FrancophonIA/ELRC3.0 huggingface dataset:
English: Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Maltese: Injezzjoni waħda taħt il-ġilda jew ġol-vina, b'doża ta' 0.5 mg ta' meloxicam / kg ta' piż tal-ġisem (i.e. 2.5 ml / 100 kg ta' piż tal-ġisem) flimkien ma' terapija antibijotika, jew ma' terapija orali ta'
English: ul.
Maltese: OĦRA
English: Meloxicam in Emdocam 20 mg/ml solution for injection for cattle, pigs and horses is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Meloxicam f'Emdocam 20 mg/ml soluzzjoni għal injezzjoni għal frat, majjali u żwiemel hi sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tar-Regolament tal-Kummissjoni (UE) Nru
English: Do not breach the vial more than 50 times.
Maltese: Ittaqqabx il-kunjett għal aktar minn 50 darba.
English: meat and offal: 5 days.
Maltese: laħam u ġewwieni tal-annimali: 5 ijiem.
English: In pigs, after intramuscular administration the mean plasma elimination half-life is approximately 2.5 hours.
Maltese: Fil-majjali, wara li jingħata b'injezzjoni ġol-muskoli, il-medja tal-half-life tal-eliminazzjoni tal-plażma hi ta' madwar 2.5 sigħat.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Maltese: Is-sustanzi mhux attivi elenkati f'sezzjoni 6.1 tal-SPC huma jew sustanzi permessi li għalihom tabella 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 tindika li l-ebda MRLs mhuma meħtieġa jew huma kkunsidrati li mhumiex fi ħdan l-iskop tar-Regolament (KE) Nru. 470/2009 meta jintużaw bħal f'dan il-prodott.
English: Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Maltese: Tużax f'annimali li għandhom indeboliment fil-funzjoni tal-fwied, tal-qalb jew tal-kliewi, u mard emorraġiku, jew fejn ikun hemm evidenza ta' leżjonijiet gastrointestinali ulċeroġeniċi.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label for 100 ml and 250 ml
Maltese: Tikketta tal-kunjett għal 100 ml u 250 ml
English: Meloxicam Meloxicam Bovine, caprine, porcine, rabbit,
Maltese: Meloxicam Meloxicam Gniedes,
English: s.r.l.
Maltese: L-ISEM
English: In case of overdose, symptomatic treatment should be initiated.
Maltese: F'każ ta' doża eċċessiva, għandu jinbeda trattament sintomatiku.
English: Horses: meat and offal: 5 days.
Maltese: Majjali: laħam u ġewwieni tal-annimali: 5 ijiem.
English: C. STATEMENT OF THE MRLs
Maltese: SC Altius SRL
English: Single intramuscular injection at a dose of 0.4 mg meloxicam/kg body weight (i.e. 2 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate.
Maltese: Injezzjoni waħda fil-muskolu b'doża ta' 0.4 mg ta' meloxicam / kg ta' piż tal-ġisem (i.e.
English: If required, a second administration of meloxicam can be given after 24 hours.
Maltese: Jekk ikun meħtieġ, it-tieni doża ta' meloxicam tista' tingħata wara 24 siegħa.
English: Cytarabine is an analogue of pyrimidine.
Maltese: Cytarabine huwa analoġiku għal pyrimidine.
English: DepoCyte is a suspension for injection that contains 50 mg of the active substance, cytarabine.
Maltese: DepoCyte hija sospensjoni għall-injezzjoni li fiha 50 mg ta' sustanza attiva cytarabine.
English: Other information about DepoCyte:
Maltese: Informazzjoni oħra dwar DepoCyte:
English: This document is a summary of the European Public Assessment Report (EPAR) for DepoCyte.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal DepoCyte.
English: In the main study, 72% of the patients who received DepoCyte responded to treatment (13 out of 18), compared with 18% of those who received the standard formulation of cytarabine (3 out of 17).
Maltese: Fl-istudju ewlieni, 72% tal-pazjenti li ngħataw DepoCyte irrispondew għat-trattament (13 minn 18), meta mqabbla mat-18% ta' dawk li ngħataw il-formulazzjoni standard ta' cytarabine (3 minn 17).
English: The marketing authorisation holder is Pacira Limited.
