FrancophonIA/ELRC3.0 huggingface dataset:
English: An additional analysis of efficacy data by KRAS (exon 2) status did not identify a subset of patients who benefited from panitumumab in combination with oxaliplatin- or irinotecan based chemotherapy and bevacizumab.
Maltese: Analiżi oħra ta' dejta tal-effikaċja skont l-istat ta' KRAS (exon 2) ma identifikatx sottogrupp ta' pazjenti li bbenefikaw minn panitumumab flimkien ma' kimoterapija bbażata fuq oxaliplatin jew fuq irinotecan u bevacizumab.
English: Very rarely, serious allergic (hypersensitivity) reactions involving symptoms similar to an infusion reaction (see “Infusion reactions”) have occurred more than 24 hours after treatment and resulted in a fatal outcome.
Maltese: B'mod rari ħafna, reazzjonijiet allerġiċi (sensittività eċċessiva) serji li jinvolvu sintomi simili għal reazzjoni għall-infużjoni (ara “Reazzjonijiet għall-infużjoni”) seħħew aktar minn 24 siegħa wara ttrattament u wasslu għal riżultat fatali.
English: These reactions are related to the pharmacologic effects of Vectibix, and the majority are mild to moderate in nature with 23% severe (grade 3 NCI-CTC) and < 1% life-threatening (grade 4 NCI-CTC).
Maltese: Dawn ir-reazzjonijet huma relatati mal-effetti farmakoloġiċi ta' Vectibix, u l-maġġoranza huma ħfief sa moderati fin-natura tagħhom, bi 23% severi (NCI-CTC grad 3) u < 1% ta' periklu għall-ħajja (NCI-CTC grad 4).
English: Dermatologic reactions and soft tissue toxicity
Maltese: Reazzjonijiet dermatoloġiċi u tossiċità tat-tessut l-artab
English: Package Leaflet: Information for the user Vectibix 20 mg/mL concentrate for solution for infusion panitumumab
Maltese: Informazzjoni għall-utent Vectibix 20 mg/mL konċentrat għal soluzzjoni għall-infużjoni panitumumab
English: Rash erythematous Rash generalised Rash macular
Maltese: Is-soluzzjoni dilwita m'għandhiex tiġi ffriżata.
English: If a severe or life-threatening reaction occurs during an infusion or at any time post-infusion [e.g. presence of bronchospasm, angioedema, hypotension, need for parenteral treatment, or anaphylaxis], Vectibix should be permanently discontinued (see sections 4.3 and 4.8).
Maltese: Jekk isseħħ reazzjoni severa jew ta' periklu għallħajja waqt infużjoni jew f'xi ħin wara l-infużjoni [eż., preżenza ta' bronkospażmu, anġjoedima, pressjoni baxxa, ħtieġa ta' trattament parenterali, jew anafilassi], Vectibix għandu jitwaqqaf b'mod permanenti (ara sezzjonijiet 4.3 u 4.8).
English: Animal studies have shown reversible effects on the menstrual cycle and reduced female fertility in monkeys (see section 5.3).
Maltese: Studji fuq l-annimali wrew effetti riversibbli fuq iċ-ċiklu menstrwali u tnaqqis fil-fertilità femminili fix-xadini (ara sezzjoni 5.3). Panitumumab jista' jaffettwa l-ħila li mara toħroġ tqila.
English: Diarrhoea when reported was mainly mild or moderate in severity.
Maltese: Dijarea meta rrappurtata ġeneralment kienet ta' severità ħafifa jew moderata.
English: Aphthous ulcer Cheilitis
Maltese: Panitumumab huwa antikorp monoklonali
English: Doses up to 9 mg/kg have been tested in clinical trials.
Maltese: Fi provi kliniċi ġew ittestjati dożi sa 9 mg/kg.
