FrancophonIA/ELRC3.0 huggingface dataset:
English: Ilaris is also indicated for the treatment of:
Maltese: Ilaris hu wkoll indikat għat-trattament ta:
English: Also contains: mannitol, histidine, histidine hydrochloride monohydrate, polysorbate 80, water for injections.
Maltese: Fih ukoll: mannitol, histidine, histidine hydrochloride monohydrate, polysorbate 80, ilma għallinjezzjonijiet.
English: Part III: Patients treated with placebo in Part II who flared regained and maintained clinical and serological response following entry into the open-label canakinumab extension.
Maltese: III: Pazjenti kkurati bil-plaċebo f'Parti II li kellhom żieda fil-gravità tal-marda reġgħu kisbu u żammew ir-rispons kliniku u seroloġiku wara li daħlu fl-estensjoni open-label ta' canakinumab.
English: Carefully withdraw the required volume depending on the dose to be administered (0.1 ml to 1 ml) and subcutaneously inject using a 27 G x 0.5 inch (13 mm) needle.
Maltese: Iġbed bil-galbu l-ammont meħtieġ skont id-doża li trid tingħata (bejn 0.1 ml u 1 ml) u injettah taħt ilġilda billi tuża labra ta' 27 G x 0.5 pulzieri (13-il mm).
English: Powder for solution for injection in a vial (type I glass) with a stopper (coated chlorobutyl rubber) and flip-off cap (aluminium).
Maltese: Soluzzjoni għall-injezzjoni f'kunjett (ħġieġ tat-tip 1) b'tapp (illaminat b'lasktu chlorobutyl) u b'għatu flip-off (tal-aluminju).
English: Patients in Part II (double-blind) received either canakinumab 4 mg/kg or placebo every 4 weeks until 37 flare events occurred.
Maltese: Pazjenti f'Parti II (double-blind) ingħataw jew 4 mg/kg canakinumab jew plaċebo kull 4 ġimgħat sa ma kien hemm 37 episodju ta' tħeġġiġ.
English: No change in pharmacokinetic parameters based on clearance or volume of distribution were observed between elderly patients and adult patients < 65 years of age.
Maltese: Ma kienx hemm bdil fil-parametri farmakokinetiċi msejsa fuq it-tneħħija jew il-volum taddistribuzzjoni bejn pazjenti anzjani u pazjenti adulti ta' < 65 sena.
English: After repeated administration of 4 mg/kg every 4 weeks the accumulation ratio of canakinumab was 1.6 fold in SJIA patients.
Maltese: Wara li ngħataw ripetutament 4 mg/kg kull 4 ġimgħat il-proporzjon miġmugħa ta' canakinumab kienet ta' 1.6 drabi aktar fil-pazjenti b'SJIA.
English: Asymptomatic and mild elevations of serum bilirubin have been observed in CAPS patients treated with canakinumab without concomitant elevations of transaminases.
Maltese: Kienu osservati żidiet asintomatiċi u ħfief tal-bilirubin fis-serum f'pazjenti bil-CAPS ikkurati b'canakinumab mingħajr ma kien hemm ukoll żieda tat-transaminasi.
English: Peak concentrations of canakinumab occurred between 2 to 7 days (Tmax) following single subcutaneous administration of canakinumab 150 mg or 2 mg/kg in paediatric patients 4 years of age and older.
Maltese: Jekk ma jintlaħaqx rispons sodisfaċenti klinikament fi żmien 7t ijiem mit-tnedija tat-trattament, wieħed jista' jikkunsidra t-tieni doża ta' 150 mg jew 2 mg/kg canakinumab.
English: Study G2306 was an open-label study to assess maintenance of treatment response with canakinumab dose reduction (2 mg/kg every 4 weeks) or dose interval prolongation (4 mg/kg every 8 weeks) in SJIA patients who were receiving canakinumab 4 mg/kg every 4 weeks.