Maltese: Id-deterntur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Pacira Limited.
English: These symptoms mainly affect the nerves, and include pain, fits, headache, problems walking, memory problems, incontinence and unusual sensations.
Maltese: Dawn is-sintomi jaffettwaw l-iktar in-nervituri, u jikkawżaw uġigħ, aċċessjonijiet, uġigħ ta' ras, problemi fil-mixi, problemi fil-memorja, inkontinenzja u sensazzjonijiet mhux normali.
English: The most common side effects with DepoCyte (seen in more than 1 treatment cycle in 10) are headache, arachnoiditis (inflammation of one of the membranes protecting the spine and the brain), confusion, nausea (feeling sick), vomiting, diarrhoea, pyrexia (fever), weakness and thrombocytopenia (low blood platelet counts).To minimise the symptoms of arachnoiditis, patients should receive dexamethasone by mouth or by injection at the same time as DepoCyte and must be closely monitored.
Maltese: L-aktar effetti sekondarji komuni b'DepoCyte (kif deher f'1 minn kull 10 ċikli) huma wġiegħ ta' ras, araknojdite (infjammazzjoni ta' wieħed mill-inforri li jipproteġu x-xewka tad-dahar u l-moħħ), konfużjoni, tqalligħ (tħossok ma tiflaħx), remettar, dijarea, piressija (deni), għejja u thrombocytopenia (għadd baxx ta' plejtlits fid-demm).
English: DepoCyte has been compared with a standard formulation of cytarabine in one main study involving 35 patients with lymphomatous meningitis.
Maltese: DepoCyte tqabbel ma' formulazzjoni standard ta' cytarabine fi studju ewlieni li involva 35 pazjent li jbatu bil-meninġite limfatika.
English: Why has DepoCyte been approved?
Maltese: Għaliex ġie approvat DepoCyte?
English: What is the risk associated with DepoCyte?
Maltese: X'inhu r-riskju assoċjat ma' DepoCyte?
English: What is DepoCyte?
Maltese: X'inhu DepoCyte?
English: The European Commission granted a marketing authorisation valid throughout the European Union for DepoCyte on 11 July 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal DepoCyte fil-11 ta' Lulju 2001.
English: DepoCyte is first given as a 50-mg injection every two weeks for the first five doses, followed by a further 50 mg four weeks later.
Maltese: DepoCyte tingħata fil-bidu f'injezzjoni ta' 50 mg kull ġimgħatejn għall-ewwel ħames dożi, segwiti minn doża ta' 50 mg oħra erba' ġimgħat wara.
English: The patient should also receive dexamethasone (a steroid) to help control some of the medicine's side effects.
Maltese: Il-pazjent għandu jirċievi wkoll dexamethasone (sterojde) sabiex jikkontrolla l-effetti sekondarji tal-mediċina.
English: This summary was last updated in 04-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fil-04-2011.
English: This is a condition in which cells from a lymphoma (a tumour in the lymphatic system) have spread to the spinal fluid and the meninges (the membranes that surround the brain and spinal cord).
Maltese: Din hija kondizzjoni fejn iċ-ċelluli tallimfoma (tumur fis-sistema limfatika) jkunu infirxu fil-likwidu tax-xewka tad-dahar u l-meninġi (ilmembrani ta' madwar il-moħħ u s-sinsla tad-dahar (meninġi).
English: DepoCyte is a ‘depot' injection (a type of injection where the medicine is prepared so that it is absorbed by the body very slowly).
Maltese: DepoCyte hija injezzjoni depot (tip ta' injezzjoni fejn il-mediċina hija preparata b'mod li tiġi assorbita mill-ġisem bil-mod ħafna).
English: What benefit has DepoCyte shown during the studies?
Maltese: Liema benefiċċju wera DepoCyte waqt l-istudji li ġew mwettqa?
English: In the body, cytarabine takes the place of pyrimidine and interferes with the enzymes involved in the production of new DNA.
Maltese: Fil-ġisem, cytarabine jieħu post il-pyrimidine u jinterferixxi mal-enzimi li jieħdu sehem fissintesi tad-DNA.
English: The active substance in DepoCyte, cytarabine (also known as ara-C), is an anticancer medicine that has been used since the 1970s.
