FrancophonIA/ELRC3.0 huggingface dataset:
English: Very stressful events, inappetance, concomitant treatment with gestagens and corticosteroids or other concomitant diseases (e.g. gastro-intestinal, infectious or inflammatory or endocrine diseases), might influence insulin effectiveness and therefore the insulin dose may need to be adjusted.
Maltese: Avvenimenti stressanti ħafna, nuqqas t'aptit, l-użu fl-istess ħin b'gestagens u kortikosterojdi jew mard ieħor fl-istess ħin (eż. gastro-intestinali, mard infettiv jew infjammatorju jew mard endokrinali), jista' jinfluwenza l-effettività tal-insulina u għalhekk id-doża tal-insulina jista' jkollha bżonn tiġi aġġustata.
English: Pregnancy and lactation:
Maltese: Inkompatibilitajiet maġġuri:
English: Use only according to the benefit-risk assessment by the responsible veterinarian.
Maltese: Uża biss skont il-valutazzjoni tal-beneficcju u r-riskju mill-veterinarju responsabbli.
English: Under clinical field conditions in diabetic dogs, time to maximal effect in lowering blood glucose concentrations (i.e. blood glucose nadir) after subcutaneous administration was not observed within 9 hours after last injection in 67.9% of dogs overall.
Maltese: Taħt kundizzjonijiet fil-post kliniku fi klieb dijabetiċi, iż-żmien għal effett massimu fuq it-tnaqqis talkonċentrazzjonijiet tal-glucose fid-demm (jiġifieri l-iżjed ammont baxx ta' glucose fid-demm) wara għoti taħt il-ġilda ma ġiex osservat fi żmien 9 sigħat wara l-aħħar injezzjoni f'67.9 % tal-klieb globali.
English: Clinical signs may include hunger, increasing anxiety, unstable locomotion, muscle twitching, stumbling or sinking in the rear legs and disorientation.
Maltese: Sinjali kliniċi jistgħu jinkludu sinjali ta' ġuħ, ansjetà, moviment instabbli, kontrazzjonijiet tal-muskoli, li lkelb jitfixkel jew jogħtor fuq saqajh ta' wara, u diżorjentament.
English: Do not use for the acute management of diabetic ketoacidosis.
Maltese: Tużax għal immaniġġjar akut ta' ketoaċidożi dijabetika.
English: In an experimental study in healthy dogs, the time to blood glucose nadir after a single subcutaneous injection of 0.8 or 0.5 IU/kg bodyweight of the product was variable between dogs (range 3 to >24 hours), as was the duration of insulin action (range 12 to >24 hours).
Maltese: L-aġġustamenti fid-doża tal-insulina fuq kors ta' darba kuljum, jekk meħtieġa, ġeneralment għandhom isiru b'mod konservattiv u gradwali, (eż. sa żieda/tnaqqis ta' 25% tad-doża kull injezzjoni).
English: Under clinical field conditions in diabetic cats the maximal action on blood glucose concentrations (e.g. blood glucose nadir) after subcutaneous administration was observed at a mean of 6 hours (range 3 to 9 hours).
Maltese: Taħt kundizzjonijiet kliniċi fil-kamp fi qtates dijabetiċi, l-azzjoni massima fuq il-konċentrazzjonijiet tal-glucose fid-demm (eż. l-ammont minimu ta' glucose fid-demm) wara l-għoti taħt il-ġilda, ġiet osservata f'medja ta' 6 sigħat (medda minn 3 sa 9 sigħat).
English: ProZinc 40 IU/ml suspension for injection for dogs
Maltese: VETERINARJU ProZinc 40 IU/ml suspensjoni għal injezzjoni għal klieb
English: The insulin dose may need to be adjusted or discontinued in case of remission of the diabetic state in cats or after resolution of transient diabetic stages in dogs (e.g. dioestrus-induced diabetes mellitus, diabetes mellitus secondary to hyperadrenocorticism).
Maltese: Id-doża tal-insulina jista' jkollha bżonn tiġi aġġustata jew imwaqqfa wara riżoluzzjoni ta' stadji transitorji dijabetiċi fil-klieb (eż. dijabete mellitus dioestrus indotta, dijabete mellitus sekondarja għalliperadrenokortiċiżmu).
