FrancophonIA/ELRC3.0 huggingface dataset:
English: Invokana 100 mg film-coated tablets Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin.
Maltese: Invokana 100 mg pilloli miksijin b'rita Kull pillola fiha canagliflozin hemihydrate, ekwivalenti għal 100 mg canagliflozin.
English: Overall, 0.7% of all female patients discontinued canagliflozin due to vulvovaginal candidiasis (see section 4.4).
Maltese: B'kollox, 0.7% talpazjenti nisa kollha waqqfu canagliflozin minħabba kandidjasi vulvovaġinali (ara sezzjoni 4.4).
English: 9.3% versus 1.3%; non-HDL-cholesterol 2.2% and 4.4% versus 0.7%; triglycerides 2.4% and 0.0% versus 7.6%.
Maltese: 3% versus 4.0%; kolesterol LDL 5.7% u 9.3% versus 1.3%; kolesterol mhux HDL 2.2% u 4.4% versus 0.7%; trigliċeridi 2.4% u 0.0% versus 7.6%. j Bidliet medji mil-linja bażi fl-ematokrit kienu 2.4% u 2.5% għal canagliflozin 100 mg u 300 mg, rispettivament, meta mqabbla ma' 0.0% għal plaċebo.
English: Placebo (N = 192)
Maltese: (N = 192)
English: h Balanitis or balanoposthitis includes the terms balanitis, balanoposthitis, balanitis candida, and genital infection fungal.
Maltese: h Balanite jew balanopostite jinkludu t-termini balanite, balanopostite, balanite candida, u infezzjoni ġenitali bil-fungu.
English: Renal impairment For patients with an eGFR 60 mL/min/1.73 m2 to < 90 mL/min/1.73 m2 or CrCl 60 mL/min to
Maltese: Għal pazjenti b'eGFR minn 60 mL/min/1.73 m2 sa < 90 mL/min/1.73 m2 jew CrCl minn 60 mL/min sa
English: A substudy of patients with baseline HbA1c > 10% to ≤ 12% with canagliflozin as monotherapy resulted in reductions from baseline in HbA1c (not placebo-adjusted) of -2.13% and -2.56% for canagliflozin 100 mg and 300 mg, respectively.
Maltese: Pazjenti b'HbA1c > 10% sa ≤ 12% fil-linja bażi Sottostudju ta' pazjenti b'HbA1c > 10% sa ≤ 12% fil-linja bażi, b'canagliflozin bħala monoterapija,
English: Add-on therapy with insulind (18 weeks) Canagliflozin + insulin
Maltese: Canagliflozin + insulina
English: Adverse reactions in table 1 are based on the pooled analysis of the four 26-week placebo-controlled studies (n = 2,313) described above.
Maltese: 26 ġimgħa kkontrollati bil-plaċebo (n = 2,313) deskritti fuq.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, biddefiċjenza ta' Lapp lactase, jew b'assorbiment ħażin tal-glukows-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Patients (%) achieving HbA1c < 7% 19.8
Maltese: Pazjenti (%) li kisbu HbA1c < 7% 19.
English: Invokana 100 mg film-coated tablets EU/1/13/884/001 (10 tablets)
Maltese: Invokana 100 mg pilloli miksijin b'rita EU/1/13/884/001 (10 pilloli) EU/1/13/884/002 (30 pillola) EU/1/13/884/003 (90 pillola) EU/1/13/884/004
English: Invokana 300 mg film-coated tablets EU/1/13/884/005 (10 tablets)
Maltese: Invokana 300 mg pilloli miksijin b'rita EU/1/13/884/005 (10 pilloli) EU/1/13/884/006 (30 pillola) EU/1/13/884/007 (90 pillola) EU/1/13/884/008 (100 pillola)
English: When canagliflozin was added to insulin therapy, hypoglycaemia was observed in 49.3%, 48.2%, and 36.8% of patients treated with canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively, and severe hypoglycaemia occurred in 1.8%, 2.7%, and 2.5% of patients treated with canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively.
Maltese: 100 mg, canagliflozin 300 mg, u bi plaċebo, rispettivament, u ipogliċemija qawwija seħħet f'1.8%, 2.7%, u 2.5% tal-pazjenti kkurati b'canagliflozin 100 mg, canagliflozin 300 mg, u bi plaċebo, rispettivament.
