FrancophonIA/ELRC3.0 huggingface dataset:
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: DETENTUR(I) TA' L-AWTORIZZAZZJONI TALMANIFATTURA RESPONSABBLI
English: Incubate for 10 minutes in this condition.
Maltese: Ħalliha fis-sħana għal 10 minuti f'din il-qagħda.
English: The solution may be diluted with sodium chloride 0.9% w/v solution for injection for more convenient injection.
Maltese: Is-soluzzjoni tista' titħallat b'0.9% w/v sodium chloride soluzzjoni għall-injezzjoni biex l-injezzjoni ssir b'mod iktar konvenjenti.
English: NAME OF THE MEDICINAL PRODUCT NeoSpect 47 micrograms, kit for radiopharmaceutical preparation.
Maltese: NeoSpect 47 mikrogramma, sett għall-preparazzjoni radjufarmaċewtika.
English: Sodium pertechnetate (99mTc) solution for injection (Ph.Eur) is used for reconstitution.
Maltese: Għar-rikostituzzjoni jintuża sodium pertechnetate (99mTc) soluzzjoni għall-injezzjoni (Ph.Eur).
English: Store in a freezer at or below -10 °C.
Maltese: Aħżen fil-friża f'temperatura ta' -10°C jew inqas.
English: Thyroid gland Bone marrow Liver
Maltese: GĦALL-HRUĠ TAL-LOTT
English: 6.3 Shelf life
Maltese: 6.1 Lista ta' sustanzi mhux attivi
English: Diagnostic agent for scintigraphic imaging.
Maltese: Sustanza dijanjostika għal ritratti xintigrafiċi.
English: Pharmacotherapeutic group: Diagnostic radiopharmaceutical for use in tumour detection
Maltese: Prodott radjufarmaċewtiku dijanjostiku biex jiġu identifikati t-tumuri
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 47 micrograms depreotide as depreotide trifluoroacetate.
Maltese: Kull fjala fiha 47 mikrogramma ta' depreotide bħala depreotide trifluoroacetate.
English: Most frequently reported were headache, nausea, vomiting, diarrhoea, abdominal pain, dizziness, flushing and fatigue.
Maltese: Dawk li ġew irrappurtati l-aktar kienu uġigħ ta' ras, nawżja, remettar, diarrea, uġigħ addominali, sturdament, fawra fil-wiċċ u għeja.
English: The corresponding negative predictive value and positive predictive value for NeoSpect in association with chest X-ray were 96-98% and 6178% respectively.
Maltese: Il-valuri negattivi u pożittivi mbassra għan-NeoSpect li jikkorrispondu ma xulxin, meta ntuża ma' raġġi X tassider kienu ta' bejn is-96 u t-98% u bejn il-61 u t-78% rispettivament.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI
English: NAME OF THE MEDICINAL PRODUCT NeoSpect 47 micrograms, kit for radiopharmaceutical preparation Depreotide
Maltese: NeoSpect 47 mikrogramma, sett għall-preparazzjoni radjufarmaċewtika
English: In a clinical study examining the pharmacodynamic effects of the recommended dose of the peptide in human volunteers during an oral GTT (Glucose Tolerance Test), no effects were observed other than the normal physiologic response to oral glucose challenge.
Maltese: Fi studju kliniku li eżamina l-effetti farmakodinamiċi tad-doża rakkommandata tal-peptajd f'nies li vvolontarjaw għal GTT orali (Test għat-tolleranza tal-glukose), ma ġie osservat l-ebda effett ħlief ir-rispons fiżjoloġiku normali għat-teħid ta' doża qawwija glukose millħalq.
English: Intravenous use
Maltese: FARMAĊEWTIKU
English: Solid sodium chloride should remain at the bottom of the jar; if there is no residue, add more solid sodium chloride and shake again for 10 to 15 minutes.
