natgillin/translations-raw huggingface dataset:
19 Herpes Zoster (shingles), leukopenia, thrombocytopenia, hypertriglyceridaemia, altered mood, aggression, agitation, crying, early morning awakening, increased libido (increased sex drive), memory impairment, disturbance in attention, poor quality sleep, reduced visual acuity (visual impairment), blurred vision, increased lacrimation (watery eyes), positional vertigo (dizziness when standing), hot flushes, gastrointestinal upset, vomiting, abnormal bowel sounds, flatulence (wind), salivary hypersecretion (excess saliva production), halitosis (bad breath), abnormal liver function test (increased liver enzymes), eczema, erythema (skin rash), pruritic rash (itchy rash), pruritus (itching), dry skin, nail disorder, night sweats, muscle cramp, neck pain, priapism (increased duration of erection) and fatigue (tiredness).
19 Herpes Zoster (pasasti izpuščaj), levkopenija, trombocitopenija, hipertrigliceridemija, nihanja v razpoloženju, nasilnost, nemir, jokanje, zgodnje jutranje zbujanje, povečan libido (povečana spolna sla), težave s spominom, motnje pozornosti, šibek spanec, zmanjšana ostrina vida (slabši vid), zamegljen vid, povečano izločanje solz (solzne oči), pozicijski vertigo (omotičnost pri stanju), vročinski vali, gastrointestinalne motnje, bruhanje, nenormalni črevesni zvoki, napenjanje (vetrovi), povečano izločanje sline, halitoza (neprijeten ustni zadah), nenormalni testi jetrnih funkcij (povečani jetrni encimi), ekcem, eritem (kožni osip), srbečica z osipom, pruritus (srbenje), suha koža, motnje nohtov, nočno potenje, mišični krči, bolečine v vratu, priapizem (podaljšanje erekcije) in omotičnost (utrujenost).
HOW TO STORE CIRCADIN
SHRANJEVANJE ZDRAVILA CIRCADIN
Do not use Circadin after the expiry date which is stated on the carton.
Zdravila Circadin ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
What Circadin contains
Kaj vsebuje zdravilo Circadin
- The active substance is melatonin.
- Zdravilna učinkovina je melatonin.
Each prolonged-release tablet contains 2 mg melatonin.
Vsaka tableta s podaljšanim sproščanjem vsebuje 2 mg
- The other ingredients are ammonio methacrylate copolymer type B, calcium hydrogen
- Pomožne snovi so amonijev metakrilat kopolimer vrste B, kalcijev hidrogen fosfat dihidrat,
phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), talc and magnesium stearate.
laktoza monohidrat, silicijev dioksid (brezvoden koloiden), smukec in magnezijev stearat.
What Circadin looks like and contents of the pack Circadin 2 mg prolonged-release tablets are available as white to off-white round bi-convex shaped tablets.
Izgled zdravila Circadin in vsebina pakiranja Circadin 2 mg tablete s podaljšanim sproščanjem so bele do umazano bele okrogle tablete bikonveksne oblike.
Each carton of tablets contains one blister strip of 20 or 21 tablets.
Vsaka škatla vsebuje pretisni omot z 20 ali 21 tabletami.
20 Manufacturer:
20 Izdelovalec:
Sites responsible for Batch Release in the EEA: -
Odgovoren za sproščanje serije v EGP:
Catalent Germany Schorndorf GmbH Steinbeisstrasse 2 D-73614 Schorndorf Germany
Catalent Germany Schorndorf GmbH Steinbeisstrasse 2 D- 73614 Schorndorf Nemčija
This leaflet was last approved in {MM/ YYYY}.
Navodilo je bilo odobreno (MM/ LLLL)
Deutschland Lundbeck GmbH Karnapp 25 D-21079 Hamburg Tel: +49 40 23649 0
Karnapp 25 D- 21079 Hamburg Tel: +49 40 23649 0
Norge Nycomed Pharma AS Drammensveien 852 N-1372 Asker Tlf: +47 6676 3030 infonorge@nycomed. no
Drammensveien 852 N- 1372 Asker Tlf: +47 6676 3030 infonorge@ nycomed. no
It is available as pink tablets (round:
Na voljo je v obliki rožnatih tablet (okrogle:
75 mg; oblong:
75 mg; podolgovate:
This medicine is the same as Iscover, which is already authorised in the European Union (EU).
