FrancophonIA/ELRC3.0 huggingface dataset:
English: Package leaflet: Information for the user Topotecan Teva 1 mg/1 ml concentrate for solution for infusion topotecan
Maltese: Informazzjoni għall-utent Topotecan Teva 1 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni topotecan
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Maltese: Il-majelosuppressjoni twassal għal sepsis u mewt minħabba s-sepsis ġew rapportati f'pazjenti trattati b'topotecan (ara sezzjoni 4.8).
English: Topotecan inhibits topoisomerase-I by stabilising the covalent complex of enzyme and strand-cleaved DNA which is an intermediate of the catalytic mechanism.
Maltese: Barra minn hekk, ġew irrapportati enzimi epatiċi elevati b'doża eċċessiva ta' topotecan ġol-vina.
English: Hepatic impairment
Maltese: Komuni ħafna Infezzjoni
English: Cervical cancer The usual dose is 0.75 mg per m2 of body surface area once daily for 3 days.
Maltese: Id-doża li ġeneralment tingħata hi ta' 0.75 mg kull metru2 ta' erja superfiċjali korporali darba kuljum għal 3 ijiem.
English: Approximately 51 % was excreted as total topotecan and 3% was excreted as N-desmethyl topotecan in the urine.
Maltese: Madwar 51 % kien eliminat bħala topotecan totali u 3 %
English: Itchy rash (or hives).
Maltese: Raxx tal-ħakk (ħorriqija).
English: In dose-finding studies involving 523 patients with relapsed ovarian cancer and 631 patients with relapsed small cell lung cancer, the dose limiting toxicity of topotecan monotherapy was found to be haematological.
Maltese: tfaċċa u 631 pazjent li kellhom mikroċitoma pulmonari li reġgħet tfaċċat mill-ġdid, id-doża li tirristriġi li ma jkunx hemm tossiċità għal monoterapija b'topotecan instabet li kienet ematoloġika.
English: Intravenous topotecan
Maltese: N-demethylated topotecan.
English: Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient self reports on an unblinded symptom scale assessment in each of these two studies.
Maltese: Topotecan orali jew ġol-vina kien assoċjat ma' palljazzjoni simili f'pazjenti b'SCLC sensittiv li rkadew fir-rapporti tal-pazjenti stess f'analiżi ta' skala sintomatika mhix inkonsapevoli f'kull wieħed minn dawn l-istudji.
English: As with other cytotoxic medicinal products, topotecan may cause foetal harm and therefore women of childbearing potential should be advised to avoid becoming pregnant during therapy with topotecan.
Maltese: Bħal fil-każ ta' prodotti mediċinali ċitotossiċi oħra, topotecan jista' jikkawża majelosuppressjoni severa.
English: Limited data indicate that the dose should be reduced in patients with moderate renal impairment.
Maltese: Tagħrif ristrett jindika li d-doża għandha titnaqqas f'pazjenti li għandhom indeboliment renali moderat.
English: How Topotecan Teva is prepared
Maltese: Kif jiġi preparat Topotecan Teva
English: Preclinical studies indicate plasma protein binding of topotecan is low (35 %) and distribution between blood cells and plasma was fairly homogeneous.
Maltese: Studji ta' qabel l-użu kliniku jindikaw li r-rabta ta' topotecan mal-proteini fil-plażma hi baxxa (35 %) u d-distribuzzjoni bejn iċ-ċelluli tad-demm u l-plażma hi pjuttost omoġenja.
English: respectively.
Maltese: pazjenti.
English: 1.5 mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.
Maltese: Jekk, waqt it-terapija bil-kombinazzjoni ta' topotecan/cisplatin il-kreatinina fis-serum taqbeż 1.5 mg/dl, huwa rakkomandat li l-informazzjoni sħiħa dwar preskrizzjoni tiġi konsultata għal parir dwar it-tnaqqis / kontinwazzjoni tad-doża ta' cisplatin.
