FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to launch of Intuniv in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Intuniv f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq (MAH) irid jaqbel dwar il-kontenut u l-format tal-programm edukattiv, li jinkludi media talkomunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspetti oħra tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: EU/1/15/1040/001 7 prolonged-release tablets EU/1/15/1040/002 28 prolonged-release tablets
Maltese: EU/1/15/1040/001 7 pilloli li jerħu l-mediċina bil-mod EU/1/15/1040/002 28 pillola li jerħu l-mediċina bil-mod
English: The effect of 2 dose levels of immediate-release guanfacine (4 mg and 8 mg) on QT interval was evaluated in a double-blind, randomised, placebo- and active-controlled, cross-over study in healthy adults.
Maltese: L-effett ta' 2 livelli ta' doża ta' guanfacine li jerħi l-mediċina fil-pront (4 mg u 8 mg) fuq l-intervall tal-QT, ġie evalwat fi studju double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bi plaċebo u b'mod attiv, tat-tip cross-over, f'adulti b'saħħithom.
English: 7.14mm round, white to off-white tablets debossed with ‘1MG' on one side and ‘503' on the other side.
Maltese: Pilloli tondi ta' 7.14 mm, ta' kulur abjad sa abjad jagħti fil-griż, imnaqqxin b'1MG' fuq naħa waħda u ‘503' fuq in-naħa l-oħra.
English: There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer.
Maltese: Kien hemm tnaqqis sinifikanti fir-rata u l-grad ta' esponiment ta' guanfacine meta jingħata flimkien ma' rifampin, induttur ta' CYP3A4.
English: 12.34mm x 6.10mm oblong shaped, white to off-white tablets debossed with ‘2MG' on one side and “503” on the other side.
Maltese: Pilloli tawwalin ta' 12.34 mm x 6.10 mm, ta' kulur abjad sa abjad jagħti fil-griż, imnaqqxin b'2MG' fuq naħa waħda u ‘503' fuq in-naħa l-oħra.
English: To minimise the risk of an increase in blood pressure upon discontinuation, the total daily dose of Intuniv should be tapered in decrements of no more than 1 mg every 3 to 7 days (see section 4.2).
Maltese: Biex jiġi mminimizzat ir-riskju ta' żieda fil-pressjoni tad-demm mattwaqqif, id-doża totali f'ġurnata ta' Intuniv għandha titnaqqas gradwalment fi tnaqqis ta' mhux aktar minn 1 mg kull 3 sa 7 ijiem (ara sezzjoni 4.2).
English: Results of the secondary endpoints were consistent with that of the primary endpoint.
Maltese: Ir-riżultati tal-punti aħħarin sekondarji kienu konsistenti ma' dawk tal-punt aħħari primarju.
English: Intuniv 1 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine.
Maltese: Intuniv 1 mg pillola Kull pillola fiha guanfacine hydrochloride ekwivalenti għal 1 mg ta' guanfacine.
English: EU/1/15/1040/006 28 prolonged-release tablets EU/1/15/1040/007 84 prolonged-release tablets
Maltese: EU/1/15/1040/006 28 pillola li jerħu l-mediċina bil-mod EU/1/15/1040/007 84 pillola li jerħu l-mediċina bil-mod
English: 28 prolonged-release tablets 84 prolonged-release tablets
Maltese: 28 pillola li jerħu l-mediċina bil-mod 84 pillola li jerħu l-mediċina bil-mod
English: Other CYP3A4/5 inhibitors may have a comparable effect, see table 3 for a list of examples of moderate and strong CYP3A4/5 inhibitors, this list is not definitive.
Maltese: Ara tabella 3 għal lista ta' eżempji ta' inibituri moderati u qawwija ta' CYP3A4/5.
English: • The 1 mg prolonged-release tablets are round and white, hard tablets, debossed with 1MG on one side and 503 on the other side.
Maltese: • Il-pilloli ta' 1 mg li jerħu mediċina bil-mod huma tondi u bojod, pilloli ibsin, imnaqqxin b'1MG fuq naħa waħda u 503 fuq in-naħa l-oħra.