Maltese: Is-sustanza attiva fid-DepoCyte, cytarabine (magħrufa wkoll bħala ara-C), hija aġent kontra l-kanċer li ilu jintuża fil-mediċina mis-snin sebgħin. ċitotossika (mediċina li toqtol iċ-ċelloli li jkunu qed jinqasmu bħaċ-ċelloli tal-kanċer) li jkunu parti mill-grupp ta' anti-metaboliti.
English: DepoCyte helps to control the symptoms of the disease.
Maltese: DepoCyte jgħin fil-kontroll tas-sintomi tal-marda.
English: The CHMP noted that DepoCyte had shown effectiveness in lymphomatous meningitis when compared with the standard formulation of cytarabine, and that it could improve patients' quality of life because fewer intrathecal injections are needed.
Maltese: Is-CHMP ikkonkluda li d-DepoCyte wera li huwa effettiv għall-kura tal-meninġite limfomatika meta kumparat mal-formulazzjoni standard tas-cytarabine, u jista' jtejjeb il-livel tal-għijxien tal-pazjenti peress li jeħtieġ anqas injezzjonijiet intratekali.
English: DepoCyte is used to treat lymphomatous meningitis.
Maltese: DepoCyte jintuża sabiex tiġi ttrattata l-meninġite limfatika:
English: DepoCyte should only be given by a doctor who has experience in the use of anticancer medicines.
Maltese: DepoCyte għandha tingħata biss minn tabib li għandu esperjenza fl-użu ta' mediċini ta' kontra l-kanċer.
English: How does DepoCyte work?
Maltese: Kif ġie studjat DepoCyte?
English: For the full list of all side effects reported with DepoCyte, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji rrapportati tad-DepoCyte, ara l-Fuljett ta' Tagħrif.
English: In DepoCyte, cytarabine is contained in liposomes (small fatty particles), from which the medicine is released slowly.
Maltese: Fid-DepoCyte, cytarabine huwa miżmum f'lipożomi (partiċelli xaħmin żgħir) minn fejn tiġi rilaxxata bilmod il-mod il-mediċina.
English: Pharmaceutical Form Route of Administration Packaging
Maltese: Għamla Farmaċewtika Mnejn Jingħata
English: Invented name Strength
Maltese: Numru ta' l-UE Isem ivvintat
English: Respiratory depression
Maltese: Dipressjoni respiratorja
English: Undesirable effects Respiratory, thoracic and mediastinal disorders Frequency ‘rare': Respiratory depression
Maltese: .8. Effetti mhux mixtieqa Disturbi respiratorji, toraċiċi u medjastinali: Frekwenza "rari": Dipressjoni respiratorja
English: Gabapentin - Respiratory depression without concomitant opioid use (EPITT no 18814)
Maltese: Gabapentin - Dipressjoni respiratorja mingħajr l-użu konkomitanti ta' opjojdi (EPITT nru 18814)
English: Gabapentin has been associated with severe respiratory depression.
Maltese: Gabapentin ġie assoċjat ma' dipressjoni respiratorja severa.
English: - if you have nervous system disorders, respiratory disorders, or you are more than 65 years old, your doctor may prescribe you a different dosing regimen
Maltese: − jekk għandek disturbi fis-sistema nervuża, disturbi respiratorji, jew jekk għandek aktar minn 65 sena, it-tabib tiegħek jista' jippreskrivilek skema tad-dożaġġ differenti
English: Adopted at the 6-9 June 2017 PRAC
Maltese: Adottati fil-PRAC ta' bejn is-6 u d-9 ta' Ġunju 2017
English: Patients with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of CNS depressants and the elderly might be at higher risk of experiencing this severe adverse reaction.
Maltese: Il-pazjenti b'funzjoni respiratorja kompromessa, marda respiratorja jew newroloġika, insuffiċjenza tal-kliewi, użu konkomitanti ta' dipressanti tas-CNS u l-anzjani jistgħu jkunu f'riskju ogħla li jesperjenzaw din ir-reazzjoni avversa severa.
English: - Trouble breathing, shallow breaths (respiratory depression)
Maltese: − Problemi biex tieħu n-nifs, nifsijiet qosra (dipressjoni respiratorja)
English: Dose adjustments might be necessary in these patients.