English: • nail disorder; breaking of the nails (onychoclasis);
Maltese: • disturb fid-dwiefer; dwiefer jinqasmu (onikoklażi);
English: • low red blood cell numbers (anaemia); low potassium levels in the blood (hypokalaemia); low magnesium levels in the blood (hypomagnesaemia);
Maltese: • għadd baxx ta' ċelluli ħomor tad-demm (anemija); livelli baxxi ta' potassium fid-demm
English: • low white blood numbers (leucopenia); low calcium levels in the blood (hypocalcaemia); low phosphates in the blood (hypophosphataemia); high glucose in the blood (hyperglycaemia);
Maltese: • għadd baxx ta' ċelluli bojod tad-demm (lewkopenija); livelli baxxi ta' calcium fid-demm (ipokalċimija); phosphates baxxi fid-demm (ipofosfatimja); glucose għoli fid-demm (ipergliċemija);
English: How to use Vectibix
Maltese: Għoti ta' Vectibix
English: These can be mild or moderate (likely to occur in approximately 5 out of 100 people who take Vectibix), or severe (likely to occur in 1 out of 100 people who take Vectibix).
Maltese: Dawn jistgħu jkunu ħfief jew moderati (probabbli li jseħħu f'madwar 5 persuni minn kull 100 persuna li jieħdu Vectibix), jew severi (probabbli li jseħħu f'persuna waħda minn kull 100 persuna li jieħdu Vectibix).
English: • blood clot in the lung (pulmonary embolism) the symptoms of which may be sudden onset of shortness of breath or chest pain; nose bleed (epistaxis); blood clot in a deep vein (deep vein thrombosis); high blood pressure (hypertension); flushing;
Maltese: • demm magħqud fil-pulmun (emboliżmu pulmonari) li s-sintomi tiegħu jistgħu jkunu bidu għal għarrieda ta' qtugħ ta' nifs jew uġigħ fis-sider; fsada mill-imnieħer (epistassi); demm magħqud f'vina tal-fond (trombożi fil-vini tal-fond); pressjoni għolja (ipertensjoni); fwawar;
English: In clinical studies, subsequent to the development of severe dermatologic reactions (including stomatitis), infectious complications including sepsis and necrotising fasciitis, in rare cases leading to death, and local abscesses requiring incisions and drainage were reported.
Maltese: Fi studji kliniċi, wara l-iżvilupp ta' reazzjonijiet dermatoloġiċi severi (inkluż stomatite), kienu rrappurtati komplikazzjonijiet infettivi inklużi sepsi u faxxite b'nekrosi, li f'każijiet rari wasslu għallmewt, u axxessi lokali li kien jinħtieġilhom li jinqasmu u jitnaddfu.
English: Nail disorder
Maltese: Disturbi vaskulari
English: • in combination with oxaliplatin-based chemotherapy, if your RAS test shows that you have mutant RAS tumour, or if your RAS tumour status is unknown.
Maltese: • flimkien ma' kimoterapija bbażata fuq oxaliplatin, jekk it-test ta' RAS tiegħek juri li għandek tumur b'RAS mutant, jew jekk l-istat ta' RAS tat-tumur tiegħek mhux magħruf.
English: In rare cases patients may experience blistering of the skin, mouth, eyes and genitals, which may indicate a severe skin reaction called “Stevens-Johnson syndrome” or blistering of the skin, which may indicate a severe skin reaction called “toxic epidermal necrolysis”.
Maltese: F'każijiet rari pazjenti jistgħu jesperjenzaw infafet tal-ġilda, ħalq, għajnejn u ġenitali, li jistgħu jindikaw reazzjoni severa tal-ġilda msejħa “sindrome ta' Stevens-Johnson” jew infafet tal-ġilda, li jistgħu jindikaw reazzjoni severa tal-ġilda msejħa “nekrolisi tossika tal-epidermide”.
