FrancophonIA/ELRC3.0 huggingface dataset:
English: - known or suspected benign or malignant oestrogen-dependent tumours e.g. uterine leiomyoma, endometrial cancer) - history of malignant oestrogen-dependent tumours - Unspecified genital bleeding - Untreated endometrial hyperplasia - Skin diseases in the external genital area caused by bacterial, fungal, or viral infections
Maltese: - Kanċer tas-sider magħruf, li għadda jew suspettat - Tumuri malinni magħrufa jew suspettati dipendenti mill-estroġenu (eż. kanċer endometrijali)
English: This part of section 3 has not been modified during this procedure]
Maltese: Din il-parti tas-sezzjoni 3 ma ġietx immodifikata matul din il-proċedura]
English: Spotting
Maltese: sturdament)
English: Dizziness, headache, migraine, anxiety
Maltese: Nawżja, nefħa, uġigħ addominali
English: A relationship between ischaemic stroke and low dose local vaginal oestrogen therapy is uncertain.
Maltese: Relazzjoni bejn puplesija iskemika u terapija lokali vaġinali bl-estroġenu b'doża baxxa hija inċerta.
English: The WHI trial found no increase in risk of breast cancer in hysterectomised women using oestrogen-only HRT.
Maltese: Relazzjoni bejn ir-riskju ta' kanċer tal-ovarji u terapija lokali vaġinali bl-estroġenu hija inċerta.
English: Incidence per 1000 women placebo arm over 5 year period*
Maltese: 1000 mara fuq perjodu ta' 5 snin*
English: Oestrogen only HRT
Maltese: HRT b'estroġenu biss
English: A relationship between breast cancer risk and local vaginal oestrogen therapy is uncertain.
Maltese: Relazzjoni bejn ir-riskju ta' kanċer tas-sider u terapija lokali vaġinali tal-estroġenu hija inċerta.
English: Intolerance to contact lenses
Maltese: Intolleranza għal-lentijiet tal-kuntatt
English: Thus, prednisolone is particularly suitable for the treatment of inflammatory dermatoses in problem areas, as it has weak anti-inflammatory, antiallergic and antipruritic properties.
Maltese: prednisolone huwa partikolarment adattat għall-kura ta' dermatożi infjammatorja f'partijiet problematiċi, peress li għandu proprjetajiet dgħajfa anti-infjammatorji, kontra l-allerġiji u kontra l-ħakk.
English: Blood clots in a vein (thrombosis)
Maltese: Qabel ma tuża [isem ivvintat]
English: Using [invented name] together with latex products (e.g. condoms, diaphragms) can reduce the functionality of such products thereby making them less reliable as [invented name] contains excipients (other ingredients, particularly stearates).
Maltese: L-użu ta' [isem ivvintat] flimkien ma' prodotti tal-latex (eż. kondoms, dijaframmi) jista' jnaqqas il-funzjonalità ta' dawn il-prodotti biex b'hekk isiru anqas affidabbli peress li [isem ivvintat] fih eċċipjenti (sustanzi oħra, b'mod partikolari stearates).
English: If VTE develops after initiating therapy, the drug should be discontinued.
Maltese: VTE wara li tinbeda t-terapija, il-prodott mediċinali għandu jitwaqqaf.
English: The occurrence of such an event is more likely in the first year of HRT than later.
Maltese: L-okkorrenza ta' tali avvenimenti hija aktar probabbli fl-ewwel sena ta' HRT milli aktar tard.
English: Arthralgias, leg cramps
Maltese: mara fergħa tal-plaċebo fuq 5
English: In rare cases benign, and in even rarer cases malignant liver tumours leading to isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances such as those contained in [invented name].
Maltese: F'każijiet rari, u każijiet saħansitra aktar rari, ġew osservati tumuri malinni fil-fwied li jwasslu għal każijiet iżolati ta' emorraġija intra-addominali ta' periklu għall-ħajja wara l-użu ta' sustanzi ormonali bħal dawk li jinstabu f'[isem ivvintat].
