natgillin/translations-raw huggingface dataset:
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL / BOTTLE (Multi dose) 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
NAME OF THE MEDICINAL PRODUCT Instanyl 50 micrograms nasal spray Fentanyl 
Instanyl 50 mikrogramov pršilo za nos fentanil
Instanyl 50 micrograms/dose nasal spray, solution 
Instanyl 50 mikrogramov/odmerek pršilo za nos, raztopina, DoseGuard
What Instanyl looks like and contents of the pack Instanyl DoseGuard is a nasal spray, solution. 
Zdravilo Instanyl DoseGuard je pršilo za nos, raztopina.
NAME OF THE MEDICINAL PRODUCT Instanyl 100 micrograms nasal spray Fentanyl 
Instanyl 100 mikrogramov pršilo za nos fentanil
1 puff (100 microlitres) contains 50 micrograms fentanyl. 
En vpih (100 mikrolitrov) vsebuje 50 mikrogramov fentanila.
Instanyl 100 micrograms/dose nasal spray, solution. 
Instanyl 100 mikrogramov/odmerek pršilo za nos, raztopina
Keep stored upright. 
Shranjujte v pokončnem položaju.
Instanyl 100 micrograms/dose nasal spray, solution 
Instanyl 100 mikrogramov/odmerek pršilo za nos, raztopina, DoseGuard
1 dose (100 microlitres) contains fentanyl citrate equivalent to 200 micrograms (mcg) fentanyl 
En odmerek (100 mikrolitrov) vsebuje fentanilijev citrat v količini, ki ustreza 200 mikrogramom (µg) fentanila.
What Instanyl looks like and contents of the pack Instanyl is a nasal spray, solution in a single-dose spray container. 
Instanyl je pršilo za nos, raztopina v enoodmernem vsebniku za pršilo.
Instanyl 50 micrograms/dose nasal spray, solution EU/1/09/531/022-025 
Instanyl 200 mikrogramov/odmerek pršilo za nos, raztopina, DoseGuard EU/1/09/531/022-025
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
Previdnostni ukrepi pred ravnanjem z zdravilom ali dajanjem zdravila
1 dose (100 microlitres) contains fentanyl citrate equivalent to 100 micrograms (mcg) fentanyl 
En odmerek (100 mikrolitrov) vsebuje fentanilijev citrat v količini, ki ustreza 100 mikrogramom (µg) fentanila.
1 puff (100 microlitres) contains 100 micrograms fentanyl. 
En vpih (100 mikrolitrov) vsebuje 100 mikrogramov fentanila.
1 dose (100 microlitres) contains fentanyl citrate equivalent to 50 micrograms (mcg) fentanyl 
En odmerek (100 mikrolitrov) vsebuje fentanilijev citrat v količini, ki ustreza 50 mikrogramom (µg) fentanila.
LIST OF EXCIPIENTS Also contains: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, purified water 
Vsebuje tudi: natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat in prečiščeno vodo.
NAME OF THE MEDICINAL PRODUCT Instanyl 100 micrograms/dose nasal spray, solution Fentanyl 
Instanyl 100 mikrogramov/odmerek pršilo za nos fentanil nazalna uporaba
100 micrograms labelling is purple. 
100 mikrogramov, ovojnina je vijolična
INSTRUCTIONS FOR USE OF INSTANYL NASAL SPRAY 
NAVODILO ZA UPORABO INSTANYL PRŠILA ZA NOS
You must make sure the pump is pressed all the way down. 
Ko bo bat črpalke do konca pritisnjen, boste zaslišali
INSTRUCTIONS FOR USE OF INSTANYL SINGLE-DOSE NASAL SPRAY Please read the following instructions carefully to learn how to use Instanyl single-dose nasal spray: 
Pozorno preberite naslednja navodila, da se naučite uporabljati Instanyl pršilo za nos v enoodmernem vsebniku:
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS INTERMEDIATE CHILD-RESISTANT BLISTER PACK (Single dose) 
VMESEN ZA OTROKE VAREN PRETISNI OMOT (enoodmerno pakiranje)
− A training course for neurosurgeons which is aimed at risk minimisation and to support safe and effective use for the product. 
− izobraževalni tečaj za nevrokirurge, katerega namen je zmanjševanje tveganja in podpiranje varne in učinkovite uporabe zdravila.
IV); - Neurophysiological monitoring techniques for surgery in eloquent brain regions. 
