FrancophonIA/ELRC3.0 huggingface dataset:
English: 0.1 ml of suspension in a pre-filled syringe (glass) with a Micro-Injection System, with attached micro-needle, equipped with an elastomer plunger stopper (chlorobutyl), a tip cap (thermoplastic elastomer and polypropylene) and a needle shielding system.
Maltese: 0.1 ml ta' suspensjoni f'siringa mimlija għal-lest (ħġieġ ) b'Sistema ta' Mikro-Injezzjoni, b'labra mikro mwaħħla, mgħammra b'tapp tal-planġer tal-elastomer (chlorobutyl), għatu tat-tarf (elastomer termoplastiku u polypropylene) u sistema tal-protezzjoni tal-labra.
English: 15 µg haemagglutinin per strain per 0.1 ml dose
Maltese: (H3N2) 15 µg emagglutinin għal kull razza għal kull doża ta' 0.1 ml
English: A/Michigan/45/2015 (H1N1)pdm09 - like strain A/Hong Kong/4801/2014 (H3N2) - like strain
Maltese: Razza simili għal A/Michigan/45/2015 (H1N1)pdm09 (A/Michigan/45/2015, NYMC
English: The other ingredients are: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Maltese: Is-sustanzi l-oħra huma: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate u ilma għall-injezzjonijiet.
English: Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed.
Maltese: Wara t-tilqima kontra l-influwenza, ġew osservati riżultati pożittivi foloz fit-testijiet seroloġiċi bl-użu tal-metodu ELISA biex jiġu żvelati l-antikorpi kontra l-HIV-1, l-Epatite Ċ, u b'mod speċjali, HTLV-1.
English: B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) .................... 15 micrograms HA**
Maltese: Razza simili għal B/Brisbane/60/2008 (B/Brisbane/60/2008, tat-tip selvaġġ) ..................................................................................................................... 15-il mikrogramma HA**
English: ** Seroconversion = negative pre-vaccination HI titre and post vaccination HI titre ≥ 40, Significant increase = positive pre-vaccination HI titre and at least a 4-fold increase in post-vaccination HI titre GMTR: Geometric mean titre ratio of individual (post-/pre-vaccination titre).
Maltese: ** Serokonverżjoni = titre HI ta' qabel it-tilqima u titre HI ta' wara t-tilqima negattivi ≥ 40, Żieda sinifikanti = titres HI ta' qabel il-vaċċin pożittiv u mill-inqas żieda ta' 4 darbiet fit-titre HI wara t
English: In a pivotal randomised comparative phase III trial, 2,606 subjects over 60 years of age received 0.1 ml of INTANZA by intradermal route and 1,089 subjects over 60 years of age received 0.5 ml of a trivalent inactivated influenza vaccine administered by intramuscular route.
Maltese: III, 2,606 individwi ta' aktar minn 60 sena, irċivew 0.1 ml ta' INTANZA permezz ta' rotta intradermali u 1,089 individwu ta' aktar minn 60 sena irċivew 0.5 ml ta' vaċċin ta' kontra l-influwenza inattivat trivalenti ġol-muskoli.
English: Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.
Maltese: Profilassi tal-influwenza f'individwi ta' 60 sena u iktar, speċjalment f'dawk li qegħdin f'riskju miżjud
English: It should be noted that the adverse reactions may be intensified.
Maltese: Wieħed għandu jinnota li r-reazzjonijiet avversi jistgħu jiġu intensifikati.
English: Across all three influenza strains, for the comparator intramuscular vaccine GMTs ranged between 34.8 (1/dil) and 181.0 (1/dil), seroprotection rates ranged between 48.9% and 87.9%, seroconversion or significant increase rates ranged between 30.0% and 46.9% and GMTRs ranged between 3.04 and 5.35-fold over baseline HI titres.
