natgillin/translations-raw huggingface dataset:
Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1,752) or placebo (n=1,739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
Bolniki so dobivali klopidogrel (300 mg udarni odmerek, nato pa 75 mg na dan, n=1.752) ali placebo (n=1.739), oboje v kombinaciji z ASA (150 mg do 325 mg kot udarni odmerek, nato 75 mg do 162 mg na dan), fibrinolitičnim sredstvom in po potrebi heparinom.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva Generics B.V. (4 tablets of 75 mg) once at the start of treatment.
Če ste imeli hudo bolečino v prsih (nestabilna angina pektoris ali srčna kap), vam lahko zdravnik na začetku zdravljenja da enkrat 300 mg zdravila Klopidogrel Teva Generics B.V.
Very rare side effects (affects less than 1 patient in 10,000): Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste.
Zelo redki neželeni učinki (pojavijo se pri manj kot 1 od 10.000 bolnikov): zlatenica, huda bolečina v trebuhu z bolečino v hrbtu ali brez nje, zvišana telesna temperatura, težave pri dihanju, ki so včasih povezane s kašljem, splošne alergijske reakcije, oteklina v ustih, mehurji na koži, kožna alergija,
Other concomitant therapy:
Sočasno zdravljenje z drugimi zdravili:
Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v obliki klopidogrelijevega klorida).
The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebotreated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogreltreated group.
Število bolnikov s primarnim opazovanim dogodkom (srčno-žilna smrt, MI, kap ali neodzivna ishemijo) je bilo 1.035 (16,5%) v skupini zdravljeni s klopidogrelom in 1.187 (18,8%) v skupini s placebom, to je 14% zmanjšanje relativnega tveganja (95% IZ od 6% -21%, p=0,0005) za skupino,
The incidence of major bleeding was similar between groups (1.3% versus 1.1% for the clopidogrel + ASA and the placebo + ASA groups, respectively).
Incidenca večjih krvavitev je bila v obeh skupinah podobna (1,3% v skupini s klopidogrelom in ASA ter 1,1% v skupini s placebom in ASA).
Clopidogrel should be given as a single daily dose of 75 mg with or without food.
• Odrasli in starostniki Klopidogrel dajemo kot enkratni dnevni odmerek po 75 mg, s hrano ali brez nje.
- a proton pump inhibitor (e.g, omeprazole) for upset stomach, - fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections, - cimetidine, medicine to treat upset stomach, - fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression, - carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy, - ticlopidine, other antiplatelet agent.
- cimetidin, zdravilo za zdravljenje težav z želodcem, - fluoksetin, fluvoksamin ali moklobemid, zdravila za zdravljenje depresije, - karbamazepin ali oksakarbazepin, zdravila za zdravljenje nekaterih oblik epilepsije, - tiklopidin, druga antiagregacijska zdravila.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Teva Generics B.V..
Če ste noseči ali mislite, da ste noseči, morate o tem obvestiti svojega zdravnika ali farmacevta,
- swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin.
- otekanje ust ali bolezni kože, kot so izpuščaj, srbenje in mehurji na koži kar so lahko znaki alergijske reakcije.
Gastrointestinal disorders
Preiskave trombocitov
Metabolism
Trombolitiki.
Patients received clopidogrel (75 mg/day, n=22,961) or placebo (n=22,891), in combination with ASA (162 mg/day), for 28 days or until hospital discharge.
28 dni oziroma do odpusta dobivali klopidogrel (75 mg na dan, n=22.961) ali placebo (n=22.891) v kombinaciji z ASA (162 mg na dan).
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN
Common side effects (affects 1 to 10 patients in 100): Diarrhoea, abdominal pain, indigestion or heartburn.
Pogosti neželeni učinki (pojavijo se pri 1 do 10 od 100 bolnikov): driska, bolečina v trebuhu, slaba prebava ali zgaga.
In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p = 0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
(intention to treat analysis) so v skupini, ki je jemala klopidogrel, opazili 939 dogodkov, v skupini, ki je jemala ASA, pa 1.020 dogodkov (zmanjšanje relativnega tveganja /RT/: 8,7%%, 95-odstotni interval zaupanja /IZ/: 0,2 do 16,4; p = 0,045), kar ustreza preprečevanju pojava novega ishemičnega dogodka na vsakih 1.000 bolnikov, zdravljenih 2 leti, dodatnim 10 (IZ: 0 do 20) bolnikom.