English: - Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer
Maltese: - Il-fatturi tar-riskju għat-tumuri dipendenti mill-estroġenu, eż. eredità tal-ewwel grad għall-kanċer tas-sider
English: Therapy should be discontinued in case a contra-indication is discovered and in the following situations:
Maltese: It-terapija għandha titwaqqaf f'każ li tiġi skoperta kontraindikazzjoni u fis-sitwazzjonijiet li ġejjin:
English: There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined or oestrogen-only HRT after the age of 65.
Maltese: WHI ta' żieda fir riskju ta' dimenzja probabbli f'nisa li jibdew jużaw HRT flimkien jew b'estroġenu biss kontinwament wara li jagħlqu 65 sena.
English: The existing relevant text need to be modified accordingly]
Maltese: Disturbi ġenerali u kondizzjonijiet ta'
English: Oestrogens stimulate epithelial cell proliferation in the genital area and urinary tract, as well as increasing collagen synthesis in the skin.
Maltese: L-estroġeni jistimulaw il-proliferazzjoni taċċelloli epiteljali fil-parti ġenitali u l-apparat urinarju, kif ukoll iżidu s-sinteżi tal-kollaġen filġilda.
English: In the Million Women Study 5 years of HRT resulted in 1 extra case per 2500 users.
Maltese: irriżultaw f'każ żejjed għal kull 2500 utent.
English: There is no evidence that HRT will prevent a heart attack.
Maltese: M'hemm ebda evidenza li l-HRT se tipprevjeni attakk tal-qalb.
English: For the treatment of atrophic disorders of the vagina and vulva, which are due to a lack of oestrogen, e.g. atrophic vaginitis, coital problems, vaginal stenosis (narrowing), vulvar atrophy with burning and itching
Maltese: Għall-kura ta' disturbi atrofiċi tal-vaġina u l-vulva, li huma dovuti għal nuqqas ta' estroġenu, eż. vaġinite atrofika, problemi koitali, stenożi vaġinali (tidjiq), atrofija vulvari bi ħruq u ħakk
English: - Gall bladder disease - Various skin disorders: o discoloration of the skin especially of the face or neck known as “pregnancy patches (chloasma) o painful reddish skin nodules (erythema nodosum) o rash with target-shaped reddening or sores (erythema multiforme)
Maltese: o noduli tal-ġilda ħamranija b'uġigħ (erythema nodosum) o raxx bi ħmura jew feriti f'forma ta' ċirku fil-mira (erythema multiforme)
English: 05 March 2014
Maltese: 5 ta' Marzu 2014
English: EMA/793605/2013
Maltese: pillola, 2.5 mg) EMA/793605/2013
English: Tibolona Aristo and Tibocina are medicines that contain the active substance tibolone; they are available as tablets (2.5 mg).
Maltese: Tibolona Aristo u Tibocina huma mediċini li fihom is-sustanza attiva tibolone; jiġu bħala pilloli (2.5 mg).
English: What are Tibolona Aristo and Tibocina?
Maltese: X'inhuma Tibolona Aristo u Tibocina?
English: Tibolona Aristo and Tibocina are generic medicines based on a ‘reference medicine', Liviella, which is authorised in Germany.
Maltese: Tibolona Aristo u Tibocina huma mediċini ġeneriċi bbażati fuq ‘mediċina ta' referenza', Liviella, li hija awtorizzata fil-Ġermanja.
English: The grounds for the referral were objections raised by Germany about the data submitted to show that Tibolona Aristo and Tibocina were ‘bioequivalent' to the reference medicine, Liviella.
Maltese: Ir-raġunijiet għar-riferiment kienu oġġezzjonijiet imqajma mill-Ġermanja dwar id-dejta sottomessa biex jintwera li Tibolona Aristo u Tibocina kienu ‘bijoekwivalenti' għall-mediċina ta' referenza, Liviella.
English: On 19 December 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicines Tibolona Aristo and Tibocina.
Maltese: Fid-19 ta' Diċembru 2013, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' ftehim bejn Stati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni tal-mediċini Tibolona Aristo u Tibocina.
