FrancophonIA/ELRC3.0 huggingface dataset:
English: This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.
Maltese: Dan iwassal għal tnaqqis fil-pressjoni tad-demm u għal tnaqqis fir-riskji assoċjati mal-pressjoni għolja tad-demm, bħal attakk ta' qalb jew puplesija.
English: How does Telmisartan Teva work?
Maltese: Għal xiex jintuża Telmisartan Teva?
English: Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day.
Maltese: Pazjenti bi tnaqqis moderat jew ħafif fil-funzjoni tal-fwied m'għandhomx jirċievu dożi ogħla minn 40 mg kuljum.
English: Therefore, the CHMP's view was that, as for Micardis, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal filkaż ta' Micardis, il-benefiċċji huma akbar mir-riskji identifikati.
English: Patients with severely reduced kidney function should receive a lower starting dose of 20 mg once a day.
Maltese: Pazjenti bi tnaqqis sever fil-funzjoni tal-kliewi għandhom jingħataw doża tal-bidu mnaqqsa ta' 20mg darba kuljum.
English: Vantobra1 (tobramycin)
Maltese: Vantobra1 (tobramiċina)
English: Further information on Vantobra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/vantobra
Maltese: ema.europa.eu/medicines/human/EPAR/vantobra
English: Vantobra is a ‘hybrid medicine'.
Maltese: Vantobra huwa “mediċina ibrida”.
English: Other information about Vantobra
Maltese: Informazzjoni oħra dwar Vantobra
English: The recommended dose is one ampoule twice a day, ideally 12 hours apart.
Maltese: Id-doża rakkomandata hija ampolla waħda darbtejn kuljum, idealment bi 12-il siegħa bejn doża u oħra.
English: The active substance in Vantobra, tobramycin, belongs to the group of antibiotics known as ‘aminoglycosides'.
Maltese: Is-sustanza attiva f'Vantobra, it-tobramiċina, tagħmel parti mill-grupp ta' antibijotiċi magħrufin bħala “aminoglikosidi”.
English: 1 Previously known as Tobramycin PARI.
Maltese: 1 Preċedentement magħruf bħala Tobramycin PARI
English: The reference medicine for Vantobra is Tobi.
Maltese: Ilmediċina ta' referenza għal Vantobra hija Tobi.
English: In addition, a ‘bioequivalence' study in 58 patients with cystic fibrosis aged 6 years and above determined whether Vantobra produces similar levels of the active substance in the body as the reference medicine, Tobi.
Maltese: Barra minn hekk, studju ta' “bijoekwivalenza” fuq 58 pazjent b'fibrożi ċistika li għandhom sitt snin u aktar iddetermina jekk Vantobra jipproduċix livelli simili tas-sustanza attiva fil-ġisem bħall-mediċina ta' referenza, Tobi.
English: Tobramycin has been used for several years to treat P. aeruginosa infection in patients with cystic fibrosis and the applicant submitted data from the literature to support the use of Vantobra.
Maltese: It-tobramiċina ntużat għal diversi snin biex tikkura l-infezzjoni P. aeruginosa f'pazjenti b'fibrożi ċistika u l-applikant issottometta data mid-dokumentazzjoni biex jappoġġja l-użu ta' Vantobra.
English: After a 28-day course of treatment, the patient stops treatment for 28 days, before starting another 28-day course.
Maltese: Wara kors ta' kura ta' 28 jum, il-pazjent iwaqqaf il-kura għal 28 jum, qabel ma jibda kors ieħor ta' 28 jum.
English: How is Vantobra used?
Maltese: Vantobra?
English: Vantobra is available as a nebuliser solution in single-dose ‘ampoules'.
Maltese: Vantobra jiġi bħala soluzzjoni għan-nebulizzatur f'“ampolli” b'doża waħda.
English: However, the following side effects are seen in up to 1 in 100 patients: dyspnoea (difficulty breathing), dysphonia (hoarseness), pharyngitis (sore throat) and cough.
Maltese: Madankollu, l-effetti sekondarji li ġejjin huma osservati f'mhux aktar minn pazjent wieħed f'100 pazjent: dispnea (diffikultà fit-teħid tan-nifs), disfonja (ħanqa), farinġite (uġigħ fil-griżmejn) u sogħla.