English: Name and address of the manufacturers responsible for batch release Boehringer Ingelheim Vetmedica GmbH Binger Strasse 173
Maltese: Isem u indirizz tal-manifatturi responsabbli mill-ħruġ tal-lott Boehringer Ingelheim Vetmedica GmbH Binger Strasse 173 55216
English: After subcutaneous injection, proteolytic tissue enzymes degrade protamine to permit the absorption of insulin.
Maltese: Wara injezzjoni taħt ilġilda, l-enzimi tat-tessut proteolitiku jiddegradaw il-protamine biex jippermettu l-assorbiment talinsulina.
English: Initiation
Maltese: KARATTERISTIĊI
English: ProZinc 40 IU/ml injection for dogs insulin human as protamine zinc insulin
Maltese: ProZinc 40 IU/ml għal injezzjoni għal klieb Insulina umana bħala insulina bi protamine zinc.
English: In an experimental study in healthy dogs, median time to blood glucose nadir was approximately 16 and 12 hours following administration of 0.5 or 0.8 IU/kg bodyweight, respectively.
Maltese: Fi studju esperimentali fi klieb f'saħħithom, iż-żmien medju għall-iżjed ammont baxx ta' glucose fiddemm kien madwar 16 u 12-il siegħa wara l-għoti ta' 0.5 jew 0.8
English: Special precautions for use in animals The insulin dose may need to be adjusted or discontinued in case of remission of the diabetic state in cats or after resolution of transient diabetic stages in dogs (e.g. dioestrus-induced diabetes mellitus, diabetes mellitus secondary to hyperadrenocorticism).
Maltese: Id-doża tal-insulina jista' jkollha bżonn tiġi aġġustata jew imwaqqfa wara riżoluzzjoni ta' stadji transitorji dijabetiċi fil-klieb (eż. dijabete mellitus dioestrus indotta, dijabete mellitus sekondarja sa iperadrenokortiċiżmu).
English: Blood parameters such as fructosamine, maximum blood glucose and decrease of blood glucose concentrations in blood glucose curves conducted over a sufficient period of time to determine a blood glucose nadir should be used as supporting tools (see also section “Special precautions for use in dogs”).
Maltese: Il-parametri tad-demm bħal fructosamine, glucose massimu fid-demm u tnaqqis ta' konċentrazzjonijiet tal-gluscose fid-demm fil-kurvi tal-glucose fid-demm) li jsiru matul perjodu ta' żmien biżżejjed biex jiġi ddeterminat l-iżjed ammont baxx ta' glucose fiddemm għandhom jintużaw bħala għodod ta' appoġġ (ara wkoll s-sezzjoni “Prekawzjonijiet speċjali għall-użu fil-klieb”).
English: Similarly, feeding cats with a high protein/low carbohydrate diet and changing the diet of any given cat or dog may alter insulin requirements and necessitate a change of insulin dose.
Maltese: Bl-istess mod, li tagħti qattus dieta b'livell għoli ta' proteini/livell baxx ta' karboidrati u tinbdel d-dieta ta' kwalunkwe qattus jew kelb jista' jibdel ilħtiġijiet tal-insulina jista' jibdel id-doża tal-insulina.
English: Not applicable.
Maltese: Immaniġġjar
English: STATEMENT OF ACTIVE SUBSTANCES
Maltese: Sustanza Attiva:
English: Re-evaluation of clinical signs and laboratory parameters should be performed as recommended by the attending veterinarian.
Maltese: L-evalwazzjoni mill-ġdid tas-sinjali kliniċi u l-parametri tal-laboraturju hi rrakkomandata.
English: ProZinc 40 IU/ml suspension for injection for cats and dogs insulin human as protamine zinc insulin
Maltese: VETERINARJU ProZinc 40 IU/ml suspensjoni għall-injezzjoni għal qtates u klieb Insulina umana bħala insulina bi protamine zinc.
English: Once absorbed from the subcutaneous site, insulin will enter the circulation and diffuse into tissues, where it binds to insulin receptors found on most tissues.
Maltese: Bl-istess mod, li tinbidel d-dieta jista' jibdel ilħtiġijiet tal-insulina u teħtieġ li tinbidel id-doża tal-insulina.
English: In general, insulin requirements during pregnancy and lactation might be different due to a change in the metabolic state.
Maltese: B'mod ġenerali, il-ħtiġijiet tal-insulina waqt it-tqala u t-treddigħ jistgħu jkunu differenti minħabba t-tibdil fl-istat metaboliku.
