need to know before you take Clopidogrel Teva Pharma How to take Clopidogrel Teva Pharma Possible side effects
Slovenian: Kaj je zdravilo Klopidogrel Teva Pharma in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzel zdravilo Klopidogrel Teva Pharma Kako jemati zdravilo Klopidogrel Teva Pharma Možni neželeni učinki
English: Warnings and precautions If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Teva Pharma:
Slovenian: Opozorila in previdnostni ukrepi Če katerokoli od spodaj navedenih stanj velja za vas, morate o tem obvestiti svojega zdravnika, preden boste vzeli zdravilo Klopidogrel Teva Pharma:
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets 28x1 film-coated tablets 50x1 film-coated tablets
Slovenian: 7 filmsko obloženih tablet 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 56 filmsko obloženih tablet 84 filmsko obloženih tablet 90 filmsko obloženih tablet 100 filmsko obloženih tablet 28x1 filmsko obložena tableta 50x1 filmsko obložena tableta
English: Then, the recommended dose is one 75 mg tablet of Clopidogrel Teva Pharma per day as described above.
Slovenian: Nato je priporočeni odmerek ena 75 mg tableta zdravila Klopidogrel Teva Pharma na dan, kot je opisano zgoraj.
English: What Clopidogrel Teva Pharma is and what it is used for
Slovenian: Kaj je zdravilo Klopidogrel Teva Pharma in za kaj ga uporabljamo
English: Your doctor should have prescribed Clopidogrel Teva Pharma plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding
Slovenian: Zdravnik naj bi vam predpisal zdravilo Klopidogrel Teva Pharma skupaj z acetilsalicilno kislino, če ne morete prejemati "peroralnih antikoagulantov", ali če nimate tveganja za večjo krvavitev.
English: If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Teva Pharma in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Slovenian: Če ste doživeli hudo bolečino v prsih (nestabilna angina pektoris ali srčni napad), so vam morda predpisali zdravilo Klopidogrel Teva Pharma v kombinaciji z acetilsalicilno kislino, učinkovino, ki je prisotna v številnih zdravilih, ki se uporabljajo za lajšanje bolečine in zniževanje zvišane telesne temperature.
English: Driving and using machines Clopidogrel Teva Pharma is unlikely to affect your ability to drive or to use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Klopidogrel Teva Pharma vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev.
English: If you take more Clopidogrel Teva Pharma than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Slovenian: Če ste vzeli večji odmerek zdravila Klopidogrel Teva Pharma, kot bi smeli Zaradi povečanega tveganja za krvavitev se posvetujte s svojim zdravnikom ali z medicinskim osebjem na najbližjem bolnišničnem oddelku za nujno zdravniško pomoč.
English: If you become pregnant while taking Clopidogrel Teva Pharma, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Slovenian: Če med zdravljenjem z zdravilom Klopidogrel Teva Pharma zanosite, se takoj posvetujte s svojim zdravnikom, saj jemanje klopidogrela med nosečnostjo ni priporočljivo.
English: Perforated unit dose blister of OPA/Al/PVC-Al containing 28x1 and 50x1 film-coated tablets in the box.
Slovenian: Perforirani, enoodmerni pretisni omoti iz OPA/Al/PVC-Al, ki vsebujejo 28x1 in 50x1 filmsko obloženo tableto, v škatli.
English: How to store Clopidogrel Teva Pharma Contents of the pack and other information
Slovenian: Shranjevanje zdravila Klopidogrel Teva Pharma Vsebina pakiranja in dodatne informacije
English: You have been prescribed Clopidogrel Teva Pharma to help prevent blood clots and reduce the risk of these severe events because: - You have a condition of hardening of arteries (also known as atherosclerosis), and - You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or - You have experienced a severe type of chest pain known as ‘unstable angina' or ‘myocardial infarction' (heart attack).
Slovenian: Zdravilo Klopidogrel Teva Pharma vam je predpisano za pomoč pri preprečevanju nastajanja krvnih strdkov in za zmanjšanje tveganja teh hudih dogodkov, ker: - imate otrdele arterije (znano tudi kot ateroskleroza) in - ste predhodno doživeli srčni napad, kap ali imeli stanje, ki je znano kot periferna arterijska bolezen, ali - ste doživeli hudo obliko bolečine v prsih, znano kot "nestabilna angina" ali "miokardni infarkt" (srčni napad).
English: What you need to know before you take Clopidogrel Teva Pharma
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Klopidogrel Teva Pharma
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC Code: B01AC-04.
Slovenian: Farmakoterapevtska skupina: zaviralci agregacije trombocitov brez heparina, oznaka ATC: B01AC
English: EU/1/09/561/001 7 film-coated tablets EU/1/09/561/002 14 film-coated tablets EU/1/09/561/003 28 film-coated tablets EU/1/09/561/004 30 film-coated tablets EU/1/09/561/005 50 film-coated tablets EU/1/09/561/006 56 film-coated tablets EU/1/09/561/007 84 film-coated tablets EU/1/09/561/008 90 film-coated tablets EU/1/09/561/009 100 film-coated tablets EU/1/09/561/010 28x1 film-coated tablets EU/1/09/561/011 50x1 film-coated tablets
Slovenian: EU/1/09/561/001 škatla s 7 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih omotih EU/1/09/561/002 škatla s 14 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih omotih EU/1/09/561/003 škatla z 28 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih omotih EU/1/09/561/004 škatla s 30 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih omotih EU/1/09/561/005 škatla s 50 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih omotih EU/1/09/561/006 škatla s 56 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih omotih EU/1/09/561/007 škatla s 84 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih omotih EU/1/09/561/008 škatla z 90 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih omotih EU/1/09/561/009 škatla s 100 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih
English: Manufacturers
Slovenian: Izdelovalci:
English: Each film-coated tablet contains 13 mg of hydrogenated castor oil.
Slovenian: Ena filmsko obložena tableta vsebuje 13 mg hidrogeniranega ricinusovega olja.
English: The most common side effect reported with Clopidogrel Teva Pharma is bleeding.
Slovenian: Najpogostejši neželeni učinek o katerem so poročali med zdravljenjem z zdravilom Klopidogrel Teva Pharma je krvavitev.
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Teva Pharma.
Slovenian: Če menite, da se karkoli od navedenega nanaša na vas, ali če ste kakorkoli v dvomih, se posvetujte s svojim zdravnikom, preden vzamete Klopidogrel Teva Pharma.
English: The pharmacokinetics of the active metabolite of clopidogrel is not known in these special populations.
Slovenian: Posebne skupine bolnikov Farmakokinetika aktivnega presnovka klopidogrela v teh posebnih skupinah bolnikov ni znana.
English: • Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
Slovenian: • odraslih bolnikih za preprečevanje aterotrombotičnih dogodkov z miokardnim infarktom (od nekaj dni do manj kot 35 dni), ishemično kapjo (od 7 dni do manj kot 6 mesecev) ali dokazano periferno arterijsko boleznijo.
English: Thus, beyond 3 months of treatment, the benefit observed in the clopidogrel + ASA group was not further increased, whereas the risk of haemorrhage persisted (see section 4.4).
Slovenian: Tako se pri zdravljenju več kot 3 mesece opažena korist v skupini, ki je prejemala klopidogrel in ASA, ni nadalje povečevala, medtem ko je tveganje za krvavitev ostalo (glejte poglavje 4.4).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Slovenian: Imetnik dovoljenja za promet: Teva B.V.