FrancophonIA/ELRC3.0 huggingface dataset:
English: However, any consideration of risk to the environment must take into account knowledge on the aspects of the specific product and its use that contribute to the actual emission in the environment, e.g. route of administration (pour-on, injectable, oral), husbandry conditions (indoor/outdoor/confined), terrestrial/aquaculture, closed/open water systems, individual animal treatment/flock treatment, control of environmental release, waste management, metabolism in the target animal, etc.
Maltese: PBT/vPvB fi prodotti mediċinali veterinarji (EMA/CVMP/ERA/52740/2012), mhijiex xierqa valutazzjoni tar-riskju kwantitattiva għall-istima tal-periklu ta' PBT. Madankollu, kwalunkwe kunsiderazzjoni ta' riskju għall-ambjent għandha tikkunsidra għarfien dwar l-aspetti talprodott speċifiku u l-użu tiegħu li jikkontribwixxi għall-emissjoni attwali fl-ambjent, eż. mnejn jingħata (jitferra', injetabbli, orali), kondizzjonijiet ta' trobbija (ġewwa/barra/konfinati), terrestri/akkwakultura, sistemi tal-ilma magħluqin/miftuħin, trattament ta' annimal individwali/trattament tal-merħla, kontroll tar-rilaxx ambjentali, ġestjoni tal-iskart, metaboliżmu fl-annimal fil-mira, eċċ.
English: Cydectin Pour-On vet Moxidectin Pour-on solution 5 mg/ml
Maltese: Cydectin Pour-On vet Moxidectin Soluzzjoni li titferra'
English: Residues in dung were toxic to dung flies for more than 7 days or for more than 28 days after treatment, depending on study duration, species and formulation.
Maltese: Ir-residwi fid-demel kienu tossiċi għad-dubbien tad-demel għal aktar minn 7 ijiem jew aktar minn 28 jum wara t-trattament, skont id-durata tal-istudju, l-ispeċi u l-formulazzjoni.
English: Annex III
Maltese: III).
English: CYDECTIN 1% Moxidectin Solution for injection
Maltese: CYDECTIN 1% Moxidectin Soluzzjoni għallinjezzjoni
English: • Faeces containing moxidectin excreted onto pasture by treated animals may temporarily reduce the abundance of dung feeding organisms.
Maltese: • Ippurgar li jkun fih moxidectin li jiġi eliminat fuq il-mergħa minn annimali ttrattati jista' jnaqqas temporanjament l-abbundanza ta' organiżmi li jagħlfu mid-demel.
English: BCFS = bioconcentration factor at steady state BCFSL = bioconcentration factor at steady state corrected for 5% lipid content BCFK = kinetic bioconcentration factor
Maltese: Bioaccumulation in Fish: Aqueous and Dietary Exposure - link bijoakkumulazzjoni ta' moxidectin.
English: The third acute study following the same procedures was conducted in bluegill (Lepomis macrochirus).
Maltese: It-tielet studju akut wara l-istess proċeduri sar fid-dott talmisluta blu (Lepomis macrochirus).