Maltese: Sodium chloride solidu għandu jibqa' f'qiegħ il-vażett; jekk ma jkunx hemm xi fdal, żid iktar sodium chloride u erġa' ħawwad għal bejn 10 u 15-il minuta.
English: Therapy with octreotide acetate can produce severe hypoglycaemia in patients with insulinomas, and other somatostatin analogues are known to impair glucose tolerance.
Maltese: It-terapija b'octreotide acetate tista' tikkawża ipogliċemija qawwija f'pazjenti li għandhom linsolinomas, u huwa magħruf li analogi tas-somatostatin ixekklu t-tolleranza għall-glukose.
English: Store the reconstituted solution for injection upright at 15 °C - 25 °C and use within 5 hours of
Maltese: Aħżen is-soluzzjoni rikostitwita għall-injezzjoni f'qagħda wieqfa f'temperatura ta' bejn il-15 °C u l-25 °C u uża fi żmien 5 sigħatminn mindu tkun ippreparajtha.
English: Bone surface
Maltese: FEJN MA
English: Before removing the syringe from the vial, withdraw a volume of gas from above the solution equal to the volume of pertechnetate added in order to normalise the pressure inside the vial.
Maltese: Qabel ma tneħħi s-siringa mill-fjala, iġbed volum ta' gass minn fuq is-soluzzjoni daqs il-volum talpertechnetate li ġie miżjud biex il-pressjoni fil-fjala tiġi normalizzata.
English: Allow the vial kit to warm to 15 °C - 30 °C and place it in a suitable shielding container and sanitise the rubber septum with sanitising alcohol swab.
Maltese: Aħżen is-soluzzjoni rikostitwita għall-injezzjoni għal mhux iktar minn 5 sigħat f'temperatura ta' bejn il-15 u l-25°C għandhom jintużaw barrieri addattati għal kontra r-radjazzjoni.
English: Place the strips upright in the respective developing solvent such that the spot is above the solvent line and the top of each strip leans against the side of the tank.
Maltese: Agħlaq it-tankijiet u ħallihom ħalli jkun hemm ekwilibrazzjoni mal-fwawar tas-solventi.
English: Based on human data, the absorbed radiation doses by individual organs of an average human adult (70 kg) from an intravenous injection of the agent are listed below.
Maltese: Il-lista li ġejja tagħti d-dożi ta' radjazzjoni assorbiti mill-organi individwali ta' bniedem adult medju (70 kg) minn injezzjoni fil-vina, skond tagħrif ibbażat fuq riċerka fil-bnedmin.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (Ara Anness I: Sommarju tal
English: NeoSpect is used to provide pictures which show the location of suspected malignant cancer tissue (a tumour) in the lung.
Maltese: Neospect jintuża biex jipprovdi ritratti li juru fejn qiegħed dak li jista' jkun it-tessut ta' kancer malinn (tumur) fil-pulmun.
English: Manufacturer responsible for batch release:
Maltese: Id-Dehra ta' NeoSpect u d-daqs tal-pakkett:
English: Using a shielded syringe, inject the required radioactivity of up to 1.8 GBq of sodium pertechnetate (99mTc) solution for injection, (diluted as appropriate with sodium chloride 0.9%
Maltese: Ħalli s-sett tal-fjala jisħon sa bejn 15 °C u 30 °C u poġġih f'kontenitur protettiv xieraq u ssanitizza s-septum tal-gomma b'biċċa mxarrba bl-alkoħol. 3. Bis-siringa protetta, injetta fi fjala protetta r-radjuattivita` li hemm bżonn sa 1.8 GBq ta' sodium pertechnetate (99mTc) soluzzjoni għall-injezzjoni (dilwit skond kif hemm bżonn b'0.9% w/v sodium chloride soluzzjoni għall-injezzjoni biex ikollok total ta' 1 ml).
English: * diarrhoea
Maltese: * dardir
English: SPECT images (Single Photon Emission Computed Tomography) obtained between 2 and 4 hours following 99mTc-depreotide injection are required for optimal image interpretation.