English: • blue colouration of the skin and mucous membranes (cyanosis);
Maltese: • lewn ikħal fil-ġilda u l-membrani mukużi (ċjanożi);
English: Bronchospasm Nasal dryness
Maltese: Bronkospażmu Imnieħer xott
English: Hypertrichosis
Maltese: Ipertrikożi
English: • The incidence of neutralising antibodies (excluding predose positive patients) was < 1%;
Maltese: • L-inċidenza ta' antikorpi newtralizzanti (minbarra pazjenti pożittivi b'mod temporanju u qabel id-doża) kienet ta' < 1%;
English: NAME OF THE MEDICINAL PRODUCT Vectibix 20 mg/mL concentrate for solution for infusion panitumumab
Maltese: Vectibix 20 mg/mL konċentrat għal soluzzjoni għall-infużjoni.
English: There is no relevant use of Vectibix in the paediatric population in the indication treatment of colorectal cancer.
Maltese: M'hemm l-ebda użu rilevanti ta' Vectibix fil-populazzjoni pedjatrika għall-indikazzjoni ta' trattament ta' kanċer tal-kolorektum.
English: Hazard ratio (95% CI)
Maltese: Proporzjon ta' periklu (CI ta' 95%)
English: Dry skin
Maltese: Tqala u treddigħ
English: The recommended infusion time is approximately 60 minutes.
Maltese: Il-ħin rakkomandat tal-infużjoni huwa ta' madwar 60 minuta.
English: The skin rash and diarrhoea observed in monkeys are considered related to the pharmacological action of panitumumab and are consistent with the toxicities observed with other anti-EGFR inhibitors.
Maltese: Ir-raxx fil-ġilda u d-dijarea osservati fix-xadini huma kkunsidrati bħala relatati mal-azzjoni farmakoloġika ta' panitumumab u huma konsistenti mat-tossiċitajiet osservati b'inibituri anti-EGFR oħra.
English: There have been reports of acute renal failure in patients who develop diarrhoea and dehydration (see section 4.4).
Maltese: Kien hemm rapporti ta' insuffiċjenza renali akuta f'pazjenti li jiżviluppaw dijarea u deidratazzjoni (ara sezzjoni 4.4).
English: • diarrhoea; nausea; vomiting; abdominal pain; constipation; decreased appetite; decreased weight;
Maltese: • dijarea; tqalligħ; rimettar; uġigħ addominali; stitikezza; tnaqqis fl-aptit; tnaqqis fil-piż;
English: • growth of eyelashes; flow of tears (lacrimation increased); redness of the eye (ocular hyperaemia); dry eye; itchy eyes (eye pruritus); eye irritation; eyelid inflammation (blepharitis);
Maltese: • tkabbir tax-xagħar tal-għajnejn; nixxija ta' dmugħ (żieda fid-dmugħ); ħmura fl-għajnejn (iperimija okulari); għajnejn jinħassu xotti; ħakk fl-għajnejn (prurite fl-għajnejn); irritazzjoni flgħajnejn; infjammazzjoni fil-kappell tal-għajn (blefarite);
English: Vomiting Abdominal pain Stomatitis Constipation
Maltese: Infezzjoni fl-apparat urinarju Follikulite
English: When prepared according to the instructions given in section 6.6, the final panitumumab concentration should not exceed 10 mg/mL.
Maltese: Meta jiġi ppreparat skont l-istruzzjonijiet mogħtija fis-sezzjoni 6.6, il-konċentrazzjoni finali ta' panitumumab m'għandhiex taqbeż 10 mg/mL.
English: Based on an analysis of all mCRC clinical trial patients receiving Vectibix monotherapy and in combination with chemotherapy (n = 2,224), the most commonly reported adverse reactions are skin reactions occurring in approximately 94% of patients.
Maltese: Ibbażat fuq analiżi tal-pazjenti kollha fil-provi kliniċi ta' mCRC li rċevew Vectibix bħala monoterapija u flimkien ma' kimoterapija (n = 2,224), l-aktar reazzjonijiet avversi rrappurtati b'mod komuni huma reazzjonijiet fil-ġilda li seħħew f'madwar 94% tal-pazjenti.