To zdravilo je enako zdravilu Iscover, ki je že odobreno v Evropski uniji (EU).
The company that makes Iscover has agreed that its scientific data can be used for Clopidogrel BMS.
Družba, ki proizvaja zdravilo Iscover, je dovolila, da se lahko znanstveni podatki tega zdravila uporabijo tudi za zdravilo Clopidogrel BMS.
Clopidogrel BMS is used in adult patients to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Zdravilo Clopidogrel BMS se uporablja pri odraslih bolnikih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdevanje krvnih žil).
Clopidogrel BMS can be given to the following groups of patients: • patients who have recently had a myocardial infarction (heart attack).
Zdravilo Clopidogrel BMS se lahko daje naslednjim skupinam bolnikov: • bolnikom, ki so nedavno imeli miokardni infarkt (srčni napad).
Clopidogrel BMS can be started between a few days and 35 days after the attack; • patients who have had a recent ischaemic stroke (non-bleeding stroke).
Jemanje zdravila Clopidogrel BMS je mogoče začeti nekaj dni po napadu in do 35 dni po njem; • bolnikom, ki so nedavno imeli ishemično kap (kap zaradi žilne zapore).
Clopidogrel BMS can be started between seven days and six months after the attack; • patients with peripheral arterial disease (problems with blood flow in the arteries); • patients who have a condition known as ‘ acute coronary syndrome ’, when it should be given in combination with aspirin (another anticoagulant), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Jemanje zdravila Clopidogrel BMS je mogoče začeti v sedmih dneh po napadu in do šest mesecev po njem; • bolnikom s periferno arterijsko boleznijo (težavami s pretokom krvi v arterijah); • bolnikom z akutnim koronarnim sindromom, pri kateri se mora zdravilo dajati skupaj z aspirinom (drugim antikoagulantom), vključno z bolniki, katerim je bil vstavljen stent (kratka cevka, nameščena v arteriji, da prepreči njeno zapiranje).
Clopidogrel BMS can be used in patients who are having a heart attack with an ‘ ST segment elevation’ (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Zdravilo Clopidogrel BMS se lahko uporablja pri bolnikih, ki so imeli srčni napad z „ elevacijo spojnice ST “ (nenormalni zapis na elektrokardiogramu ali EKG), če bi zdravnik menil, da bi jim zdravilo lahko pomagalo.
It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘ non-Q-wave’ myocardial infarction.
Lahko se uporablja tudi pri bolnikih, ki nimajo tega nenormalnega zapisa na EKG, če imajo nestabilno angino (hudo obliko bolečine v prsih) ali so imeli miokardni infarkt brez Q zobca.
The standard dose of Clopidogrel BMS is one 75 mg tablet once a day, taken with or without food.
Običajni odmerek zdravila Clopidogrel BMS je ena 75- miligramska tableta enkrat na dan, vzeta s hrano ali brez nje.
In acute coronary syndrome, Clopidogrel BMS is used together with aspirin (another anticoagulant) and treatment generally starts with a loading dose of one 300 mg tablet or four 75 mg tablets.
Pri akutnem koronarnem sindromu se zdravilo Clopidogrel BMS uporablja skupaj z aspirinom (drugim antikoagulantom), zdravljenje pa se na splošno začne z udarnim odmerkom ene 300- miligramske tablete ali štirih 75- miligramskih tablet.
This is then followed by the standard 75 mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
Temu sledi običajni 75- miligramski
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. odmerek enkrat na dan v trajanju najmanj štirih tednov (pri miokardnem infarktu z elevacijo spojnice ST) ali največ 12 mesecev (pri sindromu brez elevacije spojnice ST).
This stops the platelets becoming ‘ sticky’, reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
To preprečuje, da bi trombociti postali lepljivi, zmanjšuje tveganje za nastanek krvnih strdkov ter prispeva k preprečevanju novega srčnega napada ali kapi.
