FrancophonIA/ELRC3.0 huggingface dataset:
English: SANCUSO transdermal patch is indicated in adults for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of 3 to 5 consecutive days, where oral anti-emetic administration is complicated by factors making swallowing difficult (see section 5.1).
Maltese: Il-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda SANCUSO hi indikata f'persuni adulti għallprevenzjoni ta' dardir u rimettar assoċjati ma' kimoterapija moderatament emetoġenika jew emetoġenika ħafna, għal tul ta' żmien ippjanat ta' 3 sa 5 ijiem konsekuttivi, fejn l-għoti antiemetiku orali jiġi kkumplikat minn fatturi li jkun diffiċli biex wieħed jibla'(ara sezzjoni 5.1).
English: In patients with renal failure or hepatic impairment, the pharmacokinetics of granisetron were determined following a single 40 µg/kg intravenous dose of granisetron hydrochloride.
Maltese: F'pazjenti b'indeboliment tal-kliewi jew tal-fwied, il-farmakokinetika ta' granisetron ġiet stabbilita wara doża waħda ta' granisetron hydrochloride ta' 40 µg/kg ġol-vini.
English: Paediatric population No studies have been performed to investigate the pharmacokinetics of SANCUSO in paediatrics.
Maltese: Ma saru l-ebda studji biex jinvestigaw il-farmakokinetika ta' SANCUSO fit-tfal.
English: This potentially may have clinical significance in patients with pre-existing arrhythmias or cardiac conduction disorders or patients who are being treated with antiarrhythmics or beta-blockers.
Maltese: Dan potenzjalment jista' jkollu rilevanza klinika f'pazjenti b'arritmiji li kienu jeżistu minn qabel jew disturbi fil-konduzzjoni kardijaka, jew pazjenti li jkunu qed jiġu kkurati b'mediċini antiarritmiċi jew beta-blockers.
English: The safety profile of SANCUSO is derived from controlled clinical trials and from post-marketing experience.
Maltese: Il-profil tas-sigurtà ta' SANCUSO jinkiseb minn provi kliniċi kkontrollati u minn esperjenza wara ttqegħid fis-suq.
English: In agreement with these data, no clinically relevant interactions have been reported in clinical studies with SANCUSO.
Maltese: Bi qbil ma' din id-dejta, l-ebda interazzjoni klinikament rilevanti bejn il-mediċini ma ġew irrappurtati fi studji kliniċi b'SANCUSO.
English: In clinical trials with SANCUSO, application site reactions were reported which were generally mild in intensity and did not lead to discontinuation of use.
Maltese: Fil-provi kliniċi b'SANCUSO, ġew irrappurtati reazzjonijiet fis-sit tal-applikazzjoni li kienu ġeneralment ħfief fl-intensità u ma wasslux biex jitwaqqaf.
English: The remainder of the dose is excreted as metabolites, with 49% in the urine and 34% in the faeces.
Maltese: Il-bqija tad-doża titneħħa bħala metaboliti, b'49% fl-awrina u 34% flippurgar.
English: In a clinical study no differences were seen in the plasma pharmacokinetics of SANCUSO in male and female elderly subjects (≥ 65 years) compared with younger subjects (aged 18-45 years inclusive).
Maltese: Ma ġew osservati l-ebda differenzi fil-farmakokinetika tal-plażma ta' SANCUSO fi studju kliniku li sar fuq irġiel u nisa anzjani (≥ 65 sena) meta mqabbla ma' individwi iżgħar (li kellhom 18-45 sena,
English: Granisetron has been shown to block both sodium and potassium channels, which could affect cardiac depolorisation and repolarisation and therefore PR, QRS, and QT intervals.
Maltese: Intwera li granisetron jimblokka kemm il-kanali tas-sodium kif ukoll tal-potassium, u dan jista' jaffettwa ddepolarizzazzjoni u r-ripolarizzazzjoni kardijaka u għalhekk l-intervalli tal-PR, QRS, u tal-QTs.
English: Dyskinesia
Maltese: INDIVIDWALI
English: 5-HT3 receptor antagonists, such as granisetron, may be associated with arrhythmias or ECG abnormalities.
Maltese: Antagonisti ta' riċettur 5-HT3 , bħal granisetron, jistgħu jkunu assoċjati ma' arritmiji jew anormalitajiet fl-ECG.