English: Compared to healthy subjects, plasma AUC of canagliflozin was increased by approximately 17%, 63%, and 50% in subjects with mild, moderate, and severe renal impairment, respectively, but was similar for ESRD subjects and healthy subjects.
Maltese: Meta mqabbla ma' individwi f'saħħithom, l-AUC ta' canagliflozin fil-plażma żdied b'madwar 17%, 63%, u 50% f'individwi b'indeboliment ħafif, moderat u qawwi tal-kliewi,
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin.
Maltese: Kull pillola miksija b'rita fiha canagliflozin hemihydrate, ekwivalenti għal 100 mg canagliflozin.
English: Change from baseline (adjusted mean) Difference from sitagliptin (adjusted mean) (95% CI)
Maltese: Differenza minn sitagliptin (medja aġġustata) (95% CI)
English: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Maltese: g Kandidjasi vulvovaġinali tinkludi t-termini terms kandidjasi vulvovaġinali, infezzjoni vulvovaġinali mikotika, vulvovaġinite, infezzjoni fil-vaġina, vulvite, u infezzjoni ġenitali bil-fungu.
English: Therefore, the canagliflozin dose should be limited to 100 mg once daily in patients with eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min and canagliflozin should not be used in patients with an eGFR < 45 mL/min/1.73 m2 or CrCl < 45 mL/min (see section 4.2).
Maltese: Għalhekk, id-doża ta' canagliflozin għandha tkun limitata għal 100 mg darba kuljum f'pazjenti b'eGFR < 60 mL/min/1.73 m jew CrCl < 60 mL/min u canagliflozin m'għandux jintuża f'pazjenti b'eGFR < 45 mL/min/1.73 m2 jew CrCl < 45 mL/min (ara sezzjoni 4.2). Canagliflozin ma ġiex studjat f'indeboliment qawwi tal-kliewi (eGFR < 30 mL/min/1.73 m2 jew CrCl < 30 mL/min) jew ESRD.
English: In the dedicated cardiovascular study, where patients were generally older with a higher rate of diabetes complications, the incidences of adverse reactions related to volume depletion were 2.8% with canagliflozin 100 mg, 4.6% with canagliflozin 300 mg, and 1.9% with placebo.
Maltese: Fl-istudju kardjovaskulari assenjat, fejn il-pazjenti kienu ġeneralment ikbar fl-età b'rata ogħla ta' kumplikazzjonijiet tad-dijabete, l-inċidenzi ta' reazzjonijiet avversi marbuta ma' tnaqqis fil-volum kienu 2.8% b'canagliflozin 100 mg, 4.6% b'canagliflozin 300 mg, u 1.9% bi plaċebo.
English: Moderate increases (generally < 400 mL to 500 mL) in daily urine volume were seen that attenuated over several days of dosing.
Maltese: Dehru żidiet moderati (ġeneralment < 400 mL sa 500 mL) fil volum ta' kuljum tal-awrina li naqsu fuq perjodu ta' diversi jiem ta' għoti tad-dożi.
English: compared to 1.5% for placebo.
Maltese: 300 mg, meta mqabbla ma' 1.5% għal plaċebo.
English: • nausea
Maltese: • St.
English: EU/1/13/884/004 (100 tablets)
Maltese: EU/1/13/884/001 (100 mg - 10 pilloli) EU/1/13/884/002 (100 mg - 30 pillola) EU/1/13/884/003 (100 mg - 90 pillola) EU/1/13/884/004
English: - Prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter - For renal function approaching moderate renal impairment, at least 2 times to 4 times per year.
Maltese: - Qabel jinbdew prodotti mediċinali li se jittieħdu flimkien miegħu li jistgħu jnaqqsu l-funzjoni tal-kliewi u kull tant żmien minn hemm 'il quddiem - Għal funzjoni tal-kliewi li toqrob lejn indeboliment moderat tal-kliewi, mill-inqas darbtejn sa 4 darbiet fis-sena.
English: In a 12-week clinical study, unstimulated LH did not increase in male patients treated with canagliflozin.
Maltese: Fi studju kliniku ta'12-il ġimgħa LH mhux stimulat ma żdiedx f'pazjenti rġiel ikkurati b'canagliflozin.
