FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents FOSAVANCE should not be given to children and adolescents less than 18 years of age.
Maltese: Tfal u adolexxenti FOSAVANCE ma għandux jingħata lil tfal u adolexxenti li għandhom anqas minn 18-il sena.
English: C]alendronate, approximately 50 % of the radioactivity was excreted in the urine within 72 hours and little or no radioactivity was recovered in the faeces.
Maltese: C]alendronate, madwar 50 % tar-radjuattività kienet eliminata fl-awrina fi żmien 72 siegħa u ftit li xejn radjuattività ma kienet rikoverata fl-ippurgar.
English: There is important additional information about how to take FOSAVANCE in the package leaflet.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għal skop kummerċjali.
English: Medicines for fits (seizures) (like phenytoin or phenobarbital) may decrease the effectiveness of vitamin D. Additional vitamin D supplements may be considered on an individual basis.
Maltese: Mediċini għall-aċċessjonijiet (attakki ta' puplesija) (bħal phenytoin jew phenobarbital) jistgħu jnaqqsu l-effettività ta' vitamina D. Supplimenti addizjonali tal-vitamina D jistgħu jiġu kunsidrati fuq bażi individwali.
English: After 15 weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher (26 %) in the FOSAVANCE (70 mg/2,800 IU) group (56 nmol/l [23 ng/ml]) than in the alendronate-only group (46 nmol/l [18.2 ng/ml]).
Maltese: Wara 15-il ġimgħa ta' trattament, il-livelli medji ta' 25hydroxyvitamin D fis-serum kienu sinifikattivament ogħla (26 %) fil-grupp FOSAVANCE (70 mg/2800 IU) (56 nmol/l [23 ng/ml]) milli fil-grupp ta' alendronate biss (46 nmol/l [18.2 ng/ml]).
English: FOSAVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min (see section 4.2).
Maltese: FOSAVANCE mhux rakkomandat għal pazjenti b'indeboliment renali meta t-tneħħija tal-kreatinina hija anqas minn 35ml/min (ara sezzjoni 4.2).
English: FOSAVANCE tablet whole with a full glass of water only (not mineral water) (not less than
Maltese: FOSAVANCE tiegħek sħiħa ma' tazza mimlija ilma (mhux ilma minerali) (mhux inqas minn
English: FOSAVANCE is a tablet containing the two active substances, alendronic acid (commonly called alendronate) and colecalciferol known as vitamin D3.
Maltese: FOSAVANCE huwa pillola li fiha ż-żewġ sustanzi attivi, alendronic acid (magħruf b'mod komuni bħala alendronate) u colecalciferol magħruf bħala vitamina
English: FRI
Maltese: Ġestjoni
English: Excipients
Maltese: Eżerċizzju
English: FOSAVANCE 70 mg/2,800 IU tablets are available as modified capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘710' on the other.
Maltese: FOSAVANCE 70 mg/2800 IU pilloli jiġu bħala pilloli modifikati f'għamla ta' kapsuli, ta' lewn bajdani jew bojod jagħtu fil-griż immarkati b' kontorn ta' immaġni ta' għadma fuq naħa u '710' fuq in-naħa loħra.
English: Batch
Maltese: SIB
English: FOSAVANCE 70 mg/5,600 IU tablets alendronic acid /colecalciferol
Maltese: FOSAVANCE 70 mg/5600 IU pilloli alendronic acid /colecalciferol
English: What is FOSAVANCE?
Maltese: X'inhu FOSAVANCE?
English: Results are insufficient to support the use of alendronate sodium in paediatric patients with osteogenesis imperfecta.
Maltese: Ir-riżultati mhumiex biżżejjed biex jappoġġjaw l-użu ta' alendronate sodium f'pazjenti pedjatriċi b'osteogenesis imperfecta.
English: Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3.
Maltese: 70 mg alendronic acid (bħala sodium trihydrate) u 140 mikrogramma (5600
English: The mean half-life of vitamin D3 in the serum following an oral dose of FOSAVANCE (70 mg/2,800 IU) is approximately 24 hours.
Maltese: Il-half-life medja ta' vitamina D3 fis-serum wara doża orali ta' FOSAVANCE (70 mg/2800
English: How to store FOSAVANCE
Maltese: Studji dwar FOSAVANCE
English: Each FOSAVANCE 70 mg/5,600 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3).