Maltese: (1/dil, ir-rati tas-seroprotezzjoni varjaw bejn 48.9% u 87.9%, ir-rati tas-serokonverżjoni jew żieda sinifikanti varjaw bejn 30.0% u 46.9%, u l-GMTRs varjaw bejn 3.04 u 5.35 drabi fuq it-titres HI fil-linja bażi.
English: Neuralgia, febrile convulsions, neurological disorders, such as encephalomyelitis and Guillain-Barré
Maltese: Newralġija, konvulżjonijiet bid-deni, disturbi newroloġiċi, bħal enċefalomajelite u s-sindrome ta'
English: Vasculitis associated in very rare cases with transient renal involvement
Maltese: Vaskulite assoċjata f'każijiet rari ħafna ma' involviment renali temporanju
English: Sweating Pruritus, rash
Maltese: Għaraq Ħakk, raxx
English: In this comparative trial the geometric mean titres (GMTs), seroprotection rate*, seroconversion or significant increase rate** and the geometric mean titre ratio (GMTR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
Maltese: F'din il-prova komparattiva, it-titres medji ġeometriċi (geometric mean titres, GMTs), ir-rata tasseroprotezzjoni*, is-serokonverżjoni jew ir-rata taż-żieda sinifikanti** u l-proporzjon tat-titre medju ġeometriku (geometric mean titre ratio, GMTR) għall-antikorp anti-HA (imkejjel minn HI) ġew evalwati skont kriterji definiti minn qabel.
English: Posology Individuals 60 years of age and over: 0.1 ml.
Maltese: Pożoloġija Individwi li għandhom minn 60 sena u aktar: 0.1 ml
English: Detailed information on this vaccine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: The recommended dose is 0.1 ml for individuals 60 years of age and over.
Maltese: Id-doża rakkomandata hija 0.1ml f'adulti ta' aktar minn 60 sena.
English: The Western Blot technique disproves the false-positive ELISA test results.
Maltese: It-teknika Western Blot tgiddeb ir-riżultati tat-test ELISA li huma pożittivi-foloz.
English: Pack of 1 or 10 or 20 pre-filled syringe(s) with a Micro-Injection System
Maltese: Pakkett ta' 1 jew 10 jew 20 siringa(i) mimlija għal-lest b'Sistema ta' Mikro-Injezzjoni
English: INTANZA 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated)
Maltese: INTANZA 15-il mikrogramma/razza suspensjoni għall-injezzjoni Vaċċin ta' kontra l-influwenza (virion maqsum, inattivat)
English: INTANZA may contain residues of eggs such as ovalbumin and residues of neomycin, formaldehyde and octoxinol 9, which are used during the manufacturing process (see section 4.3).
Maltese: INTANZA jista' jkun fih residwi ta' bajd bħal ovalalbumina u residwi ta' neomycin, formaldehyde u octoxinol 9 li jintużaw waqt il-proċess tal-manifattura (ara sezzjoni 4.3)
English: INTANZA 15 microgram/strain, suspension for injection Influenza vaccine (split virion, inactivated)
Maltese: INTANZA 15-il mikrogramma/razza, suspensjoni għall-injezzjoni Vaċċin ta' kontra l-influwenza (virion maqsum, inattivat).
English: • Pain located on the nerve route, convulsions associated with fever, nervous system disorders including inflammation of the brain or spinal cord or Guillain-Barré syndrome which causes
Maltese: • Uġigħ lokalizzat fir-rotta tan-nervaturi, konvulżjonijiet assoċjati ma' deni, disturbi tas-sistema nervuża li jinkludu infjammazzjoni tal-moħħ jew tas-sinsla, jew is-sindrome ta' Guillain-Barré li jikkawża dgħjufija u paralisi estremi.
English: • The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
Maltese: • Is-Sistema ta' Mikro-Injezzjoni għal injezzjoni minn ġol-ġilda tikkonsisti f'siringa mimlija għal-lest b'labra mikro (1.5 mm) u sistema tal-protezzjoni tal-labra.
