FrancophonIA/ELRC3.0 huggingface dataset:
English: In humans, lorlatinib undergoes oxidation and glucuronidation as the primary metabolic pathways.
Maltese: Fil-bnedmin, il-passaġġi metaboliċi primarji ta' lorlatinib huma ossidazzjoni u glukuronidazzjoni.
English: The Eastern Cooperative Oncology Group (ECOG) performance status at baseline was 0 or 1 in 96% patients.
Maltese: F'96% tal-pazjenti l-istatus tal-prestazzjoni tal-Grupp tal-Onkoloġija Kooperattiva tal-Lvant (ECOG, Eastern Cooperative Oncology Group) fil-linja bażi kien ta' 0 jew ta' 1.
English: The most common speech effect of any grade was dysarthria (4.1%), and the most common Grade 3 or 4 reaction was slow speech (0.3%).
Maltese: L-aktar effett fuq id-diskors komuni ta' kwalunkwe grad kien disartrija (4.1%), u l-aktar reazzjoni komuni tal-Grad 3 jew 4 kienet diskors bil-mod (0.3%).
English: Of these, 7 patients had a baseline PR > 200 msec.
Maltese: Minn dawn, 7 pazjenti kellhom PR ta' > 200 msec fil-linja bażi.
English: Information for lorlatinib use in patients with severe (CLcr: < 30 mL/min) renal impairment is very limited.
Maltese: L-informazzjoni dwar l-użu ta' lorlatinib f'pazjenti b'indeboliment tal-kliewi sever (CLcr: < 30 mL/min) hija limitata ħafna.
English: (N = 111)
Maltese: a bi jew mingħajr kimoterapija preċedenti (N = 111)
English: Life-threatening hypercholesterolaemia (cholesterol over 500 mg/dL or over 12.92 mmol/L)
Maltese: Iperkolesterolemija ta' periklu għall-ħajja (kolesterol ta' aktar minn 500 mg/dL jew ta' aktar minn 12.92 mmol/L)
English: No dose adjustment is needed for patients with normal renal function and mild or moderate (CLcr: ≥ 30mL/min) renal impairment based on a population pharmacokinetic analysis.
Maltese: ≥ 30mL/min) abbażi ta' analiżi farmakokinetika tal-popolazzjoni.
English: In vitro studies indicated that lorlatinib is a time-dependent inhibitor as well as an inducer of CYP3A4/5 and it activates the human pregnane-X-receptor (PXR), with the net effect in vivo being induction.
Maltese: Studji in vitro indikaw li lorlatinib huwa inibitur dipendenti fuq il-ħin kif ukoll induttur ta' CYP3A4/5 u jattiva r-riċettur tal-bniedem pregnane-X- (PXR), bl-effett nett in vivo jkun ta' induzzjoni.
English: Due to the limited data on this population, no dose recommendation can be made for patients aged 65 years and older (see section 5.2).
Maltese: Minħabba d-data limitata f'din il-popolazzjoni, ma tista' ssir l-ebda rakkomandazzjoni dwar id-doża għal pazjenti ta' aktar minn 65 sena (ara sezzjoni 5.2).
English: - cough, chest pain, or a worsening of existing respiratory symptoms.
Maltese: - sogħla, uġigħ fis-sider, qtugħ ta' nifs, jew aggravar ta' sintomi respiratorji eżistenti.
English: b Lipid-lowering therapy may include: HMG CoA reductase inhibitor, nicotinic acid, fibric acid derivatives, or ethyl esters of omega-3 fatty acids.
Maltese: Inibitur tal-HMG CoA reductase, aċidu nikotiniku, derivattivi talaċidu fibriku, jew esteri etiliċi ta' aċidi xaħmin ta' omega-3.
English: Metabolism and nutrition disorders Hypercholesterolaemiaa Hypertriglyceridaemiab
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Iperkolesterolemija
English: If a strong CYP3A4/5 inhibitor must be concomitantly administered, a dose reduction of lorlatinib is recommended (see section 4.2).
