FrancophonIA/ELRC3.0 huggingface dataset:
English: It is advised not to drink alcohol while taking Pregabalin Sandoz GmbH.
Maltese: Huwa rakkomandat li wieħed ma jixrobx alkoħol waqt li jkun qed jieħu Pregabalin Sandoz GmbH.
English: Pregabalin Sandoz GmbH belongs to a group of medicines used to treat epilepsy and Generalised Anxiety Disorder (GAD) in adults.
Maltese: Pregabalin Sandoz GmbH jappartjeni għal grupp ta' mediċini li jintużaw għall-kura tal-epilessija, luġigħ nevrotiku u d-Disturb ta' Ansjetà Ġeneralizzata (GAD - Generalised Anxiety Disorder) fl-adulti.
English: Multipack: 84 (2 packs of 42) hard capsules Multipack: 100 (2 packs of 50) hard capsules Multipack: 120 (2 packs of 60) hard capsules Multipack: 84 x 1 (2 packs of 42 x 1) hard capsules Multipack: 100 x 1 (2 packs of 50 x 1) hard capsules Multipack: 210 x 1 (3 packs of 70 x 1) hard capsules
Maltese: Multipack: 100 x 1 (2 pakketti ta' 50 x 1) kapsuli ibsin. Multipack: 210 x 1 (3 pakketti ta' 70 x 1) kapsuli ibsin.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 225 mg hard capsules
Maltese: Pregabalin Sandoz GmbH 225 mg kapsuli ibsin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 200 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz GmbH 200 mg kapsuli ibsin Pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 200 mg hard capsules
Maltese: Pregabalin Sandoz GmbH 200 mg kapsuli ibsin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/053
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/053
English: Epilepsy: Pregabalin Sandoz GmbH is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Maltese: Pregabalin Sandoz GmbH tintuża sabiex tiġi kkurata ċerta forma ta' epilessija (aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja) fl-adulti.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 225 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz GmbH 225 mg kapsuli ibsin Pregabalin
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz GmbH 50 mg
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz GmbH 25 mg
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 75 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz GmbH 75 mg kapsuli ibsin Pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 100 mg hard capsules
Maltese: Pregabalin Sandoz GmbH 100 mg kapsuli ibsin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 300 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz GmbH 300 mg kapsuli ibsin Pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 150 mg hard capsules
Maltese: Pregabalin Sandoz GmbH 150 mg kapsuli ibsin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 100 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz GmbH 100 mg kapsuli ibsin Pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 150 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz GmbH 150 mg kapsuli ibsin Pregabalin
English: Blister packs: 14, 28, 56, 70, 84, 100 or 120 hard capsules.
Maltese: Folji li fihom 14, 28, 56, 70, 84, 100 jew 120 kapsula iebsa.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 75 mg hard capsules
Maltese: Pregabalin Sandoz GmbH 75 mg kapsuli ibsin
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.
Maltese: Pakketti bil-folji: 14, 21, 28, 56, 70, 84, 100 jew 120 kapsula iebsa Pakketti bil-folji (doża tal-unità): 14 x 1, 56 x 1, 84 x 1, 100 x 1 jew 210 x 1 (3 x 70) kapsula iebsa.
English: You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Sandoz GmbH than you should.
Maltese: Tista' tħossok bi ngħas, konfuż, aġitat, jew bla kwiet jekk tieħu Pregabalin Sandoz GmbH aktar milli suppost.
English: 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).
Maltese: aċċessjonijiet ta' bidu parzjali u ta' studju open label dwar issigurtà li dam sena, li sar fuq 54 pazjent pedjatriku li kellhom minn 3 xhur sa 16-il sena, bl-epilessija, jindikaw li l-avvenimenti avversi ta' deni u infezzjonijiet respiratorji fil-parti ta' fuq, ġew osservati b'mod aktar frekwenti milli fl-istudji li saru fuq l-adulti b'epilessija (ara sezzjonijiet 4.2, 4.8 u 5.2).
English: Pregabalin Sandoz GmbH may produce dizziness, sleepiness and decreased concentration.
