FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with Temybric Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.
Maltese: Il-kura b'Temybric Ellipta għandha titwaqqaf immedjatament jekk ikun iseħħ bronkospażmu paradossali.
English: Mouthpiece Air vent
Maltese: UMEC u VI wara
English: Following repeat dosing of inhaled fluticasone furoate /vilanterol, steady state was achieved within 6 days with up to 1.6-fold accumulation
Maltese: Wara dożaġġ ripetut ta' fluticasone furoate /vilanterol miġbud bin-nifs, l istat fiss inkiseb fi żmien 6 ijiem b'sa akkumulazzjoni ta' 1.6 darba Umeclidinium
English: GlaxoSmithKline d.o.o.
Maltese: GlaxoSmithKline, s.r.o.
English: The following instructions for the 30 dose (30 day supply) Ellipta inhaler also apply to the 14 dose (14 day supply) Ellipta inhaler.
Maltese: (provvista ta' 30 jum) jew inalatur Ellipta ta' 14-il doża (provvista ta' 14-il jum).
English: Co-administration of Temybric Ellipta with other long-acting muscarinic antagonists or long-acting beta2adrenergic agonists has not been studied and is not recommended as it may potentiate the adverse reactions (see section 4.8 and section 4.9).
Maltese: Antimuskariniċi oħra li jaġixxu fit-tul u agonisti beta2 adrenerġiċi li jaġixxu fit-tul L-għoti flimkien ta' Temybric Ellipta ma' antimuskariniċi li jaġixxu fit-tul u agonisti beta2 adrenerġiċi li jaġixxu fit-tul ma ġiex studjat u mhuwiex rakkomandat peress li dan jista' jkollu potenzjal għal reazzjonijiet avversi (ara sezzjoni 4.8 u sezzjoni 4.9).
English: In Study 200812, Temybric Ellipta was non-inferior compared with FF/VI+UMEC, co-administered in two inhalers, in the improvement from baseline in trough FEV1 at week 24.
Maltese: Fi studju 200812, Temybric Ellipta kien noninferjuri meta mqabbel ma' FF/VI+UMEC, mogħti flimkien f'żewġ inalaturi, fit-titjib mil-linja bażi f'FEV1 minimu f'Ġimgħa 24.
English: Talk to your doctor before using Temybric Ellipta - if you have asthma (Don't use Temybric Ellipta to treat asthma) - if you have heart problems or high blood pressure - if you have liver problems - if you have tuberculosis (TB) of the lung, or any long standing or untreated infections - if you have an eye problem called narrow-angle glaucoma - if you have an enlarged prostate, difficulty passing urine or a blocking in your bladder - if you suffer from epilepsy - if you have thyroid gland problems - if you have low potassium in your blood - if you have a history of diabetes - if you experience blurred vision or other visual disturbances
Maltese: - jekk għandek it-tuberkulożi (TB) tal-pulmun, jew kwalunkwe infezzjoni li ilha preżenti jew li ma ġietx ikkurata għal żmien twil - jekk għandek problema fl-għajnejn imsejħa glawkoma tal-angolu dejjaq. - jekk għandek prostata mkabbra, diffikultà biex tgħaddi l-awrina jew imblokk fil-bużżieqa tal awrina tiegħek
English: Read the package leaflet before use.
Maltese: Aħżen fil‑pakkett oriġinali sabiex tilqa' mill‑ umdità.
English: In FULFIL, Temybric Ellipta significantly decreased the risk of a moderate/severe exacerbation compared with BUD/FOR over 24 weeks (33%; 95% CI: 12, 48; p=0.004).
Maltese: 24 ġimgħa (33%; 95% CI: 12, 48; p=0.004).
English: tiotropium, indacaterol.
Maltese: Tfal u adolexxenti
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il mediċina.
English: Breathlessness was measured using the Transition Dyspnoea Index (TDI) focal score at week 24 in FULFIL and week 52 in IMPACT (a subset of patients, n=5,058).
