FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/057-062 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 June 2015
Slovenian: ZDRAVILOM EU/1/15/1012/011-017 EU/1/15/1012/085 DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 19. 6. 2015 10.
English: Creatinine clearance (CLcr) (mL/min)
Slovenian: Prilagoditev odmerka pregabalina glede na delovanje ledvic očistek kreatinina (OČkr) (ml/min)
English: What Pregabalin Sandoz GmbH contains - The active substance is pregabalin.
Slovenian: Kaj vsebuje zdravilo Pregabalin Sandoz GmbH - Učinkovina je pregabalin.
English: What Pregabalin Sandoz GmbH is and what it is used for
Slovenian: Kaj je zdravilo Pregabalin Sandoz GmbH in za kaj ga uporabljamo
English: What you need to know before you take Pregabalin Sandoz GmbH 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Pregabalin Sandoz GmbH
English: Pregabalin Sandoz GmbH may be taken with oral contraceptives.
Slovenian: Zdravilo Pregabalin Sandoz GmbH lahko jemljete s peroralnimi kontraceptivi.
English: The pregabalin safety profile observed in three paediatric studies in patients with partial seizures with or without secondary generalization (12-week efficacy and safety study in patients with partial onset seizures, n=295; pharmacokinetic and tolerability study, n=65; and 1 year open label follow on safety study, n=54) was similar to that observed in the adult studies of patients with epilepsy.
Slovenian: Varnostni profil pregabalina, opažen v treh študijah pri otrocih bolnikih s parcialnimi napadi s sekundarno generalizacijo ali brez nje (12-tedenska študija o učinkovitosti in varnosti pri bolnikih s parcialnimi napadi, n=295; (študija farmakokinetike in prenašanja zdravila, n = 65; in enoletna odprta nadaljevalna študija varnosti, n = 54), je bil podoben tistemu v študijah pri odraslih z epilepsijo.
English: Pregabalin Sandoz GmbH belongs to a group of medicines used to treat epilepsy and Generalised Anxiety Disorder (GAD) in adults.
Slovenian: Zdravilo Pregabalin Sandoz GmbH sodi med zdravila, ki se uporabljajo za zdravljenje epilepsije in generalizirane anksiozne motnje pri odraslih.
English: Pregabalin Sandoz GmbH is for oral use only.
Slovenian: Zdravilo Pregabalin Sandoz GmbH je samo za peroralno uporabo.
English: The percentage of subjects with at least a 50% reduction in partial onset seizures as compared to baseline was 40.6% of subjects treated with pregabalin 10 mg/kg/day (p=0.0068 versus placebo), 29.1% of subjects treated with pregabalin 2.5 mg/kg/day (p=0.2600 versus placebo) and 22.6% of those receiving placebo.
Slovenian: Delež preskušancev z vsaj 50 % zmanjšanjem pogostnosti parcialnih napadov parcialnega izvora v primerjavi z izhodiščem je bil pri preskušancih, ki so prejemali pregabalin v odmerku 10 mg/kg/dan, 40,6 % (p = 0,0068 v primerjavi s placebom), pri preskušancih, ki so prejemali pregabalin v odmerku 2,5 mg/kg/dan, 29,1 % (p = 0,2600 v primerjavi s placebom) in pri tistih, ki so prejemali placebo, 22,6 %.
English: Do not stop taking Pregabalin Sandoz GmbH unless your doctor tells you to.
Slovenian: Če ste prenehali jemati zdravilo Pregabalin Sandoz GmbH Ne prenehajte jemati zdravila Pregabalin Sandoz GmbH, razen če vam to naroči zdravnik.
English: What Pregabalin Sandoz GmbH looks like and contents of the pack 25 mg capsules Pale yellow-brown opaque cap and body, capsule size 4 (14.3 mm x 5.3 mm) filled with white to nearly white coloured powder.
Slovenian: Izgled zdravila Pregabalin Sandoz GmbH in vsebina pakiranja 25mg kapsule Neprozorna pokrovček in telo blede rumenkasto-rjave barve, velikost kapsule 4 (14,3 mm x 5,3 mm), napolnjena s praškom bele do belkaste barve.
English: PVC/PVDC//Alu unit dose blisters packed in carton HDPE container with PP screw cap packed in carton.
Slovenian: PVC/PVDC/aluminijski enoodmerni pretisni omot v škatli.