English: The mean steady-state volume of distribution of canagliflozin following a single intravenous infusion in healthy subjects was 83.5 litres, suggesting extensive tissue distribution.
Maltese: Distribuzzjoni Il-medja tal-volum ta' distribuzzjoni ta' canagliflozin fl-istat fiss wara infużjoni waħda fil-vina f'individwi f'saħħithom kienet 83.5 litru, li tissuġġerixxi distribuzzjoni estensiva fit-tessuti.
English: m Mean percent changes from baseline in blood potassium were 0.5% and 1.0% for canagliflozin 100 mg and 300 mg,
Maltese: m Bidliet perċentwali medji mil-linja bażi fil-potassium fid-demm kienu 0.5% u 1.0% għal canagliflozin 100 mg u
English: Polyvinyl chloride/Aluminum (PVC/Alu) perforated unit dose blister.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Folja ta' Polyvinyl chloride/Aluminum (PVC/Alu) b'linja toqob biex id-dożi jinqatgħu waħda waħda.
English: respectively, compared to 0.6% for placebo.
Maltese: 300 mg, rispettivament, meta mqabbla ma' 0.6% għal plaċebo.
English: Canagliflozin increased the incidence of testicular Leydig cell tumours in male rats at all doses tested (10, 30, and 100 mg/kg); the lowest dose of 10 mg/kg is approximately 1.5 times the clinical dose of 300 mg based on AUC exposure.
Maltese: 300 mg abbażi ta' esponiment bl-AUC. Canagliflozin żied l-inċidenza ta' tumuri taċ-ċellula ta' Leydig tat-testikoli f'firien irġiel bid-dożi kollha ttestjati (10, 30, u 100 mg/kg); l-aktar doża baxxa ta'
English: Content Pack size
Maltese: Il-pakkett li jmiss malprodott
English: Strength Pharmaceutical Form
Maltese: Numru tal-MA (EU) Isem ivvintat Qawwa Għamla farmaċewtika
English: Other information about Coxevac:
Maltese: Informazzjoni oħra dwar Coxevac:
English: In cattle it is very common to see a swelling of maximum diameter of 9 to 10 cm at the injection site, which may last for 17 days.
Maltese: Fil-bhejjem tal-ifrat, huwa komuni ħafna li tidher nefħa ta' dijametru massimu ta' 9 sa 10 cm fis-sit talinjezzjoni, li tista' ddum sa 17-il ġurnata.
English: Coxevac is a veterinary vaccine that contains inactivated (killed) Coxiella burnetii bacteria.
Maltese: Coxevac huwa vaċċin veterinarju li fih il-batterji inattivati (maqtula) ta' Coxiella burnetii bacteria.
English: In 2014 the CVMP considered that the submitted data were adequate for the authorisation of Coxevac to convert to a normal status.
Maltese: Fl-2014 is-CVMP qies li d-dejta mressqa kienet adegwata sabiex l-awtorizzazzjoni ta' Coxevac tinbidel għal status normali.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Coxevac on 30 September 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal Coxevac fit-30 ta' Settembru 2010.
English: This summary was last updated in November 2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Novembru 2014.
English: In goats it is very common to see a palpable reaction of 3 to 4 cm diameter at the injection site which may last for 6 days.
Maltese: Fil-mogħoż huwa komuni ħafna li tara reazzjoni palpabbli ta' dijametru ta' 3 sa 4 cm fis-sit talinjezzjoni li tista' ddum sa 6 ijiem.
English: What is Coxevac?
Maltese: X'inhu Coxevac?
English: Coxevac is a bacterial vaccine.
Maltese: Coxevac huwa vaċċin batteriku.
English: Inactivated Coxiella burnetii vaccine
Maltese: Vaċċin inattivat ta' Coxiella burnetii
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Ilbilanċ bejn il-benefiċċju u r-riskju jista' jinstab fil-modulu ta' diskussjoni xjentifika ta' dan l-EPAR.
English: Why has Coxevac been approved?
Maltese: Għaliex ġie approvat Coxevac?
English: In goats it is also very common to observe a slight increase of rectal temperature for 4 days post-vaccination without other general signs.
Maltese: Fil-mogħoż huwa wkoll komuni ħafna li tkun osservata żieda fit-temperatura rektali għal 4 ijiem wara t-tilqima mingħajr sinjali ġenerali oħrajn.
