FrancophonIA/ELRC3.0 huggingface dataset:
English: Consequently, the European Commission triggered a referral procedure on 7 September 2006 and requested the CHMP to give its opinion on whether the marketing authorisations for products containing veralipride should be maintained, varied, suspended or withdrawn across the European Union following the assessment of these safety risks their impact on the benefit/risk assessment of veralipride.
Maltese: Konsegwentement, fis-7 ta' Settembru 2006, il-Kummissjoni Ewropea tat bidu għal proċedura ta' referenza u talbet lis-CHMP biex jagħti l-opinjoni tiegħu fuq jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti li fihom veralipride għandhomx jinżammu, jiġu emendati, sospiżi jew irtirati madwar l-Unjoni Ewropea wara li tkun saret il-valutazzjoni ta' dawn ir-riskji fuq is-sigurtà u l-impatt tagħhom fuq il-valutazzjoni tal-benefiċċju/riskju ta' veralipride.
English: • The Committee, as a consequence, concluded that the benefit/risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
Maltese: • Bħala konsegwenza ta' dan, il-Kumitat ikkonkluda li l-bilanċ ta' benefiċċju/riskju ta' prodotti mediċinali li fihom veralipride m'huwiex wieħed pożittiv taħt kundizzjonijiet normali ta' użu.
English: • The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate)
Maltese: • Ir-riskju identifikat ta' tossiċità sinerġistika tal-fwied u tad-demm meta din tkun assoċjata ma' terapija kkombinata ma' mediċina antirewmatika li tibdel il-marda oħra (eż. methotrexate)
English: • The Summary of Product Characteristics • Physician Leaflet
Maltese: • Is-Sommarju tal-Karatteristiċi tal-Prodott • Il-Fuljett tat-Tabib
English: • That there is a risk of severe liver injury and so regular measurement of ALT (SGPT) levels to monitor liver function is important.
Maltese: • Li jista' jkun hemm ġrieħi severi fil-fwied u għalhekk huwa importanti li jittieħdu miżuri regolari tal-livelli ta' ALT (SGPT) sabiex tiġi monitorata l-funzjoni tal-fwied ALT (SGPT).
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) provides physicians who are expected to prescribe/use Leflunomide Teva with a physician educational pack containing the following:
Maltese: L-Istati Membri għandhom jiżguraw li d-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq jipprovdi t-tobba li mistennija jippreskrivu/jużaw Leflunomide Teva bil-pakkett edukazzjonali għat-tobba li jkun fih dan li ġej:
English: • That there is a risk of teratogenicity and so pregnancy must be avoided until leflunomide plasma levels are at an appropriate level.
Maltese: • Li jista' jkun hemm riskju ta' teratoġeniċità u għalhekk it-tqala għandha tiġi evitata sakemm il-livelli tal-plażma ta' leflunomide jilħqu livell xieraq.
English: • The need to counsel patients on important risks associated with leflunomide therapy and appropriate precautions when using the medicine.
Maltese: • Il-ħtieġa li pazjenti jingħataw pariri dwar riskji importanti marbuta ma' terapija b'leflunomide u prekawzjonijiet xierqa meta għandha tintuża l-mediċina.
English: Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory
Maltese: It-tobba u l-pazjenti għandhom ikunu konxji li hemm servizz tal-pariri ad hoc li jipprovdi tagħrif dwar it-testijiet tal-laboratorju fuq il-livell ta' leflunomide
English: The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures in the event of
Maltese: L-informazzjoni pprovduta fil-Fuljett tat-Tabib għandu jipprovdi tagħrif dwar tnaqqis fid-doża, waqfien u proċeduri ta' tneħħija f'każ ta' ALT mgħolli..
English: • The risk of infections, including opportunistic infections, and the contraindication for use in
Maltese: • Ir-riskju ta' infezzjonijiet, li jinkludu infezzjonijiet opportuniċtiċi, u l-kontraindikazzjoni għal użu f'pazjenti li huma kompromessi immunoloġikament.
English: EMA/247140/2010 EMEA/H/C/2166
Maltese: EMEA/H/C/2166
English: What is Joulferon?