English: A study in cloned human cardiac ion channels has shown that granisetron has the potential to affect cardiac repolarisation via blockade of hERG potassium channels.
Maltese: Studju f'kanali tal-ijoni kardijaċi kklonati fil-bniedem wera li granisetron għandu l-potenzjal li jaffettwa r-ripolarizzazzjoni kardijaka permezz ta' imblokk tal-kanali tal-potassium hERG.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma wrewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva (ara 5.3). Bћala prekawzjoni hu preferribli li ma jintuzax SANCUSO waqt it-tqala.
English: In human subjects, hepatic enzyme induction by phenobarbital has led to an increase in total plasma clearance (approximately 25%) following intravenous administration of granisetron.
Maltese: Fil-bnedmin, l-induzzjoni ta' enzimi tal-fwied minn phenobarbital wasslet għal żieda fit-tneħħija totali mill-plażma (madwar 25%) wara l-għoti ġol-vini ta' granisetron.
English: When tested for skin sensitising potential in guinea pigs, SANCUSO showed a low potential for irritancy.
Maltese: Meta ġie ttestjat għal potenzjal ta' sensittività tal-ġilda fil-fniek tal-Indi, SANCUSO wera potenzjal baxx għal irritazzjoni.
English: Package Leaflet: Information for the patient SANCUSO 3.1 mg/24 hours transdermal patch
Maltese: Informazzjoni għall-utent SANCUSO 3.1 mg /24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda
English: Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Maltese: Hija rrakkomandata osservazzjoni xierqa ta' pazjenti għal sintomi bħas-sindrome ta' serotonin.
English: Not applicable.
Maltese: inklużivi).
English: The population randomised into the trial included 48% males and 52% females aged 16 to 86 years receiving moderately emetogenic (ME) or highly emetogenic (HE) multi-day chemotherapy.
Maltese: Il-popolazzjoni li ntgħażlet b'mod każwali fil-prova kienet tinkludi 48% irġiel u 52% nisa li kellhom minn 16 sa 86 sena li kienu qed jirċievu kimoterapija fuq diversi jiem li kienet moderatament emetoġenika (ME) jew emetoġenika ħafna (HE). 78% tal-pazjenti kienu bojod, bi 12% ikunu Asjatiċi u 10% Ispaniċi/mill-Amerika Latina.
English: Each 52 cm2 transdermal patch contains 34.3 mg of granisetron releasing 3.1 mg of granisetron per 24 hours.
Maltese: Kull garża ta' 52 ċm2 li tipprovdi mediċina li tgħaddi minn ġol-ġilda fiha 34.3 mg ta' granisetron, li terħi 3.1 mg ta' granisetron kull 24 siegħa.
English: An initial peak in plasma concentrations of granisetron, attributable to the intravenous dose, was reached at 10 minutes post-administration.
Maltese: Massimu inizjali tal-konċentrazzjonijiet ta' granisetron fil-plażma, attribwibbli għad-doża ġol-vina, intlaħaq 10 minuti wara l-għoti.
English: Granisetron may be affected by direct natural or artificial sunlight, see section 5.3 for further information.
Maltese: Granisetron jista' jiġi affettwat minn dawl tax-xemx naturali dirett jew dawl tax-xemx artifiċjali, ara sezzjoni 5.3 għal aktar informazzjoni
English: In vitro studies using human microsomes indicate that granisetron neither stimulates nor inhibits the cytochrome P450 enzyme system.
Maltese: Studji in vitro li jużaw mikrosomi tal-bniedem jindikaw li granisetron la jistimula lanqas jinibixxi ssistema ta' enzimi ta' ċitokrom P450.
English: When tested for potential photogenotoxicity in vitro in a Chinese hamster ovary (CHO) cell line, granisetron increased the percentage of cells with chromosome damage following photoirradiation.
Maltese: Meta ġie ttestjat għal potenzjal ta' fotoġenotossiċità in vitro f'razza ta' ċelluli tal-ovarju tal-ħamster Ċiniż,
English: Pharmacological studies have demonstrated that granisetron is effective against nausea and vomiting as a result of cytostatic therapy.
Maltese: Studji farmakoloġiċi wrew li granisetron hu effettiv kontra d-dardir u rimettar bħala riżultat ta' terapija ċitostatika.
English: However, no clinically relevant effects on ECG have been observed in clinical studies with SANCUSO, including a through QT study in 240 healthy subjects (section 5.1).