English: Belgium Zoetis Belgium SA Rue Laid Burniat, 1
Maltese: Il-Belġju Zoetis Belgium SA Rue Laid Burniat, 1
English: Moxidectin Oral solution 1 mg/ml 50 mg/ml
Maltese: CYDECTINE TRICLAMOX 1 MG/ML + 50
English: Denmark Continental Farmaceutica Rue Laid Burniat 1,
Maltese: L-Estonja Continental Farmaceutica Rue Laid Burniat 1,
English: • the CVMP considered that based on the currently available data the overall benefit-risk balance is positive for the veterinary medicinal products containing moxidectin to be administered to cattle, sheep and horses as pour-on, injectable and oral formulations (see Annex I), subject to amendments in the product information and conditions on the marketing authorisations;
Maltese: • is-CVMP ikkunsidra li abbażi tad-dejta disponibbli attwalment il-bilanċ bejn il-benefiċċju u r-riskju globali huwa pożittiv għall-prodotti mediċinali veterinarji li fihom moxidectin li għandhom jingħataw lil frat, ngħaġ u żwiemel bħala formulazzjonijiet li jitferrgħu, injettabli u orali (ara l-Anness I), suġġett għal emendi fl-informazzjoni dwar il-prodott u l-kondizzjonijiet dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq;
English: • the CVMP considered that the data generated further to the fulfilment of these conditions, along with any other relevant information which might become available, will form the basis of a subsequent assessment by the CVMP of its conclusions on the benefit-risk balance for veterinary medicinal products containing moxidectin to be administered to cattle, sheep and horses as pouron, injectable and oral formulations;
Maltese: • is-CVMP ikkunsidra li d-dejta ulterjuri ġġenerata sabiex tissodisfa dawn il-kondizzjonijiet, flimkien ma' kwalunkwe informazzjoni rilevanti oħra li tista' ssir disponibbli, se tifforma l-bażi ta' valutazzjoni sussegwenti mis-CVMP tal-konklużjonijiet tiegħu dwar il-bilanċ bejn il-benefiċċju u rriskju għal prodotti mediċinali veterinarji li fihom moxidectin li għandhom jingħataw lil frat, ngħaġ u żwiemel bħala formulazzjonijiet li jitferrgħu, injetabbli u orali;
English: The uptake rate constant (k1) and depuration rate constant (k2) were estimated to be 194.7108 and 0.0739, respectively, for the low dose and 165.1532 and 0.0534, respectively, for the high dose.
Maltese: Il-fattur ta' bijokonċentrazzjoni ġie kkalkulat ukoll bħala l-proporzjon bejn il-kostant tar-rata ta' teħid (k1) u l-kostant tar-rata ta' tisfija (k2). Ilkostant tar-rata ta' teħid (k1) u l-kostant tar-rata ta' tisfija (k2) ġew stmati li kienu 194.7108 u 0.0739, rispettivament, għad-doża l-baxxa u
English: Sheep
Maltese: Żiemel
English: It appeared that the therapeutic alternatives to moxidectin do not necessarily have more favourable environmental profiles, in particular in terms of toxicity to aquatic and dung insects.
Maltese: Deher li l-alternattivi terapewtiċi għal moxidectin mhux bilfors għandhom profili ambjentali aktar favorevoli, b'mod partikolari f'termini ta' tossiċità għal insetti akwatiċi u tad-demel.
English: Earthworms were exposed to moxidectin-treated cow manure in artificial soil over a 28-day exposure period.
Maltese: Il-ħniex ġew esposti għal demel tal-baqar ittrattat b'moxidectin f'ħamrija artifiċjali fuq perjodu ta' esponiment ta' 28 jum.
English: Dublin 24, Ireland Tel (353) 1 463 2300
Maltese: Dublin 24, L-Irlanda Tel (353) 1 463 2300
English: Dublin 8, Ireland
Maltese: Dublin 8, L-Irlanda
English: ATC Code: A01AB03 chlorhexidine.
Maltese: A01AB03 kloreksidin.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of First Authorisation: 5th May 2006.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel Awtorizzazzjoni: 5 ta' Mejju 2006.
English: What Prevora contains:
Maltese: Prevora fih:
English: An individual dosing in adults is between 300 µl and 600 µl of Prevora 100 mg/ml Dental Solution.
Maltese: Doża individwali għall-adulti hi ta' bejn 300 μl u 600 µl ta' Prevora 100 mg/ml Dental Solution.
English: Store upright in a refrigerator at 2° - 8° C.
Maltese: Żomm wieqaf fi friġġ f'temperatura ta' bejn 2°Ċ u 8°Ċ.
English: For a list of full excipients, see section 6.1
Maltese: Għal lista sħiħa ta' sustanzi mhux attivi, ara t-taqsima 6.1
English: Dental Solution
Maltese: Soluzzjoni Dentali
English: Chlorhexidine in the drug product has been found at bactericidal levels to Streptococcus mutans for between 24 hours and 48 hours on the surface of adult dental patients after its application, as measured by HPLC.