Maltese: X'inhu Joulferon?
English: The application was withdrawn before ‘day 120'.
Maltese: L-applikazzjoni ġiet irtiata qabel ‘il-jum 120'.
English: It contains the active substance albinterferon alfa-2b.
Maltese: Huwa fih is-sustanza attiva albinterferon alfa-2b.
English: Albinterferon alfa-2b is a ‘fusion protein' made up of interferon alfa-2b, which is already available in antiviral medicines in the European Union (EU), attached to a protein called albumin.
Maltese: Albinterferon alfa-2b hija ‘proteina ta' fużjoni' magħmula minn interferon alfa-2b, li hija diġà disponibbli f'mediċini antivirali fl-Unjoni Ewropea (UE), magħquda ma' proteina msejħa albumina.
English: The active substance in Joulferon, albinterferon alfa-2b, belongs to the group ‘interferons'.
Maltese: Is-sustanza attiva f'Joulferon, albinterferon alfa-2b, tagħmel parti mill-grupp ta' ‘interferoni'.
English: The company presented the results of two main studies involving a total of 2,255 adults with hepatitis C infection who had not previously been treated.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' żewġ studji ewlenin li nvolvew total ta' 2,255 adult b'infezzjoni tal-epatite Ċ li ma kinux ikkurati qabel.
English: On 16 April 2010, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Joulferon, for the treatment of hepatitis C infection.
Maltese: Fis-16 ta' April 2010, Novartis Europharm Limited innotifikat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li hija xtaqet tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fis-suq ta' Joulferon, għall-kura ta' infezzjoni tal-epatite Ċ.
English: What was Joulferon expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Joulferon?
English: Both groups of patients also took ribavirin (another medicine used in hepatitis C).
Maltese: Iż-żewġ gruppi ta' pazjenti ngħataw ukoll ribavirin (mediċina oħra użata fl-epatite Ċ).
English: The studies compared Joulferon with peginterferon alfa2a (another medicine used to treat hepatitis C).
Maltese: L-istudji qabblu Joulferon ma' peginterferon alfa-2a (mediċina oħra użata għall-kura tal-epatite Ċ).
English: The effects of Joulferon were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Joulferon, għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbnedmin.
English: How far into the evaluation was the application when it was withdrawn?
Maltese: F'hiex kienet waslet l-evalwazzjoni tal-appikazzjoni meta ġiet irtirata?
English: Joulferon was expected to be used to treat adults with long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus).
Maltese: Joulferon kien mistenni li jintuża għall-kura ta' adulti bl-epatite Ċ li tkun għal terminu ta' żmien twil (marda tal-fwied minħabba infezzjoni bil-virus tal-epatite Ċ).
English: The albinterferon alfa-2b in Joulferon is produced by a method known as ‘recombinant DNA technology': it is made by a yeast that has received a gene (DNA), which makes it able to produce albinterferon alfa2b.
Maltese: L-albinterferon alfa-2b f'Joulferon huwa magħmul b'metodu magħruf bħala ‘teknoloġija ta' DNA rikombinanti':
English: This means that the CHMP was still evaluating the initial documentation provided by the company.
Maltese: Dan ifisser li s-CHMP kien għadu qed jevalwa ddokumentazzjoni inizjali provduta mill-kumpanija.
English: As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations.
Maltese: Peress li s-CHMP kien qed jevalwa d-dokumentazzjoni inizjali pprovduta mill-kumpanija, kien għadu ma għamilx rakkomandazzjonijiet.
English: Joulferon is a powder and solvent to be made up into a solution for injection.
Maltese: Joulferon huwa trab u solvent li jitħaltu biex isiru soluzzjoni għall-injezzjoni.
English: Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Maltese: Linterferoni huma sustanzi naturali prodotti mill-ġisem biex jiġġieldu kontra attakki bħal infezzjonijiet ikkawżati minn virusijiet.
English: The company informed the CHMP that the withdrawal has no impact on ongoing clinical trials, and that it will continue to make Joulferon available to patients enrolled in these trials.
