FrancophonIA/ELRC3.0 huggingface dataset:
English: Although antibiotics including Xerava fight certain bacteria, other bacteria and fungi may continue to grow.
Maltese: Għalkemm l-antibijotiċi inkluż Xerava jiġġieldu kontra ċerti batterji, batterji u fungi oħra jistgħu jkomplu jikbru.
English: The adverse reactions identified with eravacycline are presented in Table 1.
Maltese: Ir-reazzjonijiet avversi identifikati b'eravacycline huma ppreżentati fit-Tabella 1.
English: Nordimet (methotrexate)
Maltese: Nordimet (metotreksat)
English: Further information on Nordimet can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nordimet.
Maltese: Aktar informazzjoni dwar Nordimet tinstab fis-sit web talAġenzija: ema.europa.eu/medicines/human/EPAR/nordimet.
English: Nordimet is a ‘hybrid medicine'.
Maltese: Nordimet huwa ‘mediċina ibrida'.
English: Nordimet received a marketing authorisation valid throughout the EU on 18 August 2016.
Maltese: Nordimet ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-18 ta' Awwissu 2016.
English: Nordimet contains the active substance methotrexate.
Maltese: Nordimet fih is-sustanza attiva metotreksat.
English: Other information about Nordimet
Maltese: Informazzjoni oħra dwar Nordimet
English: The reference medicine for Nordimet is Lantarel FS.
Maltese: Il-mediċina ta' referenza għal Nordimet hija Lantarel FS.
English: NSAIDs (non-steroidal anti-inflammatory drugs) have not worked well enough;
Maltese: NSAIDs (mediċini kontra l-infjammazzjoni li mhumiex sterojdi) ma ħadmux sew biżżejjed;
English: The company provided data from the published literature on methotrexate.
Maltese: Il-kumpanija pprovdiet data minn dokumentazzjoni ppubblikata dwar metotreksat.
English: This means that it is similar to a ‘reference medicines' containing the same active substance, but Nordimet is available in more strengths.
Maltese: Dan ifisser li huwa simili għal ‘mediċina ta' referenza' li fiha l-istess sustanza attiva, iżda Nordimet jiġi f'aktar qawwiet.
English: No additional studies were needed as Nordimet is a hybrid medicine that is given by injection and contains the same active substance as the reference medicine, Lantarel FS.
Maltese: Ma kien meħtieġ lebda studju addizzjonali peress li Nordimet huwa mediċina ibrida li tingħata permezz ta' injezzjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Lantarel FS.
English: • active rheumatoid arthritis, a disease causing inflammation in joints;
Maltese: • artrite rewmatojde attiva, marda li tikkawża infjammazzjoni tal-ġogi;
English: • severe juvenile idiopathic arthritis (JIA), a joint disease in children, when medicines known as
Maltese: • artrite idjopatika ġuvenili severa (JIA), marda tal-ġogi fit-tfal, meta mediċini magħrufa bħala
English: • severe psoriatic arthritis, inflammation of the joints that occurs in patients with psoriasis.
Maltese: • artrite psorjatika severa, infjammazzjoni tal-ġogi li sseħħ fil-pazjenti bi psorjasi.
English: Nordimet must not be used in patients who abuse alcohol or those with liver or severe kidney problems, blood disorders, weakened immune system (body defences), severe or long-term infections such as tuberculosis and HIV infection, mouth ulcers, inflammation in the mouth, and ulcers in the digestive system.
Maltese: Nordimet m'għandux jintuża f'pazjenti li jabbużaw mill-alkoħol jew dawk bi problemi fil-fwied jew problemi severi fil-kliewi, disturbi tad-demm, sistema immunitarja (difiżi tal-ġisem) imdgħajfa, infezzjonijiet severi jew fit-tul bħat-tuberkulożi u l-infezzjoni tal-HIV, ulċeri fil-ħalq, infjammazzjoni filħalq, u ulċeri fis-sistema diġestiva.
English: What are the risks associated with Nordimet?
Maltese: X'inhuma r-riskji assoċjati ma' Nordimet?
English: For the full list of side effects and restrictions of Nordimet, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Nordimet, ara l-fuljett ta' tagħrif.
English: The way methotrexate, the active substance in Nordimet, works in patients with arthritis and psoriasis is not completely understood, but the benefits of methotrexate are thought to be due to its ability to reduce inflammation and suppress an overactive immune system.