English: Coxevac is used in cattle to lower the risk of spreading Coxiella burnetii infection and in goats to reduce abortions caused by the infection as well as reduce spreading the infection.
Maltese: Coxevac jintuża fi frat biex jitnaqqas ir-riskju li tinfirex l-infezzjoni ta' Coxiella burnetii u fil-mogħoż biex jitnaqqas ir-riskju ta' abort ikkawżat mill-infezzjoni kif ukoll titnaqqas il-firxa tal-infezzjoni.
English: The studies conducted in cattle and goats showed that Coxevac reduces bacteria shedding (which is a major factor in spreading the disease) in vaginal discharge and milk, whilst in goats Coxevac reduced bacteria shedding in faeces and the placenta as well.
Maltese: L-istudji tal-effikaċja imwettqa fil-bhejjem tal-ifrat u l-mogħoż urew li Coxevac inaqqas ix-xħit talbatterji (li huwa fattur prinċipali fit-tixrid tal-marda) fit-tnixxijiet vaġinali u fil-ħalib, filwaqt li filmogħoż Coxevac naqqas ix-xħit tal-batterji fil-feċje kif ukoll fil-plaċenta.
English: What is the risk associated with Coxevac?
Maltese: X'inhu r-riskju assoċjat ma' Coxevac?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: Id-dewmien tal-protezzjoni kienet stabbilita għal 280 jum fil-bhejjem tal-ifrat u sena fil-mogħoż.
English: In cattle and goats Q-fever can cause abortions, still births and pneumonia.
Maltese: Fil-bhejjem tal-ifrat u l-mogħoż, id-deni-Q jista' jikkawża l-aborti, twelid mejta u l-pulmonite.
English: This is of particular importance because Coxiella burnetii can lead to a disease in humans called Qfever and decreasing the disease in animals will decrease the likelihood of transmitting the disease to humans.
Maltese: Dan huwa ta' importanza partikolari peress li Coxiella burnetii jista' jwassal għal mard fil-bnedmin imsejħa deni-Q u tnaqqis fil-mard tal-annimali inaqqas il-possibiltà tat-trażmissjoni tal-marda filbnedmin.
English: The effectiveness of Coxevac was investigated in both laboratory and field studies.
Maltese: L-effikaċja ta' Coxevac kienet investigata fi studji kemm fil-laboratorju kif ukoll fuq il-post.
English: How has Coxevac been studied?
Maltese: Kif ġie studjat Coxevac?
English: In the future, if the animals are exposed to Coxiella burnetii bacteria, the immune system will be able to respond more quickly.
Maltese: Kemm-il darba fil-ġejjieni l-annimali jkunu esposti għallbatterju tal-Coxiella burnetii, is-sistema immunitarja tkun kapaċi tirreaġixxi aktar malajr.
English: This will help to protect against the disease.
Maltese: Ir-reazzjoni tonqos u tgħib mingħajr il-ħtieġa ta' kura.
English: When Coxevac is given to cattle and goats, their immune system recognises the bacteria contained in the vaccine as ‘foreign' and makes antibodies to defend against them.
Maltese: Meta Coxevac jingħata lill-bhejjem tal-ifrat u lmogħoż, is-sistema immunitarja tagħraf il-batterji li jkunu jinsabu fil-vaċċin bħala 'barranin' u tipproduċi antikorpi biex tiddefendi kontrihom.
English: 448 (4 x 112) capsules
Maltese: 448 (4 x 112) kapsula
English: Capsule, hard bottle (HDPE)
Maltese: Flixkun (HDPE)
English: MA (EU) number (Invented) name
Maltese: Numru tal-proċedura tal-EMA
English: 1 Regulation (EC) No 1394/2007
Maltese: 1 Ir-Regolament (KE) Nru 1394/2007
English: Hyalograft C autograft has been used in the following EU countries: Austria, Bulgaria, Czech Republic, Germany, Greece, Hungary, Italy, Lithuania, Poland and Romania, before the introduction of the EU
Maltese: Hyalograft C autograft intuża fil-pajjiżi tal-UE li ġejjin: l-Awstrija, il-Bulgarija, ir-Repubblika Ċeka, ilĠermanja, il-Greċja, l-Ungerija, l-Italja, il-Litwanja, il-Polonja u r-Rumanija, qabel l-introduzzjoni tarregolament tal-UE dwar prodotti mediċinali ta' terapija avvanzata fl-2009.1 Skont ir-regolament, itterapiji avvanzati li diġà huma disponibbli fl-UE għandhom jiġu evalwati mill-EMA biex jiksbu awtorizzazzjoni għat-tqegħid fis-suq fl-UE kollha.