Maltese: Il-kumpanija informat lis-CHMP li l-irtirar ma għandu l-ebda impatt fuq provi kliniċi li qed isiru, u li se tkompli tħalli Joulferon disponibbli għal pazjenti reklutati f'dawn il-provi.
English: Attaching the interferon to albumin helps to prolong its action against the hepatitis C virus after each injection.
Maltese: Ittagħqid ta' interferon mal-albumina jgħin biex itawwal l-azzjoni tagħha kontra l-virus tal-epatite Ċ wara kull injezzjoni.
English: ATCvet code: QG03XA91.
Maltese: QG03XA91.
English: Avoid introduction of contamination.
Maltese: Evita lkontaminazzjoni.
English: Date of last renewal: 10/04/2014
Maltese: Data tal-aħħar tiġdid: 10/04/2014
English: Excipient: Chlorocresol
Maltese: Ingredjent ieħor: Chlorocresol
English: Synthetic GnRF peptide analogue: Auspep Clinical Peptides PTY Ltd. 15, Mareno Road, Tullamarine, 3052 Victoria
Maltese: Peptajd Sintetiku GnRF Auspep Clinical Peptides PTY Ltd. 15, Mareno Road, Tullamarine, 3052 Victoria AWSTRALJA
English: 1348 Louvain-la-Neuve BELGIUM
Maltese: 1348 Louvain-la-Neuve IL-BELĠJU
English: Diethylaminoethyl (DEAE)-Dextran, an aqueous, non-mineral oil-based adjuvant
Maltese: Diethylaminoethyl (DEAE)-Dextran, sustanza akweja miżjuda, b'bażi ta' żejt mhux minerali
English: Pharmacotherapeutic group: Gonadotropin releasing factor analogue, conjugated.
Maltese: Gonadotropin releasing factor analogue, konjugat.
English: Outer packaging:
Maltese: Ippakkjar immedjat:
English: Polyethylene (HDPE) bottle of, 100 ml (50 doses) or 250 ml (125 doses) sealed with a rubber closure and secured with an aluminium cap.
Maltese: Flixkun tal-poli-etilin (HDPE) ta' 100 ml (50 doża) jew 250 ml (125 doża) issiġillat b'għeluq talgomma u miżmum b'tapp tal-aluminjum.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/05/ 2009
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 11 Mejju 2009
English: PACKAGE SIZE 1 x 100 ml
Maltese: DAQS TAL-PAKKETT 1 x 100 ml
English: Reduction of androstenone and skatole levels has been demonstrated from 4 to 6 weeks post second vaccination.
Maltese: Tnaqqis fil-livelli ta' androstenone u skatole dehru minn 4 sa 6 ġimgħat wara t-tieni tilqima.
English: The active substance, being a principle of biological origin intended to produce active immunity, is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bijoloġiku maħsuba sabiex tipproduċi immunità attiva ma taqgħax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: − very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: − rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tas-Sommarju tal-karatteristiċi tal-prodott huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fittabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma ikunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: Polyethylene bottle of 100 ml (50 doses) or 250 ml (125 doses) sealed with a rubber closure and secured with an aluminium cap.
Maltese: Flixkun tal-poli-etilin ta' 100 ml (50 doża) jew 250 ml (125 doża) issiġillat b'għeluq tal-gomma u miżmum b'tapp tal-aluminjum.
English: Immunisation with Improvac induces an immune response against endogenous gonadotrophin releasing factor (GnRF), a factor that controls testicular function via the gonadotropic hormones LH and FSH.
Maltese: It-tilqim b'Improvac iwassal għal rispons immunoloġiku kontra ‘gonadotrophin releasing factor' (GnRF) tal-ġisem, sustanza li tikkontrolla l-funzjoni testikulari permezz tal-ormoni gonadotrofiċi LH u FSH.
English: The patient should be advised not to administer Improvac and/or any other veterinary medicinal products with similar action in the future.
Maltese: Il-pazjent għandu jiġi mwissi biex ma jerġax jamministra Improvac u/jew prodotti mediċinali veterinarji b'azzjoni simili fil-futur.