Maltese: F'każ li jkun meħtieġ lgħoti konkomitanti ta' inibitur qawwi ta' CYP3A4/5, huwa rakkomandat tnaqqis fid-doża ta' lorlatinib (ara sezzjoni 4.2).
English: Your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely: - cough, shortness of breath, chest pain, or worsening breathing problems - slow pulse, (50 beats per minute or less), feeling tired, dizzy or faint, or losing consciousness - abdominal (belly) pain, back pain, nausea, vomiting, itching, yellowing of the skin and eyes - mental status changes; changes in cognition including confusion, memory loss, and reduced ability to concentrate; changes in mood including irritability and mood swings; and changes in speech including difficulty speaking, such as slurred or slow speech
Maltese: It-tabib tiegħek jista' jnaqqaslek iddoża, iwaqqaflek il-kura għal żmien qasir jew iwaqqaflek il-kura kompletament jekk ikollok: - sogħla, qtugħ ta' nifs, uġigħ fis-sider, jew aggravar ta' problemi fin-nifs - rata tal-polz baxxa (50 taħbita jew inqas kull minuta), tħossok għajjien, sturdut jew jagħtik ħass ħażin jew tintilef minn sensik - uġigħ addominali (fiż-żaqq), uġigħ fid-dahar, dardir, rimettar, ħakk, sfurija tal-ġilda u tal għajnejn - tibdil fl-istat mentali; tibdil fil-konjizzjoni inkluż konfużjoni, telf ta' memorja, u ħila mnaqqsa li tikkonċentra; tibdil fil-burdata inkluż irritabilità u tibdil rapidu fil-burdati; u tibdil fid-diskors inkluż diffikultà biex titkellem, bħal tgedwid jew titkellem bil-mod
English: Lorviqua 25 mg film-coated tablets Lorviqua 100 mg film-coated tablets lorlatinib
Maltese: Lorviqua 25 mg pilloli miksija b'rita Lorviqua 100 mg pilloli miksija b'rita lorlatinib
English: Microcrystalline cellulose
Maltese: Elettrofiżjoloġija tal-qalb
English: If a hormonal method of contraception is unavoidable, then a condom must be used in combination with the hormonal method.
Maltese: Jekk ma jkunx jista' jiġi evitat metodu ta' kontraċezzjoni ormonali, għandu jintuża kondom flimkien mal-metodu ormonali.
English: Eye disorders Vision disorderh
Maltese: Effetti fuq d-diskors
English: If concurrent use of the strong CYP3A4/5 inhibitor is discontinued, lorlatinib should be resumed at the dose used prior to the initiation of the strong CYP3A4/5 inhibitor and after a washout period of 3 to 5 half-lives of the strong CYP3A4/5 inhibitor.
Maltese: Jekk jitwaqqaf l-użu konkomitanti tal-inibitur qawwi ta' CYP3A4/5, lorlatinib għandu jitkompla fid-doża li kienet qiegħda tintuża qabel inbeda l-inibitur qawwi ta' CYP3A4/5 u wara perjodu ta' tneħħija ta' bejn 3 u 5 half-lives tal-inibitur qawwi ta' CYP3A4/5.
English: In vitro studies indicated that lorlatinib may have the potential to inhibit P-glycoprotein (P-gp, systemically and at the gastrointestinal [GI] tract), BCRP (GI tract), OATP1B1, OATP1B3, OCT1, MATE1 and OAT3 at clinically relevant concentrations.
Maltese: [GI]), il-BCRP (passaġġ GI), l-OATP1B1, l-OATP1B3, lOCT1, il-MATE1 u l-OAT3 f'konċentrazzjonijiet klinikament rilevanti.
English: A highly effective non-hormonal method of contraception is required for female patients during treatment with lorlatinib, because lorlatinib can render hormonal contraceptives ineffective (see sections 4.4 and 4.5).
