FrancophonIA/ELRC3.0 huggingface dataset:
English: • Hyper-active thyroid gland (may show in your blood tests)
Maltese: • Glandola tat-tirojde iperattiva (dan jista' jidher fit-testijiet tad-demm tiegħek)
English: Inlyta 3 mg film-coated tablets are red, round and debossed with “Pfizer” on one side and “3 XNB” on the other.
Maltese: Inlyta 3 mg pilloli miksijin b'rita Pillola tonda ħamra miksija b'rita b'“Pfizer” imnaqqxa fuq naħa u “3 XNB” fuq in-naħa l-oħra
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, gastrointestinal perforation-type events were reported in 1.7% of patients receiving axitinib, including anal fistula (0.6%), fistula (0.3%) and gastrointestinal perforation (0.3%).In monotherapy studies with axitinib (N = 850), gastrointestinal perforation-type events were reported in 1.9% of patients and fatal gastrointestinal perforation was reported in one patient (0.1%).
Maltese: Perforazzjoni gastrointestinali u formazzjoni ta' fistuli (ara sezzjoni 4.4) Fi studju kliniku kkontrollat b'axitinib għat-trattament ta' pazjenti b'RCC, ġew irrapportati avvenimenti tat-tip ta' perforazzjoni f'1.7% tal-pazjenti li rċivew axitinib, inklużi fistula anali (0.6%), fistula (0.3%) u perforazzjoni gastrointestinali (0.3%).
English: Reversible physeal dysplasia was observed in mice and dogs given axitinib for at least 1 month at exposure levels approximately six-fold higher than the expected human exposure.
Maltese: Ġiet osservata reversible physeal dysplasia fi ġrieden u klieb mogħtija axitinib għal mill-inqas xahar f'livelli ta' espożizzjoni bejn wieħed u ieħor sitt darbiet ogħla mill-espożizzjoni umana mistennija.
English: Management of cardiac failure events may require temporary interruption or permanent discontinuation and/or dose reduction of axitinib therapy.
Maltese: Il-ġestjoni ta' avvenimenti ta' insuffiċjenza tal-qalb tista' teħtieġ twaqqif temporanju jew permanenti u/jew tnaqqis fid-doża tat-terapija b'axitinib.
English: Each film-coated tablet contains 82.3 mg of lactose monohydrate.
Maltese: Inlyta 7 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 82.3 mg lactose monohydrate.
English: In four clinical studies with axitinib for the treatment of patients with RCC (N = 537), elevated haemoglobin above ULN was observed in 13.6% receiving axitinib.
Maltese: F'erba' studji kliniċi b'axitinib għat-trattament ta' pazjenti b'RCC (N = 537), żieda fil-livelli ta' emoglobina ogħla mill-ULN ġiet osservata fi 13.6% tal-pazjenti li rċivew axitinib.
English: Unchanged axitinib, accounting for 12% of the dose, was the major component identified in faeces.
Maltese: Axitinib mhux mibdul, li kien jammonta għal 12% tad-doża, kien il-komponent ewlieni identifikat fl-ippurgar.
English: Inlyta 3 mg film-coated tablets EU/1/12/777/007
Maltese: Inlyta 3 mg pilloli miksijin b'rita EU/1/12/777/007
English: In vitro studies indicated that axitinib inhibits P-glycoprotein.
Maltese: Din il-mediċina ma ġietx studjata fit-tfal u l-adolexxenti.
English: Treatment with axitinib should be stopped at least 24 hours prior to scheduled surgery.
Maltese: Il-kura b'axitinib għandha titwaqqaf mill-inqas 24 siegħa qabel il-kirurġija skedata.
English: Each film-coated tablet contains 33.6 mg of lactose monohydrate.
Maltese: Inlyta 1 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 33.6 mg lactose monohydrate.
English: Axitinib has not been studied in patients with severe hepatic impairment (Child-Pugh class C) and should not be used in this population (see sections 4.4 and 5.2).
Maltese: Axitinib ma ġiex studjat f'pazjenti b'indeboliment epatiku sever (Child-Pugh klassi C) u ma għandux jintuża f'din ilpopolazzjoni (ara sezzjonijiet 4.4 u 5.2).
English: Hyperbilirubinaemia Cholecystitisn
Maltese: Ir-rekwiżiti biex jiġu ppreżentati
English: Grade 3b
Maltese: Gradi % Grad 3 Kollha
English: In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, gastrointestinal perforation and fistula were reported in 1.9% of patients receiving axitinib.