Maltese: L-Istudju G2306 kien studju open-label bil-għan li jevalwa ż-żamma tar-rispons għat-trattament b'doża mnaqqsa ta' canakinumab (2 mg/kg kull 4 ġimgħat) jew b'intervall imtawwal bejn doża u oħra (4 mg/kg kull 8 ġimgħat) f'pazjenti b'SJIA li kienu qed jingħataw canakinumab 4 mg/kg kull 4 ġimgħat.
English: Patients enrolled were aged 2 to < 20 years (mean age of 8.5 years and mean disease duration of 3.5 years at baseline) and had active disease defined as ≥ 2 joints with active arthritis, fever and elevated CRP.
Maltese: Il-pazjenti msieħba kellhom bejn sentejn u < 20 sena (età medja ta' 8.5 snin u żmien medju tal-marda ta' 3.5 snin fil-linja bażi) u kellhom marda attiva ddefinata bħala ≥ 2 ġogi b'artrite attiva, deni u CRP għoli.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Maltese: Għal tagħrif dwar rkostituzzjoni tal-prodott mediċinali qabel ma jingħata, ara sezzjoni 6.6.
English: Part II: In the withdrawal period of the pivotal study, the primary endpoint was defined as the proportion of patients with a disease relapse/flare: none (0%) of the patients randomised to canakinumab flared, compared with 81% of the patients randomised to placebo.
Maltese: Parti II: Matul il-perjodu ta' waqfien waqt l-istudju pivitali, il-parametru primarju kien definit bħala l-proporzjon ta' pazjenti li jerġgħu jirkadu/li jkollhom żieda fil-gravità tal-marda: ħadd (0%) mill-pazjenti li nzertaw ingħataw canakinumab ma kellu żieda fil-gravità tal-marda, imqabbla mal-81% tal-pazjenti li nzertaw ingħataw il-plaċebo.
English: Ilaris 150 mg powder for solution for injection canakinumab
Maltese: Ilaris 150 mg trab għal soluzzjoni għall-injezzjoni canakinumab
English: Pharmacokinetic properties are similar in CAPS, TRAPS, HIDS/MKD, FMF and SJIA paediatric populations.
Maltese: Il-proprjetajiet farmakokinetiċi f'popolazzjonijiet pedjatriċi bil-CAPS, TRAPS, HIDS/MKD, FMF u b'SJIA jixxiebhu.
English: Additional dose of 300 mg or 4 mg/kg can be considered
Maltese: Tista' titqies doża oħra ta' 300 mg jew 4 mg/kg
English: However, the risk of severe hypersensitivity reactions, which is not uncommon for injectable proteins, cannot be excluded (see section 4.3).
Maltese: Madanakollu, mhuwiex eskluż ir-riskju ta' reazzjonijiet ta' sensittività eċċessiva qawwija, li mhumiex rari f'każ ta' proteini injettati (ara sezzjoni 4.3).
English: This patient presented at study entry with a history of immune thrombocytopenic purpura and an active medical condition of abnormal hepatic function.
Maltese: Fittnedija tal-istudju dan il-pazjent kellu storja ta' purpura tromboċitopenika immune u kundizzjoni medika attiva ta' funzjoni epatika anormali.
English: Place the transfer needle in the sharps container.
Maltese: Dejjem uża labar u siringi ġodda u ssiġillati.
English: Overall, there were no clinically meaningful differences in the safety and tolerability profile of canakinumab in paediatric patients compared to the overall CAPS population (comprised of adult and paediatric patients, N=211), including the overall frequency and severity of infectious episodes.
Maltese: Kollox ma' kollox, ma kienx hemm differenzi sinjifikanti klinikament fil-profil ta' sigurtà u tollerabbiltà ta' canakinumab f'pazjenti pedjatriċi meta mqabbla mal-popolazzjoni sħiħa bil-CAPS (li kienet tinkludi pazjenti adulti u pedjatriċi, N=211), inkluż il-frekwenza ġenerali ta' episodji infettivi u l-gravità tagħhom.
English: Hazard ratio to triamcinolone acetonide
Maltese: Il-marda tar-rifluss gastroesofaġali
English: A 56-week, open-label study was conducted to assess the efficacy, safety and tolerability of canakinumab in paediatric CAPS patients ≤ 4 years of age.