Maltese: Hemm bżonn ta' metodu mhux ormonali effettiv ħafna ta' kontraċezzjoni għal pazjenti nisa waqt il-kura b'lorlatinib, peress li lorlatinib jista' jagħmel il-kontraċettivi ormonali mhux effettivi (ara sezzjonijiet 4.4 u 4.5).
English: FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14-a of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Maltese: Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artikolu 14-a tarRegolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li ġejjin:
English: Calcium hydrogen phosphate
Maltese: Effett tossiku fuq is-sistema riproduttiva
English: Renal impairment
Maltese: Fertilità u tqala
English: Hepatic impairment
Maltese: Mingħajr sintomi
English: How to store Lorviqua 6.
Maltese: Kif taħżen Lorviqua 6.
English: Few data are available over the 10 to 200 mg dose range; however, no deviation from linearity was observed for AUCinf and Cmax after single dose.
Maltese: 10 mg u 200 mg; madankollu, ma kienet osservata l-ebda devjazzjoni mil-linearità għall-AUCinf u għas-Cmax wara doża unika.
English: As lorlatinib is metabolised in the liver, hepatic impairment is likely to increase lorlatinib plasma concentrations.
Maltese: Peress li lorlatinib jiġi metabolizzat fil-fwied, l-indeboliment tal-fwied x'aktarx iżid ilkonċentrazzjonijiet ta' lorlatinib fil-plażma.
English: Pfizer Luxembourg SARL Eesti filiaal Tel.: +372 666 7500
Maltese: Pfizer Luxembourg SARL, organizačná zložka Tel.: + 421 2 3355 5500
English: A highly effective non-hormonal method of contraception is required for female patients during treatment with lorlatinib, because lorlatinib can render hormonal contraceptives ineffective (see sections 4.5 and 4.6).
Maltese: Huwa meħtieġ metodu ta' kontraċezzjoni mhux ormonali effettiv ħafna għal pazjenti nisa waqt il-kura b'lorlatinib, minħabba li lorlatinib jista' jagħmel il-kontraċettivi ormonali mhux effettivi (ara sezzjonijiet 4.5 u 4.6).
English: In vitro studies indicated that lorlatinib may have the potential to inhibit UGT1A1.
Maltese: Studji in vitro ta' inibizzjoni tal-UGT Studji in vitro indikaw li lorlatinib jista' jkollu l-potenzjal li jinibixxi l-UGT1A1.
English: These symptoms could be signs of pancreatitis.
Maltese: Dawn is-sintomi jistgħu jkunu sinjali ta' pankreatite.
English: Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after:
Maltese: Lorviqua bħala monoterapija huwa indikat għall-kura ta' pazjenti adulti b'kanċer avvanzat taċ-ċelluli mhux żgħar tal-pulmun (NSCLC, non small cell lung cancer) pożittiv għall-kinażi tal-limfoma anaplastiku (ALK, anaplastic lymphoma kinase) li l-marda tagħhom ipprogressat wara:
English: The exposure at the lowest doses with embryo-foetal effects in animals was equivalent to the human clinical exposure at 100 mg, based on AUC.
Maltese: L-esponiment fl-aktar dożi baxxi b'effetti embriju-fetali fl-annimali kien ekwivalenti għallesponiment kliniku tal-bniedem f'doża ta' 100 mg, abbażi tal-AUC.
English: Population pharmacokinetic analyses have shown that lorlatinib exposure was not clinically meaningfully altered in patients with mild hepatic impairment (n = 50).
Maltese: Analiżijiet farmakokinetiċi tal-popolazzjoni wrew li l-esponiment għal lorlatinib ma nbidilx b'mod klinikament sinifikanti f'pazjenti b'indeboliment tal-fwied ħafif (n = 50).
English: Any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (e.g. dyspnoea, cough and fever) should be promptly evaluated for ILD/pneumonitis.