English: Aristo Pharma GmbH submitted Tibolona Aristo and Tibocina to the Spanish medicines regulatory agency for a decentralised procedure.
Maltese: GmbH issottomettiet Tibolona Aristo u Tibocina lill-aġenzija regolatorja tal-mediċini ta' Spanja għal proċedura deċentralizzata.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Spain) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Belgium, Germany and the Netherlands).
Maltese: Din hija proċedura fejn Stat Membru (l-'Istat Membru ta' referenza', f'dan il-każ Spanja) jivvaluta mediċina bil-għan li jagħti awtorizzazzjoni għat-tqegħid fis-suq li ser tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħra (l-'Istati Membri kkonċernati', f'dan il-każ ilBelġju, il-Ġermanja u l-Pajjiżi l-Baxxi).
English: The company had supplied additional evidence to indicate that the study samples had been stored and maintained under adequate temperature conditions, further supported by the concentrations recorded in the bioequivalence study.
Maltese: Il-kumpanija pprovdiet evidenza addizzjonali biex tindika li l-kampjuni tal-istudju nħażnu u nżammu taħt kundizzjonijiet ta' temperatura xierqa, appoġġjati ulterjorment mill-konċentrazzjonijiet irreġistrati flistudju ta' bijoekwivalenza.
English: Tibolone is a type of hormone replacement therapy (HRT) and is used to alleviate the symptoms of the menopause (such as hot flushes) in women who have not had a natural period for at least 12 months.
Maltese: Tibolone huwa tip ta' terapija ta' sostituzzjoni tal-ormoni (HRT) u jintuża biex itaffi s-sintomi talmenopawsa (bħal fwawar) f'nisa li ma kellhomx pirjid naturali għal tal-anqas 12-il xahar.
English: However, the Member States were not able to reach an agreement and the Spanish medicines regulatory agency referred the matter to the CHMP for arbitration on 31 October 2013.
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu ftehim u l-aġenzija regolatorja tal-mediċini ta' Spanja, irriferiet il-kwistjoni lis-CHMP għal arbitraġġ fil-31 ta' Ottubru 2013.
English: Further information on Trogarzo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/trogarzo.
Maltese: ema.europa.eu/medicines/human/EPAR/trogarzoema.europa.eu/medicines/human/EPAR/tro garzo.
English: Other information about Trogarzo
Maltese: Informazzjoni oħra dwar Trogarzo
English: Trogarzo is a medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Trogarzo huwa mediċina li tintuża biex tikkura adulti infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindrome tal-immunodefiċjenza akkwiżita (AIDS).
English: Trogarzo contains the active substance ibalizumab.
Maltese: Trogarzo fih is-sustanza attiva ibaliżumab.
English: What are the risks associated with Trogarzo?
Maltese: X'inhuma r-riskji assoċjati ma' Trogarzo?
English: Trogarzo is available as a solution for infusion (drip) into a vein.
Maltese: Trogarzo jiġi bħala soluzzjoni għall-infużjoni (dripp) fil-vina.
English: Similar effects were seen in a second main study with 113 adults, where 44% of patients who had maintenance doses of Trogarzo added to standard treatment had undetectable HIV levels after 25 weeks.
Maltese: Effetti simili dehru fi studju ewlieni ieħor fuq 113-il adult, fejn 44 % tal-pazjenti li kellhom dożi ta' manteniment ta' Trogarzo miżjuda mal-kura standard kellhom livelli ta' HIV mhux traċċabbli wara 25 ġimgħa.
English: Treatment is started with a single infusion of 2,000 mg followed by 800 mg every 2 weeks; if treatment is interrupted, it should be restarted in the same way.
Maltese: Il-kura tinbeda b'infużjoni waħda ta' 2,000 mg segwita minn 800 mg kull ġimagħtejn; jekk il-kura titwaqqaf, għandha terġa' tinbeda bl-istess mod.
English: The most common side effects with Trogarzo (which may affect up to 1 in 10 patients) are rash, diarrhoea, dizziness, headache, nausea (feeling sick), vomiting and tiredness.