Maltese: Twettaq studju open-label mifrux fuq 56 ġimgħa sabiex jivvaluta l-effikaċja, is-sigurtà u ttollerabbiltà ta' canakinumab f'pazjenti pedjatriċi bil-CAPS ≤ 4 snin.
English: Tumour necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) and familial Mediterranean fever (FMF) The recommended starting dose of Ilaris is: - Adults and children aged 2 years or more
Maltese: Is-sindromu perjodiku assoċjat mar-riċettur tal-fattur tan-nekrożi tat-tumur (TRAPS), is-sindromu taliperimmunoglobulina D (HIDS)/defiċjenza ta' mevalonate kinasi (MKD) u d-deni Mediterranju familjari (FMF)
English: Ilaris is used in adults, adolescents and children to treat active Still's disease including adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older if other treatments have not worked well enough.
Maltese: Ilaris jintuża fl-adulti, adolexxenti u tfal għat-trattament tal-marda attiva ta' Still inkluż il-marda ta' Still li toħroġ fl-adulti (AOSD) u l-artrite idjopatika ġovanili sistematika (SJIA) f'pazjenti li għandhom sentejn jew aktar f'każ li trattamenti oħrajn ma ħadmux tajjeb biżżejjed.
English: • 4 mg/kg for patients who weigh between 7.5 kg and less than 15 kg - Children aged 2 or 3 years
Maltese: • 4 mg/kg għal pazjenti li bejn 7.5 kg jew u anqas minn 15 kg Tfal li għandhom sentejn jew 3 snin
English: A 6-year observational registry study was conducted to provide data on the long-term safety and effectiveness of canakinumab treatment in paediatric and adult CAPS patients in routine clinical practice.
Maltese: Twettaq studju osservazzjonali tar-reġistru fuq medda ta' 6 snin sabiex jipprovdi dejta dwar is-sigurtà u l-effettività fuq perjodu twil ta' żmien tat-trattament b'canakinumab fost pazjenti pedjatriċi u adulti bil-CAPS waqt prattika klinika ta' rutina.
English: Cryopyrin-associated periodic syndromes
Maltese: Sindromi perjodiċi assoċjati mal-cryopyrin
English: The other ingredients are mannitol, histidine, histidine hydrochloride monohydrate, polysorbate 80, water for injections.
Maltese: Is-sustanzi mhux attivi huma: mannitol, histidine, histidine hydrochloride monohydrate, polysorbate 80, ilma għall-injezzjonijiet.
English: Two non-randomised HIDS/MKD patients aged > 28 days but < 2 years were included in the study and received canakinumab.
Maltese: Żewġ pazjenti b'HIDS/MKD mhux randomizzati li kellhom > 28 jum imma < sentejn kienu inklużi flistudju u ngħataw canakinumab.
English: Bioavailability in TRAPS, HIDS/MKD and FMF patients has not been determined independently.
Maltese: Il-bijodisponibbiltà f'pazjenti bi TRAPS, HIDS/MKD u FMF ma ġietx iddeterminata b'mod indipendenti.
English: Table 2 Tabulated summary of efficacy in Phase III trial, pivotal placebo-controlled withdrawal period (Part II)
Maltese: Perjodu tat-trattament waqt prova pivotali, randomizzata, ikkontrollata bi plaċebo f'Fażi III (Parti
English: For patients with a starting dose of 150 mg or 2 mg/kg, if a satisfactory clinical response (resolution of rash and other generalised inflammatory symptoms) has not been achieved 7 days after treatment start, a second dose of canakinumab at 150 mg or 2 mg/kg can be considered.
Maltese: F'każ ta' pazjenti b'doża inizjali ta' 150 mg jew 2 mg/kg, jekk ma jkunx hemm rispons kliniku sodisfaċenti (fejqan tar-raxx u ta' sintomi oħra ta' infjammazzjoni mifruxa) sa sebat ijiem wara li tinbeda l-kura, wieħed għandu jikkunsidra l-għoti ta' doża oħra ta' canakinumab b'150 mg jew ta' 2 mg/kg.