Maltese: Il-kloreksidin fil-prodott mediċinali nstab f'livelli batteriċidi kontra Streptococcus mutans fuq superfiċji ta' pazjenti dentali adulti għal bejn 24 siegħa u 48 siegħa wara l-applikazzjoni, kif imkejjel permezz tal-HPLC.
English: Step #11.
Maltese: Pass #11.
English: 6 vials of Stage 1 chlorhexidine coating in a 2 ml Type 1 glass vial 6 vials of Stage 2 sealant coating in a 2 ml Type 1 glass vial
Maltese: 6 kunjetti tal-ħġieġ tat-Tip 1 ta' 2ml kull wieħed b'likwidu għall-kisja ta' kloreksidin għall-1 Stadju 6 kunjetti tal-ħġieġ tat-Tip 1 ta' 2ml kull wieħed b'likwidu għall-kisja b'materjal għas-siġillar għat-2 Stadju
English: The active substance is Chlorhexidine diacetate.
Maltese: Is-sustanza attiva hija diaċetat tal-kloreksidin.
English: MARKETING AUTHORISATION NUMBER(S) PA 1205/1/1
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ PA 1205/1/1
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: 4.5 Effetti fuq prodotti mediċinali oħra u tipi oħra ta' interazzjoni
English: Step #5.
Maltese: Pass #5.
English: Step #6.
Maltese: Pass #6.
English: Step #10.
Maltese: Pass #10.
English: Chlorhexidine is incompatible with anionic agents.
Maltese: Il-kloreksidin mhuwiex kompatibbli ma' aġenti anjoniċi.
English: Step #9.
Maltese: Pass #9.
English: General disorders and administration site conditions
Maltese: Disturbi ġenerali u kondizzjonijiet tal-post li fuqu jiġi amministrat
English: Redness and/or temporary stinging sensation of the oral mucosa
Maltese: Ħmura u/jew sensazzjoni ta' tingiż temporanja filmembrana mukuża tal-ħalq
English: Do not chew gum for at least 24 hours.
Maltese: Tieħux chewing gum għal mill-inqas 24 siegħa.
English: 4.2 Posology and method of administration
Maltese: .2 Pożoloġija u l-metodu ta' amministrazzjoni
English: 100 mg/ml Dental Solution
Maltese: 100 mg/ml Soluzzjoni Dentali
English: 6.4 Special precautions for storage Store in refrigerator (2º to 8ºC)
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Żomm fi friġġ (f'temperatura ta' bejn 2°Ċ u 8°Ċ)
English: Figure 1 Application of Prevora 100 mg/ml Dental Solution
Maltese: Illustrazzjoni 1 L-applikazzjoni ta' Prevora 100 mg/ml Dental Solution
English: The stinging will last for a few minutes, the coating for a few hours.
Maltese: It-tingiż idum għal ftit minuti, u l-kisi għal ftit sigħat.
English: Chlorhexidine is effective against a wide range of important oral microorganisms associated with dental caries.
Maltese: Il-kloreksidin huwa effettiv kontra firxa wiesgħa ta' mikroorganiżmi importanti tal-ħalq assoċjati mattaħsir tas-snien.
English: Prevora 100 mg/ml Dental Solution Chlorhexidine diacetate
Maltese: Prevora 100 mg/ml Dental Solution Diaċetat tal-kloreksidin
English: Stage 1 chlorhexidine coating: Sumatra benzoin Ethanol
Maltese: Kisja ta' kloreksidin għall-1 Stadju: Benzojin tas-Sumatra Etanol
English: Immediate hypersensitivity reactions to chlorhexidine (urticaria or anaphylaxis)
Maltese: Reazzjonijiet immedjati ta' sensittività eċċessiva għallkloreksidin (urtikarja jew anafilassi)
English: DATE OF REVISION OF THE TEXT September 2010
Maltese: DATA TA' META ĠIE RIVEDUT IT-TEST Settembru 2010
English: Prevora should be stored in a refrigerator (2ºC - 8ºC) at your dental professional's office.
