FrancophonIA/ELRC3.0 huggingface dataset:
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted an opinion.
Maltese: Ir-reviżjoni twettqet mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli għall-mistoqsijiet dwar il-mediċini għall-użu mill-bniedem, li adotta opinjoni.
English: Dentists should use other alternative methods available for removing dental pulp.
Maltese: Id-dentisti għandhom jużaw metodi alternattivi disponibbli għat-tneħħja tal-polpa dentali.
English: On 25 April 2014, the European Medicines Agency recommended that the marketing authorisations for the dental pastes Caustinerf arsenical, Yranicid arsenical and associated names be revoked in the EU due to concerns over the risk of genotoxic effects (damage to the genetic material in cells) and cell death in tissues around the teeth.
Maltese: Fil-25 ta' April 2014, l-Aġenzija Ewropea tal-Mediċini rrakkomandat li l-awtorizazzjonijiet għat-tqegħid fis-suq għall-pejsts dentali Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati jiġu revokati fl-UE minħabba tħassib fuq ir-riskju ta' effetti ġenotossiċi (ħsara lill-materjal ġenetiku fiċ-ċelloli) u mewt ta' ċelloli fit-tessuti madwar is-snien.
English: In a review conducted by the Agency's Committee for Medicinal Products for Human Use (CHMP), analyses of data from laboratory and population studies indicate that the arsenic contained in them may pose a risk of genotoxic effects that could increase the risk of cancer.
Maltese: F'reviżjoni mwettqa mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija, analiżi ta' dejta minn studji tal-laboratorju u tal-popolazzjoni indikat li l-arseniku ta' ġo fihom jista' jkun ta' riskju ta' effetti ġenotossiċi li jistgħu jżidu r-riskju ta' kanċer.
English: They contain 3 active substances: ephedrine hydrochloride, lidocaine and arsenic trioxide (arsenous anhydride).
Maltese: Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati huma pejsts dentali li ntużaw fi proċeduri biex jitneħħew nervituri bil-ħsara fil-polpa dentali. Fihom 3 sustanzi attivi: ephedrine hydrochloride, lidocaine u arsenic trioxide (arsenous anhydride).
English: The CHMP recommendation was sent to the European Commission and on 11 July 2014 the Commission issued a legally binding decision revoking the authorisations for Caustinerf arsenical, Yranicid arsenical and associated names throughout the EU.
Maltese: Ir-rakkomandazzjoni tas-CHMP intbagħtet lill-Kumissjoni Ewropea u fil-11 ta' Lulju 2014 il-Kummissjoni ħarġet deċiżjoni li torbot legalment li tirrevoka l-awtorizzazzjonijiet għal Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati madwar l-UE.
English: The dental pastes, which contain an arsenic-based compound, arsenic trioxide, have been used to remove the damaged nerves in the dental pulp (the inside of the tooth).
Maltese: Il-pejsts dentali, li fihom kompost ibbażat fuq l-arsenju, arsenix trioxide, intużaw għat-tneħħija tan-nervituri bil-ħsara fil-polpa dentali (ġewwa tas-sinna).
English: • Caustinerf arsenical and Yranicid arsenical dental pastes will no longer be used for removing damaged nerves in teeth, because they may pose a risk of genotoxic effects (which can cause cancers) and cell death in tissues around the teeth which may be difficult to treat.
Maltese: • Pejsts dentali Caustinerf arsenical u Yranicid arsenical mhux sejrin jibqgħu jintużaw għat-tneħħija ta' nervituri bil-ħsara fis-snien, minħabba li jistgħu joħolqu riskju ta' effetti ġenotossiċi (li jistgħu jikkawżaw kanċer) u mewt ta' ċelloli fit-tessuti ta' madwar is-snien li jista' jkun diffiċli biex jiġu trattati.
English: During the review, the CHMP considered measures to minimise the risks identified with these products but concluded that restrictions and additional guidance to dentists would not reduce the risks to an acceptable level.
Maltese: Waqt ir-reviżjoni, is-CHMP ikkunsidra miżuri biex inaqqas ir-riskji identifikati b'dawn il-prodotti imma kkonkluda li restrizzjonijiet u gwida addizzjonali lid-dentisti ma jnaqqsux ir-riskji għal livell aċċettabbli.