Maltese: ILD/pulmonite (eż. qtugħ ta' nifs, sogħla u deni) għandu jiġi evalwat fil-pront għal ILD/pulmonite.
English: How to take Lorviqua
Maltese: X'inhu Lorviqua
English: Clinical studies that were conducted excluded patients with AST or ALT > 2.5 × ULN, or if due to underlying malignancy, > 5.0 × ULN or with total bilirubin > 1.5 × ULN.
Maltese: L-istudji kliniċi li saru eskludew pazjenti b'AST jew b'ALT ta' > 2.5 × ULN, jew jekk minħabba tumuri malinni sottostanti ta' > 5.0 × ULN jew b'bilirubina totali ta' > 1.5 × ULN.
English: j
Maltese: jew
English: Each pack contains 90 film-coated tablets in 9 blisters or 120 film-coated tablets in 12 blisters.
Maltese: Kull pakkett fih 90 pillola miksija b'rita f'9 folji jew 120 pillola miksija b'rita fi 12-il folja.
English: Concomitant use with moderate CYP3A4/5 inducers should be avoided, if possible, as they may also reduce lorlatinib plasma concentrations (see section 4.5).
Maltese: L-użu konkomitanti ma' indutturi moderati ta' CYP3A4/5 għandu jiġi evitat, jekk possibbli, peress li dawn jistgħu jnaqqsu wkoll il-konċentrazzjonijiet ta' lorlatinib fil-plażma (ara sezzjoni 4.5).
English: Lorviqua 25 mg film-coated tablets Lorviqua 100 mg film-coated tablets
Maltese: Lorviqua 25 mg pilloli miksija b'rita Lorviqua 100 mg pilloli miksija b'rita
English: Each pack contains 30 film-coated tablets in 3 blisters.
Maltese: Kull pakkett fih 30 pillola miksija b'rita fi 3 folji.
English: Concomitant use with moderate CYP3A4/5 inducers should be avoided, if possible, as they may also reduce lorlatinib plasma concentrations (see section 4.4).
Maltese: L-użu konkomitanti ma' indutturi moderati ta' CYP3A4/5 għandu jiġi evitat, jekk possibbli, peress li dawn jistgħu jnaqqsu wkoll il-konċentrazzjonijiet ta' lorlatinib fil-plażma (ara sezzjoni 4.4).
English: a Grade categories are based on NCI CTCAE classifications.
Maltese: TKI=inibitur tat-tirożina kinażi.
English: After oral administration of lorlatinib tablets, the mean absolute bioavailability is 80.8% (90% CI: 75.7, 86.2) compared to intravenous administration.
Maltese: 8% (90% CI: 75.7, 86.2) meta mqabbla mal-għoti ġol-vini.
English: Administration of lorlatinib with a high fat, high calorie meal resulted in 5% higher exposure compared to fasted conditions.
Maltese: Inqas minn 1% tad-doża mogħtija ġiet irkuprata bħala lorlatinib mhux mibdul fl-awrina.
English: The median time to onset for both hypercholesterolaemia and hypertriglyceridaemia was 15 days (range: 1 to 399 days).
Maltese: Iż-żmien medjan għall-bidu kemm għal iperkolesterolemija kif ukoll għal ipertrigliċeridemija kien 15-il jum (medda: 1 sa 399 jum).
English: Each film-coated tablet contains 25 mg of lorlatinib.
Maltese: Kull pillola miksija b'rita fiha 25 mg ta' lorlatinib.
English: Severe hypercholesterolaemia (cholesterol between 401 and 500 mg/dL or between 10.35 and 12.92 mmol/L)
Maltese: Iperkolesterolemija severa (kolesterol bejn 401 u 500 mg/dL jew bejn 10.
English: If a strong CYP3A4/5 inhibitor must be co-administered, the starting lorlatinib dose of 100 mg once daily should be reduced to once daily 75 mg dose (see sections 4.5 and 5.2).