English: Intuniv 1 mg prolonged-release tablets Guanfacine
Maltese: Intuniv 1 mg pilloli li jerħu l-mediċina bil-mod Guanfacine
English: • sleeping more than normal (hypersomnia)
Maltese: • irqad aktar min-normal (irqad esaġerat)
English: • itchy skin (pruritus)
Maltese: • uġigħ ta' żaqq (uġigħ addominali)
English: • concentrate.
Maltese: • jikkonċentraw.
English: Intuniv 3 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine.
Maltese: Intuniv 3 mg pillola Kull pillola fiha guanfacine hydrochloride ekwivalenti għal 3 mg ta' guanfacine.
English: Suboptimal response was defined as an ADHD-RS-IV total score of ≥24 and a CGI-S score ≥3 at screening and baseline.
Maltese: Rispons subottimali ġie definit bħala punteġġ totali ta' ADHD-RS-IV ta' ≥24 u punteġġ ta' CGI-S ta' ≥3 meta sar l-iscreening u fil-linja bażi.
English: Intuniv 4 mg prolonged-release tablets Guanfacine
Maltese: Intuniv 4 mg pilloli li jerħu l-mediċina bil-mod Guanfacine
English: 7 prolonged-release tablets 28 prolonged-release tablets
Maltese: 7 pilloli li jerħu l-mediċina bil-mod 28 pillola li jerħu l-mediċina bil-mod
English: o somnolence and sedation o hypotension o bradycardia
Maltese: • Sinjali u sintomi ta': o ngħas u sedazzjoni o pressjoni baxxa o bradikardija
English: Intuniv 3 mg prolonged-release tablets Guanfacine
Maltese: Intuniv 3 mg pilloli li jerħu l-mediċina bil-mod Guanfacine
English: Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine.
Maltese: Kull pillola fiha guanfacine hydrochloride ekwivalenti għal 3 mg ta' guanfacine.
English: Each tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine.
Maltese: Kull pillola fiha guanfacine hydrochloride ekwivalenti għal 1 mg ta' guanfacine.
English: Each tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine.
Maltese: Kull pillola fiha guanfacine hydrochloride ekwivalenti għal 2 mg ta' guanfacine.
English: Caution should be used when Intuniv is administered concomitantly with CNS depressant medicinal products (e.g., alcohol, sedatives, hypnotics, benzodiazepines, barbiturates, and antipsychotics) due to the potential for additive pharmacodynamic effects such as sedation and somnolence.
Maltese: Għandha tintuża kawtela meta Intuniv jingħata fl-istess ħin ma' prodotti mediċinali li jnaqqsu l-attività tas-CNS (eż. alkoħol, sedattivi, mediċini ipnotiċi, benzodiazepines, barbiturates, u antipsikotiċi) minħabba l-potenzjal għal effetti farmakodinamiċi addittivi bħal sedazzjoni u ngħas.
English: At the end of their double-blind treatment, a significantly larger proportion of subjects in the guanfacine compared with placebo group were normal or borderline mentally ill as measured by the clinical global impression of severity (CGI-S) that includes assessment of functioning.
Maltese: Fl-aħħar talkura double-blind tagħhom, proporzjon akbar b'mod sinifikanti ta' individwi fil-grupp ta' guanfacine meta mqabbla mal-grupp tal-plaċebo, kienu normali jew morda mentalment b'mod borderline, kif imkejla mill-impressjoni globali klinika ta' severità (CGI-S) li tinkludi evalwazzjoni tal-funzjonament.
English: Intuniv should not be administered together with grapefruit juice (see section 4.5).
Maltese: (eż. carbamazepine) (ara sezzjoni 4.5).
English: Antihypertensive medicinal products
Maltese: TAL-PRODOTT MEDIĊINALI
English: • medicines that lower your blood pressure (antihypertensives)
Maltese: • mediċini li jbaxxu l-pressjoni tad-demm tiegħek (mediċini kontra l-pressjoni għolja)
English: Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine.
Maltese: Kull pillola fiha guanfacine hydrochloride ekwivalenti għal 4 mg ta' guanfacine.
English: Dizziness postural
Maltese: Komuni ħafna
English: • tummy pain (abdominal pain).
Maltese: • pressjoni tad-demm għolja (ipertensjoni)
English: Male fertility was affected at 8 mg/kg/day, the lowest dose tested, equivalent of 10.8 times the maximum recommended human dose of 0.12 mg/kg on a mg/m basis.