Maltese: Pregabalin Sandoz GmbH jista' jikkawża sturdament, irqad u konċentrazzjoni mnaqqsa.
English: • Jaundice (yellowing of the skin and eyes).
Maltese: • Suffejra (sfurija fil-ġilda u fl-għajnejn).
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 300 mg hard capsules
Maltese: Pregabalin Sandoz GmbH 300 mg kapsuli ibsin
English: Hepatic impairment No dose adjustment is required for patients with hepatic impairment (see section 5.2).
Maltese: Indeboliment tal-kliewi Mhux meħtieġ aġġustament fid-doża għal pazjenti b'indeboliment tal-fwied (ara sezzjoni 5.2).
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 50 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz GmbH 50 mg kapsuli ibsin Pregabalin
English: How to store Pregabalin Sandoz GmbH
Maltese: Kif taħżen Pregabalin Sandoz GmbH
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 50 mg hard capsules
Maltese: Pregabalin Sandoz GmbH 50 mg kapsuli ibsin
English: Pregabalin Sandoz GmbH and certain other medicines may influence each other (interaction).
Maltese: Pregabalin Sandoz GmbH u xi mediċini oħra jistgħu jaffettwaw lil xulxin (interazzjoni).
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 25 mg hard capsules
Maltese: Pregabalin Sandoz GmbH 25 mg kapsuli ibsin
English: Pale orange opaque cap and body, capsule size 1 (19.4 mm x 6.9 mm), filled with white to nearly white coloured powder.
Maltese: Għatu u korp opaki ta' lewn oranġjo ċar, daqs tal-kapsula 1 (19.4 mm x 6.9 mm), mimlija bi trab ta' lewn abjad sa kważi abjad.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 25 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz GmbH 25 mg kapsuli ibsin Pregabalin
English: After stopping long and short-term Pregabalin Sandoz GmbH treatment, you need to know that you may experience certain side effects.
Maltese: Wara li twaqqaf kura fit-tul jew fil-qasir b'Pregabalin Sandoz GmbH, jeħtieġ li tkun taf li tista' tesperjenza ċerti effetti sekondarji.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/084
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/084
English: Adverse reactions in patients with spinal cord injury The incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased in the treatment of central neuropathic pain due to spinal cord injury.
Maltese: Reazzjonijiet avversi f'pazjenti b'korriment tal-korda spinali L-inċidenza ta' reazzjonijiet avversi b'mod ġenerali, reazzjonijiet avversi relatati mas-sistema nervuża ċentrali u b'mod speċjali n-ngħas żdiedet fil-kura ta' uġigħ newropatiku ċentrali dovut għal korriment tal-korda spinali.
English: Sexual dysfunction, ejaculation delayed, dysmenorrhoea, breast pain
Maltese: Disfunzjoni ta' natura sesswali, dewmien fl-ejakulazzjoni, diżmenorreja, uġigħ fis-sider
English: Blister packs: 21, 28, 84 or 100 hard capsules Blister packs (unit dose): 84 x 1 or 100 x 1 hard capsules Not all pack sizes may be marketed.
Maltese: Pakketti bil-folji: 21, 28, 84 jew 100 kapsula iebsa Pakketti bil-folji (doża tal-unità): 84 x 1 jew 100 x 1 kapsula iebsa.
English: Pregabalin plasma clearance and renal clearance are directly proportional to creatinine clearance (see section 5.2 Renal impairment).
Maltese: It-tneħħija ta' pregabalin mill-plasma u t-tneħħija mill-kliewi huma direttament proporzjonali mat-tneħħija tal- krejatinina (ara sezzjoni 5.2 Indeboliment tal-kliewi).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/085
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/085
English: • Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased,
Maltese: •Bidliet fir-riżultati tat-testijiet tad-demm u tal-fwied (żieda fil-kreatina phosphokinase fid-demm, żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase, tnaqqis fl-għadd ta' pjastrini, newtropenja, żieda fil-kreatinina fid-demm, tnaqqis fil-potassju fid-demm).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/030
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/030
English: White blood cell count decreased
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD ILPROVVISTA
English: Pregabalin Sandoz GmbH is for oral use only.
