FrancophonIA/ELRC3.0 huggingface dataset:
English: During the re-examination, the CHMP reviewed again the data from the only main study submitted and confirmed its opinion that the effectiveness of Reasanz had not been sufficiently demonstrated.
Maltese: Matul l-analiżi mill-ġdid, is-CHMP reġa' rreveda d-dejta mill-uniku studju ewlieni sottomess u kkonferma l-opinjoni tiegħu li l-effikaċja ta' Reasanz ma ntwerietx b'mod suffiċjenti.
English: Strength Pharmaceutical Form
Maltese: Numru ta' l-EU Isem Qawwa Għamla Farmaċewtika
English: Packaging Content (concentration)
Maltese: Il-Kontenut Id-Daqs tal-Pakkett
English: Route of Administration
Maltese: Użu orali
English: • the CHMP considered that the available data confirms that the results of the bioequivalence study are reliable and demonstrate the bioequivalence of the proposed products and the reference product the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Tibolona Aristo and associated names (see Annex I).
Maltese: • is-CHMP ikkunsidra li d-dejta disponibbli tikkonferma li r-riżultati tal-istudju ta' bijoekwivalenza huma affidabbli u juru l-bijoekwivalenza tal-prodotti proposti u l-prodott ta' referenza is-CHMP irrakkomanda l-għoti tal-awtorizzazzjonijiet għat-tqegħid fis-suq li għalihom is-sommarju tal-karatteristiċi tal-prodott, it-tikkettar u l-fuljett ta' tagħrif jibqgħu skont il-verżjonijiet finali miksuba waqt il-proċedura tal-Grupp ta' Koordinazzjoni kif imsemmi fl-Anness
English: Overall summary of the scientific evaluation of Tibolona Aristo and associated names (see Annex I)
Maltese: III għal Tibolona Aristo u ismijiet assoċjati (ara Anness I).
English: 250 mg tablets
Maltese: 250 mg pilloli
English: 300 mg suppository
Maltese: 300 mg suppożitorju
English: 500 mg/ml oral drops, solution (1 ml = 20 drops)
Maltese: 500 mg/ml qtar orali, soluzzjoni (1 ml = 20 qatra)
English: 50 mg/ml syrup
Maltese: 50 mg/ml xiropp
English: Daily maximum dose kg age capsules capsules
Maltese: Piż tal-ġisem kg età kapsuli kapsuli
English: Metamizole crosses the placental barrier.
Maltese: Metamizole jaqbeż il-barriera tal-plaċenta.
English: 500 mg/ml solution for injection/infusion
Maltese: 500 mg/ml soluzzjoni għall-injezzjoni/infużjoni
English: In case of inadvertent use of metamizole during the third trimester amniotic fluid and the ductus arteriosus should be controlled by ultrasound and echocardiographia.
Maltese: F'każ ta' użu mhux intenzjonat ta' metamizole waqt it-tielet trimestru, il-fluwidu amnijotiku u d-ductus arteriosus għandhom jiġu kkontrollati minn ultrasound u ekokardjografija.
English: For all formulations including fixed combination medicinal products
Maltese: Għall-formulazzjonijiet kollha inkluż prodotti mediċinali ta' kombinazzjoni fissa
English: 500 mg tablets/capsules (also applicable for 500mg powder for oral solution/effervescent powder/granules for oral solution)
Maltese: 500 mg pilloli/kapsuli (applikabbli wkoll għal 500mg trab għal soluzzjoni orali/trab li jfexfex/granuli għal soluzzjoni orali)
English: 10-12 years 10-30 13-14 years 15-35 ≥15 years 20-40
Maltese: 10-12-il sena 10-30 13-14-il sena 15-35 ≥ 15-il sena 20-40
English: 4 - 6 years (ca. 16 - 23 kg)
Maltese: 4 - 6 snin (ca. 16 - 23 kg)
English: Paediatric population
Maltese: Popolazzjonijiet speċjali
English: Adults and adolescents 15 years of age or older
Maltese: Adulti u adoloxxenti ta' 15-il sena jew aktar
English: In animals metamizole induced reproductive toxicity but no teratogenicity (see Section 5.3).
Maltese: Fl-annimal, metamizole indotta effett tossiku fuq is-sistema riproduttiva iżda l-ebda teratoġeniċità (ara Sezzjoni 5.3).