Maltese: Ir-ritratti SPECT (Tomografija Komputata għall-Emmissjoni ta' photon waħda) li jittieħdu bejn sagħtejn u 4 sigħat wara l-injezzjoni ta' 99mTc-depreotide huma bżonjużi biex issir l-aħjar interpretazzjoni tar-ritratti.
English: NeoSpect is for use in patients over the age of 18 years.
Maltese: NeoSpect jintuża f'pazjenti li għandhom iktar minn 18-il sena.
English: For scintigraphic imaging of suspected malignant tumours in the lung after initial detection, in combination with CT scan or chest X-ray, in patients with solitary pulmonary nodules.
Maltese: Tużax soluzzjoni għall-injezzjoni ta' sodium chloride batterjostatiku bħala dilwent għall- pertechnetate, għax jista' jaffettwa b'mod negattiv is-safa radjukimika u, għalhekk, id-distribuzzjoni bijoloġika tas-sustanza li qed tintraċċa.
English: Kit for radiopharmaceutical preparation.
Maltese: STRUZZJONIJIET GĦALL-PREPARAZZJONI TA' PRODOTTI
English: Alternative techniques, which do not involve ionising radiation, should be considered.
Maltese: Għandhom jiġu meqjusa metodi alternattivi li ma jinvolvux radjazzjoni ijonizzanti.
English: Safety and effectiveness of 99mTc-depreotide were established using investigational material shown to have a radiochemical purity of at least 90% by ITLC prior to administration to patients
Maltese: 3. Is-sigurta` u l-effett ta' 99mTc-depreotide kienu stabbiliti bl-użu ta' materjal investigattiv li ntwera li kellu safa radjukimika ta' mill-inqas 90% bl-ITLC qabel ma ngħata lill-pazjenti fi studji kliniċi.
English: Technetium (99mTc) depreotide solution for injection is a diagnostic radiopharmaceutical based upon a synthetic peptide that binds to somatostatin receptors.
Maltese: Is-soluzzjoni għall-injezzjoni ta' technetium (99mTc) depreotide hija prodott radjufarmaċewtiku dijanjostiku bbażat fuq peptajd sintetiku li jintrabat mar-riċetturi ta' somatostatin.
English: In the same prevalence range the positive predictive value was in the range 52-72%.
Maltese: Fl-istess medda ta' prevalenza l-valur pożittiv imbassar kien ta' bejn it-52 u t-72%.
English: External whole-body gamma scintigraphy showed highest location of radioactivity in the abdomen.
Maltese: soluzzjoni għall-injezzjoni jista' jaffettwa b'mod negattiv il-kwalita` tal-preparazzjoni.
English: These receptors are hyper-expressed by malignant tumours.
Maltese: Dawn ir-riċetturi jiġu espressi aktar bit-tumuri malinni.
English: The amount of radioactivity is calculated according to the planned time of injection to the patient, to obtain a single patient dose of 555 - 740 MBq from the entire
Maltese: Għal dan il-prodott, id-doża effettiva li tiġi meta tingħata attivita' ta' 555-740
English: The evaluation also includes examinations by CT-scan
Maltese: Indeboliment tal-kliewi
English: Total Events
Maltese: Avvenimenti Totali
English: • The active substance is vorapaxar sulfate.
Maltese: • Is-sustanza attiva hija vorapaxar sulfate.
English: HR 95% CI p-value (Z) vs (P) 0.83 (0.76, 0.90) <.001
Maltese: HR CI ta' 95% valur p (Z) vs (P) 0.83 (0.76, 0.90) <.001
English: Anticoagulants
Maltese: Antikoagulanti
English: (See Table 1.)
Maltese: (Ara Tabella 1.)
English: Date of first authorisation:19 January 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Jannar 2015
English: Hazard Ratio (95% CI)
Maltese: Proporzjon ta' Periklu (95% CI)
English: • Patients with any active pathological bleeding (see sections 4.4 and 4.8).