English: Suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għal injezzjoni.
English: - Adjustments of insulin dose if required should usually be done between 0.5 to 1 IU insulin per injection.
Maltese: - Aġġustamenti tad-doża tal-insulina jekk meħtieġa normalment għandhom isiru bejn 0.5 sa 1 IU
English: Each ml contains:
Maltese: Twissijiet speċjali għal kull speċi għal xiex huwa ndikat:
English: Blood parameters such as fructosamine, maximum blood glucose and decrease of blood glucose concentrations in blood glucose curves conducted over a sufficient period of time to determine a blood glucose nadir should be used as supporting tools (see also section “Special precautions for use in animals”).
Maltese: Il-parametri tad-demm bħal fructosamine, glucose massimu fid-demm u tnaqqis ta' konċentrazzjonijiet tal-gluscose fid-demm fil-kurvi tal-glucose fid-demm) li jsiru matul perjodu ta' żmien biżżejjed biex jiġi ddeterminat l-iżjed ammont baxx ta' glucose fid demm għandhom jintużaw bħala għodod ta' appoġġ (ara wkoll s-sezzjoni “Prekawzjonijiet speċjaligħall-użu fil-klieb”).
English: Treatment with insulin can cause hypoglycaemia, for clinical signs and appropriate treatment, please refer to section “Overdose”, below.
Maltese: Għal sinjali kliniċi u kura adattata, jekk jogħġbok irreferi għas-sezzjoni “Doża eċċessiva”, hawn taħt.
English: Insulin activates insulin receptors and therewith a complex cell signaling cascade which results in increased glucose uptake into the cells.
Maltese: L-effetti ewlenin tal-insulina huma t-tnaqqis fil-konċentrazzjonijiet tal-glucose li jkun jiċċirkola fid-demm u l-ħażna ta' xaħam.
English: Treatment with insulin can cause hypoglycaemia, for clinical signs and appropriate treatment, see section
Maltese: Għal sinjali kliniċi u kura adattata,ara sezzjoni 4.10.
English: Pharmacotherapeutic group: Insulins and analogues for injection, intermediate acting.
Maltese: Insulini u analogi għall-injezzjoni, li jaġixxu b'mod intermedju.
English: Avoid introduction of contamination.
Maltese: Evita` l-introduzzjoni ta'kontaminazzjoni.
English: ATCvet code: QI09AB04.
Maltese: Kodiċi veterinarja ATC QI09AB04.
English: The Netherlands
Maltese: L- OLANDA
English: Date of last renewal: 17 September 2010
Maltese: Data ta' l-aħħar reviżżjoni: 17 September 2010
English: ≥6.2 log2 TN titre1
Maltese: > 6.2Log2 TN tajter
English: Can be used during pregnancy (see details under section 4.9).
Maltese: Jista' jintuża waqt it-tqala(ara d-dettalji taħt sezzjoni 4.9).
English: Sodium chloride Phosphate buffer Simethicone Polysorbate 80
Maltese: Kloridu tas-sodjum Buffer tal-fosfat Simetikown Polysorbejt 80
English: 50 ml (25 doses)
Maltese: 50 ml (25 dożi)
English: 150 mg dl-α-tocopherol acetate
Maltese: 150 mg ta' dl-alpha - tocopherol acetate
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Maltese: Intervet International B.V Wim de Korverstraat 35 5831 AN Boxmeer L-Olanda
English: PACKAGE SIZE 100 ml (50 doses) 250 ml (125 doses)
Maltese: 4. DAQS TAL-PAKKETT 100ml (50 doża) 250ml (125 dożi)
English: titre inactivated B. bronchiseptica cells dl-α-tocopherol acetate
Maltese: Ċelloli inattivati ta' Bordatella bronchiseptica dl-alpha - tocopherol acetate
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) No 470/2009.
Maltese: Peress illi s-sustanza attiva hija ta'oriġini bijoloġika u ntenzjonata biex tipproduċi immunita attiva , ma taqax taħt ir-Regoalment tal-Kunsill (KE) Nru 470/2009.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis AR-T DF
Maltese: Porcilis AR-T DF
English: Pharmacotherapeutic group: inactivated bacterial vaccine.
Maltese: Vaċċin magħmul minn bakterja inattivata.