English: Rare: may affect up to 1 in 1,0000 people
Slovenian: Redki: pojavijo se lahko pri največ 1 od 1.000 bolnikov
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 300 mg hard capsules pregabalin NAME OF THE MARKETING AUTHORISATION HOLDER Sandoz EXPIRY DATE
Slovenian: IME ZDRAVILA Pregabalin Sandoz GmbH 300 mg trde kapsule pregabalin IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sandoz DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: 225 mg capsules: Blisters containing 14, 56, 70, 84,100 or 120 hard capsules.
Slovenian: 225 mg kapsule: Pretisni omoti, ki vsebujejo 14, 56, 70, 84, 100 ali 120 trdih kapsul.
English: Unit dose blisters containing 56 x 1, 84 x 1 or 100 x 1 hard capsules.
Slovenian: Pretisni omoti s posamezni odmerki, ki vsebujejo 56 x 1, 84 x 1 ali 100 x 1 trdo kapsulo.
English: Results of a 12-week placebo-controlled study of 295 paediatric patients aged 4 to 16 years performed to evaluate the efficacy and safety of pregabalin as adjunctive therapy for the treatment of partial onset seizures and a 1 year open label safety study in 54 paediatric patients from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory infections were observed more frequently than in adult studies of patients with epilepsy (see sections 4.2, 4.8 and 5.2).
Slovenian: Rezultati 12-tedenske s placebom nadzorovane študije pri 295 pediatričnih bolnikih, starih od 4 do 16 let, da bi ocenili učinkovitost in varnost pregabalina kot dodatnega zdravljenja parcialnih napadov in enoletne odprte študije varnosti pri 54 pediatričnih bolnikih z epilepsijo, starih od 3 mesecev do 16 let, kažejo, da so opazili neželene učinke - pireksijo in okužbe zgornjih dihal - pogosteje kot v študijah pri odraslih z epilepsijo (glejte poglavja 4.2, 4.8 in 5.2).
English: The following events have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness, suggestive of physical dependence.
Slovenian: Opisani so naslednji pojavi: nespečnost, glavobol, navzea, anksioznost, driska, gripozni sindrom, živčnost, depresija, bolečine, krči, hiperhidroza in omotica; le-ti kažejo na fizično odvisnost.
English: Blister packs (unit dose): 56 x 1, 84 x 1 or 100 x 1 hard capsules.
Slovenian: Pretisni omoti (posamezni odmerki): 56 x 1, 84 x 1 ali 100 x 1 trda kapsula.
English: How to store Pregabalin Sandoz GmbH
Slovenian: Shranjevanje zdravila Pregabalin Sandoz GmbH
English: • Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal.
Slovenian: • Motnje pozornosti, nerodnost, okvara spomina, izguba spomina, tresenje, težave pri govorjenju,
English: Pregabalin Sandoz GmbH may produce dizziness, sleepiness and decreased concentration.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Pregabalin Sandoz GmbH lahko povzroči omotico, zaspanost in poslabša sposobnost koncentracije.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/011-017
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/011-017
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/001-010
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/001-010
English: In all controlled studies, the discontinuation rate due to adverse reactions was 12% for patients receiving pregabalin and 5% for patients receiving placebo.
Slovenian: Delež prekinitev zdravljenja zaradi neželenih učinkov je bil v vseh kontroliranih študijah 12 % med bolniki,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/074-076
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/074-076
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/081-083
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/081-083
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/057-062
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/057-062
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/018-029
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/018-029
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/031-033
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/031-033
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 225 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Sandoz GmbH 225 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/042-052
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/042-052
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/063-068
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/063-068
English: How to take Pregabalin Sandoz GmbH
Slovenian: Kako jemati zdravilo Pregabalin Sandoz GmbH
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/054-056
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/054-056
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 75 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Sandoz GmbH 75 mg
English: 200 mg capsules Pale orange opaque cap and body, capsule size 1 (19.4 mm x 6.9 mm) filled with white to nearly white coloured powder.
Slovenian: 200 mg kapsule Neprozorna pokrovček in telo svetlo oranžne barve, velikost kapsule 1 (19,4 mm x 6,9 mm), napolnjena s praškom bele do belkaste barve.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/084
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/084
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/085
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/085
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 225 mg hard capsules
Slovenian: Pregabalin Sandoz GmbH 225 mg trde kapsule
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 150 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Sandoz GmbH 150 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/053
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/053
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/034-041
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/034-041
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 200 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Sandoz GmbH 200 mg
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 200 mg hard capsules
Slovenian: Pregabalin Sandoz GmbH 200 mg trde kapsule
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 300 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Sandoz GmbH 300 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/030
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/030
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/069-073
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1012/069-073
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 100 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Sandoz GmbH 100 mg
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 150 mg hard capsules
Slovenian: Pregabalin Sandoz GmbH 150 mg trde kapsule
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 25 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Sandoz GmbH 25 mg
English: Talk to your doctor or pharmacist before taking Pregabalin Sandoz GmbH.