Maltese: f'FULFIL u ġimgħa 52 f' IMPACT (subsett ta' pazjenti, n=5,058).
English: Inhalation powder, pre-dispensed (inhalation powder).
Maltese: Pulmonite (infezzjoni tal-pulmun) f'pazjenti COPD (effett sekondarju komuni)
English: Temybric Ellipta significantly improved (p<0.001) lung function (as defined by mean change from baseline in trough FEV1 at week 24) (see Table 1) and the improvement was maintained in the subset of patients who continued treatment to week 52.
Maltese: 001) il-funzjoni tal-pulmun (kif definite minn bidla medja mil-linja bażi f'FEV1 minimu f'ġimgħa 24) (ara Tabella 1) u t-titjib inżamm f'subsett ta' pazjenti li komplew il-kura sa ġimgħa 52.
English: In FULFIL, Temybric Ellipta significantly reduced (p<0.001) the use of rescue medication between weeks 1-24 compared with BUD/FOR (treatment difference: -0.2 occasions per day; 95% CI: -0.3, -0.1).
Maltese: 001) l-użu ta' medikazzjoni ta' salvataġġ bejn ġimgħat 1-24 meta mqabbel ma' BUD/FOR (differenza fil-kura: -0.2 okkażjonijiet għal kull jum; 95% CI: -0.3, -0.1).
English: For fluticasone furoate, patients with moderate hepatic impairment showed up to three times higher systemic exposure (FF 184 micrograms); therefore, patients with severe hepatic impairment received half the dose (FF 92 micrograms).
Maltese: Għal fluticasone furoate, pazjenti b'indeboliment tal fwied moderat urew esponiment sistemiku sa tliet darbiet ogħla (FF 184 mikrogramma); għalhekk, pazjenti b'indeboliment tal-fwied sever irċivew nofs id-doża (FF
English: Infection of the lung
Maltese: Infezzjoni tal-pulmun
English: Patients with moderate to severe hepatic impairment receiving Temybric Ellipta should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
Maltese: Pazjenti b'indebboliment tal-fwied moderat sa sever li jkunu qed jirċievu Temybric Ellipta għandhom jiġu mmonitorjati għal reazzjonijiet avversi relatati mal-kortikosterojdi (ara sezzjoni 5.2).
English: No clinically relevant effects of hypokalaemia were observed in clinical studies with Temybric Ellipta at the recommended therapeutic dose.
Maltese: Fi studji kliniċi b'Temybric Ellipta ma ġie osservat l-ebda effett klinikament relevanti ta' ipokalimja bid doża terapewtika rakkomandata.
English: There were no effects on development in rats at exposures 6.6fold the human clinical exposure at a daily dose of 92 micrograms, based on AUC.
Maltese: 6.6 darbiet l-esponiment kliniku tal-bniedem b'doża ta' kuljum ta' 92 mikrogramma, abbażi tal-AUC.
English: At weeks 49-52, the treatment difference was -0.28 (95% CI: -0.37, -0.19) when compared with FF/VI and -0.30 (95% CI: -0.41, -0.19) with UMEC/VI.
Maltese: kemm FF/VI (14.8%; 95% CI: 9.3, 19.9) kif ukoll UMEC/VI (16.0%; 95% CI: 9.4, 22.1).
English: The effect of the moderate P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium and vilanterol was assessed in healthy volunteers.
Maltese: Leffett tal-inibitur moderat tal-P-gp, verapamil (240 mg darba kuljum), fuq il-farmakokinetika fi stat fiss ta'
English: A higher percentage of patients receiving Temybric Ellipta responded with a clinically meaningful improvement in SGRQ total score in FULFIL at week 24 compared with BUD/FOR (50% and 41% respectively), odds ratios of response vs. non-response (OR) (1.41; 95% CI: 1.16, 1.70) and in IMPACT at week 52 compared with FF/VI and UMEC/VI (42%, 34% and 34% respectively), OR vs. FF/VI (1.41; 95% CI:1.29, 1.55) and OR vs. UMEC/VI (1.41; 95% CI: 1.26, 1.57); all treatment comparisons were statistically significant (p<0.001).