English: The recommended dose of canakinumab for patients with Still's disease (AOSD and SJIA) with body weight ≥ 7.5 kg is 4 mg/kg (up to a maximum of 300 mg) administered every four weeks via subcutaneous injection.
Maltese: Id-doża rrakkomandata ta' canakinumab għal pazjenti bil-marda ta' Still (AOSD u SJIA) li jiżnu ≥ 7.5 kg hi ta' 4 mg/kg (sa massimu ta' 300 mg) mogħtija kull erba' ġimgħat permezz ta' injezzjoni minn taħt il-ġilda.
English: Canakinumab binds with high affinity specifically to human IL-1 beta and neutralises the biological activity of human IL-1 beta by blocking its interaction with IL-1 receptors, thereby preventing IL-1 beta-induced gene activation and the production of inflammatory mediators.
Maltese: Canakinumab jeħel b'affinità kbira u b'mod speċifiku mal-IL-1 beta uman u jinnewtralizza lattività bijoloġika tal-IL-I beta uman billi ma jħallihx jitħallat ma' riċetturi IL-1, u għaldaqstant jipprevjeni milli jkun attivat il-ġene mibdi bl-IL-1 beta u l-produzzjoni ta' medjaturi infjammatorji.
English: Following canakinumab treatment, the inflammatory markers CRP or SAA and signs of acute inflammation (e.g. pain, swelling, redness) in the affected joint subside rapidly.
Maltese: Wara trattament b'canakinumab, il-markaturi infjammatorji CRP jew SAA u sinjali ta' infjammazzjoni akuta (eż. uġigħ, nefħa, ħmura) fil-ġog affettwat għaddew malajr.
English: Apparent clearance per kg body weight (CL/F per kg) was comparable between the gouty arthritis and CAPS population (0.004 l/d/kg).
Maltese: Jidher li ttneħħija għal kull kilo tal-piż (CL/F kull kilo) kienet titqabbel bejn il-popolazzjoni bil-gotta u bilCAPS (0.004 l/d/kg).
English: Exposure parameters (such as AUC and Cmax) increased in proportion to dose over the dose range of 0.30 to 10.0 mg/kg given as intravenous infusion or from 150 to 600 mg as subcutaneous injection.
Maltese: Il-parametri ta' espożizzjoni (bħalma huma l-AUC u s-Cmax) żiedu l-proporzjon tad-doża matul il-firxa tad-doża minn 0.30 għal 10.
English: Common features of AOSD and SJIA include fever, rash, hepatosplenomegaly, lymphadenopathy, polyserositis and arthritis.
Maltese: Fatturi komuni ta' AOSD u SJIA jinkludu deni, raxx, epatosplenomegalja, limfadenopatija, poliserosite u artrite.
English: Day 29
Maltese: Id-29 ġurnata
English: Additionally, 6 paediatric patients under the age of 2 years were evaluated in a small open-label clinical study.
Maltese: Barra minn hekk, 6 pazjenti pedjatriċi taħt is-sentejn ġew evalwati fi studju kliniku open-label żgħir.
English: For chronic or repeated therapies, it is also recommended to assess WBC counts periodically during treatment.
Maltese: Għal terapiji kroniċi jew ripetuti, huwa rrakkomandat ukoll li jiġi stmat l-għadd talWBC b'mod perjodiku waqt il-kura.
English: Investigations Very common Creatinine renal clearance decreased Proteinuria Leukopenia
Maltese: Investigazzjonijiet Komuni ħafna Tnaqqis fit-tneħħija tal-kreatinina mill-kliewi1,3 Proteinurija Lewkopenija
English: - Part II: Patients at flare onset were randomised into a 16-week double-blind, placebo-controlled treatment period during which they received either 150 mg canakinumab (2 mg/kg for patients with body weight ≤ 40 kg) subcutaneous (s.c.) or placebo every 4 weeks.