Maltese: L-effetti sekondarji l-aktar komuni bi Trogarzo (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma raxx, dijarea, sturdament, uġigħ ta' ras, nawżja (tħossok ma tiflaħx), remettar u għeja.
English: The active substance in Trogarzo, ibalizumab, is a monoclonal antibody (a type of protein) designed to attach to CD4, a receptor (target) found on the surface of immune cells called T cells.
Maltese: Is-sustanza attiva fi Trograzo, l-ibaliżumab, hija antikorp monoklonali (tip ta' proteina) maħsuba biex teħel ma' CD4, riċettur (fil-mira) li jinsab fil-wiċċ taċ-ċelloli immunitarji msejħa ċelloli T. Iċ-ċelloli T huma l-mira ewlenija tal-virus tal-HIV, li jużahom bħala ospitant biex jirriproduċi.
English: In a main study that included 40 adults with multi-drug resistant HIV whose HIV treatment was failing, levels of HIV virus in the blood were undetectable (fewer than 50 copies/ml) in 43% of patients after 25 weeks of combining standard treatment with Trogarzo.
Maltese: Fi studju ewlieni li inkluda 40 adult b'HIV reżistenti għal ħafna mediċini li l-kura tal-HIV tagħhom ma kinitx qed tirnexxi, il-livelli tal-virus tal-HIV fid-demm ma kinux traċċabbli (inqas minn 50 kopja/ml) fi 43 % tal-pazjenti wara 25 ġimgħa ta' kura standard ikkombinata ma' Trogarzo.
English: As for all medicines, data on the use of Trogarzo are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Trogarzo hija ssorveljata kontinwament.
English: Trogarzo taken with other HIV medicines was shown to be effective at reducing viral load (blood levels of HIV virus) in patients with multi-drug resistant HIV, that is, where standard HIV combination treatments have failed to suppress levels of HIV in the blood sufficiently.
Maltese: Intwera li Trogarzo meħud ma' mediċini oħra kontra l-HIV kien effettiv fit-tnaqqas ta' tagħbija virali (livelli tad-demm tal-virus tal-HIV) f'pazjenti b'HIV reżistenti għal ħafna mediċini, jiġifieri, fejn kuri standard ikkombinati kontra l-HIV naqsu milli jissopressaw b'mod suffiċjenti l-livelli tal-HIV fid-demm.
English: For the full list of side effects and restrictions with Trogarzo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet irrappurtati bi Trogarzo, ara l-fuljett ta' tagħrif.
English: How is Trogarzo used?
Maltese: Trogarzo?
English: The company that markets Trogarzo will carry out a study to confirm the benefits of treatment with Trogarzo in patients with multi-drug resistant HIV infection.
Maltese: Il-kura għandha tinbeda u tkun immonitorjata minn tabib li jkollu esperjenza fil-kura tal-infezzjoni tal-HIV.
English: How does Trogarzo work?
Maltese: Kif jintuża Trogarzo?
English: In patients with multi-drug resistant HIV, treatment options are limited and there is therefore an unmet medical need in this group.
Maltese: F'pazjenti b'HIV reżistenti għal ħafna mediċini, l-opzjonijiet ta' kura huma limitati u għaldaqstant hemm ħtieġa medika mhux issodisfata f'dan il-grupp.
English: Side effects reported with Trogarzo are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Trogarzo huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Trogarzo does not cure HIV-1 infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Trogarzo ma jikkurax l-infezzjoni tal-HIV-1 jew l-AIDS, iżda jista' jittardja l-ħsara li ssir lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjati mal-AIDS.
English: By attaching to CD4, ibalizumab prevents the virus from entering the T-cells and reproducing, thereby slowing down the spread of infection.
Maltese: Billi teħel ma' CD4, libaliżumab tipprevjeni lill-virus milli jidħol fiċ-ċelloli T u jirriproduċi, u b'hekk tnaqqas ir-ritmu li bih tinfirex l-infezzjoni.