Maltese: proporzjonijiet ta' probabbiltà ta' rispons kontra nuqqas ta' rispons (OR) (1.41; 95% CI: 1.16, 1.70) u f'IMPACT f'ġimgħa 52 meta mqabbel ma' FF/VI u UMEC/VI (42%, 34% u 34% rispettivament), OR vs.
English: Headache
Maltese: Farinġite
English: In IMPACT, treatment with Temybric Ellipta reduced the annual rate of severe exacerbations (i.e., requiring hospitalisation or resulting in death) by 13% compared with FF/VI (95% CI: -1, 24; p=0.064).
Maltese: F'IMPACT, il-kura bi Temybric Ellipta naqqset ir-rata annwali ta' taħrix sever (jiġifieri, li jeħtieġ dħul fl isptar jew li jirriżulta f'mewt) bi 13 % meta mqabbel ma' F/VI (95% CI: -1, 24; p=0.064).
English: Following repeat dosing of inhaled umeclidinium, steady state was achieved within 7 to 10 days with 1.5 to 2-fold accumulation.
Maltese: umeclidinium li jittieħed man-nifs, stat fiss inkiseb fi żmien 7 sa 10 ijiem b'akkumulazzjoni 1.5 sa darbtejn akbar.
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when fluticasone furoate/umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or when administered to patients who are genetically deficient in CYP2D6 activity (poor metabolisers).
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Interazzjonijiet mediċinali klinikament sinifikanti, medjati minn fluticasone furoate/umeclidinium/vilanterol b'dożi kliniċi, mhumiex ikkunsidrati bħala probabbli minħabba l-konċentrazzjonijiet baxxi fil-plażma miksuba wara dożaġġ teħid bin-nifs.
English: Lung function endpoint in FULFIL
Maltese: Informazzjoni għall-pazjent
English: Pharyngitis
Maltese: Stitikezza
English: Temybric Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Maltese: Tużax Temybric Ellipta jekk diġà qiegħed tuża dawn il-mediċini.
English: Each delivered dose contains 92 micrograms of fluticasone furoate, 55 micrograms of umeclidinium (equivalent to 65 micrograms umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate).
Maltese: Kull inalazzjoni tipprovdi doża lesta (id-doża li toħroġ mill-biċċa tal-ħalq) ta' 92 mikrogramma ta' fluticasone furoate, 65 mikrogramma umeclidinium bromide ekwivalenti għal 55 mikrogramma umeclidinium u 22 mikrogramma vilanterol (bħala trifenatate).
English: The step-by-step instructions for use of the inhaler provided below can be used for either the 30-dose (30 day supply) or the 14-dose (14 day supply) Ellipta inhaler.
Maltese: L-istruzzjonijiet li ġejjin għall-inalatur Ellipta ta' 30 doża (provvista ta' 30 jum) japplikaw ukoll għall inalatur Ellipta ta' 14-il doża (provvista ta' 14-il jum).
English: Common side effects
Maltese: Rinite Sinusite Influwenza
English: Primary elimination of vilanterol was by metabolism followed by excretion of metabolites in urine and faeces.
Maltese: L-eliminazzjoni primarja ta' vilanterol kienet permezz tal-metaboliżmu segwita mnn eliminazzjoni tal-metaboliti fl-awrina u l-ippurgar.
English: In IMPACT, Temybric Ellipta significantly reduced (p<0.001) the use of rescue medication (occasions per day) at each 4-week time period compared with FF/VI and UMEC/VI.
Maltese: rispondenti kien ukoll sinifikament ogħla (p<0.001) għal Temybric Ellipta (36%) meta mqabbel ma' FF/VI
English: There is no specific treatment for an overdose with Temybric Ellipta.