Maltese: Il-fertilità fl-irġiel ġiet affettwata f'doża ta' 8 mg/kg/jum, l-inqas doża ttestjata, ekwivalenti għal 10.
English: Guanfacine is metabolised via CYP3A4/5-mediated oxidation, with subsequent phase II reactions of sulphation and glucuronidation.
Maltese: Guanfacine jiġi metabolizzat permezz ta' ossidazzjoni medjata minn CYP3A4/5, b'reazzjonijiet sussegwenti ta' fażi
English: In adults, the mean exposure of guanfacine increased (Cmax ~75% and AUC ~40%) when Intuniv was taken together with a high fat meal, compared to intake in the fasted state (see section 4.2).
Maltese: Fl-adulti, il-medja tal-esponiment ta' guanfacine żdiedet (Cmax ~75% u AUC ~40%) meta Intuniv ittieħed flimkien ma' ikla b'ħafna xaħam, meta mqabbla ma' teħid fl-istat sajjem (ara sezzjoni 4.2).
English: • feeling agitated
Maltese: • puplesiji jew konvulżjonijiet
English: Co-administration of Intuniv and valproic acid can result in increased concentrations of valproic acid.
Maltese: L-għoti flimkien ta' Intuniv u valproic acid jista' jirriżulta f'żieda fil-konċentrazzjonijiet ta' valproic acid.
English: Strong CYP3A4/5 inhibitors CYP3A4 inducers
Maltese: Pazjenti kkurati b'inibituri/indutturi ta' CYP3A4 u CYP3A5
English: If guanfacine is combined with strong enzyme inducers, a retitration to increase the dose up to a maximum daily dose 7 mg (see section 4.2), may be considered if needed.
Maltese: Jekk guanfacine jiġi kkombinat ma' indutturi qawwija tal-enzimi, tista' tiġi kkunsidrata titrazzjoni mill-ġdid biex tiżdied id-doża sa doża massima ta' kuljum ta' 7 mg (ara sezzjoni 4.2), jekk ikun meħtieġ.
English: Prior to prescribing, it is necessary to conduct a baseline evaluation to identify patients at increased risk of somnolence and sedation, hypotension and bradycardia, QT-prolongation arrhythmia and weight increase/risk of obesity.
Maltese: Qabel ma tingħata r-riċetta, hu meħtieġ li titwettaq evalwazzjoni fil-linja bażi biex jiġu identifikati pazjenti f'riskju miżjud ta' ngħas u sedazzjoni, pressjoni baxxa u bradikardija, titwil tal-QT, arritmija u żieda fil-piż/riskju ta' obeżità.
English: The physician who elects to use guanfacine for extended periods (over 12 months) should re-evaluate the usefulness of guanfacine every 3 months for the first year and then at least yearly based on clinical judgement (see section 4.4), and consider trial periods off medication to assess the patient's functioning without pharmacotherapy, preferably during times of school holidays.
Maltese: It-tabib li jagħżel li juża guanfacine għal perijodi twal (aktar minn 12-il xahar) għandu jevalwa millġdid l-utilità ta' guanfacine kull 3 xhur għall-ewwel sena u mbagħad mill-inqas kull sena skont ilġudizzju kliniku (ara sezzjoni 4.4), u jikkunsidra perjodi ta' prova fejn titwaqqaf il-medikazzjoni biex jevalwa l-funzjonament tal-pazjent mingħajr farmakoterapija, preferibbilment matul il-btajjel taliskola.
English: Guanfacine should be prescribed with caution in patients with a known history of QT prolongation, risk factors for torsade de pointes (e.g., heart block, bradycardia, hypokalaemia) or patients who are taking medicinal products known to prolong the QT interval.
Maltese: Guanfacine għandu jiġi preskritt b'kawtela f'pazjenti bi storja medika magħrufa ta' titwil tal-QT, fatturi ta' riskju għal torsade de pointes (eż. imblokk tal-qalb, bradikardija, ipokalemija) jew f'pazjenti li jkunu qed jieħdu prodotti mediċinali magħrufa li jtawlu l-intervall tal-QT.
English: • The 2 mg prolonged-release tablets are oval and white, hard tablets, debossed with 2MG on one side and 503 on the other side.