English: Overall, 87 complete and partial responses were observed, with 13 of these occurring during cycles 5 and 6 and 3 occurring thereafter.
Maltese: Irriżulta illi kumplessivament, kienu osservati 87 rispons kompluti u parzjali, bi 13 minn dawn iseħħu bejn iċ-ċikli 5 u 6 u 3 jseħħu wara dan.
English: Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan plus BSC.
Maltese: Rapporti magħmula mill-pazjenti nfushom tas-sintomi b'eżami konsapevoli wrew xejra konsistenti ta' vantaġġ għal topotecan orali flimkien ma' BSC.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-kunjett wara EXP.
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 109/l) for seven days or more, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.25 mg/m2/day to 1.25 mg/m2/day (or subsequently down to 1.0 mg/m2/day if necessary).
Maltese: newtrofili < 0.5 x 109/l) għal sebat ijiem jew aktar, jew newtrofilja severa assoċjata ma' deni jew infezzjoni, jew li kellhom it-trattament tagħhom ittardjat minħabba newtropenja, id-doża għandha titnaqqas b'0.25 mg/m2/jum għal 1.25 mg/m2/jum (jew sussegwentement aktar baxxa għal 1.0 mg/m2/jum jekk meħtieġ).
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, Section 4.2).
Maltese: UŻU Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Relapsed ovarian cancer
Maltese: Kanċer ovarjan li rkada
English: Severe allergic (anaphylactic) reactions causing swelling of the lips, face or neck leading to severe difficulty in breathing, skin rash or hives, anaphylactic shock (a severe reduction in blood pressure, paleness, agitation, weak pulse, decreased consciousness).
Maltese: Rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000) Reazzjonijiet severi (anafilattiċi) li jistgħu jikkawżaw nefħa tax-xofftejn, il-wiċċ jew l-għonq li twassal biex ikun hemm diffikultà severa biex tieħu n-nifs, raxx tal-ġilda jew ħorriqija, xokk anafilattiku (tnaqqis sever fil-pressjoni tad-demm, sfurija, aġitazzjoni, polz baxx, koxjenza mnaqqsa).
English: A reduction in topotecan clearance was observed.
Maltese: Tnaqqis fittneħħija ta' topotecan kienet osservata.
English: The adverse events listed above have the potential to occur with a higher frequency in patients who have a poor performance status (see section 4.4).
Maltese: Ir-reazzjonijiet avversi elenkati hawn fuq għandhom il-potenzjal li jseħħu fi frekwenza ogħla f'pazjenti li għandhom stat ta' rendiment fqir (ara sezzjoni 4.4).
English: Gastrointestinal perforation
Maltese: TAL-PRODOTT MEDIĊINALI
English: KRKA - FARMA d.o.o.
Maltese: KRKA - FARMA d.o.o. V.
English: Date of first authorisation: 21 September 2009 Date of latest renewal: 8 May 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 21 ta' Settembru 2009 Data tal-aħħar tiġdid: 8 ta' Mejju 2014
English: Blister (OPA/Alu/PVC-Alu)
Maltese: Folja (OPA/Al/PVC-Al)
English: Proton Pump Inhibitors (PPI):
Maltese: Inibituri tal-Pompa Protonika (Proton Pump Inhibitors, PPI):
English: Excipients with known effect: Each film-coated tablet contains 108.125 mg lactose.
Maltese: Eċċipjenti b'effett magħruf Kull pillola fiha 108.125 mg lactose.
English: Blister (OPA/Alu/PVC-Alu) 3 years.
Maltese: Folja (OPA/Al/PVC-Al) 3 snin
English: Blister of OPA/Alu/PVC-Alu containing 7, 14, 28, 30, 50, 56, 60, 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, 60, 84, 90 u 100 pillola miksija b'rita fil-kaxxa.
English: Musculo skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Maltese: Emorraġija muskoluskeletriku (emartrosi), artrite, artralġja, majalġjia
English: Boxes of 7, 14, 28, 30, 50, 56, 60, 84, 90 and 100 film-coated tablets in blisters are available.