English: Overall, the safety profile of Trogarzo was considered to be acceptable.
Maltese: B'mod ġenerali, il-profil tas-sigurtà ta' Trogarzo kien ikkunsidrat aċċettabbli.
English: • Orencia (abatacept).
Maltese: • Orencia (abatacet).
English: • Kineret (anakinra).
Maltese: • Kineret (anakira).
English: EU/1/99/116/001 EU/1/99/116/002 EU/1/99/116/003 EU/1/99/116/004 EU/1/99/116/005
Maltese: EU/1/99/116/001 EU/1/99/116/002 EU/1/99/116/003 EU/1/99/116/004
English: PASI 75 response**
Maltese: Rispons PASI 75**
English: Fistula Response (%) Complete fistula response (%)
Maltese: Rispons Fistula (%) Rispons fistula komplet (%)
English: Reduction in CDAI ≥ 25% and ≥ 70 points.
Maltese: Tnaqqis fis-CDAI ≥ 25% u ≥ 70 punt.
English: Adults (≥ 18 years)
Maltese: Adulti (≥ 18-il sena)
English: N/A
Maltese: N/Aa
English: The available clinical experience is limited.
Maltese: L-esperjenza klinika disponibbli hija limitata.
English: placebo infliximab placebo infliximab placebo infliximab placebo infliximab
Maltese: plaċebo infliximab plaċebo infliximab plaċebo infliximab plaċebo infliximab
English: Common: Depression, insomnia.
Maltese: Komuni: Depressjoni, insomnja.
English: (% of patients)
Maltese: (% ta' pazjenti)
English: * including bovine tuberculosis (disseminated BCG infection), see section 4.4
Maltese: * inkluż tuberkulosi bovina (infezzjoni mifruxa ta' BCG), ara sezzjoni 4.4
English: • Convulsions, nerve problems
Maltese: • Aċċessjonijiet, problemi fin-nervituri
English: • Tuberculosis
Maltese: • Tuberkulożi
English: Common: Tachycardia, palpitation.
Maltese: Komuni: Takikardija, palpitazzjoni.
English: List of allergies:
Maltese: Lista ta' allerġiji:
English: The median CDAI score was 180.
Maltese: Il-punteġġ CDAI medjan kien 180.
English: • The active substance is infliximab.
Maltese: • Is-sustanza attiva hi infliximab.
English: Combined data from ACT 1 & 2
Maltese: Dejta kollettiva minn ACT 1 u 2.
English: Table 9 Effects on ACR and PASI in IMPACT and IMPACT 2 IMPACT
Maltese: Tabella 9 Effetti fuq l-ACR u PASI f'IMPACT u IMPACT 2
English: Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands
Maltese: Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, L-Olanda
English: even if their signs of illness are the same as yours.
Maltese: Sinjali jinkludu qtugħ ta' nifs jew nefħa f'saqajk.
English: EU/1/99/116/001 1 vial 100 mg EU/1/99/116/002 2 vials 100 mg EU/1/99/116/003 3 vials 100 mg EU/1/99/116/004 4 vials 100 mg EU/1/99/116/005 5 vials 100 mg
Maltese: EU/1/99/116/001 1 kunjett 1 ta' 100 mg EU/1/99/116/002 2 kunjetti ta' 100 mg EU/1/99/116/003 3 kunjetti ta' 100 mg EU/1/99/116/004 4 kunjetti ta' 100 mg EU/1/99/116/005 5 kunjetti ta' 100 mg
English: Hepatitis B virus
Maltese: Virus tal-Epatite B
English: Overall proportions of adverse events and infusion reactions were similar between the 6 to 11 and 12 to 17 year age groups.
Maltese: Proporzjonijiet globali ta' avvenimenti avversi u reazzjonijiet għall-infużjoni kienu simili bejn il-gruppi ta' età ta' 6 sa 11 u 12 sa 17-il sena.
English: Immune system disorders Common: Allergic respiratory symptom.
Maltese: Disturbi fis-sistema immuni Komuni: Sintomu respiratorju allerġiku.