English: 6.1 List of excipient(s)
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti
English: BELGIUM
Maltese: Zoetis Belgium SA
English: (a synthetic peptide analogue of GnRF conjugated to diphtheria toxoid) Adjuvant:
Maltese: (peptajd sintetiku jixbah lil GnRF ikkonjugat mat-toksojd tad-difterja)
English: − uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Maltese: − mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal)
English: In very rare cases anaphylactoid type reactions (dyspnoea, collapse, cyanosis and hypersalivation associated with or without muscle twitching or emesis) have been observed within a few minutes after the first vaccination with a duration of up to 30 minutes.
Maltese: F'każijiet rari ħafna reazzjonijiet ta' tip anafilattojdi (dispnea, kollass, sijanosi u tbeżliq eċċessiv assoċjati ma ' jew mingħajr tibrim muskoli jew rimettar) kienu osservati fi ftit minuti wara l-ewwel tilqima li ttul sa 30 minuta.
English: DEAE-Dextran Chlorocresol Urea
Maltese: DEAE-Dextran
English: GnRF analogue-protein conjugate: Zoetis Belgium SA Rue Laid Burniat 1
Maltese: Konjugat GnRF - TD Zoetis Belgium SA
English: Clinically meaningful suppression of gonadal function should be managed with supportive endocrine replacement therapy until normal function returns.
Maltese: Tnaqqis kliniku importanti tal-funzjoni tal-organi sesswali għandu jiġi mmaniġjat bl-għajnuna ta' endocrine replacement therapy sakemm il-funzjoni terġa' lura għan-normal.
English: CONTRAINDICATIONS Do not use in female pigs.
Maltese: KONTRAINDIKAZZJONIJIET Tużax fi ħnieżer nisa.
English: A gradual resolution of the local reactions occurs, but in 20-30% of the animals these may persist for more than 42 days.
Maltese: Ir-reazzjonijiet lokali jitilqu bil-mod imma f'20-30% tal-annimali dawn jistgħu jdumu sa aktar minn 42 ġurnata.
English: Aggressive and sexual (mounting) behaviours are also reduced.
Maltese: Imġieba aggressiva u sesswali (irkib) huma wkoll imnaqqsa..
English: Cardboard box with 10 bottles of 100 ml.
Maltese: Pakkett tal-kartun b'10 fliexken ta' 100 ml.
English: Cardboard box with 4 bottles of 250 ml.
Maltese: Pakkett tal-kartun b'4 fliexken ta' 250 ml.
English: Induction of antibodies against GnRF to produce a temporary immunological suppression of testicular function.
Maltese: Biex jistimula l-antikorpi kontra l-GnRF u jwassal għal tnaqqis immunoloġiku temporanju fil-funzjoni tat-testikoli.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, 1 x 100 ml and 1 x 250 ml HDPE bottles
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxex tal-kartun, 1 x 100 ml u 1 x 250 ml fliexken HDPE
English: − rare (more than 1 but less than 10 animals in 10,000 animals treated)
Maltese: − rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal)
English: Diphtheria toxoid:
Maltese: Tiffriżax.
English: The patient should be advised not to administer Improvac and/or any other product with similar action in the future.
Maltese: Il-pazjent għandu jiġi mwissi biex ma jerġax jamministra Improvac u/jew prodotti b'azzjoni simili fil-futur.
English: Entire male pigs from 8 weeks of age onwards should be vaccinated with 2 doses of 2 ml at least 4 weeks apart, with the second dose normally given 4 to 6 weeks prior to slaughter.
Maltese: Ħnieżer irġiel mhux imsewwija minn età ta' 8 ġimgħat 'il fuq għandhom jitlaqqmu b'żewġ dożi ta' 2 ml b'tal-anqas 4 ġimgħat minn xulxin, bit-tieni tilqima normalment tingħata 4 sa 6 ġimgħat qabel ilqatla.
English: Cardboard box with 1 bottle of 250 ml.
Maltese: Pakkett tal-kartun bi flixkun 1 ta' 250 ml.
English: Advice to the physician:
Maltese: Kodici ATC veterinarja:
English: In case of skin contact, wash immediately with soap and water.
Maltese: aħsel fil-pront bis-sapun u bl-ilma.
