FrancophonIA/ELRC3.0 huggingface dataset:
English: Zoledronic acid Actavis is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Maltese: Zoledronic acid Actavis mhux irrakkomandat għall-pazjenti li jkollhom indeboliment sever tal kliewi qabel tibda t-terapija, li għal din il-popolazzjoni hi meqjusa bħala CLcr <30 ml/min.
English: Temporary interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Maltese: Interruzzjoni temporanja tat-trattament b'zoledronic acid għandu jiġi ikkunsidrat sakemm ilkundizzjoni tirrisolvi u fatturi ta' riskju li jikkontribwixxu jitnaqqsu fejn possibbli.
English: During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphopsphonate class adverse reaction).
Maltese: ksur subtrochanteric u diaphyseal mhux tipiku tal-għadma tal-wirk (reazzjoni avversa tal-klassi talbisfosfonat).
English: Within three days after zoledronic acid administration, used as indicated in sections 4.1 and 4.2, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Maltese: ġiet irrappurtata spiss reazzjoni ta' fażi akuta, b'sintomi li jinkludu uġigħ fl-għadam, deni, għeja, artralġja, mijalġja, tertir u artrite b'nefħa sussegwenti fil-ġogi; dawn is-sintomi normalment jgħaddu fi ftit ġranet (ara d-deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: In a pooled analysis of safety data from zoledronic acid registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
Maltese: F' analiżi miġbura ta' tagħrif ta' sigurtà minn provi ta'reġistrazzjoni ta' zoledronic acid għall-prevenzjoni ta avvenimenti relatati skelettriċi f' pazjenti b'tumuri malinni avanzat li jinvolvu l-għadam, il-frekwenza tal-avvenimenti avversi ta' indeboliment renali suspettati li jkunu relatati ma' zoledronic acid (reazzjonijiet avversi) kienet kif ġej: maeloma multipla (3.2%),
English: - Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
Maltese: zoledronic acid ġiet assoċjata ma' żieda fir-riskju ta' osteonekrożi tax-xedaq (ONJ).
English: - Shelf life after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and at 25°C after dilution in 100 ml 0.9% w/v sodium chloride solution or 100 ml 5% w/v glucose.
Maltese: - Żmien kemm idum tajjeb il-prodott wara li jiġi dilwit: Stabilita' kimika u fiżika waqt l-użu ġiet murija għal 24 siegħa f'temperatura ta' 2˚C - 8˚C u 25˚C wara li jitħallat ma' 100ml ta' 0.9%
English: Other products containing zoledronic acid as active substances are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Maltese: Prodotti oħra li fihom zoledronic acid bħala sustanzi attivi huma disponibbli għall-indikazzjonijiet osteoporożi u trattament tal-marda tal- Paget ta' l-għadam.
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients)
Maltese: Tabella 4: Riżultati li juru l-effikaċja (pazjenti b'kanċer fis-sider jew b'maeloma multipla)
English: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria Arthritis and joint swelling as a symptom of acute phase reaction
Maltese: Astenja, edima periferali, reazzjoni fis-sit tal injezzjoni (inklużi uġigħ, irritazzjoni, nefħa, ebusija), uġigħ fis-sider, u żieda fil-piż,
English: - Zoledronic acid Actavis is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Maltese: - Zoledronic acid Actavis jingħata bħala dripp (infużjoni) ġo vina li mill-anqas għandu jdum 15il minuta u għandu jingħata bħala soluzzjoni waħda minn ġol-vina f'linja ta' infużjoni separata.
English: Other medicines and Zoledronic acid Actavis
Maltese: Mediċini oħra u Zoledronic acid Actavis
English: One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate).
Maltese: U KWANTITATTIVA Kunjett wieħed fih 5 ml konċentrat li fih 4 mg zoledronic acid (bħala monohydrate).
English: In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Maltese: Fi studji kliniċi, il-kura b'Zoledronic acid Actavis reġgħet inbdiet biss meta l-livell ta' kreatinina kien reġa ġie lura għal 10% tal-valur tal-linja bażi (ara sezzjoni 4.4).
English: Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily.