You should take Clopidogrel Teva Generics B.V. for as long as your doctor continues to prescribe it.
morate jemati, dokler vam ga vaš zdravnik predpisuje.
Due to the risk of bleeding and haematological adverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment (see section 4.8).
Če se med zdravljenjem pojavijo klinični simptomi, ki opozarjajo na možnost krvavitve, moramo zaradi tveganja pojava krvavitve in hematoloških neželenih učinkov pretehtati potrebo po določanju števila krvnih celic in/ali po drugih ustreznih preiskavah (glejte poglavje 4.8).
In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR =4.0%; CI: -22.5 to 11.7 [p=0.639]).
Pri bolnikih, ki so bili v preizkušanje vključeni samo na podlagi nedavnega MI, je bil klopidogrel numerično inferioren, vendar se statistično ni razlikoval od ASA (zmanjšanje RT: -4%%;
Some other medicines may influence the use of Clopidogrel Teva Generics B.V. or vice versa.
Nekatera druga zdravila lahko vplivajo na jemanje zdravila Klopidogrel Teva Generics B.V.
In a crossover clinical study, clopidogrel (300-mg loading dose followed by 75 mg/day) alone and with omeprazole (80 mg at the same time as clopidogrel) were administered for 5 days.
V navzkrižni klinični študiji so 5 dni uporabljali bodisi klopidogrel sam (polnilni odmerek 300 mg in potem 75 mg/dan) bodisi z omeprazolom (80 mg hkrati s klopidogrelom).
4.7 Effects on ability to drive and use machines
vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev.
OPA/Al/PVC-Al blisters containing 28, 30, 50, 56, 84, 90 and 100 film-coated tablets or perforated unit dose blister containing 28x1, 28x1 (calendar pack), 30x1, 50x1, 56x1, 84x1, 90x1 and 100x1 film-coated tablets in a carton.
OPA/Al/PVC-Al pretisni omoti , ki vsebujejo po 28, 30, 50, 56, 84, 90 in 100 filmsko obloženih tablet ali perforirani, enoodmerni pretisni omoti, ki vsebujejo po 28x1, 28x1 (koledarsko pakiranje), 30x1, 50x1, 56x1, 84x1, 90x1 in 100x1 filmsko obloženo tableto v škatli.
Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension
Žilne bolezni resne krvavitve, krvavitev operacijske rane, vaskulitis, hipotenzija
You have been prescribed Clopidogrel Teva Generics B.V. 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).
vam je predpisan za pomoč pri preprečevanju nastajanja krvnih strdkov in za zmanjšanje tveganja teh hudih dogodkov, ker: - imate otrdele arterije (znano tudi kot ateroskleroza), in
Hydrogenated castor oil
Vsebuje hidrogenirano ricinusovo olje.
There is no evidence that other medicinal products that reduce stomach acid such as H2 blockers (except cimetidine which is a CYP2C19 inhibitor) or antacids interfere with antiplatelet activity of clopidogrel.
Zanesljivih podatkov o farmakodinamskem medsebojnem delovanju klopidogrela in drugih zaviralcev protonske črpalke ni. Ni dokazov, da druga zdravila za zmanjševanje želodčne kisline, npr. antagonisti histaminskih receptorjev H2 (razen cimetidina, ki je CYP2C19 inhibitor) ali antacidi, ovirajo antitrombocitno delovanje klopidogrela.
CYP2C19 Phenotype and Genotype Frequency Frequency (%)
Pogostnost fenotipov in genotipov CYP2C19 Pogostnost
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (28, 28x1, 30, 30x1, 50, 50x1, 56, 56x1, 84, 84x1, 90, 90x1, 100, 100x1 film-coated tablets)
PRETISNI OMOT (28, 28x1, 30, 30x1, 50, 50x1, 56, 56x1, 84, 84x1, 90, 90x1, 100, 100x1 filmsko obložena tableta)
The exposure to the active metabolite of clopidogrel was decreased by 45% (Day 1) and 40% (Day 5) when clopidogrel and omeprazole were administered together.
Če sta bila klopidogrel in omeprazol uporabljena skupaj, se je izpostavljenost aktivnemu presnovku klopidogrela zmanjšala za 45% (1. dan) oz. 40% (5. dan).