English: • breast-feeding
Maltese: • treddigħ
English: 4-6 years (19-23 kg)
Maltese: 4-6 snin (19-23 kg)
English: Based on published data from pregnant women exposed to metamizole during the first trimester (n=568) no evidence for teratogenic or embryotoxic effects was identified.
Maltese: Skont data ppubblikata minn nisa tqal esposti għal metamizole waqt l-ewwel trimestru (n=568) ma ġiet identifikata l-ebda evidenza għal effetti teratoġeniċi jew embrijotossiċi.
English: A clear effect can be expected 30 minutes after parenteral administration.
Maltese: Jista' jiġi mistenni effett ċar 30 minuta wara għoti parenterali.
English: 7-9 years (24-30 kg)
Maltese: 7-9 snin (24-30 kg)
English: 10-12 years 13-18 13-14 years 18-21
Maltese: 7-9 snin 10-12 10-12-il sena 13-18 13-14-il sena 18-21
English: 13-14 years (46-53 kg)
Maltese: 13-14-il sena (46-53 kg)
English: 7 - 9 years (ca. 24 - 30 kg)
Maltese: 7 - 9 snin (ca. 24 - 30 kg)
English: 10-12 years (31-45 kg)
Maltese: 10-12-il sena (31-45 kg)
English: Use during the third trimester is associated with fetotoxicity (renal impairment and ductus arteriosus constriction) and thus the use of metamizole is contraindicated during the third trimester of pregnancy (see section 4.3).
Maltese: L-użu waqt it-tielet trimestru huwa assoċjat ma' fetotossiċità (indeboliment tal-kliewi u kostrizzjoni tad-ductus arteriosus) u għalhekk l-użu ta' metamizole huwa kontraindikat waqt it-tielet trimestru tat-tqala (ara sezzjoni 4.3).
English: For children and adolescents up to 14 years of age, a single dose of 8 to 16 mg metamizole sodium per kilogram of body weight is given.
Maltese: Għal tfal u adolexxenti sal-età ta' 14-il sena, tingħata doża waħda ta' 8 sa 16 mg metamizole sodium għal kull kilogramm tal-ġisem.
English: Age (body weight)
Maltese: Età (piż tal-ġisem)
English: Daily maximum dose kg age suppository/effervescent powder suppository/effervescent powder
Maltese: Piż tal-ġisem kg età suppożitorju/trab li jfexfex suppożitorju/trab li jfexfex
English: 1 suppository for children (equivalent to 300 mg metamizole)
Maltese: Suppożitorju 1 għat-tfal (ekwivalenti għal 300 mg metamizole)
English: Daily maximum dose kg age tablets /sachets mg tablets/sachets mg
Maltese: Piż tal-ġisem kg età pilloli /qratas pilloli /qratas mg
English: For all formulations including fixed combination medicinal products:
Maltese: Għall-formulazzjonijiet kollha inkluż prodotti mediċinali ta' kombinazzjoni fissa: Tqala
English: A clear effect can be expected 30 to 60 minutes after oral administration.
Maltese: Jista' jiġi mistenni effett ċar 30 sa 60 minuta wara għoti orali.
English: 3,450mg (corresponding to 6 capsules) is the maximum daily dose.
Maltese: 3,450mg (li tikkorrispondi għal 6 kapsuli) hija d-doża massima ta' kuljum.
English: 1-3 years 4-6 years 7-9 years 31-45 10-12 years 0.5-1.4 46-53 13-14 years 0.8-1.8 ≥ 15 years 1.0-2.0* 500-1,000* 4.0-8.0* 2,000-4,000* * If necessary, the single dose can be increased to 5 ml (corresponding to 2,500 mg metamizole) and the daily dose to 10 ml (corresponding to 5,000 mg metamizole).
Maltese: 1-3 snin 4-6 snin 7-9 snin 31-45 10-12-il sena 0.5-1.4 46-53 13-14-il sena 0.8-1.8 ≥ 15-il sena 1.0-2.0* 500-1,000* 4.0-8.0* 2,000-4,000*
English: • Section 4.2 Posology and method of administration
Maltese: • Sezzjoni 4.6 Fertilità, tqala u treddigħ
English: * If necessary, the single dose can be increased to 6,2 ml (corresponding to 2,480 mg metamizole) and the daily dose to 12,5 ml (corresponding to 5,000 mg metamizole).