English: DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 November 2000
Maltese: Data tal-ewwel awtorizzazjoni : 16 ta' Novembru 2000
English: The vaccine contains a non-toxic recombinant derivative of the Pasteurella multocida toxin and inactivated Bordetella bronchiseptica cells.
Maltese: Il- vaċċin fih derivattiv rikombinant mhux tossiku tal- velenu tal-Pasteurella multocida u ċelloli inattivati talBordetella bronchiseptica.
English: - Inactivated Bordetella bronchiseptica cells
Maltese: - Ċelloli inattivati ta' Bordatella bronchiseptica
English: Vaccinate only healthy animals.
Maltese: Laqqam biss animali f'saħħithom.
English: Cardboard box containing one PET vial of 20 ml, 50 ml, 100 ml or 250 ml.
Maltese: Kaxxa tal-kartun li fiha 1 kunjett PET ta' 20ml, 50ml, 100ml jew 250ml.
English: INDICATION(S) Vaccine against progressive atrophic rhinitis.
Maltese: INDIKAZZJONI(JIET) Tilqima kontra r-rinite atrofika progressiva
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI i.m.
English: titre2
Maltese: Tajter
English: Marketing authorisation holder and manufacturer: Intervet International B.V.
Maltese: Intervet International B.V.
English: Incompatibilities Do not mix with any other veterinary medicinal products.
Maltese: Inkompatibilitajiet Tħallatx ma l-ebda prodott mediċinali veterinarju ieħor.
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen f'temperatura ta' 2Ċ - 8Ċ.
English: Active substances: - Protein dO (non-toxic deletion derivative of Pasteurella multocida dermonecrotic toxin)
Maltese: Protein dO ( derivattiv mhux tossiku minn velenu dermo-nekrotiku
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U SL-MANIFATTURA RESPONSABBLI
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' ingredjenti mhux attivi
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Wim de Korverstraat 35 5831 AN BOXMEER L- OLANDA
English: Colonisation of the surface of the nasal mucosa by Pasteurella multocida is most often promoted by Bordetella bronchiseptica.
Maltese: Il-kolonizzazzjoni tal-mukosa fl-imnifsejn mill-Pasteurella multocida huwa ħafna drabi mgħejjun minn Bordetella bronchiseptica.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 2 ml: ≥6.2 log2 TN titre Protein dO ≥5.5 log2 Aggl.
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI Għall-doża ta' 2ml: ≥ 6.2Log2 TN tajter
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA UL-MANIFATTURA RESPONSABBLI
English: Excipient: Formaldehyde
Maltese: PARIR SABIEX
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State 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 its territory if it is established that:
Maltese: Skond l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, l-Istati Membri jipprojbixxu jew jistgħu jipprojbixxu l-importazzjoni, il-bejgħ, il-forniment u/jew l-użu tal-prodott mediċinali veterinarju fit-territorju sħiħ tagħhom jew parti minnu jekk jiġi stabbilit illi:
English: Dermonecrotic toxin producing Pasteurella multocida is the pathogen responsible for turbinate atrophy in progressive atrophic rhinitis.
Maltese: Pasteurella multocida li tipproduċi velenu dermo-nekrotiku huwa l-patoġenu li responsabbli ġħallqerda ta' passaġġi fl-imnifsejn f'rinite atrofika progressiva.
English: 2 Mean agglutination titre obtained after a single vaccination of a half dose in rabbits Adjuvant: dl-α-tocopherol acetate
Maltese: 2 Tajter ta' agglutinazjoni medju wara vaċċinazjoni waħda ta' nofs doża fil-fniek Sustanzi mhux attivi: dl-alpha - tocopherol acetate
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis AR-T DF suspension for injection for pigs
Maltese: VETERINARJU Porcilis AR-T DF suspensjoni għal injezzjoni għall-majjala
English: 20 ml (10 doses) Glass vial 50 ml (25 doses) Glass vial 20 ml (10 doses) PET vial 50 ml (25 doses) PET vial 100 ml (50 doses) PET vial 250 ml (125 doses) PET vial
Maltese: Kaxxa tal-kartun li fiha 1 kunjett PET ta' 20ml, 50ml., 100ml jew 250ml
English: PHARMACEUTICAL FORM Suspension for injection
Maltese: 3. GĦAMLA FARMAĊEWTIKA Suspensjoni għal injezzjoni
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: Is-sustanzi mhux attivi msemijja f'sezzjoni 6.1 tal- KPQ huma jew sustanzi permessi li għalihom ittabella 1 tal-anness tar-Regolament tal-Kommissjoni (EU) No37/2010 tindika li m'hemmx bżonn MRLs jew huma kunsidrati li ma jaqawx taħt l-iskop tar-Regolament (EC) No 470/2009 meta użati f'dan il-prodott veterinarju mediċinali.
