FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/98/069/001 28 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/002 50x1 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/003 84 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/004 100 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/005 30 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/006 90 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/007 14 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/011 7 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/013 28 film-coated tablets in all aluminium blisters EU/1/98/069/014 50x1 film-coated tablets in all aluminium blisters EU/1/98/069/015 84 film-coated tablets in all aluminium blisters EU/1/98/069/016 100 film-coated tablets in all aluminium blisters EU/1/98/069/017 30 film-coated tablets in all aluminium blisters EU/1/98/069/018 90 film-coated tablets in all aluminium blisters EU/1/98/069/019 14 film-coated tablets in all aluminium blisters EU/1/98/069/020 7 film-coated tablets in all aluminium blisters
Slovenian: EU/1/98/069/001 28 filmsko obloženih tablet v PVC/PVDC/Alu pretisnih omotih EU/1/98/069/002 50x1 filmsko obloženih tablet v PVC/PVDC/Alu pretisnih omotih EU/1/98/069/003 84 filmsko obloženih tablet v PVC/PVDC/Alu pretisnih omotih EU/1/98/069/004 100 filmsko obloženih tablet v PVC/PVDC/Alu pretisnih omotih EU/1/98/069/005 30 filmsko obloženih tablet v PVC/PVDC/Alu pretisnih omotih EU/1/98/069/006 90 filmsko obloženih tablet v PVC/PVDC/Alu pretisnih omotih EU/1/98/069/007 14 filmsko obloženih tablet v PVC/PVDC/Alu pretisnih omotih EU/1/98/069/011 7 filmsko obloženih tablet v PVC/PVDC/Alu pretisnih omotih EU/1/98/069/013 28 filmsko obloženih tablet v aluminijastih pretisnih omotih EU/1/98/069/014 50x1 filmsko obloženih tablet v aluminijastih pretisnih omotih EU/1/98/069/015 84 filmsko obloženih tablet v aluminijastih pretisnih omotih EU/1/98/069/016 100 filmsko obloženih tablet v aluminijastih pretisnih omotih EU/1/98/069/017 30 filmsko obloženih tablet v aluminijastih pretisnih omotih EU/1/98/069/018 90 filmsko obloženih tablet v aluminijastih pretisnih omotih EU/1/98/069/019 14 filmsko obloženih tablet v aluminijastih pretisnih omotih EU/1/98/069/020 7 filmsko obloženih tablet v aluminijastih pretisnih omotih
English: Sanofi Oy Puh/Tel: +358 (0) 201 200 300
Slovenian: Puh/Tel: +358 (0) 201 200 300
English: If Plavix is supplied in PVC/PVDC/aluminium blisters, store below 30°C.
Slovenian: Zdravilo Plavix, ki je na voljo v PVC/PVDC/alu pretisnih omotih, shranjujte pri temperaturi do 30C.
English: - 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.
Slovenian: 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.
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
Slovenian: Hypersensitivity Syndrome), kožni izpuščaj z eozinofilijo in sistemskimi simptomi, kot posledica zdravljenja z zdravilom (sindrom DRESS, Drug Rash with Eosinophilia and Systemic Symptoms), eritematozen ali eksfoliativen izpuščaj, urtikarija, ekcem, lihen planus
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia
Slovenian: Trombotična trombocitopenična purpura (TTP) (glejte poglavje 4.4), aplastična anemija, pancitopenija, agranulocitoza, huda trombocitopenija,
English: - If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine
Slovenian: - če ste alergični na klopidogrel ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Aluminium perforated unit-dose blisters in cardboard cartons containing 4x1, 10x1, 30x1 and 100x1 film-coated tablets.
Slovenian: Aluminijski perforirani pretisni omoti za enkratni odmerek v kartonskih škatlah, ki vsebujejo 4 x 1, 10 x 1, 30 x 1 in 100 x 1 filmsko obloženo tableto.
English: Excipients with known effect: Each film-coated tablet contains 3 mg of lactose and 3.3 mg of hydrogenated castor oil.
Slovenian: Ena filmsko obložena tableta vsebuje 3 mg laktoze in 3,3 mg hidrogeniranega ricinusovega olja.
English: Plavix 75-mg film-coated tablets are round, biconvex, pink, engraved on one side with the number ‘75' and on the other side with the number ‘1171'.
Slovenian: Zdravilo Plavix 75 mg filmsko obložene tablete so okrogle, bikonveksne, rožnate tablete, z vtisnjeno številko “75” na eni strani in številko “1171” na drugi strani.