The effectiveness of Clopidogrel BMS as an anticoagulant was compared with that of aspirin in a study called CAPRIE including around 19,000 patients with atherothrombosis.
Učinkovitost zdravila Clopidogrel BMS kot antikoagulanta so v okviru študije, imenovane CAPRIE, v katero je bilo vključenih 19. 000 bolnikov z aterotrombozo, primerjali z učinkovitostjo aspirina.
Neither the patient nor the doctor knew which medicine the patient was receiving.
Ne bolnik ne zdravnik nista vedela, katero zdravilo bolnik prejema.
The main measure of effectiveness was how many patients experienced a new ‘ ischaemic event’ (heart attack, ischaemic stroke or death) over one to three years.
Glavno merilo učinkovitosti je bilo, koliko bolnikov je v enem do treh let imelo novi „ ishemični dogodek “ (srčni napad, ishemično kap ali smrt).
In non-ST segment elevation acute coronary syndrome, Clopidogrel BMS was compared with placebo (a dummy treatment) in over 12,000 patients for up to a year (CURE study):
Pri zdravljenju akutnega koronarnega sindroma brez elevacije spojnice ST so zdravilo Clopidogrel BMS primerjali s placebom (zdravilom brez zdravilne učinkovine) pri več kot 12. 000 bolnikov, zdravljenih do enega leta (študija CURE):
2,172 of the patients had a stent inserted during the study.
2172 bolnikov je imelo med študijo vstavljen stent.
In ST segment elevation myocardial infarction, Clopidogrel BMS was compared with placebo in two studies:
Pri zdravljenju miokardnega infarkta z elevacijo spojnice ST so zdravilo Clopidogrel BMS primerjali s placebom v dveh študijah:
CLARITY (over 3,000 patients, where the patients received Clopidogrel BMS for up to eight days) and COMMIT (almost 46,000 patients, where the patients received Clopidogrel BMS with or without metoprolol for up to four weeks).
CLARITY (ki je vključevala več kot 3000 bolnikov, ki so do osem dni prejemali zdravilo Clopidogrel BMS) in COMMIT (ki je vključevala skoraj 46. 000 bolnikov, ki so do štiri tedne prejemali zdravilo Clopidogrel BMS z metoprololom ali brez njega).
The main measure of effectiveness was how many patients experienced an ‘ event’ such as a blocked artery, another heart attack or death, during the study.
Glavno merilo učinkovitosti je bilo, koliko bolnikov je v času študije imelo „ dogodek “, kot je zamašena arterija, nov srčni napad ali smrt.
There were 939 events in the Clopidogrel BMS group, and 1,020 in the aspirin group.
V skupini, ki je prejemala zdravilo Clopidogrel BMS, je bilo 939 dogodkov, v skupini, zdravljeni z aspirinom, pa 1020.
This corresponds to a relative reduction in risk of 9% compared with aspirin.
To ustreza relativnemu zmanjšanju tveganja za 9% v primerjavi z aspirinom.
Risk reduction means that fewer patients will have new ischaemic events when they receive Clopidogrel BMS, than if they receive aspirin.
Zmanjšanje tveganja pomeni, da bo manj bolnikov doživelo nov ishemični napad, če bodo prejemali zdravilo Clopidogrel BMS, kot pa če bodo prejemali aspirin.
In other words, about 10 patients in 1,000 will avoid having a new ischaemic event two years after starting Clopidogrel BMS instead of aspirin.
Z drugimi besedami, približno 10 bolnikov od 1000 se bo izognilo novemu ishemičnemu napadu v dveh letih po pričetku prejemanja zdravila Clopidogrel BMS namesto aspirina.
In non-ST segment elevation acute coronary syndrome, the overall relative reduction in the risk of an event compared with placebo was 20%.
Pri akutnem koronarnem sindromu brez elevacije spojnice ST je znašalo celotno relativno zmanjšanje tveganja za pojav dogodka v primerjavi s placebom 20%.