Maltese: Il-mod kif il-metotreksat, is-sustanza attiva f'Nordimet, taħdem f'pazjenti bl-artrite u l-psorjasi mhuwiex mifhum għal kollox, iżda l-benefiċċji tal-metotreksat huma maħsuba li huma dovuti għall-ħila tagħha li tnaqqas l-infjammazzjoni u trażżan sistema immunitarja attiva żżejjed.
English: The most common side effects with Nordimet (which may affect more than 1 in 10 people) are effects in the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing changes in the liver.
Maltese: L-effetti sekondarji l-aktar komuni b'Nordimet (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma effetti fis-sistema diġestiva (bħal infjammazzjoni tal-kisja tal-ħalq, indiġestjoni, uġigħ ta' żaqq, tħossok ma tiflaħx u telf ta' aptit) u testijiet tad-demm li juru bidliet fil-fwied.
English: The European Medicines Agency concluded that Nordimet was comparable to its reference medicine.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li Nordimet kien komparabbli mal-mediċina ta' referenza tiegħu.
English: How is Nordimet used?
Maltese: Kif jintuża Nordimet?
English: What benefits of Nordimet have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Nordimet li ħarġu mill-istudji?
English: As for all medicines, data on the use of Nordimet are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Nordimet hija ssorveljata kontinwament.
English: The Agency therefore decided that Nordimet's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: Għaldaqstant, l-Aġenzija ddeċidiet li l-benefiċċji ta' Nordimet huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: It should be prescribed only by doctors with expertise in the use of methotrexate and a full understanding of the risks of methotrexate treatment.
Maltese: Għandu jkun preskritt biss minn tobba b'għarfien espert fl-użu ta' metotreksat u fehim sħiħ tar-riskji ta' kura b'metotreksat.
English: Because Nordimet has the same composition as the reference medicine its benefits are taken as being the same as those of Lantarel FS.
Maltese: Minabba li Nordimet għandu listess kompożizzjoni bħall-mediċina ta' referenza l-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk ta' Lantarel FS.
English: EU/1/17/1214/001 Bavencio
Maltese: EU/1/17/1214/001 Bavencio 20 mg/mL Konċentrat għal soluzzjoni għall-infużjoni
English: The full EPAR for Mimpara can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Mimpara contains the active substance cinacalcet.
Maltese: Mimpara fih is-sustanza attiva cinacalcet.
English: Other information about Mimpara
Maltese: Informazzjoni oħra dwar Mimpara
English: What are the risks associated with Mimpara?
Maltese: X'inhuma r-riskji assoċjati ma' Mimpara?
English: This is a summary of the European public assessment report (EPAR) for Mimpara.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Mimpara.
English: Why is Mimpara approved?
Maltese: Għaliex ġie approvat Mimpara?
English: Mimpara produced a decrease in blood calcium of more than 1 mg/dl in 62% of the cancer patients (18 out of 29) and in 88% of the patients with primary hyperparathyroidism (15 out of 17).
Maltese: Mimpara pproduċa tnaqqis tal-kalċju fid-demm ta' aktar minn 1 mg/dl f'62 % tal-pazjenti tal-kanċer (18 minn 29) u fi 88 % tal-pazjenti b'iperparatirojdiżmu primarju (15 minn 17).
English: In this study, 55% (12 out of 22) children given Mimpara achieved a 30% reduction of PTH levels, compared with 19% (4 out of 21) children given placebo.
Maltese: F'dan l-istudju, 55 % (12 minn 22) wild li ngħataw Mimpara kisbu tnaqqis ta' 30 % tal-livelli ta' PTH, meta mqabbla ma' 19 % (4 minn 21) wild li ngħataw il-plaċebo.
English: Parathyroid gland cancer or primary hyperparathyroidism
Maltese: Kanċer tal-glandoli tal-paratirojde jew iperparatirojdiżmu primarju
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mimpara on 22 October 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Mimpara fit-22 ta' Ottubru 2004.
English: Mimpara has been compared with placebo (a dummy treatment) in three main studies involving 1,136 adults with secondary hyperparathyroidism who were on dialysis because they had a serious kidney disease.
Maltese: Mimpara tqabbel mal-plaċebo (kura finta) fi tliet studji ewlenin li involvew 1,136 adult b'iperparatirojdiżmu sekondarju li kienu fuq dijaliżi għax kellhom marda serja tal-kliewi.
English: Mimpara cinacalcet
Maltese: ᾿Mimpara, cinacalcet, hija aġ
English: Mimpara has been studied in a study involving 46 patients with hypercalcaemia, including 29 with parathyroid cancer, and 17 with primary hyperparathyroidism who could not have their parathyroid glands removed or in whom surgery to remove the parathyroid glands was not effective.