English: Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00
Slovenian: België/Belgique/Belgien Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00
English: You should specifically tell your doctor if you take - medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting, o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, o heparin or any other injectable medicine used to reduce blood clotting, o ticlopidine, other antiplatelet agent, o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, - omeprazole or esomeprazole, medicines to treat upset stomach, - fluconazole or voriconazole, medicines to treat fungal infections,
Slovenian: Še posebej pomembno je, da obvestite svojega zdravnika, če jemljete - zdravila, ki lahko povečajo tveganje za krvavitve, kot so: o peroralni antikoagulanti, zdravila, ki preprečujejo nastanek krvnih strdkov, o nesteroidna protivnetna zdravila, ki se običajno uporabljajo za lajšanje bolečine in/ali vnetja mišic ali sklepov, o heparin, ali katerokoli drugo zdravilo v obliki injekcij, ki se uporablja za zmanjševanje strjevanja krvi, o tiklopidin, peroralno antiagregacijsko zdravilo, o selektivni zaviralci privzema serotonina (na primer fluoksetin ali fluvoksamin, a ne le tadva), ki se po navadi uporabljajo za zdravljenje depresije, - omeprazol ali ezomeprazol, zdravila za zdravljenje težav z želodcem,
English: You should specifically tell your doctor if you take - medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting, o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, o heparin or any other injectable medicine used to reduce blood clotting, o ticlopidine, other antiplatelet agent, o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,
Slovenian: Še posebej pomembno je, da obvestite svojega zdravnika, če jemljete - zdravila, ki lahko povečajo tveganje za krvavitve, kot so: o peroralni antikoagulanti, zdravila, ki preprečujejo nastanek krvnih strdkov, o nesteroidna protivnetna zdravila, ki se običajno uporabljajo za lajšanje bolečine in/ali vnetja mišic ali sklepov, o heparin, ali katerokoli drugo zdravilo v obliki injekcij, ki se uporablja za zmanjševanje strjevanja krvi, o tiklopidin, peroralno antiagregacijsko zdravilo, o selektivni zaviralci privzema serotonina (na primer fluoksetin ali fluvoksamin, a ne le tadva), ki se po navadi uporabljajo za zdravljenje depresije,
English: Plavix 300 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Plavix 300 mg
English: Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence
Slovenian: Želodčna razjeda in razjeda na dvanajstniku, gastritis, bruhanje, navzea, zaprtje, flatulenca
English: The other ingredients are (see section 2 ‘Plavix contains lactose' and ‘Plavix contains hydrogenated castor oil'):
Slovenian: Pomožne snovi so (glejte poglavje 2:»Zdravilo Plavix vsebuje laktozo« in »Zdravilo Plavix vsebuje tudi hidrogenirano ricinusovo olje«): - Jedro tablete: manitol (E421), hidrogenirano ricinusovo olje, mikrokristalna celuloza,
English: The primary endpoint (the combined incidence of CV death, MI, stroke and BARC bleeding grade ≥2
Slovenian: Primarni opazovani dogodek (kombinirana pojavnost SŽ smrti, MI, možganske kapi in krvavitev ≥ 2 po BARC po 12 mesecih) je bil dosežen in to dokazuje neinferiornost.
English: In PVC/PVDC/aluminium blisters, store below 30°C.
Slovenian: V PVC/PVDC/alu pretisnih omotih shranjujte pri temperaturi do 30C.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 4x1, 10x1, 30x1 or 100x1 tablets
Slovenian: PRETISNI OMOT / 4x1, 10x1, 30x1 ali 100x1 tablet
English: If Plavix is supplied in all aluminium blisters, it does not require any special storage conditions.
Slovenian: Za shranjevanje zdravila Plavix, ki je na voljo v aluminijastih pretisnih omotih, niso potrebna posebna navodila.
English: Plavix 300-mg film-coated tablets are oblong, pink, engraved on one side with the number ‘300' and on the other side with the number ‘1332'.
Slovenian: Zdravilo Plavix 300 mg filmsko obložene tablete so podolgovate, rožnate tablete, z vtisnjeno številko “300” na eni strani in številko “1332” na drugi strani.
English: Plavix 75 mg film-coated tablets Plavix 300 mg film-coated tablets
Slovenian: Plavix 75 mg filmsko obložene tablete Plavix 300 mg filmsko obložene tablete
English: Musculoskeletal, connective tissue and bone disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva
English: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris France
Slovenian: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris Francija
English: Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose, Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172) and titanium dioxide (E171), Polishing agent: carnauba wax.
Slovenian: makrogol 6000 in delno substituirana hidroksipropilceluloza - Obloga tablete: laktoza monohidrat (mlečni sladkor), hipromeloza (E464), triacetin (E1518), rdeči železov oksid (E172), titanov dioksid (E171) - Polirno sredstvo: karnauba vosek.