English: As a guide, use a short needle to give 12 to 15 mm penetration.
Maltese: Bħala gwida uża labra qasira li tippenetra minn 12 sa 15mm.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Once dose (2 ml) contains:
Maltese: DIKJARAZZJONI TAS-SUSTANZI ATTIVI Doża waħda (2 ml) fiha:
English: When administered to older pigs (14-23 weeks of age) injection site swellings ranging from 2 cm to 5 cm in diameter are commonly observed, and injection site reactions at slaughter are commonly observed if the second vaccination is given only 4 weeks before slaughter.
Maltese: Meta jingħata lil ħnieżer ta' età akbar (14-23 ġimgħa), nefħiet fil-post tal-injezzjoni, li jvarjaw minn 2 sa 5 cm fid-diametru jidhru ta' spiss, u jekk l-annimali jinqatlu erba' ġimgħt wara t-tieni tilqima rreazzjonijiet fil-post tal-injezzjoni spiss ikunu jidhru.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Improvac solution for injection for pigs
Maltese: VETERINARJU Improvac soluzzjoni għal injezzjoni għal ħnieżer
English: A transient increase in rectal temperature (post-vaccination hyperthermia) of around 0.5 °C is very commonly observed during the 24-hours period post vaccination.
Maltese: Tista' tiġi osservata żieda li tgħaddi ta' 0.5 ºC fit-temperatura tar-rektum (ipertermija ta' wara t-tilqim) fil-perjodu ta' 24 siegħa wara t-tilqima.
English: Administration of a double dose of Improvac (4 ml) to 8 week old piglets very commonly resulted in palpable injection site reactions.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn Amministrazzjoni ta' doża doppja ta' Improvac (4 ml) lil qżieqeż ta' 8 ġimgħat spiss wasslet għal reazzjoni palpabbli fil-post tal-injezzjoni.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, 10 x 100 ml and 4 x 250 ml HDPE bottles
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxex tal-kartun, fliexken HDPE 10x100 ml u 4x250 ml
English: When administered to pigs at the youngest recommended age (8 weeks), injection site swellings of up to 4 x 8 cm are very commonly observed.
Maltese: Nefħiet sa 4x8 cm fil-post tal-injezzjoni dehru ta' spiss meta ingħatat lil ħnieżer tal-iżgħar età rakkomandata (8 ġimgħat).
English: Male pigs (from 8 weeks of age).
Maltese: Ħnieżer irġiel (minn età ta' 8 ġimgħat)
English: AUSTRALIA
Maltese: Xejn
English: For use as an alternative to physical castration for the reduction of boar taint caused by the key boar taint compound androstenone, in entire male pigs following the onset of puberty.
Maltese: Kwalunkwe prodott mediċinali veterinarju li ma ġiex użat jew materjal għar-rimi li huwa derivat minn dan il-prodott mediċinali veterinarju għandhom jintremew skont kif jitolbu r-regolamenti tal-pajjiż.
English: Disposal: read package leaflet.
Maltese: Mhux id-daqs tal-pakketti kollha jistgħu qegħdin fis-suq.
English: Cardboard box with 1 bottle of 100 ml.
Maltese: Pakkett tal-kartun bi flixkun 1 ta' 100 ml.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (2 ml) contains:
Maltese: (2 ml) fiha:
English: The largest reactions were seen around 7 days post administration when the maximum size was 13 x 7 cm. By two weeks post administration the maximum size had decreased to 8 x 4 cm, showing a gradual resolution of the local reactions.
Maltese: Sa ġimagħtejn wara l-amministrazzjoni l-akbar daqs kien niżel għal 8 x 4 cm, li turi li reazzjonijiet lokali jmorru bil-mod. Ġiet osservata żieda li tgħaddi ta' 0.2 sa 1.7 ºC fit-temperatura tal-ġisem fl-24 siegħa ta' wara l-amministrazzjoni, li ġiet għan-normal wara jumejn.
English: To avoid intramuscular deposition and lesions, it is recommended to use a shorter needle to give 5 mm to 9 mm penetration in undersized pigs and pigs younger than 16 weeks of age.
