FrancophonIA/ELRC3.0 huggingface dataset:
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
Maltese: (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
English: What is DuoPlavin?
Maltese: X'inhi DuoPlavin?
English: International non-proprietary name (INN): clopidogrel/acetylsalicylic acid
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): clopidogrel/aċidu aċetilsaliċiliku.
English: The CHMP normally takes up to 210 days to evaluate a new application.
Maltese: Is-CHMP normalment jieħu sa 210t ijiem biex jevalwa applikazzjoni ġdida.
English: It was to be available as tablets containing 75 mg clopidogrel plus 75 mg acetylsalicylic acid, and as tablets containing 75 mg clopidogrel plus 100 mg acetylsalicylic acid.
Maltese: Din kellha tkun disponibbli bħala pilloli li fihom 75mg ta' clopidrogel u 75mg ta' aċidu aċetilsaliċiliku, u bħala pilloli li fihom 75mg clopidogrel u 100mg ta' aċidu aċetilsaliċiliku.
English: Clopidogrel is an inhibitor of platelet aggregation.
Maltese: Clopidogrel huwa inibitur ta' l-aggregazzjoni tal-pjastrini.
English: On 23 May 2008, Sanofi Pharma Bristol-Myers Squibb officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for DuoPlavin for the prevention of atherothrombotic events.
Maltese: Fit-23 ta' Mejju 2008, Sanofi Pharma Bristol-Myers Squibb għarrfet uffiċjalment lill-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) li kienet tixtieq tirtira l-applikazzjoni għallawtorizzazzjoni għat-tqegħid fis-suq għal DuoPlavin għall-prevenzjoni ta' każijiet aterotrombotiċi.
English: How is DuoPlavin expected to work?
Maltese: Kif kienet mistennija li taħdem DuoPlavin?
English: It was expected to be used to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients who have a condition known as ‘acute coronary syndrome'.
Maltese: Kienet mistennija li tintuża sabiex tipprevjeni każijiet aterotrombotiċi (problemi ikkawżati minn emboli u minn arterji li jkunu ibbiesu) f'pazjenti li jkollhom kondizzjoni magħrufa bħala ‘sindromu koronarju akut'.
English: Clopidogrel on its own has been approved by the EU under the names Iscover and Plavix, for prevention of atherothrombotic events, in combination with acetylsalicylic acid, in patients with acute coronary syndrome.
Maltese: Clopidrogel waħdu kien ġie approvat mill-UE taħt l-ismijiet Iscover u Plavix, għall-prevenzjoni ta' każijiet aterotrombotiċi, flimkien ma' aċidu aċetilsaliċiliku f'pazjenti b'sindromu koronarju akut.
English: This included patients who were having an acute myocardial infarction (heart attack) with an ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thought that they would have benefited from the treatment.
Maltese: Dan kien jinkludi pazjenti li kien qed ikollhom infart mijokardiku akut (attakk tal-qalb) b'elevazzjoni tas-segment ST' (qari mhux normali fuq l-elettrokardjogramm jew l-ECG) fil-każ li t-tabib ikun ikkunsidra li l-pazjenti kienu jibbenefikaw mit-trattament.
English: What is happening for Iscover/Plavix with acetylsalicylic acid for treatment of atherothrombotic events?
Maltese: (acetylsalicyclic acid)
English: DuoPlavin was expected to be used in adult patients already taking clopidogrel and acetylsalicylic acid as separate tablets.
Maltese: DuoPlavin kienet mistennija li tintuża f'pazjenti adulti li kienu diġà qed jieħdu clopidrogel u aċidu aċetilsaliċiliku f'pilloli meħuda separatament.
English: It was also expected to be used in patients who did not have this abnormal reading on the ECG, if they had unstable angina (a severe type of chest pain) or a ‘non-Q-wave' myocardial infarction and who had a stent inserted (a short tube placed in an artery to prevent it closing up).
Maltese: Kienet ukoll mistennija li tintuża f'pazjenti li ma kelhomx dan il-qari mhux normali fuq l-ECG, fil-każ li kellhom anġina mhux stabbli (uġigħ gravi fis-sider) jew infart mijokardiku ‘nonQ-wave' u li jkun iddaħlilhom stent (tubu qasir li jibqa' fl-arterja biex iwaqqafha milli tingħalaq).
English: The company informed the CHMP that there are no consequences for patients who are planned to be included in clinical trials with DuoPlavin or patients currently included in clinical trials with clopidogrel and acetylsalicylic acid as separate medicines.