English: Panitumumab has been shown to cause foetal abortions and/or foetal deaths in cynomolgus monkeys when administered during the period of organogenesis at doses approximately equivalent to the recommended human dose.
Maltese: Panitumumab intwera li jikkawża abort tal-fetu u/jew mwiet tal-fetu f'xadini cynomolgus meta ingħata waqt il-perjodu ta' organoġenesi b'dożi bejn wieħed u ieħor ekwivalenti għad-doża rakkomandata fil-bniedem.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Maltese: Każijiet serji ta' keratite u keratite ulċerattiva rari kienu rrappurtati fl-ambjent ta' wara t-tqegħid fissuq.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of panitumumab.
Maltese: Kull kunjett fih 100 mg ta' panitumumab.
English: Vectibix plus FOLFOX (months) Median (95% CI)
Maltese: Vectibix flimkien ma' FOLFOX (xhur)
English: A variety of stimuli, including that from the EGFR activate KRAS and NRAS which in turn stimulate other intracellular proteins to promote cell proliferation, cell survival and angiogenesis.
Maltese: Varjetà ta' stimuli, inkluż dawk minn EGFR jattivaw KRAS u NRAS li mbagħad jistimulaw proteini intraċellulari oħra biex jippromwovu l-proliferazzjoni taċ-ċelluli, sopravivenza taċ-ċelluli u anġjoġenesi.
English: Vectibix is administered intravenously (into a vein) with an infusion pump (a device that gives a slow injection).
Maltese: Vectibix jingħata fil-vini (ġo vina) permezz ta' pompa tal-infużjoni (apparat li jagħti injezzjoni bilmod).
English: A total of 1,010 patients refractory to chemotherapy were randomised 1:1 to receive Vectibix or cetuximab to test whether Vectibix is non-inferior to cetuximab.
Maltese: Total ta' 1,010 pazjenti li ma ħadmitx fuqhom kimoterapija kienu randomised 1:1 biex jirċievu Vectibix jew cetuximab biex jiġi ttestjat jekk Vectibix huwiex inferjuri għal cetuximab.
English: • severe skin reaction with blistering of the skin (toxic epidermal necrolysis);
Maltese: • reazzjoni severa tal-ġilda b'infafet fil-ġilda (nekrolisi tossika tal-epidermide);
English: Modification of the dose of Vectibix may be necessary in cases of severe (≥ grade 3) dermatological reactions as follows:
Maltese: Modifikazzjoni tad-doża ta' Vectibix tista' tkun meħtieġa f'każijiet ta' reazzjonijiet dermatoloġiċi severi (≥ grad 3) kif ġej:
English: Patients with a history of severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Maltese: Pazjenti b'passat ta' sensittività eċċessiva severa jew ta' periklu għall-ħajja għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1 (ara sezzjoni 4.4).
English: If the first infusion is tolerated, then subsequent infusions may be administered over 30 to 60 minutes.
Maltese: Jekk l-ewwel infużjoni tkun ittollerata, infużjonijiet sussegwenti jistgħu jingħataw fuq medda ta' 30 sa 60 minuta.
English: • skin cell death (skin necrosis);
Maltese: • mewt ta' ċelluli fil-ġilda (nekrosi tal-ġilda);
English: Vectibix in combination with oxaliplatin-based chemotherapy in patients with mutant RAS mCRC or for whom RAS tumour status is unknown
Maltese: Dawn l-avvenimenti fil-biċċa l-kbira kienu jikkonsistu minn raxx u dermatite li tixbaħ lill-akne u kienu l-iktar ta' severità ħafifa sa moderata.
