FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine contains 11.1 mg sodium (main component of cooking/table salt) in each vial.
Maltese: Din il-mediċina fiha 11.1 mg ta' sodium (il-komponent ewlieni tal-melħ tat-tisjir/melħ tal-mejda) f'kull kunjett.
English: Patients treated with idursulfase may develop infusion-related reactions (see section 4.8).
Maltese: Pazjenti ittrattati b'idursulfase jistgħu jiżviluppaw reazzjonijiet assoċjati ma' l-infużjoni (ara sezzjoni 4.8).
English: The infusion will normally last for 1 to 3 hours and will be given every week.
Maltese: L-infużjoni normalment iddum bejn siegħa u 3 sigħat u tingħata kull ġimgħa.
English: There is no known interaction of this medicine with other medicines.
Maltese: Mhux magħruf li din il-mediċina tinteraġixxi ma' mediċini oħra.
English: • Flushing (redness)
Maltese: • Reazzjonijiet allerġiċi serji
English: Each vial of Elaprase is intended for single use only and contains 6 mg of idursulfase in 3 ml of solution.
Maltese: Kull kunjett ta' Elaprase huwa intenzjonat sabiex jintuża darba biss u fih 6 mg ta' idursulfase f'soluzzjoni ta' 3 ml.
English: Patients who developed a high titre of antibodies displayed less response to idursulfase as assessed by urine output of glycosaminoglycans and by liver and spleen size.
Maltese: Pazjenti li żviluppaw titre għoli ta' antikorpi urew rispons inqas għal idursulfase kif ivvalutat milleliminazzjoni ta' glycosaminoglycans fl-awrina u mid-daqs tal-fwied u tal-milsa.
English: • Dizziness, tremor
Maltese: • Qtugħ ta' nifs, tħarħir
English: Among patients who were originally randomised to weekly idursulfase in TKT024, mean maximum improvement in distance walked during six minutes occurred at Month 20 and mean percent predicted FVC peaked at Month 16.
Maltese: Fost il-pazjenti li oriġinalment ġew randomizzati għal idursulfase kull ġimgħa f'TKT024, it-titjib massimu medju fid-distanza li mxew matul sitt minuti seħħ f'Xahar 20 u l-FVC perċentwali medju mbassar laħaq il-massimu f'Xahar 16.
English: It is recommended to deliver the total volume of infusion using a 0.2 µm in line filter.
Maltese: Huwa rakkomandat li tagħti l-volum totali tal-infużjoni permezz ta' filtru ta' 0.2 µm fil-linja.
English: Paediatric population The dose for children and adolescents is the same as for adults, 0.5 mg/kg body weight weekly.
Maltese: Id-doża fit-tfal u l-adolexxenti hija l-istess bħal dik għall-adulti, 0.5 mg/kg piż tal-ġisem kull ġimgħa.
English: Adverse reactions that were reported for the 32 patients treated with 0.5 mg/kg idursulfase weekly in the TKT024 phase II/III 52-week placebo-controlled study were almost all mild to moderate in severity.
Maltese: Ir-reazzjonijiet avversi li ġew irrapportati għat-32 pazjent ittrattati b'0.5 mg/kg idursulfase fil-ġimgħa fl-istudju TKT024 fażi
English: Statistically significant increases from treatment baseline in absolute FVC volume were seen at most visits for all treatment groups combined and for each of the prior TKT024 treatment groups.
Maltese: Żidiet statistikament sinifikanti mil-linja bażi tal-kura f'volum FVC assolut dehru f'ħafna miż-żjarat għall-gruppi ta' kura kollha u għal kull wieħed mill-gruppi ta' kura TKT024 preċedenti.
English: Excipient with known effect Each vial contains 0.482 mmol of sodium.
Maltese: 482 mmol ta' sodium.