English: 11 July 2014 EMA/431170/2014
Maltese: Awtorizzazzjonijiet ta' Caustinerf arsenical u Yranicid arsenical użati fi proċeduri dentali revokati fl-UE EMA/431170/2014
English: In addition, there have been a small number of cases where arsenic is thought to have leaked into the areas around the teeth, causing parts of the tissue to die, including bone (osteonecrosis).
Maltese: Barra minn hekk, kien hemm numru żgħir ta' każi fejn huwa maħsub li arseniku nxtered għal ġo żoni madwar is-snien, u kkawża parti mit-tessut imut, inkluż l-għadam (osteonekrożi).
English: Post-marketing surveillance of Caustinerf arsenical and Yranicid arsenical has identified a small number of cases of periodontal necrosis, including 12 cases of osteonecrosis.
Maltese: Sorveljanza ta' wara t-tqegħid fis-suq ta' Caustinerf arsenical u Yranicid arsenical identifikat numru żgħir ta' każi ta' nekrożi perjodontali, inklużi 12-il każ ta' osteonekrożi.
English: In addition, epidemiology studies have shown an association between arsenic and spontaneous abortions and stillbirths.
Maltese: Barra minn hekk, studji tal-epidemjoloġija wrew assoċjazzjoni bejn arseniku u aborti spontanji u frieħ jitwieldu mejtin.
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: Trazec is a medicine contains the active substance nateglinide.
Maltese: Trazec huwa mediċina li fiha s-sustanza attiva nateglinide.
English: It is available as pink, round (60 mg), yellow, oval (120 mg) and red, oval (180 mg) tablets.
Maltese: Jiġi bħala pilloli roża, tondi (60 mg), sofor, ovali (120 mg) u ħomor, ovali (180 mg).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TRAZEC
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEA (EPAR) TRAZEC Sommarju ta' l-EPAR għall-pubbliku
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Trazec to Novartis Europharm Limited on 3 April 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Trazec lil Novartis Europharm Limited fit-3 ta' April 2001.
English: What is the risk associated with Trazec?
Maltese: X'inhu r-riskju assoċjat ma' Trazec?
English: The maximum total daily dose is 180 mg three times a day.
Maltese: Id-doża totali massima hi ta' 180 mg tliet darbiet kuljum.
English: A total of 2,122 patients received Trazec in all trials combined.
Maltese: Fl-istudji kollha b'kollox kien hemm 2,122 pazjent li ngħataw Trazec.
English: Nateglinide, the active ingredient in Trazec, stimulates the pancreas to produce insulin more quickly.
Maltese: Nateglinide, is-sustanza attiva fi Trazec, jistimula l-frixa biex tipproduċi linsulina iktar malajr.
English: Other studies also looked at ‘switching' from an antidiabetes medicine to Trazec, and ‘adding' Trazec to other antidiabetes medicines.
Maltese: Studji oħra studjaw ukoll ‘il-qlib' minn mediċini antidijabetiċi għal Trazec, u ‘ż-żieda' ta' Trazec ma' mediċini antidijabetiċi oħra.
English: Most of the patients received treatment for up to six months: 789 received it for at least six months, and 190 received it for a year.
Maltese: Ħafna mill-pazjenti ngħataw it-trattament sa sitt xhur: 789 ħaduh għal ta' l-anqas sitt xhur, u 190 ħaduh għal sena.
English: The Committee for Medicinal products for Human Use (CHMP) decided that Trazec's benefits are greater than its risks for the treatment of type 2 diabetes, in combination with metformin, in patients who are not controlled despite receiving the maximum daily dose of metformin.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Trazec huma ikbar mir-riskji tiegħu fit-trattament tad-dijabete tat-tieni tip, flimkien ma' metformin, f'pazjenti li ma jkunux ikkontrollati minkejja li jkunu qed jingħataw id-doża massima ta' metformin.
English: The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Maltese: L-istudji kejlu l-livell ta' sustanza fiddemm magħrufa bħala emoglobina glikoċilata (HbA1c), li jagħti indikazzjoni ta' kemm kien ikkontrollat tajjeb il-glucosju fid-demm.