Maltese: Fi studji kliniċi miġbura b'axitinib (N = 672) għat-trattament ta' pazjenti b'RCC, perforazzjoni gastrointestinali u fistula ġew irrappurtati f'1.9% tal-pazjenti li kienu qed jirċievu axitinib.
English: Posterior reversible encephalopathy syndrome (PRES) In clinical studies with axitinib, events of PRES were reported (see section 4.8).
Maltese: Fi studji kliniċi b'axitinib, ġew irrapportati avvenimenti ta' PRES (ara sezzjoni 4.8).
English: Inlyta 3 mg is available in bottles of 60 tablets and blisters of 14 tablets.
Maltese: Inlyta 3 mg jiġi fi fliexken ta' 60 pillola u pakketti b'folji ta' 14- il pillola.
English: However, co-administration of axitinib with paclitaxel, a known CYP2C8 substrate, did not result in increased plasma concentrations of paclitaxel in patients with advanced cancer, indicating lack of clinical CYP2C8 inhibition.
Maltese: Madankollu, l-għoti flimkien ta' axitinib ma' paclitaxel, substrat magħruf ta' CYP2C8, ma rriżultax f'żieda filkonċentrazzjonijiet ta' paclitaxel fil-plażma f'pazjenti b'kanċer avvanzat, u dan jindika nuqqas ta' inibizzjoni klinika ta' CYP2C8.
English: Categories have been assigned based on absolute frequencies in the pooled clinical studies data.
Maltese: Il-kategoriji ġew assenjati fuq il-bażi tal-frekwenzi assoluti fid-dejta tal-istudji kliniċi miġbura.
English: No dose adjustment is required when administering axitinib to patients with mild hepatic impairment (Child-Pugh class A).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża meta axitinib jiġi amministrat lil pazjenti b'indeboliment epatiku ħafif (Child-Pugh klassi A).
English: In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, venous embolic and thrombotic events were reported in 2.8% of patients receiving axitinib.
Maltese: Fi studji kliniċi miġbura b'axitinib (N = 672) għat-trattament ta' pazjenti b'RCC, avvenimenti emboliċi u trombotiċi fil-vini ġew irrappurtati fi 2.8% tal-pazjenti li kienu qed jirċievu axitinib.
English: In clinical studies with axitinib for the treatment of patients with RCC, patients with serum creatinine > 1.5 times the ULN or calculated creatinine clearance < 60 mL/min were excluded.
Maltese: Fi studji kliniċi b'axitinib għat-trattament ta' pazjenti b'RCC, ġew esklużi l-pazjenti bi kreatinina fis-serum > 1.5 darba ogħla mill-ULN jew tneħħija kkalkolat tal-kreatinina ta' < 60 mL/min.
English: Although axitinib dose adjustment has not been studied in patients receiving strong CYP3A4/5 inhibitors, if a strong CYP3A4/5 inhibitor must be co-administered, a dose decrease of axitinib to approximately half the dose (e.g. the starting dose should be reduced from 5 mg twice daily to 2 mg twice daily) is recommended.
Maltese: Għalkemm l-aġġustament fid-doża ta' axitinib ma ġiex studjat f'pazjenti li jirċievu inibituri qawwijin ta' CYP3A4/5, jekk ikun irid jiġi amministrat fl-istess ħin inibitur qawwi ta' CYP3A4/5, huwa rakkomandat tnaqqis fid-doża ta' axitinib għal bejn wieħed u ieħor nofs id-doża (eż. id-doża tal-bidu għandha titnaqqas minn 5 mg darbtejn kuljum għal 2 mg darbtejn kuljum).
English: In clinical studies with axitinib, events of gastrointestinal perforation and fistulas were reported (see section 4.8).
Maltese: Perforazzjoni gastrointestinali u formazzjoni ta' fistuli Fi studji kliniċi b'axitinib, ġew irrapportati avvenimenti ta' perforazzjoni gastrointestinali u fistuli (ara sezzjoni 4.8).
English: PHARMACEUTICAL FORM AND CONTENTS 60 tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: Management of some adverse reactions may require temporary or permanent discontinuation and/or dose reduction of axitinib therapy (see section 4.4).
Maltese: Il-kontroll ta' ċerti reazzjonijiet avversi jista' jkun jeħtieġ waqfien temporanju jew permanenti u/jew tnaqqis fid-doża tat-terapija b'axitinib (ara sezzjoni 4.4).