Slovenian: Pred začetkom jemanja zdravila Pregabalin Sandoz GmbH se posvetujte z zdravnikom ali farmacevtom.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 300 mg hard capsules
Slovenian: Pregabalin Sandoz GmbH 300 mg trde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 100 mg hard capsules
Slovenian: Pregabalin Sandoz GmbH 100 mg trde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 75 mg hard capsules
Slovenian: Pregabalin Sandoz GmbH 75 mg trde kapsule
English: Blister packs: 14, 28, 56, 70, 84, 100 or 120 hard capsules.
Slovenian: Pretisni omoti: 14, 28, 56, 70, 84, 100 ali 120 trdih kapsul.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 50 mg hard capsules
Slovenian: Pregabalin Sandoz GmbH 50 mg trde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 25 mg hard capsules
Slovenian: Pregabalin Sandoz GmbH 25 mg trde kapsule
English: EU/1/15/1012/084
Slovenian: EU/1/15/1012/001-010 EU/1/15/1012/084
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNE OMOTE
English: Ear and labyrinth disorders Common
Slovenian: Ušesne bolezni, vključno z motnjami labirinta Pogosti vrtoglavica
English: Blister packs: 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules Blister packs (unit dose): 14 x 1, 56 x 1, 84 x 1, 100 x 1 or 210 x 1 (3 x 70) hard capsules Container packs: 100, 200 or 250 hard capsules Not all pack sizes may be marketed.
Slovenian: Pretisni omoti (posamezni odmerki): 14 x 1, 56 x 1, 84 x 1, 100 x 1 ali 210 x 1 (3 x 70) trda kapsula.
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 50 mg
Slovenian: Pregabalin Sandoz GmbH 50 mg
English: Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti krči mišic, artralgija, bolečine v hrbtu, bolečine v udih, spazem v vratu
English: INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz GmbH 50 mg
Slovenian: Škatla: Pregabalin Sandoz GmbH 50 mg
English: INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz GmbH 75 mg
Slovenian: Škatla: Pregabalin Sandoz GmbH 75 mg
English: Dunajska cesta 151 1000 Ljubljana Slovenia
Slovenian: Dunajska cesta 151 1000 Ljubljana Slovenija
English: 00351 Helsinki, Finland
Slovenian: 00351 Helsinki, Finska
English: Lysaker, Norway
Slovenian: Lysaker, Norveška
English: Budapest, Hungary
Slovenian: Budapest, Madžarska
English: 00 Praha 6, Czech
Slovenian: 00 Praha 6, Češka uporaba
English: fl.8., Bulgaria
Slovenian: fl.8., Bolgarija
English: Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands
Slovenian: Kampenringweg 45 D-E, 2803 PE Gouda, The Nizozemska
English: Edifício 7 - 3º Piso 2740-244 Porto Salvo Portugal
Slovenian: Edifício 7 - 3º Piso 2740-244 Porto Salvo Portugalska
English: 167 14 Bromma, Sweden
Slovenian: 167 14 Bromma, Švedska
English: Tatoiou Street 14671 Nea Erythrea, Greece
Slovenian: Tatoiou Street 14671 Nea Erythrea, Grčija
English: United Kingdom Aventis Pharma Ltd. (or trading as Marion Merrell or Aventis Pharma)
Slovenian: Velika Britanija Aventis Pharma Ltd. (or trading as Marion Merrell or Aventis Pharma)
English: Marion Merrell S.A. Martínez Villergas, 52 28027 Madrid Spain
Slovenian: Marion Merrell S.A. Martínez Villergas, 52 28027 Madrid Španija
English: Slotsmarken 13, 2970 Hoersholm, Denmark
Slovenian: Slotsmarken 13, 2970 Hoersholm, Danska
English: Germany sanofi-aventis Deutschland GmbH Industriepark Höchst, Geb.
Slovenian: Nemčija sanofi-aventis Deutschland GmbH Industriepark Höchst, Geb.