Maltese: Madankollu, l-ebda effetti klinikament rilevanti fuq lECG ma ġew osservati fl-istudji kliniċi b'SANCUSO, li jinkludu studju bir-reqqa dwar il-QT li sar fuq 240 individwu b'saħħithom (sezzjoni 5.1).
English: No clear relationship between renal function (as measured by creatinine clearance) and granisetron clearance was identified in population PK modelling.
Maltese: Ma ġiet identifikata l-ebda relazzjoni ċara bejn ilfunzjoni tal-kliewi (kif imkejla mit-tneħħija tal-kreatinina) u t-tneħħija ta' granisetron fl-immudellar PK tal-popolazzjoni.
English: The mean plasma half-life in healthy subjects is 4-6 hours and in patients is 9-12 hours.
Maltese: Il-medja tal-half-life fil-plażma f'individwi b'saħħithom hi ta' 4-6 sigħat u fil-pazjenti hi ta' 9-12-il siegħa.
English: Co-administration of intravenous 5-HT3 receptor antagonists with oral paracetamol in human subjects has been reported to result in a block in the analgesic effect via a pharmacodynamic mechanism.
Maltese: L-għoti flimkien ġol-vini ta' antagonisti ta' riċettur 5-HT3 ma' paracetamol orali fil-bniedem ġie rrapportat li jirriżulta f'imblokk tal-effett analġesiku permezz ta' mekkaniżmu farmakodinamiku.
English: Due to a gradual increase in plasma levels of granisetron following application of the transdermal patch, a slower onset of efficacy compared to 2 mg oral granisetron may be observed at the start of chemotherapy; the patch should be applied 24-48 hours before chemotherapy.
Maltese: Minħabba żieda gradwali fil-livelli fil-plażma ta' granisetron wara l-applikazzjoni tal-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda, bidu aktar bil-mod tal-effikaċja meta mqabbel ma' granisetron 2 mg orali jista' jiġi osservat fil-bidu tal-kimoterapija; il-garża għandha tiġi applikata 24-48 siegħa qabel il-kimoterapija.
English: No significant effect on QTc prolongation was observed for SANCUSO.
Maltese: Ma ġie osservat l-ebda effett sinifikanti fit-titwil tal- QTc għal SANCUSO.
English: Skin reactions at the site of application, such as irritation, itching or redness are uncommon and may affect up to 1 in 100 people.
Maltese: Reazzjonijiet tal-ġilda fis-sit tal-applikazzjoni, bħal irritazzjoni, ħakk jew ħmura, mhumiex komuni u jistgħu jaffettwaw sa persuna 1 minn kull 100.
English: SANCUSO 3.1 mg/24 hours transdermal patch
Maltese: SANCUSO 3.1 mg /24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda
English: Granisetron is cleared primarily by hepatic metabolism.
Maltese: Granisetron jitneħħa primarjament permezz tal-metaboliżmu fil-fwied.
English: Do not use this medicine after the expiry date which is stated on the outer carton and the sachet after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna ta' barra u l-qartas wara ‘JIS'.
English: Take the transdermal patch out of the sachet.
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mid-dawl.
English: • At the request of the European Medicines Agency:
Maltese: Kategorija farmakoterapewtika:
English: - Allergic reactions including urticaria (itchy, red, raised skin rash) and anaphalaxis (a serious allergic reaction which may include sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching) - Difficulty sleeping/disturbed sleep - Excessive sleepiness - Prolonged QT interval in the ECG (changes to the heart rate trace (ECG) indicating a heart rhythm disorder) - Constipation - Diarrhoea - Lack of energy/weakness /Loss of strength
Maltese: Madankollu, meta jingħata f'dożi ogħla u fuq perijodu ta' żmien twil, ir-riskju ta' karċinoġeneċità ma jistax jiġi eskluż, iżda bil-perijodu qasir talapplikazzjoni rrakkomandat għas-sistema ta' forniment ta' mediċina li tgħaddi minn ġol- ġilda, riskju karċinoġeniku għal bnedmin mhuwiex mistenni.
English: Uncommon side effects are: - headache, a feeling of “spinning” even when you are standing still (vertigo) - decreased appetite, weight loss - flushing (or redness) - feeling sick (nausea), retching, dry mouth - pain in your joints - swelling due to water retention (oedema) - changes in liver function tests (if you are having blood tests, tell the doctor or nurse that you have been given SANCUSO).