Maltese: Il-pazjenti għandhom jingħataw ukoll suppliment mill-ħalq ta' 500 mg kalċju u 400 IU vitamina D
English: Very rare (may affect up to 1 in 10,000 people): - As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Maltese: rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid dejta disponibbli).
English: Clinical trial results in the treatment of severe osteogenesis imperfecta in paediatric patients aged 1 to 17 years
Maltese: Riżultati ta' prova klinika fil-kura ta' osteoġenesi imperfecta severa f'pazjenti pedjatriċi mill-età ta'
English: One vial contains 4 mg zoledronic acid (as monohydrate).
Maltese: Kunjett wieħed fih 4 mg zoledronic acid (bħal monohydrate).
English: Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Maltese: Ħafna minn dawn il-pazjenti kienu qed jirċievu ukoll kimoterapija u kortikosterojdi u kellhom sinjali ta' infezzjoni lokali inkluż osteomaelitis.
English: - Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) - Flu-like symptoms including arthritis and joint swelling.
Maltese: − Sintomi jixbħu lill-influwenza inkluż artrite u nefħa fil-ġogi.
English: The onset time is ≤ 3 days post-zoledronic acid infusion (used as indicated in sections 4.1 and 4.2), and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Maltese: Iż-żmien ta' meta tibda huwa ≤3 ijiem wara l-infużjoni ta' zoledronic acid (użat bħalma hu indikat f' sezzjonijiet 4.1 u 4.2), u r-reazzjoni hija wkoll magħrufa bit-termini ta' sintomi “li jixbhu linfluwenza” jew “ta' wara d-doża”.
English: Contains mannitol, sodium citrate and water for injections.
Maltese: TA' EĊĊIPJENTI Fiha wkoll mannitol, sodium citrate u ilma għall-injezzjonijiet.
English: Acute renal failure, haematuria, proteinuria Acquired Fanconi syndrome
Maltese: Insuffiċjenza renali, ħematurja, proteinurja
English: Angioneurotic oedema
Maltese: X hawn f'dan il-fuljett
English: Zoledronic acid Actavis recommended dose*
Maltese: Doża ta' Zoledronic acid Actavis rrakkomandata*
English: Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Maltese: Zoledronic acid Actavis 4 mg/5ml konċentrat għal soluzzjoni għall-infużjoni, dilwita aktar f'100 ml (ara sezzjoni 6.6), għandha tingħata bħala infużjoni waħda għal ġol-vini f'mhux inqas minn 15-il minuta.
English: Zoledronic acid Actavis is not recommended for use in adolescents and children below the age of 18 years.
Maltese: Zoledronic acid Actavis mhuwiex irrakkomandat għall-użu fl-adolexxenti u tfal taħt l-età ta' 18-il sena.
English: Respiratory, thoracic and mediastinal disorders Common:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: 1Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid as indicated in sections 4.1 and 4.2 (see section 4.8)
Maltese: 1 Reazzjonijiet avversi li seħħew bi frekwenzi <5% kienu stmati b'mod mediku u ntwera li dawn il każijiet kienu konsistenti mal-profil ta' sigurtà stabbilit tajjeb ta' zoledronic acid (ara sezzjoni 4.8).
English: The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the zoledronic acid-treated group versus 49.6% in the placebo group (p=0.003).
Maltese: Ilproporzjon ta' pazjenti b'almenu SRE wieħed (bl-esklużjoni ta' iperkalċimija) kienet ta' 29.8% fil grupp ikkurat b'zoledronic acid kontra 49.
English: - History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures
Maltese: - Storja ta' mard dentali, iġjene orali dgħajfa, mard perjodontali, proċeduri dentali invażivi (e.ż. qlugħ tas-snien) u dentaturi li ma jeħlux tajjeb.
English: Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Maltese: Fatturi possibli ta' riskju għall osteonekrożi tal-kanal awditorju estern tinkludi l-użu sterojdi u kimoterapija u / jew fatturi lokali ta' riskju bħal infezzjoni jew trawma.
