FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate), 5 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita fiha 300 mg aliskiren (bħala hemifumarate), 5 mg amlodipine (bħala besylate) u 12.5 mg hydrochlorothiazide.
English: - Cytotoxic agents
Maltese: • tnemnim jew titrix
English: Anaphylactic reactions and angioedema
Maltese: Reazzjonijiet anafilattiċi u anġjoedima
English: Vomiting, dyspepsia, altered bowel habits (including diarrhoea and
Maltese: Nuqqas ta' rqad, bidliet fil-burdata (inkluż ansjetà), dipressjoni
English: What Rasitrio looks like and contents of the pack - Rasitrio 300 mg/10 mg/12.5 mg film-coated tablets are light red, oval tablets, with “UIU”
Maltese: Kif jidher Rasitrio u l-kontenut tal-pakkett - Il-pilloli miksija b'rita Rasitrio tat-300 mg/10 mg/12.5 mg huma ħomor ċar, ovali, b'“UIU”
English: • tingling or numbness
Maltese: • imnieħer inixxi
English: Component of a multipack comprising 2 packs, each containing 49x1 tablet.
Maltese: Pakkett b'ħafna li jinkludi 2 pakketti, kull pakkett fih 49x1 pillola.
English: Although this has not been investigated for aliskiren, it is known that P-gp also controls tissue uptake of a variety of substrates and P-gp inhibitors can increase the tissue-to-plasma concentration ratios.
Maltese: Għalkemm din ma ġietx investigata għal aliskiren, huwa magħruf li P-gp jikkontrolla wkoll it-teħid ta' varjetà ta' sottostrati mit-tessuti u inibituri ta' P-gp jistgħu jżidu l-proporzjon tal-konċentrazzjoni tat-tessuti mal-plażma.
English: Arthralgia, myalgia, muscle cramps, back pain
Maltese: ġilda xotta, raxx, raxx bil-ħakk
English: - if you are taking any of the following medicines: ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis), itraconazole (a medicine used to treat fungal infections), quinidine (a medicine used to correct heart rhythm).
Maltese: Tiħux Rasitrio u kellem lit-tabib tiegħek jekk inti qed tieħu kwalunkwe waħda minn dawn ilmediċini li ġejjin: - ciclosporin (mediċina użata fit-trapjanti sabiex jevita li l-organu jkun riġettat u wkoll għal kundizzjonijiet oħrajn, eż. artrite rewmatojde jew dermatite atopika). - itraconazole (mediċina użata biex ikunu ttrattati infezzjonijiet tal-fungu). - quinidine (mediċina użata biex tirranġa r-ritmu tal-qalb).
English: Very common Increases in cholesterol and triglycerides Rare
Maltese: Żieda fil-kolesterol u t-trigliċeridi
English: Coadministration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol.
Maltese: L-għotja flimkien ta' dijuretiċi thiazide, inkluż hydrochlorthiazide, jista' jżid l-inċidenza ta' reazzjonijiet ta' sensittività eċċessiva għal allopurinol.
English: No adjustment of the initial dose is required for patients with mild to moderate renal impairment (estimated glomerular filtration rate (GFR) 89-60 ml/min/1.73 m and 59-30 ml/min/1.73 m respectively) (see sections 4.4 and 5.2).
Maltese: M'hemmx bżonn li jkun hemm aġġustamenti tad-doża tal-bidu għall-pazjenti li jkollhom indeboliment renali ħafif għal moderat (rata stmata tal-filtrazzjoni fil-glomeruli (GFR) 89-60 ml/min/1.73 m u
English: • skin rash (this may also be a sign of allergic reactions or angioedema - see “Rare” side effects below)
Maltese: • raxx tal-ġilda (dan jista' jkun sinjal ta' reazzjonijiet allerġiċi jew anġjoedima - ara l-effetti sekondarji “Rari” hawn taħt)
English: Very limited data are available on the use of Rasitrio in patients aged 75 years or older (see section 5.2).
Maltese: Hemm ftit informazzjoni disponibbli dwar l-użu ta' Rasitrio f'pazjenti li għandhom 75 sena jew aktar (ara sezzjoni 5.2).