Maltese: • Il-pilloli ta' 2 mg li jerħu mediċina bil-mod huma ovali u bojod, pilloli ibsin, imnaqqxin b'2MG fuq naħa waħda u 503 fuq in-naħa l-oħra.
English: • Do not drink alcohol when taking this medicine as it may make you sleepy or drowsy.
Maltese: • Tixrobx alkoħol meta tieħu din il-mediċina, għax jista' jqabbdek in-ngħas jew iġielgħek tħossok imħeddel.
English: • fast heart beat (tachycardia)
Maltese: • pressjoni tad-demm baxxa meta tqum bilwieqfa (pressjoni baxxa ortostatika)
English: • chest pain
Maltese: • żieda fil-piż
English: In addition a 15-week, double-blind, randomised, placebo-controlled, dose-optimisation study (SPD503-312) conducted in adolescents aged 13-17 years (n=314) to confirm the efficacy, safety, and tolerability of guanfacine (1-7 mg/day) in the treatment of ADHD.
Maltese: Barra minn hekk, twettaq studju li dam 15-il ġimgħa, double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bi plaċebo, dwar l-ottimizzazzjoni tad-doża (SPD503-312), f'adolexxenti li kellhom minn 13-17-il sena (n=314) biex jikkonferma l-effikaċja, is-sigurtà, u t-tollerabilità ta' guanfacine (1-7 mg/jum) fil-kura tal-ADHD.
English: Guanfacine showed significantly greater improvement compared to placebo on the change from baseline to final on treatment assessment in the ADHD Rating Scale (ADHD-RS-IV) score in both studies (placebo-adjusted reduction in LS mean range from 5.4 to 10.0, p<0.02).
Maltese: Guanfacine wera titjib akbar b'mod sinifikanti meta mqabbel mal-plaċebo fuq il-bidla millinja bażi sal-aħħar darba li l-pazjent ikun ħa l-mediċina, mal-evalwazzjoni tal-kura fil-punteġġ talIskala tal-Klassifikazzjoni tal-ADHD (ADHD-RS-IV) fiż-żewġ studji (tnaqqis aġġustat għall-plaċebo fil-medja tal-least squares (LS) ivarja minn 5.4 sa 10.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Intuniv is launched all healthcare professionals who are expected to prescribe Intuniv are informed through an information letter on having access to / are provided with the following items:
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiżgura li, wara diskussjonijiet u ftehim mal-Awtoritajiet Kompetenti Nazzjonali f'kull Stat Membru fejn Intuniv ikun imniedi, ilprofessjonisti kollha fil-qasam mediku li huma mistennija li jagħtu riċetta għal Intuniv, jiġu infurmati permezz ta' ittra ta' informazzjoni dwar kif jiksbu aċċess għal/jiġu pprovduti b'dawn li ġejjin:
English: Other CYP3A4 inducers may have a comparable effect, see table 3 for a list of examples of CYP3A4/5 inducers, this list is not definitive.
Maltese: Ara tabella 3 għal lista ta' eżempji ta' indutturi ta' CYP3A4/5.
English: In case of concomitant use of strong and moderate CYP3A inhibitors, a 50% reduction of the guanfacine dose is recommended.
Maltese: F'każ ta' użu fl-istess ħin ta' inibituri qawwija u moderati ta' CYP3A, hu rakkomandat tnaqqis ta' 50% fid-doża ta' guanfacine.
English: These patients should receive further cardiac evaluation based on clinical judgement (see section 4.8).
Maltese: Dawn il-pazjenti għandhom jirċievu evalwazzjoni kardijaka addizzjonali skont il-ġudizzju kliniku (ara sezzjoni 4.8).
English: This evaluation should address a patient's cardiovascular status including blood pressure and heart rate, documenting comprehensive history of concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death and accurate recording of pre-treatment height and weight on a growth chart (see section 4.4).
Maltese: Din l-evalwazzjoni għandha tindirizza l-istat kardjovaskulari ta' pazjent, li jinkludi l-pressjoni tad-demm u r-rata ta' taħbit tal-qalb, u tiddokumenta l-istorja medika komprensiva ta' mediċini li jingħataw fl-istess ħin, disturbi jew sintomi mediċi u psikjatriċi komorbidi fil-passat u fil-preżenti, storja medika tal-familja ta' mewt kardijaka għal għarrieda/inspjegabbli, u rreġistrazzjoni bir-reqqa tat-tul u l-piż qabel il-kura fuq chart tat-tkabbir (ara sezzjoni 4.4).