Maltese: - Parti II: Dakinhar li l-pazjenti nbdielhom it-tħeġġiġ tal-marda ġew randomizzati għal perjodu ta' trattament ta' 16-il ġimgħa double-blind, ikkontrollat bil-plaċebo li matulu ngħataw jew 150 mg canakinumab (2 mg/kg għal pazjenti b'piż ta' ≤ 40 kg) minn taħt il-ġilda (s.c.) jew plaċebo kull 4 ġimgħat.
English: Table 5 Efficacy for the overall study population and in a subgroup of patients currently using ULT and unable to use both NSAIDs and colchicine
Maltese: Tabella 5 Effikaċja għall-popolazzjoni sħiħa tal-istudju u f'sottogrupp ta' pazjenti li jkunu qed jużaw ULT b'mod kurrenti u ma setgħux jużaw kemm NSAIDs kif ukoll colchicine
English: Using an 18 G or 21 G x 2 inch needle (or similar as available on the market) and a 1 ml syringe, carefully withdraw the required volume depending on the dose to be administered.
Maltese: Uża labra ta' 18 G jew 21 G x 2 pulzieri (jew simili skont x'inhu disponibbli fis-suq) u siringa ta' 1 ml, iġbed bil-galbu l-ammont meħtieġ skont id-doża li trid tingħata.
English: Clinical experience with dosing at intervals of less than 4 weeks or at doses above 600 mg or 8 mg/kg is limited.
Maltese: L-esperjenza klinika dwar dożi mogħtija f'intervalli ta' anqas minn 4 ġimgħat jew ta' dożi ta' 600 mg jew 8 mg/kg hija limitata.
English: Mean values for Cmax and AUCinf after a single subcutaneous dose of 150 mg in a typical adult CAPS patient (70 kg) were 15.9 µg/ml and 708 µg*d/ml.
Maltese: Il-valuri medji għal Cmax u AUCinf wara doża singola minn taħt il-ġilda ta' 150 mg f'pazjent adult tipiku bil-CAPS (70 kg) kienu ta' 15.
English: The peak serum canakinumab concentration (Cmax) occurred approximately 7 days following single subcutaneous administration of 150 mg in adult CAPS patients.
Maltese: L-ogħla konċentrazzjoni ta' canakinumab fis-serum (Cmax) seħħet madwar sebat ijiem wara li ngħatat doża waħda ta' 150 mg taħt il-ġilda f'pazjenti adulti bil-CAPS.
English: Concomitant use of canakinumab with tumour necrosis factor (TNF) inhibitors is not recommended because this may increase the risk of serious infections (see section 4.5).
Maltese: L-użu flimkien ta' canakinumab ma' inibituri tal-fattur tan-nekrosi tat-tumur (TNF) mhuwiex irrakkomandat minħabba li dan jista' jżid ir-riskju ta' infezzjonijiet gravi (ara sezzjoni 4.5).
English: Gastrointestinal disorders Very common Upper abdominal pain Uncommon Gastro-oesophageal reflux disease Skin and subcutaneous tissue disorders Very common Injection site reaction Musculoskeletal and connective tissue disorders Very common Arthralgia Common
Maltese: Tagħrif mhux kliniku bbażat fuq studji konvenzjonali ta' reattività msallba, effett tossiku minn dożi ripetuti, immunotossiċità, effett tossiku fuq is-sistema riproduttiva u l-iżvilupp, ma juri l-ebda periklu speċjali għall-bnedmin.
English: Treatment with canakinumab induced a reduction of pain and reduced the risk of subsequent attacks in patients using ULT and unable to use both NSAIDs and colchicine, although the observed treatment difference compared to triamcinolone acetonide was less pronounced than with the overall study population.
Maltese: Kura b'canakinumab ikkaġunat tnaqqis fl-uġigħ u naqqset ir-riskju ta' attakki sussegwenti f'pazjenti li kienu qed jużaw ULT u ma setgħux jużaw kemm NSAIDs kif ukoll colchicine, għalkemm id-differenza osservata fil-kura meta mqabbla ma' triamcinolone acetonide kienet anqas tispikka minn dik fil-popolazzjoni sħiħa tal-istudju.