English: Vantobra is an antibiotic used for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged six years and older who have cystic fibrosis.
Maltese: Vantobra huwa antibijotiku li jintuża għall-kura ta' infezzjoni tal-pulmun fit-tul ikkawżata mill-batterji Pseudomonas aeruginosa f'pazjenti li għandhom sitt snin u aktar u li għandhom fibrożi ċistika.
English: Cystic fibrosis is an inherited disease in which thick mucus builds up in the lungs that allows bacteria to grow more easily, causing infections.
Maltese: Fibrożi ċistika hija marda li tintiret fejn ikun hemm akkumulazzjoni ta' mukus oħxon fil-pulmun li tippermetti lill-batterji jikbru aktar faċilment, u dan jikkawża infezzjonijiet.
English: What are the risks associated with Vantobra?
Maltese: X'inhuma r-riskji assoċjati ma' Vantobra?
English: As for all medicines, data on the use of Vantobra are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Vantobra hija ssorveljata kontinwament.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, tobramycin; however, Vantobra has a higher amount of the active substance.
Maltese: Dan ifisser li huwa simili għal “mediċina ta' referenza” li fiha l-istess sustanza attiva, it-tobramiċina; madankollu Vantobra għandu ammont akbar tas-sustanza attiva.
English: P. aeruginosa is a frequent cause of infections in cystic fibrosis patients.
Maltese: P. aeruginosa hija kawża frekwenti ta' infezzjonijiet f'pazjenti b'fibrożi ċistika.
English: Side effects with Vantobra are not common.
Maltese: L-effetti sekondarji b'Vantobra mhumiex komuni.
English: Side effects reported with Vantobra are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Vantobra huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Vantobra is inhaled using a device called Tolero nebuliser, which converts the solution in the ampoule into a fine mist.
Maltese: Vantobra jittieħed man-nifs permezz ta' apparat imsejjaħ nebulizzatur ta' Tolero, li jibdel is-soluzzjoni fl-ampolla f'raxx ħafif.
English: The results of the study showed that Vantobra can be considered comparable to Tobi.
Maltese: Ir-riżultati tal-istudju wrew li Vantobra jista' jiġi kkunsidrat komparabbli ma' Tobi.
English: Slovak Republic sanofi-aventis Slovakia s.r.o.
Maltese: Is-Slovakkja sanofi-aventis Slovakia s.r.o.
English: Karlovačka cesta 24a, Zagreb
Maltese: Altamedics d.o.o. Karlovačka cesta 24a, Zagreb
English: Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A. 2, A. Fleminga Str.
Maltese: Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A. 2, A.
English: Forest Laboratories Nederland B.V.
Maltese: Il-Ġermanja Forest Laboratories Nederland B.V.
English: ALLERTEC HELLAS AE 74 Karamanli str.
Maltese: ALLERTEC HELLAS AE 74
English: Colistineb 2000000 IE
Maltese: Colistineb 2000000
English: Beacon Pharmaceuticals Limited,
Maltese: Ir-Renju Unit Beacon Pharmaceuticals Limited,
English: Sanofi-Aventis France 1-13 boulevard R. Rolland 75014 Paris
Maltese: Sanofi-Aventis France 1-13 boulevard R.
English: Colomycin injekce 1000000 IU
Maltese: Colomycin injekce 1000000
English: Colistineb 1000000 IE
Maltese: Colistineb 1000000
English: I. 5 Rue Heienhaff Senningerberg L-1736
Maltese: Rue Heienhaff, L-1736
English: Crossways Business Park Dartford
Maltese: Crossways Business Park Dartford, Kent
English: KOLOMYCÍN INJEKCIA 2 milión IU
Maltese: INJEKCIA 2 milión IU
English: Alvogen IPCo.S.ar.
Maltese: Il-Bulgarija Alvogen IPCo.S.ar. I. 5
English: ColiFin 2 Mio.
Maltese: 2 Mio.