Maltese: • Patients bi kwalunkwe fsada patoloġika attiva (ara sezzjonijiet 4.4 u 4.8).
English: Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Maltese: Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU Ir-Renju Unit
English: EU/1/14/976/001 EU/1/14/976/002 EU/1/14/976/003 EU/1/14/976/004 EU/1/14/976/005 EU/1/14/976/006
Maltese: EU/1/14/976/001 EU/1/14/976/002 EU/1/14/976/003 EU/1/14/976/004
English: (See Table 5.)
Maltese: (Ara Tabella 5.)
English: Do not take Zontivity:
Maltese: Tiħux Zontivity:
English: (See section 4.4.)
Maltese: (Ara sezzjoni 4.4.)
English: Schering-Plough Labo N.V. Industriepark 30
Maltese: Schering-Plough Labo N.V.
English: The systemic exposure of M20 is ~20% of the exposure to vorapaxar.
Maltese: L-esponiment sistemiku ta' M20 huwa ~20% tal-esponiment għal vorapaxar.
English: (See section 5.3.)
Maltese: (Ara sezzjoni 5.3.)
English: Table 1: Tabulated List of Adverse Reactions
Maltese: Tabella 1: Lista ta' Reazzjonijiet Avversi miġbura f'Tabella
English: Conjunctival haemorrhage, diplopia
Maltese: Emorraġija tal-konġuntiva, diplopja
English: CYP2C8 substrates
Maltese: Sustrati ta' CYP2C8
English: Concomitant use of Zontivity with strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) should be avoided.
Maltese: L-użu ta' Zontivity flimkien ma' impedituri qawwija ta' CYP3A (eż., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin u conivaptan) għandu jiġi evitat.
English: Patients with events (%)
Maltese: Pazjenti b'avvenimenti (%)
English: • carbamazepine, phenytoin (anti-seizure medicines)
Maltese: • carbamazepine, phenytoin (mediċini kontra attakki tal-epilessija)
English: Incidence (%)
Maltese: Inċidenza (%)
English: Effects of other medicinal products on vorapaxar
Maltese: Effetti ta' prodotti mediċinali oħra fuq vorapaxar
English: Bleeding category definitions:
Maltese: Definizzjonijiet tal-kategoriji ta' fsada:
English: * K-M estimate at 1,080 days
Maltese: * estimu K-M fl-1,080 jum
English: Gastritis, Gastrointestinal haemorrhage, Gingival bleeding, Melaena, Rectal haemorrhage
Maltese: Gastrite, Emorraġija gastrointestinali, Fsada millħanek, Melaena, Emorraġija mir-rektum
English: Endpoints
Maltese: Punti Finali
English: Very common (≥1/10); 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: Komuni ħafna (≥1/10); 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 magħrufa (ma tistax tittieħed stima middejta disponibbli).
English: The mean volume of distribution of vorapaxar is approximately 424 litres.
Maltese: Il-medja tal-volum ta' distribuzzjoni ta' vorapaxar hija madwar 424 litru.
English: Key Secondary Efficacy Endpoint (CV death / MI / stroke)
Maltese: Punt Finali Sekondarju l-Aktar Importanti ta' Effikaċja (mewt CV / MI / puplesija)
English: • are over 75 years of age
Maltese: • għandek aktar minn 75 sena
English: • ritonavir, nelfinavir, indinavir, saquinavir (used to treat HIV-AIDS)
Maltese: • ritonavir, nelfinavir, indinavir, saquinavir (jintużaw biex jikkuraw HIV-AIDS)
English: The treatment effect of Zontivity was consistent with the overall results across many subgroups, including sex; age; renal insufficiency; medical history of diabetes mellitus; tobacco use; concomitant therapies at baseline including thienopyridine, acetylsalicylic acid, and statins.
