FrancophonIA/ELRC3.0 huggingface dataset:
English: This is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
Maltese: Dan huwa ekwivalenti għal doża mkejla ta' 400 mikrogramma ta' budesonide u 12 mikrogrammi ta' formoterol fumarate dihydrate.
English: • β blockers (such as atenolol or propranolol for high blood pressure or a heart condition), including eyedrops (such as timolol for glaucoma).
Maltese: • Beta-imblokkaturi (bħal atenolol jew propranolol għall-pressjoni għolja tad-demm jew għal kundizzjoni tal-qalb), inkluż qtar tal-għajnejn (bħal timolol għall-glawkoma).
English: When used chronically in excessive doses, systemic glucocorticosteroid effects, such as hypercorticism and adrenal suppression, may appear.
Maltese: Meta jintuża kronikament f'dożi eċċessivi, jistgħu jitfaċċaw effetti sistemiċi tal-glukokortikosterojdi, bħal iperkortikiżmu u soppressjoni adrenali.
English: Budesonide/Formoterol Teva Pharma B.V. 160 micrograms/4.5 micrograms, inhalation powder (budesonide/formoterol fumarate dihydrate)
Maltese: Budesonide/Formoterol Teva Pharma B.V. 160 mikrogramma/4.5 mikrogrammi trab li jittieħed mannifs budesonide/ formoterol fumarate dihydrate
English: • Headache.
Maltese: • Bugħawwieġ.
English: Budesonide/Formoterol Teva Pharma B.V.is indicated in adults 18 years of age and older only.
Maltese: Budesonide/Formoterol Teva Pharma B.V. hu indikat għall-użu fl-adulti ta' 18-il sena u aktar, biss.
English: High dose corticosteroids
Maltese: Tfal u adolexxenti
English: Adults (18 years and older): 1 inhalation twice daily.
Maltese: Adulti (18-il sena u iktar): 1 inalazzjoni waħda darbtejn kuljum.
English: Animal reproduction studies with formoterol have shown a somewhat reduced fertility in male rats at high systemic exposure and implantation losses as well as decreased early postnatal survival and birth weight at considerably higher systemic exposures than those reached during clinical use.
Maltese: Studji dwar ir-riproduzzjoni fl-annimali wrew fertilità kemxejn imnaqqsa fil-firien irġiel b'esponiment sistemiku għoli u telf tal-impjant kif ukoll tnaqqis fis-sopravivenza bikrija ta' wara t-twelid u fil-piż mat-twelid b'esponimenti sistemiċi konsiderevolment ogħla minn dawk milħuqa waqt l-użu kliniku.
English: Preparing your new Budesonide/Formoterol Teva Pharma B.V.
Maltese: Mediċini oħra u Budesonide/Formoterol Teva Pharma B.V.
English: Concomitant treatment of β2 adrenoceptor agonists with medicinal products which can induce hypokalaemia or potentiate a hypokalaemic effect, e.g. xanthine-derivatives, steroids and diuretics, may add to a possible hypokalaemic effect of the β2 adrenoceptor agonist.
Maltese: Tista' tirriżulta ipokalimja potenzjalment serja minn dożi għoljin ta' agonisti tal-adrenoriċetturi β2. Lgħoti konkomitanti ta' agonisti tal-adrenoriċetturi β2 ma' prodotti mediċinali li jistgħu jikkawżaw ipokalimja jew isaħħu l-effett ipokalimiku, eż. derivattivi ta' xanthine, sterojdi u dijuretiċi, jista' jżid mal-effett ipokalimiku possibbli tal-agonist tal-adrenoriċetturi β2.
English: How to use Budesonide/Formoterol Teva Pharma B.V. (page 9) 4.
Maltese: Kif għandek tuża Budesonide/Formoterol Teva Pharma B.V. (paġna 9)
English: The major part of a dose of formoterol is transformed by liver metabolism followed by renal elimination.
Maltese: Il-parti l-kbira ta' doża ta' formoterol tiġi trasformata permezz ta' metaboliżmu tal-fwied segwit b'eliminazzjoni mill-kliewi.
English: The effects include: - changes in bone mineral density (thinning of the bones) - cataract (clouding of the lens in the eye) - glaucoma (increased pressure in the eye) - a slowing of the rate of growth of children and adolescents - an effect on the adrenal gland (a small gland next to the kidney)
Maltese: L-effetti jinkludu: - bidliet fid-densità minerali tal-għadam (traqqiq tal-għadam) - katarretti (tidnis tal-lenti fil-għajn)
English: Budesonide/Formoterol Teva Pharma B.V.320 micrograms/9 micrograms should be used as maintenance therapy only.