Maltese: pulmonite f'pazjent li rċieva Temybric Ellipta.
English: Temybric Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment tal-kliewi (ara sezzjoni 5.2).
English: NAME OF THE MEDICINAL PRODUCT Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
Maltese: Temybric Ellipta 92 mikrogramma/55 mikrogramma/22 mikrogramma trab li jittieħed man-nifs, lest minn qabel
English: • Potential risk of malignancies;
Maltese: • Riskju potenzjali ta' mard malinn;
English: • Risk of malignancies.
Maltese: • Riskju ta' mard malinn.
English: The Marketing authorisation Holder (MAH) shall ensure that prior to launch of the prefilled syringe form of Stelara, all healthcare professionals who are expected to prescribe/use Stelara are provided with educational materials containing the following:
Maltese: Id-Detentur tal-Awtorizzazzjojni għat-Tqegħid fis-Suq (MAH) għandu jiżgura li qabel ma' jiġi introdott Stelara taħt forma ta' siringa mimlija għal-lest, il-professjonisti kollha fil-qasam tas-saħħa li huma mistennija li jippreskrivu/jużaw Stelara jingħataw materjal edukattiv li fih dan li ġej:
English: • Risk of reactivation of latent tuberculosis and information about the screening for tuberculosis according to the local guidance;
Maltese: • Riskju ta' rijattivazzjoni ta' tuberkulosi rieqda u informazzjoni dwar kif wieħed jiġi eżaminat għat-tuberkulosi skont il-linji gwida lokali;
English: • Local Guidance for tuberculosis screening;
Maltese: • Gwida lokali għal kif isiru testijiet għat-tuberkulosi;
English: Healthcare Professional educational pack • Patient information pack
Maltese: • Pakkett ta' tagħrif għall-Professjonisti fil-Qasam Mediku u Paramediku • Pakkett ta' informazzjoni għall-pazjent
English: The key messages and components included in the Healthcare Professional educational pack are defined as follows:
Maltese: Il-messaġġi l-aktar importanti u l-komponenti inklużi fil-pakkett ta' tagħrif għall-Professjonisti fil-Qasam Mediku u Paramediku huma definiti kif ġej:
English: • Summary of Product Characteristics
Maltese: • Sommarju tal-Karatteristiċi tal-Prodott
English: The key messages in the patient information pack are defined as follows:
Maltese: Il-messaġġi l-aktar importanti fil-pakkett ta' edukazzjoni għall-pazjenti huma definiti kif ġej:
English: • Appropriate techniques for self administration of Stelara, including use of the prefilled syringes.
Maltese: • It-teknika xierqa biex wieħed jagħti Stelara lilu nnifsu, li tinkludi l-użu ta' siringi mimlijin għal-lest
English: Am Haag 6-7
Maltese: Haag 6-7
English: Date of latest renewal: 18 December 2013
Maltese: Data tal-aħħar tiġdid: 18 Diċembru 2013
English: Trion Pharma GmbH Frankfurter Ring 193a DE-80807 Munich Germany
Maltese: Trion Pharma GmbH Frankfurter Ring 193a DE-80807 Munich Il-Ġermanja
English: Proteinuria.
Maltese: Proteinurija.
English: Gastric
Maltese: Gastriku
English: 95% CI for HR
Maltese: 95% CI għal HR
English: 2nd dose
Maltese: 2ni doża
English: Paracentesis (control) (N=88)
Maltese: Paraċentesi (kontroll) (N=88)
English: 1 sterile cannula
Maltese: 1 kannula sterili
English: Diluted Removab.
Maltese: Removab dilwit.
English: 82166 Graefelfing Germany
Maltese: 82166 Graefelfing Il-Ġermanja
English: Figure 3 Schematic illustration of the infusion system
Maltese: Figura 3 Stampa skematika tas-sistema tal-infużjoni
English: Removab contains the active substance catumaxomab, a monoclonal antibody.