Maltese: Il-kumpanija infurmat lis-CHMP li ma kien hemm l-ebda konsegwenza għall-pazjenti li kienu ippjanati sabiex jiġu inklużi fil-provi kliniċi b'DuoPlavin jew għall-pazjenti li kienu attwalment inklużi fil-provi kliniċi bi clopidrogel u bl-aċidu aċetilsaliċiliku bħala mediċini separati.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with DuoPlavin?
Maltese: X'inhuma l-konsegwenzi ta' l-irtirar għall-pazjenti li kienu qed jieħdu sehem fi studji kliniċi / programmi ta' użu b'kumpassjoni bi DuoPlavin?
English: The active substances in DuoPlavin, clopidogrel and acetylsalicylic acid, are combined into one tablet in DuoPlavin to reduce the number of tablets the patients need to take every day.
Maltese: Is-sustanzi attivi f'DuoPlavin, clopidogrel u aċidu aċetilsaliċiliku jinsabu mħallata f'pillola waħda f'DuoPlavin sabiex jitnaqqas in-numru ta' pilloli li l-pazjenti jkollhom bżonn jieħdu kuljum.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Maltese: Wara li s-CHMP kien evalwa t-tweġibiet mill-kumpanija għal lista ta' mistoqsijiet, kien għad fadal xi kwistjonijiet pendenti li baqgħu ma ġewx solvuti.
English: However the CHMP thought that the company could have addressed these concerns and was of the provisional opinion that DuoPlavin could have been approved for the prevention of atherothrombotic events.
Maltese: Madanakollu is-CHMP kien ta' l-opinjoni li l-kumpanija setgħet tieħu ħsieb ta' dan it-tħassib u kienet ta' l-opinjoni provviżorja li DuoPlavin setgħet tiġi approvata għall-prevenzjoni ta' każijiet aterotrombotiċi.
English: Active substance:
Maltese: Sustanza Attiva :
English: Fertility:
Maltese: Fertilità:
English: Aluminium hydroxide (as 100%) 16.7 mg Saponin
Maltese: Aluminjum Hyroxide (bħala 100%) 16.7 mg Saponin
English: Sodium chloride Maleic acid Simeticone emulsion Aluminium hydroxide Saponin
Maltese: Sodjum Kloride Aċidu Maleic Emulsjoni ta' Simeticone Aluminium hydroxide Saponin
English: 4.3 Contraindications None.
Maltese: 4.3 Kontraindikazzjonijiet
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/09/2010.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 06/09/2010
English: EU/2/10/106/003 EU/2/10/106/004 EU/2/10/106/005 EU/2/10/106/006 EU/2/10/106/007 EU/2/10/106/008 EU/2/10/106/009 EU/2/10/106/010 EU/2/10/106/011 EU/2/10/106/012 EU/2/10/106/013 EU/2/10/106/014
Maltese: EU/2/10/106/005 EU/2/10/106/006 EU/2/10/106/007 EU/2/10/106/008 EU/2/10/106/009 EU/2/10/106/010
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports)
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati)
English: 10 x 10 ml 10 x 20 ml 10 x 50 ml 10 x 100 ml 10 x 200 ml 10 x 250 ml 10 x 500 ml
Maltese: 10ml 10 x 10ml 20ml 10 x 20ml 50ml 10 x 50ml 100ml 10 x 100ml 200ml 10 x 200ml 250ml 10 x 250ml 500ml 10 x 500ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis BTV8
Maltese: Bovilis BTV8
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta ġo friġġ (2°C - 8°C),
English: Primary vaccination:
Maltese: Vaċċinazzjoni primarja:
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Maltese: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer L-Olanda
English: Active ingredient: bluetongue virus serotype 8: 500 antigenic units* (* inducing a virus neutralising antibody response in chickens of ≥ 5.0 log2) Adjuvants: aluminium hydroxide, saponin.
Maltese: Sustanza Attiva : Bluetongue Virus serotip 8 :500 Antigenic units* (*jinduċi rispons ta' antikorpi newtralizzanti virali fit-tiġieġ ta' ≥5.0 log2) Sustanzi mhux attivi: Aluminium hyroxide, Saponin Roża opalaxxenti b'sediment li jista' jerga' jiġi sospiż
English: BATCH NUMBER Lot {number}
Maltese: NUMRU TAL-LOTT <Lott> {numru}
English: Zero days.