English: sanofi-aventis groupe
Slovenian: Imetnik dovoljenja za promet: sanofi-aventis groupe
English: No clinically significant pharmacodynamic interactions were observed when clopidogrel was co-administered with atenolol, nifedipine, or both atenolol and nifedipine.
Slovenian: Pri sočasni uporabi klopidogrela z atenololom, nifedipinom, ali z obema - atenololom in nifedipinom - niso opazili nobenih klinično pomembnih farmakodinamičnih interakcij.
English: Plavix contains lactose.
Slovenian: Zdravilo Plavix vsebuje laktozo.
English: Plavix 75 mg film-coated tablets Pink, round, biconvex, engraved with «75» on one side and «1171» on the other side.
Slovenian: Rožnate, okrogle, bikonveksne filmsko obložene tablete, z vtisnjeno številko "75" na eni strani in "1171" na drugi strani.
English: Plavix 300 mg film-coated tablets Pink, oblong, engraved with «300» on one side and «1332» on the other side.
Slovenian: Rožnate, podolgovate filmsko obložene tablete z vtisnjeno številko "300" na eni strani in "1332" na drugi strani.
English: Plavix 75 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Plavix 75 mg
English: A significantly reduced platelet inhibition has been shown in HIV patients treated with ritonavir-or cobicistat-boosted ART.
Slovenian: Pri bolnikih s HIV, ki so prejemali z ritonavirjem ali kobicistatom okrepljeno ART, so ugotavljali značilno zmanjšanje inhibicije trombocitov.
English: The number of patients who reached the primary endpoint (time to first occurrence of stroke, MI, non-CNS systemic embolism or vascular death) was 832 (22.1%) in the group treated with clopidogrel + ASA and 924 (24.4%) in the placebo + ASA group (relative risk reduction of 11.1%; 95% CI of
Slovenian: Primarni opazovani dogodek (čas do prvega pojava možganske kapi, MI, sistemske embolije (ne v osrednjem živčevju) ali žilne smrti) je doseglo v skupini s klopidogrelom + ASA 832 (22,1 %) bolnikov in v skupini s placebom + ASA 924 (24,4 %) bolnikov (relativno zmanjšanje tveganja 11,1 %, 95 % IZ: od 2,4 % do 19,1 %, p = 0,013), predvsem kot posledica velikega zmanjšanja incidence možganskih kapi.
English: Plavix contains lactose
Slovenian: Zdravilo Plavix vsebuje laktozo
English: Plavix 300 mg film-coated tablets
Slovenian: Plavix 300 mg filmsko obložene tablete
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
Slovenian: Krvavitev v prebavila in retroperitonealna krvavitev s smrtnim izidom, pankreatitis, kolitis (vključno z ulceroznim ali
English: How to store Plavix
Slovenian: Shranjevanje zdravila Plavix
English: Store below 30°C (for PVC/PVDC/aluminium blisters) Or No special storage conditions (for all aluminium blisters)
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30C (za PVC/PVDC/alu pretisne omote).
English: Plavix 75 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
Slovenian: Ena filmsko obložena tableta vsebuje 75 mg klopidogrela v obliki klopidogrelijevega hidrogensulfata.
English: Plavix 300 mg film-coated tablets clopidogrel
Slovenian: Plavix 300 mg filmsko obložene tablete klopidogrel
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group .The incidence of major bleeding was similar between groups .
Slovenian: V študiji CLARITY je v skupini s klopidogrelom in ASA prišlo do splošnega povečanja krvavitev v primerjavi s skupino s placebom in ASA .
English: EU/1/98/069/008 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/009 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/010 100x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/012 10x1 film-coated tablets in all aluminium perforated unit-dose blisters
Slovenian: EU/1/98/069/009 30x1 filmsko obloženih tablet v aluminijastih perforiranih pretisnih omotih za enkratni odmerek.
English: Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
Slovenian: Ena tableta vsebuje 75 mg klopidogrela v obliki klopidogrelijevega hidrogensulfata.
English: Each tablet contains 300 mg of clopidogrel (as hydrogen sulphate).
Slovenian: Ena tableta vsebuje 300 mg klopidogrela v obliki klopidogrelijevega hidrogensulfata.
English: Plavix 300 mg film-coated tablets Each film-coated tablet contains 300 mg of clopidogrel (as hydrogen sulphate).
Slovenian: Ena filmsko obložena tableta vsebuje 300 mg klopidogrela v obliki klopidogrelijevega hidrogensulfata.