SZO); - tehnike za nevrofiziološki nadzor pri kirurških posegih v elokventnih območjih možganov.
Minimum requirements for a qualified training centre are: - Microscope modified for fluorescence-guided resection; - Sufficient case load (at least 10 patients per year) of malignant gliomas (WHO grade III and 
Minimalne zahteve za kvalificirani izobraževalni center so: - mikroskop, prilagojen za resekcijo, vodeno s fluorescenco; - zadostno število primerov (vsaj 10 bolnikov na leto) malignih gliomov (III. in IV. stopnje po
III trial; - Experience with Gliolan-fluorescence-guided surgery in at least 20 cases. 
- dovoljenje odbora kot nevrokirurg v skladu z lokalnimi zahtevami; - predhodno sodelovanje na tečaju ali na ustreznem tečaju med preskušanjem III. faze; - izkušnje v vsaj 20 primerih uporabe zdravila Gliolan pri kirurških posegih, vodenih s fluorescenco.
The European Commission granted a marketing authorisation valid throughout the European Union for Ziagen on 8 July 1999. 
Evropska komisija je dovoljenje za promet z zdravilom Ziagen, veljavno po vsej Evropski uniji, izdala 8. julija 1999.
In children weighing less than 25 kg the recommended dose depends on body weight. 
Pri otrocih, ki tehtajo manj kot 25 kg, je priporočeni odmerek odvisen od telesne mase.
What measures are being taken to ensure the safe and effective use of Ziagen? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ziagen?
Other information about Ziagen: 
Druge informacije o zdravilu Ziagen:
The full EPAR for Ziagen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ziagen je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended dose of Ziagen for adults and children weighing at least 25 kg is 600 mg daily. 
Priporočeni odmerek zdravila za odrasle in otroke, ki tehtajo vsaj 25 kg, je 600 mg na dan.
It is available as tablets (300 mg) and as an oral solution (20 mg/ml). 
Na voljo je v obliki tablet (300 mg) in peroralne raztopine (20 mg/ml).
This document is a summary of the European Public Assessment Report (EPAR) for Ziagen. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ziagen.
This can be taken either as a single daily dose or divided into 300 mg twice a day. 
Ta odmerek se lahko vzame naenkrat ali razdeli na dva 300-miligramska odmerka dvakrat na dan.
The main measures of effectiveness were the levels of HIV in the blood (viral load) and the number of CD4 T-cells in the blood (CD4 cell count). 
Glavna merila učinkovitosti so bile spremembe ravni virusa HIV v krvi (virusnega bremena) in števila celic T CD4 v krvi (raven celic CD4).
A risk management plan has been developed to ensure that Ziagen is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Ziagen je bil pripravljen načrt obvladovanja tveganj.
Based on its review of the quality, safety and effectiveness of the medicine, the Committee decided that Ziagen's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Na podlagi pregleda kakovosti, varnosti in učinkovitosti zdravila je zaključil, da so koristi zdravila Ziagen večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
In addition, studies were carried out to examine once daily versus twice daily dosing in children. 
Poleg tega so bile opravljene študije, v katerih so primerjali odmerjanje enkrat oziroma dvakrat na dan pri otrocih.
Hypersensitivity reactions (allergic reactions) occur in patients taking Ziagen, usually within the first six weeks of treatment, and can be life-threatening. 
Preobčutljivostne (alergijske) reakcije se pri bolnikih, ki jemljejo zdravilo Ziagen, običajno pojavijo v prvih šestih tednih zdravljenja, in so lahko življenjsko nevarne.
It does not cure HIV infection or AIDS, but it can hold off the damage to the immune system and avoid the development of infections and diseases associated with AIDS. 
Zdravilo ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
What benefit has Ziagen shown during the studies? 
Kakšne koristi je zdravilo Ziagen izkazalo med študijami?
For more information about treatment with Ziagen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Ziagen preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Patients who take Ziagen will also receive an alert card summarising the key safety information on hypersensitivity with the medicine. 
Bolniki, ki jemljejo zdravilo Ziagen, bodo prejeli tudi opozorilno kartico, ki povzema ključne varnostne informacije o preobčutljivostnih reakcijah na zdravilo.
CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV. 
Celice TCD4 so bele krvničke, ki so pomembne za obrambo pred okužbami, vendar pa jih virus HIV uničuje.
Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain (stomach ache), dyspnoea (difficulty breathing), cough, fever, lethargy, malaise (feeling unwell), headache, signs of liver damage in the blood and myalgia (muscle pain). 
Med simptomi so skoraj vedno povišana telesna temperatura ali izpuščaj, zelo pogosto pa tudi slabost, bruhanje, driska, bolečine v trebuhu, dispneja (oteženo dihanje), kašelj, povišana telesna temperatura, letargija, neugodje (slabo počutje), glavobol, znaki obolenja jeter v krvi in mialgija (bolečine v mišicah).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ziagen. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Patients with this gene are at an increased risk of having an allergic reaction to abacavir, so they should not take Ziagen. 
Bolniki s tem genom so izpostavljeni večjemu tveganju za pojav alergijske reakcije na abakavir, tako da ne smejo jemati zdravila Ziagen.
Ziagen, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. 
Če se zdravilo Ziagen jemlje v kombinaciji z drugimi protivirusnimi zdravili, zmanjša količino virusa HIV v krvi in jo ohranja na nizki ravni.
In one of the studies in adults, 77% of the patients taking Ziagen with lamivudine and zidovudine had viral loads below 400 copies/ml after 16 weeks (67 out of 87), compared with 38% of the adults taking lamivudine and zidovudine without Ziagen (33 out of 86). 
V eni študiji pri odraslih je po 16 tednih zdravljenja 77 % (67 od 87) bolnikov, ki so jemali zdravilo Ziagen v kombinaciji z lamivudinom in zidovudinom, imelo virusno obremenitev pod 400 kopijami/ml, v primerjavi z 38 % (33 od 86) bolnikov, ki so jemali lamivudin in zidovudin brez zdravila Ziagena.
Patients who cannot swallow tablets should use the oral solution, or alternatively they may crush the tablets and add them to a small amount of food or drink immediately before swallowing it. For more information, see the package leaflet. 
Bolniki, ki ne morejo pogoltniti celih tablet, naj uporabijo peroralno raztopino ali pa naj tablete zdrobijo in jih tik pred zaužitjem zmešajo z majhno količino hrane ali pijače.
The CHMP noted that the demonstration of the benefit of Ziagen was based on the results of studies mainly carried out with the medicine taken twice a day in combination with other medicines in adults who had not taken HIV treatment before. 
Odbor CHMP je ugotovil, da je prikaz koristi zdravila Ziagen temeljil predvsem na rezultatih študij, izvedenih z zdravilom, ki so ga odrasli bolniki, ki pred tem niso prejemali zdravil za zdravljenje okužbe z virusom HIV, jemali dvakrat na dan v kombinaciji z drugimi zdravili.
The most common side effects with Ziagen (seen in between 1 and 10 patients in 100) are loss of appetite, headache, nausea (feeling sick), vomiting, diarrhoea, rash, fever, lethargy (lack of energy) and tiredness. 
Najpogostejši neželeni učinki zdravila Ziagen (opaženi pri 1 do 10 bolnikih od 100) so izguba teka, glavobol, navzeja (slabost), bruhanje, driska, izpuščaj, povišana telesna temperatura, letargija (pomanjkanje energije) in utrujenost.
What is the risk associated with Ziagen? 
Kakšna tveganja so povezana z zdravilom Ziagen?
For the full list of all side effects and restrictions with Ziagen, see the package leaflet. 
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Ziagen glejte navodilo za uporabo.
Ziagen should be prescribed by a doctor who has experience in the management of HIV infection. 
Zdravilo Ziagen lahko predpiše le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
Ziagen is used in combination with other antiviral medicines to treat patients who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS). 
Zdravilo Ziagen se uporablja v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje bolnikov, ki so okuženi z virusom humane imunske pomanjkljivosti (HIV), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
In addition, the company that markets Ziagen provides educational materials for doctors about hypersensitivity reactions with the medicine, including the need to test patients for the HLA-B (type 5701) gene and to remind patients to contact their doctor immediately if they develop symptoms suggestive of hypersensitivity. 
Poleg tega bo družba, ki trži zdravilo, pripravila izobraževalno gradivo za zdravnike o preobčutljivostnih reakcijah na zdravilo, vključno z zahtevo, da je treba pri bolnikih opraviti test za določanje prisotnosti gena HLA-B (tip 5701) in jih opozoriti, da se morajo, če se pojavijo simptomi, ki kažejo na možnost preobčutljivostne reakcije, nemudoma posvetovati z zdravnikom.