English: BACKGROUND INFORMATION
Maltese: Data
English: European Medicines Agency Evaluation of Medicines for Human Use
Maltese: GĦAMLA FARMAĊEWTIKA
English: London, 23 October 2007 EMEA/338591/2007
Maltese: Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spanja
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: Il-punti tan-nuqqas ta' qbil li wasslu għal din il-proċedura ta' referenza taħt l-Artikolu 29(4) tadDirettiva 2001/83/KE kellhom x'jaqsmu ma': 1- L-indikazzjoni terapewtika li kellha tiġi estiża għal pazjenti li m'għandhomx kanċer li jsofru minn uġigħ kroniku qawwi 2- L-għażla ta' tabella(i) ta' konverżjoni li għandhom jiġu inklużi fis-Sommarju tal-Karatteristiċi tal-Prodotti (SPC) 3- Jekk it-treddigħ u l-ko-amministrazzjoni ma' agonisti parzjali ta' l-opijojdi għandhomx ikunu kontra-indikati 4- L-istudji tal-bijoekwivalenza meħtieġa biex juru l-ekwivalenza mal-prodott ta' referenza
English: 1 Article 29(4) of Directive 2001/83/EC, as amended.
Maltese: <DE/H/0739/02/MR>
English: The Rapporteur was Dr Karl Broich and Co-Rapporteur was Dr Eric Abadie.
Maltese: Mhux komuni: takikardija, bradikardija.
English: Ratiopharm GmbH submitted applications for mutual recognition of Fentanyl-ratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names, transdermal patch on the basis of the marketing authorisation granted by Germany 04 April 2006.
Maltese: Fentanyl ratiopharm 75 µg/h, dispositif transdermique L-Olanda Fentanyl ratiopharm 75 µg/uur, pleister voor transdermaal gebruik Ir-Renju Unit Telfanyl 75 microgram/hr Transdermal patch
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Fentanyl-ratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names International Non-Proprietary Name (INN): fentanyl
Maltese: Fentanyl ratiopharm 25 µg/h, dispositif transdermique L-Olanda Fentanyl ratiopharm 25 µg/uur, pleister voor transdermaal gebruik Ir-Renju Unit Telfanyl 25 microgram/hr Transdermal patch
English: This refers to the extension of the indication to non-cancer patients, the choice of conversion tables, whether contraindication for breastfeeding and for interactions with partial agonist opioids should be given inn the product information and the studies needed to demonstrate bioequivalence with the reference medicinal product.
Maltese: Sinjali ta' tossiċita' huma sedazzjoni qawwija, ataxia, miosis, konvulżjonijiet u dipressjoni respiratorja, b'dan ta' l-aħħar ikun is-sintomu ewlieni.
English: Fentanyl-ratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names, is an opioid analgesic which is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.
Maltese: F'dan il-kuntest, il-CHMP aċċetta l-indikazzjoni “Uġigħ kroniku qawwi li jista' jkun adegwatament immaniġjat biss b'analġeżiċi opijojdi”.
English: During their July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Fentanylratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Maltese: Barra minn hekk, l-anzjani jistgħu ikunu aktar sensittivi għas-sustanza attiva minn pazjenti iżgħar minnhom. Madankollu, minn studji li saru bl-użu tal-Fentanyl transdermal patch f'pazjenti anzjani, irriżulta li ma kienx hemm differenza sinjifikanti fil-parametri farmakokinetiċi ħdejn pazjenti żgħar, għalkemm il-konċentrazzjonijiet fisserum kellhom tendenza li jkunu ogħla.
English: Significant difference has been identified with regard to the proposed indication, posology and contraindications in the product information and the demonstration of bioequivalence and this was considered to be of serious public health concern.
Maltese: ħsibijiet delużjonali, eċċitament eċċessiv, astenja, dipressjoni, ansjeta', konfużjoni, anormalita' fil-funzjoni sesswali, sintomi assoċjati mal-waqfien mill-kura.
English: Revestive contains the active substance teduglutide.