Maltese: * Jekk ikun meħtieġ, id-doża waħda tista' tiżdied għal 6,2 ml (li tikkorrispondi għal 2,480 mg metamizole) u d-doża ta' kuljum għal 12,5 ml (li tikkorrispondi għal 5,000 mg metamizole).
English: B. Package Leaflet
Maltese: Għall-formulazzjonijiet kollha
English: 10 - 12 years (ca. 31 - 45 kg)
Maltese: 10 snin - 12-il sena (ca. 31 - 45 kg)
English: <12 months 1-5 1-3 years
Maltese: <12-il xahar 1-5 1-3 snin
English: Body weight kg age
Maltese: Piż tal-ġisem kg età
English: • Section 4.6 Fertility, pregnancy and lactation This wording below should be reflected in this section.
Maltese: • Sezzjoni 4.3 Kontraindikazzjonijiet Din il-formulazzjoni ta' hawn taħt għandha tiġi riflessa f'din is-sezzjoni.
English: Up to 5 suppositories for children (equivalent to up to 1500 mg metamizole)
Maltese: Sa 5 suppożitorji għat-tfal (ekwivalenti għal massimu ta' 1500 mg metamizole)
English: Adolescents of 15 years of age or older (> 53 kg) and adults can administrate 1,000 mg metamizole as a single dose.
Maltese: Adolexxenti tal-età ta' 15-il sena (> 53 kg) u adulti jistgħu jagħtu 1,000 mg metamizole bħala doża waħda.
English: Infants 3 - 11 months (ca. 5 - 8 kg)
Maltese: Trabi 3 xhur - 11-il xahar (ca. 5 - 8 kg)
English: The maximum daily dose for adults and adolescents over 15 years is 4 suppositories/sachets of effervescent powder (corresponding to 4,000 mg).
Maltese: Id-doża massima ta' kuljum għal adulti u adolexxenti ta' aktar minn 15-il sena hija 4 suppożitorji/qratas ta' trab li jfexfex (li tikkorrispondi għal 4,000 mg).
English: 3-11 months 1-3 years 4-6 years 7-9 years 31-45 10-12 years 46-53 13-14 years ≥ 15 years
Maltese: 5-8 3-11-il xahar 1-3 snin 4-6 snin 7-9 snin 31-45 10-12-il sena 46-53 13-14-il sena ≥ 15-il sena
English: 13 - 14 years (ca. 46 - 53 kg)
Maltese: 13-il sena - 14-il sena (ca. 46 - 53 kg)
English: The maximum daily dose is 10,0 mL; if needed, the daily dose may be increased up to 12,5 ml (corresponding to 5,000 mg of <invented name>).
Maltese: Id-doża massima ta' kuljum ta' 10,0 mL; jekk ikun meħtieġ, id-doża tista' tiżdied għal 12,5 mL (li tikkorrispondi għal 5,000 mg ta' <isem ivvintat>).
English: Adults and adolescents of 15 years of age or older (> 53 kg) can take 1 capsule (575 mg metamizole) as a single dose, which can be taken up to 6 times daily at intervals of 4 - 6 hours.
Maltese: Adulti u adolexxenti ta' 15-il sena jew aktar (> 53 kg) jistgħu jieħdu sa kapsula 1 (575 mg metamizole) bħala doża waħda, li jistgħu jittieħdu sa 6 darbiet kuljum f'intervalli ta' 4 - 6 sigħat.
English: 4,000 mg (corresponding to 8 tablets/sachets) is the maximum daily dose.
Maltese: 4,000 mg (li tikkorrispondi għal 8 pilloli/qratas) hija d-doża massima ta' kuljum.
English: 1 - 3 years (ca. 9 - 15 kg)
Maltese: sena - 3 snin (ca. 9 - 15 kg)
English: Up to 6 suppositories for children (equivalent to up to 1800 mg metamizole)
Maltese: Sa 6 suppożitorji għat-tfal (ekwivalenti għal massimu ta' 1800 mg metamizole)
English: A clear effect can be expected 30 to 60 minutes after rectal administration.
Maltese: Jista' jiġi mistenni effett ċar 30 sa 60 minuta wara għoti rettali.