Ziagen is a medicine that contains the active substance abacavir. 
Ziagen je zdravilo, ki vsebuje zdravilno učinkovino abakavir.
The active substance in Ziagen, abacavir, is a nucleoside reverse transcriptase inhibitor (NRTI). 
Zdravilna učinkovina v zdravilu Ziagen, abakavir, je zaviralec nukleozidne reverzne transkriptaze (NRTI).
In all of the studies, Ziagen caused a decrease in viral loads, particularly when taken with other antiviral medicines. 
V vseh študijah je zdravilo Ziagen zmanjšalo virusno obremenitev, zlasti ko so ga bolniki jemali skupaj z drugimi protivirusnimi zdravili.
Ziagen has been studied in six main studies including 1,843 HIV-infected adults (aged 18 years and over). 
Zdravilo Ziagen so raziskovali v šestih glavnih študijah, v katere je bilo vključenih 1 843 odraslih bolnikov (starih 18 let ali več), okuženih z virusom HIV.
Ziagen has also been studied in three main studies including 489 HIV-infected patients aged between three months and 18 years. 
Zdravilo so proučevali tudi v treh glavnih študijah, v katerih je sodelovalo 489 bolnikov, okuženih z virusom HIV, starih od tri mesece do 18 let.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ziagen, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Why has Ziagen been approved? 
Zakaj je bilo zdravilo Ziagen odobreno?
Ziagen's effects were compared with other antiviral medicines, placebo (a dummy treatment) or no treatment. 
Učinke zdravila Ziagen so primerjali z učinki drugih protivirusnih zdravil, placeba (zdravila brez zdravilne učinkovine) ali pa nezdravljenja.
Patients receiving Ziagen also had increases in their CD4 cell counts. 
Pri bolnikih, ki so prejemali zdravilo, se je povečalo tudi število celic CD4.
Ziagen was taken alone, or added to the combination of lamivudine and zidovudine (other antiviral medicines) or the patients' existing HIV treatment. 
Bolniki so ga jemali samostojno ali pa je bilo dodano kombinaciji lamivudina in zidovudina (drugima protivirusnima zdraviloma) ali zdravilu, ki so ga bolniki jemali za zdravljenje okužbe z virusom HIV.
One study compared the effects of Ziagen taken once and twice a day, in combination with lamivudine and efavirenz (other antiviral medicines) in 784 patients. 
V eni študiji so pri 784 bolnikih primerjali učinke zdravila Ziagen, ki so ga bolniki jemali enkrat ali dvakrat dnevno v kombinaciji z lamivudinom in efavirenzom (drugima protivirusnima zdraviloma).
It was more effective than placebo, and was as effective as other antiviral medicines in reducing viral loads in all age groups. 
V vseh starostnih skupinah je bilo pri zmanjševanju virusne obremenitve učinkovitejše od placeba in enako učinkovito kot druga protivirusna zdravila.
What is Ziagen used for? 
Za kaj se zdravilo Ziagen uporablja?
How does Ziagen work? 
Kako zdravilo Ziagen deluje?
Treatment with Ziagen should be stopped promptly if the patient has a hypersensitivity reaction. 
Če se pri bolniku pojavijo preobčutljivostne reakcije, je treba zdravljenje z zdravilom Ziagen takoj prekiniti.
How has Ziagen been studied? 
Kako je bilo zdravilo Ziagen raziskano?
What is Ziagen? 
Kaj je zdravilo Ziagen?
How is Ziagen used? 
Kako se zdravilo Ziagen uporablja?
Once- and twice-daily Ziagen had similar effects on viral load. 
Zdravilo Ziagen, ki so ga dajali enkrat na dan, je imelo podobne učinke na virusno obremenitev kot takrat, ko so ga dajali dvakrat dnevno.
Very rare, not known* 
Zelo redki, neznana*
These measures will help to protect the environment. 
Takni ukrepi pomagajo varovati okolje.
61700 Brno Czech Republic 
61700 Brno Češka
Do not give this medicine to children because it does not work. 
Otroci Ne dajajte tega zdravila otrokom, ker ne deluje.
* Information related to clopidogrel with frequency “not known” 
* Podatki se nanašajo na klopidogrel s pogostnostjo »neznana«.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila
Some other medicines may influence the use of Clopidogrel ratiopharm or vice versa. 
Nekatera druga zdravila lahko vplivajo na uporabo zdravila Klopidogrel ratiopharm in obratno.