Maltese: Prevora għandu jinżamm fi friġġ (f'temperatura ta' 2°Ċ sa 8°Ċ) fil-klinika tad-dentist tiegħek.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Maltese: F'kull taqsima ta' frekwenza, l-effetti mhux mixtieqa huma ppreżentati f'ordni ta' gravità dejjem tonqos.
English: Stage 2 sealant coating:
Maltese: Pass #4. Iżola kwadrant wieħed:
English: The cumulative monthly mean dose of chlorhexidine delivered by Prevora 100 mg/ml Dental Solution is approximately equal to that of 1.0% w/w chlorhexidine dental gel and approximately half that of 0.2% w/v chlorhexidine oral rinse.
Maltese: Id-doża medja kumulattiva ta' kloreksidin mogħtija f'xahar bħala riżultat tat-trattament bi Prevora 100 mg/ml Dental Solution hija ugwali għal madwar dik ta' 1.0% p/p ġel għas-snien bil-kloreksidin u ugwali għal madwar nofs dik ta' 0.2% soluzzjoni għat-tlaħliħ tal-ħalq bil-kloreksidin.
English: Dental use
Maltese: Użu dentali
English: Prophylaxis: Give a rubber cup prophylaxis using flour of pumice and water.
Maltese: Applika profilassi biċ-ċilindru tal-gomma (rubber cup prophylaxis) blużu ta' trab tal-ħaffiefa u ilma.
English: Hypersensitivity to chlorhexidine, Sumatra benzoin or ethanol.
Maltese: Sensittività eċċessiva għall-kloreksidin, għall-benzojin tas-Sumatra jew għall-etanol.
English: Chlorhexidine diacetate Sumatra benzoin
Maltese: Diaċetat tal-kloreksidin Benzojin tas-Sumatra Etanol
English: Marketing Authorization Holder:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Prevora 100 mg/ml Dental Solution contains: Stage 1 chlorhexidine coating:
Maltese: Prevora 100 mg/ml Dental Solution fih: Kisja ta' kloreksidin għall-1 Stadju:
English: MM/YYYY
Maltese: MA #
English: The ingredients are Ammonio methacrylate copolymer dispersion, Type B and Triethyl citrate What Prevora looks like and contents of the pack:
Maltese: L-ingredjenti huma taħlita ta' kopolimeru ta' metakrilat tal-ammonja, Tip B u ċitrat tat-trietil Deskrizzjoni ta' Prevora u l-kontenut tal-kaxxa:
English: External (oral) topical use in the dental office by a dental professional.
Maltese: Użu topiku estern (fil-ħalq) fi klinika dentali minn professjonist tad-dentistrija.
English: There have been no published reports of permanent resistance by Streptococcus mutans to the repeated use of chlorhexidine for up to 2 years and no significant resistance to Streptococcus mutans or opportunistic infections with Candida albicans were observed after treatment with Prevora over one year in adult patients.
Maltese: Ma jeżistu l-ebda rapporti ppubblikati dwar reżistenza permanenti minn Streptococcus mutans għallużu ripetut tal-kloreksidin għal perjodu ta' sentejn u ma ġiet osservata l-ebda reżistenza sinifikanti f'pazjenti adulti għal Streptococcus mutans jew għal infezzjonijiet opportunistiċi b'Candida albicans wara t-trattament bi Prevora tul perjodu ta' sena.
English: PHARMACEUTICAL PARTICULARS
Maltese: 3. KOMPOŻIZZJONI FARMAĊEWTIKA
English: • Do not chew gum for at least 24 hours.
Maltese: • M'għandux jieħu chewing gum għal mill-inqas 24 siegħa.