English: Up to 4 suppositories for children (equivalent to up to 1200 mg metamizole)
Maltese: Sa 4 suppożitorji għat-tfal (ekwivalenti għal massimu ta' 1200 mg metamizole)
English: The dose should be reduced in elderly people, in debilitated patients and in those with reduced creatinine clearance, as elimination of the metabolic products of metamizole may be prolonged.
Maltese: Id-doża għandha titnaqqas f'persuni anzjani, f'pazjenti debilitati u f'dawk bi tneħħija tal-kreatinina mnaqqsa, peress li l-eliminazzjoni tal-prodotti metaboliċi ta' metamizole tista' tittawwal.
English: The maximum daily dose is 8 mL; if needed, the daily dose may be increased up to 10 ml (corresponding to 5,000 mg of <invented name>).
Maltese: Id-doża massima ta' kuljum ta' 8 mL; jekk ikun meħtieġ, id-doża tista' tiżdied sa 10 mL (li tikkorrispondi għal 5,000 mg ta' <isem ivvintat>).
English: Up to 3 suppositories for children (equivalent to up to 900 mg metamizole)
Maltese: Sa 3 suppożitorji għat-tfal (ekwivalenti għal massimu ta' 900 mg metamizole)
English: Elderly population, debilitated patients, and patients with reduced creatinine clearance
Maltese: Popolazzjoni anzjana, pazjenti debilitati, u pazjenti bi tneħħija tal-kreatinina mnaqqsa
English: For adults and adolescents 15 years and over (> 53 kg) other strengths or pharmaceutical forms are available.
Maltese: Għal adulti u adoloxxenti minn 15-il sena 'l fuq (> 53 kg) hemm disponibbli qawwiet jew forom farmaċewtiċi oħrajn.
English: 2000 mg/5ml (i.e. 400 mg/ml) solution for injection/infusion <invented name> is contraindicated for infants below the age of 3 months or below 5 kg of body weight intravenous route: <invented name> is contraindicated for infants under 1 year of age 500 mg/ml solution for injection/infusion <invented name> is contraindicated for infants below the age of 3 months or below 5 kg of body weight intravenous route: <invented name> is contraindicated for infants under 1 year of age
Maltese: Tagħtix din il-mediċina lil trabi waqt l-ewwel 3 xhur tal-ħajja jew lil pazjenti li jiżnu inqas minn 5 kg 2000 mg/5ml (jiġifieri 400 mg/ml) soluzzjoni għall-injezzjoni/infużjoni Tagħtix din il-mediċina lil trabi waqt l-ewwel 3 xhur tal-ħajja jew lil pazjenti li jiżnu inqas minn 5 kg Tagħtix din il-mediċina minn ġol-vini lil trabi iżgħar minn età ta' sena 500 mg/ml soluzzjoni għall-injezzjoni/infużjoni Tagħtix din il-mediċina lil trabi waqt l-ewwel 3 xhur tal-ħajja jew lil pazjenti li jiżnu inqas minn 5 kg Tagħtix din il-mediċina minn ġol-vini lil trabi iżgħar minn età ta' sena Il-formulazzjonijiet kollha inkluż prodotti mediċinali ta' kombinazzjoni fissa o Tqala, treddigħ u fertilità
English: In dependence on the daily maximum dose a single dose can be administrated up to 4 times daily at intervals of 6-8 hours corresponding to a maximum daily dose of 4,000 mg. A clear effect can be expected 30 to 60 minutes after rectal administration.
Maltese: B'dipendenza fuq id-doża massima ta' kuljum, tista' tingħata doża waħda sa 4 darbiet kuljum f'intervalli ta' 6-8 sigħat li tikkorrispondi għal doża massima ta' kuljum ta' 4,000 mg.
English: In dependence on the daily maximum dose a single dose can be given up to 6 times daily at intervals of 4-8 hours.
Maltese: B'dipendenza mid-doża massima ta' kuljum, tista' tingħata doża waħda sa 6 darbiet kuljum f'intervalli ta' 4-8 sigħat.
English: Other pharmaceutical forms/strengths are available which can be appropriately dosed for infants below the age of 3 months.
Maltese: Hemm disponibbli forom/qawwiet farmaċewtiċi oħrajn li jistgħu jiġu ddożati b'mod xieraq għal trabi taħt l-età ta' 3 xhur.
