natgillin/translations-raw huggingface dataset:
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).
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).
Helicobacter Test INFAI is a breath test: breath samples are collected, which are then sent out for analysis to a specialised laboratory.
Zdravilo Helicobacter Test INFAI je dihalni test: odvzamejo se vzorci izdihanega zraka, ki se nato pošljejo na analizo v specializiran laboratorij.
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.
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.
The active substance in Helicobacter Test INFAI, 13C-urea, is the natural chemical urea that has been labelled with carbon-13 (13C).
Zdravilna učinkovina v zdravilu Helicobacter Test INFAI, 13C-sečnina, je naravna kemična sečnina, ki je bila označena z ogljikom-13 (13C).
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.
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.
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.
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.
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.
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.
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.
Ko bolnik vzame zdravilo Helicobacter Test INFAI, H. pylori razgradi 13C-sečnino, ki je v testu, v ogljikov dioksid, ki prav tako vsebuje 13C.
Other information about Helicobacter Test INFAI:
Druge informacije o zdravilu Helicobacter Test INFAI:
For full information on how the test is carried out, see the Package Leaflet.
Celotne informacije o načinu izvedbe testa so na voljo v Navodilu za uporabo.
Helicobacter Test INFAI is used to diagnose Helicobacter pylori infection in the stomach and duodenum (the part of the gut just below the stomach).
Zdravilo Helicobacter Test INFAI se uporablja za diagnosticiranje okužbe s Helicobacter pylori v želodcu in dvanajstniku (delu črevesja neposredno pod želodcem).
The Committee recommended that Helicobacter Test INFAI be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Helicobacter Test INFAI odobri dovoljenje za promet.
The full EPAR for Helicobacter Test INFAI is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Helicobacter Test INFAI je na voljo tukaj.
What benefit has Helicobacter Test INFAI shown during the studies?
Kakšne koristi je zdravilo Helicobacter Test INFAI izkazalo med raziskavami?
What is the risk associated with Helicobacter Test INFAI?
Kakšna tveganja so povezana z zdravilom Helicobacter Test INFAI?
Why has Helicobacter Test INFAI been approved?
Zakaj je bilo zdravilo Helicobacter Test INFAI odobreno?
What is Helicobacter Test INFAI?
Kaj je zdravilo Helicobacter Test INFAI?
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.
Bolnik najprej odvzame dva vzorca izdihanega zraka, pri čemer si pomaga s cevkami ali vrečkami, ki so priložene zdravilu Helicobacter Test INFAI.
What is Helicobacter Test INFAI used for?
Za kaj se zdravilo Helicobacter Test INFAI uporablja?
How is Helicobacter Test INFAI used?
Kako se zdravilo Helicobacter Test INFAI uporablja?
How has Helicobacter Test INFAI been studied?
Kako je bilo zdravilo Helicobacter Test INFAI raziskano?
How does Helicobacter Test INFAI work?
Kako zdravilo Helicobacter Test INFAI deluje?
Date of latest renewal: 8 May 2014
Datum zadnjega podaljšanja: 8. maj 2014
• Risk Management Plan (RMP)
• Načrt obvladovanja tveganja (RMP)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 September 2009
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 21. september 2009
• Your doctor may order blood tests.
• lahko vaš zdravnik naroči krvne preiskave;
Posology • Adults and elderly
Odmerjanje - Odrasli in starostniki
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 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).
• If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na klopidogrel ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
PHARMACEUTICAL FORM Film-coated tablet.
FARMACEVTSKA OBLIKA Filmsko obložena tableta.
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.
Na pakiranju 28x1 tablet lahko preverite na kateri dan ste zadnjič vzeli tableto, saj so na blistru označeni dnevi.
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.
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.
Some other medicines may influence the use of Clopidogrel Teva Pharma or vice versa.
Nekatera druga zdravila lahko vplivajo na jemanje zdravila Klopidogrel Teva Pharma in obratno.
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.
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.
Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98 % and 94 % respectively).
Klopidogrel in glavni krožeči (neaktivni) metabolit se in vitro reverzibilno vežeta na humane plazemske proteine (98 % oziroma 94 %).
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.
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.
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
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
• if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days.
• če ste imeli strdek v možganski arteriji (ishemična kap), ki se je pojavil v zadnjih sedmih dneh,
The elimination halflife of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Razpolovni čas izločanja glavnega krožečega presnovka (neaktivnega) je bil 8 ur po enkratnem in večkratnem dajanju.
You should take Clopidogrel Teva Pharma for as long as your doctor continues to prescribe it.
Zdravilo Klopidogrel Teva Pharma morate jemati, dokler vam ga vaš zdravnik predpisuje.
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.
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.
Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
Drugimi aleli, povezanimi z odsotno ali zmanjšano presnovo, so redkejši in vključujejo CYP2C19*4, *5, *6, *7 in
The co-primary endpoints were death from any cause and the first occurrence of re-infarction, stroke or death.
Sestavljeni opazovani dogodki so bili smrt zaradi kateregakoli vzroka ali prvi pojav ponovnega infarkta, kap ali smrt.
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.
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.
Cross-reactions among thienopyridines
Navzkrižne reackije med tienopiridini
• If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
• če imate zdravstveno stanje, ki trenutno povzroča krvavitev, npr. rana na želodcu ali možganska krvavitev.
What Clopidogrel Teva Pharma looks like and contents of the pack The film-coated tablets are pink, round and slightly convex.
Izgled zdravila Klopidogrel Teva Pharma in vsebina pakiranja Filmsko obložente tablete so rožnate, okrogle in rahlo izbočene.