Maltese: Kull pillola fiha 70 mg alendronic acid bħala (sodium trihydrate), u 140 mikrogramma (5600
English: In healthy adult subjects (males and females), following administration of FOSAVANCE 70 mg/5,600 IU after an overnight fast and two hours before a meal, the mean area under the serumconcentration-time curve (AUC0-80 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 490.2 ng•hr/ml.
Maltese: Wara l-għoti ta' FOSAVANCE 70 mg/5600 IU pilloli f'suġġetti adulti b'saħħithom (irġiel u nisa) wara sawma tul il-lejl u sagħtejn qabel ikla, l-erja medja taħt il-kurva tal-konċentrazzjoni tas-serum mal-ħin (AUC0-80 hrs) għal vitamina D3 (mhux aġġustata għal-livelli ta' vitamina D3 endoġena) kienet ta' 490.2 ng•hr/ml.
English: FOSAVANCE 70 mg/2,800 IU tablets alendronic acid /colecalciferol
Maltese: FOSAVANCE 70 mg/2800 UI pilloli alendronic acid/colecalciferol
English: It is unknown whether alendronate/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk alendronate/metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: Belgique/België/Belgien MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Maltese: +32(0)27766211 dpoc_belux@merck.com
English: FOSAVANCE 70 mg/2,800 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets.
Maltese: FOSAVANCE ta' 70 mg/2800 IU pilloli jiġu f'pakketti li fihom 2, 4, 6, jew 12-il pillola.
English: FOSAVANCE 70 mg/2,800 IU tablets alendronic acid/colecalciferol
Maltese: FOSAVANCE 70 mg/2800 IU pilloli alendronic acid /colecalciferol
English: †, peripheral oedema Uncommon transient symptoms as in an acute-phase response (myalgia, malaise and rarely, fever), typically in association with initiation of treatment
Maltese: Mhux Komuni sintomi temporanji bħal f'rispons ta' fażi akuta (uġigħ fil-muskoli, telqa u f'każijiet rari, deni), tipikament marbuta mal-bidu tal-kura
English: • heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing.
Maltese: • ħruq ta' stonku; diffikultà biex tibla'; uġigħ malli tibla'; ulċerazzjoni fil-griżmejn (esofagu - it tubu li jgħaqqad lil ħalqek mal-istonku) li tista' twassal għal uġigħ fis-sider, ħruq ta' stonku jew diffikultà jew uġigħ malli tibla'.
English: Each FOSAVANCE 70 mg/2,800 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) colecalciferol (vitamin D3).
Maltese: Kull pillola fiha 70 mg alendronic acid bħala (sodium trihydrate), u 70 mikrogramma (2800
English: In healthy adult subjects (males and females), following administration of FOSAVANCE 70 mg/2,800 IU tablets after an overnight fast and two hours before a meal, the mean area under the serum-concentration-time curve (AUC0-120 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 296.4 ng•hr/ml.
Maltese: Wara l-għoti ta' FOSAVANCE 70 mg/2800 IU pilloli f'suġġetti adulti b'saħħithom (irġiel u nisa) wara sawma tul il-lejl u sagħtejn qabel ikla, l-erja medja taħt il-kurva tal-konċentrazzjoni tas-serum mal-ħin (AUC0-120 hrs) għal vitamina D3 (mhux aġġustata għal-livelli ta' vitamina D3 endoġena) kienet ta' 296.4 ng•hr/ml.
English: FOSAVANCE contains lactose and sucrose.
Maltese: FOSAVANCE fih il-lactose u s-sucrose
English: Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172) Talc
Maltese: Polyvinyl alcohol Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172) Talc
English: The active substance is clopidogrel.
Maltese: -Is-sustanza attiva hi clopidogrel.
English: Cellulose, microcrystalline Colloidal anhydrous silica Crospovidone (type A) Macrogol 6000
Maltese: Colloidal anhydrous silica Crospovidone (tip A) Macrogol 6000
English: Very rare, not known*
Maltese: Rari ħafna, mhux magħruf*
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Maltese: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, il-Ġermanja
English: Macrogol 3000 (Polyethyleneglycol)
Maltese: Macrogol 3000
English: - Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil (see section 2 ‘Clopidogrel Dura contains hydrogenated castor oil') - Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000.
Maltese: -L-ingredjenti l-oħra huma: - Qalba tal-pillola microcrystalline cellulose, colloidal anhydrous silica, crospovidone (tip A), macrogol 6000, żejt ir-riġnu idroġenat (ara sezzjoni 2 ‘Clopidogrel Dura fih castor oil idroġenat') - Rita tal-pillola: polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000.