English: p = 0.030 and < 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
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: 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: Store at 2 °C - 8 °C.
Maltese: Aħżen f'temperatura ta' 2 °C - 8 °C.
English: Remicade contains sodium
Maltese: Remicade fih sodium
English: Table 7 Effects on response rate, data from ACCENT II (week-14 responders) ACCENT II (week-14 responders) Placebo Maintenance (n = 99)
Maltese: Tabella 7 Effetti fuq ir-rata ta' rispons, dejta minn ACCENT II (persuni li rrispondew sa ġimgħa 14) ACCENT II (Persuni li rrispondew sa ġimgħa 14) Manteniment bi Plaċebo (n = 99)
English: ≥ 5 x ULN
Maltese: ≥ 3 darbiet ULN ≥ 5 darbiet ULN
English: Mean ± SD
Maltese: Medja ± SD
English: • Psoriasis.
Maltese: • Psorjasi.
English: Patients with ACR20 response/ Patients evaluated (%)
Maltese: Pazjenti b'reazzjoni ACR 20 / Pazjenti evalwati (%)
English: For results see Table 6.
Maltese: Għar-riżultati ara t-Tabella 6.
English: • Feeling forgetful, irritable, confused, nervous
Maltese: • Tħossok tinsa, irritabbli, konfuż/a, nervuż/a
English: Excipients: sucrose, polysorbate 80, monobasic sodium phosphate and dibasic sodium phosphate.
Maltese: Eċċipjenti: sucrose, polysorbate 80, monobasic sodium phosphate u dibasic sodium phosphate
English: • Ulcerative colitis.
Maltese: • Kolite ulċerattiva.
English: optic neuritis and Guillain-Barré syndrome
Maltese: nevrite ottika u sindrome ta' Guillain-Barré
English: Upper respiratory tract infection (7/60 [12%]) and pharyngitis (5/60 [8%]) were the most frequently reported respiratory system infections.
Maltese: Infezzjoni fil-parti ta' fuq tal-apparat respiratorju (7/60 [12%]) u farinġite (5/60 [8%]) kienu l-aktar infezzjonijiet fis-sistema respiratorja rrappurtati b'mod frekwenti.
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%), leucopenia (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: Placebo (week 24)
Maltese: Placebo (ġimgħa 24)
English: Rare: 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: 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) ACCENT I (persuni li rrispondew ta' ġimgħa 2) % ta' Pazjenti
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: ACR response (% of patients)
Maltese: ACR rispons (% ta' pazjenti)
English: At week 54, the figures were 55.8% (29/52) and 23.5% (12/51) in the q8 weeks and q12 weeks maintenance groups, respectively (p < 0.001).
Maltese: F'ġimgħa 54, il-figuri kienu 55.8% (29/52) u 23.5% (12/51) fil-gruppi ta' manteniment tal-ġimgħat q8 u q12, rispettivament (p < 0.001).
English: Shortened infusions across adult indications
Maltese: Infużjonijiet imqassra fost l-indikazzjonijiet tal-adulti
English: AZA was given at a dose of 2.5 mg/kg daily.
Maltese: AZA ngħata f'doża ta' 2.5 mg/kg kuljum.
English: Infliximab Maintenance (5 mg/kg) (n = 96)
Maltese: Manteniment b'Infliximab (5 mg/kg) (n = 96)
English: Janssen Biotech Inc., 200 Great Valley Parkway Malvern, Pennsylvania 19355-1307, United States of America
Maltese: Great Valley Parkway Malvern, Pennsylvania 19355-1307 L-Istati Uniti talAmerika
English: Remicade is available in packs of 1, 2, 3, 4 or 5 vials.
Maltese: Remicade jiġi f'pakketti ta'1, 2, 3, 4 jew 5 kunjetti.
English: Mean baseline NAPSI scores were 4.6 and 4.3 in infliximab and placebo group.
Maltese: Punteġġi medji fillinja bażi kienu 4.6 u 4.3 fil-grupp fuq infliximab u fuq il-plaċebo.