FrancophonIA/ELRC3.0 huggingface dataset:
English: The possible contribution of fluid retention to weight gain should be individually assessed as rapid and excessive weight gain has been reported very rarely as a sign of fluid retention.
Maltese: Il-kontribuzzjoni possibbli tar-retenzjoni ta' fluwidu għal żjieda fil-piż għandha tiġi valutata individwalment billi żjieda ta' malajr u eċċessiva ta' piż ġiet rappurtata rari ħafna bħala sinjal ta' retenzjoni ta' fluwidu.
English: Red-brown film-coated tablets debossed with “GSK” on one side and "8" on the other side.
Maltese: Pilloli roża miksija b'rita li għandhom il-marka “GSK” imħaffra fuq naħa waħda u “8” fuq in-naħa loħra.
English: For dose-related adverse reactions the frequency category reflects the higher dose of rosiglitazone.
Maltese: Għar-reazzjonijiet mhux mixtieqa relatati mad-doża lkategorija ta' frekwenza tirrifletti l-ogħla doża ta'r-rosiglitazone.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha rosiglitazone maleate li jikkorrispondi għal 4 mg rosiglitazone
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 4 mg tablets rosiglitazone
Maltese: AVANDIA 4 mg pilloli rosiglitazone
English: 56, 112, 168 or 180 film-coated tablets or 56 film-coated tablets, unit dose pack.
Maltese: Il-pilloli issibhom f'pakki blister li fihom 56, 112, 168 jew 180 pillola miksijin b'rita jew 56 pillola miksijin b'rita f'pakkett b'doża unita.
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 8 mg tablets rosiglitazone
Maltese: AVANDIA 8 mg pilloli rosiglitazone
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 2 mg tablets rosiglitazone
Maltese: AVANDIA 2 mg pilloli rosiglitazone
English: Preclinical data
Maltese: U KWANTITATTIVA
English: 4.6 Pregnancy and lactation
Maltese: 4.6 Tqala u Treddiegħ
English: The Marketing Authorisation Holder (MAH) must ensure that the system of pharmacovigilance, as described in version 7.2 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jassigura li s-sistema ta' farmakoviġilanza, kif deskritta f'verżjoni 7.2 ippreżentata fil-Module 1.8.1 ta' l-Applikazzjoni għatTqegħid fis-Suq hija f'postha u tiffunzjona qabel u waqt li l-prodott ikun fis-suq.
English: The maximum dose is 8 mg of Avandia a day.
Maltese: Id-doża massima hija ta' 8mg ta' Avandia kuljum.
English: 7, 28, 56, 84, 90 or 112 film-coated tablets or 56 film-coated tablets, unit dose pack.
Maltese: Il-pilloli issibhom f'pakki blister li fihom 7, 28, 56, 84, 90 jew 112 pillola miksijin b'rita jew 56 pillola miksijin b'rita f'pakkett b'doża unita.
English: The tablets are provided in blister packs containing 56, 112, 168 or 180 film-coated tablets or 56 film-coated tablets in a unit dose pack.
Maltese: In-natura tal-materjal tal-kontenitur u ta' dak li hemm ġo fih Pakketti b'folji blister opaki (PVC/ aluminju). 56, 112, 168 jew 180 pilloli miksijin b'rita jew 56 pillola miksijin b'rita, pakkett ta' dożi individwali
English: Low blood sugar (hypoglycaemia): If you are taking Avandia with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level.
Maltese: Zokkor baxx fid-demm (ipogliċemija) : Jekk qed tieħu Avandia ma' mediċini oħra għad-dijabete, huwa aktar possibli li z-zokkor fid-demm tiegħek jinżel taħt il-livell normali.
English: If ALT levels are increased to >3X upper limit of normal during rosiglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Maltese: Jekk il-livelli ta' l-ALT jiżdiedu għal >3 darbiet il-limitu ta' fuq tan-normal waqt terapija b'rosiglitazone, il-livelli ta' l-enzimi tal-fwied għandhom jiġu rivalutati mill-aktar fis possibbli.
English: − Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: - F'60 ġurnata sa meta jrid tintlaħaq mira importanti (farmakoviġilanza jew tnaqqis ta' riskju) - Fuq talba ta' l-EMEA
English: 7, 28, 84, 90 or 112 film-coated tablets.
Maltese: Il-pilloli issibhom f'pakki blister li fihom 7, 28, 84,,90 jew 112 pillola miksijin b'rita.
English: Monitoring of liver function
Maltese: Sustanza mhux attiva
English: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Maltese: Great West Road, Brentford, Middlesex, TW8 9GS, Ir-Renju Unit.