Maltese: Mimpara ġie studjat fi studju li involva 46 pazjent bl-iperkalċemija, inkluż 29 bil-kanċer tal-paratirojde, u 17 b'iperparatirojdiżmu primarju li ma setgħux jitneħħewlhom il-glandoli tal-paratirojde tagħhom jew li fihom l-operazzjoni biex jitneħħew il-glandoli tal-paratirojde ma kinitx effettiva.
English: In children, Mimpara was compared with placebo in a study involving 43 children aged 6 to 18 years with serious kidney disease.
Maltese: Fit-tfal, Mimpara tqabbel mal-plaċebo fi studju li involva 43 wild ta' età bejn 6 u 18-il sena b'mard serju tal-kliewi.
English: Secondary hyperparathyroidism
Maltese: Iperparatirojdiżmu sekondarju
English: In these studies, about 40% of the patients taking Mimpara had parathyroid hormone levels below 250 micrograms per litre, compared with about 6% of those taking placebo.
Maltese: F'dawn l-istudji, madwar 40 % tal-pazjenti li kienu qed jieħdu Mimpara kellhom livelli tal-ormon talparatirojde iktar baxx minn 250 mikrogramma għal kull litru, meta mqabbla ma' madwar 6 % ta' dawk li kienu qed jieħdu l-plaċebo.
English: • hypercalcaemia (high blood calcium levels) in adults with cancer of the parathyroid glands or with primary hyperparathyroidism when the parathyroid glands cannot be removed.
Maltese: • iperkalċemija (livelli għoljin ta' kalċju fid-demm) fl-adulti b'kanċer tal-glandoli tal-paratirojde jew b'iperparatirojdiżmu primarju meta l-glandoli tal-paratirojde ma jkunux jistgħu jitneħħew.
English: The main measure of effectiveness was the reduction of PTH levels by 30%.
Maltese: Il-kejl ewlenieni tal-effikaċja kien it-tnaqqis tal-livelli ta' PTH bi 30 %.
English: Of these, 45 went on to a fourth, long-term study looking at the effectiveness of Mimpara over a total of almost six years.
Maltese: Minn dawn, 45 marru għar-raba' studju fit-tul li ħares lejn l-effettività ta' Mimpara fuq total ta'
English: Mimpara brought about a 42% reduction in average PTH levels compared with an increase of 8% in patients taking placebo.
Maltese: Mimpara ġab tnaqqis ta' madwar 42 % fil-livelli medji ta' PTH meta mqabbel ma' żieda ta' 8 % fil-pazjenti li kienu qed jieħdu l-plaċebo.
English: A further three studies compared Mimpara with placebo in a total of 136 patients with primary hyperparathyroidism over up to a year.
Maltese: Tliet studji oħra qabblu Mimpara mal-plaċebo f'total ta' 136 pazjent b'iperparatirojdiżmu primarju sa sena.
English: For the full list of side effects and restrictions of Mimpara, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Mimpara, ara l-fuljett ta' tagħrif.
English: The most common side effects with Mimpara (in more than 1 patient in 10) are nausea (feeling sick) and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni b'Mimpara (f'aktar minn pazjent 1 minn kull 10) huma nawżja (dardir) u remettar.
English: In patients with hypercalcaemia who also have parathyroid gland cancer or primary hyperparathyroidism, the recommended starting dose of Mimpara for adults is 30 mg twice a day.
Maltese: F'pazjenti b'iperkalċemija li għandhom ukoll kanċer tal-glandoli tal-paratirojde jew iperparatirojdiżmu primarju, id-doża tal-bidu rakkomandata ta' Mimpara għall-adulti hija ta' 30 mg darbtejn kuljum.
English: • secondary hyperparathyroidism (overactive parathyroid glands) in adults and children aged 3 years and older with serious kidney disease who need dialysis (to clear their blood of waste products).
Maltese: • iperparatirojdiżmu sekondarju (glandoli tal-paratirojde attivi żżejjed) fl-adulti u fi tfal ta' età ta'
English: Cinacalcet works by increasing the sensitivity of the calcium-sensing receptors on the parathyroid glands that regulate parathyroid hormone secretion.
Maltese: Cinacalcet jaħdem billi jżid is-sensittività tar-riċetturi li jħossu l-kalċju fuq il-glandoli tal-paratirojde li jirregolaw is-sekrezzjoni tal-ormon tal-paratirojde.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku cinacalcet
English: The dose of Mimpara should be increased every two to four weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels.