English: KOLOMYCÍN INJEKCIA 1 milión IU
Maltese: INJEKCIA 1 milión IU
English: NORMA HELLAS AE 54 Menandrou str 10431 Athens Greece
Maltese: Menandrou str 10431
English: Copenhagen S Denmark
Maltese: Copenhagen S
English: Alvogen IPCo S.à.r.l., 5 Rue Heienhaff, L-1736
Maltese: Alvogen IPCo S.à.r.l., 5
English: COLIMYCINE 1 MUI, poudre et solvant pour inhalation par nébuliseur powder and solvent for nebuliser solution
Maltese: COLIMYCINE 1 MUI, poudre et solvant pour inhalation par nébuliseur trab u solvent għal soluzzjoni għannebulizzatur
English: COLIMYCINE 1.000.000 U.I., poudre et solvant pour solution injectable powder and solvent for solution for injection
Maltese: COLIMYCINE 1.000.000 U.I., poudre et solvant pour solution injectable trab u solvent għal soluzzjoni għall-injezzjoni
English: Luxembourg Profile Pharma Limited Chichester Business Park City Fields Way
Maltese: Id-Danimarka Profile Pharma Limited Chichester Business Park City Fields
English: Colixin 1 milijun IU prašak za otopinu za injekciju powder for solution for injection
Maltese: Colixin 1 milijun IU prašak za otopinu za injekciju trab għal soluzzjoni għall-injezzjoni
English: InfectoPharm Arzneimittel und Consilium GmbH Von-Humboldt-Straße 1
Maltese: Von-Humboldt-Straße 1
English: Colistimethate sodium 1 million international units powder for solution for injection or infusion powder for solution for injection/infusion
Maltese: Colistimethate sodium 1 million international units powder for solution for injection or infusion trab għal soluzzjoni għall-injezzjoni/infużjoni
English: Colistimetato de sodio GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador powder for solution for injection, powder for nebuliser solution
Maltese: Colistimetato de sodio GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador trab għal soluzzjoni għall-injezzjoni, trab għal soluzzjoni għan-nebulizzatur
English: Colomycin Injection 2 million international units powder for soln for inj, infusion or inhalation powder for solution for injection
Maltese: Colomycin Injection 2 million international units powder for soln for inj, infusion or inhalation trab għal soluzzjoni għall-injezzjoni
English: Colixin 1 MUI polvo para solución inyectable o para solución para inhalación por nebulizador powder for solution for injection, powder for nebuliser solution
Maltese: Colixin 1 MUI polvo para solución inyectable o para solución para inhalación por nebulizador trab għal soluzzjoni għall-injezzjoni, trab għal soluzzjoni għan-nebulizzatur
English: Belgium Forest Laboratories UK Ltd. Riverbridge House
Maltese: L-Ungerija Forest Laboratories UK Limited Riverbridge House
English: Colomycin Injection 1million International Units powder for solution for injection, infusion or inhalation powder for solution for injection/infusion/ inhalation
Maltese: Colomycin Injection 1million International Units powder for solution for injection, infusion or inhalation trab għal soluzzjoni għall-injezzjoni/infużjoni/ inalazzjoni
English: Pulver zur Herstellung einer Injektions-/Infusionslösung powder for solution for injection/infusion
Maltese: Pulver zur Herstellung einer Injektions-/Infusionslösung trab għal soluzzjoni għall-injezzjoni/infużjoni
English: Greece
Maltese: Athens Greece
English: Pulver zur Herstellung einer Lösung für einer Infusionslösung powder for solution for infusion
Maltese: Pulver zur Herstellung einer Lösung für einer Infusionslösung trab għal soluzzjoni għall-infużjoni
English: InfectoPharm Arzneimittel und Consilium GmbH Von-Humboldt-Straße 1 64646 Heppenheim Germany
Maltese: 64646 Heppenheim
English: Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektionsoder Infusionslösung powder for solution for injection/infusion
Maltese: Colistimethat-Natrium Infectopharm I.E.