Maltese: Revestive fih is-sustanza attiva teduglutide.
English: The full EPAR for Revestive 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: Other information about Revestive
Maltese: Informazzjoni oħra dwar Revestive
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Revestive can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This is a summary of the European public assessment report (EPAR) for Revestive.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Revestive.
English: The active substance in Revestive, teduglutide, is similar to human glucagon-like peptide 2 (GLP-2), a hormone made in the gut that increases absorption of nutrients from the intestine.
Maltese: Is-sustanza attiva f'Revestive, it-teduglutide, hija simili għall-glucagon bħal peptide-2 (GLP-2) uman, ormon magħmul fl-imsaren li jżid l-assorbiment ta
English: Why is Revestive approved?
Maltese: Għaliex ġie approvat Revestive?
English: Because the number of patients with the condition is low, the disease is considered ‘rare', and Revestive was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 December
Maltese: Minħabba li n-numru ta' pazjenti li għandhom il-kondizzjoni huwa wieħed baxx, il-marda hija kkunsidrata bħala ‘rari', u Revestive ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fil-11 ta
English: This compares with 30% (13 out of 43) of those given placebo (a dummy treatment).
Maltese: ᾿ 30% (13 minn 43) ta᾿ dawk li ngħataw il
English: The most commonly reported side effects with Revestive (which may occur in more than 1 in 10 patients) were respiratory tract infections (infections of the throat, sinuses, airways or lungs), headache, belly ache and swollen stomach, nausea, vomiting, and reddening, pain or swelling at the site of the injection.
Maltese: 10 pazjenti) kienu infezzjonijiet fl-apparat respiratorju (infezzjonijiet fil-gerżuma, fis-sinus, fil-passaġġi tal-arja jew fil-pulmun), u
English: In a second study in children, 53% (8 out of 15) of those who received Revestive had their parenteral nutrition at 12 weeks reduced by at least a tenth, while none (0 out of 5) of the patients who received a standard treatment achieved the same.
Maltese: Fit-tieni studju fit-tfal, 53% (8 minn 15) ta i ngħataw Revestive kellhom in-nutrizzjoni parenterali mnaqqsa wara 12-il
English: Patients with short bowel syndrome are usually given nutrients as an infusion directly into their veins (parenteral nutrition).
Maltese: Il-pazjenti bis-sindromu tal-musrana ż-żgħira ġeneralment jingħataw nutrijenti bħala infużjoni direttament fil-vini (nutrizzjoni parenterali).
English: What are the risks associated with Revestive?
Maltese: X'inhuma r-riskji assoċjati ma' Revestive?
English: Revestive teduglutide
Maltese: It-teduglutide ta ħdem b
English: Revestive is a medicine for treating short bowel syndrome (or short gut) in adults and children aged 1 year and above.
Maltese: Revestive huwa mediċina għall-kura tas-sindromu tal-musrana ż-żgħira (musrana qasira) fl-adulti u ttfal minn 1 (sena)
English: Teduglutide has the advantage of lasting longer than GLP-2 in the body.
Maltese: It-teduglutide għandha l-vantaġġ li ddum aktar minn GLP-2 fil-ġisem.
English: In addition, patients with a stoma (an artificial opening at the front of the abdomen to collect faeces or urine) commonly experienced complications, such as swelling of the stoma.
Maltese: -addome biex jinġabru l-feċi u l-awrina mill-ġisem) ġeneralment esperjenzaw komplikazzjonijiet bħal nefħa fl-istoma.
English: Short bowel syndrome is a condition in which nutrients and fluids are not properly absorbed by the gut, usually because a large part of the intestine has been surgically removed.
Maltese: Is-sindromu tal-musrana ż-żgħira huwa kondizzjoni li fiha n-nutrijenti u l-fluwidi ma jiġux assorbiti sewwa mill-imsaren, ġeneralment wara t-tneħħija kirurġika ta' biċċa kbira mill-musrana.