Maltese: Budesonide/Formoterol Teva Pharma B.V. 320 mikrogramma/9.0 mikrogrammi għandu jintuża bħala terapija ta' manteniment biss.
English: Side panel: Each delivered dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Maltese: Kull doża mogħtija fiha 320 mikrogramma ta' budesonide u 9 mikrogrammi ta' formoterol fumarate dihydrate.
English: The metabolites of budesonide are eliminated in urine as such or in conjugated form.
Maltese: Il metaboliti ta' budesonide jiġu eliminati fl-awrina kif inhuma jew f'forma konjugata.
English: Budesonide/Formoterol Teva Pharma B.V. is indicated for use in adults 18 years of age and older only.
Maltese: Budesonide/Formoterol Teva Pharma B.V. huwa indikat għall-użu f'persuni adulti minn 18-il sena 'l fuq biss.
English: Close the mouthpiece cover.
Maltese: Trab abjad.
English: Budesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
Maltese: Jekk it-terapija b'Budesonide/Formoterol Teva Pharma B.V. ikollha bżonn tiġi rtirata minħabba doża eċċessiva tal-komponent formoterol fil-prodott mediċinali, irid jiġi kkunsidrat il-forniment ta' terapija xierqa b'kortikosterojd li jittieħed man-nifs.
English: Asthma
Maltese: ażma
English: Side panel: Each delivered dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Maltese: Kull doża mogħtija fiha 160 mikrogramma ta' budesonide u 4.5 mikrogrammi ta' formoterol fumarate dihydrate.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċjuu rriskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar riskji).
English: The fixed-dose combination of budesonide and formoterol, and the corresponding monoproducts have been shown to be bioequivalent with regard to systemic exposure of budesonide and formoterol, respectively.
Maltese: Il-kombinazzjoni b'doża fissa ta' budesonide u formoterol, u l-monoprodotti korrispondenti ntwerew li huma bijoekwivalenti fir-rigward tal-esponiment sistemiku ta' budesonide u formoterol, rispettivament.
English: • Feeling dizzy.
Maltese: ‘sterojdi'.
English: If there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy, care should be taken when transferring patients to a budesonide/formoterol fumarate fixed-dose combination therapy.
Maltese: Jekk ikun hemm xi raġuni biex wieħed jissupponi li l-funzjoni adrenali hija indebolita minn terapija preċedenti bi sterojdi sistemiċi, għandha ssir attenzjoni meta l-pazjenti jiġu trasferiti għal terapija kombinata b'doża fissa ta' budesonide/formoterol.
English: Front panel: This delivered dose is equivalent to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
Maltese: Din id-doża mogħtija hija ekwivalenti għal doża metrata ta' 200 mikrogramma ta' budesonide u 6 mikrogrammi ta' formoterol fumarate dihydrate.
English: Budesonide/Formoterol Teva Pharma B.V. contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Maltese: Budesonide/Formoterol Teva Pharma B.V. fih formoterol u budesonide, li għandhom modi ta' azzjoni differenti u juru effetti addittivi f'termini tat-tnaqqis fit-taħrix tal-ażma.
English: Front panel: This delivered dose is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
Maltese: Din id-doża mogħtija hija ekwivalenti għal doża metrata ta' 400 mikrogramma ta' budesonide u 12 mikrogrammi ta' formoterol fumarate dihydrate.
English: You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6).
Maltese: Inti allerġiku għal budesonide, formoterol fumarate dihydrate, jew is-sustanza l-oħra ta' din il mediċina (elenkati fis-sezzjoni 6).
English: In studies the mean lung deposition of formoterol after inhalation via the powder inhaler ranged from 28% to 49% of the delivered dose.
Maltese: Fl-istudji, id-depożitu medju ta' formoterol fil-pulmuni wara tteħid man-nifs permezz tal-inalatur tat-trab kien ivarja minn 28% sa 49% tad-doża mogħtija.
English: However, an initial small but transient reduction in growth (approximately 1 cm) has been observed.
Maltese: Madankollu, ġie osservat tnaqqis inizjali żgħir iżda temporanju fit-tkabbir (madwar 1 cm).
English: Budesonide/Formoterol Teva Pharma B.V. is taken as regular maintenance treatment with a separate rapidacting bronchodilator reliever inhaler.