Maltese: L-effett tal-kura ta' Zontivity kien konsistenti mar-riżultati totali f'ħafna mis-sottogruppi, inkluż sess; età; insuffiċjenza tal-kliewi; storja medika ta' dijabete mellitus; użu ta' tabakk; terapiji li jittieħdu miegħu fil-linja bażi inkluż thienopyridine, acetylsalicylic acid, u statins.
English: Packs of 7, 28, 30 and 100 tablets in aluminium blister cards.
Maltese: Pakketti ta' 7, 28, 30, u 100 pillola f'folji tal-aluminju rettangolari.
English: • double vision
Maltese: • vista doppja
English: Zontivity has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization (UCR).
Maltese: Zontivity intwera li jnaqqas ir-rata ta' punt finali kkombinat ta' mewt kardjovaskulari, MI, puplesija u rivaskularizzazzjoni koronarja urġenti (UCR - urgent coronary revascularization).
English: In vitro metabolism studies demonstrate that vorapaxar is unlikely to cause clinically significant inhibition of human CYP1A2, CYP2B6, CYP3A, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Maltese: Studji dwar metaboliżmu in vitro juru li mhux probabbli li vorapaxar jikkawża inibizzjoni sinifikanti b'mod kliniku ta' CYP1A2, CYP2B6, CYP3A, CYP2C8, CYP2C9, CYP2C19, jew CYP2D6 talbniedem.
English: Film-coated tablet 7 film-coated tablets 10 x 1 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 x 1 film-coated tablets 100 film-coated tablets
Maltese: Pillola miksija b'rita 7 pilloli miksija b'rita 10 pilloli x 1 miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 50 pillola x 1 miksija b'rita 100 pillola miksija b'rita
English: The mean absolute bioavailability of vorapaxar from the 2.5 mg dose of vorapaxar sulfate is 100%.
Maltese: Il-medja ta' bijodisponibbiltà assoluta ta' vorapaxar mid-doża ta' 2.5 mg ta' vorapaxar sulfate hija 100%.
English: • have a bodyweight of less than 60 kg
Maltese: • għandek piż tal-ġisem ta' inqas minn 60 kg
English: Co-administration of vorapaxar (40 mg) and digoxin (0.5 mg single-dose) increased digoxin Cmax and AUC by 54% and 5%, respectively.
Maltese: L-għoti ta' vorapaxar (40 mg) flimkien ma' digoxin (doża waħda ta' 0.5 mg) żied is-Cmax u lAUC ta' digoxin b'54% u 5%, rispettivament.
English: Vorapaxar exposure (AUC and Cmax) in patients of African descent is estimated to be 17-19% lower compared to that of Caucasians.
Maltese: L-esponiment għal vorapaxar (l-AUC u s-Cmax) f'pazjenti ta' dixxendenza Afrikana huwa stmat li huwa minn 17-19% inqas meta mqabbel ma' dak tal-Kawkasiċi.
English: • itraconazole, ketoconazole, posaconazole (used to treat fungal infections)
Maltese: • itraconazole, ketoconazole, posaconazole (jintużaw biex jikkuraw infezzjonijiet bil-fungi)
English: Evaluation of Zontivity on QTc interval
Maltese: Valutazzjoni ta' Zontivity fuq l-intervall QTc
English: Zontivity 2 mg tablets Vorapaxar
Maltese: Zontivity 2 mg pilloli Vorapaxar
English: Vorapaxar is eliminated primarily by metabolism, with significant contribution by CYP3A.
Maltese: Vorapaxar jiġi eliminat primarjament permezz ta' metaboliżmu, b'kontribut sinifikanti minn CYP3A.
English: Zontivity is contraindicated in patients with severe hepatic impairment (Child Pugh, 10 to 15 points) (see sections 4.3 and 4.4).
Maltese: Zontivity huwa kontraindikat f'pazjenti b'indeboliment qawwi tal-fwied (Child Pugh, 10 sa 15-il punt) (ara sezzjonijiet 4.3 u 4.4).