English: Colomycin Injection 1 million international units powder for soln for inj, infusion or inhalation powder for solution for injection, infusion or inhalation intramuscular use, intravenous use, inhalation use
Maltese: Colomycin Injection 1 million international units powder for soln for inj, infusion or inhalation trab għal soluzzjoni għall-injezzjoni, infużjoni jew inalazzjoni għal użu fil-muskoli, użu għal ġol-vini, biex jinġibed man-nifs
English: Forest Laboratories UK Limited Riverbridge House Anchor Boulevard Crossways Business Park Dartford, Kent DA2 6SL United Kingdom
Maltese: Crossways Business Park Dartford, Kent DA2 6SL
English: Colistin ForestTrockenstechampullen mit Lösungsmittel powder and solvent for suspension for injection, nebuliser solution intramuscular use, intravenous use, inhalation use
Maltese: Colistin ForestTrockenstechampullen mit Lösungsmittel trab u solvent għal suspensjoni għallinjezzjoni, soluzzjoni għan-nebulizzatur użu għal ġol-muskoli, użu għal ġol-vini, biex jinġibed man-nifs
English: Promixin 1 million international units (IU) powder for solution for infusion powder for solution for injection intramuscular use, intravenous use
Maltese: Promixin 1 million international units (IU) powder for solution for infusion trab għal soluzzjoni għall-injezzjoni użu għal ġol-muskoli, użu għal ġol-vini
English: Further information on Ixiaro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ixiaro.
Maltese: Aktar informazzjoni dwar Ixiaro tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/Ixiaro.
English: Other information about Ixiaro
Maltese: informazzjoni oħra dwar Ixiaro
English: The vaccine is ‘adsorbed'.
Maltese: Il-vaċċin jiġi “adsorbit”.
English: Four weeks after the final injection, 96% of these people who received both doses of Ixiaro had developed protective levels of antibodies (352 out of 365).
Maltese: Erba' ġimgħat wara l-aħħar injezzjoni, 96 % ta' dawk in-nies li rċevew iż-żewġ dożi ta' Ixiaro żviluppaw livelli protettivi ta' antikorpi (352 minn 365).
English: 99% to 100% of children who received both doses of Ixiaro had developed protective levels of antibodies against the Japanese encephalitis virus 4 weeks after the final injection.
Maltese: 99 % sa 100 % tat-tfal li rċevew iż-żewġ dożi ta' Ixiaro żviluppaw livelli protettivi ta' antikorpi kontra l-virus tal-enċefalite Ġappuniża 4 ġimgħat wara l-injezzjoni finali.
English: What are the risks associated with Ixiaro?
Maltese: X'inhuma r-riskji assoċjati ma' Ixiaro?
English: Ixiaro received a marketing authorisation valid throughout the EU on 31 March 2009.
Maltese: Ixiaro rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-31 ta' Marzu 2009.
English: In children aged between 2 months and 3 years, half the adult dose of Ixiaro (0.25 ml) should be given, and an additional 0.25 ml dose should be given four weeks later.
Maltese: Fit-tfal ta' bejn xahrejn u tliet snin, jenħtieġ li tingħata nofs id-doża tal-adulti ta' Ixiaro (0.25 ml), u jenħtieġ li tingħata doża addizzjonali ta' 0.25 ml erba' ġimgħat wara.
English: How is Ixiaro used?
Maltese: Ixiaro?
English: In adults, including those aged above 65 years, and children aged 3 years and older, a full dose of Ixiaro (0.5 ml) should be given, and an additional 0.5 ml dose should be given four weeks later.
Maltese: Fl-adulti, inklużi dawk li jkollhom aktar minn 65 sena, u fit-tfal minn tliet snin 'il fuq, jenħtieġ li tingħata doża sħiħa ta' Ixiaro (0.5 ml), u jenħtieġ li tingħata doża addizzjonali ta' 0.5 ml erba' ġimgħat wara.
English: Long-term antibody levels were similar with both schedules.
Maltese: Il-livelli fit-tul ta' antikorpi kienu simili fiż-żewġ skedi.
English: Ixiaro has been shown to trigger the production of antibodies against the Japanese encephalitis virus in 3 main studies:
Maltese: Ixiaro ntwera li jikkawża l-produzzjoni ta' antikorpi kontra l-virus tal-enċefalite Ġappuniża fi 3 studji ewlenin:
English: Ixiaro (given as 2 doses 4 weeks apart) was as effective as the comparator vaccine at triggering the production of antibodies against the Japanese encephalitis virus.
Maltese: Ixiaro (mogħti bħala żewġ dożi 4 ġimgħat bogħod minn xulxin) kien effettiv daqs il-vaċċin komparatur biex jikkawża l-produzzjoni ta' antikorpi kontra l-virus tal-enċefalite Ġappuniża.