English: Experience from individual patients who achieved a complete response following dose escalation to 600 mg (8 mg/kg) every 8 weeks suggests that a higher dose may be beneficial in patients not achieving complete response or not maintaining complete response with the recommended doses (150 mg or 2 mg/kg for patients ≥ 15 kg and ≤ 40 kg).
Maltese: Skont esperjenza miksuba minn pazjenti individwali li laħqu rispons sħiħ wara żieda fid-doża għal 600 mg (8 mg/kg) kull 8 ġimgħat jidher li doża ogħla tista' tkun ta' benefiċċju għal pazjenti li mhux qed jilħqu rispons sħiħ jew mhux qed iżommu rispons sħiħ bid-dożi rrakkomandati (150 g jew 2 mg/kg għal pazjenti ≥ 15 kg u ≤ 40 kg).
English: Additional dose of 150 mg or 2 mg/kg can be considered
Maltese: Tista' titqies doża oħra ta' 150 mg jew 2 mg/kg
English: The safety profile of canakinumab observed following long-term treatment in this setting was consistent with what has been observed in interventional studies in CAPS patients.
Maltese: Il-profil ta' sigurtà ta' canakinumab osservat wara trattament għal perjodu twil ta' żmien f'dan il-qafas kien konsistenti ma' dak li ġie osservat waqt studji osservazzjonali fost pazjenti bil-CAPS.
English: In this study, 25 patients who had a strong ACR response for a minimum of 5 months reduced their canakinumab dose to 2 mg/kg every 4 weeks and maintained a paediatric ACR100 response throughout the time the reduced dose was given (median 32 weeks, 8-124 weeks).
Maltese: F'dan l-istudju, 25 pazjent li kellhom rispons qawwi tal-ACR għal mill-inqas 5 xhur naqqsu d-doża tagħhom ta' canakinumab għal 2mg/kg kull 4 ġimgħat u żammew rispons ta' ACR 100 pedjatriku matul iż-żmien li ngħatat iddoża mnaqqsa (il-medja ta' 32 ġimgħa, 8-124 ġimgħat).
English: What Ilaris looks like and contents of the pack Ilaris is supplied as a powder for solution for injection (150 mg in a 6 ml glass vial).
Maltese: Ilaris jasal bħala trab għal soluzzjoni għall-injezzjoni (150 mg f'kunjett tal-ħġieġ ta' 6 ml).
English: These data showed similar improvements from baseline to week 12 in the adapted paediatric ACR responses and its components to those observed in the placebo controlled study (G2305).
Maltese: Din id-dejta write titjib simili mil-linja bażi sat-12-il ġimgħa fir-rispons tal-ACR pedjatriku addattat u l-komponenti tiegħu mqabbel ma' dawk osservati fl-istudju kkontrollat bi plaċebo (G2305).
English: After reconstitution, each ml of solution contains 150 mg canakinumab.
Maltese: Wara rrikostituzzjoni, kull ml ta' soluzzjoni fih 150 mg canakinumab.
English: No human data are available, but as canakinumab is an immunoglobulin of the G class (IgG1), human transplacental transfer is expected.
Maltese: M'hemmx dejta disponibbli dwar il-bniedem, iżda peress li canakinumab huwa immunoglobulina tal-klassi G (IgG1), huwa mistenni trasferiment mill-plaċenta fil-bniedem.
English: • Tumour necrosis factor receptor associated periodic syndrome (TRAPS),
Maltese: • Is-sindromu perjodiku assoċjat mar-riċettur tal-fattur tan-nekrożi tat-tumur (TRAPS),
English: Gouty arthritis
Maltese: Artrite bil-gotta
English: Overall, there were no clinically meaningful differences in the efficacy, safety and tolerability profile of canakinumab in paediatric patients compared to the overall CAPS population.
Maltese: Kollox ma' kollox, ma kienx hemm differenzi sinjifikanti klinikament fil-profil taleffikaċja, tas-sigurtà u tat-tolleranza ta' canakinumab f'pazjenti pedjatriċi imqabbel mal-popolazzjoni sħiħa bil-CAPS.