English: Aluminium/aluminium blister containing 14 film-coated tablets.
Maltese: Folja tal-aluminju/aluminju li fiha 14-il pillola miksija b'rita.
English: In vitro binding of axitinib to human plasma proteins is > 99% with preferential binding to albumin and moderate binding to α1-acid glycoprotein.
Maltese: It-twaħħil in vitro ta' axitinib mal-proteini fil-plażma tal-bniedem hija > 99% bi twaħħil preferenzjali mal-albumina u twaħħil moderat mal-glikoproteina tal-aċidu-α1.
English: In a controlled clinical study with axitinib for the treatment of patients with RCC that excluded patients with untreated brain metastasis, haemorrhagic adverse reactions were reported in 21.4% of patients receiving axitinib.
Maltese: Fi studju kliniku kkontrollat b'axitinib għat-trattament ta' pazjenti b'RCC li eskluda lil pazjenti b'metastasi fil-moħħ mhux ittrattata, reazzjonijiet avversi emorraġiċi ġew irrapportati f'21.4% talpazjenti li rċivew axitinib.
English: Secondary endpoints included objective response rate (ORR) and overall survival (OS).
Maltese: Il-punti tat-tmiem sekondarji kienu jinkludu r-rata ta' rispons oġġettiva (ORR) u s-sopravivenza globali (OS).
English: A fatal acute myocardial infarction and cerebrovascular accident was reported in one patient each (0.3%).
Maltese: Infart mijokardijaku akut fatali u aċċident ċerebrovaskulari fatali ġew irrapportati f'pazjent wieħed kull wieħed (0.3%).
English: Each film-coated tablet contains 35.3 mg of lactose monohydrate.
Maltese: Inlyta 3 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 35.3 mg lactose monohydrate.
English: Very common Fatigue Asthaeniad
Maltese: Uġigħ fl-addome Stitikezza
English: • phenytoin, carbamazepine or phenobarbital, anti-epileptics used to stop seizures or fits;
Maltese: • phenytoin, carbamazepine jew phenobarbital, antiepilettiċi użati sabiex iwaqqfu l-aċċessjonijiet jew fits
English: Pfizer Luxembourg SARL, organizačná zložka
Maltese: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel.:
English: Renal failurem
Maltese: Il-Ġermanja
English: Pruritus Erythema Alopecia
Maltese: TWISSIJA(IET) SPEĊJALI
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, one patient inadvertently received a dose of 20 mg twice daily for 4 days and experienced dizziness (Grade 1).
Maltese: Fi studju kliniku kkontrollat b'axitinib għat-trattament ta' pazjenti b'RCC, pazjent wieħed b'mod aċċidentali rċieva doża ta' 20 mg darbtejn kuljum għal 4 ijiem u esperjenza sturdament (Grad 1).
English: • Fistula (abnormal tube like passage from one normal body cavity to another body cavity or the skin)
Maltese: • Fistula (passaġġ anormali qisu tubu minn kavità tal-ġisem għal oħra jew il-ġilda)
English: The current safety database for axitinib is too small to detect rare and very rare adverse reactions.
Maltese: Id-database attwali dwar is-sigurtà għal axitinib hija żgħira wisq sabiex jiġu identifikati reazzjonijiet avversi rari u rari ħafna.
English: EU/1/12/777/002 56 tablets
Maltese: EU/1/12/777/001 28 pillola EU/1/12/777/002 56 pillola
English: Vivian Corporation Ltd. Tel: +356 21344610
Maltese: Pfizer Biofarmacêutica, Sociedade Unipessoal Lda Tel: +351 21 423 5500
English: In a controlled clinical study, the median onset time for hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg) was within the first month of the start of axitinib treatment and blood pressure increases have been observed as early as 4 days after starting axitinib.
Maltese: Fi studju kliniku kkontrollat, iż-żmien medju li fih deher bidu ta' pressjoni għolja (pressjoni sistolika tad-demm > 150 mmHg jew pressjoni dijastolika tad-demm > 100 mmHg) kien fl-ewwel xahar millbidu tal-kura b'axitinib.
English: Selection of an alternate concomitant medicinal product with no or minimal CYP3A4/5 inhibition potential is recommended.
Maltese: Hija rakkomandata l-għażla ta' prodott mediċinali konkomitanti alternattiv b'potenzjal ineżistenti jew minimu ta' induzzjoni ta' CYP3A4/5.
