FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Actelsar HCT 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: Minħabba li Actelsar HCT huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The Committee recommended that Actelsar HCT be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Actelsar HCT ikun approvat għall-użu fl-UE.
English: How is Actelsar HCT used?
Maltese: Kif jaħdem Actelsar HCT?
English: Further information on Humira can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/humira.
Maltese: ema.europa.eu/medicines/human/EPAR/humira .
English: Other information about Humira
Maltese: Informazzjoni oħra dwar Humira
English: Humira contains the active substance adalimumab.
Maltese: Humira fih is-sustanza attiva adalimumab.
English: Humira received a marketing authorisation valid throughout the EU on 8 September 2003.
Maltese: Humira rċeviet l-awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-8 ta' Settembru 2003.
English: • In non-infectious uveitis, Humira was found effective in 3 studies.
Maltese: • F'uvejtite mhux infettiva, Humira nstab li kien effettiv fi 3 studji.
English: • In hidradenitis suppurativa, 59% of patients receiving Humira in one main study and 42% of patients in another achieved at least a 50% reduction in abscesses and nodules after 12 weeks, without any increase in abscess count or fistulas.
Maltese: • Fl-idradenite suppurativa, 59% tal-pazjenti li ngħataw Humira fi studju ewlieni u 42% tal-pazjenti fi studju ieħor kisbu minn tal-inqas 50% tnaqqis fl-axxessi u n-noduli wara 12-il ġimgħa, mingħajr ebda żieda fl-għadd ta' axxessi jew fistuli.
English: Some rare but serious side effects have been reported, including serious infections.
Maltese: Xi effetti sekondarji serji, iżda rari, ġew irrapportati, inklużi infezzjonijiet serji.
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).
Maltese: Effetti sekondarji serji u rari oħra (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10,00) jinkludu nuqqas tal-mudullun milli jipproduċi ċelloli tad-demm, disturb tan-nervituri, lupus u kundizzjonijiet simili għal-lupus (meta s-sistema immunitarja tattakka t-tessuti tal-pazjent innifsu, u b'hekk tikkawża infjammazzjoni u ħsara fl-organi), u s-sindrome ta' Stevens-Johnson (reazzjoni li tista' tikkaġuna lmewt b'sintomi bħal tal-influwenza u raxx li jweġġa' li jaffettwa l-ġilda, il-ħalq, l-għajnejn u l-partijiet ġenitali).
English: • Humira also produced a greater improvement in symptoms than placebo in studies of psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis without evidence in the X-ray of ankylosing spondylitis but with clear signs of inflammation, and induction and maintenance phases of treatment for Crohn's disease, psoriasis and ulcerative colitis.
Maltese: • Humira wera wkoll aktar titjib fis-sintomi mill-plaċebo fl-istudji tal-artrite psorjatika, l-ispondilite ankilosanti, l-ispondiloartrite aksjali mingħajr evidenza fir-raġġi X tal-ispondilite ankilosanti iżda b'sinjali oġġettivi ta' infjammazzjoni, u fażijiet ta' induzzjoni u manteniment tal-kura fil-marda ta' Crohn, fil-psorijażi u l-kolite ulċerattiva.
English: In the third study in children aged 2 to 18 years with non-infectious anterior uveitis, in whom methotrexate alone did not work, treatment failed in about 60% of patients receiving placebo with methotrexate compared with about 27% of patients given Humira with methotrexate.
Maltese: Fit-tielet studju fi tfal ta' bejn is-2 u t-18-il sena li jbatu mill-uveitite anterjuri mhux infettiva, li fihom il-metotressat biss ma ħadimx, il-kura ma ħadmitx f'60% tal-pazjenti li ngħataw il-plaċebo b'metotressat meta mqabbel ma' 27% tal-pazjenti li ngħataw Humira bil-metotressat.
English: More than twenty main studies involving over 9,500 patients have looked at the effects of Humira in reducing symptoms of inflammatory conditions.
Maltese: Aktar minn għoxrin studju ewlieni li fihom ħadu sehem 'il fuq minn 9,500 pazjent ħarsu lejn l-effetti ta' Humira fit-tnaqqis tas-sintomi tal-kundizzjonijiet infjammatorji.
English: The proportions of patients taking placebo who achieved this goal were 28% in the first study and 26% in the second.
Maltese: Il-proporzjonijiet ta' pazjenti li ħadu l-plaċebo li kisbu dan l-għan kienu 28% fl-ewwel studju u 26% fit-tieni.
English: • In polyarticular juvenile idiopathic arthritis, around 40% of patients aged between 4 and 17 years receiving Humira, either alone or in combination with methotrexate, had a flare-up of arthritis, compared with around 69% of those receiving placebo.
Maltese: • Għall-artrite idjopatika ġuvenili poliartikulari, madwar 40% tal-pazjenti ta' bejn l-erba' snin u s-17il sena li rċevew Humira, waħdu jew flimkien mal-metotressat, kellhom taħrix tal-artrite, meta mqabbla ma' madwar 69% ta' dawk li rċevew plaċebo.
English: The active substance in Humira, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Maltese: Is-sustanza attiva f'Humira, l-adalimumab, hija antikorp monoklonali (tip ta' proteina) li tfassal biex jagħraf u jeħel ma' sustanza fil-ġisem imsejħa fattur ta' nekrożi tumorali (TNF).
English: Fewer patients receiving Humira with methotrexate developed antibodies against Humira (which can reduce its effects), so the results found that the use of Humira with methotrexate was more effective than Humira used alone.
Maltese: Filpazjenti li ma kinux ħadu metotressat fil-passat, il-kombinazzjoni ta' Humira u metotressat kienet ukoll aktar effettiva minn metotressat waħdu.
English: Humira is given as an injection under the skin, usually every 2 weeks.
Maltese: Humira jingħata bħala injezzjoni taħt il-ġilda, normalment kull ġimagħtejn.
English: • In rheumatoid arthritis, the greatest reductions in symptoms were seen in the studies on Humira as an add-on to methotrexate: around two-thirds of the patients adding Humira had at least a 20% reduction in symptoms after six months, compared with a quarter of those adding placebo.
Maltese: • F'artrite rewmatojde, l-akbar tnaqqis fis-sintomi ntwera fi studji li eżaminaw lil Humira bħala żieda ma' metotressat: madwar żewġ terzi tal-pazjenti li żiedu Humira kellhom minn tal-inqas 20% tnaqqis fis-sintomi wara sitt xhur, meta mqabbla ma' kwart ta' dawk li żiedu plaċebo.
English: • axial spondyloarthritis (inflammation of spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation
Maltese: • spondiloartrite aksjali (infjammazzjoni tas-sinsla li tikkawża wġigħ fid-dahar), inkluż spondilite ankilosanti u fejn ma jkun hemm l-ebda ħsara fuq ir-raġġi X iżda jkun hemm sinjali ċari ta'
English: In this study, treatment failure occurred in about 55% of patients receiving placebo compared with 39% receiving Humira.
Maltese: F'dan l-istudju, il-kura ma rnexxietx f'madwar 55% tal-pazjenti li kienu qed jirċievu l-plaċebo meta mqabbla ma' madwar 39% li ngħataw Humira.
English: What are the risks associated with Humira?
Maltese: X'inhuma r-riskji assoċjati ma' Humira?
English: • In studies in adults and children with plaque psoriasis, including psoriasis of the nail, a higher proportion of patients receiving Humira had improvements in symptoms compared with patients receiving methotrexate or placebo (a dummy treatment).
Maltese: • Fl-istudji fl-adulti u t-tfal bi psorijażi bil-qoxra, inkluża l-psorjażi tad-dwiefer, proporzjon akbar ta' pazjenti li rċevew Humira kellhom titjib fis-sintomi meta mqabbla mal-pazjenti li rċevew metotressat jew plaċebo (kura finta).
English: How does Humira work?
Maltese: Kif jaħdem Humira?
English: The studies included adult patients for the most part, but included children in studies for Crohn's disease, plaque psoriasis, polyarticular juvenile idiopathic arthritis, non-infectious anterior uveitis and enthesitis-related arthritis.
Maltese: L-istudji inkludew fil-biċċa l-kbira pazjenti adulti, iżda inkludew tfal fl-istudji għall-marda ta' Crohn, għall-psorijażi bil-qoxra, għall-artrite idjopatika ġuvenili poliartikulari u għall-artrite relatata ma' entesite.
English: • psoriatic arthritis (red, scaly patches on the skin with inflammation of the joints)
Maltese: • artrite psorjatika (rqajja' ħomor, bil-qoxra fuq il-ġilda u infjammazzjoni tal-ġogi).
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Maltese: Meta teħel mat-TNF, l-adalimumab timblokka l-attività tiegħu, għaldaqstant inaqqas linfjammazzjoni u sintomi oħra tal-mard.
English: Humira must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Maltese: Humira ma għandux jintuża f'pazjenti b'tuberkolożi attiva jew infezzjonijiet gravi oħra, jew f'pazjenti b'insuffiċjenza kardijaka moderata sa gravi (il-qalb ma tkunx kapaċi tippompja biżżejjed demm madwar il-ġisem).
English: In this study treatment failed in about 79% of patients receiving placebo compared with about 55% given Humira.
Maltese: F'dan l-istudju l-kura ma rnexxietx f'madwar 79% tal-pazjenti li kienu qed jirċievu l-plaċebo meta mqabbla ma' madwar 55% li ngħataw Humira.
English: The most common side effects with Humira (which may affect more than 1 in 10 people) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Humira (li jistgħu jaffettwaw 'aktar minn persuna 1 minn kull 10) huma infezzjonijiet (inklużi dawk fl-imnieħer u fil-griżmejn u fis-sinus), reazzjonijiet fis-sit tal-injezzjoni (ħmura, ħakk, dmija, uġigħ jew nefħa), uġigħ ta' ras u wġigħ fil-muskoli u fl-għadam.
English: Side effects reported with Humira are carefully evaluated and any necessary action taken to protect patients.
Maltese: Leffetti sekondarji rrapportati b'Humira huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Humira (adalimumab)
Maltese: materja) u ċikatriċi fuq il-ġilda
English: Humira and other medicines of its class may also affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using Humira.
Maltese: Humira u mediċini oħra tal-klassi tiegħu jista' wkoll jaffettwaw l-abbiltà tas-sistema immunitarja li tiġġieled l-infezzjonijiet u l-kanċer, u kien hemm xi każijiet ta' infezzjonijiet serji u kanċers tad-demm f'pazjenti li użaw Humira.
English: As for all medicines, data on the use of Humira are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha l-oħra, id-data dwar l-użu ta' Humira hija ssorveljata kontinwament.
English: D-13353 Berlin postal address:
Maltese: 13353 Berlin postal address:
English: Pharmaceutical form
Maltese: QUIMICA FARMACEUTICA
English: 555,6 Ph.Eur.u.
Maltese: 555,6 j. Ph.Eur.
English: 1111,1 Ph.Eur.u.
Maltese: 1111,1 j. Ph.Eur.
English: BAYER SANTE - 220, avenue de la recherche - 59120 LOOS
Maltese: 220, avenue de la recherche 59120 LOOS
English: Berkshire RG14 1JA United Kingdom trading as Bayer Plc, Pharmaceutical division
Maltese: Berkshire RG14 1JA Ir-Renju Unit trading as Bayer Plc, Pharmaceutical Division
English: Bayer Healthcare AG Kaiser-Wilhelm-Allee, Bldg. E39
Maltese: Bayer Healthcare AG Kaiser-Wilhelm-Allee, Bldg.
English: 51368 Leverkusen, Germany
Maltese: 51368 Leverkusen
English: Trasylol 500 000 KIE
Maltese: Trasylol 500 000
English: Av. Baix Llobregat, 3-5 08970 Sant Joan Despi Barcelona - España
Maltese: Baix Llobregat, 3-5 Sant Joan Despi 08970 BARCELONA
English: LU - Luxembourg Bayer S.A. 14, J.E.
Maltese: LU - Il-Lussemburgu Bayer S.A. 14, J.E.
English: Trasylol 500.000, oplossing voor infusie 10.000 KIE/ml
Maltese: Trasylol 500.000, oplossing voor infusie 10.000
English: Trasylol 10.000 KIE/mlInfusionsflasche
Maltese: KIE/mlInfusionsflasche
English: 1103 Budapest, Hungary
Maltese: HU-1103 Budapest L-Ungerija
English: Quinta do Pinheiro 5 2794-003 Carnaxide Portugal
Maltese: Bayer Portugal, S.A. Rua Quinta do Pinheiro 5 2794-003 Carnaxide Il-Portugall
English: Gedeon Richter Ltd. Gyomroi ut 19-21 Budapest HU-1103 Hungary
Maltese: Richter Gedeon Nyrt. Gyömrői út 19-21. 1103 Budapest L-Ungerija
English: Belgium
Maltese: Spanja
English: Bayer Austria GmbH Herbststraße 6-10 A-1160 Wien Austria
Maltese: Bayer Austria GmbH Herbststraße 6-10
English: Berkshire RG14 1JA UK
Maltese: Berkshire RG14 1JA Ir-Renju Unit
English: Bayer Portugal, S.A.
Maltese: BAYER, S.L.
English: Bayer Vital GmbH D-51373 Leverkusen
Maltese: DE - Il-Ġermanja Bayer Vital GmbH 51368 Leverkusen
English: Bayer Pharma Aktiengesellschaft registered business address: Müllerstr.
Maltese: DE - Il-Ġermanja Bayer Pharma Aktiengesellschaft registered business address:
English: Richter Gedeon Nyrt.
Maltese: Gedeon Richter Ltd.
English: Bayer House Strawberry Hill Newbury
Maltese: Strawberry Hill
English: Bayer Hellas AG 18 - 20 , Sorou Str.
Maltese: Bayer Hellas AG 18 - 20 , Sorou Str. 151 25 , Marousi Athens
English: Nordic Pharma Limited, Abbey House, 1650 Arlington Business Park, Theale, Reading, Berkshire RG7 4SA, UK
Maltese: 1650 Arlington Business Park Theale, Reading
English: Aprotinin 10,000 KIU/ml Injection
Maltese: KIU/ml Injection
English: SL - Slovenia
Maltese: SI - Is-Slovenja
English: H-1475 Hungary
Maltese: Pf. 27., H-1475
English: Bayer Pharma AG Berlin, D-13342 Germany
Maltese: Bayer Pharma AG 13342 Berlin Il-Ġermanja
English: Route of administration
Maltese: Energieweg 1
English: 1000000 U.I.C/100 ml
Maltese: Trasylol 1.000.000 UIC 1000000 U.I.C / 100 ml
English: Bayer HealthCare AG, 51368 Leverkusen, Germany solution for injection/infusion intravenous use
Maltese: Bayer HealthCare AG 51368 Leverkusen
English: 2000000 U.I.C/200 ml
Maltese: Trasylol 2.000.000 UIC 2000000 U.I.C / 200 ml
English: 10.000 KIE/ml
Maltese: KIE 10 ku/ml
English: Richter Gedeon Nyrt., Budapest Pf. 27.,
Maltese: SK - Is-Slovakkja Richter Gedeon Nyrt Budapest 10
English: Bayer d.o.o., Bravničarjeva 13, Ljubljana, Slovenia solution for injection and infusion intravenous use
Maltese: Bravničarjeva 13 Ljubljana Is-Slovenja
English: 500 000 UIK/50 mL
Maltese: 500 000 UIK / 50 mL Soluzzjoni għallinjezzjoni
English: Bayer Schering Pharma AG, Müllerstrasse 170-178, DE13342 Berlin, Germany
Maltese: DK - Id-Danimarka Bayer Schering Pharma AG Müllerstrasse 170-178
English: DK - Denmark
Maltese: NL - L-Olanda
English: 20 mg Capsule, hard
Maltese: 20 mg Kapsula, iebsa
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Maltese: Numru MA (UE) Isem (ivvintat) Qawwa Forma Farmaċewtika Rotta talAmministrazzjoni
English: Oral use bottle (HDPE)
Maltese: Għall-użu għal ħalq flixkun (HDPE)
English: 19 December 2013
Maltese: 19 ta' Novembru 2013
English: 23 October 2013
Maltese: 23 ta' Ottubru 2013
English: Implementation of the agreement by the Member States (submission of the variation by the Marketing Authorisation Holder(s) as applicable):
Maltese: Implimentazzjoni tal-ftehim mill-Istati Membri (preżentazzjoni tal-varjazzjoni mid-Detentur(i) tal-Awtorizzazzjoni għat-Tqegħid fis-Suq kif applikabbli):
English: Transmission to National Competent Authorities of the translations of the annexes to the agreement: 19 November 2013
Maltese: Trażmissjoni lill-Awtoritajiet Nazzjonali Kompetenti tat-traduzzjonijiet tal-Annessi għallFtehim:
English: Tomas Salmonson (Sweden)
Maltese: Tomas Salmonson (is-Svezja)
English: EMA/595578/2010 rev.1 EMEA/H/A-30/1154
Maltese: Rev.1 EMEA/H/A-30/1154
English: Company responses provided on: 29 March 2010, 17 June 2010 Opinion date:
Maltese: 29 ta' Marzu 2010, 17 ta' Ġunju 2010
English: Lipitor is also available in the EU under other trade names: Atorvastatin, Atorvastatina Nostrum, Atorvastatina Parke-Davis, Atorvastatina Pharmacia, Cardyl, Edovin, Liprimar, Orbeos, Prevencor, Sortis, Tahor, Texzor, Torvast, Totalip, Xarator and Zarator.
Maltese: Lipitor huwa disponibbli wkoll fl-UE taħt ismijiet kummerċjali oħra : Atorvastatin, Atorvastatina Nostrum, Atorvastatina Parke-Davis, Atorvastatina Pharmacia, Cardyl, Edovin, Liprimar, Orbeos, Prevencor, Sortis, Tahor, Texzor, Torvast, Totalip, Xarator u Zarator.
English: What is Lipitor?
Maltese: X'inhu Lipitor?
English: The maximum dose is 80 mg once a day.
Maltese: Id-doża massima hija ta' 80 mg darba kuljum .
English: Lipitor was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Lipitor kien identifikat li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni dwar il-Proċeduri Reċiproki u Deċentralizzati - Umani (CMD(h)).
English: The European Medicines Agency has completed a review of Lipitor.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni ta' Lipitor.
English: ‘Lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDLcholesterol (LDL-C), apolipoprotein B, and triglycerides in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Maltese: ‘Lipitor huwa indikat bħala żieda mad-dieta biex inaqqas il-kolesterol totali elevat (total-C), kolesterol tat-tip LDL (LDL-C), apolipoprotein B, u trigliċeridi f'pazjenti b'iperkolesterolimja primarja inkluż iperkolesterolimja familjali (varjant eterozigote) jew iperlipidimja kkombinata (mħallta)
English: Lipitor is authorised in the EU via national procedures.
Maltese: Lipitor huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: The CHMP harmonised the wording for lowering blood lipids as follows:
Maltese: L-oqsma armonizzati jinkludu :
English: The usual starting dose is 10 mg once a day.
Maltese: Id-doża normali tal-bidu hija ta' 10 mg darba kuljum.
English: On 15 December 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Lipitor in the EU.
Maltese: Fil-15 ta' Diċembru 2009, il-Kummissjoni Ewropea rriferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Lipitor fl-UE.
English: Why was Lipitor reviewed?
Maltese: Għaliex ġie rivedut Lipitor?
English: Lipitor is used together with diet to lower lipids (fats) known as cholesterol and triglycerides in the blood in patients with various types of hypercholesterolaemia (high blood cholesterol levels).
Maltese: Lipitor jintuża flimkien mad-dieta biex inaqqas il-lipidi (xaħmijiet) magħrufa bħala kolesterol u trigliċeridi fid-demm f'pazjenti b'diversi tipi ta' iperkolesterolimja (livelli għoljin ta' kolesterol fid-demm).
English: The CHMP agreed on the following wording for the prevention of cardiovascular events: ‘Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors'.
Maltese: Is-CHMP qabel fuq it-test li ġej għall-prevenzjoni ta' avvenimenti kardjovaskulari: ‘Il-prevenzjoni ta' avvenimenti kardjovaskulari f'pazjenti stmati li qegħdin f'riskju għoli għall-ewwel avveniment kardjovaskulari, bħala żieda għall-korrezzjoni ta' fatturi oħra ta' riskju'.