English: Ethanol
Maltese: FARMAĊEWTIKU
English: Stage 1 chlorhexidine coating:
Maltese: Kisja ta' kloreksidin għall-1 Stadju:
English: Tel: (01) 4100600
Maltese: Dublin 8, L-Irlanda Tel (353) 1 463 2300
English: Prevora 100mg/ml Dental Solution is an antiseptic solution which is applied topically to the dentition of patients for the prevention of root coronal and root caries in adult patients at high-risk of dental caries (e.g. xerostomia sufferers or those with 3 or more caries at the start of the treatment plan).
Maltese: Prevora 100mg/ml Dental Solution hija soluzzjoni antisettika li tiġi applikata topikament fuq is-snien tal-pazjenti għall-prevenzjoni ta' taħsir għeruq tas-snien tas-snien u tal-għeruq tas-snien f'pazjenti adulti b'riskju għoli ta' taħsir tas-snien (pereżempju min ibati bix-xerostomija jew min ikollu 3 sinniet imħassrin jew aktar fiż-żmien meta jinbeda l-programm ta' trattament).
English: Each 1 ml of Prevora Dental Solution (Stage 1 chlorhexidine coating) contains chlorhexidine diacetate 100 mg.
Maltese: Kull 1 ml ta' Prevora Dental Solution (kisja ta' kloreksidin għall-1 stadju) fih 100mg diaċetat talkloreksidin.
English: Prepare for the application with a tray (Figure 2), consisting of cotton rolls, cotton pellets or fine brushes, forceps, air syringe, and a vial of Stage 1 chlorhexidine coating and a vial of Stage 2 sealant coating.
Maltese: Għandek tipprepara għall-applikazzjoni billi tlesti trej (Illustrazzjoni 2) b'rombli tat-tajjar, boċċi tattajjar jew pniezel irqaq, pinzetta, siringa tal-arja, kunjett bil-likwidu għall-kisja ta' kloreksidin għall-1 Stadju u kunjett bil-likwidu għall-kisja b'materjal għas-siġillar għat-2 Stadju.
English: Chlorhexidine, the active substance in Prevora , can stain the teeth when used in a mouth rinse or gel; however, in controlled clinical studies and dental office use, the occurrence of tooth staining by the Prevora dental coating is rare.
Maltese: Il-kloreksidin, is-sustanza attiva ta' Prevora, tista' wkoll tikkawża tbajja' fuq is-snien; minkejja dan, meta l-kloreksidin jiġi applikat bħala kisja topika u temporanja tas-snien, it-tbajja' fuq is-snien huma rari.
English: Stage 2: ammonio methacrylate copolymer dispersion, Type B and triethyl citrate
Maltese: Stadju 1: Benzojin tas-Sumatra u etanol Stadju 2: Taħlita ta' kopolimeru ta' metakrilat tal-ammonja, Tip B u ċitrat tat-trietil
English: Figure 3: Apply Prevora Stage 1 chlorhexidine coating with a fine brush to the gingival margin, followed by Prevora Stage 2 sealant coating using the same techniques.
Maltese: Illustrazzjoni 3: Applika l-kisja ta' kloreksidin Prevora għall-1 Stadju mat-truf tal-ħanek permezz ta' pinzell irqiq, imbagħad applika l-kisja b'materjal għas-siġillar Prevora għat-2 Stadju bl-istess mod.
English: 100 mg/ml Dental solution, chlorhexidine diacetate Stage 2 Sealant coating
Maltese: 100 mg/ml ta' soluzzjoni dentali, diaċetat tal-kloreksidin Kisja b'materjal għas-siġillar għat-2 stadju
English: Stage 1 chlorhexidine coating
Maltese: Kisja ta' kloreksidin għall-1 Stadju
English: One treatment box of Prevora Dental solution contains 6 Type 1 glass vials of Stage 1 chlorhexidine coating along with 6 Type 1 glass vials of Stage 2 sealant coating.