English: What is Hyalograft C autograft?
Maltese: X'inhu Hyalograft C autograft?
English: How does Hyalograft C autograft work?
Maltese: Kif jaħdem Hyalograft C autograft work?
English: The main data submitted by the company came from two published studies involving 126 patients with femoral cartilage defects, which compared Hyalograft C autograft with a surgical technique known as microfracture repair.
Maltese: Id-dejta ewlenija ppreżentata mill-kumpanija ġiet minn żewġ studji ppubblikati li saru fuq 126 pazjent b'difetti fil-qarquċa tal-wirk, li qabblu lil Hyalograft C autograft ma' teknika kirurġika magħrufa bħala tiswija ta' mikrofrattura.
English: Hyalograft C autograft is a type of advanced therapy product called a ‘tissue engineered product'.
Maltese: Hyalograft C autograft huwa ‘prodott tat-terapija avvanzata kkombinata' għax jinkorpora apparat mediku (il-pjattaforma).
English: This application was withdrawn after the CAT had assessed the initial documentation provided by the company and had formulated a list of questions.
Maltese: Din l-applikazzjoni ġiet irtirata wara li s-CAT kien evalwa d-dokumentazzjoni inizjali mressqa millkumpanija u fassal lista ta' mistoqsijiet.
English: Hyalograft C autograft is an implant consisting of cartilage cells derived from the patient and planted on 2x2 cm square inserts.
Maltese: Hyalograft C autograft huwa impjant li jikkonsisti f'ċelloli tal-qarquċa meħuda mill-pazjent u impjantati f'inserts kwadri ta' 2x2 cm.
English: The evaluation of advanced therapy products involves an assessment by the Committee for Advanced Therapies (CAT) before an opinion is adopted by the Committee for Medicinal Products for Human Use (CHMP).
Maltese: Il-valutazzjoni ta' prodotti ta' terapija avvanzata tinvolvi eżami mill-Kumitat għat-Terapiji Avvanzati (CAT) qabel ma tiġi adottata opinjoni mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP).
English: It was for use in adults experiencing symptoms caused by sudden or repetitive trauma to the cartilage.
Maltese: Kellu jintuża fuq adulti li ġarrbu sintomi kkaġunati minn trawma fil-qarquċa li ġrat f'daqqa jew b'mod ripetut.
English: How far into the evaluation was the application when it was withdrawn?
Maltese: Sa fejn kienet waslet l-evalwazzjoni tal-applikazzjoni qabel ġiet irtirata?
English: On 14 January 2013, Anika Therapeutics S.r.l.
Maltese: Mistoqsijiet u tweġibiet
English: What was Hyalograft C autograft being evaluated for?
Maltese: Għaliex kien qed jiġi evalwat Hyalograft C autograft?
English: Hyalograft C autograft was being evaluated for use in repairing cartilage defects at the end of the femur (the thigh bone), where the bone forms part of the knee joint.
Maltese: Hyalograft C autograft huwa magħmul minn kondroċiti (ċelloli tal-qarquċa) meħuda mill-pazjent u mkabbra barra l-ġisem.
English: officially notified the European Medicines Agency that it wishes to withdraw its application for a marketing authorisation for Hyalograft C autograft, for repairing defects in the cartilage of the femoral condyles and trochlea (the end of the thigh bone that forms part of the knee) caused by sudden or repetitive trauma.
Maltese: Fl-14 ta' Jannar 2013 Anika Therapeutics S.r.l. għarfet b'mod uffiċjali lill-Aġenzija Ewropea għallMediċini bil-ħsieb tagħha li tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għat-tqegħid fis-suq għal Hyalograft C autograft - prodott mediċinali li jintuża għat-tiswija ta' difetti fil-qarquċa tal-kondili u ttroklea tal-wirk (tarf l-għadma tal-koxxa li jagħmel parti mill-irkoppa) ikkaġunati minn trawma li tiġri f'daqqa jew b'mod ripetut.