Maltese: 0 log2)
English: Intervet International BV Wim de Körverstraat 35, 5831 AN Boxmeer The NETHERLANDS
Maltese: Intervet International BV Wim de Körverstraat 35, 5831 AN Boxmeer L-Olanda
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (1 ml) contains:
Maltese: U KWANTITATTIVA 1 ml doża fiha:
English: Use clean and sterile vaccination equipment and avoid the introduction of contamination.
Maltese: Uża apparat għall-vaċċinazzjoni nadif u sterili u evita l-introduzzjoni ta' kontaminazzjoni.
English: It is recommended to use a multiject vaccination system.
Maltese: Huwa rakkomandat li tuża sistema ta' multiject.
English: S.C.
Maltese: A.
English: PET vials of 10, 20, 50, 100, 200, 250 or 500 ml, with a rubber stopper and aluminium cap.
Maltese: Kunjett PET ta' 10, 20, 50, 100, 200, 250 jew 500 b' tapp tal-gomma u b' kappa tal-aluminjum.
English: A post inactivation antigen quantification test should be developed after the production of 10 commercial batches
Maltese: Test post-inattivazzjoni tal-antiġen għandu jiġi żviluppat wara l-produzzjoni ta' 10 lottijiet kummerċjali
English: * (for details see section 4.4)
Maltese: *(għal dettalji ara sezzjoni 4.4)
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Trometamol
Maltese: 6.1 Lista ta' ingredjenti
English: Vials: 100 ml 200 ml 250 ml 500 ml
Maltese: 100ml 200ml 250ml 500ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis BTV8 suspension for injection for cattle and sheep
Maltese: VETERINARJU Bovilis BTV8 suspensjoni għall-injezzjoni għall-baqar u nagħaġ
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/106/001-014
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/10/106/001-014
English: Name and address of the manufacturer of the biological active substance
Maltese: Isem u indirizz tal-manufattur tas-sustanza bijoloġika attiva
English: Bovilis BTV8 is an inactivated viral vaccine, to stimulate active immunity against bluetongue virus serotype 8.
Maltese: Bovilis BTV8 huwa vaċċin virali inattivat, biex jistimula l-immunità attiva kontra l-virus talbluetongue serotip 8
English: As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Maltese: Minħabba li d-durata tal-immunità mhijiex stabbilita kompletament, kull skema ta'rivaċċinazzjoni trid tkun maqbula mal-Awtorità Kompetenti jew mal-veterinarju responsabbli, u tiġi kkunsidrata ssitwazzjoni epidemjoloġika lokali.
English: EU/2/10/106/002
Maltese: EU/2/10/106/001 EU/2/10/106/002 EU/2/10/106/003 EU/2/10/106/004
English: The vaccine is presented in cardboard boxes with 1 or 10 PET vials containing 10, 20, 50, 100, 200, 250 or 500 ml, closed with a rubber stopper and aluminium cap.
Maltese: Il-vaċċin huwa ppreżentat f'kaxxi tal-kartun b'1 jew 10 kunjetti PET li fihom 10, 20, 50, 100, 200, 250 jew 500 ml, magħluqin b'tapp tal-gomma u kappa tal-aluminjum.
English: Sheep
Maltese: Baqar
English: 0.31 mg. For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Do not freeze.
Maltese: Baqar u nagħaġ
English: Bluetongue virus serotype 8 (prior to inactivation): 500 antigenic units*.
Maltese: Bluetongue Virus serjo- tip 8 (qabel l-inattivazzjoni):500
English: Shelf life of the veterinary medicinal product as packaged for sale for 10, 20, 50 ml vials: 2 years Shelf life of the veterinary medicinal product as packaged for sale for 100, 200, 250, 500 ml vials: 1 year.
Maltese: Żmien kemm idum tajjeb il-prodott mediċinali veterinarju kif ippakkjat għall-bejgħ għall-kunjetti ta' 100, 200, 250 u 500 ml : sena.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: DATA TA' META ĠIET RIVEDUTA DIN IL-KITBA Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f'sezzjoni 6.1 tas-Sommarju tal-Karatteristiċi tal-Prodott huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan ilprodott mediċinali veterinarju
English: However, the temperature rise may be 0.5 °C higher and the swellings may be more pronounced and palpable for a longer period.
Maltese: Għalkemm, it-tlugħ fit-temperatura jista' jkun 0.5 n-nefħiet jistgħu jkunu akbar u jinħassu aktar u għal perjodu itwal.
English: In very rare cases hypersensitivity reactions may occur.