English: The Committee recommended that Trazec be given marketing authorisation.
Maltese: Għaliex ġie approvat Trazec?
English: The main studies compared Trazec to placebo (a dummy treatment), or to other medicines used in type 2 diabetes (metformin, glibenclamide or troglitazone).
Maltese: L-istudji ewlenin qabblu Trazec ma' plaċebo (trattament finta), jew ma' mediċini oħra użati fid-dijabete tat-tieni tip (metformin, glibenclamide jew troglitazone).
English: Other common side effects (seen in between 1 and 10 patients in 100) are abdominal (tummy) pain, diarrhoea, dyspepsia (heartburn), and nausea (feeling sick).
Maltese: Effetti sekondarji oħra li huma komuni (li dehru f'bejn pazjent wieħed u għaxra minn kull mija) jinkludu l-uġigħ ta' żaqq, id-dijarea, il-ħruq fl-istonku, u d-dardir.
English: Trazec is given within one to 30 minutes before breakfast, lunch and dinner and the dose is adjusted to give the best control.
Maltese: Trazec jingħata bejn minuta u 30 minuta qabel il-kolazzjon, l-ikla ta' nofsinhar u l-ikla ta' filgħaxija u d-doża tiġi aġġustata biex tagħti l-aqwa kontroll.
English: Trazec may in some cases cause hypoglycaemia (low blood glucose).
Maltese: Trazec f'xi każi jista' jikkawża ipogliċemija (livell baxx ta' glucosju fid-demm).
English: For the full list of all side effects reported with Trazec, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji rrappurtati bi Trazec, ara l-Fuljett ta' Tagħrif.
English: In combination with metformin, which mainly affected fasting plasma glucose (the amount of glucose in the blood when the person has not eaten anything), the effect of Trazec on HbA1c was better than either medicine alone.
Maltese: Intwera li Trazec waħdu kien iktar effettiv mill-plaċebo, iżda inqas effettiv minn xi mediċini antidijabetiċi oħra bħal metformin. Flimkien ma' metformin, li jaffettwa l-aktar il-glucosju fil-plażma meta wieħed ikun sajjem (l-ammont ta' glucosju fid-demm meta l-persuna ma tkun kielet xejn), leffett ta' Trazec fuq l-HbA1c kien aħjar minn kwalunkwe mill-mediċini weħidhom.
English: It is available as tablets (600 mg).
Maltese: Jiġi f'pilloli (600 mg).
English: The full EPAR for Efavirenz Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The active substance in Efavirenz Teva, efavirenz, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Maltese: Is-sustanza attiva f'Efavirenz Teva, l-efavirenz, hija inibitur mhux nukleosidiku tat-transkrittażi inversa (non-nucleoside reverse transcriptase inhibitor, NNRTI).
English: Efavirenz Teva is an antiviral medicine.
Maltese: Efavirenz Teva huwa mediċina antivirali.
English: It is used together with other antiviral medicines to treat adults and children aged three years or older infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Jintuża flimkien ma' mediċini antivirali oħra fit-trattament ta' adulti u tfal ta' tliet snin jew aktar infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu tal-immunodefiċjenza akkwiżita (AIDS).
English: EPAR summary for the public efavirenz
Maltese: Sommarju tal-EPAR għall-pubbliku efavirenz
English: Efavirenz Teva is a ‘generic medicine'.
Maltese: Efavirenz Teva huwa ‘mediċina ġenerika'.
English: This is a summary of the European public assessment report (EPAR) for Efavirenz Teva.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Efavirenz Teva.
English: The recommended dose of Efavirenz Teva for adults is 600 mg once a day.
Maltese: Id-doża rakkomandata ta' Efavirenz Teva għall-adulti hija 600 mg darba kuljum.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Efavirenz Teva on 9 January 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Efavirenz Teva fil-09 ta' Jannar 2012.
English: This means that Efavirenz Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Sustiva.
Maltese: Dan ifisser li Efavirenz Teva huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Sustiva.
English: What is Efavirenz Teva?
Maltese: Kif tintuża Efavirenz Teva?
English: Why has Efavirenz Teva been approved?
Maltese: Għaliex ġie approvat Efavirenz Teva?
English: Efavirenz Teva is a medicine that contains the active substance efavirenz.