English: Ixiaro (Japanese encephalitis vaccine (inactivated, adsorbed))
Maltese: Ixiaro Vaċċin tal-enċefalite Ġappuniża (inattivat,
English: This was compared with 94% of the people receiving the comparator vaccine (347 out of 370).
Maltese: Dan tqabbel ma' 94 % tal-persuni li rċevew il-vaċċin komparatur (347 minn 370).
English: • The third main study involved 1,869 children aged between 2 months and 18 years.
Maltese: • It-tielet studju ewlieni involva 1,869 tifel u tifla li għandhom bejn xahrejn u 18 sena.
English: The virus in Ixiaro is grown in mammal cells (‘Vero cells') under laboratory conditions.
Maltese: Il-virus f'Ixario jitkabbar f'ċelloli tal-mammiferi (“Ċelloli Vero”) f'kundizzjonijiet tal-laboratorju.
English: Adults from 18 to 65 years can also receive a rapid vaccination course, where the second dose is given seven days after the first dose.
Maltese: Adulti minn 18 sa 65 sena jistgħu wkoll jirċievu kors rapidu ta' tilqim, fejn it-tieni doża tingħata sebat ijiem wara l-ewwel doża.
English: • The first study involved 867 healthy adults and compared Ixiaro with another vaccine for Japanese encephalitis containing viruses grown in mouse brains.
Maltese: • L-ewwel studju involva 867 adult b'saħħtu u qabbel Ixiaro ma' vaċċin ieħor kontra l-enċefalite Ġappuniża li fih virusis imkabbra fi mħuħ tal-ġrieden.
English: • The second main study in 660 adults compared a rapid vaccination course (2 doses given 7 days apart) with the standard vaccination course (2 doses given 4 weeks apart).
Maltese: • It-tieni studju ewlieni f'660 adult qabbel kors rapidu ta' tilqim (żewġ dożi mogħtija sebat ijiem bogħod minn xulxin) mal-kors standard ta' tilqim (żewġ dożi mogħtija 4 ġimgħat bogħod minn xulxin).
English: Ixiaro must not be used in people who are hypersensitive (allergic) to any residual substances in the vaccine such as protamine sulphate.
Maltese: Ixiaro ma għandux jintuża f'persuni li jkunu ipersensittivi (allerġiċi) għal xi sustanza residwa fil-vaċċin bħas-sulfat tal-protamina (protamine sulphate).
English: As for all medicines, data on the use of Ixiaro are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ixiaro hija ssorveljata kontinwament.
English: A booster dose should also be considered for adults aged above 65 years before any further exposure to the Japanese encephalitis virus.
Maltese: Jenħtieġ li tiġi kkunsidrata wkoll doża buster għal adulti li jkollhom aktar minn 65 sena qabel kwalunkwe esponiment ulterjuri għall-virus tal-enċefalite Ġappuniża.
English: For the full list of side effects of Ixiaro, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Ixiaro, ara lfuljett ta' tagħrif.
English: In children, fever, diarrhoea, influenza-like illness, irritability, and reactions at the injection site (such as redness,
Maltese: Fit-tfal, id-deni, dijarea, mard simili għall-influwenza, irritabbiltà u reazzjonijiet fis-sit talinjezzjoni (bħal ħmura, uġigħ u sensittività) kienu l-effetti sekondarji l-aktar komuni (li jistgħu jaffettwaw aktar minn 1 minn kull 10 tifel u tifla).
English: The most common side effects with Ixiaro in adults (which may affect more than 1 in 10 people) are headache, myalgia (muscle pain), pain and tenderness at the injection site and tiredness.
Maltese: L-effetti sekondarji l-aktar komuni b'Ixiaro fl-adulti (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma wġigħ ta' ras, mijalġija (uġigħ muskolari), uġigħ u sensittività fis-sit tal-injezzjoni u għeja.
English: When a person is given the vaccine, the immune system identifies the inactivated virus as ‘foreign' and makes antibodies against it.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf il-virus inattivat bħala “barrani” u tagħmel antikorpi kontrih.
English: The antibodies will help to protect against the disease.
Maltese: L-antikorpi se jgħinu fil-protezzjoni kontra l-marda.
English: In adults, the second dose can be given up to 11 months after the first.
Maltese: Fl-adulti, ittieni doża tista' tingħata sa 11-il xahar wara l-ewwel waħda.