English: Patients with additional RAS mutations beyond KRAS exon 2 were unlikely to benefit from the addition of panitumumab to FOLFIRI and a detrimental effect was seen with the addition of panitumumab to FOLFOX in these patients.
Maltese: Pazjenti b'mutazzjonijiet addizzjonali ta' RAS lil hinn minn KRAS exon 2 x'aktarx ma kienux jibbenefikaw miż-żieda ta' panitumumab ma' FOLFIRI u f'dawn il-pazjenti kien osservat effett detrimentali biż-żieda ta' panitumumab ma' FOLFOX.
English: Using only a 21-gauge or smaller diameter hypodermic needle, withdraw the necessary amount of Vectibix for a dose of 6 mg/kg.
Maltese: Permezz ta' labra ipodermika b'dijametru ta' 21 gauge jew iżgħar biss, iġbed l-ammont neċessarju ta' Vectibix għal doża ta' 6 mg/kg.
English: For clinical management of skin reactions, including dose modification recommendations, see section 4.4.
Maltese: Għallimmaniġġar kliniku ta' reazzjonijiet fil-ġilda, inkluż rakkomandazzjonijiet għall-modifikazzjoni fiddoża, ara sezzjoni 4.4.
English: Eye pruritus Eye irritation
Maltese: .8 Effetti mhux mixtieqa
English: The major study objective was comparison of PFS in the oxaliplatin cohort.
Maltese: Analiżi esploratorja uriet riżultati simili għal dawk fit-tabella ta' qabel.
English: Fertility studies conducted in female cynomolgus monkeys showed that panitumumab may produce prolonged menstrual cycle and/or amenorrhea and reduced pregnancy rate which occurred at all doses evaluated.
Maltese: Studji dwar il-fertilità li twettqu fuq xadini cynomolgus femminili wrew li panitumumab jista' jipproduċi ċiklu menstrwali mtawwal u/jew amenorreja u rata ta' tqala mnaqqsa li seħħew bid-dożi evalwati kollha.
English: Vectibix should not be administered in combination with bevacizumab containing chemotherapy (see sections 4.5 and 5.1).
Maltese: Vectibix m'għandux jingħata flimkien ma' kimoterapija li fiha bevacizumab (ara sezzjonijiet 4.5 u 5.1).
English: However, an increased number of serious adverse reactions were reported in elderly patients treated with Vectibix in combination with FOLFIRI or FOLFOX chemotherapy compared to chemotherapy alone (see section 4.8).
Maltese: Madankollu, numru akbar ta' reazzjonijiet avversi serji kienu rrappurtati f'pazjenti anzjani ttrattati b'Vectibix flimkien ma' kimoterapija ta' FOLFIRI jew FOLFOX meta mqabbel ma' kimoterapija waħedha (ara sezzjoni 4.8).
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Maltese: Għamla farmaċewtika
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Maltese: L-iStat Membru għandu jassigura The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
English: • FABLYN increases risk of venous thromboembolism (VTE).
Maltese: • Fablyn iżid ir-riskju ta' trombo-emboliżmu fil-vini (VTE)
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all healthcare professionals who are expected to prescribe FABLYN or order gynaecological ultrasound of patients treated with FABLYN, are provided with access to risk minimisation educational programme.
Maltese: Id-Detentur ta' L-Awtorizazzjoni għat-tqegħid fis-suq għandu jassigura li qabel ma l-prodott jitqiegħed fuq is-suq, kull professjonist tas-saħħa li mistenni jippreskrivi Fablyn jew li jistaqsi għalultrasound ġinekoloġiku f'pazjenti kkurati bil-Fablyn, ikollu aċċess għal programm edukattiv fuq ittnaqqis tar-riskju.
English: • FABLYN causes morphologic changes, particularly the cystic atrophy of endometrium.
Maltese: • Fablyn jikkawża tibdil morfoloġiku, partikolarment atrofija taċ-ċesti tal-endometriju.
English: It results in increased mean endometrial thickness.