Recent ischaemic stroke
Nedavna ishemična kap
Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Absorpcija na podlagi presnovkov klopidrogela, izločenih s sečem, je najmanj 50%.
Intermediate metabolism: CYP2C19*1/*2 or *1/*3
Obsežna prenova: CYP2C19*1/*1 Srednja presnova: CYP2C19*1/*2 ali *1/*3 Slaba presnova: CYP2C19*2/*2, *2/*3 ali
If you forget to take Clopidogrel Teva Generics B.V.
Če ste pozabili vzeti zdravilo Klopidogrel Teva Generics B.V.
Do not use Clopidogrel Teva Generics B.V. after the expiry date which is stated on the carton and blister after EXP.
ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Name and address of the manufacturer(s) responsible for batch release
ZA SPROŠČANJE SERIJE Ime in naslov izdelovalca, odgovornega za sproščanje serije
Clopidogrel Teva Generics B.V. 75 mg film-coated tablets Clopidogrel
75 mg filmsko obložene tablete klopidogrel
Boxes of 28, 30, 50, 56, 84, 90 or 100 film-coated tablets in blisters or boxes of 28x1, 28x1 (calendar pack), 30x1, 50x1, 56x1, 84x1, 90x1 and 100x1 film-coated tablets in perforated unit dose blisters are available.
Na voljo so v škatli po 28, 30, 50, 56, 84, 90 ali 100 filmsko obloženih tablet v pretisnih omotih ali v škatli po 28x1, 28x1 (koledarsko pakiranje) 30x1, 50x1, 56x1, 84x1, 90x1 in 100x1 filmsko obložena tableta v preforiranih, enoodmernih pretisnih omotih.
CONDITIONS OF THE MARKETING AUTHORISATION
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
4.4 Special warnings and precautions for use
4.4 Posebna opozorila in previdnostni ukrepi Krvavitve in hematološke motnje
What Clopidogrel Teva Generics B.V. is and what it is used for Before you take Clopidogrel Teva Generics B.V. How to take Clopidogrel Teva Generics B.V.
in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzel zdravilo Klopidogrel Teva Generics B.V.
Consequently, NSAIDs including Cox-2 inhibitors and clopidogrel should be co-administered with caution (see section 4.4).
Zato moramo biti previdni pri sočasni uporabi nesteroidnih protivnetnih zdravil, vključno z zaviralci COX-2 in klopidogrela (glejte poglavje 4.4).
However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers,
Vendar pa so bolniki, ki so bili vključeni v klinično preizkušanje klopidogrela, brez dokazov o klinično pomembnih neželenih interakcijah sočasno jemali različna zdravila, tudi diuretike, zaviralce adrenergičnih receptorjev beta, zaviralce angiotenzinske konvertaze (ACE), kalcijeve antagoniste, učinkovine za zniževanje holesterola,
In CLARITY, there was an overall increase in bleeding in the clopidogrel + ASA group (17.4%) vs. the placebo + ASA group (12.9%).
V študiji CLARITY je v skupini bolnikov, ki so se zdravili s klopidogrelom in ASA, prišlo do splošnega povečanja krvavitev (17,4%%) v primerjavi s skupino, ki je jemala placebo in ASA
Glomerulonephritis, blood creatinine increased
Bolezni sečil glomerulonefritis,
Do not take Clopidogrel Teva Generics B.V.
Ne jemljite zdravila Klopidogrel Teva Generics B.V.
Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anaemia
4.4), aplastična anemija, pancitopenija, agranulocitoza, huda trombocitopenija, granulocitopenija, anemija
The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated 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)).
Delež bolnikov s primarnim opazovanim dogodkom [srčno-žilna (SŽ) smrt, miokardni infarkt (MI) ali kap] je bil 582 (9,3%) v skupini, zdravljeni s klopidogrelom, in 719 (11,4%) v skupini, ki je prejemala placebo, to je 20% zmanjšanje relativnega tveganja (95% IZ od 10% - 28%; p=0,00009) v skupini,
Mean inhibition of platelet aggregation (IPA) with 5 μM ADP was diminished by 39% (24 hours) and 21% (Day 5) when clopidogrel and omeprazole were administered together.