English: Each tablet contains 150 mg aliskiren (as aliskiren hemifumarate), 5 mg amlodipine (as amlodipine besylate) and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita fiha 150 mg aliskiren (bħala aliskiren hemifumarate), 5 mg amlodipine (bħala amlodipine besylate) u 12.5 mg hydrochlorothiazide.
English: Impotence General disorders and administration site conditions Not known
Maltese: Impotenza Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Mhux magħruf
English: Rasitrio 300 mg/10 mg/25 mg film-coated tablets
Maltese: Rasitrio 300 mg/10 mg/25 mg pilloli miksija b'rita
English: The concomitant use of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5 and
Maltese: L-użu ta' aliskiren ma' ARBs jew ACEIs huwa kontra-indikat f'pazjenti b'dijabete mellitus jew b'indeboliment renali (GFR <60 ml/min/1.73 m2) u mhuwiex rakkomandat f'pazjenti oħra (ara sezzjonijiet 4.3, 4.4 u
English: The concomitant use of aliskiren and ACEIs or ARBs is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see section 4.3, 4.5
Maltese: L-użu konkomitanti ta' aliskiren u ACEIs jew ARBs huwa kontra-indikat f'pazjenti b'dijabete mellitus jew b'indeboliment renali (GFR <60 ml/min/1.73 m2) (ara sezzjoni 4.3, 4.5 u 4.8).
English: - Organic anion transporting polypeptide (OATP) inhibitors Preclinical studies indicate that aliskiren might be a substrate of organic anion transporting polypeptides.
Maltese: - Inibituri tal-polypeptide organiku li jittrasporta l-anjoni (OATP)
English: Paediatric population: Based on the limited amount of safety data available from a pharmacokinetic study of aliskiren treatment in 39 hypertensive children 6-17 years of age, the frequency, type and severity of adverse reactions in children are expected to be similar to that seen in hypertensive adults.
Maltese: Abbażi tal-ammont limitat ta' dejta ta' sigurtà disponibbli minn studju farmakokinetiku ta' kura b'aliskiren f'39 tifel u tifla bi pressjoni għolja b'eta minn 6-17-il sena, ilfrekwenza, it-tip u l-qawwa tar-reazzjonijiet avversi fit-tfal huma mistennija li jkunu jixbhu lil dawk li dehru f'adulti bi pressjoni għolja.
English: Rasitrio 300 mg/5 mg/25 mg film-coated tablets
Maltese: Rasitrio 300 mg/5 mg/25 mg pilloli miksija b'rita
English: - Iodine contrasting agents
Maltese: Ir-Renju Unit
English: Hence, interactions due to inhibition or induction of CYP450 isoenzymes are not expected.
Maltese: Għalhekk, interazzjonijiet minħabba l-inibizzjoni jew linduzzjoni tal-isoenzimi CYP450 mhumiex mistennija.
English: • rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
Maltese: • raxx, ħakk, ħobbejż, diffikultà biex tieħu n-nifs jew biex tibla', sturdament (reazzjonijiet ta'
English: These doses of hydrochlorothiazide in mice and rats represent 19 and 1.5 times, respectively, the maximum recommended human dose on a mg/m basis.
Maltese: Dawn id-dożi ta' hydrochlorothiazide fil-ġrieden u l-firien jirrappreżentaw 19 u 1.5 drabi, rispettivament, id-doża massima rrakkomandata għall-bnedmin fuq bażi ta' mg/m2.
English: Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets
Maltese: Rasitrio 150 mg/5 mg/12.5 mg pilloli miksija b'rita
English: Acute angle-closure glaucoma
Maltese: Glawkoma gravi tal-għeluq tal-angolu
English: The blood-pressure-lowering effect was sustained during long-term treatment, and was independent of age, gender, body mass index and ethnicity.
Maltese: L-effett li jbaxxi l-pressjoni nżamm waqt kura li ngħatat fit-tul, u ma kienx jiddependi mill-età, sess, indiċi tal-massa tal-ġisem u etniċità.
English: There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester.