English: • bruising
Maltese: • fġir
English: EU/1/14/976/001 7 film-coated tablets EU/1/14/976/002 10 x 1 film-coated tablets (unit-dose) EU/1/14/976/003 28 film-coated tablets EU/1/14/976/004 30 film-coated tablets EU/1/14/976/005 50 x 1 film-coated tablets (unit-dose) EU/1/14/976/006 100 film-coated tablets
Maltese: EU/1/14/976/003 28 pillola miksija b'rita EU/1/14/976/004 30 pillola miksija b'rita EU/1/14/976/005 50 pillola x 1 miksija b'rita (doża waħda)
English: The apparent terminal half-life for vorapaxar is 187 hours (range 115-317 hours) and is similar for the active metabolite.
Maltese: Il-half-life terminali apparenti għal vorapaxar hija 187 siegħa (medda minn 115-317-il siegħa) u tixxiebah għallmetabolit attiv.
English: Merck Sharp & Dohme Ireland (Human Health) Limited
Maltese: Merck Sharp & Dohme Ireland (Human
English: There is less information about other types of surgery but the overall evidence does not suggest an excessive risk of major bleeding.
Maltese: Hemm inqas informazzjoni dwar tipi oħra ta' kirurġija iżda l-evidenza totali ma tissuġġerixxix riskju eċċessiv ta' fsada maġġuri.
English: Vorapaxar is a weak inhibitor of the intestinal P-glycoprotein (P-gp) transporter.
Maltese: Vorapaxar huwa impeditur dgħajjef tat-trasportatur tal-glikoproteina P (P-gp - P-glycoprotein) talmusrana.
English: Film coating Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Iron oxide yellow (E172)
Maltese: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518)
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 (ara sezzjoni 4.4).
English: Pharmacokinetics of vorapaxar are similar between patients with mild (Child Pugh, 5 to 6 points) to moderate (Child Pugh, 7 to 9 points) hepatic impairment and healthy patients.
Maltese: Il-farmakokinetika ta' vorapaxar tixxiebah bejn pazjenti b'indeboliment ħafif (Child Pugh, 5 sa 6 punti) sa moderat (Child Pugh, 7 sa 9 punti) tal-fwied u individwi f'saħħithom.
English: Adverse reactions are classified according to frequency and System Organ Class.
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont il-frekwenza u l-Klassi tas-Sistemi u tal-Organi.
English: • Patients with a history of intracranial haemorrhage (ICH).
Maltese: • Pazjenti bi storja ta' emorraġija ġol-kranju (ICH - intracranial hemorrhage).
English: The coadministration of Zontivity with anticoagulants e.g., warfarin and new oral anticoagulants (NOACs), should be avoided.
Maltese: L-għoti ta' Zontivity flimkien ma' antikoagulanti eż., warfarin u l-antikoagulanti orali ġodda (NOACs - new oral anticoagulants), għandu jiġi evitat.
English: • The other ingredients are: Tablet core: lactose monohydrate; cellulose microcrystalline (E460); croscarmellose sodium (E468); povidone (E1201); magnesium stearate (E572).
Maltese: Qalba tal-pillola: lactose monohydrate; cellulose microcrystalline (E460); croscarmellose sodium (E468); povidone (E1201); magnesium stearate (E572).
English: In the cohort of post-MI or PAD patients with no history of stroke or TIA, the net clinical outcome analysis based on multiple occurrences of endpoints (CV Death/MI/Stroke/GUSTO Severe) is constant over time at each of the censoring times examined (12, 18, 24, 30, and 36 months) at cumulative 6-month intervals.
Maltese: MI jew b'PAD mingħajr l-ebda storja ta' puplesija jew TIA, l-analiżi tarriżultat kliniku nett abbażi ta' okkorrenzi multipli ta' punti finali (Mewt CV/MI/Puplesija/GUSTO Qawwi) hija kostanti maż-żmien f'kull wieħed miż-żminijiet ta' ċensura eżaminati (12, 18, 24, 30, u 36 xahar) f'intervalli kumulattivi ta' 6 xhur.