Maltese: F'każijiet rari ħafna reazzjonijiet ta' ipersensittività jistgħu jiġru.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Bluetongue virus serotype 8: 500 antigenic units/ml.
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI Bluetongue Virus serotip 8: 500
English: Revaccination:
Maltese: Rivaċċinazzjoni:
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bijoloġiku maħsuba sabiex tipproduċi immunità attiva ma taqax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: PHARMACEUTICAL FORM Suspension for injection
Maltese: Suspensjoni għall-injezzjoni
English: Pack size: cardboard box with 1 or 10 vials.
Maltese: Daqs tal-pakkett: kaxxa tal-kartun b'1 jew 10 kunjett(i).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (10, 20, 50, 100, 200, 250 or 500 ml) PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vials (100, 200, 250 or 500 ml PET vials)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun (10, 20, 50, 100, 200, 250 jew 500ml)
English: PACKAGE LEAFLET FOR: Bovilis BTV8 suspension for injection for cattle and sheep
Maltese: FIL-PAKKETT Bovilis BTV8 Suspensjoni għall-injezzjoni għall-baqar u nagħaġ
English: Any person intending to manufacture, import, possess, sell, supply and use Bovilis BTV8 must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Maltese: Kull persuna li turi l-intenzjoni li timporta, tbigħ, tipprovdi u/jew tuża Bovilis BTV8 għandha tikkonsulta mal-Awtorità Kompetenti tal-Istat Membru dwar il-programmi ta' tilqim kurrenti qabel timporta, tbigħ, tipprovdi u/jew tuża.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Għall-użu taħt il-ġilda.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, l-Istati Membri jipprojbixxu jew jistgħu jipprojbixxu l-importazzjoni, il-bejgħ, il-forniment u/jew l-użu tal-prodott mediċinali veterinarju fit-territorju sħiħ tagħhom jew parti minnu jekk jiġi stabbilit illi:
English: IMMUNOLOGICAL PROPERTIES ATCvet code: Sheep: QI04AA02 Cattle: QI02AA08 Inactivated viral vaccine, to stimulate active immunity against bluetongue virus serotype 8.
Maltese: Vaċċin virali inattivat, biex jistimula l-immunità attiva kontra l-virus serotip 8 tal-Bluetongue.
English: Cattle from 6 weeks of age: subcutaneous injection of two doses of 1 ml, administered with an interval of approximately 3 weeks.
Maltese: Baqar minn età ta' 6 ġimgħat: injezzjoni ta' żewġ dożi ta' 1ml, amministrati b'intervall ta' madwar 3 ġimgħat.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Maltese: a) l-għotja tal-prodott mediċinali veterinarju lill-annimali tinterferixxi mal-implimentazzjoni ta' programmi nazzjonali għad-djanjosi, il-kontroll u l-eradikazzjoni tal-mard tal-annimali, jew tikkawża diffikultajiet fiċ-ċertifikazzjoni tal-assenza tal-kontaminazzjoni f'annimali ħajjin jew fl-ikel jew prodotti oħrajn akkwistati minn annimali ttrattati;
English: The safety and efficacy of the vaccine has not been established in breeding males.
Maltese: Ġie muri li dan il-vaċċin inaqqas imma ma jipprevenix it-trażmissjoni tal-virus fil-baqar.
English: (* inducing a virus neutralising antibody response in chickens of ≥ 5.0 log2) Adjuvants
Maltese: Antigenic units* (*jinduċi rispons ta' antikorpi newtralizzanti virali fit-tiġieġ ta' ≥5.
English: PHARMACEUTICAL FORM Suspension for injection.
Maltese: nefħa temporanja fil-post tal-injezzjoni.
English: GERMANY
Maltese: Xejn
English: In very rare cases vaccination may result in a slight rise in temperature (usually not more than 0.5 °C, in individual cases up to about 2 °C) for up to three days after vaccination, and temporary swellings at the injection site.
Maltese: F'każijiet rari ħafna l-vaċċinazzjoni tista` twassal għal tlugħ minimu fit-temperatura (normalment 0C, u f'każijiet individwali sa madwar 2 0C) sa tlett ijiem wara l-vaċċinazzjoni, u mhux aktar minn 0.5
English: Disposal: read package leaflet.
Maltese: DAQS TAL-PAKKETT Kunjetti:
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Maltese: F'każ li tinjetta lilek innifsek fittex parir mediku mal-ewwel u qis li turi l-fuljett ta' informazzjoni filpakkett jew it-tikketta lit-tabib.