English: The CHMP therefore concluded that Revestive's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP għaldaqstant ikkonkluda li l-benefiċċji ta' Revestive huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Teduglutide works in a similar way to GLP-2 and increases intestinal absorption by: increasing blood flow to and from the gut, reducing the speed at which food passes through and reducing acid secretions in the stomach which can interfere with absorption in the intestine.
Maltese: ᾿mod simili għall tad-demm minn u lejn l-imsaren, tnaqqas il-veloċità li biha jgħaddi l-ikel u tnaqqas it-tnixxijiet talaċidu fl-istonku li jistgħu jinterferixxu mal-assorbiment fil-musrana.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku teduglutide
English: For the full list of all side effects reported with Revestive, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Revestive, ara l-fuljett ta' tagħrif.
English: If a benefit is not observed, treatment should be stopped.
Maltese: Jekk ma jiġix osservat benefiċċju, il-kura għandha titwaqqaf.
English: Furthermore, Revestive showed an acceptable safety profile.
Maltese: ᾿ sigurtà aċċettabbli.
English: The protocol shall be submitted to the National Competent Authorities:
Maltese: Il-protokoll għandu jiġu sottomess lill-Awtoritajiet Nazzjonali Kompetenti:
English: Each Marketing Authorisation Holder of adrenaline auto-injectors shall perform a PK/PD study to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via their adrenaline auto-injector device.
Maltese: Kull Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ta' injetturi awtomatiċi tal-adrenalina għandu jwettaq studju PK/PD sabiex jifhem l-influwenza ta' fatturi differenti fuq id-distribuzzjoni, lespożizzjoni u l-attività tal-adrenalina meta tingħata permezz talapparat b'injettur awtomatiku tal-adrenalina tagħhom.
English: The Marketing Authorisation Holders of adrenaline auto-injectors shall submit to the National Competent Authorities a Risk Management Plan containing key elements as described in the CHMP assessment report (including educational materials).
Maltese: Id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq tal-injetturi awtomatiċi tal-adrenalina għandhom jissottomettu lill-Awtoritajiet Nazzjonali Kompetenti, Pjan ta' Ġestjoni tar-Riskju li jkun jinkludi lelementi ewlenin kif deskritt fir-rapport ta' valutazzjoni tas-CHMP (inkluż materjal edukattiv).
English: National Competent Authorities of Member States or Reference Member State(s), if applicable, shall ensure that the following conditions are fulfilled by the MAHs:
Maltese: L-Awtoritajiet Nazzjonali Kompetenti tal-Istati Membri jew tal-Istat(i) Membru/Membri ta' Referenza, jekk ikun applikabbli, għandhom jiżguraw li l-MAHs jissodisfaw il-kundizzjonijiet li ġejjin:
English: Further information on the HMPC assessment of chicory root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini tal-għerq taċ-ċikwejra, inklużi d-dettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Chicory root EMA/HMPC/286842/2013
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The HMPC conclusions on the use of chicory root medicines for the relief of symptoms of mild digestive disorders and temporary loss of appetite are based on their ‘traditional use'.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu ta' mediċini tal-għerq taċ-ċikwejra għas-solliev tas-sintomi ta' disturbi diġestivi ħfief u ta' telf temporanju tal-aptit huma bbażati fuq l-‘użi tradizzjonali' tagħhom.
English: In addition, the HMPC considered that chicory rood contains bitter substances that may stimulate appetite and also a study in the laboratory, which showed an effect of chicory root in stimulating an increased secretion of bile (a fluid produced in the liver that helps to break down fats), thereby supporting its use in digestive disorders.
Maltese: L-HMPC ikkonkluda li, fuq il-bażi tal-użu antik u stabbilit tiegħu, l-għerq taċ-ċikwejra jista' jintuża għas-solliev ta' sintomi ta' disturbi diġestivi ħfief (bħal meta tħossok mimli, gass fl-istonku u diġestjoni bil-mod) u telf temporanju tal-aptit.