English: Pink film-coated tablets debossed with “GSK” on one side and "2" on the other side.
Maltese: Pilloli roża miksija b'rita li għandhom il-marka “GSK” imħaffra fuq naħa waħda u “2” fuq in-naħa loħra.
English: What Avandia looks like and contents of the pack Avandia 2 mg tablets are pink and marked "GSK" on one side and "2" on the other.
Maltese: Il-pilloli ta' Avandia 2mg huma roża, mmarkati "GSK" fuq naħa u "2" fuq l-oħra.
English: Hepatobiliary disorders hepatic dysfunction, primarily evidenced by elevated hepatic enzymes5 Rare
Maltese: Mard tal-fwied u tal-marrara indeboliment tal-funzjoni tal-fwied, indikat primarjament minn għoli fl-enzimi tal-fwied 5
English: Insulin and rosiglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema and could increase the risk of ischaemic heart disease.
Maltese: L-insulina u rosiglitazone huma t-tnejn assoċjati ma' retenzjoni ta' fluwidu, meta dawn jittieħdu flimkien hemm riskju ogħla ta' edima u riskju ogħla ta' mard iskemiku tal-qalb.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Maltese: L-MAH jikkommetti li jwettaq l-istudji u attivitajiet oħra ta' farmakoviġilanza ddettaljati fil-Pjan ta' Farmakoviġilanza, kif miftiehem f'verżjoni 4 tal-Pjan għall-Immaniġġjar tar-Riskju (RMP) ippreżentat f'Module 1.8.2 ta' l-Applikazzjoni għat-Tqegħid fis-Suq u kull aġġornament ta' l-RMP li ġie wara iffissat mis-CHMP.
English: Very rare side effects These may affect up to 1 in 10,000 people:
Maltese: Effetti sekondarji rari ħafna Dawn jistgħu jaffettwaw sa 1 minn kull 10,000 persuna
English: CL/F seemed to be independent of age, but increased with weight in the paediatric population.
Maltese: CL/F dehret li donnha kienet indipendenti mill-eta' iżda żdiedet mal-piż fil-popolazzjoni pedjatrika.
English: The use of rosiglitazone in triple oral therapy, in combination with metformin and a sulphonylurea, may be associated with increased risks for fluid retention and heart failure, as well as hypoglycaemia (see section 4.8).
Maltese: L-użu ta' rosiglitazone f'terapija orali trippla, flimkien ma' metformin u sulphonylurea, jista' jkun assoċjat ma riskji ogħla ta' retenzjoni tal-fluwidu w insuffiċjenza tal-qalb, kif ukoll ipogliċemija (ara sezzjoni 4.8). Monitoraġġ aktar ta' spiss tal-pazjent huwa rrakommandat u jista' jkun hemm bżonn ta' aġġustament tad-doża ta' sulphonylurea.
English: In their entirety, the available data on the risk of cardiac ischaemia are inconclusive.
Maltese: Ma tulhom kollha, l-informazzjoni disponibbli fuq ir-riskju ta' iskemja kardijaka m'hijiex konklussiva.
English: Rosiglitazone did not stimulate pancreatic insulin secretion or induce hypoglycaemia in rats and mice.
Maltese: Huwa rakkomandat li jiżdied il-monitoraġġ tal-pazjent jekk rosiglitazone jintuża flimkien ma' metformin u l-insulina.
English: AVANDIA tablets contain lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Maltese: Pazjenti li għandhom intolleranza għal-lattożju jew bi problemi ereditarji rari ta' intolleranza għall-galattożju, in-nuqqas ta' Lapp lactase jew malassorbiment tal-lattożju-galattożju, m'għandhomx jieħdu din il-mediċina.
English: Take special care with Avandia
Maltese: QABEL MA TIEĦU AVANDIA
English: Cardiac disorders congestive heart failure/pulmonary oedema
Maltese: Pazjenti b'indeboliment tal-fwied
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone.
Maltese: Kull pillola fiha rosiglitazone maleate li jikkorrispondi għal 8 mg ta' rosiglitazone.
English: In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with a minor contribution by CYP2C9.
Maltese: Mhux mistenni li jkun hemm effetti mhux mixtieqa klinikament rilevanti b'sustrati tas-CYP2C9.
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 8 mg film-coated tablets.
Maltese: AVANDIA 8 mg pilloli miksijin b'rita.
English: Elderly (see section 4.4 Fluid retention and cardiac failure) No dose adjustment is required in the elderly.
Maltese: Pazjenti b'indeboliment renali (ara sezzjoni 4.4
English: Rosiglitazone should be used with caution during concomitant administration of CYP2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin).