In ST segment elevation myocardial infarction, fewer patients on Clopidogrel BMS had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
Pri miokardnem infarktu z elevacijo spojnice ST je bilo število bolnikov, pri katerih so se pojavili dogodki, manjše med bolniki, ki so jemali zdravilo Clopidogrel BMS, kot med bolniki, ki so prejemali placebo (262 v primerjavi s 377 v študiji CLARITY ter 2121 v primerjavi z 2310 v študiji COMMIT).
The most common side effects with Clopidogrel BMS (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal (tummy) pain, dyspepsia (indigestion), bruising and bleeding where the skin is punctured.
Najpogostejši neželeni učinki zdravila Clopidogrel BMS (opaženi pri 1 do 10 bolnikih izmed 100) so hematomi (kopičenje krvi pod kožo), epistaksa (krvavitve iz nosu), gastrointestinalna hemoragija (krvavitve v želodcu ali črevesju), bolečine v trebuhu, dispepsija (slaba prebava), podplutbe in krvavitve na mestu predrte kože.
Clopidogrel BMS should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients, or in patients who have severe liver disease, or have a disease which may cause bleeding.
Zdravila Clopidogrel BMS ne smejo uporabljati osebe, ki utegnejo biti preobčutljivi za (alergične na) klopidogrel ali katero koli drugo sestavino zdravila, imajo hudo jetrno obolenje ali imajo bolezen, ki lahko povzroči krvavenje.
The Committee for Medicinal Products for Human Use (CHMP) decided that Clopidogrel BMS’ s benefits are greater than its risks in adults for the prevention of atherothrombotic events.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Clopidogrel BMS za bolnike, pri katerih obstaja nevarnost aterotrombotičnih dogodkov, večje od z njim povezanih tveganj.
The Committee recommended that Clopidogrel BMS be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Clopidogrel BMS odobri dovoljenje za promet.
Other information about Clopidogrel BMS:
2/ 3 Druge informacije o zdravilu Clopidogrel BMS:
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel BMS to Bristol Myers Squibb Pharma EEIG on 16 July 2008.
Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel BMS, veljavno po vsej Evropski uniji, odobrila družbi Bristol Myers Squibb Pharma EEIG dne 16. julija 2008.
2/ 3 This summary was last updated in 05-2008.
Povzetek je bil nazadnje posodobljen 05- 2008.
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Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS
Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS Clopidogrel BMS
75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 300 mg 300 mg 300 mg 75 mg 75 mg
75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 75 mg 300 mg 300 mg 300 mg 75 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (PVC/ PVDC/ alu) Blister (alu/ alu)
Pretisni omot (PVC/ PVDC/ alu) 14 Pretisni omot (alu/ alu) 14 Pretisni omot (PVC/ PVDC/ alu) 28 Pretisni omot (alu/ alu) 28 Pretisni omot (PVC/ PVDC/ alu) 30 Pretisni omot (alu/ alu) 30 Pretisni omot (PVC/ PVDC/ alu) 50x1 Pretisni omot (alu/ alu) 50x1 Pretisni omot (PVC/ PVDC/ alu) 84 Pretisni omot (alu/ alu) 84 Pretisni omot (PVC/ PVDC/ alu) 90 Pretisni omot (alu/ alu) 90 Pretisni omot (PVC/ PVDC/ alu) 100 Pretisni omot (alu/ alu) 100 Pretisni omot (alu/ alu) 4x1 Pretisni omot (alu/ alu) 30x1 Pretisni omot (alu/ alu) 100x1 Pretisni omot 7 (PVC/ PVDC/ alu)
14 14 28 28 30 30 50 x 1 50 x 1 84 84 90 90 100 100 4x1 30 x 1 100 x 1 7 7
Pretisni omot (alu/ alu) 7
Excipients: each tablet contains 3 mg lactose and 3.3 mg hydrogenated castor oil.
Pomožne snovi: ena tableta vsebuje 3 mg laktoze in 3, 3 mg hidrogeniranega ricinusovega olja.
Pink, round, biconvex, engraved with « 75 » on one side and « 1171 » on the other side.
Rožnate barve, okrogla, bikonveksna, z vtisnjeno številko "75" na eni strani in "1171" na drugi strani.