Maltese: Efavirenz Teva huwa mediċina li fiha s-sustanza attiva efavirenz.
English: The CHMP concluded that, in accordance with EU requirements, Efavirenz Teva has been shown to have comparable quality and to be bioequivalent to Sustiva.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Efavirenz Teva għandu kwalità li tixbah lillprodott bijoekwivalenti Sustiva.
English: Because Efavirenz Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Sustiva.
Maltese: Peress li Efavirenz Teva huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testitjiet biex jiġi stabbilit jekk din il-mediċina hijiex bijoekwivalenti għall-mediċina ta' referenza, Sustiva.
English: It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses.
Maltese: Hija timblokka l-attività tat-transkrittażi inversa, enzima prodotta mill-HIV li tħallih jinfetta ċ-ċelloli fil-ġisem u jirriproduċi aktar viruses.
English: It is recommended that Efavirenz Teva be taken on an empty stomach and without food, preferably at bedtime.
Maltese: Huwa rakkomandat li Efavirenz Teva jittieħed fuq stonku vojt u mingħajr ikel, preferibbilment qabel il-ħin tal-irqad.
English: By blocking this enzyme, Efavirenz Teva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Billi jimblokka din l-enzima, Efavirenz Teva, meħud flimkien ma' mediċini antivirali oħra, inaqqas l-ammont ta' HIV fiddemm u jżommu f'livell baxx.
English: Because Efavirenz Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Efavirenz Teva huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji tiegħu huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Efavirenz Teva does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Efavirenz Teva ma jfejjaqx infezzjoni mill-HIV jew tal-AIDS, iżda jista' jittardja l-ħsara lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: The dose of Efavirenz Teva needs to be reduced in patients taking voriconazole (used to treat fungal infections).
Maltese: F'pazjenti ttrattati b'voriconazole (użat għat-trattament ta' infezzjonijiet fungali), jeħtieġ li titnaqqas id-doża ta' Efaverinz Teva.
English: How does Efavirenz Teva work?
Maltese: Għal xiex tintuża Efavirenz Teva?
English: Dose (mL)
Maltese: Doża (mL)
English: PURSUIT-Maintenance
Maltese: PURSUIT-Manteniment
English: ACR 70 Week 14 4% 14% p = 0.008
Maltese: ACR 70 Ġimgħa 14 4% 14% p = 0.008
English: Figure 5a
Maltese: Figura 5a
English: 105 to < 115 0.15 0.2 0.25 0.25 115 to < 125 0.2
Maltese: 105 sa < 115 0.15 0.2 0.25 0.25 115 sa < 125 0.2
English: 95 to < 105 0.15 0.2
Maltese: 95 sa < 105 0.15 0.2
English: Placebo N = 251
Maltese: Plaċebo N = 251
English: Figure 5b
Maltese: Figura 5b
English: Week 24 28% 60%*
Maltese: Ġimgħa 24 28% 60%*
English: Rare: Raynaud's phenomenon
Maltese: Fenomenu ta' Raynaud
English: Table 7 Key efficacy outcomes from PURSUIT - Induction and PURSUIT - Maintenance PURSUIT-Induction
Maltese: Tabella 7 Riżultati ewlenin tal-effikaċja minn PURSUIT - Induzzjoni u PURSUIT - Manteniment PURSUIT-Induzzjoni
English: Defined as a Mayo score ≤ 2 points, with no individual subscore > 1
Maltese: Definit bħala punteġġ Mayo ta' ≤ 2 punti, bl-ebda sottopunteġġ individwali > 1
English: Rheumatoid arthritis (RA)
Maltese: Artrite rewmatojde (RA)
English: Moderate or severe heart failure (NYHA class III/IV) (see section 4.4).
Maltese: Insuffiċjenza moderata jew severa tal-qalb (NYHA klassi III/IV) (ara sezzjoni 4.4).
English: • Store in a refrigerator (2°C-8°C).
Maltese: • Aħżen fi friġġ (2°C-8°C).