English: Further information on the risks associated with chicory root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini tal-għerq taċ-ċikwejra, inklużi l-prekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku tal-Aġenzija:
English: Chicory root is the common name for the root of the plant Cichorium intybus L. The plant is cultivated or gathered to obtain the root for medicinal use.
Maltese: Fil-valutazzjoni tiegħu, l-HMPC ikkunsidra l-użu dokumentat tajjeb tal-għerq taċ-ċikwejra fid-disturbi diġestivi u t-telf tal-aptit.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of chicory root.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali tal-għerq taċ-ċikwejra.
English: (See section 4.5.)
Maltese: (Ara sezzjoni 4.5.)
English: Gastrointestinal (GI)
Maltese: Gastrointestinali (GI)
English: Rhone 69800, France
Maltese: Rhone 69800, Franza
English: 117 Allee Des Parcs, St Priest,
Maltese: 117 Allee Des Parcs, St.
English: 117 Allée des Parcs, 69 800 Saint Priest, France
Maltese: 117 Allée des Parcs, 69 800 Saint Priest, Franza
English: Cytochrome P450 2C19 (CYP2C19)
Maltese: Ċitokromu P450 2C19 (CYP2C19)
English: Acetylsalicylic acid (ASA):
Maltese: Acetylsalicilyic acid (ASA):
English: Glycerol monocaprylocaprate (E422) Sodium lauril sulfate
Maltese: Glycerol Monocaprylocaproate (E422) Sodium lauril sulfate
English: Poly (vinyl alcohol) (partially hydrolysed) Titanium dioxide (E171)
Maltese: Poly(vinyl alcohol) (parzjalment idrolizzat) Titanium dioxide (E171)
English: Thrombocytopenia, leucopenia, eosinophilia
Maltese: Tromboċitotopenija, lewkopenija, eosinofilja
English: New cardiovascular events (primary endpoint) were prevented, with relative risk reductions of 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) and 14% (CI: -31.6, 44.2), during the 0-1, 1-3, 3-6, 6-9 and 9-12-month study intervals, respectively.
Maltese: Avvenimenti kardjovaskulari ġodda (punt aħħari primarju) ġew evitati, bi tnaqqis fir-riskju relattiv ta' 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: −26.9, 26.7), 6% (CI: −33.5, 34.3) u 14% (CI: −31.6, 44.2), matul l-intervalli tal-istudji ta' 0-1, 1-3, 3-6, 6-9 u 912-il xahar, rispettivament.
English: • Severe renal impairment (creatinine clearance <30 ml/min).
Maltese: • Indeboliment renali sever (tneħħija tal-kreatinina <30 ml/min).
English: Croscarmellose sodium Hydroxypropylcellulose Colloidal anhydrous silica Talc
Maltese: Croscarmellose sodium Hydroxypropylcellulose Silica anidrat kollojdali
English: Hydrogenated castor oil Starch pregelatinized Stearic acid
Maltese: Castor oil idroġenat Starch preġelatinizzat Stearic acid
English: Mylan Denmark ApS Tel: +45 28 11 69 32
Maltese: Mylan Denmark ApS Tlf: +45 28 11 69 32
English: Doses of 100-500 mg/day:
Maltese: Dożi ta' 100 - 500 mg/kuljum:
English: Glycoprotein IIb/IIIa inhibitors
Maltese: Inibituri ta' Glycoprotein IIb/IIIa
English: • anti-retroviral medicines (medicines used to treat HIV infections)
Maltese: • mediċini anti-retrovirali (mediċini użati għat-trattament ta' infezzjonijiet tal-HIV)
English: McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Maltese: McDermott Laboratories Limited tagħmel il-kummerċ bħala Gerard Laboratories tagħmel il-kummerċ bħala Mylan Dublin, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, l-Irlanda.