English: 2000 mg/5ml (i.e. 400 mg/ml) solution for injection/infusion Dosage is determined by the intensity of the pain or fever and individual sensitivity of response to <invented name>.
Maltese: 2000 mg/5ml (jiġifieri 400 mg/ml) soluzzjoni għall-injezzjoni/infużjoni Id-doża tiddependi mill-intensità tal-uġigħ jew tad-deni u mis-sensittività tal-individwu tar-rispons għal <isem ivvintat>.
English: <12 months 1-3 1-3 years
Maltese: <12-il xahar 1-3
English: Adults and adolescents from 15 years of age (>53 kg) can take up to 1,000 mg as a single dose.
Maltese: Adulti u adolexxenti mill-età ta' 15-il sena (>53 kg) jistgħu jieħdu sa 1,000 mg bħala doża waħda.
English: Adults and adolescents of 15 years of age or older (> 53 kg) can take 575 mg metamizole as a single dose, which can be taken up to 6 times daily at intervals of 4 - 6 hours corresponding to a maximum daily dose of 3,450mg.
Maltese: L-adulti u l-adolexxenti ta' 15-il sena jew aktar (> 53 kg) jistgħu jieħdu 575 mg metamizole bħala doża waħda, li tista' tittieħed sa 6 darbiet kuljum f'intervalli ta' 4-6 sigħat li jikkorrispondu għal doża massima ta' kuljum ta' 3,450 mg.
English: Maximum daily dose
Maltese: 13-Il sena
English: This following wording should be reflected in this section.
Maltese: Din il-formulazzjoni ta' hawn taħt għandha tiġi riflessa f'din is-sezzjoni.
English: Paediatric population <invented name> is not recommended for children younger than 15 years of age due to the fixed amount of 500mg metamizole contained in one tablet/capsule/sachet.
Maltese: Popolazzjoni pedjatrika <isem ivvintat> mhuwiex rakkomandat għat-tfal iżgħar mill-età ta' 15-il sena minħabba l-ammont fiss ta' 500 mg metamizole f'pillola/kapsula/qartas wieħed.
English: <12 months 1-3 years 4-6 years 7-9 years 31-45 10-12 years 46-53 13-14 years ≥ 15 years Single doses can be given up to four times a day, depending on the maximum daily dose.
Maltese: <12-il xahar 1-3 snin 4-6 snin 7-9 snin 31-45 10-12-il sena 46-53 13-14-il sena ≥ 15-il sena Dożi waħdanin jistgħu jingħataw sa erba' darbiet kuljum, skont id-doża massima ta' kuljum.
English: Adults and adolescents of 15 years of age or older (> 53 kg) can take up to 1,000 mg metamizole as a single dose, which can be taken up to 4 times daily at intervals of 6-8 hours corresponding to a maximum daily dose of 4,000mg.
Maltese: L-adulti u l-adolexxenti ta' 15-il sena jew aktar (> 53 kg) jistgħu jieħdu sa 1,000 mg metamizole bħala doża waħda, li tista' tittieħed sa 4 darbiet kuljum f'intervalli ta' 6-8 sigħat li tikkorrispondi għal doża massima ta' kuljum ta' 4,000 mg.
English: Hepatic and renal impairment
Maltese: Trabi u tfal
English: Section 2: What you need to know before you use X This following wording should be reflected in this section.
Maltese: Sezzjoni 2: X'għandek tkun taf qabel ma tuża X Din il-formulazzjoni li ġejja għandha tiġi riflessa f'din is-sezzjoni.
English: As the rate of elimination is reduced in patients with impaired kidney or liver function, repeated high doses should be avoided.
Maltese: Peress li r-rata ta' eliminazzjoni hija mnaqqsa f'pazjenti b'funzjoni tal-kliewi jew tal-fwied indebolita, għandhom jiġu evitati dożi għoljin ripetuti.
English: Adults and adolescents of 15 years of age or older (weighting more than 53 kg) can be given 1 - 2,5 mL intravenously or intramuscularly as a single dose; if needed, the single dose may be increased up to 6,2 mL (corresponding to 2,480 mg <invented name>).