English: Transient thrombocytopenia, transient lymphadenopathy
Maltese: Tromboċitopenja temporanja, limfadenopatija temporanja
English: Tests for HIV-1, hepatitis C virus and HTLV-1 may be affected.
Maltese: It-testijiet għall-HIV-1, il-virus tal-epatite Ċ u
English: Pharmacotherapeutic group: Influenza vaccines, ATC code: J07BB02
Maltese: Vaċċini ta' kontra l-influwenza, Kodiċi ATC:
English: Paresthesia, neuritis
Maltese: Mhux magħrufa
English: A/Wisconsin/
Maltese: B A/New Caledonia/20/99 A/Wisconsin/67/2005
English: In repeated-dose toxicity studies in rabbits there was no significant evidence of systemic toxicity.
Maltese: Fi studji dwar it-tossiċità minn dożi ripetuti fil-fniek, ma kien hemm l-ebda evidenza sinifikanti ta' tossiċità sistemika.
English: Sanofi Pasteur Sp. z o.o.
Maltese: Sanofi S.p.A.
English: Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to any residues such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1, jew għal kwalunkwe residwu bħal bajd (ovalbumina, proteini tat-tiġieġ), neomycin,
English: Reactions of not known frequency (frequency cannot be estimated from the available data) - Allergic reactions including skin reactions that may spread throughout the body such as hives, severe allergic reactions (anaphylactic reactions), swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breathe (angioedema), failure of the circulatory system
Maltese: Reazzjonijiet mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli) - Reazzjonijiet allerġiċi inkluż reazzjonijiet tal-ġilda li jistgħu jinfirxu mal-ġisem kollu bħal urtikarja, reazzjonijiet allerġiċi severi (reazzjonijiet anafilattiċi), nefħa fil-wiċċ, ilsien jew farinġi, diffikultà biex tibla', urtikarja u diffikultajiet biex tieħu n-nifs (anġjodema), kollass tassistema ċirkolatorja (xokk) li jwassal għal emerġenza medika
English: The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
Maltese: Is-Sistema ta' Mikro-Injezzjoni għal injezzjoni minn ġol-ġilda tikkonsisti f'siringa mimlija għal-lest b'labra mikro (1.5 mm) u sistema tal-protezzjoni tal-labra.
English: Systemic safety profile of INTANZA is similar to the comparator vaccine, adjuvanted or nonadjuvanted, administered intramuscularly.
Maltese: Il-profil tas-sigurtà sistemika ta' INTANZA hu simili għal dak tal-vaċċin komparatur adjuvant jew
English: Interference with serological testing: See section 4.5.
Maltese: Ara sezzjoni 4.5.
English: - Tell your doctor if you have been treated with medicines that may reduce your immune response such as corticosteroids (for example cortisone), medicines against cancer (chemotherapy), radiotherapy or other medicines affecting the immune system.
Maltese: - Għid it-tabib tiegħek jekk kont ikkurat/a b'mediċini li jistgħu jnaqqsu r-rispons immuni tiegħek bħal kortikosterojdi (pereżempju cortisone), mediċini kontra l-kanċer (kimoterapija), radjuterapija jew mediċini oħrajn li jaffettwaw lis-sistema immuni.
English: Pack size of 1 or 10 or 20.
Maltese: Daqs tal-pakkett ta' 1 jew 10 jew
English: Most of side effects listed above disappeared without treatment within 1 to 3 days after onset.
Maltese: Ħafna mill-effetti sekondarji elenkati fuq sparixxew mingħajr kura fi żmien jum 1 sa 3 jiem wara li feġġew.
English: divize vakcín sanofi-aventis, s.r.o.
Maltese: Magyarország sanofi-aventis zrt Tel.:
English: Slovenská republika sanofi-aventis Pharma Slovakia s.r.o.