English: Proton Pump Inhibitors (PPI)
Maltese: Inibituri tal-Pompa Protonika (PPI)
English: Low doses (up to 100 mg/day):
Maltese: Dożi baxxi (sa 100 mg/kuljum):
English: Mylan S.A.S Tel: +33 4 37 25 75 00
Maltese: Mylan S.A.S Tél : +33 4 37 25 75 00
English: The use of clopidogrel in CURE was associated with a decrease in the need for thrombolytic therapy (RRR = 43.3%; CI: 24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR = 18.2%; CI: 6.5%, 28.3%).
Maltese: L-użu ta' clopidogrel fi CURE ġie assoċjat ma' tnaqqis fil-ħtieġa ta' kura trombolitika (RRR = 43.3%; CI: 24.3%, 57.5%) u inibituri ta' GPIIb/IIIa (RRR = 18.2%; CI: 6.5%, 28.
English: Mylan Healthcare Sp. z o.o.
Maltese: Mylan Healthcare d.o.o.
English: • probenecid, benzbromarone, or sulfinpyrazone, medicines used to treat gout,
Maltese: • probenecid, benzbromarone, jew sulfinpyrazone, mediċini użati għat-trattament tal-gotta,
English: The patient population included 19.7% women and 29.2% patients ≥65 years.
Maltese: Ilgrupp ta' pazjenti studjati kien jinkludi 19.7% nisa u 29.2% pazjenti ≥65 sena.
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: It-total ta' 99.7% talpazjenti rċevew is-sustanzi fibrinolitiċi (speċifiċi ghall-fibrina: 68.7%, mhux speċifiċi għall-fibrina: 31.1%), 89.5% eparina, 78.7% beta blokkanti, 54.7% inibituri ACE u 63% statins.
English: Mylan Hungary Kft, Mylan utca 1, Komárom, H-2900, Hungary.
Maltese: Komárom, Mylan utca 1, Komárom, L-Ungerija.
English: The CLARITY trial included 3,491 patients presenting within 12 hours of the onset of a ST elevation MI and planned for thrombolytic therapy.
Maltese: Il-prova CLARITY inkludiet 3,491 pazjenti li ppreżentaw fi żmien 12il siegħa mill-bidu ta' infart mijokardijaku b'ST elevat, fejn kien ippjanat li tingħata t-terapija trombolitika.
English: Thrombotic Thrombocytopenic Purpura (TTP)
Maltese: Purpura Trombotika Tromboċitopenika (PTT)
English: Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenza tagħhom hija definita skont il-konvenzjonijiet li ġejjin: komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The population included 27.8% women, 58.4% patients ≥60 years (26% ≥70 years) and 54.5% patients who received fibrinolytics.
Maltese: Il-grupp studjat inkluda 27.8% nisa, 58.4% pazjenti ≥60 sena (26% ≥70 sena) u 54.5% talpazjenti li rċevew is-sustanzi fibrinolitiċi.
English: Tablet core: microcrystalline cellulose, lactose (see section 2 ‘Clopidogrel/Acetylsalicylic acid Mylan contains lactose'), croscarmellose sodium, hydroxypropylcellulose, colloidal anhydrous silica, talc, hydrogenated castor oil, pregelatinized starch, stearic acid, iron oxide yellow (E172).
Maltese: - Qalba tal-pillola: microcrystalline cellulose, lactose (ara sezzjoni 2 ‘Clopidogrel/Acetylsalicylic acid Mylan fih lactose'), croscarmellose sodium, hydroxypropylcellulose, colloidal anhydrous silica, talc, hydrogenated castor oil, starch preġelatinizzat, stearic acid, iron oxide isfar (E172).
English: Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
Maltese: Alleli oħra assoċjati ma' metaboliżmu assenti jew imnaqqas jinkludu CYP2C19*4, *5, *6, *7, u *8.
English: Other interactions with clopidogrel and ASA
Maltese: Interazzjonijiet oħra b'clopidogrel u ASA