Maltese: Hemm esperjenza limitata b'hydrochlorthiazide waqt it-tqala, speċjalment waqt l-ewwel trimestru.
English: Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers.
Maltese: Studji dwar il-mutaġeniċità ma żvelaw ebda effett relatat mal-prodott mediċinali fil-livelli tal-ġeni jew tal-kromosomi.
English: OUTER CARTON OF MULTIPACK OF 98 (2 packs of 49 film-coated tablets) - WITH BLUE BOX
Maltese: TA' 98 (2 pakketti ta' 49 pillola miksijin b'rita) - BIL-KAXXA L-BLU
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara JIS/EXP.
English: Abdominal discomfort, constipation, diarrhoea
Maltese: Palpitazzjonijiet, edima periferali
English: Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate), 10 mg amlodipine (as amlodipine besylate) and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita fiha 300 mg aliskiren (bħala aliskiren hemifumarate), 10 mg amlodipine (bħala amlodipine besylate) u 12.5 mg hydrochlorothiazide.
English: Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate), 10 mg amlodipine (as amlodipine besylate) and 25 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita fiha 300 mg aliskiren (bħala aliskiren hemifumarate), 10 mg amlodipine (bħala amlodipine besylate) u 25 mg hydrochlorothiazide.
English: Over the 12-week period, aliskiren monotherapy lowered systolic/diastolic blood pressure by 14.0/5.1 mmHg, compared to 11.6/3.6 mmHg for ramipril, consistent with aliskiren being non-inferior to ramipril at the dosages chosen and the differences in systolic and diastolic blood pressure were statistically significant.
Maltese: 6/3.6 mmHg għal ramipril, konsistenti b'aliskiren li mhuwiex inferjuri għal ramipril bid-dożi magħżula u d-differenzi fil-pressjoni sistolika u dijastolika tad-demm kienu sinifikanti statistikament.
English: dizziness
Maltese: Tqala
English: Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate), 5 mg amlodipine (as amlodipine besylate) and 25 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita fiha 300 mg aliskiren (bħala aliskiren hemifumarate), 5 mg amlodipine (bħala amlodipine besylate) u 25 mg hydrochlorothiazide.
English: The available clinical data did not indicate that higher doses of torasemide were used after coadministration with aliskiren.
Maltese: Id-dejta klinika disponibbli ma ndikatx li dożi ogħla ta' torasemide kienu użati wara għoti flimkien ma' aliskiren.
English: The safety and efficacy of Rasitrio in children and adolescents below age 18 have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Rasitrio fit-tfal u adoloxxenti ta' taħt it-18-il sena ma ġewx determinati s'issa.
English: EU/1/16/1097/001 Strimvelis million cells/ml
Maltese: EU/1/16/1097/001 Strimvelis
English: Patient specific up to 50 ml max
Maltese: Speċifiku għallpazjent sa massimu ta' 50 ml
English: Intravenous use bag (EVA)
Maltese: Użu għal-ġol-vina borża (EVA)
English: Immediate Packaging
Maltese: Daqs tal pakkett
English: 1 or more bags each with 1 luer spike interconnector
Maltese: Borża waħda jew aktar b'1 interkonnettur b'labra rqiqa luer
English: MA (EU) number Invented name Strength Pharmaceutical Form
Maltese: Numru tal-MA (UE)
English: The full EPAR for Karvea 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: Karvea is a medicine that contains the active substance irbesartan.
Maltese: Karvea huwa mediċina li fiha s-sustanza attiva irbesartan.
English: Karvea was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Maltese: Karvea tqabbel ma' plaċebo (trattament finta) f'712-il pazjent u tqabbel ma' mediċini oħra kontra lipertensjoni (etenolol, enalapril, amlodipina) f'823 pazjent.
English: Other information about Karvea
Maltese: Informazzjoni oħra dwar Karvea:
English: This is a summary of the European public assessment report (EPAR) for Karvea.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Karvea.
English: The usual recommended dose of Karvea is 150 mg once a day.
Maltese: Id-doża normalment rakkomandata ta' Karvea hija ta' 150 mg darba kuljum.