Maltese: Kaxxi disponibbli f'7, 14, 28, 30, 50, 56, 84, 90 u 100 pillola miksija b'rita ġo folji.
English: - The other ingredients are lactose (see section 2 ‘Clopidogrel BGR contains lactose'), microcrystalline cellulose, pregelatinised maize starch, macrogol 6000 and hydrogenated castor oil in the tablet core and hypromellose (E464), titanium dioxide (E171), red iron oxide (E172), talc and propylene glycol in the film-coating.
Maltese: - Is-sustanzi l-oħra fil-qalba tal-pillola huma lactose (ara sezzjoni 2 ‘Clopidogrel BGR fih lactose'), microcrystalline cellulose, pregelatinized maize starch, macrogol 6000, żejt ir-riġnu idroġenat u hypromellose (E464), titanium dioxide (E171), red iron oxide (E172), talc u propylene glycol fil-kisi tal-pillola.
English: A total of 99.7% of patients received fibrinolytics (fibrin specific: 68.7%, non- fibrin specific: 31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
Maltese: 31.1 %), 89.5% heparin, 78.7 % imblokkaturi beta, 54.7 % impedituri ACE u 63 % statins.
English: Laboratoires BIOGARAN 15, boulevard Charles de Gaulle 92707 Colombes Cedex France
Maltese: Laboratoires BIOGARAN 15, boulevard Charles de Gaulle 92707 Colombes Cedex Franza
English: Laboratoires BIOGARAN 15, boulevard Charles de Gaulle - 92707 Colombes Cedex, France
Maltese: Laboratoires BIOGARAN 15, boulevard Charles de Gaulle - 92707 Colombes Cedex, Franza
English: HDPE bottle
Maltese: Flixkun HDPE
English: What Clopidogrel BGR contains - The active substance is clopidogrel.
Maltese: X'fih Clopidogrel BGR - Is-sustanza attiva hi clopidogrel.
English: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Clopidogrel BGR contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Maltese: Clopidogrel BGR fih clopidogrel u jappartjeni għal grupp ta' mediċini li jissejħu prodotti mediċinali li jaġixxu kontra l-plejtlets.
English: There was an excess of intracranial bleeding in the clopidogrel + ASA treatment group compared to the placebo + ASA group (1.4% versus 0.8%, respectively).
Maltese: Kien hemm iżjed fsada ġewwa l-kranju fil-grupp ta' kura clopidogrel + ASA meta mqabbel malgrupp plaċebo + ASA (1.4% kontra 0.8%, rispettivament).
English: Do not take Clopidogrel BGR
Maltese: Tiħux Clopidogrel BGR
English: Clopidogrel BGR contains lactose
Maltese: Clopidogrel BGR fih lactose
English: • Severe hepatic impairment.
Maltese: - Indeboliment epatiku sever.
English: You should specifically tell your doctor if you take - medicines that may increase your risk of bleeding such as: - oral anticoagulants, medicines used to reduce blood clotting, - a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, - heparin or any other injectable medicine used to reduce blood clotting, - ticlopidine, other antiplatelet agent, - a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, - omeprazole or esomeprazole, medicines to treat upset stomach, - fluconazole or voriconazole, medicines to treat fungal infections, - efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections,
Maltese: Għandek speċifikament tgħid lit-tabib tiegħek jekk tieħu - mediċini li jistgħu jżidu r-riskju li inti jkollok xi fsada bħal: - sustanzi kontra l-koagulazzjoni tad-demm li jittieħdu mill-ħalq, mediċini li jraqqu d-demm, - mediċina li hija anti-infjammatorju li mhux sterojde, normalment użat biex jiġi ittrattat l-uġigħ u/jew kundizzjonijiet infjammatorji tal- muskoli jew tal-ġogi, - heparin jew xi mediċina oħra li tinjetta biex traqqaq id-demm, - ticlopidine, sustanzi oħra kontra l-plejtlets, - inibitur selettiv tal-ġbir mill-ġdid ta' serotonin (li jinkludi iżda mhux limitat għal fluoxetine jew fluvoxamine), mediċini li ssoltu jintużaw fil-kura tad-dipressjoni, - omeprazole jew esomeprazole, mediċini għat-taqlib tal-istonku - fluconazole jew voriconazole, mediċini li jittrattaw infezzjonijiet tal-fungu, - carbamazepine, mediċini li jittrattaw xi tip ta' epilessija,
English: Clopidogrel BGR contains lactose.