Če sta bila klopidogrel in omeprazol uporabljena skupaj, se je povprečno zavrtje agregacije trombocitov (IPA) s 5 μM ADP zmanjšalo za 39% (24 ur) oz. 21%
A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
Da bi proučili možnosti za farmakodinamične in farmakokinetične interakcije, so številne klinične študije izvedli tudi z drugimi zdravili.
Take special care with Clopidogrel Teva Generics B.V.
Bodite posebno pozorni pri jemanju zdravila Klopidogrel Teva Generics B.V.
What Clopidogrel Teva Generics B.V. looks like and contents of the pack The film-coated tablets are pink, round and slightly convex.
Filmsko obložente tablete so rožnate, okrogle in rahlo izbočene.
NAME OF THE MARKETING AUTHORISATION HOLDER Teva Generics B.V.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Teva Generics B.V.
Ελλάδα
Jetrna okvara
ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents, and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
koronarne vazodilatatorje, antidiabetike (tudi insulin), antiepileptične učinkovine in antagoniste glikoproteinov IIb/IIIa.
BEFORE YOU TAKE CLOPIDOGREL TEVA GENERICS B.V.
preden boste vzeli zdravilo Klopidogrel Teva Generics B.V.
Clopidogrel Teva Generics B.V. is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Proces je znan kot aterotromboza in lahko povzroči aterotrombotične dogodke (kot so kap, srčni napad ali smrt).
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Teva Generics B.V.:
Če katerokoli od spodaj navedenih stanj velja za vas, morate o tem obvestiti svojega zdravnika,
Nervous system disorders
Bolezni živčevja motnje okusa
Therefore clopidogrel should be used with caution in these patients (see section 4.2).
Ledvična okvara Zaradi pomanjkanja izkušenj pri zdravljenju bolnikov z ledvično okvaro klopidogrel tem bolnikom dajemo previdno (glejte poglavje 4.2).
- 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 ‘Take special care with Clopidogrel Teva Generics B.V.').
- zvišana telesna temperatura, znaki okužbe ali huda utrujenost, kar so znaki redkega zmanjšanja števila določenih krvnih celic; - znaki jetrnih težav, npr. porumenelost kože in/ali oči (zlatenica), ki so lahko povezani s krvavitvijo, ki se pojavi pod kožo kot drobne rdeče pike, in/ali zmedenostjo (glejte poglavje 2
- The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil in the tablet core and hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), talc and propylene glycol in the filmcoating.
(E464), titanov dioksid (E171), rdeči železov oksid (E172), smukec ter propilenglikol v filmski oblogi.
Contact your doctor or pharmacist before stopping.
Preden prekinete zdravljenje, se posvetujte se s svojim zdravnikom ali farmacevtom.
Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Klopidogrel previdno dajemo bolnikom, ki sočasnega jemljejo zaviralce glikoproteina IIb/IIIa (glejte poglavje 4.4).
Neutropenia, including severe neutropenia
vključno z motnjami labirinta vrtoglavica
PSURs
Heparin.
HOW TO TAKE CLOPIDOGREL TEVA GENERICS B.V.
KAKO JEMATI ZDRAVILO KLOPIDOGREL TEVA GENERICS B.V.
Driving and using machines Clopidogrel Teva Generics B.V. is unlikely to affect your ability to drive or to use machines.
Posvetujete se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Klopidogrel Teva Generics B.V.
Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
(vključno z ulceroznim ali limfocitnim kolitisom), stomatitis
The PSUR submission schedule for Clopidogrel Teva Generics B.V. should follow the PSURs submission schedule for the reference medicinal product.
Razpored predložitve PSUR za Klopidogrel Teva Generics B.V.
A pharmacodynamic interaction between clopidogrel and heparin is possible, leading to increased risk of bleeding.
Farmakodinamična interakcija med klopidogrelom in heparinom je možna in poveča tveganje za krvavitev, zato se za sočasno uporabo odločamo previdno (glejte poglavje 4.4).
Uncommon side effects (affects 1 to 10 patients in 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
bruhanje, slabost, zaprtost, preveč plinov v želodcu ali črevesju, izpuščaji, srbenje, omotica, občutek mravljinčenja in otopelosti..
NAME OF THE MEDICINAL PRODUCT Clopidogrel Teva Generics B.V. 75 mg film-coated tablets Clopidogrel
Nato je običajni odmerek ena 75-mg tableta zdravila Klopidogrel Teva Generics B.V.