Maltese: Effetti sekondarji mhux komuni huma: - uġigħ ta' ras, tħoss kollox “idur bik” anki meta tkun wieqaf (sturdament) - nuqqas ta' aptit, telf ta' piż
English: Dystonia
Maltese: Diskinesija
English: No correlation between creatinine clearance and total clearance was observed in cancer patients, indicating no influence of renal impairment on the pharmacokinetics of granisetron.
Maltese: Ma ġiet osservata l-ebda korrelazzjoni bejn it-tneħħija tal-kreatinina u t-tneħħija totali f'pazjenti bilkanċer, u dan ma jindika l-ebda influwenza ta' indeboliment tal-kliewi fuq il-farmakokinetika ta' granisetron.
English: Following SANCUSO application, granisetron is absorbed slowly, with maximal concentrations reached between 24 and 48 hours.
Maltese: Wara l-applikazzjoni ta' SANCUSO, granisetron jiġi assorbit bil-mod, bil-konċentrazzjonijiet massimi jintlaħqu fuq 24 sa 48 siegħa.
English: Based on the measure of residual content of the transdermal patch after removal, approximately 65% of granisetron is delivered resulting in an average daily dose of 3.1 mg per day.
Maltese: Skont il-kejl ta' kontenut residwu tal-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda wara ttneħħija, madwar 65% ta' granisetron jista' jintuża, li jirriżulta f'medja ta' doża ta' kuljum ta' 3.1 mg kuljum.
English: Side effects with a frequency not known (cannot be estimated from available data): - allergic skin reactions.
Maltese: Effetti sekondarji bi frekwenza mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli) huma: - reazzjonijiet allerġiċi tal-ġilda.
English: If required, use surgical bandages or medical adhesive tape to keep the transdermal patch in place.
Maltese: Jekk ikun hemm bżonn, uża faxex kirurġiċi jew adhesive tape biex iżżomm il-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda f'postha.
English: EXP
Maltese: Mejt
English: 1 transdermal patch
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: SANCUSO is a transdermal (skin) patch used to prevent nausea (feeling sick) and vomiting (being sick) in adults receiving chemotherapy treatments (medicines to treat cancer) lasting 3 to 5 days and who have difficulty swallowing tablets (for example due to soreness, dryness or inflammation of the mouth or throat).
Maltese: SANCUSO hi garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda li tintuża għal prevenzjoni taddardir u rimettar f'persuni adulti li jkunu qed jirċievu kura bil-kimoterapija (mediċini għall-kura talkanċer) li ddum minn 3 sa 5 ijiem u li jkollhom diffikultà biex jibilgħu il-pilloli (pereżempju minħabba uġigħ, nixfa jew infjammazzjoni tal-ħalq jew tal-gerżuma).
English: SANCUSO can affect the way some medicines work.
Maltese: SANCUSO jista' jaffettwa l-mod li bih jaħdmu xi mediċini oħra.
English: (furunculosis)
Maltese: (furunkulożi)
English: • Orencia (which contains abatacept).
Maltese: • Orencia (li fih abatacept).
English: EU/1/13/854/001 EU/1/13/854/002 EU/1/13/854/003 EU/1/13/854/004 EU/1/13/854/005
Maltese: EU/1/13/854/001 EU/1/13/854/002 EU/1/13/854/003 EU/1/13/854/004
English: 23 Academy-ro, Yeonsu-gu, Incheon, 22014 Republic of Korea
Maltese: 23 Academy -ro, Yeonsu-gu, Incheon, 22014
English: Пфайзер Люксембург САРЛ, Клон България
Maltese: Пфайзер Люксембург САРЛ, Клон България Тел.:
English: Adults (≥18 years)
Maltese: Adulti (≥ 18-il sena)
English: Pack sizes of 1, 2, 3, 4, 5 vials.
Maltese: Daqsijiet tal-pakketti ta' 1, 2, 3, 4, 5 kunjetti.