English: Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations (see section 4.5).
Maltese: Jekk ikun irid jiġi amministrat inibitur qawwi ta' CYP3A4/5, huwa rakkomandat aġġustament fid-doża ta' axitinib (ara sezzjoni 4.2).
English: Hyperthyroidism was reported in 1.6% of patients receiving axitinib.
Maltese: L-ipertirojdiżmu ġie rrappurtat f'1.6% tal-pazjenti li kienu qed jirċievu axitinib.
English: Inlyta 5 mg film-coated tablets Each film-coated tablet contains 5 mg of axitinib.
Maltese: Inlyta 5 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 5 mg axitinib.
English: Routine laboratory assessments detected elevated haemoglobin above ULN in 9.7% of patients receiving axitinib.
Maltese: Il-valutazzjonijiet ta' rutina fil-labortatorju identifikaw żieda fil-livell ta' emoglobina ogħla mill-ULN f'9.7% tal-pazjenti li rċivew axitinib.
English: EU/1/12/777/005 56 tablets
Maltese: EU/1/12/777/004 28 pillola EU/1/12/777/005 56 pillola
English: In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, polycythaemia was reported in 1.5% of patients receiving axitinib.
Maltese: Fi studji kliniċi miġbura b'axitinib (N = 672) għat-trattament ta' pazjenti b'RCC, poliċitemija ġiet irrappurtata f'1.5% tal-pazjenti li kienu qed jirċievu axitinib.
English: Inlyta 1 mg film-coated tablets are red, oval and debossed with “Pfizer” on one side and “1 XNB” on the other.
Maltese: Inlyta 1 mg pilloli miksijin b'rita Pillola ovali ħamra miksija b'rita b'“Pfizer” imnaqqxa fuq naħa u “1 XNB” fuq in-naħa l-oħra
English: Selection of concomitant medicinal products with no or minimal CYP3A4/5 induction potential is recommended.
Maltese: Hija rakkomandata l-għażla ta' prodotti mediċinali konkomitanti b'potenzjal ineżistenti jew minimu ta' induzzjoni ta' CYP3A4/5.
English: Post-marketing adverse reactions identified in clinical studies are also included.
Maltese: Reazzjonijiet avversi ta' wara t-tqegħid fis-suq identifikati fi studji kliniċi huma inklużi wkoll.
English: Red diamond shaped film-coated tablet debossed with “Pfizer” on one side and “7 XNB” on the other.
Maltese: Pillola għamla ta' djamant ħamra miksija b'rita b'“Pfizer” imnaqqxa fuq naħa u “7 XNB” fuq in-naħa l-oħra
English: Partially reversible dental caries were observed in mice treated for more than 1 month at exposure levels similar to the expected human exposure.
Maltese: Ġew osservati karje dentali parzjalment riversibbli fi ġrieden ittrattati għal aktar minn xahar f'livelli ta' espożizzjoni simili għall-espożizzjoni umana mistennija.
English: Reduced fertility and embryonic viability were observed in female mice at all doses tested, with exposure levels at the lowest dose approximately 10-fold the expected human exposure.
Maltese: Tnaqqis fil-fertilità u l-vijabilità tal-embriju ġew osservati fil-ġrieden femminili fid-dożi kollha ttestjati, f'livelli ta' espożizzjoni bl-inqas doża bejn wieħed u ieħor 10 darbiet l-espożizzjoni mistennija fil-bniedem.
English: - This medicine has been prescribed for you only.
Maltese: Din il-mediċina ma teħtieġx kondizzjonijiet ta' ħażna speċjali.
English: Inlyta 7 mg film-coated tablets Each film-coated tablet contains 7 mg of axitinib.
Maltese: Inlyta 7 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 7 mg axitinib.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for axitinib, the scientific conclusions of CHMP are as follows:
Maltese: Il-mediċini li ġejjin jistgħu jnaqqsu l-effettività ta' Inlyta:
English: Therefore co-administration of axitinib is not expected to reduce the plasma concentration of co-administered CYP1A1, CYP1A2, or CYP3A4/5 substrates in vivo.
Maltese: Għaldaqstant, l-għoti fl-istess ħin ta' axitinib mhuwiex mistenni jnaqqas ilkonċentrazzjoni fil-plażma ta' substrati ta' CYP1A1, CYP1A2, jew CYP3A4/5 mogħtija fl-istess ħin in vivo.