Maltese: Rosiglitazone għandu jintuża b'attenzjoni waqt li jkun jittieħed flimkien ma' impedituri CYP2C8 (e.ż. gemfibrozil) jew inducers (e.ż. rifampicin) Għandu jkun hemm monitoraġġ mill-qrib tal-kontroll gliċemiku.
English: Do not use Avandia after the expiry date shown on the pack.
Maltese: Tużax Avandia wara d-data ta' skadenza li tidher fuq il-pakkett.
English: Renal insufficiency: There are no clinically significant differences in the pharmacokinetics of rosiglitazone in patients with renal impairment or end stage renal disease on chronic dialysis.
Maltese: M'hemm l-ebda differenzi klinikament sinifikanti fil-proċessi farmakokinetiċi ta' rosiglitazone f'pazjenti b'indeboliment tal-kliewi jew fl-aħħar stadju ta' mard tal-kliewi jew dijaliżi kronika.
English: PSURs
Maltese: OĦRAJN
English: Therapy with rosiglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT >2.5X upper limit of normal) or with any other evidence of liver disease.
Maltese: Terapija b'rosiglitazone m'għandhiex tinbeda f'pazjenti b'linja bażi ta' enżimi talfwied għolja (ALT >2.5 darba l-limitu ta' fuq tan-normal ) jew b'xi ħjiel ieħor ta' mard tal-fwied.
English: In studies with a maximal duration of three years, rosiglitazone given once or twice daily produced a sustained improvement in glycaemic control (FPG and HbA1c).
Maltese: Fi studji b'tul massimu ta' tlett snin, rosiglitazone mogħti darba jew darbtejn kuljum f'terapija orali doppja ma' metformin wassal għal titjib sostnut fil-kontroll gliċemiku (FPG u HbA1c).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone.
Maltese: It-terapija b'rosiglitazone ġeneralment tinbeda b'4 mg kuljum.
English: Aluminium hydroxide
Maltese: Aluminju hydroxide
English: Laboratory of Lyon Porte des Alpes Rue de l'Aviation,
Maltese: Laboratorju ta' Lyon Porte des Alpes Rue de l'Aviation,
English: Silicon antifoam Phosphate buffer Glycine buffer Aluminium hydroxide Saponin.
Maltese: Silicon antifoam Buffer ta' fosfat Buffer ta' glycine Aluminium hydroxide Saponin.
English: **Haemolytic units.
Maltese: **Unità emolitiċi
English: EU/2/10/108/001 EU/2/10/108/002 EU/2/10/108/003 EU/2/10/108/004 EU/2/10/108/005
Maltese: EU/2/10/108/001 EU/2/10/108/002 EU/2/10/108/003 EU/2/10/108/004
English: Box of 1 bottle of 10 doses (1 x 10 ml) Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml) Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml)
Maltese: Kaxxa ta' flixkun ta' 10 dożi (1 x 10 ml) Kaxxa ta' flixkun ta' 50 doża (1 x 50 ml) Kaxxa ta' 10 fliexken ta' 50 doża (10 x 50 ml) Kaxxa ta' flixkun ta' 100 doża (1 x 100 ml) Kaxxa ta' 10 fliexken ta' 100 doża (10 x 100 ml)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 2-4 suspension for injection for sheep
Maltese: VETERINARJU BTVPUR AlSap 2-4 suspensjoni għal injezzjoni
English: *Cell culture infectious dose 50% equivalent to titre prior to inactivation (log10).
Maltese: 30 UE ** *Cell culture doża infettiva 50% ekwivalenti għal titlu qabel l-inattivazzjoni (log10). **Unità emolitiċi
English: Polypropylene bottle of 50 or 100 ml with butyl elastomer closure.
Maltese: Flixkun tal-polypropylene ta' 50 jew 100 ml b'tapp tal-butyl elastomer.
English: Bluetongue virus serotype 2 antigen ............................................................................... 6.8-9.5 CCID50* Bluetongue virus serotype 4 antigen ............................................................................... 7.1-8.5 CCID50* * Cell culture infectious dose 50% equivalent to titre prior to inactivation (log10) Adjuvants:
Maltese: CCID50* Antiġen Serotip 4 tal-virus tal-Bluetongue .................................................................... 7.1-8.5 CCID50* *Cell culture doża infettiva 50% ekwivalenti għal titlu qabel l-inattivazzjoni (log10) Adjuvantijiet:
English: EU/2/10/108/003 (1 bottle of 50 ml) EU/2/10/108/004 (10 bottles of 50 ml) EU/2/10/108/001 (1 bottle of 100 ml) EU/2/10/108/002 (10 bottles of 100 ml)
Maltese: EU/2/10/108/003 (flixkun ta' 50 ml) EU/2/10/108/004 (10 fliexken ta' 50 ml) EU/2/10/108/001 (flixkun ta' 100 ml) EU/2/10/108/002 (10 fliexken ta' 100 ml)
English: PACKAGE SIZE 10 doses (10 ml)
Maltese: DAQS TAL-PAKKETT 10 dożi ( 10 ml)
English: It induces an active and specific immunity against bluetongue virus serotypes 2 and 4 in the vaccinated animals.