Maltese: It-test attwali li għandu jitħassar huwa maqtugħ.
English: - breathing problems, which if severe you may need emergency and intensive care to continue breathing normally
Maltese: − problemi bin-nifs, li jekk ikunu severi jista' jkollok bżonn emerġenza u kura intensiva biex tkompli tieħu n-nifs b'mod normali
English: In particular, tell your doctor (or pharmacist) if you are taking or have been recently taking any medicines for convulsions, sleeping disorders, depression, anxiety, or any other neurological or psychiatric problems.
Maltese: B'mod partikolari, għid lit-tabib (jew lill-ispiżjar) tiegħek jekk qed tieħu jew kont qed tieħu dan laħħar xi mediċini għal konvulżjonijiet, disturbi fl-irqad, dipressjoni, ansjetà jew xi problemi newroloġiċi jew psikjatriċi oħra.
English: EU/1/18/1277/001 Mylotarg
Maltese: EU/1/18/1277/001
English: Powder for concentrate for solution for infusion
Maltese: 5 mg Trab għal konċentrat għal soluzzjoni għallinfużjoni
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA
English: EMA/58565/2014 EMEA/H/C/003824
Maltese: EMEA/H/C/003824
English: The full EPAR and risk management plan summary for Rivastigmine 3M Health Care Ltd 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: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku rivastigminea
English: The active substance in Rivastigmine 3M Health Care Ltd, rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Maltese: Is-sustanza attiva f'Rivastigmine 3M Health Care Ltd, rivastigmine, taħdem billi timblokka l-enzimi li jkissru acetylcholine: acetylcholinesterase u butyrylcholinesterase.
English: Rivastigmine 3M Health Care Ltd is a ‘generic medicine'.
Maltese: Rivastigmine 3M Health Care Ltd hija ‘mediċina ġenerika'.
English: Rivastigmine 3M Health Care Ltd is a medicine that contains the active substance rivastigmine.
Maltese: Rivastigmine 3M Health Care Ltd huwa mediċina li fiha s-sustanza attiva rivastigmine.
English: Because Rivastigmine 3M Health Care Ltd is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Exelon.
Maltese: Peress li Rivastigmine 3M Health Care Ltd hija mediċina ġenerika, l-istudji fin-nies ġew limitati għal testijiet biex jiġi stabbilit li din hija bijoekwivalenti għall-mediċina ta' referenza, Exelon.
English: Rivastigmine 3M Health Care Ltd is used to treat patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Maltese: Rivastigmine 3M Health Care Ltd jintuża għall-kura ta' pazjenti b'dimenzja ta' Alzheimer ħafifa sa moderatament severa, disturb progressiv tal-moħħ li gradwalment jaffettwa l-memorja, l-abbiltà intellettwali u l-imġiba.
English: Rivastigmine 3M Health Care Ltd can only be obtained with a prescription and is available as transdermal patches, which release either 4.6 or 9.5 mg rivastigmine across the skin over 24 hours.
Maltese: Rivastigmine 3M Health Care Ltd jista' jinkiseb biss b'riċetta tat-tabib u huwa disponibbli bħala garżi transdermali, li jerħu 4.6 jew 9.5 mg ta' rivastigmine fil-ġilda fi żmien 24 siegħa.
English: This is a summary of the European public assessment report (EPAR) for Rivastigmine 3M Health Care Ltd.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Rivastigmine 3M Health Care Ltd.
English: This means that Rivastigmine 3M Health Care Ltd is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exelon.
Maltese: Dan ifisser li Rivastigmine 3M Health Care Ltd huwa simili għal ‘mediċina ta' referenza' li diġà hija awtorizzata fl-Unjoni Ewropea (UE) imsejħa Exelon.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine 3M Health Care Ltd on 3 April 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Rivastigmine 3M Health Care Ltd fi 03 ta' April 2014.
English: Treatment should be started with the 4.6-mg-per-24-hours patch, with the dose increased to the higher strength 9.5 mg/24-h patch after at least four weeks if the lower dose is well tolerated.