English: The active substance in Karvea, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Is-sustanza attiva f'Karvea, irbesartan hija ‘antagonista tar-riċettur l-anġjotensina II' li tfisser li jimblokka l-azzjoni ta' ormon fil-ġisem imsejjaħ anġjotensina II.
English: Why has Karvea been approved?
Maltese: Għaliex ġie approvat Karvea?
English: What is the risk associated with Karvea?
Maltese: X'inhu r-riskju assoċjat ma' Karvea?
English: In the second kidney disease study, Karvea reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant, or death during the study by 20% in comparison with placebo.
Maltese: Fit-tieni studju dwar ilmard tal-kliewi, Karvea naqqas ir-riskju relattiv b'20% meta mqabbel mal-plaċebo li jintlaħaq flirduppjar tal-livelli tal-kreatinina fid-demm, li jeħtieġu li jsir trapjant tal-kliewi jew il-bżonn ta' dijaliżi jew li jkunu mietu waqt l-istudju.
English: Karvea is also used to treat kidney disease in adults with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Maltese: Karvea jintuża wkoll fit-trattament tal-mard renali f'adulti li jbatu minn ipertensjoni u d-dijabete tat-tip 2 (dijabete li mhix dipendenti fuq l-insulina).
English: The most common side effect with Karvea (seen in more than 1 patient in 10) is hyperkalaemia (high blood potassium levels).
Maltese: L-iktar effett sekondarju komuni b'Karvea (li deher f'iktar minn pazjent 1 minn kull 10) huwa lipogliċemija (livelli għolja ta' potassju fid-demm).
English: How has Karvea been studied?
Maltese: Kif ġie studjat Karvea?
English: What is Karvea?
Maltese: X'inhu Karvea?
English: For the treatment of kidney disease, Karvea was studied in two large studies involving a total of 2,326 patients with type 2 diabetes.
Maltese: Karvea ġie studjat ukoll f'żewġ studji kbar dwar il-mard tal-kliewi f'2,326 pazjent li għandhom dijabete tat-tip 2.
English: In the first kidney disease study, Karvea was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
Maltese: Fl-ewwel studju dwar il-mard tal-kliewi rriżulta li Karvea kien ferm aktar effikaċi mill-plaċebo biex inaqqas ir-riskju li ssir ħsara lill-kliewi kif ġiet imkejla t-tneħħija tal-proteini.
English: Karvea was originally studied in 11 trials for its effects on blood pressure.
Maltese: Oriġinarjament Karvea ġie studjat fi 11-il prova għall-effetti tiegħu fuq il-pressjoni tad-demm.
English: The CHMP decided that Karvea's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Karvea huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Karvea in combination with aliskirencontaining medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Maltese: Karvea ma għandux jintuża flimkien ma' mediċini li fihom l-aliskiren (użat fil-kura tal-ipertensjoni essenzjali) f'pazjenti biddijabete, jew insuffiċjenza moderata jew gravi fil-kliewi.
English: In the blood pressure studies, Karvea was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Maltese: Fl-istudji dwar il-pressjoni għolja, irriżulta li Karvea kien ferm aktar effikaċi mill-plaċebo biex inaqqas il-pressjoni tad-demm dijastolika u kellu effetti simili għal mediċini għall-ipertensjoni.
English: For the full list of all side effects reported with Karvea, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Karvea, ara l-Fuljett ta' Tagħrif.
English: What benefit has Karvea shown during the studies?
Maltese: Liema benefiċċju wera Karvea waqt l-istudji?
English: In this study, Karvea was compared with placebo and with amlodipine.
Maltese: F'dan l-istadju Karvea tqabbel mal-plaċebo u mal-amlodipina.
English: In patients with hypertension and type 2 diabetes, Karvea is added to some other treatments for hypertension.
Maltese: F'pazjenti li jbatu b'ipertenzjoni u dijabete tat-tip 2, Karvea huwa miżjud mat-trattamenti l-oħra għallipertensjoni.
English: This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.
Maltese: Dan iwassal għal tnaqqis fil-pressjoni tad-demm, u b'hekk jitnaqqsu ir-riskji assoċjati minn pressjoni għolja tad-demm, fosthom il-puplesija.