Maltese: F'każ li jkun hemm bżonn tal-għoti konkomitanti ta' inibitur qawwi ta' CYP3A4/5, id-doża tal-bidu ta' lorlatinib ta' 100 mg darba kuljum għandha titnaqqas għal doża ta' 75 mg darba kuljum (ara sezzjonijiet 4.5 u 5.2).
English: - increase in cholesterol and triglycerides (fats in your blood that would be detected during blood tests) - limb or skin swelling - problems with your eyes, such as difficulty seeing out of one or both eyes, double vision, or perceived flashes of light - problems with the nerves in your arms and legs, such as pain, numbness, unusual sensations like burning or pins and needles, difficulty walking, or difficulty with usual activities of daily living such as writing - increased level of enzymes called lipase and/or amylase in the blood that would be detected during blood tests - low number of red blood cells known as anaemia that would be detected during blood tests - diarrhoea - constipation - pain in your joints - weight gain - headache - rash - muscle pain
Maltese: Komuni ħafna: jistgħu jaffettwaw aktar minn persuna 1 minn kull 10 - żieda fil-kolesterol u fit-trigliċeridi (xaħam fid-demm tiegħek li jiġi identifikat waqt testijiet tad demm) - nefħa fid-dirgħajn jew fir-riġlejn jew fil-ġilda - problemi b'għajnejk, bħal diffikultà biex tara minn għajn waħda jew mit-tnejn, tara doppju, jew tara raġġi qawwijin ta' dawl - problemi fin-nervituri f'dirgħajk u f'riġlejk, bħal uġigħ, tnemnim, sensazzjonijiet mhux tas-soltu bħal ħruq jew tingiż, diffikultà biex timxi, diffikultà bl-attivitajiet tas-soltu ta' kuljum pereżempju tikteb - livell miżjud ta' enzimi li jissejħu lipażi u/jew amilażi fid-demm li jiġu identifikati waqt testijiet tad-demm - numru baxx ta' ċelluli ħomor tad-demm magħrufa bħala anemija li tiġi identifikata waqt testijiet tad-demm - dijarea - stitikezza - uġigħ fil-ġogi tiegħek - żieda fil-piż - uġigħ ta' ras - raxx - uġigħ fil-muskoli
English: Other side effects of Lorviqua may include:
Maltese: Effetti sekondarji oħra ta' Lorviqua jistgħu jinkludu:
English: - Contraception - information for women You should not become pregnant while taking this medicine.
Maltese: - Kontraċezzjoni - informazzjoni għan-nisa M'għandekx tinqabad tqila waqt li tkun qed tieħu din il-mediċina.
English: Monitor electrocardiogram (ECG) prior to initiating lorlatinib and monthly thereafter, particularly in patients with predisposing conditions to the occurrence of clinically significant cardiac events.
Maltese: Immonitorja l-elettrokardjogramma (ECG) qabel ma jinbeda lorlatinib u kull xahar wara dan, b'mod partikolari f'pazjenti b'kundizzjonijiet li jippredisponuhom għall-okkorrenza ta' avvenimenti kardijaċi klinikament sinifikanti.
English: d Hallucinations (including auditory hallucination, hallucination, visual hallucination).
Maltese: Għeja (inklużi astenja, għeja).
English: Sodium starch glycolate
Maltese: Kif taħżen Lorviqua
English: Therefore, lorlatinib is not recommended in patients with moderate to severe hepatic impairment (see section 5.2).
Maltese: Għalhekk, lorlatinib mhuwiex rakkomandat f'pazjenti b'indeboliment tal-fwied moderat sa sever (ara sezzjoni 5.2).
English: Magyarország
Maltese: Danmark
English: A total of 139 patients with ALK-positive advanced NSCLC after treatment with at least one second-generation ALK TKI were enrolled in the Phase 2 portion of the study.