Maltese: Dan jirriżulta żieda fil-ħxuna medja tal-endometriju.
English: This programme should focus on interpretation of endometrial biopsy of women treated with FABLYN.
Maltese: Dan il-programm għandu jiffoka fuq l-interpretazzjoni ta' bijopsija tal-endometriju ta' nisa kkurati b'Fablyn.
English: It must be in line with authoritative international guidelines and supported by evidence published in peer reviewed medical journals.
Maltese: Għandu jkun ukoll aġġornat ma linji gwida ta' awtorita' internazzjonali u sostenut b'evidenza ppublikata f'ġurnali mediċi rivisti mill-pari.
English: • Based on the clinical trials, the morphologic changes caused by FABLYN are benign and do not require further investigation unless vaginal bleeding occurs.
Maltese: • Meta tqis studji klinici, dan it-tibdil morfoloġiku ikkaġunat b'FABLYN huwa beninn u m'għandux bżonn aktar investigazzjonijiet sakemm ma jkunx hemm ħruġ ta' demm millvaġina
English: SmPC, including contraindication of FABLYN in patients with active or past history of VTE.
Maltese: KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU MINGĦAJR PERIKLU U EFFETTIV TAL-PRODOTT MEDIĊINALI LI GĦANDHOM IKUNU
English: 28 x 1 tablets (calendar pack)
Maltese: 28 x 1 pillola (pakkett ta' kalendarju)
English: Aripiprazole - Hyperprolactinaemia (EPITT no 18086)
Maltese: Aripiprazole - Iperprolaktinemija (EPITT nru 18086)
English: 26 February 2015
Maltese: 26 ta' Frar 2015
English: Very rare (affects less than 1 in 10,000 people)
Maltese: Rari ħafna (taffettwa inqas minn persuna 1 minn kull 10,000)
English: Summary of product characteristics (SmPC) Section 4.8:
Maltese: Sommarju tal-karatteristiċi tal-prodott (SmPC) Sezzjoni 4.8:
English: Amiodarone - Syndrome of inappropriate antidiuretic hormone secretion (SIADH) (EPITT no 18091)
Maltese: Amiodarone - Sindromu tal-Ormon Antidijuretiku mhux xieraq (SIADH) (EPITT nru 18091)
English: PRAC recommendations on signals for update of the product information EMA/PRAC/118045/2015
Maltese: Rakkomandazjonijiet tal-PRAC dwar sinjali għal aġġornament tal-informazzjoni dwar il-prodott EMA/PRAC/149181/2015
English: Adopted at the 9-12 February 2015 PRAC
Maltese: Adottat fil-PRAC tad-9-12 ta' Frar 2015
English: Description of selected adverse reactions:
Maltese: Lista tabulata ta' reazzjonijiet avversi:
English: In clinical trials for the approved indication(s) and post-marketing, both increase and decrease in serum prolactin as compared to baseline was observed with aripiprazole (section 5.1).
Maltese: Fi provi kliniċi għall-indikazzjoni(jiet) approvati u ta' wara t-tqegħid fis-suq, ġiet osservata kemm żieda kif ukoll tnaqqis fil-prolaktin fis-serum meta mqabbel mal-linja bażi b'aripiprazole (sezzjoni 5.1).
English: Very rare: Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Maltese: Rari ħafna: Sindrome tas-sekrezzjoni tal-ormon antidijuretiku mhux xierqa (SIADH)
English: Having considered the available evidence in EudraVigilance, the MAH's clinical trials and pharmacovigilance databases and the literature, the PRAC has agreed that the MAH of Abilify and Abilify Maintena should submit variations within 2 months, to amend the product information as described below (new text underlined).