English: Hepatitis B virus (HBV)
Maltese: Vajrus tal-epatite B (HBV)
English: • Bronchitis
Maltese: • Bronkite
English: Ulcerative colitis (UC)
Maltese: Kolite ulċerattiva (UC - ulcerative colitis)
English: Psoriatic arthritis (PsA)
Maltese: Artrite psorijatika (PsA)
English: Week 14 33% 55%*
Maltese: Ġimgħa 14 33% 55%*
English: CHAQ: Child Health Assessment Questionaire ESR (mm/h): erythrocyte sedimentation rate (millimetres per hour)
Maltese: ESR - erythrocyte sedimentation rate (millimetres per hour):
English: Patient's Name: _____________________ Doctor's Name: _____________________ Doctor's Phone: _____________________
Maltese: Isem tat-Tabib: _____________________ Telefon tat-Tabib: _____________________
English: • Vision disturbances
Maltese: • Disturbi tal-vista
English: 16% 31% p = 0.002 49% 62% Week 52 NA NA NA
Maltese: 16% 31% p = 0.002 49% 62% Ġimgħa 52 NA NA NA
English: • nervous system disease such as multiple sclerosis (rare).
Maltese: • mard tas-sistema nervuża bħal sklerożi multipla (rari).
English: For administration instructions, see section 6.6.
Maltese: Għall-istruzzjonijiet dwar l-għoti, ara sezzjoni 6.6.
English: 70 to < 75 0.15 0.15 0.2 75 to < 85 0.15 0.15 0.2 85 to < 95 0.15 0.2
Maltese: 15 0.2 75 sa < 85 0.15 0.15 0.2 85 sa < 95 0.15 0.2
English: Placebo N = 154
Maltese: Plaċebo N = 154
English: Injecting without pinching the skin is recommended (Figure 5a).
Maltese: Huwa rrakkomanadat li tinjetta mingħajr ma toqros il-ġilda (Figura 5a).
English: Week 24 5% 20%*
Maltese: Ġimgħa 24 5% 20%*
English: Responders, % of patients ASAS 20
Maltese: Dawk li Rrispondew, % ta' pazjenti ASAS 20
English: c 0-10 cm)
Maltese: c 0-10 ċm)
English: Patients with each sub-type of psoriatic arthritis were enrolled, including polyarticular arthritis with no rheumatoid nodules (43%), asymmetric peripheral arthritis (30%), distal interphalangeal (DIP) joint arthritis (15%), spondylitis with peripheral arthritis (11%), and arthritis mutilans (1%).
Maltese: Pazjenti b'kull tip ta' sotto-grupp ta' artrite psorijatika kienu rreġistrati, inkluż artrite poliartikulari mingħajr noduli rewmatiċi (43%), artrite periferali asimettrika (30%), artrite tal-ġogi interfalanġali distali (DIP) (15%), spondylitis b'artrite periferali (11%), u artrite mutilans (1%).
English: 175 to < 180
Maltese: 175 sa < 180
English: 2% 9% p = 0.009 16% 24% Week 52 NA NA NA
Maltese: 2% 9% p = 0.009 16% 24% Ġimgħa 52 NA NA NA
English: Simponi contains sorbitol (E420).
Maltese: Simponi fih sorbitol (E420).
English: Inject Simponi
Maltese: Injetta Simponi
English: The systemic clearance of golimumab was estimated to be 6.9  2.0 mL/day/kg.
Maltese: It-tneħħija sistemika ta' golimumab kienet stmata li hija 6.9  2.0 mL/kuljum/kg.
English: Simponi, in combination with methotrexate (MTX), is indicated for:
Maltese: Simponi, flimkien ma' methotrexate (MTX), huwa indikat għall:
English: • Melanoma (a type of skin cancer)
Maltese: • Melanoma (tip ta' kanċer tal-ġilda)
English: At week 14, 28% of these patients achieved response defined by partial Mayo score (decreased by ≥ 3 points compared with start of induction).
Maltese: F'ġimgħa 14, 28% ta' dawn ilpazjenti kisbu rispons iddefinit permezz tal-punteġġ parzjali ta' Mayo (tnaqqas bi ≥ 3 punti meta mqabbel mal-bidu tal-induzzjoni).
English: GO-FORWARD Active RA despite MTX
Maltese: GO-FORWARD RA attiva minkejja MTX
English: Statistically significant responses in BASDAI 50, 70 and 90 (p ≤ 0.017) were also seen at weeks 14 and 24.