Maltese: Pregabalin Sandoz GmbH hu disponibbli fil-preżentazzjonijiet li ġejjin:
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.
Maltese: Għatu u korp opaki ta' lewn isfar fil-kannella ċar, daqs tal-kapsula 4 (14.3 mm x 5.3 mm) mimlija bi trab ta' lewn abjad sa kważi abjad.
English: Blister packs: 14, 21, 28, 56, 84 or 100 hard capsules Blister packs (unit dose): 84 x 1 or 100 x 1 hard capsules Not all pack sizes may be marketed.
Maltese: Pakketti bil-folji: 14, 21, 28, 56, 84 jew 100 kapsula iebsa Pakketti bil-folji (doża tal-unità): 84 x 1 jew 100 x 1 kapsula iebsa.
English: A meta- analysis of randomised placebo controlled studies of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
Maltese: F'meta-analisi ta' studji magħmula b'għażla każwali, li kienu kkontrollati bi plaċebo ta' prodotti mediċinali kontra l-epilessija, ntwera ukoll li kien hemm żieda fir-riskju ta' ideat u atteġġamenti ta' suwiċidju.
English: MARKETING AUTHORISATION HOLDER Sandoz GmbH
Maltese: X'fih Pregabalin Sandoz GmbH
English: 00351 Helsinki, Finland
Maltese: 00351 Helsinki, IlFinlandja
English: Tatoiou Street 14671 Nea Erythrea, Greece
Maltese: Tatoiou Street 14671 Nea Erythrea, IlGreċja
English: Marion Merrell S.A. Martínez Villergas, 52 28027 Madrid Spain
Maltese: Marion Merrell S.A. Martínez Villergas, 52 28027 Madrid Spanja
English: Evropská 846/176a, 160
Maltese: Evropská 846/176a, 160 00 Praha 6, IrRepubblika Ċeka
English: Frankfurt am Main,
Maltese: Frankfurt am Main, IlĠermanja
English: Lysaker, Norway
Maltese: Lysaker, In-Norveġja
English: Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands
Maltese: Kampenringweg 45 D-E, 2803 PE Gouda, L-Olanda
English: Edifício 7 - 3º Piso 2740-244 Porto Salvo
Maltese: Edifício 7 - 3º Piso 2740-244
English: Ireland sanofi-aventis Ireland Ltd., T/A Sanofi 18 Riverwalk Citywest Business Campus, Dublin 24, Ireland
Maltese: L-Irlanda sanofi-aventis Ireland Ltd., T/A Sanofi 18 Riverwalk Citywest Business Campus, Dublin 24, LIrlanda
English: Bulgaria sanofi-aventis Bulgaria EOOD
Maltese: Il-Bulgarija sanofi-aventis Bulgaria EOOD
English: Slovak Republic sanofi-aventis Pharma Slovakia s.r.o Einsteinova 24, 85101 Bratislava, Slovak Republic
Maltese: Ir-Repubblika Slovakka sanofi-aventis Pharma Slovakia s.r.o Einsteinova 24, 85101 Bratislava, IrRepubblika Slovakka
English: Hoersholm, Denmark
Maltese: Hoersholm, Id
English: 167 14 Bromma, Sweden
Maltese: 167 14 Bromma, , LIsvezja
English: Italy sanofi-aventis SPA Viale L. Bodio, 37/B20158 Milano, Italy
Maltese: L-Italja sanofi-aventis SPA Viale L. Bodio, 37/B20158 Milano, L-Italja
English: Denmark sanofi-aventis Denmark A/S
Maltese: Id-Danimarka sanofi-aventis Denmark A/S
English: Netherlands sanofi-aventis Netherlands BV.
Maltese: L-Olanda sanofi-aventis Netherlands BV.