English: Placebo (N = 29)
Maltese: Plaċebo (N = 29)
English: Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co. Dublin Ireland
Maltese: Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.
English: 8 mg / 1 ml
Maltese: INDIVIDWALI 8 mg / 1 ml
English: Haemolysis and/or Methemoglobinemia
Maltese: Emolisi u/jew Methemoglobinemia
English: • The active substance is pegloticase.
Maltese: • Is-sustanza attiva hija pegloticase.
English: KRYSTEXXA contains the active substance pegloticase.
Maltese: KRYSTEXXA fih is-sustanza attiva pegloticase.
English: th infusion.
Maltese: Mhux applikabbli.
English: Number of Patients with CR (%)2
Maltese: Għadd ta' pazjenti b'CR (%)
English: EU/1/12/810/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/810/001
English: 95% Confidence Interval1
Maltese: Intervall ta' 1 Valur-p Fiduċja ta' 95%
English: M0402: EU Pegloticase post-marketing Observational Study
Maltese: M0402: Studju Osservazzjonali tal-UE ta' Wara t-Tqegħid fis-Suq dwar Pegloticase
English: Adverse Reaction
Maltese: Reazzjonijiet Avversi
English: Date of first authorisation: 08/01/2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL- AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 08/01/2013
English: Pegloticase is a uricase enzyme conjugated with mPEG at an average degree of substitution of 40.8 moles of mPEG/mole of protein (10.2 moles of mPEG/monomeric sub-unit of the mature homotetrameric uricase protein).
Maltese: Pegloticase huwa enzim ta' uricase konjugat ma' mPEG fi grad medju ta' sostituzzjoni ta' 40.8 moli ta' mPEG/mole ta' proteina (10.2 moli ta' mPEG/sub-unità monomerika tal-proteina matura omotetramerika uricase).
English: The following convention has been used for classification of the adverse reactions reported in the Phase 3 clinical trials (see Table 1 below): 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: Il-konvenzjoni li ġejja inużat għall-klassifikazzjoni tar-reazzjonijiet avversi rrapportati fil-provi kliniċi tal-Fażi 3 (ara Tabella 1 hawn taħt): 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 magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Glucose-6-phosphate dehydrogenase (G6PD) deficiency and other cellular metabolic disorders known to cause haemolysis and methemoglobinemia.
Maltese: Defiċjenza ta' glucose-6-phosphate dehydrogenase (G6PD) u mard metaboliku ċellulari ieħor magħruf li jikkawża emolisi u methemoglobinemia.
English: Instructions for preparation:
Maltese: Istruzzjonijiet għall-preparazzjoni:
English: For the PEG moiety, urinary excretion is likely to be the major route of elimination.
Maltese: Għall-PEG moiety, leliminazzjoni urinarja hija probabbli r-rotta ewlenija ta' eliminazzjoni.
English: • If you have a rare blood problem called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism.
Maltese: • Jekk għandek problema rari tad-demm imsejħa defiċjenza ta' glucose 6-phosphate dehydrogenase (G6PD) jew favism.
English: 8 mg Pegloticase Every 2 Weeks (N = 62)
Maltese: 8 mg Pegloticase Kull Ġimgħatejn (N = 62)
English: Pack size of 1 vial.
Maltese: Pakkett b'kunjett 1.
English: Risk Management Plan (RMP)
Maltese: Pjan tal-Ġestjoni tar-Riskju (RMP)
English: 4.6 Fertility, Pregnancy and Lactation
Maltese: .6 Fertilità, tqala u treddigħ
English: KRYSTEXXA can induce severe allergic responses, including anaphylactic shock with cardiac arrest.
Maltese: KRYSTEXXA jista' jinduċi reazzjonijiet allerġiċi severi, inkluż xokk anafilattiku b'arrest kardijaku.
English: The recommended dose of KRYSTEXXA is 8 mg.
Maltese: Id-doża rakkomandata ta' KRYSTEXXA hija ta' 8 mg.
English: There was potential for some accumulation with the KRYSTEXXA 8 mg every two weeks dosing regimen due to the long half-life of pegloticase (214 h; range: 123 - 444 h for terminal half-life).