English: The following response rates were observed:
Maltese: Ir-rati ta' rispons li ġejjin ġew osservati:
English: Package leaflet: Information for the user Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Maltese: Informazzjoni għall-utent Zoledronic acid Actavis 4 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni zoledronic acid
English: Teva Finland Oy Puh/Tel: +358 201805900
Maltese: Pliva Ljubljana d.o.o. Tel: +386 15890390
English: Intravenous use.
Maltese: terapija fit-tul.
English: The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 cancer patients studied.
Maltese: (indeboliment moderat), it-tneħħija ta' zoledronic acid li jikkorrispondi kien imbassar li jkun ta' 37% jew 72%, rispettivament meta mqabbla ma' pazjenti bi tneħħija tal-kreatinina ta' 84 ml/min.
English: The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.
Maltese: osteonekrożi tal-kanal awditorju estern għandha tiġi kkunsidrata f'pazjenti li qed jirċievu bisfosfonati li jippreżentaw is-sintomi fil-widna inkluż infezzjonijiet kroniċi fil-widnejn.
English: To avoid potential incompatibilities, Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion is to be diluted with 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Maltese: soluzzjoni għall-infużjoni mingħajr kalċju (0.9% w/v soluzzjoni ta' sodium chloride jew 5% w/v soluzzjoni ta' glucose).
English: Hypocalcaemia-related ADRs
Maltese: Tfal u adolexxenti
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended.
Maltese: indeboliment renali diġà eżistenti, ċikli multipli ta' Zoledronic acid Actavis jew ta' bisfosfonati oħrajn, kif ukoll l-użu konkomitanti ta' mediċini nefrotossiċi jew l-użu ta' ħin iqsar ta' infużjoni minn dak attwalment irrakkomandat.
English: Zoledronic acid Actavis should only be resumed when serum creatinine returns to within 10% of baseline.
Maltese: Zoledronic acid Actavis jista' jerġa jingħata meta l-kreatinina fis-serum terġa lura għal 10% tal-linja bażi.
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when Zoledronic acid Actavis is used in combination with thalidomide.
Maltese: F'pazjenti b'maeloma multipla, ir-riskju ta' disfunzjoni tal-kliewi jista' jiżdied meta Zoledronic acid
English: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zoledronic acid Actavis therapy.
Maltese: Il-pazjenti jrid ikollhom il-livelli ta' kreatinina fis-serum evalwati qabel kull doża ta' Zoledronic acid Actavis.
English: Anxiety, sleep disturbance
Maltese: Disturbi fis-sistema nervuża
English: Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion
Maltese: Zoledronic acid Actavis 4 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as zoledronic acid (see section 4.4).
Maltese: Każijiet ta' osteonekrożi tax-xedaq kienu rappurtati, l-aktar f'pazjenti bil-kanċer ikkurati bi prodotti mediċinali li jinibixxu r-risorbiment tal-għadam, bħal zoledronic acid (ara sezzjoni 4.4).
English: You should not be given Zoledronic acid Actavis:
Maltese: M'għandekx tingħata Zoledronic acid Actavis:
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini neħħiet l-obbligu li jissottomettu r-riżultati tal-istudji mal-prodott mediċinali ta' referenza li jkun fih zoledronic acid fis-sottogruppi kollha tal-popolazzjoni pedjatrika fit-trattament tat-tumur li jindotta iperkalċemija u prevenzjoni ta avvenimenti relatati skelettriċi f'pazjenti b'tumuri malinni avanzati li jinvolvu l-għadam (ara sezzjoni 4.2 għal informazzjoni dwar l użu pedjatriku).
English: How to store Zoledronic acid Actavis
Maltese: Jekk tingħata aktar Zoledronic acid Actavis milli suppost
English: The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Maltese: Indeboliment tal-funzjoni renali, osteonekrożi tax-xedaq, reazzjoni ta' fażi akuta, ipokalċimja,
English: Osteonecrosis
Maltese: Edima anġjonewrotika
English: Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with Zoledronic acid Actavis in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Maltese: Meta tkun ser tibda l-kura b'Zoledronic acid Actavis f'pazjenti b'maeloma multipla jew ġrieħi ta' metastasi fl-għadam minn tumuri solidi, il-kreatinina fis-serum u t-tneħħija tal-kreatinina (CLcr)
English: - If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic acid Actavis.