English: France sanofi-aventis France 1-13 Bd Romain Rolland 75014 Paris, France
Maltese: France sanofi-aventis France 1-13 Bd Romain Rolland 75014
English: One Onslow Street, Guildford Surrey, GU1 4YS, United Kingdom
Maltese: One Onslow Street, Guildford, Surrey GU1 4YS,
English: Luxembourg sanofi-aventis Belgium Culliganlaan 1C
Maltese: Il-Lussemburgu sanofi-aventis Belgium Culliganlaan 1C
English: Budapest, Hungary
Maltese: Budapest, L-Ungerija
English: Finland sanofi-aventis Oy Huopalahdentie 24 PL 22
Maltese: Il-Finlandja sanofi-aventis Oy Huopalahdentie 24
English: Norway sanofi-aventis Norge AS, Strandveien 15, PO Box 133, 1325
Maltese: In-Norveġja sanofi-aventis Norge AS, Strandveien 15,
English: United Kingdom Aventis Pharma Ltd. (or trading as Marion Merrell or Aventis Pharma)
Maltese: (or trading as Marion Merrell or Aventis
English: Aventis Pharma Ltd. Trading as sanofi-aventis or Sanofi
Maltese: Trading as sanofi-aventis or Sanofi
English: Sanofi-Aventis Malta Ltd. Triq Kan. K. Pirotta, Birkirkara BKR1114, Malta
Maltese: Pirotta, Birkirkara BKR1114, Malta
English: Germany sanofi-aventis Deutschland GmbH Industriepark Höchst, Geb.
Maltese: Il-Ġermanja sanofi-aventis Deutschland GmbH Industriepark Höchst, Geb. K 703, 65926
English: Alexander Stamboliiski Blvd.
Maltese: Alexander Stamboliiski Blvd. fl.8., Il-Bulgarija
English: Dunajska cesta 151 1000 Ljubljana Slovenia
Maltese: 1000 Ljubljana
English: Slovenia sanofi-aventis d.o.o.
Maltese: Is-Slovenja sanofi-aventis d.o.o. Dunajska cesta 151
English: Belgium sanofi-aventis Belgium Culliganlaan 1C
Maltese: Il-Belġju sanofi-aventis Belgium Culliganlaan 1C 1831 Diegem, Il-Belġju
English: 400 mg powder for injectable preparations
Maltese: 400 mg trab għal preparazzjonijiet injettabbli
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Maltese: Anness I Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, Id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq flIstati Membri
English: Deutschland
Maltese: Danimarka
English: Greece
Maltese: Is-Slovenja
English: Lek Polska Sp.z o.o.
Maltese: Lek Polska Sp.z o.o. ul.
English: EU/1/09/534/001 EU/1/09/534/002 EU/1/09/534/003 EU/1/09/534/004 EU/1/09/534/005 EU/1/09/534/006 EU/1/09/534/007
Maltese: EU/1/09/534/001 EU/1/09/534/002 EU/1/09/534/003 EU/1/09/534/004
English: Representative Office in Latvia Meza Str. 4
Maltese: Sandoz d.d. Representative Office in Latvia Meza Str. 4
English: V.J.Salomone Pharma Limited Marsa HMR 14
Maltese: V.J.Salomone Pharma Limited Marsa
English: Eesti filiaal, Pärnu mnt 105, EE-11312 Tallinn, Tel: +372 6652400
Maltese: Sandoz d.d. Eesti filiaal, Pärnu mnt 105, EE-11312 Tallinn, Tel: +372 6652400
English: H-1034 Budapest Tel.: +36 1 430 2890
Maltese: Budapest Tel.: +36 1 430 2890
English: Business Park Sofia, buil.
Maltese: Representative office Sandoz d.d. Business Park Sofia, buil.
English: INFORMATION IN BRAILLE Clopidogrel HEXAL 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Clopidogrel HEXAL 75 mg
English: Lek Pharmaceuticals d.d.
Maltese: Lek Pharmaceuticals d.d. Verovśkova 57
English: Do not take Clopidogrel HEXAL:
Maltese: Tiħux Clopidogrel HEXAL:
English: The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG).