Maltese: Kien hemm il-potenzjal għal xi akkumulazzjoni bir-reġimen tad-dożaġġ ta' KRYSTEXXA 8 mg kull ġimgħatejn minħabba l-half-life twila ta' pegloticase (214 h; firxa: 123 - 444 h għall-half-life terminali).
English: The active substance pegloticase is a covalent conjugate of uricase produced by a genetically modified strain of Escherichia coli and monomethoxypoly (ethylene glycol).
Maltese: Is-sustanza attiva pegloticase hija konjugat kovalenti ta' uricase prodott permezz ta' razza ġenetikament modifikata ta' Escherichia coli u monomethoxypoly (ethylene glycol).
English: The mean Cmax calculated on the last infusion was 2.17 µg/ml (range: 1.25 - 4.77).
Maltese: Is-Cmax medju kkalkulat fuq l-aħħar infużjoni kien ta' 2.17 µg/ml (firxa: 1.25 - 4.77).
English: Anaphylaxis (characterized by stridor, wheezing, peri-oral/lingual oedema, or hemodynamic instability, with or without rash or urticaria) occurred in 14 (5.1%) of 273 total patients treated with KRYSTEXXA in clinical studies.
Maltese: Anafilassi (ikkaratterizzata minn stridor, tħarħir, edema peri-orali/lingwali, jew instabbiltà emodinamika, bi jew mingħajr raxx jew urtikarja) seħħet f'14 (5.1%) minn total ta' 273 pazjent li rċevew kura bi KRYSTEXXA fl-istudji kliniċi.
English: KRYSTEXXA has not been studied in children or adolescents under 18 years of age.
Maltese: KRYSTEXXA ma ġiex studjat fit-tfal jew fl-adolexxenti taħt it-18-il sena.
English: Adverse Reactions System Organ Class
Maltese: Sistema tal-Klassifika tal-Organi
English: Acute gouty attacks (gout flare)
Maltese: Attakki akuti tal-gotta (rikaduti tal-gotta)
English: They were reported in 54% of the patients in the 70 to ≤100 kg weight group, 70% of the patients in the >100 to ≤120 kg weight group, and 75% of patients in the >120 kg weight group, respectively.
Maltese: Kienu rapportati f'54% tal-pazjenti fil-grupp ta' piż tas-70 sa≤100kg, f'70% tal-pazjenti fil-grupp tal-piż >100 sa ≤120kg, u f'75% tal-pazjenti fil-grupp tal-piż >120kg, rispettivament.
English: The Phase 1 pharmacokinetics showed proportionality within the dose interval (0.5 - 8 mg) as reflected in Cmax values.
Maltese: Il-farmakokinetika tal-Fażi 1 wriet proporzjonalità mal-intervall tad-doża (0.5 - 8 mg) kif rifless filvaluri tas-Cmax.
English: Name and address of the manufacturer(s) of the biological active substance
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza bijoloġika attiva
English: The mean area under the KRYSTEXXA plasma concentration versus time curve at steady-state (AUC0-t) was 445 h*µg/ml (range: 223 - 1040 h*µg/ml).
Maltese: Iż-żona medja taħt il-konċentrazzjoni ta' KRYSTEXXA fil-plasma kontra l-kurva tal-ħin fi stat stabbli (AUC0-t) kienet ta' 445 h*µg/ml (firxa: 223 - 1040 h*µg/ml).
English: KRYSTEXXA was administered by intravenous infusion with a Tmax of 2.25 h (range: 1.92 - 4.25 h for initial dose).
Maltese: KRYSTEXXA ingħata permezz ta' infużjoni ġol-vina b'Tmax ta' 2.25 h (firxa: 1.92 - 4.25 h għad-doża tal-bidu).
English: For the full list of excipients see section 6.1
Maltese: Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1
English: High anti-pegloticase antibody titres were associated with a failure to maintain normalisation of uric acid (<6 mg/dl).
Maltese: Titri għoljin ta' antikorpi kontra pegloticase kienu assoċjati ma' nuqqas li tinżamm normalizzazzjoni tal-aċidu uriku (<6 mg/dl).