Maltese: Clopidogrel BGR fih lactose.
English: 30 film-coated tablets: EU/1/09/558/011 500 film-coated tablets: EU/1/09/558/012
Maltese: EU/1/09/558/011 500 pillola miksija b'rita:
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopiodgrel BGR (4 tablets of 75 mg) once at the start of treatment.
Maltese: Jekk kellek uġigħ sever f'sidrek (anġina instabbli jew attakk tal-qalb), it-tabib jista' jagħtik 300 mg ta' Clopidogrel BGR (4 pilloli ta' 75 mg) fil-bidu tal-kura.
English: Inconsistent data on the clinical implications of this pharmacokinetic (PK)/pharmacodynamic (PD) interaction in terms of major cardiovascular events have been reported from both observational and clinical studies.
Maltese: Informazzjoni inkonsistenti dwar l-implikazzjonijiet kliniċi ta' din l-interazzjoni farmakokinetika (PK)/farmakodinamika (PD) f'termini ta' avvenimenti kardjovaskulari ewlenin ġew irrapportati sew millosservazzjoni kif ukoll mill-istudji kliniċi.
English: HDPE bottle (volume: 150 ml), PP closure with a desiccant: 500 film-coated tablets in a box.
Maltese: Flixkun HDPE (volum ta' 150 ml), għatu tal-PP b'dessikant: 500 pillola miksija b'rita ġo kaxxa.
English: HDPE bottle (volume: 15 ml), PP closure with a desiccant: 30 film-coated tablets in a box.
Maltese: Flixkun HDPE (volum ta' 15 ml), għatu tal-PP b'dessikant: 30 pillola miksija b'rita ġo kaxxa.
English: As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors, or selective serotonin reuptake inhibitors (SSRIs), or other medicinal products associated with bleeding risk such as pentoxifylline (see section 4.5).
Maltese: Bħal fil-każ ta' sustanzi oħra kontra l-plejtlets, clopidogrel għandu jintuża b'kawtela f'pazjenti li jista' jkollhom riskju ta' iktar dmija minn trawma, operazzjoni jew kundizzjonijiet patoloġiċi oħra u pazjenti li jkunu qed jirċievu l-kura b'ASA, heparin, inibituri ta' glycoprotein IIb/IIIa jew mediċini kontra l-infjammazzjoni li m'humiex sterojdi (NSAIDs) li jinkludu linibituri ta' Cox-2, jew inibituri selettivi tal-ġbir mill-ġdid ta' serotonin (SSRIs), jew prodotti mediċinali marbuta ma' riskju ta'fsada bħal pentoxifylline (ara sezzjoni 4.5).
English: Clopidogrel BGR 75 mg film-coated tablets
Maltese: Clopidogrel BGR 75 mg pilloli miksija b'rita
English: Clopidogrel BGR 75 mg film-coated tablets clopidogrel
Maltese: Clopidogrel BGR 75 mg pilloli miksija b'rita Clopidogrel
English: Bleeding events defined as all BARC occurred in 30 patients (9.3%) in the de-escalated DAPT group and in 76 patients (23.5%) in the unchanged DAPT group (p<0.01).
Maltese: pazjent (9.3%) fil-grupp ta' DAPT ta' tnaqqis fil-qawwa u f'76 pazjenti (23.5%) fil-grupp ta' DAPT mingħajr tibdil (p<0.01)
English: In patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily).