Maltese: Total ta' 139 pazjent b'NSCLC wara kura b'tal-inqas TKI għall-ALK wieħed tattieni ġenerazzjoni ħadu sehem fil-parti tal-Fażi 2 tal-istudju.
English: Lorviqua inhibits a type of enzyme called tyrosine kinase and triggers the death of cancer cells in patients with alterations in genes for ALK. Lorviqua is only given to patients whose disease is due to an alteration in the gene for ALK tyrosine kinase.
Maltese: Tiħux Lorviqua - jekk inti allerġiku għal lorlatinib jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fissezzjoni 6). - jekk qed tieħu xi mediċini minn dawn li ġejjin:
English: An alternative concomitant medicinal product with less potential to inhibit CYP3A4/5 should be considered (see section 4.5).
Maltese: Għandu jiġi kkunsidrat prodott mediċinali konkomitanti alternattiv b'inqas potenzjali li jinibixxi s-CYP3A4/5 (ara sezzjoni 4.5).
English: Slovenija Pfizer Luxembourg SARL
Maltese: Pfizer Luxembourg SARL Eesti filiaal Tel.:
English: Lorlatinib may have the potential to inhibit CYP2C9.
Maltese: Studji in vitro ta' inibizzjoni u ta' induzzjoni oħrajn tas-CYP Lorlatinib jista' jkollu l-potenzjal li jinibixxi CYP2C9.
English: - Pregnancy
Maltese: TA' EĊĊIPJENTI
English: What you need to know before you take Lorviqua 3.
Maltese: X'għandek tkun taf qabel ma tieħu Lorviqua 3.
English: PHARMACEUTICAL FORM AND CONTENTS 90 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: You must not take Lorviqua with certain medicines.
Maltese: M'għandekx tieħu Lorviqua ma' ċerti mediċini.
English: If there is any possibility that you may father a child while taking this medicine, you must use a condom during treatment, and for at least 14 weeks after completing therapy.
Maltese: Jekk ikun hemm xi possibbiltà li tista' tnissel it-tfal waqt li tkun qed tieħu din il-mediċina, għandek tuża kondom waqt il-kura, u għal mill-inqas 14-il ġimgħa wara li ttemm itterapija.
English: • mitotane (used to treat cancer of the adrenal glands)
Maltese: • mitotane (jintuża għall-kura tal-kanċer tal-glandoli adrenali)
English: Hypersensitivity to lorlatinib or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal lorlatinib jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: Lorviqua is for oral use.
Maltese: Lorviqua huwa għall-użu orali.
English: Lorlatinib was studied in a population of patients that excluded those with second-degree or third-degree AV block (unless paced) or any AV block with PR interval > 220 msec. PR interval prolongation and AV block have been reported in patients receiving lorlatinib (see section 5.2).
Maltese: Lorlatinib ġie studjat f'popolazzjoni ta' pazjenti li minnha kienu esklużi dawk b'imblukkar AV tattieni jew tat-tielet grad (sakemm ma kellhomx pacemaker) jew bi kwalunkwe imblukkar AV b'intervall tal-PR ta' > 220 msek.
English: Elevations of lipase and/or amylase have occurred in patients receiving lorlatinib (see section 4.8).
Maltese: Żidiet fil-lipażi u/jew fl-amilażi seħħew f'pazjenti li kienu qed jirċievu lorlatinib (ara sezzjoni 4.8).
English: Each film-coated tablet contains 1.58 mg of lactose monohydrate.
Maltese: Eċċipjent b'effett magħruf Kull pillola miksija b'rita fiha 1.58 mg ta' lattożju monoidrat.
English: Introduce the use of lipid-lowering therapy;b if currently on lipid-lowering therapy, increase the dose of this therapyb in accordance with respective prescribing information; or change to a new lipid-lowering therapyb.
Maltese: Introduċi l-użu ta' terapija li tnaqqas il-lipidi b; jekk attwalment tinsab fuq terapija li tnaqqas il-lipidi, żid id-doża ta' din it-terapija b skont l-informazzjoni rispettiva dwar l-għoti; jew aqleb għal terapija ġdida li tnaqqas il-lipidi b.