Maltese: Kaxxa Prevora Dental solution għal trattament wieħed fiha 6 kunjetti tal-ħġieġ tat-Tip 1 b'likwidu għall-kisja ta' kloreksidin għall-1 Stadju u 6 kunjetti tal-ħġieġ tat-Tip 1 b'likwidu għall-kisja b'materjal għas-siġillar għat-2 Stadju.
English: Prevora 100 mg/ml Dental Solution should not be applied immediately following use of an oil-based prophylactic paste or up to 3 days following application of a fluoride dental varnish.
Maltese: Prevora 100 mg/ml Dental Solution m'għandux jiġi applikat immedjatament wara li tkun intużat pasta profilattika taż-żejt u m'għandux jiġi applikat sa 3 ijiem wara li jkun ġie applikat verniċ tal-fluworidu għas-snien.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of Prevora Dental Solution (Stage 1 chlorhexidine coating) contains chlorhexidine diacetate 100mg
Maltese: Kull 1 ml ta' Prevora 100mg/ml Soluzzjoni Dentali (kisja ta' kloreksidin għall-1 Stadju) fih 100mg diaċetat tal-kloreksidin
English: How to store Prevora.
Maltese: Qabel tingħata t-trattament bi Prevora.
English: Apply Stage 1 chlorhexidine coating inter-proximally: Using a cotton pellet held in forceps, or a fine brush suitable for reaching inter-proximal areas, apply Stage 1 Chlorhexidine coating to the inter-proximal areas of all posterior teeth in the quadrant, ensuring not to apply the coating to the soft tissues.
Maltese: Il-kloreksidin, issustanza attiva fi Prevora, tista' ttebba' s-snien meta tintuża f'forma ta' ġel jew f'likwidi għat-tindif u t-tlaħliħ tal-ħalq; madankollu, waqt studji kliniċi kkontrollati u waqt l-użu fi kliniki għall-kura tassnien intwera li l-okkorrenza ta' tbajja' fuq is-snien minħabba l-użu tal-kisi tas-snien Prevora hija rari.
English: • before undergoing treatment with Prevora, to report your medical condition including asthma, eczema and other allergies, to your dentist.
Maltese: • li qabel ma tingħata trattament bi Prevora, tgħarraf lid-dentist tiegħek rigward kwalunkwe kondizzjoni medika li taf li tbati minnha, inkluż ażma, ekżema u allerġiji oħra.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Stage 1 Chlorhexidine coating
Maltese: U L-MOD(I) TA' AMMINISTRAZZJONI Kisja ta' kloreksidin għall-1 Stadju
English: • If you are allergic to chlorhexidine, Sumatra benzoin or ethanol.
Maltese: • Jekk tbati minn sensittività eċċessiva għall-kloreksidin, għall-benzojin tas-Sumatra jew għall etanol.
English: Chlorhexidine diacetate
Maltese: TWISSIJA/TWISSIJIET SPEĊJALI
English: Ammonio methacrylate copolymer dispersion,Type B Triethyl citrate
Maltese: Taħlita ta' kopolimeru ta' metakrilat tal-ammonja, Tip B Ċitrat tat-trietil
English: Repeat coating of other quadrants: Repeat steps 4 through 8 in the remaining quadrants of the dentition.
Maltese: Irrepeti l-passi 4 sa 8 fuq ilkwadranti l-oħra tas-snien.
English: Treatment of the dental patient thereafter is according to professional clinical judgment of the risk of dental caries.
Maltese: Għandu jintuża fi kliniki dentali minn professjonisti tad-dentistrija biss.
English: Stage 2 sealant coating
Maltese: Aktar tagħrif.
English: In this leaflet
Maltese: BI PREVORA
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted>
Maltese: BIL-BRAILLE <Ir-raġuni li ngħatat biex ma jkunx inkluż il-Braille ġiet aċċettata>
English: Figure 1 - Stage 1 followed by a second coating will be applied to your teeth so as to reduce your risk of tooth decay.