English: GU1 4YS United Kingdom
Slovenian: GU1 4YS Velika Britanija
English: Norway sanofi-aventis Norge AS, Strandveien 15, PO Box 133, 1325
Slovenian: Norveška sanofi-aventis Norge AS, Strandveien 15, PO Box 133, 1325
English: K 703, 65926 Frankfurt am Main, Deutschland
Slovenian: K 703, 65926 Frankfurt am Main, Nemčija
English: France sanofi-aventis France 1-13 Bd Romain Rolland 75014 Paris, France
Slovenian: Francija sanofi-aventis France 1-13 Bd Romain Rolland 75014 Paris, Francija
English: Ireland sanofi-aventis Ireland Ltd., T/A Sanofi 18 Riverwalk Citywest Business Campus, Dublin 24, Ireland
Slovenian: Irska sanofi-aventis Ireland Ltd., T/A Sanofi 18 Riverwalk Citywest Business Campus, Dublin 24, Irska
English: Denmark sanofi-aventis Denmark A/S
Slovenian: Danska sanofi-aventis Denmark A/S
English: One Onslow Street, Guildford Surrey, GU1 4YS, United Kingdom
Slovenian: One Onslow Street, Guildford Surrey, GU1 4YS, Velika Britanija
English: Finland sanofi-aventis Oy Huopalahdentie 24 PL 22
Slovenian: Finska sanofi-aventis Oy Huopalahdentie 24 PL 22
English: Netherlands sanofi-aventis Netherlands BV.
Slovenian: Nizozemska sanofi-aventis Netherlands BV.
English: Austria sanofi-aventis GmbH, Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria
Slovenian: Avstrija sanofi-aventis GmbH, Leonard-Bernstein-Straße 10, A-1220 Vienna, Avstrija
English: Bulgaria sanofi-aventis Bulgaria EOOD
Slovenian: Bolgarija sanofi-aventis Bulgaria EOOD
English: Slovak Republic sanofi-aventis Pharma Slovakia s.r.o Einsteinova 24, 85101 Bratislava, Slovak Republic
Slovenian: Slovaška sanofi-aventis Pharma Slovakia s.r.o Einsteinova 24, 85101 Bratislava, Slovaška
English: Luxembourg sanofi-aventis Belgium Culliganlaan 1C
Slovenian: Luksemburg sanofi-aventis Belgium Culliganlaan 1C
English: Italy sanofi-aventis SPA Viale L. Bodio, 37/B20158 Milano, Italy
Slovenian: Italija sanofi-aventis SPA Viale L. Bodio, 37/B20158 Milano, Italija
English: Aventis Pharma Ltd. One Onslow Street, Guildford, Surrey GU1 4YS,
Slovenian: One Onslow Street, Guildford, Surrey GU1 4YS,
English: United Kingdom or trading as
Slovenian: Velika Britanija trženje
English: Aventis Pharma Ltd. Trading as sanofi-aventis or Sanofi
Slovenian: Trading as sanofi-aventis or Sanofi
English: 400 mg powder for injection intramuscular use/intravenous use
Slovenian: 400 mg prašek za injiciranje intramuskularna uporaba/ intravenska uporaba
English: 400 mg powder for injectable preparations
Slovenian: 400 mg prašek za injekcijske pripravke
English: TARGOCID® 400 400 mg powder for solution for injection
Slovenian: TARGOCID® 400 400 mg prašek za raztopino za injiciranje
English: Belgium sanofi-aventis Belgium Culliganlaan 1C
Slovenian: Belgija sanofi-aventis Belgium Culliganlaan 1C 1831 Diegem, Belgija
English: TARGOCID® 200 200 mg powder for solution for injection
Slovenian: TARGOCID® 200 200 mg prašek za raztopino za injiciranje
English: 200 mg Powder for injection/infusion, solution
Slovenian: 200 mg Prašek injiciranje / infundiranje, raztopina
English: 400 mg Powder for injection/infusion, solution
Slovenian: 400 mg Prašek injiciranje /infundiranje, raztopina
English: 100 mg powder for solution for injection
Slovenian: 100 mg prašek za raztopino za injiciranje
English: 200 mg powder for solution for injection
Slovenian: 200 mg prašek za raztopino za injiciranje
English: United Kingdom200 mg powder for injection intramuscular use/intravenous use
Slovenian: 200 mg prašek za injiciranje intramuskularna uporaba/ intravenska uporaba
English: 400 mg powder for solution for injection
Slovenian: 400 mg prašek za raztopino za injiciranje
English: Powder and solvent for injection or infusion
Slovenian: Prašek in vehikel za injiciranje ali infundiranje
English: 200 mg powder for solution for injection/ infusion
Slovenian: 200 mg prašek za raztopino za injiciranje / infundiranje
English: 400 mg powder for solution for injection/ infusion
Slovenian: 400 mg prašek za raztopino za injiciranje / infundiranje
English: Adults and elderly
Slovenian: • Odrasli in starostniki
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/534/001 - 007
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/534/001 - 007
English: Some other medicines may influence the use of Clopidogrel HEXAL or vice versa.