Maltese: - Jekk qed tingħata l-kura sabiex jitnaqqas l-ammont ta' calcium fid-demm tiegħek, normalment tingħata biss infużjoni waħda ta' Zoledronic acid Actavis.
English: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoaesthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Maltese: Deni, sindrome li tixbah l-influwenza (inklużi għejja, tertir, tħossok marid u ssir ruxxan)
English: To assess the effects of 4 mg zoledronic acid versus pamidronate 90 mg, the results of two pivotal multicentre studies in patients with TIH were combined in a pre-planned analysis.
Maltese: Biex jiġu evalwati l-effetti ta' 4 mg zoledronic acid mqabbla ma' dawk ta' pamidronate 90 mg, ir riżultati ta' żewġ studji pivitali multiċentriċi f'pazjenti b'TIH ġew ikkombinati f'analiżi ppjanata minn qabel.
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer)
Maltese: Tabella 3: Riżultati li juru l-effikaċja (pazjenti b'tumuri solidi oħra barra dawk tas-sider u tal prostata)
English: - To prepare an infusion solution containing 4 mg Zoledronic acid Actavis, further dilute the Zoledronic acid Actavis concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Maltese: ddilwixxi l-konċentrat ta' Zoledronic acid Actavis (5 ml) ma' 100 ml ta' soluzzjoni għallinfużjoni ħielsa mill-kalċju jew minn soluzzjonijiet li jkun fihom divalent cations oħrajn.
English: Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid.
Maltese: Id-deterjorament renali, il-progressjoni għall-insuffiċjenza renali u d dijaliżi ġew irrappurtati f'pazjenti wara d-doża tal-bidu jew wara doża waħda ta' 4 mg zoledronic acid
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR VIALS
Maltese: Kontenuti tal-pakkett u informazzjoni oħra
English: Osteonecrosis of the jaw
Maltese: Osteonekrożi Osteonekrożi tax-xedaq
English: Healthcare professionals are advised not to dispose of unused Zoledronic acid Actavis via the domestic sewage system.
Maltese: Il-professjonisti tal-kura tas-saħħa huma rrakkomandati li ma jarmux Zoledronic acid Actavis mhux użata fis-sistema domestika tad-dranaġġ.
English: What Zoledronic acid Actavis is and what it is used for What you need to know before you are given Zoledronic acid Actavis How Zoledronic acid Actavis is used Possible side effects
Maltese: Jekk għandek pre-eżistenti ipokalċimija, għandu jiġi kkoreġut qabel tinbeda l-ewwel doża ta' Zoledronic acid Actavis.
English: Zoledronic acid does not inhibit human P450 enzymes in vitro, shows no biotransformation and in animal studies < 3% of the administered dose was recovered in the faeces, suggesting no relevant role of liver function in the pharmacokinetics of zoledronic acid.
Maltese: Zoledronic acid ma jimpedixxix l-enzimi tal-bniedem P450 in vitro, ma jurix biotrasformazzjoni, u fi studji li saru fuq annimali, <3% tad-doża mogħtija nstabet fl ippurgar li jissuġġerixxi li l-funzjoni tal-fwied ftit li xejn għandha rwol rilevanti fil-farmakokinetiċi ta'
English: In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients that were given zoledronic acid as indicated in sections 4.1 and 4.2.
Maltese: Sommarju tal-profil tas-sigurtà Fi żmien tlett ijiem wara l-għoti ta' zoledronic acid, użat bħalma hu indikat f' sezzjonijiet 4.1 u 4.2,
English: Ref.: EMEA/503246/2009 EMEA/H/C/1054
Maltese: EMEA/503260/2009 EMEA/H/C/1054
English: Clopidogrel 1A Pharma clopidogrel EPAR summary for the public
Maltese: Clopidogrel 1A Pharma clopidogrel Sommarju tal-EPAR għall-pubbliku
English: Clopidogrel 1A Pharma can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Maltese: Clopidogrel 1A Pharma jista' jintuża f'pazjenti li jkollhom infart mijokardiku flimkien ma' ‘elevazzjoni fis-segment ST' (riżultat anomalu tal-elettrokardjogramma jew ECG) meta t-tabib ikun ikkunsidra li jkunu se jibbenefikaw mit-trattament.