English: - Plavix 75 mg film-coated tablets
Slovenian: - Plavix 75 mg filmsko obložene tablete
English: Plavix 75 mg film-coated tablets
Slovenian: Plavix 75 mg filmsko obložene tablete
English: Plavix 75 mg film-coated tablets clopidogrel
Slovenian: Plavix 75 mg filmsko obložene tablete klopidogrel
English: EU/1/98/069/008 - Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/009 - Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/010 - Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/012 - Cartons of 10x1 film-coated tablets in all aluminium perforated unit-dose blisters
Slovenian: EU/1/98/069/009 - Škatle s 30 x 1 filmsko obloženih tablet v perforiranih pretisnih omotih za enkratni odmerek, ki so v celoti iz aluminija.
English: Batch:
Slovenian: Lot:
English: (listed in section 6).
Slovenian: z 0,6 %).
English: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France
Slovenian: 54, rue La Boétie - F-75008 Paris - Francija
English: - omeprazole or esomeprazole, medicines to treat upset stomach, - fluconazole or voriconazole, medicines to treat fungal infections, - efavirenz, or other anti-retroviral medicines (used to treat HIV infections), - carbamazepine, a medicine to treat some forms of epilepsy, - moclobemide, medicine to treat depression, - repaglinide, medicine to treat diabetes, - paclitaxel, medicine to treat cancer, - opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioid (used to treat severe pain).
Slovenian: - omeprazol ali esomeprazol, zdravila za zdravljenje težav z želodcem, - flukonazol ali vorikonazol, zdravila za zdravljenje glivičnih okužb, - efavirenz ali druga protiretrovirusna zdravila(ki se uporabljajo za zdravljenje infekcij z virusom
English: sanofi-aventis groupe 54, rue La Boétie - F-75008 Paris France
Slovenian: 54, rue La Boétie - F-75008 Paris
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 15. julij 1998
English: - If you have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: 6 months; prior intracerebral hemorrhage; significant thrombocytopenia (platelet count < 50 x 109/l);
Slovenian: Glavna merila za nevključitev bolnikov so bila potrjena peptična ulkusna bolezen v preteklih 6 mesecih, predhodna intracerebralna krvavitev, pomembna trombocitopenija (število trombocitov < 50 x 109/l), potreba po klopidogrelu ali peroralnih antikoagulantih ali intoleranca za katero od obeh snovi.
English: EXP {MM/YYYY}
Slovenian: Vistor hf.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM sanofi-aventis groupe
English: - fever, signs of infection or extreme tiredness.
Slovenian: Nemudoma se posvetujte s svojim zdravnikom, če se pri vas pojavijo: - zvišana telesna temperatura, znaki okužbe ali huda utrujenost.
English: If you experience prolonged bleeding when taking Plavix
Slovenian: Če ste prenehali jemati zdravilo Plavix
English: Eye bleeding (conjunctival, ocular, retinal)
Slovenian: Krvavitve v očesu (veznica, oko, mrežnica)
English: Annex I List of nationally authorised medicinal products
Slovenian: Priloga I Seznam zdravil z nacionalnim dovoljenjem za promet
English: Belgium Effik Benelux
Slovenian: Effik Benelux
English: Luxembourg Mithra Pharmaceuticals Sa Deltanogest
Slovenian: Luksemburg Mithra Pharmaceuticals Sa Deltanogest
English: Dienogest/Etinilestra diol Aurobindo
Slovenian: Dienogest/Etinilest radiol Aurobindo
English: Dienogest/Etinilestra diol Cinfa
Slovenian: Dienogest/Etinilest radiol Cinfa
English: Tablet
Slovenian: Finic tableta
English: Luxembourg Ratiopharm Gmbh
Slovenian: Luksemburg Ratiopharm Gmbh
English: Belgium Exeltis Germany Gmbh Serisima Continu Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $
Slovenian: Exeltis Germany Gmbh Serisima Continu dienogest 2 mg tableta, etinilestradiol 0,03 mg tableta $ placebo 0 mg tableta
English: Motion Ratiopharm Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet
Slovenian: Motion Ratiopharm dienogest 2 mg tableta, etinilestradiol 0,03 mg tableta
English: Velvet-Ratiopharm Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet
Slovenian: Velvet-Ratiopharm dienogest 2 mg tableta, etinilestradiol 0,03 mg tableta
English: Mistral Continuous Dienogest 2mg, Ethinylestradiol 0.03mg $ Lactose Anhydrous 37.26mg
Slovenian: Mistral Continuous dienogest 2 mg, etinilestradiol 0,03 mg $ brezvodna laktoza 37,26 mg