English: • changes in liver blood test results (increased alanine aminotransferase)
Maltese: • bidliet fir-riżultati tat-testijiet tad-demm tal-fwied (żieda f'alanine aminotransferase)
English: Each 2 mg tablet contains 44.82 mg of lactose (as monohydrate).
Maltese: 82 mg ta' lactose (bħala monohydrate).
English: In this 12-week (6-12 years) or 15-week (13-17 years), randomised, double-blind, parallel-group, placebo- and active-reference (atomoxetine), dose-titration study, guanfacine showed significantly greater efficacy than placebo on symptoms of ADHD based upon investigator ratings on the ADHD Rating Scale (ADHD-RS).
Maltese: F'dan l-istudju li dam 12-il ġimgħa (6-12-il sena) jew 15il ġimgħa (13-17-il sena), li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, grupp parallel, bi plaċebo u referenza attiva (atomoxetine), dwar it-titrazzjoni tad-doża, guanfacine wera effikaċja akbar b'mod sinifikanti mill-plaċebo fuq is-sintomi tal-ADHD ibbażat fuq il-klassifikazzjonijiet talinvestigatur fuq l-Iskala tal-Klassifikazzjoni tal-ADHD (ADHD-RS).
English: QTc interval
Maltese: Mhux komuni
English: Guanfacine also showed significant improvement in learning, school and family functioning as measured with the (WFIRS-P score).
Maltese: Guanfacine wera wkoll titjib sinifikanti fit-tagħlim, filfunzjonament fl-iskola u fil-familja kif imkejla bil-(punteġġ WFIRS-P).
English: In a drug interaction study, neither Intuniv nor Osmotic Release Oral System (OROS)methylphenidate HCl extended-release were found to affect the pharmacokinetics of the other medicinal products when taken in combination.
Maltese: Fi studju dwar l-interazzjoni tal-mediċina, la Intuniv u lanqas Osmotic Release Oral System (OROS)-methylphenidate HCl li jerħi l-mediċina b'mod estiż, ma nstabu li jaffettwaw ilfarmakokinetika tal-prodotti mediċinali l-oħrajn meta jittieħdu flimkien.
English: Guanfacine is cleared both by the liver and the kidneys, and at least 50% of the clearance of guanfacine is hepatic.
Maltese: Guanfacine jitneħħa kemm mill-fwied kif ukoll mill-kliewi, u mill-inqas 50% tat-tneħħija ta' guanfacine hi mill-fwied.
English: Week 5 Week 6 Week 7
Maltese: Ġimgħa 6 Ġimgħa 7
English: Atrioventricular block first degree
Maltese: Imblokk atrijoventrikulari tal-ewwel grad
English: The study was double-blind, randomised, placebo-controlled, multi-centre, dose-optimisation 9-weeks study.
Maltese: L-istudju kien double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bi plaċebo, multiċentriku, dwar l-ottimizzazzjoni tad-doża, li dam 9 ġimgħat.
English: In a maintenance of efficacy study in children and adolescents, increases in mean systolic and diastolic blood pressure of approximately 3 mmHg and 1 mmHg, respectively, above original baseline were observed upon discontinuation of Intuniv.
Maltese: Fi studju ta' manteniment dwar l-effikaċja fit-tfal u fl-adoloxxenti, mat-twaqqif ta' Intuniv, ġew osservati żidiet fil-medja tal-pressjoni tad-demm sistolika u dijastolika ta' madwar 3 mmHg u 1 mmHg rispettivament, ogħla mil-linja bażi oriġinali.
English: QT Prolonging medicinal products
Maltese: IL-PRODOTT MEDIĊINALI
English: • you have low or high blood pressure, heart problems or have a family history of heart problems
Maltese: • għandek pressjoni tad-demm baxxa jew għolja, problemi tal-qalb jew għandek storja medika tal familja ta' problemi tal-qalb
English: Invented name
Maltese: Numru ta' l-EU Isem inventat Qawwa
English: What is colistin?
Maltese: X'inhu colistin?