Maltese: - Sindromu koronarju akut bis-segment mhux ST elevat (anġina mhux stabbli jew infart mijokarijaku mhux mewġa Q): it-trattament b'clopidogrel għandu jiġi mibdi b'doża inizjali waħda ta' 300 mg (4 pilloli ta' 75 mg kollha flimkien) u mbagħad jitkompla b'75 mg darba kuljum (b'acetylsalicylic acid
English: Serum sickness, anaphylactoid reactions cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population)*
Maltese: * , sindromu awtoimmunitarju talinsulina, li jista' jwassal għal ipogliċemija severa speċjalment f'pazjenti bissottotip HLA DRA4 (aktar frekwenti fil-popolazzjoni Ġappuniża)*
English: Other medicines and Clopidogrel BGR
Maltese: Mediċini oħra u Clopidogrel BGR
English: For blister
Maltese: TA' EĊĊIPJENTI
English: Other concomitant therapy: Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Maltese: Billi clopidogrel sa ċertu punt jiġi metabolizzat għall-metabolit attiv tiegħu minn CYP2C19, l-użu ta' mediċini li jimpedixxu l-attività ta' dan l-enzim huma mistennija li jirriżultaw f'livelli mnaqqsa tal-metabolit attiv ta' clopidogrel Ir-rilevanza klinika ta' din l-interazzjoni hija inċerta.
English: 30 film-coated tablets 500 film-coated tablets
Maltese: 30 pillola miksija b'rita 500 pillola miksija b'rita
English: Haematuria
Maltese: Jastrebarsko
English: Clopidogrel BGR 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 BGR jittieħed mill-adulti biex 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: 500 film-coated tablets
Maltese: 500 pillola miksija b'rita
English: film-coated tablet
Maltese: TAL-PRODOTT MEDIĊINALI
English: Secondary prevention of atherothrombotic events
Maltese: Il-prevenzjoni ta' avvenimenti aterotrombotiċi u tromboemboliċi f'fibrillazzjoni atrijali
English: 23 May 2011
Maltese: 23 ta' Mejju 2011
English: It is authorised in Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and United Kingdom.
Maltese: Huwa awtorizzat fl-Awstrija, fil-Belġju, fil-Bulgarija, f'Ċipru, fir-Repubblika Ċeka, fid-Danimarka, fl-Estonja, fil-Finlandja, fi Franza, fil-Ġermanja, fil-Greċja, flUngerija, fl-Islanda, fl-Italja, fil-Latvja, fil-Litwanja, fil-Lussemburgu, f'Malta, fil-Pajjiżi l-Baxxi, finNorveġja, fil-Polonja, fil-Portugall, fir-Rumanija, fis-Slovakkja, fis-Slovenja, fi Spanja, fl-Isvezja u firRenju Unit.
English: The European Medicines Agency has completed a review of Octagam triggered by reports of serious thromboembolic events.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni ta' Octagam wara rapporti ta' avvenimenti tromboemboliċi serji.
English: Octagam is made by Octopharma.
Maltese: Octagam huwa magħmul minn Octopharma.
English: These events were thought to be related to problems with the medicine's manufacture, and included stroke, myocardial infarction (heart attack) and pulmonary embolism (clot in a blood vessel supplying the lungs).
Maltese: Dawn l-avvenimenti kienu maħsuba li kienu relatati ma' problemi fil-manifattura tal-mediċina, u kienu jinkludu puplesija, infart mijokardijaku (attakk tal-qalb) u emboliżmu pulmonari (embolu fil-vina jew l-arterja li jissupplixxu l-pulmuni).
English: Questions and answers on the suspension of the marketing authorisations for Octagam (human normal immunoglobulin 5% and 10%)
Maltese: Mistoqsijiet u tweġibiet dwar is-sospensjoni talawtorizzazzjonijiet għat-tqegħid fis-suq għal Octagam (immunoglobulina normali umana 5% u 10%)
English: The CHMP reviewed the reported thromboembolic events and looked at evidence related to the medicine's safety.