Maltese: Iddoża ta' Mimpara għandha tiżdied kull ġimagħtejn sa erba' ġimgħat sa 90 mg tliet jew erba' darbiet kuljum kif ikun meħtieġ biex il-kalċju fid-demm jitnaqqas sa livelli normali.
English: By increasing the sensitivity of these receptors, cinacalcet leads to a reduction in the production of PTH by the parathyroid glands.
Maltese: Billi jżid is-sensittività ta' dawn irriċetturi, cinacalcet iwassal għal tnaqqis fil-produzzjoni ta' PTH mill-glandoli tal-paratirojde.
English: In hyperparathyroidism, the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to high levels of blood calcium, bone and joint pain and deformities of the arms and legs.
Maltese: Fl-iperparatirojdiżmu, il-glandoli tal-paratirojde fl-għonq jipproduċu wisq ormon tal-paratirojde (PTH, parathyroid hormone), li jistgħu jwasslu għal livelli għoljin ta' kalċju fid-demm, uġigħ fl-għadam u filġogi u deformitajiet tad-dirgħajn u r-riġlejn. “Sekondarju” tfisser li jiġi kkawżat minn kondizzjoni oħra (mard serju tal-kliewi) waqt li “primarju” tfisser li m'hemm l-ebda kawża oħra.
English: Mimpara must not be used in patients with hypocalcaemia (low blood calcium levels).
Maltese: Mimpara m'għandux jintuża minn pazjenti li jbatu minn ipokalċemija (livelli baxxi ta' kalċju fid-demm).
English: Studies showed that Mimpara was effective in both adults and children at reducing levels of parathyroid hormone in patients with secondary hyperparathyroidism who were undergoing dialysis for kidney disease.
Maltese: Dan jispjega kif l-Aġenzija vvalutat il-mediċina biex tirrakkomanda l-awtorizzazzjoni tiegħu fl-UE u l-kondizzjonijiet ta' użu tiegħu.
English: Store below 25°C.
Maltese: Aħżen taħt 25°C
English: Date of latest renewal: 15 March 2015
Maltese: Data tal-aħħar tiġdid: 15 ta' Marzu 2015
English: Thrombocytopenia, leucopenia, eosinophilia
Maltese: Tromboċitotopeni ja, lewkopenija, eosinofilja
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 March 2010
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 15 ta' Marzu 2010
English: (See section 4.4.)
Maltese: (ara sezzjoni 4.4)
English: * Information reported in published information for ASA with frequency “not known”.
Maltese: Informazzjoni rrappurtata f'informazzjoni ppubblikata għal ASA b'frekwenza “mhux magħrufa”.
English: Zentiva Italia S.r.l.
Maltese: Italia S.r.l. Tel: 800.
English: TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome)
Maltese: TOPIC (L-Aħjar Żmien għall-Inibizzjoni tal-Plejtlits wara sindromu Koronarju akut- Timing Of Platelet Inhibition after acute Coronary syndrome)
English: Medicinal products that are strong or moderate CYP2C19 inhibitors include, for example, omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, and efavirenz.
Maltese: Prodotti mediċinali li huma inibituri qawwijin jew moderati ta' CYP2C19 jinkludu, per eżempju, omeprazole u esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine u efavirenz..
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus, fixed eruption*
Maltese: Dermatite bulloża (nekroliżi tossika tal-epidermis, isSindrome ta' Stevens Johnson, eritema multiforme), exanthematous pustulosis akuta u ġeneralizzata (AGEP),anġjoedima, sindromu ta' sensittività eċċessiva kkawżat mill-mediċina, raxx kkawżat mill-mediċina b'eosinofilja u sintomi sistemiċi (DRESS), raxx eritematożu jew bil-qoxra, urtikarja, ekżema u lichen planus, eruzzjonijiet filġilda li dejjem iseħħu fl-istess post (fixed eruption)
English: Following therapeutic doses, approximately 10% is found excreted in the urine as salicylic acid, 75% as salicyluric acid, 10% phenolic- and 5% acyl-glucuronides of salicylic acid.
Maltese: Wara dożi terapewtiċi, l-ekrezzjoni fl-awrini tkun ta' madwar 10% bħala salicylic acid, 75% bħala salicyluric acid, 10% fenoliku- u 5% aċilu-glukuronidi ta' salicylic acid.
English: • the foetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;
Maltese: • il-fetu għal: - tossiċità kardjopulmonarja ( għeluq prematur tad-ductus arteriosus u ipertensjoni pulmonarja); - disfunzjoni renali li tista' twassal għall-insuffiċjenza renali b'oligo-idroamnjożi;
English: Clopidogrel/Acetylsalicylic acid Zentiva contains clopidogrel and acetylsalicylic acid (ASA) and belongs to a group of medicines called antiplatelet medicinal products.