Maltese: sanofi-aventis Ireland T/A SANOFI
English: A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) ............................................................................................................................. 15 micrograms HA**
Maltese: (H3N2) (A/Hong Kong/4801/2014, NYMC
English: The active substances are Influenza virus (inactivated split) of the following strains*:
Maltese: Is-sustanzi attivi huma Virus tal-influwenza (inattivat, maqsum) tar-razez li ġejjin*:
English: Allergic reactions including generalized skin reactions such as urticaria, anaphylactic reactions, angioedema, shock
Maltese: Reazzjonijiet allerġiċi inklużi reazzjonijiet ġeneralizzati tal-ġilda bħal urtikarja, reazzjonijiet anafilattiċi, anġjodema xokk.
English: • Whenever the risk management system is modified, especially as the result of new information is received that may lead to a significant change to benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Very limited data in immunocompromised patients are available for INTANZA.
Maltese: Hemm tagħrif limitat ħafna disponibbli għal INTANZA f'pazjenti li huma immunokompromessi.
English: Immunisation shall be postponed in subjects with febrile illness or acute infection.
Maltese: Il-vaċċin kien immunoġeniku fil-ġrieden żgħar u fil-fniek.
English: Data were as follows (values in brackets show the 95% confidence intervals):
Maltese: It-tagħrif kien kif ġej (il-valuri fil-parentesi juru l-intervalli ta' fiduċja ta' 95%):
English: Rare reactions (may affect up to 1 in 1000 people) - Tingling or numbness, inflammation of nerves, itching and rash.
Maltese: Reazzjonijiet rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000) - Tagħrix jew tmewwit infjammazzjoni tan-nervaturi, ħakk u raxx.
English: After repetitive yearly injections the safety profile of INTANZA is similar to the previous injections.
Maltese: Wara injezzjonijiet li ngħataw ripetutament kull sena, il-profil tas-sigurtà ta' INTANZA kien simili għal dak ta' injezzjonijiet li ngħataw qabel.
English: The immunological response may be diminished if the patient is undergoing immunosuppressant
Maltese: Ir-rispons immunoloġiku jista' jitnaqqas jekk il-pazjent ikun qed jieħu kura immunosuppressanti.
English: HOW TO USE INTANZA
Maltese: Kif taħżen INTANZA
English: EXP
Maltese: Vistor
English: INTANZA is as immunogenic as the comparator trivalent adjuvanted (MF-59 containing) vaccine in terms of GMT for each of the 3 influenza strains with the SRH method and for 2 strains with the HI method.
Maltese: MF-59) f'termini ta' GMT għal kull waħda mit-3 razez tal-influwenza bil-metodu SRH u għal 2 razez bil-metodu HI.
English: Safety evaluation was performed for all subjects during the first 3 weeks following vaccination and serious adverse reactions were collected during six months of follow-up for 2,974 subjects (population of two out of the three clinical trials).
Maltese: L-evalwazzjoni tas-sigurtà twettqet fil-pazjenti kollha matul l-ewwel 3 ġimgħat wara t-tilqim u avvenimenti avversi serji nġabru matul sitt xhur ta' follow-up għal 2,974 pazjent (popolazzjoni ta'
English: - Feeling generally unwell, fever (38.0°C or higher) and shivering.
Maltese: • Sensazzjoni ġenerali li ma tħossokx tajjeb (temperatura ta' 38.0°C jew ogħla) u tertir.
English: N = 2,586
Maltese: B/Malaysia/2506/2004 N = 2,586
English: This leaflet was last revised in {MM/YYYY}.
Maltese: Id-data ta' meta jiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: Based on the experience with trivalent inactivated influenza vaccines administered by intramuscular or deep subcutaneous injection, the following events may be reported:
Maltese: Ibbażat fuq l-esperjenza b'vaċċini ta' kontra l-influwenza inattivati trivalenti mogħtija permezz ta' injezzjoni ġol-muskoli jew injezzjoni fonda taħt il-ġilda, jistgħu jiġu rrappurtati l-episodji li ġejjin:
English: Nevertheless, single and repeated administrations led to transient local erythema and oedema.
Maltese: Madankollu, għotja waħda jew għotjiet ripetuti wasslu għal eritema u edema lokali temporanji.