English: The company informed the EMA that there were no ongoing clinical trials or compassionate use programmes with Hyalograft C autograft at the time of the withdrawal.
Maltese: Il-kumpanija għarrfet lill-EMA li fi żmien l-irtirar ma kinux qed isiru xi provi kliniċi jew programmi ta' użu kompassjonali b'Hyalograft C autograft.
English: EMA/495967/2010 EMEA/H/C/001226
Maltese: EMA/495967/2010
English: It is available as pink, capsule-shaped tablets (75 mg).
Maltese: Huwa disponibbli bħala pilloli roża f'forma ta' kapsuli (75 mg).
English: The full EPAR for Clopidogrel Teva Pharma B.V. can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Clopidogrel Teva Pharma B.V. jista' jinstab fis-sit elettroniku tal-Aġenzija EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: The active substance in Clopidogrel Teva Pharma B.V., clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva f'Clopidogrel Teva Pharma B.V., il-klopidogrel, hija inibitur tal-aggregazzjoni talpjastrini (platelets).
English: Clopidogrel Teva Pharma B.V. is a ‘generic medicine'.
Maltese: Clopidogrel Teva Pharma B.V. huwa ‘mediċina ġenerika'.
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
Maltese: Imbagħad, il-kura tkompli bid-doża standard ta' 75 mg darba kuljum għal mill-inqas erba' ġimgħat (f'infart mijokardijaku b'elevazzjoni tas-segment ST) jew għal sa 12-il xahar (fis-sindromu mingħajr elevazzjoni tas-segment ST).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Teva Pharma B.V. to Teva Pharma B.V. on 16 June 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Clopidogrel Teva Pharma lil Teva Pharma B.V. fis-16 ta' Ġunju 2011.
English: This document is a summary of the European public assessment report (EPAR) for Clopidogrel Teva Pharma B.V.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Clopidogrel Teva Pharma B.V.
English: Clopidogrel Teva Pharma B.V. is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel Teva Pharma B.V. huwa mediċina li fiha is-sustanza attiva klopidogrel.
English: This means that Clopidogrel Teva Pharma B.V. is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Dan ifisser li Clopidogrel Teva Pharma B.V. huwa simili għal ‘mediċina ta' referenza' li diġà hija awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: Because Clopidogrel Teva Pharma B.V. is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Peress li Clopidogrel Teva Pharma B.V. hija mediċina ġenerika, studji f'pazjenti ġew limitati għal testijiet li jiddeterminaw li hija bijoekwovalenti għall-mediċina ta' referenza, Plavix.
English: Clopidogrel Teva Pharma B.V. is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Maltese: Clopidogrel Teva Pharma B.V. jintuża fl-adulti għall-prevenzjoni ta' avvenimenti aterotrombotiċi (problemi kkawżati minn emboli tad-demm u twebbis tal-arterji). Clopidogrel Teva Pharma B.V. jista' jingħata lill-gruppi ta' pazjenti li ġejjin:
English: What are the benefit and risk of Clopidogrel Teva Pharma B.V.?
Maltese: X'inhuma l-benefiċċju u r-riskju ta' Clopidogrel Teva Pharma B.V.?
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel Teva Pharma B.V. has been shown to have comparable quality and to be bioequivalent to Plavix.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, Clopidogrel Teva Pharma B.V. intwera li għandu kwalità komparabbli u huwa bijoekwlvalenti għal Plavix.
English: In acute coronary syndrome, Clopidogrel Teva Pharma B.V. is used together with aspirin and treatment generally starts with a loading dose of four tablets.
Maltese: Fis-sindromu koronarju akut, Clopidogrel Teva Pharma B.V. jintuża flimkien mal-aspirina u l-kura ġeneralment tinbeda b'doża tal-bidu ta' erba' pilloli.
English: Because Clopidogrel Teva Pharma B.V. is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Peress li Clopidogrel Teva Pharma B.V. huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċini ta' referenza, il-benefiċċji u r-riskji tiegħu huma meqjusa li huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Clopidogrel Teva Pharma B.V. is converted into its active form in the body.
Maltese: Clopdogrel Teva Pharma B.V. jinbidel għall-forma attiva tiegħu fil-ġisem.
English: Other information about Clopidogrel Teva Pharma B.V.:
Maltese: Tagħrif ieħor dwar Clopidogrel Teva Pharma B.V.: