FrancophonIA/ELRC3.0 huggingface dataset:
English: At very high doses adverse effects on the nervous system (ataxia, unsteadiness, twitching, tremors, convulsions, etc.) may occur in cattle.
Maltese: F'dożi għolja ħafna, effetti mhux mixtieqa fuq is-sistema nervuża ( sturdament, tbandil, tregħid, taqlib, etc.) jistgħu jiġru fil-baqar.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 100 mg/ml oral solution for chickens and turkeys
Maltese: VETERINARJU Dicural 100 mg/ml soluzzjoni orali għal flieles u d-dundjani
English: Each strength of the product is available in packs of 10, 20 and 100 tablets.
Maltese: Kull qawwa tal-prodott tiġi f'pakketti ta' 10, 20 u 100 pillola.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE Dicural 50 mg/ml solution for injection for cattle OUTER CARTON for 100 ml vial / 250 ml vial / VIAL LABEL 100 ml vial / 250 ml vial
Maltese: KARTUNA TA' BARRA għal fjala ta' 100 ml / fjala ta' 250 ml / TIKKETTA TAL-FJALA ta' fjala ta' 100 ml / fjala ta' 250 ml
English: PACKAGE SIZE 100 ml
Maltese: DAQS TAL-PAKKETT 100 ml - 250 ml
English: Chickens:
Maltese: Dundjani:
English: • Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/or Mycoplasma spp.
Maltese: • Trattament tal-marda respiratorja bovina (deni ta' waqt it-tbaħħir, pnewmonja fl-għoġġiela) ikkawżati minn mikrobu wieħed jew ħafna tipi bħal Pasteurella haemolitica, Pateurella multocida, u/jew Mycoplasma spp.
English: Chickens (broilers and future breeders) Turkeys (young turkeys up to 2 kg body weight).
Maltese: Dundjani (dundjani żgħar sa 2 kg piż korporali)
English: Medium Large
Maltese: U KWANTITATTIVA
English: In cattle: Dicural 50 mg/ml solution for injection is indicated for the treatment of bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/or Mycoplasma spp.
Maltese: Dicural 50 mg/ml soluzzjoni għal injezzjoni hija indikata għal trattament tal-marda respiratorja bovina (deni ta' waqt it-tbaħħir, pnewmonja fl-għoġġiela) ikkawżata minn mikrobu wieħed jew ħafna tipi bħal Pasteurella haemolitica, Pateurella multocida, u / jew Mycoplasma intermedius.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/016
Maltese: NUMRU TA' L-AWTORIZAZZJONI TAL-KUMMERĊ EU/2/97/003/016
English: Turkeys:
Maltese: Klieb :
English: 4 OJ No. L 272 of 25.10.96
Maltese: 4 OJ Nru. L 272 ta' 25.
English: MARKETING AUTHORISATION NUMBERS EU/2/97/003/001-003
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/97/003/001-003
English: CARTON LABEL - 1 X 250 ML BOTTLE / 1 X 1000 ML BOTTLE / 6 X 1000 ML BOTTLE VIAL LABEL 250 ml bottle / 1000 ml bottle
Maltese: Kaxxa tal-kartun bi fjala tal-ħġieġ ta' 50 ml, 100 ml jew 250 ml b'tapp tal-lastku u għatu ta' laluminjum
English: At concentrations in the water of 0.03% (= 300 ml in 1000 litres) or greater, palatability for turkeys may be affected.
Maltese: F'konċentrazzjonijiet fl-ilma ta' 0.03% ( = 300ml f'1000 litru) jew aktar, it-togħma tista' taffetwa liddundjani.
English: Cattle: Meat and offal: 46 days
Maltese: Laħam u Interjur: 46 ġurnata
English: Turkeys only - for the treatment of infections caused by Pasteurella multocida.
Maltese: Fid-dundjani biss - għal trattament ta' nfezzjonijiet ikkawżati minn Pasteurella multocida.
English: Following an oral dose (a plain tablet) in dogs of 5 mg/kg bodyweight, difloxacin reached its average peak plasma concentration of 1.8 µg/ml in approximately 3 hours.
Maltese: Wara doża mill-ħalq, (pillola) ta' 5mg/kg piż fi klieb, Difloxacin laħaq il-medja tal-ogħla livelli filplażma ta' 1.8 mikrogrammi /ml f'madwar tlett siegħat.
English: In turkeys difloxacin has a moderate oral bioavailability (approx. 58%).
Maltese: Fid-dundjani, il-biodisponibiltà ta' Difloxacin meta jingħata mill-ħalq hi moderata (madwar 58%).
English: In the urine, liver, fat and kidneys the metabolites desmethyl-difloxacin and difloxacin N-oxide can be found in small amounts in addition to the major (parent) compound.
Maltese: Fl-urina, fwied, xaħam u kliewi, il-metaboliti desmetil Difloxacin u N - ossidu ta' Difloxacin jinstabu fi kwantitajiet żgħar flimkien mal-komponent ewlieni (Difloxacin).
English: After subcutaneous administration of difloxacin peak plasma levels of 1.7 g/ml are achieved at 6 hours post dosing.
Maltese: Wara amministrazzjoni taħt il-ġilda, Difloxacin laħaq il-medja tal-ogħla livelli fil-plażma ta' 1.7 mikrogrammi /ml sitt siegħat wara.
English: Τηλ.
Maltese: Xejn
English: In dogs: Dicural 50 mg/ml solution for injection is indicated for the treatment of:
Maltese: Dicural 50 mg/ml soluzzjoni għal injezzjoni hija indikata għal trattament ta':
English: For a full list of excipients, see section 6.1
Maltese: Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1
English: [Not requested on the immediate label]
Maltese: [Mhux meħtieġa fuq it-tikketta li tmiss mal-prodott]
English: 9 OJ No. L 45 of 15.02.97
Maltese: 9 OJ Nru. L 45 ta' 15.
English: Histopathological changes were noted in the articular cartilage of weight bearing joints of young (3.5 months old) beagle dogs after the oral administration of difloxacin at doses of greater than 5 mg/kg/day (as the hydrochloride) for 90 days.
Maltese: Tibdil ħistopatoloġiku kien innutat fil-qarquċa artikulari tal-ġogi li jġorru l-piż fi klieb tal-beagle żgħar (tliet xhur u nofs) wara amministrazzjoni orali ta' Difloxacin f'dożi aktar minn 5 mg / kg/ kuljum (bħala hydrochloride) għal disgħin jum.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Dicural 100 mg difloxacin (as hydrochloride)
Maltese: Dicural 100 mg difloxacin (bħala hydrochloride)
English: ACTIVE SUBSTANCES Difloxacin (as hydrochloride) 50 mg/ml
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Difloxacin (bħala hydrochloride) 50 mg
English: MARKETING AUTHORISATION NUMBERS EU/2/97/003/004-015
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/97/003/004-015
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 100 mg
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Difloxacin (bħala hydrochloride) 100 mg
English: In chickens difloxacin is nearly completely absorbed after oral administration (approx. 96%).
Maltese: Fit-tiġieġ, Difloxacin huwa assorbit kważi kollu wara li jiġi amministrat mill-ħalq (bejn wieħed u ieħor 96%).
English: Difloxacin hydrochloride is bactericidal in activity and acts by inhibition of bacterial DNA gyrase.
Maltese: Difloxacin joqtol il-mikrobi primarjament billi jinibixxi l-attivita ta' DNA gyrase tal-bakterja.
English: It is well distributed in the body (Vd = 4.7 l/kg) and has a plasma elimination half-life of approximately 7 hours.
Maltese: Jitqassam tajjeb fil-ġisem (Vd = 4.7 ltr/kg) u għandu terminal half-life fil-plażma ta' madwar 7 siegħat.
English: Long term daily oral treatment over 180 days at 5 mg/kg bodyweight did not influence difloxacin kinetics, neither by accumulation nor by increased drug metabolism.
Maltese: Trattament mill-ħalq fit-tul, għal aktar minn 180 ġurnata b'doża ta' 5mg /kg piż ma nfluwenzax ilmovimenti ta' Difloxacin la bħala akkumulazzjoni u lanqas bħala żieda fir-rata ta' metaboliżmu.
English: Dicural 15 mg difloxacin (as hydrochloride)
Maltese: Dicural 15 mg difloxacin (bħala hydrochloride)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 150 mg coated tablets for dogs Difloxacin
Maltese: VETERINARJU Dicural 150 mg pilloli miksija għal klieb Difloxacin
English: MARKETING AUTHORISATION NUMBERS EU/2/97/003/016-018
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/97/003/016-018
English: Dicural 150 mg difloxacin (as hydrochloride)
Maltese: Dicural 150 mg difloxacin (bħala hydrochloride)
English: Following continuous oral dosing of Dicural oral solution at 10 mg/kg/day for five consecutive days the mean difloxacin steady state plasma concentrations are approximately 60 ng/ml.
Maltese: Wara li Dicural soluzzjoni orali tingħata kontinwament mill-ħalq bir-rata ta' 10mg /kg/ġurnata għal ħamest ijiem wara xulxin, il-medja tal-livell stabbli ta' Difloxacin bħala konċentrazzjonijiet fil-plażma kienu ta' madwar 60 ng/ml.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 100 mg coated tablets for dogs Difloxacin
Maltese: VETERINARJU Dicural 100 mg pilloli miksija għal klieb Difloxacin
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg/ml solution for injection for cattle
Maltese: VETERINARJU Dicural 50 mg/ml soluzzjoni għal injezzjoni għal baqar u klieb
English: The clearance of difloxacin after subcutaneous administration to cattle is 229 ml/h/kg.
Maltese: It-tneħħija ta' Difloxacin wara amministrazzjoni taħt il-ġilda għal baqar kienet ta' 229 ml/h/kg.
English: Dicural 50 mg difloxacin (as hydrochloride)
Maltese: Dicural 50 mg difloxacin (bħala hydrochloride)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 15 mg coated tablets for dogs Difloxacin
Maltese: VETERINARJU Dicural 15 mg pilloli miksija għal klieb Difloxacin
English: MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/013 - 10 tablets EU/2/97/003/014 - 20 tablets EU/2/97/003/015 - 100 tablets
Maltese: NUMRU TA' L-AWTORIZAZZJONI GĦALL-KUMMERĊ EU/2/97/003/013 - 10 pilloli
English: The recommended dose is 2.5mg difloxacin/kg bodyweight/day for 3 days (i.e. 5ml/100 kg bodyweight/day).
Maltese: Id-doża rakkomandata hija 2.5mg Difloxacin /kg piż tal-ġisem/jum għal tlett ijiem (ie. 5ml / kg piż talġisem/jum) Jekk m'hemmx progress suffiċjenti wara tlett ijiem, it-trattament jista' jitkompla għal jumejn oħra.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg coated tablets for dogs Difloxacin
Maltese: VETERINARJU Dicural 50 mg pilloli miksija għal klieb Difloxacin
English: The recommended dose is a single injection of 5.0 mg difloxacin/kg bodyweight Treatment must be continued with Dicural coated tablets (see that SPC)
Maltese: Id-doża rakkomandata hija injezzjoni waħda ta' 5.0 mg Difloxacin /kg piż tal-ġisem.
English: Following continuous oral dosing with Dicural oral solution at 10 mg/kg/day for five consecutive days the mean difloxacin steady state plasma concentrations are approximately 200 ng/ml.
Maltese: Wara li Dicural soluzzjoni orali tingħata kontinwament mill-ħalq bir-rata ta' 10mg /kg/ġurnata għal ħamest ijiem wara xulxin, il-medja tal-livell stabbli ta' Difloxacin bħala konċentrazzjonijiet filplażma kienu ta' madwar 200ng/ml.
English: DOSAGE FOR EACH SPECIES, METHOD AND ROUTE OF ADMINISTRATION Dicural oral solution must be administrated daily via the drinking water in such a concentration that the dose is 10 mg/kg bodyweight.
Maltese: .9 Doża rakkomandata u l-metodu ta' amministrazzjoni Dicural soluzzjoni orali ghandu jiġi amministrat kuljum ma l-ilma tax-xorb, f'konċentrazzjoni tali li d-doża tkun ta' 10mg / kg piż.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
Maltese: Isem u indirizz tal-manufattur(i) tas-sustanza(i) bioloġika(ċi) attiva(i)
English: Cattle: Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/or Mycoplasma spp.
Maltese: Trattament tal-marda respiratorja bovina (deni ta' waqt it-tbaħħir, pnewmonja fl-għoġġiela) ikkawzati minn mikrobu wieħed jew ħafna tipi bħal Pasteurella haemolitica, Pateurella multocida, u / jew Mycoplasma spp.
English: PACKAGE LEAFLET FOR Dicural 100 mg/ml oral solution for chickens and turkeys
Maltese: VETERINARJU Dicural 100mg/ml soluzzjoni orali għal flieles u d-dundjani
English: Marketing authorisation holder: Pfizer Limited
Maltese: Sid l-Awtorizzazzjoni għal Kummerċ: Pfizer Limited
English: Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential of cross resistance.
Maltese: L-użu tal-prodott b'mod differenti mill-istruzzjonijiet mogħtija fl-SPC jista' jżid il-prevalenza ta' batterja reżistenti għall-fluoroquinolones u jista' jnaqqas l-effettività ta' kura b'quinolones oħra minħabba l-potenzjal ta' cross resistance.
English: Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/or Mycoplasma spp.
Maltese: Trattament tal-marda respiratorja bovina (deni ta' waqt it-tbaħħir, pnewmonja fl-għoġġiela) ikkawżata minn mikrobu wieħed jew ħafna tipi bħal Pasteurella haemolitica, Pateurella multocida, u / jew Mycoplasma intermedius.
English: Taking into account the content of difloxacin in the oral solution (10%w/v), the following calculation should be made to determine the volume (ml) to be added for each 1000 litres of water:
Maltese: Meta tieħu kont tal-ammont ta' Difloxacin fis-soluzzjoni orali (10% w/v), wieħed għandu jagħmel ilkalkulazzjoni li ġejja sabiex jiddetermina il-volum (ml) li għandu jżid ma kull elf litru ta' ilma:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
Maltese: U KWANTITATTIVA Sustanzi Attiv/i :
English: Excipients: Benzyl alcohol
Maltese: Sustanzi mhux attivi Benzyl alcohol
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) Each ml contains:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Sustanza Attiva :
English: MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/004 - 10 tablets EU/2/97/003/005 - 20 tablets EU/2/97/003/006 - 100 tablets
Maltese: NUMRU TA' L-AWTORIZAZZJONI GĦALL-KUMMERĊ EU/2/97/003/010 - 10 pilloli
English: number of animals in the house X mean weight of individual animal(kg) X 100
Maltese: Numru ta' annimali fil-maħżen X piż medju ta' kull annimal individwali (kg) X 100
English: Small
Maltese: ML
English: Dicural oral solution must be administrated daily via the drinking water in such a concentration that the dose is 10 mg/kg bodyweight.
Maltese: Dicural soluzzjoni orali ghandu jiġi amministrat kuljum ma l-ilma tax-xorb, f'konċentrazzjoni tali li ddoża tkun ta' 10mg / kg piż.
English: Blister label
Maltese: Tikketta tal-blister
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 150 mg coated tablets for dogs
Maltese: VETERINARJU Dicural 150 mg pilloli miksija għal klieb
English: MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/007 - 10 tablets EU/2/97/003/008 - 20 tablets EU/2/97/003/009 - 100 tablets
Maltese: NUMRI TA' L-AWTORIZAZZJONI GĦALL-KUMMERĊ EU/2/97/003/007 - 10 pilloli
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Dicural 150 mg coated tablets
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-BLISTERS JEW L-ISTRIPS Dicural 150 mg pilloli miksija
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg/ml solution for injection for cattle and dogs.
Maltese: VETERINARJU Dicural 50 mg/ml, soluzzjoni għall-injezzjoni għal baqar u klieb.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED
Maltese: Mhux id-daqs tal-pakketti kollha jistgħu qegħdin fis-suq
English: Approximately 95 % of the oral dose was absorbed.
Maltese: Bejn wieħed u ieħor 95% tad-doża li ngħatat mill-ħalq kienet assorbita.
English: The fluoroquinolones exert their antibacterial effect against both replicating and dormant microorganisms.
Maltese: Il-fluoroquinolones għandhom effett antibatteriku kemm kontra mikro-organizmi li jirreplikaw kif ukoll dawk li m'humiex attivi.
English: Subcutaneous use
Maltese: Mhux Applikabbli
English: 8 OJ No. L 143 of 26.06.95
Maltese: 8 OJ Nru. L 143 ta' 26.
English: To be supplied only on veterinary prescription.
Maltese: Għandu jingħata biss bi preskrizzjoni medika.
English: Induction of resistance against quinolones can develop by mutations in the gyrase gene of bacteria and by changes in cell permeability towards quinolones
Maltese: Tista' tiżviluppa reżistenza kontra l-quinolones b'mutazzjoni tal-gyrase gene tal-mikrobi u permezz ta'tibdil fil-permebilita taċ-ċelloli għal quinolones.
English: White HDPE bottles with a screw cap containing 250ml or 1litre of Dicural oral solution.
Maltese: Għal flixkun tal-250ml, hemm kejl separat fuq it-tapp tal-kamin.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 15 mg coated tablets for dogs
Maltese: VETERINARJU Dicural 15 mg pilloli miksija għal klieb
English: The full EPAR for Skilarence 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: Skilarence is available as tablets (30 and 120 mg).
Maltese: Skilarence jiġi bħala pilloli (30 u 120 mg).
English: Other information about Skilarence
Maltese: Informazzjoni oħra dwar Skilarence
English: Skilarence contains the active substance dimethyl fumarate.
Maltese: Skilarence fih is-sustanza attiva dimethyl fumarate.
English: The active substance in Skilarence, dimethyl fumarate, reduces the activity of the immune system.
Maltese: Is-sustanza attiva fi Skilarence, dimethyl fumarate, tnaqqas l-attività tas-sistema immuni.
English: This is a summary of the European public assessment report (EPAR) for Skilarence.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Skilarence.
English: Skilarence dimethyl fumarate
Maltese: Sommarju tal-EPAR għall-pubbliku dimethyl fumarate
English: A main study involving 704 patients with moderate to severe plaque psoriasis found that Skilarence was more effective than placebo (dummy treatment) at treating the disease and as effective as Fumaderm (a psoriasis medicine that contains dimethyl fumarate and monoethyl fumarate).
Maltese: Studju ewlieni li involva 704 pazjenti bi psorijażi tal-plakka moderata sa severa sab li Skilarence kien aktar effettiv mill-plaċebo (kura finta) biex jikkura l-marda u kien effettiv daqs Fumaderm (mediċina tal-psorijażi li fiha dimethyl fumarate u monoethyl fumarate).
English: Psoriasis results from over-activity of the body's immune (defence) system.
Maltese: Il-psorijażi tirriżulta minn attività eċċessiva tas-sistema immuni (difiża) tal-ġisem.
English: After 16 weeks of treatment, 37% of patients taking Skilarence achieved this reduction, compared with 15% taking placebo and 40% taking Fumaderm .
Maltese: Wara 16-il ġimgħa ta' kura, 37 % tal-pazjenti li kienu qed jieħdu Skilarence kisbu dan it-tnaqqis, meta mqabbel ma' 15 % li kienu qed jieħdu l-plaċebo u 40 % li kienu qed jieħdu Fumaderm.
English: What are the risks associated with Skilarence?
Maltese: X'inhuma r-riskji assoċjati ma' Skilarence?
English: The most common side effects with Skilarence (which may affect more than 1 in 10 people) are effects on the digestive system (diarrhoea, bloating, belly ache and nausea), flushing (reddening of the skin) and low levels of lymphocytes (type of white blood cells) or of white blood cells in general.
Maltese: L-effetti sekondarji l-aktar komuni bi Skilarence (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma effetti fuq is-sistema diġestiva (dijarea, nefħa fl-istonku, uġigħ fiż-żaqq u dardir), vampati (ħmura talġilda) u livelli baxxi ta' linfoċiti (tip ta' ċelloli bojod tad-demm) jew taċ-ċelloli bojod tad-demm inġenerali.
English: Most side effects are mild or moderate.
Maltese: Ħafna mill-effetti sekondarji huma ħfief jew moderati.
English: Why is Skilarence approved?
Maltese: Għaliex ġie approvat Skilarence?
English: Because Skilarence reduces the activity of the immune system, there is a risk of serious infections, including progressive multifocal leukoencephalopathy (PML, a brain infection), but the risk can be minimised by regular tests for white blood cell counts and stopping treatment if necessary.
Maltese: Minħabba li Skilarence jnaqqas l-attività tas-sistema immuni, hemm riskju ta' infezzjonijiet serji, inkluż lewkoenċefalopatija multifokali progressiva (PML, progressive multifocal leukoencephalopathy, infezzjoni tal-moħħ), iżda r-riskju jista' jiġi mminimizzat permezz ta' testijiet regolari għall-għadd taċ-ċelloli bojod tad-demm u, jekk ikun meħtieġ, billi titwaqqaf il-kura.
English: The company that markets Skilarence will supply educational materials to healthcare professionals about the risk of serious infections, including PML, and how to minimise this risk.
Maltese: Il-kumpanija li tqiegħed Skilarence fis-suq se tipprovdi materjal edukattiv lill-professjonisti tal-kura tas-saħħa dwar ir-riskju ta' infezzjonijiet serji, inkluż PML, u kif jiġi mminimizzat dan ir-riskju.
English: How is Skilarence used?
Maltese: Kif jaħdem Skilarence?
English: The CHMP considered that the main study has shown Skilarence's short-term effectiveness, and published studies with similar medicines show that the effectiveness is maintained with continued use.
Maltese: Is-CHMP ikkunsidra li listudju ewlieni wera l-effettività fi żmien qasir ta' Skilarence, u studji ppubblikati b'mediċini simili juru li jibqa' jkun hemm l-effettività b'użu kontinwu.
English: This summary was last updated in 06-2017.
Maltese: Skilarence EMA/377398/2017
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Skilarence's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Skilarence huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Skilarence is a medicine used to treat plaque psoriasis, a disease that causes thickened, red and inflamed areas of skin with scaly patches.
Maltese: Skilarence huwa mediċina li tintuża għall-kura tal-psorijażi tal-plakka, marda li tikkawża partijiet talġilda sabiex jintefħu, isiru ħomor u infjammati bi rqajja' bil-qoxra.
English: Poligono Industrial Navatejera,
Maltese: Poligono Industrial Navatejera Navatejera,
English: Str. Domniţa Ruxandra nr. 12, parter, Sector
Maltese: Domniţa Ruxandra nr. 12, parter, Sector 2
English: Str. Livezeni nr. 7A, 540472 Târgu Mureş, România.
Maltese: Livezeni nr. 7A, 540472 Târgu Mureş, România.
English: Albert-SchweitzerGasse 3
Maltese: Albert-Schweitzer-Gasse 3
English: Teva Sweden AB Järnvägsgatan 11 Box 1070
Maltese: L-Isvezja AB Järnvägsgatan 11 Box 1070
English: 1499-016 Algés Portugal
Maltese: 1499-016 Algés Il-Portugall
English: Belgium MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Maltese: Il-Belġju MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
English: Bayer Hungaria ltd Alkotás street 50.
Maltese: L-Ungerija Bayer Hungaria ltd Alkotás street 50.
English: Teva Hungary PLC Pallagi street 13., Debrecen
Maltese: L-Ungerija PLC Pallagi street 13., Debrecen
English: 00-777 Warszawa Poland
Maltese: 00-777 Warszawa
English: Veluwezoom 22 1327 AH Almere The Netherlands
Maltese: Veluwezoom 22 1327 AH Almere L-Olanda
English: Plom, 2-4, 5ª planta 08038 Barcelona Spain
Maltese: Plom, 2-4, 5ª planta 08038 Barcelona Spanja
English: 28401 Kutná Hora Czech Republic
Maltese: 28401 Kutná Hora
English: 4879 AC Etten-Leur The Netherlands
Maltese: 4879 AC Etten-Leur L-Olanda
English: Bayer Limited The Atrium, Blackthorn Road, Dublin 18, Ireland
Maltese: Bayer Limited The Atrium, Blackthorn Road, Dublin 18, L-Irlanda
English: Teva Pharma BV Computerweg 10 3542 DR Utrecht The Netherlands
Maltese: Teva Pharma BV Computerweg 10 3542 DR Utrecht L-Olanda
English: Janssen-Cilag GmbH Johnson & Johnson Platz 1
Maltese: Il-Ġermanja Janssen-Cilag GmbH Johnson & Johnson Platz 1
English: 2710-693 Sintra Portugal
Maltese: 2710-693 Sintra Il-Portugall
English: Żwirki i Wigury 81 02-091 Warszawa Poland
Maltese: Żwirki i Wigury 81 02-091 Warszawa
English: "ARAC" At Regulatory Affairs Consulting GmbH
Maltese: Il-Ġermanja "ARAC" At Regulatory Affairs Consulting GmbH
English: Organon (Ireland) Ltd, PO Box 2857, Drynam Road, Swords,
Maltese: Organon (L-Irlanda) Ltd, PO Box 2857, Drynam Road, Swords,
English: Via Lincoln 7/A, 20092 Cinisello Balsamo (MI) Italy
Maltese: Via Lincoln 7/A, 20092 Cinisello Balsamo (MI)
English: Otto-Schott-Straße 15
Maltese: KG Otto-Schott-Straße 15