English: Results for the components of the adapted paediatric ACR which included systemic and arthritic components, were consistent with the overall ACR response results.
Maltese: Ir-riżultati għall-komponenti tal-ACR pedjatriku addattat li kienu jinkludu komponenti sistemiċi u artritiċi, kienu konsistenti mar-riżultati tar-rispons sħiħ tal-ACR.
English: The efficacy and safety profile in AOSD patients are expected to be similar to SJIA patients based on literature reports.
Maltese: Il-profil ta' sigurtà f'pazjenti b'AOSD huwa mistenni li jkun simili għall-pazjenti b'SJIA abbażi ta' rapporti mil-letteratura.
English: Pull the plunger of the syringe all the way down to the 1.0 ml mark, filling the syringe with air. Insert the syringe needle into the vial of Ilaris solution through the centre of the rubber stopper.
Maltese: Iġbed il-planġer kollu sal-marka 1.0 ml, u imla s-siringa bl-arja.
English: Pregnancy
Maltese: Ċellulite
English: • 4 mg/kg for patients with body weight ≥ 7.5 kg and < 15 kg Children 2 to < 4 years of age:
Maltese: • 4 mg/kg għal pazjenti li jiżnu bejn 7.5 kg u anqas minn 15 kg Tfal li għandhom sentejn jew 3 snin
English: TRAPS, HIDS/MKD and FMF: Adults, adolescents and children aged 2 years and older The recommended starting dose of canakinumab in TRAPS, HIDS/MKD and FMF patients is:
Maltese: TRAPS, HIDS/MKD u FMF: Adulti, adolexxenti u tfal ta' sentejn jew aktar Id-doża inizjali rrakkomandata ta' canakinumab għal pazjenti bi TRAPS, HIDS/MD u FMF hi: 150 mg għal pazjenti b'piż ta' > 40 kg 2 mg/kg għal pazjenti b'piż ta' ≥ 7.5 kg u ≤ 40 kg
English: International non-proprietary name (INN): efungumab
Maltese: Denominazzjoni Komuni Internazzjonali (INN - International non-proprietary name): efungumab
English: Ref. EMEA/129723/2007
Maltese: Londra, 20 ta' Marzu 2007 Dok. Ref EMEA/129723/2007
English: The company that applied for authorisation is NeuTec Pharma plc.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni hija NeuTec Pharma plc.
English: What is Mycograb?
Maltese: X'inhu Mycograb?
English: The main study of the medicine's effects involved 139 adults with invasive candidiasis.
Maltese: L-istudju ewlieni ta' l-effetti tal-mediċina involva 139 adult b'kandidjasi invażiva.
English: Efungumab is produced by a method known as ‘recombinant DNA technology'.
Maltese: Enfumag huwa magħmul b'metodu magħruf bħala ‘teknoloġija rekombinanti tad-DNA'.
English: The active substance in Mycograb, efungumab, is an antifungal agent.
Maltese: Is-sustanza attiva f'Mycograb, efunumab, hija mediċina kontra l-fungi.
English: On 16 November 2006, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Mycograb 2 mg/ml powder for solution for injection intended for the treatment of invasive candidiasis in adult patients, in combination with amphotericin B or a lipid formulation of amphotericin B.
Maltese: Fis-16 ta' Novembru 2006, il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, u rrakkomanda r-rifjut ta' l-awtorizzazzjoni għat-tqegħid fis-suq tal-prodott mediċinali Mycograb, trab għas-soluzzjoni għall-injezzjoni 2 mg/ml, maħsub għat-trattament ta' kandidjasi invażiva f'pazjenti adulti, f'kombinazzjoni ma' amphotericin B jew formulazzjoni lipida ta' amphotericin B.
English: Mycograb was to be used together with amphotericin B (another antifungal medicine) to treat adult patients with invasive candidiasis.
Maltese: Mycograb kien se jintuża ma' amphotericin B (mediċina oħra kontra l-fungi) biex jitratta pazjenti adulti b'kandidjasi invażiva.