Maltese: Is-CHMP irreveda l-avvenimenti tromboemboliċi rrapportati u ħares lejn l-evidenza relatata massigurtà tal-mediċina.
English: Human normal immunoglobulins are antibodies (types of protein) normally found in the blood that help the body to fight infections and other diseases.
Maltese: L-imunoglobulini normali umani huma antikorpi (tipi ta' proteini) li normalment jinstabu fid-demm li jgħinu lill-ġisem jiġġieled l-infezzjonijiet u mard ieħor.
English: The suspension will remain in place until the problem has been rectified.
Maltese: Is-sospensjoni sejra tibqa' fis-seħħ sakemm il-problema tiġi rranġata.
English: This follows an unexpectedly high number of reports of serious thromboembolic events (problems due to the formation of blood clots in the blood vessels) in patients taking the medicine.
Maltese: Dan seħħ wara numru għoli mhux mistenni ta' rapporti ta' avvenimenti tromboemboliċi serji (problemi minħabba l-formazzjoni ta' emboli fil-vini u larterji) f'pazjenti li kienu qegħdin jieħdu l-mediċina.
English: The CHMP noted that, based on the available information, there was clear evidence of a recent increase in thromboembolic events associated with Octagam but that the exact cause of the problems could not be identified with certainty.
Maltese: Is-CHMP innota li, fuq il-bażi tal-informazzjoni disponibbli, kien hemm evidenza ċara ta' żieda reċenti fl-avvenimenti tromboemboliċi assoċjati ma' Octagam iżda li l-kawża eżatta tal-problemi ma setgħetx tiġi identifikata b'ċertezza.
English: In September 2010, the German and Swedish medicines regulatory agencies suspended marketing authorisations for Octagam.
Maltese: F'Settembru 2010, l-aġenziji regolatorji tal-mediċini Ġermaniżi u Svediżi ssospendew lawtorizzazzjonijiet għat-tqegħid fis-suq għal Octagam.
English: The European Commission issued a decision on this opinion on 23 May 2011.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni dwar din l-opinjoni fit-23 ta' Mejju 2011.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that all marketing authorisations for the medicine be suspended throughout the European Union (EU) and that Octagam currently on the market be recalled.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija rrakkomanda li l-awtorizzazzjonijiet għat-tqegħid fis-suq kollha għall-mediċina jiġu sospiżi madwar lUnjoni Ewropea (UE) u li Octagam attwalment fis-suq jiġi rtirat.
English: As required by Article 107, the German and Swedish agencies informed the CHMP of their actions so that the Committee could prepare an opinion on whether the marketing authorisations for Octagam should be maintained, changed, suspended or withdrawn across the EU.
Maltese: Kif mitlub mill-Artikolu 107, l-aġenziji Ġermaniżi u Svediżi nfurmaw lis-CHMP bl-azzjonijiet tagħhom sabiex il-Kumitat seta' jħejji opinjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għal Octagam għandhomx jinżammu, jinbidlu, jiġu sospiżi jew irtirati madwar l-UE.
English: EMA/CHMP/328573/2014 EMEA/H/C/001227
Maltese: EMEA/H/C/001227
English: It is available as tablets (10, 15 and 20 mg).
Maltese: Jiġi f'għamla ta' pilloli (10, 15 u 20 mg).
English: Leflunomide medac EMA/CHMP/328573/2014
Maltese: Leflunomide medac EMA/265372/2014
English: The full EPAR for Leflunomide medac 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: The active substance in Leflunomide medac, leflunomide, is an immunosuppressant.
Maltese: Is-sustanza attiva f'Leflunomide medac, il-leflunomide, hija immunosuppressant.
English: The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis.
Maltese: Id-doża ta' manteniment rakkomandata hija 10 sa 20 mg darba kuljum f'pazjenti b'artrite rewmatika, u 20 mg darba kuljum f'pazjenti b'artrite psorjatika.
English: Leflunomide medac is a ‘generic medicine'.
Maltese: Leflunomide medac hija ‘mediċina ġenerika'.