English: Lipitor is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.'
Maltese: Lipitor huwa indikat ukoll biex inaqqas it-total-C u LDL-C f'pazjenti b'iperkolesterolimja omozigotika familjali bħala żieda ma' kura oħra li tbaxxi l-lipidi (eż. aferesi ta' LDL) jew jekk kura bħal din ma tkunx disponibbli.'
English: The CHMP also harmonised wording for other sections of the SmPC including sections on special warnings, interaction with other medicinal products, precautions for use, pregnancy and lactation, and adverse effects.
Maltese: Is-CHMP armonizza wkoll it-test għal sezzjonijiet oħra tal-SmPC inkluż sezzjonijiet dwar twissijiet speċjali, interazzjoni ma' prodotti mediċinali oħra, prekawzjonijiet għall-użu, tqala u treddigħ, u avvenimenti avversi.
English: Tacrolimus is not compatible with PVC (polyvinylchloride).
Maltese: Tacrolimus mhux kompatibbli mal-PVC (polyvinylchloride).
English: Printing ink (Opacode S-1-15083): Shellac
Maltese: Linka stampata (Opacode S-1-15083):
English: Biocodex UABTel.
Maltese: Biocodex UAB
English: Date of first authorisation: 23 April 2007 Date of latest renewal: 13 April 2012
Maltese: Data tal-aħħar tiġdid: 13 ta' April 2012
English: - Herbal preparations containing St. John's Wort (Hypericum perforatum) or extracts of Schisandra sphenanthera.
Maltese: John's wort (Hypericum perforatum) jew estratti ta' Schisandra sphenanthera
English: Capsule content: Hypromellose, ethylcellulose, lactose, magnesium stearate.
Maltese: X'fiha l-kapsula: hypromellose, ethylcellulose, lactose, magnesium stearate.
English: The treatment difference (AdvagrafPrograf) was 3.8% (95% confidence interval [-2.1%, 9.6%]).
Maltese: Id-differenza fit-trattament (Advagraf-Prograf) kien 3.8% (95% intervall ta' fiduċja [-2.1%, 9.6%]).
English: In adult liver, kidney and heart transplant patients, values of 4.1 l/h, 6.7 l/h and 3.9 l/h, respectively, have been observed.
Maltese: Fi trapjanti talfwied, tal-kliewi u tal-qalb f'pazjenti adulti ħarġu rispettivament il-valuri ta' 4.1 l/h, 6.7 l/h u 3.9 l/h.
English: Significantly more ciclosporintreated patients (n = 13) required a switch to tacrolimus than tacrolimus-treated patients to ciclosporin (n = 2) (p = 0.02) (Keenan et al., Ann Thoracic Surg 1995;60:580).
Maltese: Sinifikattiv il-fatt li kien hemm aktar pazjenti li ħadu ciclosporin (n = 13) li kellhom jaqilbu għal tacrolimus milli pazjenti fuq tacrolimus li kellhom jaqilbu għal ciclosporin (n = 2) (p = 0.02) (Keenan et al., Ann Thoracic Surg 1995; 60:580).
English: However, cases of spontaneous abortion have been reported.
Maltese: Każijiet ta' abort spontanju ġew irrapportati.
English: very rare:
Maltese: rari:
English: The frequency of adverse reactions is defined as follows: 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: Il-frekwenza tal-effetti mhux mixtieqa hu definit kif ġej: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 to < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieћed stima mid-dejta disponibbli).
English: In vitro the following substances have been shown to be potential inhibitors of tacrolimus metabolism: bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethindrone, quinidine, tamoxifen, (triacetyl)oleandomycin.
Maltese: Dawn is-sustanzi li se nsemmgħu wrew in vitro li huma inibituri potenzjali tal-metaboliżmu ta' tacrolimus: bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethindrone, quinidine, tamoxifen, (triacetyl)oleandomycin.
English: Printing ink: Shellac, lecithin (soya), simeticone, red iron oxide (E 172), hydroxypropylcellulose.
Maltese: Stampat bil-linka: shellac, lecithin (soja), simeticone, red iron oxide (E172), hydroxypropylcellulose.