English: Adults from 18-65 years who are likely to be exposed to the Japanese encephalitis virus again or who are at continuous risk of the disease should receive a booster dose of Ixiaro one to two years later and a second booster dose 10 years after the first booster.
Maltese: Adulti li x'aktarx jerġgħu jkunu esposti għal virus tal-enċefalite Ġappuniża jew li jkunu f'riskju kontinwu tal-marda jenħtieġ li jirċievu doża buster ta' Ixiaro bejn sena sa sentejn wara u t-tieni doża buster 10 snin wara l-ewwel buster.
English: This means that the virus is fixed onto aluminium compounds, to stimulate a better response.
Maltese: Dan ifisser li l-virus jeħel fuq komposti tal-aluminju, sabiex jistimulaw rispons aħjar.
English: What is closantel?
Maltese: X'inhu closantel?
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/126)
Maltese: Eżitu ta' proċedura ta' referenza skont l-Artikolu 35 tad-Direttiva 2001/82/KE (EMEA/V/A/126)
English: Consequently, on 5 February 2018, the United Kingdom initiated a procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products.
Maltese: Konsegwentement, fil-5 ta' Frar 2018, ir-Renju Unit beda proċedura skont l-Artikolu 35 tadDirettiva 2001/82/KE għall-prodotti mediċinali veterinarji msemmija hawn fuq.
English: 20 May 2019
Maltese: 20 ta' Mejju 2019 EMA/246018/2019
English: Closantel is intended for use in cattle and sheep for the treatment and control of adult and immature flukes, nematodes and larval stages of some arthropods and is administered subcutaneously by injection or as an oral solution.
Maltese: Closantel huwa maħsub għall-użu fil-frat u fin-nagħaġ għall-kura u l-kontroll ta' flukes adulti u immaturi, nematodi u l-istadji ta' larva ta' xi artropodi u jingħata taħt il-ġilda permezz ta' injezzjoni jew bħala soluzzjoni orali.
English: Why were solutions for injection containing 50 mg closantel per ml (as a single active substance) reviewed?
Maltese: Għaliex ġew rieżaminati s-soluzzjonijiet għall-injezzjoni li fihom 50 mg ta' closantel għal kull ml (bħala sustanza attiva unika)?
English: The European Commission issued a decision on 20 May 2019.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fl-20 ta' Mejju 2019.
English: Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefitrisk balance for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep, is positive and agreed that the withdrawal periods (meat and offal) for sheep should be harmonised and amended to provide assurance for consumer safety.
Maltese: Abbażi tal-evalwazzjoni tad-data disponibbli attwalment, is-CVMP ikkonkluda li l-bilanċ ġenerali bejn ilbenefiċċju u r-riskju għall-prodotti mediċinali veterinarji li fihom 50 mg ta' closantel għal kull ml (bħala sustanza attiva unika) ippreżentati bħala soluzzjonijiet għall-injezzjoni għall-użu taħt il-ġilda finnagħaġ, huwa pożittiv u qabel li l-perjodi tal-irtirar (laħam u ġewwieni tal-annimal) għan-nagħaġ għandhom jiġu armonizzati u emendati biex jipprovdu assigurazzjoni għas-sikurezza tal-konsumatur.
English: On 21 February 2019, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods (meat and offal) for sheep for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection.
Maltese: Fil-21 ta' Frar 2019, l-Aġenzija Ewropea għall-Mediċini (l-Aġenzija) temmet rieżami tas-sikurezza talkonsumatur tal-perjodi tal-irtirar (laħam u ġewwieni tal-annimal) għan-nagħaġ għal prodotti mediċinali veterinarji li fihom 50 mg closantel għal kull ml (bħala sustanza attiva unika) li huma ppreżentati bħala soluzzjonijiet għall-injezzjoni.
English: Withdrawal period refers to the minimum period of time from administering the last dose of veterinary medicinal product and the production of meat or other animal-derived products for food.
Maltese: Perjodu tal-irtirar jirreferi għall-perjodu minimu ta' żmien mill-għoti tal-aħħar doża tal-prodott mediċinali veterinarju u l-produzzjoni ta' laħam jew prodotti oħra derivati mill-annimal għall-ikel.