Maltese: Il-kura għandha tinbeda b'impjastru ta' 4.6 mg għal kull 24 siegħa, bid-doża tiġi miżjuda għal impjastru b'qawwa aktar b'saħħitha ta' 9.5 mg/24-h tal-inqas wara erba' ġimgħat jekk id-doża aktar baxxa tkun ittollerata sew.
English: By blocking these enzymes, Rivastigmine 3M Health Care Ltd allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia.
Maltese: Billi jimblokka lil dawn l-enzimi, Rivastigmine 3M Health Care Ltd jippermetti li jiżdiedu l-livelli ta' acetylcholine fil-moħħ, u b'hekk jgħin inaqqas is-sintomi tad-dimenzja ta' Alzheimer.
English: A risk management plan has been developed to ensure that Rivastigmine 3M Health Care Ltd is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Rivastigmine 3M Health Care Ltd jintuża blaktar mod sigur possibbli.
English: In patients with Alzheimer's dementia, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).
Maltese: F'pazjenti bid-dimenzja ta' Alzheimer, ċerti ċelluli tan-nervituri jmutu fil-moħħ, u dan jirriżulta f'livelli baxxi tan-newrotrażmettitur aċetilkolina (sustanza li tippermetti li ċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin).
English: Other information about Rivastigmine 3M Health Care Ltd
Maltese: Kif jintuża Rivastigmine 3M Health Care Ltd?
English: Why is Rivastigmine 3M Health Care Ltd approved?
Maltese: Għal xiex ġie approvat Rivastigmine 3M Health Care Ltd?
English: Because Rivastigmine 3M Health Care Ltd is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Rivastigmine 3M Health Care Ltd hija mediċina ġenerika u hija bijoekwivalenti għallmediċina ta' referenza, il-benefiċċji u r-riskji tagħha jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: How does Rivastigmine 3M Health Care Ltd work?
Maltese: Kif jaħdem Rivastigmine 3M Health Care Ltd?
English: How has Rivastigmine 3M Health Care Ltd been studied?
Maltese: Kif ġie studjat Rivastigmine 3M Health Care Ltd?
English: Article 35 of Directive 2001/82/EC, as amended.
Maltese: Artikolu 35 tad-Direttiva 2001/82/KE, kif emendat.
English: OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR Injectable veterinary medicinal products containing ivermectin that are indicated for use in cattle at dose of 200 μg ivermectin per kg bodyweight
Maltese: OPINJONI WARA REFERENZA SKONT L-ARTIKOLU 351 GĦAL Prodotti mediċinali veterinarji injettabbli li fihom ivermektina (ivermectin) indikati għall-użu fil-bhejjem tal-ifrat f'doża ta' 200 μg ivermektina għal kull kg tal-piż tal-ġisem
English: Ivermectin belongs to the macrocyclic lactone class of endectocides with activity against a wide rage of internal and external parasites.
Maltese: Ivermektina (ivermectin) hija endektoċida li tappartjeni għall-klassi tal-lattoni makroċikliċi (macrocyclic lactone) b'attività kontra firxa wiesgħa ta' parassiti interni u esterni.
English: The detailed grounds for the re-examination were submitted by Norbrook Laboratories Ltd on 14 April 2009.
Maltese: Ir-raġunijiet dettaljati għall-eżami mill-ġdid ġew ippreżentati min-Norbrook Laboratories Ltd fl-14 ta' April 2009.
English: Injectable veterinary medicinal products containing ivermectin, either as a single active substance or in combination with a second active substance are indicated for use in cattle for the treatment of endoparasitic and ectoparasitic infestations.
Maltese: Il-prodotti mediċinali veterinarji injettabbli li fihom ivermektina, sew bħala sustanza attiva unika u sew f'kombinazzjoni ma' sustanza attiva oħra huma indikati għall-użu fil-bhejjem tal-ifrat għat-trattament tal-infestazzjonijiet minn endoparassiti u ektoparassiti.
English: International Non-Proprietary Name (INN): Ivermectin
Maltese: Denominazzjoni Komuni Internazzjonali (DKI):
English: On 25 February 2009, Norbrook Laboratories Ltd, notified the EMEA of its intention to request the reexamination of the CVMP opinion of 11 February 2009.