English: Scientific conclusions
Maltese: Billi
English: Annex II Scientific conclusions
Maltese: Anness II
English: Overall summary of the scientific evaluation by the CHMP
Maltese: Raġunijiet għall-opinjoni tas-CHMP
English: The active substance haloperidol is a potent central dopamine type 2 receptor antagonist, lacking antihistaminergic or anticholinergic activity at recommended doses, and exerts minimal alpha 1 adrenergic activity.
Maltese: Is-sustanza attiva haloperidol hija antagonista ċentrali potenti ta' riċettur dopaminerġiku tat-tip 2, nieqsa minn attività antistaminerġika jew antikolinerġika f'dożi rakkomandati, u teżerċita attività adrenerġika minima ta' alfa 1.
English: Haldol Decanoate - an ester of haloperidol and decanoic acid, is a depot antipsychotic belonging to the butyrophenone group.
Maltese: Haldol Decanoate - ester ta' haloperidol u aċidu dekanojku, huwa antipsikotiku depot li jappartjeni għall-grupp butyrophenone.
English: A critical evaluation of the MAH's proposed harmonised SmPC is discussed below.
Maltese: Valutazzjoni kritika tal-SmPC armonizzati proposti mill-MAH hija diskussa hawn taħt.
English: Haldol Decanoate has been approved nationally in the EU with many differences in the wording of the summary of product characteristics (SmPC), in the various Member States.
Maltese: Haldol Decanoate kien approvat fuq livell nazzjonali fl-UE b'ħafna differenzi fil-formulazzjoni tassommarju tal-karatteristiċi tal-prodott (SmPC), fid-diversi Stati Membri.
English: However specific guidance on switching from other antipsychotics has not been proposed due to limited data.
Maltese: Madankollu, ma ġiet proposta ebda gwida speċifika dwar il-bidla minn antipsikotiċi oħrajn minħabba data limitata.
English: Based on clinical trial data, guideline recommendations and expert consultations by the marketing authorisation holder (MAH) and by the HCPOs, a conversion factor of 10 to 15 is supported when switching from oral haloperidol to the longacting injectable (LAI) Haldol Decanoate.
Maltese: Abbażi tad-data tal-provi kliniċi, irrakkomandazzjonijiet tal-linji gwida u l-konsultazzjonijiet mal-esperti mid-detentur talawtorizzazzjoni għat-tqegħid fis-suq (MAH) u mill-HCPOs, huwa appoġġjat fattur ta' konverżjoni ta' 10 sa 15 meta jkun hemm bidla minn haloperidol orali għall-Haldol Decanoate injettabbli li jdum jaġixxi (LAI).
English: The contraindications in section 4.3 were also amended to include the wording related to the contraindication of cardiotoxic risk of haloperidol.
Maltese: Il-kontraindikazzjonijiet fis-sezzjoni 4.3 ġew emendati wkoll sabiex jinkludu l-formulazzjoni relatata mal-kontraindikazzjoni ta' riskju kardjotossiku tal-haloperidol.
English: The proposal for the posology wording in section 4.2 has been revised with regard to transition from oral haloperidol, continuation of treatment, and supplementation with non-decanoate haloperidol up to the maximum oral dose, in adults and the elderly.
Maltese: Il-proposta għall-formulazzjoni tal-pożoloġija fis-sezzjoni 4.2 ġiet riveduta fir-rigward tattranżizzjoni minn haloperidol orali, il-kontinwazzjoni tal-kura u s-supplimentazzjoni b'haloperidol mhux decanoate sad-doża orali massima, fl-adulti u l-anzjani.
English: Given that the maximum dose of oral haloperidol in the elderly is 5 mg/day and applying the conversion factor of 15, the maximum haloperidol decanoate dose must not be in excess of 75 mg/4wk in the elderly unless elderly patients have already received higher haloperidol (oral or decanoate) doses for long-standing schizophrenia with acceptable tolerability.
Maltese: Minħabba li d-doża massima ta' haloperidol orali fl-anzjani hija ta' 5 mg/jum u wara l-applikazzjoni tal-fattur ta' konverżjoni ta' 15, id-doża massima ta' haloperidol decanoate ma għandhiex taqbeż il-75 mg/4 ġimgħat fl-anzjani, sakemm il-pazjenti anzjani ma jkunux diġà ngħataw dożi ogħla ta' haloperidol (orali jew decanoate) għal skiżofrenija fit-tul b'tollerabilità aċċettabbli.