Maltese: Removab fih is-sustanza attiva catumaxomab, antikorp monoklonali.
English: Hepatic enzymes
Maltese: Enzimi epatiċi
English: 3 Perfusion Tubing (1 mm inner diameter, 150 cm length) 5 Perfusion Lead
Maltese: 3 Tubing tal-Perfużjoni (1 mm dijametru intern, 150 ċm tul)
English: Paracentesis + catumaxomab (N=170)
Maltese: Paraċentesi + catumaxomab (N=170)
English: Hazard ratio (HR)
Maltese: Proporzjon tal-periklu (HR)
English: The induction of human anti-murine (rat and / or mouse) antibodies (HAMAs/HARAs) is an intrinsic effect of murine monoclonal antibodies.
Maltese: L-induzzjoni ta' antikorpi (HAMAs/HARAs) umani kontra l-murine (ġrieden u/jew il-firien) hi effett intrinsiku ta' antikorpi monoklonali tal-murine.
English: Uncommon Gastrointestinal haemorrhage*, intestinal obstruction*.
Maltese: Emorraġija gastrointestinali*, ostruzzjoni intestinali*.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 April 2009
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 t'April 2009
English: Hazard ratio (HR) (Catumaxomab versus Catumaxomab + Prednisolone) 95% CI for HR
Maltese: Proporzjon tal-periklu (HR) (Catumaxomb kontra Catumaxomab + Prednisolone) 95% CI għal HR
English: Performance status and BMI
Maltese: Stat tal-prestazzjoni u BMI
English: Pancreatic
Maltese: Pankreatiku
English: • 50 ml polypropylene syringes
Maltese: • siringi ta' 50 ml tal-polypropylene
English: Table 7 Preparation of Removab solution for intraperitoneal infusion Number of infusion / Dose
Maltese: Tabella 7 Preparazzjoni tas-soluzzjoni ta' Removab għall-infużjoni ġol-peritonew Numru talinfużjoni/ Doża
English: You may need to read it again.
Maltese: Ansjetà, nuqqas ta' rqad.
English: The following definitions of CTCAE criteria of the US National Cancer Institute (version 4.0) apply: CTCAE grade 1 = mild, CTCAE grade 2 = moderate, CTCAE grade 3 = severe, CTCAE grade 4 = life-threatening
Maltese: Id-definizzjonijiet li ġejjin tal-kriterji tal-US National Cancer Institute (verżjoni 4.0) japplikaw: CTCAE grad 1 = ħfief, CTCAE grad 2 = moderati, CTCAE grad 3 = severi, CTCAE grad 4 = ta' periklu għall-ħajja
English: 95% CI for median (days) p-value (log-rank test)
Maltese: 95% CI għal medjan (jiem) valur p (test log-rank)
English: • An additional air buffer of at least 3 ml is included in the 50 ml syringe.
Maltese: • Baffer tal-arja addizzjonali ta' mill-inqas 3 ml hu inkluż fis-siringa ta' 50 ml.
English: Frequency groupings are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).
Maltese: Il-gruppi tal-frekwenza huma definiti kif ġej: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100).
English: In three patients (0.4%) an intensity of CTCAE grade 4 was observed.
Maltese: Fi tliet pazjenti (0.4%) ġiet osservata intensità ta' CTCAE ta' grad 4.
English: The anti-tumour activity of catumaxomab has been demonstrated in vitro and in vivo.
Maltese: L-attività ta' catumaxomab kontra t-tumur intweriet in vitro u in vivo.
English: Acute infections
Maltese: Infezzjonijiet akuti
English: Hypersensitivity to murine (rat and / or mouse) proteins.
Maltese: Sensittività eċċessiva għal murine (proteini tal-firien u tal-ġrieden).
English: Uncommon Pulmonary embolism*, hypoxia*.