English: Myalgia
Maltese: FOLJA
English: In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, hypothyroidism was reported in 24.6% of patients receiving axitinib.
Maltese: Fi studji kliniċi miġbura b'axitinib (N = 672) għat-trattament ta' pazjenti b'RCC, l-ipotirojdiżmu ġie rrappurtat f'24.6% tal-pazjenti li kienu qed jirċievu axitinib.
English: Thyroid stimulating hormone (TSH) increased was reported as an adverse reaction in 5.3% of patients receiving axitinib.
Maltese: Iż-żieda fil-livelli tal-ormon li jistimula t-tirojde (TSH) ġiet irrapportata bħala reazzjoni avversa f'5.3% tal-pazjenti li rċivew axitinib.
English: Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Maltese: Hija rakkomandata l-għażla ta' prodotti mediċinali konkomitanti b'potenzjal ineżistenti jew minimu ta' inibizzjoni ta' CYP3A4/5.
English: Pregnant mice exposed to axitinib showed an increased occurrence of cleft palate malformations and skeletal variations, including delayed ossification, at exposure levels below the expected human exposure.
Maltese: Il-ġrieden tqal esposti għal axitinib urew inċidenza miżjuda ta' malformazzjonijiet tal-cleft palate u varjazzjonijiet skeletali, inkluża ossifikazzjoni ttardjata, f'livelli ta' espożizzjoni inqas millespożizzjoni mistennija fil-bniedem.
English: Upper abdominal pain 9.4 Flatulence
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna
English: The average Cmax and AUC increased proportionally over an axitinib dosing range of 5 to 10 mg.
Maltese: Is-Cmax u l-AUC medji żdiedu b'mod proporzjonali fuq medda ta' dożaġġ ta' axitinib ta' 5 sa 10 mg.
English: Results of this study indicated that axitinib plasma exposures up to two-fold greater than therapeutic levels expected following a 5 mg dose, did not produce clinically-significant QT interval prolongation.
Maltese: Ir-riżultati ta' dan l-istudju indikaw li espożizzjonijiet ta' axitinib fil-plażma sad-doppju tallivelli terapewtiċi mistennija wara doża ta' 5 mg, ma pproduċewx titwil klinikament sinifikanti flintervall QT.
English: In clinical studies with axitinib for the treatment of patients with RCC, cardiac failure events (including cardiac failure, cardiac failure congestive, cardiopulmonary failure, left ventricular dysfunction, ejection fraction decreased, and right ventricular failure) were reported (see section
Maltese: Fi studji kliniċi b'axitinib għat-trattament ta' pazjenti b'RCC, avvenimenti ta' insuffiċjenza tal-qalb (inkluż insuffiċjenza tal-qalb, insuffiċjenza konġestiva tal-qalb, insuffiċjenza kardjopulmonari,
English: A risk to the suckling child cannot be excluded.
Maltese: Ma jistax jiġi eskluż riskju għat-tarbija li terda'.
English: Inlyta is indicated for the treatment of advanced kidney cancer (advanced renal cell carcinoma) in adults, when another medicine (called sunitinib or a cytokine) is no longer stopping disease from progressing.
Maltese: Inlyta huwa indikat għat-trattament ta' kanċer avvanzat tal-kliewi (karċinoma taċ-ċelloli renali avvanzata) fl-adulti, meta mediċina oħra (li tissejjaħ sunitinib jew ċitokina) ma tibqax twaqqaf ilmarda milli tavvanza.
English: Tell your doctor if you experience excessive tiredness, swelling of the abdomen, legs, or ankles, shortness of breath, or protruding neck veins.
Maltese: Koleċistite tinkludi Koleċistite akuta, Koleċistite, Koleċistite infettiva
English: Findings in females included signs of delayed sexual maturity, reduced or absent corpora lutea, decreased uterine weights and uterine atrophy at exposures approximately equivalent to the expected human exposure.
Maltese: Is-sejbiet fil-ġrieden femminili kienu jinkludu sinjali ta' maturità sesswali ttardjata, tnaqqis jew assenza ta' corpora lutea, tnaqqis fil-piżijiet tal-utru u atrofija tal-utru f'espożizzjonijiet bejn wieħed u ieħor ekwivalenti għall-espożizzjoni mistennija filbniedem.
English: Inlyta 3 mg film-coated tablets Each film-coated tablet contains 3 mg of axitinib.