English: Any person intending to import, sell, supply and/or use Porcilis AR-T DF must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Maltese: Kull persuna li turi l-intenzjoni li timporta, tbiegħ, tipprovdi u/jew tuża Porcilis AR-T DF għandha tikkonsulta ma' l-Awtorità Kompetenti tal-Istat Membru dwar ilprogrammi ta' tilqim kurrenti qabel timporta, tbiegħ, tipprovdi u/jew tuża.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 2 ml: ≥6.2 log2 TN titre Protein dO (non-toxic deletion derivative of Pasteurella multocida dermonecrotic toxin) ≥5.5 log2 Aggl.
Maltese: Għall kull doża ta' 2 ml ≥ 6.2Log2 TN tajter1 Protein dO ( derivattiv mhux tossiku minn velenu dermo-nekrotiku ta' Pasteurella multocida
English: Reduced activity and lack of appetite on the day of vaccination very commonly occurs and/or a transient swelling (max diameter: 10 cm) for up to two weeks may arise at the site of injection.
Maltese: Tnaqqis fl-attivita u fl-ikel jistgħu iseħħu komunament fil-ġurnata tal-vaċċinazzjoni, u/jew xi nefħa (dijametru massimu ta' 10 ċentimetri) jistgħu iseħħu sa ġimgħatejn wara fil-post fejn ingħatat l-injezzjoni.
English: 4.6 Adverse reactions (frequency and seriousness) A mean transient increase in body temperature of 1.5 °C, in some pigs up to 3 °C, which could lead to an abortion, can generally be measured on the day of vaccination or the following day.
Maltese: Majjali trattati wrew żieda medja ta' 1.5o Ċ fit-temperatura tal-ġisem, f'xi majjali kien hemm żieda anke sa 3oĊ,li tista twassal għall-abort, fil-ġurnata tal-vaċċinazzjoni jew l-għada.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/026/001-006
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/00/026/001-006
English: titre inac.
Maltese: Xejn ġranet.
English: To stimulate active immunity in order to provide passive immunity to the progeny against progressive atrophic rhinitis.
Maltese: Il-vaċċin jistimula immunita' attiva biex imbagħad dawn jgħaddu immunita passiva liż-żgħar tagħhom kontra rinite atrofika progressiva.
English: PHARMACEUTICAL PARTICULARS
Maltese: VETERINARJU
English: For the reduction of clinical signs of progressive atrophic rhinitis in piglets by passive oral immunisation with colostrum from dams actively immunised with the vaccine.
Maltese: Għat- tnaqqis tas-sintomi kliniċi ta' rinite atrofika progressiva fil-qżieqeż permezz ta' immunita passiva orali li jieħdu meta jixorbu l-kolostrum ta' ommijiet li kienu ġew imlaqqma kontra l- marda.
English: Cardboard box containing one glass vial (Hydrolytic Type I) of 20 ml or 50 ml.
Maltese: Kaxxa tal-kartun li fiha 1 kunjett ta' 20 jew 50 millilitru, magħmul minn ħġieġ (idrolitiku tip 1).
English: Vaccination scheme:
Maltese: Grupp farmakoterapewtiku:
English: 1 Mean toxin neutralising titre obtained after repeated vaccination of a half dose in rabbits.
Maltese: 1 Tajter medju li nnewtralizza l-velenu wara vaċċinazjoni ripetuta ta' nofs doża fil-fniek.
English: Do not freeze.
Maltese: Jiskadi {xahar/sena}
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.
Maltese: U L-INDIRIZZ TAS-SID TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ Intervet International B.V.
English: B. bronchiseptica cells
Maltese: KWALITAJIET IMMUNOLOĠIĊI
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Maltese: l-għotja tal-prodott mediċinali veterinarju lill-annimali tinterferixxi ma' l-implimentazzjoni ta' programmi nazzjonali għad-djanjosi, il-kontroll u l-eradikazzjoni tal-mard tal-annimali, jew tikkawża diffikultajiet fiċ-ċertifikazzjoni tal-assenza tal-kontaminazzjoni f' annimali ħajjin jew fl-ikel jew prodotti oħrajn akkwistati minn annimali ttrattati;
English: Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/gilts.