Maltese: Emboliżmu pulmonari*, ipoksja*.
English: OTHER Neovii Biotech GmbH
Maltese: Neovii Biotech GmbH
English: Uncommon Thrombocytopenia*, coagulopathy*.
Maltese: Tromboċitopenija*, koagulopatija*.
English: In the pivotal study IP-REM-AC-01 98.1% of patients were hospitalised for a median of 11 days.
Maltese: Fi studju importanti ħafna IP-REM-AC-01, 98.1% talpazjenti kienu rikoverati l-isptar għal medjan ta' 11-il jum.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC09
Maltese: Aġenti antineoplastiċi, antikorpi monoklonali; Kodiċi ATC:
English: Cytokine release related symptoms with higher intensities In 5.1% of patients pyrexia reached an intensity of CTCAE grade 3 as it was the case with cytokine release syndrome (1.0%), chills (0.8%), nausea (3.4%), vomiting (4.4%), dyspnoea (1.6%) and hypo/hypertension (2.1% / 0.8%).
Maltese: Sintomi relatati mal-ħruġ ta' cytokines b'intensitajiet ogħla F'5.1% tal-pazjenti, id-deni laħaq intensità ta' CTCAE ta' grad 3, kif kien il-każ bis-sindrome ta' ħruġ ta' cytokines (1.0%), tertir ta' bard (0.8%), nawseja (3.4%), rimettar (4.4%), qtugħ ta' nifs (1.6%) u pressjoni baxxa/għolja (2.1%/0.8%).
English: Standard therapy or premedication, e.g. analgesic / antipyretic / nonsteroidal antiphlogistic is appropriate to limit the risk.
Maltese: It-terapija standard jew premedikazzjoni, eż. analġesiċi/antipiretiċi/antifloġistiċi nonsterojdi huma adattati biex jillimitaw ir-riskju.
English: For information on dilution and administration of Removab please refer to section 6.6 of the Summary of Product Characteristics (SmPC) included in each package of Removab 10 micrograms and Removab 50 micrograms, respectively.
Maltese: Għal informazzjoni dwar id-dilwizzjoni u l-għoti ta' Removab jekk jogħġbok irreferi għal sezzjoni 6.6 tas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC) li hu inkluż f'kull pakkett ta' Removab 10 mikrogrammi u Removab 50 mikrogramma, rispettivament.
English: Table 4 Overall survival of study IP-REM-AC-01 in post study phase Paracentesis + catumaxomab (N=170)
Maltese: Tabella 4 Sopravivenza totali ta' studju IP-REM-AC-01 fil-fażi ta' wara l-istudju Paraċentesi + catumaxomab (N=170)
English: • polyethylene perfusion tubings with an inner diameter of 1 mm and a length of 150 cm
Maltese: • tubings tal-perfużjoni tal-polyethylene b'dijametru intern ta' 1 mm u tul ta' 150 ċm
English: Prior to the intraperitoneal infusion, pre-medication with analgesic / antipyretic / non-steroidal antiphlogistic medicinal products is recommended (see section 4.4).
Maltese: Qabel l-infużjoni ġol-peritonew, premedikazzjoni bi prodotti mediċinali analġesiċi/antipiretiċi/antifloġistiċi non-sterojdi hi rakkomandata (ara sezzjoni 4.4).
English: Sodium Chloride 9 mg/ml (0.9%)
Maltese: Baffer tal-arja Sodium Chloride 9 mg/ml (0.9%)
English: LIST OF EXCIPIENTS Sodium citrate, citric acid monohydrate, polysorbate 80, water for injections
Maltese: TA' EĊĊIPJENTI Sodium citrate, citric acid monohydrate, polysorbate 80, ilma għall-injezzjonijiet
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/512/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/512/002
English: 10 micrograms on day 0
Maltese: 10 mikrogrammi f'jum 0
English: Decreased appetite* / anorexia, dehydration*, hypokalaemia, hypoalbuminaemia, hyponatraemia*, hypocalcaemia*, hypoproteinaemia.