Maltese: Rispons statistikament sinifikanti f'BASDAI 50, 70 u 90 (p ≤ 0.017) deher wkoll f'ġimgħat 14 u 24.
English: Week 24 14% 37%* Week 52 NA NA NA
Maltese: Ġimgħa 24 14% 37%* Ġimgħa 52 NA NA NA
English: Table 1 Tabulated list of ARs
Maltese: Tabella 1 Lista tal-ARs f'Tabella
English: Date of first authorisation: 1 October 2009 Date of latest renewal: 19 June 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 1 t'Ottubru 2009 Data tal-aħħar tiġdid: 19 ta' Ġunju 2014
English: Each 0.05 mL medicine contains 2.05 mg sorbitol (E420).
Maltese: Kull 0.05 mL ta' mediċina fih 2.05 mg ta' sorbitol (E420).
English: Check expiry date (see figure 2)
Maltese: Iċċekkja d-data ta' skadenza (ara figura 2)
English: • signs of immune system disorders called: lupus (rare).
Maltese: • sinjali ta' disturbi fis-sistema immuni msejħa: lupus (rari).
English: At week 16, 87% of children were ACR Ped 30 responders, and 79%, 66%, and 36% of children were ACR Ped 50, ACR Ped 70, and ACR Ped 90 responders, respectively.
Maltese: F'ġimgħa 16, 87% tat-tfal kellhom rispons ACR Ped 30, u 79%, 66%, u 36% tat-tfal kellhom rispons ACR Ped 50, ACR Ped 70, u ACR Ped 90, rispettivament.
English: Marketing Authorisation Holder and Manufacturer Janssen Biologics B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Janssen Biologics B.V.
English: All treated population (AT)
Maltese: Popolazzjoni ttrattata kollha (AT)
English: Active tuberculosis (TB) or other severe infections such as sepsis, and opportunistic infections (see section 4.4).
Maltese: Tuberkulożi attiva (TB) u infezzjonijiet oħra severi bħal sepsi, u infezzjonijiet opportunistiċi (ara sezzjoni 4.4).
English: 1 mL contains 100 mg golimumab.
Maltese: 1 mL fih 100 mg golimumab.
English: Figure 8
Maltese: Figura 8
English: N = number of patients ** p ≤ 0.001 * p ≤ 0.01 defined as a decrease from baseline in the Mayo score by ≥ 30% and ≥ 3 points, accompanied by a decrease in the rectal bleeding subscore of ≥ 1 or a rectal bleeding subscore of 0 or 1.
Maltese: N = numru ta' pazjenti ** p ≤ 0.001 * p ≤ 0.01 definit bħala tnaqqis mil-linja bażi fil-punteġġ Mayo b'≥ 30% u ≥ 3 punti, flimkien ma' tnaqqis fis-sottopunteġġ ta' fsada mir-rektum ta' ≥ 1 jew sottopunteġġ ta' fsada mir-rektum ta' 0 jew 1.
English: Table 2 Key efficacy outcomes from the controlled portions of GO-FORWARD, GO-AFTER and GO-BEFORE.
Maltese: Tabella 2 Riżultati ewlenin tal-effikaċja minn porzjonijiet ikkontrollati ta' GO-FORWARD, GO-AFTER u GO-BEFORE.
English: Do not use Simponi:
Maltese: Tużax Simponi:
English: Congestive heart failure (CHF)
Maltese: Insuffiċjenza konġestiva tal-qalb (CHF)
English: Statistically significant responses in DAS28 were also observed at weeks 14 and 24 (p < 0.05).
Maltese: Risponsi sinifikanti b'mod statistiku f'DAS28 kienu wkoll osservati fil-ġimgħat 14 u 24 (p < 0.05).
English: Similar ACR 20 responses at week 14 were observed in patients with polyarticular arthritis with no rheumatoid nodules and asymmetric peripheral arthritis PsA subtypes.
Maltese: Risponsi simili ta' ACR 20 f'ġimgħa 14 ġew osservati f'pazjenti b'artrite poliartikulari mingħajr noduli rewmatiċi u sottogruppi ta' artrite PsA asimettrika periferali.