Maltese: Tużax Budesonide/Formoterol Teva Pharma B.V. biex tittratta dawn is-sintomi tal-ażma.
English: Long-term studies with inhaled budesonide in children at mean daily doses of 400 micrograms (metered dose) or in adults at daily doses of 800 micrograms (metered dose) have not shown any significant effects on bone mineral density.
Maltese: Studji fit-tul b'budesonide li jittieħed man-nifs fi tfal b'dożi medji ta' kuljum ta' 400 mikrogramma (doża metrata) jew fl-adulti f'dożi ta' kuljum ta' 800 mikrogramma (doża metrata) ma wrew l-ebda effett sinifikanti fuq id-densità minerali tal-għadam.
English: Tachycardia
Maltese: Dardir
English: The difference is considered not to have an impact on clinical safety.
Maltese: Din id-differenza mhijiex ikkunsidrata li għandha impatt fuq is-sigurtà klinika.
English: Budesonide is excreted in breast milk.
Maltese: spostament bejn formoterol u budesonide.
English: White powder.
Maltese: KARTUNA TA' BARRA
English: Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73
Maltese: Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00
English: Mechanism of action and pharmacodynamic effects
Maltese: Mekkaniżmu ta' azzjoni u effetti farmakodinamiċi
English: Mild irritation in the throat, coughing, hoarseness
Maltese: Irritazzjoni ħafifa fil-gerżuma, sogħla, ħanqa Bronkospażmu
English: Therefore additional systemic corticosteroid cover should be considered during periods of stress such as severe infections or elective surgery.
Maltese: Għalhekk għandha tiġi kkunsidrata kopertura addizzjonali b'kortikosterojdi sistemiċi matul perjodi ta' stress bħal infezzjonijiet severi jew kirurġija elettiva.
English: Budesonide/Formoterol Teva Pharma B.V. is NOT indicated for use in children 12 years of age and younger or adolescents 13 to 17 years of age.
Maltese: Budesonide/Formoterol Teva Pharma B.V. mhuwiex indikat għall-użu fi tfal ta' 12-il sena u iżgħar jew f'adolexxenti, minn 13 sa 17-il sena.
English: EU/2/04/049/002 Purevax log 10 EID50 per dose
Maltese: EU/2/04/049/002 Purevax
English: Attenuated feline rhinotracheitis herpesvirus (FVH F2 strain): at least 4.9 log 10 CCID50 per
Maltese: Herpesvajrus attenwat tarrinotrakeite fil-qtates (FHV
English: 1ml (solvent)
Maltese: 10 fliexken ta' ml (solvent)
English: 50 bottles of 1 dose (lyophilisate) and 50 bottles of 1ml (solvent)
Maltese: 50 flixkun ta' ml (solvent)
English: Lyophilisate and solvent for suspension for injection
Maltese: Lajofiliżejt u solvent għal
English: EU Number Invente d Name
Maltese: Numru ta' l-UE Isem kummerċjali
English: Packaging Content (concentration)
Maltese: Ippakkjar Kontenut Daqs talpakkett
English: 10 bottles of 1 dose (lyophilisate) and 10 bottles of
Maltese: 10 fliexken ta'
English: 1 falcon tube with 1, 2 or 3 vials + 1 syringe + 18G intravenous catheter + 2
Maltese: Tubu Falcon b'1, 2 jew 3 kunjetti + siringa + 18G + katater intravenuż + 2 Vicryl 6.0
English: Implantation
Maltese: Impjantazzjoni
English: EU/1/09/563/001
Maltese: EU/1/09/563/001 ChondroCelect 10000 cells/µl
English: l t o r
Maltese: t x
English: Vial (glass/alu)
Maltese: Kunjetti (ħġieġ/alu) 1 ml
English: ChondroCelect cells/µl
Maltese: Qawwa Għamla farmaċewtika
English: [30 of 110 (27.3%)] (see section 5.1).
Maltese: [30 minn 110 (27.3 %)] (ara sezzjoni 5.1).
English: Volume (V)
Maltese: Volum (V)
English: Total irinotecan
Maltese: Irinotecan totali
English: 95% CI of Rate
Maltese: 95 % CI tar-Rata
English: • The active substance is irinotecan.
Maltese: • Is-sustanza attiva hija irinotecan.