Maltese: Illustrazzjoni 1 - L-1 Stadju 1 segwit mit-tieni kisja, li se jiġu applikati fuq snienek sabiex jitnaqqas irriskju tiegħek ta' taħsir tas-snien.
English: Avoid application of Prevora 100 mg/ml Dental Solution to the soft tissues.
Maltese: Evita l-applikazzjoni ta' Prevora 100 mg/ml Dental Solution fuq it-tessuti rotob.
English: Solution in nursing mothers, it is recommended that Prevora 100 mg/ml Dental Solution should not be applied if the mother is nursing.
Maltese: Għalhekk, huwa rakkomandat li Prevora 100 mg/ml Dental Solution ma jiġix amministrat waqt it-tqala.
English: There is no experience with over-dosage with Prevora 100 mg/ml Dental Solution.
Maltese: Ma ġew irreġistrati l-ebda esperjenzi li jirrigwardaw dożaġġ eċċessiv ta' Prevora 100 mg/ml Dental Solution.
English: 6.5 Nature and contents of container
Maltese: Deskrizzjoni u kontenut tal-kontenitur
English: NAME OF THE MEDICINAL PRODUCT Prevora 100mg/ml Dental Solution.
Maltese: Prevora 100mg/ml Soluzzjoni Dentali .
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: ATTIVA(I)
English: Prevora 100 mg/ml Dental Solution is administered topically to the entire dentition of the patient using a cotton pellet or fine paint brush.
Maltese: Prevora 100 mg/ml Dental Solution għandu jintuża b'attenzjoni fuq pazjenti bi storja medika ta' ażma jew ekżema.
English: Levodopa/carbidopa/entacapone
Maltese: Levodopa/karbidopa/entakapone
English: The full EPAR for Stalevo 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: This summary was last updated in 07-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'07-2011.
English: This is a summary of the European public assessment report (EPAR) for Stalevo.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Stalevo.
English: Entacapone has been authorised in the European Union (EU) as Comtess/Comtan since 1998.
Maltese: L-entakapone ilha awtorizzata fl-Unjoni Ewropea (UE) mill-1998 bħala Comtess/Comtan.
English: What is Stalevo?
Maltese: Stalevo?
English: It is available as a range of tablets in seven strengths, containing 50 to 200 mg levodopa and 12.5 to 50 mg carbidopa.
Maltese: Jiġi f'diversi pilloli b'seba' qawwiet differenti, minn 50 sa 200mg ta' levodopa u 12.5 sa 50mg ta' karbidopa.
English: Stalevo is a medicine that contains three active substances: levodopa, carbidopa and entacapone.
Maltese: Stalevo huwa mediċina li fiha tliet sustanzi attivi: il-levodopa, il-karbidopa u l-entakapone.
English: The maximum daily dose of Stalevo is 10 tablets, except for the tablets containing 200 mg levodopa and 50 mg carbidopa, for which the maximum daily dose is seven tablets.
Maltese: Id-doża massima ta' Stalevo hija 10 pilloli kuljum, għajr għall-pilloli li fihom 200 mg levodopa u 50 mg karbidopa, li għalihom id-doża massima hija seba' pilloli kuljum.
English: What is the risk associated with Stalevo?
Maltese: X'inhu r-riskju assoċjat ma' Stalevo?
English: phaeochromocytoma (a tumour of the adrenal gland); a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Maltese: mard gravi fil-fwied; glawkoma b'angolu dejjaq (żieda fil-pressjoni tal-għajnejn); feokromoċitoma (tumur tal-glandola surrenali); storja ta' sindromu newrolettiku malinn (disturb nervuż perikoluż li s-soltu jkun ikkawżat minn mediċini antipsikotiċi) jew rabdomjoliżi (tkissir tal-fibri muskolari).
English: Why has Stalevo been approved?
Maltese: Għaliex ġie approvat Stalevo?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stalevo to on 17 October 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Stalevo fis-17 ta' Ottubru 2008.