Slovenian: Nekatera druga zdravila lahko vplivajo na uporabo zdravila Klopidogrel HEXAL in obratno.
English: Children and adolescents Clopidogrel HEXAL is not intended for use in children or adolescents.
Slovenian: Otroci in mladostniki Zdravilo Klopidogrel HEXAL ni namenjeno za uporabo pri otrocih ali mladostnikih.
English: Do not use Clopidogrel HEXAL if you notice any visible sign of damage of blister or film-coated tablets.
Slovenian: Ne uporabljajte zdravila Klopidogrel HEXAL, če ste opazili vidne znake poškodovanja pretisnega omota ali filmsko obloženih tablet.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/.
English: You should take Clopidogrel HEXAL for as long as your doctor continues to prescribe it.
Slovenian: Zdravilo Klopidogrel HEXAL morate jemati, vse dokler vam ga vaš zdravnik predpisuje.
English: Published frequencies for the poorCYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
Slovenian: Objavljene pogostnosti genotipa slabega metabolizatorja s CYP2C19 so približno 2% pri Kavkazijcih, 4% pri črncih in 14% pri Kitajcih.
English: Data from the CAPRIE study indicate that phenytoin and tolbutamide which are metabolised by CYP2C9can be safely co-administered with clopidogrel.
Slovenian: Podatki študije CAPRIE kažejo, da se lahko fenitoin in tolbutamid, ki se presnavljata s CYP2C9, sočasno s klopidogrelom varno uporabljata.
English: WHAT CLOPIDOGREL HEXAL IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO KLOPIDOGREL HEXAL IN ZA KAJ GA UPORABLJAMO
English: Other side effects reported with Clopidogrel HEXAL are: -Common side effects:
Slovenian: Drugi neželeni učinki, o katerih so poročali s Klopidogrelom HEXAL, so: - Pogosti neželeni učinki:
English: What Clopidogrel HEXAL is and what it is used for Before you take Clopidogrel HEXAL How to take Clopidogrel HEXAL Possible side effects
Slovenian: Kaj je zdravilo Klopidogrel HEXAL in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Klopidogrel HEXAL Kako jemati zdravilo Klopidogrel HEXAL Možni neželeni učinki
English: Like all medicines, Clopidogrel HEXAL can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Klopidogrel HEXAL neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: 6.4 Special precautions for storage Store in the original blister in order to protect from moisture.
Slovenian: 6.4 Posebna navodila za shranjevanje Shranjujte v originalnih pretisnih omotih za zagotovitev zaščite pred vlago.
English: Taking Clopidogrel HEXAL with food and drink Clopidogrel HEXAL may be taken with or without food.
Slovenian: Jemanje zdravila Klopidogrel HEXAL skupaj s hrano in pijačo Zdravilo Klopidogrel HEXAL lahko jemljete s hrano ali brez nje.
English: If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel HEXAL in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Slovenian: Če ste doživeli hudo bolečino v prsih (nestabilna angina pektoris ali srčni napad), so vam morda predpisali zdravilo Klopidogrel HEXAL v kombinaciji z acetilsalicilno kislino, učinkovino, ki je prisotna v številnih zdravilih, ki se uporabljajo za lajšanje bolečine in zniževanje zvišane telesne temperature.
English: If you take more Clopidogrel HEXAL than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Slovenian: Če ste vzeli večji odmerek zdravila Klopidogrel HEXAL, kot bi smeli Zaradi povečanega tveganja krvavitve se posvetujte s svojim zdravnikom ali oddelkom najbližje bolnišnične nujne zdravniške pomoči.
English: • If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel HEXAL;
Slovenian: • če ste alergični na (preobčutljivza klopidogrel ali katerokoli sestavino zdravila
English: Then, the usual dose is one 75 mg tablet of Clopidogrel HEXAL per day to be taken orally with or without food, and at the same time each day.
Slovenian: Nato je običajni odmerek ena 75-mg tableta zdravila Klopidogrel HEXAL na dan, ki jo lahko vzamete s hrano ali brez nje; odmerek morate jemati vsak dan ob istem času.
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel HEXAL.
Slovenian: Če menite, da se karkoli od navedenega nanaša na vas, ali če ste kakorkoli v dvomih, se posvetujte s svojim zdravnikom, preden boste vzeli Klopidogrel HEXAL.
English: If you experience prolonged bleeding when taking Clopidogrel HEXAL.
Slovenian: Če doživite podaljšanje krvavitve v času jemanja zdravila Klopidogrel HEXAL.