Tablet core:
Pomožna snov:
How to store Clopidogrel Teva Generics B.V.
Kako jemati zdravilo Klopidogrel Teva Generics B.V.
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Take special care with Clopidogrel Teva Generics B.V.').
Pri manjših vrezninah ali poškodbah, npr. če se urežete ali brijete, navadno ni razloga za skrb, če pa ste glede krvavitve v kakršnihkoli dvomih, se morate takoj posvetovati s svojim zdravnikom, (glejte poglavje 2 »Bodite posebno pozorni pri jemanju zdravila Klopidogrel Teva Generics B.V.«).
Taking Clopidogrel Teva Generics B.V. with food and drink Clopidogrel Teva Generics B.V. may be taken with or without food.
skupaj s hrano in pijačo Zdravilo Klopidogrel Teva Generics B.V.
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije zvišana telesna temperatura
For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern.
Pri manjših urezninah ali poškodbah, npr. pri britju, navadno ni razloga za skrb, če pa vas glede krvavitve skrbi, se nemudoma posvetujte z zdravnikom (glejte »Možni neželeni učinki«);
INFORMATION IN BRAILLE Clopidogrel Teva Generics B.V. 75 mg
PODATKI V BRAILLOVI PISAVI Klopidogrel Teva Generics B.V.
Like all medicines, Clopidogrel Teva Generics B.V. can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Klopidogrel Teva Generics B.V.
Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa krvavitve v dihalih
Thrombocytopenia, leucopenia, eosinophilia
Bolezni krvi in limfatičnega sistema trombocitopenija, levkopenija, eozinofilija nevtropenija,
If you stop taking Clopidogrel Teva Generics B.V. Do not stop the treatment.
Klopidogrel Teva Generics B.V., ne dojijo.
- Keep this leaflet.
Ne prekinite zdravljenja.
Excipients
ZDRAVILA
Important information about some of the ingredients of Clopidogrel Teva Generics B.V. Clopidogrel Teva Generics B.V. contains hydrogenated castor oil which may cause stomach upset and diarrhoea.
Pomembne informacije o nekaterih sestavinah zdravila Klopidogrel Teva Generics B.V.
Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Zato je mogoče pričakovati, da uporaba zdravil, ki zavrejo delovanje tega encima, zmanjša koncentracijo aktivnega presnovka klopidogrela.
National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Pristojni nacionalni organi, katerih delo usklajuje referenčna država članica, kadar je ustrezno, zagotovijo, da imetniki dovoljenj za promet z zdravilom izpolnjujejo naslednje pogoje:
The final study report should be submitted to the National Competent Authorities by December 2016.
Končno poročilo o študiji se Odboru za zdravila za uporabo v humani medicini predloži do decembra leta 2016.
A case-control study shall be performed to further investigate the possibility of an association between pholcodine use and NMBA-related anaphylactic reactions.
Izvede se študija s „kontrolno skupino“, s katero se nadalje razišče morebitna povezava med uporabo folkodina in anafilaktičnimi reakcijami, povezanimi z živčno-mišičnimi blokatorji.
Annex III Conditions of the marketing authorisation
Pogoji dovoljenja za promet z zdravilom
A draft protocol should be submitted to CHMP for assessment and approval within 3 months of the Commission Decision.
V treh mesecih od odločbe Komisije se Odboru za zdravila za uporabo v humani medicini predloži osnutek protokola v ocenitev in odobritev.
This check may be repeated at intervals.
To preverjanje se lahko ponavlja v presledkih.
Absolute bioavailability is greater than 80%.
Absolutna biološka uporabnost je večja od 80 %.
Date of first authorisation: 26 March 2012 Date of latest renewal: 17 February 2017
Datum prve odobritve: 26. marec 2012 Datum zadnjega podaljšanja: 17. februar 2017
- if you have blood in your urine that your doctor has not checked.
- če imate kri v urinu, ki ga zdravnik ni preiskal.
The estimated volume of distribution in humans is 0.25 l/kg.
Ocenjeni volumen porazdelitve pri človeku je 0,25 l/kg.
If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.
Če opazite karkoli od tega, še posebej če ste stari več kot 65 let, takoj poiščite nasvet zdravnika.