Maltese: Jinduċi immunità attiva u speċifika kontra i-serotipi 2 u 4 tal-virus tal-bluetongue fl-annimali imlaqqma.
English: Vaccination may be followed by a small local swelling at the injection site (at most 24 cm2) for a short period (at most 14 days).
Maltese: Wara t-tilqim jista' jkun hemm xi nefħa żgħira fil-post tal-injezzjoni (massimu ta' 24 cm perijodu qasir (massimu ta' 14-il ġurnata).
English: **Haemolytic units For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: The vaccine contains inactivated bluetongue virus serotypes 2 and 4 with aluminium hydroxide and saponin adjuvants.
Maltese: Il-vaċċin fih is-serotipi 2 u 4 tal-virus inattivat tal-bluetongue bl-adjuvantijiet aluminju hydroxide u saponin.
English: 10 bottles of 50 doses (10 x 50 ml) 100 doses (100 ml) 10 bottles of 100 doses (10 x 100 ml)
Maltese: 10 fliexken ta' 50 doża (10 x 50 ml) 100 doża (100 ml)
English: BTV2 antigen ................................................................................................................ 6.8-9.5 CCID50*, BTV4 antigen ................................................................................................................ 7.1-8.5 CCID50*, Aluminium hydroxide, Saponin, qs 1 dose *.
Maltese: BTV2 antiġen ................................................................................................................ 6.8-9.5 CCID50*, BTV4 antiġen ................................................................................................................ 7.1-8.5 CCID50*, Aluminju hydroxide, Saponin, qs doża waħda*.
English: Type I glass bottle of 10 ml with butyl elastomer closure.
Maltese: Flixkun tal-ħġieġ tat-Tip I ta' 10 ml b'tapp tal-butyl elastomer.
English: Vaccination may be followed by a small local swelling at the injection site (at most 24 cm²) for a short A transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
Maltese: Jista' jkun hemm żieda temporaneja fit-temperatura tal-ġisem, normalment ta' mhux iżjed minn medja ta' 1.1˚C, fi żmien 24 siegħa wara t-tilqim.
English: Onset of immunity has been demonstrated 3 and 5 weeks after the primary vaccination course for serotype 4 and serotype 2, respectively.
Maltese: Il-bidu ta' l-immunità ġie muri 3 u 5 ġimgħat wara l-ewwel kors ta' tilqim għas-serotip 4 u serotip 2, rispettivament.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member States may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of their territory if it is established that:
Maltese: Skond l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill kif emendat, Stat Membru jista', skond il-leġislazzjoni nazzjonali tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, il-pussess, il-bejgħ, il-forniment u/jew l-użu tal-prodotti immunoloġiċi mediċinali veterinarji fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/108/001 (1 bottle of 100 ml) EU/2/10/108/002 (10 bottles of 100 ml)
Maltese: NUMRU/I TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/10/108/001 (flixkun ta' 100 ml) EU/2/10/108/002 (10 fliexken ta' 100 ml)
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu/).
English: Any person intending to manufacture, import, possess, sell, supply and use BTVPUR AlSap 2-4 must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Maltese: Kull persuna li turi l-intenzjoni li timmanifattura, timporta, tipposjedi, tbigħ, tipprovdi u tuża BTVPUR AlSap 2-4 għandha tikkonsulta ma' l-Awtorità Kompetenti ta' l-Istat Membru dwar il-programmi ta' tilqim kurrenti qabel timmanifattura, timporta, tippossjedi, tbigħ, tipprovdi u/jew tuża.
English: Box of 10 bottles of 50 doses (10 x 50 ml).
Maltese: Kaxxa ta' 10 fliexken ta' 50 doża (10 x 50 ml).
English: Name and address of the manufacturers of the biological active substances
Maltese: Isem u indirizz tal-manufatturi tas-sustanzi bioloġiċi attivi
English: Box of 1 bottle of 50 doses (1 x 50 ml).
Maltese: Kaxxa ta' flixkun ta' 50 doża (1 x 50 ml).
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 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 kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: ATCvet code QI04AA02.
Maltese: ANNESS II A.