English: A risk to the newborns/infants cannot be excluded.
Maltese: Irriskju gћat-trabi tat-twelid/trabi mhux eskluż.
English: In non-clinical studies, lorlatinib inhibited catalytic activities of non-mutated ALK and clinically relevant ALK mutant kinases in recombinant enzyme and cell-based assays.
Maltese: Fi studji mhux kliniċi, lorlatinib inibixxa l-attivitajiet katalitiċi tal-ALK mingħajr mutazzjonijiet u kinażi ta' mutazzjonijiet tal-ALK klinikament rilevanti f'assaġġi ċellulari u enzimatiċi rikombinanti.
English: The use of lorlatinib in the treatment of ALK-positive advanced NSCLC after treatment with at least one second-generation ALK TKI was investigated in Study A, a single-arm, multicentre Phase 1/2 study.
Maltese: L-użu ta' lorlatinib fil-kura ta' pazjenti b'NSCLC avvanzat pożittiv għall-ALK wara kura b'tal-inqas TKI għall-ALK wieħed tat-tieni ġenerazzjoni ġie investigat fi Studju A, studju multiċentriku, b'fergħa unika tal-Fażi 1/2.
English: The full EPAR for Angiox 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 Angiox, bivalirudin, is a synthetic substance originally derived from hirudin, the anticoagulant substance produced by leeches.
Maltese: Is-sustanza attiva f'Angiox, il-bivalirudin, hija sustanza sintetika derivata mill-irudin, l-antikoagulant prodott mis-sangisugi.
English: This is a summary of the European public assessment report (EPAR) for Angiox.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Angiox.
English: In PCI, Angiox has been compared withanother type of anticoagulant, a heparin, in two studies involving a total of almost 10,000 adults.
Maltese: Fil-PCI, Angiox tqabbel ma' tip ieħor ta' antikoagulant, l-eparina, f'żewġ studji li involvew madwar 10,000 adult.
English: The rate of the infusion needs to be reduced in patients with moderate kidney problems who are undergoing PCI.
Maltese: Ir-rata tal-infużjoni għandha titnaqqas f'pazjenti bi problemi moderati fil-kliewi li jkunu sottoposti għal PCI.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Angiox on 20 September 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Angiox valida fl-Unjoni Ewropea kollha fl-20 ta' Settembru 2004.
English: What is Angiox?
Maltese: X'inhu Angiox?
English: Angiox is used to prevent blood clots in adults who are undergoing percutaneous coronary intervention (PCI), a non-surgical procedure used to unblock the heart's blood vessels.
Maltese: Angiox jintuża għall-prevenzjoni ta' emboli tad-demm f'adulti sottoposti għal intervenzjoni koronarja perkutanea (PCI), proċedura li ma tinvolvix intervent kirurġiku intenzjonata biex tiżblokka l-vini talqalb.
English: Why has Angiox been approved?
Maltese: Għaliex ġie approvat Angiox?
English: This includes patients who are having myocardial infarction (a heart attack) with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG).
Maltese: Dan jinkludi pazjenti li għandhom infart mijokardijaku (attakk tal-qalb) b' ‘elevazzjoni segmentali ST' (qari anormali fuq l-elektrokardjogramma jew l-ECG).
English: Heparin was given in combination with a glycoprotein IIb/IIIa inhibitor (GPI, another type of medicine that helps to prevent blood clots) and some patients receiving Angiox were also given a GPI where appropriate.
Maltese: L-eparina ngħatat flimkien mal-inibitur tal-glikoproteina IIb/IIIa (GPI, tip ieħor ta' mediċina li jgħin fil-prevenzjoni tal-emboli tad-demm) u ftit pazjenti oħra li kienu qed jingħataw Angiox ukoll ingħataw GPI fejn kien meħtieġ.