English: N/A 60 N/A 49.4 N/A 6.7% N/A 1.7%
Maltese: N/A 6.7% N/A 1.7%
English: Date of first authorisation: 10 September 2013 Date of latest renewal: 21 June 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 10 ta' Setembru 2013 Data tal-aħħar tiġdid: 21 ta' Ġunju 2018
English: CELLTRION Inc. (Plant II, CLT2) 20 Academy -ro 51 beon-gil, Yeonsu-gu, Incheon, 22014
Maltese: (Plant II, CLT2) 20 Academy -ro 51 beon-gil, Yeonsu-gu, Incheon, 22014
English: placebo inflixim ab placebo inflixim ab placebo inflixim ab placebo inflixim ab
Maltese: plaċebo infliximab plaċebo infliximab plaċebo infliximab plaċebo infliximab
English: N/A 139 N/A 53.0 N/A 4.4% N/A 1.5%
Maltese: N/A 4.4% N/A 1.5%
English: Tel: +420-283-004-111
Maltese: s r.o. Tel: + 420-283-004-111
English: • Kineret (which contains anakinra).
Maltese: • Kineret (li fih anakinra).
English: Elevations of ALT ≥5 x Upper Limit of Normal (ULN) have been observed (see Table 2).
Maltese: Żidiet tal-ALT ≥ 5 darbiet ilLimitu ta' Fuq tan-Normal (ULN) ġew osservati (ara Tabella 2).
English: ≥3 x ULN
Maltese: ≥ 3 darbiet ULN ≥ 5 darbiet ULN
English: Complete fistula response (%)
Maltese: Rispons Fistula (%)
English: Invasive fungal infections
Maltese: Infezzjonijiet fungali invażivi
English: 5 years at 2 °C - 8 °C.
Maltese: 5 snin f'temperatura ta' 2°C - 8°C.
English: Store at 2 °C - 8 °C.
Maltese: Aħżen f'temperatura ta' 2°C - 8°C.
English: The median duration of follow-up was 0.8 years (incidence 5.7% [95% CI 2.65%-10.6%].
Maltese: Il-follow-up dam medjan ta' 0.8 snin (inċidenza 5.7% [95% CI 2.65%10.6%].
English: Inflectra contains sodium
Maltese: Inflectra fih sodium
English: d p = 0.030 and <0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs.
Maltese: d p=0.030 u < 0.001 għall-gruppi ta' kura b'3 mg/kg u 6 mg/kg rispettivament vs. plaċebo + MTX.
English: Sustained Steroid-Free Remission b a Reduction in CDAI ≥ 25% and ≥ 70 points.
Maltese: Tnaqqis Mingħajr Sterojdi a Tnaqqis fis-CDAI ≥ 25% u ≥ 70 punt.
English: Excipients: sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate
Maltese: Eċċipjenti: sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate.
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), acute generalised exanthematous pustulosis (AGEP), lichenoid reactions.
Maltese: Nekroliżi tossika tal-epidermide, sindrome ta' Stevens-Johnson, erythema multiforme, furunkulosi, dermatosi bullarja lineari IgA (LABD - linear IgA bullous dermatosis), pustullożi ekżantematuża mifruxa akuta (AGEP - acute generalised exanthematous pustulosis), reazzjonijiet likenojdi.
English: Republic of Korea
Maltese: Repubblika tal-Korea
English: Table 7 Effects on response rate, data from ACCENT II (Week-14 responders) ACCENT II (Week-14 responders)
Maltese: Tabella 7 Effetti fuq ir-rata ta' rispons, dejta minn ACCENT II (persuni li rrispondew sa ġimgħa 14)
English: The following adverse reactions were reported more commonly in paediatric Crohn's disease patients in the REACH study (see section 5.1) than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leukopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu rrappurtati b'mod aktar komuni f'pazjenti tfal bil-marda ta' Crohn fl-istudju REACH (ara sezzjoni 5.1) milli f'pazjenti adulti bil-marda ta' Crohn: anemija (10.7%), demm fl-ippurgar (9.7%), lewkopenja (8.7%), fwawar (8.7%), infezzjonijiet virali (7.8%), newtropenija (6.8%), infezzjoni kkawżata minn batterja (5.8%), u reazzjoni allerġika fil-passaġġ respiratorju (5.8%).
English: At single doses of 3, 5, or 10 mg/kg, the median Cmax values were 77, 118 and 277 micrograms/mL, respectively.
Maltese: F'dożi waħidhom ta' 3, 5, jew 10 mg/kg, il-valuri Cmax medjani kienu 77, 118 u 277 mikrogrammi/mL rispettivament.