Maltese: Fil-25 ta' Frar 2009, in-Norbrook Laboratories Ltd innotifikat lill-EMEA bl-intenzjoni tagħha li titlob eżami mill-ġdid tal-opinjoni tas-CVMP ddatata l-11 ta' Frar 2009.
English: 1 October 2009 Doc.
Maltese: 1 ta' Ottubru 2009 Dok ta' ref.
English: Oral explanations were given on 12 May 2009.
Maltese: L-ispjegazzjonijiet orali ngħataw fit-12 ta' Mejju 2009.
English: Eighteen Member States responded and submitted information concerning 103 of the outstanding 120 Marketing Authorisations.
Maltese: Tmintax-il Stat Membru wieġbu u ppreżentaw l-informazzjoni dwar 103 minn fost il-120 Awtorizzazzjoni għatTqegħid fis-Suq.
English: On 4 June 2008 the National Competent Authorities of the Member States were requested to provide the missing information for the outstanding 120 Marketing Authorisations.
Maltese: Fl-4 ta' Ġunju 2008 l-awtoritajiet nazzjonali kompetenti tal-Istati Membri ntalbu jipprovdu linformazzjoni nieqsa għall-120
English: The Committee appointed Dr G. J. Schefferlie as rapporteur and Dr J. G. Beechinor, Prof C. Friis, Prof R. Kroker and Dr B. Urbain as co-rapporteurs.
Maltese: R. Kroker u lid-Dott. B. Urbain bħala l-korelaturi.
English: On 9 December 2008 and 14 January 2009 two Marketing Authorisation Holders provided oral explanations at their request.
Maltese: Fid-9 ta' Diċembru 2008 u fl-14 ta' Jannar 2009 żewġ Detenturi tal-Awtorizzazzjoni għat-Tqegħid fisSuq ipprovdew spjegazzjonijiet bil-miktub fuq talba tagħhom.
English: On 21 May 2008 the EMEA received a total of 19 written explanations from the Marketing Authorisation Holders (either as a group of or individual Marketing Authorisation Holders).
Maltese: Fil-21 ta' Mejju 2008 l-EMEA rċeviet total ta' 19-il spjegazzjoni bil-miktub mid-Detenturi talAwtorizzazzjoni għat-Tqegħid fis-Suq (bħala grupp ta' Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq jew individwalment).
English: Due to concerns that the difference in withdrawal periods established across the European Union for injectable veterinary medicinal products containing ivermectin which are indicated for use in cattle and with a dose of 200µg ivermectin/kg bodyweight may present a potential serious risk to human health, the United Kingdom referred the matter to the EMEA on 14 December 2007, under Article 35 of Directive 2001/82/EC.
Maltese: Minħabba xi tħassib dwar il-fatt li d-differenza fil-perjodi ta' rtirar stabbiliti fl-Unjoni Ewropea għallprodotti mediċinali veterinarji injettabbli li fihom ivermektina indikati għall-użu fil-bhejjem tal-ifrat u b'doża ta' 200 µg ivermektina/kg ta' piż tal-ġisem tista' tippreżenta riskju potenzjali gravi għal saħħet il-bniedem, ir-Renju Unit irrefera l-kwistjoni lill-EMEA fl-14 ta' Diċembru 2007, skont l-Artikolu 35
English: With regard to the products containing ivermectin in combination with clorsulon as a second active substance a withdrawal period of 66 days for cattle was recommended.
Maltese: Għal dak li għandu x'jaqsam mal-prodotti li fihom ivermektina f'kombinazzjoni ma' clorsulon bħala sustanza attiva oħra, ġie rakkomandat perjodu ta' rtirar ta' 66 jum għall-bhejjem tal-ifrat.
English: During its 10-12 March 2009 meeting, the CVMP, appointed Dr A. Holm as rapporteur and Dr M. Holzhauser-Alberti as co-rapporteur for the re-examination of the above mentioned opinion.
Maltese: Matul il-laqgħa tiegħu li saret fl-10-12 ta' Marzu 2009, is-CVMP ħatar lid-Dott.ssa A.
English: Further to the resignation of Prof R. Kroker as CVMP member, Dr C. Ibrahim was appointed to replace him and took over the co-rapporteurship.
Maltese: Broker minn membru tas-CVMP, id-Dott.ssa C.