English: Packs of 7, 28, 30 and 100 film-coated tablets in aluminium/aluminium blister cards.
Maltese: Pakketti ta' 7, 28, 30, u 100 pillola miksijin b'rita f'folji rettangolari tal-aluminju/aluminju.
English: Patients with low body weight (<60 kg)
Maltese: Pazjenti b'piż tal-ġisem baxx (<60 kg)
English: Patients were randomized to receive daily treatment with 2.5 mg vorapaxar sulfate (n=13,225) or placebo (n=13,224) in addition to other standard therapy.
Maltese: Il-pazjenti ntgħażlu b'mod każwali biex jirċievu kura kuljum b'2.5 mg vorapaxar sulfate (n=13,225) jew plaċebo (n=13,224) miżjuda ma' terapija standard oħra.
English: Vorapaxar and the major circulating active metabolite, M20, are extensively bound (≥99%) to human plasma proteins.
Maltese: Vorapaxar u l-metabolit prinċipali attiv li jiċċirkola, M20, jintrabtu b'mod estensiv (≥99%) mal-proteini tal-plażma talbniedem.
English: Vorapaxar is eliminated by metabolism, with CYP3A4 and CYP2J2 responsible for formation of M20, its major active circulating metabolite, and M19, the predominant metabolite identified in excreta.
Maltese: Vorapaxar jiġi eliminat permezz ta' metaboliżmu, b'CYP3A4 u CYP2J2 responsabbli li jiffurmaw M20, il-metabolit prinċipali attiv tiegħu, u M19, il-metabolit prinċipali identifikat fl-ippurgar u flawrina.
English: The mean estimated vorapaxar Cmax and AUC were 30% and 32% higher, respectively, in females compared to males.
Maltese: Il-medji stmati tas-Cmax u tal-AUC ta' vorapaxar kienu 30% u 32% ogħla, rispettivament, fin-nisa meta mqabbla mal-irġiel.
English: In healthy volunteer studies, no changes in platelet P-selectin and soluble CD40 ligand (sCD40L) expression or coagulation test parameters (TT, PT, aPTT, ACT, ECT) occurred after single or multiple dose (28 days) administration of vorapaxar.
Maltese: Fi studji f'voluntiera f'saħħithom, ma seħħew l-ebda tibdiliet fl-espressjoni ta' P-selectin tal-plejtlits u ligand CD40 li jiddisolvi (sCD40L - soluble CD40 ligand), jew fil-parametri tat-test tal-koagulazzjoni (TT, PT, aPTT, ACT, ECT) wara għoti ta' doża waħda jew ħafna dożi (28 jum) ta' vorapaxar.
English: Patients with two Events Patients with ≥3 Events
Maltese: Pazjenti b'≥3 Avvenimenti
English: Zontivity contains lactose.
Maltese: Zontivity u lactose
English: Table 4: Primary and Key Secondary Efficacy Endpoints in Post-MI or PAD Patients with No History of Stroke or TIA
Maltese: Tabella 4: Punti Finali Primarji u Sekondarji l-Aktar Importanti ta' Effikaċja f'Pazjenti Wara
English: No clinically meaningful inhibition of CYP2B6, CYP3A, CYP2C19, or CYP2D6 by M20 is expected.
Maltese: Ma hija mistennija l-ebda inibizzjoni b'sinifikat kliniku ta' CYP2B6, CYP3A, CYP2C19, jew CYP2D6 permezz ta' M20.
English: However, if a patient is to undergo elective surgery, if clinically feasible, Zontivity should be discontinued at least 30 days prior to surgery.
Maltese: Madankollu, jekk pazjent tkun se ssirlu kirurġija elettiva, jekk huwa possibbli b'mod kliniku, Zontivity għandu jitwaqqaf mill-inqas 30 jum qabel il-kirurġija.