English: MedDRA* system organ class
Maltese: Sistema tal-Klassifika talOrgani MedDRA*
English: l/m t1/2 effective h
Maltese: L/m t1/2 effettiv h
English: Les Laboratoires Servier Industrie 905 Route de Saran 45520 Gidy
Maltese: Les Laboratoires Servier Industrie 905 Route de Saran 45520
English: 2- [ 4- (2-Hydroxyethyl)piperazin-1-yl] ethanesulfonic acid (HEPES buffer) Sodium chloride
Maltese: 2- [ 4- (2-Hydroxyethyl)piperazin-1-yl] ethanesulfonic acid (buffer ta' HEPES) Sodium chloride
English: SD= standard deviation
Maltese: SD= devjazzjoni standard
English: Based on Normal approximation
Maltese: Ibbażata fuq Approssimazzjoni normali
English: Figure 1: Overall survival
Maltese: Figura 1 Sopravivenza globali
English: ONIVYDE pegylated liposomal +5-FU/LV (N= 117)
Maltese: ONIVYDE lipożomali pegilat+5-FU/LV (N= 117)
English: Cmax ng/ml
Maltese: Cmass ng/mL
English: Frequencies categories used for adverse reactions are: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000)**.
Maltese: Il-kategoriji tal-frekwenzi użati għarreazzjonijiet avversi huma: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100) u rari (≥ 1/10,000 sa < 1/1,000)**.
English: Abbreviations: 5-FU/LV=5-fluorouracil/leucovorin; CI=confidence interval
Maltese: Abbrevjazzjonijiet: 5-FU/LV=5-fluorouracil/leucovorin; CI=intervall ta' kunfidenza
English: N-(carbonyl-methoxypolyethylene glycol-2000)-1, 2-distearoly-sn-glycero-3-phosphoethanolamine (MPEG-2000-DSPE)
Maltese: N-(carbonyl-methoxypolyethlyene glycol-2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine (MPEG-2000-DSPE)
English: Les Laboratoires Servier 50, rue Carnot 92284 Suresnes cedex France
Maltese: Les Laboratoires Servier 50, rue Carnot 92284
English: Grade 3 or 4
Maltese: Grad 3 jew 4
English: SN-38 is subsequently conjugated predominantly by the enzyme UDP-glucuronosyl transferase 1A1 (UGT1A1) to form a glucuronide metabolite.
Maltese: SN-38 huwa sussegwentement konjugat b'mod predominanti mill-enzima UDP-glucuronosyl transferase 1A1 (UGT1A1) biex jifforma metabolit glucuronide.
English: Unstratified log-rank test
Maltese: Test log-rank mhux stratifikat
English: Irinotecan is metabolized by carboxylesterase to SN-38.
Maltese: Irinotecan huwa metabolizzat minn carboxylesterase għal SN-38.
English: 92284 Suresnes cedex France
Maltese: Suresnes cedex Franza
English: • The other ingredients are: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC); cholesterol, N-(carbonyl-methoxypolyethylene glycol-2000)-1,2-distearoly-sn-glycero-3-phosphoethanolam ine (MPEG-2000-DSPE); Sucrose octasulphate; 2- [4- (2-Hydroxyethyl)piperazin-1-yl]ethanesulfonic acid (HEPES buffer); sodium chloride and water for injections.
Maltese: • Is-sustanzi l-oħra huma: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC); cholesterol, N-(carbonyl-methoxypolyethlyene glycol-2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolam ine (MPEG-2000-DSPE); Sucrose octasulphate; 2- [4- (2-Hydroxyethyl)piperazin-1-yl]ethanesulfonic acid (HEPES buffer); sodium chloride u ilma għall-injezzjonijiet.
English: Non-liposomal irinotecan mean (SD) 125 mg/m
Maltese: Irinotecan mhux-lipożomali medja (SD) 125 mg/m
English: BATCH NUMBER Lot:
Maltese: NUMRU TAL-LOTT LOTT:
English: The concentrate has a pH of 7.2 and an osmolality of 295 mOsm/kg.
Maltese: Il-konċentrat għandu pH ta' 7.2 u ożmolalità ta' 295 mOsm/kg.
English: Toxicity grade (value) by NCI CTCAE v 4.01
Maltese: Grad ta' tossiċità (valur) skont NCI CTCAE v 4.0
English: NCI CTCAE v 4.0 = National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Maltese: NCI CTCAE v 4.0 = (National Cancer Institute Common Terminology Criteria for Adverse Events) Kriterji tal-Istitut Nazzjonali tal-Kanċer dwar Terminoloġija Komuni għal Reazzjonijiet Avversi, verżjoni 4.0
English: Thrombocytopenia Leukopenia
Maltese: Tromboċitopenija Lewkopenija
English: The urinary excretion of non-liposomal irinotecan is 11% to 20%; SN-38 < 1%; and SN-38 glucuronide is 3%.