Maltese: Adulti u adolexxenti ta' età ta' 15-il sena jew aktar (li jiżnu aktar minn 53 kg) jistgħu jingħataw 12,5 mL ġol-vini jew ġol-muskolu bħala doża waħda, jekk ikun meħtieġ, id-doża tista' tiżdied għal 6,2 mL (li tikkorrispondi għal 2,480 mg ta' <isem ivvintat>).
English: Paediatric population <invented name> is not recommended for children younger than 10 years of age due to the fixed amount of 250 mg metamizole contained in one tablet.
Maltese: Popolazzjoni pedjatrika <isem ivvintat> mhuwiex rakkomandat għat-tfal iżgħar mill-età ta' 10 snin minħabba l-ammont fiss ta' 250 mg metamizole f'pillola waħda.
English: 3-11 months 1-3 years 4-6 years 7-9 years 31-45 10-12 years 46-53 13-14 years ≥ 15 years Single doses can be given up to four times a day, depending on the maximum daily dose.
Maltese: 5-8 3-11-il xahar 1-3 snin 4-6 snin 7-9 snin 31-45 10-12-il sena 46-53 13-14-il sena ≥ 15-il sena Dożi waħdanin jistgħu jingħataw sa erba' darbiet kuljum, skont id-doża massima ta' kuljum.
English: A clear effect is expected 30 to 60 minutes after using the medicine.
Maltese: Huwa mistenni effett ċar 30 sa 60 minuta wara l-użu tal-mediċina.
English: In dependence on the daily maximum dose a single dose can be taken up to 4 times daily at intervals of 6-8 hours.
Maltese: B'dipendenza fuq id-doża massima ta' kuljum, tista' tittieħed doża waħda sa 4 darbiet kuljum f'intervalli ta' 6-8 sigħat.
English: Daily maximum dose kg age tablets tablets
Maltese: Piż tal-ġisem kg età pilloli pilloli il sena ≥ 15-il sena 2 - 4
English: Body weight
Maltese: Suppożitorju 1
English: 32 - 53 10-14 years 1 - 2 ≥ 15 years 2 - 4
Maltese: 46-53 13-14-il sena 0.9-2.1
English: In case of fever, a dose of 10 mg metamizole per kilogram body weight is generally sufficient for children.
Maltese: Fil-każ ta' deni, doża ta' 10 mg metamizole għal kull kilogramma tal-piż tal-ġisem ġeneralment tkun biżżejjed għat-tfal.
English: The breakdown products of metamizole pass into breast-milk in considerable amounts and a risk to the breastfed infant cannot be excluded.
Maltese: Sabiex jiġi mminimizzat ir-riskju ta' reazzjoni ipotensiva, l-injezzjoni ġol-vini għandha tingħata bil-mod ħafna.
English: There are only limited data available on the use of metamizole in pregnant women.
Maltese: Hemm biss data limitata disponibbli dwar l-użu ta' metamizole f'nisa tqal.
English: The dose should be reduced in elderly people, in debilitated patients and in those with reduced renal function, as excretion of the breakdown products of metamizole may be delayed.
Maltese: Peress li r-rata ta' eliminazzjoni titnaqqas meta l-funzjoni tal-kliewi jew tal-fwied tkun indebolita, għandhom jiġu evitati ħafna dożi għoljin.
English: Paediatric population <invented name> is not recommended for children younger than 15 years of age due to the fixed amount of 575mg metamizole contained in one capsule.
Maltese: Popolazzjoni pedjatrika <isem ivvintat> mhuwiex rakkomandat għat-tfal iżgħar mill-età ta' 15-il sena minħabba l-ammont fiss ta' 575 mg metamizole f'kapsula waħda.
English: Adults and adolescents of 15 years of age or older (weighting more than 53 kg) can be given 1 - 2 mL intravenously or intramuscularly as a single dose; if needed, the single dose may be increased up to 5 mL (corresponding to 2,500 mg <invented name>).
Maltese: Adulti u adolexxenti ta' età ta' 15-il sena jew aktar (li jiżnu aktar minn 53 kg) jistgħu jingħataw 12 mL ġol-vini jew ġol-muskolu bħala doża waħda; jekk ikun meħtieġ, id-doża waħda tista' tiżdied sa 5 mL (li tikkorrispondi għal 2,500 mg ta' <isem ivvintat>).
English: Grades 3/4
Maltese: Gradi 3/4
English: 28 capsules.
Maltese: 28 kapsula.