English: Box of 1 bottle of 100 doses (1 x 100 ml).
Maltese: Kaxxa ta' flixkun ta'100 doża (1 x 100 ml).
English: Box of 10 bottles of 100 doses (10 x 100 ml).
Maltese: Kaxxa ta' 10 fliexken ta' 100 doża (10 x 100 ml).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/108/005
Maltese: EU/2/10/108/005
English: Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest FRANCE
Maltese: Laboratorju ta' Lyon Porte des Alpes Rue de l'Aviation
English: No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double-dose of the vaccine.
Maltese: L-ebda effett mhux mixtieq ħlief dawk imsemmija f'sezzjoni 4.6 ma ġew osservati wara l-amministrazzjoni ta' doża doppja tal-vaċċin.
English: Pharmacotherapeutic group: inactivated bluetongue virus vaccine for sheep.
Maltese: Grupp Farmako-terapewtiku: vaċċin tal-virus inattivat tal-bluetonguegħan-nagħaġ Kodici ATĊ veterinarja Q104AA02.
English: Box of 1 bottle of 10 doses (1 x 10 ml).
Maltese: Kaxxa ta' flixkun ta' 10 dożi (1 x 10 ml).
English: In this category of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or National Competent Authorities on the current vaccination policies against bluetongue virus (BTV).
Maltese: F'din il-kategorija ta' annimali il-vaċċin għandu jintuża biss skond kif il-veterinarju responsabbli iqis il-benefiċċju / riskju talprodott u/jew skond il-kompetenti awtoritajiet nazzjonali fuq il-politika kurrenti dwar il-tilqim kontra il-virus tal-Bluetongue (BTV).
English: 30 HU**.
Maltese: CCID50*.
English: PACKAGE LEAFLET FOR: BTVPUR AlSap 2-4 suspension for injection for sheep
Maltese: FIL-PAKKETT: BTVPUR AlSap 2-4 suspensjoni għal injezzjoni għan-nagħaġ
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Maltese: Staqsi lill-kirurgu veterinarj tiegħek dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: Annual.
Maltese: D.
English: The manufacture, import, possession, sale, supply and/or use of BTVPUR AlSap 2-4 may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Maltese: Il-manifattura, l-importazzjoni, il-pussess, bejgħ, provista u / jew l-użu ta' BTVPUR AlSap 2-4 jista' jkun ipprojbit fi Stat Membru jew ġo parti mit-Territorju tiegħu skont il-leġislazzjoni.
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Maltese: Is-sustanza attiva, peress li hija kostitwent ta' oriġini bioloġika intiża biex tipproduċi immunità attiva, mhiex fl-iskop tar-Regolament tal-Kunsill (KE) 470/2009.
English: Subcutaneous use.
Maltese: Mhux applikabbli
English: *below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission.
Maltese: Immunizzazzjoni attiva ta' nagħaġ għall-prevenzjoni tal-viraemia* u għat-tnaqqis ta' sinjali kliniċi ikkawżati mis-serotipi 2 u 4 tal-virus tal-bluetongue. *(taħt il-livell ta' detekxin bil-metodu validat RT-PCR ta' 3.68 log10 RNA kopji/ml, li jindika li ma kienx hemm trasmissjoni ta' virus infettiv).
English: Bluetongue virus serotype 2 antigen .............................................................................. 6.8-9.5 CCID50*, Bluetongue virus serotype 4 antigen .............................................................................. 7.1-8.5 CCID50*, Aluminium hydroxide
Maltese: Antiġen serotip 4 tal-virus tal-Bluetongue ................................................................... 7.1 - 8.5 CCID50*.
English: BTV 2 antigen ........................................................................................................... 6.8-9.5 CCID50/ml, BTV 4 antigen ........................................................................................................... 7.1-8.5 CCID50/ml.
Maltese: BTV4 antiġen ............................................................................................................ 7.1-8.5 CCID50/ml.
English: Avoid multiple vial broaching.
Maltese: Ripetizzjoni tal-vaċċinazzjoni
English: Sheep
Maltese: VETERINARJU
English: Avoid bubble formation, as this can be irritating at the site of injection.
Maltese: Evita li jiffurmaw bżieżaq, ghax dan jista' jkun irritanti fil-post tal-injezzjoni.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZI BIOLOĠIĊI ATTIVI U L- -MANIFATTUR RESPONSABBLI
English: BTV 2 antigen ................................................................................................................... 6.8-9.5 CCID50, BTV 4 antigen .................................................................................................................... 7.1-8.5 CCID50
Maltese: CCID50, BTV 4 antiġen .................................................................................................................. 7.1-8.5 CCID50