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 upoštevaje naslednji dogovor: pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken. 
Bolniki morajo obvestiti zdravnika in zobozdravnika, da jemljejo klopidogrel, pred vsakim načrtovanjem kirurškega posega in preden vzamejo katero koli novo zdravilo.
• If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in 
• če ste alergični na klopidogrel ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
Acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever: An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor. 
Acetilsalicilna kislina, učinkovina, ki je prisotna v številnih zdravilih, ki se uporabljajo za lajšanje bolečine in zniževanje zvišane telesne temperature: Priložnostna uporaba acetilsalicilne kisline (ne več kot 1.000 mg v katerem koli 24 urnem obdobju) na splošno ne bi smela povzročati težav, vendar pa se morate o daljši uporabi v drugih okoliščinah posvetovati s svojim zdravnikom.
Patients should be told that it might take longer than usual to stop bleeding when they take clopidogrel, and that they should report any unusual bleeding (site or duration) to their physician. 
Bolniki morajo biti obveščeni, da je lahko čas, potreben za zaustavitev krvavitve, daljši kot ponavadi, ko jemljejo klopidogrel in da morajo poročati svojemu zdravniku o kakršni koli neobičajni krvavitvi (mesto ali trajanje).
Do not use Clopidogrel ratiopharm if you notice any visible sign of damage of blister or film-coated 
Ne uporabljajte zdravila Klopidogrel ratiopharm, če ste opazili vidne znake poškodovanja pretisnega omota ali filmsko obloženih tablet.
The other ingredients are (see section 2 ‘Clopidogrel ratiopharm contains hydrogenated castor oil'): 
Druge sestavine zdravila so (glejte poglavje 2 »Zdravilo Clopidogrel ratiopharm vsebuje hidrogenirano ricinusovo olje«
Clopidogrel has no or negligible influence on the ability to drive and use machines. 
Klopidogrel nima vpliva ali ima zanemarljiv vpliv na sposobnost za vožnjo in upravljanje strojev.
Other medicines and Clopidogrel ratiopharm Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any 
Druga zdravila in zdravilo Klopidogrel ratiopharm Obvestite zdravnika ali farmacevta, če jemljete/uporabljate, ste pred kratkim jemali/uporabljali ali pa boste morda začeli jemati/uporabljati katero koli drugo zdravilo.
You should take Clopidogrel ratiopharm for as long as your doctor continues to prescribe it. 
Zdravilo Klopidogrel ratiopharm morate jemati, vse dokler vam ga vaš zdravnik predpisuje.
In a relative bioavailability study in adults, the constituted solution of clopidogrel showed a similar extent and slightly higher rate of absorption of the main circulating (inactive) metabolite compared to the 
V študiji relativne biološke uporabnosti pri odraslih je imela pripravljena raztopina klopidogrela podoben obseg in rahlo večjo hitrost absorpcije glavnega krožečega (neaktivnega) presnovka kakor odobrena
Excipients with known effect: Each film-coated tablet contains 3.80 mg of hydrogenated castor oil. 
Pomožne snovi z znanim učinkom: Ena filmsko obložena tableta vsebuje 3,80 mg hidrogeniranega ricinusovega olja.
In CAPRIE, in patients treated with either clopidogrel or ASA, the overall incidence of any bleeding was 9.3%. 
V študiji CAPRIE je bila pri bolnikih, zdravljenih bodisi s klopidogrelom ali ASA, celokupna incidenca kakršnih koli krvavitev 9,3 %.
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). 
Zaradi tveganja krvavitve in hematoloških neželenih učinkov moramo takoj pretehtati potrebo po določanju števila krvnih celic in/ali drugih ustreznih preiskav, kadar koli se v času zdravljenja pojavijo klinični simptomi, ki nakazujejo krvavitev (glejte poglavje 4.8).
If you stop taking Clopidogrel ratiopharm Do not stop the treatment unless your doctor tells you so. 
Če ste prenehali jemati zdravilo Klopidogrel ratiopharm Ne prekinite zdravljenja razen, če tako odloči zdravnik.
At the time of granting the marketing authorisation, the submission of periodic safety update reports is not required for this medicinal product. 
Redno posodobljena poročila o varnosti zdravila (PSUR) V času pridobitve dovoljenja za promet z zdravilom se za to zdravilo predložitev redno posodobljenih poročil o varnosti zdravila ne zahteva.