English: Other medicines and Clopidogrel Dura
Maltese: Mediċini oħra u Clopidogrel Dura
English: NAME OF THE MARKETING AUTHORISATION HOLDER Mylan dura GmbH
Maltese: FIS-SUQ Mylan dura GmbH
English: Blister of OPA/Al/PVC-Al containing 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in the box.
Maltese: Folji ta' OPA/AL/PVC-Al li fihom 7, 14, 28, 30, 50, 56, 84, 90 u 100 pillola miksija b'rita fil-kaxxa.
English: 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).
Maltese: Il-frekwenza tagħhom hi definita skont dawn il-konvenzjonijiet: komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia
Maltese: Purpura tromboċitopenikatrombotika (thrombotic thrombocytopenic purpura (TTP)) (ara sezzjoni 4.4), anemija aplastika, panċitopenija, agranuloċitosi, tromboċitopenija severa, emofilija A akkwiżita, granuloċitopenija, anemija
English: Clopidogrel is indicated in:
Maltese: Clopidogrel hu indikat f':
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, drug induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous, urticaria, eczema, lichen planus
Maltese: Dermatite bl-infafet (nekrolisi tossika talepidermide, Sindromu ta' Stevens Johnson, eritema multiforme), anġjoedema, sindromu ta' sensittività eċċessiva kkawżat millmediċina, raxx kkawżat mill-mediċina b'eosinofilja u sintomi sistemiċi (DRESS), raxx eritematsi, urtikarja, ekżema, lichen planus
English: The CAPRIE study included 19,185 patients with atherothrombosis as manifested by recent myocardial infarction (<35 days), recent ischaemic stroke (between 7 days and 6 months) or established peripheral arterial disease (PAD).
Maltese: L-istudju CAPRIE kien jinkludi 19,185 pazjent b'aterotrombosi li ntweriet permezz ta' infart mijokardjali riċenti (<35 jum), puplesija iskemika riċenti (bejn 7 ijiem u 6 xhur) jew mard stabbilit talarterji periferali (peripheral arterial disease (PAD)).
English: Prevention of atherothrombotic events
Maltese: Il-prevenzjoni ta' avvenimenti aterotrombotiċi
English: Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis, eosinophilic pneumonia
Maltese: Emorraġija fil-passaġġ respiratorju (emoptassi, emorraġija pulmonari), bronkospażmu, pnewmonite interstizjali, pnewmonja eosinofilika
English: Rare side effect (may affect up to 1 in 1000 people): Vertigo.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1000 persuna): Vertiġini.
English: • Renal impairment
Maltese: • Indeboliment renali.
English: Mylan dura GmbH, Wittichstraße 6, D-64295 Darmstadt, Germany
Maltese: GmbH, Wittichstraße 6, D-64295 Darmstadt, il-Ġermanja
English: • Paediatric population
Maltese: • Popolazzjoni pedjatrika.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.>
English: System Organ Class
Maltese: tal-Klassifika
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC code: B01AC04.
Maltese: Aġenti antitrombotiċi, inibituri tal-aggregazzjoni tal-plejtlets li jeskludu heparin, Kodiċi ATC:
English: Serum sickness, anaphylactoid reactions, cross reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*
Maltese: Mard minn seru barrani, reazzjonijiet anafilattojdi, reazzjoni ta' sensittività eċċessiva li hija komuni għat-tipi differenti ta' thienopyridines (bħal ticlopidine, prasugrel) (ara sezzjoni 4.4)*
English: Detailed information 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: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 September 2009
Maltese: Data ta' l-ewwel awtorizzazzjoni: 21 ta' Settembru 2009
English: Musculoskeletal, connective tissue and bone disorders
Maltese: Disturbi muskoluskeletriku, tessut konnettiv u fl-għadam
English: Therapeutic experience is limited in patients with renal impairment (see section 4.4).
Maltese: L-esperjenza terapewtika hija limitata f'pazjenti b'indeboliment renali (ara sezzjoni 4.4).
English: Tel: +33 4 37 25 75 00
Maltese: Mylan SAS Tel: +33 4 37 25 75 00
English: Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Maltese: Wara doża orali ta' clopidogrel 14C-tikkettat fil-bniedem, bejn wieħed u ieħor 50% kien mneħħi flurina u bejn wieħed u ieħor 46% ħareġ fl-ippurgar fl-intervall ta' 120 siegħa wara d-dożaġġ.