Maltese: Nuqqas ta' aptit* / anoreksja, deidratazzjoni*, ipokalemija, ipoalbuminemija, iponatremija*, ipokalċemija*, ipoproteinemija.
English: Colon
Maltese: Tal-kolon
English: Infection.
Maltese: Infezzjoni.
English: Uncommon Renal failure acute*.
Maltese: Insuffiċjenza renali akuta*.
English: 50 micrograms on day 7
Maltese: 50 mikrogramma f'jum 7
English: Estimated Probability of Being Puncture-free (%)
Maltese: Stima tal-Probabbiltà li Tkun Mingħajr Titqiba (%)
English: Endometrial *= lobular breast cancer
Maltese: Endometrijali *= kanċer lobulari tas-sider
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/512/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/512/001
English: 150 micrograms on day 10
Maltese: 150 mikrogramma f'jum 10
English: • polycarbonate infusion valves / Y connections
Maltese: • valvoli tal-infużjoni/konnessjonijiet Y tal-polycarbonate
English: 20 micrograms on day 3
Maltese: 20 mikrogramma f'jum 3
English: Back pain, myalgia, arthralgia.
Maltese: Uġigħ fid-dahar, mijalġja, artralġja.
English: Uncommon Skin reaction*, dermatitis allergic*.
Maltese: Reazzjoni tal-ġilda*, dermatitè allerġika*.
English: Systemic Inflammatory Response Syndrome (SIRS) In 3.8% of the patients symptoms of SIRS were observed within 24 hours after catumaxomab infusion.
Maltese: Sindrome tar-Rispons Infjammatorju Sistemiku (SIRS) Fi 3.8% tal-pazjenti, kienu osservati sintomi ta' SIRS fi żmien 24 siegħa wara l-infużjoni b' catumaxomab.
English: Cytokine release syndrome*, hypersensitivity*.
Maltese: Sindrome ta' ħruġ ta' cytokines*, sensittività eċċessiva*.
English: The prepared solution for infusion is physically and chemically stable for 48 hours at 2°C to 8°C and for 24 hours at a temperature not above 25°C.
Maltese: Is-soluzzjoni ppreparata għall-infużjoni hi kimikament u fiżikament stabbli għal 48 siegħa f'temperatura ta' minn 2 sa 8°C u għal 24 siegħa f'temperatura ta' mhux aktar minn 25°C.
English: Symptoms of pain and pyrexia can be ameliorated or avoided by pre-medication (see sections 4.2 and 4.4).
Maltese: Sintomi ta' wġigħ u deni jistgħu jittaffew jew jiġu evitati permezz tal-premedikazzjoni (ara sezzjonijiet 4.2 u 4.4).
English: In clinical studies infusion times of 3 hours and 6 hours were investigated.
Maltese: Fi studji kliniċi, ħinijiet tal-infużjoni ta' 3 sigħat u 6 sigħat ġew investigati.
English: (Part of the Outer Carton)
Maltese: (Parti mill-Kartuna ta' Barra)
English: Other or additional standard pre-medication with analgesic / antipyretic / nonsteroidal antiphlogistic medicinal products is recommended.
Maltese: Pre-medikazzjoni oħra jew addizzjonali standard bi prodotti mediċinali analġesiċi/antipiretiċi/antifloġistiċi nonsterojdi hi rakkomandata.
English: Uncommon Convulsion*.
Maltese: Konvulżjoni*.
English: The geometric mean apparent terminal plasma elimination half-life (t1/2) was approximately 2.5 days (range 0.7 to 17).
Maltese: Il-medja ġeometrika tal-half-life (t1/2) tal-eliminazzjoni terminali apparenti tal-plażma kienet ta' madwar 2.5 jiem (medda 0.7 sa 17).