Maltese: Clopidogrel/Acetylsalicylic acid Zentiva fih clopidogrel u acetylsalicylic acid (ASA) u jifforma parti minn grupp ta' mediċini msejħa prodotti mediċinali ta' kontra l-plejtlets.
English: The other ingredients are: - Tablet core: mannitol (E421), macrogol 6000, microcrystalline cellulose, low substituted hydroxypropylcellulose, maize starch, hydrogenated castor oil (see section 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva contains hydrogenated castor oil'), stearic acid and colloidal anhydrous silica - Tablet coating: lactose monohydrate (see section 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva contains lactose'), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172) - Polishing agent: carnauba wax
Maltese: - Il-qalba tal-pillola: mannitol (E421), macrogol 6000, microcrystalline cellulose, hydroxypropylcellulose b'sostituzzjoni baxxa, maize starch, castor oil idroġenat ( ara sezzjoni 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva fih castor oil idroġenat'), stearic acid u silica anidrat kollojdali - Fil-kisi tal-pillola: lactose monohydrate(ara sezzjoni 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva fih il-lactose') , hypromellose (E464), titanium dioxide (E171), triacetin (E1518), iron oxide isfar (E172) - Sustanza li tagħti l-lostru: carnauba wax
English: The other ingredients are: - Tablet core: mannitol (E421), macrogol 6000, microcrystalline cellulose, low substituted hydroxypropylcellulose, maize starch, hydrogenated castor oil (see section 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva contains hydrogenated castor oil'), stearic acid and colloidal anhydrous silica - Tablet coating: lactose monohydrate (see section 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva contains lactose'), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), yellow iron oxide (E172) - Polishing agent: carnauba wax
Maltese: - Il-qalba tal-pillola: mannitol (E421), macrogol 6000, microcrystalline cellulose, hydroxypropylcellulose b'sostituzzjoni baxxa, maize starch, castor oil idroġenat ( ara sezzjoni 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva fih castor oil idroġenat'), stearic acid u silica anidrat kollojdali - Fil-kisi tal-pillola: lactose monohydrate (ara sezzjoni 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva fih il-lactose'), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), iron oxide aħmar (E172) - Sustanza li tagħti l-lostru: carnauba wax
English: • if you have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency because of the risk of a particular form of anaemia (low number of red blood cells).
Maltese: • jekk għandek kondizzjoni magħrufa bħala defiċjenza ta' glucose-6-phosphate dehydrogenase (G6PD) minħabba r-riskju ta' forma partikulari ta' anemija (l-għadd taċ-ċelluli ħomor taddemm ikun baxx).
English: Hypoglycaemia*, gout* (see section 4.4)
Maltese: (G6PD) (ara sezzjoni 4.4).
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 web-portal.
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: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis.
Maltese: Emorraġija gastro-intestinali u minn wara l-peritonew b'eżitu fatali, pankreatite.
English: Eye bleeding (conjunctival, ocular, retinal)
Maltese: (konġuntivali, okulari, retinali )
English: Adults and elderly
Maltese: Pożoloġija • Adulti u anzjani
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: C-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: NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe
Maltese: sanofi-aventis groupe
English: (psoriasis),
Maltese: (PPI):
English: Clopidogrel/Acetylsalicylic acid Zentiva contains lactose.
Maltese: Clopidogrel/Acetylsalicylic acid Zentiva fih il-lactose.
English: Film-coated tablet (tablet).
Maltese: Ħmistax fil-mija (15.
English: Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence
Maltese: Ulċera ta' listonku u ulċera tad-duodenum, gastrite, rimettar, tqalligħ, stitikezza, gass flistonku
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: Although the administration of clopidogrel 75 mg/day did not modify the pharmacokinetics of S-warfarin or International Normalised Ratio (INR) in patients receiving long-term warfarin therapy, coadministration of clopidogrel with warfarin increases the risk of bleeding because of independent effects on hemostasis.
Maltese: Għalkemm l-għoti ta' clopidogrel 75 mg/jum ma mmodifikax il-farmakokinetika ta' S-warfarin jew ilProporzjon Normalizzat Internazzjonali (INR) f'pazjenti li rċevew terapija għat-tul ta' warfarin, lgħoti flimkien ta' clopidogrel ma' warfarin iżid ir-riskju ta' fsada minħabba effetti indipendenti fuq lemostasi.
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Red iron oxide (E172)
Maltese: Titanium dioxide (E171)