Maltese: Mediċina veterinarja li ma ġitx użata jew prodotti oħra li ntużaw għal din il-mediċina għandhom jintremew skond kif titlob il-liġi tal-pajjiż.
English: 4.2 Indications for use, specifying the target species For the reduction of clinical signs of progressive atrophic rhinitis in piglets by passive oral immunisation with colostrum from dams actively immunised with the vaccine.
Maltese: b) il-marda li għaliha l-prodott mediċinali veterinarju huwa intiż li jagħti immunità hija ġeneralment assenti mit-territorju.
English: Revaccination: a single injection of one dose (2 ml) should be carried out 2 to 4 weeks prior to each subsequent farrowing.
Maltese: Revaċċinazzjoni : injezzjoni waħda (2ml) għandha tingħata minn 2 sa 4 ġimgħat qabel kull twelid li jiġi wara.
English: (2015/2016 season)
Maltese: (Staġun 2015/2016)
English: Placebo (N=3843)
Maltese: Plaċebo (N=3843)
English: Adults from the age of 18 years:
Maltese: Adulti minn 18-il sena:
English: EU/1/07/394/004 EU/1/07/394/005 EU/1/07/394/007 EU/1/07/394/008 EU/1/07/394/010 EU/1/07/394/011
Maltese: EU/1/07/394/007 EU/1/07/394/008 EU/1/07/394/010
English: - Fever greater than 39.0°C
Maltese: - Deni ta' aktar minn 39.0°C
English: Outer carton box will include “Blue Box”.
Maltese: Il-kaxxa tal-kartun ta' barra se tkun tinkludi “Blue Box”.
English: Vaccine Efficacy = (1 - Relative Risk) x 100 %
Maltese: Effikaċja tat-Tilqima = (1 - Riskju Relattiv) x 100%
English: 15 micrograms HA**
Maltese: 15-il mikrogramma HA**
English: A/Switzerland/9715293/2013 (H3N2) - like strain
Maltese: A/Switzerland/9715293/2013 (H3N2) - razza simili
English: Seqirus GmbH Emil-von-Behring-Strasse 76 D-35041 Marburg Germany
Maltese: Seqirus GmbH Emil-von-Behring-Strasse 76 D-35041 Marburg Il-Ġermanja
English: Table 1: Frequency in adults (18-60 years of age)
Maltese: Tabella 1: Frekwenza fl-adulti (fl-eta ta' 18-60 sena)
English: Date of latest renewal: 01 June 2012
Maltese: Data tal-aħħar tiġdid: 01 ta' Ġunju 2012
English: * propagated in Madin Darby Canine Kidney (MDCK) cells
Maltese: * ippropagati fiċ-ċelluli Madin Darby Canine Kidney (MDCK)
English: A/California/7/2009 (H1N1)pdm09 - like strain
Maltese: A/California/7/2009 (H1N1)pdm09 - razza simili
English: % Lower Limit of One-Sided 97.5% CI
Maltese: Limitu t'Isfel ta' One-Sided 97.5% CI
English: A multinational (US, Finland, and Poland), randomized, observer-blinded, placebo-controlled trial was performed to assess clinical efficacy and safety of Optaflu during the 2007-2008 influenza season in adults aged 18 to 49 years.
Maltese: Prova multinazzjonali (Stati Uniti, Finlandja, u Polonja), randomized, observer-blinded, ikkontrollata bi plaċebo, twettqet biex tiġi evalwata l-effikaċja u s-sigurtà ta' Optaflu matul l-istaġun tal-influwenza 2007-2008 f'adulti li kellhom minn 18 sa 49 sena.
English: - Angioedema
Maltese: - Anġjoedema
English: - Paraesthesia
Maltese: - Parasteżija
English: Organ class
Maltese: Klassi ta' l-organi
English: Sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Maltese: Sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate u ilma għall-injezzjonijiet.
English: In such cases, the Western blot method is negative.
Maltese: F'każijiet bħal dawn, il-metodu Western blot ikun negattiv.
English: Neuralgia, convulsion, febrile convulsion.
Maltese: Newralġja, konvulżjoni, konvulżjoni bid-deni.
English: For intramuscular use.
Maltese: Mhux applikabbli.