Maltese: L-eliminazzjoni mill-awrina ta' irinotecan mhux lipożomali hija minn 11% sa 20%; ta' SN-38 hi ta' < 1%; u ta' SN-38 glucuronide hija ta' 3%.
English: Patients with UGT1A1 allele
Maltese: Pazjenti bl-allel UGT1A1
English: For more details see section 6.6.
Maltese: Għal aktar dettalji ara sezzjoni 6.6.
English: This was not seen in morphologically normal pups.
Maltese: Dan ma ġiex osservat fi frieħ morfoloġikament normali.
English: Non-liposomal irinotecan displays a large volume of distribution (138 l/m2).
Maltese: Irinotecan mhux lipożomali juri volum kbir ta' distribuzzjoni (138 L/m2).
English: Cox model analysis
Maltese: Analiżi tal-mudell Cox
English: Age and gender
Maltese: Età u sess tal-persuna
English: Immune system disorders Uncommon: Hypersensitivity
Maltese: Disturbi fis-sistema immuni Mhux komuni: Sensittività eċċessiva
English: Patients receiving concomitant non-liposomal irinotecan and CYP3A4 enzyme-inducing anticonvulsants phenytoin, phenobarbital or carbamazepine have substantially reduced exposure to irinotecan (AUC reduction by 12% with St John's wort, 57%-79% with phenytoin, phenobarbital, or carbamazepine) and SN-38 (AUC reduction by 42% with St John's wort, 36%-92% with phenytoin phenobarbital, or carbamazepine).
Maltese: Pazjenti li jkunu qed jirċievu irinotecan mhux lipożomali flimkien mal-antikonvulsanti phenytoin, phenobarbital jew carbamazepine li jinduċu l-enzima CYP3A4, naqqsu b'mod sostanzjali lesponiment għal irinotecan (tnaqqis fl-AUC bi 12% b'St John's wort, 57% 79% b'phenytoin, phenobarbital, jew carbamazepine) u SN 38 (tnaqqis fl-AUC bi 42% b'St John's wort, 36%-92% b'phenytoin phenobarbital, jew carbamazepine).
English: Grade 3 or 4 (despite antiemetic therapy)
Maltese: Grad 3 jew 4(minkejja tterapija antiemetika)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1130/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1130/001
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 October 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data ta 'l-ewwel awtorizzazzjoni: l-14 ta' Ottubru 2016
English: Reduce 5-FU dose by 25% (1,800 mg/m
Maltese: Naqqas id-doża ta' 5-FU b'25% (1,800 mg/m
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX19
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi, aġenti antineolastiċi oħrajn, Kodiċi ATC:
English: Tel: + 421 2 5920 41 11
Maltese: s r.o. Tel: + 421 2 5920 41 11
English: Common: Lymphopenia
Maltese: Komuni: Limfopenija
English: Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy.
Maltese: Kura ta' adenokarċinoma metastatika tal-frixa, flimkien ma' 5 fluorouracil (5-FU) u leucovorin (LV), f'pazjenti adulti li mxew 'il quddiem wara terapija bbażata fuq gemcitabine.
English: Common: Increased bilirubin, Increased alanine aminotransferase, Increased aspartate aminotransferase, Increased international normalised ratio
Maltese: Komuni: Żieda fil-bilirubina, Żieda f'alanine aminotransferase, Żieda fl-aspartate aminotransferase, Żieda fil-proporzjon normalizzat internazzjonali
English: ONIVYDE pegylated liposomal should not be administered with strong CYP3A4-enzyme inhibitors (e.g. grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole).
Maltese: ONIVYDE lipożomali pegilat m'għandux jingħata ma' inibituri qawwija tal-enzima CYP3A4 (eż. meraq tal-grejpfrut, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole).
English: Onivyde pegylated liposomal has been associated with thromboembolic events such as pulmonary embolism, venous thrombosis and arterial thromboembolism.
Maltese: ONIVYDE lipożomali pegilat ġie assoċjat ma' avvenimenti tromboemboliċi bħal emboliżmu pulmonari, trombożi fil-vini u tromboemboliżmu fl-arterji.