Maltese: In-numru ta' pazjenti li għaddew mill-punt primarju ta' tmiem [mewt kardjovaskulari (CV), infart mijokardijaku (MI) jew puplesija] kien 582 (9.3 %) fil-grupp ikkurat bi clopidogrel u 719 (11.4 %) filgrupp ikkurat bil-plaċebo, li jissarraf fi tnaqqis fir-riskju relattiv ta' 20 % (95 % CI ta' 10 % - 28 %; p=0.00009) għall-grupp ikkurat bi clopidogrel (tnaqqis fir-riskju relattiv ta' 17 % f'pazjenti li kienu kkurati b'mod konservattiv, 29 % meta kellhom anġoplastija koronarja transluminali perkutanja (PTCA) bi stent jew mingħajru u 10 % meta kellhom trapjant ta' bajpass f'arterja koronarja (CABG).
English: Cellulose, microcrystalline (E460) Crospovidone type A
Maltese: Cellulose, microcrystalline (E460) Crospovidone type A Castor oil, idroġenat
English: Clopidogrel HEXAL contains the active ingredient Clopidogrel which belongs to a group of medicines called antiplatelet medicinal products.
Maltese: Clopidogrel HEXAL fih is-sustanza attiva fi Clopidogrel li jifforma parti minn grupp ta' mediċini msejħa prodotti mediċinali ta' antiplejtlets.
English: What Clopidogrel HEXAL contains The active substance is clopidogrel.
Maltese: Is-sustanza attiva hi clopidogrel.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/534/001 - 007
Maltese: EU/1/09/534/007
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Maltese: In-numri ta' pazjenti li kellhom il-punt ko-primarju ta' tmiem (mewt b'CV, MI, puplesija jew iskemija li mhux qed tirrisondi għall-kura) kien 1,035 (16.5 %) fil-grupp ikkurat bi clopidogrel u 1,187 (18.7 %) fil-grupp ikkurat bil-plaċebo, tnaqqis ta' 14 % fir-riskju relattiv) (95 % CI ta' 6 % - 21 %, p= 0.0005) għall-grupp ikkurat bi clopidogrel.
English: Patients received clopidogrel (75 mg/day, n = =22,961) or placebo (n==22,891), in combination with ASA (162 mg/day), for 28 days or until hospital discharge.
Maltese: Il-pazjenti ngħataw clopidogrel (75 mg/kuljum, n=22,961) jew il-plaċebo (n=22,891), flimkien ma' ASA (162 mg/kuljum), għal 28 jum jew sakemm ġew illiċenzjati mill-isptar.
English: Fifteen percent (15.0%) of patients in the clopidogrel group and 21.7% in the placebo group reached the primary endpoint, representing an absolute reduction of 6.7% and a 36% odds reduction in favour of clopidogrel (95% CI: 24, 47%; p< 0.001), mainly related to a reduction in occluded infarct-related arteries.
Maltese: Ħmistax fil-mija (15.0 %) tal-pazjenti fil-grupp tal-clopidogrel u 21.7 % tal-grupp bil-plaċebo laħqu lpunt primarju u aħħari, li jirrappreżentaw tnaqqis assolut ta' 6.7 % u 36 % ta' tnaqqis probabbli favur clopidogrel (95 % CI: 24, 47 %; p<0.001), relatat prinċipalment għal tnaqqis fis-sadd ta' l-arterji assoċjati ma' infart.
English: Adults and elderly
Maltese: • Adulti u anzjani
English: Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N = 6,259) or placebo (N = 6,303), both given in combination with ASA (75-325 mg once daily) and other standard therapies.
Maltese: Ilpazjenti kienu randomised għal clopidogrel (doża qawwija tal-bidu ta' 300 mg u wara 75 mg/jum, N = 6,259) jew il-plaċebo (N = 6,303), u t-tnejn ingħataw flimkien ma' ASA (75 - 325 mg darba kuljum) u terapiji oħrastandard.
English: Box 53158-3301 Limassol, Cyprus
Maltese: For P. T. Hadjigeorgiou co ltd Postal address: P.O. Box 53158-3301 Limassol, Cyprus
English: Published frequencies for the poorCYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
Maltese: Frekwenzi ppubblikati għall-ġenotipi ta' metabolizzaturi dgħajfa ta' CYP2C19 huma madwar 2% għall-Kawkasi, 4% għas-Suwed u 14% għaċ-Ċiniżi.