English: Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $ Lactose Monohydrate 60.9mg Tablet
Slovenian: Diedita dienogest 2 mg tableta, etinilestradiol 0,03 mg tableta $ laktoza monohidrat 60,9 mg tableta
English: Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $ Placebo 0mg Tablet
Slovenian: Diecyclen dienogest 2 mg tableta, etinilestradiol 0,03 mg tableta $ placebo 0 mg tableta
English: Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $ Lactose Monohydrate 55.5mg Tablet
Slovenian: dienogest 2 mg tableta, etinilestradiol 0,03 mg tableta $ laktoza monohidrat 55,5 mg tableta
English: Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $ Lactose 37.26mg Tablet
Slovenian: Sibilla dienogest 2 mg tableta, etinilestradiol 0,03 mg tableta $ laktoza 37,26 mg tableta
English: Dienogest 2mg, Ethinylestradiol 0.03mg $ Lactose Anhydrous 37.26mg
Slovenian: Sibilla Zilnic dienogest 2 mg, etinilestradiol 0,03 mg $ brezvodna laktoza 37,26 mg
English: Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $ Lactose Monohydrate 55mg Tablet
Slovenian: Egis Pharmaceuticals Plc Omisson Daily dienogest 2 mg tableta, etinilestradiol 0,03 mg tableta $ laktoza monohidrat 55 mg tableta
English: consecutive days.
Slovenian: zaporedne dni.
English: Bioavailability in non-fasted pigs is approximately 21%.
Slovenian: Biorazpoložljivost pri prašičih, ki ne stradajo, je približno 21%.
English: Plasma protein binding is high (over 90%).
Slovenian: Vezava na plazemske proteine je visoka (nad 90%).
English: Do not smoke, eat or drink while handling the product.
Slovenian: Ne kadite, ne jejte in ne pijte med delom z izdelkom.
English: General warnings and advice relating to antimicrobial resistance have been strengthened.
Slovenian: Okrepljeni so bili splošna opozorila in nasveti glede protimikrobne odpornosti.
English: ATC vet code: QJ 01 AA 02
Slovenian: ATC vetoznaka: QJ 01 AA 02
English: 4.4 Special warning for each target species.
Slovenian: 4.4 Posebno opozorilo za vsako ciljno živalsko vrsto.
English: Excipients: For a full list of excipients, see section 6.1
Slovenian: Pomožne snovi: Za celoten seznam pomožnih snovi, glejte poglavje 6.1
English: Active substance:
Slovenian: Aktivna snov:
English: The lack of an epidemiologically based surveillance programme and standardised susceptibility testing methodology complicates interpretation of reports.
Slovenian: Odsotnost epidemiološko utemeljenega programa nadzorovanja in standardizirane metodologije preskušanja občutljivosti otežuje razlago poročil.
English: The full text will be printed on the single sachet/bag Format used is especially for this type of labelling
Slovenian: Celotno besedilo bo natisnjeno na enojni vrečki/torbici Uporabljeni format je namenjen posebno za to vrsto oznake
English: The final conclusion for the benefit-risk balance for the use of the product remains positive.
Slovenian: Končna ocena razmerja med tveganji in koristmi za uporabo zdravila ostaja pozitivna.
English: Swelling of the face, lips or eyes, or difficulty with breathing are more serious symptoms and require urgent medical attention.
Slovenian: Otekanje obraza, ustnic ali oči ali težave z dihanjem so resnejši simptomi in zahtevajo nujno zdravniško pomoč.
English: Use of the product should be based on culture and sensitivity of micro-organisms from diseased cases on farm.
Slovenian: Uporaba zdravila mora temeljiti na kulturi in občutljivosti mikroorganizmov iz obolelih primerov na kmetiji.
English: Overdoses up to 1.6 times the label recommended dose resulted in no clinical signs that could be attributed to treatment.
Slovenian: Do 1,6-krat večji odmerki od priporočenega odmerka, niso povzročili nobenih kliničnih znakov, ki bi jih lahko pripisali zdravljenju.
English: To ensure a correct dosage body weight should be determined as accurately as possible.
Slovenian: Da se zagotovi pravilno odmerjanje, je treba telesne teže določiti čim natančneje.
English: 1 gram of powder contains:
Slovenian: 1 gram praška vsebuje:
English: No further clinical trial or field trial data were submitted.
Slovenian: Predloženi niso bili nobeni drugi podatki kliničnih ali terenskih preskušanj.
English: Prescription only medicine (or similar wording, national issue)
Slovenian: Zdravilo samo na recept (ali podobno besedilo, stvar države članice)