English: AUC= area under the plasma concentration curve (extrapolated to infinity for ONIVYDE pegylated liposomal and AUC24h for non-liposomal irinotecan) Cmax= maximum plasma concentration t1/2 effective= effective half-lives
Maltese: AUC= iż-żona taħt il-kurva tal-konċentrazzjoni tal-plażma (estrapolata għall-infinit għal ONIVYDE lipożomali pegilat u AUC24h għal irinotecan mhux lipożomali) Cmass= il-konċentrazzjoni massima tal-plażma t1/2 effettiva= half lives effettivi
English: 1 vial
Maltese: Kunjett 1
English: Reduce 5-FU dose by an additional 25% (1,350 mg/m
Maltese: FU b'25% addizzjonali (1,350 mg/m
English: The analysis included 68 patients with moderate (CLcr 30-59 ml/min), 147 patients with mild (CLcr 60-89 ml/min) renal impairment, and 135 patients with normal renal function (CLcr > 90 ml/min).
Maltese: L-analiżi kienet tinkludi 68 pazjent b'indeboliment tal-kliewi moderat (CLcr 30-59 mL/min), 147 pazjent b'indeboliment ħafif tal-kliewi (CLcr 60-89 mL/min), u 135 pazjent b'funzjoni normali tal-kliewi (CLcr > 90 mL/min).
English: The active substance in ONIVYDE pegylated liposomal is irinotecan (topoisomerase I inhibitor) encapsulated in a lipid bilayer vesicle or liposome.
Maltese: Is-sustanza attiva f'ONIVYDE lipożomali pegilat hi irinotecan (inibitur ta' topoisomerase I) inkapsulata f'bilayer vesicle ta' lipidu jew liposome.
English: Table 5: Summary of mean (±standard deviation) total irinotecan and total SN-38 Analyte PK parameters
Maltese: Sommarju tal-medja (±devjazzjoni standard) ta' irinotecan totali u SN-38 totali Analit
English: The population pharmacokinetic analysis suggest that Asians have 56% lower total irinotecan average steady state concentration (3.93 [95%CI: 3.68-4.2] and 1.74 [95%CI: 1.58-1.93] mg/l, respectively) and 8% higher total SN-38 average steady state concentration (0.97 [95%CI: 0.92-1.03] and 1.05 [95%CI: 0.98-1.11] ng/ml, respectively) than Caucasians.
Maltese: L-analiżi farmakokinetika tal-popolazzjoni tissuġġerixxi li l-Ażjatiċi għandhom medja ta' konċentrazzjoni ta' irinotecan totali fl-istat fiss li hi 56% iktar baxxa (3.93 [95% CI: 3.68-4.2] u 1.74 [95 %CI: 1.58-1.93] mg/l, rispettivament) u medja konċentrazzjoni ta' SN-38 totali fl-istat fiss li hi 8% ogħla (0.97 [95 %CI: 0.92-1.03] u 1.05 [95 %CI: 0.98-1.11] ng/mL, rispettivament) millKawkasi.
English: Patients homozygous for the UGT1A1*28 allele were given a lower initial dose of ONIVYDE pegylated liposomal (see section 4.2).
Maltese: Pazjenti omożigoti għal allel UGT1A1*28 ingħataw doża inizjali iktar baxxa ta' ONIVYDE lipożomali pegilat (ara sezzjoni 4.2).
English: The plasma protein binding of ONIVYDE pegylated liposomal is negligible (< 0.44% of total irinotecan in ONIVYDE pegylated liposomal).
Maltese: It-twaħħil ta' ONIVYDE lipożomali pegilat mal-proteini fil-plażma huwa negliġibbli (< 0.44% talirinotecan totali f'ONIVYDE lipożomali pegilat).
English: In the clinical study evaluating ONIVYDE pegylated liposomal +5-FU/LV, the frequency of ≥ Grade 3 neutropenia in these patients [2 of 7 (28.6%)] was similar to the frequency in patients not homozygous for the UGT1A1*28 allele who received a starting dose of ONIVYDE pegylated liposomal of 70 mg/m
Maltese: Fl-istudju kliniku li evalwa ONIVYDE lipożomali pegilat+5-FU/LV, il-frekwenza ta' newtropenija ta' Grad 3 f'dawn il-pazjenti [2 minn 7 (28.6 %)] kienet simili għall-frekwenza f'pazjenti mhux omożigoti għall-allel UGT1A1*28 li rċivew doża talbidu ta' ONIVYDE lipożomali pegilat ta' 70 mg/m