English: Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste of food.
Maltese: Suffejra, uġigħ addominali severi bi jew mingħajr uġigħ fid-dahar; deni, diffikultajiet biex tieħu n-nifs assoċjati ma' tħarħir; reazzjonijiet allerġiċi ġeneralizzati (pereżempju, sensazzjoni ta' sħana ma' ġismek kollu b'skonfort ġenerali f'daqqa sakemm tħossok ħażin), nefħa fil-ħalq, nfafet fuq il-ġilda; allerġiji fuq il-ġilda; uġigħ fil-ħalq (stomatite) tnaqqis fil-pressjoni tad-demm; konfużjoni; alluċinazzjonijiet; uġigħ tal-għadam; uġigħ muskolari, tibdiliet fil-mod fit-togħma tal-ikel.
English: While you are taking Clopidogrel dura:
Maltese: X'fih Clopidogrel dura:
English: At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and
Maltese: Fi stat fiss, il-livell medju ta' inibizzjoni osservat b'doża ta' 75 mg kuljum kien bejn 40 % u 60 %.
English: The elimination half life of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Maltese: Il-half-life tat-tneħħija tal-metabolit prinċipali (inattiv) ċirkolanti kien 8 sigħat wara amministrazzjoni waħda u ripetuta.
English: After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min) inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Maltese: Wara dożi ripetuti ta' 75 mg ta' clopidogrel kuljum, f'persuni b'mard sever tal-kliewi (tneħħija talkreatinina minn 5 sa 15 ml/min), l-inibizzjoni ta' l-agreggrazzjoni tal-plejtlets indotti minn ADP kien iktar baxx (25%) minn dak osservat f'persuni f'saħħithom, madankollu it-titwil fil-ħin tad-dmija kien simili għal dak osservat f'persuni f'saħħithom li kienu qed jingħataw 75 mg ta' clopidogrel kuljum.Barra minn hekk, it-tolleranza klinika kienet tajba fil-pazjenti kollha.
English: What Clopidogrel dura contains
Maltese: Tieħux Clopidogrel dura:
English: In CURE, CLARITY and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
Maltese: Fi CURE, CLARITY, ACTIVE-A u wieħed mill-istudji ko-orti (Trenk), ma ġiet osservata l-ebda żieda fir-rata ta' avvenimenti bbażata fuq l-istatus tal-metaboliżżatur.
English: The dose of 0.2 mg/kg achieved the mean percent inhibition of 49.3% (5 µM ADP-induced platelet aggregation) which was comparable to that of adults taking Clopidogrel 75 mg/day.
Maltese: 3% (5 µM ta' aggregazzjoni tal-plejtlits ikkaġunat millADP) li huwa simili għal dak ta' adulti li jieħdu 75 mg/ġurnata ta' clopidogrel.
English: Clopidogrel dura 75 mg film-coated tablets clopidogrel
Maltese: Clopidogrel dura 75 mg pilloli miksija b'rita Clopidogrel
English: NSAIDs: in a clinical study conducted in healthy volunteers, the concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss.
Maltese: NSAIDs: fi studju kliniku li sar fuq voluntiera f'saħħithom l-għoti ta' clopidogrel u naproxen flimkien żid l-emorraġija moħbija gastrointestinali.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel dura 75 mg film-coated tablets
Maltese: TAL-PRODOTT MEDIĊINALI Clopidogrel dura 75 mg pilloli miksija b'rita
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel dura 75 mg film-coated tablets clopidogrel
Maltese: TAL-PRODOTT MEDIĊINALI Clopidogrel dura 75 mg pilloli miksija b'rita clopidogrel
English: Clopidogrel dura contains hydrogenated castor oil This may cause stomach upset and diarrhoea.
Maltese: Clopidogrel dura fih castor oil idroġenat Dan jista' tikkawża tqalligħ fl-istonku u dijarea.
English: Film coating:
Maltese: Farmakoġenetika:
English: • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
Maltese: • Għandek tgħarraf lit-tabib tiegħek minnufih jekk tiżviluppa kundizzjoni medika (magħrufa wkoll bħala Purpura Trombotika Tromboċitopenika jew TTP) li tinkludi deni u tbenġil taħt ilġilda li jidher bħala dbabar żgħar ħomor, b'għeja sfinita spjegabbli jew mhix spjegabbli, konfużjoni, sfurija tal-ġilda jew l-għajnejn (suffejra) (ara sezzjoni 4 ‘Effetti sekondarji
English: Very rare side effects (may affect up to 1 in 10,000 people):
Maltese: (Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna):
English: 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).