Maltese: Wara li tqieset l-evidenza kollha disponibbli fil-EudraVigilance, il-provi kliniċi tad-detenturi għallawtorizzazzjonijiet għat-tqegħid fis-suq (MAHs) u d-dejtabejż tal-farmakoviġilanza u l-letteratura, ilPRAC qabel li d-detentur ta' Abilify u Abilify Maintena għandu jissottometti varjazzjonijiet fi żmien xahrejn, biex jemenda l-informazzjoni tal-prodott kif deskritt hawn isfel (it-test il-ġdid huwa sottolineat).
English: Frequency ‘uncommon': Hyperprolactinaemia
Maltese: Disturbi fis-sistema endokrinarja Frekwenza ‘mhux komuni': Iperprolaktinemija
English: This could be an illness called ‘syndrome of inappropriate anti-diuretic hormone secretion' (SIADH).
Maltese: Din tista' tkun marda imsejħa ‘sindrome tas-sekrezzjoni tal-ormon antidijuretiku mhux xierqa' (SIADH).
English: Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable.
Maltese: Tħossok mhux sew, konfuż/a jew dgħajjef/dgħajfa, tħossok ma tiflaħx (dardir), nuqqas ta' aptit, tħossok irritabbli.
English: Section 4.8 - Undesirable effects: Tabulated list of adverse reactions: Endocrine disorders
Maltese: Sezzjoni 4.8 - Effetti mhux mixtieqa:
English: In addition, the MAH should describe the data on hyper- and hypoprolactinaemia in the SmPCs' sections 5.1.
Maltese: Barra minn hekk, id-detentur għandu jiddeskrivi d-dejta fuq iper- u ipoprolaktinemija fissezzjonijiet 5.1 tal-SmPCs.
English: Pharmacovigilance Risk Assessment Committee
Maltese: Kumitat għall-Evalwazzjoni tar-Riskji fil-Qasam tal-Farmakoviġilanza
English: PRAC recommendations on signals for update of the product information
Maltese: Rakkomandazjonijiet tal-PRAC dwar sinjali għal aġġornament tal-informazzjoni dwar il-prodott
English: Having considered the available evidence the PRAC has agreed that the MAHs of amiodarone for intravenous administration should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Maltese: B'kunsiderazzjoni għall-evidenza kollha disponibbli, il-PRAC qabel li d-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs) ta' amiodarone għal amministrazzjoni intravenuża għandhom jissottomettu varjazzjoni fi żmien xahrejn, biex jemendaw l-informazzjoni dwar il-prodott kif deskritt hawn isfel (it-test ġdid huwa sottolineat).
English: Section 4: Possible side effects Uncommon side effects (may affect up to 1 in 100 people): Increased blood levels of the hormone prolactin.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100):
English: Intravenous use vial (glass)
Maltese: Użu għal ġol-vina kunjett(ħġieġ)
English: Powder for concentrate for solution for infusion
Maltese: Trab għal konċentrat għal soluzzjoni għal infużjoni
English: EMA/618757/2017
Maltese: EMA/736569/2017 EMEA/H/C/004319
English: The full EPAR for Cyltezo 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: Treatment response was measured as a 20% or more improvement in symptom score, which was seen after 12 and 24 weeks of treatment in 67% and 69% respectively of those given Cyltezo.
Maltese: Ir-rispons għallkura tkejjel bħala titjib ta' 20 % jew aktar fil-punteġġ tas-sintomi, li deher wara 12 u 24 ġimgħa ta' kura f'67 % u 69 % rispettivament ta' dawk li ngħataw Cyltezo.
English: The reference medicine for Cyltezo is Humira.
Maltese: Il-mediċina ta' referenza għal Cyltezo hija Humira.
English: Cyltezo contains the active substance adalimumab and is a ‘biosimilar medicine'.
Maltese: Cyltezo fih is-sustanza attiva adalimumab u huwa ‘mediċina bijosimili'.
English: This compared with 61% and 65% of those given Humira.
Maltese: Dan tqabbel ma' 61 % u 65 % ta' dawk li ngħataw Humira.