English: 18 September 2017
Maltese: 18 Settembru 2017
English: Rydapt is indicated:
Maltese: Rydapt hu indikat:
English: primary endpoint;
Maltese: endpoint primarju;
English: HR (95% CI) - SCT HR (95% CI) - no SCT
Maltese: HR (95% CI) - SCT HR (95% CI) - ebda SCT
English: Rydapt (100 mg twice daily) N=142
Maltese: Rydapt (100 mg darbtejn kuljum) N=142
English: Midostaurin inhibited OATP1B1, BCRP and P-glycoprotein (P-gp) in vitro (see section 5.2).
Maltese: Midostaurin inibixxa OATP1B1, BCRP u l-glikoproteina-P (P-gp) in vitro (ara sezzjoni 5.2).
English: Placebo n=357
Maltese: Plaċebo n=357
English: Rydapt contains ethanol anhydrous (alcohol)
Maltese: Rydapt fih ethanol anhydrous (alkoħol)
English: QTc interval >470 msecs and ≤500 msecs
Maltese: Intervall tal-QTc ta' >470 msec u ≤500 msec
English: EFS (CR induction) (HR)
Maltese: EFS (induzzjoni CR) (HR)
English: Rydapt + chemo n=229
Maltese: Rydapt + kimo n=229
English: The KIT D816V mutation was detected in 82% of patients.
Maltese: Il-mutazzjoni tal-KIT D816V instabet fi 82% talpazjenti.
English: Safety pharmacology and single/repeat dose toxicity
Maltese: Sigurtà farmakoloġika u effett tossiku minn dożi ripetuti/singoli
English: ASM SM-AHN
Maltese: SM-AHN
English: Cardiac dysfunction
Maltese: Disfunzjoni kardijaka
English: Primary endpoint Overall response, n (%) (95% CI)
Maltese: Endpoint primarju Rispons globali, n (%) (95% CI)
English: 1: MIDOSTAURIN - SCT 2: PLACEBO - SCT 3: MIDOSTAURIN - no SCT 4: PLACEBO - no SCT Censored
Maltese: 1: MIDOSTAURIN - SCT 2: PLAĊEBO - SCT 3:
English: QTc interval >500 msecs
Maltese: Intervall tal-QTc ta' >500 msec
English: In vitro, midostaurin did not inhibit hERG channel activity up to the limit of solubility of 12 µM.
Maltese: In vitro, midostaurin ma inibixxix l-attività tal-kanal hERG sal-limitu ta' solubbiltà ta' 12 µM.
English: Months Midostaurin Placebo
Maltese: Midostaurin Plaċebo
English: Grade 3/4 pulmonary infiltrates
Maltese: Infiltrati pulmonari ta' Grad 3/4
English: DFS (CR induction) (HR)
Maltese: DFS (induzzjoni CR) (HR)
English: Midostaurin inhibits multiple receptor tyrosine kinases, including FLT3 and KIT kinase.
Maltese: Midostaurin jinibixxi r-riċettur multiplu tat-tyrosine kinase, inkluż l-FLT3 u KIT kinase.
English: Each soft capsule contains approximately 83 mg ethanol anhydrous and 415 mg macrogolglycerol hydroxystearate.
Maltese: Kull kapsula ratba fiha madwar 83 mg ethanol anhydrous u 415 mg macrogolglycerol hydroxystearate.
English: Concomitant administration of potent CYP3A4 inducers, e.g. rifampicin, St. John's Wort (Hypericum perforatum), carbamazepine, enzalutamide, phenytoin (see section 4.5).
Maltese: L-għoti flimkien ta' indutturi qawwija ta' CYP3A4, eż. rifampicin, St.John's Wort (Hypericum perforatum), carbamazepine, enzalutamide, phenytoin (ara sezzjoni 4.5).
English: The pharmacokinetics of the CGP62221 metabolite showed a similar trend.
Maltese: Il-farmakokinetiċi tal-metabolit CGP62221 uriet tendenza simili.
English: Probability of Survival (%)
Maltese: Probabbiltà ta' Sopravivenza (%)
English: CR induction (OR)
Maltese: Induzzjoni CR (OR)
English: Final CSR: September
Maltese: CSR finali:
English: Rydapt + chemo n=345
Maltese: Rydapt + kimo n=345