Maltese: Inlyta 3 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 3 mg axitinib.
English: These findings were observed in mice at exposure levels approximately 12-fold the expected human exposure, and in dogs at exposure levels below the expected human exposure.
Maltese: Dawn is-sejbiet ġew osservati fil-ġrieden f'livelli ta' espożizzjoni bejn wieħed u ieħor 12-il darba l-espożizzjoni umana mistennija u fil-klieb f'livelli ta' espożizzjoni taħt l-espożizzjoni umana mistennija.
English: Axitinib is a potent and selective tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2 and VEGFR-3.
Maltese: Valutat b'analiżi radjoloġika indipendenti skont Kriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi (RECIST).
English: EMA/660638/2015 EMEA/H/C/004014
Maltese: EMA/660638/2015 EMA/H/C/004014
English: The full EPAR and risk management plan summary for Cinacalcet Mylan 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: Cinacalcet Mylan is available as 30, 60 and 90 mg tablets.
Maltese: Cinacalcet Mylan jiġi baħal pilloli ta' 30, 60 u 90 mg.
English: Cinacalcet Mylan contains the active substance cinacalcet and is a ‘generic medicine'.
Maltese: Cinacalcet Mylan fih is-sustanza attiva cinacalcet u huwa ‘mediċina ġenerika'.
English: Other information about Cinacalcet Mylan
Maltese: Informazzjoni oħra dwar Cinacalcet Mylan
English: The reference medicine for Cinacalcet Mylan is Mimpara.
Maltese: Il-mediċina ta' referenza għal Cinacalcet Mylan hija Mimpara.
English: This is a summary of the European public assessment report (EPAR) for Cinacalcet Mylan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Cinacalcet Mylan.
English: In secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once a day.
Maltese: F'iperparatirojdiżmu sekondarju, id-doża tal-bidu rakkomandata għall-adulti hija ta' 30 mg darba kuljum.
English: The dose is adjusted every two to four weeks, according to the patient's PTH levels, up to a maximum of 180 mg once a day.
Maltese: Id-doża tiġi aġġustata darba kull ġimagħtejn sa erba' ġimgħat skont il-livelli ta' PTH tal-pazjent, sa massimu ta' 180 mg darba kuljum.
English: • reduce hypercalcaemia (high blood calcium levels) in patients with parathyroid carcinoma (cancer of the parathyroid glands) or with primary hyperparathyroidism who cannot have their parathyroid glands removed or when the doctor thinks that their removal is not appropriate.
Maltese: • inaqqas l-iperkalċemija (livelli għoljin ta' kalċju fid-demm) f'pazjenti b'karċinoma tal-paratirojde (kanċer tal-glandoli tal-paratirojde) jew b'iperparatirojdiżmu primarju li ma jistgħux jitneħħulhom il-glandoli tal-paratirojde tagħhom jew meta t-tabib jaħseb li t-tneħħija tagħhom mhijiex xierqa.
English: Because Cinacalcet Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Mimpara.
Maltese: Minħabba li Cinacalcet Mylan huwa mediċina ġenerika, l-istudji fil-pazjenti kienu limitati għal testijiet biex tiġi determinata l-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Mimpara.
English: Why is Cinacalcet Mylan approved?
Maltese: Għaliex ġie approvat Cinacalcet Mylan?
English: In patients with parathyroid carcinoma or primary hyperparathyroidism, the recommended starting dose of Cinacalcet Mylan for adults is 30 mg twice a day.
Maltese: F'pazjenti b'karċinoma tal-paratirojde jew iperparatirojdiżmu primarju, id-doża tal-bidu rrakkomandata ta' Cinacalcet Mylan għall-adulti hija ta' 30 mg darbtejn kuljum.
English: Cinacalcet Mylan cinacalcet
Maltese: Kif jintuża Cinacalcet Mylan?
English: The dose of Cinacalcet Mylan should be increased every two to four weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels.
Maltese: Id-doża ta' Cinacalcet Mylan għandha tiżdied darba kull ġimagħtejn sa erba' xhur sa 90 mg tliet jew erba' darbiet kuljum kif ikun meħtieġ biex il-kalċju fid-demm jitnaqqas sa livelli normali.
English: Cinacalcet Mylan can be used as part of treatment including phosphate binders or vitamin D;
Maltese: Cinacalcet Mylan jista' jintuża bħala parti minn kura li tinkludi binders tal-fosfat jew il-vitamina D;