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
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
Warnings and precautions If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Teva Pharma:
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:
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
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
Then, the recommended dose is one 75 mg tablet of Clopidogrel Teva Pharma per day as described above.
Nato je priporočeni odmerek ena 75 mg tableta zdravila Klopidogrel Teva Pharma na dan, kot je opisano zgoraj.
What Clopidogrel Teva Pharma is and what it is used for
Kaj je zdravilo Klopidogrel Teva Pharma in za kaj ga uporabljamo
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
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.
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.
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.
Driving and using machines Clopidogrel Teva Pharma is unlikely to affect your ability to drive or to use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Klopidogrel Teva Pharma vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev.
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.
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.
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.
Če med zdravljenjem z zdravilom Klopidogrel Teva Pharma zanosite, se takoj posvetujte s svojim zdravnikom, saj jemanje klopidogrela med nosečnostjo ni priporočljivo.
Perforated unit dose blister of OPA/Al/PVC-Al containing 28x1 and 50x1 film-coated tablets in the box.
Perforirani, enoodmerni pretisni omoti iz OPA/Al/PVC-Al, ki vsebujejo 28x1 in 50x1 filmsko obloženo tableto, v škatli.
How to store Clopidogrel Teva Pharma Contents of the pack and other information
Shranjevanje zdravila Klopidogrel Teva Pharma Vsebina pakiranja in dodatne informacije
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).
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).
What you need to know before you take Clopidogrel Teva Pharma
Kaj morate vedeti, preden boste vzeli zdravilo Klopidogrel Teva Pharma
Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC Code: B01AC-04.
Farmakoterapevtska skupina: zaviralci agregacije trombocitov brez heparina, oznaka ATC: B01AC
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
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
Manufacturers
Izdelovalci:
Each film-coated tablet contains 13 mg of hydrogenated castor oil.
Ena filmsko obložena tableta vsebuje 13 mg hidrogeniranega ricinusovega olja.
The most common side effect reported with Clopidogrel Teva Pharma is bleeding.
Najpogostejši neželeni učinek o katerem so poročali med zdravljenjem z zdravilom Klopidogrel Teva Pharma je krvavitev.
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.
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.
The pharmacokinetics of the active metabolite of clopidogrel is not known in these special populations.
Posebne skupine bolnikov Farmakokinetika aktivnega presnovka klopidogrela v teh posebnih skupinah bolnikov ni znana.
• 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.
• 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.
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).
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).
NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Imetnik dovoljenja za promet: Teva B.V.
The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Teva Pharma per day to be taken orally with or without food, and at the same time each day.
Priporočeni odmerek, vključno za bolnike, ki imajo bolezensko stanje, imenovano "atrijska fibrilacija" (nepravilen srčni utrip), je ena 75 mg tableta zdravila Klopidogrel Teva Pharma na dan, ki jo lahko vzamete s hrano ali brez nje; odmerek morate jemati vsak dan ob istem času.
Data from the CAPRIE study indicate that phenytoin and tolbutamide which are metabolised by CYP2C9 can be safely co-administered with clopidogrel.
Podatki študije CAPRIE kažejo, da je lahko sočasno jemanje fenitoina in tolbutamida, ki se presnavljata s CYP2C9, s klopidogrelom varno.
The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Klinično pomembni neželeni učinki, zabeleženi v študijah CAPRIE, CURE, CLARITY in COMMIT, so predstavljeni v nadaljevanju.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Teva Pharma.
Če ste noseči ali mislite, da ste noseči, morate o tem obvestiti svojega zdravnika ali farmacevta, preden vzamete zdravilo Klopidogrel Teva Pharma.
Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Glavobol, razjeda na želodcu, bruhanje, slabost, zaprtost, preveč plinov v želodcu ali črevesju, izpuščaji, srbenje, omotica, občutek mravljinčenja in otopelosti.
Medicinal products that are strong or moderate CYP2C19 inhibitors include, for example, omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, and efavirenz.
Med zdravila, ki so močni ali zmerni zaviralci CYP2C19, spadajo, na primer omeprazol in esomeprazol, fluvoksamin, fluoksetin, moklobemid, vorikonazol, flukonazol, tiklopidin, karbamazepin, efavirenz.
• Adult patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
• odraslih bolnikih z akutnim koronarnim sindromom: - akutni koronarni sindrom brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca), vključno z bolniki, katerim je bil vstavljen stent po perkutani koronarni intervenciji, v kombinaciji z acetilsalicilno kislino (ASA - acetylsalicylic acid).
Polyvinyl alcohol Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172) Talc
Filmska obloga: polivinilalkohol titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172) smukec makrogol 3000
• If you suffer from severe liver disease.
• če imate hudo jetrno obolenje.
The PSUR submission schedule for Clopidogrel Teva Pharma film coated tablets should follow PSURs submission schedule for the reference medicinal product.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Razpored predložitve PSUR za Klopidogrel Teva Pharma filmsko obložene tablete se mora ujemati z razporedom predložitve PSUR za referenčno zdravilo.
After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min), inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Po večkratnih odmerkih 75 mg klopidogrela na dan pri osebah s hudo ledvično boleznijo (kreatininski očistek 5-15 ml/min) inhibicija z ADP-jem sprožene agregacije trombocitov manjša (25 %) od tiste, opažene pri zdravih osebah.Vendar je bilo podaljšanje časa krvavitve podobno tistemu, ki so ga opazili pri zdravih osebah, ki so jemale 75 mg klopidogrela na dan.
Clopidogrel Teva Pharma contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Zdravilo Klopidogrel Teva Pharma vsebuje klopidogrel in spada v skupino zdravil, ki se imenujejo zaviralci agregacije trombocitov.