English: When an injection of INTANZA is given, the immune system (body's natural defences) will develop
Maltese: Meta tingħata injezzjoni ta' INTANZA, is-sistema immuni (id-difiżi naturali tal-ġisem) ser tiżviluppa protezzjoni kontra l-infezzjoni mill-influwenza.
English: INTANZA is at least as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 60 years of age and over.
Maltese: INTANZA hu mill-inqas immunoġeniku daqs il-vaċċin komparatur ta' kontra l-influwenza inattivat trivalenti li jingħata ġol-muskoli għal kull waħda mit-3 razez tal-influwenza f'individwi ta' 60 sena jew iżjed.
English: A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275) ................................................................................................................................ 15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) ................................................................................................................................ 15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ....................... 15 micrograms HA**
Maltese: X-263B) ........................................................................................................................ 15-il mikrogramma HA** Razza simili għal B/Brisbane/60/2008 (B/Brisbane/60/2008, tat-tip selvaġġ) ........................................................................................................................ 15-il mikrogramma HA**
English: INSTRUCTIONS FOR USE
Maltese: U INDIRIZZ TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID
English: Very common reactions (may affect more than 1 in 10 people) - At the injection site: redness, hardness, swelling, itching and pain.
Maltese: • Fis-sit tal-injezzjoni: ħmura, ebusija, nefħa, ħakk u wġigħ.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/118)
Maltese: Riżultat ta' proċedura ta' referenza skont l-Artikolu 35 tadDirettiva 2001/82/KE (EMEA/V/A/118)
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 June 2017
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 ta' Ġunju 2017 EMA/394961/2017
English: 1 CVMP opinion on Article 33(4) referral for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (Procedure no. EMEA/V/A/108) - link
Maltese: 1 CVMP opinion on Article 33(4) referral for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (Procedure no.
English: What is zinc oxide?
Maltese: X'inhu l-ossidu taż-żingu?
English: In May 2015, following a referral procedure (EMEA/V/A/108) under Article 33(4) of Directive 2001/82/EC for Gutal 1000 g/kg premix for medicated feeding stuff for piglets1, the CVMP identified a risk to the environment due to accumulation of zinc.
Maltese: F'Mejju 2015, wara proċedura ta' referenza (EMEA/V/A/108) skont l-Artikolu 33(4) tadDirettiva 2001/82/KE għal Gutal 1000 g/kg ta' taħlitiet lesti minn qabel għal għalf medikat għallqżieqeż1, is-CVMP identifika riskju għall-ambjent minħabba akkumulazzjoni ta' żingu.
English: Zinc oxide is an inorganic compound and is known to be relatively poorly absorbed.
Maltese: L-ossidu taż-żingu huwa kompost inorganiku u huwa magħruf li relattivament ma jiġix assorbit biżżejjed.
English: Nevertheless, in February 2016, due to remaining concerns related to the risk to the environment and the potential increase of prevalence of antibiotic resistant bacteria from the use of products containing zinc oxide, the Netherlands and France initiated a referral procedure under Article 35 of Directive 2001/82/EC for all orally-administered veterinary medicinal products containing zinc oxide and requested the CVMP to review all available data and to evaluate the overall benefit-risk balance of the products concerned.
Maltese: Madankollu fi Frar 2016, minħabba li baqgħa tħassib relatat mar-riskju għall-ambjent u ż-żieda potenzjali ta' prevalenza ta' batterji reżistenti għall-antibijotiċi mill-użu ta' prodotti li fihom l-ossidu taż-żingu, in-Netherlands u Franza bdew proċedura ta' referenza skont l-Artikolu 35 tadDirettiva 2001/82/KE għall-prodotti mediċinali veterinarji kollha li jingħataw mill-ħalq li fihom l-ossidu taż-żingu u talbu lis-CVMP sabiex jerġa' jeżamina d-data disponibbli kollha u sabiex jivvaluta l-bilanċ globali bejn il-benefiċċju u r-riskju tal-prodotti kkonċernati.