Maltese: Biex tevita depositu fil-muskolu u leżjonijiet huwa rakkomandat li tintuża labra iqsar biex tippenetra 5 sa 9 mm fi qżieqeż ta' piż baxx u qżieqeż iżgħar minn 16-il ġimgħa.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: Terġax tuża l-prodott mediċinali veterinarju fil-futur.
English: If pain persists for more than 12 hours after medical examination, seek medical advice again.
Maltese: Jekk l-uġigħ jippersisti għal 12-il siegħa wara l-vista medika, erġa' ħu parir mediku.
English: Do not mix with any other veterinary medicinal product.
Maltese: Tħallatx ma' prodotti mediċinali veterinarji oħra.
English: Another key contributor to boar taint, skatole, may also be reduced as an indirect effect.
Maltese: Skatole, sustanza prinċipali oħra, tista' tiġi mnaqqsa wkoll b'effett indirett.
English: Gonadotropin releasing factor (GnRF) analogue-protein conjugate min. 300 µg.
Maltese: Proteina konjugata tixbah lil Gonadotropin releasing factor (GnRF)
English: This leads to reduced production and concentration of testosterone and other testicular steroids, including androstenone, one of the main substances responsible for boar taint.
Maltese: L-effetti tat-tilqima ġejjin minn tnaqqis tal-funzjoni testikolari kkawżata minn tnaqqis fl-attività ta' GnRF. Dan iwassal għal tnaqqis fil-produzzjoni u l-konċentrazzjoni ta' testosterone u sterojdi testikulari oħrajn, inkluż androstenone, wieħed mis-sustanzi prinċipali responsabbli għar-riħa / togħma avversa assoċjati mal-faħal.
English: Special care should be taken to avoid accidental self-injection and needle stick injury when administering the veterinary medicinal product.
Maltese: Għandha tingħata attenzjoni speċjali biex tiġi evitata injezzjoni aċċidentali fuqek innifsek u ħsara minn titqib mil-labra waqt li qed jingħata l-prodott mediċinali veterinarju.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/095/005 - 100 ml
Maltese: EU/2/09/095/005 - 100ml
English: Boars given an initial dose of Improvac are immunologically primed but retain their full testicular function until they receive the second dose, which induces a strong immune response to GnRF and causes temporary immunological suppression of testicular function.
Maltese: INDIKAZZJONI (JIET) Biex jistimula l-antikorpi kontra l-GnRF u jwassal għal tnaqqis immunoloġiku temporanju fil-funzjoni tat-testikoli.
English: PACKAGE SIZE 10 x 100 ml 4 x 250 ml
Maltese: 4 x 250 ml
English: Read the package leaflet before use.
Maltese: Mhux id-daqsijiet kolha tal-pakketti jistgħu qegħdin fis-suq.
English: STATEMENT OF ACTIVE SUBSTANCES GnRF analogue-protein conjugate min. 300 µg/2 ml
Maltese: Żmien kemm idum tajjeb l-prodott mediċinali veterinarju kif wara li jkun infetaħ l-ewwel darba: 28 ġurnata f'2-8 °C.
English: This directly controls the production of androstenone and, by removing the inhibitory effect of testicular steroids on hepatic metabolism, indirectly reduces levels of skatole.
Maltese: Dan jikkontrolla b'mod dirett il-produzzjoni ta' androstenone u billi jitneħħa l-effett inibitorju tal-isterojdi testikolari fuq il-metaboliżmu tal-fwied, b'mod indirett jitnaqqsu l-livelli ta' skatole.
English: Improvac has been shown to be safe in male pigs from 8 weeks of age onwards.
Maltese: Ġie muri li Improvac huwa bla periklu fi ħnieżer irġiel ta' età minn 8 ġimgħat 'il fuq.
English: EXPIRY DATE EXP {month/year} Once broached, use by ...
Maltese: PROJBIZZJONI TA' BEJGĦ, PROVISTA, U/JEW UŻU
English: Ref. EMEA/4193/2008
Maltese: EMEA/90158/2008
English: London, 24 January 2008 Doc.
Maltese: Londra, 24 ta' Jannar 2008 Dok. Ref.