English: 14 July 2016
Maltese: 14 ta' Lulju 2016
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/111)
Maltese: Riżultat ta' proċedura ta' referenza skont l-Artikolu 35 tad-Direttiva 2001/82/KE (EMEA/V/A/111)
English: Colistin belongs to the polymyxin group of antibiotics.
Maltese: Colistin jagħmel parti mill-grupp ta' antibijotiċi polimiksini.
English: These include veterinary medicinal products containing combinations of colistin with 14 different antimicrobial substances, belonging to different classes e.g. β-lactams, tetracyclines, macrolides, sulfonamides and trimethoprim (see Annex I on the 'All documents' tab).
Maltese: Dawn jinkludu prodotti mediċinali veterinarji li fihom il-kombinazzjonijiet ta' colistin b'14-il sustanza antimikrobika differenti, li jappartjenu għal klassijiet differenti eż. β-lactams, tetracyclines, macrolides, sulfonamides u trimethoprim (ara l-Anness I fuq it-tab 'All documents' (id-dokumenti kollha)).
English: CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf
Maltese: Linja gwida tas-CVMP dwar prodotti farmaċewtiċi ta' kombinazzjoni fissa (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf għat-tqegħid fis-suq għall-prodotti mediċinali veterinarji kollha li fihom colistin f'kombinazzjoni ma' sustanzi antimikrobiċi oħra li għandhom jiġu amministrati b'mod orali.
English: Combinations of colistin with other antimicrobials are available for group treatments of gastro-intestinal and respiratory infections in food-producing animals in different European Member States.
Maltese: Il-kombinazzjonijiet ta' colistin ma' antimikrobiċi oħrajn huma disponibbli għall-kura fi gruppi ta' infezzjonijiet gastrointestinali u respiratorji f'annimali li jipproduċu l-ikel f'xi Stati Membri differenti Ewropej.
English: Commission Decision concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for all veterinary medicinal products containing "Colistin" to be administered orally ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm
Maltese: Deċiżjoni tal-Kummissjoni li tikkonċerna, fil-qafas tal-Artikolu 35 tad-Direttiva 2001/82/KE tal-Parlament Ewropew u talKunsill, l-awtorizzazzjonijiet kollha għat-tqegħid fis-suq għall-prodotti mediċinali veterinarji kollha li fihom "Colsitin" li għandhom jiġu amministrati b'mod orali ((2015)1916 tas-16/03/2015) http://ec.europa.eu/health/documents/communityregister/html/vo25478.htm
English: In May 2014 the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing colistin as sole active substance for oral administration to food-producing species (EMEA/V/A/106).
Maltese: F'Mejju 2014 il-Kummissjoni Ewropea tat bidu għal proċedura ta' riferiment skont l-Artikolu 35 tadDirettiva 2001/82/KE għall-prodotti mediċinali veterinarji kollha li fihom colistin bħala l-unika sustanza attiva għall-amministrazzjoni orali lil speċi li jipproduċu l-ikel (EMEA/V/A/106).
English: Why were veterinary medicinal products containing colistin in combination with other antimicrobial substances reviewed?
Maltese: Għaliex il-prodotti mediċinali veterinarji li fihom colistin flimkien ma' sustanzi antimikrobiċi oħrajn ġew riveduti?
English: Colistin is used for the treatment and prevention of diseases caused by sensitive bacteria (e.g. Escherichia coli) in pigs, poultry, rabbits, cattle, sheep and goats.
Maltese: Escherichia coli) fil-ħnieżer, tjur, fniek, baqar, nagħaġ u mogħoż.
English: Following a request from the European Commission, in July 2013 the CVMP and CHMP adopted scientific advice and detailed considerations on colistin
Maltese: Wara talba mill-Kummissjoni Ewropea, f'Lulju 2013, is-CVMP u s-CHMP adottaw parir xjentifiku u konsiderazzjonijiet dettaljati dwar colistin
English: On 21 April 2016, the European Medicines Agency (the Agency) completed a review of the effectiveness of and antimicrobial resistance to all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally.
Maltese: Fil-21 ta' April 2016, l-Aġenzija Ewropea għall-Mediċini (l-Aġenzija) temmet reviżjoni tal-effikaċja ta' u r-reżistenza antimikrobika għall-prodotti mediċinali veterinarji kollha li fihom colistin flimkien ma' sustanzi antimikrobiċi oħra li għandhom jiġu amministrati b'mod orali.