English: Placebo (Week 24)
Maltese: Placebo (ġimgħa 24)
English: Inflectra is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Madankollu, Inflectra jiġi dilwit f'sodium chloride 9 mg/ml (0.9%) soluzzjoni għallinfużjoni.
English: Inflectra is a biosimilar medicinal product.
Maltese: Inflectra huwa prodott mediċinali bijoloġiku simili.
English: (Cyprus Branch) Τηλ: +357 22 817690
Maltese: Τηλ: + 357 22 817690
English: Infliximab Maintenance (5 mg/kg) (n=96)
Maltese: Manteniment b'Infliximab (5 mg/kg) (n=96)
English: Patients with ACR20 response/Patients evaluated (%) Total score d
Maltese: Pazjenti b'reazzjoni ACR20 / Pazjenti evalwati (%)
English: Viral infection (e.g. influenza, herpes virus infection).
Maltese: Infezzjoni virali (eż. influwenza, infezzjonijiet bil-virus talerpes).
English: In this trial, sixty-six percent of the patients (686 out of 1,040) received at least one shortened infusion of 90 minutes or less and 44% of the patients (454 out of 1,040) received at least one shortened infusion of 60 minutes or less.
Maltese: F'din ilprova, sitta u sittin fil-mija tal-pazjenti (686 minn 1,040) irċevew mill-anqas infużjoni waħda mqassra ta' 90 minuta jew anqas u 44% tal-pazjenti (454 minn 1,040) irċevew mill-anqas infużjoni waħda imqassra ta' 60 minuta jew anqas.
English: Table 8 Effects on clinical response, clinical remission and mucosal healing at Weeks 8 and 30.
Maltese: Tabella 8 Effetti fuq ir-rispons kliniku, tnaqqis kliniku u fejqan tal-mukuża f'ġimgħat 8 u 30.
English: For preparation and administration instructions, see section 6.6.
Maltese: Għal istruzzjonijiet fuq il-preparazzjoni u l-għoti, ara sezzjoni 6.6.
English: Placebo + MTX
Maltese: Infliximab + MTX
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Fil-klassijiet tassistema tal-organi, ir-reazzjonijiet avversi huma elenkati taħt it-titli tal-frekwenza bl-użu tal-kategoriji li ġejjin: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima middata disponibbli).
English: N ≥ 90% improvement ≥ 75% improvement ≥ 50% improvement
Maltese: Titjib ta' ≥ 90% Titjib ta' ≥ 75%
English: Infliximab Maintenance 5 mg/kg (n=113) (p value)
Maltese: Manteniment b'Infliximab 5 mg/kg (n=113) (Valur p)
English: b n = 292. c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Maltese: b n=292 ċ Analiżi kienet ibbażata fuq individwi psorijatika tad-dwiefer fil-linja bażi (81.8% tal-individwi).
English: In SPIRIT, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/kg infliximab group, 87.9% in the 5 mg/kg infliximab group, and 5.9% in the placebo group (p<0.001).
Maltese: Fi SPIRIT, il-proporzjon ta' pazjenti li kisbu PASI 75 f'ġimgħa 10 kien 71.7% fil-grupp fuq 3 mg/kg infliximab, 87.9% fil-grupp fuq 5 mg/kg infliximab, u 5.9% fil-grupp fuq plaċebo (p < 0.001).
English: Table 5 Effects on response and remission rate, data from ACCENT I (Week-2 responders) ACCENT I (Week-2 responders) % of Patients
Maltese: Tabella 5 Effetti fuq ir-rispons u r-rata ta' tnaqqis, dejta minn ACCENT I (persuni li rrispondew sa ġimgħa 2)
English: Shortened infusions at doses >6 mg/kg have not been studied (see section 4.8).
Maltese: Infużjonijiet imqassra b'dożi ta' >6 mg/kg ma ġewx studjati (ara sezzjoni 4.8).
English: Infliximab Maintenance 10 mg/kg (n=112) (p value)
Maltese: Manteniment b'Infliximab 10 mg/kg (n=112) (Valur p)
English: Inflectra is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).
Maltese: Inflectra huwa indikat għall-kura għal psorjasi tal-plakka minn moderata sa severa f'pazjenti adulti li ma jkunux urew rispons għal, jew li huma kontra-indikati għal, jew li huma intolleranti għal terapija sistemika oħra li tinkludi ciclosporin, methotrexate jew psoralen ultra-violet A (PUVA) (ara sezzjoni 5.1).