Maltese: Minħabba r-riskju ta' emorraġiji u effetti ematoloġiċi mhux mixtieqa, l-għadd ta' ċelluli tad-demm u/jew kull ittestjar ieħor xieraq għandhom jiġu kkonsidrati kull meta waqt it-trattament ikun hemm sintomi kliniċi li jindikaw emorraġiji (ara sezzjoni 4.8).
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' sustanzi mhux attivi
English: - Keep this leaflet.
Maltese: L-ebda ħtiġijiet speċjali.
English: There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).
Maltese: Ma kienx hemm evidenza ta' riskju ta' kanċer meta clopidogrel ingħata għal 78 ġimgħa lil ġrieden u 104 ġimgħa lil firien meta ngħataw dożi sa 77 mg/kg kuljum (li jirrapreżenta tal-anqas 25 darba lespożizzjoni osservata fil-bniedem li kienu qed jingħataw doża klinika ta' 75 mg/kuljum).
English: Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Maltese: Uġigħ ta' ras, ulċeri fl-istonku, remettar, tqalligħ, stitikezza, ħafna gass fl-istonku jew l-imsaren, raxxijiet, ħakk, sturdament, sensazzjoni ta' tnemnim u tirżiħ .
English: Clopidogrel dura is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Maltese: Clopidogrel dura jittieħed mill-adulti sabiex jevita li jiġu ffurmati emboli tad-demm (trombi) b'vażi tad-demm li qed jibbiesu (arterji), proċess magħruf bħala aterosklerosi, li jista' jwassal għal każijiet arterotrombotiċi (bħal puplesija, attakk tal-qalb, jew mewt).
English: This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Maltese: Dan kien konsistenti fil-firxa ta' sottogruppi ta' pazjenti miġbura skont linja bażi ta' karatteristiċi u ttip ta' terapija fibrinolitika jew bil-heparin.
English: Clopidogrel dura contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Maltese: Id-Dehra ta' Clopidogrel dura u l-kontenuti tal-pakkett:
English: 4.2 Posology and method of administration Posology
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Str. Ştefan Mihăileanu nr. 31 Sector 2, Bucureşti
Maltese: Ştefan Mihăileanu nr. 31 Sector 2, Bucureşti
English: Collado mediano, s/n 28230 Las Rozas Madrid
Maltese: Collado mediano, s/n 28230
English: Janssen-Cilag AS Postboks 144
Maltese: In-Norveġja Janssen-Cilag AS Postboks 144
English: 1325 Lysaker Norway
Maltese: 1325 Lysaker
English: Karla Engliše 3201/6
Maltese: Karla Engliše 3201/6 15000 Praha 5
English: Luxembourg Janssen Cilag NV 15-17 Antwerpseweg B-2340 Beerse
Maltese: Il-Lussemburgu Janssen Cilag NV 15-17 Antwerpseweg B-2340 Beerse
English: Coup ABEE Agias Barbaras 53-55 Dafni 15235
Maltese: Coup ABEE Agias Barbaras 53-55
English: 1-10 Constantinoupoleos street 3505 Lemesos
Maltese: Medochemie ltd 1-10 Constantinoupoleos street 3505 Lemesos
English: Arena Group S.A.
Maltese: Arena Group S.A. Str.
English: S.C. Magistra C&C Str. Aurel Vlaicu nr. 82A 8700 Constanţa România
Maltese: Aurel Vlaicu nr. 82A 8700 Constanţa
English: Slovak Republic Johnson & Johnson s.r.o.
Maltese: KETOSTIN 200 mg ls-Slovakkja Johnson & Johnson s.r.o.
English: Str. Dr. Victor Babeş nr. 50 Baia Mare
Maltese: Victor Babeş nr. 50
English: A.C. Helcor s.r.l.
Maltese: Ir-Rumanija A.C. Helcor s.r.l.
English: Belgium Janssen-Cilag NV Antwerpseweg 15-17
Maltese: Janssen-Cilag NV Antwerpseweg 15-17 2340
English: 5026 RH TILBURG
Maltese: Dr. Paul Janssenweg 150 5026 RH TILBURG The Netherlands
English: United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe
Maltese: Holmers Farm Way High Wycombe
English: Terapia SA Str. Fabricii nr. 124 Cluj-Napoca Romania
Maltese: Fabricii nr. 124