English: The benefits observed with clopidogrel were independent of other acute and long-term cardiovascular therapies (such as heparin/LMWH, GPIIb/IIIa antagonists, lipid lowering medicinal products, beta blockers, and ACE-inhibitors).
Maltese: Il-benefiċċji osservati bi clopidogrel kienu indipendenti minn terapiji kardjovaskulari oħra akuti u fittul (bħall-heparin/LMWH, antagonisti ta' GPIIb/IIIa, prodotti mediċinali li jbaxxu l-lipidi,
English: • Patients suffering from acute coronary syndrome: - 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).
Maltese: - Bis-segment mhux ST elevat (anġina instabbli jew infart mijokardijaku mhux-mewġa-Q), li jinkludu pazjenti fi proċess li titpoġġa stent wara intervent koronarju perkutaneju, flimkien ma' acetylsalicylic acid (ASA).
English: 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).
Maltese: Bis-segment mhux ST elevat (anġina instabbli jew infart mijokardijaku mhux-mewġa-Q): ilkura bi clopidogrel għandha tinbeda b'doża waħda qawwija tal-bidu ta' 300 mg u titkompla b'75 mg darba kuljum (b'acetylsalicylic acid (ASA) 75 mg-325 mg kuljum).
English: Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilmediċini: http://www.ema.europa.eu/
English: Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste.
Maltese: - Effetti sekondarji rari ħafna: suffejra; uġigħ addominali qawwi flimkien ma' jew mingħajr uġigħ fid-dahar; deni, diffikultajiet fin-nifs kultant assoċjati mas-sogħla; reazzjonijiet allerġiċi ġeneralizzati; nefħa fil-ħalq; infafet fil-ġilda; reazzjoni allerġika fil-ġilda; infjammazzjoni tal-ħalq (stomatite); tnaqqis fil-pressjoni tad-demm; konfużjoni; alluċinazzjonijiet; uġigħ fil-ġogi; uġigħ muskolari; tibdiliet fil-mod ta' kif jintegħmu l-affarijiet.
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel HEXAL (4 tablets of 75 mg) once at the start of treatment.
Maltese: Jekk kellek uġigħ sever f'sidrek (anġina instabbli jew attakk tal-qalb), it-tabib jista' jagħtik 300 mg ta' Clopidogrel HEXAL (4 pilloli ta' 75 mg) darba fil-bidu tal-kura.
English: D-83607 Holzkirchen Allemagne/Deutschland Tél/Tel: + 49 8024 908 0
Maltese: D-83607 Holzkirchen Allemagne/Deutschland
English: Children and adolescents Clopidogrel HEXAL is not intended for use in children or adolescents.
Maltese: Tfal u adolexxenti Clopidogrel HEXAL m'għandux jingħata lit-tfal jew lill-adolexxenti.
English: Clopidogrel HEXAL 75 mg film-coated tablets Clopidogrel
Maltese: Clopidogrel HEXAL 75 mg pilloli miksija b'rita Clopidogrel
English: signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Take special care with Clopidogrel HEXAL').
Maltese: Madanakollu, jekk id-demm li ħiereġ jinkwetak, għandek tkellem lit-tabib tiegħek minnufih (ara sezzjoni 2 'Oqgħod attent ħafna b'Clopidogrel HEXAL').
English: HEXAL S.p.A. c/o Sandoz S.p.A. Largo Umberto Boccioni 1 I-21040 Origgio / VA Tel: + 39-02-96 541
Maltese: Largo Umberto Boccioni 1 I-21040
English: Clopidogre HEXAL 75 mg film-coated tablets
Maltese: TAL-PRODOTT MEDIĊINALI Clopidogrel HEXAL 75 mg pilloli miksija b'rita
English: Other side effects reported with Clopidogrel HEXAL are: -Common side effects:
Maltese: Effetti oħra li ġew irrappurtati bi Clopidogrel HEXAL huma:
English: HOW TO TAKE CLOPIDOGREL HEXAL
Maltese: X'fih Clopidogrel HEXAL