• Patients suffering from acute coronary syndrome:
• bolnikih z akutnim koronarnim sindromom:
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).
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).
For further information please refer to section 5.1.
Za dodatne informacije glejte poglavje 5. 1.
In patients suffering from acute coronary syndrome: − Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300-mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily).
Akutni koronarni sindrom brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca): zdravljenje moramo začeti z enkratnim udarnim odmerkom 300 mg klopidogrela in nadaljevati s 75 mg enkrat na dan (s 75 mg do 325 mg acetilsalicilne kisline (ASA) dnevno).
Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (see section 5.1).
Podatki iz kliničnih preskušanj podpirajo uporabo do 12 mesecev, največjo korist pa so opazili po 3 mesecih (glejte poglavje 5. 1).
ST segment elevation acute myocardial infarction: clopidogrel should be given as a single daily dose of 75 mg initiated with a 300-mg loading dose in combination with ASA and with or without thrombolytics.
Akutni miokardni infarkt z elevacijo ST spojnice: klopidogrel je potrebno dajati v enkratnem dnevnem odmerku 75 mg, zdravljenje pa je potrebno začeti s 300 mg udarnim odmerkom v kombinaciji z ASA ter z/ brez uporabe trombolitikov.
For patients over 75 years of age clopidogrel
Pri bolnikih, ki so
should be initiated without a loading dose.
starejši od 75 let, je treba zdravljenje s klopidogrelom začeti brez udarnega odmerka.
The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section 5.1).
Koristnosti zdravljenja s kombinacijo klopidrogela in ASA, ki bi bilo daljše od štirih tednov, v tem okviru niso preučevali (glejte poglavje 5. 1).
• Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4).
• Okvara ledvic Terapevtske izkušnje pri bolnikih z okvaro ledvic so omejene (glejte poglavje 4. 4).
• Hepatic impairment Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses (see section 4.4).
• Okvara jeter Terapevtske izkušnje pri bolnikih z zmerno boleznijo jeter, ki imajo lahko hemoragično diatezo, so omejene (glejte poglavje 4. 4).
• Hypersensitivity to the active substance or to any of the excipients. • Severe liver impairment. • Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
• Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov. • Huda jetrna okvara. • Aktivna patološka krvavitev, kot je peptična razjeda ali intrakranialna krvavitev.
Due to the risk of bleeding and haematological undesirable effects, 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).
Zaradi tveganja krvavitve in hematoloških neželenih učinkov moramo takoj pretehtati potrebo po določanju števila krvnih celic in/ ali drugih ustreznih preiskav, kadarkoli se v času zdravljenja pojavijo klinični simptomi, ki nakazujejo krvavitev (glejte poglavje 4. 8).
As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/ IIIa inhibitors or non-steroidal anti-inflammatory drugs including Cox-2 inhibitors.
Kot pri drugih antitrombotikih, moramo klopidogrel uporabljati previdno pri bolnikih s tveganjem za povečano krvavitev zaradi poškodbe, kirurškega posega ali drugih patoloških stanj in pri bolnikih, ki so na zdravljenju z ASA, heparinom, zaviralci glikoproteina IIb/ IIIa ali nesteroidnimi protivnetnimi zdravili vključno z zaviralci COX- 2.
Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/ or after invasive cardiac procedures or surgery.
Bolnike morate skrbno spremljati zaradi znakov krvavitve, vključno z okultno krvavitvijo, zlasti prve tedne zdravljenja in/ ali po invazivnih kardioloških postopkih ali kirurških posegih.
The concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4.5).
Sočasno dajanje klopidogrela s peroralnimi antikoagulanti se ne priporoča, ker lahko poveča jakost krvavitev (glejte poglavje 4. 5).
Therefore clopidogrel should be used with caution in these patients (see section 4.2).
Zato moramo pri teh bolnikih klopidogrel uporabljati previdno (glejte poglavje 4. 2).
3 Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses.
3 Izkušnje so omejene pri bolnikih z zmerno jetrno boleznijo, ki imajo lahko hemoragično diatezo.