English: Clopidogrel 1A Pharma is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel 1A Pharma huwa mediċina li fiha s-sustanza attiva clopidogrel.
English: In acute coronary syndrome, Clopidogrel 1A Pharma is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Maltese: Fis-sindromu koronarju akut, Clopidogrel 1A Pharma jintuża mal-aspirina u ttrattament ġeneralment jibda b'doża ta' tagħbija (loading dose) ta' erba' pilloli ta' 75 mg.
English: The active substance in Clopidogrel 1A Pharma, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva f'Clopidogrel 1A Pharma, clopidogrel, hu inibitur ta' l-aggregazzjoni tal-pjastrini (platelets).
English: This means that Clopidogrel 1A Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Clopidogrel 1A Pharma huwa ‘mediċina ġenerika' li jfisser li Clopidogrel 1A Pharma huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: Because Clopidogrel 1A Pharma is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Billi Clopidogrel 1A Pharma huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Plavix.
English: What are the benefit and risk of Clopidogrel 1A Pharma?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Clopidogrel 1A Pharma?
English: What is Clopidogrel 1A Pharma?
Maltese: X'inhu Clopidogrel 1A Pharma?
English: Clopidogrel 1A Pharma can be given to the following groups of patients:
Maltese: Clopidogrel 1A Pharma jista' jingħata lillgruppi ta' pazjenti li ġejjin:
English: Because Clopidogrel 1A Pharma 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: Billi Clopidogrel 1A Pharma huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċju u r-riskju tiegħu huma meqjusa l-istess bħal dawk tal-mediċina ta' referenza.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel 1A Pharma has been shown to have comparable quality and to be bioequivalent to Plavix.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Clopidogrel 1A Pharma wera li għandu kwalità komparabbli ma' u huwa bijoekwivalenti għal Plavix.
English: How has Clopidogrel 1A Pharma been studied?
Maltese: Kif ġie studjat Clopidogrel 1A Pharma?
English: The standard dose of Clopidogrel 1A Pharma is one 75 mg tablet once a day, taken with or without food.
Maltese: Id-doża standard ta' Clopidogrel 1A Pharma hija ta' pillola waħda ta' 75 mg darba kuljum, mal-ikel jew fuq stonku vojt.
English: Clopidogrel 1A Pharma is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Maltese: X'inhu l-użu ta' Clopidogrel 1A Pharma? Clopidogrel 1A Pharma jintuża f'adulti biex jipprevjeni każijiet aterotrombotiċi (problemi li jirriżultaw minn demm magħqud u t-twebbis tal-arterji).
English: How is Clopidogrel 1A Pharma used?
Maltese: Kif jintuża Clopidogrel 1A Pharma?
English: Why has Clopidogrel 1A Pharma been approved?
Maltese: Għaliex ġie approvat Clopidogrel 1A Pharma?
English: Therefore, in accordance with Article 116 of Directive 2001/83/EC, the CHMP recommends:
Maltese: Għalhekk, skont l-Artikolu 116 tad-Direttiva 2001/83/KE, is-CHMP jirrakkomanda:
English: There are 2 further studies by Hugonot et al with population of 114-127 patients, both showing superiority over placebo.
Maltese: Hemm 2 studji oħra minn Hugonot et al b'popolazzjoni ta' 114-127 pazjent, li t-tnejn urew superjorità fuq il-plaċebo.
English: There were 3 placebo controlled studies with a study population of 200-240 patients.
Maltese: Kien hemm 3 studji kkontrollati bil-plaċebo b'popolazzjoni tal-istudju ta' 200-240 pazjent.
English: The CHMP considered the MAHs' proposals for risk minimisation measures.
Maltese: Is-CHMP qies il-proposti tal-MAHs għal miżuri ta' minimizzazzjoni tar-riskju.
English: This is indicative of a causal relationship between fibrosis and dihydroergocristine.
Maltese: Dan huwa indikattiv ta' relazzjoni kawżali bejn il-fibrożi u dihydroergocristine.