English: The CVMP acknowledged that there is a risk of co-selection for resistance (the selection of multiple antimicrobial resistance genes by an antimicrobial) associated with the use of zinc oxide but that, at the present time, such risk is not quantifiable.
Maltese: Is-CVMP irrikonoxxa li hemm riskju ta' koselezzjoni għar-reżistenza (l-għażla ta' ġeni multipli ta' reżistenza għall-antimikrobiċi minn antimikrobiku) assoċjata mal-użu tal-ossidu taż-żingu iżda li, bħalissa, tali riskju mhuwiex kwantifikabbli.
English: Why were orally-administered veterinary medicinal products containing zinc oxide reviewed?
Maltese: Għaliex ġew riveduti l-prodotti mediċinali veterinarji li fihom l-ossidu tażżingu li jingħataw mill-ħalq?
English: On 16 March 2017, the European Medicines Agency (the Agency) completed a review of the safety and effectiveness of veterinary medicinal products containing zinc oxide to be administered orally to food-producing species.
Maltese: Fis-16 ta' Marzu 2017, l-Aġenzija Ewropea għall-Mediċini (l-Aġenzija) temmet rieżami dwar is-sigurtà u l-effikaċja ta' prodotti mediċinali veterinarji li fihom l-ossidu taż-żingu li għandhom jingħataw mill-ħalq lil speċi ta' produzzjoni alimentari.
English: Veterinary medicinal products containing zinc oxide are used for the treatment and/or prevention and control of post-weaning diarrhoea in piglets.
Maltese: Il-prodotti mediċinali veterinarji li fihom l-ossidu taż-żingu jintużaw għall-kura u/jew għallprevenzjoni u għall-kontroll tad-dijarea wara l-ftim fil-qżieqeż.
English: Different indications and dosages are currently recommended, but zinc oxide is mainly used in the feed at a dosage of 100 mg per kg body weight per day for 14 consecutive days, which equates to 2500 ppm zinc in feed.
Maltese: Bħalissa huma rakkomandati indikazzjonijiet u dożaġġi differenti, iżda l-ossidu taż-żingu jintuża prinċipalment fl-għalf f'dożaġġ ta' 100 mg għal kull kg tal-piż tal-ġisem kull jum għal 14-il jum konsekuttiv, li jiġi 2500 ppm ta' żingu flgħalf.
English: Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefitrisk balance for veterinary medicinal products containing zinc oxide to be administered orally to pigs is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment.
Maltese: Abbażi tal-valutazzjoni tad-data disponibbli bħalissa, is-CVMP ikkonkluda li l-bilanċ globali bejn ilbenefiċċju u r-riskju għal prodotti mediċinali veterinarji li fihom l-ossidu taż-żingu li għandhom jingħataw mill-ħalq lill-ħnieżer huwa negattiv, peress li l-benefiċċji tal-ossidu taż-żingu għallprevenzjoni tad-dijarea fil-ħnieżer mhumiex akbar mir-riskji għall-ambjent.
English: The European Commission issued a decision on 26 June 2017 and Member States may defer the withdrawal of the marketing authorisations for up to five years from this date, if they consider that immediate action may have adverse impact in their territory given the lack of availability of alternatives and the change required in pig farming practices.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fis-26 ta' Ġunju 2017 u l-Istati Membri jistgħu jiddiferixxu lirtirar tal-awtorizzazzjonijiet għat-tqegħid fis-suq sa ħames snin minn din id-data, jekk huma jikkunsidraw li azzjoni immedjata jista' jkollha impatt avvers fit-territorju tagħhom minħabba n-nuqqas ta' disponibbiltà ta' alternattivi u l-bidla meħtieġa fil-prattiki agrikoli tal-ħnieżer.
English: MA (EU) Number
Maltese: Numru tal-MA (talUE)
English: Oral use bottle (HDPE)
Maltese: Pillola miksija b'rita Użu orali flixkun (HDPE)